Dáil debates

Thursday, 9 May 2013

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

 

Debate resumed on amendment No. 4: In page 14, between lines 23 and 24, to insert the following:“(3) The Board shall, in determining an application under subsection (2), have regard to the desirability with respect to efficacy and safety of refusing to add medicinal product in the anti-epileptic drug class, used in the treatment of persons with epilepsy for the purpose of preventing seizures, to the List of Interchangeable Medicinal Products.”.- (Deputy Caoimhghín Ó Caoláin).

11:10 am

Photo of Alex WhiteAlex White (Dublin South, Labour)
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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.

11:20 am

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I had hoped that with the passage of a couple of weeks since we last debated the issue on Report Stage the Minister of State might take a different view. I regret, however, that he remains solid in his opposition to the proposed amendments from me and my colleagues in this regard. I draw to his attention what amendment No. 4 states. It proposes to insert the phrase, "The Board shall, in determining an application under subsection (2), have regard to the desirability with respect to efficacy and safety of refusing to add medicinal product in the anti-epileptic drug class...". The phrase is "shall ... have regard to". This was a compromise draft following what I had argued for on Committee Stage. What I presented on that Stage was far more specific and firm in its intent. I cannot understand why there is no inclusion of an acknowledgement of the special concerns that are particular and, I believe, unique to people with epilepsy. In this instance, the amendment only affirms that the need for due regard in terms of efficacy and safety would be incorporated in the legislation. It is not a lot to ask. It would not, of itself, lock those responsible into specific actions. However, it would require due regard in terms of efficacy and safety. These are at the core of the concerns of people with epilepsy and at the heart of the campaign of the Irish Epilepsy Ireland with regard to this legislation. It supports the legislation, but, as we do, it wishes to have it fit for purpose and applicable in all situations. It is not as if we are looking at a case of "what if?" As I told the Minister of State previously, there is ample evidence that substitution or the provision of interchangeable medicines has led to adverse consequences, not only in the international experience, which has been cited to us, but also domestically in relatively recent times. It is incumbent on us, as legislators, to ensure the legislation properly reflects the combined knowledge and wishes of Members of the House. The Bill without a reference to this very important concern gives no such indication in this regard to those who will be responsible for implementing its provisions.

I appeal to the Minister of State to reconsider amendment No. 4. Its wording would not place anybody in an uncomfortable or unreasonable position but would properly recognise the special case real concerns of epilepsy sufferers and their families regarding AEDs and their substitution and interchangeability.

Photo of Seán BarrettSeán Barrett (Dún Laoghaire, Ceann Comhairle)
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I remind Deputies that they are restricted to two minutes in the second round of debate. I call Deputy Bill Kelleher who will be followed by Deputy Denis Naughten.

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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I will be brief and not delay the passage of the Bill.

Photo of Seán BarrettSeán Barrett (Dún Laoghaire, Ceann Comhairle)
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Members who have tabled amendments are entitled to a further reply.

11:30 am

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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I endorse everything Deputy Ó Caoláin said with regard to anti-epileptic drugs. There are fundamental fears and concerns and they are well vindicated and validated by the expressions of eminent consultants, who have made passionate pleas to us to raise this issue to allay any fears arising among epileptics because of this legislation. This amendment, coupled with the preceding amendments, is simply trying to allay the fear that drugs will be substituted.

Patients may be on a generic drug already. We are trying to protect, in law, their entitlement to stay on that drug because it may be the most suitable for dealing with their condition. That is the point at stake in the amendment. I endorse everything that was said. The point raised in the amendment is critical to the very principle of fairness in allowing epileptics who have their condition under control to live independent lives without fear of seizure. The Bill, if enacted as it stands, could and probably will further epileptics’ concerns about living normal, independent lives with security of supply of a medicine that treats their condition.

Photo of Catherine MurphyCatherine Murphy (Kildare North, Independent)
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I believed that a week or a week and a half might have been enough time for the Minister of State to reflect on this matter.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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A week is supposed to be a long time in politics.

Photo of Catherine MurphyCatherine Murphy (Kildare North, Independent)
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The Minister of State said consistency of formulation is crucial. That is the point we are all trying to make; it is not that there is a problem with generic drugs. There will be competition in respect of generic drugs because, once a patent expires, it opens up that possibility. We are all trying to achieve consistency. Since we last debated this issue, constituents have contacted me about studies that were carried out showing the same kind of pattern as the one in Canada. There have been studies in the United States, Germany and Switzerland. The pattern involves people missing work, breakthrough seizures and injuries. The studies refer to substitution and a loss of consistency.

I do not know how Canada organises itself, nor do I have the ability to research it in a thorough way, but I am sure, based on the fact that the Canadians identified the problem, that there would have been a response to it. When somebody is diagnosed in this country, he or she is automatically given a monthly prescription. We make sure this happens. The regime has resulted in some very good outcomes but we are potentially going to interrupt that. If the Minister of State does not consider making some changes in primary legislation, he might make a small change that would allow for a ministerial order or other such approach.

There will not be a problem for those who are very switched on regarding their medication and the fact that it should not be changed. The problem will arise for medics and newly diagnosed patients as the latter may not be as keenly aware of the need for consistency as others. They may not be aware of the difference that even a small change in the make-up of a medicine can have. Are there additional resources, perhaps made available through the Irish Medicines Board, to ensure the most up-to-date position will be made known to those who will be prescribing and dispensing medications? This will be critical in ensuring people are not exposed to risk unnecessarily.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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I support my colleagues on this issue. We have teased it out at length and I will not dwell on it to any great extent. In fairness to the Minister of State, it is clear on all sides of the House that in practical terms we will not see the interchanging of anti-epileptic drugs, considering the risk it poses to those who rely on them for the treatment and management of their epilepsy. Anti-epileptic drugs, be they generic medicines or some of the more expensive medicines, are not ideally suited to substitution because of the difficulties associated with their formulation. We have had this debate.

