Anticipatory duties under the human right to science and international biomedical law

ABSTRACT

This paper assesses the interplay between international human rights law and international biomedical law as two specialised regimes within international law. The focus lies specifically on the anticipatory duties arising under the human right to benefit from science and its applications on the one side and under international biomedical law on the other. International biomedical law instruments adopt a human rights-based approach to the regulation of biology and medicine, so one of the questions is whether the anticipatory duties in biomedical law are indeed a specific application of the corresponding duties in international human rights law, modified, expanded and elaborated further to better address the distinctive subject matter, namely, the interface between the individual and science and technology in a medical context? Or whether the anticipatory duties in international biomedical law draw from international environmental law and/or general international law? The main question that this paper aims to address concerns the precise scope and content of the anticipatory duties under international biomedical law and their relationship to human rights.

KEYWORDS:

• Right to benefit from science
• science
• technology
• anticipatory duties
• international biomedical law
• rights of future generations

1. Introduction

This paper assesses the interplay between international human rights law and international biomedical law as two specialised regimes within international law. The focus lies specifically on the anticipatory duties arising under the human right to benefit from science and its applications on the one side and under international biomedical law on the other. International biomedical law instruments claim to adopt a human rights-based approach to the regulation of biology and medicine,¹ so one of the questions that arises is whether the anticipatory duties in biomedical law are indeed a specific application of the corresponding duties in international human rights law, modified, expanded and elaborated further to better address the distinctive subject matter, namely, the interface between the individual and science and technology in a medical context? Or whether the anticipatory duties in international biomedical law draw from general international law or other specialised regimes within it? The main question that this paper aims to address concerns the precise scope and content of the anticipatory duties under international biomedical law and their relationship to human rights.

The paper argues that under both human rights law and international biomedical law, States have a duty to ensure respect for human dignity and human rights and related to this, an obligation to regulate on the international and domestic planes to prevent the negative effects that science and scientific research on medicine, life sciences and associated technologies can have on human dignity and human rights.² In this context, international biomedical law imposes specific anticipatory duties to act with due diligence in order to maximise the benefits for the affected individuals and to minimise any possible harm,³ giving due regard to the impact of life sciences on the rights of future generations⁴ through the processes of risk assessment and management.⁵ Whilst not expressly incorporated in international biomedical law, the interrelated duties of prevention and precaution can be inferred from the duties to protect human rights and to minimise harm. Indeed, whilst the principles of prevention and precaution were first developed in international environmental law,⁶ they are now increasingly influencing the interpretation and application of international human rights law.⁷ International biomedical law borrows and adapts these anticipatory duties to ensure that medical science and technology are applied in a way respectful of human dignity and human rights, as well as to minimise the risk of harm to the individual and to humanity. Last but not least, States ought to ensure non-discriminatory, fair and equitable access to the benefits of science and its applications in order to prevent present and future inequality in the enjoyment of fundamental rights. This obligation too goes beyond human rights law and draws from general principles of non-discrimination, equity and arguably, the regime of the global commons. Recent developments pertaining to interventions in the human germline, i.e. the cells we pass to future generations, using the new CRISPR Cas-9 technology will be used as a case study to illustrate how these anticipatory duties should operate in practice in the face of a fast-developing and high-risk science and technology that promises significant benefits to the individual and humanity.

The paper begins by critically discussing the relationship between international biomedical law and international human rights law, arguing that the former incorporates human rights as an independent standard for assessing the legality of science and technology rather than translating them as individual rights in the field of biomedicine. In the second substantive part, the study discusses the nascent state of anticipatory duties in international law construing them as obligations of conduct that would benefit from more clearly defined key terms and consequences. The third and main part of the paper looks at four examples of anticipatory duties of States in relation to science and its applications, tracing their origins in international biomedical law, international human rights law, environmental law and general international law, as well as assessing their binding status under positive international law.

2. Human rights in international biomedical law

International biomedical law is as a nascent field of international law whose object of regulation are the legal issues arising out of life sciences,⁸ medicine and the associated technologies as applied to human beings.⁹ As such, it consists of a body of rules relevant to life sciences that are derived from international human rights law but also international environmental law and general international law, translated into legal and ethical principles and set out in soft-law instruments.¹⁰ International biomedical law as found in international treaties and soft law instruments will be used not only as comparison but also as an example of how human rights have informed anticipatory duties in the context of biomedicine. Indeed, it is not a coincidence that all major instruments in the field adopt or at least claim to adopt a human rights-based approach to regulating biomedicine. These include the Oviedo Convention on Human Rights and Biomedicine, the UNESCO Declarations on the Human Genome and Human Rights, on Bioethics and Human Rights and on the Responsibilities of Present Towards Future Generations. If one looks at the substance of the instruments closely, however, it becomes clear that they build on the general premise that scientific research and applications ought to be done in a manner that fully respects human dignity and human rights¹¹ without actually specifying how this ought to be achieved. Whilst they refer to the human rights principles of human dignity¹² and the prohibition against discrimination,¹³ and mention a few substantive human rights such as the right to life,¹⁴ the right to personal integrity,¹⁵ the right to respect for private life¹⁶ and the right to health,¹⁷ these are mostly mentioned in passing without clarifying their implications for the field of biomedicine or indeed the obligation-holders.¹⁸ Regrettably, despite its pertinence to science and technology in biology and medicine, none of the main instruments incorporate the right to benefit from science or its applications even if the Universal Declaration on the Human Genome and Human Rights does use the language of Article 15 ICESCR by requiring respect for scientific freedom, the international dissemination of scientific knowledge and the fostering of scientific co-operation.¹⁹ Admittedly, a number of these instruments refer to the ICESCR in their preambles, which could be seen as an implicit reference to the right to benefit from science among others. The one explicit reference to the right can be found in the UNESCO Recommendation on Science and Scientific Researchers, which refers to the right to benefit from science as a basis for the recommendation that States establish and facilitate open science and the sharing of scientific knowledge.²⁰ The only aspect of the right to benefit from science that has so far found its way explicitly in most international biomedical law instruments is the freedom of scientific research.²¹

This overall approach suggests that international biomedical law incorporates the protection of human rights as an independent standard for assessing science and technology rather than translating concrete rights into its specific context. An example of the latter could be translating human dignity into an anticipatory standard of protection of the embryo against the possible negative effects of germline editing. The main objective is to ensure that science and technology in the field of biomedicine are developed and applied in a manner respectful of human dignity and human rights as set out in human rights instruments. Ensuring the development of science and technology in accordance with this standard can be construed as an anticipatory duty.

