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On 1st September 2006, new regulations allowed homeopathic products to be marketed alongside conventional medicines while exempting them from providing scientific evidence of efficacy. The motivation for these new regulations, according to the Regulatory Impact Assessment of the Medicines and Healthcare products Regulatory Agency (MHRA), was to eliminate old-style licences and to facilitate the expansion of the homeopathic industry in the UK through new products. The changes have been denounced by many doctors and scientists.
The UK medicines regulator is proposing to scrap a controversial scheme to approve indications for the marketing of homeopathic remedies, after only one treatment was approved in five and a half years. An MHRA spokesperson said: ‘The Red Tape Challenge asks whether existing regulations are really providing the protection that is intended, or are they unnecessary or overcomplicated and need to be improved or go altogether.'
‘Even where regulations are EU derived, as many of these regulations are, there may still be scope to improve implementation and enable greater efficiency. We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections.'
Professor Edzard Ernst, professor of complementary medicine at Peninsula Medical School in Exeter and a prominent critic of the scheme, said: ‘In the past, the MHRA repeatedly stressed that the regulation comes from the EU and they have no choice but have to implement it, but the regulation is clearly nonsense and flies in the face of science.' Pulse (15th March 2012)
"The MHRA recently advertised for new members of [its] committee [the Advisory Board on the Registration of Homoepathic Products] via the Appointments Commission. My good friend and fellow HealthWatch committee member, Professor Susan Bewley, wrote to the Appointments Commission, to ask what possible use the committee was. Here is the reply she received." Majikthyse (26th October 2011)
The MHRA has vowed to keep its controversial scheme to approve indications for the marketing of homeopathic remedies, despite criticism from a House of Commons report. The Government had consulted the public on proposals to potentially scrap the National Rules Scheme for homeopathic medicines altogether or to merge the system with other regulations to simplify the process of registering homeopathic remedies in England. The results of the consultation, which formed part of the Cabinet Office's ‘Red Tape Challenge' earlier this year, are yet to be published. But the MHRA told Pulse it is not intending to make changes to the scheme. The scheme enables manufacturers to register indications for the treatment of minor conditions if they can supply a dossier of data on quality, safety and efficacy. But since the National Rules Scheme was created in 2006, only one homeopathic treatment has been given an indication – Nelson's Arnicare Arnica 30c pillules – which was able to market itself as providing ‘symptomatic relief of sprains, muscular aches and bruising or swelling after contusions'. The scheme was heavily criticised in the House of Commons health committee's ‘evidence check' report on homeopathy in 2010, which said the same ‘rigorous scrutiny' on safety, quality and efficacy applied by the MHRA for other medicines should apply to homeopathic products…In 2010, the Department of Health decided to reject a call from the House of Commons science and technology committee for a national ban on NHS funding for homeopathic treatment. The DH said it was instead up to local commissioners to decide whether requests should be funded on a ‘case-by-case basis'. Since then, funding for homeopathic treatments has been cut by some English PCTs.” Pulse (14th August 2012)
Nelsons, UK manufacturers of such products as Bach Rescue Remedies, and a range of homeopathic sugar pills, such as Teetha, have been inspected by the US authority the FDA as their products are exported to the US. The FDA reports many concerns about their manufacturing processes in London and have ordered them to report how they are going to remediate their concerns…Nelsons appear to go through the magic rituals of homeopathic preparation, including the impossible dilutions and magic shaking.Therein lies their problem. There are genuine concerns in the letter, such as the failure to keep manufacturing production free of broken glass…The [FDA] investigator also observed for Batch #36659 that one out of every six bottles did not receive the dose of active homeopathic drug solution due to the wobbling and vibration of the bottle assembly during filling of the active ingredient. The active ingredient was instead seen dripping down the outside of the vial assembly…Given that they are dripping pure water/ethanol onto sugar pills, which quickly evaporates, the fact that some pills were not getting their magic mixture is immaterial. Of course, no homeopaths have complained that the pills they received were duds as all pills are duds. Homeopathy does not work. Its a placebo treatment. Such are the absurdities of regulating magic. Some questions arise though. Why has our own medicines regulator, the MHRA, failed to spot such lax manufacturing processes on its own turf? Will Boots the Chemist and Holland & Barrett remove these products from its shelves until such time as Nelsons can demonstrate that their magic rituals are being applied appropriately? I have written to them both to find out.” Andy Lewis, The Quackometer (9th August 2012)
