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I. Introduction

A. The Terms of Reference

Regional organizations and national legislatures are beginning to respond to recent changes in international law concerning access to genetic resources and the sharing of benefits deriving from that access. The International Undertaking of 1983 had established that "plant genetic resources are a heritage of mankind to be preserved, and to be freely available for use, for the benefit of present and future generations." The Convention on Biological Diversity (CBD)⁽²⁾ significantly changes the rules relating to control of genetic resources. Article 15 of the CBD affirms a State's sovereign rights over its genetic resources and its ability to regulate access to genetic resources. Parties to the CBD, however, must also facilitate access to genetic resources for environmentally sound purposes, subject to mutually agreed terms, and prior informed consent (art. 15(2)-(5)). Any national legislation must not run counter to the objectives of the CBD (art. 15(2)). The Parties also must fairly and equitably share the results of research and development and the benefits arising from commercial and other use of genetic resources with the Party providing such resources (art. 15(6)). By creating these rules relating to access to genetic resources, the CBD seeks to conserve biological diversity, sustainably use its components, and share fairly and equitably the benefits arising from the use of genetic resources (art. 1).

Although it has revamped the legal regime relating to genetic resources, the CBD fails to address several important issues. Of particular importance for the exchange and use of plant genetic resources for food and agriculture (PGRFA), it fails to address ex situ collections acquired before entry into force of the CBD (see art. 15(3)). Ex situ centers around the world, including the International Agricultural Research Centers within the Consultative Group on International Agricultural Research (CGIAR centers), possess vast collections of germplasm held "in trust for the international community." The extent to which the CGIAR centers and their ex situ collections are affected by the CBD directly depends on a country's legislation to implement the access and benefit sharing provisions of the CBD.

This paper comprehensively assesses the impacts of access legislation on the exchange and use of PGRFA. It pays particular attention to the impacts of access legislation on the exchange and use of genetic resources by the CGIAR centers. Section I(B) concludes this introduction by identifying several key issues that the International Plant Genetics Resources Institute (IPGRI) and other CGIAR centers should address to clarify the scope of access legislation vis-a-vis the CGIAR centers. Section II summarizes the factors used to assess the impacts of national legislation on the conservation, exchange, and use of PGRFA. Section III analyzes legislation promulgated, and significant proposals drafted, in response to article 15 of the CBD. It specifically addresses legislation's potential impact on the --

• conservation, exchange and use of PGRFA;
• creation of a multilateral system of exchange as currently being discussed in the FAO's revision of the International Undertaking; and
• operations of the CGIAR centers in accessing plant genetic resources and making their resources available for use in accordance with its mission and its guiding principles on intellectual property rights, and the agreements signed with FAO placing their in-trust germplasm collections under the auspices of FAO.

Section IV recommends areas of research and identifies other types of involvement that may be desirable for IPGRI in advising national programs on access legislation. Annexes I-III includes key documents, such as the most recent revision of the International Undertaking, as well as the legislation and draft legislation reviewed in this paper. Annex IV includes an annotated bibliography of literature on access legislation looking in particular for any assessments of efficacy of existing access legislation.

B. Summary Conclusions and Key Issues

This paper concludes that regional organizations and national legislatures have paid scant attention to the impacts of access legislation on the conservation, exchange and use of PGRFA. In addition, despite the ongoing multilateral negotiations to revise the International Undertaking within the FAO and the importance or CGIAR's ex situ germplasm collections to research around the world, regional organizations and national legislatures have not crafted access legislation to promote the goals of the Draft Undertaking's Multilateral System of Access and Benefit-sharing (MUSAB) or to ensure the free exchange and use of germplasm with the CGIAR collections. In fact, not one law specifically mentions PGRFA. The draft model legislation of the Organization of African Unity (OAU) uses the term "germplasm," but then only to limit the circumstances in which the competent authority may impose restrictions on access.

