Marketing ban decision for Novartis Finland Oy concerning practices in violation of the Medicines Act related to the treatment of outpatient care patients at a medical centre
By its decision issued on 4 March 2020, Finnish Medicines Agency Fimea has prohibited Novartis Finland Oy from continuing or renewing marketing in violation of the Medicines Act.
In its decision, Fimea stated that the agreement between a medical centre and the marketing authorisation holder concerning the implementation of medicinal treatment intended for self-administration by outpatient care patients at a reduced price for patients of the medical centre constitutes improper marketing and sales in violation of section 91 of the Medicines Act. The agreement also attempted to limit the patient group eligible for treatment at a reduced price, which was considered an operating method that violates section 92 of the Medicines Act. According to Fimea's information, the operating method specified in the agreement continued between 26 September 2018 and 30 January 2019.
By its decision, Fimea prohibited Novartis Finland Oy from continuing or renewing the operating method described above. The marketing ban decision is reinforced by a conditional fine of EUR 100,000. The decision is not legally binding yet.
Fimea emphasises that, according to the definition in section 25 of the Medicines Decree, marketing means all publicity, marketing and promotional activities intended to promote the prescription, supply, purchase or use of medicinal products. As a result, contractual arrangements aiming to increase the prescription and use of medicines by means of operating models that violate the Medicines Act can be considered improper marketing in violation of the Medicines Act. In Fimea's view, an arrangement in which, at the initiative of the marketing authorisation holder, a medicinal product intended for sale at a pharmacy is offered for distribution through medical centres cannot be regarded as a normal procurement procedure and activity outside the scope of marketing when the patients receiving the medicine are not actually treated by the medical centre and are already users of the medicine in question. Medical centres can only offer their patients medicines to the extent required by hospital care.
In addition, Fimea emphasises that under no circumstances may the marketing authorisation holder attempt to use contractual arrangements to influence which patients will receive a medicinal product. Patient selection must be based on the approved summary of product characteristics and the assessment of the attending physician. In Fimea's view, influencing patient selection must be considered an activity in violation of section 92 of the Medicines Act that is likely to endanger the population’s trust in the independence of prescribing medicines.
- Esa Heinonen, Director, tel. +358 29 522 3300
- Juliana Raitis, Legal Advisor, tel. +358 29 522 3656
- Kristiina Pellas, Senior Pharmaceutical Inspector, tel. +358 29 522 3422
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