On the 22nd March 2010 ANH released their intention to challenge the EU herb law. Are you prepared to see non-European traditions of herbal medicine legislated out of existence simply because a legislative framework, foisted on herbal product suppliers, is simply too onerous to allow smaller companies to comply?
Many herbs are now illegal — Join us in protecting traditional medicinal cultures!
After April 2011, many herbal products and food supplements containing herbs became ILLEGAL. This is because of changes in law at a European level. On 30 April 2011 a European Directive, known as the Traditional Herbal Medicinal Products Directive (THMPD) came fully into force. Since this time, only herbal medicines that have been registered under the scheme will be available EU-wide. For a wide range of herbal products, especially those from non-European traditions such as Ayurveda and traditional Chinese medicine, the requirements of the scheme are either impossible to meet or are prohibitively expensive. In many cases, both constraints apply so the result is that virtually no herbal medicines from these traditions have been registered. These products have effectively been banned since end of April 2011. The ban has also effected medicinal herbs in food supplements, which are used by many thousands of people across Europe to help maintain their health.
We urgently need help from the public, practitioners and companies on the legal challenge we are in the process of preparing. We aim to challenge the EU Directive (THMPD) based on the fact that it is disproportionate, non-transparent and discriminatory. We have so far managed to raise the £90,000 (€102,240) needed to fund legal costs for the first stage of our challenge, which will be a judicial review in the UK High Court. We then aim to have our case expedited to the European Court of Justice, which will require further funding.
Please help us to raise awareness of the action we are taking to protect the rights of Europeans to use herbs. And if you use herbs, please donate generously to enable us to fund this greatly needed legal action!!! (Note: The action we are taking does not currently include a petition).
Download our A5 flyer warning practitioners of the threat of the THMPD Download Why herbal practtioners should support the ANH judicial review Download Why consumers should support the ANH judicial review Download our A5 flyer warning consumers of the threat of the THMPD Download template letter to send to MP's/MEP's Find the name of your MEP
Why we need to challenge and amend the EU Traditional Herbal Medicinal Products Directive
It discriminates against non-European Herbal Traditions by requiring at least 15 out of 30 years of usage within the EU, as the basis for proving long established, traditional usage. The basis for this requirement is the supposedly varying pharmavigilance standards in different regions, implying that standards outside of Europe may be lower than those within Europe. This provision seriously disadvantages Ayurveda, Traditional Chinese Medicine, South East Asian, Tibetan, Amazonian and southern African traditions, which are among the longest and most developed botanically-based healthcare traditions worldwide.
Particular combinations of herbal products may be disallowed. ‘Traditional use’ under the THMPD is based on use of an individual herb or specific combination of herbs. It therefore prevents use of new or innovative combinations that might be supported by emerging science.
Products are subject to pharmaceutical criteria and Good Manufacturing Practices (GMPs). Under the THMPD, manufacturers must meet pharmaceutical GMPs, including purity and stability criteria that are identical to those used in the case of conventional pharmaceuticals, under the provisions of the same base Directive (2001/83/EC). These criteria cannot be met in the case of many poly-herbal products owing to the complexity of mixtures, the masking of known markers and, in other cases, the lack of standards for identification of markers.
Traditional medicines are eligible for registration only if they are intended for minor ailments, while traditional medical systems generally have developed to cater for the full range of ailments and diseases encountered in their indigenous environments. Accordingly, the registration scheme may be discriminatory against ethnic minorities within the EU who might wish to benefit from products associated with their traditional medical system. While food supplements are able to be sold legally within the EU containing ingredients that support the health (or reduce the disease risk) of, for example, cardiovascular or neurological systems, these are disallowed under the THMPD scheme.
Excessive cost of accessing the THMPD regime. The cost of meeting the data requirements for the THMPD, including the assembly of dossiers of bibliographic and expert evidence, as well as the requirements for genotoxicity data (which typically have to be commissioned as existing data are not available) is prohibitive for many SMEs.
Herbal Products containing significant levels of vitamins and minerals will be prohibited and allowed only if the action of those nutrients is considered ‘ancillary’ to that of the herbal ingredients.
Herbal products containing non-herbal ingredients other than vitamins and minerals are currently disallowed. However, the Directive may in the future be amended to allow such ingredients, although verifying their safety to the satisfaction of the HMPC is likely to be challenging and very expensive.
Increased cost to consumer and restriction of freedom of choice given that significant compliance costs will apply, which will be passed on to the end user, making the cost of products uneconomic for some and limiting their right to make their own health choice.
Committee control. Authorisations are controlled by the HMPC, which is weighted strongly towards drug pharmacologists/cognosists, as opposed to practicing medical herbalists and others with specific expertise on traditional medical practices.
Impact on non-European herbal suppliers. Many herbs potentially eligible under the THMPD scheme are produced by small-holder farmers and communities in non-EU countries. If products containing such herbs are disallowed as botanical-containing food supplements, and are also not able to be licenced under the THMPD scheme, these rural communities could be impacted very seriously.
ANH-Intl and the European Benefyt Foundation (EBF) have developed a work plan for a judicial review of the THMPD. Guided by leading London-based European lawyers (11KBW), the principle grounds for challenge have been identified as follows:
Proportionality combined with a restriction of freedom of movement of goods argument (under Article 28 EC of the Treaty of the European Community). This argument will expose the manner in which the Directive, and associated European laws and guidelines, disproportionately impacts stakeholders associated with non-European and minor traditional systems of medicine in Europe. Amongst other things, the monographs developed by the Committee on Herbal Medicinal Products will be challenged, the unnecessarily onerous nature of the technical requirements for the scheme will be exposed in terms of the intended purpose of the Directive, and, deficiencies in the technical requirements will be revealed, demonstrating that they do not adequately guarantee the safety of products.
Transparency, an argument focusing mainly on the lack of transparency as to the nature of the technical (including quality control) requirements at the time the THMPD was passing through the legislative process, prior to 31st March 2004
A human rights/cultural discrimination argument, which will delineate the social and cultural impacts of the planned restriction of access to products associated with traditional medicinal systems.