June 1997 THE PHILIPPINES: A BRIDLE ON BIOPROSPECTING? Oscar B. Zamora The Convention on Biological Diversity (CBD), now ratified by over 165 parties, reaffirms as international law that countries have national sovereignty over their biological diversity. Further, the Convention says that access to genetic resources should be regulated by the parties along two principles: prior informed consent and mutually agreed terms. Gratuitous plundering of the biodiversity-rich countries is supposed to end. But the CBD only lays down principles. Countries have to translate them into innovative laws and regulations that are both practical and meaningful. The Philippines provides a pioneering example of how this might be done, the difficult balance of interests at stake and the problems it raises. Dr. Oscar Zamora from the University of the Philippines at Los Baños draws some lessons. The Convention on Biological Diversity, which became international law on 29 December 1993, lays down a general framework for what are supposed to be more equitable relations in access to, and benefits from, genetic resources. The first concrete expression of the CBD's governing principle of national sovereignty over biological diversity will be rules and procedures on access to each country's genetic resources. Article 15 of the CBD says that access should be based on prior informed consent and be subject to mutually agreed terms. This only applies to genetic resources acquired in accordance with the Convention, meaning after it became law irrespective of when a particular country ratified. In theory, countries now should have the right to "be in the know" when foreigners want to take samples of national germplasm. They also have the right and obligation to negotiate how people taking materials from each other will result in fair advantages for all concerned. The implicit link between access and benefit-sharing is there. It is up to national legislators to make that link explicit and fashion the appropriate mechanisms. Right now, countries throughout Africa, Asia and Latin America are developing laws on access to genetic resources. The Table highlights what is the state of these developments in selected countries and institutions. In Latin America, the Andean Pact countries (see Box) have devised a common framework on access to genetic resources which has to be implemented at the national level. In Asia, the Philippines has its law in place and the Association of South East Asia Nations (ASEAN) members are looking towards it as a possible model for other national systems if not an ASEAN-wide framework. National debates and drafting have been going on with keen public interest in countries like Costa Rica, Brazil (see Box), South Africa, India and Thailand since some time now. In other countries like Mexico, Laos, Fiji and elsewhere, the work is just starting. Countries can learn a lot from each others' initiatives in this area and many activities are going on at present to stimulate information flows across national and regional borders. There are at last two important caveats to bear in mind. The first is that what is being done is, to a large extent, damage control. The problem is not that we suddenly have a Convention that has to be implemented. The problem is that the unrelenting commodification of biological diversity is forcing developing countries to put up mechanisms to buffer the negative impacts. The new international trade regime embodied in the WTO, and especially the unwelcome obligation on parties to grant intellectual property rights on life forms, gives us no choice but to double our efforts to protect the interests of the poor against the appetite of the elites. Privatisation of biodiversity is disenfranchising local communities. And it is threatening scientific research which is supposed to be carried out in the public interest. That is why, failing to control the source of the problem, we are scrambling to limit the casualties. The second caveat is that trying to regulate bioprospecting is very new to us in the South. We have made a few steps forward but there is tremendous need for improvement. The Philippine experience highlights some of the problems that still need to be addressed. EO 247: the Philippine experience The Philippines was one of the initial developing countries to pass national legislation on access to genetic resources in accordance with the CBD. The move was considered remarkable given that the country has been described as "the single worst case scenario of loss of biological diversity in tropical Southeast Asia." Conversion of the lowlands for other uses, deforestation, unsustainable farming techniques, etc., have decimated the biological wealth of the archipelago. Today, the Philippines is ranked fifth among the world's biological "hotspots" by IUCN for its high rate of endemism — and endangered ecosystems. Collecting of biological materials, be they plant species, marine resources, human blood samples or micro-organisms, is going on all over the country, though no can say to what extent, by whom and for what purpose. One thing is clear, though. The interests of the transnational pharmaceutical industry are among the most pronounced when it comes to potential profit-making from the Philippines' biodiversity. It was mainly because of this glaring reality that the Philippines moved to enact a bioprospecting law. Executive Order 247 was signed into law by President Ramos in May 1995. As an "EO", it is an order issued by the President and legally binding during the term of that President. It is not an organic law enacted by Congress and embedded in the laws of the land. In principle, it is legally binding even