EU Herbal Campaign -- Response to Concerns


Thanks for raising your concerns about the EU herbals campaign. We had a long discussion of this issue on our team, considering many possible objections. But we spoke with key officials, politicians and professionals involved, and feel confident that we've taken the right position. For clarification purposes, at no stage of this campaign, has Avaaz implied that it is against regulations for herbal products, or that these products are all effective. Certainly, there have been a few cases of scams involving herbal medicines, and instances where misapplication of herbal medicines have harmed people. However, the current EU Directive, which aimed to introduce a simplified registration procedure for herbal medicines is seriously flawed, rendering many products completely ineligible for registration and erecting insurmountable hurdles for others.

The Directive creates a situation in which producers of herbal and other traditional remedies have to bear enormous costs, years of effort and a lengthy review process to get their products on the market. The costs of tests and submission have been estimated at €100,000 per product, and many manufacturers have hundreds of products. Large firms may have the resources to jump through these hoops, but the small scale producers that account for much of the herbal medicine industry do not.

In addition, the rules dictate that traditional herbal medicines cannot be licensed unless they have been in use for 30 years, 15 of which in the EU. But many traditional medicines sold in the EU market were registered as "dietary supplements" rather than drugs so companies cannot provide valid evidence to prove the safety and efficacy of their medicinal products in the EU market.

The application of this directive varies across the EU, but in several countries fewer than 5 herbal products have been registered during the 7 year period allowed by the EC. This means that hundreds of herbal products can be taken off the shelves any day now. Such products aren’t for everyone, but surveys show that 25% of EU citizens have used herbal products. So far not a single non-European traditional medicine products has been approved, as they were not properly included in the new directive. This means that ayurvedic, Chinese, and other Asian medicine with hundreds of years of use, now cannot be sold as medicines. This was recognised by the European Commission itself in a 2008 report, which urged extending the Directive to cover them. Nothing has been done about that since apparently the EC lack the expertise and other more pressing agendas such as veterinary medicine have taken priority.

Many Europeans will still want to get hold of herbal remedies for themselves and their families, and may have to buy them as food supplements, or from the internet, if they can’t find them in pharmacies. That will be less safe, as they won’t be able to get advice on dosage and possible side effects when mixed with other medicines. These regulations reduce consumer choice, while failing to bring in a comprehensive and effective safety regime, so we've called on the EU to amend the directive. Our team considered all sides of this argument and spoke to the relevant officials and activists. When polled, the Avaaz community gave an overwhelmingly positive response. You may not agree with this particular campaign, but we hope this response alleviates some of your concerns, and that you’ll continue to support Avaaz in future.

More information:

Alliance for Natural Health Questions and Answers:
http://www.anh-europe.org/news/frequently-asked-questions-about-eu-herbal-registrations-and-bans

ANH and Benefyt Foundation position paper:
http://www.anh-europe.org/files/100916_ANH_Benefyt_abbreviated_position_paper.pdf

European Commission Communication on the Herbal Medicines Directive:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0584:FIN:en:PDF

European Commission press release on the Herbal Medicines Directive:
http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/510&format=HTML&language=en