A. Scientific Background and Recent Developments

In November 2018 the Chinese scientist Dr He Jiankui announced the birth of the first genetically engineered babies—Lulu and Nana. This was the result of his editing and implanting of the embryos of seven couples with HIV-positive fathers in an attempt to make them resistant to the virus.Footnote ¹ The experiment was conducted in a private hospital in violation of China's non-binding ethical guidelines prohibiting heritable genome editing.Footnote ² The announcement was met with universal condemnation by scientists and international organisations,Footnote ³ strongly indicating that clinical research involving genome editing is not considered acceptable at present. The Statement of the Second International Summit on Human Genome Editing where the experiment was first announced said that ‘the procedure was irresponsible and failed to conform with international norms’.Footnote ⁴ Similar concerns were expressed by the Chinese Academy of Medical Sciences,Footnote ⁵ the French National Academy of Medicine and the Academy of SciencesFootnote ⁶ and the UK Nuffield Council on Bioethics.Footnote ⁷ In October 2019, the Russian scientist Denis Rebrikov reported editing human eggs to prevent deafness with the intention of using them to bring about a pregnancy.Footnote ⁸ These experiments raise pressing questions regarding the permissibility and current regulation of human genome editing under international law, which will be explored in this article.

Since the discovery of the structure of the human genome in 1953 by Francis Crick, James Watson and Rosalind Franklin,Footnote ⁹ scientific developments in genetics have been accelerating quickly. The 1990s saw the first clinical trials of gene therapies aimed at treating rare genetic disorders caused by a single-gene mutation.Footnote ¹⁰ This promise of revolutionising healthcare led to a surge of regulatory action on the domestic and international planes.Footnote ¹¹ However, optimism soon turned to caution due to inconsistent results and the first death caused by a gene therapy clinical trial in 1999.Footnote ¹² Shortly afterwards, in 2003, the full sequencing of the human genome was completed and made publicly available.Footnote ¹³

In 2012 Charpentier and Doudna developed a new, significantly cheaper and more precise method of genetic engineering—genome editing through the CRISPR Cas9 tool, based on the mechanism used by bacteria to defend themselves against viruses.Footnote ¹⁴ Genome editing is used to alter a selected section of DNA in a living cell by cutting the DNA at a chosen point and either deleting existing elements of the genome or introducing a new sequence. At present, the outcomes of human genome editing are far from certain. On the one hand, the use of the new tool frequently causes extensive unintended off-target mutations which ‘could lead to important genes being switched on and off’.Footnote ¹⁵ The other major safety challenge to the successful use of genome editing is ‘mosaicism’, where only some cells carry the desired edit.Footnote ¹⁶ On the other hand, genome editing holds significant promise. According to the World Health Organisation, there are over 10,000 monogenic diseases caused by an error in a single gene of the DNA,Footnote ¹⁷ which occur in 1 per cent of births.Footnote ¹⁸ Some of these diseases are fatal and many significantly reduce the quality of life.Footnote ¹⁹ Once sufficiently developed, genome editing could help alleviate and even eradicate the suffering caused by these diseases by inactivating a disease-causing gene or correcting a harmful mutation. In future, such new technology could also be used to address more complex disorders caused by mutations in multiple genes, such as cancer, cardiovascular diseases or diabetes.

Genome editing can be performed either on the somatic cells making up the body or on germline cells, such as those making up the early embryo, which contain the genetic information passed on to future generations. The latter type of human genome editing is more effective because it can be performed on a single-cell embryo with the potential to edit all of its genetic make-up in a heritable manner. However, germline editing raises the most difficult regulatory and ethical issues given the uncertainties involved in the use of this new technology, the irreversibility of the edits and the fact that any desired but also unintended negative changes would be passed on to future generations, with the potential of impacting humanity as a whole. Furthermore, editing embryos carries an inherent level of risk as it is technically impossible to determine whether they carry unintended off-target mutations without destroying them while inspecting all of their cells.Footnote ²⁰ Another important distinction in this context is between basic research, involving genome editing to help understand the functions of genes and their relationship with diseases, and clinical research which uses genome editing for the treatment of diseases. With respect to germline editing, clinical research would involve implanting an edited embryo or bringing about a pregnancy with edited reproductive cells, whereas basic research would involve embryos in vitro and not result in a pregnancy.

In 2015, Chinese scientists reported using genome editing for the first time on non-viable human embryos to edit out a blood disorder. The intended editing had a less than 20 per cent success rate.Footnote ²¹ Indeed, expert analysis of Dr He's unpublished manuscript on the Lulu and Nana experiment indicates that the team failed to reproduce the known mutation of the targeted gene and instead created a new one with unknown consequences.Footnote ²² There were also unintended off-target mutations.Footnote ²³

Given the unique challenges and opportunities presented by human germline editing (hereinafter ‘genome editing’) the research into and the clinical application of this new technology are the focus of this article.

B. Legal Issues Arising from Genome Editing

Given the rapid acceleration of scientific developments regarding genome editing and the ease with which people can cross borders to access new healthcare technologies, there is an urgent need for an international debate and a consensus on the minimum regulatory standards that should apply to editing the human genome. It is essential that this takes place before genome editing routinely becomes clinically available somewhere in the world, at which point effective regulation to ensure the safe and ethical use of the new technology would become very difficult to implement in practice.Footnote ²⁴ The pressing need for regulation is reinforced by Dr He's recent experiment. Scientists and the WHO have called for a global moratorium on heritable genome editing until its implications have been properly considered,Footnote ²⁵ as well as for the establishment of an international framework imposing conditions that ought to be met before any use of genome editing can be approved.Footnote ²⁶ The fact that international human rights law already sets out important requirements and limitations on genetic interventions is largely overlooked in the present policy debates.

