From pdh@u.washington.edu Mon Jun 7 17:52:59 1999 Received: from jason04.u.washington.edu (root@jason04.u.washington.edu [140.142.78.5]) by lists.u.washington.edu (8.9.3+UW99.02/8.9.3+UW99.01) with ESMTP id RAA42556 for ; Mon, 7 Jun 1999 17:52:58 -0700 Received: from saul3.u.washington.edu (pdh@saul3.u.washington.edu [140.142.83.1]) by jason04.u.washington.edu (8.9.3+UW99.02/8.9.3+UW99.01) with ESMTP id RAA10050 for ; Mon, 7 Jun 1999 17:52:57 -0700 Received: from localhost (pdh@localhost) by saul3.u.washington.edu (8.9.3+UW99.02/8.9.3+UW99.01) with ESMTP id RAA12817 for ; Mon, 7 Jun 1999 17:52:56 -0700 (PDT) Date: Mon, 7 Jun 1999 17:52:54 -0700 (PDT) From: Department of Zoology To: indknow@u.washington.edu Subject: Report on Access to Genetic Resources available on-line Message-ID: MIME-Version: 1.0 Content-Type: TEXT/PLAIN; charset=X-UNKNOWN Content-Transfer-Encoding: QUOTED-PRINTABLE ---------- Forwarded message ---------- Date: Mon, 07 Jun 1999 12:57:42 -0400 From: BIONET information services To: BIODIV-CONV List-Server Subject: Report on Access to Genetic Resources available on-line We are pleased to announce the availability of the report -- ACCESS TO GENETIC RESOURCES: An Evaluation of the Development and Implementation of Recent Regulation and Access Agreements -- which has been prepared by the Environmental Policy Studies Workshop of Columbia University's School of International and Public Affairs. The report analyzes a number of recent agreements and legislation regulating access to genetic resources and the sharing of benefits derived therefrom.=20 The project examines the historical context of such legislation, including the role of the Convention on Biological Diversity; obstacles to creating consensual policies; possible evaluation criteria for assessing access frameworks; and recommendations to policy-makers, practitioners and advocacy organizations. Case studies include access legislation and bioprospecting agreements in the Andean Pact, Brazil, Cameroon, Costa Rica, Fiji, the Philippines and the United States. The report is very timely given upcoming discussions on access at an intersessional meeting of the CBD later this month (Montreal; 21-23 June) and an expert panel under the CBD in October.=20 Attached is the report's Executive Summary. Full copies of the report are available in PDF format from: http://www.columbia.edu/cu/sipa/FUNC/EPS/eps_rsch.html or http://www.bionet-us.org For copies of the report in other formats, please contact BIONET directly at bionet2@igc.org. Best regards, Stas Burgiel=20 ************************************ Biodiversity Action Network (BIONET) 1630 Connecticut Ave. NW, 3rd Floor Washington, DC 20009 - USA Tel: +1.202.547.8902 Fax: +1.202.265.0222 E-mail: bionet@igc.org URL: http://www.bionet-us.org ************************************ <> In signing the 1992 Convention on Biological Diversity (CBD), the governments of the world committed themselves to creating policy and legislation to simultaneously regulate and facilitate access to genetic resources (AGR) in the interest of three interrelated goals: biodiversity conservation, sustainable economic development, and socioeconomic equity. Progress in this codification of genetic access policy varies substantially from nation to nation, as a diverse field of "stakeholders"-including resource owners, cultural groups and communities, corporations and industrial coalitions, government hierarchies, environmental advocates, and scientists-struggles to reach a point of converging interests. To achieve the goals of the CBD with regard to genetic resources, policy makers must overcome four primary obstacles. First, they must factor the special character of genetic resources into access policy. Genetic resources are both tangible (physical) and intangible (information), and they are distributed independently of political boundaries. Second, genetic resources have been used, modified, and stored in centers around the world for centuries, and effective policy must accommodate these ex situ collections. Third, before addressing the complexities of the distribution of benefits, policy makers must clearly define ownership and tenure of genetic resources. This is a difficult task, because groups as varied as humankind, states, regions, and locals have all claimed rights over genetic resources; the matter is further complicated by the conflict between customary and legal property rights. Fourth, the dearth of legal, institutional, and scientific capacity in many countries seriously hampers efforts to facilitate and regulate access to genetic resources. Finally, the often conflicting interests of large numbers of stakeholders must be reconciled if policy is to be successful. In this report, we examine and critically evaluate the efficacy of seven examples of AGR agreements in overcoming these obstacles and achieving the three goals of the CBD. These cases were chosen because they represent a broad array of policy responses involving a variety of stakeholders, including private actors, non-governmental organizations (NGOs), research institutions, and state representatives; because they represent different geographic regions; and because adequate data were available for analysis. Specifically, we examined=20 =B7 The National Biodiversity Institute (INBio)-Merck & Co., Inc. Research