Policy Issues

Biopiracy

 

The Amazon’s wealth is contained not just in its biodiversity, but also the wide scope of indigenous knowledge accumulated over thousands of years. This traditional knowledge is part of the Amazonian indigenous communities’ culture and is developed based on extensive interaction with nature and experience (Ebermann, 2012). However, this knowledge also makes the commercialization of the Amazon’s biodiversity more economically viable on an international scale because pharmaceutical drugs and other products can be developed more quickly and with less research funding. This leads to widespread abuse of indigenous knowledge through biopiracy. Intellectual property law, which is supposed to protect personal innovation, has a more difficult time protecting traditional knowledge because human knowledge cannot be characterized as a novelty or individual invention. In recognition of this, international agreements have been ratified and Brazilian laws have been passed to try to protect native knowledge and allow for just compensation for the use of indigenous knowledge in patentable products. The 1993 Convention on Biological Diversity and 1995 Agreement on Trade Related Aspects of Intellectual Property Rights both have regulations that should allow for greater dialogue between the different corporations, the Brazilian government, and the indigenous groups, but they haven’t been implemented in Brazil by an international or domestic organization powerful enough or willing to maintain the regulations (Sampath, 2005). The effectiveness of these measures has been hampered by politics and problems in the region.

The Brazilian laws have been impeded by the disagreement between different facets of society as well as fragmentation of the laws themselves (Garrafa, 2010; Finetti, 2011). This is especially important in Brazil because of the extensive amount of pharmaceutical research that occurs in the Brazilian Amazon. Biopiracy in Brazil by companies from the Global North can prevent Brazil from holding patents on major pharmaceutical advancements, and many of these innovations would help Brazil’s own research. Also, pharmaceuticals from the Global North can become too expensive for small communities; products made from indigenous people’s own resources and knowledge can be put out of their reach by the inflation of drug prices (Staral, 2012). To rectify this, Brazil has signed international agreements and has passed numerous intellectual property and patent laws pertaining to biopiracy (Sampath, 2005). In this paper, I will argue that the main barrier to effective intellectual property policy in Brazil is the lack of full implementation and enforcement of the laws, which is largely a product of international and domestic political gridlock. This will be shown by first explaining the mechanics of patent policy and why it is needed, followed by an evaluation of Brazilian policy and its shortcomings.

The principal way a country can limit biopiracy is through intellectual property right law; intellectual property (IP) rights can be used to regulate the use of resources and traditional knowledge, as well as address benefit-sharing issues between a company and group of indigenous people. This is done through a patent system, where new ideas are registered and protected by the government. Patent law comes from a combination of a country’s constitution, federal statues, and case law regarding IP rights (Mgbeoji). A proper IP system leads to intellectual innovation when the legal system promotes free competition, and can actually encourage investment by the local people in maintaining their traditional lifestyles, which in turn helps to preserve indigenous culture (Ebermann). Indigenous culture has become reliant on small communities that find original ways to use natural resources. Local communities who are dependent on natural resources have developed ways to sustainably manage resources and can provide that information to other users; in this way, traditional knowledge can significantly lower the costs of pharmaceutical research and development projects. However, it is extremely difficult to protect inventiveness in biotechnology patenting, which is the core problem that leads to biopiracy.

Discoveries in biotechnology are often the result of cumulative research, and the use of traditional knowledge can contribute in different degrees. Patent law is intended to protect inventions, not discoveries, and natural substances are only considered inventions if humans significantly alter them. The product of the invention must also be defined as “novel” by the patent system, so traditional knowledge often does not qualify (Finetti, 2010). There are several strategies a government can implement to circumvent this problem. The property rights approach addresses the problem of knowledge that is not innovative enough to fall under contemporary patent law, but requires definitions of “innovation” that are too broad in scope to actually protect indigenous knowledge from exploitation. The liability-based approach regulates specific compensation for the use of resources, and does not give the owner the right to exclude others from using the resource; when someone outside of the agreement wants to use the resource, the owner receives compensation (Ebermann, 2012). Mandatory benefit-sharing, which is when the company is required to negotiate benefits given to the indigenous before they begin research, can raise the cost of research and therefore products and puts an undue burden on the legal system; however, this is still considered the best approach that is currently being used on a global scale because it guarantees some degree of just compensation (Ebermann, 2012; Mgbeoji, 2006). All of these strategies have positive and negative aspects on IP protection, but they all provide some degree of protection to the indigenous.

The need for an international system of patents came from globalization and the growing prominence of international trade; the lack of an international patent system can actually work as a type of non-tariff trade barrier. When companies unfairly copy technology, including biotechnology, they can flood the market with cheap replicas of a product and reduce the competitiveness of the market (Ebermann, 2012). This means that as soon as an item begins to be traded globally, it needs international protection, which is why the patent process began to be internationalized almost as soon as it was initiated. The internationalization of the patent is explained by Mgbeoji, a professor of law at York University, as three stages of evolution: first, “the primitive era of patents”, followed by “the development of multilateral treaties on patents”, and finally “the linkage of trade and intellectual property rights” in the 1990s that pushed patent rights over biocultural resources into full globalization. However, even the third stage only provides a framework for regulatory systems; regional, domestic, and local laws need to be put in place to enforce those regulations (Mgbeoji, 2006). In the global economy of today, of which Brazil is a part, protecting intellectual property on the domestic level only will not be sufficient; international agreements need to be made and enforced on the domestic level for innovation to be truly protected.