The aim of this article is to assess the international human rights framework that currently regulates the research and clinical applications involving genome editing and to analyse its implications for the use of the new technology. Particular emphasis will be placed on the challenges posed by the scientific and technological advancements regarding genome editing, in order to draw conclusions as to the adequacy and effectiveness of the current regulation. Building on this, normative suggestions will be made concerning the possible future development of international law in the area of biomedicine. Domestic law comparisons fall outside the scope of this study due to the constraints of space, though they undoubtedly merit a thorough further investigation.

The key questions are whether genome editing is currently prohibited or otherwise regulated under international human rights law? What are the relevant human rights norms and standards that apply to it? Is the existing international regulatory framework sufficient or are new standards—if not a new framework specifically designed to address genome editing—needed? What guarantees can be put in place to ensure that the new technology is safe to use before it is made clinically available? And finally, how can international law help balance the risk/benefit analysis with respect to the autonomy and welfare of the individual on the one hand, and the interests of society and humankind on the other?

It will be argued that international law is the most appropriate legal order through which to channel a consensus and develop a regulatory framework for genome editing, by helping harmonise domestic laws, setting out common minimum standards, providing centralised oversight and promoting good practices through soft law. This is because international law is the only overarching legal order that has the necessary procedures to help form and implement an international consensus on matters of common interest and concern. International law has a strong humanitarian focus, particularly since the end of the Second World War Footnote ²⁷ and has developed the tools necessary to balance the welfare of the individual with the interests of humanity as a whole, through concepts including proportionality, the common heritage of mankind, global public goods and the rights of future generations. Finally, international law has the capacity to regulate both the behaviour of States and of non-State actors across national borders, thus addressing the challenge of health tourism to States with the weakest domestic regulation.

International law already plays an important role in regulating genome editing. Even though there is no international treaty of general application that directly addresses the matter, there are key regional human rights instruments containing specific provisions applicable to genetic interventions, including the Council of Europe's Oviedo Convention on Human Rights and Biomedicine (Oviedo Convention)Footnote ²⁸ and the EU Charter of Fundamental Rights (EU Charter).Footnote ²⁹ There are also important soft law human rights instruments most notably the 1997 UNESCO Declaration on the Human Genome and Human RightsFootnote ³⁰ and the 2005 UNESCO Declaration on Bioethics and Human Rights.Footnote ³¹

The regional and soft law instruments in the field of biomedicine and human rights indicate that there is an international consensus with respect to certain aspects of genetic interventions. First and foremost, according to all instruments in the field, interventions on the human genome can only be undertaken for preventive, therapeutic or diagnostic purposesFootnote ³² with eugenics being strictly prohibited.Footnote ³³ Second, any research and clinical application concerning the human genome ought to be conducted with full respect for human dignity and human rights.Footnote ³⁴ Third, the risks that may be incurred by a person ought not be disproportionate to the potential benefitsFootnote ³⁵ and, related to this, there are requirements of rigorous prior risk assessment, adequate risk management and minimising the potential risks for the individuals affected.Footnote ³⁶ Fourth, genetic interventions are subject to a strict requirement of informed consent.Footnote ³⁷ Finally, due regard ought to be given to the rights of future generations.Footnote ³⁸

A. Policy Challenges and Responses

The recent development of more precise, much easier-to-use and cheaper genome editing technology has prompted much debate among scientists, ethicists and policy-makers,Footnote ³⁹ some calling for a moratorium on its use clinically to modify the human germline and establish a pregnancy,Footnote ⁴⁰ whilst others have called for more extensive use.Footnote ⁴¹ Responses from commentators have also been mixed. According to some, genome editing could ‘remake’ the worldFootnote ⁴² in light of its radical implications for medicine and reproduction, while others warn of the dangers of its abuse, such as the possible surge of ‘designer babies’.Footnote ⁴³ There seems to be a growing consensus, however, that any decision on the clinical use of genome editing should be preceded by a broad and inclusive public debate.Footnote ⁴⁴

A number of international organisations have issued policy statements on genome editing, highlighting the challenges it presents and proposing different degrees of limitations on the research and clinical application. There is some disagreement as to whether research involving germline editing should be allowed at all. UNESCO and the EU are in favour of allowing basic research involving germline editing,Footnote ⁴⁵ as are a number of States.Footnote ⁴⁶ With respect to clinical research and clinical applications involving the new technology, UNESCO's International Bioethics Committee and the WHO have proposed a moratorium on germline editing that could result in a pregnancy and be passed on to future generations, due to the ‘unique and unprecedented ethical and technical challenges’.Footnote ⁴⁷ The broad condemnation of Dr He's experiment seems to evidence an agreement that germline editing should not be used clinically at present. The broader policy question is whether it should be prohibited as a general rule or by way of a temporary moratorium until such time as its use becomes safe and acceptable, or if not, what standards should apply to it.

