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Medicines licensing

Patients to get a voice in European Medicines Agency pilot

Guido Rasi, executive director of the European Medicines Agency (EMA), which is inviting patients to evaluate some medicines

Source: European Medicines Agency (EMA)

Guido Rasi, executive director of the European Medicines Agency, says involving patients in the regulator’s discussions ultimately contributes to the safe and rational use of medicines

Patients will for the first time be invited to give their views on the benefits and risks of some medicines in meetings with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The pilot scheme, which will run for at least a year, is part of the EMA’s push to involve patients more in the assessment of medicines throughout their lifecycle and increase transparency. It will include new medicines for which there is an unmet medical need or concerns by the CHMP; and possibly on authorised medicines where the CHMP is considering recommending withdrawing or suspending a product.

“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,” says Guido Rasi, executive director of the EMA. “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.”

The first medicine to be looked at in the pilot is intended for the treatment of a rare genetic blood disorder that causes an absolute intolerance to light and for which there is no authorised treatment. It contains the active ingredient afamelanotide.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20066658

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