The concept of "pharmaceutical effect" as criterion to delimitate food from medicinal products
An Analysis of the Jurisprudence of the European Court of Justice
For the first time the term "pharmaceutical effect" was used by the Court of Justice (CoJ) in the judgment "Van Bennekom" (Judgment of November 30,1983 Case 227/82 C.R. page 3883,3907). However, the Court did not define the term pharmacological effect or pharmacological properties.
The "Van Bennekom" case dealt with the problem if there existed a quantity of certain vitamins decisive for whether such vitamins could no longer be regarded as nutritionally substances necessary for the normal functioning of the human organism i.e. not as food stuffs but as medicinal products because they are used for therapeutic purposes. From the case report can be learned that with regard to the then current scientific knowledge it was not possible to determine whether the criterion of concentration as such could give sufficient reason to qualify a vitamin product as a medicinal one. For that reason the Court ruled that the qualification of a vitamin as medicinal product in the sense of the 2.part of the definition of Art. 1 Para. 2 of directive 65/65 was dependent from a case by case statement of the pharmacological properties taking into account the current state of scientific knowledge (see C.R. No 94 of the grounds of decision).
However, the Court additionally requested that with regard to imported products in each case it must be determined whether the sale of the product in question would constitute a real danger to health (see C.R. No 40 of the grounds of decision). Therefore, there is a link between the concept of "pharmacological properties" and "therapeutic effect" (regarding "therapeutic effect" see esp. CoJ Judgment of October 18,1991 Case C-129/91 C.R. I-5485,5509 No 20 "Ter Voort"). The assessment of a "pharmacological effect" alone also in the sense of a therapeutic effect is insufficient, however. An evaluation with a view to doses and application is imperative whether the product in question poses a serious danger to human health.
Advocate General Tesauro in his conclusions in case C 369/88 "DELATTRE" (Judgment of March 21, 1999, C.R. I-1487) came to the conclusion that if it can be determined that a product imported from other Member States has no curative or preventive properties with regard to diseases, that it is not presented as being such a product, that it contains no ingredients whose high degree of concentration could render it a medicinal product and that does not constitute a real danger to human health the introduction of a mandatory authorization and by this its evaluation as a medicinal product cannot be justified under Art. 36 of the Treaty. In the judgment the Court then refers to "Van Bennekom", but does not give any explanation what is meant by "pharmacological effect".
Advocate General Lenz in his conclusions in case C-112/98 "Upjohn" (CoJ Judgment of April 16, 1991, C.R. I-1703, esp. I-1721) tried to clarify the term also referring to the judgment "Van Bennekom". He cited the definition "pharmacological" in Meyers Enzyklopädischem Lexikon 1978 which reads " type, composition and effect of chemical substances on the organism" (Lenz No 30-31 footnote 15). Following to General Advocate Lenz this term corresponds to the deliberation which for the interpretation of the 2nd part of the definition "medicinal product" in Art. 1 Para. 2 No 2 dir. 65/65 regards the (potentially harmful) effects of a product and the evaluation of the state of the body being the cause of the application. Already in her conclusions in the "Van Bennekom"-case Advocate General Rozès came to similar results. She concluded that the definition of functional medicinal products was introduced into of dir. 65/65 in order to take into account the fact that medicinal products are toxic, in general. Medicinal products are therefore submitted to a prior authorization procedure due to their specific, toxic properties.
In the judgment "Upjohn" the Court used the term "pharmacological property" again without any explanation, however adding that the modalities of use of a substances, the scope of its circulation and its knowledge with consumers must be taken into account. In its ruling the Court interpreted the wording " ..to restoring, correcting or modifying physiological functions..." in the sense that all substances having an effect on physiological functions in the true meaning of the word are included. However, this formula does not comprehend substances which have an effect on physiological functions but do not have a considerable impact on the metabolism and therefore do not really influence the conditions of its function.
The reference to effects on the metabolism and to conditions of physiological functions alone is no help when delimitating foods from medicinal products especially with regard to the definition of food supplements under Art 2a of dir. 2002/46/EC. Food supplements are defined as "foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a ....physiological effect...". The element "physiological effect" necessarily means that such substances do in fact influence the metabolism and its conditions of function really. Not only do they have "pharmacological properties" in sense of the definition on Meyers encyclica but also in sense of the definition of the science of general and special pharmacology which defines pharmacology as the science of interactions between substances and living organisms. Consequently the Court in "Monteil and Samani" (Judgment of March 21, 1991 C-60/98 C.R. I-1547, I-1573 rule 1)B)) emphasizes that when qualifying of products as medicinal products the risks stemming from its use shall be taken into account.
The assessment of a serious hazard to human health is nothing else but a risk analysis as defined in Art.9 No 9-11 Reg.(EC)178/2002.
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