THE EUROPEAN PATENT DIRECTIVE: LICENSE TO PLUNDER May 1998 On May 13th, the Members of the European Parliament (MEPs) will decide whether or not to pass a Directive on the Legal Protection of Biotechnological Inventions. The Directive basically seeks to grant biotech corporations unprecedented rights to life, living beings and their parts. It would also open the door for biopiracy to be rewarded in Europe. Such a move would have serious implications for the fundamental rights of people and communities all around the world. The biopirates are coming Imagine that your family has used a particular plant through the ages to treat an ailment, to control pests, in religious ceremonies, or just for its delicious taste. It is highly valued and everybody in your community, and even in your region, knows it and nurtures it in their garden. You may tell people outside your community about the special properties of the plant, or choose not to. One day you come to realise that someone has taken ownership of your plant, or perhaps the chemical that gives it its value, by obtaining a patent on it. You may be completely unaware of their interest in your plant - they may have just been a casual visitor in your eyes, or they may never have even seen it. Nevertheless, because of their patent, in the future you will not be able to commercialise the plant or its products in any country accepting the patent. Never mind that you consider the plant sacred or that you do not believe that the knowledge should be freely available to human kind: those decisions are now in the hands of the patent holder. Perhaps you will find out that someone in your community is receiving a small amount of money from the patent holder for sharing their knowledge of the plant´s uses. Perhaps your community will gain some hospital equipment, or perhaps such benefits will go to a neighbouring village or to your government. If your plant is difficult to grow elsewhere, you will likely see more and more of it around but will be less and less able to buy it because its price has risen so much. If the substance of interest is easy to produce in a lab, no one will care about your plant or your people - any more. If you are beginning to wonder what on earth is going on, here is the answer: you have been biopirated. And, lucky you. This time the subject was just a plant - it could have been your own cells. Gathering a plant from a family garden in Ecuador was enough for the US-based International Plant Medicine Corporation to obtain a US Plant Variety Patent on the Amazonian sacred plant ayahuasca (PP05751). These situations have been indeed real for many indigenous peoples and rural communities that have been biopirated. Indians found that in 1995 there were 29 foreign patents on agents conferring their Neem tree insecticidal properties1. Local communities have used Neem for millennia in agriculture, public health, medicine, toiletries, cosmetics and livestock protection2. Now international demand has increased the value of a tonne of Neem seed from 300 to 8000 rupees in twenty years3, and as a result it has become much too expensive for the very people that developed it. In the Amazon, indigenous peoples have been outraged by a US citizen who gathered an ayahuasca plant from a garden and then patented it under US law, turning it into an important asset for the US-based International Plant Medicine Corporation. Ayahuasca is considered to be sacred in many Amazonian cultures, and is used in important traditional healing and visionary rituals. In Cameroon, local people have learnt that a casual visitor from the University of Wisconsin has patented "brazzein", the protein that makes their "Joublie" plant so sweet, both in the US and in Europe (EPO 684995). The University claims this researcher to be the sole "inventor" of the potentially very lucrative sweetener. The University has gone on to genetically engineer bacteria to produce brazzein, meaning that Cameroon villagers will definitely be left aside any commercial development of the sweetener that they have nurtured over the centuries4. Europeans have not been spared from biopiracy. Several Australian public agricultural research institutes have claimed Plant Breeders Rights (a softer form of intellectual property rights than patents, especially designed for plant varieties) on six traditional pasture varieties from Sardinia, Italy5. But perhaps the biggest shock came to the Guaymi people in Panama, who found that a cell line of a 26 year-old woman in their community was the subject of a US and world patent application by the US´ National Institutes of Health Institute (NIH). In this case, it was her genetic material that was of "use": her leukaemia was caused by her carrying the Human T-lymphotropic virus type II (HTLV-II)6. The President of the Guaymi General Congress expressed his outrage in the following way: "I never imagined people would patent plants and animals. Its fundamentally immoral, contrary to the Guaymi view of nature, and our place in it. To patent human material to take human DNA and patent its products . That violates the integrity of life itself, and our deepest sense of morality"7. The fate of the Guaymis was to be shared by the Hagahai People of New Guinea and the dwellers of the Solomon Islands: the NIH had applied for patents on cell lines containing another kind of human T-lymphotropic virus: HTLV-I8. Owing to international outcry, the NIH has since withdrawn all involved patent applications on the Guaymi