BIO’s take on the CBD Nagoya Protocol

Patently BIOtech

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.

Emergencies

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.

Transparency

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. 

Prospective

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.

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2 Responses to BIO’s take on the CBD Nagoya Protocol

  1. I would like to know more specifics about the Protocol, as I’m not quite clear on its terms. For instance, what exactly is meant by “access to genetic resources” and “sharing of benefits”? Honestly, it gives me pause to learn that BIO is supposed to “monitor the national implementation” as well as orchestrate the global implementation of the Protocol. Although I understand that BIO is a mammoth in biotech, isn’t this kind of like letting the foxes guard the henhouse? It strikes me that national governments, and not self-interested corporations, might be more appropriate entities for monitoring and implementing programs surrounding such critical issues as biodiversity. Of course, it seems that the Myriad patent litigation, depending on the final result, could very well change the terms of this Protocol.

    • rzwahlen says:

      I think there may be some confusion and I understand as this is a confusing issue that requires some background. The Convention on Biological Diversity (CBD) is an international treaty which is run by an international body with the stated goal of:

      1.The conservation of biological diversity
      2.The sustainable use of the components of biological diversity
      3.The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.

      As the CBD is an international body run by members from national governments, BIO has no legal authority to “orchestrate the global implementation of the Protocol.” National governments (and not trade associations like BIO) DO implement the treaty (including the Nagoya Protocol). Trade associations like BIO are directly affected by each nation’s implementation of the Protocol which is why we will “monitor” (meaning observe) how that Protocol is implemented. Finally, the United States has not ratified the treaty and so until ratification occurs cases like Myriad will have no affect on the CBD. I hope that clears up any confusion you may have. The CBD website is http://www.cbd.int if you need more background on the Convention or the Nagoya Protocol.

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