The problem-based legisprudential approach

Many doctoral dissertations in medical and biolaw have adopted a pragmatic, problem-based approach as their main research methodology.¹⁴⁶ In the problem-based approach, research questions stem from real-life situations, the objective being to systematically analyse legal rules and regulations that influence real-life situations. The research question in the more traditional legal dogmatic (and jurisprudential) approach stems

144 Bache, et al., supra note 41, 7-45.

145 Brownsword, R. “So what Does the World Need Now? Reflections on Regulating Technologies” in Brownsword, R. and Yeung, K. (eds.), Regulating Technologies: Legal Futures, Regulatory Frames and Technological Fixes. (Oxford and Portland: Hart Publishing), 2008.

146 See, e.g., Walin, supra note 96.

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from the legal system or more specifically from a legal discipline. The point of departure for the latter is the legal rule as such, whilst the problem-based approach deals with the prevailing political and/or sociocultural reality.¹⁴⁷ In contrast to the traditional legal dogmatic approach, research in the problem-based approach typically overlaps various legal disciplines. Medical and biolaw research is also typically interdisciplinary in nature, which may result in the use of unconventional reference material, such as sources of a medical or ethical nature. The more traditional legal dogmatic approach may often confine research more strictly within a particular legal discipline, which may (if successful) foster very profound legal analysis of a specific legal rule.¹⁴⁸ The problem-based approach has sometimes been criticised for generating less profound analysis. It is evident that when the research question is dispersed around different legal disciplines it may be very hard to conduct very profound analysis within one discipline and some compromises must be made. Yet the merits of this approach are elsewhere in that the problem-based approach contributes to resolving practical legal issues that arise in real-life situations. It may also serve to reveal incoherence between different legal regimes, such as the pharmaceutical regulatory system and the patent system.

As this study constitutes a regulatory review of the challenges of the ATMP Regulation from the perspective of the actual developers of ATMPs, a problem-based, legisprudential approach is used as the primary methodology. Yet, it is complemented in by the legal dogmatic one. In systematising the legal references, guidance has been sought from the legal dogmatic approach with certain reservations regarding the use of some untypical reference material as indicated in Section 3.4.4 of the study.

The study is largely concerned with the legislators’ (and stakeholders’) role in the law-making process, in contrast to the traditional jurisprudential approach in which these questions are considered from the perspective of the judge. The legisprudential approach argues that practical reason in legislation comes into practice throughout the process of law-making.¹⁴⁹ In this context, a range of questions and problems is investigated, including the validity and legitimacy of human rights norms and principles, their meaning, the structure of the legal framework of the European medical and biolaw, and so on. As in the legisprudential approach, attention is shifted from the judge to the legislator, the following questions arising: in what sense must the legislator take the systematicity of the legal order into consideration? What counts as a valid norm? For instance, does human dignity count as a valid norm? Legisprudence also builds upon the contextual interpretation of rationality, subject, and freedom in order to focus on practical reason in legislation. The legisprudential model relies on the idea of a

‘social contract’ in which the subjects trade off conceptions of freedom for conceptions

147 See, e.g., Kangas, U. “Minun metodini” in Häyhä, J. (ed.). Minun metodini. (Porvoo:Werner Söderström Lakitieto Oy), 1997: 90-109.

148 Walin, supra note 96, 24.

149 Wintgens, L. Legisprudence: Practical Reason in Legislation. (Farnham, Surrey: Ashgate), 2012.

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about freedom.¹⁵⁰ In this model, this trade-off must be justified by the norm-giver. No rule can be considered legitimate if this justification or legitimation is lacking. Freedom as a principle constitutes the basis for principles of rational legislation that can finally be realised in the duties of the legislator. ¹⁵¹ Luc Wintgens has categorised the principles of legisprudence as follows:

1. The principle of coherence requiring that those norms make sense as a whole;

2. The principle of alternativity assuming that social subjects are initially free and capable of rationally organising their freedom in a context with others. Hence they are primarily to act on conceptions of freedom. According to Wintgens, the replacement of a conception about freedom for conceptions of freedom can only be legitimate if it is legitimated or justified as an alternative for failing social interaction;

