Interpharma lends critical, but constructive support to the 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 March 2017. Interpharma is following the implementation and measuring the progress made, for example, in the time it takes to approve medicines for reimbursement. Increased delays have been reported again not only since the new pricing system came into force in March 2017, but also before this when pricing changes became effective in June 2015. In 2018 the situation even worsened. Interpharma is ready to enhance the dialogue with the authorities in order to accelerate the reimbursement procedure especially for innovative medicines (see also efficient procedures and innovative price models) and to ensure that all patients have rapid access to new medicines.
There is still a 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 remains a persistent 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 still 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 innovations.
Evaluation of the 2013-2018 Master Plan is underway at present, which should lead to a final report by the federal government. At its meeting of 14 December 2018, the Federal Council also decided to extend the Master Plan for the period 2020-2025. Stakeholders will probably be invited to submit content for a continuation of the Master Plan in Q2/Q3 of 2019.
Interpharma is interested in a new edition of the Master Plan and ready to make a constructive contribution to the process.