Prescriptions for biological medicines are only valid for one year at a time

At the beginning of 2023, an amendment to the Decree on Prescribing Medicines entered into force whereby prescriptions for all biological medicines are valid for one year. People using biological medicines should check the validity of their prescriptions with their attending physician or the pharmacy.

With the amendment to the Decree, the one-year validity period was extended to apply to all prescriptions for biological medicines. Under the earlier regulation, the one-year validity period applied to prescriptions for biological medicines for which biosimilars are available.

The changes supporting the amendment to the Decree have been made to some of the patient information systems over the course of 2023, but there are still systems where they have not been made. Because of this, the validity period of some of the prescriptions for biological medicines that have been issued after 1 January 2023 may be two years in the MyKanta service, even though in reality they are only valid for one year. 

Patients with a medical condition or disease such as rheumatism, psoriasis, diabetes or cancer use biological medicines. You can use the FimeaWeb search service Linkki toiselle sivustolleto check what medicines are biological.

Physicians and pharmacies have been given instructions regarding the change

The authorities aim to ensure that pharmacotherapies continue without interruption and any problems. The Finnish Institute for Health and Welfare (THL) and the Finnish Medicines Agency (Fimea) sent an information letter to physicians and pharmacies on 29 September 2023. 

Physicians are advised to renew the requested prescriptions, even if they would appear to be valid for two years. It is also recommended that prescriptions be renewed during appointments, even when a prescription renewal is not requested and when the one-year validity period is coming to an end. 

The letter also instructs pharmacies to check that the validity period of biological medicines is correct and to send a request for a prescription renewal when the one-year validity period specified in the decree is about to end. 

Biological medicines can soon be substituted with cheaper alternatives at pharmacies

Since 2017, physicians have had a statutory obligation to prescribe the most affordable biological medicine that is suitable for treating the patient. The legislative amendment that will enter into force at the beginning of 2024 will also allow pharmacies to substitute biological medicines with cheaper alternatives.  In practice, biological medicines will be included in the generic substitution scheme in stages from the beginning of April 2024. The aim of this to make the use of biosimilars more efficient and to curb the increase in medicine reimbursement costs. Original biological medicines and medicines similar to them, i.e. biosimilars, are equally effective and safe.

• News item of the Finnish Institute for Health and Welfare 15 November 2023: Validity periods of phone prescriptions and prescriptions for biological medicines change Linkki toiselle sivustolle(in Finnish) 

Inquiries:

Guidance for physicians: Heikki Virkkunen, Chief Physician, Finnish Institute for Health and Welfare (THL), tel. +358 295 247 169, heikki.virkkunen(at)thl.fi 

Guidance for pharmacies: Pirjo Rosenberg, Head of Section, Finnish Medicines Agency (Fimea), tel. +358 29 522 3246, pirjo.rosenberg@fimea.fi

MyKanta: Sini Palo, Specialist, Business Activities concerning Kanta Services, Social Insurance Institution of Finland (Kela), tel. +358 20 6340 092, sini.palo@kela.fi. 

Amendment to the Decree: Tuija Metsävainio, Ministerial Adviser, Ministry of Social Affairs and Health, tel. +358 295 163 449, tuija.metsavainio(at)gov.fi