Memorandum submitted by the Department of Health HO 34

Executive summary of main points

1. Decisions on commissioning and funding of any treatment are the responsibility of the National Health Service and the Government expects local providers and practitioners to take into account issues to do with safety, clinical and cost-effectiveness, and the availability of suitably regulated/qualified practitioners.

2. The Department of Health has tried to ensure there is good quality, accessible information available about complementary and alternative treatments so that consumers can make informed decisions if they are considering using any such treatment. NHS Choices is creating a directory of available CAM services and a package of information about the various therapies.

3. Homoeopathic products are licensed by the MHRA and either have Product Licences of Right (PLRs), have been granted certificates under a Simplified Scheme, or have been granted homeopathic marketing authorizations under the National Rules Scheme.

4. There is capacity for research into Complementary and Alternative Medicine therapies through the National Institute for Health Research (NIHR) which rarely turns down high quality proposals. NICE considers particular CAM therapies (where suitable evidence exists) alongside conventional treatments when developing clinical guidelines for specific conditions but it cannot provide a blanket assessment of a particular type of treatment.

5. The only complementary and alternative medicine (CAM) practitioners regulated by statute are chiropractic and osteopathy and a consultation is currently underway to consider whether, and if so how, to regulate acupuncture, herbal medicine and traditional Chinese Medicine practitioners. There are no plans to regulate homoeopathic practitioners by statute.

Brief introduction

6. Commissioning in the National Health Service is a collaborative process involving all partners including patients, public, local authorities, clinicians and is focused on outcomes. This paper will seek to provide the background to the commissioning of homoeopathy on the National Health Service.

7. Homoeopathy is a controversial subject and one on which the Department of Health receives correspondence both for and against in equal volume. The Department does not maintain a position on any complementary or alternative treatments, leaving decisions on their use by the National Health Service, to the National Health Service.

8. Clinicians need to take into account any policies on commissioning such services that their Primary Care Trust may have in place. They also need to be mindful of their obligations in relation to patient choice and Joint Strategic Needs Assessment.

9. There are three NHS Homoeopathic Hospitals in England - these are located in London, Bristol and Liverpool. There was another Homoeopathic Hospital based in Tunbridge Wells which ceased providing services in March 2009 following a significant drop in referrals in recent years and, following a public consultation, a decision to stop commissioning and funding treatments at the hospital. Scotland has one NHS homoeopathic hospital located in Glasgow.

10. The homoeopathic hospitals fall under the jurisdiction of the NHS trust in which they are based.

National Health Service commissioning

Background

11. Commissioning is the process by which healthcare services are secured to meet the needs of the populations. Primary Care Trusts (PCTs) are responsible for commissioning high quality care services, within allocated resources, to meet local patient needs and with a clear focus on improving health outcomes for the population.

12. Commissioning is one of the most important vehicles for delivering the NHS vision of a health and care system that is fair, personalised, effective and safe, and focused on reducing health inequalities, adding life to years and years to life.

13. In 2005, the Department published Commissioning a Patient led NHS. It focused on the process needed for effective commissioning, and precipitated a large-scale restructure of PCTs into larger organisations. Since this time, the focus of our programmes has been on developing PCT commissioning capability by developing an inspiring vision and a means for achieving it.

14. Weaknesses in NHS commissioning were identified through the Fitness for Purpose exercise (May 2006 - March 2007). A joint review in May 2007 by the Department and the Prime Ministers Delivery Unit highlighted similar challenges and identified a number of recommendations to ensure all PCTs become more effective commissioners. The world class commissioning programme was established in response to these recommendations.

World class commissioning

15. World class commissioning (WCC) seeks to bring a different approach to PCT commissioning: one that is focused on outcomes and one that involves all partners including patients, public, local authorities, clinicians and providers in making tough choices about priorities and how to deliver them.

16. WCC has been developed in partnership with the service involving representatives from SHAs, PCTs, Local Government and external stakeholder organisations. The service has welcomed this way of working through co-production.

17. There are three main components of the WCC programme: the vision for WCC, an assurance system that holds commissioners to account and to reward performance and development and an ongoing framework of support and development to ensure that commissioners have the resources to enable them to achieve WCC.

