Science & Communications Officer, ANH-Intl
The rapidly expanding movement to minimise the impact of full implementation of the European Union (EU) herb law, the Traditional Herbal Medicinal Products Directive (THMPD), took another major step forward on Monday 28th March at a symposium organised by the campaign group Save Herbal Medicine headed by Amarjeet Bhamra. Following the broad expression of support from a wide cross-section of European herbal interests last week, the ANH-Intl judicial review and other important initiatives were widely backed by representatives of the UK Ayurveda community.
Four resolutions were adopted by the attendees, which can be summarised as follows:
Dr Godagama, adviser to the MHRA and Dr Verkerk, the Alliance for Natural Health International
One of ANH-Intl’s main concerns with the THMPD is its disproportionate effect on non-European traditional systems of medicine, the most established of which are Ayurveda and traditional Chinese medicine (TCM). These great traditions are the main form of healthcare for around one-third of the world’s population, and are estimated to be used, in varying degrees, by millions within the EU. These long-standing, living traditions continue to evolve today and incorporate a wide diversity of holistic modalities, as well as dietary and lifestyle regimens, to improve or maintain health and wellbeing. Of course, they are usually entirely independent of the current medical orthodoxy, with its reliance on pharmaceutical intervention and surgery.
Under the fully operational THMPD, non-European medical traditions like Ayurveda will see hundreds, even thousands, of perfectly safe and effective herbal products banned from 1st May 2011 because there is no place in the Directive’s regime for them – they are simply locked out. For more detail, see this recent story or the ANH-Intl herb challenge page.
At the 28th March meeting, entitled Symposium on Ayurveda and Herbal Medicine: Looking Beyond April 2011, ANH-Intl’s Dr Robert Verkerk and Adam Smith joined a distinguished panel of Ayurveda experts and practitioners, MPs and High Commissioners to discuss the THMPD and options for resistance. The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is to be applauded that it sent its Head of Herbal Medicine Policy, Mr Richard Woodfield, to be grilled by the audience.
Lord King of West Bromwich
After an introduction from Amarjeet Bhamra of Save Herbal Medicine, Lord King of West Bromwich opened the meeting. Lord King later committed himself to the second resolution noted above – a proposal that was greeted warmly by the audience and carried unanimously.
ANH-Intl’s own Dr Robert Verkerk spoke on What is the nature and scale of the problem caused by EU and UK regulatory change for Ayurveda? He began with a statement that most of the attendees could readily agree with: “You can’t help feeling that this is a problem born out of a Western reductionist mindset that is being imposed on a cultural regime that it doesn’t understand“. This reductionism extends to the dismemberment of the Ayurvedic whole into its constituent parts, such as yoga, meditation and panchakarma, and sees further fruition in the products being registered under the THMPD: “They are generally speaking single herbs, they are generally speaking alcoholic or acetone extracts…80% of the products registered in the UK don’t contain any plant material whatsoever: they contain isolated fractions, phytopharmaceutical forms embedded in a pharmaceutical matrix.” A far cry from the watery decoctions and whole-plant materials so often used in traditional systems like Ayurveda and TCM.
Dr Robert Verkerk, the Alliance for Natural Health International
Dr Verkerk went on to explain that huge numbers of Ayurvedic and TCM products “fall between two stools” of European medicines and novel foods legislation and EU Member State food and food supplements law. From 1st May 2011, herbal products that are excluded from the THMPD or novel foods regulations, and which are no longer considered food supplements by Member States will be considered unlicensed medicines, and will become illegal. Dr Verkerk summed up the inherent problem with such an approach: “Outside of the European framework, there is no clear distinction between what is a food and what is a medicine. It is an imposition created by European law. If you are a medicine, you suddenly need to provide a massive range of data, [making] it [very] difficult to comply with.”
There are considerable flaws in the THMPD and how it is being implemented, said Dr Verkerk, which are covered in more detail here. One problem is the use of single biomarkers to determine the stability of herbal products, and Dr Verkerk revealed that he had nearly asked Mr Woodfield, “How do you prevent a fraudulent medicine being licensed under [the THMPD]?” In fact, “We already know that some companies…are ‘topping up’ products with biomarkers…there is very good reason to believe that the THMPD…does not guarantee that a fraudulent product can’t be put on the market”.
