Yesterday the European Commission proposed adoption of a regulation to implement the Nagoya Protocol Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity. COM(2012) 576 final, 2012/0278 (COD), Proposal for a Regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (Oct. 4, 2012). As explained in the proposal, this initiative is intended to lay the groundwork for the European Union to ratify the Protocol.
GENETIC RESOURCES UNDER THE CBD. The Nagoya Protocol is a supplementary agreement to the 1992 Convention on Biological Diversity (CBD). 1 Article 3 of the CBD established that nations possess “the sovereign right to exploit their own resources pursuant to their own environmental policies, and the responsibility to ensure that activities within their jurisdiction or control do not cause damage to the environment of other States or of areas beyond the limits of national jurisdiction.” 2 CBD Article 15 provided that in the exercise of such sovereignty, a country may require those who seek access to genetic materials within its territory to obtain the informed consent of the relevant authorities prior to gaining such access. 3 The CBD acknowledged the value of traditional knowledge of indigenous peoples regarding the use of genetic resources and envisioned that benefits from the exploitation of such resources would be shared equitably with the nations and communities whose contributions aided in the commercial success of products derived from genetic resources. 4
Each CBD signatory nation agreed to “endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to” the Convention’s objectives. 5 Nevertheless, most of them did not put into place effective measures to allow access to those resources in appropriate cases. As a result, international transfers of genetic resources needed for important scientific research declined dramatically in the years following adoption of the CBD. 6
THE NAGOYA PROTOCOL. The parties to the CBD adopted the Nagoya Protocol in 2010 to provide greater legal certainty regarding the CBD’s access and benefit sharing principles. The Protocol purports to remove unnecessary obstacles to legitimate bioprospecting while giving member states effective tools to protect their sovereign rights against unlawful biopiracy and to share in the benefits of exploitation of their resources. 7 92 countries (including the European Union and 26 member states) have signed the Nagoya Protocol, but to date, only six countries–Gabon, Jordan, the Lao People’s Democratic Republic, Mexico, Rwanda, and Seychelles–have ratified it.
THE COMMISSION PROPOSAL. The Commission’s proposal calls for the European Council and Parliament to adopt a regulation that would become directly effective throughout the European Union. A central purpose of the regulation would be “to secure access of EU researchers and companies to quality samples of genetic resources based on reliable access decisions at low transaction costs.”
The proposal contains a draft regulation with the following features:
- Genetic Resources. The regulation applies to “genetic resources,” defined as material of plant, animal, microbial, or other origin containing functional units of heredity and having “actual or potential value.” The regulation does not apply to genetic resources for which access and benefit sharing is governed by a specialized instrument to which the EU is a party. The explanatory notes specifically identify the International Treaty on Plant Genetic Resources for Food and Agriculture as such a specialized regime that will be unaffected by implementation of the Nagoya Protocol.
- Obligations of Users of Genetic Resources. The regulation imposes on users of genetic resources an obligation to “exercise diligence” to determine that genetic resources and traditional knowledge associated with it were accesed in accordance with applicable access and benefit sharing laws. To this end, users would be required to “seek, keep, and transfer to subsequent users” information about the following:
- the date and place the genetic resources and associated traditional knowledge were acquired;
- a description of the items acquired, using unique identifiers where they are available;
- the source from which the items were obtained;
- whether the items are subject to rights and obligations regarding access and benefit sharing; and
- any decision made regarding the access, as well as the mutually agreed terms of access.
Users would be required to maintain such information for a period of 20 years following the end of the period of use. They would also be mandated to declare at identified points that they complied with their due diligence obligation.
Union Trusted Collections. The draft regulation would establish a system of EU-trusted collections of genetic resources that would “lower the risk that illegally acquired genetic resources are used in the Union.” Users who acquire a genetic resource from a collection registered with the EU would be deemed to have exercised due diligence in requesting all necessary information.
- Compliance. The draft regulation would require each EU member state to designate one or more Competent Authorities to carry out multiple functions relating to compliance, including:
- Serving as a focal point for access and benefit sharing matters;
- Monitoring user compliance; and
- Carrying out checks to verify user compliance with requirements of the regulation.
- Penalties. The draft regulation directs EU member states to prescribe penalties for violations by users. The regulation itself does not provide specific punishments but requires that they be “effective, proportionate, and dissuasive.” The penalties may consist of fines, “immediate suspension of specific use activities,” and confiscation of unlawfully acquired genetic resources.
- Union Platform on Access. The draft regulation also would establish an EU “platform on access”–a body composed of a representatives of member states, experts, and stakeholders, who would work, among other things, toward streamlining of access conditions, providing “simplified access for non-commercial research,” and the sharing of best practices.
by Shawn N. Sullivan, Oct. 5, 2012.
- Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. The Nagoya Protocol should not be confused with the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, which is an entirely separate international agreement that establishes a framework for liability and remedial action relating to damage to biological diversity caused by genetically modified organisms. See Mexico Joins Treaty on GMO Liability & Compensation, SullivanLawNet (Sept. 30, 2012). Each treaty refers to “Nagoya” in its title because each was adopted for signature in that Japanese city. ↩
- Art. 3, Convention on Biological Diversity. ↩
- Art. 15, Convention on Biological Diversity. ↩
- Art. 15.7, Convention on Biological Diversity. ↩
- Art. 15.2, Convention on Biological Diversity. ↩
- See Shawn N. Sullivan, Plant Genetic Resources and the Law: Past, Present, and Future, Plant Physiology (May 2004). ↩
- For more information regarding the CBD and its relationship to the Nagoya Protocol, see Salvadoran Proposal To Ratify Nagoya Protocol Highlights Genetic Resources Legal Issues, SullivanLawNet (Sept. 18, 2012). ↩