EU Court of Justice - Advocate General on Medicine Definition
Advocate General Geelhoed of the European Court of Justice has recently filed his opinion, the concluding remarks in the case before the court decides later this year, in a case referred to Luxembourg by a German appeals court asking the EU court for its view on several questions. The problem that led to the cases originally was the classification by German health authorities of several food supplements as medicines, effectively banning their import into Germany:
- a lactobacillus product composed of six forms of friendly bacteria
- a vitamin C product of 1000 mg
- OPC 85, oligomeric procyanidins, a bioflavanol extract
- Acid free C - 1000 mg of vitamin C buffered by 110 mg of calcium
- E 400, capsules with 268 mg of vitamin E
The case and some of the previous documents filed by member state governments and the Commission, are discussed in this article.
The opinion of the EU court's Advocate General goes into detail on the legal question of how to separate food products from medicines. It shows the great difficulty that an extremely wide and ambiguous EU medicine definition brings in determining coherently what is a food and what instead should be registered as a medicine.
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Here are some of the salient points of the Advocate General's opinion:
In classifying products as medicines, member states are bound by the definition of a medicinal product in directive 2001/83. Decisions by national authorities are subject to review only by the national courts. In their decisions, the courts have to apply community precedent, which interprets the definitions in more detail.
An overly extensive interpretation of the definition of a medicinal product would have, according to Geelhoed, three negative effects: Firstly, the term medicinal product tends to get watered down, if products are subsumed under it which by formulation and effects should not be so classified. Secondly, it can lead to a situation where community rules for specific categories of foods (such as novel food ingredients and supplements) lose their intended purpose. Thirdly, a creeping expansion of the field of application of the medicines directive has negative effects on the free movement of goods.
While small differences in interpretation of the medicinal directive across Europe are not excluded, a member state must be able to justify classifying a product as a medicine which elsewhere in the community is classified as a food, by objective scientific data.
National food laws have to afford a high standard of health protection and must be based on scientific risk assessment and, where needed, follow the precautionary principle. It will therefore be more and more difficult for member states to cite article 30 of the of the EU treaty for reasons of protecting health. They will have to prove that products, which elsewhere in the common market have been accepted as foods following high standards of protection, are posing unacceptable risks for health. The proof has to be convincing.
If they can prove the existence of real dangers or serious risks for health, the limiting measures they wish to take must still, according to the (EU) court's jurisprudence, be in accordance with the principle of proportionality. That means the measures must be effective, they must not go beyond what is strictly necessary to achieve the intended protection, and must be in relation to the goal in the sense that the protection cannot be achieved by other measures that would be less of a hindrance to the free movement of goods. This has been re-confirmed in recent jurisprudence.
In the case of foods and food ingredients that are subject to specific community rules, member states are therefore no longer free to take immediate restrictive measures in the presence of assumed dangers, with reference to article 30 of the EU treaty. They will therefore have to first follow the consultation procedures with other member states and the Commission as specified in community legislation.
Community food law is evolving and is characterized by a situation of national health authorities working side by side. Growing commerce brings with it a dual dependence - on the one side growing and increasingly complex chains of trade are vulnerable to one-sided obstacles and limitations, on the other hand, they make for a fast expansion of possible dangers and health risks. This forces national authorites to co-operate both horizontally among themselves, and vertically with the community institutions.
Due to the potentially serious consequences of differences in interpretation and application of rules and because of the vulnerability complicated legal systems face from imprecise application, national authorities of a member state have to be well aware of the consequences of a different classification of products imported into their areas. Their duty of care implies that, before taking restrictive measures, they have to make use of the procedures community law offers to avoid trade limiting differences in interpretation and application of the law. This is especially the case when a product is seen as a medicine in one member state, while elsewhere it is considered a food product, because application of medicine law leads to much farther reaching limitations.
... as a basic rule, products are considered safe if they are in accordance with the particular regulations of the member states where they are put on the market (article 14, paragraph 9, first phrase of regulation number 178/2002 - novel foods).
(... as part of a discussion of fortified foods): A correct application of the precautionary principle requires, according to the jurisprudence of the EU court, firstly the determination of possible negative health consequences of the addition of nutrients to foods, and secondly a comprehensive evaluation of the health risk on the basis of the most reliable scientific data available and the latest international science. If it turns out to be impossible to clearly demonstrate the existence and the importance of the alleged risk, because the results of scientific studies are insufficient, inconclusive or inexact, and if there is a continued likelihood of factual danger for public health in case the risk should turn out to be real, then the precautionary principle justifies taking restrictive measures.
The term "upper safe level" has no role in determining the borderline between what is a food and what is a medicine. This is so because on the one hand, a number of foods which obviously are not medicines may necessitate determination of an upper safe level in connection with the daily dose of consumption suggested by the producer, and on the other hand, products that are far below an upper safe level can be used to restore, correct or influence human physiological functions and are thus classified as medicines. The term "upper safe level" has to be understood, regardless of product category - food or medicine - as a functional term. It is a measure which allows the consumer to obtain information needed for a responsible use of the product.