Swissmedic

What is Swissmedic?

Swissmedic is the Swiss Agency for Therapeutic Products, the national authority for medicines and medical devices. The Therapeutic Products Act simply calls it “the Agency”. Swissmedic is a federal institution under public law, run by the Confederation with the participation of the cantons. It has its own legal personality, is independent in its organisation and management, and has its own funding.

Its task follows from the purpose of the Therapeutic Products Act: to ensure that only high-quality, safe and effective therapeutic products are placed on the market. Swissmedic therefore examines a medicine before it comes onto the market and monitors it afterwards.

For health insurance, Swissmedic is the first of two hurdles. Without authorisation from Swissmedic, a medicine cannot be included in the List of Pharmaceutical Specialties. Whether basic health insurance pays for it, and at what price, is decided by the Federal Office of Public Health (FOPH). This division of tasks explains why a medicine can be available in the pharmacy without basic health insurance paying for it.

How it works

Swissmedic’s work can be divided into three areas:

1. Authorisation. A manufacturer submits data on quality, safety and efficacy. Swissmedic examines them and authorises the medicine with product information that sets out what it is used for and how. Exceptions include medicines that a pharmacy prepares on a doctor’s prescription for a specific person.
2. Licences. Anyone who manufactures, imports or sells medicines wholesale needs a licence. Swissmedic inspects these businesses.
3. Market surveillance. Manufacturers and distributors must report adverse reactions and quality defects. Professionals who dispense or use therapeutic products must report serious or previously unknown adverse reactions. Swissmedic evaluates the reports and can order warnings, batch recalls or restrictions.

For health insurance, a second procedure then begins at the FOPH. It examines the effectiveness, appropriateness and cost-effectiveness criteria, compares the price with prices abroad and with similar products, and may include the medicine in the List of Pharmaceutical Specialties with a maximum price and limitations. The two procedures can overlap in time; the KLV provides for the FOPH to be notified when an application is submitted to Swissmedic.

Legal basis

Swissmedic is governed by the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, HMG). Art. 1 HMG sets out its purpose, Art. 9 para. 1 HMG the authorisation requirement for ready-to-use medicines, and Art. 59 HMG the duty to report adverse reactions and quality defects. Art. 68 HMG sets out its legal form, Art. 69 HMG its tasks.

The link to health insurance is made by the Health Insurance Ordinance (KVV). Art. 65 para. 1 KVV requires a valid authorisation from Swissmedic for inclusion in the List of Pharmaceutical Specialties. Art. 71a KVV governs reimbursement of a medicine on the List of Pharmaceutical Specialties outside the product information approved by Swissmedic, Art. 71b KVV reimbursement of an authorised medicine that is not on the list, and Art. 71c KVV reimbursement of an imported medicine not authorised in Switzerland. Under Art. 71d KVV, this requires specific cost approval after consulting the medical adviser; the health insurer decides on a complete application within two weeks.

Example: four medicines, four situations

Ruth, 58, has already reached her deductible this year. Her doctor prescribes various medicines. The costs of CHF 200 each are assumed; the 10% retention fee is the standard rate set by law.

What this means for you

• Ask whether a new medicine is covered. The pharmacy can see whether a product is on the List of Pharmaceutical Specialties.
• Look out for generics. They are authorised by Swissmedic and often cheaper than the original.
• Have expensive treatments outside the list checked in advance. Without cost approval, you pay yourself.
• Report adverse reactions to your doctor or pharmacy; they pass serious cases on to Swissmedic.

The medicines basic health insurance pays for are the same with every health insurer. The differences lie in the premium; the premium calculator shows the comparison for your place of residence. Some supplementary insurance policies contribute to medicines outside the list; you can find the insurers under Health insurers.

Common mistakes

• Confusing authorisation with coverage by basic health insurance. Swissmedic authorises; the FOPH decides on reimbursement.
• Thinking Swissmedic is responsible for premiums. Premiums and supervision of health insurers are the FOPH’s responsibility.
• Starting off-label treatment without cost approval. Without prior approval, the bill stays with you.
• Submitting bills for non-prescription products. If they are not on the List of Pharmaceutical Specialties, basic health insurance does not pay for them.

How we handle sources is explained under How we calculate.