Biodiversity and Gene Patents

United Nations Environment Programme

UFRGSMUN | UFRGS Model United Nations Journal ISSN: 2318-3195 | v1, 2013| p.244-263

Luciana Costa Brandão Júlia Paludo

1. Historical background We are noticing an increased consciousness of biodiversity importance in our daily lives, and how its changes (and mostly its losses) strongly aff ect not only our wealth, but also several domains, such as our economy, security, and culture. According to UNEP, “[t]he roles of biodiversity in the supply of ecosystem services can be categorized as provisioning, regulating, cultural and supporting [...], and biodiversity may play multiple roles in the supply of these types of services. For example, in agriculture, biodiversity is the basis for a provisioning service (food, fuel or fi ber is the end product), a supporting service (such as micro-organisms cycling nutrients and soil formation), a regulatory service (such as through pollination), and potentially, a cultural service in terms of spiritual or aesthetic benefi ts, or cultural identity” (Ash and Fazel 2007, 161). Th us besides satisfying human needs, biodiversity also plays a strong role in our culture, whose basis is the relationship between people and the environment, which is diff erent in each society. In this sense, biodiversity loss may imply also the loss of an important set of practices and values exclusive of some communities (Sala 2009). Given its historical importance to humanity, biodiversity was considered part of the “common heritage of humankind”, but this status began to change very recently. Under the former condition, biological elements were treated as a public good, free of claims by States or private companies, and available only for peaceful and scientifi c purposes. Th is concept was internationally legalized by several Conventions, like the 1972 UNESCO Convention Concerning the Protection of the World Cultural and Natural Heritage1 (Gepts 2004). Nevertheless, from the 1970s there was a radical change in the concept of biodiversity, which began to be seen as a patentable product, that is, as a product to be owned by a specifi c body. Th e fi rst known patent ever awarded was in Greece, in the 7th century BC, when a one-year monopoly was conceded over cooking recipes, and industrial 1 Th is 1972 Convention establishes that “parts of the cultural or natural heritage are out of outstanding interest and therefore need to be preserved as part of the world heritage of mankind as a whole” (UNESCO 1972, 1). 244 UFRGSMUN | UFRGS Model United Nations Journal patent laws were established in several European countries during the 18th and 19th centuries (Crucible Group 1994). However, patent protection of organisms, in whole or in part, genetically modifi ed or not, was not allowed in most of the countries until the 1980s, even in the United States, where the patenting process was already common (Adlhikari 2005). However, the U.S. started a new trend for more than 100 years, when a patent on a purifi ed naturally occurring substance was fi rst accepted. In the 1911 case Parke-Davis v. Mulford, the applicant has isolated and purifi ed adrenaline in a form that did not existed in nature and also useful in treatments, which was considered suffi cient to satisfy the criteria of novelty, inventiveness, and utility for patents (Gepts 2004). Th is approach then was extended to living organisms over time. In fact, plant patents exist since 1930, when the United States adopted the Plant Patent Act for Fruits and Ornamentals, comprising new cultivars of asexually propagated crops, such as the potato Solanum tuberosum. Th is trend was adopted by several countries in 1961 with the International Union for the Protection of New Varieties of Plants (UPOV), whose objective is the protection of plants diversity by intellectual property right (Crucible Group 1994, Gepts 2004). However, the change on patent protection became more evident with the famous case Diamond v. Chakrabarty (1980), when the U.S. fi rst challenged the issue of whether genetically modifi ed organisms could be patentable (Gepts 2004). Ananda Chakrabarty developed a genetically engineered Pseudomonas bacterium that could break down crude oil, with the purpose of cleaning oil spills. Her application was fi rst rejected by the US Patent and Trademark Offi ce, since that living things were not patentable at that time. However, on an appeal to the US Supreme Court, the patent was granted, beginning a new era concerning biological and genetic diversity protection (Ash and Fazel 2007). It was only in the 1980s that a longstanding issue was included in the life patenting debate: the one of the recognition and protection of traditional knowledge. Th e concept of traditional knowledge (TK) is strongly linked with the relationship between a community and the environment, that is, the way people utilize biodiversity. A famous case2 involving the San people (South Africa) and the British company Phytopharm concerned about a patent on the Hoodia cactus, which was granted in 1997 by the South African Council for Scientifi c and Industrial Research (CSIR). Th e San have utilized this plant for several reasons, such as a suppress hunger during long hunting trips and to treat stomach pain, and the CSIR saw it as a potential medicine for obesity. Th e Hoodia case is important because not only the San were recognized as custodians of the knowledge involving the Hoodia plant, but also the community was promised a percentage of the company profi ts, opening the debate on access and benefi t sharing (IPR 2002,

