Dan Boyle
Ceist:11 Mr. Boyle asked the Minister for Health and Children the progress made to date on regulating complementary and alternative medicine; and if he will make a statement on the matter. [10815/04]
Amharc ar fhreagraWednesday, 7 April 2004
Ceisteanna (13)
Freagraí scríofa
As a first step towards strengthening the regulatory environment for complementary therapists, I convened a forum in June 2001 to examine and explore practical issues involved in establishing appropriate regulation. Arising from the work of the forum I asked the Institute of Public Administration to prepare a report on proposals for the way forward taking into consideration the formal views of the representative groups that participated in the forum.
The report, which was launched in November 2002, delivers on action 106 of the health strategy — quality and fairness, and makes a number of recommendations on proposals for the way forward including: the establishment of a working group to examine and consider regulatory issues in Ireland; the continuation and development of a consultation process; and support for individual therapies in developing or strengthening their systems of self-regulation. As recommended in the report, I established a national working group to advise me on future measures for the regulation of complementary therapists. The working group held its first meeting in May 2003, continues to meet regularly and is expected to report by May 2005.
A proposal for a new EU directive on traditional herbal medicinal products was agreed at European level on 11 March 2004. In order to gain the most from these types of medicinal products, it is essential that they are subject to appropriate controls to ensure that, like all other medicinal products, they are of an appropriate quality and safe for the consumer to use. The interests of public health can best be realised when there is a formal mechanism for the assessment of these products and a subsequent means of monitoring their use in order to assure their continued safety in use.
This EU proposal provides for a special legal framework for traditional herbal medicinal products, with a view to removing the differences and uncertainties about the status of these products in the member states and to further improve the protection of public health. Under the proposed directive, the quality requirements for these products are identical to those for all medicinal products. However, it is proposed that instead of conducting new tests and trials on the safety and efficacy of the product, these can be assessed on the basis of the information gathered on its traditional use over a period of at least 30 years, including 15 years in the community. Pending the implementation of this directive, the Irish Medicines Board continues to monitor the situation from a public health safety point of view.