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There are no great concerns about the safety of homeopathic treatments. What is at issue is their effectiveness. Obviously placebo effects can be powerful, nobody denies that. It is, however, quite different to assert that homeopathic treatments offer benefits beyond a placebo. Indeed, if medicines can really work even when so diluted that barely a single molecule is left, this would entail some fundamentally new scientific principle with amazingly broad ramifications. It would mean that materials like water carry imprints of their past and can remember their history, as it were, in some quite novel and mysterious way. If that were the case, it would have fundamental implications for precise experiments over the whole of science.
So it seems to me that the burden of proof on homeopathic remedies should actually be higher, not lower, than for conventional ones. Extraordinary claims demand extraordinary evidence. To put it mildly, so-called homeopathic provings seem to fall far short of that. That is why I wholeheartedly support what the noble Lord, Lord Taverne, is saying on this issue.
Lord Colwyn: My Lords, patients tend to use complementary medicine as a supplement to orthodox medicine. There is less emphasis on symptoms and the treatment is usually highly individualised. Whether the treatment is herbal, essential oils, acupuncture or homeopathic, it will be influenced by the patients personality and lifestyle as much as by the problem that is presented.
Given the massively high levels of iatrogenic disease and morbidity from orthodox treatments, I am astonished that the noble Lord, Lord Taverne, can dismiss homeopathy in such a frivolous manner. He and my noble friend Lord Jenkin imply that homeopathy can be harmful. I sat on the Select Committee to which the noble Lord referred and although I do not have the papers in front of me, I believe we felt that as homeopathic medicines were basically water, they could not be harmful.
Each year in the UK, about 850,000 adverse effects are caused by orthodox medical treatment. I am sorry to say that 120,000 of these are deaths. How can the use of homeopathy compare with this? Where is the logic of dismissing treatment by a homeopathic product which has never directly caused a death and, when analysed, is shown to contain no active ingredient? Is it not unscientific to abandon treatments that are valued and desired by patients or to dismiss treatments that a particular lobby just does not like?
To say that homeopathy is not evidence-based is completely untrue. Despite chronic underfunding, a substantial body of evidence exists to prove the effectiveness of homeopathy. Now is not the time to list them. The noble Countess, Lady Mar, mentioned some and the evidence is available. I went on a course about 15 years ago on the relationship between quantum physics and homeopathy. I probably did not understand a word I was told at the time, but at least there was evidence that the two were linked.
If homeopathic treatments are harmful, why is there almost total absence of any negligence claims to prove the point? Any case against homeopathy must rest on the argument that the most innocuous of practices may be harmful if they prevent the patient from seeking other more appropriate treatment. Despite the persistence of this line of attack and the anecdotal stories we have heard today, there is no firm evidence to support it. The homeopathic approach helps patients for whom conventional treatment has been unsuccessful or has unacceptable side effects.
It is interesting to consider why homeopathy, which of all complementary therapies is probably at most variance with orthodox medicine, should have received sufficient support from the Government to be able to maintain a number of specialised hospitals.
The new regulations clear up an anomaly and bring the UK into line with other countries and the 2005 legislation on the traditional use of herbal medicines which allows a herbal product with 30 years traditional use to include indications based on information obtained from its long-standing use and experience.
Companies will now be encouraged to register new homeopathic medicines, with the option of reregistering certain existing products, and 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. The legislation will benefit the ever-growing number of users of homeopathic medicine, and its provisions will encourage growth in the range of products in the market and enhance the consumers understanding of their benefits.
Homeopathic medicines have been used for more than 200 years and there is wide evidence to support their use and effectiveness, placebo effect or notand I have no problem with the placebo effect. They are safe and have never killed anyone, unlike many newly developed drugs for which strict testing is justifiably required. I must resist the Prayer.
Baroness Barker: My Lords, it is always interesting to follow my noble friend Lord Taverne in a debate. I look forward to taking part in debates with him as he is not only an incredibly knowledgeable but a very passionate speaker.
It is important not to lose sight of what we are talking about here. We are talking about remedies for minor self-limiting conditions, such as travel sickness and muscular pain. Most of the orthodox equivalents for those conditions would be over-the-counter medicines, which probably have efficacy rates that are equally contentious.
It therefore seems to me that the principal matter we should address is the extent to which these products are deemed to be safe and the claims that are made about them. I agree with what my noble Lord, Lord Rees, said in his introduction, although perhaps not with his conclusions.
My reading of the order before us is that an extensive process is set out by which product manufacturers are required to demonstrate safety. There is an inherent dilemma in the questions my noble friend Lord Taverne poses to the homeopathic world. While he dismisses their products as being ineffective and not scientifically proven, he then asks for scientific proof. I would imagine that those on the other side of the argument would point out that that is an impossible thing to ask. They cannot, and perhaps do not wish to, prove what they do in scientific terms. I am struck by the extent to which we have to try to keep a sense of equivalence in all of this. The noble Lord, Lord Turnberg, made an interesting point about the extent to which homeopathic remedies might make people present late for conventional treatment. The same accusation might well be levelled against conventional orthodox treatments of a minor nature. That is one of the difficulties we have.
