WORK PACKAGE ARCHITECTURE

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 hematopoietic 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. 
• 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.