Expert International Workshop on ABS
Co-hosted by Canada and Mexico
Co-sponsored by Switzerland
Cuernavaca, Mexico
October 24-27, 2004

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Terms of Reference for Panel Discussions

Dear Participant,

Thank you very much for agreeing to participate in the Expert International Workshop on Access and Benefit-sharing co-sponsored by the Governments of Canada, México and Switzerland to be held in Cuernavaca, Mexico on 24-27 October 2004.

The Workshop will be organized in Panels, each of them addressing key issues for the upcoming negotiation of the International Regime on Access and Benefit-sharing. It is our hope that the Workshop will provide a unique opportunity for experts to consider aspects of these important and complex issues in an informed and constructive manner. The timing of the Cuenavaca Workshop should allow for both the submitted papers and discussion to positively contribute to the development of the International Regime. To achieve this goal, the final report of the workshop will be transmitted to the Convention on Biological Diversity Secretariat for dissemination as an information document in advance of the first Ad-hoc Open-ended Working Group in Thailand in February 2005.

Participants are invited based on their expert personal capacity to the Workshop. This Workshop is not a negotiating forum with the emphasis being on exploring new options for achieving CBD-related ABS objectives and not merely restating formal national negotiating positions.

For these reasons, we are asking panelists to provide short papers (3-5 pages) of an analytical or conceptual nature and encourage papers to state the problematique and put forward potential solutions for the international regime. The papers will form the basis of a brief presentation to be delivered at the beginning of each Panel.

The Cuernavaca Workshop has been organized to consider both the big picture issues, as well as specific issues for consideration in the elaboration of the International Regime. The first day of the Workshop will focus on discussion of the overall vision of the International Regime and the second and third days will consider a range of specific issues. The second day will highlight various property rights issues related to genetic resources and traditional knowledge. The third day will comprise several discussions on mechanisms for monitoring and/or verification including certificates of legal provenance/source/origin. The Workshop will conclude with a discussion on ways and mechanisms to ensure benefit-sharing.

Terms of Reference for Panel Discussions

The following terms of reference for the various panel discussions are meant to provide general guidance for the panel discussions and should not preclude panelists or discussants from raising other important considerations outside their scope.

Monday

I) OVERALL VISION OF THE INTERNATIONAL REGIME

The goal of the first day of discussion is to have a full and open debate as to the vision, nature and objectives of the International Regime. In order to provide the context for this discussion of the International Regime, several panels will focus on the identification of outstanding ABS issues.

Identification of Outstanding ABS Issues

During these three Panels experts are invited to address the following questions:

• What are gaps of the existing ABS system which need to be addressed by an International Regime?
• What ABS-related problems and concerns do we want to solve or can solve through the International Regime?
• What are the missing/incomplete/non-functioning elements of the International Regime that need to be addressed?

Panel - Level of National Implementation

The panelists will discuss current levels of national ABS implementation across several regions and provide an overview of lessons learned from implementing the Bonn Guidelines. The panels are encouraged to provide their views on the potential implications for negotiating an International Regime given the current level of national implementation and similarities/differences in national laws.

Panel - National Access Laws: Challenges, Monitoring and Enforcement Issues

Panelists with experience in developing a national ABS policy and/or implementing national access laws will discuss issues that have posed challenges, as well as successes, in particular, those related to monitoring and enforcement.

Panel - Access to Genetic Resources and Intellectual Property Rights: What is Biopiracy?

The panelists will seek to describe the range of alleged "biopiracy" activities in order to facilitate an open discussion about how to best address various questions related to illegal activities and/or issues of fairness in the sharing of benefits from the use of genetic resources and traditional knowledge. The discussion should also contribute to a better understanding of what is the nature of the relationship of intellectual property rights to "biopiracy".

