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

Amendments 1 to 3, inclusive, are related and may be discussed together.

I move amendment No. 1:

In page 10, between lines 34 and 35, to insert the following:

“ “non-interchangeable medicinal product” means a medicinal product which is not interchangeable with any other medicinal product for prescription purposes in the opinion of the Irish Medicines Board in accordance with the provisions of section 5 of this Act;”.

Most of us would support a reduction in the cost of drugs. The move towards the use of generic drugs is a very good idea and it has been a long time coming.

My amendment has in mind conditions such as epilepsy where the move towards the use of generic drugs is a false economy. People with epilepsy may require lengthy treatment before their condition is stabilised. I know quite a number of people with epilepsy. It is not a benign condition. I know of a woman with epilepsy who nearly died recently. She is attempting to stabilise her condition. She has two children aged nine and 11 years. There could be repercussions for her if her condition is not stabilised. I recently met a man with epilepsy who lost his job as a result of losing his driving licence. He is now trying to meet his mortgage repayments. Trying to get his condition stabilised was a big deal. I also know of an 18 year old who developed epilepsy in her leaving certificate year which had an impact on the exam and on her life opportunities. It meant the loss of her independence. Finding the right concoction of drugs is critical to stabilising the condition and preventing breakthrough seizures; it is not something that should be played with. The use of generic drugs can be a false economy in this regard. In Northern Ireland, certain drugs are not permitted to be substituted. There can be very small differences between drugs and the dosages may need to be ramped up to achieve the desired level that will work for the patient. In some cases, patients may not be prescribed their drugs by a consultant. It cannot be presumed that pharmacists will second guess what is contained in each component. Small amounts or variations can make a difference.

A person's epilepsy may be stable for two years but a breakthrough seizure may result in the loss of a driving licence for a year which will have an impact on employment. Physical injuries such as a fractured skull or broken teeth can result from seizures. The Moran report specifically recommended that treatment for epilepsy be excluded from generic substitution. This is the case in the United Kingdom and in other EU countries. I have concerns about the ability of the Irish Medicines Board to properly evaluate or monitor what is being substituted. Breakthrough seizures can have all sorts of impacts on people's lives. General practitioners write the prescriptions in many cases. Without specialist oversight we may well cause problems for ourselves without any savings to the State in the longer term.

I appeal to the Minister of State in this regard. Generic substitution is long overdue but it may be counter-productive in some areas and the treatment of epilepsy is one such area. It makes sense for the Government to step back. I make this appeal on behalf of 40,000 people. I refer to an Australian survey which found that quite a number of people believed they had experienced some form of discrimination in the workplace because they had epilepsy. Success in the good maintenance of epilepsy has been the good news story of the past decade. Let us not put that at risk. It is very difficult to achieve the correct maintenance treatment but this is what gives people back their independence. This should not be put at risk. The Bill has some good provisions and I do not wish to vote against it but this provision must be changed.

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.

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.

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.

For the IMB to say it does not intend to do that is inadequate in the circumstances. There have already been unsafe prescribing patterns within hospitals. It is quite possible it could be repeated in GP surgeries. GPs operate as independent practitioners and the Department or the HSE does not have much of a handle on detailed prescribing patterns by GPs. It is reasonable to seek the safeguards requested and provided for in these amendments. I note the comments of the Minister of State on Committee Stage but it is necessary to go further. I ask him to reconsider his position in respect of the amendments. It is not currently safe to substitute generic drugs for AEDs for people with epilepsy. That is the bottom line and it is a legitimate fear people have. Unless the practice is specifically exempted in the legislation, it is quite possible it could happen in certain circumstances. I urge the Minister of State to rethink this.

He could go much further and give an assurance to people with epilepsy by stating clearly that no person suffering from epilepsy will be subject to generic substitution of the medications where it is unsafe to do so. That is the least the Minister of State should do. It will also be helpful, from the point of view of giving public reassurance, if the Minister of State outlined the implications for the IMB should it sanction any unsafe practice. That would be an important contribution to the debate. The only real safeguard that can be put in place is adopting the approach proposed in the amendments. I urge the Minister of State to consider them.

