Key Messages

• IFPMA supports the objectives of the Convention on Biological Diversity (CBD) and recognizes the national sovereignty of States over biological resources.
• IFPMA members have committed to gain necessary approval to remove biological materials found in situ, and to enter into formal contractual benefit-sharing agreements reflecting the mutually agreed terms (MAT) on the use of the genetic resources obtained through that removal.
• Rules governing access and benefit-sharing (ABS) should not create legal uncertainty

Background

Biopharmaceutical research is essential for improving global health. Innovation in this sector is a complex and challenging process that requires scientific excellence, commitment of significant resources and, in some cases, access to genetic material. Only through close collaboration will providers of the genetic material and the biopharmaceutical industry ensure that the research benefits are shared equitably and that access to genetic resources is provided on a fair and mutually agreed basis.

IFPMA supports fair and equitable benefit-sharing as set out in the Convention on Biological Diversity (CBD). The CBD is clear, however, that the benefit-sharing “shall be on mutually agreed terms”. Such terms will normally be embodied in a contract or other agreement that represents a meeting of the minds of the provider and the user of the genetic resources at issue. Typical rules for contracts should be applied to those contracts and agreements involving benefit-sharing.

Benefit-sharing should be handled at the point of access through mutually agreed terms embodied in an appropriate Access and Benefit-Sharing (ABS) agreement to reduce any uncertainties as to the status of genetic resources and benefits arising from their use. Consistent with principles of legal clarity and transparency, once a user has reached mutually agreed terms with the appropriate provider in accordance with the national access and benefit-sharing regime, the user should not be subject to additional claims by third parties, e.g., other communities or entities, which claim some relation to the genetic resources at issue.

In order to ensure compliance with ABS regulations, the Biopharmaceutical Industry supports a contract-based approach that includes tools currently used effectively in many international business transactions, such as private international law mechanisms including alternative dispute resolution mechanisms and civil law regarding enforcement of foreign judgments. Industry reiterates its opposition to proposals made regarding new patent disclosure requirements (e.g., regarding source/origin of genetic resources) as it is of the view that such requirements will be (a) ineffective in promoting the objectives sought (e.g., compliance with CBD principles) and (b) will introduce uncertainties into the patent system that will inhibit innovation in relevant technologies, thereby decreasing potential benefit-sharing from such efforts. Detailed and lengthy discussions in the CBD, WIPO and WTO have confirmed this view and, further, have not led to any consensus on such proposals.