REGULATIONS on homoeopathic remedies that come into force today have infuriated scientists and doctors.

For the first time, homoeopathic treatment will be allowed to claim efficacy measured by their own methods, not by the much tougher standards applied to conventional medicines, and will be able to list on their labels what conditions they are supposed to treat.

The changes have been introduced by the Government on the advice of the Medicines and Healthcare products Regulatory Agency (MHRA). They were welcomed by manufacturers of homoeopathic remedies but denounced by doctors, scientists and MPs.

Michael Baum, a cancer surgeon and former professor of surgery, said: “This is like licensing a witches’ brew as medicine so long as the bat wings are sterile.”

Evan Harris, the Liberal Democrat science spokesman, said: “The multimillion-pound homoeopathy industry should not be allowed to make health claims for its products without proper evidence of effectiveness, especially when reliance on ineffective homoeopathic ‘remedies’ may delay access to proper diagnosis and treatment of serious conditions.”

Tracey Brown, director of Sense about Science, a charity that promotes the use of good evidence in science in public debate, said: “It’s incredibly frustrating. While the Government is agonising over what constitutes evidence-based policy in so many areas, the MHRA is implementing a licensing regime that recognises homoeopathic ‘provings’ . . . observations that a substance induces the same symptoms as a disease, like watering eyes or headaches. We might as well test medicines by dropping them in a puddle to see if they float.”

Claims about homoeopathic medicines have always been carefully controlled. When the Medicines Act was introduced in 1968, it set out strict rules about the safety and efficacy of new medicines. All products already on the market were granted a Product Licence by Right. Since then no new homoeopathic products have obtained a licence, since they cannot meet the efficacy requirements demanded of normal medicines.

Since 1992 manufacturers have been allowed to sell homoeopathic remedies without evidence of efficacy, if they could show that they were produced safely and hygienically. But they could not list what they were supposed to treat.

The MHRA has now taken advantage of a new EC Directive to amend the way homoeopathic products are sold. The changes were introduced by way of a statutory instrument.

The new regulations say: “An application for a national homoeopathic product is not required to comply with the requirement to submit the results of pre-clinical tests and clinical trials.”

Applicants must supply data on pharmacology, pharmacokinetics (how the drug is handled by the body) and toxicology. On safety, “the applicant may submit data other than scientific data” if reasonable attempts are made to obtain scientific data or the applicant is satisfied that none exists. And efficacy data need consist of no more than homoeopathic provings, which are “the administration of a substance to a human subject to ascertain the symptoms produced by that substance”.

The regulation allows all homoeopathic products to state on their labels what conditions they are designed to treat.

Robert Wilson, chairman of Nelsons, a homoeopathic remedies producer, said: “This new regulation will make it much easier for customers to selfselect homoeopathic remedies, and will encourage new consumers to try these products as there will be clearer labelling and indications on the packaging. Until now, homoeopathy has been relatively inaccessible to most people.”

However, Mr Harris said that medicine regulation was being “diluted and polluted” by allowing ineffective products to be licensed. “Parliament has never had a chance to debate this significant law change because the Government only laid the instrument in the last week that Parliament sat, with a implementation date — today — in the middle of the recess. We now know what the Government was trying to sneak through.”

Professor Kent Woods, chief executive of the MHRA, said: “This is a significant step forward in the way homoeopathic medicines are regulated. Products will have to comply with recognised standards of quality, safety and patient information.”

Penny Viner, board member of the British Association of Homoeopathic Manufacturers, added: “This long-awaited regulatory development benefits the ever-growing number of users of homoeopathic medicine. Its provisions will encourage growth in the range of products on the market and enhance the consumer’s understanding of their benefits.”

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