Processes and criteria of selection of Centres of Expertise for ATMPs.
Project scope
The majority of Advanced Therapy Medicinal Products (ATMPs), require complex treatment and follow up procedures provided only in highly specialised healthcare environment. Since the ATMPs are and will be provided primarily in limited number of Centres of Expertise (CoE) across Europe, it is important patients’ representatives, healthcare providers and policy makers are better informed on the specifications of such centers.
The ambition of this workstream was to gather knowledge on the process for the selection of the Centres of Expertise that deliver commercially available Advanced Therapy Medicinal Products (ATMPs).
The objectives were to better understand what criteria are used for the selection of Centers of Expertise at hospital, company, but also national and EU levels: European Reference Networks (ERNs) and others. The work has helped to identify the common and divergent approaches in the criteria that apply for Centers of Expertise selection. The information and recommendations on the selection criteria would accelerate in the long-term national decisions and access to advanced therapies in Europe.
Stakeholder engagement
This workstream involved engagements with different stakeholders, including manufacturers of ATMPs, patient organisations, academics and ATMP expert physicians.