3. Anticipatory duties in international law

It is a truism that anticipatory duties are not well defined or developed in international law. Perhaps this is partially due to the fact that international law has traditionally developed in response to major social and political changes rather than in anticipation of them, a prime example being the development of human rights law after the two World Wars. There are but few exceptions to this trend, such as Part XI of the UN Convention on the Law of the Sea and the Outer Space Treaty, both of which pertain to the fair and equitable access and benefit-sharing in areas beyond national jurisdiction, or the so-called global commons. Notably, both frameworks were developed before the exploitation of natural resources in these areas became practically or commercially viable. Despite the ongoing debates as to their practical effectiveness and implementation,²² from an anticipatory law-making perspective these regimes could be seen as examples of good practice in the regulation of new science and technologies, as well as their anticipated benefits, that could be followed in other areas of common interest and high risk such as interventions in the human genome.

Another possible reason for the nascent state of anticipatory duties is the difficulty in defining clear thresholds of when they would be triggered in the case of future risk of harm or benefit and indeed, in regulating how risks should be avoided, mitigated or balanced with possible benefits. Anticipating the distribution of future unknown benefits is arguably the most difficult aspect of agreeing to undertake anticipatory duties. Last but not least, anticipatory duties are possibly less attractive to States due to the uncertainty as to what specific consequences they might entail in a future situation and how they might limit the States’ regulatory space. Given their character of being obligations of conduct rather than result,²³ anticipatory duties also raise uncertainty as to their proper interpretation and application in practice. This is reinforced by the absence of clear generally accepted definitions of ‘harms’, ‘risks’ and ‘benefits’ across the surveyed hard and soft law instruments and in general international law.²⁴ However, anticipatory duties are important guarantees for not compromising substantive standards of international legal protection in the face of scientific and technological uncertainty, particularly in areas where some argue there is no applicable international law, such as in the case of interventions in the human genome, particularly germline editing.

4. Anticipatory duties in international biomedical law

In addition to human rights law, a number of anticipatory provisions of international biomedical law instruments also draw heavily from principles of general international law and international environmental law but without expressly acknowledging it. Despite this heavy ‘borrowing’ from other regimes of international law, biomedical law construes its own tripartite model of anticipation including the prevention of harm, the management of risks and on the maximising of benefits. This latter aspect is specific to biomedical law and is arguably motivated by the potential benefits of biomedical science and technology for the individual and for humanity.

For example, some have argued that the protections offered by human rights law automatically render germline genome editing illegal under international law.²⁵ This is not in line with the Lotus principle stating that restrictions upon State sovereignty cannot be presumed.²⁶ Furthermore, it is preferable to see human rights law and international biomedical law as a guarantee that when viable, germline editing can be undertaken with due regard to human dignity, the right to life, the right to health and the right to benefit from science so as to promote these rights and to maximise the benefits of the technology for the individual and humankind. The anticipatory duties imposed by the right to benefit from science are particularly pertinent in this context.

4.1. Duty to regulate to prevent the negative effects of science and to promote its benefits

It has long been established that States have an obligation to bring their domestic laws in accordance with their international obligations once they have undertaken them.²⁷ The anticipatory duty to regulate to prevent the negative effects of science on human dignity and the enjoyment of human rights, as well as to promote its benefits can be seen as a corollary to the general obligations of pacta sunt servanda and relatedly, of bringing domestic law in accordance with international law but extended to cover future situations.

The duty to regulate to prevent the negative effects of science and to promote its benefits is not expressly formulated as such in the international instruments setting out the right to benefit from science. Nor is the link of this duty to the enjoyment of human rights. However, these can be extrapolated through interpretation. If we take as a starting point Article 15 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), States recognise the right of everyone to enjoy the benefits of scientific progress and its applications. Per argumentum a contrario, the choice of the words ‘benefits’ and ‘scientific progress’ implies that in order to fulfil the right, States ought to protect everyone from the negative effects of science and technology. This interpretation is supported by the 2012 Report of the Special Rapporteur in the Field of Cultural Rights²⁸ and by the Committee on Economic, Social and Cultural Rights (CESCR) in its General Comment No. 17 on Article 15(1)(c) ICESCR,²⁹ as well as by the contributions of States during the discussions of the ESC.³⁰ The Guidelines on Treaty-Specific Documents expressly link the duty of prevention to the protection of human dignity and human rights by requiring States to provide specific information on the ‘measures taken to prevent the use of scientific and technical progress for purposes which are contrary to the enjoyment of human dignity and human rights.’³¹ Similarly, General Comment No 17 provides that ‘States parties should prevent the use of scientific and technical progress for purposes contrary to human rights and dignity, including the rights to life, health and privacy’.³² The Venice Statement on the Right to Enjoy the Benefits of Scientific Progress and Its Applications goes even further in imposing an anticipatory duty on States to regulate the activities of third parties to prevent them from using science and technology in a manner inconsistent with human dignity and human rights,³³ including specifically the taking of ‘legislative measures, to prevent and preclude the utilization by third parties of science and technologies to the detriment of human rights and fundamental freedoms and the dignity of the human person by third parties’.³⁴

Despite the earlier position of the CESCR and of General Comment No 17, surprisingly, General Comment 25 on the Right to Enjoy the Benefits of Scientific Progress (General Comment 25) does not mention the duty to regulate to prevent from the negative effects of science. Instead, it focuses on the narrower obligation of States to protect from the specific harmful consequences of pseudo-science.³⁵ General Comment 25 does, however, support the anticipatory duty of States to promote the benefits of science in providing that States ought to adopt ‘policies and measures that expand the benefits of these new technologies while at the same time reducing their risks’.³⁶ Interestingly, it indirectly supports the duty to regulate science and new technologies on the international plane by emphasising that international cooperation should be enhanced with a view to developing global regulations so as to manage effectively some of the more serious risks on new technologies, highlighting the governance gap left by fragmented national responses to transnational technologies.³⁷ General Comment 25 also recommends that States promote multilateral agreements to prevent the risks related to the development of science and technology or to mitigate their effects.³⁸ Notably, international regulation is encouraged rather than mandated and there is no mention of similar regulation being required domestically.

