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Dáil Éireann debate -
Tuesday, 26 May 1998

Vol. 491 No. 3

Written Answers. - Medicinal Products.

Noel Ahern

Question:

306 Mr. N. Ahern asked the Minister for Health and Children if he will clarify the situation in relation to the prescribing of Ventolin which is used by asthma sufferers; the reason a doctor's prescription is necessary; if this is a national regulation in view of the fact that it does not seem to apply in several EU countries; if this rule can be abolished or relaxed for those suffering asthma on a long-term basis who must pay their doctor approximately £20 every six months for a repeat prescription; his views on the breakdown cost of the product, normally sold retail at £5.60, which can be bought for £2.20 in another EU state without prescription. [12175/98]

Ventolin is the brand name for a range of medicinal products containing Salbutamol, all of which are intended for the treatment of the various forms of asthma, where the relief of bronchospasm is indicated. Salbutamol, which is the active ingredient in all of these products, is a bronchodilator which must be used under medical supervision. This supervision is particularly important for these products because of their propensity for use over prolonged periods and at higher dosage levels. The classification assigned to this range of bronchodilator products in this country facilitates this essential supervision, which is in the interest of protecting public health.

The legal classification of medicinal products on the market is the subject of ongoing review in consultation with the Irish Medicines Board. In addition to their safety profile, consideration is also given to the legal classifications assigned to the various medicinal products in the other member states of the European Union. While the position, where legal classification is concerned, has not yet been harmonised, the position in this country is not significantly different from that pertaining in other member states where the law is concerned.

The position in Ireland in relation to products containing Salbutamol is that the prescription may be repeated by the pharmacist for up to six months after its date of issue. In some member states, there is no such facility for a repeat supply. Ireland's position on the control of medicinal products containing Salbutamol is wholly consistent with Resolution AP (95) 1 of the Council of Europe, which recommends a prescription only classification with a facility that the supply may be repeated for up to six months. Under this Resolution, the classifications shown are to be considered as minimum requirements. Countries, therefore, may apply stricter rules in any given case.

The system governing the pricing of medicines differs from country to country. As for any other commodity, the price of prescription medicines is influenced by a range of variables, including historical factors, social factors and the relative demand for the products in question. The system of pricing of medicines in this country has been determined by means of successive agreements between the Department of Health and Children, the Irish Pharmaceutical Healthcare Association and the Irish Pharmaceutical Manufacturers Association. The current agreement which covers the period 1 August 1997 to 31 July 2002 includes the following elements: provides that the price to the wholesaler of any new item of prescription medicine introduced to the market and covered by the agreement shall not, on the date of notification, exceed the currency adjusted United Kingdom wholesale price or the average of a basket of EU countries, whichever is the lower; and provides for a price freeze for existing drugs and medicines for the duration of the agreement. The arrangements in place under this agreement have resulted in a stabilisation of prices in Ireland as compared with the rest of Europe.
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