Thursday, December 9, 2010

APPEAL TO EUROPEAN HERBAL PRACTITIONERS

I would like to remind all European herbal practitioners of the looming dangers of the European Union (EU) “Directive” called “Directive on Traditional Herbal Medicinal Products” (THMPD) coming into force in April 2011. This “directive” (note the Soviet-style sound of this word) is the greatest threat to herbal medicine. The EU Directive (formulated and enforced by the unelected and unaccountable European Commission) sets new over-the-counter (OTC) standards adopted in April 2004 with requirement for full implementation by April 2011. In the UK this will replace S12(2) of 1968 Medicines Act for OTC products (see below).

The Traditional Herbal Medicinal Products Directive (THMPD) comes fully into force in April 2011. After this time, only herbal medicines that have been registered under the scheme will be available EU-wide. For a wide range of herbal products, especially those from non-European traditions such as Ayurveda and traditional Chinese medicine, the requirements of the scheme are either impossible to meet or are prohibitively expensive. In many cases, both constraints apply so the result is that virtually no herbal medicines from these traditions have been registered. These products will effectively be banned after April 2011. The ban will also effect medicinal herbs in food supplements, which are used by many thousands of people across Europe to help maintain their health.

The Directive has the following aims:
- Aims to ensure correct identification of medicinal plants and adoption of Good Manufacturing Practice (GMP) by suppliers and manufacturers.
- Requires that OTC herbals demonstrate 30 years safe use for registration, 15 years of which within the EU.
- Monographing herbal safety and efficacy by the European Medicines Evaluation Agency Committee on Herbals.
- Permits limited medicinal claims on THMPD products

Problems with THMPD:
- Cost of licensing high.
- Cost of quality assurance also high.
- Quality control guidelines not workable for multi-herb complexes. This now has been recognised but now no applications for multi-herb complexes will be accepted until this is sorted out. The time for all this is running out as Section 12(2) products must be withdrawn from the market from April 2011 when the THMPD is fully implemented.

In the UK, herbal practitioners have been free to practise their art since the times of Henry VIII:
Be it ordained established and enacted by authority of this present parliament, that at all time from henceforth, it shall be lawful to every person being the King’s subject, having knowledge and experience of the nature of Herbs, Roots and Waters… to practise, use and minister in, and to any outward swelling or Disease, any Herbs, Ointments, Baths, Pulters and Emplaisters, according to their Cunning, Experience and Knowledge … without suit, vexation, trouble, penalty or loss of their goods.
The Herbalists’ Charter ordained by Henry VIII, 1543.

In 1968 the UK Medicines Act was enacted:
- Provides legal basis for the supply and sale of herbal medicines.
- Herbal medicines exempt from licensing.
- SI 2130 specifically allows powerful herbal medicines to be prescribed by herbalists.
- The term “herbalist” not defined.

The implementation of the EU THMPD would supercede this Act and would have particularly dire consequences from a medical, social, economic and political point of view as it would at a stroke abolish a freedom that has existed in England since 1543.

I therefore urge European herbal practitioners to support the organizations that are working very hard to oppose or at least mitigate the THMPD before April 2011.

European Herbal and Traditional Medicine Practitioners Association (EHPA): http://www.ehtpa.eu/

Association for Natural Health (ANH): http://www.anh-europe.org/

European Benefyt Foundation: http://www.benefyt.eu/

DAO DE JING
Chapter 30 (partial)
Whoever relies on the Tao in governing men
does not try to force issues
or defeat enemies by force of arms.
For every force there is a counterforce.
Violence, even well intentioned,
always rebounds upon oneself.

Chapter 60 (partial)
Governing a large country
is like frying a small fish.
You spoil it with too much poking.
Center your country in the Dao
and evil will have no power.

Chapter 75
When taxes are too high,
people go hungry.
When the government is too intrusive,
people lose their spirit.
Act for the people's benefit.
Trust them; leave them alone.

Translation by S Mitchell