International organisations and non-governmental scientific organisations seem to agree that there is a need to establish an effective regulatory framework designed specifically to govern genome editing. Two expert bodies were set up in response to the announcement of Dr He's experiment. First, the WHO established a multi-disciplinary expert advisory committee to examine the scientific, ethical, social and legal challenges associated with genome editing and to develop a global framework for the coordination of regulation, legislation and policies in the field.Footnote ⁴⁸ The WHO Committee called for the establishment of a global registry for all research involving genome editingFootnote ⁴⁹ and stressed that ‘it would be irresponsible at this time for anyone to proceed with clinical applications of germline editing’.Footnote ⁵⁰ Second, the US National Academies of Sciences and Medicine and the UK Royal Society convened an International Commission on the Clinical Use of Human Germline Genome Editing.Footnote ⁵¹ According to its Statement of Task, the Commission is working on identifying the potential applications of germline editing and appropriate protocols for evaluating its effects in practice.Footnote ⁵² The title of the Commission and its Statement of Task contain a somewhat premature implicit acceptance of the legality and desirability of the clinical application of the new technology. Given the scientific, legal and ethical uncertainties underlying genome editing, the more cautious stance of the WHO Committee seems preferable. Unsurprisingly, scientists have called on the two bodies to speak with one voice.Footnote ⁵³

Dr He's experiment gave rise to a number of policy suggestions by scientists and medical organisations which emphasised different aspects of the challenges which need to be addressed. One of the main concerns relates to the purpose of the experiment. Scientific associations expressed serious concerns that Dr He's intention was not to cure the human embryos or prevent the transmission of HIV from the parents since there was no real risk of this, but rather to enhance an otherwise health embryo.Footnote ⁵⁴ This was seen as a dangerous use that could pave the way to eugenics,Footnote ⁵⁵ as well as failing the risk/benefit analysis given that there were other ways of addressing HIV and that editing the gene increased the risk of other infections.Footnote ⁵⁶ The other key concern was the lack of common regulatory standards concerning clinical genome editing,Footnote ⁵⁷ with some proposing the creation of an international registry of all planned or ongoing experiments,Footnote ⁵⁸ whilst others calling for a modification of the UNESCO Declaration on the Human Genome to prohibit the application of human genome editing until it is deemed safe and effective, as well as to limit it to specified therapeutic applications.Footnote ⁵⁹ Other scientists have argued that an international treaty banning the clinical uses of genome editing would be too rigid a response, advocating for a voluntary moratorium on the clinical use of the new technology, and the establishment of a coordinating body under the auspices of the WHO to foster discussions and provide regular information on the relevant developments.Footnote ⁶⁰

Overall, there is broad agreement that there is a need for new and effective international regulation of both the clinical research and the clinical application of human germline editing. The new framework ought to address whether clinical research involving germline editing is permissible, the purposes for which it can be used, the appropriate safety threshold, the acceptable levels of risk, the risk /benefit analysis for the individual and society, and establish an appropriate institutional framework for oversight.

The international policy responses seem to favour introducing regulation specifically addressing the new CRISPR Cas-9 technology for germline editing. An alternative approach could be to regulate heritable interventions in the human genome more generally. This would be preferable since new genetic engineering technologies are likely to be developed over time.Footnote ⁶¹

B. Legal Challenges and Current Landscape

Somewhat surprisingly given its significance, and save for a few policy statements,Footnote ⁶² there has been very little direct regulatory response by States.Footnote ⁶³ There is no generally accepted or clearly defined threshold of safety or acceptable risk that is required before the clinical application of genome editing is allowed. Nor is there a common understanding or definitions of the key concepts involved, ie ‘the human genome’, ‘gene’, ‘germline’, ‘embryo’Footnote ⁶⁴ or indeed ‘eugenics’. There is no agreement on how to balance the risks and the benefits for the individual and for society and a disturbing lack of clarity concerning the purposes for which germline editing could be used. Therapeutic and preventive purposes seem to be the generally accepted whilst eugenics are prohibited (although this term remains undefined). Between these poles, what constitutes ‘enhancement’, ‘prevention’ and ‘therapy’ for diseases is unclear.Footnote ⁶⁵ There are no clear legal distinctions between what constitutes a ‘disease’ as opposed to a naturally occurring mutation, let alone what is a ‘serious disease’ which might change the risk/benefit balance.Footnote ⁶⁶ For example, whether deafness is a disease is medically and legally contested, particularly by the Deaf community.Footnote ⁶⁷ It is also uncertain whether the use of the technology is reserved for peaceful purposes or whether it could have military applications, for example the creation of enhanced soldiers—be they super strong or resistant to chemical and biological weapons. There is also no clarity concerning access to the new technology, which raises issues of equality and solidarity.

Currently there is a patchwork of domestic laws and guidelines that apply to genome editing,Footnote ⁶⁸ but since most were developed in the 1990s to regulate gene therapies they are not necessarily adequate to address genome editing.Footnote ⁶⁹ Since gene therapies are much more expensive, more difficult to undertake and less accessible than genome editing, few States have regulation and, given their low success rates, many States adopted a very restrictive approach. In light of the differences between the two techniques of genetic interventions, it is not certain whether the existing legal landscape is adequate to address germline editing and if it should be applied by analogy. Furthermore, as evidenced by Dr He's experiment, the issue of the effectiveness of domestic regulations is as critical as that of their content.

