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Joint Research Centre (JRC) www. jrc. europa. eu Contact: jrc-info@ec. europa. eu Serving society Stimulating innovation Supporting legislation 5 July 2013 1

Law and ethics in embryos and xenocells: subsidiarity or harmonization?

Law and ethics ENVI/JURI’s concept of “legal safety”(Amendments 3 and 17) The legal base of this regulation (Article 95 TEC) is a single market harmonisation measure. It is not designed to cover situations in which significant national legislative differences are intended to remain. a. Legal safety on the issue of subsidiarity. There is broad agreement that the European Union should not harmonise the legislation on the use of human embryos and human embryonic stem cells. The Commission proposes to safeguard the legislative right of the Member States to subsidiarity. However, this provision is not adequate and may be challenged in the Court of Justice. In order to respect the basic principles and the proper functioning of the internal market and to ensure legal certainty, this Regulation should apply only to products made of cells which do not raise major controversies. b. Legal safety as certainty and coherence Some technologies that are banned in other European legislation should also not get authorisation. Products which intervene in the human germ line are excluded from clinical trials in Directive 2001/20/EC and are non patentable according to Directive 98/44/EC as are also human-animal hybrids being against ordre public.

Law and ethics: EC, Council, MEPs’ ethically neutral “compromise package” • All ATMP need to be regulated • Reg. 1394/07 as “ethically neutral” • JURI (and the Parliament) is concerned with law, not with ethics • Ethics belongs to MS and subsidiarity • Ethics is a matter of “powers” and not of “issues” • EP cannot legitimately use ethics through JURI (EP) because ethics is not a matter of “subjectivity”

Committees’ legal authority or MS’ subsidiarised ethics? • • • ENVI and JURI Committees Miroslav Mikolášik (PPE-DE), rapporteur (ENVI) “As the main rapporteur, I have tried to underline that the remit of that committee should be respected. In spite of the clear provisions in the Rules of Procedure on enhanced cooperation between parliamentary committees, some colleagues misuse the voice of patients’ groups, declaring that the enhanced cooperation procedure is undemocratic”. Hiltrud Breyer (Verts/ALE), draftsman of the opinion of the JURI Committee on Legal Affairs and the Internal Market, (DE) “The Rules of Procedure give the committee a most prominent role in the treatment of ethical issues, and I trust that everyone here accepts that – not just the Council and the Commission, but also many Members of this House, none of whom, I hope, are seeking to deny the members of the Committee on Legal Affairs their authority in matters of law”. The Commission and the EP • Günter Verheugen, Vice-President of the Commission, (DE) “The fact is that the regulation does not actually lay down whether or not medicines are ethically acceptable, and in this respect, we are abiding strictly by the subsidiarity principle, for ethical matters are reserved to the Member States”. • Dagmar Roth-Behrendt, on behalf of the PSE Group, (DE) “Member States who want to ban the use of foetal stem cells should be allowed to do so, and, Mrs Breyer, everybody who says that the Court of Justice would deny that and would put it under Article 95 is either not knowledgeable – which you are not – and then giving the wrong impression, I am afraid. If you read Article 30 of the Treaty, you are exactly sure that it says that public morality is always a reason to make sure that a Member State can ban something.

Defining the relations amongst law, ethics, and the market Commission, Council and EP • LAW • • ETHICS • • • MARKET • Legislation does not deal with values Regulatory powers may decide of values Does not belong to the Parliament and MEPs Ethics is not “subjective”, but it’s “public morality” (ordre public? ) Principle of subsidiarity, belongs to MS Is per se neutral and neutralises the products placed in it Harmonisation is provided through subsidiarity JURI and ENVI • • • Includes analysis of contents Juri is competent when ethics is related to safety Concept of “legal safety” • Is already a formal part of EU legal rules (Dir. 44/98, Dir. 2001/20) and so there is a need for consistency • Is neutral only if products are themselves neutral Harmonisation is possible only when there are no ethically problematic products •

