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House of Lords Hansard
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Traditional Medicines: Proposed Directive
15 January 2001
Volume 620
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asked Her Majesty's Government:Further to the Written Answer by Lord Hunt of Kings Heath on 12 December (

WA 15), whether it is their policy, in discussions on the proposed Traditional Use Medicines Directive, to extend its scope to include products which are combinations of herbs with other ingredients which have been on the market for the qualifying period either as part of the combination in question or as separate ingredients; and [HL247]

Further to the Written Answer by Lord Hunt of Kings Heath on 12 December ( WA 15), whether it is their policy, in discussions on the proposed Traditional Use Medicines Directive, to reduce the 30-year qualifying period for the demonstration of traditional use to a shorter period which would reflect the conditions of the existing United Kingdom market; and if not, why not; and [HL248]

Further to the Written Answer by Lord Hunt of Kings Heath on 12 December ( WA 15), whether in their view the proposed Traditional Use Medicines Directive is likely to provide a secure regulatory home on the market for products which are safe combinations of herbal remedies and food ingredients; and, if not, what steps they intend to take to provide one. [HL249]

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Our priority in continuing European discussions on the proposed directive is to achieve a secure regulatory regime for traditional herbal remedies. We are aware that there are also some traditional medicines which consist wholly or partly of non-herbal ingredients. Our current position is that, once the directive goes beyond relatively discrete categories such as traditional herbal remedies, it may become more difficult to contain the wider public health and regulatory consequences. We therefore wish to continue to review the developing shape of the directive and the implications for overall medicines regulation before firmly committing ourselves to supporting the principle that coverage should extend more widely.We are also considering carefully our detailed position on the definition of traditional use, including the qualifying time period, and on criteria which might apply in the case of combinations. One general consideration is that the normal regulatory requirements for medicines include demonstration of efficacy. While we have advocated in Europe the specific case for lifting the requirement for efficacy in the case of genuinely traditional herbal remedies, we would have concerns about the potential implications if the parameters for traditional use were set so loosely that a very wide range of medicinal products were no longer required to demonstrate efficacy.At this stage we do not yet know the views of other member states on specific issues relating to combination products. We would expect a clearer picture to emerge over the coming months as European discussions continue. The Medicines Control Agency (MCA) has submitted our initial response to the European Commission on the preliminary draft of the proposed directive. Copies of the MCA's letter will be placed in the Library. We will continue our current consultative approach with herbal interest groups.