A definitive look at the background to new legislation by Michael McIntyre, member of the Governing Council of the College of Medicine, and Chair European Herbal and Traditional Medicine Practitioners Association and  Professor George Lewith, College of Medicine Vice Chair and Professor of Health Research at Southampton University.

All UK practitioners prescribing herbal medicines are to be statutorily regulated via the Health Professions Council.” That was the announcement by the Secretary of State for Health, Andrew Lansley on 16th February 2011.

He explained that ‘this would ensure that practitioners would meet specified registration standards’. This would give practitioners and consumers continuing access to unlicensed manufactured herbal medicines to meet individual patient needs after the introduction of new EU legislation on 1st May this year.

This announcement follows years of campaigning. It also comes as a result of 15 years of developing the standards and educational requirements of the herbal medicine profession in the UK. Wholesale changes are now taking place in the way that herbal medicines will be supplied and provided to the public in this country.

For over 40 years, herbal medicine in the UK has been available by direct sale over- the-counter (OTC) and also through prescription by herbal practitioners to their individual patients, courtesy of Section 12.1 & 12.2 of the 1968 Medicines Act.

All this is set to change in May 2011 when a new EU Herbal Medicinal Products Directive – 2004/24/EC (THMPD) is fully implemented.

In the UK, the THMPD will make provision for the sale of herbal medicines direct to the public. The new Directive will require all herbal medicines sold OTC to hold a traditional herbal registration (THR), granted on the basis of 30 years of safe use, 15 years of which must be demonstrated within the EU.

In addition, Traditional Herbal Regulatory approval (THR) will only be granted to products that have undergone extensive quality assurance testing in the same way that conventional medicines are quality tested.

Under these terms regulated herbal medicines sold OTC will be able to make medicinal claims based on their established traditional use but these claims are limited to mild and self- limiting conditions such as ‘helps with the symptoms of  the common cold’.

The Medicines and Healthcare products Regulatory Agency (MHRA) has so far recorded 187 THR applications, of which, to date, 84 have been granted. The MHRA also reports that 32 individual herbs were represented in products currently registered, with a further 35 herbs present in applications currently being processed.

The MHRA has advised herbal manufacturers seeking THR to limit the number of herbs in each product. This is because of the difficulty in providing the necessary quality assurance data with more complex mixtures containing several herbs. They also reported some 13 combination products had achieved a THR with others in the pipeline.

The MHRA has advised herbal manufacturers seeking THR to limit the number of herbs in each product. This is because of the difficulty in providing the necessary quality assurance data with more complex mixtures containing several herbs. They also reported some 13 combination products had achieved a THR with others in the pipeline.

The implementation of the THMPD has had significant implications for UKherbal practitioners. In the past UK herbalists have used the 1968 Medicines Act as the basis for the supply of all manufactured or finished medicines, such as herbal tablets made up for them to supply to individual patients. This would not be recognised as a proper process by the new legislation unless herbal practitioners were able to obtain the legal status required for statutory regulation. This has been one of the major reasons that herbalists have campaigned for statutory regulation.

According to the main EU Medicines Directive  (Article 5.1 of Directive 2001/83/EC) ‘authorised health professionals’ can commission the manufacture and supply of medicines made up for the benefit of individual patients (so long as there is no similar licensed medicine on the market) via this ‘specials arrangement’.

The granting of statutory regulation will make UK herbalists ‘authorised health professionals’ and thus enable them to have medicines manufactured and supplied for individual patients by a recognised and appropriate third party manufacturer as ‘specials’.

This will mean such manufacture does not have to be exclusively carried out on the premises of the practitioner as this is not always possible given the safety requirements and the complexity of modern herbal medicine manufacture as well as the demands of quality control. The Secretary of State made his announcement just weeks  before the April 30th deadline.

This, however, was not the only reason that herbalists have campaigned for statutory regulation. The struggle for legal recognition of the herbal profession has been going on for well over a century in the UK.

In 1886, when an amendment to the Medical Acts proposed to make it illegal to practise medicine unless qualified as a doctor, the herbalists successfully campaigned against the Bill which was subsequently withdrawn.

In 1923, the National Association of Medical Herbalists lobbied MPs for a Medical Herbalists Registration Bill which would finally grant them safe legal status. Over 130 MPs signed up to the Private Members’ Bill which enjoyed an unopposed first reading. But the hopes of the herbalists were dashed when the Government refused to make time for the Bill to progress.

