Peter Mathews (Dublin South, Fine Gael)
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To ask the Minister for Health if he will ensure that the recommendation of the Joint Department of Health/Health Service Executive Working Group proposed Model for reference Pricing and Generic Substitution report is followed so that all anti epileptic drugs be excluded from generic substitution; and if he will make a statement on the matter. [47598/12]

Alex White (Dublin South, Labour)
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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, the 19th of 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 the 9th of August 2012. The Group is to meet with stakeholders, including the Irish Epilepsy Association, in the near future.