Neither the Minister of State nor I believe anyone would deliberately substitute one anti-epileptic medicine for another, given the associated risks. General practitioners and consultants will, as a matter of form, state on the prescription "Do not substitute". This will happen consistently across the board in regard to anti-epileptic drugs but human nature is such that mistakes do happen. A consultant or general practitioner may forget to write "Do not substitute" in a particular month. A new pharmacist may read the prescription and give the patient a generic substitute. This amendment is about preventing fear in this regard among those with epilepsy.

I have no doubt that the vast majority of people with epilepsy will be very conscious of the risk and careful when picking up their medicines. However, we are relying heavily on the patient, who trusts the general practitioner and pharmacist. The difficulty arises where older patients with epilepsy may be in receipt of a series of medications, in that they may not spot that their anti-epileptic drug has been changed. Alternatively, a person with an intellectual disability may be relying on a relative, parent or sibling to ensure he or she receives the right medicine. What happens where there is an older person with epilepsy who is relying on an elderly parent to pick up the prescribed medication? The parent may not identify that the medicine has been changed, with the result that the epileptic will end up being hospitalised.

We are trying to avoid fear by removing anti-epileptic drugs from the provisions of this legislation. We all believe the Irish Medicines Board will not approve anti-epileptic drugs for substitution or interchangeability but the risk and fear will always arise if the safety net is not in place. Even at this eleventh hour, I urge the Minister of State to reconsider his position.

11:40 am

Photo of Alex WhiteAlex White (Dublin South, Labour)
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Deputy Denis Naughten was not here when I made the point about listening to and respecting people, which I do. I have listened carefully to every word stated about this issue. I am not persuaded by the Deputy and other colleagues that the way to proceed is to provide for a hollowed out statutory exemption.

On the point made by the Deputy about human error always being a possibility in these cases, what is proposed does not arise in circumstances other than where the generic product is already on the list. The question of the consultant also does not arise, although that is an additional safeguard in circumstances where a decision has been made to substitute a medicine. There is no requirement for the protection of the "do not substitute" clause, unless the medicinal product concerned is on the list in the first instance. The safeguards are set out clearly in the legislation.

Deputy Caoimhghín Ó Caoláin has asked why I cannot accept amendment No. 4 because all it does it seek that the board have regard to the desirability with respect to efficacy and safety. With respect to the Deputy - I say this with some force, justifiably so - the criteria set out in section 5 are stronger than what is proposed in amendment No. 4, which seeks that the board have regard to the desirability with respect to efficacy and safety. Section 5(7) states:

The Board shall not under subsection (2)(a) or (4)(a) add a medicinal product to a group of interchangeable medicinal products if the Board is satisfied that--(a) there is a difference in bioavailability between the medicinal product 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,

(b) the medicinal product contains more than 2 active substances...
Subsection (7)(e) states:
...the medicinal product cannot be safely substituted for each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products.
The precise reference to "efficacy" also occurs in the course of the section. The concern which the Deputy's amendment seeks to address is, with respect, better dealt with in the body of the Bill than, perhaps, he accepts.

Deputies Billy Kelleher and Catherine Murphy spoke about fear. Fear is real in the sense that people have reason to be fearful in respect of their own health and well-being and they look to politicians and the Government to allay these fears. I accept this. We do this not by shying away from legislation because it might be better not to address an issue in an Act but by putting in place systems which ensure trust in public institutions, particularly regulatory bodies, established by the House. Fear should be addressed by having in place robust, expert public institutions such as regulatory bodies such as the Irish Medicines Board. I sympathise with Deputy Catherine Murphy in having assiduously researched this issue. While we have a great deal of expertise - or at least claim to have - we are not scientists. We are giving responsibility for this matter to the Irish Medicines Board and should join together and trust it, as an institution, to do what is required. In that way, we will allay people's fears.

It would not be appropriate to include an authority in respect of a ministerial order. What would that achieve? It would mean we would be contemplating a situation where the Minister should step in to overrule the IMB. In other words, the IMB would do something which the Minister thought was wrong and would have to overrule. That is the wrong way to go about processing legislation. We must trust institutions but set down in legislation onerous criteria to ensure they do the job we want them to do.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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Nobody is proposing to delete any part of subsection (7), as cited by the Minister of State.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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I know that.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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However, it does not cite the special case in relation to anti-epileptic drugs, AEDs. Amendment No. 4 does not seek to create exemptions; rather it seeks that due regard be had to the exceptional situation applying to people with epilepsy. There is no point in trumpeting language used elsewhere in the legislation that is not particular to the set of drugs about which we are speaking, namely, anti-epileptic drugs. It is important that the Minister of State appreciate that our persistence reflects our understanding of what is required, nothing more. We have not protracted this engagement in order to spend more time in this sorry Chamber.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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I accept that.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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We represent a broad range of political opinions and I know that our concerns are shared by members of the Government parties. It is tragic that this is not being taken on board by the Minister of State and those with whom he has engaged in preparation for the taking of these amendments. Amendment No. 4 does not seek to alter the intent of the legislation but carefully and with full appreciation of the circumstances involved would require due regard in this area. I do not propose to protract this debate any further. We have explained our point ad nauseam and it is regrettable that the Minister of State will not accept it.

Amendment put:

The Dáil divided: Tá, 42; Níl, 70.

Tellers: Tá, Deputies Seán Ó Fearghaíl and Aengus Ó Snodaigh; Níl, Deputies Paul Kehoe and Emmet Stagg.

Níl

Amendment declared lost.

