Health (Pricing and Supply of Medical Goods) Bill 2012: Committee Stage

I welcome Deputy Eric Byrne to the meeting. I welcome also the Minister of State, Deputy Alex White, and his officials.

Our only topic for discussion is Committee Stage of the Health (Pricing and Supply of Medical Goods) Bill 2012.

SECTION 1
Question proposed: "That section 1 stand part of the Bill."

Does the Minister of State want to make any opening remarks or is he happy to proceed?

We are happy to proceed unless any of the members wish me to-----

Can we make an opening remark?

You can. I will give the Deputies three minutes each.

I am not jumping the gun here. If Deputy Kelleher wants to-----

The Deputy can go ahead.

It is very disconcerting for members who have prepared to participate on Committee Stage to find the ruling that has applied-----

Can I interrupt the Deputy? The Chair has no role in that, as the Deputy is aware.

I am not addressing-----

That matter is addressed.

We will not have a discussion on that now. That matter is independent of us. It is a procedural matter.

With respect, Chairman, I have to say-----

It is a procedural matter, Deputy Ó Caoláin, and as you are aware-----

I want to contest the interpretation of the Standing Orders in this instance.

Unfortunately, Deputy Ó Caoláin, it is beyond the remit of the Chair. It is an interpretation given by the Bills Office. We have communicated to you on what we received from the Bills Office. The Chair has no involvement in matters regarding amendments, as the Deputy knows quite well being a long-term parliamentarian. That matter is concluded.

I will make this brief comment.

I am not being discourteous to the Deputy; it is just that we have no say in the matter.

The reason we have tabled these amendments is to respond in the first instance not only to the expert opinion that came before us last week from Epilepsy Ireland, including the eminent neuro-consultant who accompanied its representatives, Dr. Widdess-Walsh, but also because I have met, as I am sure is the case with Deputy Kelleher and other members here, and spoken with people who are registered epileptics. The advent of the substitution of anti-epileptic drugs, AEDs, creates not only a real concern for them but, in more than one instance where substitute generic alternatives have already applied, resulted in serious personal experiences on the part of that person. We cannot ignore that as elected members of this committee and of these Houses. That is the basis of our arguing the case. It is not about a possible charge on the Exchequer; it is about reflecting firmly and responsibly the concerns that have been made known to us.

I have read Standing Order 156(3), and I would argue that the interpretation here is too harsh, but it does not prohibit the Minister of State, Deputy White, taking action. My appeal to him is to recognise the validity of the concerns presented to us here in committee, and that have been made known to us over a period of time. We cannot ignore individual sufferers with whom we have engaged. My appeal to the Minister of State is that if the structures here are such that we will not be allowed press our amendments to seek their adoption, the Minister of State would adopt them and make them Government amendments to overcome this most regrettable obstacle.

For the benefit of the meeting and to clarify, lest Deputy Ó Caoláin thinks the Chair is not sympathetic or supportive of what he has been saying, as Chairman of the committee I have been advised that the Bill provides for the introduction of a system of generic substitution and referenced pricing of interchangeable generic medicines. Amendments Nos. 2 to 5, inclusive, in the names of Deputies Kelleher and Ó Caoláin, and amendment No. 6 in Deputy Ó Caoláin's name, seek to exclude medicinal products in the anti-epileptic drug class from the list of interchangeable products. I am advised the amendments involve a potential charge on the Exchequer as the cost to the State from reimbursement under the medical refund scheme in this regard could be greater than that of a substituted cheaper generic equivalent. Accordingly, the amendment must be ruled out of order in accordance with Standing Order 156(3), which provides that an amendment to a Bill which could have the effect of imposing or increasing a charge upon the Exchequer may not be moved, save by way of a Government amendment. That is the advice given to me. We may refer to it again on Report Stage. That matter is dealt with and I have no say in it.

I do not want to be obstructive in terms of the passage of the Bill but the only way we can make our point is by tabling an amendment and having it discussed. We put down these amendments not just based on individuals. Highly eminent professional clinicians have stated to us that they have major concerns about this legislation and the effect it may have on sufferers of epilepsy who have normalised their lives with the drug they are on currently. That is critically important because the Bills Office, in effect, has not understood the import of our legislation. We are not saying there is a difficulty with a generic drug. It is clear that some sufferers of epilepsy are on generic drugs but they are the ones that are suitable for stabilising their condition. We are not calling on the Minister of State to accept the amendments based on his having to give generic drugs. We are saying that whatever drug has been beneficial in terms of stabilising people's conditions and stopping them from having seizures from time to time should be the one that is used. That is clearly different from what the Bills Office is saying.

I reiterate the point I made to Deputy Ó Caoláin. I am very aware of the issues and I have met members of Epilepsy Ireland. I have had e-mails from members of the public who are directly affected by what is happening, but I cannot change Standing Orders no more than the Deputy can, and he is a long-standing parliamentarian also. Unfortunately, the Chair's hands are tied in terms of the Standing Order, which I have read out, and the Chair cannot reinterpret or revisit that. That is beyond my jurisdiction. I will call Deputy Naughten but if it is on this matter, we have dealt with it and are moving on. If it is on any other issue-----

It is on that issue but we will deal with it when we come to the section.

I have a brief question on section 1 regarding aids and appliances.

General aids and appliances would not come under the legislation but where a particular piece of equipment could have an impact on the treatment of a specific condition as a replacement for a pharmacological treatment, is provision made for that in the legislation?

Is this on section 1?

Essentially the section provides for the Short Title, the collective citation and the commencement. It is the provision that appears in any similar legislation but there is no proposal to incorporate the scenario to which Deputy Naughten refers. The Bill deals with the pricing and supply of medical goods and there is no proposal to extend it beyond the pricing and supply of medical goods.

