In 2004, the European Community has published a directive regarding traditional herbal medicinal products which requires a pharmaceutical registration of medicinal herbs. After a period of transition, which finished in May of 2011, it is now forbidden to sell such traditional herbal medicinal products or - as they are called in the UK - herbal remedies, without the necessary registration.
But there is a problem. The registration of medicinal herbs under the directive is extremely difficult.
Entire medicinal traditions like the Indian Ayurveda and Chinese Traditional Medicine, not to mention lesser herbal traditions of South America or Africa, are excluded from registration because they have not been officially used in Europe for 15 to 30 years. Consequently, very few of those medicinal herbs have been registered during the transition period from 2004 to now, which means the directive, in its present form, is unworkable.
This is the background against which to see an Italian initiative which seeks to save those herbal traditions, not only in Italy but in the rest of Europe as well. The Italians are proposing a way out of this impasse.
It should be made clear in this context that the registration mandated by the EU does not regard all herbs but only those herbs that are sold as medicines.
For that reason there is no danger for products sold as food supplements, even if they contain or even consist only of herbs. Italy has firmly established this position in its national legislation that transforms the food supplements directive into Italian law.
Of course not all countries treat herbal products in the same way. France, for instance is much more restrictive and allows few herbs to be sold. Germany has always had a tradition of herbal products which were called 'Naturheilmittel' or natural medicines. The situation is similar in England, where herbal remedies have existed for years before the EU directive came into force. The difference is that now, those remedies have lost their status of exemption from pharmaceutical laws.
Herbal practitioners and healers who use those remedies are saying that their work is being made more difficult. It is the representatives of age-old herbal medicinal traditions from India and China however, who are complaining most bitterly from being unceremoniously pushed out of Europe.
The EU Commission washes its hands of the matter, saying it is up to the member states to interpret and apply the directive. In this way, instead of promoting a single market of medicinal herbs, the new European law has entirely excluded the major non-european herbal traditions and has, inside Europe, created a great confusion. National health authorities are confused - no one really knows what to do with herbs any more.