11:55 am

Photo of Michael KittMichael Kitt (Galway East, Fianna Fail)
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Amendments Nos. 5 to 9, inclusive, and 11 are related and will be discussed together.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I move amendment No. 5:

In page 19, to delete lines 1 to 21.
My position on this group of amendments is contingent on how we deal with amendment No. 6. The Minister of State might appreciate that I am in a little dilemma because we must discuss amendment No. 5 and others, yet the fate of amendment No. 6 determines whether I press for the deletion of Chapter 2 and the first paragraph of Chapter 4. I hope the Minister of State can follow my point. For the sake of argument, however, the Irish Pharmacy Union, IPU, has proposed simplifying this Bill, particularly Chapter 2, the opening paragraph of Chapter 4, and subsequent sections that I also propose to delete. The IPU points out that in a report published by the European Commission in January 2013 as part of the assessment carried out every three months by the troika it was recommended that doctors be required to write prescriptions using the active ingredient rather than the name of the drug, patented or otherwise. It was argued that modifying the Bill in this way would assist in significantly increasing the level of generic substitution. I believe this to be a reasonable proposition and that is why I have tabled these amendments.

I will be interested to hear the Minister of State's view of what I have said and I hope he can be accommodating because, as he will appreciate, dealing with amendment No. 5 separately from amendment No. 6 will not make much sense. We need to consider seriously the broad proposition of general practitioners prescribing active ingredients, because our common aim is to increase generic substitution. The by-product of all that is to greatly reduce the high cost of medicines bought privately and using medical cards at significant cost to the Exchequer. If the means proposed in these amendments are unworkable I will revisit them. I would like to hear what the Minister of State has to say on this if he is not going to allow these amendments, arguing that they are impracticable or whatever, and on the arguments in support of general practitioners' prescribing the active ingredient of the drug as against the branded name in patented medicines, or, if it is the case, the generic substitute.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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During research and development a pharmaceutical substance is given an international non-proprietary name, INN, or a generic name. This INN is generated by the World Health Organisation for all pharmaceuticals worldwide. Each INN is a unique name that is globally recognised and is public property. The method used for assigning each INN promotes the identification of the drug class by the use of common stems for medicines within the same class. These factors reduce the potential for confusion when prescribing a medicine or when seeking to identify a drug that the patient has been taking. INN prescribing is supported as it is widely recognised as a means of promoting safer and clearer prescribing.

Greater levels of INN prescribing can and should be achieved in Ireland. Irish medicines law, however, does not currently mandate INN prescribing by medical practitioners for several reasons. First, many exemptions would need to be included in law for all of the circumstances in which INN prescribing is not appropriate. Second, the enforcement of such a requirement under law would be either ineffective or have consequences for patient care. I am satisfied that the provisions of this Bill will ensure that patients can access the most cost-effective and appropriate medicines available.

Part 2, Chapter 2 sets out the duties of pharmacists regarding prescriptions for interchangeable medicinal products which are written under a brand name. The purpose of this chapter is to provide clarity to both pharmacists and patients in terms of how the provisions of the Bill will apply in four different scenarios. While I do not intend outlining in detail how generic substitution will operate under these four different scenarios, on Committee Stage I agreed with Deputies on the importance of communication in ensuring the successful implementation of the Bill’s provisions. In this context, I am of the view that the professionals involved - the prescriber and the pharmacist - will communicate with the patients concerned so people know what is being done. The provisions contained in Chapter 2 provide clarity to both pharmacists and patients on how the rules about substitution will apply in these four important scenarios. This will ensure that both parties are clear on the application of the rules and will enable the pharmacist to offer to dispense the interchangeable medical product which is the least expensive to the State and the patient, thereby delivering on one of the key objectives of this Bill. For these reasons, respectfully, I do not propose to accept these amendments.

12:00 pm

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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While the Minister responded to all the amendments, the hook on which I hang my case is contained in the broad thrust of amendment No. 6. I am not asking that the order of the amendments be changed. However, will the Minister indicate his Department's view of the argument that it would aid the objective of increased generic substitution if general practitioners were to prescribe on the basis of the active ingredient rather than the branded product? There may be a variety of situations in which that prescribing methodology does not suit. Will the Minister assist the Deputies in determining whether to proceed with the amendments that seek to delete a whole chapter and other sections? It is not the Deputies’ fault that we have to address this matter earlier due to the sequencing of amendments. Will the Minister give us an insight into the Government’s position on the thrust of amendment No. 6? That would be helpful in deciding whether I should proceed with amendment No. 5 and the other amendments grouped with it.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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For the information of the House I must indicate, at the risk of irritating Deputy Ó Caoláin, that I was addressing all of the amendments - amendments Nos. 5 to 9, inclusive, and 11.

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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This goes to the heart of what the legislation is about. Fundamentally, the Bill's purpose is to save taxpayers' money with generic substitution where practical and possible. The question is whether prescribing on the basis of INNs should be mandatory or whether, as Deputy Ó Caoláin said, prescriptions should be based on the active ingredient.

We all know the pharmaceutical industry is an important component of the economy. It invests significant amounts of money into the economy through infrastructural development, employment and research and development. It has been a key component of government strategy over many years to attract inward investment in research and development. While this is welcome, equally, we have an obligation to save taxpayers' money in certain areas. This is one of these areas.

I am concerned that the Bill does not sufficiently encourage prescribers to prescribe medicines in the form of INNs as opposed to branded products. This is at the heart of what we and the Minister of State are trying to achieve. Compared to any OECD country or Western economy with a similar health system, on a pro rata and per capita basis this country pays an enormous amount of money for medicines. We have to go to the core of why we are paying too much. These amendments would address the issue.

While we did not convince the Minister on anti-epileptic drugs, these amendments would genuinely benefit the Department and the taxpayer in delivering real and substantial savings that could be invested in other health areas. I do not believe they would damage or impinge on what is an integral part of the broader economy - namely, the pharmaceutical industry. I do not believe pharmaceutical companies based in this State are here because the Department of Health purchases their products at an inflated price. The economy is too small to make it relevant to them as they are global companies. They are here for many other reasons, such as corporation tax, our highly motivated workforce and the fact that we have a skill set built up over many years. This needs to be parked as an issue. We need to ensure we save as much money as possible in certain areas so it can be spent in the areas of greatest need. Generic drug substitution is recognised as an integral part of the Government's policy. I am trying to help the Minister in delivering on savings so I can highlight other areas where the money saved could be spent.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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I support these amendments. Amendment No. 6 makes much sense and the Minister agrees in principle with the thrust of it, as he made clear in his response. The issue he has is one of timing. The amendment makes sense not only for the reasons given by my two colleagues, as well as the fact that it would ensure consistency from prescriber to pharmacist, but also because it would follow through on the label for the patient and lead to consistency across the board.

