Question 1: What evidence is there of harm to the public currently as a result of the activities of acupuncturists, herbalists and traditional Chinese medical practitioners? What is its likelihood and severity?
While I only visit fully trained and qualified practitioners, I know there are unscrupulous practitioners in other practices who do not know enough, or care about what they prescribe, or where the herbs they use are sourced and made. These individuals are a potential danger to the public and cases have been documented showing the potential health risks that these people could cause.
However, herbal medicine is actively sought as a preferred medical treatment by millions of people each year. The potential for harm comes from people not being able to access a register of statutorily regulated herbalists. Regulated herbalists would be known to be safely and competently trained, undertake continuous professional development, and have a properly operating complaints and disciplinary process, along with a Code of Ethics.
Question 2: Would this harm be lessened by statutory regulation? If so, how?
I wish to be able to be sure about the herbal practitioner I choose to use and a statutory register would enable me to make safe choices about my health treatments. It would reduce the risk of danger from an incompetent practitioner. It would allow all members of my health care team, including my GP/Consultant and Medical Herbalist, to communicate freely to the overall benefit of patient safety and well being.
Question 3: What do you envisage would be the benefits to the public, to practitioners, and to businesses, associated with introducing statutory regulation?
The public could be sure that mechanisms exist to train and monitor the practitioner they choose. Patients could be sure the practitioner they visit is appropriately qualified.
Practitioners would be working more closely with their peers in the healthcare professions which would make for better practice and understanding of healthcare needs thus promoting patient welfare. Working in a collaborative way would also improve other professions' understanding of the practice of herbal medicine.
Business would have a safe secure and guaranteed market for their products safeguarding jobs (many of which are in rural communities which often have high unemployment rates). Business would therefore be encouraged to invest in research and better equipment.
Question 4: What do you envisage would be the regulatory burden and financial costs, to the public, to practitioners, and to businesses, associated with introducing statutory regulation? Are these costs justified by the benefits and are they proportionate to the risks? If so, in what way?
The Government has already significantly increased the costs associated with regulation by holding this Consultation. Over ten years of costs and expenses associated with various reports and other consultations has been a huge investment of money and time on the part of the civil service and the professions themselves.
The recommended Regulating Body, the Health Professions Council (HPC) has already been set up and has expressed their agreement to take on this responsibility for medical herbalists. Therefore the small further cost of introducing the relevant legislation seems to be perfectly justified.
The huge potential benefits in terms of business profitability and safeguarding of jobs is also another justification for regulation.
Another issue to be considered is the huge potential SAVINGS on the nation's drug bill that could be made, if doctors were able to refer patients with long term chronic ailments which currently have restricted treatment options (such as arthritis or irritable bowel syndrome), to a medical herbalist. These patients use up huge amounts of NHS time and money and many of these patients can usefully be supported by herbal medicine which is many cases is a much cheaper option.
Question 5: If herbal and TCM practitioners are subject to statutory regulation, should the right to prepare and commission unlicensed herbal medicines be restricted to statutorily regulated practitioners?
Yes. Absolutely. The preparation of herbal medicines requires training and proper procedures that are part of the professional training of a medical herbalist or a GMP registered manufacturing facility.
Question 6: If herbal and TCM practitioners are not statutorily regulated, how (if at all) should unlicensed herbal medicines prepared or commissioned by these practitioners be regulated?
How can the Government adequately cope with this risk without regulating herbal practitioners? It is likely that without statutory regulation, protecting the supply of such medicines to properly trained professionals, that more members of the public will access them from questionable sources over the internet or in shopping malls and market stalls, thus increasing the risk of supply of harmful herbal preparations to the public.
Question 7: What would be the effect on the public, practitioners and businesses if, in order to comply with the requirements of European medicines legislation, practitioners were unable to supply manufactured unlicensed herbal medicines commissioned from a third party, after 2011?
This would restrict public choice and potentially put practitioners and businesses out of business. Rather than buying preparations from GMP licensed or accredited manufacturers, herbalists would be making their own remedies and have a far greater burden in analysis of raw material, manufacture, quality control, testing and record keeping. This takes time away from seeing patients in the clinics.
Question 8: How might the risk of harm to the public be reduced other than by statutory professional self-regulation? For example, by voluntary self-regulation underpinned by consumer protection legislation and by greater public awareness, by accreditation of voluntary registration bodies, or by a statutory or voluntary licensing regime?
Statutory regulation is the only satisfactory way to deal with all the issues. Voluntary regulation would still not prevent unscrupulous, incompetent practitioners from posing a danger to the public. Herbal preparations should also only be made by registered herbalists and accredited manufacturers.
Question 9: What would you estimate would be the regulatory burden and financial costs, to the public, to practitioners, and to businesses, for the alternatives to statutory regulation suggested at Question 8?
Statutory regulation is the most cost effective alternative. The cost for the other alternatives would be born by the general public in terms of; not being able to get guaranteed access to safe competent practitioners, nor to herbal medicines which have been produced to high quality standards.
Question 10: What would you envisage would be the benefits to the public, to practitioners, and to businesses, for the alternatives to statutory regulation outlined at Question 8?
Question 11: If you feel that not all three practitioner groups justify statutory regulation, which group(s) does/do not and please give your reasons why/why not?
All three groups should be regulated. This is the Government's stated policy and the public deserves that their healthcare is treated with the proper respect and professionalism.
