• Written Ministerial Statement• DEPARTMENT OF HEALTH• Practitioners of acupuncture, herbal medicine and traditional

Chinese medicine• Wednesday 16 February 2011

• The Secretary of State for Health (Mr Andrew Lansley): The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords’ Select Committee on Science and Technology’s report in 2000 recommended statutory regulation for the first two of these groups.

• We have today published an analysis of the 2009 consultation by the four United Kingdom Health Departments which sought views on the possible regulation of practitioners of acupuncture, herbal medicine and traditional Chinese medicine.

• This factual report has been placed in the Library and can be found on the Department of Health’s website at:

• www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_124337

• Written Ministerial Statement• DEPARTMENT OF HEALTH• Practitioners of acupuncture, herbal medicine and traditional

Chinese medicine• Wednesday 16 February 2011

• The Secretary of State for Health (Mr Andrew Lansley): The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords’ Select Committee on Science and Technology’s report in 2000 recommended statutory regulation for the first two of these groups.

• We have today published an analysis of the 2009 consultation by the four United Kingdom Health Departments which sought views on the possible regulation of practitioners of acupuncture, herbal medicine and traditional Chinese medicine.

• This factual report has been placed in the Library and can be found on the Department of Health’s website at:

• www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_124337

www.acmds.org

Analysis Report on the 2009 Consultation

• Executive Summary • This paper presents the outcome of the

joint consultation, on behalf of Health Ministers in the four UK countries, on Statutory Regulation of Practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and other Traditional Medicine Systems Practised in the UK.

• (AHMTCM)

Directed at• DH INFORMATION READER BOX • Document Purpose Policy Gateway Reference 14961• Title A Report on the Statutory Regulation of acupuncture, herbal medicine, • traditional Chinese medicine and other traditional medicine systems practiced • in the UK • Author DH/Professional Standards Division Publication Date Feb 2011 • Target Audience • • PCT CEs, NHS Trust CEs, SHA CEs, Care Trust CEs, Foundation Trust CEs , • Directors of PH, Directors of Adult SSs, Allied Health Professionals, GPs, • Communications Leads, Privately practising Alternative Medicine Practitioners, • UK professional bodies representing acupuncture, herbal medicine and TCM, • NHS bodies, Scottish Health Boards, Local Health Boards in Wales, • Community Health Councils in Wales, the NI Ambulance Service,• the Health and Social Care Board, Public Health Agency, Patient Client Council • and the Business Services Organisation, Royal Colleges, UK Regulatory Bodies, • consumer representatives, Herbal Industry, NHS Trades Unions

• Circulation List Voluntary Organisations/NDPBs

• PRO-STATUTORY REGULATION – BENEFITS AND COSTS•

– 2. Pro-statutory regulation – there was a clear majority of responses (85%) in favour of statutory regulation.

– The main benefits of statutory regulation were perceived to be:

• • Qualified practitioners – ensuring AHMTCM practitioners are qualified will be an important measure for assuring patient safety. Further work will be required to evaluate qualifications awarded as a result of training taking place outside the UK.

• • Quality and safety of practice – enhanced quality of practice/products and safety would constitute an obvious benefit to practitioners as well as to the public.

– 3. Alternatives to statutory regulation not preferable – a strong message was noted that safety would not be assured sufficiently by alternatives to statutory regulation.

– 4. Voluntary regulation as second best option – as an alternative to orthodox statutory regulation, ‘voluntary regulation’ or a licence to practise were seen as preferable to no regulation.

– 5. Financial costs unclear – generally respondents expressed difficulty in evaluating the financial costs involved in different types of regulation.

• PRO-STATUTORY REGULATION – BENEFITS AND COSTS•

– 2. Pro-statutory regulation – there was a clear majority of responses (85%) in favour of statutory regulation.

– The main benefits of statutory regulation were perceived to be:

• • Qualified practitioners – ensuring AHMTCM practitioners are qualified will be an important measure for assuring patient safety. Further work will be required to evaluate qualifications awarded as a result of training taking place outside the UK.

• • Quality and safety of practice – enhanced quality of practice/products and safety would constitute an obvious benefit to practitioners as well as to the public.