Brazil’s current IP system severely underregulates the protection of indigenous knowledge, which has led to a particularly high number of instances of biopiracy in the Amazon. One of the most serious deficiencies is the fact that Brazil does not allow patents on plants, only transgenic microorganisms; Brazil also makes no provisions for biological material removed from the country to be used in other countries. This leads to companies using “virtual patents” on biological products; if a researcher discovers a process with a specific product, then they patent the process; this means that they have a virtual patent on the product as well, even if it has no application relevant to the process (Hathaway, 2004). The patent system in Brazil was specifically designed to favor industry, but that means that no legal measures were put in place for community rights over knowledge, which is how indigenous groups share knowledge (Hathaway, 2004). Exploitation of the Amazon’s biodiversity of life and knowledge is fairly common; plants are often taken from the Amazon, rudimentarily processed nearby, and then exported to the US or other countries to be used in pharmaceuticals. This system encourages deforestation so that patches of specific plants can be planted, and leads to a loss of biodiversity (Hathaway, 2004). In addition, bacteria have been taken from the Amazon, brought to the US by pharmaceutical companies, and patented and reproduced in the US (Adejoke, 2013). It is estimated that biopiracy in Amazonia costs Brazil $16 million USD per day, mostly due to a lack of policy and poor enforcement of what protections they do have (Danley, 2011). Much of this lost revenue could be going to the indigenous in the form of benefit-sharing compensation, which would lead to an overall stimulus in local economies. The problems caused by biopiracy could be fixed with effective policy, but the combination of weak international agreements and insufficient domestic policy has prevented Brazil from protecting its natural resources.

The Convention on Biological Diversity (CBD) is an international treaty that was written in Rio de Janeiro in June 1992, with the aim of conserving biodiversity on an international scale by promoting sustainable use and benefit sharing (Finetti, 2011). The most important aspect of the CBD is its recognition that conservation and sustainable use of biodiversity can only be handled within the economic context of biodiversity; companies are driven by a need for profit, and policies need to recognize that market-driven factors drive research and development (Sampath, 2005). This is done through a system of regulated benefit sharing; Article 15 of the CBD mandates that access to a genetic resource be divided on mutually agreed terms and be subject to prior informed consent of the group providing access to the resource. The main flaws in Article 15 are that it does not explain the relationship between generating revenue and conserving biodiversity directly and it does not define appropriate compensation for the use of genetic resources (Finetti, 2011). The CBD also purposely left specific regulations to the decision of the countries who ratified it; this was a deliberate decision, because policies vary from country to country. This means that in order for the CBD to have solvency, each country needs to pass and enforce legislation relating to its regulations.

Unfortunately, Brazil has been unable to pass any legislation that directly enforce CBD goals because of domestic political gridlock, which means that the CBD has been largely ineffective in preventing biopiracy in Brazil. The closest Brazil has come is legislation in 1995 that was unanimously approved by the Federal Senate, but was never even debated in the Chamber of Deputies and has been left untouched ever since (Hathaway, 2004). Brazil is neither implementing the regulations on a national or local scale that are outlined in the CBD, nor are they participating in the international information exchanges initiated by the CBD and continued by most countries. These exchanges have led to international rules being debated and revised to take traditional knowledge into account and hold governments responsible for implementing the CBD, but Brazil is unable, or perhaps unwilling, to participate in these talks. The final problem with the CBD lies with the US; although the US participated in the convention, the US Congress never agreed to ratify the CBD. Because most of the major pharmaceutical companies in the Amazon are American, this means that many of the benefit- sharing regulations would still be extremely difficult to enforce (Danley, 2011). The CBD’s groundbreaking objectives have had few positive effects in Brazil, for the most part because of the lack of participation of the government; without international cooperation and enforcement legislation, the CBD will never be effective in Brazil.
The second main international agreement, passed in 1995, is the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which was negotiated at the end of the last World Trade Organization (WTO) round (Finetti, 2011). TRIPS aims to ensure that IP rights are protected and enforced and technological innovation maintained. It was written to partially amend, add to, and change the CBD; some of the new rules included are an expanded scope of trade-related IP rights, more means for enforcement, multilateral dispute settlements between governments, and measures to get more international participation. Overall, TRIPS strengthened patent protection in WTO countries, which is especially important considering the number of developing countries who are WTO members. IP law is particularly significant in the developing world because many of the governments have little to no patent protection or enforcement, but these countries contain a substantial amount of the world’s biodiversity (Sampath, 2005).