after the presidential elections next May 1998 (present rulings bar Ramos from serving another term), unless repealed, amended or revoked by his successor or declared unconstitutional by the supreme court. The reasons why this legal route was chosen as the means to set up some rules on access to genetic resources are that it is faster and more flexible. As such, EO 247 is no more than a basic framework to regulate bioprospecting. Its implementing rules and regulations _ a very detailed set of required procedures — are still being debated and refined. The law is there, but it is not being fully implemented until the guidelines are finalised. EO 247 basically does three things. First, it requires a formal "research agreement" between anyone wishing to access biodiversity in the Philippines and the government. There are two types of agreements, each with minimum standards and serving as a permit. If you wish to collect biological materials and you are a private person, corporation, foreign or international entity, you must get a Commercial Research Agreement (CRA) approved. The assumption is that you intend to make economic gains and that assumption is non-negotiable. If you are a researcher with a governmental or inter-governmental agency, you need only apply for an Academic Research Agreement (ARA), whose requirements are easier. If later on it is found that your academic research has commercial potential, or should you wish to transfer the collected materials to a third party, your ARA must be upgraded to the CRA category. Both types of research agreements have basic rules in common. They require that: duplicates of samples be left with local agencies; Filipino citizens retain full access to the materials and any products developed from them; a separate agreement on sharing of royalties, technologies and other benefits be made; ownership of the resources shall remain with the State; and when the collector is merely an agent of someone else, the full relationship must be examined. EO247 IN A POOL OF OTHER LAWS Republic Act No. 7586 National Integrated Protected Areas System Act Of 1992 Establishes a comprehensive system of integrated protected areas consistent with the principles of biodiversity conservation and sustainable development. This system sets out the classification, administration, and management of designated protected areas. The act provides for a general management plan to promote adoption and implementation of innovative management techniques _ e.g. zoning, habitat conservation and rehabilitation, diversity management, community organizing, socio-economic and scientific researches, site specific policy development, pest management and fire control and the protection of indigenous peoples' and migrant communities. Activities outside the scope of management plan shall be subject to an environmental impact assessment. Presidential Decree No. 1151 Philippine Environmental Policy Requires all agencies and instrumentalities of the national government, including government-owned or controlled corporations, as well as private corporations, firms and entities a detailed statement on environmental impact of any proposed undertaking which significantly affects the environment. Presidential Decree No. 705 Revised Forestry Code Of The Philippines The decree emphasizes proper classification and survey of all lands of the public domain, management and utilization, as well as the protection, development and rehabilitation of forest lands to ensure continuity of productive condition. Senate Bill No. 1728 Indigenous Cultural Communities' (ICCs)/ Indigenous Peoples' (IPs) Rights Act Of 1996* Recognizes, promotes and protects the rights of ICCs/ IPs to their ancestral domains, autonomy and self determination and cultural integrity. It further recognizes full ownership, control and protection of their cultural and intellectual property _ including special measures to control, develop and protect their sciences, technologies and cultural manifestations, including human and other genetic resources, seeds, medicines, indigenous knowledge system and practices, knowledge of the properties of fauna and flora, oral traditions, literature, designs, visual and performing arts and the right to the protection of their traditional medicines and health practices, the protection of vital medicinal plants, animals and minerals. Community Intellectual Property Rights Protection Act Or Cirpa* The bill provides for a system of community intellectual rights protection which acknowledges the innovative contribution of local and indigenous cultural communities with respect to the development of genetic resources and the conservation of biological diversity. It recognizes free sharing of knowledge and resources but does not apply if commercial utilization of innovation is involved. * pending bills in congress or senate The second pillar of EO 247 is that any form of access to biodiversity, be it through an ARA or a CRA, is strictly illegal without the Prior Informed Consent (PIC) of the local or indigenous community concerned. This is the heart of EO 247 which is supposed to put a bridle on bioprospecting. Until now, donors of genetic material which was collected for research or other purposes had no protection or rights, since their legal consent was not required. The days of this informality are over. The abuses and inequity of unshared gains from community resources have to be stopped. PIC must now be obtained before collecting in the Philippines, under penalty of stiff sanctions. The still draft implementing rules and regulations are quite explicit on the steps needed to obtain a certificate of PIC. The collector must inform the community