Natural supplements are not medicines and individual EU governments cannot classify them as such, requiring the same rigorous procedure before marketing. Supplements do not meet the two fundamental criteria established by EU directives to be classified as medicines. The requirement of «presentation» (referring to the different packaging) and, above all, that of «function», are missing because these are natural and non-chemical preparations. With this premise, the EU Court of Justice in Luxembourg (first section, sentence of 15 November in case C-319/05) condemned the Federal Republic of Germany for violating Community directive 83 of 6 November 2001 (in particular articles 28 and 30), relating to medicines for human use. "Germany has failed to fulfill its obligations as a member of the European Union", reports the Court, accepting the appeal presented by the Brussels Commission which had sued Germany for having labeled a freeze-dried garlic-based supplement in capsules as a medicine. «Classification not proportionate to the purposes of protecting public health», warns the Court (President Jann, rapporteur Barthet, Advocate General Trstenjak), highlighting «a restrictive effect» on the free trade of supplements. The German Government has strongly supported the need to protect public health, explaining that only the classification as a drug would have allowed a real control of the effects of that particular supplement. An excessively "generic" reference, replied the Court, which certainly cannot "justify being subjected to a particularly rigorous procedure", such as that necessary for placing a medicinal product on the market. Precise reasons were needed to submit the food "product" "to the regimen of medicines". «Furthermore – it goes on to read – the Member State, rather than subjecting the product in question to a complex procedure, could have provided for appropriate labelling, which warned consumers of the potential risks associated with the consumption of this product. This solution – they specify the reasons – while being compliant with the objective of protecting public health, would have led to less serious restrictions on free competition». The German Ministry of Health will have to review its convictions and will certainly not be able to reject, as it did in 2001, the request for authorization for the importation and sale of the 370 milligram capsules "with garlic extract" whose beneficial properties are known, in particular for the treatment of arteriosclerosis. Decision that "did not respect the principle of proportionality", concluded the European Court of Justice, while recognizing that medicines and supplements have a "physiological effect" in common, but underlining that their marketing must be regulated in a different way, imposing fewer constraints on natural preparations. Il Sole 24 Ore Sanita' of 04/12/2007 4-10 DECEMBER 2007 – N. 47 WORK p. 31
