Current Position on Regulation in the EU and UK as of February 2011
Current Position on Regulation in the EU and UK as of February 2011
by Paul Robin Chairman of the Acupuncture Society
The entry of Microsystems Detox Auricular Acupuncture to the Complementary & Natural Health Care Council (CNHC) register and Chinese Herbal EU regulation
This is rather an interesting time with Microsystems Acupuncture stealing the ‘regulation’ (voluntary regulation) first place position since the statutory regulation process was scuppered by the Orthodox medical profession early last year. Western trained scientists and researchers could not wrap their heads around the alien TCM medical theories, even though they are often used foremost in medicine by millions of people within China, Japan, Taiwan Korea and all East Asia.
There has been resistance to voluntary regulation by MARWG from some organizations. Also the major Acupuncture and Chinese Herbal groups which are not involved in the CNHC voluntary registration process and are still in shock over the lack of government interest in statutory regulation.
The Acupuncture Society has fully supported CNHC voluntary registration process for Auricular detox therapists through our active involvement within the Microsystems regulatory working groups (MARWG). Membership of the CNHC voluntary registration is likely in the future become a requirement for those microsystems practitioners wishing to offer detox services within the NHS environment.
As for statutory regulation of Acupuncture, this has not happened and any future regulation is likely to be voluntary and to allow for applied acupuncture and TCM skills. The Acupuncture Society who accredit CCM and other TCM courses are active members of the ASG and Microsystems regulatory working groups (MAcRWG) .
MARWG has almost completed its initial role, with a voluntary self regulatory register scheduled to open early in the new year under the governance of the Complementary & Natural Health Care Council (CNHC). The Acupuncture Society has representation on the Profession Specific Board (PSB) of the CNHC in respect of Microsystems.
Microsystems (auricular detox acupuncturists) or whole body acupuncture practitioners wishing to join CNHC register (Whole body acupuncturists who practice auricular detox acupuncture can have this aspect of their qualification verified by the society for inclusion in CNHC but must be aware that their main acupuncture practice will remain outside of the scope of practice covered by the register) can be verified by the Acupuncture Society which will enable them to be ‘grandparented in’.
They will retain their Acupuncture Society membership along side their CNHC registration. Practitioners wishing to be verified for access to the CNHC register should contact Dragomir at dragomirl@btinternet.com directly for training or skills update/assessment verification certificate.
At the moment many UK Universities have stopped their Acupuncture and Chinese Herbal courses and some BAAB/BAcC schools have had to cease tradingk due to the hard economic times that we face.
Consequently many surviving Colleges are moving to Applied Practical Courses like those run at CCM and some other professional training schools around the UK in preference to university accredited degrees courses. The new proposed university fee structures are likely to exacerbate this situation
The Society is of the view that Acupuncture and Chinese medicine and other TCM and oriental medicine techniques are best learned in the clinical environment and taught by experienced practitioners. Academic degree courses offered by UK universities appear, in our experiance, to be lacking in the practical clinical skills area with over complication of Acupuncture and TCM theory causing confusion amongst students.
The Society is promoting Applied Acupuncture Training as the best way to attain expert skills in these therapies in order to have the practical skills to practice acupuncture correctly and be able to treat patients with competence, practical skill confidence and safety.
The EU laws concerning Herbal medicine came into force in April 2011 and contrary to popular belief only apply to patent medicines and preparations made up in factories for thirds parties.
Those practitioners and retail outlets who are trading in patent medicines can soon apply for a licence to continue to supply these patent or factory prepared formulations from the HPC (see the written ministerial statement below published on 16 February 2011).
UK legislation due in early 2013 is likely to require registration of Herbal Practitioners with the HPC, it’s anticipated that this will greatly increase our acceptance within the orthodox medical community. There will be a consultion process begining in late 2012 leading to legislation expected in 2013. There will be grandparenting arrangements for all those in practice prior to the legislation coming into force. The White Paper is expected to follow simillar processes to those which were required when previous aspirant therapies attained registration to the HPC in the past. The Acupuncture Society is seeking to attain automatic grandparenting for all its Herbal Members.
Follow this link to the hpc website page on herbal regulation http://www.hpc-uk.org/aboutregistration/aspirantgroups/aspirantgroups/
Herbalists must not use endangered species animal and mineral substances in their formulae nor use patient medicines nor ask third parties to prepare them or their insurance may be void.
List of Banned Herbs and legal implications of new EU herbal regulation
A: RESTRICTED UNDER THE CONVENTION ON INTERNATIONAL TRADE IN ENDANGERED SPECIES (CITES)
Herbs which are endangered in the wild are restricted but may be traded with the appropriate CITES certification. In the case of Appendix I this is
normally only permitted for scientific purposes if at all. Suppliers can trade in Appendix II herbs but only from authenticated cultivated supply. An
example of this is XI YANG SHEN which is available from farmed sources.