Question 12: Would it be helpful to the public for these practitioners to be regulated in a way which differentiates them from the regulatory regime for mainstream professions publicly perceived as having an evidence base of clinical effectiveness? If so, why? If not, why not?
No. Medical herbalists do have an evidence base of clinical effectiveness. Many pharmaceutical drugs are based on plants both historically and also in new research into cures for a wide range of illnesses from malaria to breast cancer. Many herbs have been studied in clinical trials and are the subject of research papers documenting their clinical effectiveness. Although the body of work is smaller than many better-funded pharmeceuticals, nevertheless it is significant.
Herbal medicine has a well-documented history. Many of the companies who started in the 1800's, have well documented letters from patients and reports from practitioners recording clinical results, for over 100-150 years.
The public also demonstrably understands as evidence, the millions of people who use such therapies on an annual basis. It is unethical to apply different standards of proof to one or other medical profession. Much of mainstream medicine does not have clear ‘proof’ of effectiveness but there is no presumption that such should not be used. A clinician must be free to use judgment in these matters and assess effectiveness by what the patient reports.
Additionally, statutory regulation would enable herbalists to access research facilities, patient groups and funding which would greatly aid the health care community in understanding how much the practice of herbal medicine does work.
Question 13: Given the Government’s commitment to reducing the overall burden of unnecessary statutory regulation, can you suggest which areas of healthcare practice present sufficiently low risk so that they could be regulated in a different, less burdensome way or de-regulated, if a decision is made to statutorily regulate acupuncturists, herbalists and traditional Chinese medicine practitioners?
I understand the Government must be prudent in expenditure at this time. However, the health of the nation has been identified as an area which should be protected. The minimal cost to complete this statutory regulation should not pose a massive burden especially as all the work has now been completed and the regulatory body has already been established. Failure to see this project through to completion would be a dereliction of duty and the Government could be called to task for wasting tax payer’s money and failing to deliver the promised service.
Question 14: If there were to be statutory regulation, should the Health Professions Council (HPC) regulate all three professions? If not, which one(s) should the HPC not regulate?
The Health Professions Council should regulate all three professions.
Question 15: If there were to be statutory regulation, should the Health Professions Council or the General Pharmaceutical Council/ Pharmaceutical Society of Northern Ireland regulate herbal medicine and traditional Chinese medicine practitioners?
The Health Professions Council should be the statutory regulator.
Question 16: If neither, who should and why?
The Health Professions Council should be the statutory regulator.
a) Should acupuncture be subject to a different form of regulation from that for herbalism and traditional Chinese medicine? If so, what?
No, the Health Professions Council should be the statutory regulator for acupuncture too.
b) Can acupuncture be adequately regulated through local means, for example through Health and Safety legislation, Trading Standards legislation and Local Authority licensing?
No. These bodies do not have the necessary expertise.
Question 18: Should the titles "acupuncturist", "herbalist" and "[traditional] chinese medicine practitioner" be protected?
Yes, the titles should be protected and only used by qualified, registered practitioners.
Question 19: Should a new model of regulation be tested where it is the functions of acupuncture, herbal medicine and TCM that are protected, rather than the titles of acupuncturist, herbalist or Chinese medicine practitioner?
No. Both the functions and titles should be regulated as discussed and planned.
Question 20: If statutory professional self-regulation is progressed, with a model of protection of title, do you agree with the proposals for "grandparenting" set out in the Pittilo report?
Question 21: In the event of a decision that statutory or voluntary regulation is needed, do you agree that all practitioners should be able to achieve an English language IELTS score of 6.5 or above in order to register in the UK?
Yes. It is vital for the proper care of patients that their practitioners can speak good English and can communicate properly with them to achieve a correct diagnosis and treatment plan.
Question 22: Could practitioners demonstrate compliance with regulatory requirements and communicate effectively with regulators, the public and other healthcare professionals if they do not achieve the standard of English language competence normally required for UK registration? What additional costs would occur for both practitioners and regulatory authorities in this case?
No, practitioners cannot demonstrate compliance without a competency in the English language. The costs of learning English to the level required should be born by the individual (and/or professional body) to bring practitioners up to the required standards and not by the Government nor tax payer.
Question 23: What would the impact be on the public, practitioners and businesses (financial and regulatory burden) if practitioners unable to achieve an English language IELTS score of 6.5 or above are unable to register in the UK?
Transition arrangements could be made for such individuals already practising in this country, where they can demonstrate that they are not endangering patients through their inability to fully communicate. No new practitioners should enter the country to practice or be regulated without this English proficiency.
Question 24: Are there any other matters you wish to draw to our attention?
The Government has promised timetables for statutory regulation and failed to deliver on more than one occasion in the past. If it fails to deliver statutory regulation to this sector, combined with the impact of the Traditional Herbal Medicines Product Directive where hundreds of herbal remedies will be lost, the public, which makes great use of herbal medicine, will notice the loss of businesses, remedies, jobs and health care options. The loss of a traditional therapy with roots going back hundreds of years in the UK, and thousands of years worldwide is not to be countenanced.
The general public who use herbal medicine are generally well-informed and are making concious and deliberate health choices. It is no coincidence that the number of people buying OTC herbal remedies has grown consistently every year since 2002 by an average of 9% per year (Mintel 2007). To restrict their access to trained herbalists and properly manufactured preparations will drive many to self-diagnose and purchase on the internet from unverified and possibly unreliable sources, with potentially fatal consequences.