and Solomon cell lines, and looks set to abandon the already granted patent on the Hagahai cell lines. But who knows what other dubious patent claims are still hiding in the closet? The University of Wisconsin anticipates earning hundreds of millions of dollars from its patent on brazzein, a sweetener isolated from Cameroons favorite sweet plant, "Joublie". Cameroonians are not to expect anything at all, since the University does not acknowledge their contribution and intends to isolate brazzein in the lab (EP 684 995). Indigenous peoples have been target of patents because of their historical isolation from other groups that affords these populations high frequencies of certain genes, making them easier to isolate. However, they are not the only hunting grounds for gene prospectors. The US citizen John Moore was more than surprised to learn that cells from his sick spleen had been patented behind his back by the doctor who operated him. When Moore insisted that he should have control over his body parts, the California Supreme Court ruled that he was not entitled to any rights on his own cells after they had been removed from his body. In other cases, monopolies have been obtained by certain individuals on collective research. That is what happened when one of the teams researching on a gene causing breast cancer obtained a patent granting it control over any imaginable use of the gene. The women contributing to the research were not informed that this research would lead to privatisation of their genes. Biopiracy of human genes and parts of the human body converts us all into potential sources of genes, so that we become rather objects than subjects for our doctors. By the end of 1997, the European Patent Office had received at least 102 patent applications on human genes, proteins, cell lines or products thereof, while world-wide there are at least 394 of these applications9. This figure does not even include patents on gene sequences of unknown use. Biopiracy: creating property and shifting knowledge New ecological research confirms what indigenous peoples around the world have always known: human activity throughout history has been a motor for the development of the biodiversity we have inherited. Indigenous peoples and rural communities have been able to sustain their food, health, and husbandry needs because of their holistic understanding of the natural environment10. They have recognised that each organism or species, including human beings, are inextricably related to the environment and ultimately depend on the whole ecosystem for their survival. Indigenous peoples and rural communities have developed their innovations, from crop domestication to shaping the forests, in line with such a worldview. In the process, they have developed an impressive knowledge base of the properties of the plants they live with and ultimately depend upon. Local innovation has been the pillar of current biodiversity and is the only guarantee for its future security. In contrast, discoveries in molecular biology in the second half of this century have promoted a mechanistic vision of organisms being no more than bundles of genes with determined functions, which new technologies are able to identify, isolate and recombine at will. As a result, those with the necessary technology and capital (ie the life industry) see the world´s living resources as interchangeable pieces with which to play an immensely profitable "cut and paste" game. Their technologies are promoted as the most efficient tool even the only one to overcome the problems faced by humankind. The game, called "innovation," turns living beings into raw materials and the hereditary base of their properties into "genetic resources," which are then used in their "inventions." The US National Institutes of Health applied for world patents on cell lines from at least four indigenous peoples. A Guaymi Woman, a Hagahai man and two dwellers of the Solomon Islands. The applications were withdrawn only after strong public pressure (WO 92/08784, WO 93/03759 and WO 92/1535-A). Very often the decisions about what to "cut and paste" come from the knowledge of local innovators. But the only way patents can be applied is to expropriate such knowledge from the true innovators and transfer it to another individual: the patent holder. This kind of individualisation and privatisation of collective knowledge has very rightly been defined as Biopiracy. Patents for local innovators: the answer? Some of those who see the world as a gene mine, or that just consider unrealistic to change the status quo, have tried to attenuate this plunder by granting concessions and token rewards to local innovators. Some also promote the idea of getting local innovators to join the IPR race. However, the argument does not stand up to closer analysis. Genes are not unique to a single person, but are distributed among populations. Scientists often discover commercially interesting genes when sick patients visit them with the hope of having their ailment cured. Why should these particular individuals be granted or be allowed to grasp the benefits from a patent rather than other carriers of the same gene? Why not his or her relative who are also affected with the same sickness? Why not another community altogether? And besides, granting a patent to one particular patient or group expropriates from all of them control of their genetic makeup. Traditional knowledge of the natural environment is, by nature, collective