Written Answers. - Medicinal Products.
John Gormley
Question:
34
Mr. Gormley
asked the
Minister for Health and Children
if he will resist any moves to class natural supplements, herbal and homeopathic remedies as medicines; if his attention has been drawn to the fact that an organisation (detail supplied) is running a campaign to ensure that this does not happen; and if he will make a statement on the matter.
[18262/99]
Brendan Howlin
Question:
65
Mr. Howlin
asked the
Minister for Health and Children
if his attention has been drawn to the concerns expressed regarding the intentions of the Irish Medicines Board to define minerals, amino acids and herbal ingredients as medicinal products; and if he will make a statement on the matter.
[18244/99]
I propose to take Questions Nos. 34 and 65 together.
Under the Irish Medicines Board Act, 1995, the Irish Medicines Board is the competent authority for the regulatory control of medicinal products in Ireland. The Medicinal Products (Licensing and Sale) Regulations, 1998, which give effect to Council Directive 65/65/EEC, require that all medicinal products placed on the market must be the subject of a product authorisation granted by the Irish Medicines Board. The regulations also contain provisions for a simplified registration procedure for certain homeopathic medicines as required by Council Directive 92/73/EEC relating to homeopathic medicinal products. Before the board will 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, neither the safety, quality nor efficacy of such products would have been established.
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. Neither the directive nor the regulations make any distinction between conventional medicines or so-called natural health products or remedies. At the same time, however, it is accepted that there are a range of products on the market which may, depending on circumstances, be classified as either food supplements or medicinal products. For example, certain products such as vitamin or mineral supplements which may sometimes be regarded as food supplements, are sometimes presented at therapeutic dosage levels supported by specific medicinal claims. Indeed, it is recognised that certain vitamins and minerals can have serious side effects if taken in excessive doses.
The Irish Medicines Board recently published guidelines on the interpretation of the definition of a medicinal product as set out in the council directive. These guidelines revise and update similar guidelines published by my Department in 1988. I am aware concerns expressed both by consumers and by the organisation referred to regarding the possible application of the guidelines. However, I would like to assure the Deputies that it is neither mine nor the board's intention or desire to in any way interfere with the rights of individuals to avail of those medicines which they may wish to use. However, at the same time, it is generally accepted that, in the interest of consumer health and protection, some form of regulation of alternative medicines is desirable and, indeed, this is supported in principle by the health food and alternative medicines industry. In this respect, 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 has yet to bring forward any definitive proposals in this regard.