The substitution of medicines will cause confusion for members of the public when they pick up their prescription or someone is doing that for them. If there is consistency in labelling across the board people will know their medicine is the same medicine they got last month even though the brand name is different. That is important not just in terms of efficiencies and streamlining the entire process but also in terms of compliance with taking the particular medicine. As we know, compliance is a particular difficulty with any medicine in terms of ensuring people take it at the appropriate time and that they know the reason they are taking it. It would also help to identify where a mistake has been made because if a person's drugs are being changed from one month to the next, even though they are for the same purpose, there is a risk that someone along that chain will make a mistake, and that most likely will be the person who must take the medicine because the tablet may be similar to one they took the previous month for a different purpose. If there was consistency regarding the name of the product across the board, it would assist in that regard.

I heard what the Minister said and I understand the timing challenge he faces but I suggest as a solution that he accept the principle of the amendments tabled by Deputy Ó Caoláin and Deputy Kelleher, make specific provision for the international non-proprietary name and bring it in by ministerial order at a later date. The Minister can bring in the other aspects of the legislation straight away. He can then sit down with the general practitioners and ensure that this new process is put in place as soon as possible, and then bring it in by ministerial order. The Minister said this is a place he would like to get to, therefore, he should now make the statutory provision for that in this legislation. It also has the added advantage that if it is already in primary legislation it might be easier to encourage GPs and pharmacists to begin implementing this on the ground of their own volition on the basis that if they do not get their act together now, this legislation will be introduced anyway and it is important to work on that basis.

The difficulty, as we are aware, is that GPs have been conditioned over the years to name a particular product, and we had many debates in this House and elsewhere on that issue. Perhaps we should start conditioning them the other way by including this in the primary legislation and bringing it in by statutory instrument separately from the other aspects. It meets with the argument we are making on this side and provides the Minister with a vehicle to ensure this is implemented as soon as is practical.

12:10 pm

Photo of Alex WhiteAlex White (Dublin South, Labour)
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The Deputies make some compelling points on this issue, and I thank them for doing so. I thank Deputy Ó Caoláin for raising the issue in the manner in which he has done.

I indicated in my response my view of the INN, international non-proprietary name, and the practice of using the non-proprietary name, or the generic name, in the circumstances we are dealing with here. However, I would not be disposed to accepting this amendment from Deputies Ó Caoláin and Kelleher, notwithstanding that I am persuaded to consider this question of the INN in the context of further changes that we may be required to make or may decide to make in future in this area of prescribing and medicines. I do not need to repeat what I said about the INN. It has a huge value. Internationally we can see that, and there is no doubt that the literature points to the value of the INN.

Deputy Naughten comes close to the truth in the point he makes, which is that there is an issue of timing with regard to this but I would prefer to examine this particular proposition as a specific objective. If we decide to bring it into our law, we should do so as a specific objective. I would prefer, and this is not a criticism of Deputy Ó Caoláin or Deputy Kelleher, if we were doing this by way of legislation to have the opportunity to consider carefully its undoubted implications. One example that occurs to me is where we talk about "in the opinion of the prescriber". When a discretion is put into law it always has implications, although not necessarily bad or sinister. When a discretion is accorded to someone, how does that operate? How do they exercise that discretion? When should they exercise it? Is there a legal framework for them exercising it and so on? All of these issues would have to be addressed if we are to put this into our law.

I am not disposed to accepting the amendment. However, I repeat the points I made in my initial response. We do not currently mandate the use of INN in this country for the reasons I outlined earlier. There is an additional factor of which the House is aware because I indicated it by way of responses to Deputy Kelleher and others in the course of parliamentary questions, that is, that as part of the EU-IMF programme of financial support for Ireland, the Department and the Health Service Executive commissioned a study on pharmaceutical prices, prescribing practices and the usage of generics in Ireland compared to similar EU member states.

The ESRI was commissioned to examine this issue. Originally, its report was targeted for completion by the end of March. However, issues arose around the processing of some technical data which delayed it. These technical issues are now in hand and the report will be finalised in the coming weeks. That report will fulfil a requirement of the seventh update of the memorandum of understanding, MOU, on specific economic policy conditionality, which is part of the EU-IMF programme of financial support for Ireland. The eighth update of the MOU requires a setting of high level annual targets for increasing the share of generic drug usage in the medium term. The deadline for this commitment is the end of September 2013. These targets will be informed by the findings of the report currently being completed by the ESRI.

This commitment also requires that enabling measures such as compulsory prescription by international non-proprietary name, INN, by the end of 2013, where appropriate, required for the achievement of these targets, will be put in place and kept under further review. For that reason, the inclusion of the INN name on prescriptions is being considered.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I hear what the Minister is saying and it is a clearer response than what I was picking up in the first instance. That may be as much my fault, or mine alone, but what I read from what the Minister is saying is that it might be a good idea, and then there is a "but". We need to recognise that this Bill is about encouraging and facilitating the greatest possible generic substitution and all of the consequent savings that can be made both in terms of the public purse and the private pocket. At some point along the way, in terms of preparing legislation, we have got to make calls in regard to all of these issues. It can be very frustrating. It might be a good idea and it might actually work. We must be able to make the transition from one to the other. Kicking the can down the road is an oft-trundled out phrase but we must prepare legislation that will, to all the best information available, do its job, and I believe there is a strong case to be made for this particular change. The Minister indicated in his last remarks that this is being carefully considered rather than will be considered and on that basis I am willing to accept that that is where we are at now and trust in the Minister of State's efforts to ensure that will produce the required change at the earliest opportunity.

