1. The Government welcomes this report, the second in the new programme of work by the Science and Technology Committee to examine how the Government uses evidence to formulate and review its policies.
2. Complementary and alternative medicine, including homeopathy, has a long tradition, and very vocal proponents and opponents. The Select Committee’s report sets out evidence and opinion on each side, with a strong focus on efficacy as being one of the main criteria by which it would expect NHS decisions to be made.
3. We remain committed to ensuring that the appropriate use of sound evidence is embedded in policy-making. Efficacy is certainly important. Also important, however, are the fundamental principles that underpin the relationships between the Department and the NHS in England, between UK medicines legislation and the European regulatory framework, and between the clinician and the patient.
4. The Department sets out policy guidance and recommendations, and asks that the local NHS implements that policy in the way that is most appropriate for their local communities. Primary Care Trusts are responsible for commissioning high quality services, within allocated resources, to meet local patient needs.
5. Given the geographical, socioeconomic and cultural diversity in England, that involves a whole range of considerations including, but not limited to, efficacy. Given the pressure on the NHS in the current economic climate, we are currently looking, as part of the Quality, Innovation, Productivity and Prevention agenda, at what more we could do in terms of providing information that would help support commissioning decisions1.
6. The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health, is responsible for the regulation of medicines (including homeopathic products) and medical devices. The medicines regulatory framework is largely set at a European level. European Union legislation includes specific provisions and definitions concerning the regulation of homeopathic products. The UK, like any other EU Member State, must comply with requirements set out in European Directives.
7. Most importantly perhaps, the relationship between a clinician and a patient is one that is built on trust and understanding. Clinicians are bound by a strong moral code but also by the guidance from the General Medical Council – rather than by instructions from the Department. We believe in patients being able to make informed choices about their treatments, and in a clinician being able to prescribe the treatment they feel most appropriate in particular circumstances, within the regulatory and guidance frameworks by which they are bound.
8. We agree with many of the Committee’s conclusions and recommendations. However, our continued position on the use of homeopathy within the NHS is that the local NHS and clinicians, rather than Whitehall, are best placed to make decisions on what treatment is appropriate for their patients - including complementary or alternative treatments such as homeopathy - and provide accordingly for those treatments.
9. The Government Chief Scientific Adviser has discussed the Department of Health policy on homeopathy with lead officials, and understands the reasons for the policy decision. However, he still has concerns about how this policy is communicated to the public. There naturally will be an assumption that if the NHS is offering homeopathic treatments then they will be efficacious, whereas the overriding reason for NHS provision is that homeopathy is available to provide patient choice.
10. In order for the public to make informed choices, it is therefore vitally important that the scientific evidence base for homeopathy is clearly explained and available. He will therefore engage further with the Department of Health to ensure communication to the public is addressed. His position remains that the evidence of efficacy and the scientific basis of homeopathy is highly questionable.
Policy on NHS funding and provision of homeopathy
We recommend that the Government determine the total amount of money spent by the NHS on homeopathy annually over the past 10 years, differentiating homeopathic products, patient referrals and maintenance and refurbishment of homeopathic hospitals, and publish the figures. (Paragraph 15)
11. Data on total spending in the area of homeopathy on the National Health Service have never been routinely collected. A new requirement on the NHS to provide this sort of information would require the prior approval of the Review of Central Returns - a committee established by ministers to advise on the burden of data collections. Mandatory data collections are approved only where issues have a direct read across to either the NHS Operating Framework or its Vital Signs: this is not the case here.
12. Voluntary data collections are more feasible, but still cannot provide the level of detail sought here. As the Minister for Health, Mike O’Brien QC, set out to the Committee at the hearing in November 2009, we had requested that Primary Care Trusts provide estimates on this to the Department of Health, through their Strategic Health Authority. The majority appeared not to routinely commission or fund homoeopathic treatments with many clearly stating they did not commission or fund homeopathy.
13. We agree with the Committee that ensuring appropriate NHS spending is important, whatever the sums of money involved, but it is also important to keep spending in perspective. With an overall budget of over £100 billion, scrutinising individual trusts’ finances to the level of detail that would be needed to answer this question fully, or similar questions in other areas, could well require a disproportionate amount of resource.
