The Future of Herbal Medicine in Ireland
It is now common knowledge that certain EU legislation will come into effect from May 1st 2011 in Ireland and across the Euro zone but how it will affect herbalists and how it will affect the general public have been matters of concern and heated debate for several years already. I hope with this article to clarify the current position as there has been much confusion as to what it all actually means, or could mean for the future of herbal medicine in Ireland, and beyond. Although this article comes from a slight UK bias it is noted that what affects herbalists in the UK can consequently affect herbalists in Ireland.
The Legal Background
Back in 1154 King Henry II, king of Britain and Ireland, institutionalised a Common Law which has been the foundation of the modern legal system in the UK and Ireland ever since. Common law's basic principle is that everything is legal until it is deemed otherwise.
In 1542 the medical profession of the time tried to challenge this common law and make the practice of Herbalism illegal though King Henry VIII, himself an avid user of herbal medicines, had other plans and implemented the Herbalist's Charter:
"That at all time it shall be lawful to every person being the kings' subject having knowledge and experience of the nature of herbs, roots and waters..." (1)
This established the herbal medicine tradition in these islands, and herbalists were often well trained. In Ireland students of Herbalism were apprenticed to physician families. Kingston remarks:
"The Irish herbal physician of the 15th century and before, was trained for many, many years in highly regulated medical schools. These schools were regulated by the hereditary physician families. They established and regulated the medical schools; developed the curriculum, oversaw the practical training of the Liaig (herbalist)and ensured that the best of European learning was grafted on to indigenous knowledge through translation of manuscripts used in the great schools of Montpelier and Salerno". (Nic Dhonnchadha, 2000) (2)
The Brehon laws were a complex legal system that had existed in Ireland under the old Gaelic Order until the coming of the Normans and the Tudor Conquest, and included many laws regarding the practice of herbal medicine. The creation of the Irish Free State in 1921 saw adaptation of certain existing English legal frameworks into Irish law until the merging of Ireland in the EU zone. Ireland still has a legal system based on common law.
The 1968 Medicines Act (UK)
Although not an Irish law, the Medicines Act was a very important piece of legislation. In 1947, the British Minister of Health; Aneurin Bevan, had offered UK herbalists the opportunity of being included within the NHS (National Health Service), but the herbal tradition of the time was disunited and the opportunity passed.
Herbal medicine came under serious threat in the UK again in the late 1960's but thanks to herbalists at the time the 1968 Medicines Act permitted the continuance and practice of the tradition. Currently legislation affecting herbalists in the UK comes under the 1968 Medicines Act (3). Section 12, paragraphs 1 & 2, and Section 56, paragraphs 1 & 2. The Medicines Act applies to the UK, including Northern Ireland.
Section 12(1) gives exemption for herbal medicines from licensing provided that they are supplied after a private consultation. Section 12(2) exempts herbal medicines if they are manufactured according to standard traditional and non-industrial methods. It also specifies that no written claims may be made for the use of a remedy.
Section 56 reiterates and expands upon Section 12(1). In addition, Statutory Instrument 2130 1977 lists several herbs "in respect of which the exemptions conferred by section 56(2) do not have effect". This removed certain herbs from general sale and stated they may only be prescribed on consultation, or supplied under the supervision of a pharmacist. Maximum permitted doses for those herbs were also established.
Section 12(1) gives exemption for herbal medicines from licensing provided that they are supplied after a private consultation. Section 12(2) exempts herbal medicines if they are manufactured according to standard traditional and non-industrial methods. It also specifies that no written claims may be made for the use of a remedy.
Section 56 reiterates and expands upon Section 12(1). In addition, Statutory Instrument 2130 1977 lists several herbs "in respect of which the exemptions conferred by section 56(2) do not have effect". This removed certain herbs from general sale and stated they may only be prescribed on consultation, or supplied under the supervision of a pharmacist. Maximum permitted doses for those herbs were also established.
This Act gave herbalists in the UK (including Northern Ireland) the legal standing to obtain and dispense remedies without restriction above and beyond common law. However the term 'herbalist' is not legally defined. Herbalists themselves through their professional bodies are voluntarily self-regulated, with a strict system regarding the use of Schedule 3 herbs and as such have an excellent track record.
In Ireland herbalists still practice under Common Law, but change is afoot.
THMPD (Thumped!)
