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

My Lords, one of the great joys of being a Health Minister in this House is that I am treated to a wide range of views. I am often strongly encouraged to support rather conflicting views. I shall try to confine my remarks to making clear the Government’s role in the regulation of homeopathic products and explaining the aims of the new national rules scheme, about which there may be some misunderstanding, given the remarks made in the debate. I bow to the professional knowledge of the noble Lord, Lord McColl, on which orifice to use for which medication. The use of homeopathic products in this country has a long tradition, as a result of which a wide range has been available and regulated in the UK for many years. Homeopathic products have, for example, been available in the NHS since its inception in 1948. Successive Governments have accepted that homeopathy has its place within the range of treatment options available to patients. That is a historical fact. This Government strongly believe that consumers in the UK should be free to make informed choices about their care, and that includes the freedom to choose homeopathic products. Whether such products are supplied and paid for by the NHS is, under current funding arrangements, for local NHS service providers and primary care trusts to decide. That is exactly the same system that was in place when the noble Lord, Lord Jenkin of Roding, was a distinguished Secretary of State for Health. These new regulations flow from new EU medicines legislation, but it is optional to member states whether they bring it in. This Government have chosen to introduce the new scheme because it will improve the regulation of these products in the UK while continuing to support the principle that consumers should have the right to choose to use them if they so wish. Apart from Denmark and France, we are the only EU country so far to have introduced this scheme that will improve the protection of consumers who choose to use such products, and we have acted in patients’ interests, not in the promotion of commercial products. Because homeopathic products are different from conventional medicines, it is right that they are regulated differently. Their efficacy cannot be demonstrated in the same way as is required for conventional medicinal products to obtain a licence, but that does not mean that homeopathic products should not be available. Having listened to the debate, I am not entirely clear how such products could ever demonstrate efficacy if they were totally banned. That would be a challenging scientific proposition. The new national rules scheme that this Government have introduced provides an appropriate regulatory scheme that will improve how many current homeopathic products are regulated. The new scheme continues to give consumers assurances of quality of manufacture and of safety and will provide them with better information about the products available. It develops existing arrangements, which involve two types of registration. The first is for homeopathic products that were on the market when the Medicines Act came into force in 1971 which have product licences of right (PLRs). When these products were included in that scheme in 1971, producers were allowed to label their products to say what they could be used for. Many of those products are still on the market today. The second regime is called the simplified scheme, which was introduced in 1992, when the EU first produced legislation for homeopathic products. New products coming on to the market since then have had to comply with those EU rules or with all the rules for conventional medicines, which of course would require them to demonstrate efficacy through clinical trials. Homeopathic products clearly could not do that. Moreover, the scheme’s products may not be labelled to say what they are for—that might be a disadvantage for users. In answer to the noble Baroness, Lady Barker, those existing regulations would continue if these new regulations were not introduced. The introduction of the new national rules scheme offers an alternative approach that will bring a number of benefits for patients. First, it will, for the first time since the PLR scheme in 1971, allow homeopathic products to be marketed with information to the consumer about what they can be used for. This will provide better information to the consumer and reduce the risk of confusion. We expect that some products currently authorised under the simplified scheme will be switched because they will, for the first time if they qualify, be allowed to be labelled as suitable for the relief of specified conditions. However, to qualify for authorisation under this scheme, the manufacturer has to show, from literature, that there is a tradition of use of that product for a particular purpose. So an evidence base is being used, although it may not satisfy everyone who has spoken. Secondly, homeopathic products authorised under the new national rules scheme are required to comply with all aspects of the conventional medicines regime, except the requirement to demonstrate efficacy through clinical trials. That will bring significant benefits: improved assurances of quality in manufacture, safety, the review of information given to consumers, and the requirement to submit regular safety reports to the regulator and to submit to inspections. All those elements should reassure consumers, as the measures will enhance safety for those who choose to use homeopathic products. Thirdly, and importantly, the new national rules scheme provides a possible regulatory home previously not available when we had only the simplified scheme or a full licence available for the products with product licences of right. The MHRA intends to review all the PLRs in the next seven years to ensure that they are of appropriate quality and safety. The MHRA will allow only products authorised under the new scheme to be labelled as suitable for the relief of minor symptoms or conditions—as the noble Baroness, Lady Barker, made clear—products that you would expect to see available on general sale in, for example, supermarkets. This measure, while maintaining consumers’ freedom to choose to use homeopathic products, will ensure that such products are better regulated and provide more and better information to the consumer. Furthermore, a mandatory statement will be included in the pack instructing the patient to consult their doctor if symptoms persist. Again, that is a new measure that directs people towards conventional medicine if there is a problem. The Advisory Board on the Registration of Homeopathic Products, a committee established under the Medicines Act to advise Ministers on matters concerning homeopathic products, will be instrumental in providing advice on the indications for, and safety and quality of, products registered under the new scheme, and on the review and rationalisation of PLRs. In last year’s review of the medicines advisory committee, the advisory board was given a new and enhanced role to advise the Government directly on matters relating to homeopathy. It is an independent committee whose membership includes homeopathic practitioners, people with a wide range of clinical expertise, including GPs, paediatricians, toxicologists and pharmacists. The noble Lord, Lord Taverne, suggested that the Government are bowing to commercial pressure from the homeopathic industry in introducing this scheme. This is absolutely not the case. I have had meetings with the homeopathic industry, and I do not think that it sees us in the light that has been described this afternoon. As I have explained, the Government believe that the new national rules scheme provides a significant opportunity to improve consumer information about the use of homeopathic medicinal products on the UK market while maintaining rigorous control over their quality and safety. That will be welcomed by consumers who choose to use those products for minor conditions or illnesses. Unfortunately, a number of remarks have been made about the MHRA. It is not in breach of its statutory duties, nor does it promote homeopathic products on behalf of the industry that sells them. Having worked with the MHRA as the Minister responsible for it for two years, I regard it as a distinguished public body that has done a great deal in this country to protect the public through the regulation of medicinal products in a scientific way. The MHRA has a role in not only authorising products on grounds of efficacy, but ensuring that safety and quality standards are maintained. It is not concerned purely with efficacy. We accept that this scheme does not provide any endorsement of clinical efficacy as happens with conventional medicines. It is not designed to replace the use of more conventional treatments, which is why it is restricted to products for the relief of minor conditions that do not require medical intervention. Central to our policy was the inclusion of a statement in the product literature advising patients to consult their doctor if symptoms persist. I believe that the scheme will enable consumers to make more informed choices about the use of homeopathic products, and the regulatory regime will ensure that standards of quality and safety are maintained in the production and use of homeopathic products. That stance in no way diminishes the Government’s support for evidence-based medicine or for scientific research into new pharmaceutical products that benefit patients. We have done much as a Government to support science and research, and will continue to do so. Homeopathic products are, however, in a different category. Provided that such products are safe, properly manufactured and clearly labelled without making false claims, which they will be under the new national rules scheme, patients should not be denied access to them for the conditions to which they relate. A number of noble Lords, including my noble friend Lord Turnberg, raised the issue of NICE. The Government have no plans to refer homeopathic remedies to NICE at present. I gently draw noble Lords’ attention to the fact that NICE has quite a few things on its plate at the moment, including many potentially life-saving drugs. However, there is nothing to stop the use of the yellow card scheme, authorised under the new national rules scheme, to be applied in respect of adverse effects to homeopathic products, as is the case with conventional medicines. I believe that this is an area where we have to regulate in the way that we have done but, in our view, we must not deny people the right to use these medicines when they are safe, manufactured to an appropriate quality and properly labelled. These are good regulations that should be on the statute book.