APPENDIX I
HU GU (Os tigris)
SHE XIANG (Secreto Moschus)
XI JIAO (Cornu Rhinoceri)
XIONG DAN (Vesica Fellea Ursi)
BAO GU (Os Leopardis)
DAI MAO (Carapax Ertmochelydis)
MU XIANG (Saussurea lappa) NOTE: Vladimira species are permitted as a substitute herb.
APPENDIX II
CHUAN SHAN JIA (Squama Mantis Pentadactylae)
HOU ZAO (Calculus Macacae)
LING YANG JIAO (Cornu Antelopis)
GUI BAN (Chinemys reevesii)
SHI HU (Dendrobium species)
BAI JI (Bletilla striata)
TIAN MA (Gastrodia elata)
GOU JI (Cibotium barometz)
LU HUI (Aloe ferox)
XIAO YE LIAN (Podophyllum emodii)
ROU CONG RONG (Cistanches deserticola)
XI YANG SHEN (Panax quinquefolius) NOTE: Only applies to the whole and sliced root.
HU HUANG LIAN (Picrorrhiza kurroa)
B: RESTRICTIONS UNDER STATUTORY INSTRUMENTS
SI 2130 1997
These herbs were listed as an addition to the 1968 Medicines Act as being potent and hence in need of dosage regulation. In some cases they are
forbidden at any internal dosage.
MD= Maximum single dose MDD=Maximum Daily Dose
FU ZI/CAO WU (Aconitum species) NOTE: Permitted to use externally at a dose of 1.3% or below. Internal use prohibited.
SHI LIU PI (Punica granitum). Internal use prohibited.
BING LANG (Areca catechu) Pharmacy use only.
DA FU PI (Areca catechu) Pharmacy use only
MA HUANG (Ephedra sinica). MDD: 1800 mg. MD: 600 mg.
YANG JIN HUA (Datura stramonium). MDD: 150 mg. MD: 50 mg.
DIAN QIE CAO (Atropa belladona). MDD: 150 mg. MD: 50 mg.
TIAN XIAN ZI (Hyocyamus niger). MDD: 300 mg. MD: 100 mg.
NOTE: SI 2130 also applies to other herbs not employed in Chinese medicine.
S1 1841 2002
This ban relates to all Aristolochia species but also includes herbs which have been confused with Aristolochic species due to poor quality assurance.
The sale, supply and importation of the following is banned:
MU TONG (Aristolochia manshuriensis). NOTE: this ban also applies to Akebia quinata, Akebia trifoliata, Clematis montana and Clematis armandii.
FANG JI (Aristolochia fangji). NOTE: this ban also applies to Stephania tetrandra, Cocculus laurifolius, Cocculus orbiculatus and Cocculus Trilobus
MA DOU LING (Aristolochia contorta, Aristolochia debilis)
TIAN XIAN TENG (Aristolochia contorta, Aristolochia debilis)
QING MU XIANG (Aristolochia debilis)
SI 548 2008
All species of Senecio are prohibited for internal use due to the presence of toxic pyrrolizidine alkaloids (PA). This mainly applies to the use of Senecio
scandens QIAN LI GUANG
C: VOLUNTARY RESTRICTION
Due the presence of Aristolochic Acid in Asarum species there is a voluntary ban on the use of:
XI XIN (Asarum species)
D: RESTRICTIONS UNDER THE 1968 MEDICINES ACT
Under Section 12(1) of the 1968 Medicines Act, ‘herbal remedies’ which are administered after a one-to-one consultation with a practitioner do not
require a medicines licence (marketing authorisation). This legislation was enacted before traditional medicines from non-European cultures, which use
non-plant substances, had any significant presence in the UK.
Since the term ‘herbal remedies’ refers to plant materials, the MHRA has stated in its guidance on medicines law that the use of mineral and animal
substances, which do not have a marketing authorisation, is illegal.
Section 12(1) is currently under review and the RCHM is working to re-establish the use of animal and mineral products. It is also expected that this
redefinition of what constitutes a ‘herb’ will be clarified in European and UK legislation in the near future to include non-plant medicines.
In the meantime, members are warned that the use of these products may result in legal action by the MHRA and absence of insurance cover in the case
of a claim. Hence all animal and mineral products should not be used until otherwise informed.
Whatever the outcome of this process, the following must never be used in any form:
ZHU SHA (Mercuric sulphide) Cinnabar
QING FEN (Mercuric chloride) Calomel
HONG FEN (Mercuric oxide) Realgar
HEI XI Lead
PRESCRIPTION ONLY MEDICINES (POM)
It is strictly prohibited to include any drug which is made available only through prescription by a registered medical doctor.
This includes the following:
YING SU KE (Papaver somnifera)
MA QIAN ZI (Strychnos nux vomica)
STEROIDS Including external use in creams such as PI YAN PING or 999 SKIN CREAMS.
