By Robert Verkerk PhD
Executive and scientific director
Last Sunday saw the coming together of the UK Ayurvedic community in ways that were apparently unprecedented. Ayurveda has never quite found a comfortable foothold in the UK. There have been ideologies, approaches and personalities that have previously got in the way of a united front. Such tussles have perhaps compromised probably the longest surviving yet continuously evolving healthcare traditions.
But when Dr Indira Anand, Chair of the British Association of Accredited Ayurvedic Practitioners (BAAAP) invited everyone she felt was significant to the UK effort on behalf of this great tradition, the response was overwhelming. This culminated in the Ayurveda Healthcare and Wellbeing Conference in Wembley, north-west London.
Dr Indira Anand, Chair, BAAAP
After Dr Anand’s opening, we, the audience, speakers included, were riveted by insights about the Ayurveda tradition and related Vedic wisdom by Sankrit scholar, Revd Dr Stephen Thompson. It’s rare that someone of Caucasian origin can have this depth of understanding of an ancient language and Asian tradition, but it was no surprise to me that there are many Indians who have learned from Stephen Thompson. We were then taken on a whirlwind tour by various leading clinicians, including Dr Prasanna Kerur from the Ayush Wellness Spa in Jersey and Dr Ghanashyam Marda of the Maharashtra University, Pune, India. We then heard from a UK National Health Service consultant, specialising in the treatment of Alzheimer’s disease. His name was Dr Praddep Arya and he is a Member of the British Association of Physicians of Indian Origin. Interestingly Dr Arya made clear his thoughts that there was something wrong with the cover-up facing natural therapies and long-standing traditions. He tried to tackle the thorny issue of how Ayurveda might be better integrated into the mainstream healthcare in the UK. To support his case he cited various peer reviewed publications including one from the British Medical Journal in 2008 that showed that while there was no evidence cough medicine worked, there was some that suggested an Ayurvedic herbal mixture containing Andrographis did.
The elephant in the room
I felt Dr Anand was most insightful inviting three different speakers to discuss the regulatory challenges facing Ayurveda. Each had spent inordinate amounts of time on specific areas of the problem: Michael McIntyre on statutory regulation, Dr Dick Middleton on the EU traditional herbal medicinal products directive, and myself, trying to maintain the right to sell food supplements and prevent their removal from the market, by them being declared unnecessarily by EU or EU Member State authorities, as medicines or novel foods.
In an effort to cut to the chase, my main point to the gathered audience was that history has demonstrated that latching your wagon to any single approach is likely to be a risky strategy. Michael McIntyre would be the first to admit that, after 20 years of lobbying, consultations, enquiries and efforts to turn herbalism into a recognised profession, he’s still not sure how long it might take to yield his vision of a statutorily regulated profession. And the EU herbal directive, that was seen in the early 2000’s as a means of securing the future of all manufactured herbal medicines, has failed dismally to provide a safe harbour for products of non-European traditions, such as Ayurveda or traditional Chinese medicine (TCM). Even the European Commission said the directive was inappropriate for traditional systems of medicine in its 2008 experience report.
So, here goes, the following are the key problems and our proposed solutions in summary form.
Primary barriers in UK/EU
- Products classified as unlicensed medicine (Directive 2001/83/EC, as amended) – definition and scope of definition of a medicine too broad and ECJ requires ‘case by case’ assessment by Member States
- Products classified as unauthorised novel foods (EU Regulation 258/97) – evidence of “significant use” prior to May 1997
- EU herbal directive (Dir 2004/24/EC) “not appropriate” – EC experience report 2008 (COM(2008).584.final)
- Inadequate guidance to Member States on safety of Ayurvedic herbs from European Food Safety Authority (EFSA) – Member States unclear of how to factor in public health concerns for individual herbs listed on EFSA ‘botanicals compendium’
- Unclear status of manufactured products used under ‘herbalists exemption’ (Regulation 3(6), 2012 Human Medicines Regulations)
- Non-medically qualified practitioners not considered “authorised health-care professionals” (Article 5, Directive 2001/93/EC)
Solutions proposed by ANH-Intl
- Achieve clearer delineation of food/medicine borderline for Ayurvedic herbs, minerals and other ingredients and finished products to create greater legal certainty over food supplements status
- Potential judicial review to secure precedents in European Court of Justice case law
- Coordinate safety evaluations of most important Ayurvedic herbs (ca. 80) presently missing from the EFSA compendium of botanicals in food supplements using a scientifically meaningful risk assessment approach
- Request that EC extends EFSA terms of reference to include evaluation of above risk assessments to deliver clear guidance for manufacturers and suppliers
- Support inclusion of herbs used in Ayurveda in the BELFRIT project and the EU-funded PlantLIBRA project
- Supply customs data of trade prior to May 1997 and help establish its use as evidence in novel food disputes
- Secure recognition by the UK’s Medicine and Healthcare products Regulatory Agency (MHRA) of Ayurvedic products suitable for use or prescription by different authorised health-care professionals in UK (Article 5, Directive 2001/83/EC as amended)
- Facilitate recognition by UK Herbal Medicines and Practitioners Working Group of diversity of Ayurvedic products suitable for use under exemption in Regulation 3(6) of 2012 Human Medicines Regulations
- Secure agreement from regulators for appropriate regulatory mechanisms for manufactured, complex products, often including mineral and other non-herbal ingredients, important to the tradition, such as food supplements and unlicensed ‘specials’
- Apply pressure on EC to establish new framework for traditional systems of medicine, including Ayurveda, as proposed in EC experience report (COM(2008).584.final)
Nationwide surveys of Ayurveda
While I feel it essential that we put this strategy onto the public record via our website, and cognisant of the maximum word limit we try to keep to for our stories, I do want to make one more mention of some crucially important information delivered at Sunday’s conference. It came from Ayurvedic practitioner and researcher, Dr Vijay Murthy who has divided his professional time between India, Australia, New Zealand and the UK. He spoke of the unique work carried out by the Australian Research Centre in Complementary and Integrative Medicine (ARCCIM).
He made a plea to the audience that all the Ayurvedic associations should bury their differences and come together as one and raise funds to conduct a national survey, in collaboration with ARCCIM. Why re-invent the wheel?
Dr Vijay Murthy, proposing a new way forward for clinical research integration
He made the crucial point that with a survey, subsequently published in a major peer-reviewed journal, there would be a solid latch on which to hook the Ayurveda wagon, something that has been sorely missed until now.
This is almost certainly an essential step for the recognition of Ayurveda as a valid system of healthcare, one that perhaps has more value today than ever before given the current epidemic of diet and lifestyle mediated diseases.