Researchers and companies in the EU received a boost today with a new proposal that should provide reliable access to genetic resources from outside the Union. The proposal a draft Regulation that would implement the ‘Nagoya Protocol on Access to Genetic Resources and Benefit-sharing’ is designed to protect the rights of countries and of indigenous and local communities that allow their genetic resources and associated traditional knowledge to be used, while also giving researchers in Europe improved, reliable access to quality samples of genetic resources at low cost with high legal certainty.
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Genetic resources play a significant and growing role in many economic sectors, including plant and animal breeding, cosmetics and pharmaceuticals. Many of these resources come from biodiversity hotspots in the developing world. The Commission says that the absence of clear rules has led some countries to claim that their sovereign rights have been flouted by foreign researchers, a situation known as “biopiracy”. That lack of trust has occasionally led to restrictive conditions that hinder access to genetic resources. Today’s EC proposals are designed to address those fears, while maximizing opportunities for research, development and innovation in nature-based products and services. A level playing field for all EU users of genetic resources should bring particular benefits for SMEs and for publicly funded non-commercial research and enhance opportunities for international collaboration.
The proposed Regulation would oblige users to check that genetic resources and associated traditional knowledge have been accessed in accordance with the applicable legal requirements in the country of origin, and that the benefits are fairly and equitably shared. Users would also be obliged to declare that they have exercised the “due diligence” required by the Regulation (or will do so in future). Users found in breach of the Regulation would be sanctioned.
The Regulation also aims to help researchers and industry comply with the rules. Sectoral best practices will play an important role, and associations of users may request formal recognition of best practices on access and benefit-sharing, building on existing access and benefit-sharing codes of conduct for the academic sector and for different industries.
An EU-register of trusted collections such as seed banks and botanical gardens would be established, identifying collections committed to supplying only fully documented samples of genetic resources. Users acquiring their research material from a trusted collection would be considered to have complied with most of the due diligence obligation. An EU platform would also be set up to streamline access conditions in Member States.
Next Steps
The proposed measures will now be considered by the European Parliament and the Council and once the text agreed, it will become EU law.
The upcoming eleventh conference of the parties to the Convention on Biological Diversity in Hyderabad later this month will offer an important opportunity to explain the basic design of the legislative proposal and to continue collaboration with international partners for effective implementation of the Nagoya Protocol.
Background
Genetic resources are a vital input to numerous EU industries: 26% of all new approved drugs over the last 30 years, for example, are either natural products, or have been derived from a natural product.
The Convention on Biological Diversity (CBD), of which the EU is a party, obliges signatories to facilitate access to genetic resources over which they hold sovereign rights, and to share in a fair and equitable way the results of research and development and the benefits arising from the commercial use of such resources. But the Convention provides little detail on how access and benefit-sharing should be done in practice, and industrialized countries have been reluctant to adopt measures supporting effective benefit-sharing. This has seriously undermined global progress to conserve and sustainably use biodiversity, which is unfortunate as ‘biodiversity-hotspots’ stand to gain the most from an effective ABS framework. The ‘Nagoya Protocol on Access to Genetic Resources and Benefit-sharing’ agreed in October 2010 filled many of these gaps, obliging signatories to take measures to ensure that only legally acquired genetic resources and associated traditional knowledge are utilized within their jurisdiction. The proposed Regulation provides the mechanism to put that obligation into practice in the European Union.
Further information
Source: European Commission
