The EU's traditional herbal medicinal products (THMP) directive will not lead to the major loss of popular herbal products on the UK market feared by many in the retail sector, suggests the latest estimate from the country's medicines regulatory body.
A third draft of a Partial Regulatory Impact assessment (RIA) drawn up by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) suggests that very few herbal ingredients (perhaps only two or three of the 270 examined so far) will fail to meet the necessary criteria set out by the April 2003 proposal.
Under the proposed THMP directive products will have to demonstrate their safety through presence on the market for at least 30 years - 15 years of which must have been in Europe. But traditional herbal medicines will not have to demonstrate efficacy in order to get a registration under the directive and there is also a new provision in the latest draft of the directive which allows the European Herbals Committee to lower the requirement for 15 years in individual cases, notes the MHRA report.
The report also suggests that herbal medicinal products will be allowed to be combined with vitamins and minerals, an area that has concerned many manufacturers and the consumer group Consumers for Health Choice.
However health foods manufacturers have argued that the proposed quality standards are inappropriate and should not be similar to conventional medicines. Despite noting the concern, the MHRA said that many in the industry supported the introduction of quality standards, which would also guarantee the quality of raw materials right through to the end of the supply chain.
The agency said it will ask the retail sector to nominate companies that could discuss some of the problems posed by the directive. It has also suggested listed actions that could help the sector meet regulatory approval, such as workshops to discuss procedures for getting the necessary licences and a model for a quality system that could be used to assess herbal medicines.
Other organisations are also involved in the preparation for the directive. The European Pharmacopoeia is currently working on around 30 new monographs each year, expected to include all herbal ingredients used in products available in Europe. This would help contain registration fees, suggests MHRA, as would work by the British Herbal Medicine Association which is currently compiling dossiers of evidence for traditional use of some herbs.
The Agency is to discuss its latest report with the Herbal Forum, the association of herbal manufacturers and suppliers in the UK, over coming months. The first reading of the directive is expected to be approved before the end of 2003.