Rights and Ethics in the Patenting of Medicine - Essay Example

Rights and Ethics in the Patenting of Medicine Introduction Both manufactured and natural medicines are obtained from the biodiversity of the tropics and subtropics. Natural substances and the plants they are derived from are biogenetic resources consisting of both biochemical and genetic resources. Indigenous healers and shamans have extensive knowledge of natural medicines using local , materials, for curing health conditions. Western scientists frequently attempt to seize the information and patent the chemical cures extracted from biogenetic resources obtained from rainforests. This opposes indigenous value systems which promote the collective management of biodiversity (Carrizosa, Brush, Wright & McGuire, 2004). Intellectual property rights (IPR) related to indigenous medicines concern biogenetic resources available in nature and as commercial products. IPR includes practical applications of biogenetic resources, and traditional knowledge (TK) about natural medicine and the biodiversity of subtropical and tropical regions such as rain forests. Businesses using biogenetic resources are the prime users of intellectual property rights (IPRs) including “patents, plant variety protection (PVP) or plant breeders’ rights (PBRs), copyrights, trade marks and trade secrets” (Dutfield, 2004, p.11). Thesis Statement: The purpose of this paper is to investigate intellectual property and ethics in the patenting of medicine derived from indigenous biogenetic resources of the tropics and subtropics. Whether western scientists or indigenous people should get the patents of these medicines, will be determined. Protecting the Rights to Indigenous and Traditional Knowledge The World Health Organization indicates that approximately 80 percent of the world’s population depends on traditional medicine for its primary health care. Some traditional medicines are used in biomedical research, being sources of chemical substances with therapeutic value (Soetan & Aiyelaagbe, 2009). Therefore, traditional medicines are economically highly profitable. Indigenous communities are responsible for discovering, developing and preserving an extensive range of medicinal plants, herbal health formulations and other compounds from agricultural and forest products. These are traded internationally, thereby generating high economic value; however, due to unfair exploitation of knowledge about traditional medicines, the profits do not reach the indigenous communities who cultivate and develop the medicines (Dutfield, 2004). Indigenous people with traditional knowledge are not viewed by western scientists as authors of that knowledge, but are considered to be passive guardians of the same. Western scientists should acknowledge that indigenous people are productive inventors since they have worked on their natural resources to produce effective and valuable medicines. Therefore “traditional knowledge is not raw or passive knowledge” (Jiang, 1999, p.5). As a result, the legal perspective is that Traditional Knowledge is dynamic, with indigenous communities transforming the knowledge, which continues to change and evolve with further advances. Therefore, there is a need for legal protection of intellectual property rights of biogenetic resources in developing countries. For example, the biopiracy of anti-diabetic medicinal plants has been confirmed by research conducted by Mahop and Mayet (2007) in the Eastern Cape Province, South Africa. Further, the indiscriminate harvesting of naturally growing flora in forests and other areas results in severe loss of habitat and genetic diversity. According to Okigbo, Eme and Ogbogu (2008), several African medicinal plants such as Ancistrocladus abbreivatus, a Cameroun plant with anti-HIV potential are well known in the international markets. Similarly, research was conducted by Amusan, Sukati, Dlamini et al (2007) on Swazi phytomedicines to treat various health disorders. Such valuable, endangered medicinal plant species require sustainable management and conservation procedures as well as research and teaching, since they are potential therapeutics and due to the worldwide reliance on traditional medicinal plants for health. It is crucial that the traditional knowledge that indigenous communities have developed over several centuries of practice should be accepted and incorporated into the international intellectual property regime. Instead of using defensive measures, the possessors of traditional knowledge should use proactive techniques for protecting their interests. It is essential that the international community recognizes the importance and value of traditional knowledge as intellectual property by defining traditional knowledge in the context of a government issue, strengthening the Convention for Biological Diversity (CBD), or by revising Trade Related Intellectual Property Rights (TRIPS). Traditional Knowledge being a valuable natural resource in the third world, the economic development of these regions can be accelerated by firstly recognizing the rights of poor and indigenous people (Jiang, 1999). The main challenge is to ensure appropriate recognition of the cultural and intellectual contributions of traditional communities (WIPO, 2006). Intellectual Property Rights should take into consideration the close linkage of indigenous communities with the natural environment, enabling Tradtional Knowledge to form the basis of a sustainable and appropriate tool for locally based development. Thus, developing and poor countries should be able to benefit from the knowledge economy. The Significance of Intellectual Property Rights Patents and plant variety protection are vital aspects of intellectual property rights. “Patents provide inventors with legal rights to prevent others from using, selling or importing their inventions for a fixed period of approximately twenty years” (Dutfield, 