Towards an International Regime for Protection of Traditional Knowledge: Reflections on the role of Intellectual Property Rights Brendan Tobin Research Fellow Coordinator of the Biodiplomacy Initiative United Nations University, Institute of Advanced Studies. tobin@ias.unu.edu Draft Paper Presented at the

Towards an International Regime for Protection of Traditional Knowledge: Reflections on the role of Intellectual Property Rights Brendan Tobin Current intellectual property rights regimes are widely considered unsuitable as a means for protection of traditional knowledge. This paper examines attempts to make intellectual property rights regimes more supportive to the protection of traditional knowledge. The paper examines experiences with contracts, sui generis regimes, registers and databases, proposals for modification of patent applications procedures, as well as misappropriation and compulsory liability options. The paper proposes a framework for development of international law and policy for protection and strengthening of traditional knowledge systems. Introduction Traditional knowledge long considered little more than unscientific and irrelevant hocus pocus of witchdoctors and slavish repetition of outdated farming methods by unsophisticated peasants is increasingly being recognized as a complex and dynamic system of knowledge developed over centuries through research, investigation, application, modification, and innovation by indigenous and local communities. Far from being an outdated form of science, traditional knowledge is depended upon by a large percentage of the global population as the primary means of providing for their health, food, clothing, and housing needs. In terms of public health alone, over 80% of the population in developing countries is estimated to rely upon traditional medicine for their daily needs. Traditional knowledge far from being expendable is a crucial part of our present and future scientific knowledge base, and therefore requires both conservation and nurturing. Despite its importance there is growing concern that much traditional knowledge is rapidly being lost due to a host of internal and external pressures which reduce the capacity of local and indigenous communities to conserve their knowledge for future generations. Awareness of the plight of traditional knowledge has come, ironically, as an indirect result of increased interest during recent years by the scientific and commercial sectors in bioprospecting and the potential of traditional knowledge to provide leads for new product development. Concurrently, concerns of indigenous, local community and non-governmental organizations at the patenting of products based upon traditional knowledge, has led to global action against what is frequently referred to as “biopiracy”. Biopiracy is seen as the misappropriation of traditional knowledge through the use of intellectual property rights (IPR). IPR has therefore been seen widely as the tool of biopiracy and there has been significant resistance to efforts to define develop mechanisms for protection of traditional knowledge based upon monopolistic property rights models.

This paper will consider the role of IPR in protection of rights over traditional knowledge, and to benefit sharing, through consideration of three specific cases. First, the negotiation of a bioprospecting agreement for use of TK, involving a range of US and Peruvian parties including universities, indigenous federations and a major pharmaceutical company and development of national sui generis law for protection of collective rights over TK in Peru; Second, the role of TK databases and registers as a means for protecting traditional knowledge; and, thirdly proposals for disclosure of origin of TK and prior informed consent for its use in patent applications procedures. Two significant questions guide this analysis, these relate to rights over traditional knowledge in the public domain, and the extent to which IPR regimes may be utilized to support recognition and protection of rights over TK without distorting the essential nature of indigenous and local community knowledge systems. International debate on protection of traditional knowledge International concern to recognize and protect rights relating to traditional knowledge has advanced rapidly in the past decade. Within the framework of the Convention on Biological Diversity (CBD) a Working Group has been set up to investigate means to protect and strengthen traditional knowledge systems including development of sui generis rights regimes. At the same time, the World Intellectual Property Organization Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (WIPO-IGC) is researching potential options for the protection of traditional knowledge, promoting research into a number of potential mechanisms for protection of rights such as contracts, registers and databases. Meanwhile the 2001 Doha Declaration stipulates that in its review of Article 27.3(b) of the Word Trade Organization’s (WTO) Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) “which deals with patentability or non-patentability of plant and animal inventions, and the protection of plant varieties”, the TRIPS council “should also look at: the relationship between the TRIPS Agreement and the UN Convention on Biological Diversity; [and] the protection of traditional knowledge and folklore”i. While the international debate has tended to focus primarily on the question of biopiracy, there are many more immediate threats to traditional knowledge which require immediate attention if traditional knowledge is to be conserved and strengthened. These include loss of land and language, insensitive educational and health policies, agriculture and fisheries extension programs, and the impact of organized religion, amongst others. Development of any effective global program for protection of TK should, therefore, include not only a means for the recognition of ownership rights but also a system for strengthening the continued use and development of TK as part of the global body of science, and a mainstay of the populations in developing countries, where local sustainability and development opportunities are closely linked to the integrity of TK systems. Biopiracy, seen as the misappropriation of rights over TK and associated genetic resources has to date received the greatest attention from the international community, NGO’s, the media, and frequently indigenous peoples themselves. The international debate on protection of traditional knowledge (TK), in turn, has been largely dominated

