The European Council advances the Biotech Act I legislative process
The EU EPSCO Council took a step forward in the legislative process of the Biotech Act I by agreeing on a common position regarding the proposed Directive, paving the way for negotiations with the European Parliament.
The European Union's Health Ministers, meeting on 16 June at the EPSCO Council (Employment, Social Policy, Health and Consumer Affairs Council) held in Luxembourg, made further progress on the Biotech Act I by reaching a common position on the proposed Directive included in this legislative package.
The agreement will enable the Council to begin negotiations with the European Parliament on a text aimed at facilitating the development and implementation of biotechnological innovations within the European Union through the modernization of certain aspects of the regulatory framework.
In addition, the ministers held a policy debate on the proposed Regulation under the Biotech Act I, which is intended to strengthen the competitiveness of the European biotechnology and biomanufacturing sectors. During the exchange of views, various measures to promote innovation and reinforce the European biotechnology ecosystem were discussed.
Among the issues debated was the proposal to extend Supplementary Protection Certificates (SPCs) by 12 months for certain innovative biotechnology medicines, one of the topics generating the greatest discussion among the stakeholders involved. However, the Council did not adopt a formal position on this measure, which will continue to be part of the legislative negotiations in the coming months.
The Biotech Act I is one of the European Commission’s priority initiatives aimed at strengthening the innovative capacity and competitiveness of the European biotechnology sector in an increasingly competitive international environment.