Wonderful News for Herbal Medicine in the UK
16 February 2011
A decision has been made by the Secretary of State for Health regarding statutory regulation of herbal medicine in the UK:
Practitioners of acupuncture, herbal medicine and traditional Chinese medicine
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:
Copies are available to hon Members from the Vote Office and to noble Lords from the Printed Paper Office.
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 Healthcare 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 resolves a long-standing issue, to the benefit of both practitioners and the public who use herbal medicines.