Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Demarcation of medicinal products and food in the European Union - Focus on food supplements ***

Dr. Karin Streso (Abschlußjahr: 2005)

Language: English
 
The demarcation between foodstuffs and medicinal products has often been a problem for products with a “dual-use” -character such as certain food supplements containing e.g. vitamins or minerals. Numerous classifications had to undertaken by national courts or the European Court of Justice (ECJ).
Until 2002, most decisions were taken on national level, as there was no harmonised definition of foodstuffs. ECJ judgements emphasised the importance of the Member States in view of the absence of harmonisation, taking due account of the requirements of the free movement of goods within the community as laid down in the EC Treaty8.

In 2002, a harmonised definition of foodstuffs was finally introduced with Regulation (EC) No. 178/20025. This was an important step toward unification of the demarcation between foodstuffs and medicinal products. But because of the wide definition and the absence of a defined purpose, implementation of the definition did not solve all problems regarding demarcation.

In the same year, Directive 2002/46/EC3 came into force; this contained a definition for food supplements for the first time. Many of the regulations in the Directive have to be expressed in more concrete terms by additional rules which have still to be implemented. At the moment there are no maximum/minimum levels for nutrients and/or substances with nutritional effect; these are important for drawing the borderline between food supplements and medicinal products e.g. for vitamins or minerals. Furthermore, the Directive covers only vitamins and minerals at present. In the near future a revision or amendment of the Directive seems probable, since the validity of the Directive is currently assessed by the European Court of Justice.

In 2004, the definition of medicinal products was amended by Directive 2004/27/EC35 in order to make it more precise. The terms “pharmacological”, “immunological” and “metabolic” were included in the part of the definition dealing with the function.
The pharmacological effect was and is a crucial factor in national and ECJ judgements for the classification of a product as a medicinal product on account to its function, even though it is hard to use e.g. because there is no legal definition of the term.

In view of the new regulations and the development of decisions made on national level and by the ECJ before and after 2002, certain criteria for classification by presentation and function can no longer be used as sole evidence, such as the external form or general concentration limits (used for vitamins, for example in Germany and Austria).

Classification of a product as a medicinal product or a foodstuff is only possible on a case by case basis. The general opinion based on objective reasons regarding the product determines the classification. This general opinion is not static but can change in response to new scientific knowledge or new developments in foodstuffs.

To determine this general opinion, the following points should be taken into account:

• the pharmacological characteristic of the product in the light of current scientific knowledge
• the way in which the product is used
• the extent of its dispersal
• the degree to which the consumer is familiar with the product
• the possible risk involved in usage

To improve the classification, the following is suggested:

• a more precise definition of foodstuffs, including a purpose
• cooperation between the two Directorates of the European Commission responsible for medicinal products and foodstuffs when new regulations are drawn up and the setting up of working groups for general interpretations of law with regard to classification e.g. through the establishment of guidelines

Initial steps in this direction have been undertaken with a workshop organised by the European Commission in October 2004.

All in all, positive steps have been undertaken and have begun to improve the demarcation between foodstuffs / food supplements and medicinal products. Further developments are urgently necessary.

At present, the demarcations between foodstuffs / food supplements and medicinal products remain a problem for special products and will therefore continue to be a matter of individual assessment in many cases.

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