The existing evidence base and the placebo effect
We consider that conclusions about the evidence on the efficacy of homeopathy should be derived from well designed and rigorous randomised controlled trials (RCTs). (Paragraph 20)
We expect the conclusions on the evidence for the efficacy of homeopathy to give particular weight to properly conducted meta-analyses and systematic reviews of RCTs. (Paragraph 25)
We have set out the issue of efficacy and effectiveness at some length to illustrate that a non-efficacious medicine might, in some situations, be effective (patients feel better) because of the placebo effect. That is why we put more weight on evidence of efficacy than of effectiveness. (Paragraph 39)
We would expect the Government to have a proper understanding of the power and complexities of the placebo effect and the ethical issues surrounding its use in a clinical setting; otherwise it cannot hope to make good decisions relating to patients and public health. (Paragraph 40)
Our expectations of the evidence base relevant to government policies on the provision of homeopathy are straightforward. We would expect the Government to have a view on the efficacy of homeopathy so as to inform its policy on the NHS funding and provision of homeopathy. Such a view should be based on the best available evidence, that is, rigorous randomised controlled trials and meta-analyses and systematic reviews of RCTs. If the effects of homeopathy can be primarily attributed to the placebo effect, we would expect the Government to have a view on the ethics of prescribing placebos. (Paragraph 47).
14. The Government agrees that, when looking at the evidence base for efficacy, it is important to focus on the most scientifically robust studies and evidence. We note, however, that a “proper understanding of the power and complexities of the placebo effect” is difficult to achieve, since we are not aware of any scientific consensus at present on the mechanisms by which placebos have an effect. We note also that it is not for the Department of Health to comment on the ethics of the use of a particular treatment in a particular setting.
Patient satisfaction, trust, and the right to choose
We do not doubt that homeopathy makes some patients feel better. However, patient satisfaction can occur through a placebo effect alone
and therefore does not prove the efficacy of homeopathic interventions. (Paragraph 82)
When doctors prescribe placebos, they risk damaging the trust that exists between them and their patients. (Paragraph 97)
For patient choice to be real choice, patients must be adequately informed to understand the implications of treatments. For homeopathy this would certainly require an explanation that homeopathy is a placebo. When this is not done, patient choice is meaningless. When it is done, the effectiveness of the placebo—that is, homeopathy—may be diminished. We argue that the provision of homeopathy on the NHS, in effect, diminishes, not increases, informed patient choice. (Paragraph 101)
15. The Department of Health expects local health care providers and clinicians considering any treatment, including complementary and alternative therapies, to take account of safety, clinical and cost effectiveness, and the availability of suitably qualified and regulated practitioners.
16. Under the GMC's guidance, Good Medical Practice2, doctors are advised: "When prescribing medicines you must ensure that your prescribing is appropriate and responsible and in the patient's best interests". The guidance goes on to say that doctors should:
"Reach agreement with the patient on the use of any proposed
medication, and the management of the condition by exchanging
information and clarifying any concerns. The amount of information you
should give each patient will vary according to factors such as the nature
of the patient's condition, risks and side effects of the medicine and the
Bearing these issues in mind, you should, where appropriate:
i. Establish the patient's priorities, preferences and concerns and encourage the patient to ask questions about medicine taking and the proposed treatment
ii. Discuss other treatment options with the patient
iii. Satisfy yourself that your patient has been given appropriate information, in a way they can understand, about: any common
adverse side effects; potentially serious side effects; what to do in the event of a side-effect; interactions with other medicines; and the dosage and administration of the medicine".
17. The Department of Health wholly supports the concept of the informed patient. The informed patient is better placed to be able to make decisions about their care and well-being and better equipped to manage changes in their health status.
18. Quality information is fundamental to making informed decisions and choices. Without information, there can be no choice. We share the Committee’s view that patients should be fully informed. This information should cover the potential benefits of treatment options, as well as risks and possible side effects.
