Earl Kitchenerasked Her Majesty's Government:
(a) what are the nature and scope of the proposed forthcoming recommendations from the European Commission for possible amendments to European Union Directive 75/318 in relation to herbal remedies; and
(b) why the Commission have not made their proposals publicly available. [HL1892]
108WA
§ Baroness HaymanWe have received initial 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 current assessment is that any direct impact on herbal medicines in the United Kingdom is likely to be relatively limited. In particular, the draft directive would not change the definition of which products are classified as medicines; neither would the proposals directly affect herbal medicines exempt from the requirement for a product licence under the terms of Section 12 of the 1968 Medicines Act.
We understand that, if the Commission decides to carry the proposals forward, it will consider the need for an appropriate period of consultation.
Earl Kitchenerasked Her Majesty's Government:
What policy principles determine their approach to the regulation of herbal remedies:
- (a) in the United Kingdom; and
- (b) in Europe. [HL1893]
§ Baroness HaymanWe fully share the view, which was put to us in March by a cross-section of organisations working in the natural health sector, that the current regulatory arrangements for herbal medicines in the United Kingdom have significant weaknesses and require review. 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 UK do not have to meet any specific standards for safety, quality of efficacy. 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.
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. 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 109WA discussions about future regulatory arrangements for herbal medicines.