Patenting animals and embryos

European Patent Office • The "oncomouse" application was filed with the EPO in June 1985. The patent has been in force since 13 May 1992. • Initially, on 14 July 1989, the examining division refused the application, inter alia on the grounds that Article 53(b) of the European Patent Convention prohibits European patents on animals per se. The applicant appealed against that decision, and on 22 October 1990 an EPO technical board of appeal set it aside and sent the case back for reexamination. • The board of appeal held that Article 53(b) EPC rules out patents on animal varieties, not animals generally. The examiners therefore had to decide whether the application was for an "animal variety" within the meaning of the provision, and also whether to invoke Article 53(a) EPC which prohibits patents for "inventions the publication or exploitation of which would be contrary to ordre public or morality". • In a second decision in October 1991, the examining division granted the "oncomouse" patent as complying with the EPC, commenting that the patent application's purpose - to facilitate cancer research and prevention - was of such importance for humanity as to outweigh any disadvantages such as the suffering of the animals concerned.

Commissioner of Patents v. President and Fellows of Harvard College, 2002 SCC 76, December 5, 2002 • Control on invention In a chemical process A + B = C is always true. However, in the creation of mammals A + B = C, D, E, F…N. The chemical reaction and its products are known (once discovered) and constant, whereas the parameters of the resulting mammal are largely unknown and change every time”. Humans by law Need for • Reproduciblity test legislation and Directive 2001/18/EC on The mouse is not truly reproducible. . . because too much is left to luck and chance […]. Thus, although the gene will be present in some mice, public GMOs at some place, with some characteristics, the precise mouse, the 15) When defining consultation precise location and the precise quality of the gene are "genetically modified unreproducible. The variations of the gene are created and controlled organism" completely by the laws of nature and are infinite”. for the purpose of this Directive, human beings should not be considered as • Threshold between patentable animals and non patentable humans organisms. If the line between lower and higher life forms is indefensible and arbitrary, so too is the line between human beings and other higher life forms. How much DNA does it take before one becomes the other? The answer to these questions, once ridiculous and offensive, may now just be a matter of degree.

Judgment of the ECJ (Grand Chamber) of 18 October 2011. Oliver Brüstle v Greenpeace e. V. Reference for a preliminary ruling: Bundesgerichtshof Germany. Directive 98/44/EC - Article 6(2)(c) - Legal protection of biotechnological inventions - Extraction of precursor cells from human embryonic stem cells - Patentability - Exclusion of ‘uses of human embryos for industrial or commercial purposes’ Concepts of ‘human embryo’ and ‘use for industrial or commercial purposes’. Case C-34/10.

• Patent No. DE 19756864 C 1 of 1997 (before Dir. 44/98) neuronal precursors from embryonic stem cells • In Greenpeace e. V v. Oliver Brüstle, the Bundespatentgericht (Pat. G, art. 22, n. 1) declared the patent invalid because it involved (it was based on) the destruction of embryonic stem cells (Bundespatentgericht, December 5, 2006, Case 3 Ni 42/04) • The Bundesgerichthof referred to ECJ interpretation of art. 6(2 c) (Bundesgerichtshof, December 17, 2009, Case Xa ZR 58/07).

Brüstle v Greenpeace e. V (2011) ECJ conclusions • Broad meaning of embryo designating an autonomous concept of European Union interpreted in a uniform manner; a broad meaning to ensure harmonization • Strict “legal interpretation” of ethics the Court is not called upon to broach questions of ethical nature, but must restrict itself to a legal interpretation of the relevant provisions of the Directive • Destruction of embryos and favor towards new patents the Enlarged Board of Appeal of the European Patent Office reached the same conclusion in decision of 25 November 2008, G 2/06

WARF “Any other conclusion would lead to legal uncertainty, and risk being to the detriment of any third party who later provided an innocuous way to carry out the invention”