by discussions on the potential, limitations and for some the dangers of intellectual property rights regimes as a means for securing community rights over their knowledge. On the one hand, proponents of IPR have argued that IPR regimes can accommodate protection of TK. On the other hand, many legal experts and indigenous representatives have argued that IPR is not an appropriate mechanism for the protection of rights over traditional knowledge (TK). These issues have been discussed in detail elsewhere and the relative merits of these positions is beyond the scope of this paper, however, what is clear is that the appropriateness of any measures will need to be decided with the full and informed participation of indigenous and local communities. Contracts: the case of the PeruICBG Indigenous and local communities’ knowledge has long been sought by a range of collectors, including missionaries, anthropologists, ethnobiologists, etc. Only rarely have such communities been fully informed of the intended future uses of such knowledge and even less frequently invited to enter into negotiation of agreements for its use. With the entry into force of the Convention on Biological Diversity, this trend started to change and a number of high profile agreements have since been negotiated with the informed participation of indigenous peoples. Furthermore, some communities and peoples have established their own research protocol’s to regulate access to and use of their knowledge, these are still, however, the exception to the rule. One early example of indigenous participation in bioprospecting negotiations came within the framework of the International Collaborative Biodiversity Group Program (ICBG), coordinated by the US National Institute of Health1. This program has funded collaborative bioprospecting arrangements in many parts of the world. These projects involve a range of academic, commercial and community partners, and promote the collection of genetic resources with traditional use for development of new medicinal products.2 In the early years of the program a number of projects were established involving TK, including projects in Peru, Nigeria, and Suriname. In the latter two cases intermediaries negotiated agreements in a manner which created benefit sharing opportunities, but only the Peru ICBG actively involved indigenous peoples’ organizations in the negotiation process. The Peru ICBG agreements were negotiated in 1994-1996 in a largely unregulated environment. The agreements involved a number of US and Peruvian research Institutions (Washington University, the Peruvian Univeristy of Cayetano Heredia and the Natural History Museum of San Marcos University) as well as a US pharmaceutical company (Searle & Co., then a subsidiary of the Monsanto Corporation) and 3 federations representing Aguaruna communities of the northern Peruvian Amazon ( The Organization of Communities of the Alto Maranon (OCCAAM), the Aguaruna Federation of Dominguesa (FAD), the Federatio of Native Communities of the Nieva River (FECONARIN) and their national representative Organization CONAP (Confederation of Nationalities of the Peruvian Amazon). The indigenous organizations

1 Tobin, Render and Bannister (forthcoming) 2 Rosenthal …

were supported with independent legal advice by the Peruvian Environmental Law Society (SPDA). The Peru ICBG agreements are a complex set of related contracts, including an overarching bioprospecting agreement involving the research parties and the Aguaruna federations, a licence option between the research parties and Searl & Co. and a know-how licence between the Aguaruna federations and Searle & Co. The nature and content f the agreements reflects a concern not only for the protection of the rights of the indigenous organizations party to the agreement, and securing of the equitable benefit sharing, but also but also for establishing precedents which could support the wider indigenous movement efforts to redefine the nature of property rights over knowledge. The agreements adopted a number of interesting strategies for securing rights over TK while recognizing the potential and limitations of IPR in a number of distinct areas, including:

Treating traditional knowledge as a form of information technology and utilizing a know-how licensing arrangement to regulate access to and use of both TK and associated genetic resources.

Definition of know-how to include all relevant traditional knowledge of the Aguaruna peoples whether or not it was available in the public domain

Preventing the exercise of patent rights to restrict the use, sharing or sale of traditional medicinal products

Preventing the use of traditional knowledge in the development and patenting of life forms

Securing grant-back of royalty free licences for use of patents in research and development by the Aguaruna people.

Providing for joint ownership of patents. Research under the agreement led to an application for a patent in the names of the various research parties and the representatives of the indigenous parties to the agreement.

Utilisation of a licensing mechanism placed the Aguaruna Federations in a direct contractual relationship with Searle & Co, increased the percentage royalties payable in the event of product development, provided for milestone payments during research and development, and, made use of any plants, plant extracts or copies of extracts dependent upon the continuation in force of a know how licence for use of relevant TK. Upon termination of the licence all parties were to terminate use of all genetic resources and TK except as otherwise agreed with the Aguaruna Federations. Searle initially took the stance that they could not accept the proposal for a know-how licensing regime. Their principal legal adviser, a patent lawyer, expressed concern that this would signify a major shift in doing business, requiring approval of the CEO of Monsanto which could take up to six months to obtain. This position was however reversed within 24 hours following the decision by the Aguaruna’s negotiating team to break off negotiations unless the licensing regime was adopted. The use of a know-how license as a means to protect indigenous rights had been supported by lawyers from Patton Boggs, a blue chip law firm from Washington which provided pro bono support in reviewing the license negotiations. Likewise, Charles McManis professor of IP at WU, who, was an observer of the negotiations, sent a letter to the negotiating parties expressing his view that the know-how licensing arrangement was an appropriate means to secure more equitable benefit sharing between pharmaceutical companies and providers of resources. Despite the valuable precedents established by the negotiations the Peru ICBG agreement was not welcomed by all Aguaruna federations and there was a concerted campaign supported by a number of international NGO’s to undermine the agreements. This reflected a clear political divide between various organizations representing the Aguaruna

