News
The Secretary of State for Health has made an announcement today about regulation of herbal medicine practitioners. 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 report on Complementary and Alternative Medicine in 2000.
The Health Professions Council (HPC) has now been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines. The proposal is, following creation of this register, to make use of a derogation in European medicines legislation (Article 5 (1) of Directive 2001/83/EC) that allows national arrangements to permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients.
Accordingly, a scheme would be created enabling registered practitioners to commission unlicensed herbal medicines to meet the special needs of their individual patients. Safeguards for the public would be provided by a combination of professional regulation and linked medicines regulation, for example, to safeguard manufacturing standards.
If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12 (1) of the Medicines Act 1968. Under Section 12 (1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.
A formal consultation exercise will take place on specific legislative proposals for establishing the register and proposed reforms of medicines legislation later in 2011.
Further information is published on the Department of Health's website:
Department of Health press release: Proportionate health and social care worker regulation to protect the public (external link)
Questions and answers
1. What was announced on 16 February 2011 about regulation of herbal practitioners?
The Secretary of State for Health made an announcement on 16 February 2011 about regulation of herbal medicine practitioners (see above). The Health Professions Council (HPC) has been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines.
2. Will there be a consultation exercise on the proposals that will apply under the HPC register?
Once regulations have been drafted, the Department of Health (DH) will consult on the proposed draft legislation.
3. Does this announcement have an impact on the way MHRA implements the European Directive on traditional herbal medicinal products (2004/24/EC)?~
No. The Directive (2004/24/EC) has full effect in the UK as in other Member States. The UK implemented the Directive in 2005. The transitional period under the Directive will end on 30 April 2011. From this date, all manufactured herbal medicines placed on the market must have either a traditional herbal registration or a marketing authorisation (MA). The MHRA has published guidance on its website about the transitional arrangements that apply under the Directive. This guidance continues to apply in full.
Guidance on Transitional arrangements for the Directive on traditional herbal medicinal products
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Where the announcement does have an effect is that, following the introduction of professional regulation of practitioners, a scheme would be created allowing registered practitioners to commission an unlicensed herbal medicine to meet the special needs of their individual patient.
4. Does this announcement have an impact on the current arrangements that apply under Section 12 (1) of the Medicines Act 1968?
Section 12(1) allows practitioners to supply unlicensed herbal medicines which they have prepared on their premises to meet the needs of individual patients identified in a face-to-face consultation. This provision will continue to be available.
However, the intention is that, when the proposed HPC register is established, use of the S12 (1) scheme would be limited to registered practitioners. There would need to be a transitional period to allow practitioners adequate time to join the register.
These reforms would also provide an opportunity to progress ideas on which MHRA has previously consulted to improve public health protection. This would be achieved, primarily by reference to the professional standards and codes that attach to a regulated profession (in contrast the current situation where anyone can act as a herbal practitioner).
5. Will there be a consultation exercise on the proposed reforms to medicines legislation?
There will be a public consultation on proposed arrangements that might apply under medicines legislation in due course. The MHRA will consult on both the proposals for revising S12 (1) and for the creation of arrangements allowing registered practitioners to commission unlicensed herbal medicines from a third party (a scheme often known as “specials”). The MHRA website will be updated to reflect developments.