Herbalists subsequently campaigned to be included within the structure of the new National Health System launched by Aneurin Bevan in 1945 but Bevan declared that herbalists could only be incorporated into the NHS if they were regulated by and subordinate to the medical profession.  These terms would undoubtedly have spelt the end of independent herbal practice and in these circumstances the herbalists chose to stay outside of the National Health System.

The thalidomide tragedy of the early 1960s saw the birth of thousands of children afflicted by severe physical deformities caused by this drug that was widely prescribed to pregnant women when it had never been properly tested.  Faced with a huge public outcry about the lack of proper control over drugs, the Government rushed in legislation requiring the testing and licensing for all medicines and herbal medicines were caught up in this process.

As herbs grow wild, they cannot be patented like pharmaceutical drugs and thus cannot provide a financial return on the enormous sums of money required to license a new medicine. For this reason, the 1968 proposals to reform medicines licensing would have effectively put an end to herbal practice in the UKas there was no practical way herbal medicines could enter the new licensing scheme.

In the light of this, the herbalists campaigned for special provisions for herbal medicines to be passed into law and in this they were supported by the public which wrote thousands of letters to MPs protesting against the threatened eradication of herbal practice. Thus when the 1968 Medicines Act passed into law, it carried a special herbal provision (Section 12) that permitted herbal medicines to be sold over the counter and prescribed by practitioners exempt from licensing.

There was, however, one major flaw in this legislation; nowhere did it give any definition of who could be considered a qualified herbalist.In effect, anyone could be a herbal practitioner by virtue of hanging out a shingle and saying so.

It was in the light of this anomaly and a growing threat of EU medicines legislation impacting on the 1968 herbal provisions that, in the 1990s, the herbal profession began working with the Department of Health to explore how regulation of herbal medicine practitioners might be achieved. This process was greatly accelerated by a seminal report from the influential House of Lords’ Science and Technology Committee on Complementary Medicine published in 2000 that called for the statutory regulation of herbalists.

In 2001, the Government agreed that this regulation should go ahead and launched two committees under independent chairs; one to look at the regulation of herbalists and the other acupuncturists. The process was generously supported by the Prince of Wales and his Foundation for Integrated Medicine.

The two committees published their reports in 2003 and the following year the Department of Health (DH) undertook a public consultation on the statutory regulation of herbal practitioners. The results of this consultation were published in 2005 and showed a 98% opinion in favour of statutory regulation. That same year the DH published a timetable for such statutory regulation.

In the event, a General Election and public demand for better regulation in the wake of murders by the rogue doctor Harold Shipman brought considerable delay. The newly elected Labour administration put the herbal regulation on hold whilst it commissioned an overview of the regulation of all healthcare workers from doctors to hospital porters. This process took many months to complete and in the meantime the Government decided that there should be another DH Committee under the chairmanship of Professor Michael Pittilo to advise Government how best to regulate herbal medicine, traditional Chinese medicine and acupuncture.

The Pittilo Report, outlining specific measures to bring about this regulation, was published in 2008 and in 2009 the Government commissioned a second public consultation on this subject. Such consultations usually attract no more than about 40 – 60 responses; this one elicited an extraordinary public response with over six and half thousand replies.

A decade after the House of Lords called for the statutory regulation of herbalists, the Government finally decided that statutory regulation of herbalists should go ahead. This was the announcement made by Andrew Lansley on February 16th.  Once again the public had expressed its clear view that herbalists should be statutorily regulated. The results of the 2009 public consultation published concurrently with the Minister of Health’s announcement showed there was a massive majority (85% of the responses) in favour of statutory regulation.

There are scores of published papers on the potential benefits of herbal medicines and herbs can offer cheap, safe and effective approaches for many common complaints. The regulation of herbalists will support safe and professional practice so that the thousands of patients who consult herbalists every year can be assured about the standards of training and practice of the practitioners they see.

It may have taken Government a decade to make the decision, but this administration should be congratulated for a move that ensures that herbal treatments remain available for those who wish to consult herbalists.

As the Health Secretary himself remarked in his statement to Parliament, ‘I am pleased to say that this decision marks a significant milestone.  I am confident that this is the right decision, which will benefit both practitioners and the public who use herbal medicines.’

For more information about the work of The College of Medicine visit: http://www.collegeofmedicine.org.uk/

This article was first published in Allergy Newsletter No. 101, Spring 2011.

Allergy Newsletter is the journal of Action Against Allergy