FU ZI Internal use
E: PATENT FORMULAE
It should be noted that several patent formulae traditionally contain some of the above restricted herbs and toxic minerals, and recently some have been
found to contain drugs. These include the following, which may present a health risk if used as a patent:
NIU HUANG JIE DU PIAN (May contain arsenic)
TIAN WANG BU XIN DAN (May contain mercuric salts)
It is the responsibility of the practitioner to ensure that all patent formulae are obtained from ‘bonafide’ suppliers. In practice this means that all
ingredients are listed and none of the above are included in the formula.
There are many Acupuncture Society CPD accredited , Under graduate and Post graduate TCM Acupuncture,Herbal and Oriental Diagnosis courses being run at the College of Chinese Medicine London. Visit www.ccmlondon.com for more info.
I wish you well in the continued wonderful healing work in which you are involved in
Kindest regards to all
Paul Robin FAcS TCM
Chairman of the Acupuncture Society
Below is the latest Government regulation statement which we are happy with in its wisdom, it allows for the continuation of voluntary regulation of Acupuncture although Auricular Detox Acupuncturists can also have their qualifications verified by the Acupuncture Society and be included on the CNHC Register.
Chinese herbal medicine practitioners who do not use patent medicines and prescribe tailor made formulas specifically to their clients are also omitted.
Those who supply or prescribe patient medicine which pre manufactured or prepared by third parties will need licences from the HPC after April 2012
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
Copies are available to hon Members from the Vote Office and to noble Lords from the Printed Paper Office.
The Government has now had the opportunity to consider its overall strategy on professional regulation in light of the consultation response and I can now set out how we intend to take forward the regulation of herbal medicine practitioners and traditional Chinese medicines practitioners, specifically with regard to the use of unlicensed herbal medicines within their practice. As this matter is a devolved matter in Scotland and Northern Ireland we have had discussions with Health Departments in the three Devolved Administrations which have been constructive and we are committed to a unified UK-wide approach to the regulation of these practitioners.
When the European Directive 2004/24/EC takes full effect in April 2011 it will no longer be legal for herbal practitioners in the UK to source unlicensed manufactured herbal medicines for their patients. This Government wishes to ensure that the public can continue to have access to these products.
In order to achieve this, while at the same time complying with EU law, some form of statutory regulation will be necessary and I have therefore decided to ask the Health Professions Council to establish a statutory register for practitioners supplying unlicensed herbal medicines. This will ensure that practitioners meet specified registration standards. Practitioner regulation will be underpinned by a strengthened system for regulating medicinal products. This approach will give practitioners and consumers continuing access to herbal medicines. It will do this by allowing us to use a derogation in the European legislation to set up a UK scheme to permit and regulate the supply, via practitioners, of unlicensed manufactured herbal medicines to meet individual patient needs.
The Health Professions Council is an established and experienced statutory regulatory body which has the necessary experience to be able to successfully establish and maintain a statutory register for practitioners wishing to supply unlicensed herbal medicines. Subject to Parliamentary approval, such practitioners who wish to supply unlicensed herbal products will be required by law to register with the HPC.
The four UK Health Departments will consult jointly on the draft legislation once it is prepared. This will give practitioners and the public the opportunity to comment. Subject to Parliamentary procedures we will aim to have the legislation in place in 2012.
Until the new arrangements are in place the Medicines and Health care products Regulatory Agency (MHRA) will continue to take appropriate compliance and enforcement action where products are in breach of the regulatory requirements. In line with the MHRA’s normal approach, the action taken will be proportionate and will target products which pose a public health risk. Guidance issued by the MHRA makes clear their view that, where practitioners hold stocks of unlicensed products on 30 April 2011 that legally benefited from transitional arrangements under the European Directive, the practitioner can continue to sell those existing supplies to their patients.
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 marks a significant milestone. I am confident that this is the right decision, which will benefit both practitioners and the public who use herbal medicines.
History of UK Regulation of Acupuncture and Chinese Herbal Medicine in the UK
We are approaching the end of 2007 and there is still not a single governing body for acupuncture, TCM and Chinese herbal medicine in the UK. There are many different organizations all practising different versions of acupuncture, TCM and Chinese herbal medicine all with different lengths to their training courses. At present all these different organizations have equal standing under the law.
Students who have graduated from the College of Chinese Medicine, an ASA accredited course, are entitled to be admitted as members of The Acupuncture Society and are obliged to maintain its high professional standards and adhere to its code of ethics, rules and regulations and professional requirements.
Society involvement in the future regulation of the profession
The Acupuncture Society were asked to contribute towards the draft National Professional Standards for Acupuncture and the Department of Education has also sort the advice of The Acupuncture Society relating to how the public can best be informed about the benefits of the acupuncture profession. The Acupuncture Society are currently attending the Acupuncture Stakeholders Group meetings and are participating in the future regulation of acupuncture and Chinese herbal medicine in the UK.
Here is an article from the April 2007 issue of The Chinese Medicine Times which clearly explains the current situation.