Testing the evidence base for homeopathy
Research funding is limited and highly competitive. The Government should continue its policy of funding the highest quality applications for important scientific research determined on the basis of peer review. (Paragraph 63)
We recommend that the Government Chief Scientific Adviser and Professor Harper, Chief Scientist at the DH, get together to see if they can reach an agreed position on the question of whether there is any merit in research funding being directed towards the claimed modes of action of homeopathy. (Paragraph 64)
There has been enough testing of homeopathy and plenty of evidence showing that it is not efficacious. Competition for research funding is fierce and we cannot see how further research on the efficacy of homeopathy is justified in the face of competing priorities. (Paragraph 77)
It is also unethical to enter patients into trials to answer questions that have been settled already. Given the different position on this important question between the Minister and his Chief Scientist, we recommend that the Government Chief Scientific Adviser, Professor John Beddington, investigate whether ministers are receiving effective advice and publish his own advice on this question (Paragraph 78)
19. We welcome the Committee’s statement in paragraph 9 of its conclusions: the Government’s policy is to fund the “highest quality applications for important scientific research determined on the basis of peer review”. Each application for public research funding, whether to the National Institute for Health Research, or to the research councils, should be considered on its own merits. This is the longstanding principle upon which the UK public funding for scientific research is based.
20. With reference to recommendation 15 (paragraph 78), there is no difference in position on these issues between the Minister and the DH Chief Scientist, as the DH Chief Scientist sought to clarify when he gave oral evidence to the Committee (Q199-203). The report conflates the issue of whether there is any merit in conducting further randomised controlled trials, and whether high quality research into other aspects of homeopathy might be justified. There are already many trials and meta-analyses and therefore there currently appears to be little advantage in conducting further work of this nature.
21. That said, the National Institute for Health Research and the Medical Research Council do not exclude, a priori, any areas from investigation. So further research cannot be categorically ruled out. If proposals were to come forward which could further clarify the impact of homeopathy, they would be considered in the usual way.
22. Given the above clarification that there is no difference in opinion on funding trials or other research between the Minister and Chief Scientist’s position, the proposal that the Government Chief Scientific Adviser should investigate further is overtaken.
We conclude that the principle of like-cures-like is theoretically weak. It fails to provide a credible physiological mode of action for homeopathic products. We note that this is the settled view of medical science. (Paragraph 54)
We consider the notion that ultra-dilutions can maintain an imprint of substances previously dissolved in them to be scientifically implausible. (Paragraph 61)
In our view, the systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos. (Paragraph 70)
We recommend that the Government Chief Scientific Adviser and Professor Harper get together to see if they can reach an agreed position on the question of whether there is any good evidence for the efficacy of homeopathy and whether there is a genuine scientific controversy over the efficacy of homeopathy and publish this.(Paragraph 72)
We regret that advocates of homeopathy, including in their submissions to our inquiry, choose to rely on, and promulgate, selective approaches to the treatment of the evidence base as this risks confusing or misleading the public, the media and policy-makers. (Paragraph 73)
23. As set out in his oral evidence to the Committee (Q176), Professor Harper, Chief Scientist at the Department, is of the view that the majority of independent scientists consider the evidence for the efficacy of homeopathy to be weak or absent, and that there is currently no plausible scientific mechanism for homeopathy.
24. There remains, as demonstrated by the submissions to the Committee, some controversy, since there are peer-reviewed reports that therefore have the support of some scientists, that suggest there may be limited evidence of efficacy of homeopathy in certain circumstances. Given the depth of feeling on each side of the debate, it is unlikely that this controversy could be resolved by further analysis of literature or research on the efficacy of homeopathy. The Government Chief Scientific Adviser cannot envisage scientifically credible proposals for funding for research into homeopathy in the future, although logically they cannot be ruled out.
25. The Government Chief Scientific Adviser and Professor Harper, as recommended, will meet to discuss the issue further, including the overall weight of evidence, and its communication to the public.
NHS funding and provision of homeopathy
We recommend that the Department of Health circulate NHS West Kent’s review of the commissioning of homeopathy to those PCTs with homeopathic hospitals within their areas. It should recommend that they also conduct reviews as a matter of urgency, to determine whether spending money on homeopathy is cost effective in the context of competing priorities. (Paragraph 86)
26. We welcome this recommendation since as part of our current Quality, Innovation, Productivity and Prevention work, we are encouraging PCTs to work together to review commissioned procedures in the context of competing priorities.
