The interplay between medical and biolaw and bioethics presents methodological challenges for this study. First of all, there are limits to legal regulation. Lahti has argued that shortcomings will follow if we involve legal regulation in the fulfilment of contentious moral principles.111 Doing so would risk objectives set by law not being attained. Secondly, in such circumstances morality cannot retain its function of being critical of law and legal practice. Hence, Lahti emphasises the need for the legislator in a pluralistic society to limit himself to setting borderline conditions that are as flexible as possible and within which individuals and groups of individuals can exercise their
107 See e.g. Fuchs, M. “Translational Stem Cell Research in Pediatrics” in Hug, K., Hermerén, G. (eds.) Translational Stem Cell Research. (New York, Dordrecht, Heidelberg, London: Springer), 2011, 137-174.
108 Walin, supra note 96, 109.
109 Hartlev, supra note 93, 51.
110 Gevers, supra note 93, 261-272.
111 Lahti, R. “Life Beginnings: Law and Moral Dilemmas” in The Finnish Yearbook of International Law, (Helsinki: Ius Gentium Association), 1991(2), 438-468.
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moral autonomy.112 Especially when it comes to the subjects of legal regulation where no universal consensus exists, such as the legal status of a human embryo, there is an increased need for legislators to consider the ethical discourse and plurality of values embedded in the society underpinning the legal question.
More generally, laws have been perceived as particular concepts, whereas ethics have been seen as an abstract phenomenon. 113 Whilst ethics pursue idealistic ends such as respect for human dignity or the well-being of an individual or the society at large, the pursuit of social stability and predictability constitutes idealistic legal endeavour.114 Previous studies in medical and biolaw have adopted different approaches to the relation between law and ethics. A fundamental methodological question is whether law can be seen as a reflection of morality or whether it can be separated from morality.115 Traditionally, the approaches to the relationship between law and ethics have ranged from the total emancipation of law from morality (legal positivism) to pursuing the closest possible synchronisation of both normative structures. Among others, Laura Walin adopted a legal positivistic approach that separates biolaw from bioethics in her doctoral dissertation.116 In Walin’s approach, biolaw is perceived as being based on the rules of logic and reason. Walin has in light of Kaarlo Tuori’s Critical Legal Positivism also argued that medical and biolaw may be regarded as a stratified phenomenon whose core identity of that discipline cannot be jeopardised rapid and necessary but superficial changes.117 In contrast, Riitta Burrell adopted a more naturalistic approach in her doctoral dissertation in which biolaw was seen to stem from bioethics.118 Her approach resembles that of the school of natural law, which finds that since the law necessarily illustrates the morality of society, it cannot be based simply on reason and logic.119
A point of departure is that bioethics precedes law and is finally becoming a part of law in the form of dynamic and elastic human rights principles. Ethical considerations may also form so-called soft law or influence the wording of “hard law” as well as the interpretations of legal provisions. For this study, “soft law” means quasi-legal instruments with no formally or legally binding effect, or whose binding force is weaker than the binding effect of traditional “hard law". Roberto Andormo has pointed out that soft law instruments are vital role to the development of universal norms in bioethics.
His view is that such instruments should not be underestimated since they do not constitute binding legislation as such, because soft law may operate indirectly by means
112 Op. cit., 445, 466-468.
113 Hellstadius, supra note 50, 41.
114 See e.g., Petit, E., “An Ethics Committee for Patent Offices?” in Plomer, A., Torremans, P. (eds.), Embryonic Stem Cell Patents, European Law and Ethics, (Oxford: Oxford University Press), 2009, 305-322.
115 Hellstadius, supra note 50, 87.
116 Walin, supra note 96, 107.
117 Walin, ibid.. See Tuori, K. Critical Legal Positivism. (Dartmouth: Ashgate), 2002.
118 Burrell, supra note 96, 35-36.
119 See e.g. Pufendorft, S. “De Jure Naturae et Gentium” (Libri octo) 1672 in Böhling, F, (ed.), Gesamelte Werke Vol 4 (Berlin), 1998.
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of persuasion instead of coercion. In the long term, soft law may become a binding norm, either by resulting in a treaty or by being recognised as customary law.120
Bioethics, being the ethics of biomedical research, addresses the challenges posed by modern health technologies. From the perspective of the legislator, regulating novel health technologies is especially challenging, as such technology merges multiple disciplines ranging from medicine and bioethics to biotechnology. Bioethics analyses a range of ethical issues arising in connection with medical practice as a result of the advances in biomedical sciences and technologies.121 The early origins of bioethics date back to antiquity, where bios relates to the earthly life and its requirements, a cycle of which humanity is inevitably part.122 However, the emergence of modern bioethics stems from the Nuremberg trials in which medical researchers were found guilty of
“crimes against humanity”.123 Bioethics have since been formalised and codified in the form of a number human rights instruments in biomedical research (e.g., the Biomedicine Convention and the World Medical Association Helsinki Declaration on Ethical Principles for Medical Research Involving Human Subjects). Lahti has concluded that “bioethics has become the established umbrella term covering the ethical dimensions of medical treatment and care, healthcare, biological and medical research, and of environmental issues.”124 In the course of advancements in biotechnology, a range of related proprietary issues has also arisen, such as those concerning commercialising material of human origin. These discussions often inevitably touch upon fundamental issues such as the scope of the concept of human dignity and the question of whether the concept of property is applicable to human embryos or other biological materials of embryonic origin such as hESCs.
