BRUSSELS, Feb 13 (APM) - A new European Commission-led expert group on safe and timely access to medicines for patients - to be known as STAMP - has begun its reflections with a review of half-a-dozen initiatives in Europe and the U.S. aimed at early access to medicines, but it will not be proposing any changes to EU pharmaceutical legislation.
According to the report of the group's first meeting, seen by APM, its role explicitly excludes providing advice on revision of the basic rules on medicines authorisation.
Officials from 23 member states as well as from the European Medicines Agency attended the first meeting in Brussels at the end of January and agreed they would focus primarily on innovative products and unmet medical needs.
At the rhythm of a maximum of four meetings a year, they will discuss the experience acquired in using the current regulatory framework - including conditional marketing authorisations - to bring medicines through the authorisation process more rapidly.
At their first meeting, they reviewed progress with national early access schemes in Belgium, France and Spain.
An update the participants received on the EMA's adaptive pathways pilot highlighted the need for further discussion of how to harmonise data sources, what tools could control prescribing and how quality can be ensured in real world data.
In addition, the meeting was briefed on the U.S. Food and Drug Administration's breakthrough therapy programme.
The FDA had received 269 requests as of December 2014 (223 for drugs, 46 for biologics), of which 74 were granted the designation (66 drugs, 8 biologics). 15 of them were also granted fast track status.
The group is mandated to provide advice to the European Commission on how to improve access without compromising safety.
It has been created as a subgroup of the European Commission's Pharmaceutical Committee - composed of senior officials from national medicines agencies, who meet two or three times a year to review strategy on pharmaceutical legislation in the EU.
EU member states were asked last year to offer views on which aspects of timely access they wished to see discussed.
According to the Commission, member states were in favour of exchanging national experiences on early access schemes that used methods other than classic clinical trials.
The new group will not venture into the controversial terrain of economics. "Health technology assessment, pricing and reimbursement will not be the focus of STAMP," says the record of the first meeting.
However, "for the benefit of a more holistic approach", it will create "synergies" with existing EU networks exploring health technology assessment and related topics.
One of the participants at the meeting - a member of a national medicines agency - told APM on condition of anonymity that part of the rationale for creating STAMP is to ensure member states retain some control over the many processes underway at present that challenge existing regulatory procedures.
"We don't want to see the EMA running off with the ball on its own," said the national official.
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