Alex White (Dublin South, Labour) | Oireachtas source

In the course of the debate, Members have raised serious related issues with regard to anti-epileptic drugs, AEDs, and the general issues common to this group of amendments. Deputy Caoimhghín Ó Caoláin reminds me that we are dealing with amendment No. 4. On the last occasion, I was making the point that when issues are raised opposite, they are taken seriously, listened to and considered. That they are not accepted does not mean the respect Deputies are entitled to from the Government in this House is not accorded to them; it is. These issues have been carefully considered. I met the Irish Epilepsy Association and I have taken the steps anyone would expect a Minister of State to take in order to understand and assess the case made.

I have said that I am not disposed to hollowing out one area of medicine from the application of the Bill. I urge the House to trust the regulatory body charged with making these decisions, the Irish Medicines Board. No one should assume all the information, insight and studies the Deputies have assiduously raised are not available to the Irish Medicines Board. I assume the Irish Medicines Board will approach this and deal with it in the expert way it always does in respect of matters with which it is charged. I have no doubt that will be so if the question of AEDs and substitution were to arise in the context of the work of the Irish Medicines Board. At the risk of irritating my colleagues opposite, the point must be made that we are not substituting any drugs in this legislation. If the House agrees to it, we are setting up a statutory regime within which substitution can occur were the Irish Medicines Board deems it appropriate in any instance. Having come all this way with generic pricing and substitution legislation we are now close to passing, it would not be a good idea to put in place a regime and then include in the Bill an exception for one area of drugs. Deputies made the point that they supported, accepted and agreed to the general thrust of the Bill and agreed with the generalities of the provisions of the Bill.

That is not to say the issues raised by the Irish Epilepsy Association are not reasonable. Their concerns, as a patient advocacy group, should be taken seriously and I believe they will be. None of the issues that group, or the Deputies here, have raised are issues to which the Irish Medicines Board is oblivious. I refer particularly to the expert scientific material Deputies say is compelling and important. I am sure it is also available to the Irish Medicines Board if and when it comes to address the issue of AEDs.

The Irish Medicines Board has a list of medicines that it will, in all likelihood, be starting with as priorities. There are 20 priority drugs the Irish Medicines Board intends to address if the legislation is passed. I could read out the list but one would need five minutes to rehearse the pronunciation of many of the medicines so I will not do so. The list of 20 priority medicines does not include AEDs and that is where the Irish Medicines Board proposes to get involved if the House sees fit to pass the legislation.

Deputy Catherine Murphy raise an issue in respect of Canada in the course of the debate on the previous occasion. Deputy Catherine Murphy referred to in article published in 2009 in the Neurology academic journal and another published in The Lancet in 2010. The articles do not contain any reference to the repeal of legislation in Canada. When people say AEDs are not substituted in certain countries, they may be correct.

Deputies might be correct that the equivalent of the Irish Medicines Board in another country might have determined that AEDs should not be substituted. It is entirely proper that this should be so and it might well be the case that it will happen here too. All I am saying is that it is not appropriate or necessary to hollow out an entire group of drugs from the remit of the statutory regime we are putting in place.

Deputy Ríosín Shortall asked about guarantees. The guarantees are the safeguards we are putting into the legislation and the criteria that must be applied by the Irish Medicines Board. The safeguards we are putting in place mean the board must operate within the context of what is provided for in the legislation.

The article in The Lancetin 2010 referred to a Canadian study of generic drugs. The article stated doctors, patients and advocacy groups in England and elsewhere were concerned that generic anti-epileptic drugs might not be therapeutically equivalent to branded drugs, which could put patients at risk of breakthrough seizures or adverse events. Deputy Murphy stated the Canadian study which appeared in a neurology academic journal had concluded that multiple generic substitution was significantly associated with negative outcomes such as hospitalisation, injuries and increased health care costs. It is worth noting that the study also concluded that similar increases in risk and cost were not found for patients receiving a single generic version of the drug in question.

Legislation in a number of jurisdictions, including Canada, was reviewed as part of the work of the joint Department of Health and Health Service Executive working group on reference pricing and generic substitution. In addition, the Irish Medicines Board has reviewed the policy on interchangeability of antiepileptic drugs of a number of countries, including Denmark, Sweden, the United Kingdom and the Netherlands. A recent search of the Canadian legal database, www.canlii.org, has not thrown up any reference to a Canadian province repealing its substitution legislation. The article in the The Lancetwas written at a time when the United Kingdom was considering introducing generic substitution. This did not proceed because the United Kingdom already had a very high level of generic substitution at 83%. The article in question went on to state:

Seizures are unpredictable and can occur at random, and it is difficult to establish a cause and effect relation between switching drugs and breakthrough seizures ... Prescription of generic drugs per se is not unacceptable - indeed, many patients are treated successfully with generic drugs; however, maintaining consistency of formulation is crucial. [That appears to be common to all of these studies] We should err on the side of caution and ensure that AEDs are excluded from any sweeping policies that promote automatic generic substitution.

The Irish Medicines Board advises us that in the United Kingdom there is no official list of medicines considered unsuitable for generic prescribing, but the National Prescribing Centre makes the following comments on antiepileptic medication:

Loss of seizure control has been reported in patients after switching brands of epileptic medicines. Continuity of the same brand or the same generic preparation is recommended.

The Bill does not promote automatic generic substitution. Section 5 sets out the statutory procedures to which the Irish Medicines Board must adhere in maintaining the list of interchangeable medicinal products under the legislation. The Bill does not provide that a group of medicinal products will be included or otherwise in the list of interchangeable medicinal products. The fact that there is no exemption from substitution for a specific class of medicinal products does not mean this class of medicines will automatically be included in a group of interchangeable products. The Bill provides that the Irish Medicines Board has a statutory responsibility to decide which 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 group of medicinal products interchangeable. In this regard, section 5(8) provides that the board shall not add a group of medicinal products to the list of interchangeable products if it is satisfied that any of the products cannot be safely substituted for any one or more of the other medicinal products.

I am satisfied that the provisions of the Bill address the concerns raised regarding the substitution of antiepileptic drugs. I have met the Irish Epilepsy Association. It is an important advocacy group and I understand it is intended, although I am not sure if a date has been set, that the Irish Medicines Board will meet it. That will be a useful context for an exchange of views and the issues the association has raised to be communicated to the board.

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