Protect Traditional Medicinal Cultures

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?
 

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.

Chinese herbal medicines—seriously under threat—along with medicines from Ayurveda, Unani, Tibetan, South-East Asian, Southern African, South American and other non-European traditions
 

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

1. The Directive is relevant only for herbal products targeting minor ailments, and that ‘are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment’
    
2. Exclusion of some products from non-EU traditional cultures. The so-called ‘30-year-rule’ will restrict the availability of all products from non-European cultures that have yet to be used in the EU, or have been introduced within only the last 15 years. Such products could be permitted only if they were able successfully to pass through a full drugs-licensing regime, likely to be prohibitively expensive for most non-pharmaceutical manufacturers or suppliers
    
3. Food supplements might be categorised as herbal medicinal products. There is a significant risk that herbal products in some European member states that should rightly be considered as food supplements (botanicals category) will be considered by competent authorities as a ‘herbal medicinal product’. If they then do not qualify for the fast track under this Directive, they will again require a full drugs licence if they are to be sold
    
4. Particular combinations of herbal products may be disallowed. The traditional use must be for an individual herb or specific combination of herbs, thus preventing use of new or innovative combinations that might be supported by emerging science
    
5. Herbal products containing significant levels of nutrients will be prohibited. Combinations with vitamins and minerals will be allowed only if the action of the nutrients is considered ‘ancillary’ to that of the herbal ingredients
    
6. Products will be subject to pharmaceutical stability tests. It will be necessary for manufacturers to demonstrate six months’ stability of mixtures, which will be difficult or impossible for many complex tinctures (of three or more herbs) that have been used safely and with demonstrated benefit in specific medicinal cultures, often for centuries (eg  Indian/Ayurvedic, southern African, South American, traditional Chinese, South-East Asian and other cultures)
    
7. Increased cost to consumer. Significant compliance costs will apply, which will need to be passed on to consumers. This will force the prices of products up, putting them out of reach of significant sectors of the population
    
8. Committee control. Authorisations will be controlled by the Committee for Herbal Medicinal Products, which is weighted strongly towards drug pharmacologists, as opposed to practising medical herbalists

Statutory Regulation of Herbal Practitioners

Another way in which the practice of traditional forms of herbalism, is through regulation of practitioners. This has been a hotly contested issue.

To download the UK government proposal for Statutory Regulation of herbal practitioners and other CAM therapists, click here.

How ANH is working to protect traditional medicinal cultures

• Exposing problems for small to medium sized enterprises (SMEs) in complying with the EU Traditional Herbal Medicinal Products Directive
   
• Working to safeguard the EU food supplements regime as a safe harbour for botanical products
   
• Helping to bring together representatives from different medicinal cultures so that their common interests can be protected 
   
• Considering the feasibility of a judicial review of the Traditional Herbal Medicinal Products Directive which a) acts disproportionately on smaller suppliers of traditional herbal products, and b) discriminates against non-European herbal traditions. The ANH has sought an initial view from its leading European Law barristers who have indicated from a limited assessment of the evidence that there appear to be reasonable grounds for a legal challenge (judicial review) to the two Directives in question, on the basis of disproportionality, legal uncertainty and, potentially, even cultural discrimination.

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