I support the amendments tabled. We debated this in detail on Committee Stage. The Minister of State knows we have received much representation across our constituencies and across the country. This comes from people with epilepsy or their families and concerns generic substitution. For 95.5% of the population, generic substitution is not an issue. It concerns only a small cohort of people, as has been articulated earlier. This is the only group that has articulated specific concerns regarding generic substitution. There is a genuine fear among people with epilepsy regarding substitution of AEDs. On Committee Stage I pointed out that a substantial amount of money is spent on AEDs on an annual basis. It amounts to some €75 million, of which €40 million is prescribed almost exclusively to treat neuropathic pain. Those with epilepsy and their advocates have no disagreement with generic substitution being used for that purpose. The issue concerns medicine specifically prescribed to prevent seizures. The Minister of State is putting the onus on the individual suffering from epilepsy.

The vast majority of people with epilepsy can function fully in society. An example is the late Joe Doyle, who was a Member of this House and the Upper House. However, a certain cohort have other illnesses or disabilities. They may have learning difficulties and may be reliant on elderly parents to collect their prescriptions and ensure they take it. We are now relying on GPs to make sure they put the "do not substitute" instruction on the prescription. In 99.9% of cases that will happen but anyone who works in the medical profession knows that GPs sometimes make errors, usually on repeat prescriptions. Who is responsible if a GP does not specifically include the "do not substitute" instruction on a repeat prescription and the person with epilepsy does not realise that the medicine has been substituted and it leads to an adverse reaction?

We should not introduce legislation that will cause unnecessary concern. The view of the Minister of State is that we will not see generic substitution of AEDs for people being treated for epilepsy. I do not think the IMB will introduce such a measure. In practical terms, GPs will include the "do not substitute" instruction in case there is a possibility that it will be substituted. We seek a safety net to ensure that anyone with epilepsy can go in with confidence, have the prescription refilled and ensure they receive the exact same medicine.

In correspondence with the committee, the IMB made the point that interchangeable medicines are those that have the same quality of and quantitative composition in terms of active substances. The difficulty with AEDs is that, even when these criteria have been met, there can still be a problem for someone with epilepsy. I was at the Science Gallery in Trinity College in the past couple of weeks, since our discussion on Committee Stage. I heard a presentation on thalidomide and it referred to the wrong stereoisomers included in the medicine. If its mirror image had been used, there would not have been the huge adverse reaction to it. In that case, quantitatively and qualitatively, it was the exact same medicine at the time. Thankfully, medicine has progressed significantly since that and we would hope not to see a replication of it. However, we want to ensure that all the checks and balances are in place and we look to dispel the fear in the community of people with epilepsy and their advocates.

I ask the Minister of State to examine the amendment. In practical terms, I do not think it will happen anyway. Why not put a belt and braces approach to ensure the legislation is watertight so that people with epilepsy have the confidence to pick up a prescription and ensure the prescription is filled at the pharmacy with the exact same medicine as heretofore? People can then take the medicine and be sure they will not have an adverse reaction.

As Deputy Caoimhghín Ó Caoláin identified, the amendments in the next group deal more specifically with AEDs but we have started the debate in this group. The specifics of AEDs is more germane to the next group but I will deal with the issues raised in this group of amendments and again when dealing with the next group. We are dealing with amendments Nos. 1 to 3 and they seek to introduce a new definition of a non-interchangeable medicinal product in the Bill. A non-interchangeable medicinal product is defined in the amendments as a medicinal product that is not interchangeable with any other medicinal product as provided for under section 5 of the Bill. The framework of the Bill provides that the IMB establishes and maintains a positive list of interchangeable medicinal products under the provisions of sections 4 and 5 of the Bill.

This approach is consistent with the recommendations set out in the Department of Health-HSE report entitled, Proposed Model of Reference Pricing and Generic Substitution, or the so-called Moran report of 2010.

While some countries maintain a negative list of interchangeable medicinal products, I do not consider it appropriate to maintain both a positive and a negative list in this Bill, which is what is proposed here. A positive list means that only products on this list may be substituted. Some countries have negative lists, that is, the substitution of all medicinal products permitted with the exception of specified medicinal products. A positive list of interchangeable medicinal products is considered more desirable from a patient safety perspective and in those circumstances, I do not propose to accept these amendments.

