Information related to the specialities list
The FOPH regularly informs interested parties, particularly licence holders of drugs on the specialities list (SL/LS), on important developments relating to the list. These notifications are published here.
Impact of the adjustment to the regulation on the supply of all generic and biosimilar packages
The FOPH commissioned the Swiss research and consulting firm INFRAS to analyse the impact of Swiss regulations stipulating that generics and biosimilars must be offered in the same package sizes and dosages as original preparations in order to be included in the list of specialities. These regulations are intended to ensure security of supply, but have been criticised as a barrier to market entry. INFRAS examined international practices, conducted surveys in five countries and interviewed Swiss stakeholders. The results of the analysis show that the impact of the requirements on the number of suppliers is unclear. Completely removing the requirements would save manufacturers money and make it easier to enter the market, but could result in additional costs for authorities and risks for patient care and safety. Alternatives such as price incentives, tenders or differentiated requirements were examined in broad terms, but are complex and their effects are uncertain.
The FOPH is now examining the extent to which certain simplifications/relaxations are possible with regard to the requirements for package sizes and dosages of generics and biosimilars. Corresponding adjustments to the manual concerning the Specialities List (SL) are planned for 2026.
Internal reference price (IRP) of pharmaceuticals whose patent protection has already expired: special case
On 9 May 2022, the FOPH informed the associations of pharmaceutical companies and health insurers in writing about the immediately valid measure for conducting the IRP for a pharmaceutical whose patent protection has already expired and for which no other pharmaceutical whose patent has also expired is available as therapeutic alternative.
Exchange erates for SL/LS applications and reviews
The factors included in the FOPH’s assessment of the cost-effectiveness of drugs on the specialities list include the prices of drugs in nine reference countries in Europe (Denmark, Germany, the Netherlands, the UK, Austria, France, Sweden, Belgium and Finland). The FOPH converts foreign ex-factory prices into Swiss francs twice a year, on January 1 and July 1, at the exchange rates published here. These exchange rates are calculated on the basis of the average monthly exchange rates published by the Swiss National Bank for the previous twelve months.
Exchange rates for foreign price comparisons to the FOPH between 1 January 2026 and 30 June 2026.
List of pharmaceuticals subject to appeal
List of pharmaceuticals subject to an appeal against a decision of the FOPH.
Further information
Federal Office of Public Health FOPH
Authorisation of Pharmaceuticals
Schwarzenburgstrasse 157
3003 Bern