“The history of how we came to have the Government body [MHRA] that regulates pharmaceutical drugs and medical devices wasting their time on homeopathic products is long and complicated. However, as a result of lobbying by homeopaths, the EU created Directives that mandated countries to create regulatory schemes for these sugar pills. Unfortunately, it fell to the UK’s medicines regulator to implement the rules and enforce them. However, with the false imprimatur that statutory regulation gives their products comes the duty on homeopaths to abide by all the regulations as well. They can’t have one without the other and it would be hoped that responsible manufacturers would ensure they were fully compliant. It seems not…Whether the changes they have made to their websites is sufficient to convince the MHRA that Helios and Ainsworths are complying with the regulations is something the MHRA will have to decide. But like it or not, the Medicines Regulations exist and abiding by them is not optional — even for homeopaths. This bitter pill may be hard to swallow and they are now submitting some of their unlicensed products to the MHRA so that they can start to sell them as properly registered products. However, that still leaves the unresolved problems of Helios’ 2,495 and Ainsworths’ 3,355 homeopathic products on their website that would appear to be unlicensed homeopathic ‘medicines’.” Zeno’s blog (8th August 2012)
“If evidence and reason cannot end homeopathy, the law will. Homeopaths have been in a panic over the MHRA’s activities in cleaning up existing medicines’ law. MPs have been bombarded with desperate, but misleading claims, that the law is being changed and that they will be put out of business:
UK medicines legislation (including for homeopathy) is being consolidated. The law is not being changed. The consolidation will happen through the Human Medical Regulations 2012, which were due to come into force in July 2012. They will be laid under the negative resolution procedure.
Some homeopathic practitioners are concerned that following the consolidation the law will be enforced. They believe that this could end the sale of unauthorised homeopathic medicines over the internet and telephone. They are seeking a change in UK law…Unfortunately, not changing regulation [the Govt. rejected substantive changes] is very bad news for homeopaths because the consolidated regulations will be very clear in showing that much of homeopathic commercial activity is illegal…Some may try to practice within the law by only selecting one of the few registered products. But to remove most of their remedies is a blow to the very heart of how they define themselves. Homeopaths believe they must select the right remedy. Being unable to legally supply that remedy stops them being homeopaths. The people responsible are not bloggers like me. It is the homeopaths themselves. They failed to ensure their trade was placed on a firm legal footing. They had thirty years to get this right. Their panic in the last few weeks is no substitute. It is a failure of leadership, diligence and competence.” Andy Lewis, The Quackometer blogspot (26th June 2012)
“When it comes to alternative medicine, the UK's regulator appears only to exist to legitimise quackery…The MHRA is charged with regulating medicines and medical devices. Their ’mission statement’ is
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
This is all good. Except when it comes to superstitious and pseudoscientific forms of treatments, they casually drop the condition that providers should be able to demonstrate that they work. The result is that absurd and unproven medical treatments are able to compete on pharmacy shelves with products that have proven benefit. For consumers, it is difficult to tell that one product has an evidence base and the other is fantasy. The MHRA appear to adopt labelling policies that deliberately obscure the nature of homeopathic remedies and give ‘approval marks’ to unproven herbal remedies…A group of medics and researchers (all members of Healthwatch) have written to the BMJ [click on link above for full text of letter] …expressing their deepening concern that the MHRA are “clothing naked quackery and legitimising pseudoscience”. What has initiated this letter is the recent advertisement for ‘experts’ to sit on a Advisory Board to consider the registration of homeopathic products. The job specification calls for homeopaths who are “recognised by their peers as eminent members of their profession”. The problem is obvious. If you believe nonsense, how can you be an expert? As I have written recently, when the regulator believes in fairies, who protects the public?” Lecanardnoir, Quackometer blogspot (23rd September 2011)
Designed to “provide clarity about the rules governing the advertising of homeopathic medicines licensed under the three regulatory schemes available”. (2nd March 2011)
“At midnight last night, the Medicines and Healthcare Regulatory Authority closed its consultation on how they should label homeopathy sugar pills without misleading the public. You may not think this is a difficult task, but politics makes it so. To recap: homeopathy pills don’t work better than placebo dummy pills in trials. They are made by taking one drop of the original substance and diluting it in...