The principal question I want the Minister to answer is: what would have been the effect on public health and the health of individuals had this measure not been tabled and had the MHRA not set out the requirements that it has? Leading on from that, the key question for all of us is what the consequent marketing authorisations will be for these products. What claims will manufacturers be able to make for them? The phrase for the relief of has already been mentioned. That phrase is used by those whose products for treating minor conditions such as flu are of a more conventional nature. I am not sure that they are any more effective.
It is important that we know precisely what the marketing authorisation will be. What statement will manufacturers be able to make as a result of their product meeting the regulations? That issue was mentioned in the papers that we have been given. I note that in the consultation on the regulations there seemed to be a body of opinion that a product which had been through this process could be marketed as an anthroposophic medicinal product. I sincerely hope that that is not the case as that would be highly misleading for the general public. If as a result of going through these processes, a statement can be made that a product is based on homeopathic assessment, that is fair and reasonable. It is accurate and does not claim to be done on a scientific basis.
There is agreementwhether negative or positivethat on balance homeopathy does no harm. Certainly its efficacy is unproven. We need to be sure that the measure does not open the way for product manufacturers to take greater licence than they should on making efficacy claims for products and regarding the basis of those claims. If the noble Lord can answer those questions, I shall be content for the measure to proceed.
Lord McColl of Dulwich: My Lords, as the noble Lord, Lord Taverne, has said, if a patient has faith in a remedy, it is perfectly possible for their symptoms to be relieved, so long as they are not serious. If, in addition, the patient is made happy by that, his immune system will work better. There is good scientific evidence on that.
One of the problems with this whole subject is that it is bedevilled by various organisations putting forward explanations for how these alternative therapies work. I mention acupuncture en passant. There is no doubt that acupuncture works, probably through releasing endorphins. But this business of there being special tracks and of having to insert the needle in special places is not so. You can stick them in anywhere and the effect is still the same. In reflexology you will see a diagram of the foot and various areas described as the lung area, the heart area and various other areas. What a pity that these strange explanations are given. Why do they not say, If youre feeling ill and a beautiful young lady comes along and rubs your foot, you will feel better? That is perfectly acceptable.
Having said that, alternative therapies have been shown to help with diseases such as multiple sclerosis and cancer, as NICE has reported. Homeopathic
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The EU directive, which we were not obliged to enforce, states that, in order to acquire marketing authorisation, a herbal product must have been used in medical practice for at least 30 years, with 15 of those years having been in the EU. This directive covers only products that are taken orally, used externally or inhaled. It has obviously been forgotten that there is another route for medicines, especially in France. Does the Minister have any information on that?
Article 8 requires that the decision to license a medicine is based on the quality, efficacy and safety of the product. The fees for gaining a licence for a product will vary according to the number of active ingredients. As some products contain large numbers of ingredients, this could prove very expensive. How will it be decided which ingredients are active?
Under the directive, the efficacy of traditional herbal medicinal products does not have to be supported using clinical studies. That is a great pity. The pharmacological effects and efficacy must be shown to be plausible on the basis of long-standing use and experience. How will NICE define plausible? NICE determines all its decisions on the use of drugs on an analysis of their cost and clinical effectiveness and believes that homeopathic medicines should be treated in exactly the same way as traditional medicines in deciding whether the NHS should provide them to the public. What advice is the Minister now giving to NICE on this aspect?
The Conservatives believe that the NHS should not exclude alternative therapies. If the NHS rules out providing a herbal therapy, it should do so only on the basis of indisputable evidence, as is the case with all other conventional medicines. Equally, if the NHS decides to provide a particular treatment, this should again be done on the back of evidence. We see the most effective route as the cost-clinical effectiveness criteria which NICE employs in the decision-making process on drug regulation and use. We have always said that as long as these remedies have been proven to be safe, they should be available to buy. Consumers are then free to make their own assessment.
Baroness O'Neill of Bengarve: My Lords, I declare an interest as a trustee of Sense About Science. I believe that the public damage in these regulations does not lie in the circulation of homeopathic remedies but in the diffusion of the standard for the evaluation of remedies. It seems to me that NICE is the one body that can arbitrate in this area. I hope that the Minister will respond to the question of the noble Lord, Lord Turnberg, on the role of NICE in this matter.
The Minister of State, Department of Health (Lord Warner): 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 Governments 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
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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 schemes products may not be labelled to say what they are forthat 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 conditionsas the noble Baroness, Lady Barker, made clearproducts 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
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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 years 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, and 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.
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