ANH challenge to EU threat to traditional herbs

Check out what's happening in Europe.

In Europe, the Human Medicinal Products Directive (amended 2004/27/EC) was originally issued in 1965 (Council Directive 65/65/EC), ostensibly to protect consumers from disasters such as thalidomide. However, ironically, the definition of what constitutes a medicinal product as laid out in the Directive, is so broad that it effectively makes all food products, herbs and nutrients—even water—drugs.

The first limb of the definition of a 'medicinal product' (= drug) (Article 1.2(a)), the presentation limb, is the familiar no-go area for foods, nutritional and herbal products. The limb states that any food that is ‘presented as having properties for treating or preventing disease in human beings’ will be classified a medicine by any European regulator whose attention is drawn to the fact.

The second, so-called functional limb of the definition (Article 1.2(b)), encompasses anything at all that is used ‘with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis’.

To be regarded as a medicinal product, it is important to recognise that a product need comply with only one, rather than both, limbs of the definition.

Although the base 1965 Directive has endured since that year, there are four main reasons why there is a crucial need now to challenge legally the Directive, and more specifically, recent amendments of it:

First, only in the most recent amendment of the Directive (2004) has the phrase ‘exerting a pharmacological, immunological or metabolic action’ been added, leaving no doubt that any type of physiological effect in the body could be construed as medicinal;

Second, the original, base, 1965 Directive had exclusions in it for food (and toiletries/cosmetics);

Third, although exclusions for such things as foods and cosmetics still exist, they have been transferred to the preamble section (the ‘recitals’) of the amending Directive, where they have no firm legal authority, and;

Fourth—and probably most importantly—the most recent amendment (Article 2.2) now also indicates that ‘in cases of doubt’ and where the definition of a medicine applies even if the product is already covered under other aspects of EU legislation (eg foods), medicinal classification has supremacy.

Although the ANH succeeded in making key amendments (which were accepted by the European Parliament) to this Directive just prior to its second reading, these gains were lost in a last-minute compromise package prior to finalisation of the 2004 amendment (amending Directive 2004/27/EC), which was pushed heavily by the European Commission and the pharmaceutical industry. A sub-Directive of this is the Traditional Herbal Medicinal Products Directive (Directive 2004/24/EC), and this discriminates (acts disproportionately) against herbal medicines from non-European cultures.

The key limitations of the EU Traditional Herbal Medicinal Product are as follows:

1.    Discrimination 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.

2.    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.

3.    Products are subject to pharmaceutical criteria and 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.

4.    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.

5.    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.

6.    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.

7.    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.

8.    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. 

9.    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.

10.    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.

Source.