Regulating traditional herbal medicines

Herbal medicines must be now manufactured under good manufacturing practice in order to ensure the quality of the finished product and its safety.

Herbal medicines must be now manufactured under good manufacturing practice in order to ensure the quality of the finished product and its safety.

The use of plants, in a wide variety of forms, for their therapeutic value is widespread. Indeed, alternative herbal medicine preceded traditional medicine and now sits comfortably alongside main­stream medicine, with many even considering it as a better way to prevent disease and to promote health and well-being. Herbal remedies are easily obtainable over the counter or off the shelf, mainly due to the fact that they are regarded as harmless because they are essentially natural.

Yet, the European Union thought fit to regulate the sale and purchase of traditional herbal medicinal products in a directive, which establishes a regulatory approval process for herbal medicines in the EU. Previously, there was no formal EU-wide authorisation procedure, so each EU member state regulated these types of products at its national level. An EU ban on unregistered herbal medicine will set in at the end of April 2011, which means that only herbal medicinal products that have obtained authorisation from the EU would be allowed access to its market.

Virtually all herbal medications, traditional remedies, Chinese herbs and supplements will be banned from May unless they manage to obtain the required authorisation. The herbal medicines that are exempt from the provisions of the Traditional Herbal Medicinal Products Directive are those unlicensed remedies that are made up for a patient following a consultation with a herbalist.

In order to be so authorised, the directive lays down key eligibility criteria for herbal medicine to qualify. Only herbal medicines that are administered orally, externally, or by inhalation are admitted. Therefore any such medication that requires intravenous administration is banned from marketing in the EU. Most importantly, a company needs to demonstrate the safety and efficacy of its herbal medicine through traditional use within the EU for at least 30 years, or 15 years within the EU and 30 years outside the EU.

The intended use of a herbal medicinal product will only be authorised on the basis of its traditional history since longevity in use of a medicinal product makes its efficacy plausible on the basis of long-standing use and experience. Its efficacy can be also demonstrated by recognised pharmacological properties of its active ingredient. For this purpose dossiers and documents confirming the quality, safety and efficacy of the herbal medicinal product would need to be submitted for any eventual market authorisation of the product.

Akin to pharmaceutical compliance, herbal medicines must now be manufactured under good manufacturing practice in order to ensure the quality of the finished product and its safety, especially when purchased by average consumers. Labeling requirements on the products must also be fulfilled by manufacturers. Such products must clearly indicate what they consist of, in which cases their use is specifically indicated, and that if symptoms persist a doctor would need to be consulted.

Evidently, these requirements will impose a cost burden on manufacturers of traditional herbal medicinal products, especially small-scale companies. Besides, getting a classical herbal medicinal from a non-EU traditional medicinal culture through the EU authorisation mechanism may be hard to achieve. This may leave the EU market short of some herbal medicinals, which have been freely available for consumers for a long time. Those in favour of holistic remedies are up in arms at the new regulatory regime, citing their right to choose herbal treatments as being inviolable.

Will April 2011 therefore mark the end of herbal medicine in the EU? Not exactly, but there is concern that while some old herbal remedies, which are no longer in widespread use, could still be sold, valid new herbs that cannot meet the 30 year rule may require to be withdrawn from sale. The new rules could also mean that it may not be possible to license some traditional herbal medicines, which were in common use more than 30 years ago, but which have since fallen into disuse.

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Dr Grech is an associate with Guido de Marco & Associates and heads its European law division.


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