Universidad Peruana Cayetano Heredia

Washington University

Museo-Universidad San Marcos Indigenous

Federations

G. D. Searle and Co.

Biological Collecting Agreement

Agreement

License Option Agreement

Know-How License

Biological Collecting Agreement

Agreement

Figure 3. Agreement Structure of the ICBG-Peru. (Source Tobin 2004, based on Rosenthal 1996, Figure 4).

people as well as differences within the NGO community, between those who viewed all bioprospecting as biopiracy and those who believed it would be possible to negotiate equitable agreements where there was a will to do so. One of the most controversial aspects of the Peru ICBG was how to ensure the equitable sharing of benefits between Aguaruna, Huambisa and other Jivaro peoples, including communities which were not party to the agreements. The agreements required a mechanism to be established within three years for this purpose. In the long run this was not done due to lack of funds as well as of political will. A further potential criticism was relates to the continued use of resources, by research institutions, after the licence with Searle had terminated. In both cases it appears that the letter of the agreements were ignored where considered expedient by the principal actors both in the academic community and amongst the indigenous organizations involved. This demonstrates the limited utility of contracts and in this case at least the greater importance of personal relationships. As part of the work of the IGC, WIPO has prepared a database of Contracts with an emphasis on intellectual property rights aspects of such agreements. The database includes a limited number of both model and actual agreements, and is open for contributions. However as may be seen from the foregoing discussion of the Peru ICBG, the utility of contracts to ensure equitable benefit sharing, in an unregulated environment, must be questioned. Sui Generis Regimes The general resistance to the use of IPR regimes to protect TK has resulted in the development of a number of proposals for protection of rights over TK under sui generis regimes. These have included proposals for a Community rights regimes, a system of Traditional resource rights, a concerted international effort to negotiate a system of farmers’ rights, and the development of national and regional sui generis systems. A common underlying principle behind such proposals has been the search for recognition of some form of community right, which can be utilized to secure the communal interest over TK, while stopping short of providing a monopolistic right over knowledge. The proposals vary in their intent from efforts to create an actionable property right in favour of indigenous people, to obligation to provide some form of monetary compensation to farmers for their efforts in conserving and developing crop diversity. An important feature of such proposals is the desire to ensure continued free and open access for community use while controlling commercial and industrial use, and/or ensuring fair and equitable benefit sharing. These proposals are generally presented as being distinct from IPR regimes and in essence they are. However, in some cases the distinctions are less obvious, and regimes which provide the right to control third party use, in this case use by the scientific or commercial sectors, tend to display many oft characteristics of IPR, albeit of a sui generis nature. It is understandable that those who have decried existing IPR regimes as failing to protect TK and as providing a tool for biopiracy should seek to present their proposals for

alternative means for protection as non-IPR regimes. These efforts to present IPR style mechanisms as distinct form of sui generis system though appearing disingenuous, do in fact have a legitimate purpose, which is to break out of the confines of the existing stable of IPR mechanisms and begin the development of new mechanisms based upon a different set of underlying principles. Principles derived from the customary laws and practices of indigenous and local communities, infused with the spirit of reciprocity, sharing and communal interest, which is lacking from the dominant IPR stem. A readiness to redefine the debate by both sides could have an important impact on future negotiations. In the first place it would amount to recognition of the fact that existing IPR regimes are not written in stone, are not all embracing, and may be complemented by new forms of property rights of a non-monopolistic nature. On the other hand it would help to clarify the fact that community rights regimes which allow custodians of knowledge to place restrictions on the use of their knowledge, albeit with the inclusion of certain exemptions in order to allow for continued free access for community use, are in fact a form of IPR. This process would help indigenous peoples to more clearly recognize the nature of the debate and of the proposals being made on their behalf and would provide negotiators with a clearer picture of the claims and potential opportunities for developing sui generis regimes. A number of proposals also exist for the development of mechanisms for compensating farmers and local and indigenous communities for their effort in conserving, developing and sharing their traditional knowledge, cultivars etc. This has included most importantly the notion of farmers rights conceived as a mechanism for securing fair and equitable benefit sharing with farmers for their role in in-situ conservation and development of new crop varieties. Under negotiation for more than 10 years the concept is now formally recognized in the FAO International Treaty on Plant Genetic Resources for food and Agriculture. However, it is still a concept without teeth and much work remains before any serious benefit sharing is likely to take place. Peruvian law on collective rights over traditional knowledge In 2002 Peru adopted the first comprehensive legal regime for protection of traditional knowledge relating to biological diversity. The law …… is declaratory in nature recognizing that rights over traditional knowledge spring not from any act of government but from the existence of the knowledge. The law declares that traditional knowledge is cultural patrimony, thereby recognizing intergenerational and intragenerational rights and responsibilities relating to it. Access to and use of knowledge not in the public domain requires prior informed consent and a licence for commercial use. Benefits are to be shared not only with the participating indigenous communities but also with the wider indigenous community through a Indigenous Development fund, managed by indigenous peoples. The law recognizes a right for indigenous peoples to share in the benefits derived from use of their traditional knowledge in the public domain. The national patent office is charged with aiding indigenous peoples in protecting their knowledge by establishing an open register and a confidential register of knowledge as well as providing advice to local communities in establishing community registers. Furthermore

