The authorisation and reimbursement process

In Switzerland, only medicinal products that comply with the legal, internationally harmonised requirements in terms of safety, efficacy and quality are permitted to come onto the market. In Switzerland, Swissmedic, the Swiss Agency for Therapeutic Products, decides on the basis of a thorough review whether a medicine fulfils the legal requirements and can be authorised for sale. This procedure is designed to protect patients from harm and from imitation products.

In order to have a medicinal product authorised by Swissmedic, the applicant must provide extensive documentation, demonstrating to the authority the efficacy, quality and safety of the product in question. The identity, purity and active substance content of the medicinal product must also be documented.

Medicines can then be reimbursed by statutory health insurance providers if the Federal Office of Public Health (FOPH) places them on the List of pharmaceutical specialities (LS). Inclusion in this list depends on fulfilment of the “WZW” criteria, standing for effectiveness, appropriateness and cost-effectiveness. The decision on inclusion is taken by the FOPH at the recommendation of the Federal Medicines Commission (FMC).

The manufacturer or distributor of a medicinal product can request Swissmedic to initiate a fast-track authorisation procedure for a promising product for the treatment of a severe, disabling or life-threatening disease for which no or only unsatisfactory treatment options with authorised medicinal products are available, or if the new medicine is expected to provide a major therapeutic benefit.

If the requested authorisation is denied, the applicant can discontinue the authorisation request, apply for the application to be reconsidered, submit an appeal, or submit a new application.

Delays in the authorisation and reimbursement process

It takes a median of almost 650 days after submission of the first application by a pharmaceutical company for a medicinal product to become available to patients in Switzerland. This is considerably longer than in many other countries in Europe. The situation is the result of three factors: Pharmaceutical companies submit a new medicinal product a median of 171 days later in Switzerland than to the European Medicines Agency (EMA). In 2021, authorisation by Swissmedic took a median of 147 days longer for medicines with new active substance than authorisation by the Food and Drug Administration (FDA). The FOPH takes a median of about 200 days (instead of the 60 days stipulated in the relevant Ordinance) to issue the final decision on reimbursement. There is a need to optimise this situation, and this is a task that needs to be addressed by politicians and the authorities – if necessary by modifying the legal and regulatory requirements.

Dispensing medicines / dispensing categories

Swissmedic decides on the basis of a medicinal product’s benefit-risk profile whether it can be sold and dispensed only on presentation of a doctor’s prescription (prescription-only) or without a prescription (prescription-free). Swissmedic accordingly divides medicinal products into four dispensing categories. Prescription-only medicines are assigned to dispensing category A or B, those available without a prescription to category D or E.

Advice from a specialist is usually required in order to use a medicine correctly. This is why most medicines have to be obtained from specialist sources. Medicines in categories A and B are only available in pharmacies, while those in category D can also be sold in drugstores if specialist advice is provided. In some cantons doctors are also authorised to dispense medicines directly to patients (self-dispensing doctors). The same applies to trained staff in hospitals.

Prescription-free medicines are also referred to as OTC, standing for over-the-counter. These products are intended for self-medication, or in other words for use by the patient on their own responsibility. Medicines in category E can be sold without a prescription and without specialist advice in all retail outlets.

An overview of dispensing categories:

• Dispensing category A: Dispensed once on the basis of a doctor’s prescription.
• Dispensing category B: Dispensed on the basis of a doctor’s prescription. Under certain circumstances, pharmacists are permitted to dispense medicines in category B without a prescription.
• Dispensing category D: Dispensed without a prescription following specialist advice.
• Dispensing category E: Freely available medicinal product (without a prescription/specialist advice).

Important information on the pack

The information on the pack containing the medicine is intended to ensure that a medicinal product can be identified as such with as little room for error as possible. Each pack of medicine must therefore display the required information. This includes the proprietary name of the medicine and the active ingredient it contains as well as other important information about aspects such as safety and correct storage. Every pack also contains a patient information leaflet in the country’s three official languages. It provides information on the purpose of the medicine, how to use it correctly and the symptoms of any undesirable effects that the product may have. The contents of the patient information leaflet are regulated by strict legal conditions.