I thank Deputies Murphy and Shortall for their overall support for what this Bill seeks to achieve and I very carefully note it. I agree with what Deputy Murphy and others have said about the concerns people with epilepsy have in regard to their medicines. As politicians, we have all received representations and I have met members of the Irish Epilepsy Association. I have a personal knowledge of this area as people close to me have had epilepsy. I have an appreciation of what has been said about the implications for people and their medicines and the necessity for and importance of stability, which Deputy Murphy rightly pointed out.

Deputy Naughten and others asked me to genuinely consider this issue, which I have done. I have thought very carefully about it, as a Minister should, have met representatives of the Irish Epilepsy Association and have discussed it on a number of occasions with officials. I have gone through it very carefully and assiduously.

I emphasise the point, as I did on the last occasion, that we are not substituting medicines in this exercise. What I am asking the House to do is to agree to a statutory regime to be put in place to enable the responsible body to consider whether it should substitute medicines in particular circumstances. It is very important we remember that distinction. I do not have to remind Members of this House of that, and I do not want anybody to be offended that I make the point in those blunt terms. We are not being asked to substitute or otherwise anything in regard to particular medicines; we are being asked to put in place a statutory regime.

The expert body, the Irish Medicines Board in this instance, should have the level of trust not just from this House but publicly to do what it is required to do. It must follow - I refer to Deputy Shortall's question about guarantees - the very rigorous requirements set out in the Bill which it must honour, apply and have regard to if it is to consider the substituting of any medicine. The answer to the question about guarantees is what the House is doing in this legislation - that is, it is putting in place these rigorous requirements on the Irish Medicines Board, to which it must have regard. It is not a question that it may or it might have regard to them; it must have regard to these criteria which are quite clear and rigorous. I am asking the House to agree that they will be set out in legislation.

Deputy Naughten said that will not happen. It may not happen but it is a matter for the Irish Medicines Board - the people who are expert and who must carry out this work in the context of the requirements set out in the Bill - to make that decision. That is what I respectfully ask the House to acknowledge and agree to, that is, that it should be a matter for the Irish Medicines Board to consider this. All we are being asked to do is to put in place a statutory regime. The guarantee of and the requirement for safety are adequately dealt with in what we are asking the House to agree to in the Bill in terms of the various standards and criteria which have to be applied.

I think Deputy Murphy raised the question of the UK. I can advise the House that there is no official list of medicines considered unsuitable for generic prescribing in the UK but the national prescribing centre there makes the following comments regarding anti-epileptic medication. It states that loss of seizure control has been reported in patients after switching brands of epileptic medicines and that continuity of the same brand or the same generic preparation is recommended. Deputy Murphy mentioned that continuity is extremely important.

I mentioned the Moran report about which we should be absolutely clear. That report referred to medicines and types of medicines which, in general, would not be regarded as interchangeable. Appendix D to the report states: "General circumstances where medicines will not be regarded as interchangeable (on the basis of current evidence and manufacturing standards) include the following". It provides an extensive list, which I will not go through but which includes anti-epileptic medicines. The report refers to medicines and the types of medicines which, in general, will not be regarded as interchangeable. The report does not a call for a statutory exclusion of a medicine or group of medicines.

I fully appreciate the points Deputies raised and the concerns they have but the job we are being asked to do is to set out a statutory framework. Let us put in place a statutory framework and rely on the Irish Medicines Board to carry out the task required of it within the context of the rigorous criteria set out in the Bill.

I am really disappointed the Minister of State will not accept these amendments. The object, which we all want, is to get good value for the health service but one must look at the totality of this. I mention the impact on the State if it runs into difficulty. European countries have specifically excluded epilepsy and treated it differently. The Moran report recommended excluding it. We should consider the prospect of somebody losing his or her job and becoming dependent on the State, hospital treatment, risk to life, loss of independence because of not being able to drive and the side effects people experience when they change medicines in that they sometimes require medicines to offset the side effects of the new drug. Certainty is absolutely critical.

There is not even a saving to the State - in fact, it could cost the State. It does not achieve what it sets out to achieve. Most general practitioners would be unaware that they should write on a prescription that a substitution should not be provided, although this debate has probably been helpful from that point of view. The one way to achieve certainty is to exclude epilepsy drugs from this generic initiative. That would give the certainty all of us on this side of the House seek. It makes financial sense in terms of society's response to managing a condition which is possible to manage in most situations.

