In light of Wintgen’s legisprudential approach, the very inconsistent application and amorphous use of human dignity as a constraint may raise concerns about impaired normative coherence.348 The legisprudential principle of principle of alternativity assuming that individuals are initially free and capable of rationally organising their freedom in a context with others means that paternalistic criminalisations in embryo research raise particular concerns. Aligning freedom of science, criminal law, human
selection of persons, the prohibition on making the human body and its parts as such a source of financial gain, the prohibition of the reproductive cloning of human beings.”
345 Oliver Brüstle v. Greenpeace, EU:C: 2011:669, Opinion of AG, 10 March 2011.
346 Bache, et al. supra note 41, 31.
347 Op cit., 32. See also Busby, H., Hervey, T., Mohr, A. Ethical EU Law; The Influence of The European Group on Ethics in Science and New Technologies, Eur Law Rev 2008;33:803.
348 Please refer to Section 3.4.2. of this study regarding application of Wintgen’s legisprudential principles of 1) coherence; 2) alternativity; 3) temporality; as well as 4) necessity and normative density.
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dignity and modern biotechnology is difficult. New criminalisations in the biotechnology sector require the legislator to proceed with the greatest diligence.349 It is especially important to specify what exactly is being restricted by means of criminal law. As to the effectiveness of the preventive function of criminal law, it has been argued that the intention to prevent activities that involve merely undetermined risk and injury to “legal goods” distracts criminal law from the harm principle. Consequently, criminal law risks becoming just a punitive means of managing risks associated with novel health technologies, and thus may transform into a kind of “administrative law”.
Carlos Maria Romeo-Casabona has argued that if criminal law proceeds this way, it is open to losing its preventive effect and will be reduced to a merely symbolic function, through which it renounces its authenticity.350 Whilst Sakari Melander has addressed a relevant concern that in using human dignity as a principle for criminalisation, the risk of paternalistic criminalisations is always present.351
Criminalisations in the field of modern biotechnology also seem questionable given the legisprudential principle of the necessity of normative density, in accordance with which rules should not automatically contain sanctions as the strongest from of normative density. Hence, if sanctions are involved, this requires a specific and supplementary justification of why weaker (non-coercive, but persuasive) alternatives are not used. Tarmo Miettinen has specified the elements of the freedom of science as follows: 1) the right to conduct research; 2) the right to choose one’s own research topic and methodology, 3) the right to information needed for the research; 4) and the right to decide on the publication of research results.352 According to Walin, the right to choose one’s own research topic and methodology seems most interesting for the stem cell research community.353 However, the responsibility of the researcher constitutes a counterbalance against that freedom. Miettinen has asserted that the responsibility of the researcher covers the relevance of the study, the liability to comply with the ethical code of conduct in science, and to respect others’ rights and the environment. 354 As an example from Finnish constitutional law, Walin raises an important question with respect to the limitations of the freedom of science as a constitutional right granted by the Finnish Act on Research, section 11 § that also contains a prohibition on conducting embryo research without the permission of the National Supervisory Authority for Welfare and Health, and Section 13 of the Finnish Act on Research generally imposes restrictions on research on embryos as follows:
“[t]he production of embryos exclusively for the purpose of research shall be forbidden. Embryos that have been used for research may not be implanted in a human body or be kept alive for longer
349 Romeo-Casabona, C.M. Criminal Policy and legislative techniques in the criminal law on biotechnology. International review of Penal Law. 2011; (82):83–108.
350 Op. cit.
351 Melander, S. Ihmisarvon muuttuva oikeudellinen merkitys – erityisesti rikosoikeudessa. Oikeus 2008:37:181–199.
352 Miettinen, T. Tieteenvapaus. (in English: Freedom of Science), (Helsinki: Kauppakaari) 2001,279–285.
353 Walin, supra note 96, 54.
354 Miettinen, supra note 352, 279–285.
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than 14 days from their formation, not including any time during which they have been kept frozen.
Research may use embryos that have been stored for up to 15 years, after which the embryos must be destroyed. “
This prohibition may derive from Article 18.1 in the Biomedicine Convention that requires adequate protection for embryos. Section 15 of the Finnish Act on Research mandates that:
“[r]esearch on embryos and gametes for the purpose of developing procedures for modifying hereditary properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious hereditary disease.”