While most of these laws and bills do not actively discourage conservation, exchange, and use of PGRFA or the creation of the MUSAB, they do create substantial hurdles to the exchange and use of PGRFA held by CGIAR institutes. For example, none of the laws reviewed expressly exempt ex situ genetic resources acquired before entry into force of the CBD or the applicable implementing legislation from access procedures. In the absence of other national or international law or an agreement between the host government and the institution to the contrary, the exchange and use of these resources requires prior informed consent, the creation of an access contract, and other requirements imposed by access legislation. Although the inclusion of ex situ resources does not contravene Article 15(3) of the CBD (Article 15(3) does not exclude ex situ genetic material but rather expressly includes in situ resources in the access and benefit sharing regime), it does create substantial uncertainty concerning application of the access requirements to ex situ resources. As an example, CGIAR centers in Africa may need to ascertain the provider of all the genetic material in their collections and then obtain that person's or institution's prior informed consent before the material can be used or exchanged, regardless of when the CGIAR center collected the material.

While each law or draft presents unique problems, several problems or key issues emerge from a review of the laws and drafts. These include the ownership and control of genetic resources, especially ex situ resources, the meanings of "derived products" and "derivatives," the expansive coverage of all bioprospectors including informal plant breeders, and conditions of access that may be difficult for a CGIAR center to meet.

1. Ownership and Control of Ex Situ Collections

Most if not all of the laws and drafts do not clearly determine the applicability of access rules to ex situ collections. The laws generally declare that the State has sovereign rights over its genetic resources, including ex situ genetic resources and derivatives (or derived products), and grants the State the right to determine the conditions of access to those resources. The laws and drafts also extend the law's scope to genetic resources, including ex situ genetic resources and derivatives (or derived products).

Once they assert ownership and control over any genetic resources, these laws do not grant any exemptions for the exchange and use of ex situ collections. In doing so, the laws confuse ownership of ex situ resources, particularly those acquired before the entry into force of the CBD or access legislation. One author commenting on Peru's access legislation has written that "it is anticipated that those [ex situ genetic resources] in place before the coming into force of the Convention on Biological Diversity would not be affected at all."⁽³⁾ Regarding the Philippines access legislation, one lawyer said that the Philippines owns genetic resources.⁽⁴⁾ However, others dispute this claim, believing that no one owns genetic resources in the Philippines -- the resources are held in trust for the international community. Others note the ambiguity in national legislation and that the ambiguity creates problems relating to implementation of obligations imposed by access legislation.

The CBD is perhaps the pivotal legal moment in time for ex situ resources, because the CBD changes the legal status of genetic resources. Under the International Undertaking of 1983, genetic resources prior to the CBD were considered to be the common heritage of humankind, freely accessible and not capable of ownership. Ex situ centers collected and stored germplasm during this time. But, "to whom that treasure ultimately belongs"⁽⁵⁾ is difficult to say and requires further research. Perhaps the collections are a common heritage resource, and not subject to ownership. If so, the novel legal question is whether the CBD's subsequent, different legal regime, which allows State ownership of genetic resources, can change the ownership of resources collected under the previous legal regime.

The question also arises as to whether a State can nationalize resources acquired as common heritage resources. A strong argument can be made that the answer is "no", particularly for genetic resources for which the host country is not the country of origin. The FAO/CGIAR Agreements may provide support for this argument to the extent that a country hosting a CGIAR Center is a member of the FAO. But, these agreements are not international treaties which may prevail over inconsistent domestic legislation. At best, they are statements of policy of FAO members and CGIAR centers.

The agreement between a CGIAR Center and the host government may provide a way out of this mire. If those agreements stipulate that the genetic resources held by CGIAR Centers are held "in trust for the benefit of the international community," then it is doubtful that the host country can claim ownership over those genetic resources. IRRI's collection is exempt from Philippine access rules apparently due to language included in the agreement between IRRI and the government of the Philippines.

