§ Alan SimpsonTo ask the Secretary of State for Health what representations the UK has made in respect of the EU Traditional Herbal Medicinal Products Directive with specific reference to moves to bring herbal remedies into the regulatory regime dealing with pharmaceutical drugs; and what position the UK has taken on the proposal to extend this to cover combinations of herbs and nutrients. [57961]
§ Ms BlearsMany herbal remedies in the United Kingdom and elsewhere in the European Union already have a marketing authorisation under European medicines legislation.
Negotiations on the proposed directive on traditional herbal medicinal products are at an early stage. So far the Government have argued in particular that there should be greater flexibility to take account of non European herbal traditions and that an early date should be set for the review of the scope of the directive in relation to non herbal traditional medicines.
The medical control agency is holding a consultation exercise on the directive. This is showing that there are varied views on the proposed manufacturing and quality standards. Some respondents, including UK manufacturers of traditional herbal remedies, have argued 782W that the standards are achievable and are necessary in the interests of consumer protection and of the long-term reputation of the herbal sector.
Others, particularly from the health food sector, have argued that the standards are inappropriate or unnecessary. We have extended the consultation until the end of July in order to allow those with concerns to identify the specific areas where they believe the standards to be over-regulatory. We will further develop the UK negotiating position on this issue once we have assessed the additional information provided during the extended period of consultation.
We are currently considering representations that have been received during the consultation about the regulatory position on herbal-nutrient combination products.