Once a medicinal product has completed all the phases and passed all the tests, the pharmaceutical company can apply to Swissmedic for it to be authorised. When it submits the application for authorisation, the company also needs to supply detailed documentation of the development process, and the efficacy, quality and safety of the new medicine. The company can request “fast-track” authorisation for medicinal products intended to treat particularly serious diseases or diseases for which no effective alternatives are available on the market.
Authorisation by Swissmedic does not mean that the medicine will automatically be reimbursed by statutory basic health insurance. Swissmedic is responsible for assessing the efficacy, safety and quality of medicines. The Federal Office of Public Health (FOPH) decides whether a product must be reimbursed by the health insurers, and to this end it evaluates the effectiveness, appropriateness and cost-effectiveness (known as the WZW criteria in the Health Insurance Act) of the product. The manufacturing company must apply to the FOPH for this assessment to be performed. The cost-effectiveness review, following which the definitive reimbursement price is determined, is based on a system of internal reference pricing (IRP) and external reference pricing (ERP). The IRP review compares the cost of the new medicinal product with the cost of products that have already been authorised and lead to similar therapeutic success. The ERP review compares prices in nine comparator countries (Austria, Belgium, Denmark, Finland, France, Germany, the Netherlands, Sweden and the United Kingdom).
Phase IV – Further studies and post-marketing observation
Once the medicinal product is on the market and available to patients, the pharmaceutical company continues to study the product in a broad population in order to confirm the benefit-risk assessment and to identify rare side effects that did not emerge during the test phases. The results of the tests that the medicine has undergone are shown in the patient information leaflet in the pack. This must be approved by the regulatory authority Swissmedic. If the manufacturer learns of side effects or incidents during use of the product, it is required to notify Swissmedic and, if necessary, take measures to ensure patient safety. If major risks are identified, the pharmaceutical companies inform doctors and pharmacists via a rapid alert system in consultation with the authorities.
The success rate for new medicines in obtaining authorisation is very low. Just one product out of 10,000 candidates ultimately comes onto the market. Two of the reasons why the development of a new medicine may be halted are insufficient efficacy and serious side effects. Competition between manufacturers can also lead to research being stopped if, for example, a different supplier brings a similar medicinal product onto the market sooner.