Disagreement about dignity is not limited to questions regarding its relationship with human rights. There is no definitive consensus about what dignity means. Furthermore, the controversy surrounding the legal status of embryos relates to another problematic aspect of dignity: there is no agreement on who is entitled to dignity – this could be the human individual, or the human species. Dignity might also apply to biological entities that are not autonomous humans.309 Depending on the perception of dignity, one may talk about the dignity of the severely incapacitated, embryos, cadavers, etc. The Biomedicine Convention and its Protocols constitute the most important convention in the EEA regulating the field of biomedicine. The Convention sets out the minimum level of protection in medical and biological applications, but it does not prevent the Member States from providing a broader scope of protection.310 The Biomedicine Convention draws attention to some of these tensions and extends the human dignity to
309 O’Connell, et al., supra note 233, 64.
310 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Article 27: “None of the provisions of this Convention shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention.”
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potential humans such as embryos as members of human species by highlighting the collective and individual notion of dignity.
The prevailing moral perceptions of the notion of “human dignity” have evolved in course of the novel scientific advancements and opportunities that have also simultaneously posed new challenges to the perception of different forms of life.
Human dignity is perceived as a universal, inalienable source of human rights in international human rights instruments. The UNESCO’s Universal Declaration of the Human Genome and Human Rights (1997) with related instruments, the Biomedicine Convention and the Charter of Fundamental Rights included in the Constitution for Europe, all rely on the primacy of human dignity over the interests of scientific research and technological innovation.311 Article 2 of the Biomedicine Convention states that:
“The interests and welfare of the human being shall prevail over the sole interest of society or science.” In addition, when it comes to the dignity and protection of clinical trial subjects, Recital 1 of the Clinical Trials Regulation requires that:
[i]n a clinical trial the rights, safety, dignity and well-being of subjects should be protected and the data generated should be reliable and robust. The interests of the subjects should always take priority over all other interests.312
Also Recital 8 of the ATMP Regulation refers to respect of fundamental rights and observation of the principles reflected in the Charter of Fundamental Rights of the EU and the Biomedicine Convention. Yet, no more specific references are made to human dignity in the ATMP Regulation. Whilst the parent directive of EUCTDs (Directive 2004/23/EC) refers to the Charter and the Biomedicine Convention in its Recital 22 and to dignity in its Recital 16 that requiring that dignity of a deceased donor must be respected.
Like the Biomedicine Convention, the Charter of Fundamental Rights of the EU represents an update of human rights in the light of changes in society and scientific and technological developments.313 However, it should be noted that none of these legal instruments has provided an exact definition of the term human dignity. The text of the ECHR, unlike the Biomedicine Convention, does not explicitly mention the term dignity. Only Protocol 13 has a preambular reference to this notion. Despite this, ECtHR has increasingly incorporated dignity as a value in its judgments and individual opinions over recent decades.314 As for dignity in the Biomedicine Convention, Article 1 of the Biomedicine Convention states that:
“[p]arties to this Convention shall protect dignity and identity of all human beings and guarantee everyone, without discrimination, respect to their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.”
311 Agovic, supra note 54, 263-266.
312 Furthermore, Recital 27 requires that “[h]uman dignity and the right to the integrity of the person are recognised in the Charter of Fundamental Rights of the European Union (the ‘Charter’). In particular, the Charter requires that any intervention in the field of biology and medicine cannot be performed without free and informed consent of the person concerned”.
313 Roscam Abbing, supra note 128, 20-21.
314 O’Connell, et al., supra note 233, 66.
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Interestingly, origins of this article can be found in Kantian and Stoic philosophies, as well as in the French revolution, which promoted and popularised the idea of human dignity.315 Furthermore, the preamble to the Biomedicine Convention emphasises the need to prevent misuse in biotechnology which may result in acts that endanger human dignity, and requires the Member States to “[t]ake such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to application of biology and medicine.” Furthermore, the explanatory report to the Biomedicine Convention perceives the concept of human dignity as an essential value to be upheld.316 According to Raimo Lahti, the partial importance of the Biomedicine Convention and its Protocols is that they provide even more detailed priority and assessment norms for conflicting constitutional and human rights principles.317 While the United Nation’s previous human rights instruments ascribe the right to human dignity to living persons, the Biomedicine Convention appears to extend human dignity to potential humans such as embryos as members of the human species.318 According to the Explanatory report to the Biomedicine Convention, the initial intention of the drafters was to extend the protection of human dignity to cover risks related to genetic research and its applications not only to living human individuals, but society and the human species itself. It is stated in the Explanatory report to the Biomedicine Convention that “[i]t is not the individual or society that may be at risk but the human species itself.”
