Transcript Dias nummer 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
Agenda
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Introduction
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Patentability of hESCs
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Funding of hESC research
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Concluding remarks
Introduction
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Funding and patentability of stem cells are important
constituents of:
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The pursuit of therapeutic aspects ascribed to hESCs research
The pursuit of commercial aspects ascribed to hESCs researh
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hESCs are derived from the blastocyst stage embryo
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The deriviation results in the destruction of the human
embryo
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Different outlook upon the permissibility of hESCs research:
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Member states’ different cultural and religious inheritance
Different opinions and approaches towards the ethical issues
Introduction
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Current practice:
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Restrictive funding policy under the Commission’s Framework
programme
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The EPO’s restrictive approach towards the patentability of
hESCs
A critical perspective:
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Lacks sufficient legal foundation
Represents a democratic problem
The Patentability of hESCs
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Directive 98/44/EC
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Regulates the patentability of biotechnological inventions
Biotechnological inventinons are patentable
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Novelty
Inventive Step
Industrial application
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Articel 5 (1): Excludes patents on the human body
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Article 5(2): Elements from the human body are patentable
if;
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isolated/produced by technical means
Patentability of hESCs
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Article 6 (1):
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Article 6(2)(c):
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Inventions the commercial exploitation of which is contrary to
ordre public or morality = unpatentable
”uses of human embryos for industrial or commerical purposes”
= unpatentable
Subject to different interpretations and scope of application
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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
Patentability of hESCs
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G 2/06: (WARF):
The reference to use does not have a bearing in ethical
considerations
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The reference to use includes prior unclaimed uses of the
embryo
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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?
Patentability of hESCs
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The destruction of the human embryo criterion as a
normative standard:
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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
The Patentability of hESCs
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The reference to industrial or commercial use:
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Commerical activities:
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buying and selling
Industrial:
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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”.
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
The Patentability of hESCs
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The application of Article 6 paragraph 1?
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Requires:
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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
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No such consensus exists as to the moral/legal status of the human
embryo
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Once a European Patent has been granted it transforms into a
national patent subject to national patent law
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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
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Requirement: that the commerical exploitation is considered to be contrary
to morality in the Member State
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.”
Funding of hESCs: The Ethical Domain and EU law
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Article 6 (3) of the Treaty on European Union
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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:
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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.
Funding of hESCs:The Fundamental Legal Values
The fundamental legal values in EU law are expressed in the
European Charter on Fundamental Rights
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highly questionable if the Charter can be said to exclude certain
types of stem cell research
Funding of hESCs:The Fundamental Legal Values
The Embryo in Human Rights Law
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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.
Funding of hESCs:The Fundamental Legal Values
The Scientist in Human Rights Law
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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.
Funding of hESCs:The Fundamental Legal Values
The Patient in Human Rights Law
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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)
Funding of hESCs:The Fundamental Legal Values
Conclusion
• Human rights law offers protection of all the stakeholders
associated to human embryonic stem cell research
A critical perspective
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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