2 Th ere are three other famous cases that deserve to be mentioned: the ones involving Turmeric (India), Neem (India and South/Southeast Asia) and Ayahuasca (Amazon region). Th e patents on these plants were contested with the argument of non-novelty, giving the evidence of their traditional use (Mosimege and Holtman 2012). 245 United Nations Environment Programme

Mosimege e Holtman 2012). More recently, gene patents made even more controversial the debate on life patenting. Th e controversy is especially because of their clash with the inventiveness criteria, since that patents on products derived from nature are not a novelty anymore, but there is also a strong ethical issue in patenting genes, mainly human ones. In 1994, a patent was granted to the company Myriad Genetics (United States), who isolated BRCA1 and BRCA2 genes, whose mutations put women at high risk of breast and ovarian cancers. Th is patent allowed Myriad to off er an exclusive diagnostic testing service, whose cost (more than 3,000 dollars) has prevented several women from taking a preventive measure against cancer. Th e Association for Molecular Pathology (AMP), along with patients, breast cancer survivors, researchers, and other individuals, contested the Myriad monopoly, and appealed to the Supreme Court. Th e case Association for Molecular Pathology v. Myriad Genetics was not the fi rst one involving human genes, but it is emblematic since that it is currently challenging the legality of gene patents (Pollack 2013, Association for Molecular Pathology et al. v. United States Patent and Trademark Ofi cce et al. 2010). Th e discussion on biological and gene patents, therefore, was developed together with the growing recognition over the last three decades of the importance of biodiversity to the environment and the human well-being. Consequently, the loss of biodiversity strongly concerns the international community, and several environmental agreements since then were signed regarding biodiversity ownership, protection and governance. However, this shift did not happened without a lot of ethic and social controversies, and the main question arisen was who should benefi t from biological and genetic diversity: government, society, patent holders, or just nature itself (Ash and Fazel 2007).

2. Statement of the issue Th e link between biodiversity and gene patents comprehends a two-way relationship, which means that they aff ect each other in a mutual casual relation. Biological and genetics diversity serve as basis for every kind of future development, direct or indirectly. Th ey guarantee food security, health and also the production of materials and goods through bioprospecting activities. On the other way, international community has had to deal with the great risk of biodiversity and genetic erosion. Gene patenting and the system of intellectual property rights (IPRs) can be understood both as tools that help to ensure nature conservation but, also, from a diff erent point of view, as a threat to biological and social diversity, part of a mechanism that plunders the environment in benefi t of companies in search for economic profi t. In this session, this confl ict will be addressed considering the unique roles of multiple actors—at international, national and local level—and the multiple opinions and interests at stake.

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2.1. What is biological and genetic diversity and the risk of erosion Th e concept of biodiversity represents the idea of life’s variety on Earth. It encompasses three levels of organization: the diversity of ecosystems and habitats; the amount of living species; and, at last, the genetic diversity. Biodiversity, then, includes not only the abundance in numbers of habitats, populations, individuals and genes, but also incorporates the process among them and, recently, involves the concept of human cultural diversity (UNEP 2007). Genetic diversity is then understood as “the key to human survival” (Crucible Group 1994, xiv) and the source of necessary biomaterials that are needed to meet new opportunities3, in economic and social realms, and also to overcome possible new dangers, such as climate change. Th e loss of biodiversity consists an emerging issue and a great risk to the planet and to human life, constituting itself in a great concern for the international political community. Th e depletion of genetic diversity4 shall compromise directly the provision of food, medicines and fresh water, besides the multiple eff ects it could have over the off er of ecosystem services, such as pollination of crops. Cultural diversity, being intrinsically connected with biological and genetic diversity, would also decline (Secretariat of the Convention on Biological Diversity 2010). Due to recognitions and comprehension of the eminent risk over biodiversity loss there are increasing incentives around the international community to deal with this situation, although yet not enough and not totally eff ective ones. Th e fact that the issue on biological and genetic threats has been addressed in several international conferences and organisms does not, however, compromises the sovereignty that National States still have over their territories. Th e decision on how to use its national resources, including genetic material, still remains in the power of the State, which is reaffi rmed on international conventions (Secretariat of the Convention on Biological Diversity 2010, United Nations 1992).

