Written Answers. - Medicinal Products.
Michael Creed
Question:
223
Mr. Creed
asked the
Minister for Health and Children
if his attention has been drawn to the widespread outcry against a decision made by the Irish Medicines Board to restrict the availability of certain products (details supplied) which are freely available; if he has satisfied himself with the appropriateness of this decision and the consequences medical and financial on those who use these products; and the consideration, if any, he will give to the establishment of a consultative forum where all interested parties to these decisions can have their voice heard.
[23216/99]
Pádraic McCormack
Question:
260
Mr. McCormack
asked the
Minister for Health and Children
if he will ensure that appropriate structures are set in place to allow the health industry, healthcare professionals and his Department to work together on an ongoing basis to establish appropriate systems for control of the products and services offered by health food outlets.
[23375/99]
Pádraic McCormack
Question:
261
Mr. McCormack
asked the
Minister for Health and Children
if he will introduce a requirement where the Irish Medicines Board and his Department would in future have to consult with the health food industry and independent professional experts on any regulations concerning the naming of health foods to be put on prescription lists.
[23376/99]
Denis Naughten
Question:
266
Mr. Naughten
asked the
Minister for Health and Children
the plans, if any, he has to introduce a new labelling system for herbal preparations which would avoid the need for the withdrawal of these preparations from shops; and if he will make a statement on the matter.
[23468/99]
John McGuinness
Question:
272
Mr. McGuinness
asked the
Minister for Health and Children
if he will establish a working group from his Department, IMB and the Health Products Alliance to discuss the future of natural health products in view of the growing concern within the industry regarding the decisions taken in relation to St. John's Wort and ginko biloba and those who use and prefer natural medicine products; and if he will make a statement regarding the strategy of his Department in this area.
[23510/99]
I propose to take Questions Nos. 223, 260, 261, 266 and 272 together.
The Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland.
EU Council Directive 65/65/EEC defines a medicinal product as any substance or combination of substances for treating or preventing disease in humans or animals or which may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions. The directive does not make any distinction between conventional medicines and those medicinal products containing ingredients which may be described as "natural" or "herbal".
The Irish Medicines Board, in its recent guidelines on the interpretation of the EU definition of a medicinal product, has revised and updated the similar guidelines published by my Department in 1988. The policy in regard to the controls in force in respect of medicinal products including "natural" medicinal products has not changed in any significant way.
If a product placed on the market includes a medicinal claim, the product concerned becomes a medicinal product and should be the subject of a product authorisation granted by the Irish Medicines Board under the Medicinal Product (Licensing and Sale) Regulations, 1998. These regulations give effect in this country to the EU Council Directive 65/65/EEC. Before the board may grant an authorisation, it must first be satisfied as to the safety, quality and efficacy of the product concerned. In the case of unlicensed products that may be available on the market, neither the safety, quality nor efficacy of such products would have been established by the board.
Products containing the herb hypericum perforatum (St John's Wort) are medicinal products and, as such, must be the subject of product authorisations from the Irish Medicines Board in order that they may lawfully be placed on the market in this country. The decision by the board to recommend that products containing St John's Wort should be placed on medical prescription was taken following appropriate medical assessment by the board. This was subsequently advised to my Department. A number of reasons has been given by the board for its recommendation. These include the fact that the products appear to act as monoamine oxidase inhibitors (MAOIs). These products must therefore be used with particular care because of risks of interactions, not just with other medicines, but also with certain foods. Patients therefore may be at risk from hypertension (increased blood pressure) if these products were to be taken with certain other antidepressants, over-the-counter cough mixtures (sympathomimetics) and with foods rich in tyramine such as cheese, yeast extract and red wine. Side effects such as photosensitivity, gastrointestinal disturbances, fatigue and nervousness have also been reported. Furthermore, the board has expressed concern at the possible treatment of mild to moderate depression by use of an over the counter medicine. The board considers that the treatment of such a condition should be under medical supervision and that self-diagnosis and self-medication are inappropriate.
In relation to medicinal products containing ginkgo biloba, the position is that such products have been subject to prescription-only control since 1987.
The placing of any medicinal product under prescription-only control is carried out in the interest of protecting public health and safety and where it is considered appropriate that such products should be used only under medical supervision and advice. The criteria concerned are included in EU Council Directive 92/26/EEC concerning the classifications for supply of medicinal products for human use.
I am aware of concerns expressed by both consumers and representative organisations regarding the decision to place products containing St Johns Wort under prescription-only control and I would like to assure the Deputies that it is not my intention to in any way interfere with the rights of individuals to avail of appropriate medicines which they may wish to use. However, it is generally accepted that in the interest of consumer health and protection, some form of regulation of "alternative medicines" is desirable and this view is supported in principle by the health food and alternative medicines industry. My Department has ongoing contact with the European Commission through its various working groups and committees and I understand that the European Commission is currently considering what controls, if any, should be applied to "health food" products and "natural" medicines, including the possibility of providing simplified procedures for the licensing of alternative or traditional medicines, but no definitive proposals have been brought forward at this stage. While there is no definition of "health food" or "foodstuff" in European legislation, the forthcoming White Paper on Food Law, the aim of which is to simplify EU food legislation, may well make recommendations in this regard. Deputies may be interested to know that under European food law, no "health claims" may be made in relation to food. The White Paper is due to be published later this year.
The suggestion that special labelling could apply to these products is a matter for consideration by the Irish Medicines Board in the context of an application for a product authorisation.
On the question of consultation with the various interested parties in this debate, I would like to advise the Deputies that there has been an on-going discussion in the European Union, including the European Commission, in relation to the control of "health foods", many of which have been claimed as being "alternative" or traditional medicinal products. I am aware that the Irish Health Food industry is represented in these discussions through its participation in ESCOP (European Scientific Cooperative on Phytotherapy). The question of working groups and further consultation in this area will be kept under review.
