Approval, distribution and subsidies pf medicinal products

When a new medicinal product is to be approved prior to being put on the market in Sweden, the company applies to the Medical Products Agency for approval. The task of the Medical Products Agency is to ensure that the individual patient and the health care service have access to effective and safe medicinal products of a high standard. Once a medicine has been approved, the Medical Products Agency monitors its use and publishes information and treatment recommendations to prescribers in the health care service. It is particularly important to continually follow up the side effects profile of a medicinal product and to take action when necessary.

Distribution of medicinal products

The National Corporation of Swedish Pharmacies has the sole right to sell medicinal products to the general public and must provide for the needs of the public throughout the country. Distribution of medicinal products to the general public takes place via approximately 800 pharmacists and some 1000 pharmacy agents. The medicinal products needed for in-patient/hospital care are provided by the National Corporation of Swedish Pharmacies under one-year contracts with the health authorities via some 100 special hospital pharmacists.

Subsidy of medicinal products

The Pharmaceutical Benefits Board is responsible for taking decisions on the medicinal products that are to be subsidised and for pricing these products. The Pharmaceutical Benefits Board must make its decisions on the subsidy of medicinal products inter alia on the basis of the objectives of the health care service, namely good health and the provision of treatment on equal terms, as well as the ethical principles applying to the health care service.

Pharmaceutical benefits

Pharmaceutical benefits are regulated in the Pharmaceutical Benefits Act (2002:160) and are the same for everyone all over the country. The benefits mean that when the patient has paid SEK 1800 for medicinal products on prescription, a free pass is issued which exempts the patient from further costs over a 12-month period. The free pass is valid for 12 months from the date of the first purchase.

Before the patient receives a free pass, he or she pays the full cost of the medication up to SEK 900. After this, a graduated subsidy reduces the patients costs for medicinal products. The patient pays

50% of the costs between SEK 901 and 1700
25% of the costs between SEK 1701 and 3300
10% of the costs between SEK 3301 and 4300

A patient will never pay more than SEK 1800 over a twelve-month period.