A report on the sales channel of over-the-counter drugs emphasises safe and appropriate pharmaceutical sales

The working group appointed by the Ministry of Social Affairs and Health to investigate the expansion of the sales channel of over-the-counter drugs has published its report. The Finnish Medicines Agency Fimea is satisfied with the working group’s shared view that if the sales channel of over-the-counter drugs is expanded beyond pharmacies, the expansion should not compromise medication safety and the provision of successful medicinal treatment. 

– The working group’s view supports a key goal of the government programme, which is to ensure rational pharmacotherapy when new changes are implemented. As the national competent authority for regulating pharmaceuticals and ensuring medication safety, Fimea’s role is to ensure that the customer’s right to medication counselling and safe medicinal treatment is retained even when any changes are implemented, Fimea’s Director-General Eija Pelkonen says. 

Provision of medication counselling requires careful preparation

The Ministry of Social Affairs and Health appointed a working group to prepare the implementation of the aim concerning over-the-counter drugs included in the Government Programme in December 2023. The purpose of the working group is to prepare the expansion of the sales of some of the most commonly used over-the-counter drugs so that these products can be sold by shops other than pharmacies. Fimea was included in the working group.

According to the report, the practical aspects of the provision of medication counselling in different sales channels requires careful preparation. 

–  The purpose of medication counselling is to ensure that a condition that can be self-medicated is treated in a meaningful and customer-specific manner, which can mean taking a medicine or not, Pelkonen explains.

In the current legislation, university-educated pharmacists (Master of Pharmacy or Bachelor of Pharmacy) are responsible for the provision of medication counselling.

–  The aim of this provision has been to highlight the importance of medication counselling to those who take medicines, Pelkonen says.

According to the report, the sale of over-the-counter drugs outside of pharmacies should be based on an application submitted by the pharmaceutical company to Fimea.

Fimea sees that the application procedure is an essential and necessary policy proposed by the working group. It would allow the pharmacovigilance authority to assess, for each medicinal product individually, the suitability and safety of the product for each sales channel.

Inappropriate use of medicines must not increase

According to the working group, Fimea, which also supervises pharmacies, should be responsible for supervising the new retail outlets. This would allow one authority to have information about companies that sell, store and distribute medicinal products and it would mean that all companies would be supervised using uniform criteria. 

–  Centralised supervision ensures equal treatment of different companies, cost-effective supervision, dissemination of information and safety, Pelkonen explains.

Pricing of over-the-counter drugs sold outside of pharmacies could either be entirely liberated or determined in line with the maximum prices of the pharmaceutical tariff. According to the working group, the selected model should promote price competition and reduce the users’ cost of medicines. 

–  As the working group has stated, the key is to ensure that inappropriate use of medicines does not increase regardless of the pricing model. Medicinal products are not normal consumer goods. They are subject to several safety requirements and justified supervision, the significance and importance of which must be taken into account in further preparation”, Pelkonen explains.

Read more

Working group: The sale of over-the-counter medicines outside pharmacies should be implemented in a controlled and systematic manner (press release of the Ministry of Social Affairs and Health, 3 October 2024, stm.fi) 

Assessment of expanding the sales channel for over-the-counter medicines. Working group memorandum. (PDF in Finnish)  

The Ministry of Social Affairs and Health appoints a working group to prepare the liberation of the sale of certain over-the-counter drugs (news article of the Ministry of Social Affairs and Health, 21 December 2023, stm.fi, in Finnish)

Fimea’s report on the sale of over-the-counter drugs outside of pharmacies, 2023 (in Finnish)