the patent office is empowered to prevent the publication of material relating to traditional knowledge in breach of community rights over such knowledge. In essence the law recognizes traditional knowledge as form of trade secret and attempts to protect it accordingly. Despite its many interesting provisions the law has not received support of a wide section of indigenous peoples in Peru due in part to a lack of knowledge of the law but also to the limited opportunity for informed participation of indigenous peoples in the preparation of the law. The Peruvian law being the first of its kind provides an insight into some of the conflicts which may arise in the development of such a regime. These include conflicts of perception, of legal vision, and of interest and rights. Under the CBD indigenous and local community knowledge systems have been described in a manner which many community commentators have claimed leads to a fragmentation or dismemberment of their knowledge which encompasses all aspects of their culture including society, spirituality. law and science. Article 8 (j) of the CBD refers to the traditional knowledge, innovations and practices of indigenous and local communities. A natural tendency of those who associate rights over the product of human effort with IPR would then be to link these to the IP concepts of know-how, inventions and processes respectively. Doing so however further facilitates the process of dismemberment, a fact which I noticeable in the Peruvian law which only addresses traditional knowledge relating to the characteristics, properties and uses of biological resources, thereby effectively excluding from protection many indigenous innovations and practices. Pedro Garcia a lawyer who has lived and worked with the Aguaruna people for nearly 30 years has attempted to provide amore holistic interpretation of the terms set out in Article 8 (j). In doing so he describes knowledge as the composite of all learning, practices as the application of that learning to meet daily needs, and innovations as the application of learning to meet new challenges (see box 1). Described in this manner, the interrelationship of the various elements of indigenous knowledge systems becomes more apparent as do the dangers of fragmentation of knowledge systems. This highlights the importance of ensuring full and informed participation of indigenous and local communities in the development of mechanisms for protection of traditional knowledge rights.

Box 1 Conflicts of Perception in definition of traditional knowledge

CBD Knowledge Practices Innovations

IPR Know-how `Processes Inventions

Holistic Learning by investigation research and development

Application of learning to meet daily needs

Application of learning to meet new challenges

Recognition of the collective nature of traditional knowledge is not always easily reconciled with administrative expediency and bureaucratic pragmatism. Peruvian legislators were faced with the dilemma of how to ensure protection of cultural patrimony without ending up in a situation where a single community might effectively veto any biopropsecting activity. In the final analysis the law appears to defend the interests of individual communities to enter into bioprospecting arrangements even in the face of a dissenting majority. This creates a potential for conflict between the rights of individual communities and the rights of indigenous people as a whole over their cultural patrimony. The law recognizes that in the case of conflicts between indigenous communities they are entitled to resort to their own customary law and a practice as a means for resolving disputes. Conflicts between ancestral rights and the principle of the public domain South Pacific: what is important is how the TK came to be in the public domain, • Intention to share and purpose for sharing • Was permission given to publish or disseminate • Knowledge of potential commercial use • were indigenous peoples aware they would lose rights • impact on cultural and spiritual integrity. In developing the national law on traditional knowledge there was at times discussion of a need to balance the interests of indigenous peoples and the commercial users of knowledge. The potential conflicts of interest inherent in such a discussion require clear recognition of the distinction between these interests. Indigenous peoples rights under the law stem from their ancestral rights over their knowledge and not from ay act of government as such therefore they are fundamental rights and must be fully and effectively protected. They cannot in may way be diminished or bartered in favour of interests of commercial users which are merely that “interests”. Interests which do not need to be met or taken into consideration except to the extent that indigenous peoples may wish to take them into consideration and that they do not negatively affect the protection of rights over traditional knowledge. Where there is a desire to promote a

