February 16, 2011 will be a historic date in the story of herbal medicine. On this day, the United Kingdom’s Secretary of State for Health, Andrew Lansley, announced in a written statement to Parliament that all UK practitioners prescribing herbal medicines are to be statutorily regulated through the Health Professions Council. This marks the first time that the UK government has found a way to license herbal practices in this country.
How did we get here? Is this a positive development? Many of us UK herbalists have long relished our independence from orthodox medicine and the whole industrial-reductionist world, so that we could work with nature to support human resilience. Being part of the “system” was probably not why we chose to work in the field of herbal medicine.
The answer lies in the encroachment of European legislation onto our lives, particularly in the default position of herbal remedies as medicines. For years, herbal practitioners in the United Kingdom have prospered outside statutory law, protected by a UK citizen’s common law rights to choose the healthcare option he or she prefers. And—until this year—these rights have remained. (The famous Act of Parliament of King Henry VIII in 1542 augmented these rights as an instruction to physicians and surgeons to stop encroaching on ordinary people’s use of herbs for their health.)
Throughout history, herbal products have enjoyed various exceptions from the laws that apply to medicines. Herbal products used for therapeutic purposes, however, are classified as medicines by default, under both UK and EU law. A longstanding campaign by the European Commission (EC) to regulate the sector of herbal medicine finally concluded with the EU Traditional Herbal Medicinal Products Directive 2004/24/EC (THMPD), which will go into full effect beginning May 1, 2011.1 With this legislation, the common law rights of UK citizens to choose herbal medicines for their own use was finally and dramatically curtailed.
For over 40 years, herbal medicines in the United Kingdom have been available by sale over-the-counter (OTC) or through prescriptions by herbal practitioners to their individual patients courtesy of Sections
12.2 and 12.1, respectively, of the 1968 UK Medicines Act.2 Under Section 12.2 of this Act, herbal medicines sold OTC have been exempt from medicines licensing. After April 30, 2011, however, the THMPD will have effectively done away with these exemptions, as it requires 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 European Union. In addition, THRs will be granted only to herbal medicinal products that have undergone the same extensive quality assurance testing as required of conventional medicines. These tests include long-term stability trials and the identification of chemical markers throughout the manufacturing process.
Not surprisingly, the approval of THR applications has been slow. As of January, 2011, the UK Medicines and Healthcare products Regulatory Agency (MHRA) had recorded 187 THR applications, of which 84 have been granted. The MHRA also reported that only 32 individual herbs were represented in these registered products, and only 35 other herbs present in pending applications. Of all applications, 32 were for combination products, of which 13 have been granted.3 Illustrating the difficulty faced by these combination products, the MHRA has advised herbal manufacturers seeking THR to limit the number of herbs in each product due to the difficulty in providing the necessary quality assurance data with more complex mixtures containing several herbs.
For the handful of OTC herbal medicines that have obtained THR, medicinal claims must be based on established traditional use only, and these are limited to mild and self-limiting conditions (i.e., relieving minor symptoms). Clearly, a long road must be travelled before registered THMPD products can meet these stringent requirements!
Impact on Herbal Practitioners
The pending implementation of the THMPD has also posed significant implications for UK herbal practitioners. Herbalists are permitted to supply to their patients herbal medicines that are made up on their own premises based on Section 12.1 of the 1968 Medicines Act. Because they supply herbs on a one-to-one basis, i.e., from a practitioner to a client, they are neither placing products on the market nor engaged in the manufacture of medicinal products. Therefore, unlike Section 12.2, the THMPD does not affect the exemption of licensing of herbal medicines prescribed by herbal practitioners to their patients on this individual basis.
However, since 1968, UK herbalists have also employed Section 12.2 of the 1968 Medicines Act as the legal basis for the supply of all manufactured or finished medicines (e.g., herbal tablets) made for them to supply to individual patients. But THMPD will repeal Section 12.2, meaning that this essential route of supply of herbal medicines will no longer be available to herbalists or their patients.
In the decades since 1968, many practitioners had also come to rely on third-party prescription services specifically set up to supply their patients directly with herbal prescriptions that they had written. The introduction of the THMPD similarly threatened to remove this facility. The sale of finished products forms a key part of the income of suppliers of herbal tinctures and extracts and the additional potential loss of this business imperilled the entire sector.
