Dr. Malene Rowlandson, University of Southern Denmark

1. Funding and patentability of stem cell research in the European Union - A critical legal review of European legislation Dr. Malene Rowlandson, University of Southern Denmark Dr. Janne Rothmar Herrmann, University of Copenhagen www.welma.eu

2. Agenda • Introduction • Patentability of hESCs • Funding of hESC research • Concluding remarks

3. Introduction • Funding and patentability of stem cells are important constituents of: • The pursuit of therapeutic aspects ascribed to hESCs research • The pursuit of commercial aspects ascribed to hESCs researh • hESCs are derived from the blastocyst stage embryo • The deriviation results in the destruction of the human embryo • Different outlook upon the permissibility of hESCs research: • Member states’ different cultural and religious inheritance • Different opinions and approaches towards the ethical issues

4. Introduction • Current practice: • Restrictive funding policy under the Commission’s Framework programme • The EPO’s restrictive approach towards the patentability of hESCs • A critical perspective: • Lacks sufficient legal foundation • Represents a democratic problem

5. The Patentability of hESCs • Directive 98/44/EC • Regulates the patentability of biotechnological inventions • Biotechnological inventinons are patentable • Novelty • Inventive Step • Industrial application • Articel 5 (1): Excludes patents on the human body • Article 5(2): Elements from the human body are patentable if; • isolated/produced by technical means

6. Patentability of hESCs • Article 6 (1): • Inventions the commercial exploitation of which is contrary to ordre public or morality = unpatentable • Article 6(2)(c): • ”uses of human embryos for industrial or commerical purposes” = unpatentable • Subject to different interpretations and scope of application • Germany, Denmark and the EPO: Broad interpretation and broad scope of application • The UK and Sweden: narrow interpretation and broad scope of application • G 2/06: (WARF): Broad scope of application of the exclusion regarding uses of human embryos for industrial or commerical exploitation

7. Patentability of hESCs • G 2/06: (WARF): • The reference to use does not have a bearing in ethical considerations • The reference to use includes prior unclaimed uses of the embryo • Result: An invention based on the derivation of the hESCs from the embryo is not patentable, even though the actual derivation is not claimed in the patent application • The destruction of the human embryo criterion = a common normative standard?

8. Patentability of hESCs • The destruction of the human embryo criterion as a normative standard: • No consensus on the moral and legal status of the human embryo • Different access to carry out hESCs research • Different access to obtain patent protection for product and use claims on hECS related inventions • Vo v. France: No uniform approach towards the extension of Article 2 of the EHRC • Not all members have ratified the Oviedo Convention

9. The Patentability of hESCs • The reference to industrial or commercial use: • Recital 42: ” …whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it”. • Commerical activities: • buying and selling • Industrial: • repetitive mechanical, technical or chemical preparation of raw material • Process claims regarding the actual derivation of the cells would therefore fall within the scope of the exclusion’s application

10. The Patentability of hESCs • The application of Article 6 paragraph 1? • Requires: • Consensus among the Member States regarding the immoral nature of the invention • Case Law of the EPO: 19/90, T356/93, T866/01, T315/03 • No such consensus exists as to the moral/legal status of the human embryo • Once a European Patent has been granted it transforms into a national patent subject to national patent law • Consequence: Article 6 subparagraph 1 may therefore constitute the legal basis for the Member State to invalidate a patent once it has become subject to national patent law • Requirement: that the commerical exploitation is considered to be contrary to morality in the Member State

11. The Funding of hESCs under the Commission’s Framework Programme • Research without boundaries • The Commission: ”despite all attempts to reduce the scope of the ethical debate, on the crucial issue of research using spare human embryos created for in vitro fertilisation purposes, the fundamentally incompatible moral positions of different Member States could not be reconciled.”

12. Funding of hESCs: The Ethical Domain and EU law • Article 6 (3) of the Treaty on European Union • the Union must respect the national identities of the Member States • According to the Commission’s interpretation of this provision the Union is not competent to regulate within the ethical domain, which includes embryonic stem cell research • However: • A considerable de facto regulation of stem cell research takes place within the EU Framework Research Programmes. Under the Sixth and Seventh Framework Research Programmes a set of ethical guidelines was adopted explicitly excluding three types of research from receiving EU funding, including research involving the procurement of embryos purely for research purposes.

13. Funding of hESCs:The Fundamental Legal Values • The fundamental legal values in EU law are expressed in the European Charter on Fundamental Rights • highly questionable if the Charter can be said to exclude certain types of stem cell research

14. Funding of hESCs:The Fundamental Legal Values • The Embryo in Human Rights Law • Both UNESCO’s Universal Declaration on Bioethics and Human Rights and the Council of Europe’s Convention on Human Rights and Biomedicine address embryonic stem cell research.

15. Funding of hESCs:The Fundamental Legal Values • The Scientist in Human Rights Law • Research on embryos and embryonic stem cells operates within a legal framework that awards the scientist a number of rights • Universal Declaration of Human Rights, Article 27, the Convention on Economic, Social and Cultural Rights Article 15, the Charter of Fundamental Rights in the European Union and a number of recommendations specifically addressing the status of scientists and higher-education personnel.

16. Funding of hESCs:The Fundamental Legal Values • The Patient in Human Rights Law • The right to health and healthcare is protected in several human rights instruments including the Convention on Economic, Social and Cultural Rights, Article 12 and the ECHR Article 8. The right entails that offers of care and treatment that address the patient’s needs are made available. But to what extend does the right to health and healthcare impose an obligation on States to facilitate research that might improve existing offers? • Universal Declaration on Human Rights, Article 27 (1) and the Convention on Economic, Social and Cultural Rights, Article 15 (1)

17. Funding of hESCs:The Fundamental Legal Values • Conclusion • Human rights law offers protection of all the stakeholders associated to human embryonic stem cell research

18. A critical perspective • the common denominator of the Commission’s funding strategies and the practice adopted by the EPO is a rather restrictive approach towards hESC research and the patentability hereof • destruction of the human embryo • irreconcilable with the prevalent ethical norms in Europe • the absence of a uniform legal and moral definition of the human embryo