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Rodrigo Bonilla

ID: 67667
Added: 2004-12-02 1:38
Modified: 2004-12-12 11:01
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Comparative analysis: How the new laws deal with access to genetic resources in communities
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Not surprisingly, southern countries have been first off the mark to embark on the development of access and benefit-sharing legislation. As the primary providers of genetic resources, they have the most to gain by negotiating benefits in return for permitting access. Northern countries have a far bigger stake in expanding patent protection for users of genetic resources and consequently have been much more actively involved in pushing for global standards for the other half of the equation, namely for IPRs.

The three regional associations described above and several countries in Asia, Africa and South America have taken different approaches to the regulation of access to genetic resources in indigenous and local communities. Some countries appear to limit the right to informed consent and benefit sharing to those communities whose traditional knowledge is needed for the use of genetic resources, while others assume the right of communities to grant or withhold consent regardless of whether such knowledge is a factor. As the previous chapter noted, this distinction is far more crucial for traditional fishing communities than for farmers and for indigenous groups familiar with medicinal uses of plants. Assuming that the law does require community consent for access to aquatic genetic resources, several other issues are important for both communities and collectors:

  • What procedures should be followed to obtain consent?
  • Should academic researchers be treated differently from commercial collectors?
  • What types of benefit are most appropriate?

The following synopsis compares how the three regions and several countries (Brazil, Costa Rica, India, Peru and the Philippines20) have addressed these questions. The Philippines – the first country to pass access and benefit-sharing legislation after the CBD came into force – has the most experience with implementation. Case Study 5 at the end of this chapter provides a detailed look at the challenges the Philippines has faced. The Philippine experience holds important lessons for other countries – and for communities and collectors – about what works and what doesn’t.

Numbers in parentheses refer to the article or section number of regional model laws and national laws.

The scope of access laws: Biological and genetic resources

As Glowka (1998b) notes, drafters of legislation should be encouraged to use definitions that already appear in international agreements such as the CBD, since the terms and definitions used in such documents reflect a broad international consensus. The CBD defines biological resources as including ‘genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity’. Genetic resources are defined as ‘genetic material of actual or potential value’, and genetic material means ‘any material of plant, animal, microbial or other origin containing functional units of heredity’.

Box 5.1 Comparing Laws: Defining the Scope

Do access laws and guidelines apply to genetic resources, biological resources and/or knowledge? As the following summary shows, different countries and regions take different approaches:

OAU

Applies to biological resources and knowledge or technologies of local communities in any part of the country (s. 3). Biological resources are defined to include genetic resources, organisms or parts thereof, populations, or any other component of ecosystems (s. 1).

Andean Community

Applies to in situ and ex situ genetic resources, defined as all material that contains genetic information of value or of real or potential use (1).

ASEAN

Defines ‘bioprospecting’ as the search for wild species with genes that produce better crops and medicines, or the exploration of biodiversity for commercially valuable genetic and biological resources (3).

Brazil

Applies to access to components of ‘genetic heritage’, defined as ‘information of genetic origin’.

Costa Rica

Applies to samples of components of biodiversity, whether in situ or ex situ. Biodiversity includes the variability of living organisms of any source, whether found in terrestrial, air or marine or aquatic ecosystems or in other ecological complexes (s. 7). Access sections (ss. 62–85) apply only to genetic components (containing functional units of heredity) and biochemicals.

Philippines

Applies to biological and genetic resources.

Most laws do not distinguish between biological and genetic resources, or, as in the case of the OAU model law, define biological resources to include genetic resources. The access provisions of Costa Rica’s biodiversity law apply only to genetic components (containing functional units of heredity) and biochemicals. In all cases, the scope of the laws is broad enough to include all forms of aquatic genetic resources, although nowhere is it apparent that collection for aquaculture has been contemplated. For example, the ASEAN framework defines ‘bioprospecting’ as the search for wild species with genes that produce better crops and medicines, or the exploration of biodiversity for commercially valuable genetic and biological resources. Collections of broodstock for industrial aquaculture haven’t yet become an issue in developing countries.

Prior informed consent by communities

The primary authority for approving applications for access lies with national governments, which the CBD recognizes as having sovereignty over genetic resources. Each country designates a ‘Competent National Authority’ to oversee the approval process. Typically, under proposed and existing access laws, the national authority requires proof of consent by indigenous and local communities, although specific requirements vary considerably.