The obligation to regulate to prevent the negative effects of science and its applications finds further elaboration and specification in the field of international biomedical law. The Oviedo Convention on Human Rights and Biomedicine, which is the only binding international instrument in the field, requires States to take the necessary measures in their domestic laws to give it effect³⁹ and clarifies that the misuse of biology and medicine can lead to acts endangering human dignity.⁴⁰ These could be seen as an emanation of the obligation on States to regulate genetic interventions in order to ensure their safety and compliance with human rights. Similarly, the UNESCO Universal Declaration on the Human Genome and Human Rights together with its preparatory works suggest that there is an emerging 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 notably, the rights of future generations.⁴¹ In particular, Article 11 of the Universal Declaration on the Human Genome mandates that practices contrary to human dignity shall not be permitted, inviting States and international organisations to co-operate in identifying such practices and taking the measures necessary at both the national and international levels to ensure the respect for the principles set out in the Declaration. Interestingly the provision contains no reference to practices contrary to human rights. In addition, Article 15 makes an anticipatory recommendation that the freedom of research on the human genome should be subject to the standards of respect for human rights, fundamental freedoms and human dignity, as well as to the protection of public health.

With respect to the duty to regulate to maximise benefits, Article 12(a) of the Universal Declaration on the Human Genome requires that the applications of research on the human genome, including those in biology, genetics and medicine, pursue specific objectives in ‘seek[ing] to offer relief from suffering and improve the health of individuals and humankind as a whole’. In the context of maximising future benefits from scientific research, Article 17 recommends that States foster research whose objective is the identification, prevention and treatment of genetically based and genetically influenced diseases, including rare and also endemic diseases which affect large numbers of people. This is another manifestation of the promotion of the benefits of science. The only instrument providing limited guidance on how to balance the prevention of the negative effects of science with the maximisation of its possible benefits is the Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind. It calls on States to ‘take measures to extend the benefits of science and technology to all strata of the population and to protect them, both socially and materially, from possible harmful effects of the misuse of scientific and technological developments’.⁴² Here, the maximisation of the benefits is understood as ensuring equitable access to them.

Overall, the duty to regulate to prevent the negative effects of science and its applications and to promote their benefits is still emerging in both international human rights law and in international biomedical law. However, it could be seen as a corollary to the well-established obligation of States to ensure respect for human dignity and human rights within their jurisdiction and as such not needing express legal incorporation. The crux of the obligation in international biomedical law is informed by human rights law in that science and technology ought not have negative effects on human dignity and human rights. It is not clear, however, how precisely this ought to be achieved in practice. From a normative standpoint and in the interest of legal certainty, it would be desirable to see this obligation become more explicit and better fleshed out given the fast developments in science and technologies with the potential to significantly promote human rights whilst also carrying the risk of impairing them. The balance between preventing negative effects and maximising benefits needs further elaboration too. Regulation through legally binding instruments at both the domestic but especially on the international level is particularly desirable in the field of interventions in the human genome where there have been significant advances but also undesirable developments, such as the editing of twins in China to make them resistant to HIV in the face of significant scientific uncertainty as to the safety of the experiment or its benefits for the children who did not carry the virus.⁴³

4.2. Duties to act with due diligence in preventing harm and maximising benefits

The obligation to act with due diligence in preventing harm is now well established in international environmental law, as is the corollary procedural obligation to conduct an impact assessment in the face of a risk of significant harm.⁴⁴ The anticipatory duty to act with due diligence in preventing harm is starting to influence human rights law too.⁴⁵ The procedural obligations relating to risk assessment and management that stem from the duty to act with due diligence in preventing harm are commonly incorporated in instruments dealing with human rights in the context of biomedical law. They can be seen as an influence primarily from environmental law but with a human rights dimension given that the anticipation and management of risk is directed at the individual, their human dignity and human rights.

General Comment 25 frames the obligation of due diligence in the prevention of harm under the umbrella of the precautionary principle, despite its controversial character, interpreted as entailing an obligation to act to avoid or minimise the risk of future morally unacceptable harm in the face of scientific uncertainty. Notably, the precautionary principle is invoked in the context of the right to information and participation of the public in controlling the risks involved in scientific progress and its applications rather than as a stand-alone standard for the behaviour of States when making decisions about science and technology more broadly. The General Comment defines ‘morally unacceptable harm’ as including ‘harm to humans or the environment that is (a) threatening to human life or health, (b) serious and effectively irreversible, or (c) inequitable to present or future generations’.⁴⁶ Regrettably, there is no mention of harm to human dignity or human rights. This is the only instance in which the General Comment mentions the rights of future generations. It goes on to identify technological and human rights impact assessments as tools for identifying risks relating to the process and use of scientific applications.⁴⁷ The main consequence of the engagement of the precautionary principle seems to be providing for public participation and transparency in controversial cases of scientific research, rather than requiring States to take all necessary measures to avoid the risk of or to prevent harm as they ought to do under international environmental law.

General Comment 25 also encourages States parties to prevent and mitigate health-related risks to the individual by ensuring that medicines and medical treatments are evidence-based, that risks are evaluated and communicated clearly and transparently to patients to help inform their consent.⁴⁸ It recommends that States Parties to the ICESCR should establish legal frameworks imposing human rights due diligence obligations on non-State actors, particularly business entities so as to identify, prevent and mitigate risks of violations.⁴⁹

It would have been preferable for the General Comment to rely on the well-established principles of due diligence and the obligation to prevent harm rather than solely on the precautionary approach when grounding the anticipatory duties related to science and new technologies. The duties of preventing harm and mitigating risks should have been formulated in mandatory language given their grounding in other regimes of international law dealing with risky activities, rather than as mere recommendations. It is also regrettable that the General Comment does not include the positive anticipatory duty to maximise the benefits of science and its applications, which is emphasised in the international biomedical law instruments in the area. Moreover, it is the balance between preventing harm and maximising benefits with respect to science and its new technological applications that is the most important and difficult to strike in practice. Whilst it is helpful that the Comment defines ‘harm’, it is very regrettable that it focuses solely on physical harm and does not include harm to human dignity or human rights, despite mentioning human rights impact assessment as a tool for preventing harm. It would have been desirable to have a definition of ‘risk’ and ‘benefits’ too, as well as an indication as to the threshold at which the anticipatory duties are triggered.

