I propose to take Questions Nos. 223 and 234 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 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 Deputies.
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.