This prohibition derives from Article 13 of the Biomedicine Convention. Walin has specified that this is one of those Articles from which derogations cannot be made. The penalty for unlawful intervention on the embryo is imposed under Chapter 22, Section 3, of the Finnish Penal Code and the penalty for unlawful intervention on the genome under its Chapter 22, Section 4. From the perspective of the freedom of science, Walin finds Section 4 of the Chapter 22 of the Finnish Penal Code on unlawful manipulation of genetic inheritance the most problematic. This prohibits the cloning of a human, the generation of a human by combining embryos or the generation of a human by combining human germ cells and animal genetic material on pain of two years’
imprisonment.355
Walin especially directs her criticism towards the scarcity of argument in preparatory materials with respect to the said prohibitions, in which it has been only stated that some actions are against human dignity in the sense that they should be criminalised.356 That type of restriction of the freedom of science (Section 16 in the Constitution of Finland) may restrict the researcher’s right to work and to engage in commercial activity that is guaranteed in Section 18 in the Constitution of Finland.
Walin points out that when evaluated purely on scientific criteria, the said experiments might be relevant and their prohibition could hinder a researcher from making his/her living in the best possible manner.357 It appears very problematic that the concept of
“human” has been left undetermined in the Finnish Act on Research. The prohibition of cloning is also ambiguous at best.358 Under the Finnish law it apparently covers merely reproductive cloning. Walin has claimed that a “human” refers to a born, living human individual who has reached legal personhood status.359 Walin’s reasoning seems to be consistent with the ECtHR case law.360
355 Walin, supra note 96, 53.
356 Walin, supra note 96, 54.
357 Ibid.
358 The prohibition of cloning derives from the Additional Protocol to the Convention on Human Rights and Dignity of the Human Being with regards to the Application of Biology and Medicine, On the Prohibition of cloning Human Beings ETS 16, 12.1.1998.
359 Walin, supra note 96, 55.
360 See X v. United Kingdom (App. 8416779, decision of 13 May 1980 (1980), H. v Norway (App.
17004/90, Decision of 19 May 1992 (1992) 73 DR 155), Boso v. Italy, App. 50490/99, Vo v. France
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However, it should be noted these liberalistic perspectives have not gained universal acceptance. For instance, Resolutions of the Congresses of the International Association of Penal Law have adopted a more restrictive approach when it comes to boundaries of freedom of science and criminal law in relation to modern bio-medical techniques. 361 Section II 5.2 of Resolution of the 14th Congress of the International Association of Penal Law acknowledges that the basis and scope of legal protection of the unimplanted human embryo largely depends on its moral status. Furthermore, it is stated that irrespective of the lack of a universal consensus on its moral status
“there is unanimity that -whatever may be said of possible restrictions- in principle human life is worthy of being protected from the very moment of conjugation of gametes, without regard to whether the early embryo has to be considered a "person" or as a being possessing its own fundamental rights.”362
Yet it seems that no universal consensus exists on the scope of the protection that should be granted to such research embryos. However, Resolution of the 14th Congress of the International Association of Penal Law has chosen to deny “[a]ny sort of
"ownership" or property rights of gamete donors in embryos”. According to the Resolution, this prohibition does not exclude the possibility of getting the consent of the donor of the embryo to authorise research on that embryo.363
As the notion of human dignity seems open to substantial legal manipulation depending on the circumstances in which it is used, it is important when the human dignity argument is invoked that it must be also clearly stated where exactly the threat to human dignity relates to the action that is being restricted.364 Limitations on freedom of science should be proportional when they are balanced against the potential benefits of the research. In the light of the legisprudential principle of temporality, limitations on freedom of science must be justified as “on time”. Walin perceives human dignity as a concept whose content differs not just in space, but also in time. She has pointed out that:
(App.53924/00, Judgment of the Grand Chamber of 8 July 2004; (2005) 40 EHRR 259). These ECtHR judgments indicate that it is neither desirable nor even possible to answer the abstract question of whether the unborn child is a person for the purposes of article 2 of the ECHR. The ECtHR’s decisions mean that a Contracting State enjoys a margin of appreciation to decide under its domestic law when the right to life begins.
361 Interestingly, Section II of Resolution of the 14th Congress of the International Association of Penal Law touched upon the boundaries of the freedom of science in the context of modern bio-medical techniques and criminal law. Among other things, the Resolution points out that regulations and sanctions ranging up to penal provisions may be found necessary to deal with the prohibition on producing embryos for purposes other than human procreation. The Resolution also states that “experiments aimed at developing hybrids and chimera creatures by means of karyogamy of human cells with those of animals must be criminalised.” Resolutions of the Congresses of the International Association of Penal Law (1926-2004) Available at: http://www.penal.org/sites/default/files/files/NEP%2021%20anglais.pdf.