I too am surprised and disappointed. The Minister of State's response is an indication in itself as to why he should accept these amendments. People with epilepsy need continuity and certainty. There is no better way than to give them continuity and certainty and peace of mind than by accepting one of these amendments. While the Minister of State was replying, I read an e-mail from somebody who genuinely and passionately has huge concerns, which are not baseless. They are based on actual medical and scientific evidence.

Other countries and the Moran report have recommended that there be an exemption in regard to interchangeability.

The report does not recommend that.

Yes, it does. It states quite clearly that AEDs should not be subject to generic substitution or change. If there is to be interchangeability and substitutions, it is quite clear there will be an impact on people's lives and quality of life. They could develop seizures. As was said by many, fear alone creates considerable anxiety. In the context of the overall medical budget, what is proposed in the Bill in the context of AEDs will not save money because it is recommended that a patient should not change medicine once the correct drug is found. There will not be many changes but what I propose would give absolute certainty to people who suffer from epilepsy.

Even at this late stage, I ask the Minister of State to understand why we are pressing these amendments. We are doing so solely to give certainty to many people who have great concerns about this matter. I refer not only to people with epilepsy, but to eminent consultants who deal with it daily. The latter are pleading that what we propose be accepted.

On Second Stage, other Members and I confirmed our welcome of the intent of this legislation. This welcome did not need to be repeated in our contributions at the outset of Report Stage. However, the concerns we expressed on Committee Stage and now again on Report Stage are real and substantive. They are not our concerns in the first instance; they are the concerns of those who will be directly affected by the change. Those fears are real and substantial.

We are not being asked to substitute; that is not the task before us but, as legislators, we have a duty to provide the greatest protections possible. We do so across a range of other areas from time to time. We build into legislation clear direction as regard to the legislators' wish. We do not leave legislation to the widest possible interpretation, nor do we kick the ball to somebody else to make a decision. The courts interpret our work almost daily but legislators always endeavour to give the clearest direction possible. We have concerns about AEDs. I am certainly concerned that we are not reflecting the real fears that have been expressed to us. As I will argue in respect of amendments Nos. 4 and 18, these fears are absolutely justified based on the experience of epilepsy sufferers whose medication has been already substituted by pharmacists mindful of the change but unaware that it had not already come into play.

The Minister of State's response is disappointing. These concerns are not vexatious or frivolous in any way. As other Members have stated, there is not a queue of people objecting to generic substitution. The group to whom we refer is the only group objecting. It is doing so on very good grounds.

Does the Minister of State accept that it is not currently safe to substitute generic drugs for AEDs? If so, does the Department not have an onus to put in place the kinds of safeguards that are required? In the absence of those safeguards, one is depending on the individual patient's full awareness of his or her condition and the dangers associated with generic substitution. The patient would have to be very alert to the dangers associated with prescribed medications. One is also depending on all general practitioners being fully aware of the circumstances. That is not necessarily the case. We should also bear in mind locums, hospital prescribers and pharmacists. Everybody along the chain needs to be fully aware of the inherent or very real dangers of generic substitution of AEDs for people with epilepsy. That is a big ask. I do not have confidence that there is sufficient awareness throughout the prescribing chain.

Why is the Minister of State not prepared to include in the legislation the requested safeguards? He has not provided an explanation for that. While in the majority of cases generic medicines are absolutely safe, they are not in the case of AEDs. While medications may be perfectly safe for people with certain conditions, it does not follow that they are safe for people with every condition for which they are prescribed. Does the Minister of State accept the basic point that it is not currently safe to substitute generic medicines for AEDs? If he accepts this, why is he not prepared to provide the safeguards?

I will return to the point I made earlier. A young lady from Roscommon who contacted me in the past 24 hours is very fearful that her medicine may be substituted. Based on the criteria of the Irish Medicines Board – the Minister is correct that there are many checks and balances – and the recommendations in the Moran report, which states AEDs and a number of other medicines should not be substituted based on current medical evidence, there will not be any deliberate intention to introduce generic substitution for AEDs. If that is the case – I genuinely believe it is – why are we exposing individuals who require AEDs to the risks associated with the prescribing change?