Agreement in Costa Rica =B7 The National Cancer Institute-Universidade Paulista agreement and proposed legislation in Brazil =B7 The BioAndes attempt to bioprospect in Colombia under Decision 391 of the Andean Pact =B7 The African International Cooperative Biodiversity Groups' research and development agreements in Cameroon =B7 Access agreements and legislation in the Philippines =B7 The Strathclyde Institute of Drug Research-University of the South Pacific agreement in Fiji =B7 The Yellowstone National Park-Diversa Corporation agreement in the United States. Of each case we asked the following questions, which form the basis of our analysis: =B7 How are stakeholders identified and represented? =B7 How are property rights addressed? =B7 How is prior informed consent ensured? =B7 How are benefits distributed? =B7 Do the terms of the agreement encourage compliance and are there mechanisms in place to handle disputes? =B7 How are sustainable use and conservation addressed? A number of conclusions emerged from our analysis, and these led to several recommendations that are pertinent to policy and decision makers involved in regulating AGR. During policy development existing regional institutions and cooperation frameworks have provided operational support. One way to make regulatory efforts more expeditious and cost-effective is by using a regional cooperation framework to coordinate legislation development. Similarly, an academic or NGO cooperation framework may assist in coordinating bioprospecting efforts. It can also serve to avoid duplication of efforts and allow for the coordination of regulatory regimes among neighbors. But working in a regional framework has its disadvantages. The realities of implementing a regional regulatory regime shift point to a more complicated scenario. There may be inconsistency in the implementation, and regional legislation may be more difficult to change in the future.=20 Recommendation: We recommend that nations which currently do not have the capacity to develop regulatory regimes take advantage of existing regional institutions that can aid them in the process. New AGR regimes lack evaluation procedures which would allow an assessment of achievement of the CBD objectives. Although it is still too early to evaluate the conservation and sustainability of the access to genetic resources regimes that are currently operating in the agreements we examined, it will be essential to assess their effects. Agreements often require assessment of compliance with their own terms, but they lack specific provisions that mandate post-agreement assessment of their impacts on sustainable use, conservation, and equitable distribution of benefits in the long term. Recommendation: Independent, multidisciplinary evaluation of the success of the access policy in achieving CBD objectives must be incorporated into AGR regimes. It would be pertinent to consider this issue during negotiation of agreements so that training of in-country persons in this area or the hiring of consultants to perform this task can be arranged. In those agreements that must be periodically renewed, the renewal process could require an evaluation report. Minimizing the number of parties facilitates the establishment of agreements, but may ultimately lead to failure by excluding the interests of relevant stakeholders. Most of the cases involve access to publicly owned lands, thereby eliminating the need to consult with private parties or indigenous groups prior to gaining access to genetic resources. Participation of all stakeholders is essential to effectively implement regulations and achieve the long term goals of the CBD; failure to recognize and involve stakeholders during the formulation of agreements may jeopardize their successful implementation. Recommendation: During the policy development process the entities directly involved in policy formulation should attempt to identify and seek the participation of other stakeholders.=20 The ability of regulated AGR to expand conservation efforts is limited because most agreements take place on land where conservation is already underway. In an effort to facilitate the establishment of agreements and maximize diversity of resources they have access to, bioprospectors seek areas where (1) property rights are clearly established, (2) a minimal number of parties are involved in negotiations, and (3) biodiversity is high. Frequently, this leads them to target state-owned national parks and other protected areas. However, this strategy fails to augment current conservation efforts and therefore limits the impact access regulations can have in transforming land-use practices. Recommendation: Bioprospecting initiatives based outside protected areas should be encouraged. There is a contradiction between disclosure of terms in access agreements for stakeholder involvement and right to confidentiality of parties in the transaction. Whereas it is common business practice for the terms of agreements to remain confidential, arguably the public has the right to know the details of a financial arrangement which concerns the transfer of genetic information obtained through prospecting on public land. Although it may not be feasible to address this issue in the short term, we believe it is important to highlight the difficulties associated with the