The European Medicines Agency (EMA) today published a report from a multi-stakeholder expert meeting held on 27 May 2016 to look at feasible ways to promote the advancement of ATMPs in Europe and increase patients’ access to these new treatments.
ATMPs include:
- Gene therapies
- Tissue engineered products
- Somatic cell therapies
These medicines have potential to reshape the treatment of a wide range of conditions, mainly in disease areas where predictable approaches are insufficient. However, eight years since EU legislation on ATMPs entered into force in 2008, only five ATMPs are currently sanctioned.
According to EMA’s Executive Director Guido Rasi, ‘We have organized this meeting with all relevant stakeholders to discuss concrete proposals on how we can nurture a regulatory environment that encourages development of ATMPs, safeguards public health and, ultimately, facilitates timely access for patients to much needed treatments.’
The meeting brought together leading academics and researchers, representatives from patients’ and healthcare professionals’ organizations, small and large pharmaceutical companies, the investment community, incubators and consortium organizations, health technology assessment (HTA) bodies, national competent authorities and the European Commission. In their discussions they focused on four key areas:
- Assisting research and development areas.
- Optimizing regulatory processes for ATMPs.
- Moving from hospital release to marketing approval.
- Improving funding, investment and patient access.
The main ideas and solutions projected by the different stakeholders are sum up in the meeting report. EMA and its scientific committees, together with the European Commission and the national knowledgeable authorities, have started conversing the proposals made during the meeting. Tangible actions will be determined over the next few months and shared with stakeholders.
Date: 03/06/2016