§ Lord Pearson of Rannoch
asked Her Majesty's Government:
What is their attitude to the European Union's proposed:
- (a) Food Supplement Directive;
- (b) Traditional Herbal Medicinal Products Directive; and
- (c) amendments to the Medicines Directive. [HL4192]
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)
The directive on food supplements has now been adopted. It establishes a framework for harmonised controls on vitamin and mineral content of food supplements and introduces a number of useful labelling measures. The Food Standards Agency argued strongly in negotiations for a safety-based approach to this directive rather than the more restrictive approach favoured by the majority of other member states. The text represents a compromise which secured a number of hard-won concessions and which the Government finally supported as the best achievable outcome.
There are widely acknowledged weaknesses in the current regime in the United Kingdom for unlicensed herbal remedies placed on the market under Section 12(2) of the Medicines Act 1968. The proposed Directive on Traditional Herbal Medicinal Products potentially redresses deficiencies in relation to quality and safety standards and systematic product information for the consumer. A large number of herbal remedies should be able to demonstrate traditional use under the terms of the directive. In the light of a consultation exercise on the directive carried out by the Medicines Control Agency (MCA), the Government recognise that, while there is considerable support for many of the provisions of the directive, there are also significant concerns, particularly in parts of the health food sector. These relate principally to the issue of whether some of the proposed quality and manufacturing standards are over-regulatory and whet her some products currently legally sold under Section 12(2) might fall outside the scope of the directive.
We have extended the consultation period until the end of July in order to allow those expressing concerns to identify specific examples where they believe the directive to be over-regulatory or too restrictive. The Parliamentary Under-Secretary of State for Public Health (Ms Hazel Blears) and I will also be meeting representatives of the herbal sector in July. We will review the Government's negotiating priorities on the directive in the light of the additional points that may emerge from this further consultation and dialogue during July.
The European Commission made proposals for wide ranging changes to the body of legislation that regulates medicines for human and veterinary use, of which the Medicines Code (Directive 2001/8:3/EC) is part, in November 2001. These changes are designed to 83WA improve the regulation of licensed medicinal products, including homoeopathic products. The Government support the overall objectives of the European Commission's review but there are some specific proposals about which we have concerns. In particular, the Government are concerned about a proposal that would extend the scope of the medicines legislation to products that fall within the definition of a medicinal product, even if that product is already regulated under other sectoral legislation. The United Kingdom is firmly opposed to this proposal and is resisting it strongly in the negotiations.