Nov 2002

The Medicines Control Agency (MCA) is steaming ahead with moves that will "devastate" herbal medicine, while claiming that the natural medicines industry supports it, says Consumers for Health Choice (CHC).

In October the MCA published a summary of discussions with Health Minister Lord Hunt, about the proposed European directive that threatens to wipe hundreds of herbal remedies from the shelves of UK health food stores. The Traditional Herbal Medicinal Products Directive (THMPD), proposed by the MCA will have a devastating effect on consumer choice, and on many independent manufacturers and specialist retailers. According to CHC, "The MCA press release suggests that many of the issues were resolved and that there is widespread support for the Directive. This is simply not true. Thousands of consumers, hundreds of manufacturers and retailers across the UK are strongly opposed to this legislation and have pleaded with the Government and MCA officials to block progress of the Directive until a satisfactory solution can be reached."

Despite consumer and industry protests, the legislation is being fast-tracked in Europe. "There remains a fundamental question about the motive for this legislation", says CHC. "The fact is that the MCA already has extensive powers to immediately remove any product from shelves where it has evidence that the product is unsafe. MCA has also, to date, failed to produce even one existing product that it believes to be unsafe.

"There remain serious concerns within the herbal products industry about the implementation of the Directive, not least because MCA have still not given any indication of their fees for registering products, so manufacturers have no idea if they will be able to afford the compliance costs. The Minister was again unable to give any answers on this point yesterday."

As the Directive is currently drafted, no new herbal product can come onto the market - anywhere in Europe - ever- without a full pharmaceutical licence costing up to £1 million! This is because of the 30-year rule which allows a product to register under THMPD only if it can demonstrate 30 years existing use -15 years of which must be in Europe. The Government has still failed to propose a solution to this problem.

Amendments have been tabled in Brussels for the legislation to apply to the ingredients rather than the product. However, the MCA has made it quite clear they are not in the business of licensing ingredients - just finished products.

On July 10, the Minister asked the MCA to come forward with more information about what it considers to be a medicinal herb and at what level. To date there is no additional information on this point. As the MCA has failed to respond to the Minister's request, accurately assessing the impact of the Directive is virtually impossible.

Says the CHC: "There is still a serious issue to be resolved over the position of herb and nutrient mixtures, such as Vitamin C with Echinacea. The Directive as it is currently drafted makes no provision for these combinations, and the MCA already considers them illegal, even though the individual ingredients are legal and safe. It is simply because as a combination they have no home in law."

Sue Croft, director of Consumers for Health Choice says: "The MCA could not be less helpful. In short, there is still a long way to go!"

. http://www.healthchoice.org.uk

The 3 Threats

CHC is mobilising to resist three threats to consumer choice:

. the Food Supplements Directive, which could lead to the banning of many safe and popular nutrients, and the imposition of unnecessary limits on the potency of many others.

. the Traditional Herbal Medicinal Products Directive, which seeks to shoehorn herbal remedies into the formal regulatory environment of pharmaceutical drugs and threatens their continued availability as well as the availability of mixtures of herbs with nutrients.

. proposed Amendments to the Medicines Directive, which threaten to bring within the regulatory regime for pharmaceutical drugs some products which are defined as food supplements, again threatening their continued availability.

. To find out what action you can take, www.healthchoice.org.uk

This article is reproduced from CAM Magazine

Thanks to Simon Martin - Editor

Nov 2002