§ Mr. TredinnickTo ask the Secretary of State for Health what information he has concerning the nature and scope of the proposed forthcoming recommendations from the European Commission for possible amendments to EU Directive 75/318 in relation to herbal remedies; and if he will make a statement. [78903]
§ Ms JowellWe have recently received proposals from the European Commission for a directive which would amend the Annex to the Directive 75/318 EEC. The proposed directive seeks to clarify the data on safety and efficacy which companies are required to provide when seeking a marketing authorisation for "well established medicinal products". Our initial assessment is that any direct impact on herbal medicines in the United Kingdom is likely to be limited. In particular, the draft Directive would not change the definition of which products are classified as medicines; nor would the proposals directly affect herbal medicines exempt from the requirement for a product licence under the terms of Section 12 of the Medicines Act 1968. Ministers have asked the Medicines Control Agency to seek further clarification from the European Commission about the draft Directive and any wider implications it may have.
We have also given consideration to the wider question of future regulatory arrangements for herbal medicines in the United Kingdom. Our objective is that the public should have access to a wide range of safe, high quality 427W herbal medicines with appropriate information about the use of the product. There are currently two contrasting routes to the market for herbal medicines. Licensed herbal medicines have to meet rigorous standards of safety, quality and efficacy. Unlicensed herbal remedies in the United Kingdom do not have to meet any specific standards for safety, quality or efficacy.
We fully share the view which was expressed at a meeting held by the Under-Secretary, my noble Friend the Baroness Hayman, earlier this week by a range of organisations working in the natural health sector, that the current regulatory arrangements for herbal medicines have significant weaknesses and require review. The regime for unlicensed medicines does not give systematic protection to the public against low quality and unsafe unlicensed herbal remedies which are known to reach the UK market. Nor does it permit manufacturers legally to give written information to consumers about the intended use of the product. In contrast, elements of the regime for licensed medicines—particularly some of the efficacy requirements—are difficult for responsible companies to satisfy in relation to herbal medicines. We believe that there is a need to work towards arrangements which provide better protection and information for the public while continuing to allow responsible businesses and practitioners to operate effectively.
We have asked the Medicines Control Agency to examine options for achieving our objectives for herbal medicines, consulting widely with interested organisations. Medicines law operates within a European framework. Accordingly, we will need to develop a position which is realistically achievable within the European Union. We intend to participate actively and constructively in any ongoing EU discussions about future regulatory arrangements for herbal medicines.
§ Mr. TredinnickTo ask the Secretary of State for Health when he received a copy of the recent report on herbal medicines in Europe from the Association of European Self-Medication Industry; if he has made copies of that report available to right hon. and hon. Members; what response he intends to make to that report; and if he will make a statement. [78904]
§ Ms JowellWe received a copy of the final report "Herbal medicinal products in the European Union" earlier this month. We do not see a need to circulate, or to respond directly to, the report which explicitly states that it does not express the Commission's official views. We understand that the report is available on the European Commission's website (http://dg3.eudra.org). We intend to participate actively and constructively in any ongoing European Union discussions about future regulatory arrangements for herbal medicines.