Even if this question of ownership is resolved in favor of the CGIAR centers, the State may still regulate the use of those resources and require bioprospectors to submit a request for access to the resources of CGIAR centers. States, in general, are free to regulate persons and institutions within their jurisdiction. A State, for example, can regulate the activities of its citizens on the high seas even though that State does not have territorial jurisdiction over the high seas or the resources in it. Thus, although the CBD does not extend its access and benefit sharing provisions to pre-CBD ex situ genetic resources, it does not expressly prohibit a Party from doing so (CBD, art. 15(3)). Parties simply have no legal right under the CBD to invoke the CBD's access and benefit sharing provisions to pre-CBD ex situ collections.⁽⁶⁾ Nonetheless, the CGIAR centers' ownership of their resources may impose limits on the extent to which the State can regulate those resources. For example, a State requirement for benefit sharing relating to the use of privately owned resources could constitute an expropriation of private property, also called a "taking."

The clearest way to avoid these problems is for legislation to state expressly and precisely the status of ex situ resources. In the alternative, the CGIAR centers could negotiate agreements with the host country to exempt their collections from access requirements. This may not resolve the ownership question, but it may resolve the extent to which access legislation applies to the ex situ collections of CGIAR centers.

2. Derivatives and Derived Products

Several of the laws confuse the meaning of "derivative" and "derived product." Peru's draft access regulations, for example, refer to "genetic resources and their derived products." An "authorization of access" means permission to access "genetic resources and their derived products" (Peru Draft Regulations, art. 1). But, an "access project" means a project to investigate genetic resources and derived products (art. 1), suggesting a meaning different from a product deriving from a genetic resource. Later, the draft regulations refer to "genetic resources and their derivatives (art. 21(a)). Peruvian legislation does not define either "derived product" or "derivative", although Decision 391 of the Andean Pact, which applies in Peru, defines "derivative" to mean biochemicals not containing genetic material.⁽⁷⁾

As a result, Peru's draft regulations do not make clear whether the access rules apply to biochemicals lacking genetic material or innovations made from genetic resources. If the access procedures apply to genetic resources and any innovation of the genetic resource, then a CGIAR center may need to account carefully for the origins of all innovations deriving from genetic resources held in their collections. These innovations may be subject to prior informed consent and benefit sharing provisions, among others. For agricultural germplasm, the situation is particularly dire because one germplasm sample often derives from several, if not dozens of other genetic resources. The task of determining the lineage of all samples and of tracking any subsequent innovations is large indeed. Whether an ex situ center can accomplish such a task depends on the quality of its records and the size of its collection. The duty becomes more burdensome if the law covers pre-CBD accessions.

3. Derived Products of Traditional Knowledge

Brazil's Bill 306/95 poses an interesting twist on the derived product issue by extending the scope of the law to derived products of traditional knowledge. Local communities and indigenous populations also have "exclusive rights over their traditional knowledge, and they alone are entitled to surrender them" (Bill 306/95, art. 45). Even when the derived products or innovations are outside of Brazilian territory, the State must protect these rights (art. 44). The Bill thus asks Brazil to protect the rights of indigenous peoples to their traditional knowledge by ensuring that any bioprospectors first obtain the justified informed consent of the indigenous populations before using their knowledge, and products deriving from that knowledge. The Bill is expressly designed to protect the knowledge of indigenous and local communities "everywhere, even abroad."⁽⁸⁾

Brazil's Bill attempts to remedy past inequitable treatment of local communities and indigenous peoples, who have seen others profit from their knowledge and innovations. Thus, if someone wants to create a product that is based on their knowledge, no matter where that person is, she must obtain the consent of the appropriate community to use it and pay for the right to use it. In terms of righting past wrongs, the logic of Bill 306/95 is persuasive, and other legislatures may be attracted to it.

