(Source: Pharma Times 2014-09-30）
The European Medicines Agency has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines it reviews.
As part of the project, which the EMA says “enriches the scientific assessment of a medicine with new ways of thinking”, patients will be invited to present their views on drugs for which there is an unmet medical need and where the agency’s Committee for Medicinal Products for Human Use (CHMP) “still has concerns or doubts”.
They may also be invited to give their views on “whether to recommend the withdrawal, suspension or revocation of a marketing authorisation, or a restriction of indication of an authorised medicine”.
Clinuvel of Austria’s Scenesse (afamelanotide) is the first drug to be evaluated under the new scheme. It is currently being reviewed as the first proposed therapy for the rare disease erythropoietic protoporphyria (EPP), a genetic blood disorder which causes an absolute intolerance to light; 5,000-10,000 patients worldwide have EPP.
Two EPP patients talk to CHMP
Two of them addressed the CHMP’s September meeting and shared their experiences of living with the condition and answered specific questions. Clinuvel expects a decision on Scenesse next month.
The EMA says that inviting patients to participate “is also an opportunity to increase patient awareness of the CHMP’s deliberations and makes the assessment process of medicines more transparent”. The pilot will run for at least one year.
Although this is the first time patients have been invited to participate directly on benefit/risk, patient representatives are already involved in many other activities, the EMA stressed, such as its Pharmacovigilance Risk Assessment, Paediatric and Advanced Therapies committees. The agency also referenced the Patients and Consumers Working Party, through which they provide recommendations “on all matters of interest to patients in relation to medicines”.
Guido Rasi, EMA executive director, said that “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”.
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