The reason I asked the question is that for people on medication for pain relief, there are ways of treating pain relief other than through medicine. Sadly, the medicine people are taking while waiting for a hip replacement can have a damaging impact on the body. If at a future date a device was developed that would provide pain relief and would be an effective substitute for medicine, should not the Bill provide for that scenario? If such a device was developed the response from the Department of Health would be that it would require amending legislation before going through the HSE primary care reimbursement service, PCRS, to facilitate the equipment. We are talking about a remote possibility of this happening but as the Minister of State will argue later, this is a blueprint for developments at a later date. Given that the Irish Medicines Board will put much of the flesh on it should it not be provided for in the legislation?

In case members did not get it, the Irish Medicines Board forwarded a response which was late coming to the committee. When we received it we forwarded it to members.

I understand the point made by the Deputy but to be perfectly frank, this is not the type of legislation that would comprehend the regime be believes ought to be provided for in statutory form. In all likelihood that would require not just amending legislation but a different type of legislation. This Bill provides for the substitution of generic drugs for branded drugs. The scheme of the Bill does not contemplate the changes or facilities to which the Deputy referred. I am not saying there is anything wrong with the point he made, or that he does not make a good point, but I do not think it belongs in this legislation.

We are dealing with food as well as medicine.

Yes, so it is not purely medicine.

It is something we can contemplate in a discussion in the future on what kind of legislation would allow for the kind of scenario raised by the Deputy. We can only do a certain amount in this legislation and a huge amount is being done here. However, we cannot try to extend it outside the basic remit contemplated which is the substitution of generic drugs for branded drugs in certain circumstances, if the rigorous test is passed, and the pricing regime. As that is what this legislation is seeking to do we have to be careful not to try to do everything in one piece of legislation.

Perhaps the Minister of State would examine it for Report Stage. What we are talking about is the substitution of a device for treatment in the case of pain relief. The Minister of State is talking about substituting one medicine for another medicine, or one tablet for another tablet, for pain relief on a more cost effective basis where it has the same treatment for the individual. If a non-pharmacological replacement could have the same impact, should not provision be made for it, if it is more cost effective and more beneficial to the patient?

That precise point may not require to be provided for in a Bill at all. What the Deputy is talking about may be possible in any event. I am sceptical that this legislation is the location for the kind of scenario to which the Deputy refers. If there is anything he wishes to say to me between now and Report Stage that might develop the point, I would certainly listen.

If the Minister of State can clarify that legislation is not required for such a system to be put in place in the future I am happy enough with that.

I am being asked to clarify the issue.

I will certainly consider what the Deputy has said.

Question proposed: "That section 3 stand part of the Bill."

Question put and agreed to.
Section 2 agreed to.
SECTION 3

Do we have amendments that would impact on the section?

No. Amendments Nos. 1, 8 and 10 will be discussed together but they are not to this section. We are on section 3.

The amendments are about section 2.

Section 2 has been agreed.

Question put and agreed to.
SECTION 4
Question proposed: "That section 4 stand part of the Bill."

Representatives of the Irish Medicines Board appeared before the Joint Committee on Health and Children on previous occasions discussing many issues in the context of prescription-only medicines and the changing of medicines from prescription-only to over-the-counter. Without being critical of an organisation that is not present to defend or represent itself, urgency may not be a word given high priority in the Irish Medicines Board in general. While the Bill states that the board shall, as soon as practicable, after the commencement of this section establish and publish on its Internet website and maintain a list, what obligation is on the board to advance this urgency? It may have difficulties in terms of staffing arrangements and practical issues about whether enough support is being given to the Irish Medicines Board to adjudicate on what is interchangeable, to carry out a critical analysis and to be obliged at some stage to put it on its website. Clearly this is an issue that will revolve around the practical implications of the Irish Medicines Board being able to move fairly swiftly to publish the list. At the end of the day this is about providing a safe system to people but equally to benefit taxpayers by way of savings. That is the only issue on which I seek clarification before agreeing to the section.

As soon as the legislation is enacted and commenced, the Irish Medicines Board will decide on the medicines for inclusion in interchangeable groups on the list of interchangeable medicines. Market authorisation holders, MAHs, will be consulted on the proposed groups of interchangeable medicines and will then have 28 days in which to comment to the Irish Medicines Board. We anticipate that the first list of interchangeable medicines will be published within two to three months of the commencement of the legislation.

Will there be a sufficient lead-in time after the passing of the legislation and will it be adequate for the patient and the pharmacist? Can we allay the fears being expressed to us by pharmacists and patients in the context of communicating the changes to the public and the pharmacists?

I am satisfied that there will be sufficient time. Obviously the Irish Medicines Board is anticipating the passing of the legislation.

Therefore, it is already in a position to begin to consider and, I am advised, has begun to consider the work it will have to undertake once the Bill is enacted. It will not be a complete year zero when the President signs the legislation. Like Deputies, I have a very high degree of trust in the Irish Medicines Board and know it will carry out its work to a high standard and with a high degree of expertise. Members will be aware that the committees of the board are populated by people of considerable eminence and expertise. I have no doubt that they will expedite the work consistent with it being done properly.

My question relates to the issues for epilepsy sufferers. Am I correct to think that the Irish Medicines Board has considerable flexibility in that context and, where it has concerns, can direct that particular appropriate medicines be used?

We will deal with that under section 5.

I attended a meeting recently for people suffering from chronic pain. It was pitiful. People in awful pain must continually change their drugs. While I understand that we are trying to save taxpayers' money, when people are under duress and suffering terrible pain, we must guarantee that they do not get cheap drugs for the sake of it. Another person I have had contact with was on blood-thinning drugs for a heart condition. His doctor prescribed an expensive blood thinner rather than a generic drug because that is the one that worked for him. I want a guarantee from the Irish Medicines Board that if a doctor advises in good faith that a more expensive medicine is required, the patient will get that drug. I read here that medicines will only be substituted where it is safe to do so.

There are 37,000 people with epilepsy in the State. How much cheaper will it be to switch to generic drugs? What kind of savings are we talking about? Why can the Irish Medicines Board not provide this information before we pass the Bill? I will follow up this matter on Report Stage. I am very concerned for patients.

