Herbal Medicine - A View to the Future

According to the E. U. directive on 'Medicinal Products for Human Use', herbal medicinal products are now widely recognized as an important complement to modern chemical medicines. The public are highly motivated to use herbal medicines and 95% of herb use is conducted 'over the counter'. Herbal practice has changed very little in terms of status over the last 60 years so this belated recognition as a highly successful therapy is welcomed by all concerned. The patient / practitioner aspect of herbal medicine has been kept alive by a dedicated core of practitioners who have passed on their knowledge via apprenticeship and small teaching schools but in the last few years, university courses have been launched creating many new graduates. Yet this new face of herbal medicine has previously suffered some very difficult times.

Change on the Way

In 1994 things became very worrying for the continuation of herbal practice and the sale of herbs but huge public support swayed the government concerned and for the time being herbal medicine is being left alone. By 2000 The House of Lords Select Committee on Science and Technology published it's report on complementary and alternative medicine (CAM). This report highlighted that on issues of patient safety there were huge variations in trainings, some of which needed upgrading. The other issue raised by CAM was the widespread supply of unregulated herbal medicines. The upshot of this was a government led focus on achieving statutory self regulation for acupuncture and herbal medicine.

In 2002, the Department of Health set up two committees, one the HMRWG (Herbal Medicine Regulation Working Group) was asked to consider ways to navigate UK herbal practitioners of all traditions. The other committee, the ARWG (the Acupuncture Regulation Working Group) was also charged with considering how statutory regulation of acupuncture and herbal medicine could best be achieved. Professor Michael Pittilo chaired the H.M.W.G., the shareholders were:

The Department of Health
The Prince of Wales Foundation for Integrated Health (FIH)
The European Herbal Practitioners Association (E.H.P.A.) other shareholders were professional associations namely:-

Another area under huge discussion is the question of 'over the counter' sales of herbal remedies. This has been discussed at length within the H.M.R.W.G but also with the British Herbal Medicine Association (B.H.M.A.), The Herbal Forum and of course with the Medicine Healthcare Regulatory Agency. To this end, the need to regulate herbal practitioners is also very important as having properly registered herbal practitioners will enable the M.H.R.A. (Medicines Healthcare Regulatory Agency), to be directly involved with each other on safety issues that may arise.

Why The Traditional Herbal Medicines Directive is Welcomed for Over The Counter Sales

The proposed directive on Traditional Herbal Medicinal Products (THMP) aims to provide a simplified registration procedure for certain herbal remedies. Herbal practitioners welcome this new directive for safety reasons and the majority of reputable herb companies are also keen because the mistakes of a few reflect badly on the industry at large. There is a shortfall in systematic quality controls and although the M.H.R.A. has had several successful prosecutions in this area, (see their website www.mhra.gov.uk) there is still an alarming difference in safety and quality matters concerning herbs. A further illustration of safety concerns associated with herbal practice is contained in the Journal of the Royal Society for the Promotion of Health, Dec 2002. There clinicians report on cases of women hospitalized after having been prescribed Chinese herbal slimming remedies found to contain the Drug fenfluramine, which is linked to primary pulmonary hypertension and valvular heart disease. Many will know of the St. John's Wort concerns, this herb has been found to lower the potency of prescribed drugs such as oral contraceptives and heart medication due to it's very fast liver metabolizing capabilities. Another example is with the Chinese plant, Aristolochia. It can be confused with look-a-like plants containing nephrotoxic ingredients as a result of either similar appearance or similar nomenclatue. It has been prohibited for use and, not only Aristolchia itself, but also other similar looking plants, although they are not believed to be inherently harmful - Better safe than sorry. The Register of Chinese Herbal Medicine is working with large suppliers in China and the 'Authentification of Herbs Species Department' at Kew Gardens, London in order to put in place safer harvesting and checking methods. A range of safety issues relating to herbal remedies is covered in greater detail in the M.H.R.A.'s report on the safety of herbal medicinal products. (See their website www.mhra.gov.uk) The whole issue of herb safety is a European issue and the overall directive has come from, and will continue to be led by the council of the European Union. The council recognizes that the long tradition of herbal medicines makes it possible to reduce the need for clinical trials, in so far as the efficacy of a medicinal product is plausible on the basis of long standing use and experience. These remedies will need to prove a minimum term of use within the E.U, which at present is 10 years (which is part of a period of use of at least 30 years preceding the date of application). The European Commission has insisted on a minimum term of 15 years, however following the concerns expressed by the European Parliament, the council could agree to open up an additional route; for products with less than 15 years of use in the E.U. Products that are new will go down a different route; they will need to be formally registered. However, even a long tradition does not exclude the possibility that there may be other concerns. With regard to the product's safety the licensing process will be based on data concerned with physio-chemical, biological and microbiological tests. The herbal medicines will also be expected to comply with quality standards of recently produced European Pharmacopeia monographs. Western Herbal monographs are currently being compiled (a process which began 5 years ago) by the E.M.E.A (The European Medicines Evaluation Agency). They are in part re-evaluating older monographs produced by Germany. They will be establishing new monographs into the foreseeable future as herbs less commonly used, yet having a long herbal tradition, come to the fore from, for instance, countries who join the EU in the near and further future.

