Practitioners to gain access to unlicensed medicines via EU medicines directive

by the ANH team

A written Ministerial Statement issued today by the UK Department of Health has announced that practitioners of acupuncture, herbal medicine and traditional Chinese medicine (TCM) will be statutorily regulated by the Health Professions Council (HPC).

It has also published an analysis of the 2009 consultation by the four United Kingdom Health Departments, which had sought views on statutory regulation.

This long awaited news will come as a huge relief for most UK herbalists. Statutory regulation will effectively mean that herbalists are “authorised healthcare professionals” under EU medicines law. This means they qualify for an exclusion under Article 5(1) of the Human Medicinal Products Directive (2001/83/EC), allowing them to prescribe unlicensed medicines (in this case, herbal ones) to meet the special needs of their patients.

Article 5(1) of the Human Medicinal Products Directive states that: “A Member State may, in accordance with legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised health-care professional and for use by an individual patient under his direct personal responsibility”.


Update of UK laws

Herbalists in the UK who use manufactured herbal products are often dependent on another exemption to UK medicines law, under Section 12(2) of the UK Medicines Act 1968. However, this UK law is being superseded by the Traditional Herbal Medicinal Products Directive (THMPD) and so will expire on 30th April 2011. Any of these exempted herbal medicines that have not been registered by this date will be banned.

The Medicines and Healthcare Regulatory Agency (MHRA) has said that, once statutory regulation for practitioners is in place, it opens the way for reform of Section 12(1) of the Medicines Act. The intention is that only registered practitioners would be able to practice under Section 12(1) after regulation is in place. Some are justifiably concerned about both the time this might take and the conditions and cost of maintaining registration with the HPC.

Subject to Parliamentary approval, the Secretary of State for Health will now ask the HPC to establish a statutory register for practitioners supplying unlicensed medicines, which will ensure that they meet specified registration standards.

THMPD will severely limit consumer choice

While this is good news for herbalists who use finished products, it is important to realise that full implementation of THMPD will greatly affect consumers, who will be unable to buy unlicensed, finished herbal products over the counter or from the Internet. They would need to have an official consultation with an herbalist in order to have access to unlicensed products.


See ANH Press Release (16th Feb 2011): Consumers kept in dark over extent of EU herb ban

See also earlier ANH news item: UK herbalists threatened by Government inaction over statutory regulation

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