Tag Archives: Directive (European Union)

Government Regulates Herbal Practioners

Dioscorides’ Materia Medica, c. 1334 copy in A...

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New Regulations for Herbal Practioners

Herbal medicine has long been a thorn in the flesh of pharmaceutical companies, watching potential clients turn away from drugs, with their many adverse side effects, and choosing to be treated in traditional ways.

However, there was not doubt that many very dubious herbal remedies were to be found on the Internet, and in back-street shops.  Some were even dangerous, and with no regulation customers had no way of ensuring what they were buying was safe.

Recently the EU – aided and encouraged by pharmaceutical companies – has been looking into banning these products.

But what the pharma companies proposed would have seen many reputable herbal remedies banned under a blanket ban, together with remedies with no proven record, but which did no-one any harm, and made some customers happy.

In a bid to outlaw some of the dubious herbal remedies floating around on the internet, the Government announced the introduction of statutory regulation of herbal practitioners in the UK.   Without this new regulation their practices would be outlawed from 1st May.

Statutory Regulations

The new College of Medicine welcomed the announcement that practitioners of herbal medicine are to be statutorily regulated.  It believes that statutory regulation is vital, if UK herbal practitioners are to continue to practise and prescribe in compliance with new EU regulations.

This decision will ensure good practice, and the provision of safe products for the thousands of patients who visit herbal practitioners every year.

The register will be administered by the Health Professions Council, the independent statutory body that ensures practitioners meet proper standards of qualifications, training, professional skills and conduct.

The move to statutory regulation of this sector is in line with the College of Medicine’s aim to develop safe and evidence-based patient choice.  Without statutory regulation, the use of traditional Chinese medicine, Ayurveda or other types of herbal medicine could have been effectively outlawed once the new EU Traditional Herbal Directive comes into force.

“The Government has put the safety and interests of patients first. This is essential if the UK is to provide safe and evidence-based healthcare choices.” said College of Medicine Chairman, Dr Michael Dixon.

Professor George Lewith, College of Medicine Vice Chair and Professor of Health Research at Southampton University, said: “Evidence for the efficacy of herbal medicines is growing; they may offer cheap, safe and effective approaches for many common complaints. The College of Medicine values this pluralistic approach to care”.

Kaye McIntosh, College of Medicine Vice Chair and Acting Chair of its Patients’ Council, said: “Without statutory regulation many herbal practitioners in the UK would have been unable to continue practising and thousands of patients would be unable to make the choice to use herbal treatments. Statutory regulation of this sector is clearly the best way to ensure the safe provision of herbal practice.”

Today’s announcement is a result of Government research and public consultation over the last decade.

“This announcement has been a long time coming, so it is now essential that the HPC moves forward as fast as possible with statutory regulation. The College would like to see swift, thoughtful and robust regulation that protects the public from adulterated products, encourages the safe practice of herbal medicine and enables the development of the profession.” said Professor Lewith.

Notes

The College of Medicine is an alliance of doctors, nurses, health professionals and scientists. Eventually patients will also be involved, as it is committed to patient centred medicine; and to improving the health, wellbeing and care of individual patients and local populations.

Statutory regulation of herbal practitioners has had the backing of a report from the House of Lords’ Science and Technology Committee and two independently chaired Department of Health working parties under Professor Michael Portillo. Following the publication of the last report in 2008, the Government ran a public consultation that elicited over 6,000 responses, the majority of which favoured this Government initiative.

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Herbal remedies face the chop

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Herbal remedies face licence rule

According to the BBC, “Hundreds of traditional and imported remedies on the shelves of health food shops and herbalists are set to be banned under new licensing rules”.

An EU directive aims to protect users from any damaging side-effects that can arise from taking unsuitable medicines.   Come May 1st, all such products must be licensed.

Readers of this website will probably realise that there are very few herbal remedies that I will write about.  I am a great one for solid evidence, and so many herbal products have no clinical trials to back up their claims.  In fact the MHRA (Medicines and Healthcare Products Regulatory Agency) says that some can be dangerous.

BUT – many thousands take these remedies, and say they work for them.

And what has worried me,  watching the progress of this EU Directive, is that as far as I can see it has been driven by the drug companies – angry that their expensive products are sometimes by-passed by consumers worried about drug side effects, and preferring to take something they perceive as safe.

As usual, it is the poor patient who is in the middle, caught up in draconian laws demanded by big business.

To a certain extent, the Directive makes sense.  As a journalist I get access to many horror stories about the side effects from herbal remedies.  But I also am told by nurses of herbal remedies that help their patients, and occasionally write about these if a nurse whom I trust says something definitely seems to benefit their patients.

Provided patients tell their medical team if they are taking a herbal supplement, and they buy from a reputable source, surely there is no harm in this?

Consequences

Many people firmly believe that a herbal remedy does them good, particularly when dealing with hot flushes.  As long as they have discussed taking this remedy with their medical team, why should they now be denied something that they say is helpful?

Interviewed by the BBC, Selwyn Soe runs The Herbal Factory, a contract manufacturer of herbal remedies in Croydon, south London. He believes smaller firms like his own will be squeezed out altogether.

“Unfortunately it looks as if we will have to close down because of this legislation,” he said.  “The problem for us is that although we would have to pay many thousands of pounds for a licence to keep making each product, unlike a drug company we would not have a licence to make that product exclusively. It just will not be worth paying out the money.”

The Maple Leaf Pharmacy in Twickenham, west London, specialises in alternative and holistic medicine alongside its conventional chemist business. Owner Galen Rosenberg estimates that about 20% of the health products sold in his pharmacy will simply vanish off the shelves. In some health food shops a far larger percentage of existing lines are likely to be outlawed.

Mr Rosenberg said he welcomed improved labelling, indicating side-effects, but said the rest of the directive was over the top.  ” We have something which we recommend for hot flushes ….  results have been excellent, but from April I will not be able to order these products in, because the producing company is not large and will not be able to afford the hundreds of thousands of pounds needed to invest for the new regulations,” he said.

“The new rules are very much in favour of large companies. It is the loss of freedom of choice which worries me. We also expect massive price increases because of the cost of compliance.”

MHRA is pleased
However, the regulator of all these pills and potions says the aim is to protect consumers, not to pick off small suppliers.  Richard Woodfield, of the MHRA, rejects any suggestions that the legislation is draconian.

“What regulation does is to ensure products meet assured standards. Although the standards are challenging, they are achievable and manageable,” he said.  “We already have 24 different companies regulating under the scheme and they are certainly not all large companies.”

Yet a leading medicines specialist says he fears the consumer may not be much wiser come May this year.

Professor David Colquhoun, professor of pharmacology at University College London, said the changes were of limited value because the rules did not require makers to show any evidence of whether the newly licensed products were effective.

The ban may not help

What will probably happen is that patients, who swear by a particular herbal remedy to help their condition, instead of buying from a reputable high street shop, where the owner has a vested interest in ensuring their clients aren’t sold anything that might have harmful effects, will be shut down.

In their place the online agencies, working offshore with no regulations to worry about, will be selling their remedies in vast quantities, with no regulation or even concerns over customer safety.

What can you do?

If you swear by a certain herbal remedy, discuss this with your doctor.  If they confirm this is safe, contact the manufacturer to find out if they have applied to have this approved.

If not, then it is a case of contacting your MP or MEP.

And the irony is, the EU insists that in future, only high quality, long established and scientifically safe herbal medicines can be sold over the counter. But the label still will not be able to tell customers if they can be shown to work.

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