Three Irish MEPs hope amendments to a new EU Directive next week will protect the vibrant herbal medicines business here and prevent discrimination against non-EU traditional medicines, writes Kathryn Holmquist
Next week in the European Parliament, three Irish MEPs hope to see a series of amendments passed that will protect the herbal medicines business, a market worth €20 million annually in Ireland. Patricia McKenna, Nuala Ahern and Avril Doyle have each tabled amendments to the Proposed EU Directive on Traditional Herbal Medicinal Products.
"I've been harassed," is how McKenna describes the pressure she has experienced from the powerful alternative medicines lobby. Doyle says she herself hasn't been harassed, merely that the herbal lobby has been employing the same intensive lobbying techniques of any business that sees its interests threatened.
The directive aims to establish within the EU a legislative framework for the marketing of traditional herbal medicinal products. A simplified registration procedure would remove the differences which impede the free movement of medicinal products in the EU, while ensuring protection for public health.
Ahern believes the directive without the amendments is "terrible". "It lacked an adequate definition for traditional herbal products, and contributed to confusion between herbal products and food supplements. Furthermore, its restriction of acceptable traditional use to 30 years and 15 years within the EU is Eurocentric and discriminatory against products of non-EU origin".
"Traditional use" is a term that eliminates the need for clinical trials of herbal medicines. Ahern and others want to see "traditional use" extended to products coming from markets outside the EU such as China, which has a strong tradition of herbal medicine.
According to Ahern, one bizarre effect of the directive, if passed unamended, is that garlic and herbs such as sage and basil would no longer be allowed for sale in conventional foods, such as salad dressings. Of more concern to the business, however, is that an unamended directive would ban the sale of combination products, where herbal remedies are mixed with vitamins and minerals.
The Irish Association of Health Stores (IAHS) describes the likely impact of the directive as "devastating", if the amendments are not passed. "The directive was ultra-conservative and could be corrosive of consumer rights. Many products would disappear and others would go up in price," says Erica Murray, owner of the Hopsack health food shop in Rathmines.
Fifty per cent of Irish people use herbal medicines and food supplements - a market that caters for 123 million customers annually in Europe.
However, the Consumers Association of Ireland has accused the three MEPs of bowing to pressure from the herbal medicines lobby. "The herbal products business is a very, very significant and wealthy industry," says Dermot Doole of the CAI. "You would not have three MEPS bargaining on behalf of the pharmaceutical industry, but it seems to be OK in this case. When MEPs are lobbying on behalf of a business, a very significant line is crossed."
Doole is concerned that the consumer's voice is not being adequately represented at EU level. The herbal medicines area is perceived as "natural" and "holistic", and thus on the consumer's side, but consumers are growing mistrustful, he observes. While BUEC, the European umbrella group for consumer associations, has submitted its own responses to the directive, it's only "one small voice", says Doole.
However, Mark Griffin, of Consumers for Health Choice - a group partly funded by the health food stores and herbal medicines industries - believes that it is in the industry's interest to protect the consumer. He thinks that the European Commission should not expect the herbal medicines business to comply with the types of controls required of the pharmaceutical industry. "More and more products are being taken off the shelves and put on prescription, when there is far more evidence that some drugs marketed by the pharmaceutical industry are dangerous," he says.
But "natural" doesn't always mean safe. In the US, the FDA recorded more than 100 deaths and 2,000 toxic overdoses last year due to herbal remedies.
Jonathan Griffith, a wholesaler and distributor of herbal medicines, says that the business is realistic about potential dangers and that it has long campaigned for legislation to protect the consumer. The amended directive will protect both the business and the consumer, he asserts. "Consumers won't see stripped shelves in their local health food store," he says.
Avril Doyle says the greatest pressure to restrict the use of herbal medicines has come from France and Germany, which already operates the strictest system of approval in Europe. Ireland and the UK have had the most liberal regime, and the amendments attempt to bring all the countries involved onto an acceptable middle ground.
Irish consumers got their first taste of the German approach to herbal medicines when St John's Wort was taken off the health food store shelves and put on prescription in 2001. By taking this action, the Irish Medicines Board was complying with EU legislation. The medical director of the board, Dr Joan Gilvarry, told The Irish Times that she has met more than 40 representatives of the natural medicines business in a process of ongoing consultation.
"When the directive goes forward to the Council of Ministers, we will be putting in our own comments. There is still a lot to be fleshed out. The consumer must be protected by a system to ensure these products are safe, of appropriate quality and will do what they say they will do on the labelling," she says.
At the same time, the Government's Interim Licensing Scheme, which was introduced in 2001, aims to comply with EU legislation while eliminating bureaucracy. The IMB also supports "traditional use" as a justification for safety and does not see a need for clinical trials on traditional products.
Some medical herbalists remain concerned, however, that the regulations - amended or otherwise - will not prevent misuse of medical herbs unless the Government also brings in a system of regulation of practitioners. Rosari Kingston is a herbal practitioner in Waterford and member of the National Institute for Medical Herbalists, founded in 1864, an accrediting body with a code of discipline and ethics. She thinks that the amendments don't go far enough, because the directive fails to address the issue of the ethical use of herbal medicines. "Without this, how does the consumer know the person they are going to is not a quack?" she asks.
She is also worried that the amendments allow unrestricted use of herbal teas, such as rosemary, which can have pharmacological effects in high doses. "There is a grey area between food and medicine that is not addressed by this legislation," she warns.