European Directive on Medicinal Herbs Discriminates Against China, India, Other Cultures
CategoriesOn 31 March 2004, the European Union put the finishing touches on its directive for herbal medicinal products, which was published in the official journal and can be downloaded as a pdf here.
The directive will have to be transformed into national law by the 25 EU member countries. It introduces a simplified registration for herbal medicinal products that have been on the market in Europe for at least 30 years. Herbal meds with 15 years of European history and at least another 15 years elsewhere may also qualify.
While the directive was necessary to "salvage" a large number of registered natural medicines that existed on the German market, and which had to be terminated by the end of this year because they could not fulfill the criteria for full medicines registration, it does discriminate against herbal medicines from other traditions, such as Chinese Traditional Medicine and Ayurvedic medicinal herbs, by requiring traditional use in Europe as a pre-condition to registration.
Such non-EU traditional herbal medicines could in theory obtain a full medicine registration, but in practice there are unsurmountable barriers in the full medicine registration requirements, which are clearly slanted to favour the patentable chemical remedies of pharmaceutical manufacture.
By excluding other herbal traditions, the European herbal medicines directive seems to be at odds with an initiative of the World Health Organisation which has recently issued guidelines for the safe use of traditional, complementary and alternative medicines including herbals, which the UN body wishes to be widely available in all countries as an alternative to pharmaceutical medicines.
Down to Earth magazine, published by the Centre for Science and Environment in New Delhi, India, is preparing a comment on the World Health Organisation's herbal initiative and has asked me how this would affect international trade and how the European directive relates to the WHO guidelines. Here is my reply:
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Dear Vibha Varshney,
thank you for contacting me on the matter of the World Health Organisation's guidelines on developing consumer information for proper use of traditional medicines. Just yesterday, I published an article on my site, WHO Issues Guidelines for Herbal Medicine: Press Exaggerates Warnings, which discusses problems inherent in the press reporting about these guidelines. It appears that the report has been misrepresented in the press, possibly due to comments from pharmaceutical operators slanting the content to appear negative towards traditional and complementary medicines.
It should be noted that these consumer related guidelines are part of a larger WHO initiative to help traditional medicines emerge as a real alternative to pharmaceutically based western medicine. That initiative comprises the making of monographs for certain herbs, suggestions for quality control of products, suggestions for the training and the quality control of practitioners of traditional and alternative medicine and in general the promotion of these medicines to consumers and - more importantly - to countries which do not as yet recognize them. The overall initiative therefore appears to be a valid program directed towards achieving pluralism in medicine in those countries where western-style pharmaceutical medicine is dominating and where often the traditional and alternative forms of medicine are merely tolerated or are even subject to open persecution.
To answer your questions:
1) How would the guidelines help the consumers?If the guidelines and the successive consumer information initiatives were impartial and supplied reliable information to consumers, they could benefit consumers by allowing a conscious choice between types of medicine and types of preventive strategies each one of us could adopt.
2) Do you think that the industry would accept these?This is very much a problem in countries where pharmaceutically based medicine has a strong position. In those countries, industry is synonymous with pharmaceutical manufacturers, and there is a real possibility that regulations would meet resistance. In countries like India and China however, and in parts of Africa, where traditional medicine was never replaced by the pharmaceutical paradigm, I believe industry as a whole would welcome regulations that are directed to ensure high quality of products.
3) Would these help to promote international trade?I believe that regulations which help traditional forms of medicine gain a certain measure of respectability would be positive for international trade, bringing some balance to the flow of goods. The largely one-way flow of trade of pharmaceutical as well as dietetic products from industrialized countries to the developing world would be re-balanced where developing countries could compete in furnishing the products needed for traditional forms of medicine to the industrial nations.
4) Is there a chance that market for some products would be lost?Yes, definitely, there is a chance that market for some products could be lost, but in my view this is not due to the initiative of the World Health Organisation.
