Written answers

Tuesday, 9 July 2013

Department of Health

Generic Drugs Substitution

Photo of Regina DohertyRegina Doherty (Meath East, Fine Gael)
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490. To ask the Minister for Health the number of patients with epilepsy who have been switched to generic epilepsy medication; if he will provide the information by county in tabular form; and if he will make a statement on the matter. [32959/13]

Photo of Alex WhiteAlex White (Dublin South, Labour)
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The Health (Pricing and Supply of Medical Goods) Act 2013, which came into operation on the 24th of June, will introduce a system of generic substitution and reference pricing. Under the Act, the Irish Medicines Board (IMB) is responsible for the assessment for interchangeability of medicines. The IMB will review an initial 20 active substances, which equates to approximately 1,500 individual medicines. They include statins, proton pump inhibitors, angiotensin-converting-enzyme (ACE) inhibitors and angiotensin II receptor blockers.

It is expected that the first List of Interchangeable Medicines, containing groups of atorvastatin products, will be published in mid-August. The IMB will publish subsequent lists for other groups of medicines on an ongoing basis. It is worth noting that there are no Anti-Epilepsy Drugs (AEDs) in the initial 20 active substances to be assessed for interchangeability by the IMB. Under the legislation, generic substitution is not permitted until the products have been assessed for interchangeability in accordance with the criteria set out in the legislation and the IMB has decided to add the products to the List of Interchangeable Medicines. At present, therefore, pharmacists are not permitted to substitute AEDs and must dispense the products as prescribed.

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