Accessed 21 June 2016.
362 Op. cit.
363 Op. cit.
364 Walin; supra note 338, 254.
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“[w]henever human dignity is invoked in order to restrict individual rights, or to impose new obligations in individuals, a level of conceptual non-ambiguity is required such that the use of the concept has to be limited to a defined geographical area over a given period of time.”365
As a far as human dignity is concerned in the ATMP field, there is an obvious need for regulators to engage in new and innovative legislative approaches, as they are expected to create facilitating and proactive legislation in cooperation with all stakeholders.366 Greater reliance on legisprudential approach would permit stepping away from paternalistic criminalisations, as it significantly relies on non-coercive, flexible, self-regulatory measures (such as reliance on guidelines on research ethics and ethics commitees’ interpretations thereof in light of the most recent scientific understanding) that can smoothly adjust to varying conditions over time and place. The notion of human dignity is a noble concept; however, it is most valuable and useful where it deals with the promotion of the well-being of living human persons. To protect and promote human dignity, the regulators should focus more on safeguarding the human dignity of severely ill patients awaiting novel therapies than on protecting the human dignity of research embryos.
365Ibid.
366 Mansnérus, supra note 34, 164.
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6 Stakeholder participation influencing the legislative landscape of ATMPs
Upon the emergence of the European ATMP scene, the industry representatives and policy-makers stated that there was an urgent need for EU-wide legislation to safeguard the interests of public health and the security of patients.367 The industry lobbied for an EU-wide regulatory scene for ATMPs, as the EU is exclusively competent for economic perspectives (health care services cannot be automatically subordinated to the internal market). However, in the case of “common safety concerns in public health”, both the EU and its Member States are authorised to act, but the Member States may take action only if the EU does not act or decides not to take action.368 The proportionality and subsidiary principles mean that the “common safety concerns in public health in an area in which application of existing EU legislation and additional national measures have proven insufficient”, were the only backdoor for the European Commission to regulate the ATMPs. Concerns regarding the apparent lack of regulatory governance in this field were raised and a need for a new harmonised regulation was widely but not unanimously acknowledged.369The industry particularly argued that the nonexistence of EU-wide legislation of ATMPs risks harming patients who are denied the potential benefits of these regenerative medicines.370 EuropaBio supported harmonised regulation, as it was anticipated to create predictability and help companies make informed investment decisions, facilitating their investment in the R&D of ATMPs.371 Harmonised regulation would also be more cost efficient, as it would reduce the expenses arising from meeting diverse quality, safety, efficiency, and marketing requirements.372
Subsequently, a working group consisting of specialists in the fields of organs, tissues and cells convened a meeting to discuss the human cells and tissues regulatory regime in Europe in June 2000.373 A survey based on questionnaire-guided interviews on the existing regulation in the Member States disclosed a number of disagreements on some ethical aspects, a great deal of similarities regarding safety issues as well as an evident lack of regulation in many Member States. It was concluded that there is an urgent need for a single EU regulation on the quality, safety, traceability and vigilance of human cells and tissues.374 Furthermore, they outlined a preliminary framework in
367 Pirnay, et al., supra note 22, 554. See also Mansnérus, supra note 22, 431.
368 Pirnay, et al., op. cit., 554.
369 Pirnay, et al., ibid. Faulkner, A., Kent, J., Geesink, I., FitzPatrick, D. Purity and the dangers of regenerative medicine: regulatory innovation of human tissue-engineered technology. Soc Sci Med 2006;
63:2277–2288.
370 Pirnay, et al., supra note 22, 538. See also Mansnérus, supra note 22, 431.
371 Pirnay, et al., op. cit., 534. See also Geesink, supra note 170 for a general overview of the industry hearings.
372 Kent, et al. supra note 177, 43. See also Pirnay, et al., op. cit., 538.
373Pirnay, et al., op. cit., 535. Reference is made to Working Group’s written reports from the ‘‘Meeting on the Therapeutic Use of Human Organs and Tissues’’ held in Porto, on 14 -16 June 2000.
