The health food industry is angry at the Department of Health's decision to place St John's wort - whose botanical name is hypericum - on the Irish Medical Board's prescription-only list from January 1st, 2000. What many have yet to realise is that St John's wort, and other herbal medicines on the list, will not be legally available even with a prescription because they do not have product authorisation which is required to sell drugs on prescription.
Also on the list are blue cohosh, or squaw vine, used to support women during labour, and gingko, the most widely used herbal remedy in Europe and a scientifically proven remedy for memory loss related to normal ageing. Europe's largest manufacturer of gingko is in the Republic, yet ironically, from January 1st, people here will not be able to buy the herb.
The prohibition of St John's wort, gingko and other herbal medicines has come about as a result of EU legislation that 13 of 15 EU states are choosing to ignore in favour of their own legislation governing the sale of herbal medicines. Only the Republic, by placing herbal medicines on the prescription-only list, is following the letter of the EU law, which says that any substance with a pharmacological effect is a medicine, says Michael McIntyre, chairman of the European Herbal Practitioners' Association.
"It's a total farce," says Dr Dilis Clare, a GP and university-trained medical herbalist, who arrived in Galway from London two weeks ago to open a new practice combining "orthodox" and traditional medicine. Without St John's wort and gingko, two of the most important remedies in her herbal apothecary, Dr Clare says that she might as well close up shop and return to London, where these herbal remedies remain freely available.
The hype about hypericum - St John's wort - has clouded the real issue, which is that consumers have a right to avail of herbal medicine, which has a 2,000-year-old tradition, and they also have a right to be protected. The EU and the Government need to develop a system whereby safe, quality-controlled herbal medicines are prescribed by informed experts under a system of regulation, asserts McIntyre. A university-trained medical herbalist (there are five university programmes for medical herbalists in Britain), he believes the Republic should introduce a system of training and regulation which would limit the use of herbal medicines to licensed practitioners. The Irish Herbal Practitioners' Association has been talking to the Department of Health about this possibility, so far without success.
Herbal medicines have scientifically proven pharmacological effects that can be potentially damaging in the wrong hands. The Department of Health has particular concerns about Internet traffic in herbs and has placed two on the prescription-only list requiring product authorisation and licensing. They are tribulus terrestrix, which raises testosterone levels and is being marketed on the Internet as the herbal alternative to Viagra, and caulophyllum thalictroides, which has many uses and abuses, including one as a potential abortifacient.
The only legal means that the Department of Health currently has of protecting the consumer is the product authorisation system. But this can cost £40 million for one drug alone, because it requires expensive studies on carcinogenicity and doubleblind control medical trials. Herbal medicines manufacturers, distributors and practitioners argue that the authorisation system designed for synthetic drugs is too rigorous and costly for herbal medicines, which cannot be patented like synthetic drugs. However, Dr Des Corrigan of the Department of Pharmacology at Trinity College Dublin, points out that the herbal medicines business in Europe is worth six billion dollars annually and can well afford to ensure the safety, quality and efficacy of its products.
In late September, these issues were discussed by the pharmaceutical committee of the European Commission, which concluded that the EU should look at the possibility of assessing herbal medicines in terms of "traditional use", rather than the standard criteria of product authorisation. This approach is widely supported by people on both sides of the debate. Frank Hallinan, chief executive of the IMB, attends the EU pharmaceutical committee. "We are open to discussions on how to solve the problem. This is an evolving and developing situation and we are not fixed in a particular position," says Hallinan.
The IMB has been painted as the villain of the piece by the health food industry, but Hallinan points out that the IMB did not "go after" St John's wort. It came to the attention of the IMB because someone wishing to manufacture hypericum extract (the IMB will not reveal who) applied for a product licence which requires a product authorisation.
After investigating the herbal medicine's properties, the IMB immediately became concerned that St John's wort, which is effective against mild, clinical depression, would be self-prescribed by depression-sufferers, thereby putting them at risk of not getting the necessary medical help. John's wort also has side-effects that, in the experience of one psychiatrist who prescribes it - Dr Patrick McKeon of St Patrick's Hospital, Dublin - are as significant as the side-effects of prescription anti-depressants.
The consumer needs to realise that "natural" does not mean "safe", Dr Corrigan points out. "Quality control is important. There have been too many disasters," says Dr Corrigan. In Belgium, 90 women got kidney failure - leading in many cases to kidney cancer - when they were treated with a poisonous Chinese herb, aristolochia that had been mistaken for a safe herb, stephania. This happened again in Britain last year, when two people were affected. Measures have been taken to ensure that this could not happen here, says Kerry McBride, chairman of the self-regulating Register of Irish Chinese Herbal Practitioners, which has a record of using medicinal herbs responsibly.
In the interest of protecting the consumer, the IMB and the Department of Health are concerned about unscrupulous cowboys selling adulterated products and using false advertising. In Britain, an Irishman was prosecuted for selling a "herbal" cream for eczema which secretly contained potentially harmful steroids. Believing the cream to be "natural", consumers were covering themselves with it from head to toe. In another case, a remedy marketed as natural, contained phenylbutazone, an anti-arthritic synthetic drug that causes aplastic anaemia, a blood disease that can be fatal.
The IMB does not want to put reputable health food stores and herbal practitioners out of business. "Chasing after herbalists who are doing a reasonable job would not be on our list of priorities," Hallinan says. Nigel Griffiths of Nature's Way says that all his staff who advise on herbal remedies are fully trained and know when to refer a customer to a medical doctor.
McIntyre explains: "The health food stores have pioneered the availability of over-the-counter herbal remedies to the public and many have real expertise and integrity, but because there are no regulations it leaves the business open to shenanigans."
In the absence of a coherent European policy on herbal medicines, the public must rely on the honesty and intelligence of sellers practitioners. On January 1st next, health food shops may decide to ignore EEC/6565 by continuing to sell herbal medicines. The Department of Health is understood to be considering prosecutions as a means of focusing the health food industry's attention on the seriousness of the EU legislation. However, the IMB has yet to hire the promised enforcement officers who would go into health food stores and inspect, with powers to prosecute. And so we may have yet another Irish solution to an Irish problem.
kathryn.holmquist@weblink.ie