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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.
Disclosure statement
No potential conflict of interest was reported by the author(s).
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).
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.