of his/her intentions via public notice, a consultation must be held, and reciprocal benefits must be outlined. Signature from the relevant local authority must then confirm that the community has agreed and the PIC form is then validated by the government. The third pillar of the Philippines' access system is an Inter-Agency Committee (IAC) responsible for its implementation and review. The IAC is under the Department of Environment and Natural Resources and involves other agencies of the government, academe, non-governmental organisations, and peoples' organisations with indigenous community membership. Some of the problems with EO 247 As such, the Philippine system comprises what are currently considered basic mechanisms of any reasonable access system: PIC of the State, PIC of communities, collecting fees, provision for sharing of benefits, an implementing agency, and sanctions for non-compliance. So far, the first thing one can say is that it is scaring a lot of people off. Week by week we meet Koreans mumbling under their breath, Japanese saying they have second thoughts about coming to the Philippines, and our own researchers complaining and scratching their heads. This might be because the whole procedure is new and a radical break with the old "free access", do-as-you-please regime. But it might also have to do with the fact that countries are experimenting with how to regulate access best and we need to adjust the rules and procedures more. There are a number of problems already apparent through our brief experience now with EO 247: Definition: The Philippines, like many countries, is bound to legal instruments which already define territorial rights, rights of indigenous communities and the State's sovereignty over natural resources (see Box). The problem with EO 247 is its definition of "bioprospecting". Prospecting means to explore, to look for. It is not so much the "looking for" that is regulated under the EO, but the act of sampling or collecting materials. And collecting is not the only activity that leads to unjust benefits derived from national resources. Merely documenting or publishing information about indigenous materials or practices can have detrimental cultural, political and economic effects. Scope: The scope of the EO covers all "genetic resources in the public domain including natural growths in private lands". This raises three problems. Given that the Constitution of the Philippines considers all flora and fauna as the property of the State, it is not clear whether human genetic material falls under the terms of the EO (much less the legal grip of State ownership). This is a major issue since indigenous communities here have already been subject to collecting of their blood, saliva and root hair samples used in medical research to exploit their genetic resistance to disease. So long as the EO does not explicitly cover human genetic materials, the sampling of DNA of indigenous communities in the Philippines will continue unbridled and uncontrolled, much against the original intent of the law. Second, the scope is limited to genetic "resources", i.e. physical materials. It does not extend explicitly to associated information and knowledge about those resources - which often contribute enormously to their commercial and other value. Third, the scope is limited to in situ resources. The EO does not explicitly mention regulation of access to genebanks. ANDEAN PACT ACCESS REGIME In July 1996, the five countries of the Andean Pact (Bolivia, Colombia, Ecuador, Peru and Venezuela) adopted Decision 391 on a Common Regime for Access to Genetic Resources. The regime constitutes a framework agreement: Decision 391 automatically becomes national law due to sovereignty cession by memberstates, while implementation is left to each country. The agreement took several years to hammer out and was shaped in accordance with the provisions of the Convention on Biological Diversity. Its objective is to regulate access to genetic resources of the memberstates in order to achieve an equitable sharing of benefits, set the basis for recognising rights to genetic resources, promote conservation, use and technology transfer and, importantly, upgrade the negotiating power of the memberstates. Decision 391 applies to genetic resources of which the Andean Pact members are countries of origin. This includes materials derived from indigenous genetic resources as well as the intangible components of these resources (such as associated knowledge and information about them). The regime excludes from its ambit human genetic material and the exchange of genetic resources by indigenous, AfroAmerican and local communities for their private use. The tension between the authority of the state and the authority of communities over genetic resources is apparent: genetic resources are defined as goods which belong to the nation or state, yet the Decision allows for sui generis regimes on access to genetic resources and knowledge from local communities. Access to genetic resources of the Andean Pact countries is subject to a contract between the State and the applicant (genebanks, researchers, companies, etc.). The contract must provide for: participation of Andean Pact country nationals in the research, support to Andean Pact research work, transfer of knowledge and technology, sharing of information on the genetic resource in question, capacity building of local communities, deposit of duplicates of any samples collected, communication of research results and agreed terms of transfer of material to third parties. Any use of the material thus acquired for biological warfare is strictly prohibited! When the request for access