I welcome that and will be guided on my position vis-à-vis Chapter 2 and the other chapters. Accordingly, I will withdraw amendment No. 5.

12:20 pm

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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I should have paid more attention to the Minister's final summing up, but am I correct in understanding that the use of INNs in prescribing is being considered? Will primary legislation will be required if a decision is made to include INNs?

With regard to what the Minister of State said regarding discretion and reasoned opinion, there are always consequences when these are included in legislation, but we have this all the time. We allow discretion and reasoned opinion to many people in legislation and my amendment does no more and no less.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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I did not say it could not be done.

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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I know. Of course there are consequences, but we trust the people to whom we allow discretion and reasoned opinion. Such legislation is currently before the health committee and discretion will be given to medical professionals in determining the outcomes for patients on a continual basis. I do not accept the argument regarding discretion where there is a reasoned opinion of a prescriber. They are entitled to that much independence anyway. All this amendment suggests is that there should be mandatory generic prescribing using INNs and that if this is not done a reason should be provided - for example, if the prescriber, on the basis of his reasoned opinion, provided the branded product because he deemed it was best for the health, safety and welfare of the patient, nothing more or less.

This amendment relates to the core principle of the Bill. We have talked around the edges of what the Bill is trying to achieve, but that is what is in my amendment. The same point was made by Deputy Ó Caoláin in the context of his amendment. I cannot understand why the Minister does not embrace this and thank us for supporting his legislation and attempting to make it more definitive in its outcomes by obliging prescribers and dispensers, where possible, to substitute and prescribe generic products. That is the essence of the Bill.

The Minister of State mentioned the review of INN prescribing and that primary legislation might be needed. He has the opportunity to get ahead of himself by accepting this amendment.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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If the requirement in respect of INNs was to be put into law, it would need to be included in primary legislation. It would not be appropriate for it to be included in this legislation. It would be necessary to amend the medicines legislation in order to achieve what the Deputies' amendments propose.

With regard to discretion, I did not say one could not have legislation that gives doctors discretion but that, looking at the particular amendment, I see a number of issues that require careful consideration before I could agree to its inclusion in primary legislation. I am sure also that this is something that would require consideration by the Attorney General to assess the impact and effect of the exercise of discretion. When speaking earlier I just picked one example, but I was not saying we could not allow discretion. I was simply saying it is something we want to get right. Deputies Kelleher and Ó Caoláin have been very assiduous and have been helpful in their contributions to this debate, but if I was to do this by way of primary legislation, which is what would be required, I would rather give it closer consideration. I accept that the INN issue is live and it is being considered in the Department.

Amendment, by leave, withdrawn.

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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I move amendment No. 6:

In page 19, between lines 3 and 4, to insert the following:“7.--The prescriber shall ensure that he/she prescribes in the most cost-effective manner by only writing the common or International Non-proprietary Name of the medicinal product on the prescription except where in the opinion of the prescriber it would be inappropriate to do so from a patient safety and welfare perspective.”.

Amendment put:

The Dáil divided: Tá, 36; Níl, 78.

Tellers: Tá, Deputies Seán Ó Fearghaíl and Aengus Ó Snodaigh; Níl, Deputies Joe Carey and Emmet Stagg.

Níl

Amendment declared lost.

Amendments Nos. 7 to 9, inclusive, not moved.

12:30 pm

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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I move amendment No. 10:

In page 21, between lines 18 and 19, to insert the following:“12.--(1) The prescriber shall detail the purpose of each medicine on the patient's prescription.

(2) The pharmacist shall include the purpose of each medicine on the label when dispensing the medicine.”.
This amendment arises from the discussions on Committee Stage. On foot of those discussions, I tabled this amendment which states that the prescriber, who is the doctor, shall detail the purpose of each medicine on the patient's prescription, and the pharmacist shall include the purpose of each medicine on the label when dispensing the medicine to the patient. It comes back to the point I made when discussing the last amendment, as well as on Committee Stage, which is that there is an issue of familiarity with regard to the medications people are prescribed. They may only know it is, say, a pink tablet of a particular name that they have been taking for their heart condition for perhaps five or six years. It is important that we not only look at the issue of trying to save money through generic prescribing but also that we try to save money in regard to compliance by patients with the instructions for a particular medicine, for example, that they take it at the proper time. In order for them to do that, however, they need to know what the medicine is for. It would improve compliance if people knew exactly what their medicine is for, and this would also ensure that if there is a mistake on the prescription, the person will see this very quickly.

I know the Minister of State will say the pharmacist has to explain to the person that this is a replacement for a previous medicine they had, and that everything will be hunky-dory as a result. As we know, the biggest current problem with medicines is in regard to people complying with the instructions for taking them. If we could improve that, people would not have to be admitted to hospital on as frequent a basis. There is also a huge potential saving in the long term for the Exchequer if we could have a greater level of compliance in regard to medicines, and one way of ensuring this is if people know exactly why they are taking the medicine.

The Bill will add to the confusion. I know the pharmacist will explain to the patient, or the person picking up the prescription for them, what is the purpose of this measure. However, in many cases concerning compliance issues, we are dealing with older people who may get confused due to having to take a whole series of medicines. They will ask what the pharmacist has told them to do and wonder whether they should take the medicine at a certain time, even though this may be written on the label. It is not the case that we are dealing with just one medicine in isolation. It is not uncommon for people to be taking 15 or 20 different tablets a day for different medical conditions. I will use the example of an older person, Mrs. Murphy, who has been taking a particular branded product for her heart condition for six years. Following the introduction of this legislation, she will be told by the pharmacist when she goes to pick up her medicine that there is a cheaper substitute and that, while she can continue to get her branded product, she will have to pay the difference, or she can have the cheaper alternative. If she also uses a cholesterol medicine or coagulant, the option to use a cheaper generic alternative will be given to her. Older people will have to try to remember what each medicine is for and remember exactly what the pharmacist told them about each one. In practical terms, that is what is going to happen on the ground.