The international instruments in the field of biomedical law do not expressly mention the precautionary approach or the duty of due diligence in preventing harm. They focus instead on the corollary procedural anticipatory duties of carrying out an impact assessment of both risks and benefits, of weighing the possible risks and benefits for both the individual and for humanity as a whole, as well as of taking due account of the rights of future generations to inform decision-making. For example, the Universal Declaration on the Human Genome requires rigorous assessment of the potential risks but also of the benefits pertaining to the individual’s genome prior to any research, treatment or diagnosis that involves it.⁵⁰ The UNESCO Declaration on Bioethics and Human Rights emphasises not only the need of risk assessment but also of adequate risk management in relation to medicine, life sciences and associated technologies.⁵¹ Related to this, it recommends that States give due regard to the impact of life sciences on future generations.⁵²

With respect to the balancing between risks and benefits, the UNESCO Declaration on Bioethics and Human Rights recommends that in applying and advancing scientific knowledge and technologies, the benefit to affected individuals such as patients should be maximised and any possible harm ought to be minimised.⁵³ The Oviedo Convention on Human Rights and Biomedicine adopts a proportionality approach in requiring that scientific research on a person may only be undertaken if, inter alia, ‘the risks which may be incurred by that person are not disproportionate to the potential benefits of the research’.⁵⁴ In general, all instruments provide that in case of conflict, the interests and welfare of the individual will always prevail over the interests of science and society.⁵⁵ Most of the instruments, however, fail to offer more detailed guidance on how to strike the balance between minimising the risk of harm with the possible benefits in the face of scientific uncertainty. Most balancing models seem to focus primarily on the risks and benefits of science and technology for a patient or a directly affected individual rather than the broader risks and benefits for the community or indeed humanity as a whole.

There are some instruments which account for the broader public interest in the context of maximising benefits. For example, the UNESCO Declaration on Bioethics and Human Rights stresses that the applications of research in genetics and medicine concerning the human genome ‘shall seek to offer relief from suffering and improve the health of individuals and humankind as a whole.’⁵⁶ The requirement in the Oviedo Convention on Human Rights and Biomedicine that genetic interventions ought to be undertaken only for preventive, diagnostic or therapeutic purposes and provided that their aim is not to introduce any germline modification, can be read in similar vein.⁵⁷ During the drafting of the Convention in the late 90s, following an intensive debate as to the safety of germline editing it was decided that the procedure was too risky at the time and therefore it was outlawed.⁵⁸ However, the ban was intended to be only temporary and subject to periodic review in light of the most recent scientific and technological developments.⁵⁹ Interestingly, during the drafting of the Oviedo Convention, the working party discussed as an alternative approach to banning germline modifications allowing them in exceptional cases, provided that: (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.⁶⁰ This is the most detailed guidance on what the minimising of risk and maximising of benefit analysis should look like in the context of germline editing and could be used as a starting point for discussion in the negotiation of a future binding instrument in the field. This model can be seen as a translation of the proportionality analysis to the germline editing context as it specifies what the risks and benefits are in the context of germline editing, namely the risks posed by a genetic abnormality that cannot be corrected otherwise on the one side and the alleviation of human suffering for the individual concerned and more broadly for humanity. It also defines the applicable standard of due diligence as a strict standards of reliability and safety.

4.3. Duty to give due regard to the rights of future generations

The obligation to give due regard to the impact of life sciences on the rights of future generations is another anticipatory duty found in biomedical law instruments that can be seen as a manifestation of the principles of precaution, prevention and due diligence extended in time to include consideration of the near and distant future.⁶¹ It can be construed as a standard of good decision-making in the face of a risk of harm that may materialise in the future calling on States to take due account of the rights of future generations when allowing activities which may affect them. The rationale of the standard is to help ensure that the existence, rights and well-being of the future generations won’t be compromised or significantly undermined by the actions of the present ones. This concept too originated in environmental law and is commonly found in environmental treaties,⁶² as well as in some treaties relating to the protection of cultural heritage.⁶³ It is also rooted in the concept of sustainability of human rights as defined in the Sustainable Development Goals.⁶⁴ There are only a few treaties involving individual rights that use the concept of future generations.⁶⁵ More recently, the rights of future generations started being used in instruments regulating biomedicine.⁶⁶

The ‘rights’ of future generations are not ‘rights’ properly so-called, as there is no right holder, the object of protection does not yet exist, nor is there a human right-based substantive content. The obligation holder are arguably the present generations who are too abstract and general a subject to impose duties on under international law or to legally hold to account. It is better to think of the rights of future generations as an abstract legal concept expressing a general principle of intergenerational equity and imposing procedural obligations on States to act with precaution and due diligence with respect to activities likely to affect future generations so as to prevent harm to them.

The ‘rights of future generations’ are the most anticipatory of all anticipatory duties in international law. They can be construed as imperfect duties to anticipate that are not owed to anyone in particular or that are owed to everyone, i.e. society, the international community or humanity as a whole. They are particularly relevant to the regulation of science and new technologies related to health, especially those aimed at modifying the human germline, as these will have an inevitable, significant but uncertain impact on future generations. Accordingly, States should regulate high-risk scientific and technological applications that will impact upon the rights of future generations. In particular, they should take into account the risk of harm, as well as the benefits for the existence, well-being and rights of future generations when making decisions concerning both the legality and permitted applications of interventions in the human genome, as well as act with due diligence to prevent possible harm. 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 scientific and technological applications. Arguably, another important consequence of the anticipatory duty to take due account of the rights of future generations is to provide the public access to scientific knowledge and to allow public participation in the decision-making concerning high risk and benefit science and technology. Such an approach is adopted in the Aarhus Convention,⁶⁷ which regulates environmental matters.⁶⁸ No one is better placed to represent and take responsibility on behalf of the present generations than the global public who should be enabled to contribute to the debates concerning the levels of acceptable risk and harm, as well as the desirable benefits when it comes to biomedicine. Informed, pluralistic and democratic public debate on the fundamental questions raised by the developments in biomedicine and their possible applications are mandated by the Ovideo Convention and a number of the soft law instruments in the field.⁶⁹

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 a basic obligation to ensure that scientific and technological progress do not impair or compromise the preservation of the human species.⁷⁰ UNESCO declarations in the field provide for a mix of obligations and recommendations to give due regard to the impact of life sciences on the rights of future generations so as not only to safeguard but also to promote their rights.⁷¹ For instance, the Preamble of the Oviedo Convention emphasises the beneficence aspects of the obligation in requiring ‘that progress in biology and medicine should be used for the benefit of present and future generations’.⁷² The Universal Declaration on Bioethics and Human Rights defines as one of its objectives the dual obligation to safeguard and promote the rights of present and future generations.⁷³ It recommends that States give due regard to the impact of life sciences on future generations and their genetic constitution.⁷⁴ The UN Declaration on the Rights of Future Generations requires that ‘[t]he present generations have the responsibility of ensuring that the needs and interests of present and future generations are fully safeguarded.’⁷⁵ As a minimum, the present generations should strive to ensure the continuation of humankind with due respect for the dignity of the human person.⁷⁶

