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THE FIRST TRULY INDEPENDENT WATCHDOG FOR THOSE
WORKING WITH NATURAL AROMATIC MATERIALS
E: info@cropwatch.org T: ++44 (0)7771 872 521
Traditional Herbal Medicine Under Threat.
The purpose of this Cropwatch emergency mailing is primarily to ask
all of you to seriously consider signing the Save Our Herbs petition at
http://www.gopetition.com/petitions/support-herbal-medicine.html This
organisation not only campaigns on behalf of the general public, but
also represents a very significant proportion of medical herbalists of
both Eastern and Western traditions, practising in the UK.
Time is very short - if you want to support this very worthy campaign
ensuring the continued availability of safe Herbal Medicinal Products,
the continued free use of a wide range of our safe endemic &
imported Herbs by ordinary people according to our traditions,
preventing the takeover of small Herbal Medicine Suppliers by
pharmaceutical concerns, & opposition to Statutory Regulation of
Herbalists, you will need to sign the petition by 31st October 2009.
The Save Our Herbs campaign’s official website can be found at
http://www.saveourherbs.org.uk/index.html and provides a wealth of
background information to this potential crisis for Herbal Medicine.
Cropwatch strongly recommends you to read through the
comprehensive information to be found there.
Cropwatch’s Own View.
There are a number of inevitable consequences for Traditional Herbal
Medicine as a result of the implementation of the EU Commission’s
Traditional Herbal Medicinal Products Directive 2004/24/EC, which
came into force on 30th April 2004.
§1. Traditional Herbal Medicinal Products (THMP’s). All THMP’s
placed on the market post the implementation date of the new EU
2
legislation, must have a national authorisation to be marketed, and
whilst several EU member countries have had national schemes in
place, the UK has previously enjoyed a virtually unregulated market.
In the UK, for products already on the market prior to the introduction
of this legislation, marketing concerns have until 30th April 2011 to
obtain authorisation (from the Medicines and Healthcare products
Regulatory Agency - MHRA) and to work to GMP. The MHRA’s
Traditional Herbal Registration Scheme, and its relative lack of
uptake – undoubtedly due to the excessive costs involved (as shown
by the low cumulative total of THR registrations) can be viewed at
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicines/
PlacingaherbalmedicineontheUKmarket/TraditionalHerbalMedicinesR
egistrationScheme/index.htm As we have witnessed in other seento-
fail & discriminatory areas of EU legislation (that pertaining to
Biocides regulation for example), unnecessary, over-intrusive and
crippling financial burdens are placed on the SME’s which market
natural products, a situation which plays straight into the hands of the
pharmaceutical / chemical companies. It should also be remembered
that the MHRA themselves have been severely criticised as being too
close to the pharmaceutical industry (e.g. in House of Commons
Health Committee Report (2005) entitled ‘The Influence of the
Pharmaceutical Industry’:
“A House of Commons Health Committee Report from 2005, entitled
‘The Influence of the Pharmaceutical Industry’ is highly critical of the
MHRA and its close relationship with the pharmaceutical industry. It
states, ‘(t)here are regular interchanges of staff, common policy
objectives, agreed processes, shared perspectives and routine contact
and consultation. Many of the senior staff of the MHRA have previously
worked with the industry …’1 It is therefore doubtful whether the
MHRA can be trusted to serve the best interests of herbal
medicines, herbalists and their patients”.
For a breakdown of expected MHRA fees for THMP’s, please refer to
a document drawn up by Dave Blackwell of Herbs4Healing Ltd. under
Appendix A at the end of this document, and reproduced with his kind
permission.
§2. The Possible Illegality of Actions by Regulatory Officials Meddling
with the Free Availability of Natural Remedies in the UK.
The UK differs from other European Member States, since there has
long been a legal recognition of Herbal Practitioners, dating back to
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Henry VIII’s Charter, which defines a Herbalist and the right to
practice & minister:
Common Law set down by Henry VIII defines a herbalist '…henceforth it
shall be lawful to every Person being the King's subject. having
Knowledge and Experience of the Nature of Herbs, Roots, and Waters,
or of the Operation of the same, by Speculation or Practice, within any
part of the Realm of England, or within any other the King's Dominions,
to practice, use, and minister in…'
(see Watt 2009: http://www.aromamedical.com/articles/traditionalherbalists.
htm, reproduced by kind permission). Cropwatch
understands this Charter has never been repealed.
