research of cloning humans is permitted

What are the laws about human cloning in the United States?

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Currently five states prohibit the cloning of human beings. In most states, specific exceptions are provided for the purpose of scientific research and cell-based therapies. A complete list of current state laws on cloning human.

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Cloning Fact Sheet

The term cloning describes a number of different processes that can be used to produce genetically identical copies of a biological entity. The copied material, which has the same genetic makeup as the original, is referred to as a clone. Researchers have cloned a wide range of biological materials, including genes, cells, tissues and even entire organisms, such as a sheep.

Do clones ever occur naturally?

Yes. In nature, some plants and single-celled organisms, such as bacteria , produce genetically identical offspring through a process called asexual reproduction. In asexual reproduction, a new individual is generated from a copy of a single cell from the parent organism.

Natural clones, also known as identical twins, occur in humans and other mammals. These twins are produced when a fertilized egg splits, creating two or more embryos that carry almost identical DNA . Identical twins have nearly the same genetic makeup as each other, but they are genetically different from either parent.

What are the types of artificial cloning?

There are three different types of artificial cloning: gene cloning, reproductive cloning and therapeutic cloning.

Gene cloning produces copies of genes or segments of DNA. Reproductive cloning produces copies of whole animals. Therapeutic cloning produces embryonic stem cells for experiments aimed at creating tissues to replace injured or diseased tissues.

Gene cloning, also known as DNA cloning, is a very different process from reproductive and therapeutic cloning. Reproductive and therapeutic cloning share many of the same techniques, but are done for different purposes.

What sort of cloning research is going on at NHGRI?

Gene cloning is the most common type of cloning done by researchers at NHGRI. NHGRI researchers have not cloned any mammals and NHGRI does not clone humans.

How are genes cloned?

Researchers routinely use cloning techniques to make copies of genes that they wish to study. The procedure consists of inserting a gene from one organism, often referred to as "foreign DNA," into the genetic material of a carrier called a vector. Examples of vectors include bacteria, yeast cells, viruses or plasmids, which are small DNA circles carried by bacteria. After the gene is inserted, the vector is placed in laboratory conditions that prompt it to multiply, resulting in the gene being copied many times over.

How are animals cloned?

In reproductive cloning, researchers remove a mature somatic cell , such as a skin cell, from an animal that they wish to copy. They then transfer the DNA of the donor animal's somatic cell into an egg cell, or oocyte, that has had its own DNA-containing nucleus removed.

Researchers can add the DNA from the somatic cell to the empty egg in two different ways. In the first method, they remove the DNA-containing nucleus of the somatic cell with a needle and inject it into the empty egg. In the second approach, they use an electrical current to fuse the entire somatic cell with the empty egg.

In both processes, the egg is allowed to develop into an early-stage embryo in the test-tube and then is implanted into the womb of an adult female animal.

Ultimately, the adult female gives birth to an animal that has the same genetic make up as the animal that donated the somatic cell. This young animal is referred to as a clone. Reproductive cloning may require the use of a surrogate mother to allow development of the cloned embryo, as was the case for the most famous cloned organism, Dolly the sheep.

What animals have been cloned?

Over the last 50 years, scientists have conducted cloning experiments in a wide range of animals using a variety of techniques. In 1979, researchers produced the first genetically identical mice by splitting mouse embryos in the test tube and then implanting the resulting embryos into the wombs of adult female mice. Shortly after that, researchers produced the first genetically identical cows, sheep and chickens by transferring the nucleus of a cell taken from an early embryo into an egg that had been emptied of its nucleus.

It was not until 1996, however, that researchers succeeded in cloning the first mammal from a mature (somatic) cell taken from an adult animal. After 276 attempts, Scottish researchers finally produced Dolly, the lamb from the udder cell of a 6-year-old sheep. Two years later, researchers in Japan cloned eight calves from a single cow, but only four survived.

Besides cattle and sheep, other mammals that have been cloned from somatic cells include: cat, deer, dog, horse, mule, ox, rabbit and rat. In addition, a rhesus monkey has been cloned by embryo splitting.

Have humans been cloned?

Despite several highly publicized claims, human cloning still appears to be fiction. There currently is no solid scientific evidence that anyone has cloned human embryos.

In 1998, scientists in South Korea claimed to have successfully cloned a human embryo, but said the experiment was interrupted very early when the clone was just a group of four cells. In 2002, Clonaid, part of a religious group that believes humans were created by extraterrestrials, held a news conference to announce the birth of what it claimed to be the first cloned human, a girl named Eve. However, despite repeated requests by the research community and the news media, Clonaid never provided any evidence to confirm the existence of this clone or the other 12 human clones it purportedly created.

In 2004, a group led by Woo-Suk Hwang of Seoul National University in South Korea published a paper in the journal Science in which it claimed to have created a cloned human embryo in a test tube. However, an independent scientific committee later found no proof to support the claim and, in January 2006, Science announced that Hwang's paper had been retracted.

From a technical perspective, cloning humans and other primates is more difficult than in other mammals. One reason is that two proteins essential to cell division, known as spindle proteins, are located very close to the chromosomes in primate eggs. Consequently, removal of the egg's nucleus to make room for the donor nucleus also removes the spindle proteins, interfering with cell division. In other mammals, such as cats, rabbits and mice, the two spindle proteins are spread throughout the egg. So, removal of the egg's nucleus does not result in loss of spindle proteins. In addition, some dyes and the ultraviolet light used to remove the egg's nucleus can damage the primate cell and prevent it from growing.

Do cloned animals always look identical?

No. Clones do not always look identical. Although clones share the same genetic material, the environment also plays a big role in how an organism turns out.

For example, the first cat to be cloned, named Cc, is a female calico cat that looks very different from her mother. The explanation for the difference is that the color and pattern of the coats of cats cannot be attributed exclusively to genes. A biological phenomenon involving inactivation of the X chromosome (See sex chromosome ) in every cell of the female cat (which has two X chromosomes) determines which coat color genes are switched off and which are switched on. The distribution of X inactivation, which seems to occur randomly, determines the appearance of the cat's coat.

What are the potential applications of cloned animals?

Reproductive cloning may enable researchers to make copies of animals with the potential benefits for the fields of medicine and agriculture.

For instance, the same Scottish researchers who cloned Dolly have cloned other sheep that have been genetically modified to produce milk that contains a human protein essential for blood clotting. The hope is that someday this protein can be purified from the milk and given to humans whose blood does not clot properly. Another possible use of cloned animals is for testing new drugs and treatment strategies. The great advantage of using cloned animals for drug testing is that they are all genetically identical, which means their responses to the drugs should be uniform rather than variable as seen in animals with different genetic make-ups.

After consulting with many independent scientists and experts in cloning, the U.S. Food and Drug Administration (FDA) decided in January 2008 that meat and milk from cloned animals, such as cattle, pigs and goats, are as safe as those from non-cloned animals. The FDA action means that researchers are now free to using cloning methods to make copies of animals with desirable agricultural traits, such as high milk production or lean meat. However, because cloning is still very expensive, it will likely take many years until food products from cloned animals actually appear in supermarkets.

Another application is to create clones to build populations of endangered, or possibly even extinct, species of animals. In 2001, researchers produced the first clone of an endangered species: a type of Asian ox known as a guar. Sadly, the baby guar, which had developed inside a surrogate cow mother, died just a few days after its birth. In 2003, another endangered type of ox, called the Banteg, was successfully cloned. Soon after, three African wildcats were cloned using frozen embryos as a source of DNA. Although some experts think cloning can save many species that would otherwise disappear, others argue that cloning produces a population of genetically identical individuals that lack the genetic variability necessary for species survival.

Some people also have expressed interest in having their deceased pets cloned in the hope of getting a similar animal to replace the dead one. But as shown by Cc the cloned cat, a clone may not turn out exactly like the original pet whose DNA was used to make the clone.

What are the potential drawbacks of cloning animals?

Reproductive cloning is a very inefficient technique and most cloned animal embryos cannot develop into healthy individuals. For instance, Dolly was the only clone to be born live out of a total of 277 cloned embryos. This very low efficiency, combined with safety concerns, presents a serious obstacle to the application of reproductive cloning.

Researchers have observed some adverse health effects in sheep and other mammals that have been cloned. These include an increase in birth size and a variety of defects in vital organs, such as the liver, brain and heart. Other consequences include premature aging and problems with the immune system. Another potential problem centers on the relative age of the cloned cell's chromosomes. As cells go through their normal rounds of division, the tips of the chromosomes, called telomeres, shrink. Over time, the telomeres become so short that the cell can no longer divide and, consequently, the cell dies. This is part of the natural aging process that seems to happen in all cell types. As a consequence, clones created from a cell taken from an adult might have chromosomes that are already shorter than normal, which may condemn the clones' cells to a shorter life span. Indeed, Dolly, who was cloned from the cell of a 6-year-old sheep, had chromosomes that were shorter than those of other sheep her age. Dolly died when she was six years old, about half the average sheep's 12-year lifespan.

What is therapeutic cloning?

Therapeutic cloning involves creating a cloned embryo for the sole purpose of producing embryonic stem cells with the same DNA as the donor cell. These stem cells can be used in experiments aimed at understanding disease and developing new treatments for disease. To date, there is no evidence that human embryos have been produced for therapeutic cloning.

The richest source of embryonic stem cells is tissue formed during the first five days after the egg has started to divide. At this stage of development, called the blastocyst, the embryo consists of a cluster of about 100 cells that can become any cell type. Stem cells are harvested from cloned embryos at this stage of development, resulting in destruction of the embryo while it is still in the test tube.

What are the potential applications of therapeutic cloning?

Researchers hope to use embryonic stem cells, which have the unique ability to generate virtually all types of cells in an organism, to grow healthy tissues in the laboratory that can be used replace injured or diseased tissues. In addition, it may be possible to learn more about the molecular causes of disease by studying embryonic stem cell lines from cloned embryos derived from the cells of animals or humans with different diseases. Finally, differentiated tissues derived from ES cells are excellent tools to test new therapeutic drugs.

What are the potential drawbacks of therapeutic cloning?

Many researchers think it is worthwhile to explore the use of embryonic stem cells as a path for treating human diseases. However, some experts are concerned about the striking similarities between stem cells and cancer cells. Both cell types have the ability to proliferate indefinitely and some studies show that after 60 cycles of cell division, stem cells can accumulate mutations that could lead to cancer. Therefore, the relationship between stem cells and cancer cells needs to be more clearly understood if stem cells are to be used to treat human disease.

What are some of the ethical issues related to cloning?

Gene cloning is a carefully regulated technique that is largely accepted today and used routinely in many labs worldwide. However, both reproductive and therapeutic cloning raise important ethical issues, especially as related to the potential use of these techniques in humans.

Reproductive cloning would present the potential of creating a human that is genetically identical to another person who has previously existed or who still exists. This may conflict with long-standing religious and societal values about human dignity, possibly infringing upon principles of individual freedom, identity and autonomy. However, some argue that reproductive cloning could help sterile couples fulfill their dream of parenthood. Others see human cloning as a way to avoid passing on a deleterious gene that runs in the family without having to undergo embryo screening or embryo selection.

Therapeutic cloning, while offering the potential for treating humans suffering from disease or injury, would require the destruction of human embryos in the test tube. Consequently, opponents argue that using this technique to collect embryonic stem cells is wrong, regardless of whether such cells are used to benefit sick or injured people.

Last updated: August 15, 2020

Should Human Cloning Be Allowed? No, It’s a Moral Monstrosity

Published December 5, 2001

The Wallstreet Journal

By Eric Cohen

Dr. Michael West, the lead scientist on the team that recently cloned the first human embryos, believes his mission in life is “to end suffering and death.” “For the sake of medicine,” he informs us, “we need to set our fears aside.” For the sake of health, in other words, we need to overcome our moral inhibitions against cloning and eugenics.

The human cloning announcement was not a shock. We have been “progressing” down this road for years, while averting our gaze from the destination. Now we have cloned human embryos. That means that women’s eggs were procured, their genetic material removed, the DNA from someone else inserted, and the resulting cloned embryos manufactured as genetic replicas of an existing person. In Dr. West’s experiments, the embryos died very quickly. But the hope is that someday these embryos will serve as a source of rejection-free stem cells that can help cure diseases.

For now, this is science fiction, or a rosy form of speculation. No one has ever been treated with “therapeutic cloning” or embryonic stem cells. There have been no human trials. But it is true that this research may work in the future (though the benefits would likely be decades away). In addition, beyond cloning, scientists have larger ambitions, including “tinkering” with DNA before it is placed in an egg, and adding designer genes that would make clones into “super clones,” stem cells into “super stem cells.”

Yet while Dr. West and his colleagues say that they have no interest in creating cloned humans — on the grounds that doing so is not yet safe — they do not seem too frightened by the prospect of laying the groundwork for those who would do just that. “We didn’t feel that the abuse of this technology, its potential abuses, should stop us from doing what we believe is the right thing in medicine,” Dr. West said.

The Senate, it seems, is also not very concerned. Majority Leader Tom Daschle wants to put off until spring a vote on the Human Cloning Prohibition Act, which the House passed by 265-162 in July. And on Monday, the Senate chose not to consider a six-month moratorium on all human cloning. As Sen. Harry Reid has said, a moratorium for “six months or two months or two days would impede science.” And that, he believes, we cannot do.

It is understandable that many senators want to avoid a decision on this controversial issue, and no surprise that those driven by a desire to advance science and to heal the sick at any cost resist a ban. But as the ethicist Paul Ramsey wrote, “The good things that men do can be complete only by the things they refuse to do.” And cloning is one of those things we should refuse to do.

The debate is usually divided into two issues — reproductive cloning (creating cloned human beings) and therapeutic cloning (creating cloned human embryos for research and destruction). For now, there is near-universal consensus that we should shun the first. The idea of mother-daughter twins or genetically-identical “daddy juniors” stirs horror in us. Our moral sense revolts at the prospect, because so many of our cherished principles would be violated: the principle that children should not be designed in advance; that newborns should be truly new, without the burden of a genetic identity already lived; that a society where cloning is easy (requiring a few cells from anywhere in the body) means anyone could be cloned without knowledge or consent; and that replacing lost loved ones with “copies” is an insult to the ones lost, since it denies the uniqueness and sacredness of their existence. For these reasons, Americans agree that human cloning should never happen — not merely because the procedure is not yet “safe,” but because it is wrong.

Many research advocates say that they, too, are against “reproductive cloning.” But to protect their research, they seek to restrict only the implantation of cloned embryos, not the creation of cloned embryos for research. This is untenable: Once we begin stockpiling cloned embryos for research, it will be virtually impossible to control how they are used. We would be creating a class of embryos that, by law, must be destroyed. And the only remedy for wrongfully implanting cloned embryos would be forced abortions, something neither pro-lifers nor reproductive rights advocates would tolerate, nor should.

But the cloning debate is not simply the latest act in the moral divide over abortion. It is the “opening skirmish” — as Leon Kass, the president’s bioethics czar, describes it — in deciding whether we wish to “put human nature itself on the operating table, ready for alteration, enhancement, and wholesale redesign.” Lured by the seductive promise of medical science to “end” suffering and disease, we risk not seeing the dark side of the eugenic project.

Three horrors come to mind: First, the designing of our descendents, whether through cloning or germ-line engineering, is a form of generational despotism. Second, in trying to make human beings live indefinitely, our scientists have begun mixing our genes with those of cows, pigs, and jellyfish. And in trying to stamp out disease by any means necessary, we risk beginning the “compassionate” project of killing off the diseased themselves, something that has already begun with the selective abortion by parents of “undesirable” embryos.

Proponents of the biogenetic revolution will surely say that such warnings are nothing more than superstitions. Naive to the destructive power of man’s inventions, they will say that freedom means leaving scientists to experiment as they see fit. They will say that those who wish to stop the unchecked advance of biotechnology are themselves “genetic fundamentalists,” who see human beings as nothing more than their genetic make-ups. Banning human cloning, one advocate says, “would set a very dangerous precedent of bringing the police powers of the federal government into the laboratories.”

But the fact is that society accepts the need to regulate behavior for moral reasons — from drug use to nuclear weapons research to dumping waste. And those who say that human identity is “more than a person’s genetic make-up” are typically the ones who seek to crack man’s genetic code, so that they might “improve” humans in the image they see fit. In promising biological utopia, they justify breaching fundamental moral boundaries.

C. S. Lewis saw this possibility long ago in “The Abolition of Man.” As he put it, “Each new power won by man is a power over man as well.” In order to stop the dehumanization of man, and the creation of a post-human world of designer babies, man-animal chimeras, and “compassionate killing” of the disabled, we may have to forego some research. We may have to say no to certain experiments before they begin. The ban on human cloning is an ideal opportunity to reassert democratic control over science, and to reconnect technological advance with human dignity and responsibility.

Source Notes Copyright: 2001 The Wall Street Journal

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Should human cloning be allowed?

A Nobel Prize-winning scientist has claimed that human cloning could become a reality within the next 50 years.

The British biologist Sir John Gurdon carried out pioneering frog cloning work during the 1950s and 60s – research which led to the creation of Dolly the sheep in 1996.

During an appearance on BBC Radio 4’s The Life Scientific , Gurdon said that the time period between his cloned frogs and Dolly the sheep could be similar to the time we have to wait until the first human clone.

He said: "When my first frog experiments were done, an eminent American reporter came down and said 'How long will it be before these things can be done in mammals or humans?'”

"I said: 'Well, it could be anywhere between 10 years and 100 years – how about 50 years? It turned out that wasn't far off the mark as far as Dolly was concerned. Maybe the same answer is appropriate."

Advocates of human cloning argue that it would have important uses, such as allowing parents to clone a child who’s been tragically lost in an accident or through illness. The technology could also allow scientists to grow replacement tissues and organs that are accepted by the body without the need for immunosuppressive drugs.

On the flipside, critics highlight the fact that many cloned animals end up being deformed, warning that human clones could be similarly damaged. Others worry that cloning might lead to a loss of human dignity and individuality, as vividly depicted in Aldous Huxley’s dystopian novel Brave New World .

Despite such complex ethical issues, however, Gurdon believes that human cloning would soon be accepted by the public if it turns out to have valuable medical uses.

• What’s the biological difference between identical twins and clones?
• Could we clone a mammoth or a dinosaur?

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• Published: 21 March 2017

The global governance of human cloning: the case of UNESCO

• Adèle Langlois 1  

Palgrave Communications volume  3 , Article number:  17019 ( 2017 ) Cite this article

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Since Dolly the Sheep was cloned in 1996, the question of whether human reproductive cloning should be banned or pursued has been the subject of international debate. Feelings run strong on both sides. In 2005, the United Nations adopted its Declaration on Human Cloning to try to deal with the issue. The declaration is ambiguously worded, prohibiting “all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life”. It received only ambivalent support from UN member states. Given this unsatisfactory outcome, in 2008 UNESCO (the United Nations Educational, Scientific and Cultural Organization) set up a Working Group to investigate the possibility of a legally binding convention to ban human reproductive cloning. The Working Group was made up of members of the International Bioethics Committee, established in 1993 as part of UNESCO’s Bioethics Programme. It found that the lack of clarity in international law is unhelpful for those states yet to formulate national regulations or policies on human cloning. Despite this, member states of UNESCO resisted the idea of a convention for several years. This changed in 2015, but there has been no practical progress on the issue. Drawing on official records and first-hand observations at bioethics meetings, this article examines the human cloning debate at UNESCO from 2008 onwards, thus building on and advancing current scholarship by applying recent ideas on global governance to an empirical case. It concludes that, although human reproductive cloning is a challenging subject, establishing a robust global governance framework in this area may be possible via an alternative deliberative format, based on knowledge sharing and feasibility testing rather than the interest-based bargaining that is common to intergovernmental organizations and involving a wide range of stakeholders. This article is published as part of a collection on global governance.

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UNESCO (the United Nations Educational, Scientific and Cultural Organization) was founded in 1945, aiming to “build peace in the minds of men” through education, science, culture and communication ( UNESCO, 2007 ). Its Bioethics Programme began in 1993. The organization deems itself uniquely placed to lead the way in setting bioethical standards, as the only UN agency with a mandate for both the human and social sciences ( UNESCO, 2016e ). To this end, it has adopted three declarations on bioethics: the 1997 Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), the 2003 International Declaration on Human Genetic Data (UNESCO, 2003) and the 2005 Universal Declaration on Bioethics and Human Rights (UNESCO, 2005b). After drafting three declarations in the space of a decade, UNESCO decided to take a “normative pause” and instead focus on fostering take-up of the existing declarations regionally and nationally ( UNESCO, 2005a ). Before long, however, it started to consider a fourth bioethics instrument, an international convention on human cloning. From 2008 to 2011 it investigated whether an international convention to ban human reproductive cloning is warranted. The Working Group assigned to this question “flip-flopped” back and forth: in 2008 it recommended a convention, in 2009 it decided continued international dialogue would be sufficient and in 2010 it went back to a convention. As member states could not agree on a way forward, the issue was dropped in 2011 without a firm decision being made on the need or otherwise for a convention. This can be seen as a global governance failure. In 2014, the Bioethics Programme began to revisit the issue. This time there was greater consensus on the need for a ban on human reproductive cloning, but no practical progress has been made.

This article takes a traditional global governance scenario—a debate within a UN agency about whether to draft an international convention—and asks why the outcome was unsatisfactory. The analysis draws on first-hand observations of UNESCO’s publicly held bioethics meetings in 2010 and 2011, official UNESCO records of these and other meetings and UNESCO reports on human cloning. After a brief introduction to (a) developments in global governance and (b) the science and ethics of human cloning, the article charts the progress and ultimate collapse of the UNESCO cloning debate from 2008 to 2011 and developments from 2014 onwards. It concludes that, although human reproductive cloning is a challenging subject, establishing a global governance framework in this area may be possible via an alternative deliberative format.

Global governance

Ruggie (2014 : 5) defines governance as “systems of authoritative norms, rules, institutions, and practices by means of which any collectivity, from the local to the global, manages its common affairs”. At the global level these systems, particularly within formal intergovernmental settings such as UNESCO, are increasingly seen to be inadequate, with scholars variously describing them as “facing a deep crisis” ( Pauwelyn et al., 2014 : 737), “suboptimal” ( Ruggie, 2014 : 15) and suffering the “pathologies” of gridlock, fragmentation, disconnect between related issue areas and conflicts of interest ( Pegram and Acuto, 2015 : 586). The old, hierarchical model of multilateral governance is considered too rigid ( Pauwelyn et al., 2014 : 737) and to have “limited utility in dealing with many of today’s most significant global challenges” ( Ruggie, 2014 : 8). Traditional intergovernmental organizations have not adapted to the increasing complexity of society and the ensuing need for flexible regulatory mechanisms that can keep pace with scientific development ( Pauwelyn et al., 2014 : 742–743).

These problems have led to changes and innovations in both the theory and practice of global governance ( Ruggie, 2014 ; Weiss and Wilkinson, 2014 ; Pegram and Acuto, 2015 : 588). As Pauwelyn et al. (2014: 734) note, “Formal international law is stagnating in terms of both quantity and quality. It is increasingly superseded by ‘informal international lawmaking’ involving new actors, new processes, and new outputs”. They refer to this stagnation as “treaty fatigue” ( Pauwelyn et al., 2014 : 739). The international system is becoming more pluralist and less dominated by sovereign states pursuing narrow interests. There has been movement towards voluntary rather than binding regulation, as well as capacity building ( Pauwelyn et al., 2014 : 736; Pegram and Acuto, 2015 : 591). Particularly for emerging areas, such as the internet, regulation has been informal, with no discussion of a legally binding treaty ( Pauwelyn et al., 2014 : 738). In turn, a “second generation” of global governance scholarship, which recognizes the complexity of global governance in a changed global context, is focusing less exclusively on intergovernmental politics. In the introduction to their special issue of Millennium on global governance’s “interregnum”, Pegram and Acuto (2015 : 586 and 588) predict a “more innovative global governance research and practice-oriented agenda” and a transition to “a potentially more pluralist (and hopefully more democratic) intellectual and practical ecosystem, as well as to new structures of power”. This article applies some of these new practices and ideas to UNESCO’s human cloning debate, answering Pegram and Acuto’s call for “more empirical research” ( Pegram and Acuto, 2015 : 595).

Human cloning and its current international regulation

Although the idea of human cloning excites strong views, there is much confusion about what it would actually entail. Cloning can take two forms: “reproductive” cloning and “therapeutic” or “research” cloning. These terms are not scientifically accurate, but are commonly used nevertheless. They stem from the process of somatic cell nuclear transfer, whereby an enucleated egg receives a nucleus from a somatic (body) cell. In reproductive cloning, the embryo is implanted into a female for gestation. Through this method, Dolly the Sheep became the first mammal to be cloned in July 1996. In therapeutic cloning, an embryo is harvested for stem cells rather than brought to term ( Wilmut et al., 1998 : 21; Bowring, 2004 : 402–403; Isasi et al., 2004 : 628; United Nations University Institute of Advanced Studies, 2007 : 6). Although therapeutic cloning is held by many to have great potential medically, as a source of compatible tissue and organs for those who need transplants, it generates considerable controversy. For people who see human life as beginning at fertilization, therapeutic cloning is also reproductive ( Isasi et al., 2004 : 628; Lo et al., 2010 : 17).

Since the cloning of Dolly the Sheep, ethicists, lawyers and scientists have argued vigorously both for and against developing this technology for use in humans. Those in favour draw on liberal values, citing reproductive freedom, or hope that cloning will provide a new means to tackle infertility. Those against fear for the psychological health of the clone, who would be unable to enjoy what they see as the inherently human quality of having a unique identity. Clones might be expected by their “parents” to conform to a particular life pattern, or feel shackled by knowing about the life of the person from whom they were cloned. Those on both sides mostly agree that, based on the poor success rate in animal cloning and the potential health risks to mother and child, on safety grounds it would be unethical to attempt human cloning currently ( Kass, 1998 : 694–695; Robertson, 1998 : 1372, 1410–1411 and 1415–1416; Burley and Harris, 1999 : 110; de Melo-Martín, 2002 : 248–250; Harris-Short, 2004 : 333 and 344; Tannert, 2006 : 239; Mameli, 2007 : 87; Morales, 2009 : 43; Shapsay, 2012 : 357; The Ethics Committee of the American Society for Reproductive Medicine, 2012 : 804–805; Wilmut, 2014 : 40–41).

Many countries have banned reproductive and/or therapeutic cloning. In most cases, their laws refer to somatic cell nuclear transfer rather than cloning more generally and thus newer technologies are not covered ( Lo et al., 2010 : 16). Several international and regional measures also prohibit human reproductive cloning: UNESCO’s 1997 Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), the World Health Organization’s resolutions of 1997 and 1998 on the implications of cloning for human health (WHO, 1998), the Council of Europe’s 1998 Additional Protocol to the Convention on Human Rights and Biomedicine, on the Prohibition of Cloning Human Beings (Council of Europe, 1998) and the European Union’s 2000 (amended 2007) Charter of Fundamental Human Rights (European Union, 2012). As the Council of Europe’s protocol has been ratified by only 23 of its 47 member states, the EU Charter is limited to the enactment of EU law and UNESCO’s declaration is by definition non-binding, none of these represent an absolute ban ( Council of Europe, 2016 ; European Commission, 2016 ). Hence, at the request of France and Germany, in 2001 the UN General Assembly began to deliberate on a binding treaty to prohibit human reproductive cloning. Four years of dispute and discord followed. Some states were concerned that an embargo on reproductive cloning specifically would implicitly endorse therapeutic or research cloning, whilst those wishing to pursue therapeutic cloning could not support a holistic ban. With agreement on a binding convention seemingly elusive, the General Assembly opted for a non-binding declaration. The United Nations Declaration on Human Cloning was duly adopted on 8 March 2005, but not unanimously. 84 states voted in favour, 34 voted against and 37 abstained ( Arsanjani, 2006 ; Isasi and Annas, 2006 ; Cameron and Henderson, 2007 ). The declaration, rather ambiguously, calls on states to “prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life” ( United Nations, 2005 ). It is considered too weak an instrument to either thwart rogue research or promote legitimate scientific endeavour ( Isasi and Annas, 2006 : 63; United Nations University Institute of Advanced Studies, 2007 : 19).

The UNESCO Bioethics Programme

The UNESCO Bioethics Programme began in 1993 with the formation of the International Bioethics Committee (IBC), made up of independent experts. An Intergovernmental Bioethics Committee (IGBC), comprising state representatives, followed in 1999. Each committee has 36 members. The IBC meets yearly and the IGBC biennially. Regular joint meetings of the two committees are also held. The IBC has various functions, including promoting bioethics education and reflection on ethical issues. The IGBC’s mandate is to examine the recommendations of the IBC and report back to the Director-General of UNESCO ( UNESCO, 1998 ). The IBC works on the basis of 2-year Work Programmes (human cloning, for example, featured in the 2008–2009 and 2010–2011 programmes), with reflections on particular topics being drafted by specially appointed Working Groups, comprising a small number of IBC members, over the 2-year cycle. Each Group presents their work-in-progress at IBC and IGBC meetings and takes the views expressed at these meetings into account in their final reports.

Scholars from both within and without the Bioethics Programme have analysed its efficacy as a forum for ethical debate and standard-setting. Footnote 1 These analyses have mostly focused on the negotiation of the 2005 Universal Declaration on Bioethics and Human Rights . The interest-based bargaining often seen within intergovernmental organizations led to vague wording on beginning and end of life issues and risk assessment, while controversial issues such as sex selection, gene therapy and stem cell research were left out entirely, as states could not reach a consensus on these ( Schmidt, 2007 ; Langlois, 2013 ). UNESCO claims that its status as an intergovernmental body differentiates it from ethics institutions outside of the UN like the World Medical Association, a professional body ( ten Have, 2006 : 342). However, there has been a lack of buy-in from the global bioethics community, particularly academics, who have questioned the expertise and representativeness of the IBC ( Cameron 2014 : 237 and 240). The lack of enforcement power of the 2005 declaration, as a non-binding instrument, has also been noted. Yet Cameron (2014 : 252 and 261) argues that declarations have advantages over conventions, because of their reliance on moral persuasion and their inclusivity in comparison to conventions, which are only binding on those states that accede to them. UNESCO suffered a major setback in 2011, when the United States withdrew funding in light of Palestine’s admittance as a member state, a cut of 22 per cent of the operational budget ( UNESCO, 2011e ; UNESCO, 2013a ). 2 The Bioethics Programme has emerged relatively unscathed, however, as its budget allocation has largely been protected (UNESCO, 2013c; UNESCO, 2016a ).

The human cloning debate at UNESCO 2008–2011

At the request of then Director-General of UNESCO, Koïchiro Matsuura, in 2008 the IBC decided to investigate the possibility of a convention on human cloning and appointed a Working Group on Human Cloning and International Governance ( UNESCO, 2009a : 1–2). This was a response to the publication of a report the previous year by the United Nations University’s Institute of Advanced Studies, entitled Is Human Reproductive Cloning Inevitable: Future Options for UN Governance . The Working Group was tasked with reviewing “whether the scientific, ethical, social, political and legal developments on human cloning in recent years justify a new initiative at international level”, rather than examining the ethics and science of human cloning per se or drafting a legal text ( UNESCO, 2008a : 1). The IBC and IGBC meetings where human cloning was discussed took place as follows: ( Table 1 )

The Working Group’s first report was an interim report, published in September 2008. It recommended a new, binding international convention to ban human reproductive cloning ( UNESCO, 2008b : 4). The report was discussed the following month by the IBC and IGBC (the IBC met for 2 days by itself and then jointly with the IGBC for 2 days), where it was given an ambivalent reception. Many participants did not believe there had been sufficient change in national positions to avoid a repetition of the fractious debate and unsatisfactory outcome at the UN General Assembly a few years before. On the other hand, some delegates underlined the potential utility of a convention for those developing countries yet to legislate on cloning ( UNESCO, 2010a : 6 and 12). In response to these discussions, the Working Group was more cautious in its final report of June 2009. Judging that the introduction of a new international normative instrument would be premature, it recommended increased global dialogue as an alternative ( UNESCO, 2009a : 7). This suggestion was commended by the IGBC at its July 2009 meeting, with several participants noting that developing countries that do not have “a well-developed national bioethics infrastructure” would benefit particularly from international level debate ( UNESCO, 2009b : 4).

The cloning mandate continued into the next Work Programme of 2010–2011. After discussion at its November 2009 meeting and on the advice of the IGBC, the IBC instructed an expanded Working Group to continue its work on cloning by examining three issues: (a) the ethical impact of terminology (b) dissemination activities and (c) regulation of human reproductive cloning (including by moratorium). The Working Group duly delivered a draft report to the IBC and joint IBC–IGBC meetings of October 2010. On options for regulation, it found that a more robust instrument on human reproductive cloning than existed currently was needed, such as an international convention or moratorium ( UNESCO, 2010b : 1 and 6). The reception from the IBC and IGBC was again mixed, as reported by the UNESCO website:

IBC members were unequivocal in expressing concern that the recent scientific developments have raised a need for a binding international legal instrument. However, feedback by Member States of IGBC was indicative that the political hurdles that have prevented the realization of such instrument in the past are still in place. [ sic ] ( UNESCO, 2016b )

As noted in the official record of the IBC-only meeting, members considered it “imperative” that binding international law to ban human reproductive cloning be put in place ( UNESCO, 2011d : 6). By contrast, within the joint IBC–IGBC meeting that followed, the US delegation was perplexed as to why the possibility of a convention was “back on the table”, after it had seemingly been rejected in the 2008–2009 Working Group’s final report. It advocated ongoing dialogue instead, alongside support for states developing national regulations on cloning. Germany and Brazil also backed the status quo, prompting one IBC member to ask why in 2010 they believed a convention to be premature, when in 2001, the year the idea was first put to the UN, they had thought one timely. Meanwhile, some developing countries stated their desire for a convention on cloning (but not necessarily a prohibitive one) (personal observations, Joint Session of the IBC and IGBC, October 2010). Given the diversity of views, it was left that the IGBC would “thoroughly examine the issue” at its next session (to be held in September the following year), after the IBC, via the Working Group, had finalized its report (UNESCO, 2016b).