current state of affairs so as to stimulate the discussion of this topic. The fact that a large portion of current worldwide bioprospecting is done on public lands adds relevance to this issue. There may be few incentives arising from access to genetic resources to preserve resources that local communities do not legally own. Governments have asserted their sovereign rights over genetic resources, but in many cases the land remains under traditional tenure while the property rights system grants ownership of all genetic resources therein to the state. Usually, only resource owners and users participate in the negotiation of agreements, and only the resource owner receives the benefits. The burden of sustainable use and conservation, however, rests on the communities. It is unlikely that sustainable land-use practices will be embraced by local communities if AGR policy does not provide them with ownership of the genetic resources they tend and benefits derived therefrom. Recommendation: National policy should address the conflict between traditional land tenure and legal property rights of genetic resources, so as to match conservation obligations with the benefit sharing rights implicit in AGR policy. AGR regulations may raise the costs of negotiating access and create a disincentive to use biodiversity. Pursuant to the goals of the CBD, AGR policy aims to both regulate and facilitate access. Clearly defined regulatory protocols can facilitate access by informing potential users of source-country requirements prior to initiating the application process, but only if the regulations are not prohibitively restrictive. Extreme regulation raises the overall cost (monetary and otherwise) of using genetic resources-many of which were easily accessible until recently-and may prevent genetic resources from being used. This problem affects national, international, commercial, and non-commercial ventures alike. Because the goals of conservation and distribution of benefits can only be achieved if genetic resources are accessed, it is imperative that policy makers reconcile the potentially conflicting goals of regulating and facilitating access to genetic resources. New AGR regulations may further increase the cost of negotiating access by nullifying pre-existing agreements or requiring renegotiation of terms. Consequently, the often lengthy process of developing regulations creates a "window of uncertainty" during which parties are reluctant to apply for access, and source country authorities are inclined to reject or postpone them. Based on the cases we examined, it is difficult to determine the extent to which the balance between regulating and facilitating access has been achieved. The complexity of the issue is illustrated by the failed BioAndes applications to gain access in Colombia. In the Philippines only two of 37 applications have been approved, but it must be noted that these two successful cases will most likely serve as templates for future applications, thereby improving the chance of their approval. An additional hindrance to AGR is the use of the same standards in commercial and non-commercial research access requests. Since commercial access deals with such high monetary stakes, access regulations have become increasingly restrictive and commercially-oriented. Hence, a cumbersome, unnecessarily strict application process is imposed on what is considered basic, not-for-profit research. This basic scientific investigation is required to understand natural processes and almost invariably precedes commercially oriented research. Failure to explicitly recognize the fundamental differences between commercial and non-commercial research in AGR policy may cause essential research to grind to a halt. For instance, full enforcement of Decision 391 in Colombia would render all current scientific collection projects inside the country-including those performed by national universities and state agencies-illegal. However, it is often impossible for source country authorities to distinguish between commercial and non-commercial projects. Recommendation: Since there is no objective criterion to draw the boundaries between non-commercial and commercial research, and to avoid discouraging research that may benefit biodiversity conservation, we recommend that countries provide a "two-track" application process, wherein any access applicant would be able to choose between either one of the two "tracks" according to their priorities. =B7 Type I agreement: A simple research permit in which researchers forgo the right to any future monetary benefits arising from commercialization and IPRs, which belong to the resource owners. =B7 Type II agreement: A more complex contractual agreement which would involve negotiations of IPRs and both monetary and non-monetary benefits with the resource owners, as defined in the specific national and local context. The advantage of this system is that the users themselves define their intentions, avoiding the need to infer them from the project description or other criteria. Large numbers of stakeholders must be consulted and detailed terms of benefit sharing negotiated only when IPR and financial benefits are an issue. By stating in a legally binding agreement that they do not claim any ownership rights over future commercial discoveries and resulting benefits, parties interested only in basic research could avoid more costly negotiations. Somewhat counter-intuitively, the Type I agreement represents one of the most restrictive agreements possible, in which users are only granted ownership to the sample itself and permission to study the material they collect.