It should also be remembered that there is a clause in the Treaty of
Rome of 25th March 1957 which can be interpreted as preventing
interference with the availability of natural remedies: “2. The Union
shall respect fundamental rights, as guaranteed by the European
Convention for the Protection of Human Rights and Fundamental
Freedoms signed in Rome on 4 November 1950 and as they result
from the constitutional traditions common to the Member States, as
general principles of Community law.” Watt (2001) discusses the
validity of the above argument and further protections of natural
remedies afforded by other clauses in the Treaty of Rome at
http://www.aromamedical.com/articles/mlx249.html (scroll down to
“Controls on Natural Remedies.”
The interference with free availability of natural herbs and medicines
also impacts on religious freedom & worship and use of herbs in both
the Islamic and Judaeo-Christian traditions. Cropwatch understands
that representations to Ministers / MP’s by a delegation representing
views of individual members of the Islamic and Christian faiths
respectively, are in progress, in order to avert any possibility of the
prospect of religious or cultural discrimination by the regulatory
authorities.
§3. Statutory Regulation of (the Title & Function of) Herbalists.
A Consultation Document was published by the Department of Health
(DH) of the UK Government on 3rd August 2009: A joint consultation
on the Report to Ministers from the DH Steering Group on the
Statutory Regulation of Practitioners of Acupuncture, Herbal
Medicine, Traditional Chinese Medicine and Other Traditional
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Medicine Systems Practised in the UK. The consultation period ends
on 3rd Nov 2009. The Save Our Herbs campaign has produced a
draft response to the consultation at
http://www.saveourherbs.org.uk/files/Download/Response%20To%20
Consultation%20Document.pdf which Cropwatch strongly
recommends you read.
We are told by the Department of Health (DH) that the purpose of
Statutory Regulation (SR) is / was to safeguard public safety but
many herbal practitioners would maintain that this is a nonsense,
since existing self-regulation is already proven adequate. The Pitillo
Report (see below) further states: “Statutory regulation can more
effectively assure the standards of those regulated, protecting the
public from poor or bad practice, because legal sanctions exist to
remove individuals from a register. Statutory regulatory bodies
determine standards of practice and competence.” But as Cropwatch
pointed out in 2008, CAM is not the issue. The UK-based inquiry
started in 2000, decided that the medical practitioner Dr Harold
Shipman allegedly killed up to 250 of his patients, some 218 of whom
have been subsequently identified. Similarly the confidence &
assurance in health officials supposedly assured by regulation did not
help the victims of Nurse Beverly Allit, knicknamed the ‘Angel of
Death’ by the popular press. Health care authorities had to
subsequently carry out heavy modifications to medical practice,
belatedly increasing patient protection. Conversely, we are not aware
that any practicing Herbalist has killed or injured anybody in the UK
(an MHPRA document (July 2008) “Public Health Risks with Herbal
Medicine: An Overview” only identified (only) a single major incident,
in a Belgian slimming clinic, where an irresponsibly prescribed herb of
the Aristolochia spp. resulted in 100 women developing kidney failure
many of whom allegedly went on to develop cancer). Further, in spite
of 22 million annual visits to herbalists in the UK (Thomas et al. 2001
thro’ The Pitillo Report) and with one in three US citizens taking
herbal medicines on a regular basis, no safety assessment of herbal
medicine has ever taken place, either in the UK or at an international
level. Attempts to demonize widely used herbal medicines such as St.
Johns Wort Hypericum perforatum by the pharmaceutical industry,
pale into insignificance when it is realised that the herbal drug has
been found to be as effective as major conventional synthetic antidepressants,
and to have fewer side-effects (Linde et al (2008)
5
Cochrane Database Syst Rev 8 (4)). In conclusion, under the
government's own protocol, before Statutory Regulation can be
established, a risk assessment tool for herbal medicine would have to
be established, and no such assessment tool exists. There is also a
requirement for an established knowledgebase to be in place, and
this is also not established.
On the other hand, with regard to conventional medicine, for some
curious reason we hear relatively little in the media about the
statistics surrounding the failure of MD's working in the National
Health Service (NHS) to correctly diagnose & prescribe the
appropriate treatment for a given patient's ills (a major concern). The
British Medical Journal (BMJ) Evidence Centre at
http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp reveals
that of around 2500 [commonly used NHS] treatments covered, 13%
are rated as beneficial, 23% likely to be beneficial, 8% as trade off
between benefits and harms, 6% unlikely to be beneficial, 4% likely to
be ineffective or harmful, and 46%, the largest proportion, as
unknown effectiveness.
