Amendments to pharmaceutical legislation aim to ensure availability and sufficiency 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.
The Government submitted the amendments for approval and the President of the Republic approved the bills on 9 July 2020. The acts will enter into force on 13 July 2020.
The Ministry of Social Affairs and Health 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 this 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.
More effective means to anticipate supply disruptions
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 Ministry of Social Affairs and Health 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.
Better availability of medicines and supplies intended for treating infectious diseases
Under the Communicable Diseases Act, the Ministry of Social Affairs and Health 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 event 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.
Tuija Metsävainio, Senior Specialist, [email protected]