2.2. Biodiversity as an economic resource As aforementioned, biological diversity is oft en used and has an immeasurable importance in several economic sectors. Bioprospecting is “the exploration of biodiversity for new biological resources of social and economic value” (Beattie 2005, 273), including several activities such as pharmaceuticals5, crop protection, agricultural seeds, etc. In some cases, biological material provides the fi nal 3 Industries like the pharmaceutical ones, of cosmetics and personal care, biomimetics, ecotourism, construction and crop protection are a few examples of areas on which biological and genetic diversity are already being explored for its economic value (Beattie 2005). 4 Th e accounting system of Ecological Footprint allows one to compare the current loss of biodiversity in contrast with the total amount of available biocapacity in the world, including the demand for genetic diversity. In this sense, it can be an interesting tool to evaluate the use of biodiversity per country (GFN n.d.). 5 Th e development of the aspirin pill and also the treatment of Malaria disease are both examples of bioprospecting in the pharmaceutical industries. While aspirin had its formula derived from natural products, the treatment of Malaria consists in using drugs that come from natural products—such as quinine—and, more recently, the artemisinins compost, precedent from the Chinese herb Qinghao (Beattie 2005). 247 United Nations Environment Programme product itself, but the organism can also serve as an inspiration or model to create something new. Sometimes, for example, it is prospected only a part of the genetic material contained in the living organism. Th e process of bioprospecting, however, is made of several steps and, usually, is very expensive, requiring an exorbitant amount of initial investments (Beattie 2005). Bioprospecting has been developed, more recently, by small companies that search for new discoveries and, later on, sell those discoveries to bigger companies that can pay for the high development costs of the new drug through combinatory chemistry or other process. It is estimated that more than 60% of the drugs used in cancer treatment can be traced its origins to natural products in some extent. Th e same phenomenon is also present when referring to antihypersensitive drug research. When analyzed the sources of all new chemicals entities between 1981 and 2002, around 63% were, in some way, derived or inspired by some natural product, as can be noticed on Figure 1 below (Beattie 2005). Between 2002 and 2003, this number goes to 80% (UNEP 2007). Another study proves that, of all drugs prescriptions in United States in 1993, 57% contained at least one natural compound (Beattie 2005).

Figure 1. Sources of All New Chemical Entities, 1981–2002 (Beattie 2005, 278). Th e activity of bioprospecting is also a very profi table one. In a 1997’s research was founded that 10, of the 25 best-selling drugs were in somehow related to biological or natural products. Th at amount represented 42% of all pharmaceutical industry sales, responding for 17.5 billion dollars at the time. In 2000, two drugs derived from the species T. baccata yielded 2.3 billion dollars in sales. When considering the estimated value of plants not yet discovered in tropical forest, this amount goes up to more than 100 billion dollars (Beattie 2005). 248 UFRGSMUN | UFRGS Model United Nations Journal

Th e economic and profi table utilization of genetic diversity, however, does not guarantee alone the conservation and sustainable use of ecosystems and may, sometimes, increase the threat to biodiversity integrity. Some marine species have been overexploited for medical research and in some countries in Africa where control over bioprospecting activity is very hard it is common to happen the exploitation of biodiversity over the sustainable limit (Beattie 2005).

2.3. Intellectual Property system and gene patents Th e discussion on bioprospecting enlightens the recent “enclosure movement” of genetic resources, in the form of genetic patenting and IPR request over gene expressions and other living forms (UNEP 2007). Th e idea of patenting a living organism—or part of its genetic code—poses a series of diffi cult questions that divide the international opinion. Besides the ethical and moral concern with the idea of life patenting, there is also the problem of how the ownership of living organisms will be organized6—what possibility arose aft er the development of biotechnology in the 20th century. “For the fi rst time in human history it is possible to have monopoly ownership over the “formulae” that make life—including the genes and gene complexes that establish characteristics. (…) It now seems possible, with the patent on all forms of transgenic cotton, to lay claim to processes of life across entire species. Even the successive generations and further invention related to a species might be subject to the original patent. Th is, some argue, is a qualitatively diff erent issue than mere property ownership” (Crucible Group 1994, 14-15). When considering gene patenting, one must have in mind the original concept of patent, which relates with the idea of “innovation”. Th e concept of “innovation” distinguishes itself from “discoveries”. While a discovery is merely uncover a new knowledge, innovation relates with the invention of a new process or product. To get a patent, someone must make an invention and be able to explain how to reproduce it. Most of the times, however, both things are part of the same process, which means that many inventions are based on discoveries. In this context, “the sequence of gene is a discovery, pure and simple. It is knowledge about something that already exists. However, it may enable new things to be produced, and these may be patented” (Crucible Group 1994, 105). Patent on a gene7, henceforth, is usually not claimed over natural genes, for they already exist, not being able to be classifi ed as inventions. Generally, the patent claim is over the gene, but this have to be isolated from its natural

