SWITZERLAND Trends and Developments Contributed by: Tobias Meili and André S. Berne, Wenger Plattner
itisation plays an important role since an electronic register will be established to document objections or consents to organ donation. The electronic iden- tity (e-ID) shall ensure the reliable and accurate iden- tification of each registered individual. However, the implementation of such identification method, and thus the register, is contingent upon the enactment of the Federal Act on Electronic Identity. Thus, the new regulation is expected to take effect no earlier than spring 2027. Increasing Costs of the Swiss Healthcare System The healthcare system in Switzerland is based on a social health insurance system according to which every Swiss resident is required to be insured with a compulsory health insurance provider. This system is designed to guarantee high-quality care at the lowest possible cost while also fostering solidarity between those who are ill and those who are healthy. How- ever, this also means that all Swiss citizens are equally affected by cost increases in the Swiss healthcare system in the form of higher insurance premiums. Insurance premiums have been continuously rising over the past 15 years. For 2026, health insurance premiums again rose by an average of 5.2% com- pared to the previous year, even though inflation is low compared to other European countries. Thus, in recent years, these ongoing cost and premium hikes have become a significant economic challenge and topic of political debate. In addition to the uniform financing of outpatient and inpatient treatments, aimed at reducing disincentives (see the discussion on uniform financing of inpatient and outpatient medi- cal services above), the Federal Council addresses this issue through a cost containment programme, in terms of which various stakeholders of the healthcare system convene bi-annually to collaboratively define specific cost containment strategies. During an ini- tial meeting in November 2024, stakeholders con- curred on the objective of achieving annual savings of approximately CHF300 million starting in 2026, which corresponds to 1% of health insurance premiums. Additionally, on 1 January 2026, the “TARMED” tariff framework for outpatient medical services, which has remained unchanged for 20 years and served as the principal basis for invoicing outpatient medical servic-
es, was replaced by the new “TARDOC” single-service tariff framework, introducing a flat rate tariff structure that may be further developed, improved and sup- plemented on an annual basis. Relationship with the EU As already mentioned, the EU is Switzerland’s largest trading partner. Thus, Switzerland and the EU entered into a Mutual Recognition Agreement (MRA) in rela- tion to conformity assessment. The MRA is designed to remove technical barriers to the trade of industrial goods between the parties and applies, inter alia, to Good Manufacturing Practices (GMP) inspections of medicinal 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 the production authorisations provided by the competent authorities of the other party. In addition, foreign authorities are permitted – under certain conditions and after noti- fying the Swiss Authority for Therapeutic 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 author- ised in the territory of one 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 guarantee mutual recognition of certificates of conformity, facilitation of reciprocal market access, co-ordinated market surveillance, and information sharing between authorities. However, the European Commission ties such update to further progress on 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 medi- cal devices, requiring Swiss companies to incur higher administrative efforts to place medical 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
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