European Information Network - Ethics in Medicine and Biotechnology
A project of the European Commission,Quality of Life and Management of Living Resources Programme
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European Information Network - Ethics in Medicine and BiotechnologyA project of the European Commission,Quality of Life and Management of Living Resources Programme |
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| Date: | 28.09.2004, 09:30-17:30h |
| Location: | Eigtveds Pakhus, Asiatisk Plads 2G, 1448 Copenhagen K, Denmark Copenhagen Denmark |
| Keywords: | Biotechnology - Embryo research - Gene therapy - Genetic research/engineering - Genetic testing/counselling - Genome analysis - Intellectual property/Patenting - Stem cell research |
| Details: | This conference is intended to provide the opportunity to initiate discussion between European politicians, ethics councils and the actors within research, industry and health services about the challenge of integrating ethical considerations in the patenting of human genes and stem cells at European level. The conference will include a half-day workshop, in which various groups of delegates will identify recommendations concerning patent requirements in the field and the inclusion of the ethical dimension in the patenting process Two critical issues will be addressed at the conference: The first question addresses the degree to which granting patents has an inhibiting or a promoting effect on biotechnology research and development, and on the possibilities of making available relevant therapeutic and diagnostic services and products. The second critical issue concerns how and in what areas ethical aspects could and should be applied in the granting of European patents. Background It is widely recognized that in public opinion patent protection for genetic inventions remains controversial. Thus one of the conclusions from the OECD workshop Genetic Inventions, Intellectual Property Rights and Licensing Practices held in January 2002 was that it is necessary to directly address concerns relating to ethics or access to health care, which are at the heart of public debate on gene patenting. Likewise the Nuffield Council on Bioethics in 2002 recommended renewed discussion about the justification for patenting DNA. The Nuffield Council questions whether the practice evolved for patenting DNA strikes the right balance between accommodating public and private interests. Many of the patents granted on DNA sequences are considered to be wide-ranging, furnishing the inventor with rights to all future applications of a given DNA sequence. The EU Commission in its first report on the implementation of the patent directive also acknowledges the need to further analyse two areas of the directive, i.e. patenting of human stem cells and cell lines and considerations of the extent to which sequences or partial-sequences of genes isolated from the human body should be patentable. The Commission has now established a panel of experts within economics, law and natural science, to analyse these problems and provide the Commission with a recommendation. Ethical considerations are, however, not included in this programme of work. There is therefore a need for clarification of ethical dilemmas that are raised by the present patent rules and the mechanisms for their resolution. The conference is intended to provide the opportunity for the initiation of discussion on two critical issues at European level. Building on recent work undertaken by the Nuffield Council on Bioethics, the EGE, the OECD, the Danish Council of Ethics and others, participants representing various stakeholders will consider recommendations, which concern the governance by national authorities and supranational patent bodies of the patenting of biomaterial. 1. Do patents advance or impede research and scientific progress within biotechnology? The first question addresses the degree to which granting patents has an inhibiting or a promoting effect on biotechnology research and development, and on the possibilities of making available relevant therapeutic and diagnostic services and products. Thus, based on experience to date from the allocation of gene and stem cell patents, the question is whether the present administration of the patent system is appropriate in this domain and fulfils its aims - namely to stimulate innovation for the public good while rewarding people for useful new inventions. It is a characteristic of DNA that one gene will often generate more than one product, which is generally not the case in other areas of patenting. Thus a researcher who is granted a product patent in relation to a DNA sequence as a research tool, will also gain exclusive rights for the use of that sequence in other areas, e.g. a diagnostic test. Instead of stimulating innovation, such patents?on the contrary?may limit both research and diagnosis. The Nuffield Council questions whether the practice evolved for patenting DNA strikes the right balance between accommodating public and private interests. The Nuffield Council?s view is that patenting human DNA must still be possible but that the rules for allocating such patents need to be tightened. If that happens, it is foreseen that the granting of these types of patents will in future be the rare exception rather than the rule, as has been the case in the past. Similar recommendations are made by the European Group on Ethics in its opinion to the European Commission. The group recommends that, when granting patents on human embryonic stem cells, the requirements that some new process or some inventive step must be involved should be adhered to closely, and that an industrial application must be specified for the modified stem cell. At the following workshop, discussion should be devoted to consideration of the degree to which patents in the field have contributed to or had an inhibiting effect on research and innovation within the field; and in addition, whether the scope of patents in this context have covered too wide an area and whether requirements of novelty, inventiveness and usefulness have been stringently applied. The road ahead might lie in seeking to limit patents to specific uses of a gene in combination with increased demands for inventiveness? 2. Ethical considerations and patents claiming human DNA within the EU regulatory context The second critical issue is how and in what areas ethical aspects could and should be applied in the granting of European patents. The directive does not provide clear guidance about the ethical acceptability of patenting genes and stem cell lines. Article 6 in the patent directive does stipulate, however, that inventions should not be patentable if their application is contrary to 'ordre public' and morality in a society. What exactly should be understood by the concept of 'ordre public' and 'morality' is unclear. One example is the culturally and religiously based differences in perception of the moral status of the human embryo. These differences are reflected in the diverse legislation in the EU, which regulates research in human embryonic stem cells. Thus a granted patent which involves the use of human embryonic stem cells will not be able to be put to use in certain member states. This variation in approach amongst European states and population may have implications for the introduction of the Community Patent. The Nuffield Council recommended that the EPO seek general guidance from the European Group on Ethics (EGE) in clarifying how the principles of morality and 'ordre public' can be applied to patent applications. This requires expertise in areas that are not presently represented in patent offices such as moral philosophy, environmental ethics and public policy. The European Group on ethics on its part recommends that ethical evaluations from independent experts were to be included in the assessment of this type of patent application, both nationally and at EU level. They further recommend that advisory councils of independent experts be appointed to assist the patent offices in assessing individual patent applications involving human genes and stem cells. |
| Organizer: | The Danish Council of Ethics; The University of Copenhagen; The Danish Inter-ministerial BioTIK Taskforce , Copenhagen , Denmark |
| Contact: | Address: The Danish Council of Ethics, Ravnsborggade 2, 2200 Copenhagen N, Denmark Tel: +45 - (0)35 - 37 58 33 Fax: +45 - (0)35 - 37 57 55 Email: info@etiskraad.dk |
| Webpage: | http://www.etiskraad.dk/sw3246.asp |
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