27. The review referred to is already available from West Kent PCT’s website3. The various papers that went to the PCT Board are also available:4
September 2007 - first report and approval for withdrawal of funding (pre judicial review)
July 2008 - second report and approval for withdrawal of funding following completion of full Equality Impact Assessment (post judicial review)
January 2009 - first update regarding implementation of approved mitigation factors and initial draft Individual Treatment Panel (ITP) criteria for Board approval
March 2009 - final draft ITP Criteria for Board approval
September 2009 - final update to the Board with request for approval for closure of the Homeopathy Review
The NHS Constitution
When the NHS funds homeopathy, it endorses it. Since the NHS Constitution explicitly gives people the right to expect that decisions on
the funding of drugs and treatments are made “following a proper consideration of the evidence”, patients may reasonably form the view that homeopathy is an evidence-based treatment. (Paragraph 109)
28. Under administrative law, PCTs' decisions about commissioning must be rational, procedurally fair and within their powers. The statutory Directions5, which underpin the right in the NHS Constitution places an additional, explicit duty on PCTs to justify in writing, on request, their policies on whether to fund a particular drug or treatment.
29. Therefore, where there are concerns about the evidence base for a particular treatment (such as homeopathy), the Directions create a means whereby PCTs are required to justify their decisions to fund it. It is the responsibility of treating clinicians to discuss the risks and benefits of specific treatment options with individual patients.
30. We note the Committee’s comment that when the NHS funds homeopathy it endorses it, and we will keep the position under review. However, we believe that providing appropriate information for patients should ensure that they form their own views regarding homeopathy as an evidence-based treatment.
The funding of homeopathy and homeopathic hospitals
We accept that NICE has a large queue of drugs to evaluate and that it may have greater priorities than evaluating homeopathy. However, we cannot understand why the lack of an evidence base for homeopathy might prevent NICE evaluating it but not prevent the NHS spending money on it. This position is not logical.(Paragraph 90)
The Government should stop allowing the funding of homeopathy on the NHS. (Paragraph 110)
We conclude that placebos should not be routinely prescribed on the NHS. The funding of homeopathic hospitals—hospitals that specialise in the administration of placebos—should not continue, and NHS doctors should not refer patients to homeopaths. (Paragraph 111)
31. The issue of whether the Department should or should not disallow the prescription of placebos is dealt with at paragraphs 14-16 above.
32. We welcome the acknowledgement by the Committee about NICE’s remit. NICE already has a full work programme that Ministers have referred to them, which focuses on reviewing evidence to support the development of authoritative guidance where appropriate, and therefore is unlikely to initiate a review on homeopathy in the near future.
33. This is not inconsistent with the Department’s position in allowing the NHS to spend money on homeopathy, and Primary Care Trusts assess the needs of their populations and commission services, including homeopathic services, to best meet those needs within the available funding. PCTs examine the relevant evidence about the services they commission and, in partnership with patients, clinicians, the public and providers, make the difficult decisions about priorities and how to deliver them. Some PCTs, for example, choose to fund homeopathic services on an exceptional basis for certain individuals. It is not appropriate for the Department of Health to remove the right of PCTs to make these decisions on a case-by-case basis.
34. Capital investment decisions in the NHS are planned and decided at local level. The commissioning plans of local PCTs set out the type of services that need to be provided and therefore drive decisions about the nature of new facilities needed, or the need to maintain, update or replace existing facilities.
Personal health budgets
We recommend that if personal health budgets proceed beyond the pilot stage the Government should not allow patients to buy non-evidence-based treatments such as homeopathy with public money. (Paragraph 104)
35. A personal health budget may only be used to buy treatments if they are agreed in a care plan as likely to meet the individual’s health and wellbeing needs. PCTs should not agree a care plan if they do not believe that a treatment is appropriate, or it will not meet the individual’s needs.
36. These decisions are made locally – just like other PCT commissioning decisions. The principles are the same, whether or not the funding is provided in the form of a personal health budget. Personal health budgets are not a way to circumvent other NHS commissioning policies.