Better, Safer Labeling for Herbal Products

Needless to say labeling and user package leaflets will need to reflect the new guidelines for sales which is welcomed by many Herbal Companies because the language allowed was previously and still is based on 12:1, legislation which came under 'food' laws. This meant that by law only scant language which lacked clear descriptions could / can be used which leads to confusion. The idea that these highly useful medicines can be properly described is a huge sigh of relief for the industry, the public and for herbal practitioners alike. Incidentally and very importantly; this licensing process it is hoped will be fully in place by 2011 with the first licensed products appearing in approx 2006. Qualified Herbalists will still be able to commission a third party to make up and industrially produce a remedy to the herbalist's specification to fulfill special needs. This will be vital for the proper work of herbalists who may not find a suitable licensed/registered herbal product and may wish a more individualized approach, which is occasionally the hallmark of how a herbal practitioner works in clinic. Furthermore, the supply of potent herbs not suitable for over the counter sales will be restricted to those practitioners with appropriate training and who are on a statutory register.

How Herbal Companies Feel

In my position as senior consultant of Herbs Hands Healing Ltd I need to say that this company, like many others, (with whom I regularly meet) are every inch behind the new regulations, because as hard and costly as the changes will be, the good name of herbs, their quality, safety and to some extent the efficacy can be redeemed, trust can be restored, maintained and in some cases better provided. I was lucky enough to sit on the H.M.R.W.G and have been working with the E.H.P.A. for well over a decade now. It is thrilling to know that history is being made, even with the roller-coaster highs and lows that it has entailed.Many members of the public have sympathetically approached our company and empathized with the news they've heard, that "herbs will be taken away from the shelves and us". This climate of telling half the story has been difficult for us and it is wonderful to be able to put the record straight in this article. We're not sure where we'll end up but we believe so strongly on regulation for safety that in a way we're prepared to take anything on. So on the whole we're very optimistic about the future for us as a small company. As a company we've found it easy to keep in touch with the MHRA and engage in discussion; additionally we receive regular, herbal safety news updates from their herbal policy unit. These frequently concern herb and drug interactions but they warn us about anything that has come to their attention. Our company policy has always been to warn against combining drugs and herbs because of their unknown outcomes. Obviously in the clinic, this is entirely different and a more individual and watchful route can be undertaken.

The Different Herbal Traditions

Herbs Hands Healing Ltd. is a herb house which provides western traditional herbal medicine. To date the three main traditions in the UK are Ayurvedic, Chinese and Western but there also exists Japanese and others and it is hoped more will join over time. Western tradition is an ethnic mix of North American Indian and European plants and traditions. Historically the lineage goes back to Ancient Greece, Ancient Egypt a wide range of North American Indian Tribes who continue to contribute their knowledge and wisdom. Anthropologically this is a very interesting fusion of ideas and traditions which provides a rich and diverse pool of healing knowledge that is being taught on Western Herbal Medicine degree courses today alongside the bio-chemistry of plants and much much more.

Herb Farming

Already more herbs are to be seen growing commercially in Europe and to assist this some enlightened Horticultural and Agricultural Colleges in Britain are teaching herb modules with a view to assisting a new generation of growers, they all seem to be getting the message that we require organic quality and that nothing less is appropriate for medicines. There is also a wide respect amongst practitioners and some importers concerning the intellectual property rights of peoples whose plants are of medicinal interest to the west. This and other ecological factors will hopefully maintain and gain more interest and understanding from the public as well.

What is a Herbal Medicine?

Research on animals is 'non-acceptable' by all Western Herbal Medicine Associations previously mentioned in this article, just as the use of animal parts is clearly not acceptable. Western herbal medicine is defined as a system of medicine which uses various remedies derived from plants and plant extracts to treat disorders and maintain good health. Herbal practitioners further define this by stating that herbs are used whole from the entire plant or particular parts of the root, flower of leaf etc. These are then powdered and placed in capsules or soaked in alcohol and water and made into a tincture. Many other old, tried and tested ways of making herbal medicines exist and are used traditionally. The use of isolated plant constituents (sometimes called standardized extracts) is not generally seen as herbal medicine by the majority of herbal practitioners although the whole subject is invariably treated as 'one' by members of the public. It is hoped that legislation will provide a route to divide and clarify this issue.

Finally...

Finally, it is rumored that meat companies are turning to herbs like garlic, thyme, sage and cinnamon for their antibiotic properties, digestive and therefore flesh building abilities. Antibiotics and steroids will be removed from all EU reared meat over the next 2 years which is wonderful news for the health of the nation but poses problems for meat producers. They feel that herbs may be a route through.We all look forward to a safer herbal future with herbal medicine and herb use, taking a greater stage in the arena of health care in Europe. I leave you with images of herb fields grown for medicinal, cooking and meat production use, a new vision for the British countryside.Jill Davies is an active member of the EHPA and has participated in meetings for over 10 years. She also sat on the HMRWG as vice-chair of the AMH.