The Pharmaceutical Journal
Vol 278 No 7442 p286
10 March 2007

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Traditional herbal medicines

Future of UK herbal industry good as long as it adapts to new framework

The future of the UK’s herbal industry is good, provided that companies adapt to the new framework of Directive 2004/24/EC, said Richard Middleton, past chairman of the British Herbal Medicines Association. This means planning and choosing service providers wisely, and actioning their registration programmes expeditiously. Although herbal medicines have long existed as a popular health care choice in the UK, in recent years, their safety and efficacy have come under increased scrutiny. Under the new EU Directive, all manufactured traditional medicinal herbal products are required to be registered under the Traditional Herbal Medicines Registration Scheme (THMRS).

The THMRS requires manufacturers, importers and wholesalers to obtain a product registration for all herbal medicinal products available in the UK. Applicants must provide evidence to prove that the product (or an equivalent product) has been in use as a traditional medicinal product in the EU for a period of at least 30 years (or 15 years in the EU plus 15 years outside the EU). It is not possible to make claims about the product’s efficacy but only about its traditional use.

Companies must submit a bibliographic review of safety data, justification for the application under this scheme and a dossier describing quality assurance. Pharmacovigilance is also a legal requirement but this is difficult in a sector dominated by small and medium sized companies, and outsourcing the monitoring of relevant literature is an option, said Romanus Lehnfeld, physician, preclinical and clinical studies at Phytolab GmbH & Co.

According to Dr Middleton, the UK’s largely unregulated market for herbal medical products will be transformed to one which regulates the quality and safety of such products. However, Richard Woodfield, group manager herbal policy at the Medicines and Healthcare products Regulatory Agency, raised concerns that some sectors of the UK herbal industry are not yet engaged in the legislative changes. He said that the MHRA faces a huge challenge to change the culture in a medicines sector that has become accustomed to operating in a largely unregulated environment.

Producers, wholesalers, and retailers have until 2011 to register products under this new framework. Products which do not have a registration by then will have to be withdrawn. A herbal advisory committee, made up of academics, doctors, pharmacists and practitioners of traditional medicine, has been established at the MHRA to give independent expert advice to the Government.

Conference participants (left to right): Linda Anderson; Jose Prieto of the School of Pharmacy, London; Romanus Lehnfeld; Michael Heinrich of the School of Pharmacy, London; Keith Helliwell of W. Ransom & Son; Colin Newbould of Essential Nutrition Ltd; Werner Knoess of the Federal Institute for Drugs and Medical Devices, Germany; Richard Middleton; Phil Routledge of the University of Cardiff; Sabine Heinrich of the School of Pharmacy, London

Some herbal products give others a bad name

Herbal medicinal products that are not of acceptable quality give the products in general a bad name, said Linda Anderson, principal assessor at the Medicines and Healthcare products Regulatory Agency.

Examples of poor quality medicines include products which contain, in addition to the herbal product, heavy metals or other pharmaceuticals like glucocorticoids or sildenafil.

Dr Anderson stated that many current herbal medicinal products are already assessed and monitored appropriately. She added that one needs to be concerned about the potential impact on public health of poor quality products in an unregulated market. However, ensuring the quality of herbal medicinal products presents a number of unique challenges compared with conventional pharmaceutical formulations.

At their simplest herbal medicinal products will contain one herb but this, in turn, will consist of a complex mixture of phytochemical constituents.

Also, many herbal medicinal products, especially Ayurvedic and traditional Chinese medicines, contain a mixture of different herbal materials. Mixtures of six or more ingredients are not uncommon.

Two UK herbals now registered by THMRS

Two product registrations have been granted in the UK under the new Traditional Herbal Medicines Registration Scheme: an arnica gel for topical application and a Devils’ Claw extract for use in chronic pain and inflammation. In Germany, the largest European herbal medicinal products market, two products have so far been registered: a bitter aromatic carminative and digestive (Klosterfrau Melissengeist) and a hawthorn tea for the supplementary treatment of mild cardiac problems. The interpretation of the 2004/24/EC differs in the various member countries and a continued dialogue between the interested parties in all member countries is needed.