In setting aside the qualification of a range of herbal infusions as medicine, and acquitting a charge of illegal exercise of pharmacy, a Court of Appeal stated that:
Neither the presentation nor the indications allowed the products to be qualified as medicines;
The plants included in the infusions are “traditionally known for their properties other than medicinal properties”; Certification (“Ecocert”, “AB”) and approvals (“dietary product / supplement”) provided (by the Belgian authorities, the AFSSAPS - French Health Products Safety Agency) constitute “clear proof that (…) the product had appeared to the certifiers as foodstuff, and manifestly not as a medicine”.
The Criminal Division of the Court of Cassation quashed this decision on the following grounds:
- The Court of Appeal should have examined firstly, and “on a case by case basis, taking into account all the characteristics of each product, particularly its composition, pharmacological properties (…), methods of use, the extent of its distribution, consumers’ knowledge and the health risks which its use may involve”, whether it could be qualified as a medicine by presentation or by function, independently of the certification it had obtained; (our emphasis)
- The products, composed of plants listed in the European pharmacopoeia, were likely to be subject to the pharmacists’ monopoly (article L. 4211-1 5° CSP).
A product may be a medicine in one Member State and a dietary supplement in another, in accordance with a decision of the ECJ (ECJ 15 Jan. 2009, Case C-140/07, Hecht- Pharma).
According to the Criminal Division, the pharmaceutical monopoly is not contrary to Community law (article 30 of the EC Treaty: possible national restrictions on freedom of movement, for the protection of health). This position is in accordance with that of ECJ (ECJ 19 May 2009, Joined Cases C-171/07 and C-172/07 Apothekerkammer des Saarlandes).
Legal uncertainty arises from the proclaimed independence of the judge with regard to the certifying authorities or organisations: enjoyment of a label or certification does not protect against criminal proceedings.