HC Deb 09 December 2002 vol 396 cc157-60W
Mr. Austin Mitchell

To ask the Secretary of State for Health (1) how many products now on free sale will be required to be licensed when the European directives on nutritional supplements on herbal remedies come into effect; and whether grandfather rights will be given to products already on free sale; [83839]

(2) what steps he intends to take to secure a continued route to market, other than full pharmaceutical licensing, for those products which are not able to demonstrate they have been on the European market for the period specified by the Traditional Herbal Medicinal Products Directive, but which are able to demonstrate a tradition of safe use in another country. [84524]

Ms Blears

Directive 2002/46/EC on Food Supplements does not require licensing of any products.

There is currently no requirement for the Medicines Control Agency (MCA) to be notified of unlicensed herbal remedies placed on the market under section 12(2) of the Medicines Act 1968 and therefore there is no information available on the number of products placed on the market under this provision and which may fall within the terms of the proposed Directive on Traditional Herbal Medicinal Products. We expect that some broad pointers as to the likely numbers of products for which registration might be sought will emerge from continuing discussions between the MCA and the herbal sector, particularly in the light of further refinements to the text during continuing negotiations.

There is no provision within the Directive for grandfather rights to be given as such. However, in the MCA's consultation on the proposed Directive earlier this year, the herbal sector was invited to submit examples of products which are currently legal but which may fall outside the terms of the proposed Directive. Analysis to date of the responses suggest that there will be few existing herbal medicine on the United Kingdom market which, while having 30 years use, are unable to meet the proposed requirement that at least 15 years use should have been within the European Union. This assessment also takes account of the proposed five year transitional period for products already on the market, during which time evidence of traditional use can continue to be accumulated.

A recent proposed amendment from the European Parliament, which we will support, would reduce the required minimum period of EU usage from 15 years to 10 years. This would further reduce any possibility that products currently on the UK market would fall outside the Directive solely by virtue of the required minimum period of EU usage.

Where non industrially produced unlicensed herbal remedies are supplied following one to one consultation in accordance with the terms of section 12(1) of the Medicines Act 1968 there is no requirement to demonstrate traditional usage of the remedy.

Mr. Austin Mitchell

To ask the Secretary of State for Health what representations he has received on, and how many were(a) for and (b) against, the proposed new EU directives on nutritional supplements and herbal remedies from (i) small and medium enterprises, (ii) large manufacturers, (iii) drug firms and (iv) the public. [83842]

Ms Blears

Directive 2002/46/EC on Food Supplements came into force on 12 July 2002 and must be transposed into member states' national legislation by 31 July 2003. The Food Standards Agency (FSA) is currently consulting on draft implementing Regulations.

During lengthy negotiations on the Directive the FSA received a large number of representations from a wide range of stakeholders expressing a range of views.

We have also received a large number of representations about the proposed Directive on Traditional Herbal Medicinal Products. It is not possible to provide a breakdown of responses in the categories requested as many of those commenting have made specific comments rather than directly indicated support for, or opposition to, the proposed Directives.

To the best of our knowledge, we have not received any representations, either for or against the Directive, from any manufacturers not already involved in the manufacture of products in the natural health sector.

The position of representatives of United Kingdom manufacturers of herbal remedies was set out in a letter from the Herbal Forum to my noble Friend the Parliamentary Under-Secretary of State (The Lord Hunt of Kings Heath) on 18 November. The membership of the Forum, which covers small, medium and large businesses operating in the sector, comprises the Health Food Manufacturers' Association, the Proprietary Association of Great Britain, the British Herbal Medicine Association, the Council for Responsible Nutrition, the Natural Medicines Manufacturers' Association, the Ayurvedic Trade Association, the Trade Association of Producers and Suppliers of Ayurvedic Products from India, the Chinese Medicine Association of Suppliers, the European Herbal Practitioners Association, the Aromatherapy Trade Council, and the Small Growers and Producers Association.

The Forum indicates its view that the traditional medicines sector needs appropriate regulation in order to ensure that the public is properly protected against inferior quality products which the current system can allow on the market. The Forum also says that its members appreciate the need for the proposed Directive, while outlining a number of areas of specific concern that it wishes to be addressed through the continuing European negotiations or at national level. We welcome the stated intention of the Forum to continue to work constructively with the Government and the MCA in particular, to address the various issues identified.

We have received a wide range of representations from stakeholder interest groups in herbal sector in the form of letters and through points made in discussions with Ministers and with the MCA. The stakeholders cover many interests including, manufacturing, retailing, consumers, herbal practitioners, other complementary and alternative medicine groups, pharmacists, doctors, other health care professionals and academics. Some have been supportive of the Directive or have been supportive subject to the resolution of specific concerns. Others have raised specific points without indicating an overall view of the Directive. A minority has indicated strong opposition. Among representative groups wholly or broadly supportive of the Directive are the British Herbal Medicine Association, Consumers Association, the Royal Pharmaceutical Society of Great Britain and the European Herbal Practitioners Association. Representative groups expressing strongest opposition to the Directive include Consumers for Health Choice (CMC) and the National Association of Health Stores (NAHS).

In a number of meetings Ministers have held with a wide range of stakeholders directly involved in the sector the position taken by the majority of interest groups has been that the UK should support the Directive as being in the interests both of the sector and of consumers, while arguing for additional flexibility on a number of issues; and that the Directive should be interpreted and implemented in a way which minimised regulatory impact, consistent with the protection of public health. A minority of stakeholder groups has expressed strong opposition, citing fears in particular that the Directive would have an adverse effect on specialist health food retailers and consumer choice.

Representations from individual companies also express a wide variety of positions, ranging from strong support to concern or opposition.

We have received around 1,300 letters, mainly from the public, opposing the Directive. Many of these express the fear that large numbers of herbal remedies would no longer be available as a result of the Directive. A significant proportion specifically indicate support for the position against the Directive taken by CHC or the NAHS. We have received a number of petitions expressing a similar point of view. A number of these representations from the public also express opposition to the Food Supplements Directive.

We have in addition received around 400 letters from the public opposing the possibility of traditional use registration applying to flower essences. This followed a statement by the MCA, in response to a request from a company, that it might be possible in principle for a company to secure a traditional use registration for a product. Nearly all those writing were concerned that the possibility of a company making a successful application implied a requirement that all flower essences should be registered under the Directive. This however is not the case.