Dominic Hannigan (Meath East, Labour)
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589. To ask the Minister for Health if his Department has reviewed the position of the Canadian Government when it introduced generic drug legislation but had to repeal a section of it due to the problems it encountered with epilepsy replacement generic drugs; and if he will make a statement on the matter. [20438/13]

Alex White (Dublin South, Labour)
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Legislation from a number of jurisdictions, including Canada, was reviewed as part of the work of the Joint Department of Health/HSE working group on reference pricing and generic substitution. In addition, the Irish Medicines Board has reviewed the policy on interchangeability of anti-epileptic drugs of a number of countries, including, Denmark, Sweden, the UK, and the Netherlands. I am not aware of any issues in relation to legislation introducing generic substitution in Canada.

As the Deputy will be aware, the Health (Pricing and Supply of Medical Goods) Bill, passed Committee Stage on 19 March and is currently at Report Stage. Under the 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:

- there is a difference in bioavailability between the medicinal products and the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products which may lead to a clinically significant difference in efficacy between them, and

- any of the medicinal products cannot be safely substituted for any one or more of the other medicinal products in the group.

I would like to emphasise that in making a decision to add a medicinal product to a group of interchangeable medicinal products or a group of medicinal products to the List of Interchangeable Medicinal Products the Board is obliged to have regard to the criteria as set out in the Bill and that these criteria fully reflect the recommendations set out in the Joint Department of Health/HSE report 'Proposed Model of Reference Pricing and Generic Substitution' (the Moran Report, 2010) regarding criteria for interchangeability. 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 the provisions of the Bill address the concerns raised in relation to the substitution of anti-epileptic drugs. I met with the Irish Epilepsy Association in January and explained this position. It is also 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.