| The future of Chinese medicine in the UK |
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| Features | |
| Monday, 05 July 2010 | |
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UK’s Chinese medicine profession has encountered two alarming issues in the past decade. Firstly, a European directive that came into effect in 2004 required all medicines sold in member countries over-the-counter to the public to obtain a licence. This potentially “bans” most Chinese medicines from the UK market because the strict pharmaceutical inspection required to obtain such a license is ill-suited to inspect Chinese medicines. Secondly, lobbying efforts to change Chinese medicine practitioners’ voluntary regulation status to statutory regulation since 2000 has achieved little satisfactory result to date. Under voluntary regulation, the inability to distinguish between qualified and unqualified practitioners is placing public safety at risk. As well, Chinese medicine practitioners’ lesser status is preventing a full integration of Chinese medicine into the UK healthcare system. As the European directive’s final implementation date April 2011 is approaching, UK’s Chinese medicine profession is witnessing a historical moment. The current crisis can be temporarily alleviated if one of these issues is solved: on the one hand, if practitioners are given statutory regulation status, they may continue to prescribe the currently unlicensed Chinese medicine to their patients, and on the other hand, if the new European directive is amended to no longer require Chinese medicine to obtain licenses, they will continue to be widely available to the public. Currently, neither possibility is close to realising, meaning that UK consumers face the prospect of losing complete access to many Chinese medicines that they are customised to use. Sadly, few Chinese practitioners realise the seriousness of the current situation even to this date, let alone the general public. Furthermore, the directive also requires manufacturers and importers of processed herbal medicine products to obtain a license to continue the supply medicine after next April, but few have understood this requirement let alone started the process of applying for one. Yet, there is no time to be lost. If no favourable outcome is achieved in the next few months, practitioners may become jobless, companies may go out of business and the public may experience a significant reduction in consumer choice. Professor Manfong Mei, chairman of the Chinese Medical Council, believes that unity within the profession is essential at this critical moment. “Only when we speak with one voice, will the government listen to us,” he said. Working towards a united front Professor Mei giving a speech at the Chinese Medicine Legislation Forum Because Chinese medicine practitioners are not regulated by a single statutory body assigned by the government, many organisations have formed over the years to voluntarily regulate practitioners. Although lacking the legal power of a statutory regulator to prohibit unqualified practitioners from treating patients, these voluntary regulators have each used their reputation to assure patients the ability of their member practitioners, who abide by their respective codes of conduct. Over time, the various regulators’ different agendas and ideologies created division within the profession. Consequently, when they together lobbied for statutory regulation, their disunited voices were ineffective. In 2004, the Chinese Medicine Council (CMC) was established with the aim of creating a single voluntary regulator which can then negotiate with the government on regulatory issues and thereby promote Chinese medicine within the UK healthcare system. Since its establishment, five voluntary registration organisations have joined - the Anglo Chinese Medical Doctors Society (ACMDS), the Associate of Chinese Medicine Practitioners (ACMP), the Chinese Healthcare Institute & Register (CHIR), the Federation of Traditional Chinese Medical Practitioners (FTCMP) and the Chinese Medical Institute and Register (CMIR). However, two registration organisations – the Association of Traditional Chinese Medicine (ATCM) and the Register of Chinese Herbal Medicine (RCHM) - have not yet joined, preventing the council from representing the profession in its entirety. Chinalife - a Chinese medicine shop in Camden Soon after the election in May, Ambassador Xiaoming Liu from the Chinese Embassy called a meeting, which saw the establishment of a working group to help the profession overcome its current crisis. By including representatives from the CMC, the RCHM and the ATCM, the working group gave unity to all the regulators of Chinese medicine. It also included representatives from the Federation of Traditional Chinese Medicine (FTCM), an organisation that promotes and conducts research on Chinese medicine, and Dr&Herbs, together with representatives from major retailers. As a member of the group, Professor Mei revealed that “the group is currently in a fact-finding stage because the law regarding Chinese medicine regulation is not clear.” He said that each organisation knows different pieces of information and the first stage for progress is to agree on the overall situation. “But once we have found the facts, the next stage must be to create unity within the profession.” In Professor Mei’s opinion, an ideal solution is for the UK government to make the CMC an approved body or part of an overarching statutory body that specifically regulates Chinese medicines and practitioners. “The council’s existing expertise will enable it to fully consider the unique and complex characteristics of Chinese medicine and its practice during the regulation process, by doing so the general public will be properly protected and at the same time benefit from Chinese medicine”, he said. The problem of regulating Chinese medicines Historically, all medicines sold in the UK need to obtain a marketing authorisation (MA) license, but section 12(2) of the Medicines Act 1968 has given exemption to herbal products considering that their organic nature make them unsuitable to undergo the vigorous inspection process of MA. This exemption has allowed Chinese medicines to be sold over-the-counter without a licence. However, the rise in popularity of herbal products over the years has witnessed an increasing number of reported cases concerning adverse drug reactions, side effects and interactions between herbal and other medicines. The EU responded to this phenomenon by introducing the Traditional Herbal Medicinal Products