The Traditional Herbal Medicinal Products Directive (or THMPD - a sub‐Directive of the Human Medicinal Products Directive [2001/83/EC, amended by 2004/24/EC]) came into being in 2004 and into force in 2005. Under this legislation all herbal medicinal products are required to obtain an authorisation to market within the EU. Products which had been manufactured before 2004 had a period of grace and could continue to trade their herbal products until 30 April 2011. Any products brought to market after 2004 have to obtain a license.
It is important to bear in mind at this stage that there is a difference between a product and an ingredient, as we shall see later. The THMPD legislation is solely concerned with over the counter (OTC) products.
All products must also now be manufactured under GMP (Good Manufacturing Practice) to demonstrate quality and safety. For a herbal product to be declared 'safe and effective' under THMPD it needs to have been used in Europe for at least 30 years. Of immediate concern is that some herbal remedies which were in use 30 years or more ago and are no longer in vogue could still be traded while new herbs which may be very useful to our practices but which do not meet the 30 year rule could be withdrawn.
Products which have been traditionally used for more than 30 years must also:
· Provide quality data on the product and its ingredients
· Demonstrate evidence of well-established traditional use
· Provide a bibliographic review of safety
For a herb to qualify under the new rules it has to meet the following criteria:
· Only herbs administered orally, externally or by inhalation are suitable
· Only herbs given without supervision by a doctor are authorised by this scheme
· Only herbs authorised on traditional history (30 year rule) or because of recognised phytochemistry
· Vitamins and minerals may be added if their use is 'ancillary' to the herbal ingredients
· Isolated active ingredients from herbs will not receive authorisation (not regarded as herbal remedies)
Finally the scheme also calls for restriction on medical claims on labelled products. Claims are allowed to be made on THMPD-authorised products though restrictions will still apply to the actual wording.
There is some confusion over THMPD and Directive 2002/46/EC on food supplements and Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. This regulation concerns the European Food Safety Authority (EFSA) assessing and approving health claims associated with food and food supplements, including herbal products that are not otherwise registered as medicines. As of May 2011, food products with health claims require EFSA approval. The purpose of both THMPD and this directive is to create guidelines for consumer safety and assurance and to remove products of questionable quality and/or with unreasonable health claims. Therefore herbal products without a THMPD license or without EFSA approval can still be marketed as long as the products are recognised as foods and make no health claims.
To sum up - THMPD is concerned with the registration of herbal products. It does not cover products that need to be licensed under orthodox medical law nor does it cover bulk ingredients or products that are being sold as foods or food supplements without claims.
The Effects of THMPD
Now some practitioners feel that the legislation will have a beneficial effect because:
a. It secures a legal basis for herbs and the practice of herbal medicine
b. It will have a beneficial impact on the quality of herbal products under GMP
c. Both the IMB and MHRA have stated they will be sensitive in interpreting the rules to permit continuance of TCM, Ayurveda and other traditional practices.
However many practitioners and stake-holders believe that there are other consequences and have raised the following concerns:
· Currently herbal products are exempt from licensing but under THMPD all products will have to apply for a license. The cost of a license is prohibitively expensive so many products are going to disappear.(In fact it will cost you €375/£250 just to look at the application criteria!). An unlicensed herbal product can still be sold as a 'food product' but this does not have the same quality control measures as medicinal products resulting in potentially misleading labeling and thus a potential reduction in overall quality.
· The 30 year rule could see herbs such as Uncaria tomentosa (Cat's Claw) which has only recently become popular being withdrawn despite its excellent reputation - many herbs may face a similar fate and remain unlicensed, or effectively banned
· Licensing requirements may potentially mean there will be fewer herbs available to practitioners!
Key Concerns over THMPD
1. Discrimination against non‐European Traditions (TCM, Ayurveda) under the 30 year rule, and as both are dependent on multi-component products.
2. Certain combinations of herbs may be banned - with 'traditional use' being pre-defined new combinations of herbs could be prevented.
3. OTC products are licensed under Pharmaceutical criteria - herbal combinations (multi-component) cannot meet that criteria due to the complexity of polyherbal formulas. In Ireland herbalists tend to use multi-herb combination products. In other Member States, single herb products tend to be prescribed by medical doctors. Practitioners will not be prevented from prescribing extemporaneous prescriptions following a consultation however.
4. As noted the cost and criteria of product registration effectively pushes small companies to one side in favour of large corporations. A single herb registration could cost over €40,000, in many cases small companies cannot afford the registration process.
5. Products which also contain significant amount of vitamins or minerals (above RDA) will be effectively prohibited (however this applies only to those products containing isolated, purified ingredients - foods that contain amounts higher than the RDA won't be banned per se. These levels are currently under review).
