This month’s Life Sciences & Healthcare newsletter bring you a short overview of how off-label use of medicinal products is regulated in the Baltics. This is especially interesting in the light of the recent judgement of the European Court of Justice on off-label use of medicinal products.
Risk-benefit balance includes risks resulting from off-label use
The judgement of European Court of Justice dated 15 May 2024 pertains to off-label use and its connection with the suspension, revocation and variation of marketing authorisation (MA) by the competent authorities, pursuant to Article 116 of Directive 2001/83/EC on medicinal products for human use.
The applicant sought the annulment of Commission Implementing Decision C(2022) 3591 of 24 May 2022. The decision required member states to suspend the national MAs for certain medicinal products primarily due to fact that the products were used off-label (“non-adherence to the product information continued to exist”) and there was a risk of serious harm to patients. The cases of non-adherence to the product information were, in Pharmacovigilance Risk Assessment Committee’s (PRAC) view, due not only to a lack of awareness, but “appeared to be the result of an intentional choice on the part of prescribers”. As a result, the PRAC concluded that the risk-benefit balance of the medicinal products concerned was unfavourable and recommended that the marketing authorisations for those products be suspended.
The applicant alleged that the conditions laid down in Article 116 of Directive 2001/83 have not been satisfied, because the assessment should be done only in the context of the use of the medicinal products following the approved indications (and not including off-label use). The court, however, interpreted the concept of risk-benefit balance set out in Article 116 and found that the concept also covers consideration of the risks resulting from the off-label use of a medicinal product. The court also reaffirmed that the protection of public health must unquestionably take precedence over economic considerations.
The court’s decision essentially means that also the off-label use of medicinal products may affect the risk-benefit balance of a product, and hence, may result in suspension of marketing authorisation.
Off-label use in Estonia
Estonian law does not specifically regulate off-label use. In practice, off-label use is not uncommon and even the Estonian Health Insurance Fund has accepted the off-label use of certain products.
The Estonian Health Insurance Act provides that when deciding on the financing of a medicinal product, the proven medical efficacy of the medicinal product and the needs of the insured person, inter alia, are taken into account. Of course, the cost of the product and availability of funds are also taken into account, which means that often the decision is made not to reimburse the product value, due to an claimed lack of funds. The question has been raised whether it is acceptable to in practice prefer off-label use instead of an existing on-label product if off-label use is economically more favourable.
As local laws must also be interpreted in compliance with fundamental principles deriving from European Union laws and European Court of Justice practice, proven medical effectiveness should always be a priority – i.e. the requirement for marketing authorisation cannot be derogated from due to financial reasons.
Off-label use in Lithuania
Off-label use of a medicinal products is not allowed in Lithuania, except in special cases provided for by the Law on Pharmacy:
- when pathogenic or chemical agents, toxins or ionising radiation dangerous to health are suspected or detected
- in the event of a national emergency or quarantine
- in the event of a state of war or emergency
In these special cases, the Minister of Health may temporarily prescribe or recommend the off-label use of medicinal products, provided that the therapeutic indications, dosage and/or course of treatment prescribed or recommended are scientifically justified. Marketing authorisation holders, manufacturers and healthcare professionals shall not be liable for the consequences related to off-label use of medicinal products, provided that they have been recommended or instructed to do so by the Ministry of Health.
Off-label use in Latvia
Latvian law does not specifically regulate off-label use.
Certain provisions derive from the laws applicable to the advertising of medicines. According to Cabinet Regulation No. 378 “Procedures for Advertising Medicinal Products and Procedures by Which a Medicinal Product Manufacturer is Entitled to Give Free Samples of Medicinal Products to Physicians” (Regulation), one of the general requirements for the advertising of medicines is that the information provided in the advertising must conform to the particulars listed in the description of the medicine. Accordingly, and as explained in the guidelines for merchants who produce or distribute medicinal product advertising developed by the Health Inspectorate, advertising of medicines must not include information that contradicts or is not indicated for the relevant medicine in its description, for example “off-label use” 1. It is also prohibited to advertise prescription medicines to the general public.
The provisions of the Regulation, however, do not apply to information provided to an individual patient by a specialist regarding specific medicinal products which are needed by the patient.
1 https://www.vi.gov.lv/lv/media/5655/download
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