Despite the Bill's good intentions, it creates serious enforcement problems. The first problem relates to the definition of derived product -- all subsequent innovations deriving from traditional knowledge, no matter how remotely, are included within the definition. Any subsequent innovation is within Brazil's sovereign control and must be protected by the Brazilian State. Either the State, the providers of each subsequent generation of traditional knowledge, or the users, must enforce this provision. This difficult enforcement problem magnifies over time as products evolve and become less and less related to (derivative of) the traditional knowledge. Several questions emerge: How does one track subsequent uses/derived products of traditional knowledge? How does one distribute benefits to the original suppliers of traditional knowledge as the derived product grows increasingly more distant from the traditional knowledge originally obtained? How does one determine when a product no longer "derives from" a particular traditional knowledge? Who determines when a product no longer "derives from" a particular traditional knowledge?

4. Application to Informal or Noncommercial Plant Breeders

Every law reviewed in this paper applies its access procedures broadly to include almost any bioprospecting activity or potential bioprospector, including CGIAR centers. Drafters of access legislation, to the extent that they carefully consider the law's scope, are erring on the side of expansive coverage. Thus, even informal plant breeders must comply with access legislation and those undertaking research for noncommercial purposes.

The laws generally create a few exceptions, but most do not extend to CGIAR centers or informal plant breeders. For example, most laws exempt the exchange and collection of genetic resources and traditional knowledge by local communities and indigenous populations (e.g. Decision 391, art. 4), which clearly would not apply to CGIAR centers but may apply to many informal plant breeders. Some laws create exceptions or at least more lenient access rules for academic or noncommercial activities, but these laws themselves are the exceptions. The access regimes of the Philippines and the Andean Pact allow universities to enter into framework access agreements which are designed to permit several different access activities under one contract. These more lenient provisions apply only to certain classes of bioprospectors, such as universities and research institutions. Only the Costa Rican law specifically distinguishes between commercial and noncommercial bioprospecting by any person as a means to determine whether more lenient access procedures should apply (Law No. 7788, art. 71).

The exemption for local communities and indigenous peoples may be too politically charged to be useful, because the designation as a local community or indigenous population may trigger other benefits or rights. Both the exemption for local communities and for academic institutions may be too narrow to incorporate many informal plant breeders or CGIAR centers.

The distinction between commercial and noncommercial bioprospecting is perhaps easiest to apply if the goal is to exclude informal plant breeders and CGIAR centers from access requirements. Still, fears may persist that noncommercial transactions may take a country's genetic resources to another country. There, a commercial transaction occurs, a person develops a profitable product, but the country of origin no longer has jurisdiction to require benefit sharing. This problem could be resolved by using a material transfer agreement (MTA) that prohibits any commercial use or transfer for commercial purposes of the genetic resource. The MTA could also require any noncommercial transfer to a third party to include a similar provision, unless the person subjects herself to the benefit sharing and/or other access provisions required by the country of origin. This issue bears further investigation.

5. Conditions of Access

Most of the laws include similar conditions for access. For example, all or most of the laws require the bioprospector to:

• submit duplicate samples of any genetic resources collected to a designated institution within the country of origin;
• include a national institution or national researchers in the collection of genetic resources and/or research relating to the genetic resources collected;
• share existing information relating to the genetic resource for which access is requested and any uses of that resource;
• share research results with the competent national authority and the providers of the genetic resource;
• assist in the strengthening of institutional capacities of national institutions relating to genetic resources; and
• share specific financial benefits.

The laws differ, however, by whether they require a bioprospector to meet each condition or whether the conditions constitute a "basket of benefits"⁽⁹⁾ that the bioprospector, the provider of the resource, and the State may negotiate. Decision 391 of the Andean Pact, for example, allows the parties to negotiate the provisions (Decision 391, art. 17) while Peru requires the bioprospector to meet each of Decision 391's conditions and then a few more (Peru Draft Regulations, art. 21). The "basket" approach has clear benefits for many bioprospectors because they may not be able to provide the type of information or support that the Peruvian approach requires. Bioprospectors and providers can negotiate conditions that are within their means and meet their needs.

