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 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.
Interpharma campaigns to ensure that these target times are actually observed and monitors them accordingly. After the new regulation was introduced, there was an initial increase in the number of applications processed within these 60 days. But since the changes in the price-setting rules in July 2015 and the entry into force of the new price-setting system in March 2017, the timelines have been observed very much less often. While more than 50% of products were still being included in the list of reimbursable medicines within 60 days in 2015, this proportion fell to one-third in 2016 and 2017. In 2018 the situation even worsened.
In view of these massive delays, Interpharma stepped up its dialogue with the FOPH and proposed that the process for reimbursement be linked to the Swissmedic’s accelerated procedure. Swissmedic has both a fast-track procedure covering therapies offering high (scientifically founded) medical benefits and therapies for very serious diseases and a prior notice procedure. Further models are under discussion to take account also of the medical advances.
The FOPH already uses in exceptional cases the “early dialogue” model today, which involves an early discussion of complex cases that is already initiated in parallel with the Swissmedic procedure. With a standardization of this model, the FOPH and the pharma company can evaluate early on which reimbursement procedure should be applied along with the corresponding planning of resources.