Further, tens of thousands of patients die or suffer serious sideeffects
from certain prescribed (and by now, notorious)
pharmaceuticals. It has been admitted that in the decade up to the
year 2007, 80,000 patients had died from iatrogenic disease and that
a further £46 million had been spent by the NHS on treating the
survivors. Since that time reports have been issued that this state of
affairs has further deteriorated, in part blaming the increasingly
complex MHRA approved drug regimes employed. By comparison,
those therapies now being attacked with the threat of regulation are
becoming ever increasingly safer! (Information provided by Robert
Scott).
Finally, let us turn to the darkly hilarious but thorough reporting of an
extensive study by the Union of Concerned Scientists to the effect
that embarking on a course of conventional drug treatment appears
to statistically increase the chances of shortening your life. This is
quite aside from the serious chances of dying or losing limbs from
hospital acquired infections, or recent media reports of lack of care &
attention and even cruelty shown towards elderly NHS patients. Yes,
the conventional medical profession / NHS is in serious need of
effective statutory regulation, whereas any need for increased
6
regulation of CAM is, by comparison, not only completely
disproportionate to the degree of health risk posed, but, is essentially,
nothing but a sideshow, and a waste of taxpayers money.
4. The Government Reconsiders the Need for Statutory Regulation.
There are some strong signs that the Government is re-examining
any need for the imposition of Statutory Regulation (SR) of Herbalists
whatsoever (in spite of a House of Lords Select Committee
recommendation and the recommendation of three DH working
groups in favour of SR). At the same time they are apparently
reconsidering any need and the practicality of changes to the 1968
Medicines Act Section 12.1 (bear with us: this is an exemption from
various medicines licensing requirements in the Medicines Act which
allows herbal practitioners to prepare or obtain from a third party,
unlicensed herbal medicines to meet individual patient needs
identified in a consultation). Instead some reports indicate that they
are considering a less severe licensing system, perhaps based more
around self-regulation or self-licensing. This follows the publication of
the Report to Ministers from The Department of Health Steering
Group on the Statutory Regulation of Practitioners of Acupuncture,
Herbal Medicine, Traditional Chinese Medicine and Other Traditional
Medicine Systems Practised in the UK May 2008 (‘The Pitillo Report’)
which can be accessed by following links from
(www.dh.gov.uk/en/consultations/liveconsultations/DH_103567).
However, one of the recommendations of the above report is that
Herbal Medicine, Acupuncture and Traditional Chinese Medicine
(TCM) should come under statutory regulation by the Health
Professionals Council (HPC), a body totally unsuited to the task.
It was pointed out by Robert Scott in a letter to the Health Authorities
(seen by Cropwatch), that the proposal to regulate Herbal Medicine
by Mr. Marc Seale, registrar of the HPC, was made after aggressive
lobbying by the chairman (a certain Mr. Michael McIntyre) of the
European Herbal Traditional Practitioners Association (EHTPA) who
sat as one of three stakeholders on the committee chaired by
Professor Pittilo mentioned above. The recommendation to ‘strategy
regulate’ was originally sent by Marc Seale to Alan Johnson in his
role as the previous Secretary of State, although we believe the
matter was handled by Ben Bradshaw a junior Minister of State at the
Department of Health. It appears that both these gentlemen have
7
now been transferred to different departments. But to quote from the
letter mentioned above:
“The chairman of the EHTPA, by his own admission, had a major
influence on the Pittilo report. As he is also closely associated with
the National Institute of Medical Herbalists (NIMH), this establishes a
somewhat troublesome incestuous link between these organisations,
which jeopardises the integrity of the final report.
Although the EHTPA likes to put forward that its stance in favour of
statutory regulation is supported by the majority of practising
herbalists, this claim is not supported by their voting record. The
largest body within the EHTPA certainly is NIMH, but only a
ridiculously small amount of its membership actually voted in support
of this move. The vast majority either abstained or voted against.
The membership of the Unified Register of Herbal Practitioners,
another organisation that is a member of the EHTPA, was threatened
with expulsion from their professional register if they voted against
this proposition.