Section 4 contains the words "as soon as is practicable". No matter what way one reads it, there is no defined period by which the board is required to deal with the issue of the interchangeables. I do not question board members' eminence or ability, but the issue of resources and priorities could come into play. I am also concerned about high-tech drugs and the complexities of that. High-end drugs come on the market and are under patent for a period. When the drugs come out of patent, does the board have the competence, experience and resources to adjudicate on the medicines which become available immediately afterwards? I am concerned that the wording of the section is vague and does not contain specific timelines for adjudication and publication in respect of medicines. Timelines are also lacking to encourage people to apply and to force the board to act promptly where people apply and put their products up for interchangeable use.

I anticipated that some of these issues would be raised, many of which are more germane to section 5 than section 4. I am in the Chairman's hands as to when we will deal with them.

We will wait until section 5. Deputy Kelleher's question pertains to section 4.

I am in the committee's hands. I will deal with any of these issues as they are very fair. The issue of timing is specific to section 4. Deputy Kelleher is correct that there is no defined timeline. It would not be reasonable to have precise timelines and Deputy Kelleher would not expect us to legislate for them. The section provides that the board "shall" act as soon as is practicable, which is a strong mandate to the board to do this work. The section provides that the board will publish the list of medicinal products in respect of which it is satisfied in accordance with section 5. The board has very careful, analytical work to carry out based on the principles set out in section 5, which are extremely important and at the heart of the issues raised by Deputies Mitchell O'Connor and Dowds. This is not a charter for cheap drugs as may have been suggested. It is far from that.

The big worry Deputies and patients have is about communication with older people who may not have Internet access or who do not read the notices in pharmacies. How do we plan to communicate with such people?

That will be an important requirement. I accept that.

I am not being ageist in that.

Not at all. The Irish Medicines Board is devising, as it must, a communications strategy which does not rely solely on the Internet, as has been suggested.

The point I am making is that there is no obligation on the board to inform anybody. Surely, there should be a mechanism in section 4 which obligates the board to inform the Minister or some relevant body the reasons for any delays. The phrase "as soon as practicable" means "as far as the board is concerned". There must be some obligation. I am not saying the board must have everything done within three or four months, but it should be obliged to inform the Minister as to why a certain issue is delayed. It is open-ended. The board has not been proactive in other areas. The board has attended the committee and we have asked it these questions. It has been far from proactive about analysing prescription-only versus over-the-counter drugs.

Section 4 deals with the establishment of the list of interchangeable products. Section 5 deals with its maintenance, upkeep and amendment. We are dealing with it at the outset and timeframes are very important. The Minister of State is giving us an indication on establishment. It is very difficult to talk about section 4 without referring to section 5, as the Minister of State has acknowledged, and I hope the Chairman does not mind. Whatever timeframe may be involved in the establishment of the list, the changes that will present as the list is updated on an ongoing basis will create further concerns. There is a need for clarity on timeframes for new product introduction. I ask the Minister of State to address that. I acknowledge that discussion will come under section 5, but we are starting to kick the ball on section 4.

A range of concerns present regarding the pharmacies sector and the position on GPs and the do-not-substitute requirement within the legislation, particularly in the event of a failure to indicate "do not substitute" but where the knowledge of the pharmacist involved may be more extensive.

They are looking for certainty and clarity on their position. Are they to adhere rigidly to the direction "Do not substitute" and, if it is not there, do they have the freedom to substitute as they deem appropriate, given their exceptional knowledge? In correspondence with us, the IPU has also raised the issue of GPs prescribing ingredients rather than products by name.

We are on section 4.

If we deal with section 4 we can come back to the Deputy's point later.

That is all right. These matters arise now for the establishment of this list. That is the point that I cannot erase from my mind as we look at it. The Chairman says section 5 deals with it, but this is the starting point.

I am aware that section 13-----

We are debating section 4.

I am aware that section 13 allows doctors discretion in prescribing only brands. I have met many people who have epilepsy. They are very concerned. If we substitute these drugs with generic drugs they will not have faith in them. People with epilepsy are subject to different types of seizure.

The Deputy has strayed into section 5 and he is playing the square ball.

I only want to ask the Minister of State whether he can give the 40,000 people who suffer from epilepsy 100% assurance that if they change to generic drugs-----

That is in section 5. The Deputy can come back in on section 5.

I think my point arises on section 4 but I find it hard to distinguish between the sections. There was a drug used to treat skin cancer. I have forgotten its name.

Roaccutane.

I think we were using a shorter name at the time. At the start we were told it could not be administered because it was too expensive. Then the Minister went into negotiation with the company and the price came down. I understand that is what we want. If I or someone belonging to me or someone I know had skin cancer would that person be prescribed the drug that he or she needs, or a cheaper one? I am sorry that Senator Crown is not present today. Are we going to give cheap drugs for the sake of it? I would like a guarantee that patients will get the most up-to-date, advanced drugs to treat cancer. I am talking about serious health problems. The same applies to epilepsy. I want a guarantee that it will not be done on the cheap and that patients will get the drugs they need.

I think the Deputy is referring to ipi.

Senator Crown cannot be here because this is a select committee.

I understood he would not be here. It is just a pity that he is not.

The question of the kind the Deputy mentions would not arise. That is a newly patented drug. That is not what we are talking about here. We are talking about generic substitution. I can understand people's concerns and this is new to our system. We have never had proper legislative provision for generic substitution. It is not a willy-nilly charter for cheap drugs. It is unfortunate that this impression has been given.

Section 5 is very rigorous. The Irish Medicines Board is required to apply considerable tests. I know we are not discussing section 5 but so many references are being made to this issue that I feel it necessary to make it absolutely clear to the committee that this is not some kind of charter for cheap drugs. We are imposing a rigorous requirement on the Irish Medicines Board only to allow generic drugs in the circumstances contemplated in section 5.

