Adoption of regulation on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization (Nagoya Protocol)
(BRUSSELS 11 March 2014): EFPIA welcomes today’s European Parliament resolution on the conclusion by the EU of the Nagoya Protocol, as well as the adoption of the EU Regulation on Access to Genetic Resources and the fair and equitable sharing of benefits arising from their utilization. These are a step forward in the long process towards implementation of the Nagoya Protocol, which shall only enter into force after 50 countries have ratified it. The EU’s ratification is the 30th but will certainly give a major boost to the international effort.
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.
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About EFPIA
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA provides the voice of 1,900 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. The pharmaceutical industry invests 30 billion on research and development per year in Europe and directly employs 700,000 people including 116,000 in R&D units in Europe.
EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
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