SWITZERLAND Trends and Developments Contributed by: Tobias Meili and André Berne, Wenger Plattner
curred on the objective of achieving annual sav- ings of approximately CHF300 million starting in 2026, which corresponds to 1% of health insur- ance premiums. Additionally, by 2026, the TARMED tariff frame- work for outpatient medical services – instituted in 2004 and serving as the principal basis for invoicing outpatient medical services – will be replaced by a new TARDOC single-service tariff framework and a flat-rate tariff structure. Relationship with EU As already mentioned, the EU is Switzerland’s largest trading partner. Thus, Switzerland and the EU entered into a mutual recognition agree- ment (MRA) in relation to conformity assess- ment. The MRA is designed to remove technical barriers to the trade of industrial goods between the parties and applies, inter alia, to good manu- facturing practices (GMP) inspections of medici- nal products and to the certification of batches. Consequently, in the case of medicinal products, each party recognises the results of inspections conducted by the competent authorities of the other party at the premises of manufacturers, as well as recognising the production authorisa- tions provided by the competent authorities of the other party. In addition, foreign authorities are permitted – under certain conditions and after notifying the Swiss Authority for Thera- peutic Products ( “Swissmedic” ) – to audit Swiss companies active in the life sciences sector. The MRA also applies, inter alia, to medical devices. Conformity assessments of medical devices authorised in the territory of a party are therefore, in principle, also acknowledged within the jurisdiction of the other party. In view of the recent changes to the EU regulatory framework on medical devices, it is necessary to revise the MRA’s provisions on medical devices to guar-
antee mutual recognition of certificates of con- formity, facilitation of reciprocal market access, co-ordinated market surveillance, and informa- tion sharing between authorities. However, the EC ties such update to further progress in the stalled political negotiations with Switzerland, which were interrupted between May 2021 and March 2024. As a result of this impasse, the EU currently (still) treats Switzerland as a third country in terms of medical devices, requiring Swiss companies to incur higher administrative efforts to place medi- cal products on the EU market. To counteract these negative impacts, in May 2021 the Swiss Federal Council amended the legal framework regarding medical devices to provide unrestrict- ed access to EU-certified medical devices and to establish long transitional periods, therefore reducing supply issues in Switzerland. With the negotiations between Switzerland and the EU having resumed in March 2024 and the substantive negotiations being concluded in December 2024, a political breakthrough seems possible – albeit still subject to the uncertainty of a legislative referendum. The achieved agree- ment focuses on health security, including full access of Switzerland to the EU’s health secu- rity mechanisms, the European Centre for Dis- ease Prevention and Control (ECDC) and the crisis preparedness area in the EU’s multi-year programme (currently “EU4Health” ). Thus, it remains an open question whether the compro- mise will also unblock the impasse regarding the MRA on medical devices. Outlook Switzerland’s life sciences sector has faced sig- nificant challenges in recent years due to tech- nological progress, developments in the EU, cost increases, regulatory amendments, and
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