– 3. Alternatives to statutory regulation not preferable – a strong message was noted that safety would not be assured sufficiently by alternatives to statutory regulation.

– 4. Voluntary regulation as second best option – as an alternative to orthodox statutory regulation, ‘voluntary regulation’ or a licence to practise were seen as preferable to no regulation.

– 5. Financial costs unclear – generally respondents expressed difficulty in evaluating the financial costs involved in different types of regulation.

• ANTI-STATUTORY REGULATION

– 6. Anti-statutory regulation -–a significant minority of respondents (15%) including medical Royal Colleges, considered that the scientific evidence base for efficacy of alternative treatments needs to be strengthened before statutory regulation can be considered.

– 7. Unjustified credibility resulting from statutory regulation – in the absence of such evidence, a decision to statutorily regulate may give the impression that the current evidence base for alternative treatments is on an equal footing with that for mainstream clinical practice (‘orthodox western medicine’).

– 8. Clearer public information – need for clearer information for the public relating to the risks and benefits of alternative treatments and products, so they can make informed choices.

• ANTI-STATUTORY REGULATION

– 6. Anti-statutory regulation -–a significant minority of respondents (15%) including medical Royal Colleges, considered that the scientific evidence base for efficacy of alternative treatments needs to be strengthened before statutory regulation can be considered.

– 7. Unjustified credibility resulting from statutory regulation – in the absence of such evidence, a decision to statutorily regulate may give the impression that the current evidence base for alternative treatments is on an equal footing with that for mainstream clinical practice (‘orthodox western medicine’).

– 8. Clearer public information – need for clearer information for the public relating to the risks and benefits of alternative treatments and products, so they can make informed choices.

• IMPACT OF EUROPEAN MEDICINES LEGISLATION – 9. EU medicines legislation – as a consequence of complying

with EU medicines legislation in the UK, respondents estimated that unless practitioners were regulated the supply of alternative herbal products would decrease and that there would be a detrimental impact on ‘consumer choice’

• REGULATE ALL THREE GROUPS? – 10. Treat all 3 practices the same – the general consensus

was that it would be simpler and more cost effective to regulate herbalism, TCM and acupuncture in the same way.

• WHICH REGULATOR? – 11. Regulation - The Health Professions Council (HPC) was the

preferred option for regulating all three practices. – 12. Alternative regulation - establishing a ‘Complementary and

Alternative Medicine’ (CAM) Council was a popular alternative to HPC regulation.

– 13. Local regulation – considered by some that it would lead to complications and be impractical for practitioners if they were required to register with multiple Local Authorities.

• IMPACT OF EUROPEAN MEDICINES LEGISLATION – 9. EU medicines legislation – as a consequence of complying

with EU medicines legislation in the UK, respondents estimated that unless practitioners were regulated the supply of alternative herbal products would decrease and that there would be a detrimental impact on ‘consumer choice’

• REGULATE ALL THREE GROUPS? – 10. Treat all 3 practices the same – the general consensus

was that it would be simpler and more cost effective to regulate herbalism, TCM and acupuncture in the same way.

• WHICH REGULATOR? – 11. Regulation - The Health Professions Council (HPC) was the

preferred option for regulating all three practices. – 12. Alternative regulation - establishing a ‘Complementary and

Alternative Medicine’ (CAM) Council was a popular alternative to HPC regulation.

– 13. Local regulation – considered by some that it would lead to complications and be impractical for practitioners if they were required to register with multiple Local Authorities.

• IMPACT OF EUROPEAN MEDICINES LEGISLATION – 9. EU medicines legislation – as a consequence of complying

with EU medicines legislation in the UK, respondents estimated that unless practitioners were regulated the supply of alternative herbal products would decrease and that there would be a detrimental impact on ‘consumer choice’

• REGULATE ALL THREE GROUPS? – 10. Treat all 3 practices the same – the general consensus

was that it would be simpler and more cost effective to regulate herbalism, TCM and acupuncture in the same way.

• WHICH REGULATOR? – 11. Regulation - The Health Professions Council (HPC) was the

preferred option for regulating all three practices. – 12. Alternative regulation - establishing a ‘Complementary and

Alternative Medicine’ (CAM) Council was a popular alternative to HPC regulation.

