Guest guest Posted March 10, 2008 Report Share Posted March 10, 2008 McIntyre gave a lecture to final year Herbal Medicine students (of the Western, Ayurvedic and Chinese traditions) at Middlesex University on Wednesday 20 February. We thought you might appreciate some feedback. McIntyre began with his version of the modern history of HM that he has recently espoused in an interview that can be accessed at: http://www.chinesemedicinetimes.com/section.php?xSec=132 He also gave the usual justifications for Statutory Regulation (SR) and reform of Section 12(1) of the Medicines Act 1968. These, you may be aware, are all about risk management and have no sound evidence base. The following were the main points of interest from his talk: 1) The Steering Group report on the regulation of HM (and Acupuncture) will be published within the next couple weeks. 2) It will propose that SR protect both the `title' and `function' of herbalists. 3) HM will be regulated by the `Health Professions Council' (HPC) and membership will cost under £100 per annum. 4) Members of existing professional associations (PAs) will automatically be transferred onto the HPC's register of SR'ed herbalists (all others will have to apply and potentially be `grandparented' onto the scheme). 5) McIntyre foresees some shrinkage in the number of existing PAs as practitioners start shopping around. He was also at pains to point out that PAs will continue to have an important role to play under SR - he described them as `Trade Unions' - looking after the interests of HM and herbalists. 6) Herbalists that choose not to be regulated would have to maintain a low profile and would lose access to Schedule III herbs (and may lose access to all herbal medicines). McIntyre didn't use the word `criminalised', but we get the sense that unregulated practitioners could be prosecuted, but who knows how or what the punishment would be. 7) Very recently, Woodfield from the MHRA gave McIntyre a guarantee that individual herbalists will continue to be allowed to make/produce their own tinctures. However, the MHRA may make some stipulations about where, how and under what conditions. How they would enforce such rules is anyone's guess. 8) Practitioners like Homeopaths, Naturopaths, Osteopaths etc. using herbs in a Section 12(1) fashion (in other words, like a herbalist) would also have to be part of SR and be `grandparented' onto the HPC. 9) It appears that the new licensing regime stipulated by the THMPD will not stop at GMP. Soon, another hoop, called GACP, will also have to be jumped through by our suppliers. This will raise even further the cost of maintaining an MHRA manufacturer's licence. As it is, we foresee the cost of herbal medicines doubling by the April 2011 deadline for the full implementation of the THMPD. 10) McIntyre stated that he was aware that the THMPD discriminated against our 'cottage industry' type suppliers. He said that this was unfortunate and that he had written a 'stern letter' to some apparatchik on the issue, to no avail. He foresees some consolidation among our suppliers by 2011. We are concerned that the cost of obtaining and maintaining a manufacturer's licence from the MHRA is prohibitive; this clearly favours `big business' manufacturers and so opens the way, we fear, for pharmaceutical companies to swallow up our `cottage industry' HM. However, McIntyre's fall back position on the THMPD seems to be 'at least we'll still have access to our herbs'. 11) McIntyre was asked about the possibility of opting out of THMPD, but he didn't seem to know the difference between an EU directive and an EU regulation. He fudged the issue by saying the THMPD was inescapable as it is part of EU medicines law (from which no opt out is possible). We believe this not to be true. 12) It appears that a positive/inclusive list or codex of herbs, similar to the British Herbal Pharmacopoeia, will at some point in the future, be created. However, it is not clear who will draw this up or what role it will play legally. 13) McIntyre is under the impression that some form of SR will also be implemented in Ireland. Our contact in the IIHM has stated categorically that the idea of SR for herbalists in Ireland is dead. 14) McIntyre concluded by emphasising that SR sets an example for the rest of Europe and will protect UK herbalists from any aggressive EU legislation. Without SR, he gives us no more than 20 years. Yours truly, Canal 12 group of independent medical herbalists. Caton, Nathalie Chidley, Carol Church, Church, Tim Lane, Kym Murden, Neil Pellegrini, Sally Viney, Emmett Walsh, Wharam and Ania Zwozdiak Quote Link to comment Share on other sites More sharing options...
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