The loss of these supply lines to the public was the major reason why the majority of UK herbalists have campaigned for statutory regulation. According to Article 5.1 of Directive 2001/83/EC, the main EU medicines legislation, “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). In the United Kingdom this is called the “specials arrangement.” The recent granting of statutory regulation to UK herbalists will make them “authorised health professionals,” and thus enable them to have medicines manufactured and supplied for individual patients by third-party manufacturers as “specials.” Through this route, complex herbal products, including the formulated mixtures used in traditional Chinese, Indian, and other systems of healthcare will continue to be available to the public, and not dependent on the limited compounding facilities of individual practitioners.
The Long Road to Statutory Regulation
The Secretary of State made his announcement at a compelling time—just weeks before the April 30, 2011 full-enforcement deadline. In his statement, Lansley explained that his measures “would ensure that practitioners would meet specified registration standards” giving practitioners and consumers continued access to unlicensed manufactured herbal medicines to meet individual patient needs after the introduction of new EU legislation on May 1st of this year.
The Minister’s statement is the result of years of discussion about the recognition of herbal practitioners in the UK, whose very basis for existence has been threatened at various times throughout the last 150 years. In 1886, when an amendment to the Medical Acts proposed to restrict the practice of medicine to qualified physicians, herbalists successfully campaigned against the Bill, which was subsequently withdrawn.
In 1923, the National Association of Medical Herbalists lobbied lawmakers for a Medical Herbalists Registration Bill, which would finally grant them legal status. Over 130 Members of Parliament (MPs) signed the Private Members’ Bill, which enjoyed an unopposed first reading. But the hopes of herbalists were dashed when the Government refused to make time for the Bill to progress. The passage of the Pharmacy Act in the Second World War was another threat narrowly averted.
When the new National Health System (NHS) was launched by the Minister of Health, Aneurin Bevan, in 1945, herbalists initially sought inclusion within the structure of NHS. However, Bevan declared that herbalists could be incorporated into the NHS only if they were regulated by and subordinate to the medical profession. These terms would have undoubtedly spelled the end of independent herbal practice and the herbalists chose to stay outside the NHS.
The thalidomide tragedy of the early 1960s saw the birth of thousands of children afflicted by severe physical deformities caused by this drug, which was widely prescribed to pregnant women even though it lacked proper testing. Faced with a huge public outcry about the lack of proper control over drugs, the government rushed in legislation requiring the testing and licensing of all medicines. Herbal medicines were caught up in this and the early draft of the 1968 Medicines Act left no scope for licensing them, other than as patentable pharmaceutical drugs. Faced with the end of herbal practice in the United Kingdom, the herbal community campaigned for special provisions for herbal medicines, and in this they were supported by the members of the public, who wrote thousands of letters to MPs. Thus, when the 1968 Medicines Act passed into law, it carried a special herbal provision (the aforementioned Section 12, which permits herbal medicines to be sold OTC and prescribed by practitioners exempt from licensing). There was, however, one major flaw within this legislation: nowhere did it give any definition of who could be considered a qualified herbalist. Anyone could be an herbal practitioner by virtue of hanging out a shingle and just claiming to be so.
In the light of this anomaly and under a growing threat of EU medicines legislation impacting the 1968 herbal provisions, leading to another major scare in the 1990s, the herbal profession began working with the Department of Health (DH) to explore how regulation of herbal medicine practitioners could be achieved.* This process was greatly accelerated by a seminal report in 2000 from the influential House of Lords Science and Technology Committee on Complementary Medicine that called for the statutory regulation of herbalists. A year later, the government agreed that this regulation should go ahead and launched 2 committees headed by independent chairs, one to look at the regulation of herbalists and the other to focus on acupuncturists. The process was generously supported by Prince Charles, the Prince of Wales, and his Foundation for Integrated Medicine.
The 2 committees published their reports in 2003 and the following year, the DH undertook a public consultation on the statutory regulation of herbal practitioners. The results of this consultation, published in 2005, showed a 98% opinion in favor of statutory regulation.4 The consultation also published a timetable for such statutory regulation, but a general election and a public call for better medical regulation in the wake of murders by the rogue doctor Harold Shipman brought considerable delay. The newly elected Labour administration put the herbal regulation case on hold while 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 on how best to regulate herbal medicine, Traditional Chinese Medicine (TCM), and acupuncture.