Domestic laws are not only inconsistent but also, at times, internally incoherent. For example, some States expressly prohibit germline editing for the purposes of procreation through criminal law sanctions,Footnote ⁷⁰ others impose civil law sanctions,Footnote ⁷¹ and others set out the prohibition in non-binding guidelines.Footnote ⁷² Russia and the EU do not prohibit germline editing but disincentivise it by making it non-patentable.Footnote ⁷³ There are also States that allow clinical use of the new technology for procreation.Footnote ⁷⁴ The domestic laws in MexicoFootnote ⁷⁵ and JapanFootnote ⁷⁶ are incoherent in that they prohibit research involving genome editing but do not prohibit implantation of embryos that have been edited.Footnote ⁷⁷ More coherent approaches are found in GermanyFootnote ⁷⁸ and France, where the prohibition is reflected in both the Civil and the Criminal Codes, and methods of germline modifications are non-patentable.Footnote ⁷⁹

Overall, the current legal landscape does not address any of the key concerns raised by genome editing satisfactorily. There is, then, a pressing need to consider the regulation of genome editing on the international plane. Agreeing on minimum regulatory standards would be the strongest guarantee against the unsafe, unethical and inequitable uses of genome editing.

A. Germline Editing under Human Rights Law: Restrictions and Entitlements

There is a widely held view that germline editing is prohibited under human rights law in Europe. For example, the Preamble of the EU Biotech Directive, asserts that ‘there is a consensus within the Community that interventions in the human germ line … offends against ordre public and morality’.Footnote ¹¹² This is largely due to the Oviedo Convention, which, however, has not been ratified by 18 of the of the 47 Members of the Council of Europe, including a number of EU Member States such as Austria, Belgium, Germany, Ireland, Italy, Luxembourg, Malta, the Netherlands, Spain, Sweden and the UK.

The most controversial issue during the drafting of the Convention was the prohibition of germline editing in Article 13 which provides that ‘[a]n intervention seeking to modify the human genome may only be undertaken … if its aim is not to introduce any modification in the genome of any descendants’. The reasons for this were the scientific uncertainty and unpredictable effects on future generations.Footnote ¹¹³ However, there were also calls for leaving open the possibility of authorising germline therapies given the prospect that future scientific advances might permit the prevention of genetic diseases.Footnote ¹¹⁴ The Working Party that drafted the Convention considered allowing germline interventions in exceptional cases, provided: (i) that there was no conceivable alternative that would correct recognised abnormalities, (ii) that the purpose was to alleviate severe human suffering and (iii) that strict standards of reliability and safety were met.Footnote ¹¹⁵ Ultimately, the drafters decided on a temporary prohibition on germline interventions, which could be reviewed in the light of progress in scientific knowledge.Footnote ¹¹⁶ The safeguards were, therefore, not included. Yet, they could be a helpful starting point when considering how to address the safety concerns surrounding genome editing, and also help inform risk/benefit analyses.

Article 13 prohibits interventions which aim to modify the germline, rather than those that do so. This was to allow genetic interventions for the purpose of somatic modification but whose side effects may affect the germline.Footnote ¹¹⁷ Thus the Oviedo Convention permits somatic genome editing for therapeutic or preventive purposes where modifications in the germline are incidental to the primary process.

The Working Party also considered whether to permit research on the germline. There was broad agreement that this ought to be allowed, even by those who considered germline modifications should be prohibited.Footnote ¹¹⁸ Draft Article 13 was modified to ban specifically the modification of the genome of any descendants, thus implicitly allowing basic research on germ cells which are not used to bring about a pregnancy.Footnote ¹¹⁹ The Explanatory Report affirms that, ‘[m]edical research aiming to introduce genetic modifications in spermatozoa or ova which are not for procreation is only permissible if carried out in vitro with the approval of the appropriate ethical or regulatory body’.Footnote ¹²⁰ Furthermore, neither Article 13 nor Part IV of the Convention regulating the human genome prohibit basic research involving modifications of the genome, provided the edited embryos are not implanted passing the modifications on to descendants. Article 15 also affirms the freedom of scientific research in the fields of biology and medicine, subject to the protection of human rights. It can therefore be concluded that even under the restrictive approach adopted by the Oviedo Convention, basic research involving germline editing is permissible. This reflects the generally held view that freedom of scientific research is universally accepted as a human right.Footnote ¹²¹ However, freedom of research is not absolute, ie, Article 15 of the ICESCR permits restrictions on scientific research to protect human dignity and rights, public order, health or morality.

The EU Charter of Fundamental Rights also has provisions directly applicable to genome editing. However, its potential to regulate genome editing in Member States is limited since according to Article 51, the Charter only applies ‘to the institutions, bodies, offices and agencies of the Union’ and ‘to the Member States only when they are implementing Union law’.

The EU Network of Independent Experts on Fundamental Rights, which was set up by the European Commission to monitor fundamental rights in the EU, was tasked to prepare a Commentary on the Charter to provide guidance on its implementation for Member States and EU institutions.Footnote ¹²² According to the Commentary Article 3 of the Charter, concerning the right to physical and mental personal integrity, should be interpreted broadly and include any form of medical treatment without or against their will.Footnote ¹²³ The Commentary says:

This progressive interpretation of Article 3(1) does not find any support in the text itself. It is arguable that if the drafters wanted to include the protection of the embryo against genetic modifications in the provision addressed specifically to biomedicine, they would have done so expressly, just as they prohibited eugenic practices and reproductive cloning. Using the concept of future generations to bridge the gap between human rights protection and unborn children is also problematic and not supported by practice.Footnote ¹²⁵ It can therefore be concluded that the EU Charter does not prohibit germline editing.