balance between levels of protection of rights and recognition of interests of commercial users with a view to promoting a trade in traditional knowledge this will need to be achieved with full and active participation of indigenous peoples. Traditional Knowledge Databases and Registers The potential role of TK registers and databases as a means to secure community rights over traditional knowledge is receiving ever increasing attention both in international fora and in national debates. Registers and databases to compile and protect traditional knowledge have been established by indigenous peoples, local communities, non-governmental organizations, research institutes, and government bodies. Since the early 1990’s India has played a leading role in the development of community registers with experiences such as the Honey Bee Network, the Farmer’s rights Information System, Peoples Biodiversity, and the Traditional Knowledge Digital Library. These were established without any legislative basis, however, efforts are being made to extend protection to certain databases under the Indian Biodioversity Bill. The majority of experiences in India may be considered to fall into a general category which may be referred to as cooperative community registers. The majority of, these experiences involve what are in essence unofficial registers maintained by nongovernmental organizations or research institutions in which a record is kept of the relevant information and of the person or community which claims a right over it. The status of these unofficial registers and of the information they contain is very unclear. Indigenous peoples have also begun to establish their own databases for preservation of knowledge and as part of the process to secure recognition of and protection of land rights. One of the most ambitious experiences of this nature involves Inuit, who have established a number of associated databases dealing with different aspects of traditional knowledge, land and environmental issues. Innovative work has also been carried out by the Tulalip Tribes in North America. Important efforts have also been made to support the protection of traditional knowledge by the compilation of oral and visual records by Institutes such as the Vanuatu Cultural Center and the Australian Institute for Aboriginal and Torres Straits Islanders Studies (AIATSIS). The majority of databases and registers have primarily served as a basis for compilation of information and have not been linked to any national regimes for granting or recognition of rights over knowledge. These registers have little if any force in law to protect rights over the information which is held and registration may result in placing the information in the public domain and may be deemed to amount to a renunciation of rights over the relevant knowledge. The IGC has taken an interest in the potential of registers and databases as a source of prior art for patent search procedures thereby, providing a means for defensive protection of TK. Inspired by the Indian experience with development of the TKDL an open access database on Ayudervic knowledge, work advanced within the IGC and in the

International Patent Classification Union to … which has led to the inclusion of new registrations for medicinal plants. This process is not without difficulties. The establishment of standard criteria for registration of traditional knowledge, based upon principles of registration designed for IPR regimes may effectively result in TK being categorized and rights recognized based upon registration rather than upon the existence of the knowledge. This could be seen as bringing TK within the IPR fold through the back door. The potential of TK registers and databases to provide for defensive protection was researched in a report by UNU-IAS which considered a range of databases established by Research Institutes, NGO’s, and State bodies, and their recognition under law. The report noted that a number of the databases and registers considered in the study would not serve as sources of evidence of prior art due to their confidential nature. It further concluded that “…databases and registers alone do not provide a means for the effective protection of TK. Rather they must be seen as one element or mechanism in a wider system of TK governance including customary law and practice, national access and benefit-sharing legislation, and sui generis law and policy.” The report highlighted the catch-22 position faced by indigenous people, whereby, placing their knowledge in the public domain as a means to securing protection against biopiracy effectively amounts to renunciation of rights over such knowledge. There have been many claims made regarding the utility and promise of such mechanisms as a means for protection of traditional knowledge, and they are no doubt very useful as a means to record traditional knowledge for the benefit of present and future generations. However, as a tool for protecting rights over knowledge, as opposed to a means for prevent its misappropriation the case in favour of databases and registers appears to be overstated. Part of the problem with the debate on registers and databases may arise from a blurring of the distinction between these two instruments. In many cases the terms are used indiscriminately failing to distinguish between a compilation of data in a database and the documentation of rights over property which is the usual role of a register. For this reason many people appear to believe that establishing a database or register of traditional knowledge is related to the recognition and protection of rights over the information they contain. In the absence of specific legislation to recognize rights over knowledge in databases or registers the information they include may be considered to have been placed in the public domain, resulting in the loss of rights rather than their protection. To date there is legislation in only a handful of countries recognising rights over traditional knowledge in registers and databases, and even fewer functional official registers for documentation of traditional knowledge. Community registers can indeed help to define rights over community knowledge within a community, however, there legal effect as a means for protection of traditional knowledge is limited absent recognition of their stats under national and/or international law. It is to e hoped that the progressive development of national law, such as the Peruvian law on protection of collective rights over traditional knowledge, which

recognizes a possibility for development of community registers will develop into more specific recognition of such registers and of their role as a source of prior art. To date, the majority of traditional knowledge held in databases is not under the control, direct or indirect, of indigenous and local communities, but is managed by research institutions, national archives, NGO’s, commercial organizations and international bodies. Much of this information was collected without any specific agreements with indigenous peoples regarding its use, and is now considered to have become part of the public domain. This poses serious problems for those wishing to protect and control the access to and use of traditional knowledge for spiritual, cultural, economic and other purposes. Biodiversity conservation in the era of knowledge economy is largely about information. The advent of electronic communication has dramatically increased the speed and geographical distribution of information exchange. Biodiversity information has entered the public domain at a rate unconceivable just a decade ago: a recent issue paper from IUCN3 lists at least 18 websites devoted to this topic. Many of them allow visitors to search online databases of biodiversity-related resources. These sites include UNEP-WCMC’s Biodiversity Information Service and the Biodiversity Conservation Information System (BCIS), backed up by a coalition of 12 NGOs