The IBC held its next meeting in May–June 2011, at which the Working Group presented a draft “final statement” rather than a finalized version of the draft report of the previous year. This statement repeated the recommendations of the 2010 draft report, emphasizing that developing countries that do not have national regulations on human reproductive cloning are in particular need of a binding international convention or moratorium. In addition, it suggested that “technical manipulations of human embryo, either for research or therapeutic purposes” [ sic ] (that is, what is commonly known as therapeutic or research cloning) should carry on being regulated at domestic level, in accordance with social, historical and religious contexts ( UNESCO, 2011b : 3). The IBC chose not to adopt the statement because of the now “divergent positions” of its members on both the ethics and governance of cloning ( UNESCO, 2011c : 4). At the ethical level, some members were not convinced that the potential for detrimental genetic determinism was a strong enough argument against reproductive cloning, whilst at the political level, some felt the committee could make little progress while consensus among states remained elusive (personal observations, Eighteenth Session of the IBC, May–June 2011).

At the IGBC’s September 2011 meeting, the outgoing IBC Chair reported on his committee’s activities. With regard to the cloning debate, he explained that despite some members having wanted to go to a vote on whether to adopt the Working Group’s draft statement, he had opposed this, because the IBC had always operated by consensus in the past. He also expressed his belief that consensus on a ban will always be impossible to achieve, because at its core the issue is philosophical rather than scientific, concerning the status of the early embryo. IGBC delegations agreed for the most part, the United States, Austria and Denmark echoing IBC members in predicting that further efforts to reach an agreement on regulation would prove fruitless (personal observations, Seventh Session of the IGBC, September 2011). The official conclusions of the meeting noted the topic’s ongoing importance, but also the absence of any consensus among both states and IBC members. Hence the IGBC merely called on UNESCO “to continue to follow the developments in this field in order to anticipate emerging ethical challenges” ( UNESCO, 2011a: 3 ). Subsequently, the 2012–2013 IBC Work Programme consigned cloning to monitoring by a few IBC members, who were in turn to report any significant developments in the field to the committee and thereby the Director-General of UNESCO ( UNESCO, 2016f ).

After 4 years of work and discussion, then, UNESCO’s inability to come to a consensus on whether or not a convention to ban human reproductive cloning would be desirable meant that a decision against a convention was made by default. The Working Group’s draft final statement of 2011 had concluded, “The current non-binding international regulations cannot be considered sufficient in addressing the challenges posed by the contemporary scientific developments and to safeguard the interests of the developing countries that still lack specific regulations in this area” ( UNESCO, 2011b : 3). If this is the case, UNESCO’s failure to meet the need identified by its Working Group is problematic, as there is a governance gap.

2014–2015 developments

In its 2014–2015 Work Programme the IBC revisited the topic of human cloning as part of its wider efforts to update its earlier work on the human genome and human rights. The June 2015 draft report of the Working Group appointed to this task reiterated the need for a ban on human reproductive cloning. It also called for “a global forum of scientists and bioethicists, under the auspices of the United Nations” to investigate what the consequences of new genomic technologies might be and stated, “The United Nations should be responsible for making fundamental normative decisions. The precautionary principle should be respected, ensuring that substantial consensus of the scientific community on the safety of new technological applications be the premise for any further consideration” ( UNESCO, 2015b : 25–27).

The IGBC, on reviewing this draft report at its July 2015 meeting (Ninth Session), found the IBC’s recommendations to be “pertinent and timely” (UNESCO, 2015a: 2). This was in marked contrast to the comments by some of its members a few years before that a ban on human reproductive cloning would be “premature” ( UNESCO, 2009a : 7). Perhaps wary of ceding “territory”, the IGBC stressed that UNESCO was the appropriate forum for discussion of a ban. In the official conclusions of the meeting, it also invited the Secretariat of the Bioethics Programme to “collect and compile existing legal models, case studies and best practices” on cloning and other issues relating to the human genome addressed in the report ( UNESCO, 2015a : 2–3). The draft was revised in light of the IGBC’s comments and then discussed and revised again at the IBC’s 22 nd Session in October 2015. The final version— Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights —states that the UN should be responsible for fundamental normative decisions “through its several agencies and bodies and other possible procedures of consultation and evaluation” rather than a new global forum. It also asserts UNESCO’s position as a key player in the bioethics community, adding that, in terms of any revisions to existing declarations, “First of all, this is a task to perform for UNESCO, building on its well-established, pivotal role as a global forum for global bioethics” ( UNESCO, 2015c : 27–29).

The report addresses several issues that fall under the banner of the human genome and human rights, not just cloning. Nevertheless, cloning is prominent. The Executive Summary includes an “open list” of recommended actions for states and governments. The first item is: “Produce an international legally binding instrument to ban human cloning for reproductive purposes”. There are also recommendations for scientists and regulatory bodies, who are to “renounce the pursuit of spectacular experiments that do not comply with the respect of fundamental human rights” ( UNESCO, 2015c : 3–4). The main text expands on this, to state that such experiments should be discouraged (by not being allocated public funds, for instance) and in some cases prohibited, where there is no medical justification and a risk to safety. That this refers to cloning is made explicit, as follows: “Research on the possibility of cloning human beings for reproductive purposes remains the most illustrative example of what should remain banned all over the world” ( UNESCO, 2015c : 26). More generally, the report advocates a conservative approach to decision- and law-making that may be particularly relevant to human embryonic stem cell research, or “therapeutic cloning”. It encourages the adoption of legislation at international and national levels that is “as non-controversial as possible, especially with regard to the issues of modifying the human genome and producing and destroying human embryos”, to respect differing sensitivities and cultures ( UNESCO, 2015c : 3 and 6). Footnote 2 With regard to developing countries, the report acknowledges that they may not have major access to new genomic technologies in the near future, but recommends that LMIC (low and middle income country) governments develop national policies on genomics “within the context of their national economic and sociocultural uniqueness” ( UNESCO, 2015c : 29). The report also makes recommendations for “all actors of civil society”, including the media, educators and businesses. The former are to “avoid any sensationalism”, whilst the latter are not to chase profit by operating in countries with weak regulations ( UNESCO, 2015c : 3–4).

Hofferberth (2015 : 616) is critical of the assumption that “global problems are tractable and solutions feasible if actors will only come and work together to solve them”. As shown above, some members of the IBC and IGBC believed that the reason why they failed to reach consensus during the first 4 years of debate on human cloning (2008–2011) was the inherently irresolvable nature of the problem itself. But other controversial areas, such as business and human rights, have not proved immune to recent efforts towards policy and norm convergence ( Ruggie, 2014 : 6). Another possible explanation for the failure, then, is that the legal and organizational structures directing the deliberation did not lend themselves to consensual decision-making. In the early 2000s the UN General Assembly had found that the old model of state-based treaty negotiation did not work for human cloning, when it failed to agree on a convention and chose a non-binding declaration instead. UNESCO’s experience was similar, although it was not negotiations on treaty content that failed, but the preceding stage of deciding whether or not to attempt to draft a treaty. In raising the possibility of a convention in 2008, UNESCO was going against the emerging trend within global governance towards voluntary rather than binding regulation, combined with capacity building. Germany, for example, which was one of the states that originally espoused the idea of a human cloning convention at the UN in 2001, now looks for other, less rigid means by which the goals of a proposed treaty can be reached ( Pauwelyn et al., 2014 : 739). Within UNESCO, as in other intergovernmental organizations, it is states that make the final decisions, so even if in 2011 the IBC (made up of independent experts) had continued to insist on the desirability of a convention, it would only have had the power to recommend to member states that they take the idea forward.

Pauwelyn et al. (2014 : 734) advocate “thick stakeholder consensus” over the “thin state consent” that is the hallmark of the old hierarchical approach to governance. As a treaty could be based on back-room deals between undemocratic states and yet be recognized as international law, they argue that formality is no guarantee of legitimacy, if the latter is assessed in terms of inclusiveness and effectiveness rather than tradition. Rather, the process by which agreement is reached is crucial, as well as the outcome. Careful, open and expert deliberation can lead to high quality outputs, which may or may not be legally binding ( Pauwelyn et al., 2014 : 748–749). One way to achieve both process and output would be to loosen UNESCO’s understanding of “consensus”. By sticking to a rigid definition of consensus at its 2011 meeting, the IBC effectively gave each member a veto. Pauwelyn et al. (2014 : 754–755) contrast this type of arrangement with the “standards world” (that is, the International Organization for Standardization and the International Electrotechnical Commission), which sits outside the intergovernmental system. Here, where governance is seen to be nimbler and more flexible than in traditional governance settings, “consensus” means that “the views of all parties concerned must be taken into any account and an attempt must be made to reconcile conflicting arguments”, so that general agreement can be reached. This level of consensus might be a more realistic target for the IBC and IGBC, enabling them to move forward.

One problem the Bioethics Programme has faced consistently is lack of time for in-depth discussion. At the IBC meeting in May–June 2011, for instance, the public session devoted to cloning lasted little more than an hour (although the committee later continued its discussions in a private meeting). This was not unusual. At the IGBC’s September 2013 meeting (Eighth Session), which reviewed 20 years of the Bioethics Programme, one delegate stated that their government would stop funding their attendance at such meetings unless more time were given to dialogue and papers were sent out early enough for delegates to consult with the relevant ministries on what position they should take (personal observations, Eighteenth Session of the IBC, May–June 2011 and Eighth Session of the IGBC, September 2013 4 ). The Bioethics Programme has already started to implement such changes. More time was allocated to each discussion topic at the IBC and joint IBC–IGBC meetings of September 2014 than at previous sessions, an online forum for past and present IBC members has been established and concept notes to invite written comments from the IGBC on the IBC’s work ahead of meetings have been introduced ( UNESCO, 2015d : 2 and 17).

If deliberations were to emulate recent innovations in other intergovernmental fora, they might be improved further. After its disappointing Copenhagen round in 2009, the Conference of the Parties to the United Nations Framework Convention on Climate Change has moved from formal treaty negotiations that encouraged bargaining and confrontation to workshops and roundtables designed to foster knowledge exchange. This has resulted in “positive competitive dynamics” among states wishing to be leaders in the field of climate change mitigation ( Rietig, 2014 : 372–374). Other stakeholders have also been given a stronger voice; the Paris conference of 2015 made space for NGOs, businesses and cities to share best practices. Furthermore, the Paris Agreement of December 2015 takes a bottom-up approach, in that it is based on Intended Nationally Determined Contributions (pledged targets and actions) by individual states ( Busby, 2016 : 3, 4 and 7). Similarly, after the UN failed to adopt both a code of conduct and a set of norms on business and human rights after several years of trying, it piloted a different standard-setting method. Based on a series of site visits to firms and communities, extensive research and testing of key proposals through feasibility studies, pilot grievance mechanisms and scenario-based exercises, as well as multistakeholder consultations, the Guiding Principles on Business and Human Rights were endorsed by the Human Rights Council in 2011 and have since been adopted by several other bodies, including business associations. Ruggie (2014 : 5–6 and 10), who directed the consultation process, claims that producing the guiding principles through this “polycentric governance” enabled them to achieve the “thick” consensus advocated by Pauwelyn et al .

Ruggie (2014 : 10) argues that conceptual arguments must be supported by experiential ones if they are to persuade people of the need for change. The cloning debate is necessarily conceptual, as while questions over safety prevail there is no way to experience cloning to see whether fears (about autonomy and individuality, for example) are founded or unfounded. The closest proxies are animal cloning and twin studies. Yet sharing of national regulations and policies on cloning via workshops and roundtables and scenario-based exercises involving potential stakeholders would be feasible. Similar exercises (collating examples of legal frameworks, best practices and case studies) were suggested by the IGBC in their response to the IBC’s 2015 draft report on the human genome and human rights. Such activities could meet developing countries’ needs for something on which to base national cloning legislation, identified by all three IBC Working Groups (2008–2009, 2010–2011 and 2014–2015), by alternative means to a binding international convention, the latest recommendations of the IBC on this (and the IGBC’s endorsement of them) notwithstanding. Continuing to develop the Bioethics Programme’s deliberative format, away from short, formal discussions within committees towards more in-depth information exchange between a broader range of stakeholders, bottom-up pledges of action and development of best practice through feasibility studies, may not result in a decision to begin negotiating a treaty (or even a softer declaration), but could lead to a set of resources and commitments that might prove equally effective in promoting ethical behaviour on the part of states and other actors. An added benefit would be that this type of less legalistic, more flexible deliberative output could be more easily adapted and developed to take account of future scientific advances ( Pauwelyn et al., 2014 : 742–743). Even if UNESCO were to decide to follow the IBC’s 2015 recommendation to pursue the elaboration a further international legal instrument on human cloning, adopting these measures could result in a qualitatively stronger instrument than the Universal Declaration of Bioethics and Human Rights , for example, as there would be less interest-based bargaining and more buy-in from stakeholders.

When intergovernmental organizations are unable to agree on a form of binding international law such as a convention, they sometimes settle for a declaration, which is less demanding of states. This occurred at the UN in 2005, when the General Assembly could not resolve its members’ differences on what the content and reach of a convention on human cloning should be. Declarations have been the preferred option for UNESCO’s Bioethics Programme in the past, as the drafting period is usually shorter than for a convention and the final product is more likely to inspire consensus, partly because it will be seen to be more flexible and less onerous than a binding piece of legislation ( Langlois, 2013 : 65–66). But this was not a viable path for UNESCO when it came to the regulation of human cloning, because an international declaration—the United Nations Declaration on Human Cloning of 2005—already existed. The Bioethics Programme thus broke with previous practice and began to investigate the possibility of a convention on cloning in 2008. There was tension between IBC and IGBC members over whether a convention would be desirable, with the former (the independent experts) supporting a ban on human reproductive cloning and the latter (representing states) concerned that negotiations would simply revisit the disagreements of the UN General Assembly debates of a few years before. Ultimately, with consensus within and between the two committees proving elusive, the idea of a cloning convention dropped from their agendas in 2012.

The idea was taken up again in 2014, as part of the IBC’s work on the human genome. We can only speculate as to why the IGBC of 2015 was keener on a ban on human reproductive cloning than the IGBC of 2008–2011. The United States was no longer a member, but Germany and Brazil still were ( UNESCO, 2016c ). It could be that, since the first human therapeutic (or research) cloning via somatic cell nuclear transfer took place in 2013 ( Tachibana et al., 2013 ), human reproductive cloning has moved from the realms of science fiction to real possibility in the eyes of policy-makers. Or the changes to the deliberative format at IBC and IGBC meetings introduced in 2014, such as pre-session concept notes and longer discussions, may have engendered greater consensus between the two committees. Yet, despite this consensus, there has been no move on the part of UNESCO to start to develop a treaty. In past standard-setting endeavours, an IBC Working Group has done the initial drafting, but the IBC Work Programme of 2016–2017 makes no mention of human cloning ( UNESCO, 2016d ).

For those states that have yet to formulate national regulations or policies on human cloning, the continued lack of clear guidance at international level may be particularly unhelpful. Thus better global governance in this area is needed. In its 2015 report on the human genome and human rights, the IBC fell somewhere between old and new forms of global governance. There was a strong call for an international binding instrument on human reproductive cloning, to be produced by states and governments, but there were also recommended actions and principles for a broad range of stakeholders, including national governments, scientists, the media, educators and corporations. The science and politics of human cloning have moved on since 2011, when states’ positions were seemingly intractable. Were the Bioethics Programme to mirror successful moves in other fora, such as the Conference of the Parties to the United Nations Framework Convention on Climate Change and the Human Rights Council, towards knowledge sharing, scenario-based exercises and action pledges involving a wide range of stakeholders, a robust global governance framework for human cloning—whether a legally binding instrument or something more flexible—might be achievable.

Data availability

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Additional information

How to cite this article : Langlois A (2017) The global governance of human cloning: the case of UNESCO. Palgrave Communications . 3:17019 doi: 10.1057/palcomms.2017.19. Footnote 3 Footnote 4

See, for example, Macpherson CC (2007) Global bioethics: Did the universal declaration on bioethics and human rights miss the boat? Journal of Medical Ethics ; 33 (10): 588–590; Snead CO (2009) Bioethics and self-governance: The lessons of the Universal Declaration on Bioethics and Human Rights. Journal of Medicine and Philosophy ; 34 (3): 204–222; Kirby M (2010) Health care and global justice. Singapore Academic of Law Journal ; 22 (special ed. 2): 785–800; Langlois A (2013) Negotiating Bioethics: The Governance of UNESCO’s Bioethics Programme . Routledge: Abingdon; Cameron NM de S (2014) Humans, rights, and twenty-first century technologies: The making of the Universal Declaration on Bioethics and Human Rights. Journal of Legal Medicine ; 35 (2): 235–272.

This cautious, conservative approach is in marked contrast to the advice John Harris, an ethicist, gave at the celebration event to mark the twentieth anniversary of UNESCO’s Bioethics Programme, held at UNESCO headquarters in Paris in September 2013. He stated, “There is the danger—and this is the note on which I wish to end—the danger presented by the precautionary principle itself, which I also believe is one of the biggest dangers facing society and humanity. People often believe that there is some moral imperative to be ultra-cautious in permitting new research, particularly in the general field of genetics. And this caution has also been very true of UNESCO’s approach. However, it is not unusual to find this so-called precautionary principle being invoked in circumstances in which it is far from clear in which direction, if any, caution lies. We cannot know in which direction caution lies without having some rational basis for establishing the scale of likely dangers from pursuing particular programmes of research and innovation and comparing those with the on-going costs of failing to pursue that research to a conclusion. … I hope UNESCO will avoid the terrible mistake it made in Article 11 of the declaration on the human genome of saying, without argument or evidence, without a scintilla of support, that human cloning was contrary to human dignity and must be outlawed. We’re going to have to rethink that. We’re going to need human cloning as one technique among many others. … We need to rethink our prejudices. We need to be slow to outlaw technology. That doesn’t mean we shouldn’t do it, but we should also do so on the full consideration of the evidence and the argument and never simply because it would be cheap, easy and popular.” (Transcribed from the live webcast of the event, 5 September 2013. Available at: mms://stream.unesco.org/live/room_11_en.wmv . Last accessed 5 September 2013.)

After 2 years of withholding its dues, the United States lost its General Conference voting rights in 2013 ( UNESCO, 2013b ). It has not had a seat on the IGBC since 2011.

The author listened to the Eighth Session of the IGBC in September 2013 via live webcast. ( mms://stream.unesco.org/live/room_11_en.wmv . Last accessed 5 September 2013.)

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Human Cloning Policies

Reproductive Cloning

Many countries have passed legislation banning human reproductive cloning, including Australia, Austria, Argentina, Belgium, Brazil, Canada, the Czech Republic, Costa Rica, Denmark, France, Germany, India, Israel, Italy, Japan, Lithuania, Mexico, the Netherlands, Norway, Peru, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Trinidad and Tobago, and the United Kingdom.

Approximately 46 countries have formally banned human cloning. While encouraging, this represents less than a quarter of all countries.

International organizations have also been working towards prohibitions on reproductive cloning. For example, in 1998 the Council of Europe issued an amendment to its Convention on Human Rights and Biomedicine . The Additional Protocol to the Convention on the Prohibition of Cloning Human Beings prohibits "any intervention seeking to create a human being genetically identical to another human being, whether living or dead."

Advocates of human reproductive cloning hope to make it happen before a global ban is in place, in the expectation that opposition will weaken in the face of a fait accompli. Estimates as to when a human clone might be born, if no action is taken to prevent it, range from immediately to five or ten years.

Research Cloning

Some countries, notably France, Germany, and Canada, explicitly ban the creation of clonal embryos. These countries have done so without infringing upon reproductive rights or jeopardizing a woman's right to an abortion. Many feminists, political progressives, and supporters of social justice in those countries support these bans on cloning.

In January 2001 the United Kingdom authorized the creation of clonal embryos for medical research. Sweden, China and Israel have also declared that they are not opposed to the creation of clonal embryos for research. There is pressure in the United States, Germany and elsewhere from the biomedical and biotechnology community to allow this as well.

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Human Cloning: Biology, Ethics, and Social Implications

Affiliations.

• 1 MAGI'S LAB, Rovereto (TN), Italy.
• 2 Department of Pharmaceutical Sciences, University of Perugia, Perugia, Italy.
• 3 MAGI EUREGIO, Bolzano, Italy.
• 4 MAGISNAT, Peachtree Corners (GA), USA.
• 5 School of Food Science and Environmental Health, Technological University of Dublin, Dublin, Ireland.
• 6 Department of Psychology and Neuroscience, Dalhousie University, Halifax, Nova Scotia, Ca-nada.
• 7 Department of Ophthalmology, Center for Ocular Regenerative Therapy, School of Medicine, University of California at Davis, Sacramento, CA, USA.
• 8 Centre for Bioethics, Department of Philosophy and Applied Philosophy, University of St. Cyril and Methodius, Trnava, Slovakia.
• 9 Department of Biotechnology Engineering, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
• 10 nstitute of Ophthalmology, Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.
• 11 MAGI BALKANS, Tirana, Albania.
• 12 Department of Biotechnology, University of SS. Cyril and Methodius, Trnava, Slovakia.
• 13 International Centre for Applied Research and Sustainable Technology, Bratislava, Slovakia.
• 14 UOC Neurology and Stroke Unit, ASST Lecco, Merate, Italy.
• 15 Center for Preclincal Research and General and Liver Transplant Surgery Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
• 16 Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.
• 17 Department of Biomedical, Surgical and Dental Sciences, Università degli Studi di Milano, Milan, Italy.
• 18 UOC Maxillo-Facial Surgery and Dentistry, Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico, Milan, Italy.
• 19 Department of Medical Genetics, Faculty of Medicine, Near East University, Nicosia, Cyprus.
• 20 Department of Medical Genetics, Erciyes University Medical Faculty, Kayseri, Turkey.
• 21 Vascular Diagnostics and Rehabilitation Service, Marino Hospital, ASL Roma 6, Marino, Italy.
• 22 San Francisco Veterans Affairs Health Care System, University of California, San Francisco, CA, USA.
• 23 Univ. Grenoble Alpes, CNRS, Grenoble INP, TIMC-IMAG, SyNaBi, Grenoble, France.
• 24 Department of Biotechnology, University of Tirana, Tirana, Albania.
• 25 Total Lipedema Care, Beverly Hills, California, and Tucson, Arizona, USA.
• 26 Federation of the Jewish Communities of Slovakia.
• 27 Department of Psychological Health and Territorial Sciences, School of Medicine and Health Sciences, "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy.
• 28 Unit of Molecular Genetics, Center for Advanced Studies and Technology (CAST), "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy.
• 29 Department of Anatomy and Developmental Biology, University College London, London, UK.
• PMID: 37994769
• DOI: 10.7417/CT.2023.2492

This scholarly article delves into the multifaceted domains of human cloning, encompassing its biological underpinnings, ethical dimensions, and broader societal implications. The exposition commences with a succinct historical and contextual overview of human cloning, segueing into an in-depth exploration of its biological intri-cacies. Central to this biological scrutiny is a comprehensive analysis of somatic cell nuclear transfer (SCNT) and its assorted iterations. The accomplishments and discoveries in cloning technology, such as successful animal cloning operations and advances in the efficiency and viability of cloned embryos, are reviewed. Future improvements, such as reprogramming procedures and gene editing technology, are also discussed. The discourse extends to ethical quandaries intrinsic to human cloning, entailing an extensive contemplation of values such as human dignity, autonomy, and safety. Furthermore, the ramifications of human cloning on a societal plane are subjected to scrutiny, with a dedicated emphasis on ramifications encompassing personal identity, kinship connections, and the fundamental notion of maternity. Culminating the analysis is a reiteration of the imperative to develop and govern human cloning technology judiciously and conscientiously. Finally, it discusses several ethical and practical issues, such as safety concerns, the possibility of exploitation, and the erosion of human dignity, and emphasizes the significance of carefully considering these issues.

Keywords: Human cloning; biology; dignity; ethical considerations; safety; social implications.

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The Ethics of Human Cloning and Stem Cell Research

• Markkula Center for Applied Ethics
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Report from a conference on state regulation of cloning and stem cell research.

"California Cloning: A Dialogue on State Regulation" was convened October 12, 2001, by the Markkula Center for Applied Ethics at Santa Clara University. Its purpose was to bring together experts from the fields of science, religion, ethics, and law to discuss how the state of California should proceed in regulating human cloning and stem cell research.

A framework for discussing the issue was provided by Center Director of Biotechnology and Health Care Ethics Margaret McLean, who also serves on the California State Advisory Committee on Human Cloning. In 1997, the California legislature declared a "five year moratorium on cloning of an entire human being" and requested that "a panel of representatives from the fields of medicine, religion, biotechnology, genetics, law, bioethics and the general public" be established to evaluate the "medical, ethical and social implications" of human cloning (SB 1344). This 12-member Advisory Committee on Human Cloning convened five public meetings, each focusing on a particular aspect of human cloning: e.g., reproductive cloning, and cloning technology and stem cells. The committee is drafting a report to the legislature that is due on December 31, 2001. The report will discuss the science of cloning, and the ethical and legal considerations of applications of cloning technology. It will also set out recommendations to the legislature regarding regulation of human cloning. The legislature plans to take up this discussion after January. The moratorium expires the end of 2002.

What should the state do at that point? More than 80 invited guests came to SCU for "California Cloning" to engage in a dialogue on that question. These included scientists, theologians, businesspeople from the biotechnology industry, bioethicists, legal scholars, representatives of non-profits, and SCU faculty. Keynote Speaker Ursula Goodenough, professor of biology at Washington University and author of Genetics , set the issues in context with her talk, "A Religious Naturalist Thinks About Bioethics." Four panels addressed the specific scientific, religious, ethical, and legal implications of human reproductive cloning and stem cell research. This document gives a brief summary of the issues as they were raised by the four panels.

Science and Biotechnology Perspectives

Thomas Okarma, CEO of Geron Corp., launched this panel with an overview of regenerative medicine and distinguished between reproductive cloning and human embryonic stem cell research. He helped the audience understand the science behind the medical potential of embryonic stem cell research, with an explanation of the procedures for creating stem cell lines and the relationship of this field to telomere biology and genetics. No brief summary could do justice to the science. The reader is referred to the report of the National Bioethics Advisory Committee (http://bioethics.georgetown.edu/nbac/stemcell.pdf) for a good introduction.

Responding to Okarma, were J. William Langston, president of the Parkinson’s Institute, and Phyllis Gardner, associate professor of medicine and former dean for medical education at Stanford University. Both discussed the implications of the president’s recent restrictions on stem cell research for the non-profit sector. Langston compared the current regulatory environment to the Reagan era ban on fetal cell research, which he believed was a serious setback for Parkinson’s research. He also pointed out that stem cell research was only being proposed using the thousands of embryos that were already being created in the process of fertility treatments. These would ultimately be disposed of in any event, he said, arguing that it would be better to allow them to serve some function rather than be destroyed. President Bush has confined federally-funded research to the 64 existing stem cell lines, far too few in Langston’s view. In addition, Langston opposed bans on government funding for stem cell research because of the opportunities for public review afforded by the process of securing government grants.

Gardner talked about the differences between academic and commercial research, suggesting that both were important for the advancement of science and its application. Since most of the current stem cell lines are in the commercial sector and the president has banned the creation of new lines, she worried that universities would not continue to be centers of research in this important area. That, she argued, would cut out the more serendipitous and sometimes more altruistic approaches of academic research. Also, it might lead to more of the brain drain represented by the recent move of prominent UCSF stem cell researcher Roger Pedersen to Britain. Gardner expressed a hope that the United States would continue to be the "flagship" in stem cell research. Her concerns were echoed later by moderator Allen Hammond, SCU law professor, who urged the state, which has been at the forefront of stem cell research to consider the economic impact of banning such activity. All three panelists commended the decision of the state advisory committee to deal separately with the issues of human cloning and stem cell research.

Religious Perspectives

Two religion panelists, Suzanne Holland and Laurie Zoloth, are co editors of The Human Embryonic Stem Cell Debate: Science, Ethics and Public Policy (MIT Press, 2001). Holland, assistant professor of Religious and Social Ethics at the University of Puget Sound, began the panel with a discussion of Protestant ideas about the sin of pride and respect for persons and how these apply to human reproductive cloning. Given current safety concerns about cloning, she was in favor of a continuing ban. But ultimately, she argued, cloning should be regulated rather than banned outright. In fact, she suggested, the entire fertility industry requires more regulation. As a basis for such regulation, she proposed assessing the motivation of those who want to use the technology. Those whose motives arise from benevolence--for example, those who want to raise a child but have no other means of bearing a genetically related baby--should be allowed to undergo a cloning procedure. Those whose motives arise more from narcissistic considerations -- people who want immortality or novelty -- should be prohibited from using the technology. She proposed mandatory counseling and a waiting period as a means of assessing motivation.

Zoloth reached a different conclusion about reproductive cloning based on her reading of Jewish sources. She argued that the availability of such technology would make human life too easily commodified, putting the emphasis more on achieving a copy of the self than on the crucial parental act of creating "a stranger to whom you would give your life." She put the cloning issue in the context of a system where foster children cannot find homes and where universal health care is not available for babies who have already been born. While Zoloth reported that Jewish ethicists vary considerably in their views about reproductive cloning, there is fairly broad agreement that stem cell research is justified. Among the Jewish traditions she cited were:

The embryo does not have the status of a human person.

There is a commandment to heal.

Great latitude is permitted for learning.

The world is uncompleted and requires human participation to become whole.

Catholic bioethicist Albert Jonsen, one of the deans of the field, gave a historical perspective on the cloning debate, citing a paper by Joshua Lederburg in the 1960s, which challenged his colleagues to look at the implications of the then-remote possibility. He also traced the development of Catholic views on other new medical technologies. When organ transplantation was first introduced, it was opposed as a violation of the principal, "First, do no harm" and as a mutilation of the human body. Later, the issue was reconceived in terms of charity and concern for others. One of the key questions, Jonsen suggested, is What can we, as a society that promotes religious pluralism, do when we must make public policy on issues where religious traditions may disagree. He argued that beneath the particular teachings of each religion are certain broad themes they share, which might provide a framework for the debate. These include human finitude, human fallibility, human dignity, and compassion.

Ethics Perspectives

Lawrence Nelson, adjunct associate professor of philosophy at SCU, opened the ethics panel with a discussion of the moral status of the human embryo. Confining his remarks to viable, extracorporeal embryos (embryos created for fertility treatments that were never implanted), Nelson argued that these beings do have some moral status--albeit it weak--because they are alive and because they are valued to varying degrees by other moral agents. This status does entitle the embryo to some protection. In Nelson’s view, the gamete sources whose egg and sperm created these embryos have a unique connection to them and should have exclusive control over their disposition. If the gamete sources agree, Nelson believes the embryos can be used for research if they are treated respectfully. Some manifestations of respect might be:

They are used only if the goal of the research cannot be obtained by other methods.

The embryos have not reached gastrulation (prior to 14 to 18 days of development).

Those who use them avoid considering or treating them as property.

Their destruction is accompanied by some sense of loss or sorrow.

Philosophy Professor Barbara MacKinnon (University of San Francisco), editor of Human Cloning: Science, Ethics, and Public Policy , began by discussing the distinction between reproductive and therapeutic cloning and the slippery slope argument. She distinguished three different forms of this argument and showed that for each, pursuing stem cell research will not inevitably lead to human reproductive cloning. MacKinnon favored a continuing ban on the latter, citing safety concerns. Regarding therapeutic cloning and stem cell research, she criticized consequentialist views such as that anything can be done to reduce human suffering and that certain embryos would perish anyway. However, she noted that non-consequentialist concerns must also be addressed for therapeutic cloning, among them the question of the moral status of the early embryo. She also made a distinction between morality and the law, arguing that not everything that is immoral ought to be prohibited by law, and showed how this position relates to human cloning.

Paul Billings, co-founder of GeneSage, has been involved in crafting an international treaty to ban human reproductive cloning and germ-line genetic engineering. As arguments against human cloning he cited:

There is no right to have a genetically related child.

Cloning is not safe.

Cloning is not medically necessary.

Cloning could not be delivered in an equitable manner.

Billings also believes that the benefits of stem cell therapies have been "wildly oversold." Currently, he argues, there are no effective treatments coming from this research. He is also concerned about how developing abilities in nuclear transfer technology may have applications in germ-line genetic engineering that we do not want to encourage. As a result, he favors the current go-slow approach of banning the creation of new cell lines until some therapies have been proven effective. At the same time, he believes we must work to better the situation of the poor and marginalized so their access to all therapies is improved.

Legal Perspectives

Member of the State Advisory Committee on Human Cloning Henry "Hank" Greely addressed some of the difficulties in creating a workable regulatory system for human reproductive cloning. First he addressed safety, which, considering the 5 to 10 times greater likelihood of spontaneous abortion in cloned sheep, he argued clearly justifies regulation. The FDA has currently claimed jurisdiction over this technology, but Greely doubted whether the courts would uphold this claim. Given these facts, Greely saw three alternatives for the state of California:

Do nothing; let the federal government take care of it.

Create an FDA equivalent to regulate the safety of the process, an alternative he pointed out for which the state has no experience.

Continue the current ban on the grounds of safety until such time as the procedure is adjudged safe. Next Greely responded to suggestions that the state might regulate by distinguishing between prospective cloners on the basis of their motivation, for example, denying a request to clone a person to provide heart tissue for another person but okaying a request if cloning were the only opportunity a couple might have to conceive a child. Greely found the idea of the state deciding on such basis deeply troubling because it would necessitate "peering into someone’s soul" in a manner that government is not adept at doing.

