Afraid of Statutory Regulation not going ahead? Reassurance for you

By Philip Evans and Lynda Jones - Medical Herbalists

Having read many fearful predictions concerning losses of herbal medicines if statutory regulation (SR) does not take place, we find the need to write something reassuring for herbalists, their patients, and the public alike.

As a starting point, it needs to be recognised that the government is unable to regulate herbal practitioners, for three reasons:

1) There exists no risk-assessment tool for herbal practice.
2) There is no evidence-base for herbal practice - these two requirements before a profession can be regulated are set out in the Report of the Working Group on Extending Professional Regulation, which was published last year just prior to the public consultation on the Steering Group’s Report.

3) The argument put forward by the pro-SR campaign, that the Traditional Herbal Medicinal Products Directive will severely affect access to medicines, and therefore herbalists must be regulated, is one that cannot be taken into account by the government.

In the EU document ‘Communication from the Commission to the Council and the European Parliament’, dated Sept. 2008, it is stated “ should be emphasised that Community legislation on medicinal products, in particular Directive 2001/83/EC laying down the procedures for placing products on the market, follows a product-specific approach and does not attempt to provide a framework for the regulation of traditions of medical practice”. This statement goes out of its way to state that the THMPD solely concerns the marketing of products, and not the regulation of practitioners: therefore the government is simply not allowed to link the two together, and bring in statutory regulation for herbalists as an integral part of the implementation of the Directive.

The other point that needs making is this: whilst the current public campaign is saying that if there is statutory regulation all unlicensed herbal products will be saved, this should be seen in the light of what the MHRA (Medicines and Healthcare products Regulatory Agency), which is the body in charge of all of this, itself has to say on the matter:
‘These products [‘manufactured’ herbal medicines] would require either a marketing authorisation [MA] or traditional herbal registration [THR], unless it is possible to construct a UK scheme under the derogation in Article 5.1 of Directive 2001/83/EC [European medicines legislation]. The MHRA further says: ‘If there were to be a version of this arrangement for herbal practitioners [i.e. a UK scheme under Article 5.1 of Directive 2001/83/EC] this would require further specific consultation…’

The expressions ‘unless it is possible to construct a UK scheme’ and ‘if there were to be a version of this arrangement for herbal practitioners.....this would require further specific consultation’ are not the language of something that is already in place. So if you think that it is just a question of having SR, and then a derogation under Article 5.1 can come into force, you are mistaken. The fact is that whilst the Directive provides the possibility for a derogation, there is no guarantee that this would be enacted in the UK. This is what the MHRA is making clear. If you are beginning to have doubts about the claims being made by the pro-SR campaigners, why not ask them “If there is SR, can you give me an absolute guarantee that we will have continued access to all our unlicensed herbal products?” If their answer is “yes”, then you might like to quote the above references to them, and ask for an explanation.

A number of fearful scenarios have been put forward suggesting that vast numbers of medicines will be lost after the implementation of the THMPD in April 2011, if SR does not go ahead. Therefore we would like to provide some reassurance for herbalists and the general public alike:
Some of the specific fears expressed for post-2011 concern: loss of dispensary services, creams, syrups, and capsules. The simple solution without SR, is that herbalists will have to do more pharmacy themselves, and work from what are designated ‘start-up materials’, rather than use finished products requiring product licences. Doing some more pharmacy themselves would perhaps also be good for herbalists’ own development. By buying in their own materials and stocks, herbalists will be able to continue providing everything to their patients: for example they can buy in a base cream and add their own therapeutic ingredients to make Marigold cream Etc.; they can buy in Licorice and Thyme syrups separately (or even make their own), and mix them together to make Licorice and Thyme syrup; to avoid the alcohol content of tinctures for any patients, they can do their own capsuling from powdered herbs, or give herbal teas; they can stock their own tinctures and other start-up materials rather than use a prescription service, which is what most herbalists do anyway; they can also make their own tinctures (not really very difficult). None of this is exactly rocket science surely, is it?

We hope therefore that we can all accept the new reality, that statutory regulation is off, with calmness, rather than with fear and panic. Many vague and unsubstantiated fears have been expressed about the future, along the lines of ‘will we be able to keep giving our patients St Johns Wort and Black Cohosh if we are not regulated?’ and ‘once we get on the steep and slippery slope, all our herbs become vulnerable’. Our hope is that all herbalists, whether for or against statutory regulation, can now work together, along with their patients and the public, to safeguard and protect this country’s access to herbal medicines from any concrete threats, when or if they occur.

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