On 6 May 2015, the second meeting of the expert group on safe and timely access to medicines for patients ("STAMP") took place in Brussels. The expert group is set up to advise the Commission on policy, programmes, and implementation of legislation with a view to improve timely and safe access to medicines for patients. To this end, it will share experiences and exchange views on initiatives on a national and European level.
During the first two meetings, the STAMP expert group considered various Member States and EMA experiences with the conditional marketing authorization and accelerated assessment procedures. As a result, the experts will work on recommendations for the interpretation of the criteria for the application of these regulatory options (e.g., what conditions should be considered "seriously debilitating" or "life threatening" for the purpose of granting a conditional marketing authorization).
The STAMP experts were also updated on EMA's initial experiences with the pilot project on adaptive pathways. The concept of adaptive pathways is based on a progressive approach for authorization using existing regulatory tools. It can either take the form of (i) a first approval in a well-defined patient subgroup with a high medical need followed by a second approval for a wider indication and a larger patient population, or (ii) an early conditional approval with uncertainty subsequently reduced through the collection of post-approval data.
From a national perspective, a number of Member States including Belgium, France, Spain and UK shared their experiences with national routes to make medicines available to patients before authorization in the form of early access schemes, compassionate use and medical need programs, etc.
Pricing and reimbursement matters and health technology assessments are not the primary focus of the STAMP expert group. However, given the importance of such matters for access to medicines, there are opportunities to exchange information on initiatives of the European HTA network and Network of competent authorities for pricing and reimbursement (CAPR).
It is important to note that the STAMP discussions take place within the boundaries of current legislation. The European Commission has not expressed any intention to review the legal framework.
The Group will meet four times a year and will produce reports and reflection papers.
More information on the agenda and activities of the STAMP expert group can be found on the European Commission website:http://ec.europa.eu/health/documents/pharmaceutical-committee/stamp/index_en.htm