The impact of regulation on universities was the focus of Debra Zumwalt’s presentation. As Stanford University general counsel, Zumwalt talked about the necessity of creating regulations that are clear and simple. Currently, federal regulations on stem cells are unclear, she argued, making it difficult for universities and other institutions to tell if they are in compliance. She believes that regulations should be based on science and good public policy rather than on politics. As a result, she favored overall policy being set by the legislature but details being worked out at the administrative level by regulatory agencies with expertise. Whatever regulations California develops should not be more restrictive than the federal regulations, she warned, or research would be driven out of the state. Like several other speakers, Zumwalt was concerned about federal regulations restricting stem cell research to existing cell lines. That, she feared, would drive all research into private hands. "We must continue to have a public knowledge base," she said. Also, she praised the inherent safeguards in academic research including peer review, ethics panels, and institutional review boards.

SCU Presidential Professor of Ethics and the Common Good June Carbone looked at the role of California cloning decisions in contributing to the governance of biotechnology. California, she suggested, cannot address these issues alone, and thus might make the most useful contribution by helping to forge a new international moral consensus through public debate. Taking a lesson from U.S. response to recent terrorist attacks, she argued for international consensus based on the alliance of principle and self-interest. Such consensus would need to be enforced both by carrot and stick and should, she said, include a public-private partnership to deal with ethical issues. Applying these ideas to reproductive cloning, she suggested that we think about which alliances would be necessary to prevent or limit the practice. Preventing routine use might be accomplished by establishing a clear ethical and professional line prohibiting reproductive cloning. Preventing exceptional use (a determined person with sufficient money to find a willing doctor) might not be possible. As far as stem cell research is concerned, Carbone argued that the larger the investment in such research, the bigger the carrot--the more the funder would be able to regulate the process. That, she suggested, argues for a government role in the funding. If the professional community does not respect the ethical line drawn by politicians, and alternative funding is available from either public sources abroad or private sources at home, the U.S. political debate runs the risk of becoming irrelevant.

"California Cloning" was organized by the Markkula Center for Applied Ethics and co-sponsored by the Bannan Center for Jesuit Education and Christian Values; the Center for Science, Technology, and Society; the SCU School of Law; the High Tech Law Institute; the Howard Hughes Medical Institute Community of Science Scholars Initiative; and the law firm of Latham & Watkins.

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Article Contents

I. i. introduction, ii. the germline gene editing science race, iii. iii. legal approaches to human germline editing, iv. iv. from prohibition to regulation of hgge, v. v. the blurring boundary between treatment and enhancement, vi. vi. individual and collective dimensions of human rights law, vii. vii. from human rights to self-regulation by the scientific community, viii. viii. conclusion.

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Rewriting the human genome, rewriting human rights law? Human rights, human dignity, and human germline modification in the CRISPR era

Britta van Beers is professor of Biolaw and Bioethics at VU University Amsterdam, Faculty of Law, Department of Legal Theory. Britta van Beers teaches and writes about the legal–philosophical aspects of the governance of biomedical technologies. She is particularly intrigued by the legal and philosophical questions raised by assisted reproductive technologies, such as wrongful birth and wrongful life claims, selective reproduction, and reproductive tourism. In more recent work, she has focused on issues related to personalized medicine and human gene editing. She has actively contributed to public debates on new technologies by writing essays and op-eds, and speaking as an expert for the Dutch Senate and House of Representatives. Her publications include the volumes Personalised Medicine, Individual Choice and the Common Good (co-edited with Sigrid Sterckx and Donna Dickenson, Cambridge University Press 2018), Symbolic Legislation and Developments in Biolaw (co-edited with Bart van Klink and Lonneke Poort, Springer 2016), and Humanity across International Law and Biolaw (co-edited with Wouter Werner and Luigi Corrias, Cambridge University Press 2014).

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Britta C van Beers, Rewriting the human genome, rewriting human rights law? Human rights, human dignity, and human germline modification in the CRISPR era, Journal of Law and the Biosciences , Volume 7, Issue 1, January-June 2020, lsaa006, https://doi.org/10.1093/jlb/lsaa006

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In most legal orders, human germline modification is either prohibited or severely restricted. A recurring thought in these legal frameworks is that heritable genome editing would result in practices that are at odds with principles of human rights, such as dignity, justice, and equality. However, now that CRISPR is bringing heritable genome editing within human reach, the question has risen as to whether these human rights bans still make sense. The call is growing louder to lift the ban on heritable genome editing for therapeutic purposes as soon as the technology is safe for introduction in the clinic. This article critically examines these recent proposals from a human rights perspective. First, it examines the question as to how realistic the proposed distinction between the therapeutic and the nontherapeutic uses of human germline modification is in the CRISPR era. Second, it argues that these proposals rely on a one-dimensional understanding of the meaning of human rights for this issue. Finally, it suggests that this one-dimensional understanding paves the way for a regime of self-regulation by the scientific community that leaves little room for public debate on the question as to whether or how human germline modification fits in the long-term aspirations of society.

In November 2018, biophysicist, He Jiankui, announced on YouTube 1 that two genetically modified babies, ‘beautiful little Chinese girls named Lulu and Nana’, had come ‘crying into the world as healthy as any other babies’. 2 The Chinese scientist had used the genetic cut-copy-paste technology CRISPR-Cas9 to modify the DNA of human embryos and then implanted these for a pregnancy. With his ‘genetic surgery’, as he calls it himself, He had targeted a gene called CCR5 in an effort to create babies who are resistant to infection from HIV. In total, he involved eight couples in this project, of whom the male partner is HIV-positive. Two days after his YouTube announcement, while speaking during the International Summit on Human Genome Editing in Hong Kong, He informed a stunned audience that a third genetically modified baby was on its way. 3

The news on the Chinese ‘CRISPR babies’ sent a shockwave throughout the world. Members of the global scientific community responded with a mixture of indignation and horror upon learning how He had defied scientific conventions, ignored basic rules for research on human subjects, and violated multiple norms of medical practice. The technology that He used is still in a very experimental stage, and much work needs to be done to make it safe and effective. Indeed, his data suggest that the procedure was only partially successful, if at all, resulting in a mosaic of altered and unaltered cells for both embryos 4 and off-target genetic changes. 5 Moreover, the on-target modifications lead to a novel genetic variation of CCR5 that is similar but not identical to the known mutation of CCR5 that confers natural HIV resistance. 6 As such, He and his team created genetic ‘changes that had never been seen in humans before’. 7 Yet He chose to go ahead, thereby exposing the health of the twins to huge risks. As Jennifer Doudna, one of the inventors of CRISPR-Cas9, summarizes the scientific upheaval: ‘He’s fateful decision to ignore the basic medical mantra of “do no harm” and risk the unintended consequences will likely be remembered as one of the most shocking misapplications of any scientific tool in our history.’ 8

Nevertheless, it is clear that the birth of a genetically modified baby ‘was something everyone in the burgeoning, multibillion-dollar field of genome editing knew would come one day.’ 9 In contrast, for the public at large, the news served as a wake-up call on the possibilities of human germline gene editing (HGGE) and its potentially far-reaching implications for the future of human reproduction. If He’s claims are true, then it can be said that he has single-handedly brought humankind a significant step closer to taking genetic fate into its own hands. Admittedly, reproductive technologies such as noninvasive prenatal testing (NIPT) and preimplantation genetic diagnosis (PGD) have made it technologically possible to genetically select a certain type of child for quite some time. Yet in those cases of selective reproduction, the child’s entire genetic profile is still the outcome of a biological recombination of parental genes. CRISPR opens up the possibility of genetically modifying one’s offspring. That means that it becomes possible to override the outcomes of the genetic lottery.

How should legal orders respond to the birth of the ‘CRISPR babies’? Interestingly, both national and international legal systems have long anticipated the arrival of this groundbreaking technology. Already since the late 1990s, when the first legal frameworks for the regulation of biomedical developments came into existence, the use of HGGE technologies for reproductive purposes has been prohibited in many national and international jurisdictions. A recurring thought in these legal frameworks is that genetically modifying offspring results or may result in practices that are at odds with human rights and their underlying principles, such as dignity, justice, and equality. However, now that HGGE has come within human reach, a worldwide debate has erupted about the question as to whether these human rights bans still make sense in the CRISPR era. As I will discuss hereafter, the first cracks in existing human rights legal frameworks are starting to appear. Moreover, in scientific, political, and academic circles, the call is growing louder to move from prohibition to regulation of HGGE. According to these recent proposals, the ban on heritable genome editing can be lifted for therapeutic purposes as soon as the technology is safe for introduction in the clinic.

In this article, I examine the shift that is currently taking place in the discussion on human rights and HGGE. I argue that many of the calls to lift or reconsider existing bans and restrictions on HGGE are rooted in a novel, but impoverished understanding of the meaning of human rights for this issue. To substantiate that claim, I compare the understanding of human rights which underlies these recent proposals with the human rights approaches to HGGE as contained in existing legal frameworks in this field, such as UNESCO’s Universal Declaration on the Human Genome and Human Rights (1997) and the Council of Europe’s Convention of Human Rights and Biomedicine (1997).

I start with an overview of the technological (Section II) and legal developments (Section III) that preceded the birth of the first CRISPR babies. This is followed by an examination of proposals to allow HGGE for therapeutic purposes once the technology is safe for clinical application (Section IV). In the remainder of the article, I offer a critical analysis of these proposals on three levels. First, I examine the question as to how realistic the proposed distinction between the therapeutic and the nontherapeutic uses of human germline editing is in the CRISPR era (Section V). Second, I argue that these proposals rely on a one-dimensional understanding of the meaning of human rights for this issue (Section VI). Finally, I suggest that this one-dimensional understanding paves the way for a regime of self-regulation by the scientific community that leaves little room for public debate on the question as to whether or how HGGE fits in the long-term aspirations of society (Section VII).

For a few years now, 10 scientists worldwide are using CRISPR-Cas9 to modify the genetic code of organisms. As CRISPR offers the possibility of cut, copy, and paste with the letters C, G, A, and T in which DNA is encoded, this process is also known as gene editing. This revolutionary technology is relatively cheap and easy to use. Even amateurs have discovered CRISPR. Do-It-Yourself CRISPR kits are available online, offering so-called biohackers the opportunity to experiment with DNA in their home labs and garages, including their own DNA. 11 Members of the biohacking movement have embraced CRISPR as a means to bring an end to the biotech sector’s monopoly on genetic engineering and thereby ‘democratize’ the life sciences. Yet, also for the biotech sector, the possibilities of CRISPR are myriad. The commercial stakes are high in the pursuit of CRISPR applications, as is strikingly illustrated by the CRISPR ‘patent wars’ 12 that are currently taking place.

Correspondingly, CRISPR is already having a real impact on the world of plants and animals. Various types of apes, dogs, birds, insects, and fish have been ‘welcomed to the CRISPR zoo’. 13 Wild plans are made, ranging from bringing back extinct animals such as the mammoth to producing ‘micropigs’ that grow to only around 15 kilograms, as a new type of pet. Indeed, as a 2016 article in the journal Nature on the subject concludes, ‘the CRISPR zoo is expanding fast and the question now is how to navigate the way forward’. 14

In the light of the birth of the genetically modified babies in China, these last words have acquired a new urgency. If, at some point in the future, the technology is deemed safe for application on human life, would there be convincing reasons against welcoming the human species to the CRISPR zoo too? If there are not, how can legal orders guide this process of human ‘self-domestication’ 15 into the right direction, ensuring a sustainable, responsible, and equitable usage of this technology? Will existing legal bans on genetic modification have to make place for regulatory frameworks in that process? If so, will the formulation of a set of ‘rules for the human zoo’ be necessary in order to actively confront the challenges of human genetic modification, as German philosopher Peter Sloterdijk argued two decades ago in his provocative essay of the same name? 16

In this discussion, two possible applications of CRISPR on humans should be distinguished. CRISPR can be used for the purpose of ‘somatic gene editing’. This type of genetic intervention affects the genes in the targeted cells of existing patients. As such, somatic modifications are not inherited by future generations. This article focuses on a different, more radical form of genetic modification: the use of CRISPR to alter the DNA of human embryos or gametes. This type of intervention is commonly known as human germline gene editing because it involves the genetic modification of germ cells. Unlike somatic gene editing, HGGE affects all body cells of the future individuals in question, from their brains and organs to their vessels and skin. Moreover, because the changes will equally come to expression in their gametes, the genetic modifications are also inherited by their offspring and their offspring’s offspring. In that sense, rewriting the human germline also means ‘rewriting the gene pool of future generations’. 17

Despite legal bans on germline editing, breakthroughs in this field have followed one after the other in recent years as part of what appears to be an international science race. That race took off in April 2015, when Chinese stem cell researcher Junjiu Huang and his team published an article in which they described their attempts to genetically modify human embryos. Although the researchers had used nonviable embryos for their study (thereby excluding the possibility of initiating a pregnancy), 18 and although they had failed to repair the targeted genetic deficiency, their CRISPR experiment created a huge upheaval: they had broken the taboo on using CRISPR to genetically modify human life.

Exactly a year later, in April 2016, a genetically modified Jordanian baby was born in Mexico. The boy’s birth did not become known until September 2016, when John Zhang, the New York-based Chinese–American fertility doctor who was responsible for the genetic modification, came forward with the news. 19 Zhang had not used CRISPR for the modification, but a procedure called ‘human nuclear genome transfer’ (HNGT) also known as ‘mitochondrial replacement therapy’. 20

First, Zhang and his team transplanted the nucleus of the intending mother’s egg cell into an enucleated egg cell donated by a third party. They then fertilized the resulting, composite egg cell with the intending father’s sperm. This particular HNGT technique is known as ‘maternal spindle transfer’. Because the gametes of three parties are brought together during HNGT, popular media referred to the event as the birth of the first ‘three parent baby’.

The parents had contacted Zhang because the mother is carrier of a mitochondrial disorder: Leigh Syndrome. By replacing her dysfunctional mitochondrial DNA with the egg donor’s healthy mitochondrial DNA, Zhang aimed to prevent the transmission of the mitochondrial disorder to the boy. How successful the intervention was, especially given possibly adverse long-term effects on the boy’s health, 21 remains to be seen.

It should be noted at this point that only 15–20 per cent of all mitochondrial diseases are caused by mutations in mitochondrial DNA. For the remaining 80–85 per cent, nuclear genome transfer is useless. 22 However, HNGT can also be used for other purposes. Indeed, a few months after the birth of the Jordanian boy, in January 2017, another ‘three parent baby’ was born, a Ukrainian girl, as part of a fertility treatment. This time, a different HNGT technique was used, pronuclear transfer, which involves transferring the nuclear material of the intending mother’s fertilized egg into a fertilized enucleated donor egg. The Ukrainian fertility clinic in question had used HNGT because the 34-year-old intending mother had been suffering from ‘unexplained infertility’. 23 In a similar vein, the aforementioned John Zhang was making plans to offer HNGT on a commercial basis for the rejuvenation of egg cells through his start-up ‘Darwin Life’, 24 until the US Food and Drug Administration sent him a warning. 25

HNGT has a much smaller genetic impact than CRISPR germline editing. It only affects mitochondrial DNA, which constitutes less than 1 per cent of a person’s total DNA, thereby leaving the nuclear DNA unaffected. Even so, there are convincing reasons to regard HNGT as a form of human germline genetic modification. 26 First, it is hard to deny that the procedure affects the genetic composition of germline cells. Second, if daughters are born, as was the case in Ukraine, they will pass on these genetic changes to their offspring (inheritance is generally 27 through the maternal line).

In the summer of 2017, the first successful CRISPR modification of embryonic nuclear DNA took place. The Kazakh–American biologist Shoukhrat Mitalipov and his American–Chinese–South-Korean team managed to repair a genetic mutation that is linked to a serious heart disease. 28 The resulting ‘CRISPR embryos’ were, however, not implanted for a pregnancy. With the birth of the Chinese ‘CRISPR babies’ in November 2018, this last step now also seems to have been taken.

Although He’s actions were widely condemned, the science race still appears to be in full swing. In June 2019, the Russian molecular biologist Denis Rebrikov announced his intentions to genetically modify human embryos for reproductive purposes before the end of the year, targeting the same gene as He did. 29 In addition, he unfolded plans to use HGGE to prevent the transmission of deafness. 30 Rebrikov is already conducting experiments on human egg cells to be able to achieve this goal. 31 His long-term plans include using HGGE to target genes related to dwarfism and blindness. 32

From a legal perspective, the widespread condemnation of He’s efforts to create genetically modified babies is quite understandable. ‘Globally’, as Françoise Baylis writes, ‘the political consensus on heritable human genome editing—such as it is—inclines toward an outright ban, and if not a ban, at least a moratorium.’ 33 Interestingly, the oft-heard expression that the law inevitably lags behind technological developments proves false in the case of HGGE. Most existing legal bans and restrictions have been effective for quite a while. Indeed, from the very first debates on the regulation of biomedical developments, the possibility of genetically designing children played a vital role within the public imagination. 34 Moreover, in that context, human rights and human dignity are often invoked as main frame of reference. However, even if the first bans on HGGE were established already in the late 1990s and are typically rooted in human rights discourse, these legal frameworks are currently under pressure. The first cracks are starting to appear ever since CRISPR and HNGT put human germline genetic modification back on the legal–political agenda. In this section, I first explore national legal frameworks in this field (Section III.A). I then examine the international legal landscape (Section III.B). Finally, I address several pressing questions with regard to these legal frameworks (Section III.C).

III.A. III.A. National legal approaches to human germline modification

Most countries with legal frameworks for the regulation of biomedical developments either ban or severely restrict HGGE technologies. 35 Admittedly, the scope, means, and nature of these national bans and restrictions vary greatly. 36 At one end of the spectrum, there are countries where human germline modifications are categorically prohibited and accompanied by criminal sanctions, such as many European countries, Australia, Canada, and Brazil. 37 At the other end of the spectrum, there are countries which allow, for example, HGGE for research purposes. Yet, also these more permissive national orders, of which China, the USA, and the UK are the most prominent, have laws and regulations that impose strict limits to the use of this technology. A brief look at the regulatory situations in the latter three countries can make that clear.

As mentioned earlier, the first attempt at human germline modification was made in China, and the first genetically modified babies were born in China. Hence, one would expect the Chinese rules on germline editing to be lax. However, China equally bans genetically modifying offspring. A Chinese ministerial guideline provides that ‘gene manipulation on human gametes, zygotes and embryos for the purpose of reproduction is banned.’ 38 The National Health and Family Planning Commission is responsible for the enforcement of this rule. Accordingly, Chinese officials have denounced He Jiankui’s actions as ‘extremely abominable in nature’ and in violation of Chinese laws and science ethics. 39 For a long time, it was unclear how He Jiankui would be punished. The existing rules do not mention any penalties for violating the aforementioned ban. Nevertheless, in December 2019, He Jiankui was sentenced to 3 years in prison. Moreover, in response to the scandal, Chinese authorities have proposed to tighten the rules and introduce penalties. 40

Also in the USA, the most prolific country with regard to basic genome editing research, 41 several legal limits to HGGE are in place. These limits are part of what has been called ‘a complex regulatory and statutory web concerned with human embryo research in general and human germline modification in particular.’ 42 Although HGGE is not formally prohibited, currently several mechanisms, taken together, practically impede the clinical introduction of this technology. First, the National Institutes of Health, which is responsible for research funding in the USA, has stated that it ‘will not fund any use of gene-editing technologies in human embryos’. 43 Second, the US Food and Drug Administration, which has the authority to regulate products and drugs involving gene editing, including human gene editing, has so far stood in the way of using HGGE for reproductive purposes and is also not likely to change its policy in the near future. Since December 2015, US Congress has regularly added an amendment to the FDA’s funding bill, a so-called ‘bill rider’, making it impossible for the FDA to consider any application which involves ‘research in which a human embryo is intentionally created or modified to include a heritable genetic modification’. 44 Without the FDA’s approval, implantation of a genetically modified human embryo is illegal in the USA. However, genetically modifying human embryos for research purposes are permitted, even though such experiments remain ineligible for public funding. 45

Finally, the UK legal situation is worth mentioning in this context. The UK can be said to be at the forefront of germline editing because of its status as first country in the world to explicitly permit HNGT. In 2015, after many years of political debate, the UK Parliament gave green light to the clinical use of HNGT, 46 resulting in the ‘Mitochondrial Donation Regulations 2015’. 47 The UK’s decision to legalize HNGT for the purpose of preventing mitochondrial disorders was much discussed worldwide. As legal scholar Samvel Varvaštian explains the controversy: ‘the UK has not only become the first state to explicitly allow mitochondrial donation, but the first to openly challenge the fragile global policy with regard to germline gene modification.’ 48

Nevertheless, HGGE for reproductive purposes, in general, remains prohibited in the UK. According to the ‘Human Fertilisation and Embryology Act 1990’ (HFE Act), all uses of gametes and embryos outside the body are prohibited unless carried out on the basis of a license issued by the Human Fertilisation and Embryology Authority. Some activities cannot be licensed according to the HFE Act and are therefore absolutely prohibited. One of these activities is placing embryos or gametes other than ‘permitted embryos or gametes’ in a woman. According to Section 3ZA(4b) of the HFE Act, an embryo can only qualify as a ‘permitted embryo’ if ‘no nuclear or mitochondrial DNA of any cell of the embryo has been altered’. However, in 2008, an opening was created for HNGT when, during the 2008 revision of the Act, Section 3ZA(5) was added, which stipulates the following:

Regulations may provide that an egg can be a permitted egg, or an embryo can be a permitted embryo, even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease.

This is exactly what happened in 2015: Parliament voted in favor of regulations that make an exception to the general ban on germline editing to allow HNGT to prevent passing on serious mitochondrial diseases. 49 Nevertheless, also under this regulation, the use of HNGT for fertility treatment remains off-limits.

In sum, despite the wide variety of regulatory frameworks, there is broad consensus that HGGE is a technology with potentially far reaching consequences and that bans and restrictions are in order. Moreover, in most legal orders, the ban on reproductive HGGE appears to be firmly established: an extensive legislative procedure will be needed to lift it. The latter is also the case for the UK. The possibility that was built into the HFE Act in 2008 to amend the definition of ‘permitted embryo’ was, as explained, a constrained one. If the UK government ever wanted to lift the ban on editing the nuclear DNA of human embryos, it would have to go through the much more drastic process of changing its primary legislation.

However, this is not the case for all countries, as the legal situations in China and the USA indicate. In these countries, the existing legal frameworks can be adapted much more easily. As the Chinese prohibition is contained in a ministerial guideline, it can presumably be amended without having to pass through a legislative, parliamentary procedure. Moreover, as the UK Nuffield Council on Bioethics writes, ‘encouraged by international competition and given its Confucian traditions, China appears to be a candidate to lift the ban on intergenerational genome editing if sufficient evidence was adduced to support a move into clinical use.’ 50

As to the US restrictions on HGGE, these may be changed without any rigorous legislative revisions, for example, if the NIH changes its funding policy or if the FDA would be able to consider an application for human germline editing. Indeed, in June 2019, several Democratic lawmakers proposed to eliminate the bill rider which currently stands in the way of the FDA to consider trials for HGGE. 51

If the bans in these countries were lifted, and the Rubicon thus be crossed, it is likely that other countries will follow their example in today’s competitive ‘knowledge economy’. Moreover, it can be expected that medical tourism will bolster this legal ‘domino effect’, thereby creating the risk of a race to the bottom. This makes the question as to the international legal norms in this field all the more urgent.

III.B. III.B. International legal approaches to human germline modification

Characteristic for existing international human rights frameworks on biomedical technologies is the thought that with the application of germline genetic modification, a fundamental line would be crossed for humankind from which there is no turning back. 52 A striking illustration is the legal approach chosen by the Council of Europe, whose European Convention on Human Rights is effective in 47 states. Already in 1982, the Parliamentary Assembly of the Council of Europe considered in its ‘Recommendation on genetic engineering’ that ‘the rights to life and to human dignity protected by Articles 2 and 3 of the European Convention on Human Rights imply the right to inherit a genetic pattern which has not been artificially changed’. 53 These words are an early expression of the idea that human rights are of special importance within the regulation of human genetic technologies and that restrictions to the use of genetic technologies may be in order to ensure the protection of the fundamental values and rights protected by human rights discourse. 54 However, the Recommendation left the question unanswered as to what the exact scope of the proposed restrictions to germline interventions should be. 55 Instead, it recommended that the Committee of Ministers performs this task at a later stage by drawing up a European agreement on the topic, based on the rights and principles that are contained in the European Convention on Human Rights. 56

In 1997, this European agreement would take on the form of the ‘Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine’. As this treaty was opened for signature in Oviedo, Spain, it is more commonly known as the ‘Oviedo Convention’. The Oviedo Convention is the first international legally binding instrument in the field of biomedical law. According to Article 13 of this convention, ‘an intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.’ The emphasized words imply a categorical ban on using HGGE for reproductive purposes.

According to the Oviedo Convention’s Explanatory Report, the prohibition contained in Article 13 goes back to the thought that misuse of HGGE ‘may endanger not only the individual but also the species itself.’ This sentence is a direct reference to the following, central phrase within the convention’s preamble: ‘convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being’. In the light of this reference, it appears that human dignity is one of the prohibition’s underlying principles, even if it is not mentioned explicitly by the Explanatory Report at this point. Indeed, the concept of human dignity is generally interpreted as a principle which protects the interests of both the individual and humanity, as is discussed more elaborately in Section VI. This raises the question as to how human dignity would be at stake in the context of the ban on HGGE. An answer is provided by the subsequent phrase in the Explanatory Report: ‘the ultimate fear is of intentional modification of the human genome so as to produce individuals or entire groups endowed with particular characteristics and required qualities’. 57

More recently, the ban on reproductive HGGE has been reaffirmed by both the Council of Europe’s Parliamentary Assembly 58 and Committee on Bioethics. 59 At this point, it should be noted, however, that the Oviedo Convention has actually entered into force in only 29 of the 47 Council of Europe’s member states. The states that are missing in this list have diverging reasons for not signing or ratifying the convention. Germany, for example, abstained from signing because the treaty was deemed too permissive. 60 The UK, on the contrary, did not sign because the convention was considered too restrictive. 61 Another interesting case is Ukraine, where the first baby after pronuclear transfer was born, as described above. This country signed the Oviedo Convention but failed to ratify it.

Nevertheless, member states that have not signed or ratified the Oviedo Convention are still faced with a ban on HGGE, albeit in a different form, if they are also European Union member states. 62 For over two decades, the EU has regarded germline gene modification as conflicting with fundamental values of the European legal order. ‘There is’, in the words of the preamble of the ‘Biotech Directive’ (1998), ‘a consensus within the Community that interventions in the human germ line and the cloning of human beings offend against “ordre public” and morality’. 63 Correspondingly, Article 6 of the Biotech Directive excludes from patentability ‘processes for modifying the germ line genetic identity of human beings’ and ‘processes for cloning human beings’. Also, within this context, human dignity played an important role in the legislative process. Recital 16 of the Biotech Directive emphasizes that ‘patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person’. The Court of Justice has taken this to mean that ‘the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could thereby be affected’. 64

Within the EU ‘Charter of Fundamental Rights’ (2000), the interconnections between human rights, human dignity, and biomedical developments in EU law are further elaborated. The Charter’s first chapter, entitled Human dignity , includes a ‘prohibition of eugenic practices, in particular those aiming at the selection of persons’ [Article 3(2) sub b]. Of more direct importance to human germline editing are the EU rules on clinical trials that were introduced in 2001. According to both the ‘Clinical Trials Directive’ 65 and its successor, the ‘Clinical Trials Regulation’, 66 ‘no gene therapy clinical trials may be carried out which result in modifications to the subject’s germ line genetic identity.’ 67 As a clinical trial is indispensable for the safe introduction of HGGE in the clinic, it could be said that the reproductive use of germline modification technologies is effectively blocked by this legal provision. Even so, there is discussion on the question as to whether the EU rules on clinical trials formally apply to trials involving HGGE, as those will be discussed in the next subsection.

Also outside Europe international human rights norms have been established for HGGE, with UNESCO’s ‘Universal Declaration on the Human Genome and Human Rights’ (1997) as main example. The declaration is not a legally binding instrument. Like the Oviedo Convention, it expresses the thought that germline editing touches upon the collective interests of humanity, albeit in a slightly different way. As Article 1 states, ‘The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity’. What these words mean for HGGE is suggested by Article 24, in which the International Bioethics Committee (IBC) is assigned the task to disseminate the principles set out in the declaration. According to this provision, the task also entails giving ‘advice concerning the follow-up of this Declaration, in particular regarding the identification of practices that could be contrary to human dignity, such as germ-line intervention.’

If there were any remaining doubts on UNESCO’s position on HGGE, these are taken away in a recent report. In this report from 2015, the IBC offers reflection on the relation between human rights and the human genome in the light of recent technological developments, including not only the rise of personalized medicine, NIPT, and direct-to-consumer genetic testing but also human germline editing. As to the latter, the IBC expresses its support for the Oviedo Convention’s ban. Building on Article 1 of the Declaration and its notion of the human genome as the heritage of humanity, the IBC states that making any genetic changes which are passed on to descendants should be prohibited. 68 According to the committee, ‘the alternative would be to jeopardize the inherent and therefore equal dignity of all human beings and renew eugenics, disguised as the fulfillment of the wish for a better, improved life’. 69

III.C. III.C. Persisting ambiguities and current discussions

Although various formulations are used within the international legal frameworks in this field, it is clear that human dignity emerges as a core idea. According to UNESCO, the Council of Europe, and the EU, this legal principle is compromised as soon as eugenic practices emerge, human reproduction degenerates into the production of humans, or children are reduced to objects of design.

Yet, many questions remain. UNESCO’s IBC, for example, is ambiguous about its exact position on HGGE. As discussed, the IBC supports the Council of Europe’s ban on the use of this technology for reproductive purposes. However, in its report’s final recommendations, the IBC appears to take a slightly different position than the Council of Europe by advocating a differentiated approach to human cloning 70 and HGGE. In the IBC’s words:

The IBC reaffirms the necessity for a ban on human cloning for reproductive purposes and recommends a moratorium on genome editing of the human germline. There is no medical or ethical argument to support the former. As to the latter, the concerns about the safety of the procedure and its ethical implications are so far prevailing’ (emphasis added). 71

Unfortunately, what the exact implications of the IBC’s distinction between ‘ban’ and ‘moratorium’ are in this context and what its words ‘so far’ allude to remains unexplained. Does this mean that the IBC could change its position depending on the circumstances and that it does not endorse a categorical ban? If so, then these recommendations are at odds with the IBC’s firmly expressed concerns about HGGE, dignity and justice, as expressed earlier in the report.

Furthermore, discussion is possible on the exact scope of the various existing prohibitions, also in EU law. For example, what is exactly meant by the term ‘eugenic practices’ to which the EU Charter of Fundamental Rights refers? According to the explanatory memorandum, ‘the reference to eugenic practices, in particular those aiming at the selection of persons, is related to possible situations in which selection programs are organized and implemented, involving campaigns for sterilization, forced pregnancy, and compulsory ethnic marriage among others’. 72 This list seems to suggest that cases in which selective reproduction is the outcome of individual, voluntary decision-making, in other words, instances of ‘liberal eugenics’, do not qualify as ‘eugenic practices’ under this provision. At the same time, the words ‘among others’ indicate that this list of possible eugenic situations is not exhaustive.

More specific questions have risen about both the EU Biotech Directive’s and the Clinical Trials Regulation’s references to ‘the germ line genetic identity’. When can it be said that a germline intervention affects the future person’s germline genetic identity? Is this the case for all types of germline interventions, or only more radical ones? A possible line of reasoning is that HNGT falls into a category of germline interventions that do not affect the future person’s genetic identity, and therefore remains outside the scope of both provisions. However, as a number of ethicists point out, this line of reasoning has serious weaknesses. 73 In their words, ‘modification of the mitochondrial DNA is not substantively different from modification of the nuclear DNA in terms of its effects on the identity of the future person’. 74

Nevertheless, both UK and Dutch legislature, for example, have come to a different conclusion. In the UK and The Netherlands, modifications of nuclear embryonic DNA are banned, whereas modifications of nuclear mitochondrial DNA are not. It seems that the lawmakers of both EU states (at the time, the UK still was an EU member state) have interpreted the EU legislation’s references to ‘genetic identity’ to mean that only modifications of nuclear embryonic DNA are targeted by the current bans, thus leaving the possibility open for member states to permit modifications of mitochondrial DNA. 75 Even so, despite the absence of a national legal ban, The Netherlands has, as of yet, neither explicitly nor actively endorsed this technology. This is due to other legal provisions that impede the use of HNGT. 76 In the UK, on the contrary, clinical trials were given the green light in December 2016 by the HFEA, which was hailed by the journal Nature as a ‘historic decision’. 77

However, media reports from 2019 suggest that the UK was probably not even the first EU member state to permit clinical trials in this field. 78 Equally in 2016, Greek health authorities gave permission for clinical trials involving HNGT. This information was not shared with the general public until a Spanish–Greek team of fertility doctors announced in April 2019 that a genetically modified baby had been born in Greece after an IVF procedure with HNGT. This boy is not only the ‘first three parent baby born in clinical trial to treat infertility’, as media headlined, 79 but also the first ‘three parent baby’ born in the EU. The purpose of the nuclear genome transfer had not been to prevent passing on mitochondrial disorders, which is the sole purpose for which HNGT can be used in the UK. Instead, like the Ukrainian case, the fertility doctors sought to increase the chances of a successful fertility treatment. The team that initiated the procedure, the Spanish company Embryotools, had decided to move the trials to Greece because of legal hurdles in Spain. 80 The Greek National Authority of Assisted Reproduction formally approved these clinical trials at the end of 2016, 81 apparently assuming that EU clinical trials legislation permits this kind of germline intervention.

In addition to these discussions about the meaning of ‘genetic identity’, there is disagreement about the meaning of the terms ‘clinical trials’ and ‘subject’ as used in the EU Clinical Trials Directive 82 and Regulation. 83 For example, in its 2018 report on HGGE, the British Nuffield Council of Ethics raises the question as to whether HGGE clinical trials would fall within the EU law’s definition of a clinical trial, given the centrality of the notion ‘subject’ in that definition. 84 The authors of the report have doubts because the germline intervention is performed on embryos and not fully grown individuals. 85 Against this view, the argument can be made that the subject in question is not so much the embryo but rather the future person that will be born after the genetic intervention.

