Myth: Common herbal remedies could be under threat as from the new year due to a new EU Directive that prohibits the sale of unlicensed medicines. Under the Directive herbal treatments such as garlic pills and ginseng have to be classified as medicines and therefore be licensed, costing manufacturers up to £100,000 each and putting many sales outlets out of business.
Sources: The Times, The Guardian (20 October 1994), Daily Telegraph,Daily Express (21 October 1994), Mail on Sunday (23 October 1994)
Response: This is not so. The relevant piece of Community legislation in fact dates from 1975, and lays down quality standards and other criteria for medicines being entered onto the marketplace. Specifically, products need either a national or a Community licence, and this has applied to all new products since 1975. For those medicines in existence before 1975, a 15 year transitional period was granted, ending in 1990.
The only thing that is due to change on 1.1.95 is the procedure for granting Community-wide licences. This will be undertaken by the European Agency for Medicinal Products, to open in London on this date.
If herbal remedies are packaged and sold as medicines they are indeed subject to the same rigorous tests as all other medicines. If on the other hand these products are not sold as medicines they are not subject to Community legislation.
On 11 November (1994) Tom Sackville, the Parliamentary Secretary for Health, announced that the exemption for herbal products under the UK Medicines Act would continue under the new legislation which comes into force on 1 January 1995. The position of herbal medicines has been safeguarded by judging that those herbal medicines currently exempted under UK law are made according to a number of traditional processes that fall outside the interpretation of an industrial process – the term outlines in Article 2 of the European Directive.
This is perfectly compatible with European Community Law