Directive (THMPD), a license designed especially for herbal medicines of traditional usage. Although easier to obtain than a MA, the THMPD license gives herbal medicines greater freedom of sales promotion and allows them to make medical claims – powers not covered by Section 12(2) of the Medicines Act. By restricting the over-the-counter sales of herbal medicine to ones that have been found to be safe by the regulation body Medicines and Healthcare products Regulatory Agency (MHRA), the public is thus protected from dangerous herbal products – such as the pills that contained Aristolochia fangchi which damaged the kidneys of Patricia Booth in February 2010. Although the directive is well-intended, realistically the pharmaceutical criteria stipulated under the Traditional Herbal Medicine Registration Scheme (THMRS), set up by the HMRA in response to the directive, are almost impossible to fulfil by Chinese medicines. By June 23, 2010, the THMRS has received 144 applications and granted license to 61, the majority of which contained less than three substances. Unlike most western herbal medicines, Chinese medicines tend to consist of many different herbal substances, meaning that the inspection process would take longer and be more costly. Furthermore, the requirement to demonstrate six months’ stability of mixtures is almost impossible to meet by poly-herbal Chinese medicine because the compounds are reactive. Following MHRA’s advice for companies to register simple products first, applications for complex Chinese medicines have been submitted, but none has yet received a license. Another concern is that medicines containing primarily of mineral or animal substances are excluded from the THMRS, which only apply to herbal products. But out of the 12807 known Chinese medicines, only 11146 satisfy this criterion. Additionally, the directive requires manufacturers of medicines to comply with the EU’s Good Manufacturing Practice (GMP) which differs from the GMP standard in China. Importers will also need to apply for a Wholesale dealer’s import license, which costs up to £3,636, giving small and medium businesses a relatively heavy burden. Even the European Commission realised that the THMPD’s scope is narrow and discriminatory towards non-Europeans medicines. In 2007, it conducted a public consultation on a proposal to extend the scope of the directive to, for example, include medicines of animal and mineral substances. However, in 2008, it decided that this proposal is not the best solution because the regulation of foreign medicines would require a completely different approach. But the European Commission has taken no further action to date.
Professor Mei giving lecture to doctors In Professor Mei’s opinion, the CMC should take an important role in relation to the MHRA in the implementation of the directive, to ensure safety for the public as well as the continuing development of good Chinese medicine which is beneficial to the general public. There are commonly used Chinese medicines which can be sold over the counter, and there are medical formulations that must be strictly prescribed by the practitioners that CMC recognises as qualified. “The MHRA’s current regulation regarding Chinese medicines ignores their complexity.” Although many practitioners are relieved to find that the directive restricts only industrially processed medicines, meaning that they may continue to prescribe raw herbs, Professor Mei has warned that the potential disappearance of industrially processed medicines is a slippery slope to threaten the survival of raw herbs. “The definition of industrially processed is ambiguous. For example, Fuzi is amongst many other dried herbs used in a prepared or processed format in prescriptions, it is poisonous otherwise. Does this make prepared Fuzi which is commonly used in China but is banned in the UK, industrially processed as described in the THMPD? If so, does it apply to many other processed herbs such as prepared rehmannia root?” A final concern Professor Mei admitted is the use of terminologies in the Department of Health’s 2009 Consultation that create division within the Chinese medicine profession, such as “herbalists”, “traditional Chinese medicine practitioners” and “acupuncturists”. “It is irrational to divide practitioners of herbs and acupuncture because often the two are used together and in aid of one another. The term ‘traditional’ creates the assumption that Chinese medicine cannot be modern, which is not true either. The only way to unite the profession is to give all practitioners the encompassing title of ‘Chinese medicine practitioners’.” The east meets the west – integration of medical systems In China, western medicines are not only freely available but often prescribed, sold and consumed with Chinese medicines. In fact, it is so integrated within the Chinese medical system that few patients would consciously think of them as “Western”. As a Chinese medicine practitioner that grew up in the West, Professor Mei has devoted himself to the integration of Chinese medicine into the UK healthcare system for over three decades. He thinks that “the medical profession in China and the Chinese government has been increasingly concerned with the current crisis in the future of Chinese medicine in Europe despite the lack of clear information and the tendency of China to concentrate on domestic affairs. It is clear to them that EU laws should not be discriminatory to non-European cultures. They will insist on mutual respect and mutual benefits as being the principle of any international relationship. The THMPD should follow this principle in its implementation.” Chinese medicine has been historically perceived as alternative and complementary to western Evidence Based Medicine (EBM). However, Chinese medicine has proven some “magical” powers in the West, such as increasing the fertility of women in cases where IVF has failed. But it has not received rightful recognition because much of Chinese medicine’s benefit cannot be measured by empirical evidence, as in the benefit of Chinese medicine and acupuncture in relieving stress and depression. Ironically, recent data published by the British Medical Journal’s online journal Clinical Evidence showed that even conventional western medicine is far from having a complete evidence base - only about 13% of the 2,500 medical treatments surveyed are rated as “beneficial” compared to the 46% rated as “of unknown effectiveness”. Professor Mei feels that statutory regulation is the only way for Chinese medicine to gain recognition and fully benefit