What I propose in this amendment is that the GP would write out the purpose of the medicine, whether it is for a heart condition, cholesterol or otherwise, and the pharmacist would ensure this is put on the adhesive label on the outside of the receptacle containing the medicine. This would deal immediately with the confusion that can be caused by the substitution of medicines but also, more important, it would have an impact in regard to compliance with the taking of medicines, which would be an added benefit. In addition, it would also help in regard to the issues raised on the previous set of amendments in terms of consistency. It would help to identify where mistakes are made because patients can identify whether they have, for example, received their heart condition medicines correctly, or, alternatively, that they had received cholesterol medication when they do not have a problem with cholesterol. There would also be a benefit in that people may be taking medicines unnecessarily because they have always been prescribed it by their GP but do not actually need it.

There are potential savings to be made, as well as dealing with compliance issues and addressing the issue of familiarity that people have with a particular medicine. We must address some of the confusion that will be caused due to the introduction of this legislation, even taking into account the checks and the safety net the Minister has included in the legislation. We have to remember we are talking about people, many of them older people who get confused easily and who are dealing not just with one or two medications but with many. The amendment would help in achieving the purpose of the legislation. The Minister of State agreed with the principle of my point on Committee Stage and I hope he can now accept the amendment.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I support Deputy Naughten's proposal and believe the amendment is eminently sensible. I would like to offer one additional observation and, by doing so, suggest it does not discount the case. In the instance Deputy Naughten has cited of people on up to 15 or more tablets per day, invariably, and particularly in the case of older people, they are not looking at 15 separate vessels of whatever description because the tablets are usually provided through what are known as blister packs that are designated for "morning", "lunchtime", "teatime", "bedtime" and so on, and they work through the blister pack groupings, as prescribed by the GP. Despite the fact one is looking at a cohort of tablets with varying roles, the cover of the blister pack that describes the content can accommodate exactly what Deputy Naughten is arguing for.

I know from personal experience, in particular for older people and those who are coping with early Alzheimer's disease, where there is difficulty remembering what any given tablet or group of tablets are for, that it would be hugely beneficial and helpful in reminding them why they are taking any particular number of tablets at any given time.

It is eminently sensible and there should be no resistance to it. It should be done in the entire context of transparency and the provision of information for patients. This is something we need to work towards. The amendment would undoubtedly provide for that change and the consequences would be beneficial on a range of levels.

12:40 pm

Photo of Alex WhiteAlex White (Dublin South, Labour)
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The proposed amendment would require that the clinical indications be included in both the prescription by the prescriber and the medicine label by the pharmacist. Two mandatory requirements are suggested in the amendment. It is important to note that many medicines have multiple clinical indications. I fully appreciate the importance of patients having full information on the correct use of medicines. We had a discussion about this issue on Committee Stage and I understand and agree with the principle elucidated by Deputy Denis Naughten.

The current legislation on the prescribing and control of supplied medicines, the Medicinal Products (Prescription and Control of Supply) Regulations 2003-2011, sets out the minimum requirements relating to the dispensing of prescriptions and the information the pharmacist must record on the label. In addition to these requirements, pharmacists are not precluded from including additional information where this is deemed appropriate. It is open to them to record the indications on the label, where appropriate. This is considered best practice for certain vulnerable groups. In addition to the information provided on the label, pharmacists are also obliged under the Retail Pharmacy Business Regulations 2008 to provide information and counselling for the patient. This ensures patients receive all information relevant to their medicines. The regulations also provide that the pharmacist must review the prescription having regard to the pharmaceutical and therapeutic appropriateness of the medicine for the patient. This provision can be an important step in the safe use of certain medicines. In view of these requirements and also recognising the wishes of some patients who may not wish to have a clinical indication recorded, I do not propose to accept the amendment.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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The Minister of State has made the argument for me. As he notes, a particular drug can be used for a number of purposes. For the pharmacist to explain to the patient, he or she needs to know what the drug is for in the first place. He or she must ring the GP to find out. What we are talking about is the GP stating, possibly in generic form, what the medicine is for, but, at least, the patient would know why he or she was taking a particular medicine. It would significantly improve compliance and the information should be provided on the label to provide that clarity because the Minister of State is right - drugs can be used for different purposes. We heard that argument in respect of anti-epileptic drugs which are used to treat a series of neurological conditions, not necessarily just epilepsy. It is important, when one is talking about medicines that are interchangeable, that people know exactly why they are taking a particular tablet which differs from the one they have been taking for the past six years. I again urge the Minister of State to reconsider the amendment on that basis.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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It is simply one line. Of course, the patient would be taking the substituted generic medicine for the same reason they would have previously taken the branded one. The reason they are taking it does not change.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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Exactly. Again, the Minister of State is making the argument for me.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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There is no new information provided.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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The Minister of State is right. That is where one has consistency, which is the point I am making. With generic substitution, one does not have consistency from the patient's perspective. The Minister of State is not listening to me.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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I am listening and I disagree with the Deputy.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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The Minister of State is wrong to disagree with me. For example, medicine A, manufactured by White Pharmaceuticals, is used to treat a heart condition. After this legislation goes through, the decision will be taken by the Irish Medicines Board that the same medicine manufactured by Naughten Pharmaceuticals is 50% cheaper. The elderly person who has been taking the medicine manufactured by White Pharmaceuticals for six years knows that this medicine is his or her heart medicine to treat an irregular heart beat or a cholesterol problem. Now all of a sudden, he or she will go to the pharmacist and receive a number of replacement medicines. The pharmacist will explain that he or she will not give the patient the traditional medicine manufactured by White Pharmaceuticals because it is too expensive and will instead give the medicine produced by Naughten Pharmaceuticals. The elderly person will go home and a week or fortnight later will go through his or her medicines and wonder what a particular tablet manufactured by Naughten Pharmaceuticals is for. He or she will have to work out, by a process of elimination, what the new tablet is for, go back through the other 14 or 15 medicines and say, "Well that one must be for my heart condition." That is where the difficulty lies. The Minister of State is right. In saying a medicine is used to treat a heart condition, one has a level of consistency. Regardless of what generic medicine one is taking, one knows it is to treat one's heart condition, regardless of whether it is produced by Kelleher Pharmaceuticals, Ó Caoláin Pharmaceuticals or White Pharmaceuticals. It makes no difference because one knows it is one's heart medicine. That is the one issue that will arise with generic substitution. There will be a difficulty in respect of compliance. The amendment would assist in dealing with that compliance issue, clarifying the position and ensuring people knew exactly what a medicine was for.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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I understand the point the Deputy is raising, but I do not think his case is strengthened because of the requirements under the legislation. In so far as he has a case to make for the amendment, it is already dealt with. A person will have new medicines for the same purpose; therefore, if he or she has one, two or three branded medicines, one, two or all three might be replaced in the future. They will still have three medicines. If the Deputy has a case to make for having a more rigorous information regime, it is already made. They are replacement drugs. Does the Deputy understand the point I am making?

