Herbal Medicines EU Directive Regulation.

Traditional Herbal Medicine Products Directive (TPHMD).

Dr Dilis Clare MBBCH, DRCOG, BSc (Herbal Medicine), Honorary Clinical Fellow NUIG Medical School.

12/5/11

Herbal Medicines cannot be sold unless they have been through a process of regulation subject to an EU Directive. This EU Directive legislation has been in effect since 30/4/11 subject to stocks being sold off.

The Directive is part of the harmonisation of trade process and was not generated by safety concerns of herbs as medicines. The regulation can be applied only to herbs available within the EU over the past thirty years; all other herbs do not qualify for regulation.

The regulation of herbal medicine is beneficial.However this legislation is not fit for the purpose of regulation of blends of herbs. Regulation ensures Good Manufacturing Practice of herbs, including herb identity verification and traceability, good labelling instructions, indication of traditional use and ensures there is no contamination of heavy metals or microbial contamination.

However the EU Directive has created a legislative road block by specifying stability testing of herbs to pharmaceutical standards. Stability testing is possible for a single herb but not for a blend of herbs as traditionally used. Any single herb may have up to 350 individual constituents, of which we may be able to identify a small number, the active constituent(s) may or may not be known, some constituents may be toxic and other constituents may neutralise the toxic effects. Many constituents act like vegetable constituents, beneficial but not to the extent they would alter physiology to a therapeutic extent. To establish the stability of a blend of herbs is comparable to establishing the stability of vegetable soup, to pharmaceutical standards, it is a pointless exercise. Pharmaceutical stability standards are developed for a single chemical e.g. paracetamol or diazepam. The roadblock to applying the EU Directive to blends of herbs is that these standards cannot be applied because suitable techniques are not available.

Historical context; Despite lobbying by members of the profession, there has been a failure by the Department if Health to regulate Medical Herbalists as a profession in Ireland over the past ten years, which has resulted in a failure to protect the welfare of Irish people.

The Higher Education and Training Awards Council (HETAC) has put a moratorium on the accreditation of any courses in alternative and complementary medicine. In the absence of professional regulation there is a concern that accreditation of courses will be taken as professional validation.

The role of the Irish Medicines Board (IMB) is to implement the EU Legislation regulating the use of herbs. However the IMB have been aware of the difficulty in regulating herbal medicines in the absence of regulating Medical Herbalists since 2002, when the Scientific Committee published a report on Herbal Medicine that specifically outlined these regulation concerns.

The most significant lobby against the EU legislation comes from the Chinese and Indian governments who rightly argue that although their medicines have not been available in the EU for thirty years, they have been established as safe practice in their home continents. Their respective communities living in the EU will not have ongoing access to their Traditional Chinese and Ayurvedic medicines. I would argue that Irish people will similarly not have access to our own traditional Western Herbal Medicine formulary of herbal blends. Exports of TCM and Ayurvedic medicines contribute significantly to the Chinese and Indian economies.

In Ireland the Irish Institute of Medical Herbalists has worked with the Cork Institute of Technology to successfully establish a BSc in Herbal Sciences. Their work has underpinned the necessary qualifications for graduates to engage in the development of an herbal industry in Ireland. There has been considerable financial investment in the development of a Masters in Clinical Herbal Medicine which has been halted by the moratorium on accreditation by HETAC. Currently there is considerable interest in the commercial growing of medicinal herbs which again will be adversely affected by the current legislation.

Currently the practise of herbal medicine is affected by the availability of herbs commercially as a consequence of this legislation. Herbs which are not commercially viable will not be available to professional herbalists. Because it is only single herbs that are suitable for regulation and of these only the top ten sellers will make the costs of regulation worthwhile the result will be a lack of choice for the consumer and for the medical herbalist.

These negative consequences of the EU Directive are not as a result of safety concerns. In fact herbal remedies have an exemplary safety record. The sad reality is that consumers will source their herbal products from the internet, with a lot less accountability than currently applies to herbs sold in health food shops. There will be a knock on effect of jobs lost in the retail sector with the possibility of closure of some Health Food Stores.

Most of the reports of significant side effects of some herbs such as Black Cohosh result from single herb supplements which as a general rule use higher doses than herbs used in traditional herbal medicine blends. More of these reports can further endanger the safe use of herbs in traditional doses. Using single herbs (in much the same way that drugs are used) does not have the thousands of years of empirical evidence of safety.

The implementation of this EU Directive will lead to availability of a small number of single herbs regulated at higher cost to the manufacturer; this cost will be inevitably passed to the consumer. There will be less competition as it is mainly the large Phytoceutical (plant pharmacology) and Pharmaceutical companies that will have the resources to front load the expenditure. Germany is particularly well placed to market such products as many doctors prescribe herbs in this way for general medical practice, this is not the practice of traditional western herbal medicine. Consequently Germany has a well established Phytoceutical (plant pharmacy) industry which is ideally suited for this regulatory process.

In light of the overall effects of the TPHMD EU legislation I propose the implementation of this directive be opposed by the Irish Government.

1. A small number of well regulated herbal medicines will be available.

BUT

2. The potential to develop a significant medicinal herbal industry, with employment potential, in Ireland will be stymied.

3. Choice for the consumer will be severely restricted.

4. Insurmountable technical obstacles block the availability of traditional blends of Western Herbal Medicine, this is our indigenous medicine.

5. Internet sales will expand with greater safety issues than are resolved by the legislation.