Comments on the Proposal for a Regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization in the Union (as amended by the European Parliament)
ICC and its members are fully supportive of the aims of both the CBD and the Nagoya Protocol. However, the implementation of the CBD and the Nagoya Protocol will lead to additional burdens for authorities, industries and researchers in terms of compliance, documentation and auditing. It is important to keep this burden as low as possible. Otherwise both the use of genetic resources and the development of new products therefrom will be severely hampered. This would run counter the objectives of the CBD as well as the Nagoya Protocol.
ICC is concerned about the way the Nagoya Protocol may be implemented in the European Union. The draft EU Regulation to implement the Protocol, as amended by the European Parliament, comprises elements of retroactivity and goes beyond the scope of the Nagoya Protocol in terms of material scope and due diligence requirements.
ICC calls upon the European Union to take account of the following aspects in the process of implementation of the Nagoya Protocol in EU legislation:
The draft Regulation provides for retroactive effect. It thereby extends the scope of both the CBD and the Nagoya Protocol (NP) and leads to high legal uncertainty.
2. Material Scope
With respect to its material scope, the draft Regulation also goes beyond what is provided for by the CBD and the Nagoya Protocol. The instances of extended scope mentioned will significantly impact on the practicability of access and use of genetic resources. The resulting deterrent effect will negatively affect the intended benefit sharing.
3. Due Diligence
Requirements Some of the due diligence requirements established by the draft Regulation are burdensome and provide a source of legal uncertainty. They will have deterrent effect to the access to as well as to the use of genetic resources and will thereby run counter the objectives of the CBD and the Nagoya Protocol.