The debate on the Moran report concerns whether there should be a statutory footing. The argument has been made by Epilepsy Ireland that placement on a statutory footing would ensure there will be no risks along the prescribing chain. Not only would there be the checks and balances, there also would be provision for the general practitioner to stipulate that there should be no substitution in regard to the prescription. The pharmacist, under section 50, has discretion not to dispense. Surely, therefore, rather than allowing a mistake to happen somewhere along the prescribing chain, would it not be far more advantageous to make a statutory provision specifically in regard to AEDs prescribed for the purpose of treating epilepsy? This would provide the clarity that is required and get rid of the unnecessary fear that is currently hanging over people who rely on AEDs to manage their epilepsy daily. The Government should deal with this issue once and for all. It should provide certainty and confidence in the legislation so we can all endorse its passage.

The fear that Deputy Naughten talked about is the fear of something that may happen in the future. The fact is that we are giving direction. Deputy Ó Caoláin should note that we will be giving direction in the legislation, if it is passed, because we are setting out the criteria that the Irish Medicines Board will be required to follow.

We are giving a direction in that regard.

On the question of safety, interchangeability and the experience overseas, there are six main classes of anti-epileptic drugs, AEDs, and a number of medicines in each of these classes. The Irish Medicines Board has reviewed the policy on interchangeability of AEDs in a number of countries, including Denmark, Sweden, the United Kingdom and the Netherlands. Some AEDs are listed as interchangeable in some of these countries but not in others. The board points out that where a medicine is not listed on a country's website, it has no further information on it. However, there may be a number of reasons for a medicine not being listed, including that it is not authorised in the country or that the list only contains medicines which are subject to reimbursement. In addition, there may be practise guidelines in operation in the country of which the board is unaware. For example, in the case of the Netherlands the board advises that there is automatic substitution for an AED.

The Moran report was mentioned a number of times. It is important to point out again that the report does not contain a recommendation that there be a statutory exception made for AEDs. That is not so. The Irish Medicine Board's commentary in the report which I have read and will read again if I have the time, although I probably will not, is on the propriety or otherwise of medicines being interchanged, which is the type of issue with which the board will have to deal when it arises. The report states:

...General circumstances where medicines will not be regarded as interchangeable (on the basis of current evidence and manufacturing standards) include the following:

1. Where there is a difference in bioavailability between brands of the same medicines, particularly if the medicine has a narrow therapeutic index. Changing preparations may result in sub-therapeutic or toxic doses. [Products in this group include anti-epileptic and other drugs.]

2. Where modified release preparations are not interchangeable...

In its commentary the Irish Medicines Board lists the types of drugs which in its view will not generally be regarded as interchangeable. I have no doubt that the board will have regard to the literature, experience and expertise available in this area, as well as to the criteria set out in the Bill, which also draws from expert opinion.

Where a person develops epilepsy and is treated with a generic drug which works for him or her, what is proposed is fine. What is at issue is the interchangeability of drugs. Many people with epilepsy have not seen a consultant and are managed by a general practitioner who may not have the range of knowledge of a specialist in the field. I take issue not with the Irish Medicines Board approving particular types of drugs for use but with the interchangeability of drugs. We are giving far too much responsibility to pharmacists and general practitioners in terms of the requirement to write particular words on prescriptions. This is risky. What if the Minister of State is wrong? What if we are giving them too much responsibility? What we are seeking is certainty in this regard.

Amendment put:
The Dáil divided: Tá, 46; Níl, 77.