Licensing of homeopathic products
We are concerned that homeopathic products were, and continued to be, exempted from the requirement for evidence of efficacy and have been allowed to continue holding Product Licences of Right. We recommend that no PLRs for homeopathic products are renewed beyond 2013. (Paragraph 121)
We conclude that the MHRA should seek evidence of efficacy to the same standard for all the products examined for licensing which make medical claims and we recommend that the MHRA remove all references to homeopathic provings from its guidance other than to make it clear that they are not evidence of efficacy.(Paragraph 128)
We consider that the MHRA’s consultation, which led to the introduction of the NRS, was flawed and we remain unconvinced that the NRS was designed with a public health rationale. (Paragraph 135)
We fail to see why the label test design should be acceptable to the MHRA given that, first, it considers that homeopathic products have no effect beyond placebo and, second, Arnica Montana 30C contains no active ingredient and there is no scientific evidence that it has been demonstrated to be efficacious. We conclude that the user testing of the Arnica Montana 30C label was poorly designed with parts of the test actively misleading participants. In our view the MHRA’s testing of the public’s understanding of the labelling of homeopathic products is defective. (Paragraph 140)
If the MHRA is to continue to regulate the labelling of homeopathic products, which we do not support, we recommend that the tests are redesigned to ensure and demonstrate through user testing that participants clearly understand that the products contain no active ingredients and are unsupported by evidence of efficacy, and the labelling should not mention symptoms, unless the same standard of
evidence of efficacy used to assess conventional medicines has been met. (Paragraph 141)
We consider that the way to deal with the sale of homeopathic products is to remove any medical claim and any implied endorsement of efficacy by the MHRA—other than where its evidential standards used to assess conventional medicines have been met—and for the labelling to make it explicit that there is no scientific evidence that homeopathic products work beyond the placebo effect. (Paragraph 146)
It is unacceptable for the MHRA to license placebo products—in this case sugar pills—conferring upon them some of the status of medicines. Even if medical claims on labels are prohibited, the MHRA’s licensing itself lends direct credibility to a product. Licensing paves the way for retail in pharmacies and consequently the patient’s view of the credibility of homeopathy may be further enhanced. We conclude that it is time to break this chain and, as the licensing regimes operated by the MHRA fail the Evidence Check, the MHRA should withdraw its discrete licensing schemes for homeopathic products. (Paragraph 152)
37. Homeopathy has a long tradition in Europe and is a recognised and widely used system of medicine across the EU. The Government takes the view that consumers who choose to use homeopathic medicines should be fully informed about their purpose and assured that standards of quality and safety are maintained. If homeopathic medicines were not subject to any kind of regulatory control consumers would not have access to such information or assurances. Conversely, if regulation was applied to homeopathic medicines as understood in the context of conventional pharmaceutical medicines, these products would have to be withdrawn from the market as medicines. This would constrain consumer choice and, more importantly, risk the introduction of unregulated, poor quality and potentially unsafe products on the market to satisfy consumer demand.
38. The concern to achieve consumer choice while protecting public health is also reflected at a European level. Thus Recital 9 to Directive 92/73/EEC6 made clear the overall policy position concerning homeopathic products in the EU
: “Whereas, despite considerable differences in the status of alternative medicines in the Member States, patients should be allowed access to the medicinal products of their choice, provided all precautions are taken to ensure the quality and safety of the said products.”
39. Articles 13 and 14 of Directive 2001/83/EC7, as amended, require EU Member States to establish a simplified registration procedure for homeopathic products8. Article 14.2 specifically makes clear that proof of therapeutic efficacy is not required under the simplified registration procedure. Article 16 allows Member States to introduce national rules in accordance with the principles and characteristics of homeopathy as practised in that Member State. It is not open to the UK to set aside its obligations in European law to provide regulatory arrangements for homeopathic medicines.
40. The main public health risk that can arise from homeopathic medicinal products is their inappropriate use in serious conditions. The National Rules Scheme (NRS) is based on the premise that public health protection is better served where it is clear that the use of these products should be restricted to minor self-limiting conditions. In response to recommendation 30, that claimed indications should not be permitted in products without demonstrated efficacy, we do not think public health will be enhanced by increasing the proportion of over the counter medicinal products sold without information as to their intended purpose.