6. Intellectual Property Rights and Sui Generis Rights

The use of intellectual property rights (IPRs), especially utility patents, to protect life forms such as new plant varieties is a growing international trend. Several of the access laws reviewed here expressly permit the patenting of new varieties of plants, although most are silent on this question. Several laws expressly reject patenting of genetic sequences and life forms (e.g. Costa Rica, Law No. 7788, art. 78).

In those countries in which the law grants IPR protection to new varieties of plants, CGIAR centers may find their goal of holding resources "in trust for the international community", freely available, more difficult to implement. As new varieties of a staple crop become protected, CGIAR centers may have greater difficulty obtaining the new variety for their collection without limitations imposed by the IPR holder. And, although the CGIAR centers have a policy of accepting limitations on distribution of a genetic resource "only to the extent necessary and for a limited time,"⁽¹⁰⁾ that policy may become untenable as IPR protection for plant varieties and gene sequences grows. If a CGIAR center can acquire new germplasm only with limitations imposed on its distribution and use, the center will incur greater transaction costs. It will need to draft an increasing number of material transfer agreements (MTA) that include limitations unique to a new accession and it will need to monitor subsequent uses of the restricted material to ensure that the material is used in accordance with the MTA.

Similarly, several laws create, or enable the creation of, sui generis rights to protect the knowledge and innovations of local communities and indigenous populations (e.g. Brazil, Bill 306/95, arts. 44-47; Costa Rica, Law No. 7788, arts. 82-85). These rights tend to grant local communities and indigenous populations "exclusive rights" over their knowledge which "they alone are entitled to surrender" (Brazil Bill 306/95, art. 45). While a local community or indigenous population may be willing to submit to the conditions of an MTA, that possibility seems unlikely in light of the history of biopiracy. These groups are unlikely to use their new-found rights to donate their resources and knowledge so that others may continue to profit by it without compensating the providers of the knowledge. This view is unquestionably reasonable. Just as with IPR-protected material, however, if local communities assert their rights by imposing limits on the use of their resources, CGIAR centers may be unable to easily acquire new germplasm and they will incur additional costs in negotiating unique MTAs with local and indigenous communities as well as with subsequent users of the germplasm.

1. Instructor of Law, Northwestern School of Law of Lewis and Clark College. Mr. Wold is also an attorney with the Environmental Law Alliance Worldwide-U.S., and Of Counsel with the Center for International Environmental Law.

2. Convention on Biological Diversity, June 5, 1992, entered into force December 29, 1993, 31 I.L.M. 818 (1992).

3. Anonymous, "Regulation Concerning Access to Genetic Resources of Peru," page 4 (31 May 1998)(emphasis added).

4. Personal Communication with Armmand Mejia, Tanggol-Kalikasan (May 21, 1999).

5. Susan H. Bragdon and David R. Downes, Recent Policy Trends and Developments Related to the Conservation, Use and Development of Genetic Resources, 17 (June 1998)(Issues in Genetic Resources, No. 7, International Plant Genetics Resources Institute).

6. For a similar conclusion, see Lyle Glowka, A Guide to Designing Legal Frameworks to Determine Access to Genetic Resources, para. 2.1 (1998).

7. Decision 391 of the Andean Pact defines "derivative" as "a molecule or combination or mixture of natural molecules, including raw extracts of living or dead organisms of biological origin, derived from the metabolism of living organisms" (art. 1).

8. Personal Communication I, with Eugênio Arcanjo, Legislative Advisor to the Brazilian Senate (April 28, 1999).

9. I am indebted to Kerry ten Kate for this phrase. See Kerry ten Kate, The Common Regime on Access to Genetic Resources in the Andean Pact, Biopolicy, vol. 2, Paper 6, Section 6 (PY97006) (1997) (available on the internet at: http://www.bdt.org.br/bioline/py).

10. IRRI, "Policy on Intellectual Property Rights," Protocol III, para. 2 (undated).