Vision and Nature of an International Regime (IR): Goals, Challenges, Gaps and Role of CBD and Other Bodies

Panelists are invited in this section to address the following questions:

• What should be the purpose (goals/objectives) of the International Regime, for example, establishing minimum standards, harmonizing national laws, establishing user country measures, creating more effective enforcement measures, etc.?
• What are the limitations of national ABS laws that support the development of an International regime?
• What are the main challenges to address in the creation of an effective IR?
• Are there models (co-operative, market-based incentives, innovation policy, international development) or specific aspects of other international instruments concerning property rights, environmental regulation or enforcement (e.g. CITES permit system) that may be applicable or adaptable to the development of the International Regime?
• How should the various international (e.g. WTO, WIPO) and regional (e.g. Andean Pact, ASEAN Community) organizations/fora/processes identified as having a possible role in the development of an International Regime coordinate their efforts with the Convention on Biological Diversity?

Tuesday

II SPECIFIC ISSUES FOR CONSIDERATION IN THE ELABORATION OF THE INTERNATIONAL REGIME

The goal of the second and third days of the Workshop is to have an in-depth consideration of specific issues important for elaborating the International Regime.

In this series of panels, presenters are invited to address the following questions:

• What instruments/tools could help achieve the objectives of an International Regime and bridge potential gaps (e.g., certificate of legal provenance)?
• What other tools/instruments could help to achieve the objectives of the International regime (e.g., codes of conduct)?
• What are the pros and cons of these tools/instruments?
• Should these instruments/tools be voluntary or binding?

Most of Day 2 of the workshop will focus on property rights issues related to ABS. While the issues under discussion in the development-intellectual property agenda are numerous and important, in the Workshop we invite participants to focus specifically on those most directly related to the construction of an effective International regime. Besides considering the relationship and role of IPRs in an ABS context, the discussion will also consider the role of sui generis regimes to protect genetic resources and traditional knowledge, the issue of derivatives as tangible and/or intangible property rights and the protection of traditional knowledge and genetic resources through the use of community-level prior informed consent by indigenous and local communities.

Intellectual Property Issues

Panel - Interface of the International Regime with the Existing IP System & Opportunities and Limitations of Using Existing Intellectual Property Rights in Support of ABS Objectives.

Intellectual property rights have been the subject of ABS-related discussions in multiple international for a including the CBD, WIPO and the WTO-TRIPS Council. In many CBD decisions language has been agreed upon that the CBD and intellectual property rights systems ought to be mutually supportive of each others' objectives. One view is to find sufficient flexibility in IP law to provide specific measures in support of biodiversity objectives, in particular, the equitable sharing of benefits from the use of genetic resources. Another view is that a legally-binding instrument (which may include language on IPRs) is necessary in order to codify State's sovereign rights over their genetic resources. Others may wish to propose undertakings in support of both approaches? A partial list of the potential questions to encourage discussion includes:

• How should IPRs be addressed in an International Regime?
• What is the potential nature of the interface of an International Regime with existing IP treaties and national laws? What flexibility is their under WTO-TRIPS to undertake IP-related measures under an International Regime?
• How can the patent system be adapted to support monitoring and/or enforcement of ABS rights?
• What are the opportunities for using existing IPRs to achieve CBD-related objectives and related economic development in developing countries? In particular, some have suggested that there is a role for trademarks, certification marks and appellations of origin.
• What are the limits of using existing IPRs to achieve CBD-related objectives and related economic development in developing countries? Do the limitations of the existing IP system suggest that there is a need to consider sui generis forms of protection for genetic resources and traditional knowledge which seek to attain CBD rather than IP objectives?

Panel - Derivatives

For a number of years, the issue of derivatives as subject matter for ABS-related rights has been the subject of debate. A full discussion is needed to discuss differing views as to the scope of the term "derivatives" and the potential implications of extending the scope of subject matter and rights under ABS to include derivatives. At the heart of the discussion are the potential rights associated with the tangible and intangible nature of genetic resources.

