COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) ON ISSUES TO BE ADDRESSED BY THE TECHNICAL EXPERTS GROUP ON CONCEPTS, TERMS, WORKING DEFINITIONS AND SECTORAL APPROACHES
Introduction: Decision IX/12 of the Ninth Session of the Conference of the Parties (COP-9) of the Convention on Biological Diversity (CBD) “[i]nvites Parties, Governments, international organizations, indigenous and local communities and relevant stakeholders to provide information and views related to the issues to be addressed by each expert group.” The Biotechnology Industry Organization (BIO) appreciates this opportunity to set forth its views on matters to be addressed by the Technical Expert Group on Concepts, Terms, Working Definitions and Sectoral Approaches (“Concepts TEG”). BIO respectfully requests that the experts selected for the Technical Experts Group take these comments into consideration during their deliberations.
Scope of the International Regime: BIO members firmly believe that the proposed international regime on access and benefit-sharing should be within the scope of the CBD. For example, under the CBD, the access and benefit-sharing provisions only apply to access of “genetic resources.” Therefore, the rules in the international regime imposed with respect to genetic resources should be applied consistently with the definition of genetic resources in CBD Article 2 and should not cover the broader concept of biological materials or categories such as derivatives or products, however defined. Suppliers and recipients of genetic resources, however, may elect to assess benefits on biological materials or derivatives arising from the use of those resources through mutually agreed terms.
The international regime should provide for appropriate exclusions, including those areas already explicitly excluded from the CBD, such as human genetic resources.1 In addition, pathogens and commodities (genetic resources already made freely available) should be excluded from the international regime. The paradigm underlying the CBD access and benefit-sharing rules is “bio-prospecting” for genetic resources. That is, a research entity seeks to access a genetic resource in situ or in an ex situ collection and to develop a commercially viable product therefrom. Access to pathogens and to genetic resources that are made freely available do not fit this paradigm. Thus, applying the access and benefit- sharing obligations in the CBD to pathogens and commodities does not appear to be socially beneficial, and it would be inappropriate to apply these rules in the international regime based on the paradigm to pathogens and commodities.
No “One Size Fits All” Approach for Access and Benefit-sharing: It is also our strong belief that suppliers and recipients of genetic resources will obtain optimum economic and social benefits through the negotiation of “mutually agreed terms” for access and benefit-sharing at the “point of access”, rather than applying a fixed access scheme and a fixed “basket” of benefits mandated by a treaty. Negotiations at the point of access would allow suppliers and recipients to determine the appropriate balance between “up-front” and “back-end” benefits for the relevant transaction as well as to determine an appropriate level of benefits arising from the contemplated arrangement.
The terms of reference of the Concepts TEG provide that the experts group will consider the following questions, labeled as (a) – (d). The questions are reproduced below, along with BIO’s comments.
(a) What are the different ways of understanding biological resources, genetic resources, derivatives and products and what are the implications of each understanding for the development of the main components of the international regime on access and benefit-sharing, including in relation to sectoral and subsectoral activities and in relation to commercial and non-commercial research? CBD Article 2 provides the following definitions: "Biological resources" includes 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" means genetic material of actual or potential value. "Genetic material" means any material of plant, animal, microbial or other origin containing functional units of heredity. Consequently, genetic resources are a subset of biological resources that have “functional units of heredity.” An example of a genetic resource is a seed of a tree or young tree plant. An example of a biological resource that is not a genetic resource is a chemical extract from that seed or plant. Some genetic resources may be commercial commodities. Many biological resources would be commercial commodities. The “benefit-sharing” objective in CBD Article 1 is limited to “genetic resources” – it does not encompass “biological resources.” CBD Article 15, which sets forth the obligations on access and benefit-sharing, is also limited to genetic resources.
The concept of “derivatives” is not contained in the CBD provisions on benefit-sharing. This concept is further not defined in the agreement, although the term is used in the definition of “biotechnology” in CBD Article 2.We firmly believe that the proposed international regime on access and benefit-sharing should be within the scope of the CBD. The access obligations in the CBD only apply to genetic resources and the benefit-sharing obligations only apply to use arising from the accessed genetic resources. Therefore, the rules in the international regime imposed with respect to genetic resources should not be applied to “derivatives” (regardless of the definition of the term) of acquired genetic resources. Providers and recipients of genetic resources should define “derivatives” for the purposes of their individual endeavors and determine what benefits, if any, should be based on such derivatives on an endeavor-by-endeavor basis.
