New EU regulations on herbal medicines come into force

[Guest guest]

New EU regulations on herbal medicines come into force

By Dominic Health correspondent, BBC News

New European Union rules have come into force banning hundreds of traditional

herbal remedies.

The EU law aims to protect consumers from possible damaging side-effects of

over-the-counter herbal medicines.

For the first time, new regulations will allow only long-established and

quality-controlled medicines to be sold.

But both herbal remedy practitioners and manufacturers fear they could be forced

out of business.

To date, the industry has been covered by the 1968 Medicines Act, drawn up when

only a handful of herbal remedies were available and the number of herbal

practitioners was very small.

But surveys show that about a quarter of all adults in the UK have used a herbal

medicine in the past two years, mostly bought over the counter in health food

shops and pharmacies.

The regulations will cover widely used products such as echinacea, St 's

Wort and valerian, as well as traditional Chinese and Indian medicines.

But safety concerns have focused on the powerful effects of some herbal

remedies, as well as the way they interact with conventional drugs.

For example, St 's Wort can interfere with the contraceptive pill, while

ginkgo and ginseng are known to have a similar effect to the blood-thinning drug

warfarin.

From now on only products that have been assessed by the Medicine and Healthcare

products Regulatory Agency (MHRA) will be allowed to go on sale.

Manufacturers will have to prove that their products have been made to strict

standards and contain a consistent and clearly marked dose.

And to count as a traditional medicine, products must have been in use for the

past 30 years, including 15 years within the EU.

They will also only be approved for minor ailments like coughs and colds,

muscular aches and pains, or sleep problems.

Remedies already on sale will be allowed to stay on the shelves until they reach

their expiry date.

Free from contamination

Woodfield, head of herbal medicine policy at the MHRA, says so far there

have been 211 applications, of which 105 have been granted registration.

" Crucially, this EU directive and the registration scheme puts consumers in the

driving seat so they can identify that a product meets assured standards on

safety, quality and information about safe use.

" Safety speaks for itself, but quality means, are they using the right part of

the plant? Is it free from contamination? Is the claimed shelf life suitable?

" Product information will include possible side effects and interactions with

other drugs, but above all it must make very clear that it is based on

traditional use. "

And that is a key point for the Royal Pharmaceutical Society, which believes the

new regime is a step forward in improving safety and quality.

But Prof Jayne Lawrence, chief science adviser to the society, says there are

still some concerns about herbal products.

" They certainly haven't been tested on the same basis as a conventional medicine

and some of these compounds are very potent.

" Patients might not realise that in some cases they should not take other

medicines with them, or if they're going for surgery they should tell their

doctors they are taking these particular medicines because there may be

complications.

" So we're very concerned that patients appreciate they must be very careful when

they take these medicines and, ideally, should talk to their doctor or

pharmacist. "

The manufacturers of herbal remedies have had seven years to prepare for the new

rules after the European Directive on Traditional Herbal Medicinal Products was

introduced in 2004.

Too onerous?

These regulations apply to over-the-counter sales, which form the bulk of herbal

remedies sold in the UK.

But some manufacturers and herbal practitioners have expressed concern, arguing

the new rules are too onerous for many small producers.

McIntyre, chairman of the European Herbal and Traditional Medicines

Practitioners Association, says there will be a significant impact on herbal

medicine practitioners and their suppliers, but admits the rules do need

bringing up to date.

" Products that go on the market now will definitely do what it says on the

bottle, while we didn't know how good they were in the past.

" But registration is expensive so perhaps there may be fewer products on the

market and a smaller range.

" It's difficult to argue that the market should stay as it is, without any

regulation, but how many businesses will pack up and walk away? I can't say. "

A Department of Health spokesperson said: " We have swiftly introduced a system

to register herbal practitioners using unlicensed herbal medicines, so consumers

will be able to continue to use unlicensed herbal medicines if they wish. "

http://www.bbc.co.uk/news/health-13215010