In a recently publicised ruling made last November, the German Federal Administrative Court instructed regulators to take an all-inclusive approach that considers the pharmacological, immunological or metabolic properties of a product before final classification.
“The decisive question 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,” says Dr Nils Rauer, partner at law firm Pinsent Masons.
“The issue is important because the marketing of medicinal products is subject to greater regulation than products merely classed as food supplements.”
Ginkgo Biloba extract
The case in question refers to a manufacturer, who wanted to sell its products in Germany, having applied to the Federal Office for Consumer Protection and Food Safety (BVL), who rejected the application.
Manufactured and marketed in Austria as food supplements, these capsules contained 100 milligrams (mg) dry extract of Ginkgo Biloba leaves (GBE) with a recommended intake of one capsule per day.
The BVL stated its reasons for rejection as stemming from this recommended dosage, which they believed qualified the product as a medical product.
The Federal Office referred to the Federal Institute for Drugs and Medical Devices (BfArM), which concluded a GBE dosage of greater than 80mg per day produced a pharmacological effect.
Details from the judgement revealed this effect applied to physiological functions that included the reduction of blood viscosity and improvement in blood flow in certain brain regions.
The judgement added that assumptions of a product triggering effects on physiological functions did not necessarily lead to it meeting all the characteristics of a medicinal product under EU law.
If a product affected physiological functions fell into the grey area between food supplement and drug, then the possible health risks took on heightened significance regarding its evaluation.
Health risks accounted for
The German Federal Administrative Court concluded that the product’s classification as medicinal is acceptable in such instances if recognisable health risks needed to be accounted for.
The dispute over the classification of these GBE capsules was referred back to the appeal court for re-examination on that reasoning.
In case commentary, Dr Rauer adds the decision has far reaching implications within the EU as definitions for what constitutes a medicinal product can differ throughout the region.
“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,” he says.
“Therefore, the mere fact that the product could be marketed as a food supplement in Austria, was not decisive or instructive as regards Germany."
Dr Rauer adds the Court ruled products marketed as food supplements in one EU country can apply in another EU country until authorities in those countries set out 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 says.
Court of Justice of the EU rulings
In summing up, Dr Rauer adds the decision may act as instruction on how to interpret relevant EU legislation that counts the rulings made by the Court of Justice of the EU (CJEU).
One notable example is the CJEU’s interpretation of medicinal products as stated in the EU's instruction 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,” he adds. “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."