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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I understand the Deputy has contributed three times.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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The Minister of State has also contributed a third time.

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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As we allowed him some leniency, we will also allow the Deputy some leniency.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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I will make my point briefly. If all of a person's medicines are replaced - sadly, it is not just three, as many people have many more - ten days down the road, he or she will not know what each of them is for. He or she knows there is an anti-coagulant, a medicine to treat a heart condition and another to treat a cholesterol problem, but he or she will not know which is which. That is the point I am making.

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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The Minister of State cannot reply.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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Patients will not be any less informed than they are currently.

Photo of Denis NaughtenDenis Naughten (Roscommon-South Leitrim, Independent)
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I disagree.

Amendment put and declared lost.

Amendment No. 11 not moved.

12:50 pm

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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Amendments Nos. 12 and 13 are related and may be discussed together.

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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I move amendment No. 12:

In page 25, line 33, after “decision” to insert the following:“and to prescribers, pharmacists, the Irish Pharmaceutical Union and the Irish Medical Organisation”.
I do not expect the Minister, the HSE or anyone else to baby-sit pharmacists, medical practitioners or others who are commercial entities and highly qualified professionals. Those who are obliged to keep themselves informed need to have the information as much as the Minister and the HSE. The manufacturer of a medicine is informed of the removal of any medicine from the medical reimbursement scheme. However, the prescribers, pharmacists and the IPU are not informed. Pharmacies and GP surgeries need to be run effectively and I would expect them to be informed when a particular medicine or brand is removed from the reimbursement list. If a pharmacy is unaware that a medicine has been removed from it, it may be left with unused stock. A centralised electronic system to inform the IPU, pharmacists and GPs would be preferable, nor would it be onerous. It would make sense in order that pharmacists and others would not continue to dispense medicines for which the patient would not be reimbursed. I will not go into the trenches over this. There may be practical reasons the Minister of State cannot accept the amendments, but I would like to hear why they are not acceptable.

Photo of Alex WhiteAlex White (Dublin South, Labour)
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Part 4 of the Bill sets out statutory procedures for the supply and reimbursement of medicines and other items to patients under the GMS and community drug scheme. Section 19 sets out the action to be taken by the HSE where it makes a relevant decision under section 18 to add or refuse to add an item to the reimbursement list, to remove an item from the list or to retain an item on it. This is part of the procedure and sequence that must be followed.

Section 19(1) provides that as soon as practicable but not later than 14 days after making a relevant decision under section 18, the HSE shall give notice in writing of the relevant decision, together with the reasons for it, to the supplier of the item which is the subject of the relevant decision. Section 19(2) provides that where the HSE has used expert opinions or recommendations in reaching a relevant decision, it shall attach a copy of such expert opinions or recommendations to the notice of the relevant decision provided for the supplier under section 19(1).

Deputy Billy Kelleher proposes to amend section 19(1) to provide that the notice of a relevant decision on an application from a supplier of an item which is the subject of a relevant decision also be supplied to prescribers, pharmacists, the Irish Pharmacy Union and the Irish Medical Organisation. The Deputy further proposes to amend section 19(2) to provide that expert opinions or recommendations provided for suppliers under this subsection also be provided for prescribers and pharmacists. The core of my response to the Deputy's amendment is that as the purpose of section 19 is to outline the actions to be taken by the HSE in giving notice in writing of a relevant decision under section 18 to the supplier of an item or a listed item which is the subject of the relevant decision, I consider that the proposed amendments are not relevant to the section.

Section 17 which has already been agreed to deals in some detail with the establishment of the reimbursement list which will be available and accessible to members of the public, including prescribers and pharmacists. Section 19 deals with a narrower part of the regime where, when an application is made by a supplier, there are certain requirements on the HSE to revert to it within particular time periods on any particular decision it makes. I am satisfied that the requirement under section 17 for the HSE to publish the reimbursement list on its website addresses the Deputy's concerns about the information flow he regards as being important in the operation of the system. I agree with him on that point and that is the purpose of section 17.

The current practice whereby monthly updates to the list, highlighting both additions and deletions, are published on the HSE website will continue. In addition, the HSE supplies the Irish Pharmacy Union directly with an updated list on a monthly basis. In the circumstances I do not propose to accept the amendments, as they are not relevant to section 19. The very reasonable issues and legitimate questions raised by the Deputy are adequately dealt with in section 17.

:

Amendment, by leave, withdrawn.

Amendment No. 13 not moved.

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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Amendments Nos. 14 and 16 are related and will be discussed together.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I move amendment No. 14:

In page 30, lines 16 to 18, to delete all words from and including "to" where it secondly occurs in line 16 down to and including "who" in line 18.
I am not pressing either amendment as they were contingent on the position on amendment No. 6. If they were validly for consideration, I deeply regret that amendment No. 15 was disallowed, allegedly because it might involve a charge on the Exchequer. Such a terrible thing and it happens all the time.

Amendment, by leave, withdrawn.

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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Amendment No. 15 is out of order.

