If you’ve benefited from herbal medicine in any way and feel it’s important to keep access to herbal medicine open in the UK, please read on and find out how you can make your voice heard.
What is happening to herbal products?
The ANH understands the challenges facing UK herbalists and recognises that there is a diversity of concerns throughout the different disciplines of herbal medicine.
The situation regarding statutory regulation is further complicated by European legislation in the form of the Traditional Herbal Medicinal Products Directive (2004/24/EC) (THMPD). In April 2011, once the transition phase of THMPD, the sub-Directive of the EU Human Medicinal Products Directive (EC Directive 2001/83/EC) (HMPD) ends, there is a grave risk that many of the products, currently used by herbalists and prescribed under special exemptions form UK medicine’s law dating back to Henry VIII’s time, will fall outside both the fast-track medicinal licencing regime offered by THMPD as well as the botanicals regime within the Food Supplements Directive.
What is happening to the special provisions in the UK Medicines Act?
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that Section 12(2) of the Medicines Act 1968, under which practitioners currently have the right to access finished herbal medicines from manufacturers and herbal suppliers, will be superseded by THMPD at the end of the transition phase. This is of course not just a problem for herbal practitioners, but a direct threat to the herbal manufacturers and suppliers who are finding that the very legislation designed for their sector, is proving a barrier to trade due to disproportionately onerous data requirements. Particularly affected will be the Chinese medicine, and Ayurvedic sectors that mostly rely on traditional formulations made by third-party supply.
In addition, the right of herbalists to make up and dispense herbal medicines from their own premises, under the same UK Medicines Act 1968 Section 12(1), is in question. Possible options for reforms of this section of UK law are being considered by the MHRA, alongside the issue of whether to proceed with statutory regulation (SR) or not. If it is decided not to proceed with SR then the MHRA states that it will reconsider the reforms of s12(1).
Many UK herbalists have been pinning their hopes on statutory regulation as a way to maintain herbal supply and continue being able to dispense herbal remedies in their practice.
The MHRA have proposed that third-party medicines requested by practitioners for individual patients could be supplied under an MHRA licence via section 5.1 of the EU HMPD (EC Directive 2001/83/EC). Since this provision is for statutory regulated health professionals only, many herbalists, under the umbrella of the European Herbal and Traditional Medicine Practitioners Association (EHTPA) believe that statutory regulation is the answer. But not all practitioners are aligned with the EHPTA or its views.
Is Statutory Regulation one compromise too far?
The question of statutory regulation is dividing herbalists at a time when cohesiveness and collaboration should be paramount. There are a significant number of practitioners who are particularly unhappy about giving up their long term rights under the the UK Medicines Act 1968.
They feel strongly about preserving traditional herbal medicinal cultures exactly as they are and have always been. They feel statutory regulation is a compromise they are not prepared to make. In their opinion, self-regulation of herbalists has a very healthy track record. Herbs have been freely available to herbalists and the public to-date, people have benefited greatly from them, the safety record is very good (much better than the safety record of the food industry, for example) and the status quo should be allowed to continue.
Whilst we at the ANH are committed to keeping people’s access to nature as wide open as possible, we are also aware that the European Union is marching on relentlessly trying to place almost every aspect of our lives, and especially all forms of natural medicine practice on highly restrictive regulatory regimes. The real question in many of our minds is: can you afford to put all your eggs in the basket of self-regulation, when Europe has got some very serious plans to remove as much of our natural medicine toolbox as possible form our grasp?
We are hoping that increasing pressure from the Chinese and Indian governments might be one way of making the European regulators see sense. Can they afford to upset two major super-powers who have intimate connections with their natural medicine heritage which dates back thousands of years?
UK Government stalling on promises
With the arrival of this latest DoH Consultation the UK Government appears to be stalling on the whole question of statutory regulation and not surprisingly, many herbalists feel caught between the devil and the deep blue sea.
It’s possible that the UK Government is stalling over its original intention to bring in UK statutory regulation for herbal medicinal practitioners because the full extent of the impact that the end of THMPD transition (April 2011) will have on the existing Sections 12(1) and 12(2) of the 1968 UK Medicines Act remains to be seen.