concerns an intangible component of the materials, the contract must have a special annex including the terms of benefitsharing with the concerned individual or local community. Memberstates have the right to deny access to genetic resources in the following cases: endemism or risk of extinction, ecological vulnerability, risk of genetic erosion, biosafety precautions and cases involving strategic genetic resources. Penalties are foreseen for not following the guidelines, including when transactions are made with products "synthesised" from indigenous materials, which would readily cover biotechnology activities carried out on Andean Pact genetic resources. This also includes nonrecognition of IPRs or any other right asserted over Andean Pact materials accessed without conforming to the rules of Decision 391. In the end, the states have fairly full authority over their genetic resources. They have a battery of means to assert, negotiate, monitor and control national rights over genetic resources in accordance with the regime. It now remains to be seen how much space will be offered for the implementation of local community rights. Source: GRAIN, based on Gaceta Oficial del Acuerdo de Cartagena, "Decision 391: Regimen Común sobre Acceso a los Recursos Genéticos", Lima, 17 de julio de 1996; and consultations. PIC of communities: The provisions for prior informed consent of communities where sampling will take place are top-down. The current procedure in the implementing rules amounts to no more than notification of the community and signature of a paper that notification has indeed occurred. In fact, the PIC form that has to be signed only says that communities have been notified of a research "proposal". Confirmation of the fact that you have been notified of a research intent can surely be a form of consent. But it is a far cry from dialogue about the research itself and actual negotiation over the benefits. If PIC only authenticates that you have been notified, it leaves you no space to say "no" to the collecting activity. Yet that space is fundamental. Further, a PIC mechanism that does not foresee negotiation between communities and collectors is paternalistic. Only higher authorities will have the power to set the conditions for access to local genetic resources. Who is subject to the rules: The EO and its rules are supposed to govern all acts of collecting of biological diversity on the territory, whether by nationals or foreigners. There are even well prepared conditions for those circumstances where nationals are employed by foreigners to do the collecting. However, because of its wording, the EO and its guidelines do not apply to the entire international agricultural research system which brought us the Green Revolution and is now promoting a biotechnological overhaul of our farming and food systems. Agencies like the International Rice Research Institute (IRRI) funded by the Consultative Group on International Agricultural Research (CGIAR) are not bound to the terms of EO 247. IRRI, which is based in the Philippines, is neither a private international agency nor an intergovernmental entity, in which cases the EO would apply. IRRI and all its sister institutes of the CGIAR family can continue to freely collect crop genetic resources, microorganism, and aquatic and marine germplasm from Filipino farmers outside the reach of EO 247 and its provisions on consent and benefit-sharing. This is very critical germplasm for food production and trade that is completely unregulated, especially since the CGIAR and its institutes like IRRI are not party to the overarching CBD. Benefits: The benefits to be derived from access to genetic resources foreseen in EO 247 are classic by now: payment of a collecting fee, participation and training of nationals, technology transfer, guaranteed access to all materials collected and a share of royalties should intellectual property be granted upon new inventions derived from the resources. How the communities stand to benefit is not clear. It is said that all benefits will be shared "equitably" between the State and the local communities, but it does not say fifty-fifty. Further, it is stipulated that all benefits accruing to communities must be allocated to conservation measures. Obligations and incentives are not the same thing. This very much undermines the sovereignty that PIC is supposed to grant communities, such as decision-making power on how best to use their "benefits". Implementation and enforcement: The interagency committee that was set up to implement EO 247 is underfunded and far away in the bureaucratic tangles of Manila. It might be much easier and more efficient to make national scientific research institutions responsible for implementation, in the same way that they now have institutional committees to regulate biosafety in their biotechnology research. Permits could be processed much faster and be more easily monitored for PIC compliance and so on if implementation was decentralised to the level of the research institutes. Another problem with implementation through the interagency committee is that it has no police powers. Even if it had such powers, it is not clear how it could possibly monitor export of germplasm to verify compliance with the EO or not. It is virtually impossible. Seeds, buds and all sorts of samples can be very small. And, besides, the Philippines has more than 30,000 km of coastline. Material can just escape and render the EO ineffective. Disincentive: The biggest question of all is perhaps whether or not regulations on access to biodiversity such as EO 247 will act as a disincentive to research. The administrative procedures that