The Regulation of Herbal Medicine in the UK and Europe
This is a historical interview from 2006. The regulatory landscape has continued to evolve since publication; for current guidance, see the Register of Chinese Herbal Medicine (RCHM).
On this page
- History of the EHPA
- The 1994 herbal ban and the THMPD
- TCM patent medicines and statutory regulation
- Timeline for UK regulation
- Qualifications required
- Herbal medicine and acupuncture categories
- Safety of herbs in the UK
- Practice across Europe
- The future
History of the European Herbal Practitioners Association
Q: What is the history of the European Herbal Practitioners Association (EHPA)’s involvement in herbal regulation in the UK and Europe?
In the early 1990s, it became clear the European Union was going to have a major impact on herbal regulation in the UK and EU. In 1992, I came across a document published by the European Committee on Proprietary Medicinal Products (CPMP) listing some 30 herbal remedies described as having “serious risks without any accepted benefit”. To my astonishment, several herbs on the list were being used daily in herbal practice and, properly used, are in my opinion not at all unsafe. For example, the list contained parsley seed — a common ingredient in food. Also on this list was Berberis vulgaris because it contained the alkaloid berberine. This list had serious implications for Chinese herbal medicine as well as Western herbal medicine, as several Chinese herbs such as Huang Lian (Coptis chinensis) contain this alkaloid and could not be used.
Back in 1992, I realised there was going to be a problem and I was aware that if we were to be able to continue using medicinal herbs, all those using them should work together to safeguard the legislative basis for our practice. In the UK this could only be achieved by the dual strategy of gaining statutory regulation for practitioners and reforming Sections 12 and 56 of the Medicines Act of 1968.
In 1947, the Minister of Health Aneurin Bevan had offered UK herbalists the opportunity of being included within the NHS, but they were too disunited to present a unified profession and so the opportunity was lost. When I founded the EHPA in 1993, we sought to represent Western and Chinese herbal organisations, as well as Ayurvedic, Tibetan and Japanese medicine organisations.
The 1994 herbal ban and the THMPD
In 1994 there was a disastrous threat to herbal medicine in the UK. The UK government signed up to a European Directive governing all medicines — the idea was that every medicine in Europe had to have a licence. We were told that every herb, whether Chinese, Western or Ayurvedic, would have to have a full medicine licence.
People often ask why herbs shouldn’t have a full licence as they are medicines. There are several problems with this notion. Herbs are generic; they can grow in people’s back gardens and so cannot be patented — for this reason no company could recoup the huge sums of money required to license a herb. In addition, the licensing requirements require active constituents to be precisely identified, which is not usually possible when it comes to a herbal remedy containing an orchestra of chemicals. The requirement for all herbs to be licensed would have amounted to a complete ban on herbal medicine in the UK.
When the MCA (now the MHRA) said there could be no change in policy, we contacted the main national newspapers and the Today programme and in a short space of time we had the most incredible publicity for our cause. We were most generously helped by Paul McCartney who lent us the expertise of his PR company, completely free. John Major’s government became alarmed at how much damage the adverse publicity about the “herbal ban” was doing. Thousands of letters were written to the government, MEPs and MPs by angry members of the public. As soon as the Prime Minister became personally involved, Government lawyers managed to find a way to patch up the legislation by saying that herbal medicines were not industrially produced but traditionally produced, and therefore not subject to the main EU Medicines Directive.
Shortly afterwards, a senior civil servant at the MHRA said that the herbal legal “solution”, were it to be challenged in a European court, probably would not stand up to scrutiny. In short, new legislation was needed.
In 2004 we got the Traditional Herbal Medicinal Products Directive (THMPD), which provides new regulations governing over-the-counter herbs sold direct to the public. When fully implemented in the UK, this Directive will replace Section 12(2) of the Medicines Act of 1968 dealing with the OTC herbal sector.
Problems with the THMPD
Conventional medicines need to prove safety and efficacy to qualify for a marketing authorisation, and evidence of efficacy can only be obtained by double-blind clinical trials or significant published scientific data. The European Commission recognised this problem and decided that herbal medicines could prove efficacy based upon tradition: a herbal product has to demonstrate 30 years of traditional use, with 15 years of this being in Europe. In 1986 I started the first Chinese herbal import company in the UK, so most herbs have been used in Europe for more than 15 years — but for new herbs, a THMPD licence will be a problem.
There is another problem with the THMPD concerning the Quality Control Guidelines. These demand constant monitoring of markers for all herbs used in a product from start to finish of the production process. Whilst this is possible for single-herb products, it becomes extremely difficult to achieve for multi-herb compounds (such as Chinese traditional formulations), because some herbal chromatographs can obscure others with which they are combined. In trying to get something done about this, we have been extremely fortunate in having the active support of the Prince of Wales, who organised a meeting with Dr Keller, head of the EU HMPC. As a result of lobbying, the EMEA has agreed to review the Quality Control Guidelines for multi-herb compounds.
