EMA launches pilot project to integrate patients’ views into CHMP discussions
Involving patients in CHMP discussions brings the patients’ voice into the decision-making process, says EMA head
Patients are to be given a voice in Committee for Medicinal Products for Human Use (CHMP) discussions on the benefits and risks of medicines in a new pilot project.
The 12-month project, launched by the European Medicines Agency (EMA), is the next step in bringing patients’ views and values to the assessment of medicines throughout their lifecycle.
‘As patients live with their condition on a day-to-day basis, their views on the therapeutic effect of a medicine and its impact on their quality of life - particularly when these are balanced against the risks - may differ from those of other stakeholders,’ said Guido Rasi, EMA Executive Director.
‘Involving patients in CHMP discussions brings the patients’ voice into the decision-making process and ultimately contributes to the safe and rational use of medicines.’
As part of the pilot project, patients will be invited to give their views on medicines for which there is an unmet medical need and where the CHMP still has concerns or doubts. They may also be invited to give their views when the Committee is considering whether to recommend the withdrawal, suspension or revocation of a marketing authorisation, or restricting an indication of an authorised medicine.
A document outlining the main principles of the project is available here. This pilot project stems from a wider EMA strategy to involve patients in the Agency’s activities more.
The first medicine to be included in the pilot project contains the active substance afamelanotide. It is intended for the treatment of erythropoietic protoporphyria (EPP), a rare genetic blood disorder which causes an intolerance to light. Currently there is no authorised medicine for this condition.
Inviting patients to participate in the CHMP is also an opportunity to increase patient awareness of the Committee’s deliberations and makes the assessment process of medicines more transparent, the Agency said.
A report on the experience gained will be presented to the CHMP at the end of the pilot phase.