HC Deb 12 July 2002 vol 388 cc1270-3W
Mr. Heald

To ask the Secretary of State for Health (1) what progress the Government have made in its negotiations within Europe to amend the drafting of the European Traditional Herbal Medicinal Products Directive to ensure that account can be taken of herbal traditions from outside the EU in satisfying the 30 years qualifying period for herbal products without proof of efficacy; [66852]

(2) if he will place in the Library the evidence of people being harmed by unregulated herbal medicines referred to by the Parliamentary Under Secretary of the Department of Environment, Food and Rural Affairs, European Standing Committee C on 18 June 2002, Official Report. column 11W; [66851]

(3) if he will list the criteria being used to determine which herbal products will be included on the positive list of herbal substances under Article 16f of the amendment proposed to Directive 2001/83/EC regarding traditional herbal medicinal products; [66773]

(4) what representations his Department has received to reduce the length of period that a herbal product or combination of herbal products must have been in use to 15 years; and if he will make a statement; [66858]

(5) what estimate his Department has made of the number of herbal products available in the UK that will be excluded under the current draft of amendments to Directive 2001/83/EC concerning traditional herbal medicinal products; [66855]

(6) what plans he has to inform the public of the difference between a licensed and a registered herbal product; and what this difference will mean in terms of the safety and efficacy of the herbal product; [66859]

(7) what evidence his Department has received of products that have contained dangerous combinations of herbs; if he will list these combinations; and what harmful effect each combination had on humans; [66856]

(8) if he will define the terms very high, high and medium in terms of pounds sterling, with regard to compliance costs referred to in the regulatory assessment for the prosposals amending Directive 2001/83/EC regarding traditional herbal medicinal products. [66774]

Ms Blears

An assessment of safety issues associated with herbal medicines, whether comprising of one or more ingredients, will be placed in the Library. In summary, safety issues relating to unlicensed herbal remedies leading to public health risk have arisen in the United Kingdom and elsewhere as a result of a number of factors. These include: interactions between herbal remedies and other medicines; the inherent toxicity of a herbal ingredient; the inclusion of toxic herbal ingredients or contamination as a result of poor manufacturing standards; and the adulteration of herbal remedies with other ingredients, such as prescription only cortico-steroids.

There are a range of possible reasons why a product currently sold as an unlicensed herbal remedy under Section 12(2) of the Medicines Act, 1968, might not satisfy the criteria of the proposed Directive on Traditional Herbal Medicinal Products. There are no specific quality or safety standards set under the current regulatory regime for unlicensed herbal remedies and it is therefore possible that in some cases, without adjustment to the product, the safety and quality standards applicable under the proposed directive might not be met. Concerns have been expressed by some respondents to a recent consultation exercise (MLX 283) carried out by the Medicines Control Agency (MCA) that some products, currently legally sold as unlicensed herbal remedies may fall outside the scope of the directive as a result of an inability to demonstrate traditional usage as currently defined in the directive. The consultation period has been extended to the end of July specifically to allow those expressing concerns to identify any examples of such products.

As the MCA's consultation exercise on the proposed directive is still in progress analysis of the results is ongoing. There have, however, been some representations suggesting that the 30 year period for demonstrating traditional use might be reduced. The figure of 30 years as a reasonable indicator of traditional usage was one that commanded wide support among many member states throughout the informal development of the directive. The specific examples which the MCA has asked the herbal sector to provide by the end of July should help to demonstrate whether the proposed 30 year criteria would in practice present a significant threat to the regulatory position of herbal remedies which could reasonably be regarded as traditional.

An initial discussion of the proposed directive took place in the Council of Ministers' working group on 10 June. The UK Government indicated their view that the quality, reliability and relevance of the evidence of traditional use was more important than its geographical origin. We will continue to argue this position as negotiations proceed.

The purpose of the positive list of herbal substances within the proposed directive is to facilitate applications for traditional use registrations so that, where an application complies with the positive list, the applicant need not demonstrate safety or traditional use of the product. The directive proposes that the Committee on Herbal Medicinal Products will be responsible for establishing and maintaining the list. Items will be included on the list where the committee accepts that a particular herbal substance, used within the parameters laid down in the list for example as to strength and therapeutic indication, meet the requirements of the directive as to safety and traditional usage.

The terms used in the initial regulatory impact assessment of the proposed directive were intended to give a very broad indication of the relative impact of the proposals. The actual costs attributable to the directive are likely to vary widely between companies, depending on many factors. For example, the impact of the directive could be very high on a company which was currently placing large numbers of herbal medicines on the market while not following any systematic quality standards. This assessment of very high regulatory impact is unlikely to apply, for example, to those UK companies which manufacture unlicensed herbal remedies in compliance with various systematic codes of practice operated by a number of trade associations in the herbal medicines and health food sector. Similarly, the potential for increased sales, which may for example flow from increased public confidence in the quality of products on offer and improved product information will depend on the response of individual companies.

The proposed directive would require product information for a herbal medicine with a traditional use registration to include a statement indicating that the efficacy of the product was not proven. A separate proposal in the review of European Union legislation for licensed medicines would allow companies to state in advertising that a medicine with a marketing authorisation was licensed. Both herbal medicines with a marketing authorisation and those with a traditional use registration would have been assessed by the competent authority as having acceptable safety. The indication for a traditional use registered product would be based on long usage rather than proven efficacy, as is required for a product with a marketing authorisation. The MCA has indicated that it has no present plans to review licensed herbal medicines with a view to assessing whether some might more appropriately come within the category of traditional use registration. This is a complex issue and it is possible that the Committee on Herbal Medicinal Products as proposed in the directive may develop guidance on this area in due course.

Concerns have been expressed by some in the health sector that the proposed quality and manufacturing standards may be over-regulatory. Those expressing such concerns have been invited during the extended period of consultation on the directive to identify which particular standards might be regarded as unnecessary or inappropriate. Further dialogue on this issue should enable the regulatory impact assessment to be enhanced.

Mr. Heald

To ask the Secretary of State for Health whether he intends to make further representations to the European Commission about the proposed Traditional Herbal Medicinal Products Directive. [67968]

Ms Blears

We intend to participate actively in negotiations on the proposed Directive on Traditional Herbal Medicinal Products and will make representations and propose, support or oppose amendments to the directive as may be necessary in the interests of public health and consumer choice in the United Kingdom. We have extended the period of the Medicines Control Agency's consultation on the directive until the end of July in order to allow those with concerns an opportunity to provide more specific evidence. My noble Friend the Parliamentary Under-Secretary of State for Health and I are meeting representatives of the herbal sector during July to discuss the proposed Directive. In the light of points which may emerge from this further consultation and dialogue, we will consider what additional points we may wish to pursue during the course of the negotiations. We have already highlighted that we wish to see greater flexibility to take account of non-European herbal traditions and that we intend to press for an early date to be specified for the review of the scope of the directive with a view to its possible extension to at least some categories of non herbal traditional medicines.