Herbal Medicines Directive (Hansard, 7 January 2003)

§ Mrs. Gillan
To ask the Secretary of State for Health (1) what level of fees the Medicines Control Agency will charge under the proposed Traditional Herbal Medicinal Products Directive for considering applications for the registration of herbal medicines under the terms of the directive; [88688]
(2) what estimate he has made of the compliance costs in terms of registration charges, documentation, storage costs and analysis for companies seeking a full pharmaceutical licence for a herbal product under the proposed Traditional Herbal Medicinal Products Directive. [88689]

§ Ms Blears
I refer the hon. Member to the reply I gave my hon. Friend the Member for Great Grimsby (Mr. Mitchell) on 5 December 2002,official Report, column 966W.

§ Mrs. Gillan
To ask the Secretary of State for Health (1) what assessment he has made of how the pharmaceutical production and testing standards for products under the draft Traditional Herbal Medicinal Products Directive will affect the commercial value of the products on the UK market, with special reference to those produced by smaller specialist companies and distributed through specialist retailers. [88690]
(2) what assessment he has made of how the fees charged by the Medicines Control Agency for considering applications for the registration of herbal products under the terms of the proposed Traditional Herbal Medicinal Products Directive will affect the commercial value of the products on the UK market, with particular reference to those produced by smaller specialist companies and distributed through specialist retailers. [88691]

§ Ms Blears
Existing regulatory arrangements do not allow the public readily to distinguish which unlicensed herbal remedies on the United Kingdom market are made to acceptable standards. There is continuing evidence of an international trade in herbal remedies made to unreliable standards. Currently, the commercial value of herbal remedies made to good quality standards, as well as public health, can be compromised by products made to low standards.
The requirements of the proposed Directive on Traditional Herbal Medicinal Products should mean that the public will have access to a wide range of herbal remedies made to assured the requirements of the proposed Directive on Traditional Herbal Medicinal Products should mean that the public will have access to a wide range of herbal remedies made to assured standards of safety, quality and product information. Many in the herbal sector share our view that this could lead to increased public confidence in herbal medicines, and lead to greater stability for business.
192W
In continuing detailed discussions with industry about the Directive the Medicines Control Agency will continue to pay close attention to issues of regulatory impact which are of specific concern to small business.

§ Mrs. Gillan
To ask the Secretary of State for Health what effect the proposed Traditional Herbal Products Directive will have on the choice of herbal products available to the consumer. [88692]

§ Ms Blears
Our expectation is that, subject to the successful outcome of negotiations on the proposed Directive on Traditional Herbal Medicinal Products, the customer will have access to a wide range of traditional herbal remedies made to assured standards of safety and quality and with systematic information about the safe usage of the product.

§ Mrs. Gillan
To ask the Secretary of State for Health (1) what opportunities exist for new herbal products under the proposed Traditional Herbal Medicinal Products Directive; [88694]
(2) how many routes to the market will be allowed by the proposed Traditional Herbal Medicinal Products Directive for herbal remedies other than by obtaining a full pharmaceutical licence. [88686]

§ Ms Blears
Under the proposed Directive on Traditional Herbal Medicinal Products, non active ingredients within the traditional herbal remedy, need not have traditional usage. The possibility of permitting the inclusion of nutrients with traditional herbal remedies is currently under consideration in European negotiations on the Directive.
Where non industrially produced unlicensed herbal remedies are supplied following one to one consultation in accordance with the terms of s12(1) of the Medicines Act 1968 there is no requirement to demonstrate traditional usage of the remedy.