This information explosion, however, has not come without risks, particularly when it comes to the issue of protection of rights over traditional knowledge. Today, highly localised practices, developed through the centuries and often jealously guarded by indigenous communities, are only a mouse-click away for academic researchers, private companies and conservation practitioners throughout the world. Often, there is little or no benefit for the communities involved from making their knowledge available in the public domain.

This has sparked an intense debate on the need to balance the property rights of indigenous communities, on the one hand, and the free flow of scientific information in the public domain, on the other. The clash is somehow exacerbated by the fact that the internet as a medium has historically evolved within the academic community, and by large internet users have adopted the ethos of free exchange of information which is typical of that environment The importance of clearly defining the public domain in order to ensure continued access for scientific, development and subsistence needs is clear. However, the principle of the public domain cannot be utilized to legitimize the historic expropriation of TK. Calls for the redefinition of the public domain or review of its application to TK has led to a growing challenge to existing perceptions of the public domain under western legal systems. Legislation, such as the recent sui generis law for protection of collective rights over TK in Peru, discussed in more detail below, and a draft model law for protection of TK in the South Pacific, demonstrate a growing preparedness of authorities in developing countries to find means to redefine the rights of indigenous peoples over TK in the public domain. 3 Sue Stolton and Nigel Dudley, Sharing Information with Confidence, An issues paper, May 2004

Database trusts Efforts to develop functional national laws to implement systems for protection of traditional knowledge Disclosure of Origin In the years immediately following the entry into force of the CBD proposals began to emerge for modification of patent application procedures as a means to support the Conventions provisions on ABS. Proposals suggested requiring applicants to retrace the origin of genetic material used, indicate the extent to which it was used and state the conditions under which it was aquired (Hendrickx et al 2004), establishing a primarily voluntary system which would not affect the grant of patents per se. On the other hand, it was proposed that applications should only be accepted subject to provision of evidence of origin and of prior informed consent for use of genetic resources and traditional knowledge (Tobin 2004). As part of this latter proposal, it was suggested that the establishment of a standardized international ‘certificate of origin’, as evidence of PIC, would facilitate more effective implementation of disclosure requirements. Both disclosure of origin and certificates of origin are now being widely researched as part of the process towards negotiation of an international regime on ABS, as well as with regard to the work of the IGC.

evidence of PIC as a condition for grant of IPR, product Shift burden of proof regarding the right to use TK Market tools to control market use Penalize illegal use – loss of patents or failure to obtain product approval Incentive to seek PIC sooner rather than later International Certificate as evidence of PIC not of equity – facilitating and

tracking TK flow The term ‘certificate of origin’ was originally coined in 1994 to describe a proposal for protection of rights over traditional knowledge, developed in response to concerns regarding the original negotiations relating to the Peruvian ICBG program (Tobin 1994). The original concept was to develop a market tool to control market use of traditional knowledge by requiring applicants for patents to provide information on the use of traditional knowledge and of prior informed consent for its use.4 It was suggested that establishment of a standardized certificate of origin which would act as evidence of prior informed consent would exempt patent officers from the need to examine all of the documentation related to an ABS agreement to verify compliance with the CBD. The term has since taken on a wider meaning which broadly encompasses tracking flows of genetic resources and documenting evidence for the right to use genetic resources. 5 Proposals now also exist for certificates of source and legal provenance. 4 Tobin 1997 5 Cunningham et al. 2004

The secretariat to the CBD has been mandated to undertake further examination of an internationally recognised certificate of origin/source/legal provenance of genetic resources and associated traditional knowledge as part of the negotiation of an international regime on ABS. Analysis is also called for regarding the potential role certificates might play in a system requiring the disclosure of origin of genetic resources and associated traditional knowledge in applications for intellectual property rights. Despite several preliminary investigations and many informal discussions at international meetings, there is still no clear understanding of how a certificate of origin system could operate in practice, or what should be the scope or nature of any such system. A preliminary list of the information that may perhaps be included in a certificate of origin, include:

• Particulars of the provider and user; • Particulars of the indigenous or local communities parties to the agreement; • Details of genetic resources or traditional knowledge; • Details of the approved use which may be made of the resources; • Details of any restrictions on use; • Period of the agreement; • Conditions relating to transfer of rights to third parties; and • Details of the issuing authority.6