But what is a local community? Brazilian law defines it as a ‘human group, differentiated by its cultural conditions, which is traditionally organized along successive generations and with its own customs, and conserves its social and economic institutions’ (Article 7). Philippine law describes it simply as ‘the basic political unit where biological and genetic resources are located’ (2). The OAU model law describes it as ‘a human population in a distinct geographical area, with ownership over its biological resources, innovations, practices, knowledge and technologies governed partially or completely by its own customs, traditions or laws’ (1). It is not yet clear how different countries will translate such broad definitions into practice both in regulatory frameworks and in dealing with groups whose concept of themselves as a community may differ a great deal from that of a government agency.

There is no consistency among countries on the issue of whether collectors need consent for all collections of genetic resources or only when seeking access to traditional knowledge. Peru and Brazil specifically link the requirement to obtain indigenous community consent to access to traditional knowledge. Countries such as the Philippines require consent for access to genetic resources without limiting the right to communities whose knowledge is required for the use of genetic resources. The OAU model law recognizes the rights of communities over their biological resources, innovations, practices, knowledge and technologies and the right to benefit from their use (16).

Notable in some laws are the restrictions on the authority of communities to withhold consent. The Costa Rican law recognizes the right of communities to oppose any access to their resources or associated knowledge, whether for cultural, spiritual, social, economic or other motives (66). In Brazil, however, access may be permitted without consent ‘in instances of relevant public interest’ (17). Under the OAU model law, communities can refuse access if it will be ‘detrimental to the integrity of their natural or cultural heritage’ (19). It remains to be seen how different countries will handle refusals of consent by communities that are simply unsatisfied with the benefits offered to them, or give no reasons for refusal, and what impact such refusals are likely to have on both academic and commercial research. There are still too few instances of negotiations with communities to determine whether the withholding of consent is likely to be a common trend. As discussed below, bureaucratic hurdles under the new laws have already led to ‘research chill’ even before negotiations with communities become a reality.

Regional guidelines and national laws spell out principles but generally don’t provide specific guidance on procedures for obtaining community consent. As the majority of laws discussed here are either in draft form or very new, regulations implementing national laws are virtually non-existent outside the Philippines. Under the Philippine regulations, a collector must obtain consent from the mayor of a local community or head of an indigenous people, hold a community assembly, fully describe the research proposal in a language or dialect understandable to local people, and describe proposed benefits. As Case Study 5 illustrates, community advocates have criticized these provisions for not requiring sufficient consultation with communities that don’t believe a municipal mayor represents their interests. In addition, local people may not fully understand the implications of proposed activities and uses of genetic resources, and may lack the capacity to conduct negotiations effectively without assistance.

Box 5.2 Comparing Laws: Community Right to Consent

OAU

Access to biological resources, knowledge and/or technologies of local communities is subject to the written prior informed consent of the Competent National Authority as well as that of concerned local communities, ensuring that women are also involved in decision-making (s 5). An access permit is granted through a written agreement between the Competent National Authority, concerned local communities and the applicant or collector (7). Local communities can refuse access if it will be detrimental to the integrity of their natural or cultural heritage (19) and can withdraw consent or place restrictions on activities relating to access if they are likely to be detrimental to their socio-economic life or their natural and cultural heritage (20). Women are to fully and equally participate in decisions about prior informed consent for access (18).

Andean Community

Parties to access agreements are the state and the applicant (32). Applicants may make ancillary contracts with the owner, possessor or manager of the land where the biological resource containing the genetic resource is located (41). No specific mention of communities.

Brazil

The state recognizes the right of the indigenous communities and of the local communities to decide on the use of their traditional knowledge related to the genetic heritage of the country (1).

Peru

Collectors wishing to obtain access to collective knowledge for scientific, commercial or industrial purposes must request the prior informed consent of one or more indigenous peoples possessing the collective knowledge (7).

Costa Rica

Prior informed consent for access to genetic components and biochemicals must be obtained from representatives of the place where access will occur, whether regional councils of Conservation Areas, owners of farms, or indigenous authorities (s 63). Local communities and indigenous peoples can oppose access to their resources and associated knowledge for cultural, spiritual, social, economic or other reasons (s 66).

Philippines

Prospecting within ancestral lands and domains of indigenous cultural communities is allowed only with their prior informed consent, obtained in accordance with customary laws. Prior informed consent must also be obtained from concerned local communities, defined as basic political units where the biological and genetic resources are located (2). Research proposals must be submitted to the recognized head of any affected local or indigenous cultural community (4).

Protection of traditional knowledge

In some cases, access and benefit-sharing laws have made efforts to address potential conflicts over rights to knowledge by providing for sui generis protection of traditional knowledge. The advantages of unique legal forms of protection for community property rights have been much discussed, but how they will be crafted to fit into existing legal systems remains to be seen.