6 A current possibility being discussed at international level is the creation of a World Patents System, harmonizing at the international level the legislations over the matter, and establishing a supranational institution able to register and control patents and property rights all over the world. Whereas a mechanism like that would bring a higher level of control over patents and great benefi ts for multinational companies, it is argued that it could also hamper the sovereignty of national states and create obstacles for developing countries and small enterprises (FNI 2012). 7 Th e case of engineered genes, such as those of transgenic plants, is not included in this concept. 249 United Nations Environment Programme surroundings. Also, the patent can be claimed over products containing the isolated gene. Th ese can be considered “gene inventions” (Crucible Group 1994). Some groups, however, believe that the patent system is inadequate to deal with the new challenges evolving the commercial use of biological and genetic diversity. Th ey claim that “an international system created almost 125 years ago to patent machines and factory pots may not be the best system for plants, animals and microorganisms” (Crucible Group 1994, 60) and, therefore, new methods to deal with new challenges should be developed. Th ere is also the opinion that the patent system, and, moreover, the intellectual property (IP) system as a hole, is self-adaptable and fl exible enough to comprise the new challenges in the 21st century, such as gene patenting. It is said that intellectual property is a form of protection, a human right and a social need. Without patents the society would lose the benefi t of inventions and the investment in research and innovation would not happen. Enterprises only expend great amounts in unpredictable research, because they know they can get back their investments through protection mechanisms like patents, which is even more critical when dealing with biological materials. On the other side, some groups oppose to the patent system over biological and genetic resources because consider they as anti-ethical and prejudicial to forms of life. IP systems would, in reality, act as legal monopolies created by the State in favor of the great and powerful, and against the small and weak. Th is mechanism would create a gap between the developed and undeveloped, raising barriers to the entrance of new groups in a similar “kicking away the leader” mechanism, as described by Ha-Joon Chang (Crucible Group 1994, Chang 2003). In this sense, products of basic needs, such as food and medicines, should not be on the reach of patents claim. Some yet consider IP as an important indirect cause of genetic erosion, since it enhances the incentives for commercial plant breeding, driving toward the development of varieties with high commercial and market value. Th ose varieties are, however, concentrated in just a few products and, thereaft er, all the other varieties ends up, somehow, neglected. “To this end, IP results in increased genetic uniformity and, where diversity still exists, more genetic erosion” (Crucible Group 1994, 17).

2.4. Loss of biodiversity and the global response One of the most important documents that tried to address the issue of access to biological diversity and its conservation is the Convention on Biological Diversity (CBD), launched in 1992 (United Nations 1992). Its unfolding, however, was not so positive, and the objective of reducing biodiversity loss was not achieved. On the contrary, some recent indicators even show that biodiversity loss is increasing in some areas. Medicinal plants, for example, are considered one of the resources more in need for conservation, and statistics proves they are on great risk of 250 UFRGSMUN | UFRGS Model United Nations Journal extinction, especially in Southern America and African regions, where the risk of extinction exceeds 40% of species, as pointed out in Figure 2 (Secretariat of the Convention on Biological Diversity 2010).

Figure 2. Conservation status of medicinal plant species in diff erent geographic regions. (Secretariat of the Convention on Biological Diversity 2010, 30)

2.5. Benefi t-Sharing and Traditional Knowledge Th e great amount of biological diversity is located, nowadays, on tropical zones. On the other hand, the biggest companies and research centers, mainly those involved in activities of bioprospecting and gene patenting are located in developed and industrial countries, on temperate zones. It is possible to say, then, that there is a geographical mismatch between centers of biodiversity and centers of research and development (Beattie 2005). Th is fact illustrates the diff erences between north and south countries, which is in the center of most political contradictions concerning biodiversity exploration and gene patenting. Since the State guards the sovereignty over its natural resources, it is claimed that bioprospecting and research activities should only happen with the consensus of the State. Also it is argued that the profi ts arising from these natural resources should be, somehow, divided with the owners of the territory. Th e mechanism of benefi t sharing initially created by the Convention on Biological Convention tries to address this issue. However, according to legal and 251 United Nations Environment Programme jurisdictional principles, the Convention cannot have retroactive eff ect. Th is means that all the products created before the convention based on natural resources from other countries cannot be object of dispute (Crucible Group 1994). Th e mechanism of benefi t sharing relates with the idea that “any commercial benefi t arising from a regional resource must be shared equitably with the region” (Beattie 2005, 287). Agreements over benefi t sharing may involve not only the distribution of a margin of the profi ts, but also several diff erent types of benefi ts such as increase in food production, better health, capacity-building, improvements in education, creation of jobs, etc. Th ose initiatives that promote the transference of technology are one way of trying to overcome this issue. Also, recently was established the creation of an international fund to coordinate initiatives of this kind and also to promote technology transfer. However, still is a very hard task to get the accordance of companies on yield their technologies to other countries (Crucible Group 1994). In addition, State and companies are not the only actors involved in this dispute. Recently has been recognized, within a change in the political scenario, the importance of indigenous and local populations as well as small farmers in the transactions regarding genetic resources (Beattie 2005). Until the CBD, the historical contribution of those communities had not been acknowledged. However, this situation has changed and, nowadays, they are already recognized as important actors (Secretariat of the Convention on Biological Diversity 2010). Th e character and the function that those communities are related also changed over time. Th e old idea of the indigenous population seen merely as a “guardian of the forest” is not enough anymore. Th ose communities claimed and are starting to be recognized as holders of traditional knowledge, therefore challenging the traditional patent system that does not accomplish for this concept (Almeida 2008, Crucible Group 1994). One option is to remark the diff erence between what can be called the formal systems of innovation—the traditional area of research related with scientists, laboratories and public and private institutes—and the informal systems of innovation, encompassing the traditional knowledge and local communities8 (Crucible Group 1994). At the same time, the challenge is to fi nd ways that those two diff erent realms might cooperate and work together, developing new strategies for conservation and sustainable use of biodiversity. Improvements in the patent system through the mechanism of benefi t sharing are part of this process.

