Some of you may remember this story, about MHRA plans to change regulation of homeopathic remedies, and allow them to make medical claims with no evidence, which I wrote about on the last day of 2005, and which becomes law today.
Below is the press release from the MHRA. There’s quite a lot about this that raises eyebrows for me. Firstly, the statutory instrument got slipped in to parliament a couple of days before the recess, so nobody could scrutinise it. Secondly, this press release is a bit of an advert for homeopathy, a treatment which, frankly, has had its day: there are meta-analyses examining vast numbers of papers which show it is no better than placebo (the very existence of these papers is still denied by various people in the homeopathy community, including many medics and, bizarrely, the British Homeopathic Association itself).
So the press release talks about how the changes “will enhance consumer confidence with respect to the safety, quality and use of these medicines.” Which is not a good thing for a treatment that doesn’t work.
It also offers to put you in touch with some friendly homeopaths: I fail to see what business that is of the Medicines and Healthcare Products Regulatory Authority.
Lastly, it features a man who makes money making these sugar pills saying that its provisions will “encourage growth in the range of products on the market” as if this is a good thing, and something that a government should be involved in encouraging.
I don’t think I can be bothered to write about it all over again – unless you either (a) think I should or (b) have some good jokes I can steal on the subject – but I thought you might like to see the press release. In the meantime if anyone finds an example of a new homeopathic remedy making a claim to be useful in a condition, do let me know.
The bigger problem in the background is this: the MHRA, and the bodies that came before it, are serious regulatory bodies that are engaged in serious business, checking that medicines are safe, and that pharmaceutical companies do not make unreasonable claims. They brought in the Yellow Card System as a response to things like Thalidomide. And here their credibility is, in my mind, undermined. This change will be exploited by quacks to suggest that their treatments have received tacit endorsement, as has happened many times before.
Anyway [coughs] just remember, back in Dec ’05 you heard it first in Bad Science….
Embargoed until 00.01 hrs on Friday
1 September 2006
Date: 01 September 2006
Subject: National Rules Scheme for homeopathic medicines
Contact: Press Office xxxxxxxxxxxxxxxxxxx
Improved patient information and greater consumer choice â€“ new rules to regulate homeopathic medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has today introduced a new scheme to improve and strengthen the regulation of homeopathic medicines in the UK. The National Rules Scheme for homeopathic medicines will enhance consumer confidence with respect to the safety, quality and use of these medicines.
From today, companies will be encouraged to register new homeopathic medicines under this scheme, with the option of re-registering certain existing products. For the first time since Product Licences of Right were issued in 1971, companies will be allowed to include information about the treatment and relief of minor, self-limiting conditions based on the use of the product within the homeopathic tradition. For example, labels may indicate that a product may relieve the symptoms of common colds and coughs, hay fever or chilblains. All homeopathic medicines authorised under the new scheme will have clear and comprehensive patient information leaflets to help consumers use their medicines safely and effectively.
Professor Kent Woods, Chief Executive of the MHRA, said, â€œThis is a significant step forward in the way homeopathic medicines are regulated. Products authorised under the National Rules Scheme will have to comply with recognised standards of quality, safety and patient information.â€
Penny Viner, Board Member of the British Association of Homeopathic Manufacturers (BAHM), said, â€œThe British Association of Homeopathic Manufacturers welcomes the coming into force of this new scheme. This long-awaited regulatory development benefits the ever-growing number of users of homeopathic medicine: its provisions will both encourage growth in the range of products on the market, and enhance the consumerâ€™s understanding of their benefits.â€
Notes to Editors
1. The MHRA press office can assist you with any queries you have in making contact with homeopathic practitioners. Call ### #### ####
2. The National Rules Scheme for homeopathic medicines was introduced today following a full public consultation in 2005. There was widespread support for the proposals. The summary of responses can be seen at:
3. Homeopathic medicines in the UK are currently covered by either the Product Licences of Right (PLRs), or by certificates of registration under the Simplified Registration Scheme. PLRs were issued to all medicines on the market when the Medicines Act 1968 was introduced. The National Rules Scheme will build on these existing regulatory frameworks, with a particular emphasis on indications and appropriate labelling and literature.
4. All homeopathic medicines fall within the scope of the Yellow Card Scheme, which will allow patients and healthcare professionals to report suspected side effects to the MHRA. For over 40 years, the Yellow Card Scheme has been the cornerstone of medicines safety monitoring in the UK. Since the Yellow Card scheme was set up, over 500,000 reports of suspected side effects (known as adverse drug reactions) have been completed, enabling the MHRA to identify and take action on a wide range of previously unrecognised medicines safety issues. Adverse effects associated with the use of homeopathic medicines should be reported to the MHRA using the Yellow Card Reporting Scheme. www.yellowcard.gov.uk
5. The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.
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