researchers are expected to follow are heavy. The costs of processing fees and sharing the economic returns are new. Endemics aside, some portion of genetic materials found in the country can be readily found in nearby Malaysia, Indonesia or elsewhere. If access laws are means to facilitate the marketing of national biodiversity, we could soon see a glut on the global market. Even if the costs of doing research in the Philippines were comparatively low and allowed the country to compete, it does not mean that the regulatory or political environment enhanced by EO 247 will stimulate research. It might force-feed conservation budgets, but it is a deterrent to people who are inclined to do research. BRAZIL DEBATES ACCESS LAW In November 1995, civil society organisations in Brazil teamed up with Senator Marina Silva, a longtime colleague of the late Chico Mendes, to draft a national Law on Access to Genetic Resources. The bill aims to establish enforceable rules on bioprospecting, with distinctions as to whether collecting activities aim at wild or domesticated species, germplasm itself and/or community knowledge about the material. Proponents of the national law set their highest priority on ensuring that it entrenches the right of local communities (indigenous and farmers) to oppose specific bioprospecting activities. Prior Informed Consent (PIC), as Brazilian NGOs helping shape the law would have it, cannot be reduced to a piece of paper lamely stating "We've been informed". PIC must mean that communities targeted for sampling have the right to say no to each proposal and the right to receive training and capacity-building in actually negotiating the agreements and their terms on benefit-sharing. This last provision is found in the Andean Pact's General Access Regime, but has yet to be seen translated into national law anywhere. The debate on the Brazilian draft law is currently focusing on issues such as: what form benefits to local communities will take, who has the authority to grant notice of PIC from the community level, whether to allow special access provisions for national public research institutes or for sensitive agricultural crops, enforcement procedures and penalties. The Senate's Social Affairs Commission hopes to finalise its work on the draft in June and see it passed through first reading in the Senate afterward. It will then need to go the lower house of the National Congress, so no one expects final adoption and enactment of the law until 1998. Source: David Hathaway, AS/PTA Improving the tools As we gain experience in setting up and actually implementing legal regimes on access to genetic resources, developing countries should hopefully learn from each other and try to gain mutual benefits. At the international level, the renegotiation of the International Undertaking on Genetic Resources for Food and Agriculture could set up a framework for multilateral and bilateral provisions on access that take the principles of the CBD a step further for what concerns the basis of food security and a big share of international trade. If the Undertaking in its final form truly reflects the aspirations of developing countries, then it should become a binding protocol to the CBD. At the national level, we have yet to sort out a number of difficulties. The most important is how communities are consulted and how we facilitate the most appropriate benefits to them. In the Philippine law, this has to be improved. Also, we might have to face intrinsic difficulties with enforcement due to the very nature of biological diversity and our institutional set-up. Even if the EO is slated as unenforceable, it does give farmers, villagers and peoples' organisations the right now to stop collectors and ask to see their permits. Given the pressures of privatisation and commodification, it's not clear whether access laws are really incentives to conserve and sustainably use genetic resources or whether they are just means to accommodate those pressures and the agendas they serve. As new obligations and more bureaucracy appear, access regimes might actually stifle the research and innovation processes that underpin meaningful utilisation of biodiversity. Even if they do work in favour of conservation and use (by force or by incentive), we have yet to solve the problem of unjust monopolisation and the disenfranchisement of the poor. By taking a share of royalties in the name of equitable benefits, you are accepting that someone should be able to patent your seeds or your group's knowledge about the health care properties of a plant. We might be regulating bioprospecting, but we still have to stop biopiracy. Dr. Oscar Zamora may be reached at: Department of Agronomy, University of the Philippines Los Baños, College, Laguna 4031, Philippines. Fax: (63-49) 536 24 68. Email: [email protected]. Sources: - Antonio La Viña et al (eds), Regulating Access to Biological and Genetic Resources in the Philippines: A Manual on the Implementation of Executive Order No. 247, Foundation for the Philippine Environment and World Resources Institute, 63 pp., 1997. - Walter Reid et al, "Translating genetic resources rights into sustainable development: gene cooperatives, the biotrade and lessons from the Philippines", in Plant Genetic Resources Newsletter, No. 102, 1995, FAO/IPGRI, Rome. - Philippine News and Features, "RP ranks 5th in biodiversity", Philippine Daily Inquirer, 23 November 1996. For copies of EO 247 and the implementing rules and regulations, as well as further information, please contact Ms. Norma Molinyawe or Ms. Josie De Leon, PAWB, DENR, Quezon Avenue, Diliman, Quezon City, Philippines. Fax: (63-2) 924 01 09. Email: [email protected].