During the parliamentary debates on HNGT, the UK Department of Health used a different line of reasoning to arrive at the same conclusion. It argued that trials for HNGT are actually, not clinical trials in the sense of the EU Clinical Trials Regulation and that, therefore, the ban does not apply to this situation. In essence, the Department argued that when Article 90 of that Regulation posits that ‘no gene therapy clinical trials may be carried out which result in modifications to the subject’s germ line genetic identity’, the Regulation does not mean to imply anything for trials in the field of germline interventions. For this position, the Department offers two reasons.

First, this regulation is formally known as the ‘Regulation on clinical trials on medicinal products for human use’ (emphasis added). According to the Department, no medicinal products are involved with HNGT. Ergo , the Regulation does not apply. Second, the Health Department points out that Article 2(1) defines clinical trials as having ‘the objective of ascertaining the safety and/or efficacy of […] medicinal products’. The Department argues that the licenses which the HFEA issues to clinics to perform HNGT cannot qualify as ‘clinical trials’ because they ‘will not be licensed with the objective of ascertaining the safety and/or efficacy” of the treatment. The primary objective will be to prevent the transmission of serious mitochondrial disease’.

Nonetheless, the licenses that the HFEA has issued in the meantime are widely perceived as official permissions to perform clinical trials in this field. 86 Furthermore, the Health Department’s interpretation is questionable because the broad wording of Article 90 suggests ‘that it was intended to prohibit all gene therapy clinical trials involving germline editing, irrespective of whether they relate to medicinal products.’ 87 Finally, the Department’s position that no medicinal products are involved in case of HNGT can be challenged in the light of ongoing discussions about the meaning of the term ‘medicinal products’. 88 Varvaštian observes in this context ‘that the compliance of the Mitochondrial Donation Regulations 2015 with the EU legislation on clinical trials could indeed be questioned by the European Court of Justice, should a case be brought before it.’ 89

Such a court decision could have a huge impact. Either the UK and Greece rely on a wrong interpretation of Article 90 and would have to stop their clinical trials (that is, as long as the UK is still a member state), or the UK and Greece are right, in which case the ruling would not only affect the governance of HNGT, but, possibly, of HGGE at large. After all, many of the arguments made to allow HNGT trials under the Clinical Trials Regulation, equally remove clinical trials for HGGE from the scope of the clinical trials directive.

A final important question that needs to be addressed is what the existing prohibitive or restrictive legal approaches to germline modification imply for research in this field. For example, although EU law prohibits clinical trials in which the subject’s germ line genetic identity is affected, the question remains unanswered as to what the rules are for preclinical or basic research in this field. According to the European Group on Ethics in Science and New Technologies (EGE), which is the European Commission’s advisory body on ethical matters, not only the clinical application of this technology would be ground for serious concerns, but also the research activities in this field, ‘given the profound potential consequences of this research for humanity’. 90 However, the EGE fails to indicate how these concerns should be translated in either law or policy and what this means for the various stages of research.

The Oviedo Convention is less ambiguous in that regard. This treaty contains, what could be called, a de facto ban on research in this field. Article 18(2) of the Oviedo Convention prohibits the creation of embryos for research purposes. Nonetheless, research aimed at developing HGGE requires one-cell stage embryos, which can only be obtained by creating embryos for research purposes. 91 Embryos that are left over from an IVF treatment are not suitable for this purpose. This means that this kind of research is practically impossible in those countries that have ratified the Oviedo Convention.

In several countries that have not signed the Oviedo Convention, such as Germany and Canada, a more explicit, overall prohibitive approach can be found. 92 In these countries, editing the human germline involves crossing a red line, regardless of whether the intervention serves research or reproductive purposes. Isasi, Kleiderman, and Knoppers suggest that this type of prohibitive approach, with ‘upstream’ limitations on research activities in this field, is ultimately based on ‘a critical attitude toward science because of fears of commodification of potential life’, 93 be it unborn life (ban on creating research embryos) or the life of the person-to-be (ban on germline editing). However, one can also imagine a different line of reasoning: research in this field is prohibited because it can be regarded as lacking purpose as long as the reproductive use of HGGE is categorically prohibited in these countries.

As discussed in the previous section, both national and international legal orders have been well prepared for the rise of HGGE technologies. In this case, it can be said that law outpaced technology, instead of, as is often claimed, the other way around. At the same time, it is clear that the first cracks are becoming visible within the existing legal frameworks in this field. A clear sign is that two EU member states, the UK and Greece, are currently at the global forefront of HNGT, even though the European legal order is among the strictest when it comes to the governance of genetic modification technologies.

For now, the challenges to existing human rights frameworks mostly take on the form of legal-technical disputes on the exact scope and meaning of terms such as ‘germline genetic identity’ and ‘clinical trials’ or the distinction between bans and moratoria. Yet, it is quite evident that behind this façade of legal technicalities a substantial, normative shift is taking place. Indeed, where most legal discussions have so far focused on the terms used within existing laws, discussions elsewhere focus on the question as to whether it is time to revise these laws altogether.

Ironically, just when technological developments in this field have finally caught up with existing legal frameworks and legal bans and restrictions could thus start to play the role as originally intended by the legislatures, these frameworks are being called into question by various parties. A straightforward explanation for this situation is offered by legal scholar Henry Greely: at the time, when the bans and restrictions on this technology were called into existence, many people were still in favor because ‘it wasn’t hard to renounce something that you could not do.’ 94

Whatever the reason is, fact is that the call for a revision of existing laws on HGGE is growing louder, especially among scientific and medical-professional bodies, academies, and societies. 95 Examples are manifestos and open letters from groups of biomedical scientists, 96 statements from medical-professional organizations, 97 advisory reports from various national science academies, 98 concluding statements from international summits organized by science academies, 99 and recommendations from health and ethics councils. 100

What these proposals have in common is that they ‘do not favor an international treaty that would ban all clinical uses of germline editing’, 101 such as the Oviedo Convention’s ban. Such a prohibitive approach would be ‘too rigid’. 102 Instead, they advocate a ‘responsible,’ 103 ‘prudent path forward’. 104 This entails defining a ‘translational pathway to germline editing’, 105 along with developing a ‘pathway to effective governance’ 106 of this technology. According to this line of thought, bans on HGGE for reproductive purposes will be needed for the time being, for example through a self-imposed temporary ban (‘moratorium’) 107 from the science community. However, the idea is that this ban can be lifted as soon as clinical requirements are met. From that moment on, a governance model for HGGE will replace the existing bans on this technology. In essence, the proposals for regulation instead of prohibition rest on three tiers.

First, basic and preclinical research in this area should be facilitated in order to make a safe introduction of this technology in the clinic possible. On a practical level, this also means that bans on the creation of embryos for research purposes, such as, for example, contained in Article 18 of the Oviedo Convention, have to be lifted. Second, as soon as HGGE is found safe enough for introduction in the clinic, these proposals recommend lifting the ban on this technology. From then on, HGGE should be made available for strictly therapeutic purposes, that is, to eliminate serious genetic diseases and conditions. Reproductive use of HGGE for nonmedical reasons, such as improving intelligence or appearance, must remain prohibited, at least initially. 108 Third, the proposals underline the importance of a public debate on the issue. That public debate should focus on the conditions under which reproductive HGGE should be allowed.

How should these proposals for a regulatory pathway to reproductive HGGE be viewed from a human rights perspective? Evidently, they conflict with the existing bans on the clinical use of this technology, as contained in the Oviedo Convention and as suggested by UNESCO’s IBC. Nevertheless, both the Council of Europe’s Committee on Bioethics 109 and UNESCO’s IBC 110 have stressed the need for an ongoing public debate about the human rights questions raised by these technological developments. Indeed, Article 28 111 of the Oviedo Convention explicitly recognizes the general need for public debate on such questions. Moreover, it is widely recognized that even fundamental rights and their underlying principles are open to dynamic or evolutive interpretation. 112 Therefore, notwithstanding the current human rights bans on genetically modifying offspring, the need for a debate on the meaning of human rights for this technology has never been more urgent.

By means of this article, I hope to contribute to the debate. Hereafter, I formulate three concerns about the recent proposals for a regulatory pathway to HGGE, using human rights discourse as my main frame of reference. First, I argue that this model is based on a distinction between healing and enhancing offspring that may be useful and realistic enough for the regulation of PGD but is much more problematic in the case of human germline editing (Section V). Second, although these proposals also refer to human rights, they rely on an impoverished understanding of what human rights and human dignity mean in the context of biolaw (Section VI). Third and finally, I discuss how this impoverished understanding of human rights sets the stage for a type of deliberation on HGGE in which the voice of the scientific community dominates at the cost of more public perspectives (Section VII).

Have existing bans on HGGE become ‘outdated’ 113 in the light of recent technological developments? Should we ‘update’ these legal frameworks ‘to recognize, permit, and regulate new techniques to allow safe HGGE for therapeutic and preventive aims’? 114 At first sight, these thoughts, which can be recognized in publications from, for example, the US National Academies of Sciences, Engineering and Medicine (NASEM), the UK Nuffield Council on Bioethics, the Hinxton Group, the European Society of Human Reproduction and Embryology (ESHRE), the European Society of Human Genetics (ESHG), and several prominent scholars, 115 seem convincing. After all, how can one oppose the prevention of grave diseases?

Moreover, under most of these proposals, the use of HGGE with the purpose of enhancing offspring remains off-limits. From a human rights perspective, the distinction between healing and enhancing is a highly relevant one. For example, while Article 13 of the Oviedo Convention categorically bans heritable genome editing, it also states that human genetic modifications in general can only be undertaken for preventive, diagnostic, or therapeutic purposes. Similarly, Article 14 prohibits ‘the use of techniques of medically assisted procreation […] for the purpose of choosing a future child’s sex, except where serious hereditary sex-related disease is to be avoided.’

Furthermore, it can be argued that a regulatory model will be more realistic and effective than a prohibitive model. Alta Charo, for example, writes that ‘calling for a moratorium may feel satisfying, [but] it does little to stop rogue actors, nor does it help scientists who […] wish to pursue the technology cautiously and responsibly.’ According to this pragmatic line of reasoning, a comprehensive regulatory approach ‘will do more to control and guide this technology than a moratorium or formal ban.’ 116 In a similar vein, several authors fear that a prohibitive approach would fuel CRISPR tourism. 117

Finally, the fear for a slippery slope toward eugenics seems unfounded if a sound regulatory framework is established with strict and transparent limits to the use of HGGE. Indeed, the proposed regulatory frameworks show strong resemblance to the regulatory schemes that have been developed in many countries to regulate PGD. Hence, some refer to this governance model for HGGE as the ‘PGD model’. 118 Genetically selecting embryos for reproductive purposes through PGD are, typically, only permitted according to medically determined requirements, such as the gravity of the genetic condition for which PGD is used and whether it is untreatable. 119 These legal limits of PGD are usually established through a regulatory mix of national laws and medical-professional guidelines and appear to work quite effectively and convincingly in these countries.

However, in order to make the PGD model truly effective and feasible in case of HGGE, a clear demarcation of the terms ‘serious disease or condition’ is necessary. 120 If this turns out to be practically impossible, then those who, like Lanphier et al. , ‘oppose germline modification on the grounds that permitting even unambiguously therapeutic interventions could start us down a path toward nontherapeutic genetic enhancement’ 121 have a valid point. 122

Upon closer inspection, there are several substantial differences between PGD and human germline editing that suggest that it is problematic to apply the PGD model without reservations to germline editing. First, the risk of a slippery slope is much greater in case of HGGE. Contrary to PGD, HGGE breaks with the principle of reproduction through genetic recombination. Consequently, the number of possible choices increases exponentially. For example, as discussed, the Chinese genetically modified twins have a novel variation of the CCR5 gene that has not been seen in humans before. Moreover, in theory, it is possible to introduce not only nonparental DNA but also even nonhuman DNA. The Nuffield Council offers an interesting list of several possibilities opened up by CRISPR, including creating ‘supersenses or superabilities’ and ‘tolerance for adverse environmental conditions (such as those that might be envisaged as a result of climate change or in space flight)’. As the Nuffield Council explains, ‘what opens up these possibilities is a change in perspective from one focused on the achievement of a limited purpose—one that may have animated the initial research and innovation—to a vision animated by the exploitation of a technology to secure the maximum value from its use.’ 123 Accordingly, it can be said that the eugenic potential of HGGE exceeds that of PGD multiple times. 124

Second, compared with PGD, it will be even more difficult to define what ‘therapeutic’ means in case of HGGE. The Chinese CRISPR babies offer a striking illustration of that difficulty. Did He Jiankui’s intervention serve a medical purpose? The biophysicist sought to make the babies resistant to infection from HIV. In other words, he was not trying to cure them from a disease. Instead, he exposed these babies, with whom in principle nothing was wrong, to serious health risks. At the same time, the intervention could perhaps be labeled as medical, because its main purpose was the prevention of a disease: AIDS. 125

If the possible side effects of the genetic intervention are also taken into account, the discussion becomes even more complex. According to neurobiologists, it is quite likely that He’s intervention also affected various brain functions. More specifically, the inhibition of that particular gene has been linked to greater recovery of neurological impairments and improvement of cognitive functions. 126 It is, therefore, possible that He’s genetic modifications also resulted in human enhancement, more specifically, cognitive enhancement. 127 Such ‘incidental enhancements’ complicate line drawing substantially. 128

Third, in many cases of HGGE, it will be hard, if not impossible, to decide whether the interference yields an overall positive impact on the future child’s health, with positive effects outweighing the negative ones. Again, He’s ‘genetic surgery’ offers the perfect example of the complexities. Even if his genetic modification turns out to be successful, with off-target effects kept to a minimum, there still is a reason to doubt whether it has truly benefitted the twins. According to geneticists, the intended genetic mutation may provide resistance against HIV infection, but it also increases the vulnerability to infection from the West Nile virus and influenza. 129 As such, the Chinese case offers a glimpse of the complex trade-offs and vexing dilemmas with which the reproductive use of CRISPR would confront parents-to-be. 130

In short, HGGE is likely to result in a further blurring of the medical boundary between healing and enhancing. Moreover, it can be argued, as the Nuffield Council does, that ‘we have to take care when applying categories such as “therapy” and “enhancement” […] to the anticipation of people who do not yet (and may never) exist.’ 131

What does all of this imply for the governance of HGGE? For the Nuffield Council, the conclusion is that the medical boundary is too problematic to be able to function as a red line for human germline modification. 132 The advisory body proposes a new legal-ethical standard: the genetic intervention should serve the welfare of the future child. As the Nuffield Council explains, this means that ‘there is no a priori reason that preferences beyond the avoidance of disease should not also be consistent with the welfare of the future person.’ 133

It has to be said that the Nuffield Council’s proposal for governing HGGE is more realistic than the PGD model that is recommended by most scientific and professional bodies and organizations. However, the UK proposal is also much more radical: the medical boundary (which only allows interventions of a therapeutic or preventive nature) is abandoned, with the result that human enhancement also becomes one of the possibilities. 134 This is also problematic from a human rights perspective. As UNESCO’s IBC writes:

The goal of enhancing individuals and the human species by engineering the genes related to some characteristics and traits […] impinges upon the principle of respect for human dignity in several ways. It weakens the idea that the differences among human beings, regardless of the measure of their endowment, are exactly what the recognition of their equality presupposes and therefore protects. It introduces the risk of new forms of discrimination and stigmatization for those who cannot afford such enhancement or simply do not want to resort to it. 135

Evidently, another conclusion is also possible. If it is practically impossible to draw a sharp line between therapy and enhancement in this context, is the promise of a strictly regulated and limited use of HGGE not fundamentally illusory? Moreover, if HGGE remains prohibited, the interests of prospective parents with serious genetic diseases in their families can continue to be taken seriously. In almost all cases, PGD already offers these couples the possibility of reproducing without passing on their genetic disorders, with the added benefit that such an arrangement is considerably less risky and radical in nature.

A second set of questions elicited by the recent proposals to revise current laws on human germline editing relates to their understanding of the concept of human rights and human dignity. While this understanding tacitly informs many of these proposals, it is explicitly addressed by legal scholar Robin Alta Charo, who is a member of the organizing committee of the Hong Kong International Summit on Human Genome Editing and co-author of the 2017 NASEM report. In an essay she wrote on the occasion of a symposium the seventieth anniversary of the Universal Declaration on Human Rights, Alta Charo argues ‘that the current human rights law on germline editing misunderstands both the mechanisms of genetics and the moral basis for human rights, suggesting a more nuanced approach as we move forward and keep pace with new gene-editing technologies.’ 136 In other words, Alta Charo is open about the fact that her interpretation breaks with existing human rights approaches to this issue. Interestingly, as will be discussed hereafter, her exploration of the moral basis of human rights even leads her to suggest that, ultimately, the concept of humanity may not be necessary for the proper functioning of human rights discourse at all.

It seems Alta Charo is not alone in her line of reasoning. In a similar vein, the recent calls for a regulatory pathway to HGGE do not or hardly make mention of humankind, human dignity, or the human species. To come to a better understanding of the normative shift that is thus taking place in this context, I first describe the vision of human rights and human dignity as implied by the existing human rights law on germline editing. I then juxtapose it with the vision on human rights as unfolded in the recent proposals to replace the bans on genetically modifying offspring with regulatory schemes.

Within the Oviedo Convention and the Universal Declaration on the Human Genome and Human Rights, fundamental interests of both an individual and a collective nature are protected. According to its Explanatory Report, the Oviedo Convention aims to address concerns about biomedical developments at three levels: the level of the individual; the level of society; and the level of the human species. 137 Similarly, UNESCO’s IBC states that the rise of HGGE necessitates reflection about the possible consequences of this technology ‘on human rights and freedoms as well as on the future of humanity itself.’ 138 Moreover, the IBC stresses that ‘ethics is not simply a matter of individual morality but it involves society as a whole’ and ‘must therefore also pursue the common good’. 139 In that context, the committee warns for ‘a radical conception of autonomy, according to which any medical progress should be at the disposal of patients, who are turned into consumers (clients).’ 140

Accordingly, human dignity is explained within this approach as a legal principle that not only affords protection to individual rights and freedoms (referred to within scholarly literature as ‘the individual dimension of human dignity’ or ‘dignity as empowerment’) but also to the collective interests of humanity upon which human rights are built (‘collective dimension of human dignity’ or ‘dignity as constraint’). 141 Concerns about both dimensions of human dignity can be detected in the Council of Europe’s and UNESCO’s approach to human germline editing.

As to dignity’s individual dimension, both human rights bodies, evidently, subscribe to the necessity of clinical safety. They also underline that new genetic technologies ‘are likely to offer unprecedented tools against diseases.’ 142 However, they are concerned that HGGE may give rise to new forms of discrimination and may impact negatively on the self-perception and sense of freedom of the resulting individuals. UNESCO’s IBC, for example, expresses the fear that social-economic inequalities will become engrained on a genetic level 143 and expresses concern about ‘the significant effects on the life of individuals who could be considered designed on demand by someone else without their consent’. 144

As to dignity’s collective dimension, these human rights bodies stress that, while genome editing in general is ‘one of the most promising undertakings of science for the sake of all humankind’, 145 reproductive HGGE may lead to a renewal of eugenics. 146 More specifically, as discussed above, international bans on this technology aim to prevent practices in which individuals or entire groups are produced with particular characteristics and required qualities. 147 The underlying logic appears to be that human dignity is affected by HGGE to the extent that this technology opens up the possibility of one person designing the other.

Within this approach, the collective and individual dimensions of human dignity are regarded as inextricably and fundamentally connected, even though it is clear that certain tensions may arise between both sides. The underlying thought which unites both dimensions is that fundamental freedoms cannot be exercised to the detriment of the collective foundations of these freedoms, which is the humanity of humankind. The IBC expresses this fundamental thought in the context of germline editing as follows: ‘the human genome [is] one of the premises of freedom itself and not simply […] raw material to manipulate at leisure.’ 148 The other way around, collective dignity should always serve the long-term goal of protecting individual dignity, 149 just as human dignity as empowerment and human dignity as constraint both serve to protect the individual. Without this caveat, there is a danger that individual freedoms are sacrificed to preserve ‘the dignity of the whole’. 150 Accordingly, Article 2 of the Oviedo Convention states that ‘the interests and welfare of the human being shall prevail over the sole interest of society or science.’

In line with the emphasis on both individual and collective interests, a recurring thought within this approach is that ‘the human genome, metaphorically speaking, belongs to all of us’, 151 and that, ‘in a symbolic sense, it is the heritage of humanity’ (Article 1 Universal Declaration on the Human Genome and Human Rights). As these technologies touch upon the future of human reproduction, they merit a broad international and societal debate. In other words, from this perspective, ‘no one has the moral warrant to go it alone’ when it comes to HGGE. 152

In contrast, many who advocate lifting the ban on HGGE neglect or even negate the collective dimensions of human rights. More specifically, whereas the Oviedo Convention addresses concerns at the level of the individual, of society, and of the human species, the recent proposals rely exclusively on the first two. In this vein, the Nuffield Council’s main line of reasoning with regard to HGGE rests on two principles: the principle of the welfare of the future person and the principle of social justice and solidarity. Accordingly, it recommends lifting the ban on HGGE, first, for purposes that are in line with the future child’s welfare (i.e. level of the individual) 153 and, second, in circumstances in which it cannot be reasonably expected to produce or exacerbate social inequalities (i.e. level of society). 154 As to concerns at the level of the human species, the Nuffield Council actively dismisses human dignity as a guiding principle for the governance of HGGE, 155 because of reasons that will be discussed below.

A similar line of reasoning can be detected in the NASEM report on human gene editing. The authors of this report describe their own normative framework as follows:

The committee focused on principles that are aimed at protecting and promoting the health and well-being of individuals; approaching novel technologies with careful attention to constantly evolving information; respecting individual rights; guarding against unwanted societal effects; and equitably distributing information, burdens, and benefits. 156

No mention is made of the various collective interests of humankind. Moreover, where the report does mention human dignity, it brings only dignity’s individual dimension to the fore, as in the following sentence: ‘The principle of respect for persons requires recognition of the personal dignity of all individuals, acknowledgment of the centrality of personal choice, and respect for individual decisions’ (emphasis added). 157

In brief, in both the NASEM and Nuffield Council report, the collective dimensions of human rights discourse and human dignity are pushed aside. What remains are considerations related to safety risks, individual rights, reproductive autonomy, and social justice. How can this normative shift be explained? The Nuffield Council invokes the well-known line of thinking that human dignity is a vague or even useless concept 158 and that it does not have added value to the functioning of human rights: ‘Whereas human dignity has been advanced by some as the basis of human rights, the coherent functioning of human rights discourse does not depend on accepting this claim’. 159 Moreover, even if it can be agreed that human dignity is the basis of human rights, then it would still not be at stake with HGGE. This is because ‘entitlement to human rights does not depend on the possession of a “human genome”’. 160 To suggest otherwise, would be to engage in ‘genomic essentialism’, the authors of the report argue. 161 Other authors, 162 including Alta Charo, 163 argue along similar lines.

I agree that such essentialism would indeed be problematic: the human species has evolved over time and it would be reductionist to understand both dignity and humanity in genetic terms. However, that is not what the existing human rights law in this field claims to protect. Indeed, Article 3 of the Universal Declaration on the Human Genome and Human states that ‘the human genome, which by its nature evolves, is subject to mutations.’ Accordingly, as discussed in Section III.B, the ban on HGGE as contained in human rights law is not so much about the preservation of the human genome, but about the fear that HGGE would give rise to new forms of discrimination and eugenics. 164

Furthermore, questions can be asked about the NASEM’s and Nuffield Council’s own understanding of humanity and dignity. As already discussed, in these reports, human dignity is equated with the protection of individual freedoms, thereby ignoring the collective dimension of that principle. This does impoverish not only human rights discourse but also the public debate on this issue, as will be discussed in the next section.

Moreover, these proposals appear to pave the way for a more transhumanist or posthumanist approach. As already discussed, the Nuffield Council is not willing to hold on to the medical boundary between healing and enhancing. Additionally, when discussing transhumanism in its report, the UK ethics body suggests that if human germline editing were to result in ‘the self-overcoming of the human species’, 165 this would not necessarily be problematic. Indeed, it may be warranted because of the huge impact that humankind is having on the environment in an age that is already being referred to as the ‘Anthropocene’. According to the Nuffield Council, if certain parts of the world became inhabitable because of air pollution or climate change, ‘genome editing could offer a remedy to this predicament by allowing the introduction of characteristics that will fit future generations better for the conditions in which they may be required to live.’ 166 Even though the authors of the report admit that ‘such a project would be reckless at present’, they argue that the precautionary principle ‘would at least seem to mandate further research and development of genome editing technologies as a way of hedging against future threats.’ 167 In other words, based on this remarkable view of the role that the precautionary principle would have to play in the Anthropocene, the authors argue that a good response to the negative impact that humans are having on the natural world would be to also subject ‘human nature’ to human intervention. This is in sharp contrast with views held by, for example, the German Ethics Council. According to the Council, given the fact that the current geological epoch is already referred to as the Anthropocene, and given the manner in which the human genome is strongly linked to individual and collective self-images of humankind, more extensive reflection processes are needed to be able to bear responsibility for the heavy decisions to come. 168

In a similar vein, Peter Mills, assistant director of the Nuffield Council, openly questions the humanist foundations of human rights discourse altogether. He argues that:

whatever the ground of ‘human’ rights is, it should be seen as a threshold rather than a property exclusive to natural kind or class. It follows, therefore, that such rights as are currently enjoyed by humans should equally extend to a non-human, a posthuman or even an artificial intelligence, who is capable of being welcomed into our moral community. 169

Alta Charo agrees with Mills on this. In the closing words of her essay on germline engineering and human rights, she raises the possibility of a human rights discourse that dispenses with the notion of the human altogether:

Understanding that Homo sapiens is a species with blurry boundaries, and that we carry within us genetic traits that trace back to Neanderthals and even far more primitive life forms, should make us question whether germline editing in any way undermines the basis for according human rights, and indeed, whether being human is essential to human rights at all. 170

Evidently, the idea of a human rights approach without a notion of the human is a radical departure from the humanist foundations of human rights discourse. Moreover, Alta Charo’s, Mills’, and the Nuffield Council’s line of argumentation raises the question as to whether their understanding of human rights and human dignity does not give rise to a self-destructive dynamic within human rights discourse: what, initially, appears as merely a reinterpretation of humanist notions such as human rights and freedoms gives rise, in the long run, to the possibility of an abandonment of humanism altogether or even a self-overcoming of the human species. 171

The neglect of the more communal or collective dimensions of human rights, as they come to expression in principles such as human dignity or the view of the human genome as heritage of humankind, also has repercussions for the terms in which the public deliberation about this issue is framed. Instead of asking the question which kind of future the human community wants to build for itself, the issue is narrowed to questions of safety risk, reproductive rights of prospective parents, and health interests of future children. Evidently, the health and rights of those directly involved in HGGE are of great concern and need to be taken very seriously. However, more is at stake. Human rights law in this field does aim to protect not only the rights of prospective parents and their future offspring but also the rights and interests of future generations. It does aim to protect not only our health but also our humanity. In other words, ‘human genome editing raises questions that cannot be dealt with only in terms of medical ethics principles relating to safety, informed consent and individual reproductive rights.’ 172

Moreover, because this technology may determine the future of human reproduction, it is a collective responsibility of society to take ‘stock of alternative imaginable futures’ and to decide ‘which ones are worth pursuing and which ones should be regulated, or even prevented.’ 173 As such, HGGE is one of the most striking examples of the more general need to ‘reclaim biotechnology for the common good.’ 174 Accordingly, the future of HGGE deserves a broad, democratic debate in which society’s long-term aspirations and visions of the good life can be explored and imagined. 175

However, so far, a certain perspective dominates. Characteristic for the recent proposals to move from prohibiting to regulating HGGE is the central position afforded to biomedical professionals and scientific bodies in that process. Not only is self-regulation by the biomedical community propagated in the form of ‘the Asilomar 176 model’, 177 but also the voice of biomedical researchers and professionals becomes decisive within regulation as soon as it is based primarily on medical standards such as clinical safety and prevention of serious diseases. 178 Indeed, the position taken by certain scientific bodies has gradually become more outspoken over the years. Even the birth of the genetically modified twins in China has not been able to break this trend thus far. Especially, striking in that regard is the changing view on the need and purpose of broad societal discussion and consensus. The evolving position of the national science academies of the USA, China, and the UK can serve as an example.

In December 2015, the US National Academy of Sciences, the US National Academy of Medicine, the Chinese Academy of Sciences, and the UK Royal Society together hosted the first International Summit on Human Gene Editing in Washington, DC. During this 3-day event, experts from around the world came together to discuss the scientific, ethical, and legal questions raised by human gene-editing. The event was concluded with a so-called summit statement, which included recommendations with regard to HGGE. According to the organizing committee:

it would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application. 179

Moreover, the committee stressed the need for an international forum to discuss these matters and called upon national academies of China, the UK, and the USA to take the lead in this. Accordingly, in the following years, national science bodies from the USA and UK issued reports on the subject.

First, the NASEM published a report on gene editing in February 2017. The report indicates a subtle, yet important shift. Whereas the 2015 Summit statement endorses a ‘not allowed, unless’ approach to human germline editing, the NASEM seem to switch to ‘allowed, if’, as becomes clear in the following excerpt from the report’s public summary:

Given both the technical and societal concerns, the committee concludes there is a need for caution in any move toward germline editing, but that caution does not mean prohibition. It recommends that germline editing research trials might be permitted, but only after much more research to meet appropriate risk/benefit standards for authorizing clinical trials. Even then, germline editing should only be permitted for compelling reasons and under strict oversight. 180

Even if the NASEM equally underlines the importance of input by the public, a partially new stance now seems to be taken compared with the 2015 Summit statement, which narrows the scope of the propagated public debate considerably. The tacit normative shift in the NASEM approach to human germline editing is aptly described in a 2017 report on human germline editing from the German Ethics Council:

It is clear that the US-American academies are no longer focusing on a partially fundamental, partially risk-related strong rejection of germline therapy by genome editing but on a fundamental permission guided by individual formal and material criteria. […] Apparently, speculations now concentrate less on whether but rather only on when the first genetically modified [babies] by genome editing will be born. 181

In July 2018, the UK Nuffield Council on Bioethics issued its report on HGGE, in which, as discussed in the previous sections, the Nuffield Council takes an even more permissive approach than the NASEM by also leaving the door open to HGGE for enhancement purposes.

In November 2018, the Second International Summit on Human Gene Editing took place in Hong Kong, only days, as mentioned, after He’s shocking announcement. A day before the 3-day summit’s official kick-off, the organizing committee issued a statement in response to the news on the Chinese CRISPR babies. 182 The statement, in which little of the general indignation about He’s actions can be recognized, was criticized by many as rather ‘bland’. 183 A stronger condemnation followed, however, in the committee’s concluding statement. Even so, it is evident from the words used in that concluding statement that the trend toward a more permissive approach has not been reversed by the news from China. On the contrary, unlike its predecessor, this summit’s organizing committee proposes that a ‘translational pathway’ be developed toward the clinical use of this technology.

The organizing committee concludes that the scientific understanding and technical requirements for clinical practice remain too uncertain and the risks too great to permit clinical trials of germline editing at this time. Progress over the last three years and the discussions at the current summit, however, suggest that it is time to define a rigorous, responsible translational pathway toward such trials. A translational pathway to germline editing will require adhering to widely accepted standards for clinical research, including criteria articulated in genome editing guidance documents published in the last three years [reference at this point to aforementioned NASEM and Nuffield Council reports]. Such a pathway will require establishing standards for preclinical evidence and accuracy of gene modification, assessment of competency for practitioners of clinical trials, enforceable standards of professional behavior, and strong partnerships with patients and patient advocacy groups. 184

The first summit’s requirement of ‘broad societal consensus’ is barely mentioned anymore beyond underlining the need for ‘strong partnerships with patients and patient advocacy groups’. Therefore, as Greely writes, the second summit’s concluding statement can be read as saying: ‘There are a lot of technical things scientists need to figure out before this can be done. The public should have a chance to comment, but they will not make the decisions. We will.’ 185

In brief, although the need for public debate and democratic deliberation on the matter is formally recognized, the common tenor within the scientific community is that the main question to be answered is not whether HGGE should be pursued, but how and under which circumstances. 186 Moreover, the general thought seems to be that the answer to the ‘how question’ can also largely be provided by the scientific community itself, for example, through the erection of self-regulating oversight bodies and the development of protocols.

Although scientists will need to be involved in the decision-making on this issue, primarily to provide inside information on the latest technological developments and on possible health risks, the dominance of the voice of scientists in current debates on heritable genome editing is a reason for concern. For Petra De Sutter, a Belgian professor of gynecology and Rapporteur for the Council of Europe’s Parliamentary Assembly, the risk of conflicts of interest is the main problem:

There is a natural tendency for scientists to want to be the pioneers of genetic technology developments, to endeavour to publish papers thereon and to reap economic benefits from their research (for example by participating in technological companies). This raises the question of possible conflicts of interest. In my opinion, science provides knowledge, but it should not be left to scientists alone to decide on research policies (for example on where to set the limits of such research) and how the research is used. 187

Others argue that proposals for self-regulation rely on an outdated understanding of scientific practice according to which the development of new technologies takes place in a political and legal vacuum. 188 The danger is that reckless scientists such as He Jiankui will interpret such an approach to science as an encouragement to further push the boundaries of what is legally and ethically accepted. Commercially, they have a reason to persist in that thought. He, for example, raised around 40 million dollars from investors for his biotech start-ups.