The issue of derivatives poses some important questions:

• What is the nature and scope of the term "derivative"?
• What are the limits/boundaries/constraints on the rights of providers of genetic resources in the product development process?
• Should rights over derivatives be limited to contractual obligations or is their a need to incorporate derivatives within the scope of rights and obligations afforded genetic resources? Are there feasibility/practical issues related to providing rights to derivatives (e.g. identical genes and chemicals may exist in different species in different countries) that need to be considered?
• What is the current situation? How are rights in derivatives currently exercised by providing countries?
• Are there issues related to derivatives (such as third party access and use of genetic resources) that need to be addressed? What are the rights/enforcement issues that need to be addressed?
• How should the issue of derivatives be addressed within the International Regime?

Panel - New Forms of Sui Generis Protection for Genetic Resources and Traditional Knowledge Relevant for the International Regime

There has been a significant discussion of the need for new forms of sui generis protection in the CBD Working Group on Article 8(j) and the CBD Working Group on ABS. CBD COP7 decisions on Article 8(j) support further work on understanding the customary laws of indigenous and local communities and the development of elements of a sui generis system to protect traditional knowledge. CBD COP7 decisions on ABS support additional analysis of the development of sui generis regimes to protect genetic resources and associated traditional knowledge, as well as other innovative mechanisms (e.g. coupling resource management practices with certification marks) that can be used to achieve ABS objectives. To encourage discussion experts are encouraged to propose elements of new sui generis protection for genetic resources and associated traditional knowledge that will assist in achieving ABS objectives. The subject matter of any proposals could include, inter alia:

• In-situ biodiversity (microorganisms, plants and animals)
• Taxonomic Information
• DNA and Genes (Unknown/Described)
• Genomic databases
• Traditionally used biodiversity (medicines, food)
• Domesticated plant varieties/animal breeds in a country
• Land races/community plant innovation
• Traditional food or herbal products
• Secretly held Traditional Knowledge
• Traditional symbols, marks and designs of Indigenous and Local Communities
• Traditional Knowledge in databases

Panel - Indigenous and Local Communities: Community-level PIC for Accessing Traditional Knowledge and Genetic Resources

In many countries, indigenous and local communities are part of the foundation of the ABS process. Not only are indigenous and local communities often users and custodians of key genetic resources, but they also are holders and creators of traditional knowledge associated with these genetic resources. In many cases, ensuring that ABS occurs at the local level may be necessary to ensure in-situ conservation and sustainable use of biodiversity. Dealing in-depth with the range of ABS-related issues affecting indigenous and local communities is beyond the scope of the Workshop. However, this panel will consider one important issue - Community-level PIC for Accessing Traditional Knowledge and Genetic Resources. This panel will consider how community-level PIC can be incorporated into national ABS systems and the International Regime. Recognizing that this is a preliminary discussion of this issue, a non-exhaustive list of questions is provided to facilitate discussion.

• How is traditional knowledge held by indigenous and local communities in different regions of the world?
• What is the process for obtaining community-level PIC in different countries depending on how traditional knowledge is held?
• How can awareness and transparency of community-level PIC processes be fostered?
• How can community-level PIC systems be incorporated into national ABS laws and the International Regime?
• Under a national ABS regime and/or the International Regime what are the potential options for redress if community-level PIC is not obtained when accessing genetic resources and associated traditional knowledge?
• What capacity-building needs to be undertaken at the community-level level to develop PIC processes and to ensure benefit-sharing through mutually-agreed terms?

Mechanisms for Monitoring/Verification and Compliance

Of all the mechanisms proposed as part of the International Regime, monitoring/ verification and compliance mechanisms are among the ones that have attracted the most attention. The Convention on Biological Diversity establishes that States have sovereign rights over their biological/genetic resources; the question remains as to how the recognition of these sovereign rights are to be implemented in an effective manner within and amongst countries. A range of voluntary and legally-binding mechanisms in support of monitoring/verification and compliance in both provider and user countries have been identified. It is likely that the optimal level of monitoring/verification and compliance will be achieved through the use of a combination of complementary approaches. As all countries are potential sources/users of genetic resources there is a shared goal amongst countries and stakeholders to ensure that any international system of monitoring/verification and compliance is designed to be effective, fair, efficient and transparent. A key objective of this Workshop is to have a more in-depth discussion of the potential merits of various options for monitoring and ensuring compliance.