The UNESCO Declaration on Science and the Use of Scientific Knowledge focuses on the positive obligation to promote the rights of future generations. It requires sciences to be of service to humanity as a whole and contribute, inter alia, to better quality of life for present and future generations.⁷⁷ It also provides that scientific research and the use of knowledge from that research should always aim at the welfare of humankind and take fully into account the responsibility towards present and future generations.⁷⁸ The UNESCO Recommendation on Science and Scientific Researchers requires States to ensure that scientific research and development are carried out for the protection and enhancement ‘of the cultural and material well-being of [their] citizens in the present and future generations’.⁷⁹

Regrettably, the Universal Declaration on the Human Genome and Human Rights does not contain a reference to the rights of future generations, however, the concept was discussed during its drafting. There was some confusion as to its character during the discussions of the International Bioethics Committee, which considered the concept of ‘future generations’ as forming part of the concept of ‘humanity’ and, as such, a subject of international law that had rights and responsibilities towards itself,⁸⁰ including the obligations to protect its genetic diversity.⁸¹

It is not a coincidence that even international biomedical law instruments, which commonly employ the concept of the rights of future generations, do not actually link it to the protection of human rights. Most define it as entailing an obligation not to compromise the existence of the future generations, many also refer to ensuring a benefit for them and some link it to protecting their interests and well-being. It is only the UN Declaration on the Rights of Future Generations that links the concept to human dignity but steps short of referring to human rights. The possible tension between construing future generations as right-holders and the rights of children has been rightly highlighted by scholars.⁸² Indeed, there are also those who define the rights of future generations as referring to ‘the [human] rights of current youth and children when they grow into adulthood, as well as other people who will live in the future.’⁸³ These scholars try to justify the idea of future generations as human right-holders on the basis of the universality of human rights, which transcends time, as well as with reference to the principle of human dignity.⁸⁴ However, the question as to the temporal scope of human rights protection is far from uniformly settled, particularly in the context of the start of life and personhood.⁸⁵ As confirmed by the ECtHR, under the ECHR, ‘the full protection of the right to life starts only with the birth of the child’.⁸⁶ Whilst it might be normatively appealing to use the concept of the rights of future generations to bridge the gap in human rights protection between those who are born and those who are yet to be born, including those who are already conceived, such an extension of the concept is not currently grounded in positive international law. It is not present in human rights treaties and indeed, the UN High Commissioner on Human Rights herself referred to ‘the principle of intergenerational equity recognized in the Paris Agreement’ that ‘places a duty on us to act as responsible stewards of our environment, and ensure that future generations can fulfil their human rights.’⁸⁷ Arguably, the concept of the rights of future generations can be extended to encompass the obligation not to compromise the dignity of future generations and their ability to enjoy basic human rights, including the right to life and the right to health.

4.4. Duty to give access to the benefits of science and its applications

The duty to give access to the benefits of science and its applications is arguably the most controversial anticipatory duty in both human rights and biomedical law but also one of the most important ones, given the emphasis on equality of access with respect to economic, social and cultural rights.⁸⁸ The rationale behind it is to prevent future inequality in access to science and technology, which may, among other things, lead to inequality in the enjoyment of fundamental human rights. For example, to avoid a ‘brave new world’ where only those with significant resources have access to germline editing to ensure healthier, stronger or smarter descendants. The controversy is partly due to the tension between the right to benefit from science and its applications on the one side and the right of authors to benefit from the moral and material interests resulting from their scientific production.⁸⁹ Another practical challenge is that most of modern day scientific progress and especially its applications are driven by private actors rather than States, so it is important to incentivise such initiatives though IP law protections which in turn could make it more difficult for States to afford giving access to the benefits of science and its applications to everyone without discrimination. Last but not least, giving access to scientific applications to everyone could involve significant costs for States. For example, the most recent development in somatic genome editing therapy to treat the genetic blood diseases sickle cell anemia and beta thalassemia costs around $2.8 mln per person, making it ‘the most expensive single dose drug’.⁹⁰ There is also uncertainty as to the type of access States ought to give to the benefits of science and its applications – is it merely non-discriminatory access or the more intensive forms of equitable, affordable or even free access? Ultimately, it falls upon States to legislate in order to make sure that human rights continue to apply to individuals and corporations working in the field of biomedicine.

The Guidelines on Treaty-Specific Documents to be Submitted by States Parties under Articles 16 and 17 of the ICESCR support an interpretation of Article 15 that requires States Parties ‘to ensure affordable access to the benefits of scientific progress and its applications for everyone, including disadvantaged and marginalized individuals and groups’.⁹¹ According to the ESC, accessibility as a key aspect of the content of the right entails free access to scientific information and affordable access to scientific applications. Similarly, the Special Rapporteur in the Field of Cultural Rights held that ‘States should ensure that the benefits of science are physically available and economically affordable on a non-discrimination basis.’⁹²

General Comment 25 on the other hand speaks merely of ‘equal access to the applications of science, particularly when they are instrumental for the enjoyment of other economic, social and cultural rights.’⁹³ It is not clear what ‘equal’ means and whether it is the same as the better-established category of ‘non-discriminatory’ access. When clarifying the obligation to fulfil the right to benefit from science, the Comment makes a qualified more ambitious recommendation that ‘[s]cientific progress and its applications should be, as far as possible, accessible and affordable to persons in need of specific goods or services.’⁹⁴ With respect to access to science, the Comment speaks of ‘open science’ whilst acknowledging that it cannot be achieved by States alone and requires the contribution of all stakeholders, particularly those whose research was financed by public funds.⁹⁵ The General Comment also recognises that IP law can negatively affect access to the benefits of science and requires States ‘to take all steps to avoid the possible negative effects of IP on the enjoyment of the right’,⁹⁶ including making all efforts through their domestic regulations and international agreements on IP to avoid an ‘unacceptable prioritization of profit for some over the benefit for all.’⁹⁷ The Comment requires that a balance is reached between IP protection on the one side and open access and sharing of scientific knowledge and the access to the benefits of science, specifically those linked to the realisation of the right to health, on the other.⁹⁸ However, no further guidance is given as to concrete steps that can be taken to achieve this in practice. The only specification given is that States party have a duty to prevent unreasonably high costs for access to, inter alia, essential medicines.⁹⁹

Notably, the Comment uses hortatory language when speaking about States promoting scientific research through financial support and other incentives to create new medical applications and make them accessible and affordable to everyone, including the most vulnerable.¹⁰⁰ General Comment 25 also uses the aspirational language of ‘should’ in recommending that the benefits of any scientific research and its applications are shared with the international community and particularly, developing countries.¹⁰¹

In effect, General Comment 25 adopts the interpretation that States have an obligation to give equal access to the benefits of science and its applications whilst recommending that they should go further and strive to provide affordable access. This approach can be contrasted with the more progressive attitude adopted in General Comment 14 on the Right to the Highest Attainable Standard of Health which emphasises that accessibility is one of the essential elements of the right,¹⁰² defining it as both physical and economic, i.e. affordability.¹⁰³ General Comment 14 underlines that ‘States have a special obligation to provide those who do not have sufficient means with the necessary … health care facilities’.¹⁰⁴ General Comment 14 interprets the anticipatory duty to give access as one of giving equitable access to scientific applications and new technologies relevant to human health. From a normative standpoint, this is the better interpretation, however, the approach adopted in General Comment 25 better reflects what happens in practice. The obligation of giving equitable access to health facilities could have important financial implications for States who introduce genome editing at the clinical level as they would have to make it affordable to the socially disadvantaged groups irrespective of whether it is a publicly or privately provided service.