Furthermore, the birth of the genetically modified twins does not give reason for much optimism on the capacity of the scientific community to prevent human germline editing from spiraling out of control. In the wake of the scandal, several doubts have been expressed. For example, why did the various scientists, whom He had consulted for his CRISPR experiment, remain silent about the dangerous path that he had embarked upon? 189 Moreover, can it be said that ‘the implicit endorsement of reproductive gene editing in [the NASEM and Nuffield] reports facilitated the work of rogue actors such as He, providing ethical cover for his work?’ 190 Indeed, He has defended his actions by claiming that they are in line with the guidelines from the NASEM report on gene editing. 191 Perhaps, this can explain in part why He chose to defy the existing Chinese guidelines and regulations. 192 The Chinese biophysicist argues that he genetically modified the twins only to prevent a serious disease in the absence of reasonable alternatives, exactly as prescribed by the NASEM. Although He’s rather loose interpretation of these guidelines can be regarded as mere rationalization, his claim is not entirely without ground. Responding to the birth of the genetically modified twins, Victor Dzau, president of the US National Academy of Medicine, admitted that the existing guidelines are not clear enough and too open for interpretation. 193 As such, the event did serve as a ‘wake-up call from Hong Kong’ for the NASEM. 194

All of this suggests that attempts at self-regulation from the biomedical community have so far not only failed to prevent He’s reckless experiment with the twins but also even helped to create ‘an increasingly permissive climate among elite scientists that may well have emboldened He’ 195 in the first place. At worst, this scientific elitism may take on the shape of outright contempt for the idea of legal rules and democratic deliberation itself. A striking example is the approach taken by the Russian scientist Denis Rebrikov, who, as discussed, plans to follow in He’s footsteps to create genetically modified babies. In an interview with SCIENCE, he offers the following views on the regulation of scientific progress and human enhancement:

‘We cannot stop progress with words on paper. So even if we say, let us not do the nuclear physics, because it can make a bomb, a lot of scientists will still do this. We cannot stop it. A lot of groups will try to do experiments with embryos to transfer to women, and maybe it will not be in my group, but we will see in the next years that they will have some results, and they will publish it. That’s maybe the problem for humans on the planet, that we cannot stop the progress. […] [Human enhancement] will be the next step. But in 20 to 30 years. Now, I’m opposed to it. In 2040, I’ll support it. I’m not against the idea itself. And these people who are opposed want to have all these things in their children but only by “divine providence,” not by science. They are liars or stupid.’ 196

Should individuals have the possibility to change the genetic constitution of their descendants? Since the rise of CRISPR, this question is no longer theoretical. Traditionally, national and international legal orders have answered this question with a clear and adamant ‘no’. Most of the existing bans and restrictions on this technology go back to the human rights frameworks that were adopted in the late 1990s to regulate biomedical developments. A recurring idea in these frameworks is that reproductive HGGE is at odds with the human rights principles of freedom, equality, and dignity, as this technology would make it possible to produce individuals to fit certain requirements. In other words, it could open the door for unprecedented forms and practices of eugenics.

However, now that CRISPR has taken the biotechnology world by storm, these provisions are under increasing pressure. Even the uproar created by He Jiankui’s attempts at genetically modifying offspring has not been able to break this trend. Especially, among scientific and medical-professional bodies, academies, and societies, the view is gaining ground that the existing bans should be lifted and that reproductive gene editing should be allowed for therapeutic purposes as soon as the technology is safe for clinical application.

How should these proposals be viewed from a human rights perspective? Interestingly, in most of the reports, articles, and manifestos that advocate a regulatory pathway approach to HGGE, human rights are equally invoked. The Nuffield Council’s report, for example, explicitly refers to human rights discourse as its prime ethical framework, 197 while the NASEM report states that its overarching framework is ‘embedded within the larger context of international conventions and norms for protection of human rights’. 198 In other words, these proposals rely on human rights to justify why the existing human rights ban on reproductive gene editing should be lifted. This suggests that conflicting views on the meaning of human rights and human dignity are at the heart of current legal-ethical debates on HGGE. As such, HGGE indeed touches on the normative foundations of human rights law.

It is widely recognized that the meaning of human rights and their underlying principles may evolve over time. In this vein, the European Court of Human Rights has characterized the European Convention on Human Rights as a ‘living instrument, which must be interpreted in the light of present day conditions’, even when it comes to core human rights such as the prohibition on torture and inhuman or degrading treatments or punishments. 199 The same line of thinking necessarily applies to the principles underlying these rights, such as human dignity.

Similarly, the meaning of human rights and human dignity for the issue of human germline editing is not set in stone and may evolve over time. This is also recognized by bioethics committees of both the Council of Europe and UNESCO, when they emphasize the vital importance of a public debate on this matter. In this article, I have aimed to contribute to that debate by addressing three human rights concerns about the recent proposals for a regulatory pathway approach to reproductive gene editing.

First, I have discussed the distinction that many of these proposals make between human germline editing for therapeutic and nontherapeutic purposes. According to this line of thought, using genetic modification for enhancement purposes would conflict with human rights law, whereas using this technology to prevent serious diseases and conditions would not. Although the medical boundary between healing and enhancing can indeed be recognized in the human rights frameworks for the regulation of biomedical technologies, I have argued that the medical boundary will be much harder to maintain in case of HGGE than PGD. Hence, once the ban on HGGE is lifted, it will be hard to prevent the practice from gradually sliding down toward more eugenic applications.

Second, I have focused on the view and concept of human rights that underlie the recent proposals to go from prohibition to regulation of heritable gene editing. Some authors have argued that editing the human germline is tantamount to editing human nature and that this would therefore disrupt the foundation of human rights. 200 This paper goes back to a different thought, namely, that proposals to lift the ban on germline editing are mostly rooted in a one-dimensional reading of human rights that radically parts with existing human rights discourse on biomedical technologies. Existing human rights approaches, as laid down in international law documents from the Council of Europe and UNESCO, address concerns at the level of the individual, society, and humanity. The recent proposals, however, only take into account the individual and societal dimensions of human rights discourse. References to humanity, humankind, human dignity, or the idea of the human genome as heritage of humanity are conspicuously absent. If human dignity is mentioned, it is reduced to a principle that only protects individual freedoms and rights. In other words, the collective dimension of human dignity is ignored. For a proper debate on the meaning of human rights for heritable genome editing, both sides need to be taken into account. A careful balance needs to be found between, on the one hand, the health and rights of prospective parents and their future offspring and, on the other hand, the long-term interests of society, future generations, and humankind.

Third, I have argued that this dismissal of the collective dimensions of human rights discourse also has repercussions for the public deliberation on this matter. Once the issue is framed as one concerning exclusively the health and rights of those directly involved, vital questions are lost from view. Questions such as: what kind of lives do we wish for future generations? And: how can we protect our humanity in an increasingly technological and data-obsessed society? Moreover, the way in which the issue is reframed, with a strong focus on medical standards such as safety and the medical boundary between healing and enhancing, bolsters the tendency to leave the discussion and governance to the scientific community itself.

From this perspective, democratic interests appear to be at stake as well. In a way, CRISPR is turning democracy upside-down. In a ‘CRISPR democracy’, 201 citizens take the place of scientists when they, as biohackers, start tinkering with DNA, under the guise of ‘democratizing’ the life sciences. The other way around, scientists take the place of citizens when their voice becomes decisive in the governance of highly controversial technologies that may have a lasting impact on no less than the future of humankind.

The He Lab, About Lulu and Nana: Twin Girls Born Healthy After Gene Surgery As Single-Cell Embryos , www.youtube.com/watch?v=th0vnOmFltc (accessed July 19, 2019).

Antonio Regalado, Chinese Scientists Are Creating CRISPR Babies , MIT Technology Review, Nov. 25, 2018.

Charlotte Jee, A Second CRISPR Pregnancy Is Already Under Way, Claims Chinese Scientist , MIT Technology Review, Nov. 28, 2018.

Gina Kolata & Pam Belluck, Why Are Scientists So Upset About the First Crispr Babies? , New York Times, Dec. 5, 2018; Kiran Musunuru, We need to know what happened to CRISPR twins Lulu and Nana , MIT Technology Review, Dec. 3, 2019.

Henry Greely, CRISPR’d babies: human germlinegenome editing in the ‘He Jiankui affair’ , 6 J. L. & Biosci. 111, 116–117 (2019); Antonio Regalado, China’s CRISPR babies: Read exclusive excerpts from the unseen original research , MIT Technology Review, Dec. 3, 2019.

Greely, CRISPR’d babies, supra note 5, at 117.

Jennifer Doudna, He Jiankui , Time Magazine, Apr. 29, 2019.

Sharon Begley & Andrew Joseph, The CRISPR shocker: How Genome-Editing Scientist He Jiankui Rose From Obscurity to Stun the World, STAT, Dec. 18, 2018.

In 2012, CRISPR-Cas9 was mentioned for the first time in scientific literature (Martin Jinek et al., A Program-mable Dual-RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity , 337 Science 816 (2012)).

Alex Pearlman, Biohackers Are Using CRISPR On Their DNA and We Cannot Stop It , New Scientist, Nov. 15, 2017.

For a brief overview of these patent wars, see Ana Nordberg et al., Cutting Edges and Weaving Threads in the Gene Editing (Я)evolution: Reconciling Scientific Progress With Legal, Ethical, and Social Concerns , 5 J. L. & Biosci. 35, 68–71 (2018).

Sara Reardon, ‘Welcome to the CRISPR Zoo’, 531 Nature 160 (2016).

Id . at 163.

Peter Sloterdijk, Regeln für den Menschenpark. Ein Antwortschreiben zu Heideggers Brief über den Humanismus (1999). For an English translation, see Peter Sloterdijk, Rules for the Human Zoo: A Response to the Letter on Humanism , 27 Environ. Plann. D 12 (2009).

David Cyranoski, The CRISPR-Baby Scandal: What’s Next for Human Gene-Editing , 566 Nature 440 (2019).

David Cyranoski & Sara Reardon, Chinese Scientists Genetically Modify Human Embryos , 250 Nature 593 (2015).

Jessica Hamzelou, World’s First Baby Born With New ‘3 Parent’ Technique , New Scientist , Sept. 27, 2016.

I use the term ‘human nuclear genome transfer’ instead of ‘mitochondrial replacement therapy’ for reasons explained by Françoise Baylis, Human Nuclear Genome Transfer (So-Called Mitochondrial Replacement): Clearing the Underbrush , 31 Bioethics 7 (2017).

See Sara Reardon, Genetic Details of Controversial ‘Three-Parent Baby’ Revealed , 544 Nature 17 (2017); Steve Connor, When Replacement Becomes Reversion , 35 Nat. Biotechnol . 1012 (2017).

Françoise Baylis & Alana Cattapan, Personalised Medicine and the Politics of Human Nuclear Genome Transfer , in Personalised Medicine, Individual Choice and the Common Good 26 (Britta van Beers, Sigrid Sterckx & Donna Dickenson eds., 2018).

Susan Scutti, Controversial IVF Technique Produces a Baby Girl; And for Some, That’s a Problem , CNN, Jan. 18, 2018, https://edition.cnn.com/2017/01/18/health/ivf-three-parent-baby-girl-ukraine-bn/index.html (accessed July 19, 2019).

Emily Mullin, The Fertility Doctor Trying to Commercialize Three-Parent Babies , MIT Technology Review, June 13, 2017.

The FDA sent the following letter to Zhang: https://www.fda.gov/media/106739/download?source=govdelivery&utm_medium=email&utm_source=govdelivery (accessed July 19, 2019).

Many scientists also regard nuclear genome transfer as germline genetic modification (e.g. Guido de Wert et al., Responsible Innovation in Human Germline Gene Editing: Background Document to the Recommendations of the ESHG and ESHRE , 26 Eur. J. Hum. Genet. 550 (2018)). However, the UK Government maintained that while MRTs ‘do result in germ-line modification, the techniques [do not] constitute genetic modification’ (see Rosamund Scott & Stephen Wilkinson, Germline Genetic Modification and Identity: the Mitochondrial and Nuclear Genomes , 37 OJLS 886, 887 (2017)).

Although the rule is that mitochondrial disorders are generally inherited through the maternal line, occasionally, these disorders may be transmitted by the father as well (see: Thomas McWilliams & Anu Suomalainen, Mitochondrial DNA Can Be Inherited from Fathers, Not Just Mothers , 565 Nature 296 (2019)).

Heidi Ledford, CRISPR Fixes Disease Gene in Viable Human Embryos , 548 Nature 13 (2017).

David Cyranoski, Russian Biologist Plans More CRISPR-Edited Babies , 570 Nature 145 (2019).

Michael Le Page, Five Couples Lined Up for CRISPR Babies to Avoid Deafness , Scientist, July 4, 2019.

David Cyranoski, Russian Scientist Edits Human Eggs in Effort to Alter Deafness Gene , 574 Nature 465 (2019).

Jon Cohen, Russian Geneticist Answers Challenges to His Plan to Make Gene-Edited Babies , Science, June 13, 2019.

Françoise Baylis, Human Genome Editing: Our Future Belongs to All of Us , 35 Issues Sci. Technol. 42, 42 (2019).

Rinie van Est et al., Rules for the digital human park: Two paradigmatic cases of breeding and taming human beings—Human germline editing and persuasive technology 15 (2017).

Rosario Isasi, Erika Kleiderman & Bartha Knoppers, Editing Policy to Fit the Genome? , 351 Science 337 (2016); Motoko Araki & Tetsuya Ishii, International Regulatory Landscape and Integration of Corrective Genome Editing Into In Vitro Fertilization , 12 Reprod. Biol. Endocrinol. 108 (2014).

As Isasi, Kleiderman and Knoppers characterize the legal diversity: ‘Internationally, policies extend across a continuum that distinguishes between degrees of permissiveness, that is, between legally binding legislation and regulatory and/or professional guidance or research versus clinical applications’ (Isasi, Kleiderman & Knoppers, supra note 35, at 337).

Artt. 3.7 & 3.9 of the 2003 ‘Technical Norms of Human Assisted Reproductive Technologies’ (see Nuffield Council on Bioethics, Genome Editing and Human Reproduction: Social and Ethical Issues 111 (2018); Di Zhang, & Reidar K. Lie, Ethical Issues in Human Germline Gene Editing: A Perspective from China , 36(1–4) Monash Bioethics Review, 23 (2018).

Research Activities of Persons Halted Over Gene-Edited Babies Incident , XinhuaNet, Nov. 29, 2018, http://www.xinhuanet.com/english/2018-11/29/c_137640174.htm (accessed July 19, 2019).

Ian Sample, ‘Chinese scientist who edited babies’ genes jailed for three years’, Guardian, Dec. 31, 2019, https://www.theguardian.com/world/2019/dec/30/gene-editing-chinese-scientist-he-jiankui-jailed-three-years (accessed Mar. 24, 2020); David Cyranoski, ‘China to Tighten Rules on Gene Editing in Humans’, Nature, Mar. 6, 2019, https://www.nature.com/articles/d41586-019-00773-y (accessed July 19, 2019).

Nuffield Council, supra note 38, at 109.

I. Glenn Cohen & Eli Adashi, The FDA Is Prohibited From Going Germline , 353 Science 545 (2016).

See statement by NIH Director Francis Collins, Statement on NIH Funding of Research Using Gene-editing Technologies in Human Embryos , Apr. 28, 2015, https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos (accessed July 19, 2019).

Greely, CRISPR’d babies, supra note 5, at 128–129. For a critical discussion of this legal situation, see Glenn Cohen & Adashi, supra note 42. Also see Nuffield Council, supra note 38, at 109–110.

Glenn Cohen & Adashi, supra note 42.

Rowena Mason & Hannah Devlin, MPs Vote in Favour of ‘Three-Person Embryo’ Law , Guardian, Feb. 3, 2015.

The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015 (S.I 2015 No. 572).

Samvel Varvaštian , UK’s Legalisation of Mitochondrial Donation in IVF Treatment: A Challenge to the International Community or a Promotion of Life-saving Medical Innovation to Be Followed by Others? , 22 Eur. J. Health L. 405, 424 (2015).

Nuffield Council, supra note 38, at 112.

Lev Facher, Why Democrats Reopened the Debate About Germline Gene Editing , STAT, June 18, 2019, https://www.statnews.com/2019/06/18/democrats-reopened-debate-about-germline-editing/ (accessed July 1, 2019).

Roberto Andorno & Alicia Ely Yamin, The Right to Design Babies? Human Rights and Bioethics , Open Global Rights, Jan. 8, 2019, https://www.openglobalrights.org/the-right-to-design-babies-human-rights-and-bioethics/ (accessed July 19, 2019).

Parliamentary Assembly of the Council of Europe, Recommendation on Genetic Engineering , Recommendation 934 (1982), sub 4a.

Roberto Andorno, Biomedicine and International Human Rights Law: In Search of a Global Consensus , 80 Bulletin of the World Health Organization 959 (2002).

According to Scott & Wilkinson, supra note 26, this Recommendation leaves the door open for forms of germline editing that aims to prevent diseases, because of par. 4c: ‘the explicit recognition of this right must not impede development of the therapeutic applications of genetic engineering (gene therapy), which holds great promise for the treatment and eradication of certain diseases which are genetically transmitted’.

Parliamentary Assembly of the Council of Europe, Recommendation on Genetic Engineering , supra note 53, sub 4a & 7a.

Explanatory report to the Convention on Human Rights and Biomedicine, European Treaty Series, nr. 164, sub 89, https://rm.coe.int/16800ccde5 (accessed Aug. 1, 2019).

Parliamentary Assembly of the Council of Europe, The Use of New Genetic Technologies in Human Beings , Recommendation 2115 (2017), sub 3.

Committee on Bioethics (DH-BIO), Statement on Genome Editing Technologies , Dec. 2, 2015, https://rm.coe.int/168049034a (accessed Aug. 1, 2019).

Roberto Andorno, The Oviedo Convention: A European Legal Framework at the Intersection of Human Rights and Health Law , 2 J. Int. Biotech. L . 134 (2005).

28 out of 47 Council of Europe member states are EU member states.

Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions, C/2016/6997, OJ C 411, preamble sub 40.

Case C-34/10, Oliver Brüstle v. Greenpeace e. V , EU:C:2011:669, sub 34.

Directive 2001/20/EC of the European Parliament and of the Council of Apr. 4, 2001 on the approximation of the laws, regulations, and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L 121, 1.5.2001, at 34 (hereafter: Clinical Trials Directive).

Regulation (EU) No 536/2014 of the European Parliament and of the Council of Apr. 16, 2014 on clinical trials on medical products for human use, and repealing Directive 2001/20/EC (hereafter: Clinical Trials Regulation).

Previously art. 9 par. 6 Clinical Trials Directive; replaced by art. 90 Clinical Trials Regulation.

International Bioethics Committee, Report of the IBC on Updating Its Reflection on the Human Genome and Human Rights , UNESCO, SHS/YES/IBC-22/15/2 REV.2 (Paris, October 2, 2015), sub 107.

Id. sub 107.

A prohibition on reproductive cloning can be found in the Additional Protocol to the Oviedo Convention on the Prohibition of Cloning Human Beings.

Id. sub 111.

Explanations Relating to the Charter of Fundamental Rights , 2007/C 303/02.

E.g. Annelien Bredenoord et al., Ethics of Modifying the Mitochondrial Genome , 37 J. Med. Ethics 97 (2011); Scott & Wilkinson, supra note 26.

Bredenoord et al., supra note 73, at 97.

For a further analysis of how this disctinction between nuclear and mitochondrial DNA has affected the UK’s regulation of HNGT, see Scott & Wilkinson, supra note 26, especially at 897–898. For the Dutch legislature’s position, see the travaux préparatoires of the Dutch Embryo Act (Parliamentary document Kamerstukken II 2000/01, 27 423, nr. 5, p. 99–100).

According to the Dutch minister of Health, this has to do with the Dutch ban on creating embryos for research purposes. This ban has made it impossible for Dutch scientists to do research in this field ensuring that the technology is safe for introduction in the clinic (see Parliamentary document Kamerstukken II 2016/17, 29 323, nr. 105, p. 12–13). For a further analysis of the Dutch policy in this field, see Britta van Beers, Charlotte de Kluiver & Rick Maas, The Regulation of Human Germline Genome Modification In the Netherlands , in: Human Germline Modification and the Right to Science. A Comparative Study of National Laws and Policies 309–344 (Andrea Boggio, Cesare Romano, & Jessica Almqvist (eds.), 2020).

Ewen Callaway, Historic Decision Allows UK Researchers to Trial ‘Three Person’ Babies , Nature (2016), https://www.nature.com/news/historic-decision-allows-uk-researchers-to-trial-three-person-babies-1.21182 (accessed Aug. 1, 2019).

Emily Mullin, Pregnancy Reported in the First Known Trial of ‘Three-Person IVF’ for Infertility , STAT, Jan. 24, 2019.

Helen Thomson, ‘First 3-parent baby born in clinical trial to treat infertility’, New Scientist, Apr. 11, 2019, https://www-newscientist-com.vu-nl.idm.oclc.org/article/2199441-first-3-parent-baby-born-in-clinical-trial-to-treat-infertility/ (accessed July 19, 2019).

Embryotools Achieves the World’s First Pregnancy With a New Nuclear Transfer Technique for Treating Infertility , Jan. 17, 2019, http://www.pcb.ub.edu/portal/en/noticies/-/noticia/no_embryotools-aconsegueix-el-primer-embaras-del-mon-amb-una-nova-tecnica-de-transferencia-nuclear-per-tractar-la-infertilitat (accessed July 19, 2019).

Mullin, Pregnancy Reported in the First Known Trial , supra note 78.

For full reference, supra note 65.

For full reference , supra note 66.

See Art. 2(2) Clinical Trials Regulation; and Art. 2(a) Clinical Trials Directive.

Nuffield Council, supra note 38, at 122–123.

See for example the title of the article in Nature in which the news on the licences is shared (Callaway, supra note 77).

Rumiana Yotova, The Regulation of Genome Editing and Human Reproduction Under International Law, EU Law and Comparative Law (background report for the Nuffield Council on Bioethics) (2017).

Varvaštian, supra note 48, at 421–422 (note 92).

Varvaštian, supra note 48, at 99.

European Group on Ethics in Science and New Technologies, Statement on Gene Editing , https://ec.europa.eu/research/ege/pdf/gene_editing_ege_statement.pdf (accessed July 19, 2019).

De Wert et al, supra note 26, at 456.

Isasi, Kleiderman & Knoppers, supra note 35, at 337.

Quoted in Antonio Regalado , Engineering the Perfect Baby , MIT Technology Review, Mar. 5, 2015.

For an overview of the ethics statements on HGGE, see Carolyn Brokowski, Do CRISPR Germline Ethics Statements Cut It? , 1 CRISPR Journal 115 (2018); and Nuffield Council, supra note 38, at 129–132;

E.g. David Baltimore et al., A Prudent Path Forward for Genomic Engineering and Germline Gene Modification , 348 Science 36 (2015); Hinxton Group Statement, Statement on genome editing technologies and human germline genetic modification , 2015, http://www.hinxtongroup.org/Hinxton2015_Statement.pdf (accessed July 19, 2019); George Daley, Robin Lovell-Badge, Julie Steffann, After the Storm: A Responsible Path for Genome Editing , 380 New Eng. J. Med. 897 (2019); Eric Lander et al., Adopt a Moratorium on Heritable Genome Editing , 567 Nature 165 (2019).

De Wert et al., supra note 26.

E.g. in the US: National Academies of Sciences, Engingeering and Medicine, Human Genome Editing: Science, Ethics, and Governance (2017); in Germany: Leopoldina, ACATECH, & UNION, The Opportunities and Limits of Genome Editing (2015); and in the Netherlands: KNAW, Genome Editing. Position Paper of the Royal Netherlands Academy of Arts and Sciences (2016).

E.g. Organizing Committee for the International Summit on Gene Editing, On Human Gene Editing: International Summit Statement , Washington Dec. 1–3, 2015, http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12032015a (accessed July 19, 2019); Federation of European Academies of Medicine, The Application of Genome Editing in Humans , October 2017, https://www.feam.eu/the-application-of-genome-editing-in-humans/ (accessed July 19, 2019); Organizing Committee for the International Summit on Gene Editing, On Human Genome Editing II. Statement by the Organizing Committee of the Second International Summit on Human Genome Editing , Hong Kong Nov, 29, 2018, http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b (accessed July 19, 2019).

E.g. Nuffield Council, supra note 38; Netherlands Commission on Genetic Modification (COGEM) & Health Council of the Netherlands (Gezondheidsraad), Editing Human DNA: Moral and Social Implications of Germline Genetic Modification (2017).

Lander et al., supra note 96, at 168.

See the subtitle of Daley, Lovell-Badge, Steffann, supra note 96: ‘A Responsible Path for Genome Editing’.

See the title of Baltimore et al., supra note 96: ‘A Prudent Path Forward for Genomic Engineering and Germline Gene Modification’.

See statement from Organizing Committee for the International Summit on Gene Editing, supra note 99.

Robin Alta Charo, Rogues and Regulation of Germline Editing , 380 New Eng. J. of Med. 977 (2019).

There is disagreement among those who propagate a pathway approach as to the need of a moratorium (for more details on this discussion, see Eli Adashi & I. Glenn Cohen, Heritable Genome Editing: Is a Moratorium Needed?, 322 JAMA 104 (2019)).

The UK Nuffield Council on Bioethics takes a different stance and rejects the medical boundary between healing and enhancing as a useful red line. This will be discussed in further detail in Section V.

Committee on Bioethics, supra note 59.

International Bioethics Committee, supra note 68, sub 117 & 118.

‘Parties to this Convention shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation.’

See, e.g., ECtHR, Apr. 25, 1978, Tyrer v. UK , application no. 5856/72.

Peter Sykora & Arthur Caplan, The Council of Europe Should Not Reaffirm the Ban on Germline Genome Editing in Humans , 18 EMBO Reports 1871 (2017).

E.g. Isasi, Kleiderman & Knoppers, supra note 35; Alta Charo, Rogues , supra note 93; Sykora & Caplan, supra note 99.

Alta Charo, Rogues , supra note 106, at 976.

E.g. Eli Adashi & I. Glenn Cohen, ‘Germline Editing: Could Ban Encourage Medical Tourism?’, 569 Nature 40 (2019). Elsewhere, I critically discuss the pragmatic line of reasoning with regard to reproductive tourism, see Britta van Beers, Is Europe ‘Giving in to Baby Markets’? Reproductive Tourism in Europe and the Gradual Erosion of Existing Legal Limits to Reproductive Markets , 23 Med. L. Rev. 103 (2015).

Isasi, Kleiderman & Knoppers, supra note 35, at 339.

For an analysis of and possible human rights approach to this issue, see Erika Kleiderman, Vardit Ravitsky & Bartha Knoppers, The ‘Serious’ Factor in Germline Modification , 45 J Med Ethics 508 (2019).

Edward Lanphier et al., Do not Edit the Human Germline , 519 Nature 411 (2015).

Likewise, the European Group on Ethics writes in its 2016 Statement on Gene Editing that ‘the blurring of the lines between clinical applications in pursuit of therapeutic or enhancement goals […], must be considered’ (see European Group on Ethics, supra note 90).

Nuffield Council, supra note 38, at 47.

However, according to the Nuffield Council, concerns about function creep and slippery slopes can be countered through reliable regulation (see Nuffield Council, supra note 38, at 53–55).

For a more elaborate discussion of the difficulty to define ‘therapeutic’ in the context of HGGE, see Eric T. Juengst, Crowdsourcing the Moral Limits of Human Gene Editing? , 47(3) Hastings Cent. Rep. 15, 21 (2017).

Mary Joy et al., CCR5 Is a Therapeutic Target for Recovery after Stroke and Traumatic Brain Injury , 176 Cell 1143 (2019).

Antonio Regalado, ‘China’s CRISPR twins might have had their brains inadvertently enhanced’, MIT Technology Review, Feb. 21, 2019.

For this expression, and for an elaborate discussion of this issue, see Eric T. Juengst et al., Is Enhancement the Price of Prevention in Human Gene Editing? , 1 CRISPR Journal 351, 353 (2018).

Kolata & Belluck, supra note 4.

Given these complexities, future parents may come to rely on algorithms for reproductive decisionmaking, not only in the case of ‘easy PGD’ (a combination of in vitro gametogenesis, PGD and genome sequencing, see Henry Greely, The End of Sex and the Future of Human Reproduction (2016)), as Sonia Suter has set out in a recent article ( The Tyranny of Choice , 5 J. Law Biosci . 262 (2018) but also in the context of heritable germline editing.

Nuffield Council, supra note 38, at 71.

Id. at 71 and 91–92.

For a comparison between the NASEM report and the Nuffield Council Report, see Eli Adashi & I. Glenn Cohen, The Ethics of Heritable Genome Editing: New Considerations in a Controversial Area , 320 JAMA 2531 (2018).

International Bioethics Committee, supra note 68, sub 111.

Robin Alta Charo, Germline Engineering and Human Rights , 112 AJIL Unbound, 344 (2018).

Explanatory Report Oviedo Convention, supra note 57, sub 14.

International Bioethics Committee, supra note 68, sub 34.

Id. sub 30.

Id. sub 28.

E.g. Deryck Beyleveld & Roger Brownsword, Human Dignity in Bioethics and Biolaw (2002); Roberto Andorno, Human Dignity and Human Rights as a Common Ground for a Global Bioethics, 34 J. Med. Philos. 223 (2009); Micha Werner, ‘Individual and collective dignity’, in: The Cambridge Handbook of Human Dignity: Interdisciplinary Perspectives 343 (Marcus Duewell, Jens Braarvig, Roger Brownsword & Dietmar Mieth eds., 2014).

International Bioethics Committee, supra note 68, sub 128.

Id . sub 108.

Id . sub 105.

Id . sub 103.

Id . sub 107.

Explanatory Report Oviedo Convention, supra note 57, sub 89.

Andorno, Human Dignity , supra note 141, at 233; German Ethics Council, Intervening in the Human Germline: Executive Summary & Recommendations sub 55 (2019).

Andorno, Human Dignity , supra note 141, at 233; Teresa Iglesias, The Dignity of the Individual: Issues of Bioethics and Law 3 (2001).

Baylis, Human Genome Editing, supra note 33, at 44.

Katie Hasson & Marcy Darnovsky, Gene-Edited Babies: No One Has the Moral Warrant to Go It Alone , Guardian, Nov. 27, 2018. Also see International Bioethics Committee, supra note 68, sub 116.

Nuffield Council, supra note 38, at 75.

Nuffield Council, supra note 38, at 87.

Especially see box 3.4 in the report, that is entirely devoted to this argument (Nuffield Council, supra note 38, at 93–94).

National Academies, supra note 98, at 32.

At this point the Nuffield Council refers to Ruth Macklin, Human Dignity Is a Useless Concept , 327 British Med J 1419 (2003); and Mirko Bagaric & James Allan, The Vacuous Concept of Dignity , 5 J. Human Rights 257 (2006).

‘Whereas human dignity has been advanced by some as the basis of human rights, the coherent functioning of human rights discourse does not depend on accepting this claim’ (Nuffield Council, supra note 38, at 94).

Nuffield Council, supra note 38, at 96.

E.g. Iñigo de Miguel Beriain, Human Dignity and Gene Editing, EMBO Reports, e46789, (2018); Peter Mills, Genome Editing, Human Rights and the ‘Posthuman’ , 3 October 2017, http://nuffieldbioethics.org/blog/genome-editing-human-rights-posthuman (accessed July 19, 2019).

Alta Charo, Germline Engineering , supra note 136, at 348–349.

Françoise Baylis & Lisa Ikemoto, The Council of Europe and the Prohibition on Human Germline Genome Editing , 18 EMBO Reports 2084 (2017).

Nuffield Council, supra note 38, at 91.

Id. at 90–91.

German Ethics Council, supra note 149, at 4.

Mills, supra note 162.

Alta Charo, Germline Engineering , supra note 136, at 349.

This is also one of the central theses of Harari’s bestseller Homo Deus : ‘The rise of humanism also contains the seeds of its downfall. While the attempt to upgrade into gods takes humanism to its logical conclusion, it simultaneously exposes humanism’s inherent flaws’ (Yuval Harari, Homo Deus: A Brief History of Tomorrow 65 (2016)).

Van Est et al., supra note 34, at 15.

Sheila Jasanoff, J. Benjamin Hurlbut & Krishanu Saha , CRISPR Democracy: Gene Editing and the Need for Inclusive Deliberation , 32 Issues Sci. Technol. 25 (2015).

See Donna Dickenson, Me Medicine vs. We Medicine: Reclaiming Biotechnology for the Common Good (2013); and Britta van Beers, Sigrid Sterckx and Donna Dickenson (eds.), Personalised Medicine, Individual Choice and the Common Good (2018).

Elsewhere, I offer further reflection on the need for public imagination in the debate on human germline genetic modification (see Britta van Beers, Imagining Future People in Biomedical Law: From Technological Utopias to Legal Dystopias Within the Regulation of Human Genetic Modification Technologies , in: Risk and the Regulation of Uncertainty in International Law 117 (Monika Ambrus, Rosemary Rayfuse & Wouter Werner eds. 2017).

Jasanoff, Hurlbut & Saha, supra note 173.

See, for example, Baltimore et al., supra note 96.

On Human Gene Editing: International Summit Statement , http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12032015a (accessed Aug. 1, 2019).

See Report Highlights , p. 3, available at: https://www.nap.edu/resource/24623/Human-Genome-Editing-highlights.pdf (accessed Aug. 1, 2019). Also see National Academies, supra note 98, at 134–135 and 189–190.

Deutscher Ethikrat, Germline Intervention in the Human Embryo: German Ethics Council Calls for Global Political Debate and International Regulation 3 (2017).

Statement from the Organizing Committee on Reported Human Embryo Genome Editing , http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11262018 (accessed Aug. 1, 2019).

E.g. Ed Yong, The CRISPR Baby Scandal Gets Worse by the Day , The Atlantic, Dec. 3, 2018, https://www.theatlantic.com/science/archive/2018/12/15-worrying-things-about-crispr-babies-scandal/577234/ (accessed July 19, 2019).