The Pittilo report, outlining specific measures to bring about the regulation, was published in 2008. In 2009, the government commissioned a second public consultation on this subject. Such consultations usually attract about 40-60 responses; this one elicited an extraordinary public response with over 6,500 replies. More than 10 years after the House of Lords called for the statutory regulation of herbalists, the government finally decided that statutory regulation of herbalists should go ahead. Once all the devolved administrations† had agreed to this, the announcement was made by the Secretary of State for Health on February 16, 2011. Published concurrently with the announcement, detailed results of the 2009 public consultation showed a massive majority (85% of the responses) in favor of statutory regulation.5
There are thousands of published papers on the potential benefits of herbal medicines and herbs can offer inexpensive, safe, and effective approaches for many common complaints. The thousands of patients who consult herbalists every year can now be assured in 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 herbal treatments remain available.
Statutory regulation was opposed by many orthodox doctors, including the Royal College of Physicians. They argued that giving statutory regulation to herbalists would confer a spurious validity on treatments without proof of efficacy. But in the end, the government sided in favor of the patient’s right to choose and a less top-down, dictatorial, and more open-minded interpretation of medicine. 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.”
Note from co-author, Simon Mills: These important recent developments for herbal medicine should not pass without acknowledgement of the extraordinary work by my co-author, Michael McIntyre. From the mid-1990s, he has taken on leadership of herbal practitioners, including those from Western, Chinese, Indian, and other traditions. He led the setting up of the European Herbal and Traditional Medicine Practitioners Association (www.ehtpa.eu), and through this, has spearheaded the work of 8 professional groups. He has taken criticism from all sides for his strong commitment to the future of herbal practice in an increasingly hostile European context. Let the preceding report be a testament to his work and its incredible contribution to our lives!
Michael McIntyre is a graduate of Oxford University and has been an herbal practitioner since 1980. He is currently Chairman of the European Herbal and Traditional Medicine Practitioners Association (EHTPA), a post he has held since 1993. McIntyre is the former President of the National Institute of Medical Herbalists and is a Doctor at Middlesex University, where he is also a visiting professor. He is a Fellow of the Register of Chinese Herbal Medicine, as well as a member of the British Acupuncture Council and the Council of the College of Medicine. He writes, broadcasts, and lectures widely on herbal medicine.
Simon Mills is a Cambridge University medical sciences graduate who has been an herbal practitioner in the United Kingdom since 1977. He has led the National Institute of Medical Herbalists, the College of Practitioners of Phytotherapy, and the British Herbal Medicine Association. He is the co-author of 2 classic herb textbooks with Kerry Bone: Principles and Practice of Phytotherapy (Churchill-Livingstone, 2000) and Essential Guide to Herbal Safety (Churchill-Livingstone, 2005), which was awarded the American Botanical Council’s James A. Duke Excellence in Botanical Literature Award in 2005. He also co-produced the 1996 edition of the British Herbal Pharmacopoeia. He founded the first master’s degree program in herbal medicine in the United States at Tai Sophia Institute for the Healing Arts. He has been a professional member of the Herbal Medicines Advisory Committee, the first UK Government committee in this area, and is also Secretary of the European Scientific Cooperative on Phytotherapy, the lead European body working to ensure quality, safety and efficacy for herbal medicinal products with the European Medicines Agency.
- The European Parliament and the Council of the European Union. Directive 2004/24/EC of the European Parliament and of the Council of March 31, 2004, amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Communities. April 30, 2004;85-90. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0085:0090:en:PDF.
- Government of the United Kingdom. Medicines Act of 1968. Chapter 67. October 25, 1968. Available at: www.legislation.gov.uk/ukpga/1968/67. Accessed February 28, 2011.
- Public Assessment Reports for herbal medicines. UK Medicines and Healthcare products Regulatory Agency website. Available at: www.mhra.gov.uk/ Publications/PublicAssessmentReports/PublicAssessmentReportsforherbalmedicines/index.htm. Accessed March 2, 2011.
- Statutory regulation of herbal medicine and acupuncture: Report on the consultation.United Kingdom Department of Health; Responses to Consultations. February 14, 2005. Available at: http://collections.europarchive.org/tna/20100509080731/http://dh.gov.uk/en/Consultations/Responsestoconsultations/DH_4103372. Accessed February 28, 2011.
- Analysis report on the 2009 consultation on the statutory regulation of practitioners of acupuncture, herbal medicine, traditional Chinese medicine and other traditional medicine systems practised in the UK. United Kingdom Department of Health; Responses to Consultations. February 16, 2011. Available at: www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_124337. Accessed February 28, 2011.
*For example, in 1994, the United Kingdom signed up to the main EU Medicines Directive and had it not been for a major public campaign, this would have been the end of special exemption from licensing for herbal medicines.
† Scotland, Wales, and Northern Ireland