The lack of international consensus concerning the prohibition of germline editing under human rights law is further evidenced by the text and preparatory works of the 1997 UNESCO Universal Declaration on the Human Genome and Human Rights (UNESCO Declaration).Footnote ¹²⁶ Arguably, this is currently the most important international instrument in the field of human genetics, in the absence of an international treaty of general application. While not legally binding, the UNESCO Declaration sets out internationally agreed standards and good practices concerning genetic interventions, which were supported by a broad international consensus at the time of its adoption and are still pertinent today.

The traveaux préparatoires and text of the Declaration show that there was no consensus on prohibiting the research and the clinical application of germline editing at the time of its drafting, when gene therapies were much less effective than today. The Declaration does not prohibit interventions in the human genome or modifications of the germline, despite lengthy discussions of proposals that it should.Footnote ¹²⁷

The basic assumption of the drafters was that the human genome should be the object of special protection, in order to safeguard the integrity of the human species.Footnote ¹²⁸ Following an international consultation with States, however, the idea that the human genome should be inviolable was abandoned, due to the potentially beneficial effects of genetic interventions.Footnote ¹²⁹ As regards clinical research, however, it was felt that given the state of scientific knowledge, ‘any experiment designed to transmit to future generations human genetic characteristics modified by human intervention is ethically unacceptable, even for therapeutic purposes’.Footnote ¹³⁰ It was ultimately decided not to include germline editing in the Declaration's list of practices which are prohibited for being contrary to human dignity.Footnote ¹³¹ However, there was a strong perception that clinical research would be inappropriate and unethical less sufficient scientific progress to make it safe. In light of the recent developments in genome editing, it would be desirable to revisit the debate and ascertain whether there is still a consensus regarding the permissibility of heritable interventions in the human genome.

Even though human rights law does not directly prohibit germline editing, it does impose certain requirements on States. The UNESCO Declaration together with its preparatory works suggest that there might be a positive obligation on States to regulate high-risk genetic interventions, such as genome editing, in order to ensure they are in accordance with human dignity, human rights and the rights of future generations.Footnote ¹³² Similarly, the Oviedo Convention contains a number of provisions requiring States to legislate to give it effect domestically. This could be seen as an affirmation of the existence of a positive obligation on States under general international law to regulate genetic interventions in order to ensure their safety and compliance with human rights. Indeed, according to the Committee on Economic, Social and Cultural Rights, States parties to the ICESCR are required to regulate in order to prevent the negative effects of science and scientific research on medicine, life sciences and associated technologies.Footnote ¹³³ Related to this are the requirements of maximising the benefits for individuals affected and minimising any possible harmFootnote ¹³⁴ through processes of risk assessment and risk managementFootnote ¹³⁵ and the obligation to give due regard to the impact of life sciences on the rights of future generations.Footnote ¹³⁶

There are also human rights that could be used as an argument in favour of using the technology and be relied upon directly by parents should the technology become clinically available, including the right to health, the rights of disabled people and the rights of the child.Footnote ¹³⁷

The right to health has been interpreted as entailing an obligation to ‘enable women to go safely through pregnancy and childbirth and provide couples with the best chance of having a healthy infant’.Footnote ¹³⁸ If this broad construction of the right is accepted, it could be relied on by parents with genetic diseases to argue for genetically editing their reproductive cells or embryos to provide them with the best chance of having a healthy child. The rights of the child could also be used by parents to call on the State to ‘ensure to the maximum extent possible the survival and development’Footnote ¹³⁹ of their future child. Such use of these rights would give expression to the principle of individual autonomy but would need to be carefully balanced with the broader public interests on a case-by-case basis.

The rights of disabled people are an expression of the principles of human dignity, equality and autonomy. They require respect for difference, acceptance of persons with disabilities as part of human diversity and respect for the right of children with disabilities to preserve their identity.Footnote ¹⁴⁰ Accordingly, disabled parents cannot be required to edit their embryos in order to remove a disability. Furthermore, States ought to carefully consider the preservation of human genetic diversity and the identity of disabled people when deciding on the permissible therapeutic uses of genome editing.

Overall, it can be concluded that germline editing is presently not prohibited under human rights law and that freedom of basic research in the field is protected. However, given the current state of scientific knowledge, the clinical research or applications involving modification of the germline could be contrary to human dignity, the rights of parents and intergenerational equity. Furthermore, States are under a positive obligation to regulate genome editing domestically in order to ensure its compliance with human dignity and human rights, as well as to protect the affected individual, future generations and society at large from the possible negative effects of the new technology. If and when germline editing becomes clinically available, States should ensure its regulation is in full accordance with existing human rights and the dignity of the future person.