Many of the problems Brazil has with the CBD also apply to TRIPS; there are very few ways the government is enforcing its mandates, and TRIPS itself contains some major loopholes. The agreement tries to deal with all biopiracy cases on an international level within WTO courts, but treating these cases the same way is usually unsuccessful and it is extremely difficult to find agreement within the current WTO round of negotiations (Sampath, 2005). Brazil specifically has issue with Article 27 of TRIPS; this article allows for plant varieties to be patented, but never mentions any form of benefit-sharing or compensation to indigenous users. This provision is in direct conflict with the CBD, and Brazil along with several other WTO countries is working to amend Article 27 (Danley, 2011). TRIPS also made very little progress in dealing with the definition of traditional knowledge; despite this being one of the main issues with biopiracy, there is no explicit mention of traditional knowledge in TRIPS, and it is treated like all other ways of innovation (Ebermann, 2012). Despite the improvements TRIPS was supposed to bring to IP protection and prevention of biopiracy, it can actually be considered a setback because of the international disagreements and gridlock surrounding some of its measures.

While Brazil clearly has not been successful in using international agreements to prevent biopiracy, some of Brazil’s domestic measures could be considered effective IP policy. Unfortunately, despite the fact that they were considered achievements when passed, even these policies have proven fairly ineffective in the long run. The sui generis system, which is a policy system that focuses on flexibility rather than one defining characteristic, is considered the greatest strength of Brazilian patent and IP system by University of New Hampshire Law professor Oyewunmi Adejoke because the text of Brazilian law code encourages research and analysis of the indigenous knowledge, which is supposed to lead to more protection. However, the report goes on to say that it is almost impossible to enforce Brazil’s system, which is why the article advocates for a combination of the Brazilian flexibility with South African methods of enforcement (Adejoke, 2013). There are two main efforts in Brazil to enforce biopiracy legislation, as described by economist David Hathaway. In 2000, a provisional law was passed that regulated access to genetic assets. This meant that foreigners could only bioprospect, or work with the indigenous to carry out research and development in a healthy way, if they were associated with a Brazilian research institution; however, there were no penal sanctions included in the legislation for companies who weren’t in accordance with the legislation, and nothing specific against the act of biopiracy itself. Later, in 2002, the Novartis Act began to be used as a law, but it was never voted on by the National Congress, and anyone who disobeyed the rules outlined were never punished. A Provisional Measure was passed by the President in an attempt to legitimize the act, but a Provisional Measure still has little validity until Congress approves it to become law. The Novartis Act allows communities to decide how traditional knowledge can be used by scientists or companies; this would be an important protection for indigenous communities in the Amazon, but since it is never regulated, there is little effect (Hathaway, 2004). These domestic policies have been just as ineffective as Brazil’s international agreements and have taken just as much political capital to pass through the government.

Biopiracy is not a new issue in Brazil, and it will continue to be a problem if their policy solutions continue to remain unenforced and mired down in political conflict. This means that indigenous groups who have used natural resources for years will not see benefits from their discoveries and large corporations will continue to abuse the Amazon to succeed on the global market. Nevertheless, Brazil has the tools necessary to effectively regulate biopiracy; if the CBD or TRIPS regulations were properly enforced in Brazil, even the recognition of community rights would help the indigenous significantly in protecting their traditional knowledge. A movement in Brazil toward community rights would have widespread repercussions on the international scale, as well, because major pharmaceutical and research companies would be forced into finding ways to work with indigenous, as opposed to finding loopholes in the current agreements. This could help indigenous communities across the globe effectively commercialize and market their traditional knowledge, which would benefit all global consumers.

Works Cited
Adejoke, Oyewunmi O. “Sharpening the Legal Tools to Overcome Biopiracy in Africa through Pro-Development Implementation of Normative International Standards: Lessons from Brazil, South Africa, and India.” African Journal of International and Comparative Law 21.3 (2013): 447-66. Print.
Danley, Vanessa. “Biopiracy in the Brazilian Amazon: Learning Form International and Comparative Law Successes and Shortcomings to Help Promote Biodiversity Conservation in Brazil.” Florida A&M University Law Review 7 (2011): 292-328. Print.
Ebermann, Petra. Patents as Protection of Traditional Medical Knowledge? A Law and Economic Analysis. Cambridge: Intersentia, 2012. Print.
Finetti, Claudia. “Traditional Knowledge and the Patent System: Two Worlds Apart?” World Patent Information (2010). Print.
Garrafa, V., and H. Ten Have. “National Bioethics Council: A Brazilian Proposal.” Journal of Medical Ethics 36.2 (2010): 99-102. Print.
Hathaway, David. “Biopiracy in Brazil.” Under the Sign of Biopolitics: Critical Voices from Civil Society I (2004): 39-50. Print.
Mgbeoji, Ikechi. Global Biopiracy: Patents, Plants, and Indigenous Knowledge. Cornell University Press, 2006. Print
Sampath, Padmashree Gehl. “Chapter 3.” Regulating Bioprospecting: Institutions for Drug Research, Access, and Benefit-sharing. Tokyo: United Nations UP, 2005. 34-62. Print.
Staral, J.M; Sekerak, J.A. “Fighting Biopiracy at the Source.” INTED Proceedings (2012). 6381-6390. Print.

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