– 13. Local regulation – considered by some that it would lead to complications and be impractical for practitioners if they were required to register with multiple Local Authorities.

• The 2009 consultation also looked at practitioners of acupuncture. The practice of acupuncture is not affected by the EU Directive and, therefore, compliance is not required. I am confident that acupuncturists have their own voluntary regulatory measures in place, which are sufficiently robust. Additionally, local authorities in England have powers to regulate the hygiene of the practice of acupuncture, to protect against the risk of transmission of certain infectious diseases. Similar measures are also in place in Scotland, Wales and Northern Ireland.

• I am pleased to say that this decision resolves a long-standing issue, to the benefit of both practitioners and the public who use herbal medicines.

What, when & why

16th February 2011

• 4.12 The extension of statutory regulation to currently unregulated professional or occupational groups, such as some groups in the healthcare science workforce, will only be considered where there is a compelling case on the basis of a public safety risk and where assured voluntary registers are not considered sufficient to manage this risk.

• 4.13 The exception to this is practitioners of herbal medicine, including Chinese herbal medicine. Under European law, manufactured medicines placed on the market require a suitable product licence, and from April 2011 this also applies to manufactured herbal medicines.

• However, Member States have the power to operate national arrangements permitting appropriately authorised healthcare professionals to commission an unlicensed medicine to meet a patient's special needs and the UK already does so for doctors and certain other appropriately regulated prescribers.

• While there is evidence of public health risk where unlicensed herbal medicines are supplied by unskilled practitioners, the impact on practitioners and on consumer choice of preventing the supply of all such herbal medicines would be disproportionate.

• We therefore propose to introduce regulation for these practitioners by the HPC, to ensure that the public are able to access these products if they should choose to do so and to provide improved assurance of the competence of practitioners. The focus of regulation will be solely on minimising risk to the public.

• 4.12 The extension of statutory regulation to currently unregulated professional or occupational groups, such as some groups in the healthcare science workforce, will only be considered where there is a compelling case on the basis of a public safety risk and where assured voluntary registers are not considered sufficient to manage this risk.

• 4.13 The exception to this is practitioners of herbal medicine, including Chinese herbal medicine. Under European law, manufactured medicines placed on the market require a suitable product licence, and from April 2011 this also applies to manufactured herbal medicines.

• However, Member States have the power to operate national arrangements permitting appropriately authorised healthcare professionals to commission an unlicensed medicine to meet a patient's special needs and the UK already does so for doctors and certain other appropriately regulated prescribers.

• While there is evidence of public health risk where unlicensed herbal medicines are supplied by unskilled practitioners, the impact on practitioners and on consumer choice of preventing the supply of all such herbal medicines would be disproportionate.

• We therefore propose to introduce regulation for these practitioners by the HPC, to ensure that the public are able to access these products if they should choose to do so and to provide improved assurance of the competence of practitioners. The focus of regulation will be solely on minimising risk to the public.

16th February 2011

• The Health Secretary also announced to Parliament today that herbal medicine practitioners will be regulated from April 2012.

• The four UK health departments have agreed that the Health Professions Council (HPC) should hold a statutory register of practitioners who supply unlicensed herbal medicines to people to enable the supply of herbal medicines to continue after 30 April 2011.

• This will ensure that practitioners have met specified registration standards. Practitioner regulation will be underpinned by medicines legislation which will provide further safeguards to protect public health.

16th February 2011

• The Health Secretary also announced to Parliament today that herbal medicine practitioners will be regulated from April 2012.

• The four UK health departments have agreed that the Health Professions Council (HPC) should hold a statutory register of practitioners who supply unlicensed herbal medicines to people to enable the supply of herbal medicines to continue after 30 April 2011.

• This will ensure that practitioners have met specified registration standards. Practitioner regulation will be underpinned by medicines legislation which will provide further safeguards to protect public health.

• 12. Alternative regulation - establishing a ‘Complementary and Alternative Medicine’ (CAM) Council was a popular alternative to HPC regulation.

• 13. Local regulation – considered by some that it would lead to complications and be impractical for practitioners if they were required to register with multiple Local Authorities.