Department of Health (DH) consultation paper on the regulation of complementary and alternative medicine

Complementary and alternative medicine is under the spotlight in the joint consultation on the "Statutory regulation of practitioners of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and other traditional medicine systems practised in the UK", which was published by the DH on the 3 August 2009.

1. Current regulatory regime

Voluntary professional self-regulation operates by establishing a professional body which sets rules for the practice of that profession. Typically practitioners will be required to reach minimum standards for education, practice and conduct. This helps to give consumers confidence that the practitioner is bona fide. The costs of voluntary registration are borne by practitioners and their customers.

However, voluntary regulation lacks legal sanctions, so practitioners who choose not to register (or who have been removed from the register) may still practice legally. As the regulator will be profession-led, the public cannot be guaranteed of the quality of the threshold standards or how actively those standards are enforced.

Acupuncture is the method of inserting solid sterilised needles into specific tissues in the body. It is used by many types of healthcare practitioners, yet there is no single body representing all acupuncturists.

Regulation is currently voluntary (except for those acupuncturists who are also regulated health professionals, i.e. a doctor or physiotherapist using acupuncture as part of a specific therapy). The DH considers the system of self-regulation for acupuncturists as quite robust.

Herbal medicine is the use of plant materials for medication. Practitioners may voluntarily register with a professional body to promote their own professional standards.

Traditional Chinese Medicine (TCM) is a profession that uses herbal medicine, acupuncture, moxibustion, cupping, Qi Gong and therapeutic massage. As with the previous two professions, a few voluntary regulatory bodies operate in the UK.

In addition, the herbal medicines market is currently part regulated and part not. Industrially prepared herbal medicines are subject to systematic regulation under European legislation and 'traditional herbal registration' will be fully effective in 2011. Practitioners may use licensed medications or legally commission the manufacture of unlicensed medicines using a legislative exemption in section 12(1) of the Medicines Act 1968.

Businesses also have to comply with health and safety, trading standards and advertising legislation, which offer the public some means of complaint and redress. However, this does not ensure that appropriate standards are followed, and there is insufficient trading standards resource to make inspection of these three professions a priority.

2. Previous analysis

A DH consultation in 2004 received strong support for statutory regulation of acupuncture and herbal medicine (but not TCM, following the recommendations of a report in 2000 by the House of Lords' Select Committee on Science and Technology).

The 2008 report of the DH Steering Group for the 'Statutory Regulation of Acupuncture, Herbal Medicine and TCM' recommended that a consultation exercise was performed due to the difficult and controversial issues involved.

Three key areas of risk were identified in 2008 report:

(i) Products

This includes issues relating to use of toxic/potent herbs, poor-quality ingredients, low manufacturing standards, lack of information given to patients concerning side effects and inappropriate labelling of medications.

(ii) People

This includes the risk to the public of using unqualified, incompetent or unscrupulous practitioners or those who cannot communicate clearly in English.

(iii) Premises/providers

This includes the use of unhygienic premises and non-compliance with other health and safety considerations.

3. Proposed regulatory alternatives

The purpose of statutory regulation would be to better protect patients from poor practice and to promote public confidence in complementary and alternative medicine. But the method of regulation should be proportionate to the identified risks. The DH consultation suggests the following alternatives.

(a) Statutory regulation.

Where the risks warrant it, statutory regulation has the benefit of being transparent and consistent. This involves the registration of practitioners who meet a particular standard of qualification, conduct and practice. It would be unlawful for unregistered practitioners to practice under a specific title or to practice a specific medical function.

But statutory regulation means extra taxation to pay for the development of legislation and the implementation of the new regulatory regime. The additional direct cost for a practitioner to register and maintain the required standards may be onerous and force some practices to close. Patient choice and accessibility could be restricted as a result. The risks requiring public protection must be significant to justify the additional costs and bureaucracy connected with statutory regulation.

The consultation considers who would be the statutory regulator. It does not favour the creation of a new regulator, but prefers instead the expansion of the remit of an existing regulator, like the Health Professions Council or General Pharmaceutical Council.