3. The principle of temporality requiring that limitation of freedom on a conception about freedom must be justified as “on time”. According to Wintgens, any justification is embedded in a context, because rationality as reasonableness is context related, and therefore historically situated. Hence, if the justification of a norm is successful it will only be temporarily so, as norms can become obsolete. Wintgens thus argues that principle of temporality then requires an ongoing justification over time, and not simply at the moment that a norm is issued; and 4. The principle of the necessity of normative density, in accordance with which rules should not

automatically contain sanctions as the strongest from of normative density. Wintgens’s view is that if sanctions are included, this requires a specific and supplementary justification of why weaker alternatives (information campaign, incentives, labelling, covenants and so on) are not used.¹⁵²

This legisprudential approach to the rationality of legislation provides an interesting alternative perspective on the problematic exponential increase in legal systems and the decreasing quality of legislation in most European democracies. It has been argued by Wintgens that

“upon the requisite that a norm-giver considers more seriously his way of creating norms and the requirement to show how he did by justifying his norms legisprudence has the potential to contribute to an improvement of the quality of legislation.”¹⁵³

According to Wintgens, such an improvement of the quality of legislation as the main purpose of legisprudence may be expected to result in a decrease in legislative norms, since better norms need less correction, adaptation and change. Legisprudence also

150 In Wintgens’ view social contract theorists Hobbes and Rousseau fail the promise of modernity by reviving pre-modern attempts to portray law as a representation of the natural order, rather than as a creation of human will. Wintgens, L. “Legitimacy and Legitimation from the Legisprudential Perspective”

in (eds.) Wintgens, L., Thion, P. Legislation in Context: Essays in Legisprudence. (Farnham, Surrey:

Ashgate),2007), 10.

151 Vlad Perju has pointed out that in Wingens’ model there is an inherent difficulty in distinguishing between will and reasoning about will. Its central difficulty is how far reflection on pure will qua will can take us, according to Perju. In his view “[r]eliance on pure will may just be, as social theory has discovered since the nineteenth century, a form of surrender to the normatively blind social processes that shape that will.” Perju, V. A comment on “legisprudence”. BUL Rev. 2009;(89):427.

152 Wintgens, supra note 149, 231-282.

153 Op. cit., 6.

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allows for stepping away from paternalistic criminalisations, as it significantly relies on non-coercive, flexible, self-regulatory measures that can adjust smoothly to varying conditions over time and place. Yet, it has been argued Vlad Perju that despite Wintgens’s inviting approach to judicial review opens interesting avenues for legisprudence, “it would be unfortunate for scholars to turn a blind eye on the work of courts now that legislation begins to receive the attention it deserves”. By contrast, Perju finds that “[a]s such articulating principles of legislation for use within the proportionality framework is an area where legisprudence can make an important contribution.”¹⁵⁴ In this study, Wintgens approach will be applied when assessing proportionality of limitiations imposed to freedom of science.

As described in Chapter 4 of this study, the current European regulatory framework for novel health technologies is legally fragmentary, multilayered and lacking internal coherence. Consequently, the complexity of the regulatory framework risks constitute significant impediments for the market entry of ATMPs, and there is an obvious need for the European legislator to get involved in novel and innovative legislative approaches to create facilitating, proactive and more flexible legislative solutions in collaboration with all stakeholders. This brings us to another important aspect;

stakeholder participation influencing legislative processes. It appears that various stakeholders participate today because of their failure to influence the legislative process on the content of the existing regulatory framework.¹⁵⁵ The opportunity to participate in the legislative process by expressing values is an essential characteristic of a democratic society. As described by Shawn Harmon, stakeholder participation may take place either upstream or downstream. Upstream participation may influence priority settings such as research funding policies and hence indirectly influence the commercialisation prospects of ATMPs, whereas downstream participation may involve measures once the regulatory framework exists, such as biotechnology patent invalidation proceedings.