The issue that is germane to section 4 is Deputy Kelleher's original question about how quickly the board will move. He and others then moved on to other issues to do with timelines which are also relevant to section 5. In response to the question about the board, the legislation is being introduced to ensure value for money in the supply of medicines. That is an overall requirement. Therefore, the medicines that will be reviewed first are those that cost the most for the patient or the Exchequer. The Department of Health has asked the Irish Medicines Board to prioritise the classes of medicine that result in the greatest cost. There are 20 currently identified, including statins, proton pump inhibitors, angiotensin-converting enzyme or ACE inhibitors, and angiotensin II receptor blockers. I have a table that I can give to the committee. There are 6,000 different items, so this will have to be phased in. It will not be possible to do it immediately or quickly across the board. The Irish Medicines Board is expert in this area. The Department of Health has held conversations with it about its general work programme. It will deal with the areas that I have mentioned first and it will take time for the matter to be addressed.

Question put and agreed to.
SECTION 5

Amendments Nos. 1 and 8 are related and may be discussed together.

I move amendment No. 1:

In page 14, subsection (3)(b), lines 30 and 31, to delete all words from and including “the” in line 30 down to and including “run” in line 31 and substitute the following:

“the running of the period of 180 days referred to in subsection (2) is, upon the giving of the notice referred to in paragraph (a) to the applicant, suspended”.

Section 5 provides that the authorisation holder of a medicinal product may apply to the Irish Medicines Board to have the product added to a group of interchangeable medicinal products or to add a group to the list of interchangeable medicinal products. It sets out that the board shall have 180 days to make decisions on such applications and allows it to request further information from the authorisation holder if necessary. As currently drafted, the 180-day period does not begin to run until such time as this additional information is provided.

In addition, section 18 provides that a supplier of an item may make an application to the HSE seeking the inclusion of a product on the list of reimbursable items. The HSE shall agree a reimbursement price for the supplier and make a final decision for inclusion on the list within 180 days. The HSE may seek further information from the supplier as part of the application process. As currently drafted, the 180 days shall not begin until the further information requested has been supplied. This is not fully in compliance with Article 6 of Council Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products. Article 6 of the directive provides for the suspension of time limits pending receipt of the additional information rather than setting the clock back at zero. This article must be interpreted as applying to any decision which influences the amount of coverage by reimbursement systems. This includes decisions on reference groups or groups of interchangeable medicinal products as well as pricing decisions. Accordingly, I am proposing to amend sections 5(3)(b) and 18(3)(b) to provide for a clock-stopping arrangement so that decisions on interchangeability and reimbursement are taken within a total timeframe of 180 days. This means that if additional information is sought on day 49 the clock will begin to run again at day 50 on receipt of the information. This brings these sections into line with the transparency directive.

Section 5 is the one causing the most angst to members of the committee. We have all met with representatives of Epilepsy Ireland, which made a very strong case at our meeting last Thursday morning and raised several issues that need to be teased out here. I have also received e-mails from people who, separately from the advocacy role of Epilepsy Ireland, have genuine concerns.

We must take a stand on this issue. I oppose section 5 in view of the fact that none of my amendments were accepted. I cannot accept a section that does not address the concerns that I and many Deputies on this committee, as well as the general public, have. Eminent clinicians are also exceptionally concerned about the issue of bioavailability of particular epilepsy drugs.

In the interest of alleviating concerns - and it is not only a question of concern and disquiet - I cannot in conscience support legislation that overrules strong clinical advice from eminent neurologists and others who are closely associated with this area and who work with patients suffering from epilepsy. Many people make the mistake of thinking that those who are campaigning for the inclusion of our amendments to the legislation support the idea that epileptics must always take advanced drugs and are concerned that they might be moved to generic drugs. However, that is not the case. Many epileptic sufferers use generic drugs already but they are suitable for their condition as they prevent them from going into seizure frequently. The idea is not that all those who suffer from epilepsy are on high-end drugs and that as a result of a change in the legislation they will all be on cheap drugs. That is not their concern. Their concern is that they will not be able to remain on the drugs they are currently on, some of which are generic, and that there may be obligations as a result of the legislation to change from one generic to another generic. That is the clear issue of concern here.

Eminent people, representatives of organisations and professionals have appeared before this committee. We have had numerous representations from individuals who are extremely concerned about this. There are also organisations and advocacy groups representing other patient cohorts which have not raised concerns, because most people subscribe to the idea that we, in our role of overseeing the spending of taxpayers' money, will campaign for the use of generic drugs.

I have considered publishing a Private Members' Bill to ensure that we have generic substitution where possible and feasible. However, with regard to people who suffer from epilepsy, there is a clear body of evidence across the water in the UK. Nothing in section 5 gives me any reason to do other than object to it and call a division. The issue is to do with bioavailability. The Minister knows about this and obviously he has been well briefed on it, but that is the issue of the concern. The fact that we cannot move our amendments to section 5 means that I must oppose the section in its entirety because of the concerns of those on anti-epileptic drugs and the fact that no genuine effort is being made, not to appease them but to address them.

Under Standing Orders, the Deputy's amendment was ruled out of order. The Chair cannot revisit Standing Orders. I call Deputy Ó Caoláin.

I would like to return to the earlier points I made-----

We are dealing with section 5.

-----under section 5 on the issue of anti-epileptic drugs, AEDs. I again record the fact that it is deeply regrettable that we were not able to pursue the amendments we have validly tabled. I would like to share with the committee a case of which I have become aware. The person has epilepsy but it was controlled by the medication he or she was using. It takes some time to get to that point, as it is a matter a trial and error. However, at end of last year a substitute was introduced which had very clear adverse consequences for the person. Such situations are real. It is not a matter of an alleged fear; rather, it is a reality that will present not for all of those concerned but for some of them. It is out of concern for that particular cohort of people who suffer from epilepsy that we had sought to deal with this point.