NHS spend on homeopathic products and services (including NHS homeopathic hospitals)

18. Data on spending in the area of homoeopathy on the National Health Service has never been routinely collected. However, we have requested that Primary Care Trusts provide estimates on this to the Department, through their Strategic Health Authority, at the earliest opportunity. We have also asked for details about what they base their decisions on when commissioning and funding homoeopathy.

Why the NHS funds homeopathy

19. The Department does not maintain a position on any complementary or alternative treatments, leaving decisions on their use by the National Health Service, to the National Health Service. The Government expects local providers and practitioners to take into account issues to do with safety, clinical and cost-effectiveness, and the availability of suitably regulated/qualified practitioners. Each of these are considered in detail below.

What evidence the NHS has considered in its decision to fund homeopathy

20. The Department of Health has tried to ensure there is good quality, accessible information available about complementary and alternative treatments so that consumers can make informed decisions if they are considering using any such treatment. NHS Choices is creating a directory of available CAM services and a package of information about the various therapies. In the meantime however there is a considerable amount of information about homoeopathy on the NHS Evidence website (www.evidence.nhs.uk).

Research

21. There are over 20 systematic reviews, and in excess of 150 trials, of homeopathy. The Department considers for this reason that commissioning a further systematic review would not be appropriate. However, the Department is one of the largest mainstream UK funders of research into complementary and alternative medicine (CAM).

22. The Department of Health commissions research to underpin policy and practice in health and healthcare through the National Institute for Health Research (NIHR) and the DH Policy Research Programme.

23. The Department does not exclude, a priori, any areas from investigation and has funded and continues to fund research on various branches of CAM. Over the last 10 years, central funding and local NHS R&D budgets have both contributed to the total investment.

24. Implementation of the Department's research strategy Best Research for Best Health has resulted in an expansion of our research programmes and in significant new funding opportunities for health research. The strategy is delivered by the NIHR.

25. DH-funded research aims to support the best science and so achieve the best outcomes for patients and for the NHS. For that reason our NIHR programmes do not ring fence funds for expenditure on particular topics. Research proposals in all areas compete for the funding available. Applications are then are subject to peer review and judged in open competition, with awards being made on the basis of the scientific quality of the proposals made.

26. A number of NIHR awards have been made in the last year or so in support of studies directly concerned with demonstrating whether specific CAM therapies work and whether they represent good value. If researchers continue to come up with high quality proposals, there is no reason why they should not continue to attract NIHR support

27. A £3.4 million complementary and alternative medicine personal award scheme was included in our research capacity development programme. The scheme, which began in 2003, has supported 18 CAM researchers at the doctoral and postdoctoral level. These award holders have undertaken a total of 9 studies and have nurtured the methodological skills of the more junior researchers in their teams. Their presence in the Research Development Capacity Programme has allowed factors specific to CAM practice to be incorporated into approved generic research methodologies.

28. The Department has also funded research on the role of CAM in the care of cancer patients (three projects were commissioned, are complete and have been published); and on the use of complementary medicine in primary care.

29. The research capacity development programme also funds CAMEOL (Complementary and Alternative Medicine Evidence Online). This is a collaboration between the Research Council for Complementary Medicine and the University of Westminster School of Integrated Health. It involves a detailed review and critical appraisal of the published research in specific complementary therapies, focusing on their use in NHS priority areas.

30. The R&D funding regime that operated from 1998 to 2006 - under which we allocated some £500m a year to individual NHS organisations - gave those organisations the means of supporting a large number of projects concerned with the use of CAM. The former National Research Register lists well over 100. It also allowed the Department to provide research and development support to the Royal London Homeopathic Hospital.

SAFETY: LICENSING OF HOMEOPATHIC PRODUCTS

31. 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.

32. 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 homeopathics 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.

33. Under current licensing arrangements, homeopathic products either have Product Licences of Right (PLRs), have been granted certificates under a Simplified Scheme, or have been granted homeopathic marketing authorizations under the National Rules Scheme. PLRs are licences that were issued to all products on the market at the time that the Medicines Act 1968 was implemented in 1971.

