The Council of Europe’s approach to regulating novel health technologies is a multilayered one, ranging from the fundamental human rights principles included in the ECHR to more technical rules specified in a number of rather technical documents that regulate particular health technologies.233 The more general rules not only appear to have a broader scope of regulation, but also seem to possess a stronger legal status as so-called “hard law” (as opposed to “soft law” comprising the recommendations and guidelines that complement mandatory legislation and often guide governance of health technologies at a more practical level).234 However, the fundamental rights incorporated in the ECHR seem simultaneously to regulate novel health technologies indirectly, whereas the soft law constituting of recommendations and comparable soft law instruments more directly and practically regulates development and use of such technologies.235 The Biomedicine Convention and its Additional Protocols seem to be positioned somewhere in between the fundamental human rights specified in the ECHR and technology-specific soft law instruments. Since the adoption of the Biomedicine Convention in 1997 and its later protocols on Cloning (1998), Transplantation (2002), Biomedical Research (2005) and Genetic Testing for Health Purposes (2008), the Council of Europe has been actively involved in developing a normative framework for human rights in biomedicine, which has evolved from the ECHR (1950).236 The Biomedicine Convention addresses developments in modern biotechnology and
233 See e.g. O’Connell, R., Gevers, S. “Fixed points in a Changing Age” in Flear, M., Farrell, A-M., Hervey, T.A. and Murphy, T. (eds.), European Law and New Health Technologies. (Oxford: Oxford University Press), 2013, 46-69.
234 Op. cit., 52-55, 69.
235 Op. cit., 69.
236 See e.g. Ashcroft, supra note 21, 310, 321-322.
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medicine by complementing the ECHR in biomedicine and genetic science and by establishing European standards in this field.237 Whilst protection of human rights constitutes a core objective for the Biomedicine Convention, its scope is not restricted to that. The Biomedicine Convention not only contains provisions that are relevant for everyday health care, but some of its provisions are also applicable to very technical procedures and medical research.238
In addition, the Council of Europe’s regulatory framework governing novel health technologies seems quite flexible and variable.239 This depends partly on the intergovernmental character of its regulatory instruments such as the Biomedicine Convention, and the margin of appreciation doctrine applied by the ECtHR. Hence the ECtHR makes a dynamic interpretation in light of “present day’s circumstances or conditions”. 240 According to the ECtHR’s view, the ECHR is not designed to guarantee theoretical rights, but effective and practical rights. In Henriette Roscam Abbing’s view, human rights instruments are “living instruments” and the codification of fundamental values in human rights does not remove the philosophical and moral concept of the norm, as the norm “floats” in the sphere of those concepts and remains a stimulant for innovative jurisprudence and fresh regulation. O’Connell et al. by contrast have pointed out that the flexibility of the system also seems qualified, as the margin of appreciation granted to the contracting states may vary over time241 and there is a possibility that the ECtHR may find specific factors that justify closer scrutiny.242 This flexibility has been deemed to be disguised as the margin of appreciation and that doctrine has been criticised every now and then as spineless and perceived merely as a pragmatic substitute for a thought-out process.243 This is kind of criticism is quite understandable as novel health technologies such as translational hESC research and cell reprogramming research in particular raise a number of ethical issues and disagreement. While the Council of Europe’s human rights framework is not infinitely
237 Please refer to paragraphs 8-20 and 165 of the Explanatory Report to the Biomedicine Convention.
238 O’Connell, et al., supra note 233, 50. See also Dute, J. “The Leading Principles of the Convention on Human Rights and Biomedicine” in Gevers, S., Hondius, E. and Hubben, J.H. (eds.), Health Law, Human Rights and the Biomedicine Convention (Leiden: Martinus Nijhoff), 2005.
