Health Supreme by Sepp Hasslberger

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July 19, 2004

European Directive on Medicinal Herbs Discriminates Against China, India, Other Cultures

On 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:

= = = = = = =

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:

Meet Codex Alimentarius

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.


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 It should be strongly supported as it is currently the only initiative working in the direction of changing the European mind towards allowing health traditions from all cultures access in the European market and allowing European consumers a meaningful and wide choice in health matters.

Kind regards
Josef Hasslberger


Other relevant articles:

Sweet Wormwood Heals Malaria

WHO Issues Guidelines for Herbal Medicine: Press Exaggerates Warnings

India asks EU to exempt ayurvedic drugs from curbs
NEW DELHI, AUG 24, 2005: India has requested the European Union (EU) to exclude ayurvedic products from the proposed directive on traditional herbal medicinal products (THMPD). The directive, when implemented, would result in acceptance of only those medication which have been in use in Europe for at least 15 years.

In a letter to EU trade commissioner Peter Mandelson India's commerce and industry minister Kamal Nath said that this directive would become a barrier to trade since it straightaway removes ayurvedic medicines from consideration, which have been in use in India for centuries but which may not have found a place in Europe 15 years ago. The directive is to be implemented from October.

Codex: Labelling Committee Asked to Allow Information on Food Preventive Effects

New EU 'Medicine' Definition: Difficult Times for Natural Cures and Prevention

Food Supplements in Europe - What is the Problem?

Kava Kava - Germany, UK To Review Ban

EU Traditional Medicines: India Asks for Ayurveda Exemption
In a letter to EU trade commissioner Peter Mandelson India's commerce and industry minister Kamal Nath said that this directive would become a barrier to trade since it straightaway removes ayurvedic medicines from consideration, which have been in use in India for centuries but which may not have found a place in Europe 15 years ago. The directive is to be implemented from October.

A recent development (February 2007):
EU relaxes 15-year usage norm for Indian herbal exports
The European Union has relaxed its norms of 15-year usage criteria under the Herbal Medicinal Product Directive that posed technical barriers to the Indian exporters of herbal products.

The Indian side emphasized that Ayurveda is a holistic health science and its teaching, practice and products are properly regulated in India and EU's concerns relating to safety and quality control are being addressed by mandatory testing for heavy metals/microbial load/pesticide residue and institution of export inspection mechanism.


posted by Sepp Hasslberger on Monday July 19 2004
updated on Tuesday December 21 2010

URL of this article:


Related Articles

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December 05, 2003 - Sepp Hasslberger

Kava Kava - Germany, UK To Review Ban
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New US bill on supplement ingredients proposed
Legislation has been introduced in the US House of Representatives which would establish a strict regime of controls on products containing herbs and other ingredients that are not vitamins and minerals. Michael McGuffin, the president of the American Herbal Products Association (AHPA) says that the burden of the controls that are proposed for herbs exceeds comparable burden on drugs. Update July 2005: This bill was re-introduced on 30 June 2005... [read more]
November 07, 2003 - Sepp Hasslberger

Heavy Metals Warning For Ayurvedic Herbs Is A Distraction From The Real Threats To Your Health
..."What this announcement fails to mention is that a whole lot of the food products in the United States is also contaminated with heavy metals. There was an article a few months ago about a girl in the United States who, for a science fair project, found heavy metal poisoning in canned foods made right here in the U.S. There was also another story about candy made in Mexico that... [read more]
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Herbal Medicines: Italy Seeks Clarification
27 December 2004 - The Italian Ministry of Health has published an outline of recent European legislative changes that will affect supplements, specifically those containing herbs and plant extracts, asking industry to help shape the European discussion intended to clarify the borderline between what is a medicine and what is not. Reference is made to the European directive on food supplements, a contested piece of EU legislation that seems to... [read more]
January 05, 2005 - Sepp Hasslberger




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