Medicines

Government proposal to Parliament for an Act amending the Medicines Act, Government Decree amending the Medicines Decree, Government Decree amending the Government Decree on the Tariff of Medicines and Decree of the Ministry of Social Affairs and Health amending Section 1 of the Decree of the Ministry of Social Affairs and Health on the Substitution of Medicines

The proposal proposes to amend the retail price regulation for self-care medicines in accordance with the Medicines Act and certain decrees.

According to the legislation in force, retail prices for self-medication products are uniform throughout the country. The retail price of self-medication products is determined by adding the pharmacy’s gross profit according to the Decree on the Tariff of Medicines, which is determined by price category, to the national wholesale price of the medicinal product. In addition, VAT is added to the retail price. A service charge per batch is also added to the retail price when the self-medication product is prescribed by prescription.
The proposed amendment would focus on the retail price of the medicinal product at which pharmacies sell self-medication products to consumers. According to the proposal, a pharmacy could, if it so wishes, sell a self-medication product at a lower price than the uniform retail price provided for in the Decree on the Tariff of Medicines by reducing the share of the pharmacy’s gross profit in the retail price of the medicinal product. This change would not apply to the wholesale price of the medicine at which the medicine is sold to pharmacies. The retail price of self-medication products would be at least equal to the national wholesale price of the medicinal product and not more than the retail price calculated in accordance with the Decree on the Tariff of Medicines. In addition, the proposal provides, exceptionally, for some self-medication products to be subject to a single national retail price by decree, if the product is not suitable for price competition.
The pricing of medicinal products is regulated in more detail in the Decree on the Tariff of Medicines, which would for example prohibit the sale of two or more medicine packages or a medicine package and over-the-counter product at a reduced, bundled price, as well as the supply and sale of a medicinal product or medicine package at a reduced price combined with the purchase of another medicinal product, medicine package or other commodity. Furthermore, the medicinal product should not be sold at a reduced price on the grounds that it is about to expire. Offering of discounts would also be taken into account in drug substitution situations in the Decree on the Substitution of Medicines. In addition, the necessary clarifications on price regulation would be made to the Medicines Act and the Decree on the Tariff of Medicines.
The regulation concerning online pharmacy services would be amended so that the legislation would provide more detailed provisions on the conditions for banning a pharmacy’s online service, the provision of the pharmacy’s online service during a change of pharmacist, and the need for the pharmacist to ensure appropriate storage and transport conditions in respect of
medicines delivered through the pharmacy’s online service. In addition, the Act would require the pharmacist to be responsible for the operation, maintenance and inspection of the online service. The pharmacy’s online service must offer an adequate product range, taking into account different therapy groups, and must also offer the most affordable medicinal products available.
The proposal also includes a number of other amendments concerning pharmacy activities. Among other things, it is proposed that the Act contain a new provision on pharmacy pick-up lockers and the Finnish Medicines Agency Fimea could temporarily close the pharmacy in situations where patient safety is endangered.