B. The Lawful Purposes of Genome Editing under Human Rights Law

All human rights instruments in the field of genetics specify that genetic interventions should only be allowed for therapeutic purposes. Article 13 of the Oviedo Convention provides that interventions seeking to modify the human genome ‘may only be undertaken for preventive, diagnostic and therapeutic purposes’. The main objective of the drafters was to limit interventions in the human genome to those undertaken for the protection of health.Footnote ¹⁴¹ There was broad agreement that no intervention ‘shall be permitted for the purpose of perfecting human existence (rendering human beings more intelligent, musical, athletic, etc)’.Footnote ¹⁴² According to the Council of Europe's Explanatory Report ‘[t]he 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.’Footnote ¹⁴³ This detailed definition of the permissible aims of genetic interventions is preferable to the more general wording of the UNESCO Declaration, which refers to relief from suffering but also to the improvement of the health of individuals and humankind as a whole. The latter phrase blurs the lines between therapy and enhancement.

The EU Charter specifies that in the fields of medicine and biology there is a ‘prohibition of eugenic practices, in particular those aiming at the selection of persons’.Footnote ¹⁴⁴ This approach is narrower than that of other human rights instruments as it does not rule out lesser forms of enhancement. With respect to the scope of the prohibition of eugenic practices, the Presidium explained during the drafting of Article 3(2) that it refers to those practices aiming at the selection of persons in serious situations involving ‘campaigns for sterilisation, forced pregnancy, compulsory ethnic marriage’ as carried out in Nazi Germany and in Bosnia and Herzegovina.Footnote ¹⁴⁵ According to the Commentary, however, less serious forms of eugenic practices would also be covered and the prohibition should apply not only to States, but also to non-State actors.Footnote ¹⁴⁶ The Commentary further specifies that Article 3(2) should be construed as a specific limitation on the freedom of research, including clinical research, under Article 13 of the EU Charter.Footnote ¹⁴⁷ Given that the term ‘eugenic practices’ is not defined in the text of the EU Charter or in its Commentary, and in light of the examples given by the Presidium, it is not clear what lesser forms of eugenics might fall within the prohibition and whether it would extend to all other forms of enhancement, including those undertaken at the initiative of private individuals, that is parents, rather than States. This uncertainty is reinforced by the broad ordinary meaning of the term ‘eugenics’ used by scientists. According to the Oxford Dictionary, it denotes ‘[t]he science of improving a population by controlled breeding to increase the occurrence of desirable heritable characteristics’.Footnote ¹⁴⁸ Whilst Dr He's clinical trial would certainly fall within this definition, it might not fall under the meaning of Article 3(2) of the EU Charter.

The UNESCO Declaration too limits the purposes of genetic research allowing research which affects the genome and does not have any direct health benefit only if it is intended for the benefit of others and is compatible with human rights.Footnote ¹⁴⁹ The purposes of clinical applications of genetic research on humans are even more restricted—they ought to seek to relieve suffering and to improve the health of individuals and humanity as a whole.Footnote ¹⁵⁰ During the drafting of the Declaration, a number of States emphasised the need to regulate strictly the purposes of genetic interventions so as to prevent any eugenic abuse or the use of genetics for military purposes.Footnote ¹⁵¹ The declaration reflects the broad international consensus that genetic interventions in the human genome may only be undertaken for scientific, therapeutic or diagnostic purposes.Footnote ¹⁵²

It can be concluded that under international human rights law, genetic interventions can be only be undertaken for therapeutic, preventive and diagnostic purposes, with eugenics being strictly prohibitedFootnote ¹⁵³ and enhancement being implicitly excluded from the lawful applications. These limitations apply both to the research and to the clinical applications of genome editing. International law, however, does not contain definitions of the key terms, ie ‘therapy’, ‘prevention’, ‘enhancement’ or ‘eugenics’. Any future instrument in the field ought to fill this gap.

C. The Social Effects of Genome Editing: Equality and Solidarity

Another key concern is access to the new technology and how to prevent it from replicating if not exacerbating social inequalities. Human rights instruments have approached this in different ways. The Oviedo Convention is innovative in this respect, with Article 3 providing for equitable access to health care. The drafters considered this to be an important application of the principle of non-discrimination, meaning that, ‘Parties could not refuse a disabled person equitable access to health care even if such care costs more than average.’Footnote ¹⁵⁴ However, the provision was not intended to create an individual right enforceable against the State but to affirm an economic and social objective subject to the available resources and the needs of the individual concerned.Footnote ¹⁵⁵ Article 3 of the Oviedo Convention could be seen as a regional example of good practice, addressing the broader equality challenges posed by new healthcare technologies while leaving regulatory space for States to determine whether access would be open, free or equitable. It is to be hoped that this approach would be followed in any new instrument regulating genetic interventions.

