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WORK PACKAGE ARCHITECTURE

Policy and Advocacy

Context:

Gene and cellular therapies are subject to EU and national regulations affecting their preparation, administration and patient access. These new therapies challenge the  regulations which were designed for more traditional pharmaceutical products and health authorities are assessing how they will adapt.

Overall aim:

Represent and promote the interests of the GoCART coalition and its stakeholders in EU policy making by engaging with EU institutions and other relevant stakeholders. 

Activities to be developed:

  • Develop a shared policy and advocacy strategy.
  • Advocate key Coalition positions with policy makers.
  • Contribute to European policy making on topics concerning gene and cellular therapies from cells and tissues of haematopoietic origin.
  • Specific topics of interest include but are not limited to: regulation on Substances of Human Origin (SoHO) and Hospital Exemption. 

Main achievements to date: 

  • GoCART contributed through our founding organisations to the draft proposal by the European Commission on the Revision of the EU legislation on Blood, Tissues and Cells. Key areas identified were the introduction of the joint regulation approach promoting harmonisation across the Member States as well as the principles of voluntary unpaid donations and donor protection measures. 
  • EBMT organised a joint event at the European Parliament in May 2023 to discuss these issues. The European Parliament adopted the EU Commission’s proposal for the SoHO Regulation in September 2023. This now needs to be approved by the EU Council (i.e. EU Member States). If not all of the amendments are adopted, or countries wish to add their own amendments, the proposal will go back to Parliament for a second reading.
  • Further plans include developing a shared policy and advocacy strategy to advocate key Coalition positions with policy makers in order to contribute to European policy making on gene and cellular therapy topics, including SoHO regulation and Hospital Exemption.