TITLE: Patent på gener måste förbjudas (No Monopoly on Genes) AUTHORS: Thomas Bodström (Minister of Justice, Sweden), Kjell Larsson (Minister for the Environment, Sweden), Leif Pagrotsky (Minister for Trade, Sweden) PUBLICATION: Dagens Nyheter (Stockholm) DATE: 10 December 2000 URL: http://www.dn.se NOTE: This is an unofficial courtesy translation. Dagens Nyheter 10 December 2000 NO MONOPOLY ON GENES The development of gene technology is moving faster and faster and we are all faced with difficult ethical dilemmas. Our knowledge about the building blocks of life itself have evolved so far that science is about to give us answers as to why we are susceptible to serious diseases, and how we can in the near future, cure those affected. This is indeed a welcome development which benefits must be shared by society as a whole. This new knowledge has however also a downside that carries with it a frightening dimension. Commercial forces believe they have the right to claim ownership of the discoveries of the inner building blocks of life. Such an attitude is totally unacceptable to us. It is absolute vital that this information is freely accessible to society as a whole. We must clearly set the ethical framework for society. For us it is essential to guarantee a pluralistic view by providing public financial support to research. But it is equally important that other factors do not limit the independence of science. This is why the right to claim patents on genetic material must be strictly limited. It would not only be illogical from a research and development perspective to create a system that limits the use of genetic information and knowledge; it would also be ethically questionable. President Bill Clinton and Prime Minister Tony Blair this spring issued a joint statement where they underlined the importance of making the knowledge on the human genome freely available in order not to hamper the development of new significant innovations in the pharmaceutical and food sectors. We fully endorse this view. Furthermore, we believe that no one should be allowed to patent genes, plants and animals in their natural state. Neither genes nor organisms identified with the help of new methods can be considered as inventions. It is nothing but discoveries. Not until a new discovery is applied in an industrial process or other commercial application could a patent be considered. This is in line with existing Swedish legislation and also established through the EC-directive on legal protection of biotechnological inventions adopted in 1998. No one shall be allowed to monopolise the building blocks of life. Research on genes and their functions is one of the most rapidly expanding scientific disciplines in the world. Today, the genetic make-ups of a number of species have been mapped at research institutions around the world. Examples are the fruit fly, rice and now also the human genome. Sweden is at the forefront in genomic research and recently an additional 800 million SEK was allocated to Swedish Universities in support of this research. Knowledge of our and other organisms genes and their functions is of the utmost importance. It does not only increase our understanding of evolution and the internal biological systems of humans and other organisms. It also makes it possible to develop better and more efficient treatments for several currently incurable or severe diseases, in particular hereditary diseases. Increased knowledge about genes and their functions will of course also provide benefits in the health and food sectors. In view of our fundamental opinion it is most welcome that several major companies have clearly distanced themselves from a development that limits access to genetic information purely for profit reasons. One example is the Human Genome Project that in part is financed by the British Medical Company GlaxoWellcome, where all information is made available for research and development of new pharmaceuticals. When the Convention on Biological Diversity (CBD) was adopted in 1992 a paradigm shift took place as regards the right of access to the genetic resources of the world. The Convention recognises the authority of every country to determine access to its genetic resources. One of the main reasons for the Convention to emphasise the sovereign right of every country to its genetic resources was to give developing countries the possibility to share the benefits arising from the commercial use of genetic resources that often arise in developed countries. Bearing in mind that most developed countries are poor in genetic diversity but rich in technical and financial resources and most developing countries are rich in genetic diversity but poor in resources, the concept of sovereignty is correct. Multinational companies should not be allowed to collect genetic resources from developing countries and exploit them commercially without sharing the benefits with the countries of origin. But the fact that countries now possess the exclusive right to their genetic resources could also have undesired repercussions regarding the use of genetic resources in research and development Let us give a concrete example: the fungal disease Phytophtera infestans is a threat to the cultivation of potatoes in Sweden. To fight Phytophtera without increasing the use of chemicals new varieties with effective resistance to Phytophtera is needed. Such resistant varieties, and thus genes, could only be found in the country of origin for potatoes Peru. Peru is about to adopt legislation that more or less makes access to it genetic resources impossible without undergoing an extensive consent procedure. This will render development of, for example, new Phytophtera resistant potato varieties, difficult. In other words, regardless of whether it is a multinational company or individual countries that restrict access to genes and genetic information it can cause very concrete effects for people. Sweden is active in the international arena to find models and systems to achieve the objective of the fair and equitable sharing of benefits arising from the use of genetic resources. The term ?benefits? to us means more than money. It also encompasses capacity building and transfer of technology and knowledge. At the moment intensive negotiations are under way in the FAO on how free access to genetic resources for food and agriculture can be secured for research and development, whilst the benefits from commercial use of these resources shall be shared fairly with the stakeholders. Patenting, access to genetic resources for food and agriculture as well as genetically modified organisms (GMOs) are intimately linked and will without doubt affect many of the already complex and difficult international processes in coming years. The recently adopted global Biosafety Protocol is a clear example of this. The Protocol underscores the need for clear rules on the handling of GMOs as well as the central role of the Precautionary Principle to safeguard the protection of the environment and human health. The Environment Ministers of the EU have proposed new legislation that clearly puts the responsibility for avoiding negative environmental and health effects on the producers of GMOs. The possibility for consumers to make informed choices is another key element that is secured in the proposal by requiring labelling of products containing GMOs. Gene politics is high on the international agenda. The Governments of the world negotiate gene politics issues in a number of forums in addition to the CBD and the Biosafety Protocol, such as the WTO, The World Intellectual Property Organisation (WIPO), the WHO and the OECD. We welcome an open and transparent discussion on these issues. The discussion must include the whole Gene Politics area and all its complex issues. The Government has, and will continue to hold, an open dialogue on these issues. It is necessary to hold such a dialogue and to survey all relevant rules, identifying which rules that need to be reviewed and where rules are lacking. This discussion is urgently needed to make it possible to develop a comprehensive Gene Politic. Gene Politics spans most areas of society, e.g. health and consumer aspects, trade, environment, research, forestry, agriculture, development assistance and intellectual property rights. This means that Gene Politics is not sufficiently integrated neither at the national nor international level. In December 1999 the Environment Minister invited representatives of various organisations and research institutions for a round table discussion on formulating a Swedish Gene Politic. Recently the Trade Minister invited to an international hearing on patents and genetic diversity. These were the first steps of the intensified dialogue that the Government undertakes in order to develop a comprehensive Swedish Gene Politics with all stakeholders. For us it is self-evident that such politics must be based on the view that no one should be allowed to monopolise genes. Thomas Bodström Minister of Justice Kjell Larsson Minister for the Environment Leif Pagrotsky Minister for Trade