After several years of negotiations, the 10th Conference of the Parties of the Convention on Biological Diversity (CBD) successfully adopted the Nagoya Protocol. The Protocol provides benefits to the biotechnology industry by creating a legal framework to regulate access to genetic resources and provide fair and equitable sharing of benefits. In addition, the Protocol does not apply retroactively or hinder regulation or a country’s intellectual property systems. Assuming nations implement the Protocol appropriately, we can meet the joint goals of conservation and sustainable use of biodiversity.
The biotechnology community recognizes several important aspects of the Protocol.
Mutually Agreed Terms
Article 4.1 creates the obligation to share benefits on mutually agreed terms between the provider and user of genetic resources. Both parties will understand their rights and obligations regarding the transfer of genetic resources which will create a synergetic relationship.
The Protocol recognizes the need to access genetic resources to respond to imminent emergencies that threaten or damage human, animal or plant health. Article 6(b) answers these needs by ensuring national access and benefit sharing (“ABS”) requirements do not impede a response to a public health crisis.
Those Parties requiring prior informed consent must take legislative, administrative or other policy measures to provide legal clarity and transparency under the Protocol. Article 5.2 requires a “clear and transparent written decision” in a reasonable time. These requirements enable biotechnology companies to comply with national access and benefit sharing laws.
The Protocol appears to be prospective and applies only to genetic resources transferred after the entry into force of the Protocol. This particular provision however, is a bit unclear and will require more study, particularly during the implementation phase. Retroactive application would create widespread uncertainty and litigation and should be avoided.
Intellectual Property Laws/Marketing Approval
The Protocol does not create new rules or laws for intellectual property or for marketing approval for new products. Article 13.1(a) provides for checkpoints which will help monitor the collection of information providing transparency and respect for mutually agreed terms.
The Nagoya Protocol represents a series of compromises with many provisions in the text still unclear. As a result, BIO will monitor the national implementation of the Protocol and the implementation of the “global multilateral benefit-sharing mechanism” used for genetic resources existing in transboundary situations or where no prior informed consent is obtainable. (Article 7 bis) However, we believe that the successful implementation of the Protocol is likely to result in positive relationships between the biotechnology industry, governments, and other stakeholders.