Government proposes generic substitution of biological medicines by pharmacies

The Government proposes that the generic substitution of biological medicines by pharmacies be made possible as from 2024. It also proposes that the reference price system could include reference price groups for both original biological medicines and biosimilars.

Finland introduced generic substitution by pharmacies in 2003. The reference price system was introduced in 2009. The proposed amendments to the Medicines Act would make it possible to include biological medicines and biosimilars in the generic substitution scheme. It is proposed that biological medicines and biosimilars could be replaced with generic versions every six months. 

A biosimilar means a biological medicine developed to be similar and comparable to the original biological medicine. 

Pharmacies are already obliged to provide customers with information on medicines and prices when dispensing medicines to them. To ensure patient safety, pharmacies’ obligation to provide information would be supplemented so that pharmacies would be required to provide the buyer with information on medicines and medical devices when they replace a biological medicine or biosimilar. In addition, the generic substitution of insulin products by pharmacies would be introduced in stages over the course of two years to ensure medication safety. 

The Health Insurance Act would be amended so that the reference price system could include reference price groups consisting of original biological medicines and biosimilars. The reimbursement received by the medicine user would be paid on the basis of the price charged for the medicinal product if the biological medicine or biosimilar was included in the reference price group and dispensed in accordance with the proposed regulation on generic substitution. 

The aim of the proposed amendments is to reduce the pharmaceutical costs incurred by medicine users and to cut central government expenditure on medicine reimbursements. By reducing central government expenditure on medicine reimbursements, it is possible to direct funding to wellbeing services counties and contribute to enabling central government funding for the minimum staffing level for care personnel. The proposals are part of the set of measures which includes the government proposal for improving the cost-effectiveness of pharmaceutical services. 

The proposal is included in the 2023 budget proposal and its amendment. 

The Acts would enter into force on 1 January 2024.

Inquiries:

Tuija Metsävainio, Senior Specialist, firstname.lastname@gov.fi 
Anne Hautala, Senior Specialist, firstname.lastname@gov.fi