Statement by the Organizing Committee of the Second International Summit on Human Genome Editing , http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b (accessed Aug. 1, 2019).

Henry Greely, How Should Science Respond to CRISPR’d Babies? , 35 Issues Sci. Technol. 32, 36 (2019).

J. Benjamin Hurlbut, Human Genome Editing: Ask Whether, Not How , 565 Nature 135 (2019); Donna Dickenson & Marcy Darnovsky, Did a Permissive Scientific Culture Encourage the ‘CRISPR Babies’ Experiment? , 37 Nat. Biotechnol . 355 (2019).

Petra De Sutter, The Use of New Genetic Technologies in Human Beings (Explanatory Memorandum to Recommendation 2115 of the Parliamentary Assembly of the Council of Europe) , doc. 14328, May 24, 2017, sub 32.

Natalie Kofler, Why Were Scientists Silent Over Gene-Edited Babies? , 566 Nature 427 (2019).

Hasson & Darnovsky, supra note 152.

Antonio Regalado, Rogue Chinese CRISPR Scientist Cited US Report As His Green Light , MIT Technology Review, Nov. 27, 2018.

Another important factor is the failure to implement and enforce the Chinese regulations, see Zhang & Lie, supra note 38; and Erika Kleiderman & Ubaka Ogbogu, Realigning Gene Editing with Clinical Research Ethics: What the “CRISPR Twins” Debacle Means for Chinese and International Research Ethics Governance , 26(4) Accountability in Research 257.

Sharon Begley, After ‘CRISPR babies’, International Medical Leaders Aim to Tighten Genome Editing Guidelines , STAT, Jan. 24, 2019.

Victor Dzau, Marcia McNutt & Chunli Bai, Wake-Up Call From Hong Kong , 362 Science 1215 (2018).

Dickenson & Darnovsky, supra note 186, at 356.

Cohen, supra note 32.

Nuffield Council, supra note 38, at 59.

National Academies, supra note 98, at 29.

ECtHR, Apr. 25, 1978, Tyrer v. UK , application no. 5856/72.

E.g. Francis Fukuyama, Our Posthuman Future (2002); George Annas, Lori Andrews & Rosario Isasi, Protecting the Endangered Human: Toward an International Treaty Prohibiting Cloning and Inheritable Alterations , 28 Am. J.L. & Med. 151 (2002).

See title of Jasanoff, Hurlbut & Saha, supra note 173.

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Human reproductive cloning remains universally condemned, primarily for the psychological, social, and physiological risks associated with cloning. A cloned embryo intended for implantation into a womb requires thorough molecular testing to fully determine whether an embryo is healthy and whether the cloning process is complete. In addition, as demonstrated by 100 failed attempts to generate a cloned macaque in 2007, a viable pregnancy is not guaranteed. Because the risks associated with reproductive cloning in humans introduce a very high likelihood of loss of life, the process is considered unethical. There are other philosophical issues that also have been raised concerning the nature of reproduction and human identity that reproductive cloning might violate. Concerns about eugenics , the once popular notion that the human species could be improved through the selection of individuals possessing desired traits, also have surfaced, since cloning could be used to breed “better” humans, thus violating principles of human dignity, freedom, and equality.

There also exists controversy over the ethics of therapeutic and research cloning . Some individuals and groups have an objection to therapeutic cloning, because it is considered the manufacture and destruction of a human life, even though that life has not developed past the embryonic stage. Those who are opposed to therapeutic cloning believe that the technique supports and encourages acceptance of the idea that human life can be created and expended for any purpose. However, those who support therapeutic cloning believe that there is a moral imperative to heal the sick and to seek greater scientific knowledge. Many of these supporters believe that therapeutic and research cloning should be not only allowed but also publicly funded, similar to other types of disease and therapeutics research. Most supporters also argue that the embryo demands special moral consideration, requiring regulation and oversight by funding agencies. In addition, it is important to many philosophers and policy makers that women and couples not be exploited for the purpose of obtaining their embryos or eggs.

There are laws and international conventions that attempt to uphold certain ethical principles and regulations concerning cloning. In 2005 the United Nations passed a nonbinding Declaration on Human Cloning that calls upon member states “to adopt all measures necessary to prohibit all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life.” This does provide leeway for member countries to pursue therapeutic cloning. The United Kingdom , through its Human Fertilisation and Embryology Authority, issues licenses for creating human embryonic stem cells through nuclear transfer . These licenses ensure that human embryos are cloned for legitimate therapeutic and research purposes aimed at obtaining scientific knowledge about disease and human development . The licenses require the destruction of embryos by the 14th day of development, since this is when embryos begin to develop the primitive streak, the first indicator of an organism’s nervous system . The United States federal government has not passed any laws regarding human cloning due to disagreement within the legislative branch about whether to ban all cloning or to ban only reproductive cloning. The Dickey-Wicker amendment , attached to U.S. appropriations bills since 1995, has prevented the use of federal dollars to fund the harm or destruction of human embryos for research. It is presumed that nuclear transfer and any other form of cloning is subject to this restriction.

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Human Cloning: Unmasking the Controversy

by Francisco Galdos

Suppose you have a year-old laptop that has been working well for you. You begin to notice one day that the computer freezes more frequently, and you continue to have problems. After taking your computer to the engineers, the engineers discover that a few of the small components of the motherboard are faulty, so they decide to replace it. Sounds simple doesn’t it? If we compare the act of replacing a computer part with the feat of replacing a faulty organ in our bodies, we can greatly appreciate the idea of interchangeable parts. Imagine, for example, that someone is born with a defective heart and has had so many surgeries that all that is left is a stiff and scarred heart. If we equate the body to a laptop we could say, “why not replace the organ with a new one?” Why not produce healthy clones of our organs so that we can just replace them when they are defective?

Although a simple idea, scientists and physicians have struggled for more than 50 years to understand how we can manipulate our cells in order to replace or regenerate our bodies. As scientists continue to advance techniques in cloning technologies, we have seen an increase in the number of ethical debates on the future of cloning. Cloning, albeit a straightforward solution to generating new organs, has become taboo in itself, causing the path to duplication to become less linear and more complicated for the scientist. If we would like to see medicine reach an era of curative intervention rather than palliative treatment, it becomes necessary more than ever to fully understand the fundamental scientific questions that cloning has sought to answer. As we look into the history and science of cloning, we find that it reveals a remarkable flexibility in our biology that could allow us to repair many of the problems that often lead to death.

Cloning: A Background

To find the origins of cloning, we need to go back to the 1950s. Embryologists had long been grappling with understanding how the vast diversity of cells in the body could be derived from a single fertilized egg cell. Scientists were puzzled by the concept of cellular differentiation , the ability of a fertilized egg cell to become a unique cell type within the body [1]. Up to this point in history, all that scientists knew was that within the nucleus of a cell there was genetic information, and this nucleus was bathed within the surrounding fluid in the cell, known as the cytoplasm. In order to investigate cellular differentiation, two scientists, Robert Briggs and Thomas King, sought to answer whether there was some type of irreversible change that occurred in the nucleus of the cell, which caused cells early in development to differentiate into the vast array of specialized cells in our tissues and bodies. They pioneered a laboratory technique known as somatic cell nuclear transfer (SCNT)[1].  SCNT involved taking the nucleus of a frog cell that they deemed to be further along in differentiation, and transferring the nucleus into a frog egg cell that had had its nucleus removed. Briggs and King hypothesized that a differentiated cell nucleus that has undergone irreversible genetic changes should have a decreased potential to develop into other cell types, since it would be lacking the genetic information needed to differentiate into all the cells of the body of an animal. Many scientists shared this hypothesis, as well as the idea that some factors within the cytoplasm cause irreversible changes to the genetic material in the nuclei of cells. In 1962, however, a graduate student by the name of John Gurdon conducted SCNT experiments in which he took differentiated frog intestinal cells and transferred their nuclei into enucleated egg cells. Gurdon modified his experimental procedure to conduct serial nuclear transplantations in which he took the already transplanted nuclei, and transplanted them again. In 1966, Gurdon demonstrated that he could effectively obtain adult frog clones with this method [2]. He proposed that if a differentiated cell nucleus could be used to form all the tissues of an entire animal, then the nucleus of a differentiated cell must not have undergone irreversible changes during cellular differentiation [2].

Gurdon’s frog experiment represents the first time in history that anyone had effectively cloned an animal, and also the first time that anyone had experimentally shown that during differentiation, cells do not undergo irreversible genetic changes. In a time when the secrets of molecular genetics were still being experimentally discovered, Gurdon proposed that it was through some type of mechanism that genes were turned on and off rather than lost as the embryo began to differentiate [2]. The idea that you could take a fully mature cell and reprogram it to become a cell capable of becoming any cell in the body led to the coining of the term pluripotency, which is the idea that a cell can become any cell in the body. His idea that all cells in the body maintain the same genome and have the potential to be reprogrammed into pluripotent cells inspired efforts to discover new ways to reprogram cells. To start, scientists began by studying the pluripotent cells—the embryonic stem cells. In 1998 James Thompson derived the first human embryonic stem cells [3]. By deriving these cells, scientists such as Thompson were interested in discovering the various genetic factors responsible for maintaining the pluripotent state. Theoretically, if pluripotent stem cells, i.e. embryonic stem cells, could be derived from a patient’s cells, such as a skin cell, scientists and physicians could use the pluripotent cells to make replacement tissues that are derived from the patient’s own cells.

In 1996, Ian Wilmut effectively derived the first embryonic stem cells using SCNT in a mammal and effectively cloned the first mammal—Dolly the sheep [4]. This lead to widespread fear and resistance that SCNT could be used to clone human beings, and that embryonic stem cells destroyed human life in the process of their derivation. Such fears lead to an 8 year national ban on the use of federal funds for the creation of new embryonic stem cell lines during the Bush administration, which caused massive funding problems for the field of regenerative medicine [5]. Because human embryonic stem cells are both expensive to derive, and ethically controversial to use, they became incredibly inefficient to use for therapeutic purposes. Moreover, as a clinical application, reprogramming was in its infancy since at the time, derivation of human pluripotent stem cells through SCNT had not been done. It was not until 2006 that Shinya Yamanaka and Kazutoshi Takahashi demonstrated the derivation of mouse pluripotent stem cells using the over-expression of four transcription factors [6]. This paper revolutionized the field of cellular reprogramming because it provided an effective alternative to deriving cells equivalent to embryonic stem cells. This effectively took the place of SCNT as a reprogramming technology, as it was accepted as a less controversial form of deriving pluripotent stem cells. SCNT was deemed as controversial because it generates embryos whose embryonic stem cells are then harvested to generate pluripotent cells in a dish. Yamanka’s method bypassed the need to generate the embryo and developed pluripotent embryonic-like stem cells directly from a differentiated cell in the body. Indeed, Yamanaka’s induced pluripotent stem cells (iPSCs) have been derived from human cells and have been used for a variety of purposes. Despite the shift to Yamanaka’s technology, this year, a group of US researchers in Oregon successfully derived the first human embryonic stem cell lines using SCNT, both reviving the scientific discussion of reprogramming and the controversy over human cloning [7]. Looking back, in more than a half-century of research, reprogramming experiments have demonstrated the remarkable flexibility of our cells to be converted into different cell types that can serve as the basis for regenerative therapies.

 Therapeutic Hope, The Promise of Cloning

As we saw with the engineer replacing a laptop’s motherboard, we can now see how cloning technologies could be used to achieve such “replacements” in our bodies. Cells, it turns out, can be thought about as computers. The DNA of our cells can be thought of as the motherboard of a computer in that DNA essentially controls all the functions of the machine, our cells. The motherboard controls the entire computer’s functions depending on how it is programmed. Similarly, cells also depend upon how the DNA is programmed to express certain genes that carry out a particular function. Knowing this, we can then try to drive stem cells such as pluripotent stem cells to differentiate into a cell type that we are interested in obtaining. Take for example, a heart attack patient. During a heart attack, the heart muscle often dies off, causing irreplaceable damage in the heart that often puts patients on heart transplant lists [8]. Making heart cells from pluripotent stem cells would allow us to regenerate the damaged heart.

            Regenerative technologies do not solely depend upon the generation of pluripotent stem cells. Scientists such as Doug Melton have sought to explore the possibility of bypassing the pluripotent state altogether and directly reprogram one cell type to another. Melton and coworkers showed that a type of cell known as an exocrine cell, located in the pancreas, could be directly reprogrammed into an insulin producing ß-cell by expressing transcription factors that are only present in ß-cells. If Melton’s group can one day make fully mature and functional ß-cells, these cells could effectively be engineered in such a way that they can be transplanted into the pancreas of a patient with type 1 diabetes, which could in theory cure the patient’s diabetes.

            The fundamental promise of cloning is that scientists can take a person’s own cells and manipulate the biology of these cells to regenerate injured or diseased tissues. Using Yamanaka’s induced pluripotent cell (iPS) technology, it is even possible to take cells that may have genetic defects, such as defective genes, and genetically engineer the iPS cells derived from a patient such that the defective gene is replaced with the correct gene [8]. For example, consider a patient with muscular dystrophy who has a mutation in the gene called dystrophin. Using iPS technology, we could theoretically take skin cells, make iPS cells, replace the defective dystrophin gene with the correct gene, and make muscle tissue that could be transplanted into the patient to effectively cure his muscular dystrophy [9]. In addition to fixing genetic defects, scientists and physicians such as Harald Ott at the Harvard Stem Cell Institute are pioneering new technologies in what is known as whole-organ assembly [10]. The idea of whole-organ assembly consists of using iPS cells to seed tissue scaffolds that can be assembled to create on-demand replacement organs for patients [10]. Such technology could one day provide patients with fully functional replacement organs made from their own cells.  

Breaking Down the Controversy

Despite the incredible promise of these technologies, they continue to find opposition from groups that argue that the use of embryonic stem cells and cloning of human cells into embryonic stem cells devalue human life, and could potentially give rise to the cloning of human beings [11]. The controversy is fueled by questions of right to life and individual determinism [12]. The fact that embryonic stem cells (ESCs) have the potential to give rise to all the cells in the body, and theoretically give rise to human beings, creates vast opposition based on fears that human lives are essentially being killed through the use or creation of these cells [14].

When John Gurdon cloned the first animal, the scientific question he sought to answer was whether cells have some irreversible change in their nuclei as they differentiate. Today, scientists are taking this question a step further towards understanding the molecular and cellular biology of how pluripotent cells undergo cellular differentiation. The Oregon study, which developed SCNT reprogramming of human cells, will serve as a vital study for modifying iPS technologies to make reprogramming more effective, and to remove the inefficiencies of genetic reprogramming that we often see with iPS technologies compared to SCNT [7].

Induced pluripotent stem cells were hailed as ethically acceptable because they bypass the need to use human eggs and human embryos. Although the goal of iPSCs is to replace embryonic stem cells as a away to avoid using human embryos, iPSCs contain many genetic differences that currently make them unsuitable to use for therapeutic purposes [8]. The golden standard for deriving pluripotent cells is in fact an embryonic stem cell derived from an embryo that has been made from the fertilization of an egg. If we are to work out the kinks in the iPS system, the use of embryonic stem cells will be key for making iPSCs suitable for clinical use.  Thus, if the controversy arises due to the creation of embryonic stem cells, the following question arises: if we are to perfect iPS technology to effectively derive pluripotent cells that are equivalent to ES cells, should iPS cells be banned as well since our golden standard of comparison must be derived from human blastocysts that have the potential to become a human individual?

            If a human life is defined from the moment that a cell has the potential to become a human being (i.e. conception), we find ourselves in an ethical conundrum when thinking about our genome as a whole. We know that all differentiated cells are equivalent in their genomes’ potential to become any cell in our bodies, and to also generate an entirely new adult, as we saw with Gurdon’s frogs and Wilmut’s sheep. Thus, does this indicate that all cells in the body have the potential to form a life and therefore should be considered as such? The beauty of John Gurdon’s, Ian Wilmut’s, the Oregon Group’s, and Yamanaka’s experiments are not that they derived a Brave New World type of technology to institute human cloning, but rather they reveal the inherent flexibility of our biology. If we define life from the moment we make a cell that has the potential to produce an entire individual, then we potentially must begin to categorize everything in our bodies by their own inherent potential to form an individual. It becomes incredibly difficult to make these categorizations. Unfortunately, the biology of our cells cannot be so clearly confined with these strict definitions. We are constantly learning that cells are dynamic systems. One way we could think about the flexibility of our cells is that engineering them for medicine capitalizes on this inherent biological flexibility. We should also keep in mind that when developing an ethical position, we should remember both the incredible life saving potential of these cloning technologies, as well as the historical scientific questions that they have answered.

Towards the Future 

Cloning technologies have the potential to drive medicine into an era of regeneration. If we define human life as beginning when a cell has the potential to become a full human being, then we may run into difficulties when we consider that essentially any cell in our bodies has the potential to become a full human being. Many ethical arguments against cloning technologies and embryonic stem cell research argue that doing such research inherently destroys human life. We cannot dismiss these arguments, as they propose a valid question, that is—how do we define a human life? Ideally, for the benefit of both scientists and society, we would set ethical boundaries that would allow cloning technologies to benefit humanity in the best possible way.

Acknowledgements:

I’d like to thank my editor Jennifer Guidera for all of her help and feedback during the writing process.

 1.         Briggs, R. and T. King, Transplantation of Living Nuclei From Blastula Cells into Enucleated Frogs’ Eggs. Proceedings of the National Academy of Sciences of the United States of America, 1952. 38 (5): p. 455-463.

2.         Gurdon, J. and V. Uehlinger, “Fertile” intestine nuclei. Nature, 1966. 210 (5042): p. 1240-1241.

3.         Thomson, J., et al., Embryonic stem cell lines derived from human blastocysts. Science (New York, N.Y.), 1998. 282 (5391): p. 1145-1147.

4.         Campbell, K., et al., Sheep cloned by nuclear transfer from a cultured cell line. Nature, 1996. 380 (6569): p. 64-66.

5.         Stolberg, S.G., Bush Vetoes Measure on Stem Cell Research , in The New York Times . 2007. p. A21.

6.         Takahashi, K. and S. Yamanaka, Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell, 2006. 126 (4): p. 663-676.

7.         Tachibana, M., et al., Human embryonic stem cells derived by somatic cell nuclear transfer. Cell, 2013. 153 (6): p. 1228-1238.

8.         Takahashi, K. and S. Yamanaka, Induced pluripotent stem cells in medicine and biology. Development (Cambridge, England), 2013. 140 (12): p. 2457-2461.

9.         O’Connor, T. and R. Crystal, Genetic medicines: treatment strategies for hereditary disorders. Nature reviews. Genetics, 2006. 7 (4): p. 261-276.

10.       Soto-Gutierrez, A., et al., Perspectives on whole-organ assembly: moving toward transplantation on demand. The Journal of clinical investigation, 2012. 122 (11): p. 3817-3823.

11.       Pollack, A., Cloning Is Used to Create Embryonic Stem Cells , in The New York Times . 2013.

12.       Franklin, S., Stem Cells R US: Emergent Life Forms and the Global Biological , in Global Assemblages: Technology, Politics, and Ethics as Anthropological Problems . 2005, Blackwell Publishing Ltd.

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Variations and voids: the regulation of human cloning around the world

Shaun d pattinson.

1 Sheffield Institute of Biotechnological Law and Ethics (SIBLE), University of Sheffield, UK

Timothy Caulfield

2 Health Law Institute, Faculty of Law and Faculty of Medicine and Dentistry, University of Alberta, Canada

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

No two countries have adopted identical regulatory measures on cloning. Understanding the complexity of these regulatory variations is essential. It highlights the challenges associated with the regulation of a controversial and rapidly evolving area of science and sheds light on a regulatory framework that can accommodate this reality.

Using the most reliable information available, we have performed a survey of the regulatory position of thirty countries around the world regarding the creation and use of cloned embryos (see Table ​ Table1). 1 ). We have relied on original and translated legislation, as well as published sources and personal communications. We have examined the regulation of both reproductive cloning (RC) and non-reproductive cloning (NRC).

Summary of regulation*

* The International Digest of Health Legislation http://www3.who.int provides translations of the legislation of Austria (1993, vol 44); Denmark (1997, vol 48); Israel (2000, vol 51), Norway (2003, vol 54), Peru (1998, vol 49), and Switzerland (1999, vol 50, and 2003, vol 54). The Bulletin of Medical Ethics provides translations of the legislation of Finland (Feb 2000, p7) and Germany (Dec 1990, p9). In addition, we have used English translations of the legislation of Greece http://www.coe.int , the Netherlands http://www.minvws.nl , and Sweden (Ministry of Health and Social Affairs, Swedish Act concerning Use of Gene Technology on Human Beings and Experiments with Fertilised Ova , 1991).

While most of the countries studied have enacted national legislation, the absence of legislation in seven of these countries should not be equated with the absence of regulation. Senator Morin was not correct in stating that the majority of recent legislation bans both RC and NRC. Recent regulatory moves are united only with regard to the banning of RC. While NRC is not permitted in seventeen of the countries examined, it could be permitted in up to thirteen countries.

Conclusions

There is little consensus on the various approaches to cloning laws and policies, and the regulatory position in many countries remains uncertain.

"The immense majority of countries who have passed legislation recently do ban both reproductive and therapeutic cloning" (Senator Morin, The Standing Senate Committee On Social Affairs, Science And Technology, Ottawa, Canada, Wednesday 18 February, 2004) .

In February 1997 an article was published in Nature announcing the birth of what was to become the most famous sheep in history [ 1 ]. That sheep, known as Dolly, was the product of asexual reproduction. As the world's media unhesitatingly announced, she was a clone. The prospect of a human clone led to immediate calls for regulatory controls on the technology. There were, however, divisions, particularly when it became apparent that the potential uses of the technique were not limited to reproduction. Other potential uses came one step closer when, in the following year, it was announced that embryonic stem cells had been successfully extracted from non-cloned human embryos [ 2 ]. Now, a year after the death of Dolly [ 3 ], it is appropriate to review the current regulatory position on the creation and use of cloned embryos around the world [ 4 , 5 ] – particularly considering the public debate that has surrounded the recent cloning experiments in Korea, the granting of the first "research cloning" license in the UK, and the past and impending UN cloning debates.

This paper is concerned with the creation of functional embryos, whether by nuclear transfer or embryo splitting. As this suggests, we will use 'embryo' to refer to any human entity considered theoretically capable of implantation and development in the womb. Many regulatory positions distinguish between the creation of a cloned embryo for reproductive purposes and for other purposes. For our purposes, the former will be called reproductive cloning ( RC for short ) and the latter non-reproductive cloning ( NRC for short ). This paper will examine the regulatory position of the thirty countries for which we have been able to obtain reliable information (see Table ​ Table1). 1 ). Where possible, we have relied on copies of the original legislation or of English translations of that legislation. In some situations we have also found it necessary to rely on other published sources [ 6 ] and personal communications.

Understanding the complexity of this "regulatory patch work" is essential [ 7 ]. It provides a sense of the vast differences between nations, the issues on which there are different views, and the existing regulatory uncertainties. In addition, it highlights both the challenges associated with the regulation of a controversial and rapidly evolving area of science and the need for a regulatory framework that can accommodate this reality. Finally, it demonstrates that policy makers cannot rely on the existence of a single regulatory trend to inform policy development. Only on the banning of RC (reproductive cloning) do the world's legislatures and policy-makers display anything approximating a single mind. Senator Morin, who is a member of Canadian Senate, was not right to claim that a majority of recent legislation bans both RC and NRC (non-reproductive cloning). Even looking beyond recent legislation, only a narrow majority of the thirty countries studied actually prohibit NRC. What is more, a large minority of countries have yet to enact national legislation.

This paper is divided into sections. The next, section II, will examine the degree of regulatory variation in the countries studied. Section III will ask whether the existence of legislation answers all regulatory questions. Using examples drawn from those countries with legislation, we seek to show how broad interpretative strategies are sometimes required to avoid unintended lacunae. Section IV uses examples to demonstrate the evolving nature of regulatory positions and increasing reliance on legislation. Section V examines the impact of international initiatives in European (ie the European Convention on Human Rights and Biomedicine) and the United Nations. Section VI will explain why the regulatory outcome usuallysays little about the ethical approach adopted by a particular jurisdiction. Section VII is the conclusion.

Variation between countries

As many commentators have noted, there is great variation in regulatory approaches even within countries that have decided to create relevant laws and policies [ 4 , 5 , 7 , 8 ]. No two countries have adopted identical regulatory measures on cloning, though the effect of those adopted in some countries is very similar. There is only one area of regulatory agreement – no jurisdiction has, yet, adopted legislation or guidelines permitting RC. As a result, there are essentially only two regulatory approaches to RC: prohibition or regulatory silence. Regulatory silence usually means that RC is technically legal in the jurisdiction in question, though if it were attempted, there would likely be a rapid regulatory response.

The majority of the countries studied have now enacted national legislation (see Table ​ Table1). 1 ). Only seven have yet to do so. The absence of national legislation in these seven countries should not, however, be taken to amount to an absence of regulation or, in the case of the US, an absence of state legislation. Legislation is just one of many possible regulatory responses. Ireland provides an illustrative example. The Eighth Amendment to the Irish Constitution (which forms Article 40.3.3) states that,

"The State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect, and, as far as practicable, by its laws to defend and vindicate that right."

While this provision does not mention cloning, it has been taken to protect in vitro embryos and thereby prohibit NRC. In addition, doctors must comply with the guidance of the Medical Council, as this body has the power to remove their licence to practise in Ireland. The Medical Council's guidelines declare that " [t]he creation of new forms of life for experimental purposes or the deliberate and intentional destruction of human life already formed is professional misconduct" [ 9 ]. Also, it limits the manipulation of sperm or eggs to the "improvement of health" and adds that "if the intention is...the creation of embryos for experimental purposes, it would be professional misconduct" [ 9 ]. Thus, the absence of legislation in Ireland does not render all things permissible.

Variation and non-reproductive cloning (NRC)

NRC represents the source of considerable regulatory variation. While NRC is not permitted in seventeen of the countries studied, it could be permitted in up to thirteen other countries. Regulatory uncertainties make it impossible to be sure in some of these counties. Also, some countries (such as the US) have many jurisdictions, each capable of adopting a different regulatory position. Given the superficial similarity of many of these countries and jurisdictions, it is hard to explain such stark variation on cultural differences alone [ 8 , 10 ].

Only Belgium and the UK have deliberately enacted or extended legislation for the purpose of permitting the creation of cloned embryos for research [ 6 , 11 ]. The UK licensing authority has, in fact, granted its first licence to conduct NRC [ 12 ]. Similarly permissive approaches, albeit non-legislative, have been adopted by China (which issued Ministerial Regulations in August 2003 to allow cloning research for therapeutic purposes) [ 6 , 13 ] and Korea (where the government is in the process of approving limited research on limited somatic nuclear transfer research) [ 6 ].

In contrast, Finland, Greece, Israel, Russia and Sweden appear to allow NRC only because their legislation has potential gaps [ 14 ]. The Greece legislation is the most striking, because it is the most recently enacted. The Greek Law 3089/2002 explicitly prohibits 'human reproduction' by any cloning method, but no mention is made of NRC. This must have been deliberate, because the provision allowing embryo research does so by allowing research (with consent) on "fertilized ova" that are surplus following assisted reproductive treatment. Indeed, the legislation's Explanatory Memorandum declares that

"only reproductive cloning is prohibited. It could be thus construed that therapeutic cloning is permitted....This position has also been supported in the Report of the National Bioethics Committee regarding the use of stem cells in biomedical research and clinical practice (21.10.2001), submitted to the Prime Minister on 11.1.2002."

This is nonetheless controversial in Greece, which has ratified both the European Convention on Human Rights and Biomedicine, and its Additional Protocol on cloning (discussed below).

The US, India, and Portugal are anomalous. In the US, what little national legislation there is only concerns the use of federal funds [ 4 ] and some States (such as California and New Jersey) have even adopted permissive legislation [ 15 ]. The Indian Council of Medical Research has declared that "research on cloning with intent to produce an identical human being, as of today, is prohibited", but has not declared NRC to be so prohibited [ 16 ]. However, an Indian Government policy document "opens the door to therapeutic cloning considered on a case-by-case basis by the National Bioethics Committee" [ 6 ]. Portugal has no national legislation, but has ratified the European Convention and its Additional Protocol (see below).

Legislative gaps and uncertainties

There are, of course, many nations that have long standing laws that are relevant to cloning technologies. In many of these nations, however, the laws were designed prior to Dolly and the recent advances in stem cell research. As such, how these laws might apply to cloning is sometimes unclear. Also, these laws are not a result of a public and political dialogue about the complex scientific and ethical issues that are associated with cloning and stem cell technologies. [ 10 ] In addition, there are a number of countries where recent legislative intervention has failed to answer all legal questions relating to human cloning.

The legislation of some countries clearly encompasses somatic cell nuclear transfer (SCNT). The Spanish Law 35 of November 1998 is an example of a pre-Dolly legislation of this type. This Act not only renders it an offence to create identical human beings where it is aimed at race selection, it also renders it an offence to create "human beings by cloning in any of the variants or any other procedure capable of originating several identical human beings." The Canadian Assisted Human Reproduction Act 2004 is an example of post-Dolly legislation of this type. Under this Act, the creation and implantation of a "human clone" are prohibited. "Human clone" is defined under s. 3 to mean "an embryo that, as a result of the manipulation of human reproductive material or an in vitro embryo, contains a diploid set of chromosomes obtained from a single – living or deceased – human being, foetus or embryo". This clearly captures SCNT.

In a number of contrasting countries, SCNT is only captured by a broad, non-literal interpretation of the relevant provisions. The Swedish Law No. 115 of 14 March 1991 is an example of pre-Dolly legislation of this type. This Act only regulates experiments performed on "fertilised ova" or gametes "before fertilisation". The Finnish Medical Research Act 1999 is a rare example of post-Dolly legislation of this type. This Act has many provisions with respect to research on embryos (including a prohibition on the creation of embryos for research) and it prohibits all research conducted with the aim of cloning a human being. However, s. 2 of the Act defines an embryo as "a living group of cells resulting from fertilisation not implanted in a woman's body". Thus, the Dolly technique only appears to be covered insofar as its use involves "research with the aim of cloning human beings" (Also, s.1 of the Constitution secures the inviolability of human dignity, but there is no authoritative interpretation on whether (and how) this provision could apply to cloning). If this aim is only correctly attributed to RC, then NRC might not be covered at all.

The dangers of non-literal interpretation of pre-Dolly provisions should not be exaggerated. Although there are a number of countries that have such legislation (notably, Austria and Germany and, until very recently, France) [ 5 ], in reality the courts are likely to adopt a broad, purposive approach to interpretation. A very broad approach was, for example, taken when the domestic courts addressed the UK's Human Fertilisation and Embryology Act 1990 [ 17 ]. The Act explicitly prohibited only one form of cloning (the creation of a clone by replacing the nucleus of an embryo) leaving the licensing authority to regulate activities such as the creation, storage, and use of in vitro embryos. More precisely, the Act imposes a licensing requirement on the creation of an in vitro embryo (ss.3(1)(a) and 1(2)); storage or use of in vitro embryos (ss.3(1)(b) and 1(2)); storage of gametes (s.4(1)(a)); and use of gametes, unless 'services are provided for the woman and man together' (s.4(1)(b)). Yet, under s. 1(1) of the Act, "embryo" is defined as "a live human embryo where fertilisation is complete", including "an egg in the process of fertilisation". This raised the question of whether SCNT fell outside the Act altogether. Nonetheless, the House of Lords recently held that SCNT produces a functional embryo that falls within the ambit of this Act (in effect, holding that the Act's definition of embryo is non-exhaustive and restricted in purpose) [ 18 ].

Evolving nature of the laws

Not only is there a great deal of variation between nations and much uncertainty as to the scope of existing laws, many of the existing laws and policies are in a state of flux. Indeed, some countries have built in review provisions.

The Dutch legislation, the Embryo Act 2002, presents an example. This Act prohibits procedures undertaken for the purpose of creating genetically identical human individuals and prohibits the creation of embryos for research. Yet, s. 33 of the Act allows for the future repeal of the prohibition on the creation of embryos for research. Likewise, the recently enacted Canadian legislation states that a Parliamentary review of the law is required within three years of proclamation.

Some countries, such as Israel, New Zealand and Russia, have even adopted time-limited legislation. The Israel legislation of 1999, for example, states that, for a period of 5 years , no intervention will be carried out on human cells for the purpose of human cloning or to bring about the creation of a person by the use of reproductive cells that have undergone permanent intentional genetic modification [ 19 ]. What is more, the Act states that the Minister of Health may (upon satisfaction of a number of conditions) permit the creation of a human being through the use of genetically modified cells. Non-legislative bans are often time-limited or chosen because of the ease with which they can be reconsidered.

Other countries are in the process of considering a revision to their existing law. Ireland has set up a Commission on Assisted Human Reproduction in 2000 to explore this topic [ 20 ] and the Irish government has officially stated its opposition to cloning [ 21 ]. There are voices calling for revision of the Germany legislation [ 22 ]. The recently passed Italian legislation might have to be reconsidered because a referendum on a disputed law can be forced if 500,000 signatures are obtained and it has been reported that over a million people have signed a petition calling for a referendum [ 23 ]. The Swedish legislation might well be amended in the near future, to close the gaps mentioned in the last section. If the Government Bill 2003/04:148 on stem cell research is enacted, it will come into force on the 1st of January 2005. This Bill seeks to extend the existing legislation to make it clear that RC using the somatic nuclear transfer is encompassed and to explicitly allow somatic nuclear transfer as a way of creating embryos for non-reproductive purposes. Thus, Sweden is likely to join Belgium and the UK in permitting NRC by legislation.

International initiatives

I) european convention.

The European Convention on Human Rights and Biomedicine has now been signed by 31 of the 45 member States of the Council of Europe, of which 15 have also ratified the Convention [ 24 ]. It has not been signed by any of the non-member participants (which include Australia, Canada, the Holy See, Mexico, and the US). While this Convention does not specifically address human cloning, a number of its provisions have implications for cloning.