Monitoring and compliance with the national ABS laws of countries providing genetic resources poses unique monitoring/verification and enforcement challenges across a wide range of sectors and stakeholders, as well as across provider countries with differing national circumstances (e.g. size/borders, economic development). Many countries expect that a key component of an effective International Regime will be to ensure voluntary compliance, as well as creating effective legal mechanisms for enforcement and sanctions in order to induce adherence to national ABS legislation.

In this workshop, we would like to focus on voluntary and legally-binding mechanisms dealing with three related but different realms: stakeholders - the scientific community and industry - and country-level mechanisms to ensure compliance with the ABS laws of other countries. This discussion will be guided by the principle of equity that a person should not be able to benefit from the commercialization of products or processes (including inventions) based on genetic resources or associated knowledge acquired in contravention of any national laws or international treaties governing access to that material.

There are several variations of what may constitute complementary instruments, ranging from the certificates of legal provenance to company certification to scientific codes of conduct. A significant portion of time has been allocated to discuss proposals for certificates of legal provenance/source/origin. Panelists are invited to reflect on the purpose/design, efficiency and practicality issues surrounding these mechanisms including:

• What kind of monitoring/verification/compliance mechanisms are desirable as part of the International Regime?
• What objectives can various monitoring/verification/compliance mechanisms achieve or not achieve?
• What are the implications of various monitoring/verification/compliance mechanisms across sectors (e.g. agriculture and food versus pharmaceuticals)?
• What are the potential regulatory/cost implications of various monitoring/verification/compliance measures on scientific research and firms commercializing biodiversity-based products and processes?
• What implications do they have for other regulatory processes (e.g., intellectual property applications, product approval processes, etc.)?
• What are the potential advantages in monitoring/verification/compliance at the national level that could be realized by collaborating to develop effective monitoring/verification/compliance governing international trade in genetic resources at the multi-lateral level?

Panel - Mechanisms Promoting Compliance by the Scientific Community

Scientists have a central role in providing access to and using genetic resources. There is a common interest to ensure that the advancement of scientific understanding (e.g. taxonomy) is not hampered by mechanisms to achieve ABS objectives. On the other hand, there are many examples whereby scientific enquiry using biodiversity has led to commercial applications. Getting the balance right suggests that a key goal will be to design mechanisms that encourage scientific activities while still ensuring that there is equitable benefit-sharing if research leads to commercial applications.

• What is the role of the scientific community of provider/user countries in the global exchange and scientific/commercial use of genetic resources?
• Are cases of non-compliance with national ABS laws by domestic/foreign scientists primarily due to a lack of awareness of ABS or the result of deliberate efforts to circumvent legal obligations?
• What kind of voluntary/legal mechanisms could be developed to encourage compliance with ABS by the scientific community? What are the appropriate policy responses to various reasons for non-compliance?
• What are the potential implications on the scientific community of specific elements of the International Regime (e.g. regulatory, intellectual property rights, certificates, etc.) or elements that may be developed across a range of international for a (e.g. Law of the Sea, CITES, FAO, etc.)?
• How do we best involve the scientific community in this discussion?

Wednesday

Panel - Monitoring and Compliance through Product and Process Certification

Following the CBD COP7 decision on the negotiation of an international regime, the issue of certificates of legal province/source/origin will be an agenda item for the next Working Group on ABS meeting.

• At what levels would such a certificate system function - PIC certificate in providing country, export permit, import permit, disclosure in IP applications, company manufacturing facility permits or at the wholesale/retail level?
• Concerns have been raised by some about the potential cost and regulatory burden of a certificate system so how can a certificate system be designed to minimize these costs?
• How will the feasibility/effectiveness of a permit system vary across sectors?
• Will there be national level and/or community-level certificates to prove that PIC at the community-level has been obtained?
• How will a certificate system potentially impact on the scientific community, in particular, efforts in support of the Global Taxonomy Initiative?
• Would a certificate system have certain aspects of certification systems under both environmental regulation and property rights? Are there lessons to be learned from other certificate systems, for example, CITES or deposits of biological material under the WIPO Budapest Treaty?
• Will it be necessary to create lists of ABS species (i.e. genetic resources) like CITES lists in order to facilitate international compliance?
• What will be the role of the certificate in obtaining redress in another country?
• How will international flows of pre-CBD genetic resources which will not have national PIC certificates be affected by an international certificate system?
• Will genetic resources under the FAO International Treaty on Plant Genetic Resources for Food and Agriculture also need certificates?