I am not surprised that the Irish Medicines Board has presented this document to us. It was here when we walked into the room and we did not have prior sight of it. The position was explained by the Chairman; it was not his fault or the fault of the secretariat. This is very much what the Irish Medicines Board would say - namely, that these people are adequately protected and the matter is catered for within the legislation - but I am not buying that. International practice shows us that five member states of the European Union, including our nearest neighbour, already accept and provide for the exclusion of AEDs from such provisions, given the experience and knowledge they have regarding the particular need of those with epilepsy for very refined medication. Make no mistake about it; that should not be a surprise to any of us. The issue of the address of epilepsy is not only for the body but is very much of the mind. This is an area of very particular and specific address and science; it is something not to be played with.

The consequences for people of a resumed attack, an epileptic episode or a seizure are huge. A person who has been seizure-free for a number of years would be able to drive and, hopefully, hold down a job if he or she was fortunate enough to have one. A range of things are immediately turned on their heads if a further event takes place. We need to be cognisant of all of that in our deliberations on this matter.

I again ask the Minister of State to refer to the points I have made in terms of notification. We are talking about five amendments which deal with the ongoing maintenance of the list, etc., and the timeframes with regard to pharmacists, prescribers and the general public. Can the Minister of State elaborate on any or all of that? What about the point in regard to the do-not-substitute requirement, under which the GP is obliged to write in his or her own handwriting a "Do not substitute" message to the pharmacist? Will the Minister of State address that point and the consequences for the pharmacist in that situation? What should the pharmacist do in such a situation as it presents?

With regard to the prescribing of ingredients rather than named products - this applies to those who suffer from epilepsy but also to others - that was something the troika had argued for, and it needs to be addressed. Will the Minister of State advise what his notes in preparation for today's exchange indicate on these matters?

I should have mentioned at the start of the meeting that apologies have been received from Deputy Seamus Healy, who could not be here today.

I echo the comments made by the two previous speakers and do not want to go over them again, but those speakers articulated the concerns, as has the Chairman, that have been given in evidence by representatives of people with epilepsy and in individual representations we have received.

For a person with epilepsy, anti-epileptic drugs are like a pair of shoes. One cannot give someone a different pair of shoes as they may be the wrong size and they may end up taking the feet off them, so to speak. In the case of epilepsy, changing a person's medications can be far more serious because it can have both short-term and long-term consequences. In fairness to Epilepsy Ireland, there is an issue in regard to AEDs. Approximately €75 million per annum is spent on AEDs and, of that, approximately €40 million is spent on one particular drug. The vast majority of people taking that drug are using it to treat neuropathic pain rather than epilepsy. In instances in which a medication is being prescribed specifically to prevent seizures, there should not be the flexibility to replace it, because of the implications it could have for the patient.

It is not just Epilepsy Ireland or those suffering from epilepsy who have said it; the Moran report, published by the Department in 2010, specifically highlights the issue and states it should be excluded from generic substitution. The case has been made in the Upper House and at the committee. If the intention is to ensure there will not be generic substitution for persons with epilepsy, why not provide them with reassurance and include a technical amendment in the legislation to facilitate this?

I asked the same question. Some 40,000 people in Ireland have epilepsy and they are concerned about generic substitutes. Can we do our best to provide more confidence for them? I have friends and family members who have epilepsy and ask the Minister of State to look after them.

I agree with much of what has been said and ask the Chair for some latitude. How can section 13 be of help where a doctor can include on the prescription that the drug prescribed cannot be changed? Is that section a source of comfort for us, in conjunction with section 5?

No one has mentioned those with chronic pain. They receive their drugs and the next step is an epidural, followed by a spinal drug implant - I am not sure what it is called. However, I am concerned that the people I have met - there are thousands around the country - may go from phase 1 to having an epidural and a spinal drug implant. Will they be able to get it? I am talking about cheap drugs. Will section 13 be of comfort in order that people will be able to get the epilepsy drugs they need and that the pharmacy or the Irish Medicines Board will not be able to change them? The Irish Medicines Board states medicines will only be substituted where it is safe to do so. Will it be of help if the prescribing doctor includes on the prescription that the drug prescribed cannot be changed?

I have received an e-mail from a 39 year old woman who is concerned about changing medicines that may cause havoc in coping with epilepsy. Over the weekend I met epileptics who had a difficulty. Part of the difficulty is the confidence factor in making a change. We need to allay the concerns of those who are genuinely upset. We heard from the Irish Epilepsy Association on Thursday and it presented a strong case to us. It is not opposed to the legislation, but there is a fear which is partly due to a disengagement on the part of the Irish Medicines Board from Epilepsy Ireland and partly due to the change in the branding of medication. It is a matter of confidence and familiarity. Deputy Denis Naughten has made the point that when an anti-epileptic drug, AED, is changed, it has a profound impact. We must allay that fear.

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

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

(a) has the same qualitative and quantitative composition in each of its active substances as each of the active substances of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products,

(b) is in the same pharmaceutical form as, or in a pharmaceutical form that is appropriate for substitution for, each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products, and

(c) has the same route of administration as each of the interchangeable medicinal products which currently fall within the group of interchangeable medicinal products.

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

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

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

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

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

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

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

I thank the Minister of State for going through this in such detail. I hope the Irish Epilepsy Association representatives are listening to the committee's deliberations because they should have good grounds for having their confidence enhanced. The Minister of State has gone to a great deal of trouble to tie everything down and to ensure everybody gets the appropriate medicine. He was correct to emphasise the need for us to push for generic medicines because the money being wasted in the State drug payments, which could be easily be used more effectively for other health services, is scandalous and we have to stick to this. I presume if there are problems for epilepsy sufferers in this area following the passage of the legislation, they will be examined. However, it seems to me that the Minister of State has covered everything.

