Will tighter EU laws hit herbal remedies?

Are EU Directives closing in on alternative medicines? Sylvia Thompson reports

There is a growing fear in alternative and complementary medicine circles that new stricter European laws governing the sale of homeopathic and herbal medicines may significantly reduce the range of such medicines available to the public.

While some EU states has a strong tradition of homeopathic and herbal medicine, practitioners and manufacturers fear the Pharmaceuticals Directive will effectively ban some herbs which have been safely used for many years or wipe them off the shelves where companies who produce them cannot afford the costly regulatory process to ensure approval.

The net effect would be the disappearance of many safe and proven herbals from health shop shelves and curtailment of innovative natural substances.

As EU Directives on homeopathy and herbal medicine are reviewed alongside larger legislation dealing with all medicines, many believe homeopathy and herbal medicine may become the fall guys in the race to harmonise a European marketplace.

"The subject of homeopathic medicines is currently not treated with a sufficient degree of seriousness by the European Commission and European Parliament. A lot of conventional pharmacologists and pharmacists are making legislation for medicines they don't fully understand. Many conventional doctors, pharmacists and scientists do not take homeopathy seriously yet millions of EU citizens use homeopathic medicines on a daily basis," says Stephen Gordon, homeopath and general secretary of the European Council for Classical Homeopathy.

Gordon says suggested improvements to the legislation for homeopathic medicines were ignored by Members of the European Parliament (MEPs) recently, partly because of the administrative burden this would have placed on parliamentarians who wish to conclude business on such directives before current MEPs end their term in April.

He also believes that there is there is a strong drive against non-conventional medicines. "There is a huge uptake of complementary medicines and this is threatening the sale of pharmaceutical drugs," he says.

One of the biggest worries for users of homeopathic remedies is that manufacturers will produce only the most popular remedies which sell well due to new lengthy and expensive licensing costs. "There are between two and three thousand homeopathic remedies and the availability of lesser used ones is under threat. For instance, in Holland now, manufacturers are manufacturing only about 300 homeopathic remedies," explains Gordon.

In Ireland, the Irish Medicines Board are just about to begin the process of licensing homeopathic medicines, following the transfer of the EU Homeopathic Directive into Irish law.

Jonathan Griffith is a wholesaler of complementary healthcare products in Ireland. "The net impact will be negative. Products which have a low turnover will not be registered so the availability to consumers will be reduced. In so far as these products are mainly generic medicines, they could still be made up in pharmacies to prescription but this is a specialist procedure that is not properly facilitated within existing Irish law," explains Griffith.

There are currently 8,000 homeopathic medicinal products available on the Irish market and the IMB have received notification regarding licensing for only 344 products to date.

Mary Perry, a homeopath who manages Ireland's only homeopathic pharmacy, Nelson's Pharmacy, in Duke Street, Dublin, says that there has been a huge increase in numbers of people coming directly to the pharmacy for advice on what homeopathic medicines to take. "There is an increasing belief among the public that the natural approach is best," she says.

Martin Murray, a manufacturer of herbal and homeopathic medicines in Limerick and a member of the European Coalition on Homeopathic and Anthroposophic Medicinal Products, welcomes the IMB's regulation but is still seeking changes at European level.

He adds:"We believe the definition of homeopathic remedy is too restrictive. In particular it requires that every remedy has to be diluted to a level not less than one part to 10,000. That's fine for toxic substances but it's not for substances such as camomile, echinacea and Vitamin C which can be safely taken in whole form."

Jonathan Griffith is also concerned that as the legislation stands in Ireland, homeopathic products cannot carry specific health claims on their packaging. "The IMB are not unsympathetic to our case but if we aren't allowed to make such claims on our products, the industry will be closed down," he says.

Griffith also believes the homeopathy industry should engage in research into the effectiveness of homeopathic products.

Dr Des Corrigan, lecturer in the School of Pharmacy, Trinity College, Dublin, and specialist in traditional plant medicines, is more optimistic about the Traditional Herbal Medicines Directive. "This directive gives a secure legal framework for a whole range of products which were technically in breach of the law and it provides the consumer with a guarantee of high quality products.

"Most problems with herbal medicines have been to do with bad quality control rather than toxicity within the plants themselves. I hope to see an expansion of products available here from countries such as France, Germany and Poland where there is a long history of the use of herbal medicines."

Green Party MEP Nuala Ahern notes: "When there is a bringing together of European legislation, you do sometimes lose out on some issues for the sake of the greater good."

She adds: "People glaze over when you discuss EU Directives and it will only be when products start disappearing from the shelves that they'll realise the losses. While we need to protect consumers from herbal products which aren't what they say they are - as in the recent case of an echinacea product on sale which didn't contain any echinacea - I believe that it's not the safety issue which is driving through these changes but the harmonisation deal.

"Ireland and Britain have more liberal regimes in the use of herbal medicine than France and Germany but it [the legislation] has gone too far - way beyond issues of quality control and safety."

Ahern specifically questions the 30-year rule which requires all herbal medicines to have been used safely for 30 years before they are allowed for sale on the European market.

"What will happen when something new starts circulating? On the one hand, you will have overregulated control and on the other hand, you will have people experimenting at will with products which they can buy over the Internet."