A call to reform or repeal the EU Directive on Herbal Medicines

This article calls for either the amendment or repeal of the EU Traditional Herbal Medicinal Products Directive (2004/24/EC), the THMPD in short, enacted back in 31/03/2004 and in force as of 01/05/2011. This directive has licensing requirements for safety and quality, but also imposes steep costs typically between €97 000 (£80 000) and €145 600 (£120 000) due mainly to the cost of testing. This is because the licensing requirements are intended to be similar to those for pharmaceutical drugs. Not a single license is in place for Ayurvedic medicine or traditional Chinese medicine which have both been in use for thousands of years, along with herbal remedies from all over the world including the Amazon basin.

The problems caused by the THMPD

The problems that this directive causes is that it actually reduces customer choice due to many herbal medicines not being able to meet the steep licensing costs and it also risks putting manufacturers of natural based medicine out of business as well. Furthermore, explanations of the health benefits are no longer allowed on the packaging (or are allowed with restrictions).

Even though it had been recognised, even by the European Commission, that "Medical traditions such as [Ayurveda and Traditional Chinese Medicine] are based on a holistic approach, and the set of requirements for the simplified registration procedure under Directive 2004/24/EC is not appropriate for a global regulation of such medical practices.", several member states are still applying the Herbal Medicine Directive on holistic approaches as well as food supplements used for many years, rendering them illegal unless registered under the Traditional Herbal Medicinal Products Directive.

It is wrong to class herbal medicines as if they are pharmaceutical-style drugs because herbal medicines are not necessarily purified, they are made from natural and biological sources - indeed purifying the active ingredients can change their nature and efficacy. The active ingredient alone in its pure form is not guaranteed to be the same as in its natural state with other ingredients, indeed there is a synergistic effect which modern science should investigate further and not dismiss.

The directive benefits pharmaceutical corporations

The notion of licensing practitioners of natural-based medicine sounds good in principle, after all it is good to be assured that the doctors are licensed, but only so long as it is fair and is done for the benefit of the people. The reality is that the directive was not drawn up for the benefit of the people or for herbal medicine. It was drawn up for the benefit of big pharmaceutical corporations, so they can help preserve their oligopoly and profits, and therefore eliminate the competition. The question is where the licensing money actually goes to and what it is used for. Licensing herbs is wrong in principle, because this is either a tax on clean living or making money from nature, from plants that grow naturally.

Unanswered questions

There are also unanswered questions. I wonder how much lobbying there was been behind the scenes by pharmaceutical lobbyists. The directive was drawn up due to "safety concerns due to health alerts from unlicensed practitioners of aristolochia", but who knows whether the said alerts are truly genuine and a scapegoat was needed, or whether these were staged events with dirty tricks behind the scenes in order to justify this directive.

There are also claims that this directive forms part of the Codex Alimentarius Code, originally conceived to codify food additives and to set up international food standards, but which has been accused of trying to make sure people are always unhealthy, of lowering the Recommended Daily Allowance (RDA) of vitamins and minerals way below the true level, and ultimately of handing over control over food and health to big pharmaceuticals and big agribusiness.

Whatever the truth of the matter is, there is no denying that is hypocritical to criticise safety standards on herbal medicine while ignoring those who tragically receive overdoses of pharmaceutical drugs and other safety concerns.

A call to repeal or reform the THMPD

Any directive or law that is passed should be there to protect the people first and foremost, and should not be about preserving corporate oligopolies and corporate power. I thus call for the directive to either be repealed or to have the following reforms:

Exempt herbs from the definition as a drug. The manufacturing process is totally different between natural-based and chemical-based pharmaceutical medicine.
If there really is a need to classify herbal medicine, it should be done in an untreated natural based medicines category.
Eliminate the licensing costs for herbs.
While there is no harm in officially registering herbal medicine practitioners, the process should be fair to the public and the said practitioners.

Legal challenge by the ANH Europe

At the time of writing, the Alliance for Natural Health Europe have prepared (that is, raised funds) for the first stage of their legal challenge against this directive, a judicial review in the UK High Court, after which the ANH Europe aim to take their legal challenge to the European Court of Justice.

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Sunday 19 May 2013