Written answers

Tuesday, 26 June 2007

Department of Health and Children

Medicinal Products

10:00 pm

Photo of Róisín ShortallRóisín Shortall (Dublin North West, Labour)
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Question 328: To ask the Minister for Health and Children if she will seek a detailed explanation from the Health Service Executive as to the reason a medication (details supplied) was withdrawn from the market here before a replacement was available; the number of days that elapsed before an alternative was available on the Irish market; if her attention has been drawn to the life-threatening implications of such a decision for users who were left with no alternative medication as a result of the decision; the procedures and criteria applying to decisions on the withdrawal of licences; if she will ensure that future decisions on medications are made with due consideration to the alternatives and lack of them for dependent users; and the licensed medication available on the market here for users who require non-steroid forms of tilade. [17539/07]

Photo of Mary HarneyMary Harney (Dublin Mid West, Progressive Democrats)
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There is a common list of reimbursable medicines for the General Medical Services and Drug Payment schemes. This list is reviewed and amended monthly, as new products become available and deletions are notified. For an item to be reimbursed, it must comply with published criteria, including authorisation status as appropriate, price and, in certain cases, the intended use of the product. In addition, the product should ordinarily be supplied to the public only by medical prescription and should not be advertised or promoted to the public. Products are considered for reimbursement on application by a supplier.

Under Clause 9.1 of the agreement recently negotiated between the Irish Pharmaceutical Healthcare Association and the Health Service Executive on the supply terms, conditions and prices of medicines supplied to the health services, manufacturers, importers or their agents, who experience foreseeable or prolonged stock shortages, or the possibility of such shortages, must notify the HSE as soon as they become aware of the problem. Furthermore, the supplier shall endeavour to source, within the notice period, an alternative supply.

In this particular instance the manufacturer concerned notified the Health Service Executive in a notice dated 15 February 2007 that supplies of Tilade were in short supply. It was the company's intention to replace the Tilade with a CFC free version of the product. However, due to unforeseen administrative difficulties the CFC free version of this product will not, according to the company, become widely available until July. I understand that the manufacturer concerned has undertaken to source an alternative supply of this product and make it available for patients who require it. Cromogen was removed from the common list of reimbursable drugs and medicines at the request of the manufacturer.

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