Costa Rica’s biodiversity law recognizes and protects sui generis community intellectual rights over knowledge, practices and innovations related to the use of components of biodiversity and associated knowledge (82), and provides that no form of intellectual or industrial property rights protection can affect these historic practices. The law provides for a participatory process with small farmer and indigenous communities to determine the nature and scope of sui generis rights (s 83).

The OAU model law also takes a step towards the enshrinement of sui generis rights by providing that the Community Intellectual Property Rights of local communities are inalienable (23). Community Intellectual Property Rights are defined as those rights held by local communities over their biological resources or parts or derivatives thereof, and over their practices, innovations, knowledge and technologies. The state recognizes and protects community rights as enshrined under the norms, practices and customary law, whether written or not (17). The Philippines, in addition to its bioprospecting law, has adopted separate legislation for the protection of Community Intellectual Property Rights.

Some community advocacy groups have criticized the concept of sui generis rights for trying to fit traditional knowledge into a property rights model that has no relevance to traditional community governance systems. Indigenous communities with long traditions of sharing all community resources, including knowledge, may be suspicious of sui generis initiatives based on IPRs models based on individual rights. For some groups, recognition of rights over genetic resources can only be settled through acknowledgement of full rights to manage and control local ecosystems and the biological and genetic resources within them. The Costa Rican and OAU initiatives are the most progressive among access and benefit-sharing laws to date, but it remains to be seen how they will work in practice. Bangladesh and the Philippines have moved a step further by drafting stand alone community rights legislation.

One of the primary incentives for national initiatives to protect traditional knowledge is to provide a legal barrier against its unauthorized use by collectors of genetic resources. As discussed in previous chapters in this book, sui generis protection of traditional knowledge bolsters the rights of plant communities but may be largely irrelevant to the collection of aquatic genetic resources in fishing communities. This is because, while dependence on traditional knowledge may be the rule in the use of plant genetic resources, it’s the exception in the use of aquatic genetic resources. Consequently, drafters of laws that apply to the collection of genetic resources in general need to consider very carefully the implications for both plant and aquatic collections.

Intellectual property rights protection

Most developing countries are amending their patent laws to comply with the WTO TRIPS Agreement, which requires all countries to extend their patent systems to include all technologies and all inventions. This includes the patenting of micro-organisms and microbiological processes, although countries can exclude plants and animals. In addition, developing countries are facing pressure to go beyond the TRIPS agreements. For example, preferential trade, aid, investment or technical assistance privileges may be tied to a commitment from developing countries to adopt more hard line standards for IPRs on life forms, including International Union for the Protection of New Varieties of Plants (UPOV) standards of plant variety rights or industrial patent rules over plants and animals (GRAIN, 2002a).

The tension between TRIPS and CBD commitments is reflected in differing approaches taken by access and benefit-sharing laws. The Brazilian law notes that protection of traditional knowledge ‘shall not affect, damage or limit rights related to intellectual property’ (8) and requires that access and benefit-sharing contracts include provision for IPRs (28). By contrast, the OAU model law provides that collectors must agree not to apply for intellectual property protection over a biological resource or its derivatives without community consent (8); it also prohibits patents on life forms and biological processes (9). Costa Rica provides for the protection of IPRs with several exceptions, including the prohibition of IPRs for ‘inventions which, to be commercially exploited through a monopoly, can affect farming or fishing processes or products which are considered basic for the food and health of the inhabitants of the country’ (78).

The question of IPRs is a sore point for many indigenous peoples, not only because of understandable suspicions about the unauthorized appropriation of traditional knowledge, but also because the concept of private ownership of ideas directly contradicts indigenous traditions of sharing knowledge for the benefit of all members of a community. Case Study 3 describes negotiations for access to charr broodstock that failed in large part because of indigenous communities’ discomfort with proposals to patent processes for gene mapping. In this example, there was no relationship whatsoever between the IPRs sought by the user and the traditional knowledge held by Inuit communities. What will happen if indigenous communities demand a prohibition on IPRs as a condition for providing consent for access, even though the collector’s invention owes no debt to traditional knowledge? It’s a stalemate that is especially likely to happen during negotiations for access to living creatures as opposed to plants, and policy makers would do well to anticipate such scenarios. The right to intellectual property protection to inventions is frequently one of the key benefits collectors expect to take away from what may prove to be very expensive negotiations.