3. Previous international action According to UNESCO, the idea of internationalizing heritage protection has 8 Th e idea of ex-situ and in-situ conservation is also part of this dichotomy. Ex-situ strategies stands for methods that keeps the genetic material outside their place of origin, in gene banks, for example, and is related with formal innovation; while in-situ conservation relates with informal innovation and local communities, referring to strategies for conserve biodiversity—and also cultural and social diversity—in its local of origin (Crucible Group 1994). 252 UFRGSMUN | UFRGS Model United Nations Journal emerged aft er World War I, giving birth to the 1972 Convention concerning the Protection of the World Cultural and Natural Heritage, which has legalized the concept of “common heritage of mankind”, as it was said. In Article 6.1, it is stated that, respected the sovereignty and legislation of each State, it is a duty of the international community to co-operate on the protection of common heritage, be it cultural or natural (UNESCO 1972). Moreover, the Convention brought an innovative approach by using the terminology “heritage” instead of “property”, giving not only rights over the shared resources, but also duties regarding their protection and management (Gepts 2004, Lixinski 2008). A key document regarding biodiversity and gene patents is the 1992 Convention on Biological Diversity (CBD), although—as already mentioned—the objective of reducing biodiversity loss is not being achieved. According to UNEP, the CBD “is the main global instrument to date that prioritizes a concern for international justice, through its Article on access to genetic resources and benefi t sharing […] To date, there are 193 parties to the CBD and with such broad support, the convention represents a breakthrough in international politics, which puts common concerns of humanity and their ethical resolution at the forefront of international negotiations” (Schroeder and Pisupati 2010, 7). Besides referring to access to genetic resources and benefi t sharing, the CBD also works on several issues, such as climate change, sustainable use of biodiversity, traditional knowledge and technology transfer and cooperation. Furthermore, like the 1972 Convention, it respects sovereignty over living forms (UNEP 1992). However, one year before (1991), the 1961 Convention for the Protection of New Varieties of Plants was revised. Its idea of life protection is quite diff erent from the two Conventions above, that is, it defends the protection by Intellectual Property Rights (IPRs). Adlhikari argues that “[t]he UPOV [International Union responsible for the Convention] model is suitable only for the developed countries, where farming is a commercial activity, farmers constitute only one to fi ve percent of the total population, and the loss of agri-biodiversity is a non-issue” (Adlhikari 2005, 273). Th e Convention, which was signed by 71 countries, defends IPRs in order to encourage the development of new varieties of plants, aiming the welfare of society (UPOV 1961). Th e IPRs were subject of a crucial international agreement in 1994, aft er being discussed in the Uruguay Round of the General Agreement on Tariff s and Trade (GATT): the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS objective is “to contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations” (WTO 1994).

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Regarding living forms, the Agreement states in Article 27.3 (b) that members have the option to not patent “plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an eff ective sui generis system or by any combination thereof” (WTO 1994). Th e TRIPS has raised a lot of controversial issues which are being discussed until today, specially the article above. Together with the UPOV Convention, these documents are in direct confl ict with CBD, and there is no doubt that they have to be harmonized. Th e clash between them could be organized in four topics—the fi rst one involves sovereignty over biological resources: while the CBD recognizes it, TRIPS overlook it, subordinating biological resources to private IPRs. Second, the CBD institutes a mechanism of sharing benefi ts regarding the use/exploitation not only of biological resources, but also of traditional knowledge, while TRIPS does not have such concern. Th ird, the CBD requires the prior informed consent of the country of origin, while TRIPS again does not have such provision. Finally, CBD places conservation and sustainable use above private interests, while TRIPS does exactly the opposite (Adlhikari 2005, 266). In order to overcome these confl icts in international legislation over biodiversity and gene patents, among other issues, a set of international actions were taken during the past decade, starting with the World Intellectual Property Organization (WIPO) Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC), set up in 2000 in order to discuss “intellectual property issues that arise in the context of access to genetic resources and benefi t sharing (ABS), the protection of traditional knowledge, innovations and creativity, and the protection of expressions of folklore” (WIPO 2000). According to Gepts, this kind of initiative can be explained by the diff erence between the system of innovation and information dissemination of developed countries and the one of indigenous societies or little farmers, that is, the latter does not fi t into a western, developed country IPR system (Gepts 2004). In the same year, the Bill on Access to Biological Resources and Associated Traditional Knowledge was draft ed. Th e Bill not only recognizes the rights of local and indigenous communities over TK, but also strictly prohibits patents over biodiversity and gene patents. Following the Bill concern over the community rights, the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefi ts Arising out of their Utilization were adopted by the CBD in 2002. Th ey were recognized as a useful tool to implement CBD provisions regarding access to genetic resources and benefi t sharing, and it is expected that this discussion continue to be present on international forums (Gepts 2004, UNEP 2002).