EU regulation – a home for botanicals?
The THMPD is so limited that so far it hasnt allowed a single ‘classical medicine’ from the a major non-European culture (e.g. Traditional Chinese Medicine, Ayurveda, Unani, Tibetan Medicine, Amazonian traditions, Southern African herbal medicine, etc) to obtain a fast-track medicines license.
This means the only ‘safe harbour’ for herbal medicines that can’t get licensed is the botanicals regime of the EU Food Supplements Directive. With a good wind behind natural medicine, this is hopefully a short-term solution as it may in the longer-term be possible to restore some sense to the THMPD regime by way of future amendments. But this will take time to implement—and such amendment is only feasible if the political and public will is there.
Unlike the case of vitamins and minerals in food supplements, the EU has no immediate plans to harmonise laws for botanicals in food supplements across the EU. The European Food Safety Authority (EFSA) has been busy trying to develop a framework for risk assessment for botanicals in food supplements that can be used by EU Member States in their national laws on food supplements.
Its likely that some Member States will maintain very strict policies on botanicals in food supplements (e.g. Denmark), whilst others with a higher regard for them (e.g. Italy) will be much more liberal. We are greatly concerned that for many botanicals currently on the market, there is a risk that they will fall between two stools: between the stool of the centralised traditional medicinal products licensing regime (THMPD) and the national rules for botanicals in food supplements. This, obviously, would be a disaster.
The one glimmer of hope is the Mutual Recognition Regulation which came into force EU-wide in May 2009. This means, if you as a trader can demonstrate that you have had a product safely on the market in one Member State, you should be able to sell it freely in another. Obviously, there will be much debate over what constitutes safe sale—but this is really something worth working with.
EU: the potential for specific provisions for traditional medicinal systems
In September 2008, the European Commission (EC) produced a report on ‘specific provisions applicable to traditional herbal medicinal products’. Through this document, the EC indicate that they have been made aware that traditional practice requires a different approach from that introduced by THMPD, and they may (in the future) consider a separate legal framework for such systems.
Why should herbalists insist on statutory regulation?
We believe that, short of a legal challenge, statutory regulation may actually be a good option for the beleaguered herbalists. This of course doesn’t mean it’s the only option. But if herbalists have a chance to feed into the consultation, we think they should take this opportunity, even if they feel ultimately self-regulation isnt the best option.
From the Government’s standpoint, statutory regulation is the one thing that allows a herbalist to set him or herself from the person in the street. It’s one chance to show that the years of training and clinical experience are worth something and that, in recognition of this, the regulated herbalist might be able to have access to products that the person in the street doesn’t have. Just maybe.
Experience has taught us at the ANH that if we want to keep what a regulator insists is a ‘medicinal regime’ (read: making people better), it is unrealistic for us to expect that, in the current climate, we can have it unregulated.
This may have to be the compromise for a win win situation for the future of herbalism, i.e. to enable the therapy to continue, and for the herbal practitioner’s toolbox to not be an empty one.
Responding to the Consultation
UK practitioners, patients and supporters may all respond….
The following information may be helpful in responding to the Consultation. Please do the following, both if you can:
Try to personalise your answers, as this will require the Department of Health to record your response as an individual rather than a ‘template’ answer.
It is believed that the Consultation document is written in a confusing way, with some questions having potential double meanings, or default answers easily being produced. One might almost think it was written like this to ensure a particular outcome!
For a guide to answering the Consultation document (from a pro-SR point of view) click here.
Event: Saturday 7th November 2009. There will be a "Celebration of Traditional Herbal Medicine" event in Bristo Square, Edinburgh between 2 and 4pm. For details please visit the Save Our Herbs Scotland Campaign website.
Event: Tuesday 10th November 2009. There will be a pro-SR mass lobby outside the Scottish Parliament between 2 and 4 pm. For further details please visit the Save Our Herbs Scotland Campaign website.
Event: Monday 2nd November 2009. Medical Herbalists will undertake a Mass Lobby of their MPs between 2.00 and 4pm during a demonstration from noon until 4pm at Old Palace Yard. Details are given on the National Institute of Medical Herbalists website.