To ensure that patients have prompt access to innovative medicines and to preserve the attractiveness of Switzerland as a pharmaceutical industry hub, efficient regulatory approval procedures with the Swiss Therapeutic Products Agency Swissmedic are just as essential as rapid procedures for the inclusion of new medicines in the Specialties List (SL) of the Federal Office of Public Health (FOPH). Interpharma monitors the timelines of both procedures.
APPROVAL TIMES AT SWISSMEDIC
Interpharma has carried out a benchmark study together with the other industry associations and Swissmedic for several years, measuring regulatory approval times at Swissmedic. The results are compared with the approval times of the US regulatory authority (FDA) and the medicines agency of the EU (EMA).
FASTER PROCEDURES FOR THE ADOPTION OF MEDICINES IN THE SL
Interpharma also measures the times taken to approve medicines for inclusion in the SL. In June 2013, ordinance amendments came into force designed to accelerate the inclusion of new medicines in the SL. As a rule, this procedure should be completed within 60 days of the medicine being granted marketing authorization by Swissmedic. This acceleration was part of an agreement between the pharmaceutical industry and the Federal Department of Home Affairs (FDHA), which was concluded in April 2013. In return, the pharmaceutical companies committed to withdraw all pending appeals concerning a system in the change for reviewing the prices of medicines and not to lodge any new appeals.
Interpharma campaigns to ensure that these target times are actually observed and monitors them accordingly. Since the new regulation was introduced, the number of applications processed within these 60 days has increased. However, since the new price-setting rules came into force in July 2015 the timelines are observed much less often and only a small proportion of the applications are processed within 60 days.