The UK government has convened the Herbal Medicines and Practitioners Working Group (HMPWG) to find solutions to long-standing issues surrounding the regulation of herbal products and practitioners in the UK. In essence, these thorny problems arise through a clash between European Union (EU) law, particularly the Traditional Herbal Medicinal Products Directive (THMPD; Directive 2004/24/EC), and the use of herbs and herbal products by practitioners under UK law.
In a nutshell, there are two options on the table for practitioner regulation:
1. Statutory regulation (SR) – only suitably qualified herbalists whose names are added to a government-approved register will be legally able to practise herbal medicine
2. Voluntary self-regulation (VSR) – professional associations will be responsible for policing their members under a strengthened Code of Practise.
A broad debate on this issue is extremely important, since its implications go well beyond practitioners of herbal medicine. Numerous disciplines use herbs on a daily basis, and it is vital that they understand how their access to herbs may be affected by the government’s eventual decision.
What do you think about government regulation?
Has your professional association polled its members to gauge feeling on this issue? If not, we urge you to get in touch with them and politely request that they do so. It is key to have access to data on each of the options and make up your own mind. Please feel free to use any of the material in this letter or the referenced documents to support your request.
What are the issues?
The THMPD is supposed to provide a registration/licensing regime for manufactured herbal medicines that is similar to, but simpler than, the licensing system for pharmaceutical drugs. However, there are numerous problems with the THMPD, but the key point here is that it applies to all manufactured/industrially produced herbal products. Many of these are relied upon by herbal practitioners, especially practitioners of non-Western herbal traditions, such as Indian Ayurveda or traditional Chinese medicine. Since it is extremely difficult for companies to obtain a license under the THMPD scheme – known as Traditional Herbal Registration (THR) in the UK – hundreds of products are being taken out of the hands of herbalists.
In May 2011, the UK government proposed SR as the solution. Statutorily registered herbalists would become ‘authorised health-care professionals’ under Article 5.1 of EU medicines law (Directive 2001/83/EC), thereby regaining access to the full range of herbal products. The current working group, the HMPWG, was set up when it later became clear that this option would conflict with certain rulings of the European Court of Justice. However, the government is still considering SR as a means of ensuring public safety[i], since only competent practitioners will gain access to the register, however, this has not yet been demonstrated to the satisfaction of many attending the WG meetings.
For more information on SR and VR you can go to two documents on our web site:
“Table of options: ‘SR’ and voluntary self-regulation compared” takes a close look at the arguments both for and against SR and VSR, along with the option of maintaining the status quo. This document is tailored toward herbalists.
The second enclosed document, entitled “How statutory regulation and voluntary self-regulation will affect all practitioners”, shows how the government’s decision may affect your daily practise, whatever your speciality.
Have practitioners even been consulted?
The Association of Master Herbalists polled their members last year on the subject of SR vs VSR, and they came out overwhelmingly in favour of VSR. In order to inform and guide the vote, the AMH listed the pros and cons of each option (SR or VR), with the help of a briefing document drawn up by the ANH. The AMH position was that 1) if SR were the only option then we would be fools not to support it but that 2) if there were another option we would be fools not to consider it, and 3) the members should have a say in any decision made on their behalf. The result was an overwhelming 80% in favour of VR over SR.
We are not aware of any recent polling by other professional associations, whether large ones like the European Herbal & Traditional Medicine Practitioners Association (EHTPA) or smaller ones, to gauge how their members feel about SR/VSR in the current climate. Clearly, a more open debate on this subject would be educative for all concerned.
Herbal Users and Practitioners Forum
Contact firstname.lastname@example.org for more information[i] It should be pointed out that no clear evidence has been submitted on the actual level of risk posed to the public by either herbs or herbalists. Apparently some evidence will be submitted at the next HMPWG meeting, however it remains to be seen how impartial this will be.