As an information tool, the impact assessment (IA) has a significant role in how law and policy are being developed and decided in the EU. ¹⁵⁶ Sections 6.1 and 6.2 of this study analyse the impact of various stakeholders affecting the scope and content of the EUCTDs and the ATMP Regulation, as well as emphasising the legislators’ duty to collaborate with different interest groups to create a balanced normative framework in this field. Stakeholders being involved in the legislative process involves interest groups ranging from the industry representatives (both SMEs and big pharma) to tissue establishments, academia and patient organisations. Section 6.3 discusses upstream stakeholder participation affecting the creation of the Clinical Trials Regulation, and Section 6.4 discusses the impact of stakeholders in drafting the Biotech Patent

154 Perju, supra note 151, 434.

155 Harmon, S., From Engagement to Reengagement: The Expression of Moral Values in European Patent Proceedings, Past and Future. Eur Law Rev 2006;31(5): 642-666. See also Hellstadius, supra note 50, 91.

156 See, e.g., Meuwese, A. “Impact Assessment in the Multilevel Context of the European Union” in Tala, J., Pakarinen, A. (eds.) Better Regulation – A Critical Assessment. (Helsinki: Hakapaino Oy), 2010.

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Directive, whilst the Brüstle case discussed in Research Article II and the ISCO case in Research Article III represent examples of downstream stakeholder participation.

Furthermore, there are certain principles such as “the principle of protection of human dignity” that require further clarification and justification, especially when that principle is used as a constraint in contexts limiting other constitutional rights, such as the freedom of science in translational research. Lahti has also argued that in a moral (ethical) discussion we should pursue rationality, i.e., we should among other things at least seek to achieve consensus on the concepts used in discussing bioethical questions and we should utilise research findings on biology and medicine as far as possible. ¹⁵⁷ The objective of Research Article I of this study is to introduce the biomedical context that constitutes the basis for further ethical discussion and legal analysis of the concept of human dignity. This approach does not exclude the possibility of differences in the value judgments of those participating in this discourse.¹⁵⁸ Instead, Lahti refers to Jabbari’s notion of “reflexive law”¹⁵⁹, in accordance with which he thinks that there is reason to believe that the regulation on human embryos should be “continually reflexive” to changes in medical technology and in the enlightened public discourse.¹⁶⁰ Hence, in line with Jabbari’s view, Lahti concludes that “in the context of embryo research we cannot appeal to substantive moral values, for agreement is denied by the conflict of ethical theories”.¹⁶¹ This observation also boils down to the need to create institutions (such as ethical committees) which serve as a forum for informed discussion and procedures that can promote compromise.¹⁶² Darryl Marcer has also pointed out that pursuant to the idea of the flexible reflexive law, in regulating science ethical committees that can issue resolutions after having consulted experts just as issues relating to embryo research allow for justification of a certain actions pro tem.¹⁶³ This not only calls for the legislator having an active role in who should actively cooperate with interest groups, but it also requires that the legisprudential principle of temporality must be taken into account.

Any limitation of freedom on a conception about freedom must be justified as “on time” and any such justification must be adequately embedded in its context. To better understand how using the principle of protection of human dignity could be justified in the age of personalised medicine, Research Article I addresses the issue of how recent developments in cell reprogramming complicate our perception of human dignity, whilst Chapter 5 discusses how the notion of human dignity manifests itself in the existing legislative instruments. Section 4.3 discusses the difficulties that arise in trying

157 Lahti, supra note 111, 439, 466-452.

158 Op. cit.

159 Jabbari, D. Role of Law in Reproductive Medicine: a New Approach. J Med Ethics. 1990 Mar;16(1):35-40.

160 Lahti, supra note 111, 468.

161 Ibid.

162 Ibid.

163 Marcer, D. Shaping Genes: Ethics, Law and Science of Using New Genetic Technology in Medicine and Agriculture. Eubios Ethics Institute. 1990:325-347.

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to accommodate the human rights approach in the European regulatory framework for novel health technologies.