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In addition to the CBD, the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), which came into force in 2004, also provides ABS arrangements for genetic resources, focusing on agricultural activity. Its diff erential is the multilateral approach regarding benefi t sharing, “obliging anyone who obtains benefi ts from commercialization based on these resources to pay a predetermined share to a multilateral fund aimed at the conservation of agricultural biodiversity” (Schroeder and Pisupati 2010, 19). Furthermore, Farmers’ Rights were consolidated as a legal concept, recognizing their great responsibility over the conservation and the development of plant genetic resources, which is essential to food production all over the world (Lambrou n.d.). More recently, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefi ts Arising from their Utilization was adopted by the Conference of the Parties of the CBD in 2010, but it still not came into force, giving that it has only 18 ratifi cations by now. Th e Protocol objective is to help put in practice the CBD provisions regarding access and benefi t sharing, insuring the R&D sector and local and indigenous communities they will receive what they deserve. Th erefore, it sets for countries a range of obligations, including to ensure prior informed consent, to encourage contractual provisions on disputes and to monitor the utilization of genetic resources in each stage of the value-chain: R&D, innovation, pre-commercialization and commercialization (UNEP 2010). Th e Conference in Nagoya also has adopted an updated Strategic Plan for Biodiversity 2011-2020, including Aichi Biodiversity Targets. Th e most important target is to cease biodiversity loss, which was not successful until now, as it was said. Moreover, 2010 was declared by UN as the International Year of Biodiversity (Resolution 61/203), in order to prioritize biodiversity in the international agenda. Biodiversity thus remains as a hot topic, but there are still a lot of controversies regarding patents on life that have to be resolved (UNEP 2010). Above all needs, it is crucial that the several international documents about biodiversity and gene patents be harmonized, resolving the confl icts illustrated in the CBD vs. TRIPS debate. Th erefore, the question primarily rose—who should benefi t from biological and genetic diversity—remains unresolved.

4. Bloc positions Th e broader discussion over gene patenting and biodiversity may be addressed from two diff erent confl icting positions: on one side, the developed countries, rich in technology, have the greatest potential to make economic use of biodiversity, through activities such as genetic engineering or pharmaceutical production. Th e Intellectual Property Rights (IPRs) protect and encourage investments through a revenue system, most complacent with developed countries reality. On the other side, however, the emerging and undeveloped countries are usually rich in biodiversity, which is closely related with cultural diversity and traditional 255 United Nations Environment Programme knowledge. Th ese countries, most of the times, do not have the necessary technology to take profi t from its own natural resources (Gepts 2004). Furthermore, private companies, most of them from developed countries, have historically explored much of this biodiversity for economic purpose. Also, the local communities, like indigenous communities, are taking active part on the discussion, claiming their sovereignty over the land where they live, demanding attention and more eff ective measures from their National States and from international organizations. With that in mind, there are also several particularities concerning each State that shall be addressed next. Th e European Union member states—as Germany, France, United Kingdom, Sweden and Turkey—have its patent activity coordinated by a supranational body, the European Patent Offi ce (EPO), a uniform application procedure for all the 40 European countries (European Patent Offi ce 2013). Th e European Law regulates the legal protection of biotechnological inventions, including gene patenting. In this case, “biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature” (European Parliament 1998). In Europe, 16% of its patent activity relates to biodiversity, including those from pharmaceutical activity and sectors as agriculture, cosmetics and biotechnology (European Environment Agency 2010). European countries also hold a great capability in pharmaceutical sciences and genetic crop improvement. Some of the major pharmaceutical companies and seed companies are located in countries like United Kingdom, Sweden, France and Germany (Gepts 2004). In the United States of America there are more than 47,000 patents on inventions involving genetic material. Th is country has a historical tradition on regulating gene patenting, with the fi rst one dating from the beginning of the 20th century, registered on the U.S. Patent and Trademark Offi ce (USPTO) (Gepts 2004). Th ere are also cases of patenting whole organisms, like plant species and genetically modifi ed bacteria. Recently, however, the U.S. Supreme Court decided that human genes cannot be subject to patenting, which may also have impact over gene patenting of plants, bacteria, animals and other natural organisms (Th e Levin Institute 2013). Th e United States patent system, however, remains acting upon its basic principles, which are to provide incentives to innovations by guaranteeing the opportunity for inventors to recover their costs on R&D investments (Saez 2013). Diff erent from USA, which is not party on the Convention on Biological Diversity (CBD), Canada is a state member of the Convention and has put a great eff ort on advancing the situation on utilization of genetic resources and benefi t sharing (Canada 2009). Canada’s territory encompass a great amount of life diversity around its several ecosystems, and has, therefore, tried to develop mechanisms of biological conservation in accordance with the Aboriginal people that occupy this land. Although there are some struggles between Canadian

