Health: Remedies and red tape: And EU rules may also hit common herbal cures - taking them into the back streets. Lee Rodwell explains

It is almost 400 years since the English botanist and herbalist John Gerard recommended chrysanthemum pathenium to readers of his 'Herball or General History of Plantes'.

'Feverfew dried and made into pouder and two drams of it taken with hony or sweet wine, purgeth by seige melancholy and flegme; where for it is very good for them that are giddie in the head, or which have the turning called Vertigo, that is, swimming and turning in the head.'

Modern herbalists still use feverfew to treat migraine and there is growing interest in its use to alleviate the symptoms of arthritis. Yet feverfew, along with ginkgo (used mainly for circulatory conditions and symptoms of ageing), ginseng (a popular tonic) and echinacea (taken to combat the symptoms of winter ailments) may soon have to be withdrawn from sale.

That, at least, is what the British Herbal Medicine Association claimed last week, warning that new Euro-regulations will sweep hundreds of established herbal remedies off the shelves. But is this just another Euro-scare, like the tales of straight bananas, the demise of the British banger or the disappearance of the traditional pint of beer?

To understand what is going on, it is necessary to turn the clock back to the 1968 Medicines Act, introduced after the thalidomide tragedy to try to prevent potentially harmful medicines from coming on to the market. Under the Act, medicines with a long safety record already on sale were granted licences 'of right'. These included a number of herbal medicines.

Since then, the Department of Health's Medicines Control Agency (MCA) has reviewed all those licences and reassessed the safety and efficacy of products sold as medicines. About 700 herbal products currently have licences and can therefore sold as herbal 'medicines'. This means they can make medicinal claims.

Boots Stress Tablets, for example, are licensed, and can be sold 'for relief from the stresses and strains of modern living and to help overcome irritability'. Boots Feverfew tablets, which do not have a licence, can be sold, but they can claim only to be a 'traditional herbal remedy'.

This is because section 56 of the Act created a second tier of herbal products. As Victor Perfitt, chairman of the BHMA, explains: 'These are herbal remedies identified as medicinal products that can, in certain circumstances, be sold exempt from licensing. This means that a product can be stocked on a shelf, or used by a herbal practitioner, as a 'remedy'. But you are not allowed to make any medicinal claims on the packaging or in the advertising.

'Now the MCA has announced plans to harmonise the UK Medicines Act with EU directives in anticipation of the new single market in pharmaceuticals. One effect of this will be to remove the exemptions from licensing for the production of herbal remedies, for supply by medical herbalists or through health shops and pharmacies.'

If this happens, all herbal products classifed as 'remedies' will have to be reclassified either as medicines (for which a licence is required) or as foods. If they are deemed to be foods, they will come under the control of the Ministry of Agriculture, Fisheries and Food (MAFF). But here the picture becomes even more complicated. Mr Perfitt says: 'European Court judgments have made it plain that anything that looks like a medicine - if it is in tablet form, for example - must be deemed to be a medicine. Yet if it is a medicine, it requires a licence.

'In any case, if I'm asked whether a feverfew tablet is a food, I'd have to say no - it's a herbal remedy. So MAFF could come along and say that since feverfew is not a food, looks like a medicine but has no licence, it must be withdrawn from sale. Yet just applying for a licence costs between pounds 7,000 and pounds 84,000; on top of that are the costs of supplying data on quality, safety and efficacy. Stability studies alone can cost pounds 25,000.'

Simon Mills, project co-ordinator at the Centre for Complementary Health Studies, University of Exeter, is currently carrying out double- blind studies looking at treatment and relief of arthritic pain with a licensed herbal medicine. He fears that UK compliance with the EU directive will lead to a drop in standards of herbal products and in the money available for research.

'Because herbal remedies had a de facto medical status, the industry had an incentive to apply the same standards of manufacturing practice for non-licensed products as for licensed ones. And because of the health-food shop and pharmacy sales, there was an incentive for keeping quality up and putting money into research and development. I suspect that will all disappear if everything is dismantled.

'The shelves won't be cleared of herbal remedies on 1 January, but it will be increasingly difficult for these products to be supplied. The danger is that we will end up with a situation like the one in America, where there is a huge market in herbal preparations, which are sold as food supplements,' Mr Mills says.

'In the UK, if designated a food, they would come under the aegis of the environmental health officers, who have the power to remove them from the shelves. That could lead us to a back-street situation without any regulation at all.'

Andrew Chevallier, president of the National Institute of Medical Herbalists, and a practising herbalist for eight years, is also concerned.

'We all have patients who are chronically ill,' he says. 'Herbal medicines allievate their symptoms. We will be able to continue to see patients, but we won't be able to purchase many industrially produced remedies from our suppliers because of the effect of the EU directive on existing exemptions.'

Most herbalists buy their stocks of tablets and tinctures from manufacturing companies that would have to apply for the new licences and may decide it is too expensive.

'One of my patients has poor circulation as a result of a heart condition.

She takes a herbal medicine I make that includes ginkgo, a Chinese herb.

Ginkgo is not a licensed herbal medicine, so the only way I could go on using it and other unlicensed products would be if it was personally prepared. I would guess that only one in four herbalists make their own medicines.'

Clearly, herbalists might face problems if Britain complies with the EU directive. But wouldn't consumers be better protected? At the moment the only sure way of knowing whether a product is a licensed herbal medicine rather than a herbal remedy is to look for the letters ML (medicines licence) and PL (product licence), followed by a number.

As David Dickinson, editor of the Consumers' Association magazine Which? Way to Health says: 'For a long time we have wanted to see the loophole closed where products that are not licensed as medicines are labelled in a medicine-like way.'

Mr Perfitt counters: 'The EU directive is a blunt instrument which says that all medicinal substances which have a physiological action have to be licensed. It will create crazy situations. For example, juniper oil has a physiological action - yet if you have three or four gins in the pub, you'd get more juniper oil than you would when taking a herbal remedy.'

Not everyone in the business - now worth pounds 200m a year - is so tough on the Eurocrats. Tony Hampson is managing director of Potters Herbal Supplies, all of whose products are licensed - sales of Nod-Off, its licensed herbal sleeping aid, have recently soared. He says: 'Brussels can make a good case.

If someone is sick and is taking a product to help them get better, they have a right to expect that product to be safe, pure and efficacious. That is the criteria upon which a licence is granted'.