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Finnish Supreme Administrative Court: Sleep-Inducing Products to be Classified as Medicines

The Supreme Administrative Court of Finland has recently ruled in two cases (KHO T -1393 and KHO T- 1394) that sleep-inducing products are to be classified as medicines instead of food supplements. This means that marketing of such products requires a marketing authorization for medicinal products. The rulings uphold decisions taken in 2011 by the Finnish Medicines Agency Fimea.

Fimea had classified two products as medicines, the other containing valerian (200 mg) as its active ingredient, and the other containing melatonin (2 mg). The two companies that marketed the products sought to have the decisions overturned, stating that the effect of the products is typical of food supplements and not strong enough to justify their classification as medicines. As a side note, Fimea has allowed the marketing as food supplements of products which contain 0.5 – 1 mg of melatonin, in accordance with the health claims approved by the European Commission.

In both of the cases, the Supreme Administrative Court declined the companies’ claims to request for a preliminary ruling from the Court of Justice of the European Union (CJEU). In the case concerning the valerian product, the Supreme Administrative Court referred to Hecht Pharma GmbH (C-140/07), stating that there was no juridical ambiguity in the case. While it was true that the product could not be classified as a medicine only because it has some effect on the vital functions, Fimea had shown the product to have such a pharmacological effect that it could be regarded as a medicine. In the case concerning the melatonin product, the appellant company had alleged that the national Court did not have the required expertise to rule on the matter. The Supreme Administrative Court stated, referring to Octapharma France (C-512/12) and Chemische Fabrik Kreussler (C-308/11), that the classification of a particular product as a medicine is a question for the national courts.

In both cases, the Supreme Administrative Court stated that requiring a marketing authorization for a product classified as a medicine does not restrict imports between the EU Member States, as prohibited in Article 34 of the Treaty on the Functioning of the EU (e.g. Commission v. Spain (C-88/07). Thus the fact that the products were marketed as food supplements in other Members States did not affect the classification in Finland.

Proposals and Developments Regarding the Organic Food Industry

The Finnish Government has on 24 April 2014 proposed a new Act on supervision of organic products. With this Act, Finland is implementing EU legislation and amending current domestic provisions. No dramatic changes are proposed. The main objective is to modernize and simplify the current provisions. Pursuant to the proposal, the Finnish Food Safety AuthorityEvira would gain a stronger role as the  leader and coordinator of the supervision and as an expert authority. Evira would also be responsible for reporting to the EU Commission. The distribution of supervision responsibilities between the four supervising authorities (Evira, the Centers for Economic Development, Transport and the Environment (ELY Centers), National Supervisory Authority for Welfare and Health Valvira and Finnish Customs) would be more clearly defined, but the current system would not be changed, just clarified. Even though the proposed Act with amendments are rather technical, the proposal may be seen as a part of a bigger reform on the EU level with regard to legislation on organic food industry, planned to enter into effect by the end of the decade at the latest.

The European Commission has proposed new Regulation on organic food production and labeling of organic products. One of the objectives is to simplify and codify legislation. The Commission’s proposal introduces obligatory tests on traders and harmonized sanctions if non-authorized substances are detected in organic products. The Regulation aims to remove the possibility to exempt certain retailers from provisions regarding organic products. It allows the officials to adapt the frequency of supervision and control, so that low risk operators may be inspected less frequently than annually, which is supposed to reduce the administrative burden on smaller operators. In the proposal a group certification system is adopted in order to help small farmers to enter the supply chain. With the proposal, the Commission also aims to improve the traceability of products. In order to give enough time for farmers to adapt to the new provisions, there will be a conversion period of two or three years.

Evira has launched a new search service that allows consumers to check whether the products that are marketed and sold as organic are being sold by actually verified organic producers. It should be noted that organic alcoholic beverages are not included in the search results.

In Brief

CJEU Rules on Pre-2010 Application of Health Claim Requirements

The Court of Justice of the European Union (CJEU) has recently given a new decision on health claims. In the case Ehrmann (C-609/12) the CJEU ruled that the special EU law requirements for health claims have been in force ever since Regulation No 1924/2006 on nutritional and health claims was given. There had previously been uncertainty whether the special requirements set in Article 10(2) of the Regulation applied before the drafting of a list of health claims in 2010, which was after the case Ehrmann became pending. This decision clarifies the application of the EU health claims regime as well as the application of transitional measures in EU law.

The case Ehrmann was referred by the Federal Supreme Court of Germany to the CJEU. It dealt with  the marketing of a quark product as equivalent to milk despite the high sugar content of said product, which could be considered a health claim. The matter in dispute was whether the additional requirements for health claims set forth in the Regulation were applicable at the time the case became pending.