41. The fact that homeopathic medicinal products come within a regulatory scheme strengthens the ability of MHRA to take regulatory action where inappropriate claims are made about a product. In recent years the MHRA has removed from the market homeopathic products being promoted for the prevention of malaria and the treatment of cancer. The consultation on the NRS was also based on the need to create a level playing field to ensure that the same product carried the same
Under Art 1 of Directive 2001/83/EC
, as amended, a homeopathic medicinal product is defined as “Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles.” information regardless of when it was registered. This in turn will also
serve to lessen the risk of confusion and inappropriate use.
42. We accept that in certain aspects there is some scope to bring additional clarity to regulatory arrangements. The MHRA will continue its action to bring eligible homeopathic Product Licences of Right (PLRs)9 within one of the relevant regulatory schemes. This will serve to reduce the complexity of the arrangements. The MHRA is undertaking a project to consolidate UK medicines legislation including the Medicines Act 1968. Outstanding issues concerning the future of PLRs will be considered as part of this project.
43. The MHRA is currently reviewing its guidance on the regulation of homeopathic medicines under the NRS to ensure that the position on efficacy is clear.
44. Recommendations concerning user testing raise wider issues about the labelling of homeopathic products. The MHRA will review the labelling requirements under the NRS to ensure that these deliver clarity as to the status of products and their composition.
45. MHRA registration of products under appropriate regulatory schemes does not imply that the regulator is endorsing homeopathic products. As stated above, the MHRA is reviewing product labelling requirements and elements of the guidance to ensure there is greater clarity on the position concerning efficacy as accepted within homeopathic practice.
The role of pharmacies
Although it goes wider than the scope of this Evidence Check inquiry we must put on record our concern about the length of time the RPSGB appears to be taking to investigate and reach conclusions on cases where it has been alleged that its guidelines on the sale of homeopathic products have been breached. We recommend that the Government enquires into whether the RPSGB, and from the 2010 handover, the General Pharmaceutical Council, is doing an adequate job in respect of the time taken to pursue complaints. (Paragraph 151)
Under Art 13 of Directive 2001/83/EC, as amended, Member States can continue to maintain their national regulatory arrangements for homeopathic products licensed before 1 January 1994.
46. The Council for Healthcare Regulatory Excellence (CHRE) is charged with monitoring the performance of the health professional regulatory bodies. Once the regulation of pharmacy moves from RPSGB to the General Pharmaceutical Council (expected in September), by virtue of the Pharmacy Order 2010, the General Pharmaceutical Council will have to publish information on its forward plans and accounts and place them in the Westminster and Scottish Parliaments to allow appropriate scrutiny. It will also be obliged to report on complaints handling in its annual report. The Council, to which members are appointed by the Privy Council, will hold its staff to account for the timeliness and thoroughness of their work. We understand that the General Pharmaceutical Council has already undertaken a due diligence review of the fitness to practise cases it is due to inherit. We will bring this to the attention of CHRE and request that, as part of its performance review process, it reviews the RPSGB's handling of complaints in terms of both thoroughness and timeliness.
By providing homeopathy on the NHS and allowing MHRA licensing of products which subsequently appear on pharmacy shelves, the Government runs the risk of endorsing homeopathy as an efficacious system of medicine. To maintain patient trust, choice and safety, the Government should not endorse the use of placebo treatments, including homeopathy. Homeopathy should not be funded on the NHS and the MHRA should stop licensing homeopathic products. (Paragraph 157)
47. We note the Committee’s view that allowing for the provision of homeopathy may risk seeming to endorse it, and we will keep the position under review. However, we do not believe that this risk amounts to a risk to patient trust, choice or safety, nor do we believe that the risk is significant enough for the Department to take the unusual step of removing PCTs’ flexibility to make their own decisions. We believe that providing appropriate information for commissioners, clinicians and the public, and ensuring a strong ethical code for clinicians, remain the most effective ways to ensure quality outcomes, patient satisfaction and the appropriate use of NHS funding.
48. The regulation of homeopathic products enables the MHRA to protect the public from unsafe products and unwarranted claims to treat serious illness. The requirement for regulation of homeopathic products is laid down in a European Directive and is a treaty obligation of the UK.
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