§ Mr. ToddTo ask the Secretary of State for Health, pursuant to his reply of 20 December 2000,Official Report, column 196W, (1) what steps he plans to take to provide a secure regulatory framework on the market for those products which are safe combinations of herbal remedies and food ingredients; and if he will make a statement; [145568]
(2) pursuant to his answer of 20 December 2000, Official Report, column 196W, if it is his policy to promote within discussions on the proposed Traditional Use Medicines Directive efforts to reduce the 30 year qualifying period for the demonstration of traditional use to a shorter period that reflects the conditions of the existing UK market; [145582]
(3) pursuant to his answer of 20 December 2000, Official Report, column 196W, if it is his policy to promote within the discussions on the proposed Traditional Use Medicines Directive the objective of extending its scope to include products which are combinations of herbs with other ingredients and which have been on the market for the qualifying period (a) as part of the combination in question or (b) as an ingredient separate from the one with which it is to be combined; [145581]
(4) what response the Medicines Control Agency has made to the European Commission in its call for comments on the draft Traditional use Medicines Directive; and if he will arrange for that response to be published in the Official Report. [145389]
§ Ms StuartOur 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 156W 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.