Source: The Whitehouse Consultancy
Health Minister Lord Hunt today called for a round of further discussions into the proposed EU Directive on Traditional Herbal Medicinal Products by extending the Medicines Control Agency's (MCA) consultation exercise on the regulatory initiative.
Speaking to a conference of the Health Food Manufacturers Association, Lord Hunt said that he was looking for greater dialogue between the MCA and the herbal sector and hoped that extending the consultation period would allow those with concerns to provide the MCA with further information to illuminate their case.
A series of meetings with representatives of interested groups is also to take place in July to ensure that a wide span of views on the Directive will be heard.
Lord Hunt said:
"The clear message we are receiving from many respondents, including representatives of small UK manufacturers of traditional remedies and herbal practitioners, is that the Directive is needed to ensure adequate safety and quality standards and to give consumers systematic information about the safe use of the product.
"However, the consultation has identified specific concerns which we need to explore in greater depth. Parts of the health food sector in particular have indicated their fears that the Directive could have a detrimental affect on the availability of products. We want to allow them more time so that they can provide specific evidence to the MCA."
Lord Hunt asked those who were concerned about the impact of the Directive to provide specific information in three areas:
- Quality and manufacturing standards. A range of respondents, including representatives of small UK manufacturers of traditional herbal remedies, have said that the standards are necessary and achievable - while others are arguing that the proposals are over-regulatory. Lord Hunt asked those with concerns to provide MCA with details of which of the proposed standards they regarded as unnecessary or over-regulatory
- Non European traditional herbal remedies. Lord Hunt indicated that the UK will press for greater flexibility in the Directive to take account of non European traditions. He asked the trade associations for specific details of any herbal remedies currently legally on the UK market which might be affected by the provision in the draft Directive requiring traditional remedies from outside the EU to have at least 15 years use in the EU
- Existing unlicensed herbal remedies on the UK market. A great many herbal remedies on the UK market should be able to demonstrate traditional use as defined in the Directive. But Lord Hunt noted the concerns expressed that some herbal remedies, currently legally on the UK market might fall outside the scope of the Directive. Trade associations are asked to send the MCA examples of any products which might fall into this category.
During consultation a number of respondents have called for a new legislative provision to allow herbal/nutrient combination medicines without the need for a product licence.
Lord Hunt recognised the strength of feeling on this issue and said that he would look carefully at the points raised. However, he warned against a "pick and mix" approach to different herbal medicines in new products, because interactions may occur.
"Companies wishing to mix herbal medicines together in different ways should do so either on the basis of proving their efficacy and safety or on the basis of evidence of long usage, for example by herbal practitioners.
"I undertake to look very carefully in the coming weeks at the various representations and suggestions which have been made on the issue of herbal nutrient combinations in relation to products which are correctly classified as medicines."
Notes for editors
1. The MCA's consultation exercise on the European Commission's proposals for a Directive on Traditional Herbal Medicinal Products (MLX 283) began in March 2002. It will now be kept open until July 31.
2. For media enquiries only, please contact David Daley in the Department of Health Media Centre on 020 7210 5656.