TCM patent medicines and statutory regulation
The THMPD is designed to licence traditional medicines to be sold OTC direct to the public without any practitioner intervention. For this reason it is not really suitable for the supply of most TCM patent medicines. The THMPD requires that the product’s indications are clearly displayed on the label — but how could this be done for Liu Wei Di Huang Wan (Six-Ingredient Decoction with Rehmannia)? If one wrote that this is good for lower back pain on the packet, it could lead to misuse by someone with Kidney Yang Xu rather than Kidney Yin Xu. These Chinese patent medicines need the intervention of a trained Chinese doctor.
A possible solution: the main EU Medicines Directive permits “authorised health professionals” to approach a company and order specific patient formulations, which can be industrially produced without the need for a licence. The MHRA has produced a discussion paper proposing this route of supply. To qualify, practitioners must be statutorily regulated — otherwise they could not be considered “authorised health professionals”.
Timeline for UK regulation
Q: When will regulation come into effect in the UK and Europe?
When we launched the EHPA in 1993, Department of Health civil servants told me we might be statutorily regulated by 1998–99, but we are still struggling to achieve this goal in 2006. Since 2003 we’ve had some seven ministers and almost as many civil servants running our sector, so there has been significant delay. The Foster Report recommends that we should not have our own Council (Acupuncture, Herbal Medicine and TCM) but should be attached to the Health Professions Council. I have considerable reservations — I fear it may lead to us losing control of our regulatory process. I hope we can persuade the Government to change its mind and support the launch of a new Council.
Qualifications required to practise
In the UK there will be a grandparenting scheme in place, so all the practitioners who are practising safely are likely to get onto the register. The emphasis on all healthcare workers will be on revalidation. This means all TCM practitioners, herbalists and acupuncturists will have to undergo regular revalidation and participate in mandatory continuous professional development. Standards can be maintained and raised by means of revalidation and CPD. We should try and be inclusive as possible.
Should herbal medicine have its own category?
Q: Should herbal medicine have its own category in the UK or be mixed with acupuncture to form TCM?
When the EHPA answered the Department of Health’s consultation document in 2003, we suggested a range of titles. There should be a TCM title for those that practise Chinese herbal medicine and TCM acupuncture, a title for TCM herbalist, a TCM acupuncturist, and possibly another title reserved for so-called Five-Element acupuncturists as well. This would enable patients to know precisely what kind of treatment they were receiving, and researchers to be aware of what tradition they were researching.
Safety of herbs used in the UK
The MHRA has put in place the Herbal Medicines Advisory Committee (HMAC). This new body has the same ranking as the Committee of the Safety of Medicines. If any question concerning herbal safety arises, HMAC will determine whether dry herbs are safe or not, based on current evidence. The HMAC committee is made up of people from Ayurveda, TCM, Western herbal medicine and pharmacologists.
For dried herbs, the MHRA wants to see clear systems in place so that if a herb is suddenly discovered to have been mixed up with another, a practitioner can access their database, see who has been prescribed that herb, and warn patients to stop taking it.
If there is one major threat to the progress of UK Statutory Regulation of TCM, it is the constant stream of horror stories in the media about Chinese patent medicines and the fraudulent or irresponsible practice of some TCM outlets — bad publicity about Chinese patent medicines containing heavy metals such as arsenic, mercury and lead, or illegally adulterated with Western medicines. Further cases of kidney damage have been recorded in the UK because of the illegal supply of Mu Tong and Fang Ji. A number of UK TCM business chains have been successfully prosecuted for outrageous advertising claims.
How does practice differ across Europe?
Other Member States don’t have Section 12 of the 1968 Medicines Act, so the practice of Chinese herbal medicine is much more precarious than in the UK. With the advent of the THMPD there is now no “grey area” between foods and medicines to allow the sale of medicinal herbs in many Member States.
In France and Spain there is strong medical opposition to anyone practising medicine who isn’t a doctor. In Holland and Denmark the authorities are more easygoing, but it’s still difficult to practise. A friend who works as a herbalist in Denmark asked the authorities the legal status of herbal medicine; he was told to study the laws that pertain to waiters at a table, because when he was giving herbs to a patient he was, as far as the law was concerned, giving foods to a customer in a restaurant.
Looking ahead
The UK has been setting the pace for other Member States in gaining a firm legal basis for the practice of TCM. I very much hope that other Member States will follow the UK’s example so that TCM can flourish across Europe. The need for us all to work together has never been more apparent. Regulation of our sector will enable the public to choose well-trained and regulated practitioners who use herbs and herbal products with an assured quality.
