Written Answers. - Medicinal Products.
Caoimhghín Ó Caoláin
Question:
36
Caoimhghín Ó Caoláin
asked the
Minister for Health and Children
the contacts, if any, his Department has had with the European Com mission in relation to the regulation of health foods and alternative medicines.
[22818/99]
Jim Higgins
Question:
43
Mr. Higgins (Mayo)
asked the
Minister for Health and Children
if his attention has been drawn to the fact that the implementation of S1 271 of 1999 concerning the herbal product known as hypericum, scheduled to come into effect on 1 January 2000, will mean that Ireland will be the only European country with this restriction on the product; and if he will make a statement on the matter.
[22191/99]
Austin Deasy
Question:
53
Mr. Deasy
asked the
Minister for Health and Children
if his attention has been drawn to the concern among members of the public who use homeopathic remedies that proposals are being made to have them made available as prescription medicine only; and if he will make a statement on the matter.
[22834/99]
Pádraic McCormack
Question:
71
Mr. McCormack
asked the
Minister for Health and Children
the reason for the decision to have St. John's Wort, hypericum perforatum, available only on prescription from 1 January 2000 in view of the fact this product has been freely available in health shops over the past number of years; and if he will make a statement on the matter.
[22193/99]
Liz McManus
Question:
73
Ms McManus
asked the
Minister for Health and Children
if his attention has been drawn to the concern at the decision of the Irish Medicines Board to reclassify certain vitamin, mineral and herbal supplements as medicines which makes their over the counter sale in non-pharmaceutical outlets illegal; if his attention has further been drawn to the implications of this decision not only for health food stores but also for freedom of choice among consumers; and if he will make a statement on the matter.
[22839/99]
Trevor Sargent
Question:
130
Mr. Sargent
asked the
Minister for Health and Children
the way in which it came about that an order is to be made limiting the sale of hypericum or St. John's Wort which has prophylactic qualities in the treatment of varicose veins and mild depression; his role in making the decision; and if his attention has been drawn to the fact that Ireland is out of line with its EU neighbours in requiring St. John's Wort to be made a prescription medicine.
[23004/99]
Trevor Sargent
Question:
131
Mr. Sargent
asked the
Minister for Health and Children
his views on whether making hypericum or St. John's Wort a prescription medicine appears to be a case of the medical profession trying to preserve a monopoly for itself instead of acting in the public interest; and the measures, if any, he will take to protect the rights enjoyed by people for many years to access to this effective treatment for mild depression which has no significant side affects and does not require a prescription.
[23005/99]
David Stanton
Question:
179
Mr. Stanton
asked the
Minister for Health
and Children his views on the decision that St. John's Wort and ginkgo biloba will only be available by way of doctors prescription from 1 January 2000; the reason for this decision; the plans, if any, he has to intervene to reverse it; and if he will make a statement on the matter.
[23120/99]
I propose to take Questions Nos. 36, 43, 53, 71, 73, 130, 131 and 179 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. 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. John's 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 position in other European countries is that products containing hypericum are usually treated as medicinal products and in some instances are subject to national marketing authorision procedures. While the prescription classification might currently be unique to this country within the EU, I am advised that the nature of the medical claims being made in support of the product and their promotion, particularly via the Internet, may also lead to greater controls, including prescription control in other countries.
I would also like to clarify for Deputies that the recent guide published by the Irish Medicines Board has not altered the position in relation to homeopathic medicinal products. The Medicinal Products (Licensing and Sale) Regulations 1998 already contain provisions for a simplified registration procedure for certain of these products as required by Council Directive 92/73/EEC. Under these simplified arrangements, while quality and safety must be established, evidence of product efficacy is not required in order to obtain registration for placing on the market.
Finally, I am not aware of any proposal that health foods or homeopathic medicinal products should be put under prescription only control nor is there any proposal that these products should be removed from non pharmaceutical outlets. I am also unaware of any attempt by the medical profession to preserve a monopoly for itself in this area.