Dr Verkerk pointed out that some EU legislation is actually useful in promoting the cause of traditional systems of medicine. The Mutual Recognition Regulation means that, “If a product was selling safely in one Member State, you can sell it another on the condition that the potentially banning Member State can’t prove that it is harmful.” This may provide a potent weapon, possibly in court, to force Member States with repressive regimes to rethink their ways when products they wish to ban are sold elsewhere in the EU. “Holland and the Czech Republic are the two Member States that have seen the most liberal systems [for herbal products], so there’s an awful lot that we can do in terms of Mutual Recognition there.”
Dr Verkerk ended by summarising the three-pronged strategy being pursued by ANH-Intl and the European Benefyt Foundation:
Dr Godagama, adviser to the MHRA on Ayurvedic products
Next, Dr Shantha Godagama spoke on Status of Ayurveda in the UK: how has it grown, how has it been fragmented, and what is its future? Dr Godagama is an adviser to the MHRA on Ayurvedic products, so his influence on the eventual THMPD regime as it relates to Ayurveda is obvious. He emphasised the huge scope of Ayurvedic medicine, saying, “We are not [simply] herbalists, we are Ayurvedic physicians…Ayurveda is a complete system of medicine.” After briefly tracing the development of official recognition of Ayurveda in the UK, Dr Godagarma proposed the formation of a single body to promote the cause of Ayurveda in the UK. His idea was developed into the first proposal shown above, and carried unanimously.
After an address by His Excellency Mr PM Amza, from the Sri Lankan High Commission, Dr Godagama introduced Richard Woodfield of the MHRA as, “The most important person in the room”. While we could not possibly comment on such an evaluation, Mr Woodfield was certainly the man to answer the audience’s many questions about the THMPD, and his presentation was eagerly awaited.
Richard Woodfield of the MHRA
According to Mr Woodfield, the THMPD was necessary because, “We know from our research that people believe that ‘natural’ means ‘safe’…there are some operators who are taking advantage of that belief…the reputation of medical systems like TCM and Ayurveda is put at risk from poor practice from people on the fringes of the sector.” He gave an update on product registrations under the THMPD: just over 200 applications have been made, of which 101 have been granted; the registered products contain a total of 37 different herbs; 18 combination products have been registered, and another 17 applications are pending.
Crucially, Mr Woodfield admitted that, “We have had no applications…for products from the TCM or Ayurveda traditions.” His response to this situation was that, “[The MHRA has] always thought that most [TCM] and Ayurvedic medicines would be more suitable for the practitioner route,” due to their high potency, health claims that fall outside the THMPD scheme and lack of evidence relating to traditional use.
Despite a lively question and answer session, it was clear that the MHRA is keeping its cards close to its collective chest. No clarity was provided on the apparent limbo that threatens to descend between 1 May 2011, when the THMPD comes into full force, and finalisation of statutory regulation legislation supposedly in 2012. Mr Woodfield summed up his Agency’s position well at one point: “Once all these reforms come to fruition, the public will be able to identify products that are made to good standards under the herbals Directive, and practitioners that are properly accountable under the proposed professional regulation arrangements…that will be a big change from the previous position.”
Mr Woodfield had little to say about the plight of retailers or manufacturers of herbal products under the THMPD, many of whom stand to lose huge swathes of their product lines from 1 May 2011. Jai Brierley of Maharishi Ayurvedic Products and Daksha Hathi of Hesh Ayurvedic Healthcare attempted to redress the balance. “What we’ve found is that…there are prohibitive costs in preparing dossiers [necessary to apply for THMPD registration],” explained Mr Brierley, “and they range between £10,000 to £70,000 for registration of a single ingredient”. These costs go a long way toward explaining why no applications have yet been received from companies making Ayurvedic herbal products, he continued. Other reasons include the requirement that the product have been used in the EU for 15 years, out of a total of 30 years’ use, and the fact that non-herbal ingredients, such as ghee, cannot be included in registered products.
Jai Brierley of Maharishi Ayurvedic Products
“We think the products will go underground,” said Ms Hathi. “[If this happens] will this legislation, which is trying to protect the consumer, have succeeded? Surely [the MHRA] need to be helping us register properly, by guiding us properly, if they want to stop this going on?” She referred to the concept of ‘gradualism’, where legislation slowly tightens its grip, as being a huge problem for Hesh and similar Ayurvedic companies. “We have tried to get a lot of smaller companies…to join this campaign…and the smaller producers are already [pulling out of the Ayurvedic market],” she explained. “It’s already starting to die, and we really need to do something.”