  • Broughan, Thomas P.
  • Calleary, Dara.
  • Collins, Joan.
  • Collins, Niall.
  • Colreavy, Michael.
  • Crowe, Seán.
  • Daly, Clare.
  • Doherty, Pearse.
  • Donnelly, Stephen S.
  • Ellis, Dessie.
  • Ferris, Martin.
  • Flanagan, Luke 'Ming'.
  • Fleming, Sean.
  • Fleming, Tom.
  • Grealish, Noel.
  • Halligan, John.
  • Healy, Seamus.
  • Healy-Rae, Michael.
  • Kelleher, Billy.
  • Kitt, Michael P.
  • McConalogue, Charlie.
  • McDonald, Mary Lou.
  • McGrath, Finian.
  • McGrath, Mattie.
  • McGrath, Michael.
  • McLellan, Sandra.
  • Martin, Micheál.
  • Moynihan, Michael.
  • Murphy, Catherine.
  • Naughten, Denis.
  • Nulty, Patrick.
  • Ó Caoláin, Caoimhghín.
  • Ó Cuív, Éamon.
  • Ó Fearghaíl, Seán.
  • Ó Snodaigh, Aengus.
  • O'Brien, Jonathan.
  • O'Dea, Willie.
  • O'Sullivan, Maureen.
  • Pringle, Thomas.
  • Ross, Shane.
  • Shortall, Róisín.
  • Smith, Brendan.
  • Stanley, Brian.
  • Tóibín, Peadar.
  • Troy, Robert.
  • Wallace, Mick.

Níl

  • Bannon, James.
  • Breen, Pat.
  • Burton, Joan.
  • Butler, Ray.
  • Buttimer, Jerry.
  • Byrne, Catherine.
  • Byrne, Eric.
  • Carey, Joe.
  • Coffey, Paudie.
  • Collins, Áine.
  • Conaghan, Michael.
  • Conlan, Seán.
  • Connaughton, Paul J.
  • Conway, Ciara.
  • Coonan, Noel.
  • Creed, Michael.
  • Daly, Jim.
  • Deasy, John.
  • Deering, Pat.
  • Doherty, Regina.
  • Donohoe, Paschal.
  • Dowds, Robert.
  • Durkan, Bernard J.
  • Farrell, Alan.
  • Feighan, Frank.
  • Ferris, Anne.
  • Fitzpatrick, Peter.
  • Flanagan, Charles.
  • Gilmore, Eamon.
  • Griffin, Brendan.
  • Harrington, Noel.
  • Harris, Simon.
  • Hayes, Brian.
  • Hayes, Tom.
  • Heydon, Martin.
  • Hogan, Phil.
  • Humphreys, Heather.
  • Humphreys, Kevin.
  • Keating, Derek.
  • Kelly, Alan.
  • Kenny, Seán.
  • Kyne, Seán.
  • Lawlor, Anthony.
  • Lynch, Kathleen.
  • Lyons, John.
  • McEntee, Helen.
  • McGinley, Dinny.
  • McLoughlin, Tony.
  • McNamara, Michael.
  • Maloney, Eamonn.
  • Mathews, Peter.
  • Mitchell, Olivia.
  • Mitchell O'Connor, Mary.
  • Mulherin, Michelle.
  • Nash, Gerald.
  • Neville, Dan.
  • Nolan, Derek.
  • Ó Ríordáin, Aodhán.
  • O'Donnell, Kieran.
  • O'Donovan, Patrick.
  • O'Mahony, John.
  • O'Sullivan, Jan.
  • Penrose, Willie.
  • Perry, John.
  • Phelan, Ann.
  • Phelan, John Paul.
  • Quinn, Ruairí.
  • Ring, Michael.
  • Ryan, Brendan.
  • Shatter, Alan.
  • Spring, Arthur.
  • Stagg, Emmet.
  • Stanton, David.
  • Timmins, Billy.
  • Tuffy, Joanna.
  • Varadkar, Leo.
  • White, Alex.
Tellers: Tá, Deputies Catherine Murphy and Seán Ó Fearghaíl; Níl, Deputies Joe Carey and Emmet Stagg.
Amendment declared lost.

Amendment No. 2 has already been discussed with amendment No. 1.

Can I discuss it further?

Of course, the Deputy can.

I move amendment No. 2:

In page 13, between lines 14 and 15, to insert the following:

"(2) The Board shall, as soon as is practicable after the commencement of this section, establish and publish on its Internet website, and maintain, a list (in this Act referred to as the "List of non-Interchangeable Medicinal Products"), in such form as it thinks fit, of groups of medicinal products in respect of which it is satisfied, in accordance with section 5, as respects each such group, that all the medicinal products which fall within the group are, for prescription purposes, not interchangeable with each other.".

The Deputy will have to wait until we resume after lunch to discuss the amendment further.

Debate adjourned.
Sitting suspended at 1.30 p.m. and resumed at 2.30 p.m.