The key concerns of giving access to new technologies relevant to health and of preventing them from replicating if not exacerbating social inequalities are addressed somewhat inconsistently in international biomedical law too. The UNESCO Declaration on Human Rights and Biomedicine defines as one of its aims ‘to promote equitable access to medical, scientific and technological developments as well as the greatest possible flow and the rapid sharing of knowledge concerning those developments and the sharing of benefits, with particular attention to the needs of developing countries’.¹⁰⁵ The Declaration also uses hortatory language in suggesting that the benefits resulting from scientific research and its applications should be shared not only domestically but also with the international community as a whole with special emphasis on the needs of developing States.¹⁰⁶

The Universal Declaration on the Human Genome and Human Rights is more progressive in mandating that the benefits from the advances in biology, genetics and medicine concerning the human genome ‘shall be made available to all, with due regard for the dignity and human rights of each individual’.¹⁰⁷ It does not clarify, however, whether this entails equal, equitable or free access.

The Oviedo Convention is more explicit in this respect, with Article 3 requiring parties to provide 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.’¹⁰⁸ However, the provision was not intended to create an individual right enforceable against the State but merely to affirm an economic and social objective subject to the available resources and the needs of the individual concerned.¹⁰⁹ Article 3 of the Oviedo Convention could be seen as an 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.

5. Conclusion

The anticipatory duties of States in relation to scientific progress and its applications are increasingly important given the fast development of science and technology, particularly in the context of human health. Without these anticipatory duties it will be very difficult to prevent the possible negative effects of science and technologies on the individual and humanity or to maximise their benefits. Yet, most anticipatory duties are relatively new and underdeveloped.

The obligation to regulate high risk science and technology in the field of biomedicine can be seen as a foundation for all anticipatory duties of the State in this field. It is grounded in general international law and a good faith interpretation of the human right to benefit from science and its applications.

The duties to act with precaution and due diligence in preventing harm stem from international environmental law but refocused on the dignity and rights of the individual as the object of protection. They have important implications for the management of risks to the individual and their human dignity and human rights in the face of scientific uncertainty. Whilst merely duties of conduct rather than result, they can contribute significantly to improving the decision-making process of States by requiring impact assessments, public participation in decision-making and the taking of due account of the rights of future generations. Notably, international biomedical law adapts the traditional risk v benefit analysis from environmental law into a model seeking to minimise harm whilst maximising benefits.

The obligation to give access to the benefits of science is the least settled anticipatory duty of States. Whilst it is clear that such access ought to be given on a non-discriminatory basis, it is far from certain whether States are required to give equal, equitable, open or free access. There is increasing support for a duty to provide equitable access to science and technology coming from human rights law bodies and converging into biomedical law instruments.¹¹⁰ Whilst normatively desirable, this process has not yet fully materialised as a matter of positive international law.

It can be hoped that in fulfilling their duty to regulate high risk science and technology, States will in the future conclude a binding universal international biomedical law instrument based on human rights and overseen by an international institution to clarify and further elaborate these anticipatory duties.

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Additional information

Notes on contributors

Rumiana Yotova

Rumiana Yotova is an Assistant Professor in International Law at the Faculty of Law of the University of Cambridge and a Fellow at Gonville & Caius College. Her research interests lie in the areas of general international law, particularly its sources and the responsibility of States, the settlement of international disputes, international investment law, and the nascent field of international biomedical law. Rumiana's publications center around international communitarian norms and their legal effects in different regimes. She practices as an Academic Door Tenant at Thomas More Chambers where she advises on issues of public international law and acts as counsel in investment law and arbitration. Rumiana completed her PhD in Cambridge under the supervision of Prof. James Crawford and assisted him with cases before the ICJ and arbitral tribunals as his Research Associate. Prior to this, she spent time at the Secretariat of the Permanent Court of Arbitration, the European Commission in Brussels and the International Tribunal for the Law of the Sea. Rumiana did her Magister Juris at the University of Sofia, an LL.M Advanced in International Law at Leiden University and was awarded the Hague Academy Diploma in International Law cum laude.

Notes

1 See e.g, UNESCO Universal Declaration on Bioethics and Human Rights (2005), art. 2 and 3; UNESCO Universal Declaration on the Human Genome and Human Rights (1997), art 2 and Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Human Rights and Biomedicine (1997) (‘Oviedo Convention on Human Rights and Biomedicine’), Art 1.

2 CESCR, General Comment No. 17 The Right of Everyone to Benefit from the Protection of the Moral and Material Interests Resulting from any Scientific, Literary or Artistic Production of Which He or She is the Author (2005), E/C.12/GC/1712, at para. 35 and General Comment No. 25 on science and economic, social and cultural rights (2020), E/C.12/GC/25, at para. 81.

3 UNESCO Universal Declaration on Bioethics and Human Rights, supra note 2, art. 4 Benefit and Harm.

4 Ibid, art. 16 Protecting Future Generations. See also UN Declaration on the Responsibilities of the Present Generations Towards Future Generations (1997), art. 6 Human Genome and Biodiversity and UNESCO Declaration on Science and the Use of Scientific Knowledge (1999), at para. 39.

5 Ibid, art. 20 Risk Assessment and Management.

6 See e.g., Pierre-Marie Dupuy and Jorge Viñuales, International Environmental Law (Cambridge: Cambridge University Press, 2015), at 55-71. See in general Caroline Foster, Science and the Precautionary Principle in International Courts and Tribunals (Cambridge: Cambridge University Press, 2011).