The consultation also considers how to regulate complementary/alternative medicine under statute. It notes that there would be issues where practitioners are already registered under other regulatory regimes (i.e. physiotherapists practising acupuncture), or where practitioners are practicing safely but either do not meet threshold qualifications or have sufficient competence in English.

(b) Reinforcing voluntary regulation  

Statutory regulation may be unnecessarily burdensome and disproportionate to the risks.

The current regime could instead be reinforced by providing the public with better access to information of the risks involved in complementary or alternative medicine, for example on the DH website.

Voluntary registration bodies could benefit from independent accreditation, so that regulation is limited to 'policing the policeman', for instance by giving power to an independent adjudicatory body to consider fitness to practice cases. This may allow fewer professions to be included in the statutory regulation framework.

(c) Product regulation

Licensing 'over the counter' products can help to safeguard health without the need for practitioner expertise.

The consultation suggests two changes to the current regulatory regime:

  1. The abolition of section 12(1) Medicines Act 1968, so that the supply and use of unlicensed herbal medicines is banned. This would help to assure the public that products are made to assured standards and are accompanied by appropriate information, or (where the product is prescription only) dispensed with the advice of a qualified healthcare professional.
  2. Not to repeal section 12(1) Medicines Act 1968, but instead to increase efforts to inform the public of the health risks involved in using this type of medication, with the use of ad hoc bans when specific safety issues are identified.

This suggestion recognises that after April 2011, European legislation allows only 'authorised healthcare professionals' to commission manufactured unlicensed herbal medicines for specific patients. 'Authorised' professionals are regarded as being statutorily regulated practitioners, so that unless the UK establishes a national scheme and allow regulated practitioners to make use of this exemption after 2011, the impact will be the same as in point (i) above.

However, product regulation alone cannot guarantee that the methods of use of safe products are safe. There is no certainty that the practitioner is an expert or will be accountable, and so the consultation suggests that product regulation is considered as an additional but not alternative means of regulation to one of the other options.

(d) System regulation

This regulates service providers and not individual practitioners. It is the organisation and not the individual that fails to meet the relevant standards, and is subject to audit and inspection. This is less bureaucratic for practitioners, but puts the responsibility on service providers to police their employees.

The establishment of this method of regulation would require new legislation. Due to the expense of inspecting a large number of independent, self-employed providers, inspections may be limited.

The consultation recognises that the regulation of complementary/alternative medicine is excluded from the remit of the new Care Quality Commission which regulates other healthcare activities. So there is also the question of which body would be appropriate to regulate the three professions.

(e) Local authority licensing schemes

Local authorities have the power to regulate acupuncture and businesses providing tattoo services, piercing and electrolysis.

New legislation would be required for local authorities to regulate herbal medicine and TCM.

(f) Statutory or voluntary licensing schemes

This is a less onerous and burdensome version of statutory regulation, but more robust than voluntary regulation.

New legislation would be needed to cater for the compulsory licensing of any practitioner with an accredited qualification. Additional criteria for obtaining a licence could be passing a criminal record check and not being listed as unsuitable to work with vulnerable people.

The licensing authority would have the power to revoke a practitioner's licence if the licence conditions were breached or following complaint and investigation. The licensing authority would also have the power to suspend a licence if they were reasonably satisfied that a clear threat to safety existed. Practitioners would have a right of appeal where their licence was revoked or suspended.

This would not check a practitioner's fitness to practice and the practitioner would not have to be registered with a professional body to practice.

A voluntary system would not require statutory underpinning and practitioners would not be obliged to register to be able to practice legally. This system could be reinforced by efforts to make the public aware of the risk of using unlicensed practitioners.

Conclusion

Any regulatory solution has both its merits and demerits.

A lack of effective statutory regulation could shift the commercial advantage away from responsible and competent practitioners and undermine confidence in the professions.

But with increased regulation comes increased costs and potentially decreased choice.

The consultation is concerned with how the DH strikes the right balance. Responses are sought by 2 November 2009. The consultation paper can be found on the DH website.