Pharmaceutical Industry & EU Vs. Traditional Herbal Medicine Products

By Manon Godot, 29^th of October 2010

Echinacea

In 2004, a European Regulation (2004/24/EC) was voted in order to establish a list of herbal medicines allowed on the EU market. The Traditional Herbal Medicinal Products Directive (THMPD)’s goal was to provide a regulatory approval process for all herbal medicine products sold over the counter within the EU. According to this Directive, any herbal remedy which is not listed officially cannot be legally sold on the market. The Directive came into effect on the 30^th April 2004. This Directive establishes a series of criteria with which all herbal medicines must comply, in order to obtain the authorization to be marketed within the EU.

Transitional measures were established regarding the herbal medicines marketed before the regulation. According to these measures, these herbs could continue to be sold on the market until the 30^th of April 2011. In April 2011, ALL herbal medicines will be submited to this regulation.

The products affected by the Directive are “any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparation.” (art 1. 1. 30. of the Directive).

That includes: Ayurvedic Herbs, Chinese Herbs, Western Herbs, Tibetan Herbs, South East Asian Medicines, Amazonian and Southern African Traditional Medicines,  or any kind of Medicinal Herb. This Directive doesn’t apply to Homeopathic Remedies, which are regulated under the Directive 2001/83/EC. The point (6) of the Directive’s preamble specifies that the registration of medicinal products will be limited in a first step to traditional herbal medicinal products. So for now, no other traditional medicinal products are concerned by the Regulation.

The Committee for Herbal Medicinal Products, established by the European Agency for the Evaluation of Medicinal Products, will carry out the task of authorising and registering herbal medicine products.

In order to be allowed on the EU market, an herbal medicine product will have to comply with several requirements. If it does, it will be classified as “drug”, and will be sold on the EU market. If it does not, it will simply become illegal, and will disapear from the market.

To be sold legally on the EU market, a traditional herbal medicinal product will have to:

• Be intended to be used without supervision of a medical practitioner.

• Be administred orally, externally or by inhalation. Medicines requiering intraveanous administration are forbidden.

• The company marketing the product will need to demonstrate its safety and efficacy, through the traditionnal use of it within the EU for 30 years, or 15 years within the EU and 30 years outside of the EU, and though pharmacological evidences. This demonstration requires that applications for the authorisation of an herbal medicine contain “physico-chemical, biological or microbiological tests as well as pharmacological and toxicological tests and clinical trials carried out on the product and thus proving its quality, safety and efficacy.” (preamb. (1) of Directive 2004/24/EC). This means any herbal medicine product in which pharmacological properties are not recognized will become illegal within the EU, exculding from the EU any kind of herbal medicine based on non-Western conventional medicine.

Another point on this matter is the fact that no scientific research is made on Herbal Medicine. Why is that? Scientific research is very expensive, and even Western Conventional Medicine research lacks funds. No State or Industry are going to finance research on herbal medicine, because it’s non-profitable. So how do you demonstrate the efficacy of a product with no research-based data?

When a herbal medicine practitioner prescribes herbs for a patient, he usually prepares a remedy combining several herbs, and each remedy can vary depending on the patient and the symptoms, making it very difficult to establish scientific data for each plant or component. No financial or technical support is given to the traditional herbal medicine to give it a chance to demonstrate its efficacy.

The applicant will also have to demonstrate “by detailed references to published scientific literature”(preamb. (2)) that the product is safe and efficient, which is obviously very difficult for some non-Western traditional herbal products. The Directive specifies, “Where there is limited evidence of use within the Community, it is necessary to assess carefully the validity and relevance of use outside the Community.” (preamb (7)). Any non-Western written evidence of the product’s efficacy is going to be considered by the EU as suspicious evidence, which might not be taken into account by the EU Committee in charge of examining the matter.

The Directive, moreover, is asking applicants to demonstrate non-Western medicine’s efficacy from a Westerm pharmaceutical point of view, which is not always possible. Some products will be banned simply due to the impossibility of demonstrating synergystic properties under a Western model of isolation and control.

The point here is not wether they work. Most of these products have been used  in a safe way for centuries in non-Western traditions. To be allowed to be sold on the EU market, the applicants will have to demonstrate that the product is Safe and Effective. In short, if a product is safe but is not considered as effective from a pharmacological point of view, it will be banned from the EU market. A product shouldn’t however be banned from the maket only because it is useless, or at least considered as such.

Forbidding most of the herbal medicine products, the EU is also limiting the ability of EU citizens to choose the kind of medicine they want for themselves, and is discriminating against non-Western forms of medicine. These limitations could be considered as violations of the articles 8 & 9 of the European Convention on Human Rights, and articles 7 & 10 of the EU Charter of Fundamental Rights, that protect EU citizen’s “private and family life” and their “freedom of thoughts, conscience and religion”. The prohibition of a non-harmful product, for the only reason that its use is judged useless from a pharmaceutical point of view, and while it is consumed by some EU citizens in accordance to their cultural practices, is an attempt to their fundamental rights to live in accordance to their cultural and/or spiritual practices and/or beliefs.

This Directive was clearly voted under the pressure of pharmaceutical companies, in order for the pharmaceuticals products monopolize the health market. Not much money is made indeed with the marketing of medicinal herbs, and no lobbies are interested in defending them. On one hand there is the pharmaceutical industry, with huge economic, and consequently political power, and on the other hand there are traditional herbal medicine practicioners and consumers, who have no economic or political power whatsoever. The consequence is that from now on, herbal medicine products will have to become “drugs” marketed by the pharmaceutical industry, or they will be banned from the EU to protect the industry’s interests.

This Directive is part of a whole process of control of our food and health by the pharma & food industry, supported by our governments themselves.  As a general rule, if a product which cannot be owned and patented threatens a market, patent holders of products within the same market lobby to have non-patentable products scrutinized and subsequently banned.

The striking renewal of natural medicine within the EU during the past few years was a posible threat for the pharmaceutical Industry, which could have lost control on a big part of the health market. To goal of the corporations is just to keep control over the “health trade”. People’s health is not a factor which does not interfere in their considerations.

The Alliance for Natural Health (ANH) and the European Benefyt Foundation have launched a joined initiative to protect the availability a herbal medicine products in the EU. On 22th of March 2010, ANH announced they would challenge the THMPD in the European Court of Justice (ECJ), via UK and maybe Gremany and Hungary court before the end of 2010. In an interview given to the Food Navigator.com, Dr Robert Verkerk, ANH-I executive director, said that:

“…the EU authorities should respect the equivalence of non-European standards as set by their respective pharmacopoeia, rather than force non-European herbs through western scientific standards that are neither appropriate nor relevant. To-date, not a single product from either the Ayurvedic or Chinese tradition has been registered.”

http://www.anh-europe.org/campaigns/protect-traditional-medicinal-cultures

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:en:PDF

http://www.pranapositive.com/shm/

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