Emerging R and D law: the Nagoya Protocol and its implications for researchers.

Utilization to the Convention on Biological Diversity (the Nagoya Protocol). Like the Biosafety Protocol, It is a protocol made under the Convention on Biological Diversity (CBD), and it provides a binding legal framework to ensure fair dealing in the utilization of genetic resources found in biodiversity. Countries around the world are now preparing or amending national legislation to implement their Protocol obligations, including to regulate researchers’ access to genetic resources and their compliance with obligations on its subsequent use. This will have signicant impact on the conduct of both commercial and non-commercial research and investment. For the international research community the most signicant of these new laws is going to be the European Union (EU) draft regulation on access to genetic resources and compliance with the fair and equitable sharing of benets arising from their utiliszation within the EU. The object of the EU regulation is to ensure that researchers use only lawfully obtained genetic resources and comply with its conditions of use. The European Council will consider this new law for nal approval in early 2014. Once adopted it applies to all 28 EU member states and will bind researchers in the EU along with (by necessary association) their research collaborators elsewhere. Some Background. The Nagoya Protocol was adopted by the 193 member countries of the Convention on Biological Diversity (CBD) on 29 October 2010 at a meeting in Nagoya, Japan. It becomes operational 90 days after the 50th country ratication, which is expected to occur in the second half of 2014. To date 92 countries (including the EU and 23 of its members) have signied their intention to ratify, and 29 have ratied. The Protocol provides the necessary machinery to realize the third objective of the 1994 CBD, that is, the fair and equitable sharing of benets from the use of genetic resources. Negotiation of the Protocol was necessary because progress on this third objective had stalled. The CBD attempted to provide for it through a broad framework, which recognized each country’s sovereignty over their genetic resources along with the right to control access to them and, in return for facilitating that access, obtain a fair and equitable share in benets arising from its use. Access would be granted with a provider country’s prior informed consent (PIC), usually in the form of a permit, and on mutually agreed terms (MAT) including terms for benet sharing, usually in the form of a contract. However, in practice, this broad framework was not consistently introduced nor applied. Many countries did not have the capacity to develop enabling domestic laws, and developing countries in particular were concerned that such agreements would not be honoured once genetic material left their jurisdictions. Conversely, many developed country researchers found obtaining access dicult and subject to excessive negotiation and expense, resulting in delay and a lack of legal certainty, leaving them open to accusations of biopiracy. The Nagoya Protocol seeks to resolve these uncertainties. The cross-cutting issue now addressed by the Protocol is the need for legal certainty when providing, obtaining, and using genetic resources. Prior to the Protocol, source countries were concerned about unauthorized use of their genetic resources (biopiracy), users were concerned that in many countries securing access to such resources was itself legally uncertain, while investors in the commercialization chain were concerned that unclear legal rights led to unacceptable investment risks.