1,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000, 000,000,000,000 drops of water
...then taking one drop of that solution, which is now just water, and shaking it near some pills, which you then buy to treat an illness. Current MHRA wording says: “a homeopathic medicinal product used within the homeopathic tradition for the treatment of [whatever condition]”. Homeopaths like this because it’s ambiguous. Their internal lobbying document (which I have helpfully posted on the internet for everyone to read), explains that this wording “avoids the need to prove the science” and so “allows us to practise as normal”.
Can the MHRA walk the line between evidence, politics, and clarity? Quack remedies are in their own world of silliness, but we are entitled to have higher expectations of regulators, since they themselves expect to be taken more seriously.” Ben Goldacre, Bad Science (19th February 2011)
The results of Ben Goldacre’s invitation to members of the public to write the label better than MHRA - see comments section. Ben Goldacre’s Posterous (17th February 2011)
"The Medicines and Health Regulatory Authority (MHRA), has just launched yet another consultation…The consultation concerns what should be done, about homeopathy in the wake of the scarifying report of the House of Commons Select Committee, and the government’s response to that report...More honest labelling was about the only sensible thing recommended by the Government’s response. On this topic the MHRA proposals verge on the laughable. At present the labelling allowed under the NRS includes:
“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of ...”
It is proposed to change this to:
“A homeopathic medicinal product licensed only on the basis of safety, quality and use within the homeopathic tradition”
“A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of…”
Spot the difference!
The is utterly inadequate. In fact it verges on the pathetic (and on the dishonest)…Why, oh why, cannot the MHRA bring itself to simply tell the truth? It seems to be so stifled by some perversion of political correctness that it is unable to do what it must know is right.”
Professor David Colquhoun, DC Science (26th January 2011)
“The MHRA say they test the public's understanding of homeopathic labeling; they do not such thing…The MHRA appear to completely miss the point over homeopathy. As I have written before, they fail twice over. Firstly, they endorse misleading labels on homeopathic products and fail in their primary mission to “ensure that medicines and medical devices work.” Secondly, they appear to be blind to the blatant abuses that do go on in the creation of homeopathic medicines where claims are made explicitly and implicitly without even seeking MHRA approval. The mistake that all regulatory efforts from this government has made is to attempt to regulate alternative medicines as if they were medicines. They are not: they are pseudo-medicines and need a different style of thinking. Trading Standards should take a more leading role in prosecuting misleading claims as they would with any other consumer product. The MHRA need to stop feeling they need to treat homeopathy as if it were medicine and give special dispensations in the claims that they can make. As with any other medicine, homeopathy should only be allowed to make claims if they can back them up with sound evidence.” The Quackometer (15th January 2010)
The Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006 [pdf]
From Professor Michael Baum (Emeritus Professor of Surgery, University College London), Dr Evan Harris MP (Liberal Democrat Science Spokesman), Professor David Colquhoun (Professor of Pharmacology, University College London), Professor Edzard Ernst (Professor of Complementary Medicine, University of Exeter), Professor Gustav Born (Emeritus Professor of Pharmacology, Kings College London), Professor John Garrow (Emeritus Professor of Human Nutrition, University of London), and Tracey Brown (Director, Sense About Science). Comments published by Sense About Science.
"…..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." A critical commentary on the new regulations from Ben Goldacre, MD (Bad Science)
"Here we have a completely ludicrous system of medicine that does not work, a government regulatory agency which is meant to ensure that medicines are not only safe but that they work, and yet that very government agency is not only supporting, but promoting, the use of bogus medicine!" John Jackson (UK Skeptics)