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 deciding whether to add a group of medicinal products to the List of Interchangeable Medicinal Products, the Board must be satisfied that each medicinal product which falls within the group:
(a) has the same qualitative and quantitative composition in each of its active substances as each of the other medicinal products which fall within the group;
(b) is in the same pharmaceutical form as, or in a pharmaceutical form that is appropriate for substitution for, each of the other products in the group; and
(c) has the same route of administration as each of the other medicinal products which fall within the group.
In addition, the Bill provides that the Board is not permitted to add a group of medicinal products to the List of Interchangeable Medicinal Products where, for example, any of the medicinal products cannot be safely substituted for any one or more of the other medicinal products in the group. To further enhance the patient safety aspect of generic substitution, Section 13 of the Bill allows a prescriber to indicate on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted. I am satisfied that these provisions address the concerns raised by the Deputy.
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. 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 met with the Irish Epilepsy Association, amongst others, on the 20th of November as part of its stakeholder meetings.
