The EU Traditional Herbal Medicinal Products Directive (2004) is fully enforced for the first time today, May 1, 2011.
The directive, agreed in April 2004, actually came into force on October 30, 2005, but there was a transitional period for products legally on the market on April 30, 2004, giving them protection until 2011.
In February, I wrote about some of the major concerns about this draconian and regressive directive, for those of us who believe in the right to choose a natural approach to sustained good health:
- 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.
I will be undertaking more research, and talking to people on both sides of the argument about the impact of the directive, before writing a detailed report, within the next few weeks.