Belgium adds detail to herbal drug plans
of draft amendments to a Royal Decree that may switch the
classification of 250 herbal products from food and food supplement
ingredients to medicines.
The amendments state that those herbs already on market but not registered under Belgian national law that has transposed the European Union Traditional Herbal Medicinal Products Directive (THMPD) or European pharmacological regulations, must notify AFMPS. Even those in compliance with pharmaceutical laws but which have not been brought under the remit of the THMPD must notify the AFMPS. Ambivalent plants The Belgian Federation for Food Supplements, Dietary and Organic Products (NAREDI) said AFMPS intended to delete "ambivalent plants" from a positive list of botanicals authorised for food supplements use under a 1997 Royal decree. These are plants that have both medicinal and other uses such as food ingredients. Garlic is an example. The THMPD gives companies until the end of 2011 to gain registrations where required but the Belgian laws may require action within six months. It will also place a high cost on manufacturers as the registration process could cost upwards €2500 per product. NAREDI is concerned the Decree will restrict availability to many herbal products such as valerian and Echinacea. The draft Decree stipulates companies name manufacturers, importers and dealers, as well as the members of their staff responsible for information and pharmacovigilance. A thorough traceability system and a recall procedure is also required. If AFMPS authorises the submissions, products will be required to carry a notification number on the product packaging until a registration number is issued. Precedents Industry points to a 2007 case in the European Court of Justice (ECJ) that found against a German government move to classify garlic supplements as medicines. The ECJ found that Germany's position was an unfair barrier to trade within the bloc and also that "the intended use" of the product was not medicinal and therefore garlic supplements should not be classified as such. "Many of the botanicals AFMPS considers as being 'ambivalent' are consumed in exactly the way and available for purchase in the same was as garlic supplements are in Germany, so we think there is a case for their classification remaining under food law if the government pursues the line it is taking with this," said Nathalie Guillaume, NAREDI secretary general. The THMPD was in part designed to create a specialist category for herbal products across the EU's 27 member states that fell between medicines law and food law, but its long lead-times and procedural uncertainty have meant its transposition into member state law has not been consistent. Governments in other member states such as Poland have announced intentions to take matters into their own hands by similarly classifying a host of herbal products as medicines.