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EMA wants to embed patient viewpoint within drug assessment

Will pilot CHMP benefit-risk evaluation project

European Medicines Agency (EMA) - logo The European Medicines Agency (EMA) has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in its scientific advisory committee.

The project is one of the first of its kind to include patients' views and values in the assessment stage for medicines.

As part of the project, patients will be invited to present their views on medicines for which there is an unmet medical need and where the Committee for Medicinal Products for Human Use (CHMP) still has concerns or doubts.

Patients may also be invited to give their views in cases where the CHMP is considering the withdrawal, suspension or revocation of a marketing authorisation or a restriction of indication of an authorised medicine.

Guido Rasi, EMA executive director, said: “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.”

“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,” he added.

Patients who participate will give their views and may actively take part in the discussion, including posing questions to the company. They will, however, not take part in any decision-making process.

The first medicine to be included in the project is the orphan drug afamelanotide and its use to treatment a rare genetic blood disorder which causes an absolute intolerance to light called erythropoietic protoporphyria (EPP).

The pilot project will run for at least one year to allow a full assessment of the feasibility of involving patients in the CHMP explanations. A report on the experience will be presented to the CHMP at the end of the pilot phase and will address issues including organisational aspects, feedback from the CHMP and patients involved and areas for improvement.

Article by
Kirstie Pickering

30th September 2014

From: Regulatory



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