Dáil Éireann Debate, Tuesday - 5 November 2013
1247. Deputy Patrick Nulty asked the Minister for Health the steps he will take to ensure persons who cannot take generic drugs for epilepsy continue to receive the medication they are currently entitled to under all schemes in which the State has a role; and if he will make a statement on the matter. [47086/13]
Amharc ar fhreagraThe 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.
The first List of Interchangeable Medicines, containing groups of atorvastatin products, was published by the IMB on the 7th August. The second and third lists containing groups of esomeprazole and rosuvastatin products were published on the 20th and 24th September, respectively. The fourth and fifth lists containing groups of omeprazole and pravastatin products have also been published (on the 11th and 22nd October, respectively). 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.