2004, p.11). To patent a new invention or discovery, the applicant has to fulfill the requirements of a national patent issuing authority about the medicine, product or plant derivative being new, with potential for useful application which was at a level higher than the present knowledge about the product, and it was not already known to skilled practitioners in the field. Particularly in the case of life science firms, patents help to achieve high returns on their research and development investments, because of the high cost of the process of discovering new products, developing them and acquiring regulatory approval to sell them. Towards achieving universal human rights, treaties, conventions, statutes and other sources of international law are legally binding on states that have agreed to them. These instruments are contracts defining the rights and freedoms of individuals and communities, and may be bilateral between two parties, or multilateral between many States and open for any State to sign up to at any time (Smith, 2009). The Department of Foreign Affairs and Trade (2004, p.18) reiterates that “from a human rights perspective, the most important source of international law remains treaty law” used for international conventions or treaties, and secondly law related to international custom. Several international agreements relate to patents, the most important being Trade Related Intellectual Property Rights (TRIPS) and the 1883 Paris Convention for the Protection of Industrial Property. Plant variety protection (PVP) systems protect new plant varieties which are unique, uniform and stable. The Union for the Protection of New Varieties of Plants (UPOV) Convention is responsible for new plant variety protection. Both these types of intellectual property rights: patents and PVP, are for a limited period of time (Dutfield, 2004). The UPOV’s rules define in specific detail the legal system necessary for countries to provide, for being members of the Union. Intellectual Property Rights: Do they Protect Traditional Knowledge? Treaties and the development of international norms consider the legal and ethical imperatives for protecting traditional knowledge. Developing countries feel motivated to protect Traditional Knowledge for the following reasons. First, there is a requirement to improve the livelihoods of traditional knowledge holders and communities. Secondly, protecting Traditional Knowledge can benefit the national economies. Thirdly, vital environmental conservation can be undertaken. Fourthly, biopiracy has to be prevented through protecting TK. Thus, there are crucial reasons for the government to protect Traditional Knowledge, but the process cannot be undertaken in isolation of the more fundamental needs, interests and rights of the holders of TK such as land rights, and the innovations, practices and technologies of their communities (Greene, 2002). At the same time, Intellectual Property Rights do not provide opportunities that traditional people and indigenous communities can avail of. The issue of Traditional Knowledge protection in the context of western intellectual property rights needs to be based on a wide spectrum of negotiations between traditional people and communities, national governments, businesses and scientists. Negotiations should openly and comprehensively address the most primary concerns of indigenous communities and people including self-determination for the indigenous people, their territorial rights and human rights. However, from the planning to the implementation stages, several challenges to the protection of Traditional Knowledge are presented by IPRs, relating to copyrights, patents, trade secrets or undisclosed information, trade marks, geographical indications, plant variety protection, and utility models (Dutfield, 2004). Significantly, one of the reasons why IPR cannot protect Traditional Knowledge is the collectivist approach of indigenous people. Indigenous societies believe that each member has individual rights and collective responsibilities that are linked to each other. This is in contrast to the western individualistic approach to creativity, and ownership of the end-product of that creativity. The formal Intellectual Property Rights system is not feasible among indigenous people, since it is related to collective responsibilities and the collective nature of customary rights over Traditional Knowledge. Further, if present, individual property rights over traditional knowledge will frequently be accompanied by certain duties. Additionally, the sources of Traditional Knowledge are difficult to trace because “either two or more peoples or communities share the knowledge, or because the originator is simply unknown” (Dutfield, 2004, p.96). Further, in order reinforce the distinctiveness of Indigenous Knowledge as different from western knowledge, it is generally overlooked that “indigenous knowledge like all knowledge is changeable and permeable” (Anderson, 2009, p.7). Moreover, indigenous interests are based on vastly different social and cultural experiences, ontologies and epistemologies. Thus, the category Indigenous Knowledge is an unstable one, and this instability is reflected in Intellectual Property Law in general which struggles to manage and find appropriate solutions for problems related to indigenous knowledge experienced at more localized levels. This is reiterated by Blakeney (2000), who states that indigenous people and other traditional communities have widely different perceptions and views. Some indigenous groups do not attribute authorship to a human being or a group of people. They normally attribute authorship to the creator spirit or to pre-human creator ancestors, replacing authorship with interpretation through initiation. Indigenous People’s Self-Protection of Traditional Resource Rights Among indigenous communities, the concepts of Traditional Resource Rights, community Intellectual