Our understanding from discussions between the Medicines and Healthcare products Regulatory Agency (MHRA) and the herbal medicine sector is that much of practice in traditional Chinese and Ayurvedic medicine is based on products prepared to meet individual patient needs. The main regulatory route for such herbal medicines in the United Kingdom would be through the provision of section 12(1) of the Medicines Act 1968 rather than traditional herbal registration scheme set up under European Directive 2004/24/EC.
It is likely that it would be possible in some cases for an applicant seeking a product registration under the traditional herbal registration scheme to demonstrate that a traditional Chinese or Ayurvedic medicinal product had had sufficient usage in the European Union (EU) for at least 15 years. There is also a provision in the directive under which the Herbal Medicinal Products Committee at the European Medicines Agency can lower the 15 years requirement in specific cases where all other requirements of the scheme are met.
We recognise that it is necessary to require demonstration of an adequate period of traditional use, given that this is the basis for lifting or easing a number of the normal requirements in medicines regulation in relation to the demonstration of efficacy and safety. However, we would like to see greater flexibility over the requirement for evidence of usage specifically within the EU. We have received a variety of representations on this issue over a period from a number of interested parties such as businesses and practitioner representatives. These have generally argued the case that the specific requirement for evidence of 15 years use within the EU is unduly onerous. The UK is not in position to set aside the provisions of a European Directive. The MHRA presented the case for changing the European legislative requirements in responding to the European Commission’s consultation in 2007 on the early operation of the directive and also alerted interested parties to the opportunity to comment. We await the outcome of that review.
Compliance costs of the traditional herbal registration (THR) scheme fall largely on manufacturers and wholesalers rather than retailers. The Medicines and Healthcare products Regulatory Agency (MHRA) has been running an extensive programme to manage the impact of the THR scheme. This has included well over 100 meetings held free of charge to help companies progress their plans and applications. The MHRA has taken a range of measures to help companies, for example publication of public assessment reports on registration granted, and has also issued a range of pragmatic guidance, for example on how companies can use monographs published by the European Herbal Medicinal Products Committee to mitigate the effects of delay in development of the Community positive list. The MHRA regularly meets the industry’s Herbal Forum to discuss progress of the THR scheme and whether there is further action that either MHRA or industry itself can take to facilitate progress. Recently two specialist small or medium sized businesses achieved their first grants of THR, demonstrating the possibilities for this kind of company.
(2) what his objective is in relation to the future availability of safe and proper herbal remedies; and what steps he is taking to achieve that objective;
(3) when Ministers of his Department last visited the facilities of small and medium-sized manufacturers of specialist herbal remedies to discuss the impact upon their business of the Traditional Herbal Medicinal Products Directive;
(4) what steps he has taken to establish whether chromatographic fingerprinting is an appropriate requirement in the testing of multi-ingredient herbal remedies in relation to registration under the Traditional Herbal Medicinal Products Directive; and what estimate he has made of the cost of commissioning such tests for a single product containing several herbal ingredients.
Companies are not required to notify the Medicines and Healthcare products Regulatory Agency (MHRA) of products marketed under section 12(2) of the Medicines Act 1968, therefore no estimates are available in relation to these products. Following the expiry of the transitional period permitted under Directive 2004/24/EC manufactured herbal medicines placed on the market will require either a marketing authorisation or a traditional herbal registration (THR). As now there will continue to be some herbal products that potentially can be placed on the market either as medicinal products or under other product regulatory regimes depending on their presentation.
The Government's objective in relation to over the counter herbal medicines is that the public should have access to a range of herbal medicines made to assured standards of safety and quality and accompanied by systematic information about the safe use of the product. The previous regulatory arrangements for unlicensed herbal remedies marketed under section 12(2) left companies free to decide whether to meet any standards and put responsible companies, and in particular those with specialist expertise wishing to operate to high standards, at a significant disadvantage. Consumers were unable to tell which products were made to acceptable standards. The MHRA will continue to operate the THR scheme in a proportionate way, in line with the principles of better regulation. Thereby we expect to see a competitive market offering consumers a wide range of licensed and registered herbal medicines.
Chromatographic fingerprinting is an accepted methodology in the analysis of herbal products and has been included in European Guidelines and the European Pharmacopoeia since the early 1990s. With regard to multi-ingredient herbal medicinal products it is recognised that identification and assay of individual herbal ingredients in the herbal product is difficult to perform and sometimes impossible. The European Herbal Medicinal Product Committee has recently developed a guideline, in consultation with industry, which addresses the issue of multi-ingredient herbal products. The guideline states that if testing for identity, assay or to demonstrate stability cannot be performed in the herbal product, alternative strategies may be considered. The guideline refers to appropriate fingerprint chromatograms, appropriate overall methods of assay and physical or other appropriate tests. The applicant is therefore able to select appropriate methods and justify their use.
In its regulatory impact assessment of the THR scheme the MHRA estimated that typically the overall costs of registering a product under the scheme, which includes the cost of conducting appropriate quality testing, could be several tens of thousand pounds. The impact assessment also recognised that the figure would vary widely according to specific circumstances, not least, depending on whether companies already had systematic quality control systems in place. This assessment has not changed.
I recently met a small manufacturer of herbal medicines. The MHRA has had well over a hundred meetings with companies, including small and medium sized businesses, to discuss the progress of actual or prospective applications under the THR scheme. The MHRA has also undertaken a number of site visits.