The lack of support for statutory regulation from the membership of
URHP had even been acknowledged in writing by the chairman of the
EHTPA.”
These extracts seen by Cropwatch only touch the tip of the iceberg
regarding the political manoeuvring and ‘behind the scenes’ power
games invisible to the hapless regulatory officials who are only
served up selected titbits by those players who would seek to control
the direction of the regulation of Herbal Medicine. If Cropwatch can
find the time, we may open this can of worms further and dissect the
odious contents a little later on.
As you can gather then, the basis of the HPC’s support for Statutory
Regulation based on the recommendations of the above report is
therefore totally undermined – not only has it failed to take into
consideration the unique character of Traditional Herbal Medicine but
it is also in danger of acting contrary to the principles of the Islamic &
Judaeo-Christian religions (see §2 above).
Thanks to Martin Watt & Robert Scott for kind permission to include
their material.
8
Appendix A – by kind permission of David Blackwell.
CRITIQUE OF THMPD AND ITS IMPLEMENTATION IN THE UK
The latest information and detailed explanation on costs are attached.
Dried Herbs and simple Tinctures (Reduced categories I and II)
Many herbal suppliers currently offer a wide range of dried herbs or tinctures for
direct sale to the public (e.g. Baldwins and many internet shops). The fee per
item (£577 - £864 every 3 years) plus other costs such as inspection and
preparation of dossiers will mean that many raw herbs and simple tinctures will
cease to be available to the public. The costs are considerably higher where a
herb has not previously been included in a product which has been granted a MA
or THR, which the vast majority in the western herbal pharmacopoeia have not.
In this case the fees rise to an eye-watering £5,185 per herb/tincture. Each
different preparation requires a THR. This means that if you supply a single herb
as a dried herb (tea), powder, capsules, tinctures of different strengths, alcoholfree
extracts, fluid extracts, infused oils and essential oils, plus the organic
versions if marketed separately, each would require a separate application. For
example Baldwins currently offer in the region of 550 products of which between
10-15% will be considered for the Reduced categories, while the rest will be
Complex i.e new registrations. This adds up to an estimated £2,600,000 initially
then £360,000 every 3 years thereafter.
This is a very unfair system, since the first to apply for a previously unregistered
product will have to pay the full cost (Complex), while subsequent applications
will fall into the Reduced category.
Herbal Remedies (Reduced categories I and II) - usually referred to as
Complexes, but this term is avoided to avoid confusion with the THR category
In theory this applies in a similar manner as for simples (above), but in most
cases will be subject to higher fees if there are more than 3 ingredients, ranging
from £864 for teas to £1,297 for other preparations and £7,7791 for previously
unregistered ingredients. However Herbs Hands Healing have been told that it
will not be possible to register very complex products and to consider issuing
them as kits containing all the ingredients separately. The MHRA Public
Assessment Reports reveal that where a product includes 2 or more active
ingredients genotoxicity data will need to be provided, at least by the time the
registration has to be renewed. EC genotoxicity testing involves expensive in
vitro and in vivo (live animal) procedures. The assumption here is that
combinations of herbs pose a significantly elevated risk and ignores the long
history of herb combining and the lack of evidence to suggest that a potential
problem exists. If we compare hospitalizations and deaths through food
1 Applies to combinations of 2 or more ingredients
9
consumption (e.g. allergic reactions and food poisoning together with the health
risks of long term poor food choices) with that arising from the use of herbs, it is
clear that food is far more dangerous. Yet it is ludicrous to imagine a time when
a simple aubergine bake in tomato sauce with oregano, black pepper, salt and
topped with cheese could be subjected to similar concerns and regulations, but
here it is happening with herbal medicines. Also we are well aware of the
limitations of such testing when it comes to protecting the public from
unforeseen adverse effects, as has happened with many pharmaceuticals.
It is anticipated that most specialist herbal suppliers, which can be classed as
small to medium businesses, will be unable to finance the registration of their
existing range of products and those consulted have come to the conclusion that
they will have to wind up their businesses.
Oriental and other World Herbs
Many products will fall foul of the 15 year rule. This includes complex products
and herbs from traditions such as Ayurveda and Unani-Tibb, which have no longestablished
OTC history in the EC. TCM products are more widely available in the
UK and tend towards traditional i.e. fixed formulations, however it may still be
difficult to establish 15 years use in many instances. Furthermore the “applicant
and registration holder must be established in the Community”, meaning that the
onus falls upon importers to arrange THRs. This means that ethnic communities
and those who show a preference for oriental medicines are likely to be more
disadvantaged by the new rules.
