Medicine or medical device ?

Gynocaps : medical device here, medicine there

The decision of the Court of Justice of the European Union (CJEU), 3 October 2013 (Case C-109/12 Laboratoires Lyocentre c/ Lääkelan turvallisuus – ja kehittämiskeskus), is an unusual case in which the court had to judge whether the same health product could be considered as a medical device in one Member State and as a medicinal product in another.

In this case, the French pharmaceutical company, Laboratoires Lyocentre sold the product “Gynocaps”, a vaginal capsule containing live lactobacilli, as “a medical device or accessory” in Finland and other Member States. However, after a vaginal preparation similar to Gynocaps, containing live lactobacilli, was marketed in Finland as a medical device, the Finnish National Agency of Medicines (Lääkelaitos) reconsidered Gynocaps’ classification, requiring its manufacturer to classify it as a medicinal product and to order a marketing authorisation.

Following a dispute between the two parties, the Finnish Courts referred the following questions to the CJEU for a preliminary ruling.

The first question focused on whether “a definition given in one Member State […] by which a product is regarded as a medical device or accessory […] preclude[s] the competent national authority of another Member State from defining the product concerned, on the basis of its pharmacological, immunological or metabolic effects, as a medicinal product”.

The CJEU answered that a product falling within the definition of a medical device in one Member State could be considered as a medicinal product in another. Indeed, the national authorities of each Member State must determine “on a case-by-case basis, […] taking account of all the characteristics of the product, in particular its composition, its pharmacological, immunological or metabolic properties”. The difference of schemes between two Member States reflects the “existence of differences in the classification of products as between Member States”.

The Finnish court also asked the CJEU whether two non-identical products, containing “the same substance and having the same mode of action” could be marketed “in the same Member State both as medicinal products […] and as medical devices”. The CJEU replied that in principle the same classification would be imposed, but that if a health product had a “characteristic that is specific to that product”, it would not “preclude the product from being classified as a medicinal product and marketed as such”.

It is therefore the case that manufacturers of medical devices, who benefit from a more flexible marketing scheme for their health products than manufacturers of medicinal products, intending to market a health product within the European Union, will have to verify its classification on a Member State by Member State basis.