Foreign biotech and pharmaceutical companies wishing to enter the Swiss market must navigate a comprehensive regulatory framework, primarily overseen by the Swiss Agency for Therapeutic Products, Swissmedic. Understanding the key regulations and standards is essential for successful market entry and operations.
About Swissmedic
Swissmedic is the cornerstone of Switzerland's pharmaceutical and biotechnology regulatory landscape. It is responsible for reviewing applications to market pharmaceutical products in Switzerland and granting the necessary authorisations. For a company to launch a medicine on the Swiss market, it must obtain a Pharmaceutical Establishment Licence (PEL) and be designated as a Marketing Authorisation Holder (MAH). This authorisation is essential in order to apply to Swissmedic for product authorisation. In cases where a company does not yet hold a marketing authorisation, the submission to Swissmedic can be facilitated through a third party, with the option of later transferring the MAH to the company itself. This mechanism allows simultaneous application for marketing authorisation and submission of the product to Swissmedic.
Swissmedic’s Approval Pathways
Swissmedic offers various pathways for authorization, including the standard process, fast-track, Article 13 TPA* (foreign reference), ORBIS, Access Consortium and Promise Pilot pathway. Each route caters to different scenarios, ranging from standard review times to expedited processes for critical or breakthrough therapies. Read more about Swissmedic and its approval process in our Swizzard Insight No. 1.
Navigating the Reimbursement Landscape
Access to the Swiss market also involves navigating the reimbursement landscape, crucial for ensuring that patients can afford the medicines. The primary route for reimbursement is inclusion in the Specialty List (SL), managed by the Federal Office of Public Health (FOPH). Medicines listed in the SL are eligible for reimbursement by Swiss health insurers. The marketing authorization holders typically engage with the FOPH for a pricing procedure aimed at SL inclusion.
To streamline the parallel processing of applications by Swissmedic and the FOPH, a new early submission procedure has been introduced, facilitating the simultaneous reimbursement of essential medicinal products at the time of market authorization through the Early Access Pathway.
Case-by-Case Reimbursement
Additionally, Switzerland has provisions for case-by-case reimbursement, a unique feature that allows for the reimbursement of medicines either not fully compliant with the approved Summary of Product Characteristics, not yet listed in the SL, or not yet authorized in Switzerland. This flexibility is grounded in Articles 71a-d of the Health Insurance Act, providing a significant advantage in certain situations.
In summary, entering the Swiss pharmaceutical market requires compliance with specific regulatory standards and an understanding of the complex reimbursement environment. Swissmedic's role as the regulatory authority, along with the processes for obtaining marketing authorization and navigating the reimbursement landscape, are key considerations for foreign biotech and pharmaceutical companies.
Interested in learning more about how to enter the Swiss market? Feel free to reach out to us.
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