Alex White (Dublin South, Labour) | Oireachtas source

I thank the Chairman and committee members for raising this matter. I appreciate the concerns expressed and have met Epilepsy Ireland to discuss the matter. I have carefully considered everything that has been, including the matters raised at the committee last week. I met the relevant body sometime back and had a good discussion with it.

With the permission of the Chairman, I will spell out the provisions of section 5. The Irish Medicines Board will, if the legislation is passed, have statutory responsibility for establishing and publishing a list of interchangeable medicinal products. The Minister or the Department will not perform this task. It will be an expert decision taken by the Irish Medicines Board. Nothing we are doing today or in the course of passage of the legislation will cause a particular drug to be included or substituted for another. That will not be done by Parliament or the Minister. It will only be done by the Irish Medicines Board under a very strict and robust regime that it will have to follow, as set out in section 5(5), which provides that the board shall not add a medicinal product to a group of interchangeable products unless it is satisfied that the medicinal product has the following characteristics:

(a) has the same qualitative and quantitative composition in each of its active substances as each of the active substances of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products,
(b) is in the same pharmaceutical form as, or in a pharmaceutical form that is appropriate for substitution for, each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products, and
(c) has the same route of administration as each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products.

I accept that this is an issue of confidence and trust. We should have trust in public institutions. We need to be able to trust institutions such as the Irish Medicines Board. The Oireachtas has that trust and if it is a question of communicating that trust and confidence; we have a responsibility to do so and ensure people are confident. The Irish Medicines Board briefed the committee and the point is well encapsulated by the quotation provided by Deputy Mary Mitchell O'Connor. The board points out - it is true - that medicines will only be substituted where it is safe to do so. That is not a generalised statement on safety, whereby the Oireachtas will state to the board that it only should do so if it is safe. We are spelling out what we mean by safe. The medicine must be interchangeable in the context I have set out.

Section 5(7) provides that the Irish Medicines Board shall not add a medicinal product to a group of interchangeable products if satisfied that there is a difference in bioavailability, in other words, the amount of the active substance. This refers to the element of the drug that has an effect and does the job the drug is supposed to do. If there is a difference in bioavailability between the product and the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products, the board cannot approve it if it "may lead to a clinically significant difference in efficacy between them". That is a strong requirement and test. The board cannot substitute or add a medicinal product where it contains more than two active substances, or where the device for the administration of the product carries significantly different instructions for use than the devices for the administration of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products, where the medicinal product is a biological rather than a chemical entity, or where it cannot be safely substituted for each of the interchangeable products which currently fall within the group of interchangeable products. Only where the board is satisfied that the medicinal product satisfies the conditions set out in section 5(5) and (7) can it add it to the group of interchangeable products.

The point raised by Deputy Mary Mitchell O'Connor and others concerns section 13. In addition to the protection provided in section 5(5) and (7), section 13 includes the provision that where a branded interchangeable medicinal product is prescribed for a patient and the prescriber is satisfied that the medicinal product should, for clinical reasons, be exempt from substitution, the prescriber shall write “do not substitute” on the prescription.

In these cases, the pharmacist must dispense what is written under prescription, that is, he or she is not permitted to substitute with any product in the same group of interchangeable products. I emphasise that the Bill does not provide that medicinal products will be included or otherwise in a group of interchangeable medicinal products. It is not appropriate that there should be a statutory exemption and I will come back to that in due course. It follows that the non-inclusion of an exemption does not mean a product will automatically be included in a group of interchangeable products. We are not making a decision under the legislation to include products in a list or to make products interchangeable; we are simply providing a statutory framework for the IMB to do the work it is required to do and to follow the test set out for it in the Bill. The committee will not make a decision that this or that product will be interchangeable for this or that other product. We do not have the expertise to do that anyway. As Minister of State, I do not and most, if not all, committee members would not purport to be in a position to do that. The IMB is available to us to do that and there is a justifiably high level of trust in the board to do that.

The purpose of the Bill is to provide that the IMB has statutory responsibility to decide what medicinal products will be included in a group of interchangeable medicinal products. In doing so, the board is required to have regard to a comprehensive set of qualifying conditions, all of which must be complied with before a decision is taken to make a medicinal product interchangeable. I also 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 products, the IMB is obliged to have regard to the criteria set out in section 5. These criteria fully reflect the recommendations set out in the joint Department of Health-HSE report entitled, Proposed Model of Reference Pricing and Generic Substitution, the so-called Moran report of 2010, regarding criteria for interchangeability, to which Deputy Naughten referred.

This is why I respectfully disagree with the suggestion that there should be a blanket statutory exclusion of any drug or class of drugs. It would be inappropriate in this context to include a provision that would have the effect of statutorily excluding a particular class of medicinal products from being added to a group of interchangeable medicinal products while the IMB would have responsibility for determining whether all other medicinal products marketed in the State should be added to a list of interchangeable products. It is not an appropriate way to legislate when one consider what we are doing. We are introducing for the first time a statutory basis for generic substitution, which everybody has called for for years. I do not make a partisan point about this but it is finally happening now and everybody is in favour of it. It is right that we should support the introduction of this regime but we are only setting down the statutory basis for this. We are putting rigorous controls and a rigorous test in place and we will rely on the expert decision-making of the IMB.

I do not wish to pre-empt or seek to anticipate what decision the board will make on AEDs. I do not know what the decision will be but we should not fetter the professional, expert discretion of the board's members in this regard. I have met representatives of Epilepsy Ireland and I had a good discussion with them during which I explained my position on this. Generic medicines must meet the same standards of quality and safety and have the same effect as the originator medicine. All the generic medicines on the Irish market are required to be properly licensed and to meet the requirements of the IMB and, therefore, that is the basis on which I strongly urge colleagues to support the approach we are taking.