Treating academics like commercial collectors: A recipe for research chill

Some laws distinguish between applications for commercial and academic research purposes. The OAU model law simply provides that applications must state the relationship of the applicant with industry (11) and that permit fees may differ depending on whether the research is for commercial or academic purposes (12). Brazilian law appears to require an access and benefit-sharing contract only when there is a possibility of commercial use (16). The Philippine law uniquely provides for separate commercial and academic research agreements – the latter being restricted to institutions within the country (3). Academic research agreements can be broader and more general in character (4), with each agreement covering all scientists and researchers at an institution. If it later becomes evident that academic research resulting from collections has commercial prospects, a scientist must reapply for a commercial agreement (5). Under either type of agreement, collectors must obtain the prior informed consent of communities where collections take place; under academic agreements, collecting institutions can develop their own internal guidelines for obtaining prior informed consent.

Drawing meaningful distinctions between academic and commercial research is one of the most difficult challenges that policy makers face. Obviously, encouraging pure academic research is absolutely vital for countries that are serious about developing the comprehensive knowledge needed not only to conserve biological and genetic diversity but also to explore new uses that may be either commercially valuable or in the public interest. This is even more important in the aquatic than in the plant world given the current state of understanding of (and growing commercial interest in) aquatic ecosystems. The very activity of research also builds important technical capacity in the country.

Unfortunately, the days of independent research institutions appear to be numbered and the boundaries between academic and commercial activities are becoming less and less clear. In these days of downsizing, many research institutions both in government and in the academic world are forced to become ever more dependent on corporate support just to survive – and consequently may face pressure to focus on research with promising commercial applications. A scientific institution that collects sponges for taxonomic purposes may also have an agreement with the American Cancer Institute to provide samples for screening. The conundrum for policy makers is how to design processes for approval for access to genetic resources that ensure a fair return from commercial applications without being so onerous that they shut down scientific research altogether. As Case Study 5 at the end of this chapter illustrates, the distinctions between academic and commercial research under Philippine law appear to have done little to facilitate academic research and indeed have hindered it.

Box 5.3 Comparing Laws: Academic vs Commercial Uses

OAU

Research applications must state the objective of the research and the relationship of the applicant to industry (s. 11). Permit fees may differ depending on whether research is for commercial or academic purposes (s. 12).

Philippines

Research for commercial purposes, directly or indirectly, requires a Commercial Research Agreement (CRA). Application for Academic Research Agreements (ARAs) is restricted to Philippines universities and academic institutions, domestic governmental entities and intergovernmental entities (3). ARA proposals can be broader and more general in character than CRA proposals (4). One ARA can cover all scientists and researchers at an institution (5). Scientists operating under an ARA must later apply for a CRA if it becomes clear that research and collection has commercial prospects (5).

In addition to distinguishing between academic and commercial purposes, some laws also differentiate between nationals and foreigners. India’s law specifically notes that no non-Indian person can obtain any biological resource or associated knowledge without approval of the National Biodiversity Authority (3). Under Philippine law, foreign applicants must apply for collection in partnership with a Philippine national research institute or university. Their research applications must include a proposal stating the purpose, source of funds, duration and a list of biological and genetic materials and amounts to be taken (4).

Sharing benefits with communities

Defining the nature, amount and method of delivery of benefits to communities will likely be the greatest challenge of all for both policy makers and those involved in access negotiations. Some laws mention benefits in the most general terms without elaboration; others, such as Philippines Executive Order 247, specifically mention benefits such as royalties. From the viewpoint of communities, the drawbacks of limiting benefits to royalties have long been apparent because the likelihood of developing a marketable product from a single collection (at least in the pharmaceuticals field) is so low. The Philippines legislation has been sharply criticized by civil society organizations for providing only for royalties and for not specifying how they will be divided between communities and government. The OAU model law, which appeared three years later, addressed this concern by requiring at least a 50 per cent share for communities.

Non-monetary benefits, such as technology transfer, training and employment can ultimately be not only far more useful to communities but also more effective in facilitating sustainable, conservation-based economies. Generally, under existing and proposed laws, the responsibility to determine appropriate types of benefits and the manner of ensuring their delivery lies primarily with national authorities. The effectiveness of access and benefit-sharing legislation will consequently depend to a large extent on the ability and motivation of governments to work with communities and collectors alike to facilitate creative solutions.

One important question that appears to remain largely unresolved is whether benefits should be distributed only to those communities in which collections occur, or on a broader scale. Peru, recognizing that collective knowledge may be shared among a variety of indigenous groups, takes the approach of providing for the transfer of monetary benefits to a general fund for the development of indigenous peoples. (This in some ways resembles a similar approach taken in the corporate world by Shaman Pharmaceuticals, which decided to divide a portion of its profits among all communities where collections took place, whether or not any given community’s contribution led to the development of a marketable product.)

