On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12).  The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU).  However, in the majority of cases the Court follows the Advocate General.

National courts use the preliminary ruling procedure if they are in doubt about the interpretation or validity of an EU law. In such cases, they may ask the CJEU for advice. The Advocate Generals provide the CJEU with public and impartial opinions to assist the Court in its decision making. The Advocate Generals’ opinions are advisory and non-binding, but they are nonetheless influential.

The Finnish Supreme Administrative Court sought a preliminary ruling on three questions.  In brief:

1. Can one Member State classify a product as a medicinal product while another Member State classifies it as a medical device?
2. What is the process for reclassifying a medical device as a medicine?  Is it sufficient to follow the procedures set out in Directive 2001/83/EC (the Medicinal Products Directive)?  Or is it necessary, prior to initiating procedures under the Medicinal Products Directive, for the competent authorities to follow the applicable provisions of Directive 93/42/EEC (the Medical Devices Directive), particularly Articles 8 and 18?
3. Can a product with the same active substance and mode of action be on the market in one Member State as both a medicine and a medical device?

Background

Laboratories Lyocentre manufactures a vaginal capsule used for correcting bacterial imbalances.  The product’s composition consists of a particular bacterium of the lactobacillus genus, together with lactose and magnesium stearate.  Gelatine is used for the capsule’s protective shell.  Until 2006, the product was marketed in Finland as a natural medicine under the name Gynophilus.  Since 2006, the same product has been marketed in Finland under the name Gynocaps as a medical device with a CE marking.  It is also sold and marketed in the same manner in Austria, Spain, Italy and France.

In 2008, the Finnish National Agency for Medicines considered the composition and mechanism of action of the product and decided that Gynocaps could no longer be marketed as a medical device within the meaning of the Finnish Law on medical devices and accessories.  It considered the product to be a medicine that required a marketing authorization.  Laboratories Lyocentre appealed the decision, and the Finnish Supreme Administrative Court subsequently sought a preliminary ruling on Questions 1 – 3.

Opinion

The Advocate General’s Opinion does not consider the actual classification of the product at issue.  It takes no position on the merits of the National Agency for Medicines’ decision to reclassify the product as a medicine.  However, it address the three Questions 1 – 3 referred by the Finnish court.  In summary, the Advocate General expressed the following opinions:

Question 1

The Medical Devices Directive and the Medicinal Products Directive do not exclude the possibility that a product can be classified as a medicine in one Member State and as a medical device in another.  The Advocate General states: “In my opinion, as long as there is no complete harmonisation with respect to these types of product, it is possible for one Member State to conclude with confidence that a given product is a medical device whereas another takes the position that the same product is a medicinal product.” (para. 55).  Although he goes on to recognize that different classifications in different Member States may result in legal uncertainty and create some impediment to the smooth functioning of the single market, he states that “those consequences are the corollary of incomplete harmonisation.” (para. 67).

Question 2

The Advocate General discusses the overlap of Article 18 of the Medical Devices Directive, which concerns “wrongly affixed CE marking,” and Article 8, the “safeguard clause” allowing Member States to take action to remove unlawful or unsafe products from their markets.  He also considers these provisions in the context of the Medicinal Products Directive.  In brief, the Advocate General opined that “where a product which has previously been classified as a medical device ought in fact to be classified as a medicinal product only immediate removal from the market can achieve compliance with both sets of rules [the Medical Devices Directive and the Medicinal Products Directive].” (para. 95).  Further, “a product that is reclassified as a medicinal product cannot remain or be placed on the market until a marketing authorisation has been obtained and the other conditions set out in the Medicinal Products Directive have been met.” (para. 98).

Question 3

If two products are identical in all respects, a Member State cannot classify the products differently and allow one product to be marketed as a medicine and the other as a medical device.  In cases of doubt, the Medicinal Products Directive must apply.  However, EU law does not preclude Member States from classifying two similar products differently, even if they contain the same active substance and have the same mode of action.  The Advocate General concludes that “the mere fact that two products contain the same substance and have the same modes of action is insufficient to conclude that they must be classified and put on the market in the same manner...” (para. 74)

Concluding remarks

The Advocate General’s opinion confirms that Member States must make classification decisions on a case-by-case basis.  It recognized that there is incomplete harmonization in the EU.  As such, there is a risk that Member States may adopt different views leading to inconsistent positions in each jurisdiction.  It will be interesting to see whether the CJEU follows the Advocate General’s opinion in its final judgment on the case.