|
Project
objectives and state of the art
The
project aims to provide an analysis of the EU patent system, as
applied to biotechnological inventions in general and to human
embryonic stem cell related technology in particular with a view
to harmonise ethical and legal divergence on the operation of
the ‘public morality’ exclusion in Article 6 of the Biotech
Directive. This has so far not been done and seems vital to enable the adoption of a responsible
European policy on the regulatory environment for
biotechnological research and human embryonic stem cell research.
The
need for such a European position has also been acknowledged by the EU Commission. The Commission is committed to the
adoption of a responsible policy on biotechnological research
and human embryonic stem cell research which addresses the moral
concerns of citizens in Europe. The present uncertainty regarding the legal scope and reach
of the Biotech Directive in regard of
research on human embryonic stem cells gives rise to concerns that this could potentially create
a position of dependence from private industry in other
parts of the world. This project directly addresses such
concerns by examining the impact of ethical constraints on
existing legal controls and limitations on intellectual property
rights in this area and exploring options to resolve bottlenecks
and problems.
The
starting point of the project is the so called ‘morality’
clause in Article 6 of the Biotech Directive. and the emerging
divergence in the policies across Europe, notwithstanding the views of the European
Group on Ethics on the ethics of human embryonic stem cell
patents. The project will identify and compare the patenting
policies in Europe for
human embryonic stem cell research. Emerging differences will be
analysed in the light of other differences in the background
national legal regimes, including differences in domestic patent
and medical law, the interpretation of human rights and the moral exclusion clause in European patent law. .
A
responsible policy on biotechnological research and human
embryonic stem cell research must adequately address the moral concerns of citizens in
Europe and has to be developed against the European Union’s
commitment to democracy and respect for diversity and ethical
pluralism. This project will examine the role of institutions
such as the National Bioethics Commissions through which moral
principles are mediated and make recommendations as to how
democratic processes may be strengthened to improve
communication and dialogue between scientists, society and
policy makers.
The
project also intends to make a contribution to how Europe could
best respond to the global challenges presented by human
embryonic stem cell research and develop its policies to take
advantage of these opportunities in the international arena. The
approach will be comparative in nature and it will analyse both
the ethical and the moral aspects of the issues involved, as
well as the intellectual property and other legal issues
involved. This will include not only the legal and ethical
approaches from the
EU Member states but also present the US and Canada perspectives. It will thus also provide a roadmap against which could be tested
the competitiveness and feasibility of any suggested approach
that is different from that adopted by the direct overseas
competitors of our European biotechnology and stem cell industry.
|
