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Health (Pricing and Supply of Medical Goods) Bill 2012 [Seanad]: Report Stage (Continued)

Wednesday, 24 April 2013

Dáil Éireann Debate
Vol. 800 No. 4

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Deputy Billy Kelleher: Information on Billy Kelleher Zoom on Billy Kelleher I support what Deputy Murphy has said. We have met with various organisations which represent and advocate on behalf of people with epilepsy. We have met individuals who have epilepsy and for whom, as Deputy Murphy pointed out, huge advances have been made to manage the condition, which helps them to reach their full potential in work and life generally. Clearly, the Bill's provisions in this regard represent a retrograde step.

Most Deputies welcome the Bill and recognise the need to move to generic substitution, where possible, to reduce the burden on the taxpayer. It is only in this context that a grouping has come to us to advocate and to ask us to plead with the Government to consider their concerns about interchangeable medicines. Mr. Norman Delanty and other eminent consultants in the area have said this is an issue of major concern. He set out stories on the medical and scientific side and pointed out the impact on people who are experiencing concern and fear. Having stabilised and managed their condition, a possible change of medication means they face going back to a situation in which seizures may occur. They do not know what will happen. In the context of the Bill and the support for its aims in every other respect, this is the one issue of huge concern. I urge the Minister of State, Deputy Alex White, to consider the amendments in that context to ensure that people with epilepsy are not put in a position in which they cannot trust that they will receive the drugs they always got which allowed them to continue to manage their conditions.

Deputy Murphy has spoken for all of us in highlighting the issue. When we met representative organisations and individuals, what was striking was the fear. If the legislation is passed without these amendments, people will not be able to trust that the medication they are prescribed is the medication that has always managed their condition. The Minister of State knows what we are talking about and we urge him to look at the amendments. This is our last chance to make the provision. We have advocated for the amendment on Committee Stage and the issue was highlighted in speeches on Second Stage. The people affected have been very genuine in their lobbying and discussions with Members. Given that eminent consultants have intervened for no other reason than concern for patients, we urge the Minister of State to accept the proposal by way of whichever amendment is deemed most suitable. The thrust of the amendments should be accepted and I cannot see any reason it would not be. There is no concern about generic drug substitution in other areas. People may have views but there is no strong scientific evidence or medical evidence that substitution will cause problems. In the case of anti-epilepsy drugs, there is a body of evidence. The issue has raised its head internationally and exemptions have been made for anti-epilepsy drugs in legislation in other countries. People are not just advocating in Ireland - there is concern internationally that the therapeutic index is too narrow for anti-epileptic drugs. To change from one drug to another may have an impact on a patient's ability to lead a normal life.

I urge the Minister of State to accept the amendments.

Deputy Caoimhghín Ó Caoláin: Information on Caoimhghín Ó Caoláin Zoom on Caoimhghín Ó Caoláin I support the three amendments in the grouping. It is arguable that others could be grouped with them. I note the single distinction between amendments Nos. 1 to 3, inclusive, and amendments Nos. 4 and 18 is that the latter are particular to anti-epilepsy drugs while the former are non-specific about interchangeable and non-interchangeable medicines. While it has been pointed out that the critical focus of our concerns is anti-epilepsy drugs, there may be other areas of concern, about which we do not currently have knowledge, in which there will need to be a listing of non-interchangeable medicines.

There is a sound and practical case for making amendment No. 1 to include in the Bill a definition of "non-interchangeable medicinal products". It is a reasonable proposition for which the Bill, as presented on Report Stage, has not provided. I support the proposition. Deputy Murphy's wording fits my understanding and that of Members across the House of how non-interchangeable medicines should be defined. Amendments Nos. 2 and 3 are proposed in the interests of transparency. The non-interchangeable products should be listed as well as the interchangeable ones, for the latter of which provision is made. It is critical to list non-interchangeable products also as patients have an entitlement to the fullest information possible. There is also a responsibility on the State and its agencies - in this instance the Irish Medicines Board - to provide all possible clarity on the suitability or otherwise of substitution. As emphasised in amendment No. 4, the efficacy and safety of any given alternative should be clear. I hope the Minister of State will accept the rationale behind each of the three amendments being discussed together. I await hearing his reply before offering any further comment.

Deputy Róisín Shortall: Information on Róisín Shortall Zoom on Róisín Shortall I support the Bill fully and commend the officials who have done so much work on it over so many years. It is finally wending its way slowly through the Houses of the Oireachtas. I am very aware of the many obstacles which have been put in its way over a number of years. It would be worthwhile to examine those obstacles more closely. The legislation is a welcome contribution to tackling the unacceptably high drugs bill in the State and should benefit the taxpayer and consumers. While I support the Bill generally, I also support the amendments proposed to safeguard the interests of people who suffer from epilepsy.

Like other Members, I have been contacted by representatives of people who have epilepsy to express their concern about the legislation. While there are certain safeguards in place and it will be open to a general practitioner to write "do not substitute" on a prescription, the Bill is not safe enough as far as people who suffer from epilepsy are concerned. It has been brought to my attention that some groups involved are aware of cases - mainly in the context of hospital prescribing - where unsafe generic substitution is already happening. I recognise the efforts the Irish Medicines Board has made to provide an assurance. Nobody doubts its bona fides and good work and there is no question of the board sanctioning deliberately an unsafe practice. However, the concern is that the legislation as drafted leaves open the possibility of unsafe substitute medicines being prescribed for people who suffer from epilepsy. That has very serious implications.


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