Comments on Draft EU Regulation

  • 11 November 2016
ICC policy statement old

Comments on Draft EU Regulation on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union

As the proposal recognizes, genetic resources play a significant and growing role in many economic sectors and involve a broad range of players, including but not limited to industry. Each sector may access, use and create value from resources covered by the CBD in different ways.

To translate raw genetic resources into commercially viable products that can contribute to economic growth and consumer choice, business actors engage in lengthy research and development processes that require significant investments with uncertain outcomes.

Businesses are only able to undertake such investments if the regulatory framework is clear and provides legal certainty, and if operating and transaction costs are proportionate to the commercial potential. Administrative requirements should therefore not be overly burdensome or costly, and should be easily implemented in normal business operations.

Positive elements of the EU proposal

ICC believes that the approach taken by the draft Regulation is generally helpful in meeting the above criteria, subject to clarifications on certain points. We support in particular the following elements:

However, there are still several areas of the draft regulation which require clarification and may cause undesired effects.

Business users will make the efforts necessary to comply with the requirements of the final Regulation, but need to have clarity and legal certainty to be able to implement the provisions in practice.

Implementing regulations will play an important role in clarifying many of the points and making the Regulation operational. Business users look forward to working with the EU, member states institutions and other stakeholders in developing these.