Regulation of medicinal products - Interpharma

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Regulation of medicinal products

The process of manufacturing a medicinal product involves investments and risks.

Overview Biologicals and biosimilars Generics List of pharmaceutical specialities Paediatric medicinal products Parallel imports Regulation of medicinal products The Pharma Cooperation Code Use of medicinal products

The Swiss medicinal products market is heavily regulated in terms of both the authorisation and pricing of prescription and reimbursable medicines and distribution channels.

After a medicine has been authorised by Swissmedic, the Federal Office of Public Health (FOPH) decides whether to include it in the List of pharmaceutical specialities (LS), thus making it reimbursable by the statutory health insurance providers. The fundamental criteria here are effectiveness, appropriateness and cost-effectiveness. The decision on inclusion is taken by the FOPH at the recommendation of the Federal Medicines Commission (FMC). Factors that are taken into account are the added therapeutic value, i.e. the action of a medicinal product in comparison with products that have already been authorised in the same indication, and the price situation in other countries. The FOPH then determines the binding maximum reimbursement price for a medicine.

Medicines are also divided into dispensing categories by the regulatory authority Swissmedic. Depending on the category to which it is assigned, a medicine can be sold by pharmacies, self-dispensing doctors (who are authorised to dispense medicinal products directly to their patients), hospitals or drugstores. Pharmacies are the major distribution channel, accounting for over 50 percent of sales. The cantonal regulations also play a major role. Cantons with a high proportion of self-dispensing doctors generally have a substantially lower density of pharmacies than other cantons. There is a particularly high number of self-dispensing doctors in the German-speaking part of Switzerland (Baselland, Zurich).

Market development

In 2020, the Swiss pharmaceutical market had a volume of CHF 6.3 billion at ex-factory prices. This represents a slight increase of 2.9% compared with 2019. Sales of patent-protected medicines in the cash-strapped segment grew by +4.6% compared to 2019, while the number of packs sold declined slightly by -1.8% to 183 million packs in 2020.

Once a patent has expired, other manufacturers can also produce and sell medicines containing the active substance used in the original product. These medicinal products are known as generics. The volume of reimbursable generics sold in 2020 totalled CHF 760 million by value.

Further information

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Interpharma, the association of Switzerland’s research-based pharmaceutical industry, was founded in Basel in 1933.

Interpharma informs the public about issues that are important to the research-based pharmaceutical industry in Switzerland, including the pharma market in Switzerland, healthcare and biomedical research.

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