6. Consumer freedom of choice is seriously affected along with increased costs. The overly optimistic outlook of a fast-growing herbal sector supplying high quality, safe and effective products is looking rather less likely than one in which company closures are accompanied by a sharp decrease in consumer choice; product development is stifled by high cost barriers: and the supposed gains in consumer safety are undermined by an exodus from UK and Irish retailers to buying from totally unregulated suppliers selling over the internet.
7. The HMPC which oversees THMPD registrations is 'strongly weighted' towards pharmacologists and NOT herbalists.
8. The impact on rural communities, small holders and cottage industry will be serious. Given the current financial climate when small to medium sized indigenous businesses might be established for the production of herbal medicines and sundries we do not require legislation that has the opposite effect.
The net result will mean less choice for consumers and less choice for practitioners through their suppliers which will diminish the overall variety of herbals available. This can only be to the detriment of us all! The Alliance for Natural Health has launched a judicial review of THMPD. (7)
Government Bodies
The government bodies overseeing the implementation of this legislation in Ireland is the Irish Medicines Board (8) and in Northern Ireland - UK Medicines and Healthcare Products Regulatory Agency (9).
I'm sure all herbalists would agree that safe and effective products are vital but that this methodology and this legislation are inappropriate to that end. Numerous groups have been voicing their concerns and disapproval for some time. There is also concern that this could be the beginning of further restrictive legislation to come. It is important not to speculate on this but to encourage practitioners to join professional organisations of high standing and to lobby to protect the role of the professional herbalist and the practice of the wider herbal tradition.
How will practitioners be affected?
Practitioners are still able to obtain bulk ingredients such as tinctures and bulk herbs from suppliers for making up remedies on their premises following a consultation as before:
· In Ireland this practice is permitted under Common Law. However practitioners will not be permitted to obtain unlicensed finished herbal products from third party suppliers. Please note the difference between a finished product (capsules for example) and bulk ingredients. It is this difference which has caused much confusion in this debate.
· In Northern Ireland this practice is permitted under Section 12 of the Medicines Act, however Section 12.2 will be repealed under THMPD. This has up until now allowed herbalists to obtain finished herbal medicines from third party suppliers e.g. tablets and to have third-party dispensaries post prescriptions to their patients directly. Neither of these activities will be possible from May 1st onwards until practitioners are statutorily regulated under the Health Professions Council. Once statutorily regulated, the way is open for herbalists to commission third-party suppliers and manufactures to make up finished herbal medicines for the benefit of individual patients under Article 5.1 of Directive 2001/83/ECI, however the UK government has given the green light for statutory registration which will be introduced in 2012. Registered herbalists are expected to be able to continue to practice while unregistered herbalists will not be permitted to practice. The full implications of this will be spelled out over the next 12 months, and it is possible that similar legislation may take effect in Ireland.
What Can You Do
These are some the problems facing herbalists at the moment and without a united front the tradition could go into decline. It is imperative that practitioners and consumers stand together on this issue.
If you wish to contact your political representative on these matters you can do so here
Dáil Éireann Members Database -
MEP Database -
A template letter can be found here:
Write to newspapers, phone in to radio stations and add your voice! Continual lobbying and focused pressure is required, and it isn't too late to add your voice.
A United Front
Herbalists have fought and won many battles over the years and have succeeded in keeping the tradition alive, and this is no exception. Our passion and excellent safety record will continue to stand us in good stead. However in order to lobby successfully, we need to present ourselves as a united body with the highest levels of professionalism, through our professional organisation and individual dedication. There is much opportunity for the development of a herbal industrial sector on the island and there are many other ways to promote and preserve this most fascinating tradition.
Appendices:
(1) Herbalist's Charter-
(3) Medicines Act 1968 - http://www.opsi.gov.uk/RevisedStatutes/Acts/ukpga/1968/cukpga_19680067_en_1
(4)Traditional Herbal Medicines Registration Scheme -
(5)Traditional Herbal Medicines Products Directive -
(6) The Committee on Herbal Medicine Products (HMPC) - http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000264.jsp&murl=menus/about_us/about_us.jsp&mid=WC0b01ac0580028e7c&jsenabled=true
(8) Irish Medical Board -
(9) Medicines and Healthcare Regulatory Agency -
(10) The Restriction on Supplements
The Human Medicinal Products Directive (2004), the Nutrition and Health Claims Regulation (2006) and the Food Supplements Directive (2002) represent further legislation that could impose a ban on many familiar supplements and natural products.
No comments:
Post a Comment