Earl Kitchenerasked Her Majesty's Government:
What information they have concerning the outcome of the recent meetings at the European Commission at which possible amendments were considered to European Union Directive 75/318. [HL2276]
§ The Parliamentary Under-Secretary of State, Department of Health (Baroness Hayman)At a meeting of the European Pharmaceutical Committee on 15 April there was broad support from member states for the European Commission's proposed amendments to the Annex to Directive 75/318 EC in relation to the data required to satisfy the safety and efficacy requirements for the licensing of well established medicines. We await information on how that proposal will be further progressed by the Commission. Our assessment remains that this proposal would have limited impact on herbal medicines seeking a product licence in the United Kingdom and no effect on unlicensed herbal remedies.
A number of member states, including the UK, also advanced the case at the Pharmaceutical Committee for a further, and more wide ranging, initiative designed to move towards a European regulatory framework for herbal medicines which recognises more appropriately the particular characteristics of these products. The committee indicated its support in principle and the Commission will be considering the inclusion of further work on herbal medicines in its next work programme.
Our overall objective is that the public should have access to a wide range of safe high quality herbal remedies with appropriate information about the use of the product.