This is an important issue and we have received many representations on this. We have also had hearings and I want clarification. I thank the Minister of State for his response. I again refer to the shoe analogy. If he goes into a shoe shop tomorrow morning to buy a pair of shoes and picks a pair out and the retailer says he has another pair in the same size that look the same but are €20 cheaper, he would not buy them without first trying them on and that is the difficulty for someone with epilepsy. It might say the same thing on the tin and that will be the case because if it is a generic medicine, it will be a substitute for whatever is the market leader. There is a niche in the market and some of the largest players in generic medicine in Europe are based in this country. They are successful and they can see a market leading drug that is coming out of licence. They will manufacture this product, which is supposed to be the same as the product on the market. It would not be a generic medicine if that was not the case. That is grand for 99.5% of the population but there are people who, for one reason or another, will have a reaction to the medicine, possibly because of the way it is formulated and so on. We can identify a cohort of the population who have a problem with generic substitution, that is, epilepsy sufferers.

The Minister of State said section 7(1) provides reassurance that substitution cannot happen if there is a clinically significant difference in the efficacy of the drug. I fully accept that but the difficulty is there is not in many cases a clinically significant difference between the two groups but, on an individual basis, people react differently because of the type of condition epilepsy is and the legislation cannot make provision for this because of the way it is worded and because of its purpose.

The other issue is a greater concern, which we will deal with later under section 13, but it was referenced by the Minister of State in arguing his case. He said in regard to substitution that the IMB will progressively go through a number of different medications and it could be a while before it gets to AEDs or other substitute drugs for epilepsy sufferers. The difficulty is pharmacists are substituting medicines at the moment and they are not even telling the patient that they are substituting the particular medicine.

As stated, we will return to this matter when we come to section 13. However, what I have described is happening. If that is the case and statutory provision has not been made, how can the Minister of State assure us that it will only apply to the 20 target groups in question once the legislation has been enacted? It is already happening, which runs contrary to the provisions in the existing legislation.

I welcome the Minister of State's explanation as to why he cannot or will not accept our views. What he said, however, will not assuage people's concerns. Equally, he did not really address the fundamental issue. I read the relevant passage of the Moran report and it indicates that anti-epileptic drugs, AEDs, cannot be classed as interchangeable in the absence of a critical analysis being carried out of availability and all the other considerations relating to particular medicines. It is fine for the phrase "do not substitute" to be written on prescriptions, but there comes a time when patients find comfort in and benefit from certain drugs, be they generic or otherwise. I refer to those who suffer from epilepsy and the drugs to which I refer prevent them from having frequent seizures. There are no difficulties with many of the other medicines being used by epileptics in the treatment of pain, migraines, etc. Those with epilepsy are specifically concerned about those medicines which prevent them from having seizures. Consultant neurologists and others also have grave concerns about this matter. I am certainly not competent to second-guess their opinions, but I certainly respect these opinions which are very clear and state AEDs should be exempt from the rules on substitution. That is why we should be extremely cautious in the moves we are making in this regard.

The various advocacy groups have not expressed the same concerns as those expressed by Epilepsy Ireland and consultant neurologists about the practice of substituting medicines. Epilepsy Ireland has stated, "However, we are vehemently opposed to any system that will allow for patients currently prescribed a particular brand to be switched from that brand to a generic form of the drug, or to be switched from one generic to another." The issue of concern which arises, therefore, is not switching to generic drugs but rather the concept of switching in the first instance. That is why I will be opposing section 5 in its entirety. I will be seeking all the support I can muster, but my prospects in that regard do not appear very hopeful. Another reason I will be opposing the section is this matter has given rise to huge disquiet.

As the Minister of State is aware, the Moran report - he probably has a copy of it in front of him - contains a recommendation to the effect that AEDs should be excluded from the terms of the promised legislation on generic substitution. That is my clear recall of what is contained in the report which was produced by a joint working group involving the Department of Health and the HSE. The line taken in the report should be both followed and adhered to. As other members and I have stated, the practice in many other jurisdictions - not only in Europe but elsewhere - must give rise to concerns in our proceeding along the course suggested. It is not the case that we should be using trial and error in respect of those who have found stability in their lives in the aftermath of a process of trial and error. The consequences of a misfit for those on anti-epileptic drugs could be absolutely life-changing. That is the real concern.

I am sure that, like me, other members have been advised of specific cases in the not too distant past in which substitution has occurred, perhaps in pharmacies, in the filling of prescriptions. I am not completely clear on whether substitution took place at that point or at the point where such prescriptions were actually written. However, that would be my guess. When substitution occurred, it gave rise to serious consequences. In one instance about which I am very clear, the patient was obliged to return to both their GP and their specialist and put back on the original branded product. In that case, it was not another generic substitute but a branded product. The incident to which I refer occurred at Christmas time. As the Minister of State is aware, when such an incident occurs, a patient must not have a seizure for a full 12 months before he or she can resume driving and a number of other activities. It is extremely important that those with epilepsy and who drive do not have occurrences or events which can significantly impact on the quality of their lives. The risk is too great. We should, therefore, adhere to what is recommended in the Moran report.

It is my view that we should press the amendment, but I do not want a division to occur. I intend no personal criticism of the Minister of State, but there is obstinacy in this matter. I support the Bill and also what it is intended to achieve.

We are dealing with section 5.

This is an exceptional situation which merits an exceptional response.

In the context of Deputy Billy Kelleher's comments, pharmacists do a tremendous job in serving people. I say this lest anyone might be confused by what the Deputy said about the substitution of medicines, etc.

I am somewhat confused about the point the Chairman is trying to make.

The Deputy stated pharmacists substituted products.

I made the point about pharmacists switching products.

I apologise to Deputy Billy Kelleher. It was Deputy Denis Naughten who said it.

I was not questioning the professional competency of pharmacists in the matter. The point I was making was that in the instances to which I referred, pharmacists did not inform customers that they were replacing branded products with generic substitutes. There is provision for this to happen in the legislation, but there is no such provision in the existing legislation.

I again apologise to Deputy Billy Kelleher.

