TITLE: Biotechnology and intellectual property AUTHOR: Parliamentary Assembly of the Council of Europe PUBLICATION: Recommendation 1425 (provisional edition) DATE: 24 September 1999 SOURCE: Press Unit PACE URL: http://stars.coe.fr/index_e.htm NOTES: The recommendation below was adopted in plenary on 23 September 1999. The original proposal calling for this motion (Doc. 8459) as well as the committee opinion on it (Doc. 8532) can both be downloaded from the PACE website in English or French. A political organisation set up in 1949, the Council of Europe works to promote democracy and human rights continent-wide. It also develops common responses to social, cultural and legal challenges in its 41 member states. Council of Europe Parliamentary Assembly Strasbourg, 24 September 1999 Provisional edition BIOTECHNOLOGY AND INTELLECTUAL PROPERTY Recommendation 1425 (1999) [*] 1. The Assembly recalls its Recommendation 1213 (1993) on developments in biotechnology and the consequences for agriculture. 2. It is aware that the patent system, as a system for the protection of intellectual property, is an integral part of market economy and therefore can be a driving force for innovation in many technological questions. 3. A guideline on patents legislation should help to develop criteria for granting patents continuously according to technological progress in favour of both the interests of the claiming party, as well as the interests of the public in regard to public order, morality and general aspects of state economy. 4. Living organisms are able to reproduce themselves even if they are patented and in view of this special quality of living organisms, the scope of a patent is difficult to define, which makes it nearly impossible to find a balance between private and public interests. 5. The Assembly deems it necessary to oblige scientists, as well as scientific research and development units working in the field of biotechnology, to conform with the Convention on Biological Diversity (Rio de Janeiro, 1992). guaranteeing both the principle of free scientific approach to worldwide genetic resources and the interests of developing countries in sharing the benefits of technological progress. 6. However, it is aware that for ethical reasons there are also severe reservations against patenting living organisms. 7. It considers that the issue of patenting living organisms should comply with the provisions of the Convention on Biological Diversity, and that greater account should be taken of the interests of developing countries in the Agreement on TradeRelated Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organisation; it asks the World Trade Organisation to comply with the Convention on Biological Diversity. 8. The Assembly has taken note that Directive 98/44/EEC on the legal protection of biotechnological inventions of 6 July 1998 (BioPatenting Directive of the European Community) was challenged at the European Court of Justice by the governments of the Netherlands and Italy, and that Norway is considering not implementing it. 9. The Assembly considers that monopolies granted by patent authorities may undermine the value of regional and worldwide genetic resources and of traditional knowledge in those countries that provide access to the these resources. 10. It considers that the aim of sharing the benefits from the utilisation of genetic resources on this broader view does not necessarily require patentholding but requires a balanced system for protecting both intellectual property and the "common heritage of mankind. 11. It also considers that the many outstanding questions regarding the patentability and the scope of protection of patents an living organisms in the agrofood sector must be solved swiftly taking into account all interests concerned, not least those of farmers and developing countries. 12. The Assembly therefore believes that neither plant, animal nor human derived genes, cells, tissues or organs can be considered as inventions nor be subject to monopolies granted by patents, 13. For these reasons, the Assembly recommends that the Committee of Ministers, in cooperation with the European Union, the World Intellectual Property Organization, the Food and Agriculture Organization, the World Trade Organization, Unesco and in accordance with the Convention on Biological Diversity (CBD): i. study in detail all aspects linked to the protection of intellectual property in biotechnological innovations with a view to further improving international legislation in this field; ii. assess and review the effects of granting patents on a broad scope as regards the progress of research and development and the free market; iii. develop a code of conduct for scientists and scientific units working in the field of biotechnology which guarantees both free scientific approach to worldwide genetic resources and benefitsharing with developing countries; iv. discuss a suitable alternative system of protecting intellectual property in the field of biotechnology fitting the purposes of the CBD and meeting the needs of worldwide private as well as public interests; v. encourage the ratification by those member states that have not yet done so of the 1963 Convention of the Council of Europe on the Unification of Certain Points of Substantive, Law on Patents for Invention, and envisage updating the Convention in the light of the conclusions of the report; vi. consider the ethical aspects of the patentability of inventions involving biological, and in particular human material. [*] Assembly debate on 20 September 1999 (25th Sitting). See Doc. 8459, report of the Committee on Agriculture and Rural Development (rapporteur: Mr Wodarg) and Doc. 8532, opinion of the Committee on Legal Affairs and Human Rights (rapporteur: Mr Vishnyakov). Text adopted by the Assembly on 23 September 1999 (30th Sitting).