The collaboration between the EMA and EUnetHTA started in 2010 to address recommendations by the Pharmaceutical Forum, a high-level group of European policy makers, to improve the way data published by E.U. regulators as part of their benefit-risk assessment contribute to relative effectiveness assessments by HTA organizations.
The EMA and EUnetHTA started a project in the same year that looked specifically into how the information on the benefits and risks of a medicine contained in European public assessment reports (EPARs) could better address the needs of HTA organizations. The project has resulted in a series of improvements to the EPAR template. The EMA and EUnetHTA are in the process of publishing the outcome of this project in more detail.
Key areas for the next three years include scientific advice/early dialogue with sponsors, involving medicines regulators and health-technology assessment (HTA) bodies; exchange on the development of scientific and methodological guidelines to facilitate clinical-trial design that can generate data relevant for both benefit-risk and relative effectiveness assessments; development of approaches for collection of post-authorization data to support activities of both medicines regulatory authorities and HTA bodies; and orphan medicinal products, exploring ways of sharing information for the common benefit of patients affected by rare diseases and the financial sustainability of the healthcare systems.
The EMA and EUnetHTA will review and update the work plan as necessary, at least once annually.