One might also ponder whether the Biomedicine Convention represents an explicit step in pronouncing a common European consensus on human dignity. However, very irregular ratification of the Biomedicine Convention makes it very difficult to demonstrate that it represents such a view.319 Even if it is very hard to argue that the Biomedicine Convention expresses a pan-European consensus on human dignity, the dignity orientation still seems very strong in the Biomedicine Convention.320 The invocation of human dignity as a restriction in the Biomedicine Convention has also provoked some significant criticism. Among others, Susan Millns perceives the reliance on dignity as “remarkable” and “fuzzy”,321 whereas Gilbert Hottois has argued that the Biomedicine Convention contains “techno-scientophobic” suggestions and enshrines value judgments that are not universally accepted.322
315 Agovic, supra note 54, 265.
316 Council of Europe, Biomedicine and human rights: the Oviedo Convention and its additional protocols. Council of Europe Publishing, 2009, 23.
317 Lahti, supra note 261.
318 Agovic, supra note 54, 265.
319 By September 2015, only 29 of 47 Council of Europe contracting states had ratified the Biomedicine Convention.
320 O’Connell, et al., supra note 233, 66.
321 Millns, S. “Consolidating Bio-rights in Europe” in Francioni, F (ed.) Biotechnologies and International Human Rights. (Oxford and Portland: Hart Publising), 2007.
322 Hottois, G. A Philosophical and Critical Analysis of the European Convention of Bioethics. J Medicine and Philosophy 2000; 2:133-146. See also O’Connell, et al., supra note 233, 66.
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Despite the criticism surrounding the notion of dignity as a constraint as stipulated in the Biomedicine Convention, it has still influenced the national laws of the Member States regulating embryo research. For instance, Raimo Lahti has claimed that the special emphasis on the human rights stipulated in Article 1 of the Biomedicine Convention in which “protection of humans” is paralleled with “protection of human beings” indicates some type of change in the existing priority rankings in the prevailing ideas of constitutional and human right norms in Finland. More specifically, the emphasis on protection of human beings seems to represent some change in the protected values as, according to Lahti, it may be understood as “a reason for increased legal protection of the human embryo”.323 To illustrate this, the threat of imprisonment for violations against fetuses, embryos and the human genome was incorporated into the Finnish Penal Code.324 Furthermore, it has also been important to investigate how the use of SCNT techniques should be regulated subsequent to the ratification of the Biomedicine Convention. As a starting-point, Article 18.1 of the Biomedicine Convention emphasises the need to protect embryos in research settings by stating that
“Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo,” whereas Article 18.2 of the Biomedicine Convention bans creation of embryos for research purposes.
In his Concurring Opinion in the ECtHR’s Parillo v. Italy case, Judge Pinto de Albuquerque points out that this provision affirms the application of the subsidiarity principle by establishing that the primary legal parameter to consider is the domestic law of the contracting state in question.325 According to his interpretation of the provision, paragraph 18.1 establishes a mandatory legal status “that must be secured to the embryo, which must benefit from “adequate protection”. Therefore, he argues that
“the use of embryos for scientific purposes must not be assessed on a casuistic basis, but subjected to a principled evaluation of the “adequateness” of the protection provided to the embryo, according to the European legal parameter.” 326
As the Biomedicine Convention complements the ECHR in the field of biomedicine and genetic science, Judge Pinto de Albuquerque has noted that two consequences follow from this. First, the ECtHR is the ultimate interpreter and guarantor of the rights, freedoms and obligations set out in the Biomedicine Convention (Article 29 of the Biomedicine Convention) and consequently, the “adequateness” of the protection provided to the embryo, especially regarding genetic engineering techniques contrary to
323 Lahti, supra note 261.
324 Proposition HE 156/2008 vp. with respect to amendments in the Penal Code (19.12.1889/39) regarding Chapter 22 violation of a foetus, embryos and the human genome.