=20 It must be noted that the Type I agreement would not preclude the need for fair compensation-either monetary or in-kind-to the local community, source country, or source-country institutions, as provided by their regulations. It would also not preclude the commercialization of the discoveries by the resource owners. Furthermore, it would not prevent users from entering into a more complex Type II agreement equipped with benefit sharing provisions in the future. Type II agreements could be structured as a framework agreement containing a variable number of clauses that come into effect as they become applicable. Although the uses permitted in the Type I agreement could be viewed as the first step in the establishment of the Type II agreement, treating them as completely separate agreements underscores the fundamental differences between commercial and non-commercial ventures and encourages the basic biological research that is essential to achieving the goals of the CBD by preventing over-regulation. The main benefits to be obtained from access agreements will most likely be non-monetary, i.e., capacity building, technology transfer, joint research, and training. A common argument in AGR discussion, as it relates to the goals of the CBD, is that substantial cash profits that would enhance conservation can be generated from bioprospecting. Nonetheless, at the time of this analysis, no royalty or commercialization-derived monetary benefits have resulted from any of the agreements. During this study, we noted a heightened awareness of the costs and risks associated with bioprospecting. Many of the access agreements we reviewed strongly emphasize the training and capacity-building responsibilities of the foreign parties. Thus, source countries collect the significant non-monetary benefits that prospectors are willing to exchange for access from the very beginning of a project. Therefore training and capacity building, as emphasized by these agreements, are likely to be much more important than monetary benefits in the short and long term. They may also address conservation goals in a shorter term. Recommendation: When establishing agreements all parties should acknowledge that benefits obtained from access will for the most part be non-monetary and that monetary benefits may be elusive. In conclusion, do the agreements we examined provide ways to overcome the obstacles to regulating access and achieving the goals of the CBD? As can be expected, the degree to which they accomplished this varies among the cases examined and the types of obstacles. Some of the obstacles outlined here seem to be very difficult to overcome, while others are being reduced.=20 Those obstacles arising out of the nature of genetic resources-such as the difficulties in dealing with genetic resources as information-are more difficult to overcome, but can be incorporated when designing and evaluating regulations or agreements. The incongruence between the political framework and the geographical pattern of ecosystem distribution may be addressed more effectively in those cases where regional initiatives are under way. The conflicts surrounding property rights have not been addressed successfully, essential as this is to the implementation of benefit sharing mechanisms. As was discussed above, the complications that arise out of the new, post-CBD genetic resource ownership regime are still relatively unexplored, and they must be overlaid on centuries-old land rights strife. As illustrated by the Yellowstone-Diversa agreement and the differences between the alternative federal bills in Brazil, reconciling the diverging interests of stakeholders remains a challenge in many instances. But in others, such as the agreements in Fiji, the involvement of a variety of stakeholders seems to have resulted in a satisfactory arrangement for all involved. In the case of ex situ collections, the practicality and rationale of repatriating museum collections and herbaria are severely questioned by the scientific community. Scientists argue that the disintegration of large collections would hinder research activities and that most developing nations would find the cost of maintaining large scientific collections to be prohibitively high. The obstacles arising out of low institutional, legal, and scientific capacity are most rapidly affected by AGR agreements and regulations. Examples abound in our case studies of instances wherein the development of a private contract greatly improved the ability of a country to handle requests for access. As those countries currently developing legislation implement it, and if they recognize the consequences brought about by over-regulation, it is expected that access procedures will become clearer and more effective for both national and foreign interests. We hope that the recommendations we provide here will be considered by policy makers, for we feel that they highlight areas that need to be addressed if countries are to achieve the objectives of the CBD. .