Vol. 511 No. 6
248 Ms O'Sullivan asked the Minister for Health and Children if he will revoke SI 271/99 which confines St. John's Wort to prescription only use from 1 January 2000 in order that the whole issue of herbal remedies can be properly debated in consultation with those who use these remedies; and if he will make a statement on the matter. [25593/99]
282 Ms O. Mitchell asked the Minister for Health and Children if he will revoke SI 271/99 pending the drafting of a traditional medicines directive in the EU and the introduction of a workable licensing system for these products; and if he will make a statement on the matter. [25087/99]
I propose to take Questions Nos. 248 and 282 together.
The need and usefulness of specific EU legislation for traditional medicinal products was considered at the 48th meeting of the EU Pharmaceutical Committee which took place on 27 and 28 September last – one month after my signing of the regulations referred to by the Deputy. After an intensive debate, the committee agreed that "the regulation of traditional medicinal products clearly deserves attention; that there may be a case for sorting out existing problems through specific Community legislation; that any future legislation in this sector would have to take into account the fact that there is a very strong national component to this issue and that the possibilities for full harmonisation may be limited; and that the scope of the products concerned should be clearly defined and a possible future regulation should not serve as a safe haven for all sorts of non-effective products."
It is clear from this that any Community proposals that may attempt to address the issue of traditional medicinal products (including any eligible herbal medicinal products) are a long way off. While it is recognised that there is little harmony between the member states and that there is little prospect of agreement being reached if an attempt to introduce a directive were made, at the same time it is recognised that public health must be protected and that while some form of "traditional use" claims might be acceptable in certain circumstances, there can be no compromise where safety and quality are concerned. The matter, therefore, continues under examination at EU level and the question of my revoking SI 271/99 does not arise at this stage.
