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House of Lords Report
(http://www.nhsdirectory.org/default.aspx?page=HLReport)
The House of Lords Science and Technology Committee, sixth
report On complementary medicine divided therapies into three separate
groups.
Group One embraces
what may be called the principal disciplines, two of which, Osteopathy
and Chiropractic, are already regulated in their professional activity
and education by Acts of Parliament. The others are Acupuncture,
Herbal Medicine and Homeopathy. Their evidence indicated that each
of these therapies claim to have an individual diagnostic approach
and that these therapies are seen as the 'Big 5' by most of the
CAM world.
Group Two contains
therapies which are most often used to complement conventional medicine
and do not purport to embrace diagnostic skills. It includes Aromatherapy,
The Alexander Technique, Body Work therapies, including Massage,
Counselling, Stress therapy, Hypnotherapy, Reflexology and probably
Shiatsu, Meditation and Healing.
Group Three embraces
those other disciplines which purport to offer diagnostic information
as well as treatment and which, in general, favour a philosophical
approach and are indifferent to the scientific principles of conventional
medicine, and through which various and disparate frameworks of
disease causation and its management are proposed.
These therapies can be split into two sub-groups:
Group 3a includes
long-established and traditional systems of healthcare such as Ayurvedic
medicine and Traditional Chinese medicine.
Group 3b covers
other alternative disciplines which lack any credible evidence base
such as Crystal therapy, Iridology, Radionics, Dowsing and Kinesiology.
A guide to the EU Traditional Herbal Medicines Directive
and its possible implications
The EU Directive on Traditional Herbal Medicinal Products
(agreed in April 2004) will come into force on 30th October 2005. There
will be a transitional period for products legally on the market on 30
April 2004, giving them protection until 2011.
The Directive requires traditional, over-the-counter herbal remedies to
be made to assured standards of safety and quality and for regulations
to be standardised across Europe.
Some medical herbalists believe the Directive will have a beneficial effect
overall, both for practitioners and consumers. Because.
The regulations for implementing this Directive in the UK can now be found
by clicking here. You can scroll down to the bottom of these regulations
to read the more helpful "Explanatory Notes."
Legality
• It provides a secure legal basis for herbal medicinal products
and the practice of herbal medicine.
• It is likely to have a beneficial impact on the quality of over
the counter herbal medicines.
• The MHRA (UK Medicines and Healthcare Products Regulatory Agency)
have declared their intention to implement the Directive in a sensitive
manner - interpreting it to allow the continuance of systems such as Traditional
Chinese Medicine and Ayurveda.
But others have concluded that some consequences could be less desirable
and may restrict consumer choice. These include
Licensing requirements
• At present many herbal products sold in the UK are exempt from
licensing. The new regulations mean that manufacturers will have to apply
for a licence for every product, and each must comply with the official
published standards.
• The cost to a manufacturer of licensing an individual herbal product
is prohibitively expensive.
• This means that many popular herbal products, such as garlic and
ginseng, may still be commercially viable, but others may disappear from
sale because it is not worth the expense of getting them certified.
• Herbal products, without licences, must currently be sold as 'food
products'. These are not subject to the same quality control or restrictions
as 'medicinal products' and there have been instances in the past of misleading
or erroneous labelling, such as in one instance feverfew tablets which
contained no feverfew.
The 30-year rule
• The Directive also demands that a traditional herbal medicinal
product must be shown to have been in use for 30 years in the EU (or at
least 15 years in the EU and 15 years elsewhere) for it to be licensed
and obtainable over the counter.
• The effect of this is that some herbal remedies of 30 years ago,
which are no longer in widespread use, could still be sold. But that valid
new herbs such as Peruvian cat's claw, which was only specified in the
1970s and not much found in the shops in the 1990s, may be withdrawn from
sale.
• It could also mean that some traditional herbal medicines which
were in common use more than 30 years ago, but have since fallen into
disuse, may not be licensed..
Other problematic consequences of the Directive concern:
Restricted herbs
• The supply of some herbs - such as lobelia, belladonna and ephedra
spp - is currently restricted to registered herbal practitioners only.
There are likely to be more herbs, such as wormwood, poke root and mistletoe
included in this category. This might reduce choice but could protect
the consumer from buying herbs with potentially harmful properties over
the counter.
• The Directive could also mean that due to licensing requirements,
there will be fewer herbs available to practitioners as well.
European Directive 31 March 2004
Directive 2004/24/EC of the European Parliament and of the Council
This directive amends, Directive 2001/83/EC relating to herbal medicinal
products for human use.
The 2004 directive provides for a special simplified registration procedure
for traditional herbal medicinal products provided, of course, that they
do comply with the directive.
Both the 2001 and the 2004 Directives can be found set out in full on
the EU Website.
In addition the UK Medicines and Healthcare Products Regulatory Agency
(MHRA) has issued detailed Guidance on permitted medicinal indications
to qualify herbal products for registration under the 2004 Directive.
In particuar, Annexes 1 and 2 to the Guidance give, respectively, detailed
lists of examples of what are likely to be permitted and and what are
not. For example, "Difficulties falling asleep" is permitted
but "Chronic Insomnia" is not. The Guidance can be found on
the MHRA Website.
The Guidance draws attention to the point that products eligible for the
registration scheme, "…will have indications exclusively appropriate
to traditional herbal medicinal products which, by virtue of their composition
and purpose' are intended and designed for use without the supervision
of a medical practitioner for diagnostic purposes or for prescription
or monitoring of treatment…".
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