Governments that adopt such an approach could follow up with institutional arrangements for promoting community development and biodiversity conservation through, for example, transfer of small-scale technologies (and training in their use) to support sustainable livelihoods, help in the development of marketing skills and mechanisms, and assistance in the development of conservation strategies that contribute to economic well-being. In fishing communities, this might include, for example, providing help with the development of sustainable fisheries that may or may not have been traditionally practised. Costa Rica’s biodiversity law promotes community participation in the conservation and sustainable use of biological diversity through technical assistance and special incentives, especially in areas with rare, endemic or endangered species. To this end, it requires the Ministry of Environment and Energy to give priority to projects for community management of biodiversity (102). Using this type of model, governments elsewhere might channel a portion of benefits received at the national level to local and indigenous communities, to the advantage of the country as a whole.

Such a broad-based approach to benefit sharing makes sense because it can enable national authorities to use the proceeds from the use of genetic resources for the benefit of many communities rather than just the few that may be involved in negotiating agreements. It may also help avoid the detrimental effects that might arise if one community’s benefits place it at a significant advantage over neighbours who may share similar genetic resources (and knowledge) but weren’t party to an agreement. This could conceivably happen to communities that negotiate in good faith, only to discover that the collector moves to another community that can meet his needs with fewer demands – just as collectors may avoid a country with strict regulations (like the Philippines) in favour of a nation with fewer restrictions.

As discussed earlier, while the general trend in access legislation has been to require prior informed consent of communities whether or not their knowledge contributes to the use of a genetic resource, not all countries take this approach. The effect of some current laws could be to leave fishing communities entirely out of the benefit-sharing equation and to create an imbalance in which objectives for the conservation of terrestrial biodiversity are met at the expense of aquatic biodiversity. This is another reason why drafters of access and benefit-sharing laws will need to consider the implications of legislative provisions not just for plant genetic resources but also for aquatic genetic resources and the communities that provide them. Chapter 6 discusses strategies for developing benefits that are appropriate for fishing communities and that can help promote conservation and sustainable use.

Box 5.4 Comparing Laws: Sharing Benefits with Indigenous and Local Communities

OAU

Under the agreement with the Competent National Authority and communities, the collector undertakes to: provide for the sharing of benefits; inform concerned communities of all research and development findings; contribute economically to community efforts to regenerate and conserve the biological resource collected and to maintain the innovation, practice, knowledge or technology to which access is sought (s. 8). Communities are entitled to a share of earnings derived when any biological resource and/or knowledge generates a product used in a production process (12). The state must ensure that at least 50 per cent of benefits so derived are channelled to concerned local communities in a manner that treats men and women equitably (22).

Andean Community

Applications for access and access contracts shall include conditions for strengthening and development of the capacities of the native, Afro-American, and local communities with relation to the associated intangible components (know how, innovations, practices), the genetic resources, and their by-products (17). Access contracts shall stipulate fair and equitable distribution of profits from the use of genetic resources or by-products with an intangible component (35).

Brazil

Indigenous and local communities that create, develop, hold or conserve traditional knowledge associated with genetic heritage have the right to receive benefits from the economic use by third parties of associated traditional knowledge to which they hold rights (9).

Costa Rica

Requirements for access include technology transfer and equitable distribution of benefits, as agreed in permits, agreements and concessions (63).

India

National Biodiversity Authority approval of access depends on securing equitable sharing of benefits arising from the use of biological resources, their by-products, innovations and practices associated with their use and applications and knowledge related thereto (21). Required benefits may include: joint ownership of IPRs with benefit claimers; technology transfer; location of production, research and development units in such areas which will facilitate better living standards to the benefit claimers; association of benefit claimers and local people in biological resources; venture capital funds to help benefit claimers; and payment of monetary and non-monetary benefits to benefit claimers (21). ‘Benefit claimers’ includes conservers of biological resources, their by-products, creators and holders of knowledge and information to use biological resources, innovations, and practices associated with such use and application (21). If approving collectors’ applications of IPRs, the National Biodiversity Authority may impose a benefit-sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising from the commercial use of such rights (6).

Peru

Whoever gains access to the collective knowledge of an indigenous people must destine at least 0.5 per cent of the value of sales resulting from the marketing of products developed from such knowledge to the Fund for the Development of Indigenous Peoples (7). The Fund will support projects and activities approved by an Administrator Committee.

Philippines

Commercial agreements between the applicant and government must include provision for payment of royalties to the national government, local or indigenous cultural community (5).







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