Potential Outcomes
The regulations will undoubtedly change the face of herbal medicine within the
UK. It is anticipated that there will be an upsurge in the marketing of a small
range of commercially viable herbal products; those that have entered the wider
public consciousness and which have gained a reputation as being cures for
certain conditions. Examples would be Black Cohosh for the menopause,
Feverfew for migraines, Valerian for stress, Echinacea for colds etc. Other herbal
ingredients and remedies are likely to disappear from the nation’s shelves or be
drastically reduced in range. There will be a shift in public perception of herbal
medicine towards a more pharmaceutical model where herbs are treated as
drugs for specific conditions rather than to treat individual symptom patterns.
THMPD will also enable mass marketing of products and will usher in a transition
towards supermarkets and chemists as the primary outlets.
Many existing businesses will be severely impacted by the new regulations
(wholesalers, manufacturers and retailers) and it is envisaged that many will
close as a result, either as April 2011 arrives in the following 3-5 years. The
impact of this restructuring of the herbal industry will be felt by herbal
practitioners in 2 ways. Firstly the increased demand for certain ‘popular’ herbs
10
and the buying power of larger corporations will lead to an inevitable price rise
and possible supply problems for these. Secondly, the contraction in demand for
other less popular herbs due to the closure of businesses may see a reduction in
the range stocked by wholesalers. It is impossible to foresee the full
consequences of this, just as no one predicted the sharp rise in world food prices
and shortages caused by biofuel production.
The effects could be devastating. Without wishing to be alarmist, the vast
majority of small to medium UK herbal businesses could rapidly disappear,
leaving many unemployed. Pharmaceutical companies, Chemists and
Supermarkets will gain from increased freedom to market products and will no
doubt increase their market share and profits. It’s somewhat akin to selling
mineral and timber extraction rights in the Amazon; the big conglomerates move
in and extract everything of value, leaving behind cultural and environmental
devastation.
The system is unwieldy, expensive, overly bureaucratic and unnecessary. If
anyone truly believes this will protect the public, they are sadly mistaken. There
is simply no evidence that there is any significant health risk to be protected
from, plus it will be impossible to prevent internet purchases from abroad,
thereby creating an uncontrolled marketplace where before there were
responsible UK companies who were subject to regulation.
MHRA Charges for THMPD Registration, not including site inspections,
stability testing, genotoxicity testing or other miscellaneous costs
CATEGORY
£
FEE
Standard
All products unless Reduced or Complex
3 or fewer existing herbal active ingredients 2,593
More than 3 existing herbal active ingredients 3,890
Reduced
Category I
Herbal teas, excluding ingredients not previously registered*
3 or fewer existing herbal active ingredients 577
More than 3 existing herbal active ingredients 864
Category II
Tinctures, Essential Oils, Oils, or Capsules, excluding ingredients not
previously registered*
3 or fewer existing herbal active ingredients 864
More than 3 existing herbal active ingredients 1,297
Complex*
Applies where an active ingredient has not previously been included in a
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medicinal product which has been granted a MA or THR
Single new herbal active ingredient 5,185
2 or more new herbal active ingredients 7,779
The definitions for fees categories are as follows:
"Reduced registration application category I" means an application other
than a complex registration application for a traditional herbal registration
relating to a medicinal product which is presented in the form of a herbal tea;
"Reduced registration application category II" means an application, other
than a complex registration application, or a traditional herbal registration where
the application falls within one of the descriptions specified in sub-paragraphs (a)
to (d) as follows -
(a) the application relates to a medicinal product which is presented in the form
of a herbal tincture;
(b) the application relates to a medicinal product which is presented in the form
of an essential oil;
(c) the application relates to a medicinal product which is presented in the form
of a fatty oil; or
(d) the application relates to a medicinal product which contains only herbal
substances in a capsule;
"Standard registration application" means any application for the grant of a
traditional herbal registration which is not a complex registration application, a
reduced application category I, a reduced registration application category II or a
change of ownership application;
"Complex registration application" means an application for a traditional
herbal registration relating to a medicinal product containing an active ingredient
that has not previously been included as an active ingredient in a medicinal
product in respect of which a marketing authorization (other than a product
licence of right) or a traditional herbal registration has previously been granted
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