Amendments Nos. 15 and 16 not moved.

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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I move amendment No. 17:

In page 34, between lines 4 and 5, to insert the following:"(b) in section 14(1) by deleting paragraph (f),".
I have still not received a satisfactory explanation in my inquiries regarding the bankruptcy of professionals. I cannot find a logical reason a person who is eminently professionally qualified as a pharmacist is no longer permitted to practise as a pharmacist in the event of being declared bankrupt. I need clarity as to why that is so. There are many people who are on the edge or could be bankrupt very quickly. Many got involved in property speculation and all that goes with it. Why should that remove their eminent qualifications to dispense medicines? I cannot rationalise it. If a GP goes bankrupt, he or she can still practise as a doctor. The Minister is taking away a person's last legitimate entitlement to provide a living for himself or herself and his or her family by using his or her professional qualifications in a case where there is no question as to his or her integrity, ethics or ability, other than the fact that he or she is financially bankrupt. I understand the reason it applies to Members of the Oireachtas and others, in order to avoid a conflict of interest, for example, and also to maintain certain standards. However, it defies logic that a person who has gone to college for seven years and has a highly sought-after qualification cannot practise if bankrupt.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I support Deputy Billy Kelleher in this argument. Like him, I am absolutely incredulous of the provision which debars a pharmacist from practising because he or she has fallen on difficult economic times. It seems to be an absolutely inappropriate measure. It is only compounding whatever difficulties he or she has to contend with. We have to recognise and realise that it in no way infringes his or her ability to carry out work, whether in a business with which he or she is associated or, as in many cases, where he or she becomes a substitute pharmacist covering for pharmacists on holidays, who are ill, etc.

It is something many of the professionals in question could do well. There should be no restriction due to bankruptcy. I support the case made by Deputy Billy Kelleher entirely.

1:00 pm

Photo of Alex WhiteAlex White (Dublin South, Labour)
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An interesting issue has been raised by Deputy Billy Kelleher on which we also had some discussion on Committee Stage. In so far as there is a rationale for the restriction, which presumably there is historically, that is the status quo. If we want to find the rationale, it is in the existing legislation that has been there for whatever number of years with regard to regulated professions. Some professions, of course, are not regulated - at least not yet. The Pharmacy Act 2007 includes this provision. I do not make the point and assert simply that because it is there it should stay there. I agree with the Deputy that the fact that the provision exists is not of itself a reason for us to say we should never look again at whether it is necessary, right or defensible that someone should be excluded from professional practice - leaving aside the issue of managing a business, a distinction which Deputy Kelleher has made - solely on the grounds that he or she is an undischarged bankrupt. I do not say that.

The Irish Pharmacy Union and the Pharmaceutical Society of Ireland have submitted a number of amendments to the Pharmacy Act 2007, including an amendment in the form suggested by Deputy Billy Kelleher. These amendments are being considered in the Department. I acknowledge that this is the second time I have used the word "considered" today, but I ask the Deputies opposite to accept that I am speaking in good faith. I ask the Deputies to bear with me as we come close to the end of the debate on this important legislation. There has been additional work in the Department associated with the Irish Presidency of the Council of the European Union and certain issues have not been addressed as quickly as we would have preferred. We will start to address these issues later in 2013 and I will be interested to examine the issue raised by Deputy Kelleher's amendment, as will the Department. I give no commitment on the matter, but I ask the Deputy to understand that I have an open mind.

Without saying too much about it, we have had extensive debates more broadly about bankruptcy, bankruptcy status and our attitudes to them. Traditionally, the position has been different in this country. We have made very good changes on bankruptcy in the insolvency legislation. There are different traditions abroad with regard to bankruptcy. Often in Ireland it was seen as the end of the road for people, which we all probably agree ought not necessarily to be the case. People should not be gone forever simply because of a particular issue which leads to their being declared bankrupt. The law has changed in that regard and attitudes have changed. On the question of the application of bankruptcy to professional practice and the registration of pharmacists, there is a provision in the Pharmacy Act 2007. We have been asked to consider it, which we will definitely do, but not today.

Photo of Billy KelleherBilly Kelleher (Cork North Central, Fianna Fail)
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It is welcome that the proposal is being considered. I make the point because people are under huge pressure and are being declared bankrupt or are on the verge of it. The one thing we do not want is to deny them the ability to provide for their families. I am talking about the conduct of their profession. I can understand that there might be an issue with owning a pharmacy and running a business but, as the law is constituted, a person cannot practice as a pharmacist if he or she is declared bankrupt. I will withdraw the amendment and look forward to dealing with this down the road.

Amendment, by leave, withdrawn.

Photo of Caoimhghín Ó CaoláinCaoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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I move amendment No. 18:

In page 36, after line 30, to insert the following:"37.--The Minister shall, within three months of the commencement of this Act, prepare and lay before Dáil Éireann a report on the potential implications on patient safety and public health, in the event of medicinal products in the anti-epileptic drug class, when used in the treatment of persons with epilepsy for the purpose of preventing seizures, being determined as interchangeable medicinal products by the Board under section 5.".

Amendment put and declared lost.

Bill received for final consideration.

Question proposed: "That the Bill do now pass."

Photo of Alex WhiteAlex White (Dublin South, Labour)
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I thank my colleagues on both sides of the House for their attention to the detail of the legislation and their support for the generality of what it proposes to introduce for the first time in the history of the State. It is long-awaited legislation, which will serve us well. It represents a genuine sea change on pricing and generic substitution of medicines in this jurisdiction. I thank the Deputies warmly for their support for our overall objectives. I welcome the tone and content of the debate, which have been extremely helpful.

I thank the officials in the Department of Health for their attention to this complex and important legislation, which they approached with their usual professionalism and close care. I thank all who have been involved in the passage of this important legislation.

Question put and agreed to.

Photo of Robert TroyRobert Troy (Longford-Westmeath, Fianna Fail)
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A message shall be sent to the Seanad acquainting it accordingly.