Property Rights, Community Intellectual Rights, and the model provisions represent alternatives to Intellectual Property Rights. These concepts are able to address more adequately the concern of traditional communities to prevent others from privatizing their knowledge and resources. Among the above concepts and related measures, the Traditional Resource Rights (TRR) concept is more comprehensive and subsequently more effective in several ways. It underscores the right to self-determination, including territorial and human rights. Further, it has a broad coverage, encompassing the rights to protect not only knowledge and biogenetic resources but also cultural property, folklore, and even landscapes. At the same time, Traditional Resource Rights concept does not eliminate the need for Intellectual Property Rights, but includes IPR as one of several rights (Posey & Dutfield, 1996). According to Timmermans & Hutadjulu (2000), it is essential to formulate governmental legislation protecting a country’s biodiversity assets unique to certain geographic locations through the use of geographical indications. This refers to the use of a place name to describe a product as distinct in quality and/ or specific traits. Access and Benefit-Sharing for Both Bioprospectors and Providers Towards a transition from an era of confrontation between developing and industrialized countries to an era of cooperation, their mutual interdependence and synergy of working together is promoted by global intellectual property law. According to Curci (2010), developing countries willing to transfer genetic material and indigenous knowledge, commonly favor the creation of legal conditions that promote the local exploitation of patents. This measure is considered to be more effective, and in compliance with the goals of Trade Related Intellectual Property Rights (TRIPS) and the benefit-sharing obligation ruled by the Convention on Biological Diversity (CBD), than royalties or lump-sum payments. Developing countries are often rich in biodiversity and poor in technology. They exchange their Traditional Knowledge such as information on the germplasm, with the technical and commercial knowledge exemplified by the biodiversity-based new products and processes developed by industrialized countries rich in technology and frequently lacking in biodiversity. Thus, equitable profit sharing is achieved both by bioprospecting companies from advanced nations and provider countries which have the authority to determine access to their genetic resources. Further, only through negotiation of agreements between provider States and bioprospectors can the former’s biological resources be accessed. However, the international obligations of international patent law have to be complied with. Among the different types of statutory contractual provisions, “the local working of the patent” is considered to be the most effective in establishing the production in situ or in the same location, “of the biodiversity-based innovative products patented by a foreign company” (Curci, 2010, p.106). Conclusion This paper has examined intellectual property and ethics in the patenting of indigenous medicines. The various issues investigated include the crucial need to protect indigenous people’s rights to their traditional knowledge, the significance of intellectual property rights, why intellectual property rights are able to offer protection of traditional knowledge only to some extent, the need for indigenous people to undertake self protection of traditional resource rights, and equal access as well as benefits-sharing between indigenous people and bioprospectors from developed countries. The intellectual property framework provides support for indigenous self-protection, allowing the exercise of control over the uses and circulation of Traditional Knowledge. However, Anderson (2009) cautions that legal frameworks alone are inadequate in ethically promoting indigenous rights, since social and cultural norms have to be reconciled with. For example, it is necessary to include the vast body of intangible knowledge resources also termed as folklore, and the collectivist approach of indigenous communities in bestowing authorship to the creator spirit or ancestors. Therefore, the most suitable measure for intellectual self-protection by indigenous people is a broad spectrum instrument such as Traditional Resource Rights which includes Intellectual Property Rights. Finally, it has been identified that there is a requirement to promote profit-sharing and access to indigenous medicines and traditional knowledge both for the providers as well as for the bioprospectors. The groups who have an interest in Traditional Knowledge should not oppose each other as rivals, but need to work together as partners for achieving best outcomes for all concerned. Therefore, it is concluded that neither western scientists alone nor indigenous people solely should get the patents for indigenous medicines. Both groups should benefit from the traditional knowledge which contributes to further research and development in medicine for worldwide use. ---------------------------------------------- References Amusan, O.O.G., Sukati, N.A., Dlamini, P.S. and Sibandze, F.G. (2007). Some Swazi phytomedicines and their consequences. African Journal of Biotechnology, 6(3): pp. 267-272. Anderson, J.E. (2009). Law, knowledge, culture: The production of indigenous knowledge in intellectual property law. Massachusetts: Edward Elgar Publishing. Blakeney, M. (2000). Protection of traditional knowledge under intellectual property law. European Intellectual Property Review, 22: pp.251-261. Carrizosa, S., Brush, S.B., Wright, B.D. & McGuire, P.E. (Eds.). (2004). Accessing biodiversity and sharing the benefits: Lessons from implementing the Convention on Biological Diversity. Issue 54 of IUCN Environmental Policy and Law Paper. 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