the UK public. To be statutorily regulated also means that doctors and GPs will be able to refer their patients to Chinese medicine practitioners and also that Chinese medicine practitioners will be able to carry out commissioned work under the NHS. “Being able to practice is not enough,” he said, “to be placed on an equal level with western practitioners and together develop new treatments that combine the advantages of both systems is the ultimate goal of integration.” In fact, knowing the difficulty that many Chinese medicine practitioners will face to achieve statutory regulation’s language requirement of IELTS 6.5, Professor Mei still considers that this language requirement is necessary in the long run. “I know this is unfair and discriminatory for Chinese practitioners, but eventually we need to achieve effective communication if we want to be an integral part of the UK healthcare system. However, I think it is fair to allow a transitional period of about five years for our practitioners to improve their English when statutory regulation comes into place.” Andy Burnham and the CNHC In April 2010, Labour Health Secretary Andy Burnham announced that he is “minded to legislate” such that all practitioners supplying unlicensed herbal medicines must be registered with the Complementary and Natural Healthcare Council (CNHC), a voluntary regulatory body for complementary healthcare founded in 2008 that has official government backing. His brief and evasive announcement stirred much panic and unified protest from herbalists. The CNHC was criticised as lacking the statutory power to qualify practitioners as “authorised health professionals” under the terms of the EU directive and hence cannot allow them to continue to provide their patients medicine from suppliers and manufacturers after next April. Some consider the CNHC lacks the structure, staff, financial resources and legal power to protect the public. However Professor Mei thinks that “once the Department of Health designates CNHC as being an approved regulative body, many of these difficulties could be overcome in a relatively short period of time to enable CNHC to perform its functions.” Peter Conway, president of the College of Practitioners of Phytotherapy called Mr Burnham’s announcement “a disgrace”. Michael McIntyre, chairperson of the European Herbal & Traditional Medicine Practitioners Association (EHTPA), insisted that the new government should re-examine the past ten years of work towards achieving statutory regulation for herbalists separate from the ex-Labour Health Secretary’s decision. However, although both the Conservatives and the Lib Dems have favoured to statutory regulation before the election, they have not yet started to address this issue. The wider picture: a decade’s fight for statutory regulation The fight for statutory regulation has in fact started before the introduction of the European directive and is the unified effort of all herbalists in the UK. In fact, statutory regulation was first recommended in 2000 by a House of Lords Select Committee. In 2002, the Department of Health established the Herbal Medicine Regulatory Working Group (HMRWG) to make recommendations on the regulation of herbal medicine practitioners. Working in parallel to the HMRWG was the Acupuncture Regulatory Working Group (ARWG) which was charged to make recommendations on the regulation of acupuncturists. In 2004, the Department of Health ran a consultation on the regulation of the two professions based on the two working groups’ findings and 98.5% of the 698 responses it received were in favour of statutory regulation. “One of the biggest impediments to statutory regulation was the publication of the final report of the Shipman Inquiry in 2005. This incident prompted the Department of Health to publish the white paper Trust, assurance and safety in 2007, which consequently put the momentum to statutorily regulate herbalists to a halt,” said Michael Mclntyre. “The second reason for the delay is due to the large number of government ministers that worked on this issue. It is fair to say that the Department of Health suffered from organisational amnesia,” he said. “But a third reason is the fact that although we had consensus for statutory regulation right across the medical field in 2005, once the delay came in, complementary and alternative medicines became subject of ridicule by scientific and medical groups, such as Sense about Science. These groups campaigned ferociously which caused the government ministers to lose their nerves.” In 2006, the Department of Health sat up the Steering group for the regulation of Acupuncture, Herbal Medicine and Traditional Chinese Medicine, which again recommended statutory regulation in 2008. Based on the steering group’s findings, the government held another public consultation in 2009. Different from the 2005 consultation, this one contained several rather repetitive questions proposing to regulate herbal medicine and traditional Chinese medicine practices separately from acupuncture. This intention received opposition from even some western medical groups. In response to the consultation, the College of Practitioners of Phytotherapy insisted that “all three practitioner groups should be statutorily regulated together” although most members of the college practiced herbal medicine only. Acupuncture The government’s decision to run the second consultation in 2009 severely shook the confidence of herbalists who have anticipated the receiving of statutory regulation for years. Campaigns, rallies and online petitions rapidly emerged in the period leading up to the 2010 election. One group that worked hard to protect Chinese and Indian medicines is the Alliance for Natural Health International (ANH-Intl), a NGO that works to shape the regulatory and scientific framework affecting natural health. In March 2010, it consulted a leading European barrister, who voiced his opinion that “the THMPD, in its present form, runs counter to some fundamental principles of European law.” In a recent article, Dr Robert Verkerk, director of the ANH-Intl, also stressed “the disproportionate impact against non-European herbal medicinal products” as a prime issue of the directive. As the enforcement of the THMPD is rapidly approaching, a serious threat is increasingly likely to become a sad reality. The next few months will definitely witness vigorous negotiations and actions that play a key role in deciding the currently uncertain future of Chinese medicines in the UK. Cecily Liu |
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