The Biotechnology Industry Organization (BIO) is disappointed that the effort to revise the FAO International Undertaking on Plant Genetic Resources (the Undertaking) was not successfully completed last week. We believe a number of the outstanding issues can be resolved, and look forward to working with others in the coming months to conclude the Undertaking. BIO supports this process because it shares the common objectives of conserving and making more effective and sustainable use of plant genetic resources for food and agriculture.

BIO approached the discussions last week with the hope that through good faith negotiations, the stakeholders in this process could conclude an agreement that respects all interests involved and serves the common objectives of the Undertaking. BIO made a sincere effort to respond to the concerns voiced by many countries during the more than seven years of discussions to revise the Undertaking. For example, during last week's meeting, BIO refuted rumors that its Members did not support the concept of benefit sharing. Instead, BIO sought clearer and more effective commitments in the Undertaking on benefit sharing, including an obligation to pay commercially reasonable royalties on sales of products that make significant use of material obtained from the multilateral system. BIO made it clear that its Members supported this requirement regardless of the form of intellectual property protection used to protect the products being commercialized, and supported language in the Undertaking to ensure these obligations would apply where specific genes from material obtained from the multilateral system were used in the product that is commercialized. Thus, rather than opposing the benefit sharing obligations, BIO sought to ensure that the obligations would be practical from a commercial perspective and legally enforceable through contracts.

Unfortunately, the revised text of the Undertaking contains a number of provisions that have not been finally resolved or have been framed in unclear terms. Crucial among these are provisions that concern the availability and use of intellectual property protection for plant, nucleic acid and other inventions arising from study and use of materials in the multilateral system. BIO is puzzled by the failure of the negotiators to reach an acceptable formulation on the availability and use of patents given that the revised Undertaking presumes use of patents as a precondition to payment of compensation under the new benefit sharing structure. The only apparent reason for not accepting a provision that reflects the reality that patents will be granted and used in the system designed by the Undertaking appeared to be an ideological opposition to patents. This is troubling and we hope a more focused effort can be made to devise an acceptable formulation on intellectual property rights in the Undertaking.

A satisfactory resolution of the intellectual property issue is crucial to the success of the system being created by the Undertaking. Simply put, effective and comprehensive intellectual property protection in products and technologies made using materials from the multilateral system is a precondition to commercial interest in these materials. Materials that are covered by the Undertaking are exotic and require many years of examination and research to deploy them in new varieties that meet the stringent demands of farmers. Without effective and comprehensive protection for their products and technologies, companies cannot justify making the investments needed to characterize and use plant genetic resources as they are found in the multilateral system.

Unclear provisions on benefit sharing and intellectual property protection will frustrate the objectives of the revised Undertaking, including those related to preservation and facilitated access. If parties to the Undertaking are forced to limit the use of intellectual property rights in their products as a condition of use of materials from the multilateral system, much of the material in the system will not be used and will remain uncharacterized, and therefore useless to those who seek the shared benefits industry is willing to provide. Similarly, if the Undertaking is unclear about the obligations imposed on private parties who use material in the multilateral system, these materials will not be used. If these problems are left unresolved, the potential value of the materials in the multilateral system will be reduced, making it increasingly difficult for governments to justify the expense of preserving and characterizing these materials – precisely the trend that BIO and the International Undertaking seek to reverse. We urge the negotiators to ensure that the Undertaking imposes clearly defined and commercially realistic conditions.

BIO remains ready to support a revision to the Undertaking to resolve the outstanding issues, and hopes this can be done in time for the revised Undertaking to be adopted by the FAO Commission on Plant Genetic Resources at its November meeting.