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State and its indigenous people (Saez 2010), the country supports Indigenous participation on its delegation and puts a great eff ort on developing institutions responsible for incorporating measures of access and benefi t-sharing among with the Aboriginal Canadian people (Convention on Biological Diversity n.d.). In accordance with the other OECD countries, Japan provides patents over genes since the 1990s. Th e Japanese law has a broad defi nition for innovation, which permits to include isolated genes derived from nature on this category (Gold and Carbone n.d.). Japan is one of the countries with higher level of patent claims, especially regarding marine organisms, which accounts for almost half of Japanese patents (Arnaud-Haond, Arrieta and Duarte 2011), and eff orts have been recently made to increase the research and applications of gene patents (Japan Information Network 2000). On this regard, the Japanese Patent Offi ce made a joint statement along with European and U.S. Patent offi ces rejecting the argument that genes cannot be patented because they can be found in nature and reaffi rming that the capacity of isolating a gene creates the condition for it to be patented as any other chemical compound (Gold and Carbone n.d.). As already mentioned, most part of the world’s biodiversity is located in the territory of developing nations. Brazil’s biological diversity is the largest one in the world, owing almost 23% of the planet’s biological resources. In this regard, this Nation State has several interests in addressing the issue of preserving biodiversity in consonance with economic development, through the regulation of IPR system for biopatents. Along with other developing countries, Brazil, supported by other countries from Latin America, urges that the obligations in the TRIPS Agreement should become consistent with the Convention on Biological Diversity, and that mechanisms of ABS related to traditional knowledge are better institutionalized (GRAIN and Kalpavriksh 2002, Gosain 2002). Although Brazilian law doesn’t permit the patent of living beings, and establishes that any access to Brazil’s genetic resources has to be authorized by the Federal Government, the country has been a target of biopiracy several times, with Brazilian plants being patented and commercialized in other countries, such as USA and Japan (Gosain 2002). Th e eff orts to monitor and stop biopiracy have not shown effi ciency in Brazilian territory, and the attempts to create a system for protecting the traditional knowledge of indigenous people have been made via cooperative agreements between the local communities, the governments and third parties interested in exploring their resources (Gosain 2002). Th e People’s Republic of China is also one of the countries with the largest share of biodiversity in the globe and also refuses patents to “life forms”, although gene patents are allowed (Fowler 2010). Th e level of patent activity in China has increased in the last years, and among with other developing nations like Brazil and India, China has become an active player in the matter both at national and international level (Oldham 2006). At the same time, the Chinese economical project has a strong commitment in building strong national biotech industries,

257 United Nations Environment Programme attracting international partnerships and establishing an active participation in international negotiations over trade and benefi t sharing (World Health Organization 2013). Regarding international measures to improve its scientifi c research and promote the goals of biodiversity, the China National Genebank has established international partnerships, increasing the Chinese biorepository (BioSpectrum Bureau 2013). India, along with Brazil and China, is a developing country trying to achieve a higher level of competence in gene-based research and its applications (World Health Organization 2013). Despite that, India’s national law has a specifi c device that prevents the granting of biopatents and does not permit the patent of genes or cells (Fowler 2010), since it doesn’t consider traditional knowledge as a patentable invention (Costa and Bastos 2012) due to the cultural “recognition that the bulk of the work had already been accomplished by generations of anonymous experimenters” (Shiva n.d.). India’s great biodiversity has also been a target of biopiracy. Th e most classical case involves the patenting of a chemical compound from the Neem Tree (Azadirachta indica) and its byproducts by American and Japanese companies (Shiva n.d.). In this regard India, together with other Asian countries, adopts the position of asking for a complete review of the TRIPS Agreement, so this document can be harmonized with the CBD (GRAIN and Kalpavriksh 2002). Australia possesses a huge biological diversity, including several diff erent ecosystems like rainforests, deserts and marine habitats, and also a great cultural diversity, with several indigenous communities living in the country (Janke 1999). Australia is considered a developed nation and recognizes the role of the patent system as a contributor to conserve biodiversity through the mechanism of benefi t sharing. Australia’s legislative framework focuses on guaranteeing that the sharing of benefi ts arising from commercial use of biodiversity is respected within patent agreements (Lawson 2010). At last, the National Strategy for the Conservation of Australia’s Biological Diversity recognizes the contribution of indigenous people to the conservation of Australia’s biodiversity, while respecting the principle of National sovereignty over the biological resources (Janke 1999). On the rest of the South Pacifi c region, occurred several attempts to make this a “life form patent free-zone”, which culminated in the Treaty on the Life- Forms Patent-Free Pacifi c and Related Protocols (GRAIN and Kalpavriksh 2002, Mead 1996). Papua New Guinea, along with others islands of the region, have to deal with the situation of conserving their great biological and cultural diversity, while part of this resources are economic explored and patented by international companies9, pushing these countries to fi nd a common solution in order to harmonize the cultural and intellectual rights of the indigenous people along with the current international patent system (Mead and Ratuva 2007).