One potential embodiment of a certificate of origin may be likened to a passport that accompanies genetic resources, either through their entire history from collection to use (‘cradle to grave’) or only for certain transactions such as border crossings (Figure 1). Possible check-points for a certificate could be at borders, patent offices or the registration points for other commercial applications not covered by intellectual property rights. The alternatives to the certificate of origin which have been suggested such as a ‘certificate of source’ or a ‘certificate of legal provenance’ seek to respond to concerns that identification of the ‘origin’ may prove impossible in many cases. There are also those who oppose these options due to the potential implications for collections of genetic resources collected prior to the entry into force of the CBD, or subsequently without any PIC or MAT. A certificate of source would track the genetic resource only as far as the place where the user obtained it, which may be a collection or depository and not necessarily the country of origin. A certificate of legal provenance would document evidence that the resources had been obtained from a legally entitled provider. In the face of continuing uncertainties regarding legal rights over resources and absent a binding international regime on ABS, legal provenance would fall to be decided by the laws of the country where the resources were sourced, potentially providing an opportunity for circumvention of the rights of countries of origin.

6 Barber et al. 2003

Developing an international regime for protection of traditional knowledge. Carlos Correa has described what he terms a misappropriation option as an alternative to IPR protection, including use of databases and a disclosure of origin system. Such a system would include national civil and or criminal law to prevent unapproved use traditional knowledge. Protection would not be subject to registration and would last as long as conditions that give rise to it exist. Identification of rights to use knowledge would be linked to a system of documentation of knowledge, through databases or otherwise, and an obligation to identify the origin of resources in IPR claims, as well as evidence of PIC.7 With the adoption of the Bonn Guidelines the Conference of the Parties to the CBD has sent a strong message to national governments in so-called user countries that they should take measures to ensure that the use of genetic resources and traditional knowledge conforms to the rights of countries of origin and local and indigenous communities. Progressive implementation of the Guidelines may lead to development of some of the elements of a misappropriation regime. Increasing implementation of disclosure of origin requirements and development of an international system of certificates of origin, as well as advances in the documentation of traditional knowledge may further strengthen the basis for promotion of an international misappropriation regime. Support for the concept of a misappropriation regime has come Professor J. Reichmann he suggests, however that such a regime might best be limited to what he terms historical elements of traditional knowledge. He proposes in turn the development of a compulsory licensing regime as a means to protect future innovation based on traditional knowledge. He argues that “efforts to protect sub-patentable innovations under modern conditions need to return to their historical roots, with a view to overcoming market failure without impoverishing the public domain.” 8 This proposal is based upon the notion that traditional knowledge can be separated into a historical traditional knowledge to be protected by a misappropriation regime, secret knowledge which may b protected by trade secrets if so desired and incremental advances in traditional knowledge which should be protected as a form of know-how without the granting of exclusive monopolies. In recognition of the fact that the lead time which historically provided the basis for compensation relating to use of know-how is now effectively eroded by technology he suggests the need for a sui generis regime to provide “… some functional equivalent of artificial lead time to overcome market failure without disaggregating the information commons”.9 One of the important elements of the liability regime proposed by Reichmann involves blanket licence for certain forms of traditional knowledge such as medical treatments as

7 Carlos Correa: Traditional Knowledge and Intellectual Property: Issues and option surrounding the protection of traditional knowledge QUNO. 2001 8 J. H. Reichmann, A compensatory Liability Regime for applications of Traditional Knowledge, Draft paper Presented at the Cardozo Symposium on Legal Protection of Traditional Knowledge, New York, February 23-24, 2001 9 Ibid.

