Master plan for biomedical research and technology, Federal Department of Home Affairs, 2013.

Master plan for biomedical research and technology, Federal Department of Home Affairs, 2013.

Interpharma lends critical, but constructive support to implementation of the master plan for strengthening biomedical research and technology, which was published in December 2013. Elements already implemented include accelerated procedures for inclusion in the Specialties List (as a rule 60 days after Swissmedic approval), the Swissmedic strategy for efficient marketing authorization procedures, faster approval procedures for clinical trials and the pricing system which came into force in June 2015, but which has to be revised as the result of a federal court ruling. Interpharma is following the implementation and measuring the progress made, for example, time it takes to approve medicines for reimbursement. Since the new pricing system came into force in June 2015 (which is already under revision again however) increased delays have been noted again.

Major need for action on ethics committees

Progress has been made in certain areas, but in other areas there is still major need for action, for example when it comes to the protracted procedure for the approval of clinical trials by the ethics committees. Here, amongst other things, there has been massive failure to comply with the schedules enshrined in law, and the newly introduced lead principle, by which only one ethics committee materially reviews a research application, is not being properly respected. Interpharma is actively engaged in efforts to establish a new, additional (fast-track) procedure for the approval of clinical trials for medicines in clinical phases 1, 2 and 3, which is assigned to a centralized or one of the existing ethics committees.