I will try to make my original point in slightly different terms. The Irish Medicines Board will have a central role to play in what is contemplated in the legislation. I do not want any of those present - members, the Chairman and everyone else involved in the legislative process - to react to what I am about to say because it is not intended in a critical way. The point is that we cannot substitute ourselves for the Irish Medicines Board. The board has the relevant expertise in this area; not only that, it will also be required to carry out very robust tests under section 5. No one has said this; in fact, the opposite has been said. I appeal to colleagues not to, as it were, imagine that the Irish Medicines Board cannot be trusted in some way or that we have to keep certain elements of what is proposed away from its control. That would be the effect of providing for a statutory exclusion of a particular drug or class of drugs. We should proceed with the Bill in accordance with the scheme we have put in place and trust and have confidence in the Irish Medicines Board in what we are calling on it to do with regard to AEDs or other drugs.

I wish to make matters absolutely clear in respect of the Moran report. I understand why it might be interpreted as having recommended that AEDs be excluded.

It does not recommend the exclusion of AEDs. The Moran report sets out ten criteria in terms of interchangeability which the Bill reflects. It then 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 the following anti-epileptic medicines … CFC-free Beclomethasone metered dose inhalers, etc.

The report is essentially stating anti-epileptic drugs are examples of the types of drugs that should not be considered for interchangeability. If they are not interchangeable and the report is correct, they would not pass the test as set out in section 5. We are setting out the test which the Irish Medicines Board must observe. I appeal to colleagues to communicate trust and confidence in the board, as Deputy Peter Fitzpatrick said. The legislation sets the statutory basis and it is up to the board to carry out this important work.

Some of my colleagues are concerned that consultant neurologists' prescriptions to treat epilepsy will be superseded by pharmacists giving an interchangeable drug. Will the legislation, particularly section 13, ensure this does not happen?

Section 13 will provide an additional protection to those listed in section 5. Section 13 states:

When a branded interchangeable medicinal product is prescribed for a patient and the prescriber [the doctor] is satisfied that the medicinal product should, for clinical reasons, be exempted from substitution in accordance with Chapter 2, the prescriber shall write, legibly and by hand, “do not substitute” on the prescription beside the name of the medicinal product.

In such cases, the pharmacist must dispense what is written on the prescription and is not permitted to substitute with any product in the same group of interchangeable products. This section offers additional comfort to the robust test that has to be adhered to in the provisions laid down in section 5.

It assumes a doctor will write legibly.

In the example I gave, there is generic substitution. The inclusion of the clarity for which we have been arguing in this legislation will immediately deal with that aspect. There have been recorded consequences. It is hugely important not to wait for the Irish Medicines Board's review and decisions. There is already ample evidence that there is an issue to be addressed and one way to address it, contrary to the Minister's argument, is to place the exemption clearly in the legislation.

Generic products are being dispensed perfectly legally in the system, not improperly. If a medicine is prescribed generically, pharmacists can fill the prescription with the appropriate product. Pharmacists can also supply a parallel-imported product. As matters stand, this is perfectly legal and I am not suggesting it should be otherwise.

I have stated we are dealing with a human situation where people rely on medication to treat epilepsy. Concerns have been raised with us by Epilepsy Ireland and some medical doctors. My officials and I have carefully considered what has been said. I am well aware of the human dimension of this issue and personally aware of cases.

I have received an e-mail from a woman who has had epilepsy since she was 15 years old. While she cannot drive a car and sometimes feels isolated, she believes she must carry on because she is alive, which is a beautiful gift.

Amendment agreed to.

Amendments Nos. 2 to 6, inclusive, have been ruled out of order.

Question proposed: "That section 5, as amended, stand part of the Bill."

Amendments Nos. 2 to 6, inclusive, not moved.

The human dimension cannot be forgotten. In some cases, there may be a number of brands of a product that can be substituted. One can have Mrs. Murphy, for example, receiving brand A for her heart condition for the past six years but receiving brand B one day and brand C on another. This may be only one of her medications, as she could be on 15 tablets for 15 conditions. This switch could confuse her.

Will the Minister of State ensure that if substitution takes place there is some consistency, so that a patient is not switching every month from one medicine to another? That only adds to the confusion.

More important, there is a requirement for measures to be put into the legislation such that the adhesive label that the pharmacist puts on the medicine outlines the particular medical condition that is being treated. At least then, if an individual has 14 or 15 medications and the brand is changed from month to month or every few months, he will know that a given medicine is for his blood pressure or something else, because he will be used to having a medicine from one particular manufacturer. Such an individual understands that a given tablet is for his heart and so on. This is not only to ensure compliance in taking the medication but also to deal with the fact that when that individual visits a consultant and the consultant asks whether he is on anything for his heart, he might say that he does not know because he has 15 different tablets and he is unsure what they are for. Unless that individual brings the bag of medication with him he will be unable to explain the details to the consultant. There is an issue of familiarity with regard to medications prescribed at the moment.

I have no difficulty with generic substitution but there should be some consistency and, more importantly, the exact purpose of any given medication should be put on the label in order that the individual knows he is taking a particular tablet for a given condition. It would facilitate compliance.

We have given this matter a substantive period for discussion.

The Deputy raises some fair points which probably have a broader application to the whole area of drugs and medicines than the area contemplated in this Bill. It is fair to have regard to people's information and knowledge about the drugs they are prescribed. The professionals across the board have an interest in the communication of accurate information to patients and in ensuring that people know what they are taking.

The Deputy makes a fair point about consistency and the need for communication. I will consider more carefully what he has had to say with regard to the broader question as well but I am unsure whether it is something we need to change specifically in this legislation. Anyway, he has made some fair points and given some good insights.

I accept that it is not specific to this legislation, but the difficulty is that the enactment of the legislation will compound an existing problem. I know from first-hand experience that a person will ring up a health care professional and indicate that he is on a particular tablet and the professional will explain that it is for his heart. However, if the medications are being changed frequently then even the health care professionals will not know the details. A small amendment to the legislation could address that and it could be applicable not only to this legislation but across the board. Introducing this legislation without the consumer focus will lead to confusion and problems with compliance from the point of view of citizens and patients when it comes to taking medication.

First, a communications strategy is certainly essential, as I indicated earlier. Second, section 24 is of some relevance to the point raised by the Deputy because it has to do with the intervals between reviews. It is not as if it would take place every week or every couple of weeks. Intervals will be provided for with regard to price reviews.