239 O’Connell, et al., supra note 233, 53-57.
240 Roscam Abbing, supra note 128, 20.
241 Goodwin v. United Kingdom, (Application no. 28957/95), 11 July 2002.
242 Dickson v. United Kingdom, (Application no. 44362/04), 4 December 2007.
243 See Evans v. the United Kingdom ([GC], no. 6339/05, ECHR 2007-I) that concerned the fate of frozen human embryos. According to the joint dissenting opinion of Judges Türmen, Tsatsa Nikolovska, Spielmann and Ziemele, “[a] sensitive case like this cannot be decided on a simplistic, mechanical basis, namely, that there is no consensus in Europe, therefore the Government have a wide margin of appreciation; the legislation falls within the margin of appreciation … that margin of appreciation should not prevent the Court from exercising its control, in particular in relation to the question whether a fair balance between all competing interests has been struck at the domestic level. The Court should not use the margin of appreciation principle as a merely pragmatic substitute for a thought-out approach to the problem of proper scope of review”. More recently, according to the Concurring Opinion of Judge Pinto de Albuquerque in Parrillo v. Italy (App. no. 46470/11), an identical remark could be made in Parrillo. See also O’Connell, et al. supra note 233, 69. See also Murphy T. Repetition, Revolution and Resonance: An Introduction to New Technologies and Human Rights. (Oxford: Oxford University Press), 2009; 1-18.
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plastic, it does appear to play two important roles.244 According to O’Connell et al., the first is defining and safeguarding a minimum level of respect for human rights (the autonomy type of rights in particular, including the requirement of free and informed consent,245 the right to respect for private life,246 as well as the right to health,247 and equality and non-discrimination).248 Its second important role is to specify what interests must be considered, balanced and promoted in any applicable national legislative context.
Furthermore, it should be noted that the Biomedicine Convention and the ECHR have adopted different approaches to notions of human dignity. Whilst both of these regulatory instruments rely on notions of dignity, this reliance is explicit in the case of the Biomedicine Convention and associated with the ethical idea of dignity as a restriction on certain kinds of action.249 This difference notwithstanding, potential conflicts may be largely avoided by the intergovernmental character of the Biomedicine Convention and the margin of appreciation doctrine applied by the ECtHR (as well as the victim standing requirement of the ECHR).250 However, this does not imply a European consensus on human dignity. Furthermore, in light of the ECtHR’s recent ruling in Parrillo v. Italy (App. no. 46470/11) there appears to be a disagreement regarding the appropriate scope of the margin of appreciation doctrine as applied to the status of donations surplus IVF embryos to medical research.
The Council of Europe’s approach to regulating novel health technologies allows significant flexibility for the contracting states (subject to safeguarding human rights) in regulating health technologies at a national level. The ECtHR jurisprudence and the Biomedicine Convention, however, have both stimulated the need for informed public debate on these bioethical questions in a democratic society.251 Despite the Council of Europe’s position on regulating novel heath technologies being multilayered, variable and flexible, the human rights framework still appears to provide some reference points that can guide our interpretation of the scope and extent of human rights in the course of rapid developments in stem cell science and therapeutic opportunities in the age of translational, personalised medicine. Some of these reference points seem more obvious than others. For instance, the notion of human dignity is very often referred to in the context of hESC research as a limitation on certain types of actions. However, there is
244 O’Connell, et al., supra note 233, 69.
245 Glass v. United Kingdom (App. no. 61827/00), 9 March 2004. VC v. Slovakia (App. no. 18968/07), 8 November 2011.
246 S. and Marper v. United Kingdom (App. nos. 30562/04 and 30566/04), 4 December 2008.
247 Oyal v. Turkey (app. no. 4864/05), 23 March 2010.
248 O’Connell, et al., supra note 233, 69.
249 In the context of hESC research, Article 18.1 of the Biomedicine Convention emphasises the need to protect embryos in research settings by stating that “[w]here the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.” Article 18.2 of the Biomedicine Convention however bans creation of embryos for research purposes by stipulating that “[t]he creation of human embryos for research purposes is prohibited.”
250 O’Connell, et al., supra note 233, 69.
251 Ibid.
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no definitive consensus on the exact scope and extent of the use of human dignity as a constraint. As will be discussed in Chapter 5 of this study, some commentators have even argued that this concept risks becoming too amorphous to be useful.