Rather, products could be lost because of restrictive international legislation (giudelines) being considered in the Food and Agriculture Organization's Codex Alimentarius. This legislation is not directly concerning herbs and traditional medicines, but is restrictive with regard to what may be marketed as food supplements, which in many western nations include not only vitamins and minerals but also traditional healthy foods used in alternative medicine and herbs. These discussions are taking a very restrictive bent and you can see some specific articles reporting on that on my site:
South Africa breaks ranks at Codex Nutrition Committee
Codex 2003 - Grossklaus and Mathioudakis: Nutrition not relevant to Health
Codex Alimentarius - Optimizing Nutrient Intakes
South Africa Opposes Codex Rule on Food Health Information
While Codex Alimentarius is dealing with foods and in this context majorly with nutrients, restrictive rules in that area would definitely influence the fields of traditional and alternative medicines - making it much harder to introduce the products needed by these practices in western countries where the pharmaceutical paradigm has a close grip on what may be registered as a medicine and with what kinds of scientific proof.
5) How do these guidelines compare with EU's directives on traditional herbal medicines - is there a linkage?The WHO guidelines could conceivably provide a counter-balance to the EU's quite restrictive directives, both on food supplements (already passed) and on traditional herbal medicines, recently still under consideration. There is also a third EU directive, which is the medicinal laws directive, where the newly revised definition of a medicine promises to be so restrictive that theoretically, it is up to the EU health authorities to declare ANYTHING a medicine and require onerous registration procedures to be followed. This requirement for pharmaceutical registration is almost guaranteed to keep the various traditional medicines out of European markets.
The traditional medicines directive of the EU, which was published on 30 April, limits the acceptability of products that may be registered under the directive to products that have a EUROPEAN tradition of a minimum of 30 years, 15 of which in Europe and 15 years in another market - products in other words, that have been legally on the European market for between 15 and 30 years. This would automatically exclude most of the products of non-European herbal traditions from registration under the provisions of the directive and would erect a one-way trade barrier discriminating against products from developing countries.
The European Union is also the major driving force for the restrictive Codex Alimentarius regulations on supplements mentioned previously. With now 25 countries, which practically have to act as one compact bloc of votes, and with the European Commission's Basil Mathioudakis leading the EU voting power in shaping the restrictive Codex rules on supplements in the exact image of the European directive on that same subject, there is a very real possibility that the EU can impose its restrictive view on these products on the world through Codex.
To overcome this barrier being erected, there are two possible courses of action:
a) The World Health Organisation's guidelines would have to be considerably strengthened to become binding on the western nations, eventually overriding the European laws. This is a course of action which for obvious reasons does seem to have little chance of success.
b) The European directives would have to be challenged in court to encourage a more open approach by the European Union to the concept of healing traditions in the food area. This is necessary because the pharmaceutical area in Europe is under an exceedingly strict control by huge commercial interests, which slant the field in favour of pharmaceutical products and against traditional and food-based remedies.
Conclusion:
I would like to conclude with a suggestion.
If traditional medicines are to be allowed and in fact promoted to become a real alternative to pharmaceutical medicine, the developing world will have to throw its weight behind actions that are already in progress to achieve this aim:
i) The WHO initiative to increase the stature of traditional and alternative medicine and make it a real alternative to pharmaceutically controlled western medicine.
ii) The efforts of South Africa in the deliberations of Codex Alimentarius, to open the way to a food-based health strategy, both in regards to the Codex guidelines on vitamin and mineral supplements and to the guidelines on claims, that is, the possibility to inform consumers of positive health properties of foods and traditional and alternative remedies that do not have full pharmaceutical registration as intended in western countries.
iii) The ongoing efforts to legally challenge the European food supplements directive and to influence the legislative course of the traditional herbal medicines directive as well as the pharmaceutical directive of the European Union. This effort is being spearheaded by the Alliance for Natural Health, an alliance of consumers, retailers, traditional medicine practitioners and producers of natural remedies. The Alliance for Natural Health has a website which can be accessed at http://www.alliance-natural-health.org/ It should be strongly supported as it is currently the only initia
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