Health supplement or medicinal product: a holistic view is required

In a judgment issued in November last year that has only recently been publicised, the German Federal Administrative Court said regulators must take a holistic view of a product, including any health risks it poses, before classifying that product as a medicine.

In the underlying case, the court considered the basis on which a regulator in Germany had refused to issue a certificate to a company enabling it to market its product as a food supplement.

The Ginkgo biloba extract (GBE) product, provided in 100mg capsules, is sold in Austria as a food supplement. However, the German Federal Office of Consumer Protection and Nutrition Security refused the manufacturer permission to market it as a food supplement in Germany.

The regulator viewed the recommended dosage of GBE – 100mg per day – as qualifying the product as a medical product. It reached that view after considering the views of the Federal Institute for Drugs and Medical Devices (BfArM) and prevailing scientific opinion which assumes that a GBE dosage of greater than 80 mg per day produces a pharmacological effect.

The decisive question before the German Federal Administrative Court was whether an undisputed pharmacological effect of a product can automatically lead to the categorisation of that product as a medicinal product or whether other aspects, notably any potential health risks involved in the use of the product, need to be taken into account.

The issue is important because the marketing of medicinal products is subject to greater regulation than products merely classed as food supplements.

The German Federal Administrative Court ruled that authorities must take a holistic view when assessing whether a product qualifies as a health supplement or medicinal product. That assessment cannot be made solely through consideration of the dosage of a substance that has a proven pharmacological effect on humans, it said. The dispute over the classification of the GBE capsules at issue in this case was referred back to the appeal court for reconsideration on that basis.

Dr Nils Rauer of Pinsent Masons, the law firm behind Out-Law, said: "The Federal Administrative Court judges said that the decision whether a product is to be regarded as a medicinal product can differ throughout the EU. Although the standards for assessing the conditions under which a product is to be classified as a medicinal product are harmonised within the EU, the evaluation of the scientific knowledge and the risks to human health may differ depending on which authority is in charge. Therefore, the mere fact that the product could be marketed as a food supplement in Austria, was not decisive or instructive as regards Germany."

"However, the court made clear that products marketed as food supplements in one EU country can be marketed as such in another EU country until such time as the relevant authorities in those other countries establish reasons why that practice is wrong. In this respect, the burden of proof on whether a health supplement is in fact a medicinal product rests with the national authorities," he said.

In its decision, the court explored the definition of a medicinal product under EU law. This provides that a product is a medicinal product when it is demonstrated to have, when used as intended and in a significant way, a positive pharmacological, immunological or metabolic impact. The court confirmed that the therapeutic efficacy of a product is not an essential element in the classification of a product as a medicinal product.

The judges also considered that whilst a physiological function is necessary for a product to qualify as a medicinal product, not all products containing a physiologically active substance may be classified as functional medicinal products under EU law. This is because some products producing physiological effect can also qualify as food supplements under EU law. In this regard, the judges found that a product cannot be classed as a functional medicinal product if the effects of the physiological functions of the product do not exceed the effects that a food consumed in reasonable quantities can have.

Assumptions of a significant effect on the physiological functions of the human body does not necessarily lead to it to meet all the characteristics of a medicinal product for the purposes of EU law, the court said. On the contrary, possible health risks are a further independent factor to be considered in the assessment. If the effects of a product on physiological functions of the body are within the borderline area between food supplement and drug property, then the possible health risks are of particular importance for the assessment, the court said. This means that the classification as a medicinal product is only justified in such cases if it is necessary to account for the existence of recognisable health risks.

Dr Nils Rauer of Pinsent Masons, the law firm behind Out-Law, said: "The judicial comments may provide guidance beyond Germany as they ultimately rest on an interpretation of EU law, including precedent set by the Court of Justice of the EU (CJEU), notably on the definition of medicinal products set out in the EU's directive on medicinal products for human use."

"In essence, the judgment establishes the manufacturer's right to a thorough and comprehensive evaluation of the product at issue. Authorities may not jump to isolated factors reaching premature decisions. The eventual outcome might be the same and the dosage of a certain substance may very well play a decisive role, but, the assessment must go beyond such criterion. Overall, the decision forms well-reasoned case law requiring the authorities to be precise and reasonable in their review and assessment," he said.