Patient involvement must improve, says European regulator
pharmafile | December 31, 2009 | News story | Sales and Marketing | EMEA, patients
The European Medicines Agency (EMEA) has admitted that the level of patient involvement in its activities is unsatisfactory.
As a result the agency’s management board proposes to widen the scope of patient and consumer groups’ involvement in a number of areas.
These include consultation during benefit-risk evaluation of medicines, participation as observers in meetings of the pharmacovigilance working party and contribution to the EMEA’s safety communication.
The EMEA concedes that interaction is currently “not well structured”, particularly in areas relating to assessing drugs at Committee for Medicinal Products for Human Use (CHMP) level.
It says the involvement of patients and consumers offers “added value” so it needs to come up with a way of systematically assessing how patients are involved in the CHMP.
Patients “enrich regulatory outcomes by complementing them with the views of those directly affected by regulatory decisions”, the EMEA adds.
The sort of involvement it is talking about is as representatives of organisations – for instance in written consultations and meetings – and as experts.
The EMEA has also accepted the need to financially support the – mostly volunteer – patients and consumers who participate in EMEA activities.
At present they receive no money for loss of income or additional expenses incurred by attending.
As a result the EMEA will now double its daily allowance “to experts and delegates in need of it under certain conditions”.
The proposals come nearly five years after the EMEA set out to investigate how patients and consumers could better contribute to its work.
Patients have already been members of three EMEA committees because there is a legal requirement to do so.
These are the COMP (for orphan drugs), the PDCO (products for paediatric use) and the CAT (advanced therapy medicinal products).
But as a result of its investigation, the EMEA found some woolliness over the roles patients play in other scientific committees.
“What is expected from their contribution should be [better] defined,” the management board says.
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