34. The Simplified Scheme for homeopathic medicinal products was introduced in 1992 under European Directive 92/73/EC. In 2006, the UK introduced the National Rules Scheme, which allows the marketing of homeopathic products, with a strictly limited range of therapeutic indications in accordance with the principles and characteristics of homeopathy as practised in the UK. Only products which are indicated for the relief of minor symptoms and minor conditions in humans are eligible for a homeopathic marketing authorization under this scheme. For these purposes, minor symptoms are those which can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor.

35. Applicants for both the Simplified Scheme and the National Rules scheme must submit a dossier demonstrating the safety and quality of the product. Safety and quality are monitored during the life cycle of the product in similar terms to pharmaceutical medicines with full marketing authorisations. The schemes recognise that these products contain a very low level of active principles and recognises the difficulty of applying to them the conventional statistical methods relating to clinical trials. However, the regulatory framework requires that in accordance with the principles and characteristics of homoeopathy as practised in the Member State, the applicant must provide one or more of the following:

· Study reports in relation to the product which is the subject of the application;

· Published scientific literature;

· The method by which the profile of a homoeopathic remedy is determined

36. Whatever data are provided must be sufficient to demonstrate that UK homeopathic practitioners would accept the efficacy of the product for the indications sought.

CLINICAL AND COST-EFFECTIVENESS: NICE AND CAM THERAPIES

37. This Government established NICE to provide authoritative, independent advice on different health-related interventions and pathways of care, increase fairness in access to treatments, to be a national source of robust clinical guidance and to speed up the uptake of cost-effective treatments in the NHS.

38. NICE helps to tackle variations in prescribing practice by issuing robust, evidence-based guidance which we expect clinicians to take fully into account. NICE also spreads good practice, and helps protect patients from out-dated or unproven treatments. Broadly, NICE develops four forms of clinical guidance: clinical guidelines (management of particular clinical conditions), technology appraisal guidance (guidance on specific health interventions, including pharmaceuticals), public health guidance and guidance on the safety and efficacy of interventional procedures.

39. NICE considers particular CAM therapies (where suitable evidence exists) alongside conventional treatments when developing clinical guidelines for specific conditions. Some guidelines produced by NICE have already included references to CAM therapies - most recently in May 2009 guidance on non-specific lower back pain including recommendations for the use of osteopathy, spinal manipulation and massage.

40. What NICE cannot produce, however, is blanket guidance on complementary medicine, which has been called for in the past.

41. Where possible, we have also aimed to develop the evidence base on which NICE makes its judgements on clinical and cost-effectiveness.

REGULATION OF HOMOEOPATHIC PRACTITIONERS

42. At present there is no statutory regulation system in the UK governing the practice of complementary and alternative medicine (CAM), with the exception of chiropractic and osteopathy which are regulated by statute. A report (May 2008) from a UK working group made recommendations which are the subject of a consultation which ends on 2 November 2009. It seeks respondents' views on whether, and if so how, to regulate acupuncture, herbal medicine and traditional Chinese Medicine practitioners.

43. Once the consultation responses have been analysed, a decision will be made as to whether or not to move towards statutory regulation of these professions. Previous experience of regulating new professions suggests that, if a decision were made to regulate these professions by statute, we would be unlikely to reach statutory regulation until 2011/12 at the earliest.

44. DH commissioned the Prince's Foundation for Integrated Health (FIH) to develop voluntary self-regulation amongst a range of currently unregulated therapies. FIH were awarded a Government grant of £900,000 over three years to carry out this work. As a result of the work carried out by the working group, the Complementary and Natural Healthcare Council (CNHC) was set up in 2008 and its register opened in January 2009.

45. The CNHC is a new voluntary professional regulator. Individuals who belong to one of the therapies it covers may choose to register with it (but do not have to do so). Registration with the CNHC will enhance public safety as it gives assurances that the practitioner has met certain entry standards (e.g. has an accredited qualification), that they subscribe to a set of professional standards, and hold appropriate and sufficient insurance. Breach of these standards could result in removal from the register. The Department of Health supports the work of the CNHC and has funded its start up costs.

November 2009