based on the free exchange of knowledge and biodiversity11. In contrast, intellectual property rights of any kind are, by definition, a limitation of this knowledge flow and collective nature, and thus are against the very nature of this kind of knowledge, its development, and even its survival. It is this very survival which is at stake as countries are forced to adopt patents on life. In the European Union, the European Parliament is on its way to approve a directive which would allow patents on all life forms genes, crops, animals and human cell lines. Once it has adopted this directive, the European Union will probably join the United States and Japan to force all countries in the world to adopt patents on animals and on plants in the upcoming renegotiation of the Trade Related Intellectual Property Rights (TRIPs) agreement of the World Trade Organisation, due in 1999. Even now Northern countries, particularly the US, do not miss any opportunity to put pressure on Southern countries to adopt such patents - either in the form of regional trade organisms or bilateral treaties. Myriad Genetics has taken ownership of the results of the efforts of many charities, scientific teams and volunteer women to identify and isolate genes thought to cause breast cancer through its patent (EP 705 902). If IPRs on biodiversity and associated knowledge are imposed upon the world, countries in the South will be forced to uphold patents obtained by foreign companies on their own biodiversity and on the associated knowledge of their indigenous peoples and local communities. Therefore, "cut and paste" biopiracy would further undermine and denigrate traditional knowledge systems that have generated biodiversity. At stake for indigenous peoples and rural communities are the options to create and develop their local resources in a way that bests suits their development needs. At stake for humankind is the chance to keep alive the biodiversity and knowledge systems that it depends upon. References 1 Narayanan Madhavan , "India Girds To Defend Its Biodiversity". Reuters, New Delhi, 2 K. Vijayalakshmi et al (1995), Neem: A Users Manual, Centre for Indian Knowledge Systems and Research foundation for Science, Technology and natural Resource Policy, New Delhi. 3 Vandana Shiva as quoted in V.Reyes (1997), "Sangre de Drago: la comercializacón de una obra maestra de la naturaleza", Biodiversidad y Derechos de los Pueblos Acción Ecológica, Quito, pp. 98-113 4 RAFI (1995), "Biopiracy Update: A Global Pandemic", RAFI Communiqué September/October 1995 5 RAFI (1998), Doing Well by Doing Little or Nothing? A partial List of Varieties Under RAFI Investigation. http://www.rafi.org The names of the varieties are: Goulburn, York, Orion, Caprera, Leura and Denmark. 6 N. Weemaels (1997), "Patentes sobre la vida: el caso de los ngobe-bugle (Guaymi) de Panamá", Biodiversidad y Derechos de los Pueblos Acción Ecológica, Quito, pp.123-127 7 RAFI (1994) , "The Patenting of Human Genetic Material" RAFI Communiqué January/February 1994. 8 RAFI (1994) , "The Patenting of Human Genetic Material" RAFI Communiqué January/February 1994. 9 According to a research on the Derwent Biotechnology Abstracts database. 10As noted in the UNRSD Discussion Paper 57, "Parks, People and Professionals: Putting "participation" into protected area management", by Michel P. Pimbert and Jules N. Pretty, 1995. 11 If access to knowledge is not general within a community, those holding it do not own it, but rather keep it in trust for the whole group. Even if a given knowledge is not shared between groups, the notion of preventing others from developing it again is absolutely alien to local innovators, as GRAIN points out in "Towards A Biodiversity Community Rights Regime", GRAIN Discussion Paper, 1995. Biocyte corporation holds a patent allowing it to decide whether or not any hospital may use the umbilical cord of newborn babies for doing transplants, and at what price. Mothers have no choice but to donate the cells for free, nor to prevent Biocyte from earning money at their expense (EP 343 217). What can we do as citizens? Make sure that our countrys IPR legislation specifically excludes patents on life, living beings and their parts, since the privatisation of life forms through any intellectual property rights regime violates the basic right to life and is against morality and public order. Pressure our governments to take measures ensuring that the conservation and sustainable use of biological diversity overrides any other international and national commitment. In political terms, this means that compliance with or beyond the commitments undertaken under the Convention on Biological Diversity (CBD) should be prioritised over compliance with or beyond the commitments undertaken under other fora, such as the World Trade Organisation. Ensure that access to genetic resources or related knowledge is based on the previous informed consent of indigenous peoples and local communities, and that it does not conflict with their collective rights. In Europe, this means that the European Parliament should reject at Second Reading the current Proposal for a Council and European Parliament on the Legal Protection of Biotechnological Inventions, or, at least, to ensure that their amendment 76 (rev) conferring some protection against biopiracy is re-included in the text. GRAIN Genetic Resources Action International Girona 25, pral E-08010 Barcelona, Spain Phone: (34) 93 301.13.81; Fax: (34) 93 301.16.27 Email: