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

rose to move, That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 21 July, be annulled (S.I. 2006/1952). [44th Report from the Merits Committee]. The noble Lord said: My Lords, I declare an interest as the chairman of a charity, Sense About Science, which is concerned with the promotion of good science and an evidence-based approach to the public understanding of scientific issues. The statutory instrument which I seek to annul regulates the marketing of homeopathic products. It was laid before Parliament in July this year, a few days before the House rose for the summer Recess, and there has been no opportunity to debate it. It took effect on 1 September. Under European law, there was no obligation for the Government to introduce the regulation. EC Directive 2001/83 left it explicitly to nation states to decide how to regulate homeopathy, provided they meet the basic safety requirements of manufactured products. This regulation was made by the Medicines and Healthcare products Regulatory Agency—the MHRA—explicitly for the benefit of the manufacturers of homeopathic products. As the Explanatory Memorandum explains, the law as it stood formerly did not allow new homeopathic products to make claims for therapeutic benefits on their labels and failure to change the law would, in the words of the MHRA, "““inhibit the expansion of the homeopathic industry””." There was nothing to stop products being sold under what is known as the ““simplified scheme”” introduced in 1992, but a claim for efficacy could not then be made which was not scientifically tested. The new regulation, by the way, is concerned solely with homeopathy, not with alternative medicines in general. It has nothing to do with other so-called complementary medicines such as herbal medicines and acupuncture. I mention that because there has been some confusion about it. There is one very important, absolutely fundamental objection to this regulation. For the first time in the history of the regulation of medical products, it allows claims of efficacy to be made without scientific evidence. It is an abandonment of science and the evidence-based approach. Under this new regulation, the sole basis on which claims of efficacy can be made for homeopathic products quite legally is ““homeopathic provings””. There is no need for clinical or scientific tests. Homeopathy is not based on science and is not a science in any sense whatever. It is a system originally based on two laws proclaimed by the German physician Hahnemann in 1796. The first was that ““like cures like””. For this there is no evidence, any more than there is for the medical practice common at the time of suppressing symptoms by the treatment of opposites. However, as treating ““like with like”” could mean administering a poison, which is not exactly beneficial, he added a second law: the ““law of infinitesimals””, which states that the more a substance is diluted, the greater the benefit. Most homeopathic medicines are just about infinitely diluted in water, commonly by 10 to the power of 30—that is, one followed by 30 noughts. What remains is one part in 1 million million million million million. Nothing of the original substance remains. Not surprisingly, when homeopathic substances have been tested scientifically by double-blind experiments, no evidence has been found that they work any more than as a placebo. This was recently confirmed by a review in the Lancet of more than 100 different studies, which found that there was insufficient evidence that homeopathy is efficacious for any single clinical condition. The mechanism just cannot work. If it does work, it can only be by magic or miracle. Of course, a placebo can be helpful, because when people believe that something works, it often does—or they get better anyway—but it is the equivalent of witchcraft. Placebos work in odd ways, however. Injections have been found to work better than pills, and blue pills work better than red ones, except in the case of Italian men. However, dependence on the equivalent of coloured water can be harmful if people who are seriously ill believe in it strongly enough to avoid taking orthodox medicine. Some sellers of homeopathic products also make claims that, if acted on, could lead to serious consequences. Recently, Sense About Science exposed the fact that homeopathic remedies were being recommended against malaria—a very dangerous recommendation indeed. Evidence-based medicine has brought huge benefits to mankind. It is disgraceful that this regulation rejects the evidence-based approach. It undermines the value of a licensing regime. There is still much public concern about tragedies such as thalidomide, and we have gradually improved the regulation of medicines based on scientific evidence. The Medicines Act 1968 was part of this progress. There have been further improvements since. That is what we have come to expect. Now we get this regulation. It is not surprising that it has come as a shock to the medical and scientific world. Those who support evidence-based medicine in the strongest possible terms know that what is at issue here is the relationship of trust between the public and drug regulation. At Sense About Science, we have been inundated with expressions of concern. These include comments from the Royal Society, the Academy of Medical Sciences, the Medical Research Council, the Royal College of Pathologists and very many other scientific bodies. Let me read just three of the comments, the first from the British Pharmacological Society. I quote it first because two members of the MHRA, including the chairman, have pharmacological qualifications. The society says: "““The British Pharmacological Society believes that any claim for a medicine must be based on evidence, and that it is the duty of the regulatory authorities, in particular the MHRA, to ensure that no claims can be made for the efficacy of any form of medicine unless there is good evidence that the claim is true. Despite many years of investigation, we have no convincing scientific evidence that homeopathic remedies work any better than placebo””." Please note that that comes from the chairman of the MHRA, himself a professor of pharmacology. The Royal College of Pathologists made the following statement: "““For the first time in its history the regulation of medicines has moved away from science and away from clear information for the public. The College is deeply alarmed””." Thirdly, I quote the Biosciences Federation, which represents just about every relevant professional society in this field and has also expressed its extreme concern. It declared: "““The new regulations do not comply with the MHRA’s duty to ensure safety and efficacy of medicines, and to provide clear, honest advice to the public””." How can the Government ignore these concerns? How could the MHRA possibly justify this regulation? As the Biosciences Federation points out, the MHRA is in breach of its statutory duties, yet no one from that official body has come forward to defend its regulation since it became clear that there is a deep concern in all scientific quarters at what it has done. Both on 1 September and this last week all interviews were refused. That in itself is indefensible, since the MHRA is supposed to be accountable and transparent. Anyway, it is not the business of the MHRA to promote homeopathy or, indeed, any other trade or industry. Its declared aims include helping people to understand the benefits and risks of medical products and to communicate reliable information and advice. Are the Government going to rewrite the objectives of the MHRA to include the promotion of industry? I hope that the Minister will answer that point explicitly. Can we envisage as a next step that the MHRA will weaken the requirements of scientific testing of drugs, because failure to do so would inhibit the expansion of the pharmaceutical industry? As I said, that is the reason explicitly given for this regulation in the case of the homeopathic industry. What it has done is to promote what is in effect the selling of snake oil. This statutory instrument should be withdrawn—it is a disgrace. I beg to move. Moved, That an humble Address be presented to Her Majesty praying that the regulations, laid before the House on 21 July, be annulled (S.I. 2006/1952). [44th Report from the Merits Committee].—(Lord Taverne.)