EMA's pharmacovigilance risk assessment committee (PRAC) adopts rules of procedure on public hearings
Public hearings are a new tool for the European Medicines Agency to engage patients and the public in the supervision of medicines and to hear patients’ views and experiences. The EU pharmacovigilance legislation revised in 2010 includes a new provision on such public hearings that can be held as part of safety reviews of some medicines.
Public hearings, what for?
Public hearings provide an opportunity to hear the concerns of patients and the public particularly on what action regulators should take to manage and/or minimise risks associated with a certain medicine. Hearings will be held on a case-by-case basis, where the PRAC believes that hearing evidence from patients and the public will bring added value to its review. The PRAC will take the contributions from patients made during public hearings into account in its discussions and decision-making.
A major step forward for patients' involvement in EMA's work
Although the EMA has for many years developed various ways of involving patients in its work, public hearings are a new concept that will open up the process to the wider public. The hearings will be open to all interested persons, with registration in advance. Remote participation possibilities will be organised. The hearings will be conducted in English. More information can be found in the rules of procedure (here).
The EMA says public hearings could already take place during late 2016, if a relevant topic is identified. Hearings will be announced on the EMA’s website.
The EMA press release can be found here.