9 Th e classical case of gene patenting involving Papua New Guinea is the Hagahai patent case. For more information, see Pareake and Ratuva (2007). 258 UFRGSMUN | UFRGS Model United Nations Journal

Th e African continent has an enormous diversity of biological resources, being home to a quarter of world’s biodiversity, with many of endemic species, which means they occur nowhere else on earth (Wynberg 2000). Most part of those resources has economic value, and is used by the local inhabitants, or exported around the world as raw materials that can be used by research institutions and transnational corporations in developed countries. African countries have played an infl uential and strong role in international discussions about gene patenting and biodiversity, coordinating their eff orts and adopting a common position, rejecting the patenting of life forms and arguing that the CBD should have supremacy over the TRIPS (Egziabher 1999), in order to exclude microorganisms from patentability and trying to fi nd a way that patent systems can also protect the innovations and practices of farming communities (Wynberg 2000). Th e biggest challenge for African countries, however, is the lack of appropriate national legislations to regulate the matter of biopatents and access to natural resources, making these nations very susceptible to biopiracy (Egziabher 1999). Th e necessity of reinforce the sovereignty of African countries over their natural resources has been addressed from a regional perspective, with documents and organizations10. South Africa stands as an example in this context, due to its recent eff orts in creating a legal framework to comply with the CBD through the South African Biodiversity Act (2004) and the Patents Amendment Act Number 20 (2005), which regulates the “access by foreign companies to indigenous biological resources by requiring them to comply with access and benefi t sharing regulations” (Groenewald 2008) and ensures that African communities are compensated when the inventions are derived from traditional knowledge (Spoor 2008). Besides that, South African has a well-developed bioprospecting system that combines the country’s rich biodiversity with its advanced institutional and research capacity. Th eir system of protected areas to coordinate the collection of genetic resources for commercial purposes poses as an example of institutional initiative to regulate bioprospecting activities at national level (UNU/IAS 2003).

5. Questions to ponder How this committee should address the will of local and indigenous communities to take more active participation in the discussions and decisions regarding biodiversity and gene patenting? What new mechanisms of procedure can be established to include these groups opinion on the directives, especially those about traditional knowledge and benefi t sharing? In which sense this committee perceives the relation between gene patenting and conservation of biodiversity? Th e entire system of gene patenting and Intellectual

10 Some examples are the “African Model Legislation for the Protection of the Rights of Local Communities, Farmers and Breeders, and for the Regulation of Access to Biological Resources”, developed by the OAU, and the multi-national organizations OAPI (African Intellectual Property Organisation) and ARIPO (African Regional Intellectual Property Organisation). 259 United Nations Environment Programme

Property Rights should be seen as a threat to biodiversity or as a mechanism of safeguard? Considering the obligations of UNEP with environmental preservation, what kinds of actions should be taken to address this matter? Th e international agreements of TRIPS and the CBD propose diff erent approaches to address the issue of gene patenting. How this committee should deal with those diff erences? What measures could be taken to overcome the discrepancies of those documents, contributing with their harmonization? How this committee should perceive the diff erent strategies for conserving biodiversity—e.g. gene banks and in situ conservation? What other options there are? How they relate with the challenges posed by the system of intellectual property rights?

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Abstract During the last decades, there has been a signifi cant change in biodiversity governance: from the “common heritage of mankind”, biodiversity is becoming a resource subject to national sovereignty and Intellectual Property Rights. Bioprospecting is increasingly supported by laws and measures, at both national and international levels, involving ethics, patenting, and benefi t-sharing. Th is change, led not only by scientifi c development but also by policy and judicial changes, isn’t occurring without controversy, and the main question is who should benefi t from it: government, community, patent holders, or just nature itself. Among all causes of disagreement, the fi rst question is over the nature of biodiversity patents, whether genes or organisms are appropriately classifi ed as patents, both being natural in themselves, and therefore challenging the basic criteria of novelty, inventiveness, and utility. Th e second issue is how to distribute properly the benefi ts of bioprospecting. Ideally, patents can promote eff ective benefi t sharing by supporting the development of new products and processes to society. Finally, at the national level, there is the issue of traditional knowledge, coming from local and indigenous communities who conserve and utilize biodiversity in a sustainable way.

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