Legal reforms on card to ensure availability of medicines

Three acts – the Medicines Act, the Act on Obligatory Storing of Medicines, and the Communicable Diseases Act will be amended to ensure the availability and sufficiency of medicines in all situations, said a government press release.

The government submitted the amendments for approval and the president approved the bills on 9 July 2020. The acts will enter into force on 13 July 2020.

The social Affairs and health ministry will be able to temporarily restrict or target the distribution and sale of medicinal products in an actual or expected incident affecting the availability of medicines when it is necessary to protect public health. It will have the right to decree that scarce stocks of medicines be allocated on an equal basis to as many people as possible, following the principle of rational use of medicines.

All relevant actors will be better informed of any disruptions in the distribution of medicines. Pharmaceutical wholesalers will be obliged to notify of any disruptions in the distribution of medicinal products without delay. The notification obligation of marketing authorisation-holders, too, will be specified.

The amendments will make the rules on the stockpiling obligation of pharmacies more precise. Pharmacies must maintain a stock corresponding to at least two weeks’ average need by their usual customers. However, the obligation does not apply to medicines with a retail price exceeding EUR 1,000 and rarely used medicines. Other amendments specify the provisions on the pharmacies’ premises.

The amended Act on Obligatory Storing of Medicines will give the Finnish Medicines Agency (Fimea) and pharmacy inspectors the right to issue orders to operators obligated to maintain medicine stocks. Compulsory stockpiles will have to be located in Finland and the social affairs and health ministry can decide that the goal level set for compulsory stockpiles may fall below a set amount when there is a risk of wide-scale problems with availability.

Under the Communicable Diseases Act, the ministry has the right to temporarily restrict or authorise the prescription and dispensing of medicines intended for treating infectious diseases. The new amendments will expand this right to apply even to medicines intended for preventing infectious diseases and for treating the symptoms and complications of infectious diseases.

The ministry’s right to deviate from the conformity assessment of certain medical devices and supplies before placing the products on the market will be expanded to cover a larger group of medical devices and supplies.

The legislative amendments aim to safeguard the availability and rational use of medicines and medical devices and supplies on an equal basis.