7 See e.g., ‘The Precautionary Principle’ UNESCO (2005); Tătar v Romania, ECtHR, Judgment 27 January 2009, (Application No 67021/01), at paras 106-107; and M Malaihollo, ‘Due Diligence in International Environmental Law and International Human Rights Law: A Comparative Legal Study of the Nationally Determined Contributions under the Paris Agreement and Positive Obligations under the European Convention on Human Rights’, Netherlands International Law Review 68, (2021):121.

8 Biological sciences including biology, biochemistry, anatomy and genetics according to the online edition of the Oxford English Dictionary, https://www.oed.com/dictionary/life-science_n?tab=factsheet#9939460052 (last accessed August 24, 2023).

9 UNESCO Declaration on Bioethics and Human Rights, supra note 2, article 1 Scope.

10 See in general Roberto Andorno, Principles of International Biolaw: Seeking common ground at the intersection of bioethics and human rights (Bruxelles: Bruylant, 2013) and Chamu Kuppuswamy, The International Legal Governance of the Human Genome (London and New York: Routledge Taylor & Francis Group, 2009).

11 See e.g. Universal Declaration on the Human Genome and Human Rights, Preamble, supra note 2, at para. 6, UNESCO Declaration on Bioethics and Human Rights, supra note 2, art 3.

12 UNESCO Declaration on Bioethics and Human Rights, supra note 2, art 3(a); Universal Declaration on the Human Genome and Human Rights, supra note 2, art 1 and 2(a).

13 Universal Declaration on the Human Genome and Human Rights, supra note 2, art 6 and UNESCO Declaration on Bioethics and Human Rights, art 11.

14 UNESCO Declaration on Bioethics and Human Rights, supra note 2, art 2(c).

15 Ibid, art 8.

16 Oviedo Convention on Human Rights and Biomedicine, supra note 2, art 10.

17 Ibid, art 14(2).

18 But see ibid, art 2.

19 Universal Declaration on the Human Genome and Human Rights, supra note 2, art 12 and 18.

20 UNESCO Recommendation on Science and Scientific Researchers (2017), s. 21.

21 Ibid, Art 12 and 14 and UNESCO Declaration on Bioethics and Human Rights, supra note 2, art 2(d).

22 See e.g, Isabel Feichtner and Surabhi Ranganathan, ‘International Law and Economic Exploitation in the Global Commons: Introduction’, European Journal of International Law 30, no. 2 (2019): 541.

23 See Certain Activities Carried out by Nicaragua in the Border Area

(Costa Rica v Nicaragua) and Construction of a Road in Costa Rica along the San

Juan River (Nicaragua v Costa Rica), ICJ Reports 2015 noted by Rumiana Yotova, ‘The Principles of Due Diligence and Prevention in International Environmental Law’, Cambridge Law Journal 75, no. 3 (2016):445.

24 Admittedly, there are persuasive definitions offered in interpretative documents, such as in General Comment No 25, supra note 3, which defines ‘benefit’. However, these are not legally binding or generally accepted.

25 Katherine Drabiak, ‘The Nuffield Council’s green light for genome editing human embryos defies fundamental human rights law’, Bioethics 34 (2020): 223. But see Andrea Boggio and Rumiana Yotova, ‘Gene Editing of Human Embryos is not Contrary to Human Rights Law: A Reply to Drabiak’, Bioethics 35, no. 9 (2021): 956.

26 The Case of SS Lotus (France v Turkey), PCIJ Reports, Ser. A, No. 10 (1927), at 18.

27 Exchange of Greek and Turkish Populations, Advisory Opinion, PCIJ Reports, Ser B No 10 (1925), at 29.

28 Report of the UN Special Rapporteur in the Field of Cultural Rights, Farida Shaheed ‘The Right to Enjoy the Benefits of Scientific Progress and Its Applications’ UNCHR (2012) UN Doc A/HRC/20/26, at para. 43

29 Ibid and General Comment No. 17, at para. 35.

30 General Discussion on the Right to Take Part in Cultural Life as Recognized in Article 15 of the ICESCR, ESC (1992), E/C.12/1992/2, at paras 207 and 220.

31 Guidelines on Treaty-Specific Documents to be Submitted by States Parties under Articles 16 and 17 of the ICESCR, ESC (2008), E/C.12/2008/2, at para. 70(b).

32 General Comment No 17, at para. 35.

33 Venice Statement on the Right to Enjoy the Benefits of Scientific Progress and Its Applications (2009) (‘Venice Statement’), at para. 14(a).

34 Ibid, at para. 15(a).

35 General Comment No 25, at para. 52 (11).

36 Ibid, at para. 74.

37 Ibid.

38 Ibid, at para. 81.

39 Oviedo Convention on Human Rights and Biomedicine, art 1(2).

40 Ibid, Preamble, at para. 11.

41 UNESCO, Birth of the Universal Declaration on the Human Genome and Human Rights

(UNESCO, 1999), International Consultation, at 71.

42 Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind, GA Res, 3384 (XXX) (1975), at para. 6.

43 ‘World’s first gene-edited babies created in China’, The Guardian, 26 November 2018: https://www.theguardian.com/science/2018/nov/26/worlds-first-gene-edited-babies-created-in-china-claims-scientist (accessed August 24, 2023).

44 See in general Anne Peters, Heike Kieger and Leonard Kreuzer, ‘Due Diligence: the risky risk management tool in international law’, Cambridge International Law Journal 9, no. 2 (2020):121 and Yotova, ‘The Principles of Due Diligence and Prevention in International Environmental Law’, at 445. See in particular, Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (1989), art 4(2); Epsoo Convention on Environmental Impact Assessment in a Transboundary Context (1991); Convention on the Law of the Non-Navigational Uses of International Watercourses (1997), art 7(1) and 2; and Paris Agreement (2015), art 7(9)(c). See also Responsibilities and Obligations of States with Respect to Activities in the Area, Advisory Opinion, ITLOS Reports 2011, at para. 145; Certain Activities Carried out by Nicaragua in the Border Area (Costa Rica v Nicaragua) and Construction of a Road in Costa Rica along the San Juan River (Costa Rica v Nicaragua), at paras 104, 153 and 168.

45 See e.g., Convention on Preventing and Combating Violence against Women and Domestic Violence (2011), Art 5.

46 General Comment No. 25, supra note 3, at para. 56.

47 Ibid.

48 Ibid, at para. 71.

49 Ibid, at para. 75.

50 Universal Declaration on the Human Genome, supra note 2, art 5.

51 UNESCO Declaration on Bioethics and Human Rights, supra note 2, art. 20 Risk Assessment and Management.

52 Ibid, art. 16 Protecting Future Generations.

53 Ibid, art. 4 Benefit and Harm.

54 Oviedo Convention on Human Rights and Biomedicine, supra note 2, art 16(ii).

55 Ibid, Art 2. See also UNESCO Declaration on Bioethics and Human Rights, supra note 2, art 3(2).

56 Oviedo Convention on Human Rights and Biomedicine, supra note 2, article 12(b).

57 Ibid, art 13.

58 Steering Committee on Bioethics, CDBI/INF, Preparatory Works on the Convention on the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, (Strasbourg, Council of Europe, 2000), at 64.