The right to benefit from science and the right to health are also relevant here. The right to health is a fundamental human right found in numerous universal human rights instruments.Footnote ¹⁵⁶ The Constitution of the WHO defines ‘health’ as ‘a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity’.Footnote ¹⁵⁷ The CESCR's General Comment No 14 on the Right to the Highest Attainable Standard of Health emphasises that accessibility is one of the essential elements of the right,Footnote ¹⁵⁸ defining it as both physical and economic, ie affordability.Footnote ¹⁵⁹ The CESCR underlines that ‘States have a special obligation to provide those who do not have sufficient means with the necessary … health care facilities’.Footnote ¹⁶⁰ Therefore, the obligation of providing equitable access to health care facilities could have important financial implications for States which introduce genome editing at the clinical level, requiring them to make it affordable to socially disadvantaged groups irrespective of whether it is a publicly or privately provided service. This conclusion is further reinforced by the right to benefit from science and its applications set out in Article 15 of the ICESCR which requires States to provide access to scientific advances to everyone within their jurisdiction. According to the Special Rapporteur in the Field of Cultural Rights, ‘States should ensure that the benefits of science are physically available and economically affordable on a non-discrimination basis.’Footnote ¹⁶¹ The draft General Comment on the right requires States to ensure ‘fair access’ to science and its applications,Footnote ¹⁶² as well as open access to scientific information.Footnote ¹⁶³ While not binding, these interpretations are persuasive. Yet, the regulation of access to and sharing of scientific benefits and applications at the inter-State level is much more loose,Footnote ¹⁶⁴ highlighting that the human rights framework does not currently adequately address the challenge of solidarity between States.

The UNESCO Declaration addresses the challenges of equality and solidarity in a different way, drawing on the concept of the ‘common heritage of humanity’ found in the international law of the seaFootnote ¹⁶⁵ and applying it to genetic governance. The drafters considered this to be both the cornerstone and the main innovation of the declaration.Footnote ¹⁶⁶ The definition of the human genome as common heritage was the most debated aspect of the instrument. For some, declaring the human genome the common heritage of humanity meant protecting the rights of the individual in the field of genetics. Others saw the concept as entailing an obligation to protect the human genome itself in its past, present and future expressions as a source of diversity and genetic evolution.Footnote ¹⁶⁷ Some thought that, when applied to the human genome, the concept of the common heritage could create a tension between the individual heritage of the person and that of the species as a whole.Footnote ¹⁶⁸ There were also those who feared that qualifying the human genome as common heritage could allow States to take authoritarian measures in the fields of public health and demographic policy, limiting the right of individuals to procreate freely and transmit their genetic heritage to their descendants, or compelling individuals to undergo diagnostic, preventive or therapeutic operations in the interests of society.Footnote ¹⁶⁹ One group cautioned against equating the human genome to an economic resource whose use must be controlled at the international level.Footnote ¹⁷⁰ Others countered that the genetic information contained in the genome was a resource and that the right to exploit it in the common interest belonged to the international community as a whole.Footnote ¹⁷¹ The qualification of the human genome as common heritage of humanity was also addressed in the comments of a number of States. Some emphasised that the human genome was first and foremost the property of the individual while others responded that they did not recognise ownership over the human body.Footnote ¹⁷² The UNESCO International Bioethics Committee (‘IBC’) that drafted the Declaration clarified that the concept of common heritage did not automatically exclude the possibility of patenting genome research, which helps stimulate further research, but was meant to emphasise the principle of freedom of access to scientific knowledge concerning the genome, to genomic research data and to its results.Footnote ¹⁷³

It was ultimately agreed that the common heritage concept denoted the need to establish a dynamic balance between the protection of individual rights and the common interest of humanity, and that the two values were indivisible and mutually reinforcing.Footnote ¹⁷⁴ Further, the concept of common heritage was seen as an affirmation that the human genome is a universal value whose safeguarding is the duty of the international community, taking into account its individual and collective, tangible and intangible diversity.Footnote ¹⁷⁵ In this context, the IBC also considered the concept of ‘future generations’ as being part of ‘humanity’ and, as such, a subject of international law that had rights and responsibilities towards itself,Footnote ¹⁷⁶ including the obligations to protect genetic diversity.Footnote ¹⁷⁷ In addition, the IBC emphasised the importance of the principle of solidarity in this field, in particular the sharing of knowledge derived from scientific research.Footnote ¹⁷⁸

Treating the human genome as the common heritage of humanity addresses both the challenge of solidarity within the State and between States, as well as that of balancing the interests of the future individual with those of humanity. However, as evidenced in the preparatory works of the UNESCO Declaration, this concept is not universally accepted and its implications give rise to controversies. Furthermore, the concept of the common heritage was originally developed in the law of the sea as a tool for the common management of resources and thus centres around the principle of non-appropriation.Footnote ¹⁷⁹ It is therefore difficult to transpose it automatically to something as intrinsically linked to the individual as the human genome without running the risk of its commodification. It would therefore be worth revisiting the concept of common heritage when discussing any new instrument concerning genetic interventions or finding an alternative concept that would address the challenges it was intended to address. Such an alternative could be the global public goods, understood as ‘those whose scope extends worldwide, are enjoyable by all with no groups excluded, and, when consumed by one individual are not depleted for others’.Footnote ¹⁸⁰ Treating the human genome as a global public good would promote access to knowledge and data, encourage peaceful and beneficial applications in the field of human genetics, and emphasise the broader public interest.

