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11.03.14
EFPIA supports the objectives of the Convention on Biological Diversity (CBD) and the Nagoya Protocol and welcomes the successful resolution by EU policy-makers of the complex discussions on access and fair benefit sharing.
We believe that the EU has been largely successful in striking a careful balance between competing considerations. It has proposed an innovative approach to the Protocol based on due diligence, which will encourage responsible utilization of genetic resources and promote compliance, while providing legal certainty for users of resources.
EFPIA also welcomes the EU’s recognition of the need for a regime which is adaptable to the needs of different business sectors. A flexible and contract-based approach, supported where necessary by codes of conduct and sectoral best practices, is necessary to facilitate a responsible use of genetic resources by all stakeholders.
While today’s vote represents a step forward in meeting the objectives of the CBD, many challenges remain. It is now up to the different stakeholders to work together to ensure a smooth implementation of the Regulation’s mechanisms and to facilitate compliance by all users along the chain.
A particular challenge arises to ensure timely access to seasonal influenza viruses. Influenza manufacturers and health authorities have to work together to develop efficient ways and practical mechanisms to comply with the requirements of the new Regulation without undermining annual production timelines and vaccination campaigns.
EFPIA looks forward to working will all relevant stakeholders to find practical solutions to ensure compliance with the new Regulation, as well as timely development and access to medicines.