Joint projects and collaboration between the FOPH and Swissmedic
The Federal Office of Public Health (FOPH) and Swissmedic work closely together to ensure the safety and efficacy of medicinal products and the protection of public health in Switzerland.
Medicinal product authorisation and pricing and reimbursement are clearly legally separated in Switzerland: On the basis of the Therapeutic Products Act (TPA), Swissmedic is responsible for authorisation, while the Federal Office of Public Health (FOPH) is responsible for pricing and inclusion in the List of Pharmaceutical Specialties (LS) in accordance with the Health Insurance Act (HIA).
In addition to authorisation by Swissmedic, new medicinal products also have to successfully go through the FOPH's reimbursement process in order to be included in the List of Pharmaceutical Specialties (SL) and have their costs covered as standard by the compulsory basic health insurance (OKP).
Swissmedic and the FOPH closely coordinate the authorisation and reimbursement processes to speed up access to innovative medicinal products in Switzerland. To this end, the authorities can exchange data on medicinal products and current applications on the basis of Art. 82 of the Therapeutic Products Ordinance (TPO).
The common aim of Swissmedic and the FOPH is to make medicinal products available to Swiss patients as quickly as possible in accordance with the criteria set out in therapeutic products and health insurance legislation. Swissmedic and the FOPH are continuously optimising their processes with regard to inter-authority efficiency and effectiveness and together helping to ensure rapid access to medicinal products.
Distribution of roles between Swissmedic and the FOPH regarding medicinal product authorisation, pricing and reimbursement
Swissmedic: Medicinal product authorisation (Therapeutic Products Act, TPA)
Swissmedic assesses whether medicinal products are safe, effective and of a high quality based on authorisation documents submitted by companies. In addition to clinical efficacy, safety also plays a key role in this assessment of the benefit-risk profile. Here, the key question is what potential risks and what undesirable effects patients will be exposed to compared with the benefits. A medicinal product may only be placed on the market in Switzerland once it has been authorised by Swissmedic.
FOPH: Reimbursement process (Health Insurance Act, HIA)
In the reimbursement process, the FOPH (together with the Federal Medicines Commission, FMC) examines, at the request of companies, whether and at what price medicinal products are included in the List of Pharmaceutical Specialties (LS) and are thus reimbursed by the compulsory basic health insurance (OKP). The therapeutic efficacy, appropriateness and economic efficiency (“EAE criteria”) are assessed in comparison with treatment alternatives.