well as some form of computerized collection society to handle royalty management. A similar proposal has been made by Peter Drahos who argues for the establishment of a Global Bio-Collecting Society as part of a proposal for the development of a treaty on what he terms Traditional Group Knowledge and Practice (TGKP). Drahos suggests that the time is not yet right for development of substantive international norms of protection such as a misappropriation regime, but proposes that states should focus on creating a treaty that does not discourage the development of national approaches but rather offers a means for cooperating and coordination on enforcement of rights over traditional knowledge. As noted at the outset of this paper biopiracy is only on of many threats to traditional knowledge, and may be far from the most dangerous. National educational programs which exclusively promote foreign values, science, languages etc. can undermine belief in traditional knowledge. Likewise, insensitive health programs may downplay the importance and the effectiveness of traditional health practices. Agricultural and fisheries extension programs can lead to displacement of traditional farming and fishing practices, replacement of traditional crops and introduction of invasive species, to t detriment of long term food security and subsistence. Promotion of cash crops at the expense of traditional crop diversity can affect family budgets and cultural integrity without brining lasting development. In a similar fashion introduction of foreign religious practices and the loss of traditional rites can affect retention and transfer of traditional knowledge. Amongst the most serious threat to traditional knowledge are loss of land which displaces communities and separates them from the environment associated with their knowledge, and loss of language, without which much knowledge cannot be transferred. Considering these multiple interwoven threats to traditional knowledge it is considered desirable that the international community adopt, a process for development of relevant law and policy which focuses not only on regulating access to and exercising control over traditional knowledge, but which also establishes clear measures designed to promote and strengthen such knowledge systems. Development of international law and policy is only a support for law and policy at the national level, which in turn cannot succeed without the commitment and engagement of local and indigenous communities. Efforts should be made without delay to modify or strengthen national law and policy to enhance the recognition of traditional knowledge and of rights over it. This is part of a process of pluralism and cultural respect which is vital for securing the rights of indigenous and local communities. Efforts at the national and international level will however be fruitless if not supported by and complemented by community action. Use of traditional knowledge has been described by many commentators as the key to its protection and development. Engaging communities in the development of national law and policy as well as of programs for protection of TK will be vital to their success. Communities should not however await government assistance of legislative enactments before commencing their own programs to revive and strengthen their store of traditional knowledge. Awareness building programs designed to highlight the importance of traditional knowledge for present and future community development and as a cultural legacy will be more effective where

driven by community members. A schematic framework for a regime to protect and strengthen traditional knowledge would include a number of different actors including indigenous and local communities, countries within which knowledge is sourced, countries where knowledge is being used for scientific and commercial purposes, private sector users and the international community. (See tables 1 and 2) Tables on TK protection A key element to the success of these various processes and strategies is the recognition of traditional decision making authorities and of the need to develop an effective interface between national and international law and customary law and practice of indigenous peoples and local communities. Traditional knowledge is closely linked to both cultural and biological diversity, frequently representing the capacity of humankind to develop a harmonious holistic alliance with our environment. As our dominant development strategies present their insensitivity to the environment the need to tune into the wisdom of centuries is ever more apparent, so too must be the reasons for respecting those who hold this wisdom and who nurture and develop it so that it may continue to serve future generations. In the light of such reality the role of IPR as a tool to restructure traditional knowledge into a commercial commodity must surely pale against the need to ensure that IPR supports the continuing capacity of communities to develop their knowledge for present and future needs. Global Regime

Existing access laws tend to impede flows of genetic resources and TK Obtaining PIC of indigenous communities is the most time consuming element of

bioprospecting Requiring PIC in the country of use of TK will reduce need for restrictive TK and

access laws Development of awareness of community rights can facilitate negotiations

Customary law

Customary law cannot protect TK outside the bounds of community jurisdiction Many customary law systems do not contemplate commercialization of TK Customary law is not always democratic law Respect for customary law should not conflict with human rights, in particular

those of women National law may be required to ensure that chiefly authority is not abused.

Source country TK regulation

Recognition of TK as Cultural patrimony Recognition of role of customary law and practice Requirement for PIC for access to TK Sui generis regime for protection of TK including protection of landraces

Limitations of national jurisdiction – need for complementary laws in country of use. Measures in country of use

Certification and codes of conduct Import and transport regulations Disclosure of Origin Access to Justice/ Enforcement mechanisms Unfair trading practices Technology transfer

International community

Misappropriation regime Disclosure of Origin obligations under international IPR law International certificate of origin system Compensatory liability regime International Bio-collecting Agency Recognition of customary law and practice Flexible Revise principle of public domain Address the question of sources of prior art to allow for inclusion of community

registers.

Table 2 - International TK control regime - Prior Informed Consent (PIC)

Indigenous peoples

Source country

Country of use

End user International community

Define Conditions for access. Basis – PIC

Establish regulations requiring PIC

Discourage illegal use, require PIC for use

Contracts PIC -legal certainty for use

Build Bridge between source and end user – Address issue of public domain

Customary law and practice. Community protocols

Export controls ABS law Sui generis regimes

Import controls Product approval IPR grants

Codes of conduct Require evidence of PIC

Protocol to CBD Define Principles of Equity Arbitration Database trusts Revise sources of prior art

Fundamental underlying principle - PIC - Basis for legal certainty

Table 2 - Policy and law to strengthen TK and innovation systems

Indigenous peoples

Source country

Country of use

End user International community

Community research on uses and threats to TK. Awareness

law and policy to support local use. Incentives

Inventory of databases Require disclosure of TK

Codes of conduct. Company database search

Investigate status and trends on TK Devise int’l strategy for support of TK

Community registers Community gardens Transmission education

Revise curricula Integrated health programs. TK Institute

Funding. Capacity- building Repatriation Education Respect TK

Train staff / contractors Repatriation Share info. re utility of TK. Respect TK

financial and Technical aid. Investigate role of customary law. Fund TK CHM Fund Databases

Fundamental guiding principle – full informed participation in decision making

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