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A guide to the EU Traditional Herbal Medicines Directive

and its possible implications

The EU Directive on Traditional Herbal Medicinal Products (agreed in April 2004) will come into force on 30th October 2005. There will be a transitional period for products legally on the market on 30 April 2004, giving them protection until 2011.

The Directive requires traditional, over-the-counter herbal remedies to be made to assured standards of safety and quality and for regulations to be standardised across Europe.

Some medical herbalists believe the Directive will have a beneficial effect overall, both for practitioners and consumers. Because.

The regulations for implementing this Directive in the UK can now be found by clicking here.  You can scroll down to the bottom of these regulations to read the more helpful "Explanatory Notes."

Legality

• It provides a secure legal basis for herbal medicinal products and the practice of herbal medicine. 
• It is likely to have a beneficial impact on the quality of over the counter herbal medicines.
• The MHRA (UK Medicines and Healthcare Products Regulatory Agency) have declared their intention to implement the Directive in a sensitive manner - interpreting it to allow the continuance of systems such as Traditional Chinese Medicine and Ayurveda.

But others have concluded that some consequences could be less desirable and may restrict consumer choice. These include

Licensing requirements

• At present many herbal products sold in the UK are exempt from licensing. The new regulations mean that manufacturers will have to apply for a licence for every product, and each must comply with the official published standards.
• The cost to a manufacturer of licensing an individual herbal product is prohibitively expensive.
•  This means that many popular herbal products, such as garlic and ginseng, may still be commercially viable, but others may disappear from sale because it is not worth the expense of getting them certified.
• Herbal products, without licences, must currently be sold as 'food products'. These are not subject to the same quality control or restrictions as 'medicinal products' and there have been instances in the past of misleading or erroneous labelling, such as in one instance feverfew tablets which contained no feverfew.

The 30-year rule

• The Directive also demands that a traditional herbal medicinal product must be shown to have been in use for 30 years in the EU (or at least 15 years in the EU and 15 years elsewhere) for it to be licensed and obtainable over the counter.
• The effect of this is that some herbal remedies of 30 years ago, which are no longer in widespread use, could still be sold. But that valid new herbs such as Peruvian cat's claw, which was only specified in the 1970s and not much found in the shops in the 1990s, may be withdrawn from sale.
• It could also mean that some traditional herbal medicines which were in common use more than 30 years ago, but have since fallen into disuse, may not be licensed..

Other problematic consequences of the Directive concern:

Imported goods

• Imported US herbal products are subject to almost no quality control, and some combine herbal medicines with vitamins and minerals. Some medical herbalists hope that US companies will reformulate their products to comply with the new EU regulations within the 5-7 year implementation period.

Restricted herbs

• The supply of some herbs - such as lobelia, belladonna and ephedra spp - is currently restricted to registered herbal practitioners only. There are likely to be more herbs, such as wormwood, poke root and mistletoe included in this category. This might reduce choice but could protect the consumer from buying herbs with potentially harmful properties over the counter.
• The Directive could also mean that due to licensing requirements, there will be fewer herbs available to practitioners as well.

European Directive 31 March 2004

Directive 2004/24/EC of the European Parliament and of the Council

This directive amends, Directive 2001/83/EC relating to herbal medicinal products for human use.

The 2004 directive provides for a special simplified registration procedure for traditional herbal medicinal products provided, of course, that they do comply with the directive.

Both the 2001 and the 2004 Directives can be found set out in full on the EU Website.

In addition the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued detailed Guidance on permitted medicinal indications to qualify herbal products for registration under the 2004 Directive.  In particuar, Annexes 1 and 2 to the Guidance give, respectively, detailed lists of examples of what are likely to be permitted and and what are not.  For example, "Difficulties falling asleep" is permitted but "Chronic Insomnia" is not.  The Guidance can be found on the MHRA Website.

The Guidance draws attention to the point that products eligible for the registration scheme, "…will have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose' are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment…".

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