The Alliance for Natural Health (ANH) says it expects to file its legal challenge to the Traditional Herbal Medicinal Products Directive (THMPD) at the High Court in London by the end of March after hitting its first-stage funding target of £90,000.
ANH hopes the High Court will refer the case to the European Court of Justice.
ANH argues that it is the “problematic” legal text of the THMPD, as it is currently framed, that is responsible for what it calls the “excessively restrictive eligibility requirements” of the traditional herbal registration (THR) scheme (administered in the UK by the MHRA).
ANH argues that this, together with onerous quality controls, means that the THMPD, effectively discriminates against non-European herbal traditions and poly-herbal products in general. It says that by forcing specialist herbals manufacturers into a pharma-style manufacturing and testing regime, it establishess criteria that cannot be met in the case of most poly-herbal products. And it points out that, to date, “with few exceptions, and only a few”, most successful applications under the directive relate to alcoholic extracts of single-herbs — impregnated into chemical bases as tablets or capsules along modern, Western pharmaceutical lines.
Working in partnership with the European Benefyt Foundation (EBF), ANH is being advised by leading London-based EU law specialists 11KBW. Its lawyers says there is basis for a legal challenge on grounds of proportionality, transparency and human rights:
• Proportionality: This argument will aim to expose the manner in which the Directive, and associated European laws and guidelines, disproportionately impact stakeholders associated with non-European and minor traditional systems of medicine in Europe.
Transparency: This argument focuses mainly on what lawyers will say was a lack of transparency as to the nature of the technical requirements of the THMPD when it was passing through the legislative process, prior to 31st March 2000.
Human rights: This will argue the social and cultural impacts of the planned restriction of access to products associated with traditional medicinal systems.
While the ANH acknowledges that the High Court hearing is just stage one of a long process, it believes that it is an important milestone and has signalled its gratitude to the companies and private individuals who have contributed to its £90,000 first-phase fighting fund.
ANH says the purpose of the case is to resolve the “inequalities and negative impacts that the THMPD has on herbal products that have long been available, without significant safety concerns, to consumers all over the EU”. It has said that, ultimately, it hopes that a successful legal challenge “will see the directive sent back to the drawing board to be reframed in a way that is appropriate to the real needs of consumers”.
• For more information visit http://www.anh-europe.org/