Similarly, the term “product” is not used in CBD Article 15 or in any other provision relevant to benefit-sharing. BIO reiterates that the international regime should be commensurate in scope with the CBD. Similarly as above, any definition of “product” should be left to providers and recipients in the development of material transfer agreements (MTAs) that will reflect the specific terms of access and benefit-sharing that will apply to the particular transaction at issue. Consistent with this notion, the Food and Agriculture Organization (FAO) International Treaty for Plant Genetic Resources for Food and Agriculture (ITPGRFA) also does not contain the term “product” or seek to define it. Nonetheless, it is 4
defined as part of the Standard Material Transfer Agreement (SMTA) under that treaty.3 BIO does not believe that an SMTA is workable in respect of the International Regime. The FAO ITPGRFA context is much narrower and therefore more amenable to a standard agreement. Nonetheless, the FAO system is instructive in that the SMTA is where the term is defined. Similarly, the “mutually agreed terms” (usually envisioned to be an MTA) between the recipient and provider are the appropriate mechanism to define such terms if needed with respect to the broader range of transactions envisioned under the International Regime.
(b) Identify different forms of utilization of genetic resources in relation to sectoral and subsectoral activities in the context of Article 15, paragraph 7, of the Convention; Genetic resources are used in a wide variety of ways in the biotechnology sector. For example, when used in the research-intensive biopharmaceutical industry, genetic resources are generally used as instruments to create an “end” product either as a research tool or as a component in the process of making the product. Although with respect to certain products, such as vaccines, the genetic resource itself may be in the end product.
(c) Identify and describe sector specific characteristics of access and benefit-sharing arrangements and to identify the differences, if any, between approaches in sectors; Benefit-sharing arrangements in the research-intensive pharmaceutical and agricultural biotechnology sectors vary widely and may involve sharing benefits before and/or after the marketing of a product arising from use of accessed genetic resources. There is some sentiment among commentators that suggests that emphasis on benefits that accrue after marketing may be misplaced, particularly given that many genetic resources are investigated for pharmaceutical potential but few give rise to a marketable product.
Agreements involving the research-intensive biopharmaceutical sector are nearly always individually negotiated, albeit negotiators may start with a familiar, model agreement as a starting point.4 IFPMA and BIO have published guidelines to educate and assist their members on access and benefit-sharing practices. BIO has also published a model material transfer agreement (MMTA). While not intended to be standard agreements or codes of conduct, these guidelines help identify “best practices” in the industry and also are intended to be updated as practices change. A copy of the BIO guidelines and the BIO MMTA are attached as an Annex to this document.
(d) What are the range of options and approaches for taking these different characteristics into account and that may bring coherence to access and benefit-sharing related practices in different sectors? BIO supports a flexible approach for the International Regime that takes into account different needs of different industry sectors and other stakeholders. The International Regime should facilitate the implementation of clear and transparent national ABS systems. This includes providing for clear points-of-contact for national authorities that can be easily identified by those who seek access.
In addition, flexibility with respect to “mutually agreed terms” should be employed. The International Regime should not attempt to regulate specific terms applicable to all agreements or to otherwise attempt to impose strict conditions that go beyond the ABS principles enshrined in the CBD. This would not only be counterproductive, but would not be consistent with the notion of “mutually agreed terms used in the CBD itself. A system that permits the provider and recipient to come to agreement based on the specific circumstances surrounding the proposed access will help to provide a workable framework that will facilitate implementation of the ABS objectives of the CBD at the national level, while, at the same time, be able to provide necessary flexibility to meet the goals of both parties.
A number of options can be employed to meet these goals and thereby bring coherence to ABS-related practices that may apply to different sectors under the International Regime. Broad measures to build capacity in developing countries will help in establishing clear, transparent national ABS regimes that are more easily understood by others. Efforts to increase awareness of national ABS laws among those seeking access to genetic resources will assist in compliance. In addition, detailed guidance could be incorporated into the International Regime with respect to access rules in order to facilitate implementation of systems with clear points of contact that give legal security and certainty to those who seek access in good faith. Further, aspects to be dealt with in the area of compliance, e.g., use of mediation and arbitration dispute settlement mechanisms, may help to build greater confidence in the implementation of appropriate mechanisms to reach mutually agreed terms.