Fears over homeopathy regulation

Homeopathic medicine regulation is changing

Patients will be put at risk by a new regulatory system being brought in for homeopathic medicine, critics say.

The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing rules to allow remedies to specify the ailments for which they can be used.

But critics argue the treatments will not be rigorously tested as they do not need to undergo the clinical trials orthodox drugs do to get a licence.

Homeopathic remedies have not been able to make health claims since 1968.

This will boost the homeopathic industry but will not benefit anyone else Professor Michael Baum, of University College London

Homeopathy is a system of therapy based on the concept that disease can be treated with drugs (in minute doses) thought capable of producing the same symptoms in healthy people as the disease itself.

Under the voluntary scheme, called the National Rules Scheme, homeopathic products will receive a licence if they can provide data proving the treatments are safe.

But they will have not have to produce evidence of efficacy from clinical trials.

They will also be allowed to indicate what sort of symptoms they can relieve, although this will be limited to minor ailments such as colds, coughs and hay fever.

To make such a claim, the manufacturers need only show that the product has been used to treat those particular conditions within the homeopathic industry.

Critics have also been angered by suggestions the MHRA has been partly motivated by a desire to boost the homeopathic industry.

In its consultation, the MHRA said failure to introduce the new system would inhibit the industry's expansion.

Michael Baum, professor of surgery at University College London, said he was perplexed by the new system as the MHRA was giving approval to products that had not been rigorously tested.

"This will boost the homeopathic industry but will not benefit anyone else. In fact, it could even put patients at risk.

"If someone suffers from a cough, it could be the first sign of lung cancer.

"However, if they use homeopathic medicine and the cough disappears it means doctors are not being given a chance to diagnose the condition in the early stages."

And Dr Evan Harris, science spokesman for the Liberal Democrats, said: "It's wrong that this country's medicines regulatory arrangements are being diluted and polluted by processes which allow ineffective products to be licensed as medicines without having to provide any scientific evidence of effectiveness."

But the MHRA said its key motivations were "protecting consumers and promoting choice" rather than boosting the industry.

Health claims

Homeopathic medicines on the market before 1968 were given Product Licences of Right (PLR), which allowed them to make claims about health benefits.

But once the UK entered the EU in the 1970s this stalled new products coming on to the market, because the nature of homeopathic medicines meant there was not the clinical evidence to support licensing regulations.

A simplified version was brought in 1992, which allowed homeopathic medicines to be licensed, but prevented them from making health claims.

Over 3,000 homeopathic medicines have licences, most of them PLRs.

Professor Kent Woods, chief executive of the MHRA, said: "This is a significant step forward.

"Products authorised under the scheme will have to comply with recognised standards of quality, safety and patient information."

Penny Viner, of the British Association of Homeopathic Manufacturers, said: "The provisions will both encourage growth in the range of products on the market and enhance the consumer's understanding of their benefits."