Case C-109/12, Lyocentre – when a medical device becomes a medicinal product [judgment 2013, ECLI:EU:C:2013:626]

Can a product be a medical device in several Member States but a medicinal product in another Member State? And what then of the internal market?

Facts

The CJEU’s summary indicates that Gynocaps has been sold as a preparation in Finland since 1984. After 2006, it was sold as a ‘medical device’ for the purposes of Directive 93/32, and has an EC mark. Gynocaps was also bought and sold as a ‘medical device’ in other EU Member States too, namely, in Austria, Spain, Italy and France.

In 2008, the Finnish Medicines Authority decided that Gynocaps was not a medical device or accessory under the Finnish law implementing Directive 93/42, but rather it was a preparation suitable for use as a ‘medicinal product’ within the meaning of the Finnish law implementing Directive 2001/83. Accordingly, a marketing authorisation was required. Apparently, the Finnish authority took this decision because a rival company had also wished to sell a lactic acid bacterial preparation which corresponded to Gynocaps, and the other product had been defined as a medicinal product.

After successive appeals through the Finnish court system, the matter ended up at the Finish Supreme Administrative Court. It recognised that under C-140/07, Hecht Pharma one Member State’s definition of a product as a medicinal product does not preclude another Member State’s refusal to define it the same way. Equally, in Case C-88/07, Commission v Spain, one Member State’s definition of a product as a food supplement does not preclude another importing Member State from defining it as a medicinal product, when the product displays those characteristics.

And yet, to the Finnish Court’s knowledge there was no case law about the power of a national authority to take a decision of its own volition that a product was not a medical device but a medicinal product – even though that product was EC-marked and sold in other countries as a medical device. Equally, there appeared to be no case law about which procedure such a body should follow when determining whether something was a medicinal product.

Questions Referred

According to the Curia website, the Finnish Supreme Administrative Court asked:

Does a definition given in one Member State in accordance with the Devices Directive 93/42/EEC, by which a product is regarded as a healthcare device or accessory in accordance with the Devices Directive and is provided with a CE marking, preclude 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 in accordance with Article 1(2)(b) of the Medicinal Products Directive 2001/83/EC?

If the answer to the previous question is in the negative, can that competent national authority define the product as a medicinal product observing only the procedures under the Medicinal Products Directive 2001/83/EC or is it necessary, prior to initiating procedures under the Medicinal Products Directive to define the product as a medicinal product, to follow the safeguard clause procedure in Article 8 of the Devices Directive or to comply with the provisions of Article 18 concerning an unduly affixed CE marking?

Does the Medicinal Products Directive 2001/83/EC, the Devices Directive 93/42/EEC or European Union legislation otherwise (including the protection of human health and life and consumer protection) preclude products containing the same substance and having the same functions from being on the market in the same Member State both as medicinal products in accordance with the Medicinal Products Directive 2001/83/EC, requiring a marketing authorisation, and as healthcare devices or accessories in accordance with the Devices Directive 93/42/EEC?

Update
This case is scheduled to be heard on 20 February 2013 by the Fourth Chamber.