Dáil Éireann debate -
Tuesday, 20 Jun 2000

Vol. 521 No. 4

Written Answers. - Controlled Medicines.

John Gormley

Question:

147 Mr. Gormley asked the Minister for Health and Children if the regulations currently in place to control the sale and supply of medicines were enacted in the 1960s following the thalidomide disaster, to protect the public from such a tragedy recurring; if he has had inquired into the establishment of a simpler regulatory system for herbal and homeopathic medicines which could reside within the Department of Health and Children and be administered by relevant experts within these disciplines given that the practice of medicine today is dominated by the use and development of powerful pharmaceutical drugs which must be strictly controlled; if he will make a statement on the progress and the steps being taken to ensure the industry will be included in the process given that he has asked both officials from his own Department and the IMB to progress regulation specifically in the area of herbal medicines; if he has had inquiries made into other models being implemented in other member states, particularly Belgium and Holland, given that many countries in the EU are grappling with the same legislative hurdles concerning the regulation of traditional and homeopathic medicines; and his views on whether the practice of this traditional medicine is in grave danger given that herbal practitioners are professionals specifically trained in the use and application of herbal medicines but are currently prohibited from using many herbs in their practice by the proscribing of these herbs. [17131/00]

Minister for Health and Children (Mr. Martin)

The current regulations are a continuation of the controls first introduced in the early 1950s to control medical preparations containing cortisone, barbiturates and oral diabetic treatments. The thalidomide disaster of the early 1960s and the debate which followed in subsequent years alerted authorities to the potential dangers of medicinal products regardless of their source.

The position is that all medicinal products placed on the market must be safe, effective and of appropriate quality for their purpose. In this country the competent authority, having the expertise in this area, is the Irish Medicines Board. It would be wasteful and inappropriate to set up a second authority to discharge this function. In any event any such authority would of necessity have to act on the basis of the same rules laid down by law that the Irish Medicines Board must currently follow. There can be no compromise where the protection of public health is concerned.

My Department has sanctioned the appointment of an additional senior assessor by the Irish Medicines Board to facilitate a detailed review of arrangements to be put in place for the introduction of the interim licensing scheme. The assessor, titled "Project Manager-Herbal Medicines" is required to be a graduate in the medical, biological or pharmaceutical area with a demonstrated knowledge of herbal medicines. One of his tasks will be to liaise with the industry and with other interested groups and individuals.

The recent debate has highlighted the lack of a common approach at EU level to the regulation of traditional medicinal products. This matter is being addressed by a working group set up by the EU Pharmaceutical Committee last year. I do not anticipate an early resolution to the difficulties of harmonisation in this area. Any national scheme introduced therefore, must of necessity have to be on an interim basis pending the introduction of appropriate EU measures when full authorisation of such products will be required on the basis of whatever requirements are to be eventually agreed. Obviously, in the drawing up of any such interim scheme consideration will be given to regulatory models in use in other member states.

I do not accept that the practice of traditional medicine as described by the Deputy is in grave danger.