Generic substitution of biological medicines by pharmacies to be introduced in stages in 2024–2026
The amendment to the Medicines Act will make it possible for Finland to introduce the generic substitution of biological medicines by pharmacies in stages between 2024 and 2026. Changes will also be made to the reference price system, as a result of which the system can in future include reference price groups consisting of both biological medicines and biosimilars that are interchangeable with them. The aim of the relevant legislative amendments is to reduce the prices paid by medicine users and to cut central government expenditure on medicine reimbursements.
Finland introduced generic substitution by pharmacies in 2003. Generic substitution by pharmacies means the practice of pharmacies substituting prescribed medicines with cheaper interchangeable medicinal products.
With the legislative amendments, pharmacies will also be allowed to substitute biological medicines and biosimilars that the Finnish Medicines Agency has assessed to be mutually interchangeable. From the beginning of 2024, the generic substitution scheme regarding biological medicines will include enoxaparin products and all low-molecular-weight heparins that belong to the same medicine group. All other biological medicines will be included in the scheme at the end of 2024, and reference price groups will be introduced for them as from 1 January 2025. Exceptions to this are long-acting insulin products, which will be included in the scheme at a later stage. The generic substitution scheme will not apply to underage users of biological medicines or include short-acting insulins.
The government adopted the legislative amendments on 2 March 2023 and the President of the Republic will handle the amendments on 3 March 2023. The president will decide whether the legislative amendments will be adopted.
Inquiries:
Tuija Metsävainio, Senior Specialist, firstname.lastname@gov.fi
The press release was corrected on 2 March 2023 16.37 pm. There was added the information that the President of the Republic will handle the legislative amendments on 3 March 2023, and the amendments will not be adopted before that.