Brussels, 16 October 2023 – The Spanish Presidency of the Council of the European Union has established several priorities for the second half of 2023 to ensure Europe's global position and strategic autonomy, including promoting the transition towards a more sustainable agri-food production model and strengthening EU's health autonomy through European-based innovation.

EuropaBio National Associations Council, with the support of AseBio - the Spanish Association of Biotechnology Companies, shares their recommendations, based on their Presidency event, for two fundamental policy proposals - the revision of the general pharmaceutical legislation and the proposal for a regulation on plants obtained by certain New Genomic Techniques.

On the revision of the general pharmaceutical legislation, national associations emphasize the importance of an adequate and balanced incentives framework and recommend that any conceptualization of "unmet medical need" is non-legislative and agreed upon in a multi-stakeholder patient-centric approach. Biotechnology developers also stress the need to boost the clinical research environment, improving the numbers of clinical trials in Europe and building on the Cross-Border Healthcare Directive achievements to ensure early patient access to innovative therapies.

For the use of new genomic techniques for plants, national associations stress the need to ensure regulatory certainty for product authorization. It is crucial to accelerate the overall revision of the GMO framework across sectors beyond plants to align with existing scientific advances and have a proposal for additional policy actions on genetically modified microorganisms. Claire Skentelbery, Director General of EuropaBio commented:

“It is now more important than ever to guarantee that Europe can achieve strategic autonomy and robust supply chains. In a geopolitically unstable environment, Europe must ensure it can innovate and create new alternatives for the agri-food sector and the next generation of therapies for European patients. EuropaBio National Associations remain committed to working with our partners during the remainder of the Spanish Council Presidency while it prepares the work for the upcoming Belgium Presidency.”