Ethical philosophy aims at universally applicable content and transcendent viewpoints, whereas the nature of the legal system is concrete and specific.125 This causes an unavoidable dilemma since the main ethical principles involved in bioethics are not universally recognised or subject to universal consent. It appears that in the age of modern biomedicine, human dignity as a universal right provides national legislators with a wide margin of appreciation in some important value-choice questions, whereas some codified ethical principles remain just principles and their impact on law and the decision-making process is treated by institutional means such as ethics committees
120Andormo, R. The Invaluable Role of Soft Law in the Development of Universal Norms in Bioethics, paper at a Workshop jointly organised by the German Ministry of Foreign Affairs and the German UNESCO Commission, Berlin, 15 February 2007. Available at: http://www.unesco.de/1507.htm.
Accessed 21 June 2016.
121 See e.g. Plomer, A. The Law and Ethics of Medical Research: International Bioethics and Human Rights. (London: Cavendish Publishing), 2005.
122 See e.g., Kemp, P., Lebech, M., Rendtorff, J. Den bioetiske vendning, En grundbog i bioetik.
(Copenhagen: Spektrum/Forum Publishers) 1997.
123 Yale Law School. The Avalon Project. The International Military Tribunal for Germany. Contents of The Nuremberg Trials Collection. Available at: http://avalon.law.yale.edu/subject_menus/imt.asp.
Accessed 18 August 2016. See also Hellstadius, supra note 50, 89 that refers to Nuremberg trials’ role in context of emergence of modern bioethics. See also e.g., Kemp, et al. supra note 122.
124 Lahti, supra note 97, 250.
125 Hellstadius, supra note 50, 87.
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supervising research governance.126 In addition, national competent authorities and agencies tend to interpret general and imprecise legislation based on case-by-case examination, international declarations without legal status, and codes of conduct by professional organisations beyond the law. Hence, the use of the soft law instrument can be significant as it influences the legislation and the decision-making processes in parliaments.127 For instance in case of ATMPs, the GMP Guidelines are not as such legally binding. Yet, in practise they will get a binding effect when GMP compliance is required by the authorities as a condition for a clinical trial authorisation or a marketing authorisation.
Beyond the legal philosophical discussions, when the relation between bioethics and medical and biolaw is analysed at a more practical level, it appears that this relation differs from country to country in the EU (e.g., Member States have adopted very different approaches to bioethical and legal aspects of the governance of hESC research). Ethical values and human rights are dynamic.128 Despite medical and biolaw being an area where law and bioethics overlap significantly, not everything can or should be regulated by law. Yet, the overlapping area between bioethics and medical and biolaw should not be too small, according to Göran Hermerén.129 This relation has been initially described by Rainer Moufang as two intersecting circles, which only leaves out the overlapping area of legal rules of a morally neutral, purely technical nature.130
Interestingly, the ATMP Regulation can be seen as a rather technical piece of legislation. It has been described being “ethically neutral”.131 However, as described in Section 6.2 some significant ethical considerations regarding the use of materials of human origin were raised in course of its drafting process. Currently, the human rights perspective appears from its Recital 8 stating that as a starting point the ATMP Regulation respect the fundamental rights and observes the principles reflected in the Charter of Fundamental Rights of the EU and also takes into account Biomedicine Convention. The approach adopted in the ATMP Regulation allows for some significant flexibility and a wide margin of appreciation in ethical issues. For example, in Recital 7 it is stated the ATMP Regulation does not interfere with the decisions by Member States (for instance, positions adopted by ethical committees of Member
126 Hellstadius op. cit., 93.
127 Hellstadius, op.cit., 87.
128 Hermerén, G. “European Values, Ethics and Law”, Jahrbuch für Wissenschaft und Ethik, (Berlin, New York: Band 11), 2006, 5-40. See also Roscam Abbing, H. “Health and human rights in the European context” in (eds.) Rynning, E. and Hartlev, M. Nordic Health Law in a European Context – Welfare State Perspectives on Patients’ Rights and Biomedicine. (Leiden: Martinus Nijhoff Publishers), 2011; 17-30.
129 Hermerén, op. cit., 5-40.
130 Moufang, R. “Patenting of Human Genes, Cells and Parts of the Body? – The Ethical Dimensions of Patent Law”, IIC.1994; 4(25):487-515. See also Hellstadius, supra note 50, 89.
131 Favale, M., Plomer, A. Fundamental Disjunctions in the EU Legal Order on Human Tissue, Cells and Advanced Regenerative Therapies. Maastricht Journal on European and Comparative Law 2009;(1):89-111. (See especially pp. 103,109).
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States) on wheter to allow the use of any specific type of human cells, such as those of human embryonic origin. Hence, the ATMP Regulation does not seek to affect the application of national legislation prohibiting or restricting the sale, supply or use of medicinal products containing, consisting of or derived from these cells. Yet, it seeks to facilitate market access of any types of ATMPs, including hESC based products providing that sale, supply or use of such products is not prohibited by national laws of a particular Member State.