Clear rules on access to genetic resources
In October 2010, the global community adopted the ‘Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization’. This new treaty, which is a Protocol to the Convention on Biological Diversity, sets out clear rights and obligations of states in relation to how genetic resources should be made available for research and development and how conditions for their use will be enforced. The Commission has now tabled draft legislation to implement the Nagoya Protocol.
Genetic resources – the gene pool in both natural and cultivated stocks – play a significant and growing role in many economic sectors. They are used by researchers and companies in areas such as plant and animal breeding, cosmetics, food and pharmaceuticals. Over the past 30 years, 26% of all new approved drugs are either natural products or derived from them.
But the absence of clear international rules on access and benefit-sharing has led to complaints of ‘biopiracy’ – allegations that foreign researchers, mainly in the developed world, have at times ridden roughshod over the rights of countries, mainly in the developing world, in their pursuit of these precious resources. That breakdown in trust can restrict access to the valuable raw material.
The Nagoya Protocol addresses these issues, confirming the rights of indigenous and local communities that hold traditional knowledge associated with genetic resources that could provide vital information for scientific discoveries.
Enshrining principles in law
The draft EU legislation will bring benefits to users and providers of genetic resources. It will provide the latter with guarantees that their rights will not be violated and ensure the former reliable access to genetic resources at low cost and with high legal certainty.
Under the proposed rules, European researchers and companies would have to ensure that genetic resources and associated traditional knowledge used by them were obtained in full compliance with the law of the country of origin and that the benefits of their research are fairly and equitably distributed.
Users would exercise ‘due diligence’ by gathering basic information on the resources used, such as when and where they were obtained. They would also be obliged to act if available information would indicate the material was illegally acquired, used without a proper access permit or without a benefitsharing agreement in place. Users would face penalties if they cannot demonstrate this when inspected.
The primary suppliers of genetic resources to EU users are collections such as seed banks and botanical gardens. To reduce costs and increase legal certainty, the Commission is proposing to set up a register of ‘EU trusted collections’, to allow users to be sure that their material already complies with a major part of the due diligence obligation.