Herbs In Medicine

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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…".

Your views on Legislation

There was a lively discussion on legislation at the Herb Society Annual Conference on 8 September 2002. A report on this is given in Herbs, Vol. 27, No. 4, pp 8-9, 2002) and can be viewed below.
Penny Ody gave her personal views on developments in EU herbal legislation at our Annual conference on 18 September 2004. Her talk is summarised in Herbs, Vol. 29 No. 4, p 7.

Discussion On Herbal Legislation

Held during the Annual Conference on 8 September 2002

The Panel

Roger Tabor, Former Chairman of the Herb Society
Ian Thomas, Chairman, Culpeper Ltd
Chris Hayne, past Herb Society legislation adviser, now groups co-ordinator

Foreword

The most likely outcome of the present discussions with the Government in the UK is that herbal medicine will be governed by Statutory Self-Regulation (SSR), which would make alternative health treatments part of the National Health Service. The panel discussed this situation and invited questions from the audience.

A Condensed Version Of The Discussion

In the 1940s the Pharmacy and Medicines Bill would have relegated herbs to the kitchen. Fortunately Hilda Leyel and her influential friends were able to modify the bill before it became law. It is due to Mrs Leyel and the Herb Society that we are now able to get herbal prescriptions, although it was not until 1968 that herbalists gained statutory recognition. The Society is not in the same position of influence today, but members do have a responsibility to think about the situation and make their views known. Herbal medicine has moved from a strong empirical basis to an increasingly scientific system of healing and there has been enormous progress in the last four years.

Roger stressed that the Herb Society holds no brief for being pro or anti. ‘This is an opportunity for everyone to have say. Andrew Chevalier (Herb Society Council Member) looking at the net gains and balances feels that the situation is good, particularly in that more people will have a proper training’.

Some medicinal items will be taken off the shelves, but the panel felt that perhaps that was not such a bad thing. Where certification of herbs is concerned, traditional medicinal herbs will be allowed. It is new mixtures of herbs that present a problem.

Provided they are proven to be safe and of a certain quality, herbal products are seen as acceptable for medical treatment but when the EC Directive comes into force certain herbs will appear on the restricted list except when prescribed by practitioners. If herbal products are to stand side by side with pharmaceutical – they must conform to equal tests.

Regulation will mean an awful lot of work. It may be a very good thing from the point of view of safety and quality but we should consider the political aspect. ‘The EEC is set up in such a way that elected members decide what needs to be done and initiate the legislation which becomes the law. We are going to get continual interference’ (Ian Thomas).

From The Floor

Q. If dossiers are required on each herb it will be very expensive to produce less-used herbs. Nobody will be able to afford to put them on the market. Supply will go down and they will become unavailable.

A. If a herb has not had a 15-30 year history of use within the UK it will need to gain recognition. There are already 16 licensed remedies and 180 loosely called ‘medicinal herbs’. In the USA it can cost anything up to $40m to have a herb certified but here evidence-based or long-use based costs are comparatively trivial (although it may not seem like it). Some herbs may become unavailable as they represent a small percentage of turnover. Then herbalists will be restricted in choice unless the fees for certification are reasonable. At least we are still allowed to grow herbs. What you grow in your own garden is up to you. You can doctor your neighbour, but you take responsibility for what you do.

Q. There is a fear that big companies are going to take over the supply of medicinal herbs. We are being battered with legislation to make large companies richer.

A. This has happened with St John’s wort. If you go into Boots the main drug stockists, you have to search for pharmaceuticals among the herbal remedies. When there’s a large demand the quality inevitably goes down.

Q. Will the EU remove our right to use traditional remedies?

A. Within the European regulations most countries continue to do their own thing. France Germany, Denmark and other European countries have established systems specific to them. There are many loopholes for certain national practices to take place.

Q. Isn’t there still a disinclination among the medical profession to encourage the use of herbs?

A. Most patients don’t admit to taking herbal material on a regular basis. It is now apparent that herbs do work and therefore interaction can occur with conventional medicines. At least if medicinal herbalism becomes part of mainstream medicine, people won’t be ashamed to admit to taking herbs.

Q. Is the Government trying to stop the sale and use of medicinal herbs?

A. The Medicines Control Agency (MCA) is concerned with adulteration and substitution, micro-biological contamination, pesticides used in non-European countries and toxic material. Most of these concerns are genuine. We do need safety standards but not over-cautious legislation arising from the tendency to sue.

Note To The Reader

At present three government directives are causing concern:

Traditional Medicinal Products Directive
Food Supplements Directive
Amendments to the Medicines Directive.

There is a timescale on the legislation so if you have views, please let us know as soon as possible.

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