To carry out European Union (EU) obligations under the Nagoya Protocol on Access to Genetic Resources and Benefit-Sharing, the European Commission (EC) has proposd a regulation that would ensure that only legally acquired genetic resources and associated traditional knowledge are used in the EU and that such resources are fairly and equitably shared.

According to the EC, a broad array of interests throughout the EU, including plant and animal breeding, biocontrol, cosmetics, food and beverage, horticulture, industrial biotechnology, and pharmaceutical, uses resources found in “biodiversity hotspots in the developing world.” For example, 26 percent of all new drugs approved during the past 30 years “are either natural products or have been derived from a natural product.” In the absence of clear rules on acquisition and benefit sharing, European researchers and companies have apparently “been accused of ‘biopiracy’ by countries claiming a violation of their sovereign rights.” The Nagoya Protocol, expected to take effect in 2014, will require signatories to follow certain procedures so that the rights of countries and of indigenous and local communities are protected while researchers in Europe are also given “improved, reliable access to quality samples of genetic resources at low cost with high legal certainty.”

If adopted, the proposed regulation will impose obligations on users of genetic resources, establish an EU register of trusted collections, require member states to designate competent authorities to oversee its implementation and monitor user compliance, and provide for penalties, such as fines, suspension of specific use activities and confiscation of illegally acquired genetic resources, for transgressions. See European Commission Press Release, October 4, 2012.