New regulations on licensing of homeopathy

http://www.senseaboutscience.org.uk/index.php/site/project/86

The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006

On 1st September 2006, new regulations came into force that permit homeopathic products to make medical claims but exempt them from providing any scientific evidence that they are effective. This is the first time in its history that the regulation of medicines has moved away from science and from clear, meaningful information for the public. What is more, it happened without parliamentary time or public debate.

The need for evidence-based medicine needs to be restated as fully and publicly as possible. Sense About Science has produced a statement for signing online (just click at the bottom of the pdf).

On 9th October, Sense About Science summarised for parliament hundreds of responses. These were instrumental in pressing for the debate that was held in the House of Lords on 26th October. The serious concerns of the scientific and medical community were raised by Lord Taverne (Chairman of Sense About Science), Lord Rees of Ludlow (President of the Royal Society), Lord Turnberg, Lord Jenkin of Roding, Lord McColl of Dulwich and Baroness O’Neill of Bengarve. You can read the debate here and see some of the media coverage here.

Efforts are being made to continue this debate in the Commons and to bring the objections directly to the attention of the Government and the regulatory authorities. Please do continue to

• sign the statement and send in comments (click at the bottom of the pdf)
• contact medics and scientists and urge them to do the same
• ask your organisation what it is doing on this matter

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The regulations

The mission of the UK’s licensing body, the Medicine and Healthcare products Regulatory Agency (MHRA), is to ensure “that medicines and medical devices work, and are acceptably safe”. However, with the introduction of the new rules for homeopathy, it now accepts homeopathic provings as evidence of efficacy. A ‘proving’ is the method homeopaths use to determine the symptoms a substance causes (with a view to treating diseases with similar symptoms). Provings are not carried out on the finished product and are nothing to do with efficacy.

The regulations also mean that, for the first time in more than 30 years, homeopathic products will be able to make medical claims such as “For the relief of...”. Such claims, however worded, imply efficacy where none has been proven.

The MHRA did not have to change the regulations in this way. It was not required to do so by EC Directive 2001/83. The MHRA set out four options to government, including doing nothing. It chose to eliminate the old, stricter licences in order to facilitate the “expansion of the homeopathic industry” through new products.

The MHRA has designed the regulations to respond to pressure from the homeopathic industry, which wants to expand (see impact assessment right).