Earlier this month on the 3rd of May the EFPC, together with their colleagues in the HTA Health Care Professionals group (EUPHA, PGEU, CPME, among others), was invited by Dr. Andriukaitis and his staff to discuss issues connected to the proposed new regulation regarding Health Technology Assessment in the European Union. On behalf of the EFPC, Diederik Aarendonk and Elena Petelos were present.
The proposal aims at improving the availability of innovative health technologies for EU patients (including pharmaceuticals and medical devices), the transparency of their assessment, at ensuring an efficient use of resources and strengthening the quality of HTA across the EU.In his introduction, he underlined several points: focus on clinical domains, transparency of all results, stakeholders involvement, mandatory for each member state, finances available to provide support to the system including the involvement of professional and patient representatives.
On the 9th of July, a next meeting is planned in Brussels and he strongly needs the support of all major stakeholders in this meeting in order to convince the member states and EU parliament. In particularly some member states are reluctant to opt for the mandatory clause as they fear their autonomy in the decision on the acceptance of new drugs and technology on their market. According to HTA expert David Banta in his recent article in the International Journal of Technology Assessment in Health Care, “the larger countries resist harmonization because they do not trust the industry-influenced results of other HTA programs.“
Our EFPC comments were in line with this remark of David Banta, with a strong message to keep industry funding away from all processes of HTA. But we also emphasized the promised financial support (we did not get our travel costs reimbursed for meeting the commissioner on the 3rd of May!) and made clear that we believe that re-assessment procedures after market authorization, are extremely important for as well pharmaceuticals and technology and in which Primary Care plays a very important role as the practice results can be best seen at community level where GP’s, nurses, community pharmacists, Occupational Therapists, and all other Primary Care professionals are best placed to see and measure the effects of those new drugs and medical devices.
We were happy to provide these critical remarks and that we were part of the discussion afterward and will be in the months coming and hope these comments were noted and will be included in future legislation.
Diederik Aarendonk, EFPC coordinator