Panel - Company Certification and Standards

The are many examples of research institutions, botanical gardens and corporations that have developed codes of conduct governing their access and use of genetic resources. National or international industry codes of conduct, company certification of compliance with ABS principles/laws and/or the establishment of industry standards can have a significant contribution to ensuring compliance with national PIC systems and to supporting fair and equitable benefit-sharing with provider countries and indigenous and local communities. This panel will consider best corporate practices and the potential role of company certification and standards.

• What role can institutional and corporate leaders on ABS play in the development of an International Regime and in encouraging other institutions/corporations to adopt best practices?
• How can governments and other stakeholders encourage best ABS practices by corporations?
• What is the role for company certification and standards in the development of the International Regime?
• Are best practices, company certification and industry standards likely to vary across sectors depending on differences in the use and valuation of genetic resources to an industry, market conditions, the nature of competition and historical industry practices and conduct? How do corporations engage provider countries and indigenous and local communities in developing certification systems or an industry standard? What is the legitimate process of engagement to develop certification systems or standards?

Panel - Government Measures to Support Compliance by Users of Genetic Resources

The previous three panels, in particular the discussion of product/process certificate systems, identified potential roles for governments to adopt measures to support compliance by users of genetic resources, namely the scientific community and industry. This panel will consider any additional measures by countries to ensure compliance by users of genetic resources at the national level as well as considering multilateral options for ensuring compliance and resolving ABS disputes.

• What are the monitoring/verification/compliance measures that countries with users of genetic resources have proposed and/or adopted? What can countries do to create incentives for compliance by users in their country?
• What is the potential for multilateral cooperation for the development of international standards and enforcement governing the inter-country use of genetic resources?
• How can international disputes concerning both access and benefit-sharing be effectively and fairly resolved?
• Are there trade dispute settlement mechanisms or international arbitration systems that are appropriate for all or some types of disputes?
• In the context of an International regime, what dispute or arbitration mechanism is appropriate for cases where access to genetic resources was illegally obtained in a country through non-compliance with national prior informed consent provisions under national ABS law or users in full compliance with national PIC systems are subsequently treated unfairly by the providing country?
• What international dispute or arbitration system, if any, is appropriate for cases where the user of genetic resources or the providing country is in non-compliance with the contract that have been mutually agreed terms? How should ABS issues related to third party access to genetic resources be addressed?

Benefit-sharing

Panel - Benefit-sharing

The question of benefit-sharing figured prominently in CBD COP7 discussions on the International Regime. Some argued that there is already access so the focus of the International Regime should focus solely on benefit-sharing. Various mechanisms in support of prior informed consent and benefit-sharing have already been discussed in the Workshop. This final panel will consider successful, not-so-successful and potential models to derive national and local benefits from the use of biodiversity as genetic resources. Some questions for discussion include:

• Who is doing research on genetic resources?
• What is the nature of benefits that can be expected from public research organizations and universities?
• What are the most important factors determining corporate investments in biodiversity-based research of a commercial nature?
• Can biodiversity/genetic resources alone be enough to attract foreign direct investment or are other factors that support private sector investments in innovation (e.g. S&T infrastructure, incentives) also necessary? In other words, is biodiversity a necessary but not sufficient condition to attract private sector investment?
• What is the probability of research success and time frame for realizing benefits from research on genetic resources used to develop innovative to pharmaceutical products?
• What type of biodiversity-based products or markets (e.g. microorganisms, food, low regulatory costs) are likely to yield financial benefits from successful commercial products and processes in the short-term?
• What country-to-country scientific partnerships/models might lead to the successful commercialization of products and resulting benefit-sharing?