374 Pirnay, et al., op. cit., 535, 529, (Table 1., section 2.4).
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which an umbrella directive would set out general principles, whereas more detailed appendices would address some particular issues (such as quality and safety). In addition, they identified a need for standards regulating each type of tissue or cell.375 The working group also emphasised that the shortage of organs and tissues should be taken into consideration in enacting new legislation, and no legislation limiting the availability of living or cadaver donors should be passed.376 Thereafter, health ministers of the Member States reached a similar outcome by supporting the idea of a directive that imposes requirements for high safety and quality standards for the procurement, testing, processing, storage, and distribution of human tissues and cells to ensure the safety of the patients.377
An evaluation study conducted by DG Sanco in 2003 reported that as TEPs differ in many respects from medical devices and pharmaceuticals, they are not appropriately covered by the existing EU legislative framework.378 TEPs were actually clearly excluded from the scope of Medical Devices Directive and the Medicinal Products Directive (which covers GTMPs and CTMPs among other things, but leaves TEPs beyond of its scope).379 As the EUCTDs were drafted in the spirit of public health arguments (Article 152 of the Amsterdam Treaty), in contrast to the existing European Commission procedures regarding approximation of legislation relating to medical products, the EUCTDs do not have specifying rules for the marketing of cell human cell and tissue-based products and therapies as their primary objective.380 The impact assessment report the ATMP Regulation notes that the EUCTDs do not pursue an
“internal market” objective. Efficiency criteria are not mentioned either.381 In this dual approach adapted by the European Commission, the EUCTDs were formed to encompass tissues and cells that are not a part of a biotechnological process and hence
“substantially manipulated” (i.e., predominantly, “traditional transplants”), while the ATMP Regulation was created to cover products and therapies that are subject to biotech processes that necessitate both specific regulation and comprehensive harmonisation of requirements to accelerate their path to the EU market.382 Consequently, the degree of manipulation in this dual approach regulates whether a graft is classified as a traditional transplant or a commercial product. Generally speaking, ‘substantial manipulation’ means that the biological characteristics, functions,
375 Pirnay, et al., op.cit., 535, 529, (Table 1., section 2.5).
376 Op.cit., 535, 529, (Table 1., section 2.8).
377 European Union Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended. Pirnay, et al., supra note 22, 535, 529, (Table 1., section 2.6).
378 Bock, et al., supra note 77,3.
379 Bock, et al., op. cit., 32. European Union Directive 2001/83/EC, supra note 69.
380Pirnay, et al., supra note 22, 538. See also EurActiv. Health Ministers discuss possible new Directive on human tissue and cell transplants. Available at: http://www.euractiv.com/cap/health-ministers-discusspossible-new-directive-human-tissue-cell-transplants/article-112726. Accessed 21 June 2016.
381 ATMP IA Report, supra note 170, see section 2.2. European Union Council directive 93/42/EEC, supra note 377.
382 Pirnay, et al., supra note 22, 535.
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or properties relevant for the therapeutic effect have been altered.383 Several stakeholders had raised a terminological issue about the significance of the concept
‘engineered’, arguing that it should be more exactly defined to avoid borderline problems with other cell-based products.384 The European Commission responded to these concerns by providing a definition that actually followed the FDA approach to defining non-substantial manipulations of TEPs. 385 Certain manipulations of the cells and tissues were defined as not substantial. According to Annex 1 of the ATMP Regulation, these include (tissue) cutting, grinding, shaping, centrifugation, soaking in antibiotic or antimicrobial solutions, sterilisation, irradiation, cell separation, concentration or purification, filtering, freezing, cryopreservation, and vitrification.386 It seems that from the very beginning the European Commission had decided to leave TEPs beyond the scope of the EUCTDs and regulate them by the specific ATMP Regulation.387 This regulatory pathway leaving TEPs outside the scope of the EUCTDs resulted in an intentional regulatory gap.
To illustrate the emergence of a broader legislative landscape for ATMPs, the emergence of the Clinical Trials Regulation and the Biotech Patent Directive need to be discussed briefly. The Clinical Trials Regulation that was created to ensure consistency of clinical trials in the EU and to promote transparency to foster innovation affects the commercialisation landscape of ATMPs in the EU. Some questions that have arisen in connection with public consultations regarding the Clinical Trials Regulation will be briefly discussed in Section 6.3 below. Furthermore, the emergence of the Biotech Patent Directive, which has resulted in disharmonised implementations of the so-called morality clause (Article 6.2.c. in particular affecting the patentability of hESC based innovations) will be briefly discussed in Section 6.4 below.
383 Kent, J. Making connections—linking ethics and regulation in the social world of tissue engineering.
383 Kent, J. Making connections—linking ethics and regulation in the social world of tissue engineering.