Article 18(2) of the Convention prohibits the "creation of human embryos for research purposes". The phrase "human embryos" is not defined by the Convention and subsequent negotiations of the working party on the protection of the human embryo and fetus appear to have failed to reach agreement on this and other issues. This provision only prohibits NRC if it captures the creation of all functional human embryos for research. While the Convention makes provision for referrals of questions of interpretation to the European Court of Human Rights (Article 29), referral is unlikely because the Convention arguably leaves such decisions to the discretion of individual States. The Strasbourg court itself allows individual States a wide discretion (known as the 'margin of appreciation') in controversial policy areas. The court has, for example, adopted this approach when considering whether the fetus is included in the provision of the European Convention on Human Rights and Fundamental Freedoms that grants 'everyone' a right to life (see the latest case: Vo v France (no. 53924/00)). Moreover, before signing or ratifying the Convention on Human Rights and Biomedicine, any State could make a reservation to this provision insofar as it is inconsistent with their pre-existing law (Article 36). This is what we would expect the UK to do if it eventually signs the Convention.

Whether RC is implicitly prohibited by the Convention is more controversial. Those who hold that cloning violates human dignity will no doubt point to Article 1, which requires parties to the Convention to "protect the dignity and identity of all human beings". This seems tenuous. There is, however, an Additional Protocol on the Prohibition of Cloning Human Beings [ 25 ]. Article 1 of the Additional Protocol declares that,

Any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited.

Since "genetically identical" is defined, under Article 1(2), as "sharing with another the same nuclear gene set", use of the Dolly technique on humans is included within this prohibition. This provision clearly captures RC. What is more controversial is whether it covers NRC. To foreclose this possibility, when the Dutch government signed the Protocol it added an interpretative statement declaring that it "interprets the term "human beings" as referring exclusively to a human individual, ie a human being who has been born". This interpretative statement is arguably unnecessary, because, in the absence of a definition of human being in the Convention itself, States are free to interpret this provision in accordance with their own national policy.

The impact of these international instruments is particularly important with regard to the three countries that have ratified both: Portugal (which has no legislation), Greece (whose legislation only explicitly prohibits RC), and Spain (which has comprehensive legislation in this area). In Greece, the Explanatory Memorandum to the legislation declares that ' [i]t could be...that therapeutic cloning is permitted exactly as in Article 1 paragraph 1 of the Additional Protocol on Cloning'. We understand that conservative opinion is of the view that this interpretation is in conflict with Article 18(2) of the Convention itself. However, neither the Convention nor the Protocol on Cloning provide any sanctions for violation.

ii) United Nations

The United Nations' struggle to agree on a cloning treaty exemplifies both the variation of approaches and the challenges associated with seeking consensus in a morally contested area [ 26 ]. In December 2001, the UN General Assembly established an Ad Hoc Committee to consider "the elaboration of an international convention against the reproductive cloning of human beings" [ 27 ]. Since that time, a number of treaty proposals have been considered. A proposal by France and Germany, for example, recommended a narrow ban on RC only, leaving NRC for future debate [ 28 ]. A second proposal supported by Spain and the US, argued for a comprehensive ban on cloning, including NRC [ 29 ]. The most recent proposal, which was put forward by Costa Rica, would require states to establish criminal offences for all human cloning, including NRC [ 30 ].

There has, however, been little consensus on how to proceed. Though all countries agree that RC should be banned, there is deep division regarding NRC. Neither the Ad Hoc cloning committee nor the UN's Legal Committee could reach a consensus on which proposal to support and bring before the General Assembly. In November 2003 the Legal Committee voted (80-79) to recommend a two-year deferral on a General Assembly decision – a compromise that was put forward and supported by most of the members of the Organization of the Islamic Conference. This decision was largely seen as a victory for those countries supporting a more permissive approach to cloning policy [ 31 ]. Indeed, some viewed the two year delay as an ideal opportunity for the scientific community to promote the value of NRC [ 32 ]. However, in response to pressure from those countries seeking a comprehensive ban, the General Assembly came to yet another compromise. In January 2004 the General Assembly overturned the Legal Committee's recommendation and supported a one year delay on the debate over the cloning treaty. This October, the General Assembly re-opened the debate, again with no apparent compromise from either camp [ 33 ].

The fact that the deep division at the UN is primarily about NRC reflects the lack of any consistent approach to cloning policy. For example, one would expect an emerging trend toward the banning of NRC, as suggested in the quote by Senator Morin, to be reflected in the building of consensus or, at least, a degree of flexibility at the UN General Assembly.

Ethical considerations

Few areas of regulation are as evidentially driven by ethical views as the regulation of cloning and cloning research. This is not the place for in-depth analysis of the underlying debate. Elsewhere we have both argued that existing regulatory attempts to prohibit RC have rarely been underpinned by thoughtful exposition of underlying ethical principles [ 5 , 10 , 34 ]. Policy statements frequently rely on claims that are tautologous, under specified, poorly considered, or a combination of these things. Our claim here is more modest. In this section we seek to show why attempts to understand the ethical basis of the existing law cannot focus solely on the existing regulatory outcomes. And, of course, the regulatory outcome does not, necessarily, represent a jurisdictional consensus on the central ethical issues.

Lawyers rarely look to regulatory outcome to understand ethical debates. Unfortunately, in the area of cloning many commentators do that very thing. As our starting quotation demonstrates, politicians and commentators are all too ready to find support for their ethical views in regulatory positions adopted elsewhere. There are, however, varying levels of ethical agreement. Agreement on the appropriate regulatory position does not imply agreement on the underlying ethical principles.

Consider the relationship between ethical positions on the moral status (or dignity) of the cloned embryo and NRC. The cloned embryo could be considered to have full, no, or limited moral status [ 18 , 35 ]. The full status position would grant the embryo the same level of moral duties as you or I. The no status position would grant the embryo no more status or dignity than your hair or nails. The limited status position would grant the embryo a fixed or gradualist level of intrinsic moral value between these two extremes. The full status position will require the prohibition of NRC (destructive use of embryos is considered murder) and the no status position will usually require NRC to be permitted (unless such an approach will interfere with the moral interests of those who do matter). The limited status position is, however, potentially compatible with either regulatory position, depending on the particular status given to the early embryo and the weight given to potential benefits of NRC. It follows that the fact that the regulatory position permits or prohibits NRC does not do even tell us what status the embryo is considered to have. This is further complicated by the fact that supporters of the no or limited status position might be prepared to accept more restrictions than are strictly required by their position to protect a more important moral goal. Only supporters of the full status position cannot coherently make such pragmatic compromises [ 18 ].

Similarly, the existing positions on RC could be supported by radically different ethical views. Prohibitions could be supported by those who hold that RC is absolutely wrong (eg always violates human dignity) and by those who hold that cloning at present would be wrong. Even time-limited prohibition does not enable us to discern whether it is underpinned by, for example, the view that RC is wrong because of current safety issues or the view that RC is not wrong but the most effective way to get there is by initially prohibiting it.

In sum, the majority of regulatory outcomes could be coherently explained by reference to one or more underlying ethical positions. Thus, similar or even identical regulatory outcomes imply less by way of ethical agreement than some may be inclined to believe.

Cloning laws and policies are far from uniform across the globe and the legal position in some countries remains uncertain. This will give little comfort to scientists and policy makers hoping to gain clear direction from the international position. For the time being at least, policymakers must accept the reality of international "dissensus" and scientists wishing to undertaken research on NRC are best advised to consider conducting their research in only a handful of countries. Even where there is agreement as to the regulatory outcome, policy-makers should not confuse this with agreement on underlying ethical principles. Like many topics concerning the developing genetic and reproductive technologies, cloning remains controversial.

Competing interests

The author(s) declare that they have no competing interests.

Authors' contribution

Both authors contributed to the original concept for the paper, the writing and revision of the manuscript and the analysis of the law.

Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1472-6939/5/9/prepub

Acknowledgements

Professor Caulfield is a Canada Research Chair in Health Law and Policy and would like to thank the Alberta Heritage Foundation for Medical Research, Genome Prairie and the Stem Cell Network for research support. We would like to thank those who provided information on the laws of other jurisdictions, in particular, Tina Garanis-Papadatos (Greece), Salla Lötjönen (Finland), Deirdre Madden (Ireland), André Pereira (Portugal), and Elisabeth Rynning (Sweden). Finally, we would like to thank the reviewers for their useful comments.

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• Jia H. New Chinese rules permit cloning for research http://www.scidev.net/News/index.cfm?fuseaction=readnews&itemid=1217&language=1 February 3, 2004. Accessed July 14, 2004.
• Israel's health committee approves human cloning in principle. LifeSite Daily News. http://www.lifesite.net/ldn/2004/mar/04031206.html March 12, 2004. Accessed July 14, 2004.
• Round-up of cloning and stem cell research news. Bionews org. http://www.bionews.org.uk/new.lasso?storyid=1927 December 16 2003. Accessed July 15.
• Indian Council of Medical Research Ethical Guidelines for Biomedical Research on Human Subjects New Delhi, India. 2000. p. 48.
• R (Quintavalle) v Secretary of State for Health UKHL 13. 2003.
• Beyleveld D, Pattinson S. Globalisation and human dignity: some effects and implications for the creation and use of embryos. In: Brownsword R, editor. Global Governance and the Quest for Justice. Volume IV: Human Rights. Oxford, England: Hart Publishing; 2005. [ Google Scholar ]
• Law 575 – Prohibition of Genetic Intervention (Human Cloning and Genetic Manipulation of Reproductive Cells)
• Assisted reproduction commission set up. Department of Health and Children http://www.doh.ie/pressroom/pr20000225a.html February 25, 2000. Accessed July 15, 2004.
• Micheal Martin Speech by Mr Micheal Martin, TD, Minister for Health and Children, on the occasion of the opening of the conference organized by the Commission on Assisted Human Reproduction Department of Health and Children. http://www.doh.ie/pressroom/sp20030206.html February 6, 2003. Accessed July 15, 2004.
• Germany hints at loosening of stem cell law. Deutsche Welle. http://www.dw-world.de/english/0,3367,1430_A_1016499_1_A,00%20.html October 10, 2003. Accessed July 15.
• Arie S. Italians force referendum on fertility law. The Guardian. 1 Oct 2004.
• Council of Europe, Committee of Ministers. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, CETS No 164. 1997.
• Council of Europe, Committee of Ministers. Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings, ETS No 168. 1998. [ PubMed ]
• Edwards RG. United Nations and human cloning: a slender and fortunate defence for biomedical research. Reproductive BioMedicine Online. 2003; 7 :700–2. http:// www.rbmonline.com Accessed July 15, 2004. [ PubMed ] [ Google Scholar ]
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• Bosch X. United Nations debates human cloning ban. The Lancet. 2002; 360 :1574. doi: 10.1016/S0140-6736(02)11586-8. [ PubMed ] [ CrossRef ] [ Google Scholar ]
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Research/Study Research/Study

Inside Project 2025's attack on reproductive rights: IVF

Special Programs Abortion Rights & Reproductive Health

Written by Sophie Lawton , Jacina Hollins-Borges & John Knefel

Published 06/24/24 1:30 PM EDT

At least 22 partner organizations of Project 2025, a coalition of over 100 conservative groups looking to staff the next potential administration of former President Donald Trump, have publicly criticized in vitro fertilization, according to a Media Matters review.

Project 2025 is organized by conservative think tank The Heritage Foundation, and has laid out a radical plan for governance during a second Trump term. The initiative's wide-ranging policy proposals are laid out in its “ Mandate for Leadership ,” a staunchly anti-choice document. Although the Mandate itself doesn’t mention IVF, Heritage has published several pieces opposing the procedure and celebrated a ruling by the Alabama Supreme Court that extended de facto personhood rights to frozen embryos, severely curtailing access to IVF. After abrupt political backlash , Alabama’s governor passed a law protecting IVF providers from legal liability, which some Project 2025 partner organizations have criticized for rendering the original “fetal personhood” ruling moot.

The organizations and individuals associated with Project 2025 who oppose IVF have raised various objections, none of which are scientifically or medically sound. Some opponents, for example, have elided the difference between the legal definition of “viable” — like that used by Louisiana, which has the most restrictive anti-IVF laws in the country — and the medical definition. Louisiana allows IVF but prohibits the destruction of embryos, forcing fertility clinics to ship them to other states for storage. These organizations will often point out that despite this law, Louisiana has more babies born through IVF than Alabama, though they fail to mention that both states have some of the lowest rates of IVF births in the country.

Similarly, some partner organizations have suggested following European countries' leads in regulating IVF, several of them naming Italy as a suitable example. Italy once had laws classifying embryos as living people and severely regulating IVF procedures; all of them were repealed after IVF became more difficult to access and less likely to succeed.

Other Project 2025 associates have argued that IVF is a form of eugenics or that it will lead to cloning or extreme forms of genetic modification and experimentation. Still others have baselessly claimed that IVF is underregulated, ignoring the multiple federal and state guidelines and licensing requirements that providers must meet. 

For the full report on Project 2025's attack on reproductive rights, click  here .

Select a Partner Organization

The heritage foundation, alabama policy institute, alliance defending freedom, the american conservative, american family association, american principles project, americans united for life, amac action, california family council, concerned women for america, discovery institute, eagle forum, ethics and public policy center, family policy alliance, family research council, independent women’s forum, dr. james dobson family institute, liberty university, media research center, mississippi center for public policy, students for life of america, susan b. anthony pro-life america, turning point usa.

• In a post to X, The Heritage Foundation appeared to express support for the Alabama IVF ruling, writing, “FACT: The Alabama Supreme Court decision does not threaten access to IVF,” and claiming that the decision “reassures parents” that frozen embryos will be safer.  [Twitter/X, 3/7/24 ]
• Senior legal fellow Thomas Jipping wrote that the Alabama Supreme Court ruling on embryos that imperiled IVF “got it right” and further suggested that abortion should not be legal.  Jipping also denied the ruling is “an attack on IVF technology itself ... or could have revolutionary ripple effects,” belittling “the media, politicians, and activists” who discussed the ruling’s consequences. He concluded that while this case was about destroyed embryos, “causing the death of an unborn child by abortion is legal [in] more than half of the United States.” [The Heritage Foundation, 4/2/24 ]

The Heritage Foundation's Emma Waters has written extensively against assisted reproductive technologies, particularly IVF and surrogacy. Her opposition draws on unsubstantiated concerns about possible harms to children who lack access to both biological parents and on biblical teaching about proper procreation. [Media Matters, 3/1/24 , 4/2/24 ] 

In a March article titled “Why the IVF Industry Must Be Regulated,” Waters laid out policy recommendations that would impose heavy medical restrictions on IVF and make the procedure more difficult for couples to access and harder for facilities to perform. [Media Matters, 3/19/24 ]

In an article describing her biblical reasoning for not supporting IVF, Waters argued that it is important for Protestants specifically to “take a firm and authoritative stance on reproductive technology” because “Protestants necessarily hold a central place in America’s political and institutional life.” [The Heritage Foundation, 1/24/24 ]

Waters celebrated the Alabama Supreme Court ruling on IVF, calling it “an unqualified victory” and claiming “parents should be grateful that their embryos will receive greater protection.” In another piece on the ruling, Waters suggested states adopt stricter laws around IVF procedures, like those that exist in some European countries. [The Heritage Foundation, 2/27/24 , 2/28/24 ]

In a 2023 article, Waters complained about a California bill that would allow single parents or same-sex couples to access IVF through their health care service plans, stating, “No amount of technology or health insurance coverage can alter God’s created order.” She also claimed that allowing more widespread use of IVF procedures would create a “human trafficking market.” [The Heritage Foundation, 6/20/23 ]

Waters repeated her complaints about LGBTQ couples using IVF and other assisted reproductive technologies in another article titled “Radical ‘Right to Build Families Act’ Would Unleash IVF and Commercial Surrogacy.” In the article, Waters claimed that “the pro-abortion and the LGBTQ coalitions” are pushing assisted reproductive technologies, writing that both coalitions “have been quite hostile to the rights of children and the unborn.” [The Heritage Foundation, 1/13/23 ]

In an interview with the Family Policy Alliance, Alabama Policy Institute president and CEO Stephanie Smith claimed, “The Alabama Supreme Court ruled — correctly, in our opinion — that those embryos were children and should be treated as children under our wrongful death statutes.” Referencing Louisiana’s strict IVF laws, she went on to suggest new parameters that would make the treatment more difficult to receive. [YouTube, 2/29/24, 2/29/24 ]

API released a joint statement with Susan B. Anthony Pro-Life America criticizing Alabama’s stop-gap measure to protect providers of IVF from criminal charges. The statement said, “It is unacceptable the Alabama Legislature has advanced a bill that falls short of pro-life expectations and fails to respect the dignity of human life.” [The New York Times, 2/28/24 ]

In an article titled, “In IVF case, Alabama Supreme Court protects life from conception,” Alliance Defending Freedom senior counsel Denise Burke claimed the Alabama ruling was “a victory for life and the rights of parents.” Burke argued, “Cases like this one demonstrate that being pro-life entails more than just protecting unborn children from abortion.” [Alliance Defending Freedom, 3/18/24 ]

In a statement, Burke called the Alabama ruling “a tremendous victory” for “unborn children created through assisted reproductive technology.” [The New York Times, 2/22/24 ]

An article in the American Conservative by contributor Carmel Richardson claimed IVF is helping the “LGBT movement” distort the meaning of family. Richardson wrote, “To limit the baby-making industry is to give hard answers to those who would like a chicken in every pot and a baby in every lesbian, gay, bisexual, and transgender arm.” Richardson later disparaged IVF for allowing even a “transgender pedophile” to have a child. [The American Conservative, 3/1/24 ]

Contributor Christopher Brunet argued in a piece titled, “A personal IVF story” that he “should be allowed to condemn IVF” because “while one may born as the result of a rape, for example, it does not mean that they can’t condemn rape.” Brunet called IVF “the hope and despair of professional women in middle management” and “propaganda against nature, persuading a generation of collegiate women that they're not losing fertility every day after they turn 20.” Brunet also admonished Republicans for caving to pressure to support IVF, writing, “Just as there is now no going back on IVF, there is also no going back on gay marriage, civil rights, demographic replacement.” [The American Conservative, 2/28/24 ]

Them Before Us President Katy Faust published a story in The American Conservative titled “Alabama sets the stage for a Supreme Court fight over IVF,” in which she praised the Alabama ruling and claimed Louisiana has similar guidelines about embryos. Faust claimed these laws “protect children from their rampant destruction at the hands of #BigFertility” and called on conservatives to “not only challenge the baby-taking industry, but the baby-making industry.” [The American Conservative, 2/24/24 ]

In a call to action against Mississippi’s “anti-life” bill HB 1688, American Family Association claimed the bill would grant an “unrestricted right to destroy unborn children” through procedures such as IVF. The organization called it a “very bad amendment” and asked readers to contact their local lawmakers about the bill. HB 1688 would protect the right to assisted reproductive procedures in Mississippi. [American Family Association, 3/8/24 ; Mississippi Today, 3/7/24 ]

In a second call to action against Mississippi’s HB 1688, AFA Vice President Walker Wildmon stated that the bill “creates an unrestricted right to destroy unborn children as part of very broadly defined ‘treatments or procedures.’” [American Family Association, 3/11/24 ]

On his podcast At The Core , Wildmon claimed, “The ruling in Alabama had to do with wasting embryos, or dumping embryos or discarding” and went on to state “eyes are being opened to how much of a disregard as a culture we’ve had for babies with this IVF discussion.” [American Family Radio, At The Core , 2/28/24 ]

In a Facebook live panel hosted by AFA about the Alabama IVF ruling, Wildmon claimed, “An embryo is a baby,” and stated, “IVF is not being threatened here.” [Facebook, American Family Association Action, 3/1/24 ]

American Principles Project President Terry Schilling tweeted about IVF: “If America isn’t careful, we could actually create a government backed institution of buying and selling human beings. Which, I thought, we decided long ago was wrong.” American Principles Project previously tweeted a statement by Schilling where he told Republicans to “come up with reasonable policy” and that “they should come up with what they actually believe and support and stand for.” [Twitter/X, 3/7/24 , 2/27/24 ]

In a February statement posted to its website, Americans United for Life praised Sen. Cindy Hyde-Smith (R-MS) for blocking legislation that would protect the right to reproductive treatments. The statement claimed that “embryonic children are typically treated as property rather than persons” and that there is a “near-total lack of patient health and safety regulations and meaningful regulatory oversight” in the IVF industry. [Americans United for Life, 2/28/24 ]

Chief legal counsel for AUL Steve Aden spoke with The Washington Post, criticizing Trump’s statement about IVF treatments and stating that “the ethical approach to IVF is to ensure that human lives are not wantonly created and destroyed in the process.” The Post also highlights the “model legislation to limit the number of embryos created per IVF cycle” that AUL previously drafted. [The Washington Post, 2/24/24 ]

In 2022, Aden compared IVF treatments to “eugenics,” telling The Guardian he considers “most” kinds of IVF “untenable in a culture that respects all human life.” [The Guardian, 5/12/22 ]

In a piece on the Association of Mature American Citizens Action website, author John Moor suggested giving the Alabama Supreme Court credit for “having the courage” to make the ruling limiting IVF. He went on to compare a “preborn child” to people who “fall under a government protected characteristic,” claiming the government protects individuals from discrimination “based on age, mental capacity and appearance like skin color” and therefore should protect embryos as well. [AMAC Action, 3/18/24 ]

On Instagram, the California Family Council claimed, “By the numbers the IVF Industry is responsible for the loss of more embryonic life every year than the abortion industry.” [Instagram, 3/6/24 ]

In a statement on its website, the CFC claimed there are “grave moral concerns inherent to IVF,” and, “We cannot ignore the plight of our embryonic brothers and sisters.” The statement heavily doubled down on the idea that embryos are humans and advocated for the adoption of laws like those regulating IVF in Louisiana and countries like Germany, Italy, France, Poland, New Zealand, and Australia. [California Family Council, 3/8/24 ]

In 2023, CFC attacked a California bill it claimed “would require employers to provide insurance plans that cover all nonexperimental fertility treatments, including … for a surrogate hired by any couple or single person.” The CFC statement criticized the bill for expanding fertility treatments to include LGBTQ families, stating, “Children have the natural right to their biological father and mother, and they suffer tremendously in every area of life when this right is infringed upon.” [California Family Council, 6/19/23 ]

Valerie Bynog, a legislative strategist for Concerned Women for America Legislative Action Committee, wrote in a blog on the organization’s website, “An embryo … is a living being.” Bynog criticized the American IVF industry for not having laws like “many European countries” that have “common sense regulations” around IVF. [Concerned Women for America, 2/29/24 ]

Discovery Institute Chair and Senior Fellow Wesley J. Smith wrote in 2017 that IVF is lacking the “moralistic restriction” of only being used by infertile married couples, and referred to the treatment as “positive eugenics.” [Discovery Institute, 10/27/17 ]

Smith previously wrote in 2013 that IVF opens the door for “polyamorous threesomes or lesbian couples” to have children and claimed it must be stopped. He also claimed, “We already know that children born via IVF have poorer health outcomes than children conceived naturally,” and compared IVF treatments to cloning animals. [Discovery Institute, 9/26/13 ]

In a statement on its website, Eagle Forum claimed, “Other states and countries are performing IVF in ethical ways,” referencing Louisiana and European countries, and claimed Louisiana’s IVF regulations “clearly haven’t deterred fertility clinics.” The statement attacked Sen. Tammy Duckworth’s (D-IL) Access to Family Building Act, saying it expands reproductive protections too widely to include “not only IVF, but cloning, gene editing, experimentation on embryos, commercial surrogacy, ‘designer babies’, and more,” and that it removes “religious conscience protections” around IVF. [Eagle Forum, 2/29/24 ]

Appearing as a guest on a Facebook live panel hosted by the American Family Association, Eagle Forum executive director Becky Gerritson claimed the Alabama ruling “did not stop IVF, it did not regulate IVF” and told the panel that Eagle Forum is “promoting and pushing” more regulation of the IVF industry. [Facebook, American Family Association Action, 3/1/24 ] 

The Ethics and Public Policy Center published a piece on its website by fellow Patrick Brown in which he claimed that Republicans are making “a mistake” by criticizing the Alabama ruling and called for Republicans to refuse “broad progressive legislation that would make access to IVF an ‘individual right.’” Brown pushed back on calls for IVF to be an individual right, claiming that it has “weakened” the “family as an institution,” and suggested policy that would cover IVF for only “legally married couples using their own sperm and egg.” He also called the Alabama ruling a “modest” case against IVF. [Ethics and Public Policy Center, 3/2/24 ]

EPPC President Ryan Anderson published a piece titled, “The truth about Alabama’s ruling on IVF” wherein he claimed that “the media … falsely claimed IVF was about to be banned— and Republicans fell for the claim.” Anderson’s whole piece referred to IVF embryos as “frozen embryonic children” and called IVF “morally and emotionally fraught.” [Ethics and Public Policy Center, 2/28/24 ]

EPPC fellow Andrew Walker criticized Christians and pro-life Americans for not having a stronger stance against IVF. He called IVF “morally problematic” for taking sexual intercourse out of conception, breaking a “holy and inviolable seal,” and for creating embryos that won’t be used, claiming, “In Christian language, these embryos are our neighbors.” [Ethics and Public Policy Center, 2/28/24 ]

EPPC fellow Aaron Kheriaty wrote a piece for Newsweek titled “After Alabama ruling, it's time for a serious look at the ethics of the IVF industry,” in which he claimed that “there is no morally just solution” for modern IVF treatments. [Newsweek, 2/29/24 ]

In a Family Policy Alliance podcast, Director of Public Policy Joseph Kohm stated, “Each of those fertilized embryos that are frozen is a unique human life,” before praising the Alabama Supreme Court for addressing the issue of IVF. [YouTube, 2/29/24 ]

Family Research Council President Tony Perkins told The Associated Press that the Alabama Supreme Court’s decision was “a beautiful defense of life.” [The Associated Press, 2/23/24 ]

On X, Perkins asserted that Sen. Tammy Duckworth’s (D-IL) bill protecting reproductive services was “an overreach designed to advance the Democrats’ radical, Frankensteinian agenda.” He also claimed the bill would legalize “creation of animal-human hybrids (‘chimeras’)” and “trafficking and destruction of human embryos.” In a later post, Perkins pushed for more “IVF safeguards.” [Twitter/X, 2/28/24 , 2/28/24 ] 

On his podcast, Washington Watch, Perkins claimed Duckworth’s bill “raises numerous moral and bioethical issues that go far beyond ensuring the IVF issue” and again claimed it would allow the creation of human-animal hybrids. [YouTube, Washington Watch, 2/28/24 ]

On the Independent Women’s Forum’s She Thinks Podcast, Natural Womanhood editor Grace Emily Stark argued that “all across the board people, even medical professionals, have this really inflated idea of how successful IVF is that does not match reality.” [Independent Women’s Forum, She Thinks Podcast , 2/17/23 ]

On the High Noon podcast, IWF senior fellow Emily Jashinsky argued, “The pro-life movement should lead with the reality that there is a way for IVF to be done ethically where you’re not discarding embryos.” Later, host Inez Stepman asked: “Do we really want to live in a world where we’re eugenically selecting babies, where we are commodifying the act of pregnancy?” [Independent Women’s Forum, High Noon , 2/28/24 ] 

IWF cross-posted an article originally written for Fox News by IWF visiting fellow Emma Waters, warning that “AI will fuel disturbing ‘build-a-child’ industry.” Waters claimed: “Seventy-five percent of IVF clinics in the U.S. offer genetic testing. This allows parents to create multiple embryos and select the one that matches their preferred sex and eye, hair, and skin color.” She added: “They can also gauge if a child will develop certain health problems. In one controversial case, deaf parents tried to create a child who would inherit their deafness. Of course, clinics destroy the unwanted embryos.” [Independent Women’s Forum, 8/4/23 ]

In a Q&A post on the Dobson Digital Library, James Dobson declared that he is “strongly opposed to the practice of creating fertilized eggs from ‘donors’ outside the immediate family (this would include the donation of sperm or eggs from a brother or sister of the husband and wife wishing to conceive),” because such activity would be to “play God.”  Dobson added that IVF is “less problematic” if “all the fertilized eggs are inserted into the uterus (i.e., no ova are wasted or disposed of after fertilization.” He also argued that implanting an already existing frozen embryo is akin to “adoption.” [Dobson Digital Library, accessed 4/2/24 ]

Liberty University posted a summary of a law school panel discussion on reproductive rights after the Dobbs decision, highlighting comments from The Justice Foundation’s Allan Parker on “how to advance that victory [Dobbs] by abolishing in vitro fertilization to protect frozen eggs that have already been fertilized, which he explained is an expansion of the idea that life begins at conception.” Parker said: “I think we need more scholarly research and more public education (on this topic) before the Supreme Court is willing to accept the argument that the right to life under the constitution protects life from the moment of conception.” He added, “It takes time to change culture. But we need to do the historical research, get the education about it to where the judges, based on the appropriate case with the appropriate evidence, will be comfortable making that judicial determination.” [Liberty University, 2/14/24 ]

Media Research Center’s Tierin-Rose Mandelburg responded to the Alabama Supreme Court decision in a blog post, writing, “This is a good thing. Regardless of whether a child is conceived naturally or by artificial implantation, that child has value and has sanctity and deserves to be treated as such. Throwing embryos away should be considered murder, as, now in Alabama, it is.” Mandelburg’s blog began with the line, “Sweet Home Alabama just got even sweeter for babies.” [NewsBusters, 2/19/24 ]

Media Research Center’s Jorge Bonilla argued that the mainstream media’s response to Alabama’s ruling was disingenuous and simply a cover to advocate for abortion rights, writing, “The panic point for the media is the Court’s grant of personhood to human embryos.” “Such a finding, were it to be upheld by the United States Supreme Court, drives a dagger into efforts to codify Roe,” he continued. He later added: “Personhood, even if not uttered out loud, is the whole ball game and the media know it. It’s hard to imagine the liberal media caring too much about IVF except that these stories enable advocacy for a Roe restoration. Personhood gets in the way of that.” [NewsBusters, 2/23/24 ]

Similar to the Heritage Foundation, the Mississippi Center for Public Policy argued more than a decade ago in support of a proposed “personhood amendment” to the state’s constitution, claiming it was “unlikely” to “be used to justify a ban on in vitro fertilization (IVF).” MCPP added: “IVF procedures can be performed without destroying human embryos, and therefore would still be permissible under Initiative 26. As is currently being done in many cases, any excess embryos not implanted in the womb could be frozen and implanted later or adopted out to other parents.” [Mississippi Center for Public Policy, 11/3/11 ]

Students for Life of America argued that a “consistent, intellectually-honest stance holds that human life begins at conception/fertilization,” and views discarding embryos as “a human rights violation,” claiming that the current process of IVF encourages “targeted killing” based on “undesirable traits” and “leads to eugenics.” [Students for Life of America, 1/27/22 , 4/21/22 , 2/23/24 ]

In a blog post, Students for Life of America prepared supporters to discuss IVF by raising the argument that “more die from IVF than abortion.” [Students for Life America, 2/23/24 ]

Susan B. Anthony Pro-Life America has advocated against federal bills drafted to protect IVF after the Alabama ruling. SBA Pro-Life America argued against Rep. Nancy Mace’s (R-SC) non-binding resolution that states “strong support” for IVF, arguing that it “leaves no room for reasonable laws like the one in Louisiana that for decades has protected human embryos while also allowing IVF.” The organization also heavily criticized Sen. Tammy Duckworth’s (D-IL) bill, saying it “would even codify a right to human cloning and genetic engineering of human embryos.” [Susan B. Anthony Pro-Life America, 2/28/24 , POLITICO, 2/27/24 ]

Turning Point USA’s Alex Clark, who frequently criticizes fertility care and birth control, has written about her changing stance on IVF, concluding in 2022 that IVF is not “really any different than an early abortion.” [Turning Point USA, 8/11/22 , 8/29/22 ; Media Matters, 6/11/23 , 2/14/23 ]

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Providing resources when people need them most

February 2, 2024

Warning: This story talks about suicide. If you or someone you know needs help, please call, text or chat the Suicide and Crisis Lifeline at 988. You matter. You are important. Michigan State University is one of the top public research universities in the world and a member of the prestigious Association of American Universities, widely regarded as among the top research-intensive institutions in North America. The following story highlights one of the many examples of MSU’s research excellence and innovation.

Which community members are the focus of this research?

One large group of people who consider and attempt suicide are those who have interacted with the criminal-legal system. For example, a significant percentage of police calls are related to mental health, substance use and partner violence. Our research shows that 21% of adults who die by suicide in the U.S. have spent at least one night in jail in the past year, making this population an important focus for suicide prevention.

To get some perspective, how many people interact with the criminal-legal system in the U.S. each year?

More than you might expect. This year alone, there will be:

• 240 million 911 calls
• 53 million police contacts
• More than 7 million people will be arrested and detained in jail for at least one night
• More than 1 million people will receive a jail sentence
• 6 million will serve probation in the community

It’s important to understand that jail is different than prison. Jails are local and typically run by counties or cities. More than 80% of people in jail are not convicted and half will be released in less than a week. Prisons are operated at the state or federal level and hold people who are convicted and sentenced to more than a year.

How can we tell who is at risk and when their risk is highest?

Our research shows that individuals are often suicidal before being arrested. Detention often happens when people are in crisis. In fact, some individuals go to jail because of a suicide attempt like an attempted overdose, reckless driving or picking a fight and hoping to be killed. Once released, the risk of suicide in the following year is even higher than the risk of suicide in jail.

How is NCHATS working to match vulnerable people with suicide prevention services?

