By William Dartmouth MEP • On the 1st of May this year the EU’s Traditional Herbal Medicinal Products Directive came into full effect.
No longer can you walk into a shop to buy unregistered herbal remedies, No longer can you buy them online. It is illegal. These remedies are now treated like licensed pharmaceuticals: they must be dispensed under the supervision of a practitioner.
There were good reasons for drugs to be tested and licensed. They are chemicals the body has never experienced before and can kill. The reason we have been using herbal remedies for millennia is that correctly prescribed they generally work. Indeed as sold under food law (until April 30th) they had to be safer than a slice of bread. No deaths have been recorded due to herbal remedies properly sold under food law for 40 years. Objectively, there is really no case to subject herbal remedies to a similar regulatory structure to pharmaceuticals.
In contrast, properly licensed drugs are, despite all attempts to regulate away risk, a big killer. More than 40,000 deaths are recorded in the UK alone. This is a well known problem in the medical profession, so well known that they have a name for the branch of medicine that cures the ills caused by risky prescribing and doctoring - Iatrogenics (classical Greek for ‘caused by doctor’).
As a result of the EU’S meddling we will be left with a much reduced choice of herbal remedies and supplements. So far that list is 100, though more may be added. Herbal medicines are not a tiny niche market: a quarter of the adult population in the UK buys them. The wholesale market here is worth more than £3bn a year.
All pills and potions made from herbs marketed as having medicinal properties have to be registered under the Traditional Herbal Registration scheme. Packs must have a THR number on the back.
To get this ‘kite mark: the manufacturer must prove the herb has been used for the condition for at least 30 years and for at least 15 years inside the EU; that it is made to strict standards and contains a consistent and clearly marked dose.
Like prescription pharmaceuticals; products must include a leaflet with safety information. These changes almost all superfluous make it much more difficult both to manufacture and sell herbal medicines.
Vitamin and mineral supplements are already subject to EU rules under a separate directive ostensibly to protect the free movement of goods. I should declare an interest here, I have taken vitamins and mineral supplements for more than 40 years and continue to do so. Moreover, my grandmother, Dame Barbara Cartland, - best known as a novelist - was strongly committed to herbal medicines and vitamin and mineral supplements. Indeed, my grandmother helped found, and was the first President of, the National Association for Health.
The manufacturers and retailers of herbal medicines and vitamins tend to be small and medium-sized businesses. The EU directives constitute a significant regulatory burden. Already some shops and websites specializing in natural remedies have either closed or emigrated outside the EU; the US is one destination.
It is of course a nonsense to attempt, as the EU is doing, to regulate natural herbs, used since time immemorial, as though they were licensed drugs. It is difficult if not ridiculous to patent natural substances, so companies cannot afford to do safety studies - they will not recoup their investment
Remedies threatened include traditional herbal cures using hawthorn and meadowsweet plus a swathe of herbs used in traditional Indian Ayurvedic, Chinese and Amazonian remedies. If the product does not fit into a food supplement category its sale is illegal.
The EU is trying to do the impossible. Is garlic, which some studies show lowers cholesterol, a herb or a food? If garlic pills are sold as “a traditional herbal medicinal product used to help maintain healthy cholesterol levels and maintain a healthy heart” they must have a THR number on the pack. If the same product is sold as a garlic pill it could be classified as a food supplement and fall under a less stringent set of rules.
This is highlighted by the different ways member states now sell herbal remedies. The Czech Republic and the Netherlands adopted a liberal approach so many herbal remedies are construed as ordinary foodstuffs, which indeed they are, and escape regulation.
The UK and Belgium are more illiberal in their interpretation of the EU’s directive, outlawing many more unregistered herbal remedies.
To add to the muddle, some plants are available in both herbal and homeopathic products. Arnica creams contain plant extracts which have some action on bruising. But arnica pills are homeopathic remedies that do not contain any measurable arnica. Until now, both herbal and homeopathic remedies have fallen under the same regulatory umbrellas.
It could have been even worse: remedies made up by herbalists could have been banned altogether. Earlier this year the British government provided a get-out clause. EU rules allow the sale of herbal medicines prescribed by a registered health professional SO the government opened the Health Professions Council to herbalists. Now they have the right to prescribe individualised remedies.
Even though the EU is trying to do the impossible, these directives will disadvantage the enterprises and the people involved in the world of natural herbal remedies and vitamins. It has been demonstrated over time that herbal remedies and vitamin and mineral supplements can have an invaluable part to play in maintaining health - so more worrying still, the directives are likely to be adverse to people’s overall health.