325Concurring Opinion of Judge Pinto de Albuquerque in Parrillo v. Italy (App. no. 46470/11), 27 August 2015, at para 24.
326 Op.cit.
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human dignity.327 Second, Judge Pinto de Albuquerque’s view is that the ratification of the Biomedicine Convention and its Protocols by a large number of contracting states is a strong indication that a growing European consensus has been built around its provisions. However, it appears quite difficult to agree with his latter perspective as, since the adaption of the Biomedicine Convention in 1999, only 29 of the 47 Council of Europe member states (that are party to the ECHR) have ratified it thus far. 328 In particular, there is no consensus regarding Article 18.2 of the Biomedicine Convention.
This problematic provision has resulted in divergent ratification approaches among the Council of Europe’s Member States. When it comes to the impact of Article 18.2 on national regulations, in Finland, for instance, therapeutic cloning is allowed, but Finland has not established a reservation as stipulated in the Article.329 Accordingly, only reproductive cloning is prohibited in Finland. Hence, the Finnish legislation has not been clarified in that respect. In contrast, Sweden deemed it necessary to make a reservation in Article 18.2 upon the ratification of the Biomedicine Convention to allow for therapeutic cloning. It was made permissible by an amendment in law on 1 April 2005, in which legislation was amended to cover research on ova and the results of somatic cell nuclear transfer.330 Semantically, the notion of “human being” seems to be broader than the concept of “human”; hence, it may cover earlier stages of a human life in which the human being is not an independent legal entity, i.e., an individual, in addition to the type of “human” that is a legal subject. If a live-born individual human can be seen as a legal subject, it is still unclear that when an embryo may possess so much human dignity than it can be considered as a human being on which that dignity also may confer rights.
Human dignity is also very frequently mentioned as a criterion for evaluating the legal status of the human embryo in some of the EU Member States’ legislations. For instance, many European countries (such as France, Germany, the Netherlands, Spain, Italy, Austria and Ireland) refer to human dignity in their legislative texts, albeit with different connotations.331 Among others, Portugal and Spain set out to safeguard human dignity in the context of biomedical research and some IVF practices.332 Likewise, the notion of human dignity appears in Estonian, Finnish, Swedish, and Swiss embryo research policies that prohibit abusing or damaging the embryo with the purpose of safeguarding its dignity.333 Furthermore, the EGE has found the principle of respect for
327 He further points out that the above-mentioned problem of the distinction between “therapeutic”
techniques and techniques aiming at the “enhancement of normal characteristics” is not always apparent only increases the need for careful oversight by the ECtHR.
328 The Convention (ETS no. 164) was adopted on 4 April 1997 in Oviedo, Spain, and entered into force on 1 December 1999.
329 Proposition p. HE 27/II.
330 Walin, supra note 96, 11-13. See also Lahti, supra note 97, 257.
331 See e.g., Knoppers, et al., supra note 34, 36-43.
332 Spanish Law No 14/2007 on Biomedical Research, 2 July 2007; Portuguese Law No 32/2006 on Medically Assisted Reproduction, 26 July 2006.
333 Estonia, Embryo Protection and Artificial Fertilisation Act (1997); Finland, Medical Research Act, no.
488/1999 (1999); Sweden, Act 1991:115 on Measures for Purposes of Research and Treatment Involving
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human dignity to be a fundamental ethical principle governing stem cell research.334 A similar position has been adopted in the EU’s Sixth and Seventh Framework Programmes, in which research projects (including stem cell research) must be conducted in compliance with fundamental ethical principles, including the protection of human dignity. It is also noteworthy that the European Commission has maintained its position not to finance research projects that involve destruction of embryos under the Seventh Framework Programme and Horizon 2020.335
Despite the notion of protection of human dignity often being mentioned in the national laws governing biomedical research in the EU Member States, statements by the EGE336 and EU research funding policies, these political and legal instruments fail to specify how exactly the concept of human dignity should be understood or applied in the hESC research context. Furthermore, the ECtHR has not been able provide a uniform European interpretation of how respect for human dignity translates into respect for embryonic life. Instead, the ECtHR has acknowledged the great diversity of national legal and moral norms and perceptions regarding protection of human embryos and human dignity. It has shifted the final decision-making power to them by granting a wide margin of appreciation to its contracting states in important value-choice questions.