Because of high volume, short stays, the unpredictable length of stays and limited health staffing, jails have difficulty connecting people to community services. They are not equipped for this. But we are finding answers. One solution is more community mental health funding at the state and county levels to avoid criminal-legal involvement for situations like homelessness or public nuisances. Another answer is to find more scalable ways to connect people to community mental health care after a criminal-legal encounter. The NCHATS team has identified high levels of risk in this group and effective interventions. We also have discovered that advances in technology now give us the ability to scan publicly available data for matches to a health system. This means that we can gather publicly available arrest and release information and then alert local health systems so they know to reach out and check on their patients who may be in crisis. We also provide health systems with training in best practices for suicide prevention. This approach is currently working in Ohio, and we’re excited to make it available nationally. In the end, it’s as simple as alerting people to reach out a hand and be another point of contact to folks who may be experiencing a turbulent time in their lives. It’s a genius, scalable solution. More information about this research is available.

This story originally appeared in MSUToday.

Content Search

Legal research officer.

• ECPAT International

Job title: Legal Research Officer

Duty station: Globally Remote

Remuneration: Salary and Benefits will be determined by location

Contract Period: Initial 12 months with possibility of extension.

ABOUT ECPAT INTERNATIONAL

ECPAT International (ECPAT) is a global network of civil society organisations working collectively for the elimination of all forms of child sexual exploitation. We seek to encourage the world community to ensure that children everywhere enjoy their fundamental rights free and secure from all forms of sexual exploitation. The ECPAT network currently consists of 125 member organisations in 104 countries. The ECPAT Secretariat coordinates the global work of ECPAT and has a central office in Bangkok, Thailand.

ABOUT THE ROLE

The Legal Research Officer conducts legal research, analysing legislation and policies and produces/oversees the production of analytical reports to build evidence, knowledge and learning that support effective internal (within the network) and external action and advocacy by ECPAT International.

RESPONSIBILITIES

• Develops various research publications, in particular reports/sections of reports based on legal research and alternative reports for submission with global or regional human rights mechanisms, including coordinating inputs by ECPAT network members and other partners.
• Undertakes secondary research related to national substantive and procedural legislation as well as national policies and frameworks on various forms of sexual exploitation of children.
• Conducts secondary literature reviews and desk research to map and document various legal practices to prevent and respond to the sexual exploitation of children.
• Develops and adapts various legal research and data collection methodologies for primary research focusing on topics such as access to justice and legal remedies with key stakeholders, including justice professionals, law enforcement officers, government officials, non-governmental organisations; and analyses data collected through these primary research activities, conducted directly by the Legal Research Officer or by other colleagues/partner organisations.
• Liaises and coordinates with project partners to ensure timely and successful delivery of legal research and project-related activities and ensuring among others prompt follow-ups and organising and facilitating meeting, as needed.
• Liaises with ECPAT network members and other project partners to ensure the accuracy of legal analyses and related publications.
• Supports ECPAT network members in their legal /legal research queries and requests for technical input as needed.
• Manages consultancies and partnerships linked to legal research/research-related work.
• Contributes to the development of donor proposals and reports particularly in relation to legal research/research area as requested.
• Promotes evidence-based advocacy and contributes to the development of policy briefs and dissemination, uptake and advocacy strategies for ECPAT legal research/research work.
• Collaborates with the Communications Team to promote the legal research work of the organisation, through website, social media and other targeted campaigns and dissemination plans.
• Liaises with suppliers and consultants, such as translators and editors, including contract preparation and procurement support.
• Ensures technical and language editing and verification of text and sources of key research publications as necessary.
• Works with designers to complete layout of research publications.
• Implements monitoring and evaluation processes of ECPAT’s legal research/research work to assess uptake.
• Other tasks as required to support the organisation.

Knowledge, Experience and Skills

• Demonstrated knowledge on human rights law, child rights, and preferably legal issues related to child sexual abuse and exploitation .
• Knowledge of legal research practices and tools.
• Three to five years of experience in conducting legal research, preferably on topics related to child sexual abuse and exploitation, and proficient in employing legal research methodologies to gather, analyse, and interpret legal information effectively.
• Experience in developing research reports;
• Experience in effectively liaising and collaborating with diverse external partners and stakeholders to ensure collaborative and well-informed research efforts;
• Experience contributing to the development of research methods and tools;
• Previous engagement with local and grassroots civil society organisations and understanding of their operating context.

Skills – technical and personal

• Ability to synthesise large amounts of information into concise formats.
• Attention to detail.
• Ability to work autonomously and multi-task.
• Excellent writing skills for a variety of audiences and skilled cross-cultural communications.
• Strong organisational skills and ability to manage time and meet deadlines.
• Excellent English language skills (written and spoken). Knowledge of other network languages (French/ Spanish/ Russian/ Arabic) is desirable.

Qualifications

• Bachelor’s degree AND Master’s degree in Law with a focus in international law and/or human rights or equivalent.

ADDITIONAL INFORMATION

• This position can be internationally home-based, and candidates should have the legal right to work in that location.
• For candidates who will be working at home, an employment contract will be offered through our Employer of Record partner, depending on the candidate’s country of nationality or residence.
• Given ECPAT International’s head office is Thailand, candidates should preferably reside in the time zones, GMT 0 to GMT +6, and should have some flexibility in their working hours to accommodate international meetings.

OUR COMMITMENTS

As ECPAT’s International Secretariat we recognise that our strength lies in the diversity of the people who make up our global network, staff, volunteers and consultants. We are committed to being an inclusive workplace where people of all backgrounds and cultures can strive and be themselves. This means we will challenge ourselves to do better and to continue learning, to create and maintain a working environment steeped in respect, tolerance, safety, and where all parties are valued equally.

As a child-focused organisation, ECPAT has a strong commitment to child safeguarding and rigorous procedures. The successful candidate will be required to provide two referees (one from your last employer) and a criminal record from the country of residence or origin (as applicable).

How to apply

For this position, please send our completed application form and cover letter to [email protected] mentioning your name and Legal Research Officer in the subject header and the country you wish to be based.

Due to the high volume of applications we receive, we are not able to respond to every application. If you have not heard back from us within 3 weeks from deadline, it means that your application has not been successful.

Deadline: 14th July 2024

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On Thursday, the European Court of Human Rights declared an application concerning the planning decision to construct Berlin Brandenburg Airport inadmissible. Thus, the petitioners who owned property near the airport have not successfully challenged the airport expansion.

According to the judgment of John Buttner and Jutta Krebs v. Germany , a decision was made to consolidate Berlin’s three airports into one single airport, now operating as Berlin Brandenburg Airport, in 1996. In 1998, the planning authority, including the Ministry of Urban Development, Habitation, and Transport of the Land of Brandenburg, established a working group to draft an outline of the arrival and departure flight paths. This outline was essential for assessing the airport’s expected impact on the surrounding area as part of the planning approval process. The proposed flight paths were designed to run parallel several kilometers after take-off. In 2004, the planning authority approved the planning application and identified the areas where residents could request protective measures or compensation based on the parallel flight paths. However, a working group member raised concerns, pointing out that using the runways simultaneously would require the flight paths to diverge by at least 15 degrees. The final plan of the flight paths, which diverged by more than 15 degrees, was not made public until 2010.

In 2010, the applicants, whose homes are situated respectively 7.5 km and 9 km east of the center of the airport’s southern runway, asked the planning authority to revoke the planning approval or to prohibit the simultaneous use of both runways. They argued that the planning decision was unlawful. After the planning authority rejected their request, the applicants brought the case to the Federal Administrative Court in 2011. In 2012, the court dismissed the case as ill-founded, stating that there were no legal errors in the planning decision. The court examined the noise impact implications of the diverging flight paths compared to the parallel flight paths on which the planning documents had been based and found that the population density in the areas affected was broadly similar. Thus, the court ruled out the idea that the procedural defects of the planning approval procedure regarding the public consultation process and the assessment of the airport’s environmental impact had affected its outcome.

The applicants subsequently lodged a constitutional complaint with the Federal Constitutional Court, alleging that the Federal Administrative Court had wrongfully found the planning decision lawful. In 2017, the Federal Constitutional Court declined to accept the complaint, stating that the planning authority had adequately balanced the competing interests and that the outcome of the planning decision would not have been more favorable to the applicants, even without procedural defects.

In 2018, the applicants complained to the European Court of Human Rights. Article 6 of the European Convention on Human Rights stipulates that everyone is entitled to a fair and public hearing within a reasonable time by an independent and impartial tribunal established by law in determining his civil rights and obligations. Article 8 stipulates that everyone has the right to respect his private and family life, home, and correspondence. Relying on these provisions, the applicants argued that their right of access to a court had been violated and that they needed access to all the relevant information necessary to make a practical challenge to the planning decision. The court noted that the German courts had rejected the complaints after carefully looking at the merits and providing detailed reasons. The court also agreed with the findings, including that the planning authorities had balanced the interests at stake correctly despite procedural defects and that the outcome would not have been more favorable to the applicants. Therefore, the court unanimously declared the application inadmissible.

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Would You Clone Your Dog?

By Alexandra Horowitz

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A few miles off the highway in Hempstead, Long Island, on a gently curving street of tidy two-story homes and raked lawns, there is a sprawling ranch house with a back yard, a pool, and a large, netted enclosure, like an aviary, built to house seventeen cats. But when I drove there, on a bright, chilly fall day, I had not come to see the cats. I pulled in to the driveway, a screen door opened, and two small white dogs emerged, attached by harnesses and long leashes to John Mendola, a retired police officer in his fifties with a mild manner and a broad, kind face. (The house is his mother’s; he lives in a smaller place nearby.) He introduced me to the dogs, Princess Ariel and Princess Jasmine. They were named for a deceased, much mourned dog named Princess—part Shih Tzu, part Lhasa Apso—whom they strongly resemble. As they should: they are Princess’s clones.

Mendola took me inside and sat on a sofa, a new Princess on each side, while he told me about their forebear, a stray who was brought into the police precinct when he was on duty one day in 2006. “We had animals my whole life,” he said. “I never had one that was so affectionate. She’d look at me and give me that soulful eye.” He gave a sigh of satisfaction. “It was a special bond.” As he spoke, he reached out and stroked Princess Jasmine reflexively.

In 2016, the original Princess was given a diagnosis of cancer, and Mendola was devastated. He had seen a television program about pet cloning, and, looking online, he found a company in Texas called ViaGen Pets & Equine. ViaGen could cryogenically preserve a pet’s cells indefinitely and generate a new pet from the old cells, for a fee of fifty thousand dollars. Mendola sent off for one of ViaGen’s biopsy kits, and, when Princess had surgery to remove a cancerous mass, he asked the vet to take a tissue sample, which he sent to the company.

Princess died in March, 2017, but Mendola spent months grieving before he made up his mind to go ahead with cloning her. Once he had made the decision, after ViaGen advertised a twenty-per-cent discount, he travelled to a suburb of Austin to visit ViaGen’s genetic-preservation site. “I saw the facility,” he said. “I have a picture of it, and a little video of where the liquid nitrogen is.” Standing outside the building where Princess’s cells were cryopreserved, he said to himself, “They’re in there. Your little ones are in there.”

Mendola placed his order with ViaGen on the first anniversary of Princess’s death. Eight months later, he went to LaGuardia Airport to meet the two resultant puppies. In a video taken of their meeting, Mendola starts tearing up as he grabs hold of them. “Are you my little Princesses?” he coos. Two months old, they squirm in his grip.

The little Princesses, now five, fussed as Mendola stroked them and tried to hold them in place. As they moved, they were indistinguishable: small bundles of soft fur, trimmed close. When they sat still for a treat, I could see that they had similar, though not identical, golden markings on their bodies. And, like the original Princess, each has one misaligned eye—a different eye in each clone, so that they look like mirror images of each other.

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It has now been nearly thirty years since cloning mammals became possible. The technology has mainly been used to produce cattle, sheep, and pigs. The F.D.A. has signed off on the use of cloned farm animals as meat, although most agricultural clones are used for breeding. Meanwhile, since 2005, more than two thousand dogs have been successfully cloned. Biologically, their genesis is not very different from that of cloned cows or sheep, but in other respects the cloning of pets is far more uncanny.

The domestic dog, Canis familiaris , is seen by most owners as a species of individuals, with distinct personalities and quirks. I am a scientist who studies dog behavior and cognition, and the pet dogs who participate in my studies all bring their own idiosyncrasies with them. Early in the domestication of the species, dogs were presumably kept for functional roles—guard, hunter, herder—but in contemporary society they are kept for companionship. As a result, we have projected our ideas of selfhood onto them, giving them biographies, preferences, fears, plans, and moods.

But, if it is dogs’ individuality that we value, what should we make of the idea that their unique and unreproducible selves can, in fact, be reproduced? Cloning is the ultimate expression of genetic determinism—chromosomes as character. ViaGen’s Web site declares that a cloned dog “is simply a genetic twin of your dog, born at a later date.” The assertion is not untrue, as far as it goes, but it’s a sales pitch that dodges a host of complicated ethical and identity issues. There are issues of exploitation—both of the bereaved owners whose desire to somehow cheat death is being monetized and, more viscerally, of the unseen animals whose bodies are used in making a clone. There’s the issue of supply: the production of bespoke dogs in a society when so many good, naturally born ones in shelters are in need of adoption. Finally, there’s an existential issue: who, exactly, is produced when a dog is cloned?

The business of cloning is an outgrowth of the discovery of genomic equivalence, the fact that the DNA sequence is identical in all the cell types of our body. Evidence for genomic equivalence began to accumulate in the mid-twentieth century, and, in 1962, the British biologist John Gurdon succeeded in growing adult African clawed frogs from the intestinal cells of tadpoles, work for which he later won the Nobel Prize in Medicine. In 1996, a sheep called Dolly became the first mammal clone to be born. Dolly was euthanized in 2003, at the age of six, after veterinarians found tumors in her lungs, but she was preserved in taxidermied form at the National Museum of Scotland and also had offspring of her own, fathered the old-fashioned way, by a ram named David.

In 2005, researchers at Seoul National University, in South Korea, took an ear-skin sample from an Afghan hound named Tai and made two dogs: Snuppy (a portmanteau of “Seoul National University” and “puppy”) and another, unnamed twin, who died after twenty-two days. Snuppy lived for ten years, all of them in a laboratory. At the age of five, he was himself cloned: four re-Snuppys were born, of whom three survived. Since Snuppy’s birth, dog cloning has joined the cloning of livestock as a retail business. All told, more than a dozen mammalian species have been cloned, including macaques, red deer, cats, and water buffalo. Hwang Woo-suk, who led the team that cloned Snuppy, now clones camels raised for racing and for mazayna (a kind of camelid Westminster Dog Show) in Abu Dhabi.

Like Dolly and Snuppy, all clones are conceived through somatic-cell nuclear transfer: the nucleus of a skin cell from one animal is extracted and implanted into an egg whose nucleus has been removed. The transplanted nucleus contains all the instructions needed to make the new organism. At ViaGen’s genetic-preservation site, the building near Austin that Mendola had stood expectantly outside, I met with the company’s cell-culture manager, Sanaz Arenivas, who told me that she recommends that people send a sample of skin cells around the size of half a pencil eraser, but sometimes people just send in a whole ear from their dead dog. “Time is of the essence in a post-mortem situation,” ViaGen’s Web site warns grieving (or pre-grieving) owners.

Often, the samples arrive at ViaGen accompanied by photographs and stories about the dogs from whom they came. Arenivas showed me the lab where she isolates the cells from the samples, after which she puts the cells in a petri dish with a growth medium until there are about a million of them. With a cryopreservant added, each of these cell lines is then kept chilled, by liquid nitrogen, at minus a hundred and fifty degrees Fahrenheit, in large silver tanks. Arenivas put on insulated gloves and safety glasses and opened the top of one of the tanks for me. Clouds of vapor escaped as she reached in and pulled out a rack of vials, like a core sample from a sulfurous spring. The tanks house up to fifty thousand vials of cells. Each sample has a unique identifying number—“like V100-Buddy,” she told me. “We have a lot of Buddys.”

When it comes to actual cloning, each attempt requires making use of two other dogs. The first of these, the donor, provides developing eggs, known as oocytes. A dog in estrus is operated on to extract these oocytes. Then, under a microscope, the nucleus of an oocyte is sucked out with a tiny pipette and replaced with the nucleus from a skin cell of the dog who’s being cloned. Electricity is used to stimulate cell division, and, when this embryo is still just a bundle of cells on the scale of micrometres, a second dog, also in estrus, is operated on to become a surrogate mother. Her ovaries are pulled outside her body, and a catheter full of embryos is plunged into her oviduct. Typically, the surrogate receives multiple embryos from several different cell lines. Many of these embryos will die; those that survive live in her uterus for the usual canine gestation period, around sixty days, after which, with any luck, a pup is born.

ViaGen is the only business in the U.S. that clones dogs, and its cloning process is patented. A few months ago, I drove to visit its president, Blake Russell, who lives on a hundred-acre ranch ninety minutes north of Dallas. As the buildings lining the interstate got smaller and the scrubby forest grew denser, I noticed a dead armadillo on its back, legs splayed. I wondered if this unfortunate creature might be a nine-banded armadillo, a local species that gives birth to four genetically identical young—almost like clones of one another.

A tall man wearing a blue Baja hoodie and a day’s worth of stubble, Russell had to crouch to see me in my compact rental car, but he was talking even before I rolled down my window. “That’s Beatrice,” he explained, as a long trailer pulled by a pickup slowly rolled by, emitting a series of whinnies. Beatrice was a surrogate horse, and she was with her foal, a two-month-old clone.

Russell joined ViaGen in 2005. At the time, the company cloned many farm animals, but the agricultural business, which produces cattle, sheep, and pigs, is now separate from the pet-cloning side, which produces dogs, horses, and cats. Oddly, for the head of a company that has cloned hundreds of dogs, Russell said that he is “not a dog person.” As a child, he was mauled by a German shepherd and needed a large number of stitches in his face. Still, he owns two ranch dogs, including Lucy, a large hound mix. Before he adopted her, she was the surrogate mother to a litter of wolf-dog hybrid clones.

Russell—a third-generation horseman, as he told me several times—is much more hands-on when it comes to cloning horses. The ranch is home to a couple of hundred mares—many pregnant—and a few dozen foals. Most of these are the company’s, not Russell’s, but he has gene-banked his father’s favorite horse, Chief Comanche, and plans to revive him for his presumed future grandkids. He led me to a heated stall with two newborn foals: a day-old quarter horse, his head fuzzy and tail short, and another, born prematurely without a suckle reflex, who had a tube inserted from his nose to his stomach. Later, Russell escorted me to the horse-cloning facility, a two-room office in a tiny cluster of low-rise buildings a short drive from his ranch. The site’s embryologist led me past a small fridge labelled “oocytes,” then gestured toward a cluster of large boxes where the embryos were developing. “These are our incubators,” she told me, unwittingly quoting a line from “Brave New World” nearly word for word.

As Russell showed me around the ranch, he pointed out a “really famous horse”—he meant a clone of a really famous horse—from England, who, at four months old, was all legs, and a chestnut foal destined to be a polo horse. The client had ordered five clones each from five different polo-horse antecedents. Russell is keen on the idea that cloning could be used for conservation—ViaGen has helped clone endangered species, such as the Przewalski’s horse and the black-footed ferret—or even to bring back the woolly mammoth. “One day, my pastures are going to be filled with baby rhinos in draft mares,” he said. “Would that not be the coolest thing ever?”

Dogs were comparatively late to the cloning game. One set of reasons for this is biological. Canine eggs are very dark, almost black, because of an unusually high lipid content, and as a result it is hard to see the nucleus that is to be removed. Dogs ovulate only once or twice a year and mature their eggs in the oviduct for a relatively long time. This makes it difficult to determine the timing for extraction, and the maturation process has proved challenging to re-create in the lab. And the failure rate of dog clones is higher than that of many other mammals; for some reason, many dog embryos in petri dishes don’t survive past about eight cells.

The other big reason for dogs’ late start is societal. There are plenty of mammals that contemporary society treats purely instrumentally; we are prepared to risk harming horses in races, to kill livestock for food, to shoot deer for sport or for pest control. Our attitude toward dogs is that they are members of our families. They share our sofas and beds; we throw them birthday parties and dress them in sweaters. But, for each special, beloved dog that is cloned, two non-special, nameless dogs must be operated on, giving up their eggs or womb. For many potential customers, this creates an uneasiness that the Harvard veterinarian and bioethicist Lisa Moses calls the “ick factor.”

I asked Moses if she would find cloning more ethically palatable if, say, an embryo could be grown in an artificial womb. She paused. “In some ways,” she said, “that’s actually even more distasteful to me. Because that means, from the beginning until birth, that individual animal’s life is completely divorced from—I don’t like to use the word ‘natural’—but from the way that animals are created normally.” Another bioethicist, Jessica Pierce, was even more emphatic, telling me that although, in her line of work, she mostly navigates the gray areas between right and wrong, that wasn’t the case here. “Cloning to me is black-and-white,” she said. “I just don’t see any countervailing benefit. It seems frivolous and wasteful and ethically obnoxious.” Even if the cost were not so exorbitant, and even if it could be done without using other animals, it would still highlight our objectification of dogs, she added—“viewing them as products or toys or somehow not quite animate beings with feelings and thoughts and life projects of their own, but as our stuff .” As heartbroken as we are when a beloved family member dies, it doesn’t occur to us to bring a dead child or parent back as a clone.

In serving to both replace and recapitulate a past dog, the business of cloning becomes a kind of scientific magic trick, dealing in the language of cell cultures, cryopreservation, embryo transfers—opaque words for an opaque process. It’s a black box, into which cell and electricity are deposited, producing, after a suspenseful pause, a copy of the original. ViaGen works hard to keep all ickiness inside the black box. Its social media and its waiting-room walls show images of happy clones, with no hint that any other dogs are involved. “We chose many years ago to just go trade secret on everything we do,” Russell said. The dog side of the business is managed by ViaGen’s attending veterinarian, Kerry Peacock, who performs the surgeries required to extract the eggs from the donor dogs and implant the embryos in a surrogate. Speaking to me over Zoom from a ViaGen location someplace near Rochester, New York, she cited “biosecurity” concerns as the reason for keeping the dog-cloning process under wraps.

ViaGen doesn’t own the dogs that supply the eggs and the wombs; instead, they’re rented from what the company calls “production partners.” “People often ask if we’re using shelter animals as surrogates, and, unfortunately, we can’t do that,” Peacock said. “There’s just too many germs out there.” But she wouldn’t divulge who the owners were, or anything about the dogs’ living conditions or postoperative fates. Peacock described these dogs as “purpose bred” but cited the confidentiality of the breeders as the reason that ViaGen could not allow me to meet the dogs, see photographs of them, hear about their personalities, or learn their names. She did tell me that “they come in all different kinds of shapes, sizes, and colors,” and that working with a variety of dogs “makes it fun” for her team. Russell told me that he has production partners all over the country, including in Texas, South Carolina, Hawaii, and upstate New York.

Peacock said that ViaGen does its best to have ex-surrogates adopted, but, since they are owned by the company’s production partners, “some of them are utilized for other projects.” People I spoke to who cloned their dogs had expressed an interest in adopting the surrogate and were told that they couldn’t. The dogs used for their eggs are even more invisible. Hwang, in scientific papers about his cloning work, describes donors that are mixed-breed dogs, between one and seven years old, housed in indoor kennels, and fed once a day. ViaGen would not confirm whether its donors live in similar conditions, but U.S.D.A. guidelines specify that dogs kept for such use must be provided a minimum amount of floor space, calculated as the square of the sum of the dog’s length plus six inches. Thus a beagle (the typical lab dog) who is twenty-four inches long might be housed in a cage three feet long and two feet wide.

After a clone is born, Peacock oversees the process of exposing it to stimuli—noises and smells, new objects—which is important in the first weeks of a puppy’s life. Some clients send photographs, or voice recordings for Peacock to play for the puppy. Sometimes, as with Mendola’s two Princesses, there will be more than one puppy from a given cell line; any extras are thrown in for free. The puppies are sent to their new homes at around ten weeks of age. Clients who ask to pick up their puppies in person are turned down; instead, they meet the reincarnations of their beloved dogs at a distant, neutral site, such as a parking lot or a hotel lobby.

Of course, these are the clones that make it—most cloned embryos do not. Others may wind up deformed: researchers working under Hwang have reported on defects that have appeared in cloned dogs, such as puppies born excessively large or with a hypertrophied tongue, a cleft palate, a very small eye, a fatal overdevelopment of musculature, or genital abnormalities. These problems are likely due to epigenetics—broadly, the effect of non-DNA matter, like proteins in the cell, on gene expression. The exact source of such mutations is not yet clear, but they do not come as a surprise to biologists. In cloning, the nucleus of the epithelial cell needs to essentially erase its memory and be reprogrammed. If the reprogramming is incomplete, the subsequent development will be affected. The egg cell, too, may have components from the donor dog, such as mitochondria, that influence how the cloned dog’s DNA is expressed.

Peacock told me that she had not seen any of the abnormalities I mentioned. “Not to say that we’ve never seen anything abnormal,” she said. “Just like in any breeding system, we do occasionally see some congenital abnormalities”—birth defects or embryo deaths—“and things like that.” Like many ViaGen employees, she herself owns a clone, Pippa, who was cloned from her Cavalier King Charles spaniel Piper. Pippa is tricolor, with long ears, a distant gaze, and an underbite that, Peacock mentioned, Piper didn’t have. She recalled that one of Piper’s littermates did have an underbite, but I immediately thought about a research paper that noted the incidence of underbites in cloned dogs, which might be traceable to epigenetic effects of cloning.

The United States is home to some eighty million owned dogs, and the most popular type is the so-called purebred. Unlike with a mutt, the purebred’s parentage is assured, recorded by such national dog organizations as the American Kennel Club. Physically and genetically distinct breeds have been developed through intensive inbreeding. A registered, purebred German shepherd results from a mating of two other registered dogs, often closely related. And each can trace its ancestry back to one Horand von Grafrath, a dog from Thuringia who, in 1899, was chosen as an ideal specimen to form a newly named breed. Dog breeding began in order to segregate what were seen as the best exemplars of the species from the canid hoi polloi.

It’s possible to see dog cloning as merely an extension of what is already a bizarre and highly unnatural process. In Fort Worth, Texas, I met a clone of a dog called Eudoris. The clone’s owner, Jeff, who didn’t want his last name used, was on the phone as I approached, but Eudoris 2—or E2, as he’s known—turned to look at me. His body was shaped like a German shepherd’s, but he lacked the swayed back of the kennel-club German-shepherd lines, whose hind legs buckle in a way that people liken to frog legs. E2’s face was more vulpine, too. I made a sound of greeting to him, and he folded his ears back. Within half a minute, he had turned his rump toward me beseechingly, the universal dog body language for requesting a scratch above the tail.

The original Eudoris was a mix of a Belgian Malinois and a Dutch shepherd, and had been bred by Joshua Morton, a trainer of tactical working dogs, who felt that Eudoris was the ideal specimen. He had ViaGen clone him, and not just once. Thirty-five clones have been made from Eudoris so far. Jeff got E2 as a protection dog for his wife, who travels frequently to compete in rodeos. E2 was their second Eudoris clone. The first, E4, drowned in an irrigation ditch four months after they got him. Jeff and Morton felt that E4 was so special that they sent some of his tissue to ViaGen. Since then, Morton has used E4’s cells to clone yet another line of dogs, which he dubs the Red Squadron Myrmidons, called M1, M2, and so on. “The DNA of M1 is the same as the DNA of E1 through E-whatever,” Jeff said. “And the same as Eudoris Actual, the biological Eudoris.” Hearing his name, E2 began wagging his tail.

Though E2 is highly trained to distinguish friend from foe, the primary impression he gave, like all the clones I met in person or over Zoom, was of a very normal dog. The dogs all did dog things —barked at noises, rolled onto their backs for belly rubs, chewed on bones, nose-bumped their owners for attention.

With every dog clone I encountered, I went through two stages. I’d start out looking for resemblances to the original—a characteristic marking, the fold of an ear, distinctive behaviors. But soon I’d find myself looking for differences. They were numerous. Although the genome is for the most part identical in cloned and clone, from the moment that the host cells begin dividing the clone inexorably diverges from its parent. Each experience of the surrogate’s that affects her health—an uptick of stress or a dip in nutrition—affects the growing embryo. After birth, the number of individuals, canid and hominid, who interact with and shape the clone skyrockets; the possible environments go from finite to indescribably many. There can be no cloning of the world that shaped the original, no repetition of the scenes and smells they encountered. Life leaves its mark.

Few people who clone their dogs believe that they are truly buying the same individual that they once cherished. Zehra Peynircioglu, a psychology professor at American University, teaches a graduate seminar on cognition and memory. She opens one class with a provocative question: “Without your memories, are you ‘you’? If you had a head injury and lost all your memories, would that still be you?” Her interrogation of the subject is especially interesting given her decision to clone her handsome white husky-poodle mix, JonJon. But she went into the process with open eyes. “I knew I was not going to get another JonJon,” she told me, of her clone, named Joniki. “But I knew I was gonna get an essence of JonJon.”

Most of the cloning clients that I spoke to struggled to say exactly what it was about the original animal that they had wanted to reproduce, especially in contrast to other dogs they had loved but hadn’t felt like cloning. Many spoke of the original as simply “special”—but the specific nature of that specialness seemed to be ineffable. This dog was sociable, that one was empathetic; this one loved to swim, that one had curly hair; this one was moody, or grouchy, or affectionate. I began to wonder if the desire was less about re-creating the dog qua dog than about restoring the distinctive relationship that had been forged with the animal. In several cases, the cloned dog’s appeal appeared to lie partly in physical problems or a difficult start in life: the dog found as a mangy stray or rescued from a kill shelter or a bad breeder; the needy dog or the purebred with a non-ideal characteristic.

Lara Gale, a Seattle-based photographer who cloned her Ibizan hound Georgia and now lives with Georgia’s clone, Kismet, told me over Zoom that Georgia’s physical problems were so severe that vets recommended euthanizing her as a puppy. Georgia was born with dwarfism and hyperflexion—Gale held out her fists and bent them down, as though revving a motorcycle—so her legs were angled backward, leaving her unable to walk. After that was treated, Georgia developed luxating patellas, a condition where her kneecaps shifted out of place. Before her second birthday, Georgia blew out one of her knees and wound up having two surgeries on it. Gale assiduously massaged Georgia’s hamstring and took her to many rounds of rehab. As we talked, Kismet bobbed her head in and out of view of the computer camera. She has none of her predecessor’s maladies. Scratching Kismet’s neck playfully, Gale acknowledged that Georgia could be grumpy, no doubt because of those ailments. “You know, I spent a lot of time worrying about her,” Gale said. “Just having to stay away from everybody” when Georgia was recovering, she added, “kind of made us a little more attached to one another.”

The intensity of the experience of caring for “damaged” dogs may be part of what some people are trying, unconsciously, to recapture. Nurturing, like parenting, is neurologically rewarding for humans. James Serpell, an emeritus professor of ethics and animal welfare at the University of Pennsylvania’s veterinary school, has suggested that humans’ drive to nurture has, in fact, led us to breed pets with health and behavior problems. The brachycephalic (small-skulled) dogs, including pugs and French bulldogs, who are bred to have ever-flatter faces, usually have severe difficulty breathing, requiring a dependence on owners that, research has found, the owners actually enjoy. Some studies indicate that owners of dogs with extreme phenotypes caused by inbreeding are more attached to their dogs than those with healthier or more “normal” dogs; similarly, owners of dogs with behavioral problems because of challenging early-life events still rate their relationships with their dogs as decidedly positive. Barbra Streisand famously cloned Samantha, her small white-coated Coton de Tulear, after the dog’s death. Streisand has written that she chose cloning because she “couldn’t find another curly-haired Coton”: the breed’s coat is usually straight or wavy, whereas tightly curled hair is considered a fault, according to the breed standard. Of the four pups produced by the cloning, one died within a few weeks of being born, one was given away by Streisand, and two were kept. Accompanying an article she wrote in 2018 to explain her decision to clone is a photograph that captures the two clones sitting in a stroller in a garden, gazing toward Samantha’s headstone. Having insinuated themselves into human society, dogs are now the objects of both our salutary and our pernicious impulses.

When Finnegan, my family’s charismatic black mutt, was in the final weeks of his life, in 2022, I felt myself prematurely grieving his loss. Age had robbed him of voluntary control of his rear quarters, foreclosing the possibility of him performing any Finnegan-characteristic behaviors, like racing through puddles or wagging his tail. What wouldn’t I have given to have him rejuvenated, brought back to an earlier stage of life in which he could run and gallivant? More specifically, would I have given a small skin sample and fifty thousand dollars? And, had I done this, would the result be the same Finn? Certainly not. For some people, though, even just the possibility of a future Finnegan is enough to leaven the grief of losing the current one. The great majority of the samples at ViaGen will remain in their cryopreserved state in a vat of liquid nitrogen. Their owners never clone them—for want of money or nerve, or because cloning is less straightforward and morally messier than they’d realized, or simply because time steps in and reveals that grief, unimaginably, does fade.

When Dolly, the cloned sheep, was born, there was a lot of speculation and concern about the possibility that people might soon be cloned, too. President Bill Clinton tasked the National Bioethics Advisory Commission with making recommendations on human cloning; the commission came out resolutely against it, calling it “morally unacceptable,” and citing the risk of harm to the fetus, child, donors, and surrogates, as well as ethical concerns around individuality, objectification, and the slide toward eugenics. Writing in The New Republic , the physician Leon Kass argued that cloning a person would be “inherently despotic,” because creating a copy undermines the intangible otherness of a new life, the unknown child whom parents should accept for whomever that child becomes. The cloned person, he wrote, “will not be fully a surprise to the world.”

But a lack of surprise turns out to be just the thing that people seem to want, at least when it comes to their dogs. When I visited John Mendola, in Long Island, he scrolled through his social-media feed for me, lingering on the posts that showed the Princesses sitting, begging, panting in tandem. “Look at this one,” he said. “Look at this.” The Princesses peered up at him, momentarily still. Then, as if on command, they shook off, pivoted, and turned away. I watched as they both began to drink from the same water bowl, lapping in perfect synchrony. ♦

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