The rights of future generations is another concept which addresses solidarity challenges on an intergenerational scale. The concept originated in environmental law and is commonly found in environmental treaties,Footnote ¹⁸¹ as well as in some treaties relating to the protection of cultural heritage.Footnote ¹⁸² More recently, the concept started being used in instruments regulating science and human health.Footnote ¹⁸³ According to the UN Declaration on the Responsibilities of the Present Generations Towards Future Generations, in the field of the human genetics the concept entails an obligation to ensure that scientific and technological progress do not impair or compromise the preservation of the human species.Footnote ¹⁸⁴ UNESCO declarations in the field provide for obligations to give due regard to the impact of life sciences on the rights of future generations.Footnote ¹⁸⁵

The ‘rights’ of future generations are not really rights as such, as there is no legal rights holder, nor do the so-called ‘rights’ have a substantive content. Instead they are a legal construct expressing a general principle of intergenerational equity and imposing procedural obligations on States to act with due diligence with respect to activities likely to affect future generations and prevent harm to them. The rights of future generations are relevant to the regulation of genome editing as the technology will have an inevitable, significant but uncertain impact on them. Accordingly, States ought to regulate germline editing as a high-risk genetic intervention that will impact upon the rights of future generations. In particular, they ought to take into account the possible impacts of genome editing on the rights of future generations when making decisions concerning both its legality and permitted applications, as well as to act with due diligence to prevent harm to those rights. This could be achieved through continuous impact assessments of the possible long-term consequences, risk-monitoring, risk-management and constant re-evaluation when authorising specific applications of genome editing. As highlighted by the Aarhus Convention,Footnote ¹⁸⁶ which regulates environmental matters, another way of ensuring respect for the rights of future generations is providing public access to relevant scientific information and allowing public participation in decision-making.Footnote ¹⁸⁷ This approach could be applied by analogy to genome editing.

Turning to the more granular level, a particular legal manifestation of the principle of equality is the prohibition against discrimination. While it is arguable that genetic discrimination is already prohibited under the umbrella of the general principle of non-discrimination, biomedical legal instruments also do so explicitly. Article 11 of the Oviedo Convention prohibits any form of discrimination against the person based on their genetic heritage, the key concern being that genetic diseases, or even the predisposition to them, might become a means of selection and discrimination.Footnote ¹⁸⁸ Article 21 of the EU Charter also prohibits discrimination on various grounds, including genetic features.Footnote ¹⁸⁹ Some States, such as Canada, have passed specific laws prohibiting genetic discrimination defined as requiring an individual to undergo or disclose the results of a genetic test as a condition for providing goods, services or entering into a contract.Footnote ¹⁹⁰ Indeed, the first reported legal case concerning genetic discrimination in China failed on the ground that discrimination on the basis of genetic features was not considered to fall under the general prohibition against discrimination in the Chinese Constitution.Footnote ¹⁹¹

In order to address equality challenges, any future instrument regulating the human genome and genetic interventions should expressly prohibit discrimination based on genetic characteristics, specifying that this also entails a ban on requiring individuals to undergo genetic tests as a condition for entering into a contract or being provided with goods and services.

D. Genome Editing under Human Rights Law: Critical Appraisal

While it is true that all international instruments addressing genetic interventions to date purport to regulate them from a human rights perspective, the implications of this framework for genome editing and its adequacy to address the challenges it poses remain open to question. The main difficulty, which was highlighted during the drafting of the UNESCO Declaration, the Oviedo Convention and the EU Charter, is the applicability of human rights in the absence of a legally recognised ‘person’ in the period before birth, let alone to the future generations of this person. While human rights are valuable and important for the protection of persons in relation to somatic genome editing, the germline seems to mostly escape their safety net.

The second challenge presented by the human rights framework is that of striking the right balance between the rights of the individual(s) concerned (in germline editing cases, these would be the parents) and the broader public interest. As exemplified by the express provision on this in the Oviedo Convention, from the perspective of human rights law the rights of the individual will always prevail over the interests of science and society.

Thirdly, human rights are mostly territorial in that States are obliged to respect, protect and promote them with respect to persons within their jurisdiction and a purely human rights approach cannot itself bridge the gap between scientifically developed and developing States, nor guarantee solidarity and equitable access. A global public goods or common heritage-based approach would promote solidarity and equitable access more effectively, giving due weight to the common interests at hand.

Fourthly, human rights do not define the safety threshold that needs to be met before the technology becomes clinically available, nor the acceptable levels of risk or harm. These aspects of genome editing could be regulated by drawing from relevant principles of environmental law that have been recognised to apply to human health, including the precautionary approach,Footnote ¹⁹² the requirement of prior impact assessment,Footnote ¹⁹³ the rights of future generations and the principle of no harm.Footnote ¹⁹⁴ A distinct advantage of drawing on environmental law in this context is that it places the burden of proving the safety and efficacy of the new technology on those seeking to use it. In contrast, a human rights-based proportionality analysis places the burden of proving that the technology is not sufficiently safe or effective to use on the State that wants to impose regulatory limits.

Finally, and possibly most problematically, human rights only create direct obligations for States and State entities. Given recent trends in funding, research and developments in science and technology, it is highly likely that the major breakthroughs in genome editing will be made and put into practice by private entities.Footnote ¹⁹⁵ Accordingly, it is up to States to legislate to make sure that human rights continue to apply to individuals and corporations working in the field of biomedicine, ideally before genome editing clinical trials and applications are made available to the general public.

This is not to say that human rights are not an indispensable part of the regulatory framework for genome editing. But they need to be developed further to protect the embryo and complemented by other standards to ensure the safe and equitable use of genetic interventions. As seen in the UNESCO Declaration and the two European human rights treaties, there are a number of human rights and principles compliance with which is critical to ensure that the new technology is used for the benefit of human beings, namely the principle of respect for human dignity, the prohibition against genetic discrimination, the freedom of scientific research and the right to equitable access to healthcare.