Dáil Éireann Debate, Wednesday - 7 November 2012
192. Deputy James Bannon asked the Minister for Health if he will amend the provision of the Health (Pricing and Supply of Medical Goods) Bill 2012 to exclude all antiepileptic drugs, AEDs, from generic substitution and remove any threat to patient safety; and if he will make a statement on the matter. [48810/12]
View answer199. Deputy Thomas P. Broughan asked the Minister for Health his views on proposals to exclude antiepileptic drugs from generic substitution as occurs in a range of OECD states; his views on whether generics to treat epilepsy should only be used when prescribed by an epilepsy specialist after the initial diagnosis and there is certainty of continuity of supply; and if he will make a statement on the matter. [48867/12]
View answerI propose to take Questions Nos. 192 and 199 together.
Under the Health (Pricing and Supply of Medical Goods) Bill, the Irish Medicines Board has statutory responsibility for establishing and publishing a list of interchangeable medicinal products in respect of which it is satisfied that all the medicinal products which fall into a group of interchangeable medicinal products are, for prescription purposes, interchangeable with each other. It is important to point out that generic medicines must meet exactly the same standards of quality and safety and have the same effect as the originator medicine. All of the generic medicines on the Irish market are required to be properly licensed and meet the requirements of the Irish Medicines Board. To further enhance the patient safety aspect of generic substitution, section 13 of the Bill gives a prescriber the option of indicating on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted.
The Health (Pricing and Supply of Medical Goods) Bill 2012 was published on the 13th of July 2012. The Bill completed its passage through the Seanad on Wednesday, 19 September, and is currently continuing its passage through the Dáil. An implementation group on generic substitution and reference pricing has been established and it held its inaugural meeting on 9 August 2012. The group is to meet with stakeholders, including the Irish Epilepsy Association, in the near future.
