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Dept of Health

Answer

Mr. Tredinnick: To ask the Secretary of State for Health (1) what assessment he has made of differences in the (a) regulation and (b) supply of herbal products in each EU member state; and what steps he intends to take through the Herbal Medicinal Products Working Group to ensure that the requirements in respect of (i) quality standards and (ii) other matters for the registration of dossiers under the Traditional Herbal Medicinal Products Directive are set at a level appropriate to traditional herbal medicinal products; [222528] (2) whether he intends to make it his policy in implementing the Traditional Herbal Medicinal Products Directive fully to use all the options afforded for national flexibility; and what account he will take of the potential regulatory burden on small and medium sized enterprises; [222529] (3) when the Medicines and Healthcare products Regulatory Agency expects to issue a comprehensive assessment of the costs of implementation of the Traditional Herbal Medicinal Products Directive; [222530] (4) when he expects the Medicines and Healthcare products Regulatory Agency to consult on the fees for processing registrations under the Traditional Herbal Medicinal Products Directive; whether that consultation will assess the impact of the proposed fee levels upon small and medium sized enterprises; and whether in setting the date for that consultation he expects the Agency to take account of the need of such enterprises to assess the impact of those costs before deciding whether to submit registrations under the provisions of the legislation prior to the deadline of October. [222531] Miss Melanie Johnson: [holding answer 17 March 2005]: Before the European Commission brought forward proposals for the Directive on Traditional Herbal Medicinal Products (Directive 2004/24/EC) a study was carried out for the Commission on the then arrangements for regulation of herbal medicines across the European Union (EU). This demonstrated that there were significant differences between member states. The Medicines and Healthcare products Regulatory Agency (MHRA) understands from discussion with industry and regulatory authorities in other EU member states that this assessment has been widely supported, and we do not see any need to replicate the work. There are many thousands of herbal products on the market of one or more EU member state and variously falling within different categories, such as medicines, foods, food supplements, cosmetics or general consumer products. We do not see a case for commissioning a comparative assessment of the position in each member state and doubt its practicality. The main requirements on quality and on the information and data to be included in dossiers flow directly from the terms of the Directive. There are existing European guidelines on the quality and manufacturing standards for medicines, including herbal medicines. We understand that the Herbal Medicinal Products Committee, based at the European Medicines Agency, may review whether any additions or modifications to existing guidelines are desirable or whether further guidelines are required on other issues relating to the Directive. However, there is no fundamental reason why quality standards, for example as to the identity and quality of ingredients, freedom from unacceptable levels of contamination, and the claimed shelf life of the product, should be lowered for traditional herbal medicines as compared with the requirements for other medicines with a marketing authorisation. The absence of such standards in the existing United Kingdom regime for unlicensed herbal medicines has been associated with evidence of risk to public health from low quality products. The UK appointed member of the Committee has extensive scientific and practical regulatory knowledge of herbal medicines and has regular discussions with industry and other interested parties. There is a range of opportunities for industry to make its views known to the Committee and the MHRA has encouraged the UK industry to contribute actively in this area. Subject to the outcome of a further consultation on legislation to transpose the Directive into UK legislation, we intend to take advantage of the flexibility under the Directive to permit a transitional period to run until 2011 before products legally on the UK market at April 2004 are required to comply with the Directive. We also intend to permit product information to state the nature of the herbal tradition, which we believe will be helpful to consumers and to industry. The MHRA has an extensive programme of work in hand to help industry, and in particular small and medium-sized enterprises, prepare for the Directive. Measures have included: a programme of workshops for industry; around 30 meetings with individual companies to advise them on the possibility of registering their products under the Directive; extensive website guidance on the Directive; and regular discussions with the industry's Herbal Forum to identify and respond to issues of concern. The Agency has received considerable positive feedback on the help provided to industry. The MHRA gave indicative information on fee levels in the partial regulatory impact assessment published in 2003. In the light of detailed work that has taken place in the interim, updated specific proposals will be published for consultation by the early summer of 2005 along with an updated regulatory impact assessment. October 2005 is the date by which a registration scheme under the Directive must be introduced. It does not represent a deadline by which companies must apply to register products.

Secondary information

Type

Written question

Reference

432 c755-7W; 222528;222529;222530;222531

Session

2004-05

EC documents

DIR2004/24/EC

Subjects

Costs Fees and charges EU action Registration Testing Implementing legislation Herbal medicine

Link

View this Written question on www.publications.parliament.uk