The THMPD regulates herbal products, and the UK is unique in the EU in that the government has announced that it will regulate herbal practitioners through the Health Professions Council (HPC). As we have pointed out recently, there are conflicting signals coming from the government and the MHRA on this topic, and Adam Smith of ANH-Intl attempted to make sense of the situation in a presentation entitled Can statutory regulation of herbal practitioners offer the solution for continued practice of traditional medicine in the UK?
In short, the problem boils down to an issue of managed perception: the government is making out that it has side-stepped the THMPD, and therefore the EU, by choosing to regulate herbalists; but in fact, statutory regulation (SR) is the mechanism whereby the government complies with EU medicines law.
Herbalists currently operate under two exemptions to the 1968 UK Medicines Act, Sections 12(1) and 12(2), which allow individualised herbal prescriptions to be made up onsite and the manufacture of herbal medicines, respectively. EU medicines law, in the form of Directive 2001/83/EC – of which the THMPD is a sub-Directive – is supreme over UK law, and the THMPD replaces Section 12(2). As for Section 12(1) that enshrines the right to onsite prescribing, as Mr Smith pointed out, “It has to be an “authorised health-care professional” who prescribes unlicensed [i.e. individualised] herbal medicines. The government has announced that herbalists will be authorised health-care professionals…as you can see, SR is actually complying with EU law, not side-stepping it.”
Further confusion stems from the MHRA’s own announcement that SR will “Permit those designated as “authorised healthcare professionals” to commission unlicensed medicines to meet the special needs of their patients.” According to Mr Smith, “This is the worry we have, the use of the word ‘commission’. It potentially opens the door to something…termed ‘magistral prescriptions’…whereby, if an herbalist needs to prescribe a medicine for an individual patient…they have to send that prescription off to a certified pharmacist who then makes up the prescription and sends it back to the herbalist.” Loss of onsite prescribing would greatly increase the cost of herbal medicine to the consumer, since the pharmacists would have to be Good Manufacturing Practice (GMP)-certified: a highly expensive process adding considerably to prescription costs.
Daksha Hathi of Hesh Ayurvedic Healthcare
Interestingly, Mr Woodfield earlier stated that, “Our only plan in relation to Section 12(1) is, in time, to limit Section 12(1) to registered practitioners, once practitioner registration is in place.” Later, however, in answer to a direct question about commissioning, Mr Woodfield said, “Once [practitioner registration is in place], it will be possible for us to give these practitioners access to the so-called ‘specials’ scheme, which allows a registered health-care professional to commission an unlicensed product to meet the special clinical needs of their patient.” From these contradictory statements, it sounds like the MHRA’s long-term plan is to prevent anyone other than government-registered herbalists from selling, supplying, manufacturing or assembling herbal medicines of any sort, and to make practitioners use a third party for individualised prescriptions.
Given all this, as Mr Smith said, “The battle has only just begun in terms of SR: even if the government has made an announcement on SR, the legislation hasn’t been written yet, and it’s up to all of us to ensure that the final shape of that legislation…is what we really want to see.” This translated into the fourth resolution noted above, which was passed unanimously.
Every day, it seems, more and more people and organisations are waking up to what an appalling threat the THMPD and related legislation represents, both to the public’s access to herbal medicines and to the very practice of traditional forms of medicine. Now that a definite movement to reform the THMPD and protect these precious traditions is emerging, it is vital that we maintain and build our momentum until we become unstoppable. Tell your friends, your family, your work colleagues, anyone you can think of about what’s happening – you’ll be surprised at how many people will be interested! Even people who don’t use herbal medicines will be appalled at the loss of freedom, of fundamental rights to the EU monolith.
Together, we can do anything. ANH-Intl thanks and honours everyone involved in the campaign so far, from our supporters and collaborators, to practitioners and users of herbal medicine in all its forms, to manufacturers and retailers of natural products and to other campaigning organisations. This is what we need so desperately: a unified voice – and it’s beginning to find its power!
Updated: 6 Apr 2011
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