59 Ibid.

60 Ibid, at 63.

61 Ibid, art. 16 Protecting Future Generations. See also UN Declaration on the Responsibilities of the Present Generations Towards Future Generations (1997), supra note 5, art. 6 Human Genome and Biodiversity and UNESCO Declaration on Science and the Use of Scientific Knowledge (1999), supra note 5, at para. 39.

62 See Rio Declaration on Environment and Development (1992), art 3.

63 According to the UNTS database, 149 international treaties contain a reference to the rights of future generations only one of which links them to human health in the context of managing radioactive waste.

64 See UN GA Res 71/313 (2017) 2030 Agenda For Sustainable Development.

65 See e.g., Joint Convention on the Safety of Spent Fuel Management and on the Safety of Radioactive Waste Management (1997), art 1(ii) and Aarhus Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (1998), art. 1.

66 See e.g, Preamble of the Oviedo Convention supra note 2, requiring that progress in medicine is used for the benefit of future generations.

67 Aarhus Convention on Access to Information, supra note 68.

68 Ibid, art. 1.

69 See Oviedo Convention, Art 28; UNESCO Universal Declaration on Bioethics and Human Rights, Art 18; UNESCO Recommendation on Science and Scientific Researchers, para. 4.

70 UNESCO Declaration on the Responsibilities of the Present Generations Towards Future Generations (1997), supra note 5, art. 6.

71 Universal Declaration on Bioethics and Human Rights, supra note 2, art. 16 and UNESCO Declaration on Science and the Use of Scientific Knowledge, supra note 5, at para. 39.

72 Oviedo Convention, supra note 2, Preamble, at para. 1.

73 UNESCO Declaration on Bioethics and Human Rights, supra note 2, art 2(h).

74 Ibid, art 16.

75 UNESCO Declaration on the Responsibilities of the Present Towards Future Generations, supra note 5, art. 1.

76 Ibid, art 3.

77 UNESCO Declaration on Science and the Use of Scientific Knowledge, supra note 5, Preamble, at para. 1.

78 Ibid, at para. 39.

79 UNESCO Recommendation on Science and Scientific Researchers, supra note 21, at para. 4.

80 UNESCO, Birth of the Universal Declaration, supra note 44, Fourth Meeting of the Legal Commission of the IBC, 27 April 1994, at 54.

81 Ibid, Third Meeting, at 50.

82 Aoife Nolan, ‘The Children are the Future- Or Not? Exploring The Complexities of the Relationship between the Rights of Children and Future Generations’, EJIL:Talk! (2022) https://www.ejiltalk.org/the-children-are-the-future-or-not-exploring-the-complexities-of-the-relationship-between-the-rights-of-children-and-future-generations/#:~:text=Future%20–%20Or%20Not%3F-,Exploring%20The%20Complexities%20of%20the%20Relationship%20between,of%20Children%20and%20Future%20Generations&text=This%20piece%20addresses%20an%20issue,rights%20and%20future%20generations%27%20rights. (accessed August 24, 2023).

83 Sigrun Skogly, ‘The Right to Continuous Improvement of Living Conditions and Human Rights of Future Generations – A Circle Impossible to Square?’ in The Right to the Continuous Improvement of Living Conditions: Responding to Complex Global Challenges, eds. Jessie Hohmann and Beth Goldblatt (Oxford: Hart Publishing, 2021), at 148.

84 Ibid, at 156.

85 See Rumiana Yotova, ‘Regulating Genome Editing under International Human Rights Law’ International and Comparative Law Quarterly, 69 (2020): 653, at 668.

86 Brüggemann and Scheuten v Germany, 12 July 1977, DR 10, 100.

87 Michelle Bachelet, ‘ONE UN Side event: SDG16 and realising the right to participate – empowering people as agents of more effective climate change’, 9 December 2019, https://www.ohchr.org/en/statements/2019/12/25th-session-conference-parties-one-un-side-event-sdg-16-and-realizing-right (accessed August 24, 2023).

88 See e.g., General Comment No 25, supra note 3, at para. 37.

89 Cf International Covenant on Economic, Social and Cultural Rights 993 UNTS 3 (1966), art 15(1)(b) and (c). See also CESCR, General Comment No 17 supra note 3.

90 Hannah Kuchler, ‘Revolutionary CRISPR gene editing speeds from lab to treatment room’, 19 August 2022 Financial Times at: https://www.ft.com/content/e3c12117-190c-4fc9-9988-57eb9ab9de56 (accessed August 24, 2023).

91 Guidelines on Treaty-Specific Documents to be Submitted by States Parties under Articles 16 and 17 of the ICESCR, ESC (2008), E/C.12/2008/2, 15, at para. 70(a).

92 Report of the Special Rapporteur in the field of cultural rights, Farida Shaheed on ‘The Right to Enjoy the Benefits of Scientific Progress and its Applications’ A/HRC/20/26 (2012), at paras 26-30.

93 General Comment No 25, supra note 3, at para. 17.

94 Ibid, at para. 47.

95 Ibid, at para. 49.

96 Ibid, at para. 66.

97 Ibid, citing Venice Statement, supra note 36, at para. 10.

98 Ibid.

99 Ibid.

100 Ibid, at para. 67.

101 Ibid, at para. 80.

102 CESCR, General Comment No. 14: The right to the highest attainable standard of health (2004), E/C.12/2000/4, at para. 12.

103 Ibid.

104 Ibid, at para. 19.

105 UNESCO Declaration on Human Rights and Biomedicine, supra note 2, art 2(f).

106 Ibid, art 15(1).

107 Universal Declaration on the Human Genome and Human Rights, supra note 2, art 12(a).

108 CBDI, Preparatory Works of the Oviedo Convention, supra note 61, at 52.

109 Ibid, at 18.

110 Cf Guidelines on Treaty-Specific Documents to be Submitted by States Parties, supra note 94, at para. 70(a), CESCR General Comment No 14, supra note 105, at para. 12 and Oviedo Convention, supra note 2, art 3, Universal Declaration on the Human Genome, supra note 2, art 12(a) and UNESCO Declaration on Human Rights and Biomedicine, supra note 2, art 2(f).