That relates to the approved list and not to the fact that a pharmacist could administer medicines A, B and C to a patient in three consecutive months. The legislation is weak at the consumer end and it needs to be strengthened.

Question put:
The Committee divided: Tá, 6; Níl, 3.

  • Buttimer, Jerry.
  • Conway, Ciara.
  • Dowds, Robert.
  • Fitzpatrick, Peter.
  • Mitchell O'Connor, Mary.
  • White, Alex.

Níl

  • Kelleher, Billy.
  • Naughten, Denis.
  • Ó Caoláin, Caoimhghín.
Question declared carried.
Section 6 agreed to.
SECTION 7
Question proposed: "That section 7 stand part of the Bill."

Section 7(3) is similar to subsection (3) for the next series in chapter 2 and provides that where medicines for the patient or person acting on behalf of the patient are being substituted, the patient has the option of not agreeing to the substitution. If we take that in the context of the reference pricing that we will come to later, it means that if a patient refuses to take the substituted medicine, he or she will have to pay the difference in the cost.

To return to the point I made earlier, it is important that people are given an explanation of exactly what is happening here in regard to generic substitution. I am concerned that a patient on a medical card will go to the supplier with a list of 14 or 15 prescribed medicines and pay the prescription charge and that he will then be told that medicines A, B and C have been substituted. The patient will be told he can accept the substitution or pay an extra €15, or whatever the charge, if he wants the original brands prescribed. It is important the situation is explained to patients and that they are reassured with regard to the generic medicine they are being given. It should be pointed out to them which medicine is being substituted and its purpose. Time must be given to the patients and they should not be just told that they take the alternative medicines or take their usual ones and get charged extra. The approach used with patients is important. It should not just be a case of telling them that it will cost them if they opt for their existing medicine.

I could not disagree with anything the Deputy has said. Communication is important and it is important the professionals involved, the prescriber and the pharmacist, communicate with the patients concerned so that people know what is being done. When this legislation and new regime are implemented, it will behove everybody involved, particularly the professionals, to ensure there is clarity and communication and that the maximum information and reassurance is given to patients.

Communication is critical to help pharmacists and patients.

Yes, absolutely. I hope also that all of us, as citizens and patients, will be encouraged to take a closer interest in medication and medicines prescribed for people. We have a role as agents of our own health and well-being in this regard. However, the principal responsibility lies with the professionals to ensure there is proper communication on this.

I know Deputy Naughten did not intend it would be taken from his remarks that it was not the practice of the professionals to communicate adequately with clients. We could all attest to the fact that pharmacists in the front line do as a matter of course - this is my personal experience and observation - take the time to engage with clients and present information on prescription fulfilment etc. However, there may be exceptions and situations that do not tick the boxes as well as most do. Therefore, should there be some strengthening of the indication given on this? This should not just apply to pharmacists. GPs may also require a prompt in this regard. Deputy Naughten may elaborate if he was directing this in some other way.

It does no harm to seek that patients be given a full explanation. Nobody in either profession would take offence at that. The critical issue is that patients, now as never before, need to understand the situation, because they are now being presented with a choice that heretofore they never had to make. Taking a little extra time with them and ensuring they have full knowledge and understanding of the change is important. I agree with the sentiment of what Deputy Naughten said, but I feel that is already the practice in the overwhelming number of situations. However, there may be some who need that extra prompt.

Deputy Caoimhghín Ó Caoláin is correct that I am not questioning the professionalism of pharmacists. I believe they do an exceptional job. However, the difficulty is that in many cases what will happen is that GPs will prescribe the active ingredient and the pharmacist will fill the prescription based on the cheapest generic drug available.

The pharmacist is complying with the law in this area as it currently stands and as envisaged in the guidelines set out by the Irish Medicines Board. The difficulty is that it is not actually explained in some isolated instances. I do not really have a concern if somebody is getting a once-off prescription for one or two medications. I am talking about the many cases in which an elderly person - perhaps a relative - is picking up the prescription. If a change is made all of a sudden to a branded product that he or she has always been on and is used to, he or she might get confused. As we introduce this new regime, we need to take time to acknowledge that it will present a particular challenge to a particular cohort of the population. Deputy Ó Caoláin was right to point out that this does not relate to pharmacists only, as it also relates to GPs. I will come to that when we reach section 13.

It is fair to say we are well served by pharmacists across the country. I want to express the committee's gratitude for the work they do. The pharmacists I deal with in Cork city are most professional, caring and considerate. They take the time to talk to patients and focus on those who visit them.

The pharmacists and their representative body are well engaged with what is proposed here. I am quite sure the points made by Deputies Naughten and Ó Caoláin, which I support, about this new environment are being taken on board by them.

Question put and agreed to.
Sections 8 to 12, inclusive, agreed to.
SECTION 13
Question proposed: "That section 13 stand part of the Bill."

I would like to ask a question on section 13. GP surgeries are extremely busy at the moment. They have a huge throughput of patients. When errors are made with prescriptions, the pharmacists pick it up 99.99% of the time. I will give the example of someone with epilepsy. When he or she gets to see a consultant, a prescription will be made after a series of trial and error uses of various medications. The patient and the consultant settle on a particular medication and the consultant writes on the prescription that the medication cannot be substituted for any other generic medicine. That is fine. The patient gets the prescription filled by the pharmacist and off they go. When the patient needs a repeat prescription, he or she goes back to the GP and everything is fine. What happens if, six months down the road, the GP forgets to reiterate on the next repeat prescription script that the medication should not be substituted? Some type of safety net is needed to ensure that a medication which has consistently been used is not substituted all of a sudden if it is not mentioned on the prescription that it is not to be automatically substituted. Some type of safety net is required to double-check that there has not been a change in the prescription.

I will return to a question we considered earlier. The Irish Pharmacy Union has sent us a communication asking us to raise this matter with the Minister. All sorts of circumstances could present themselves if the "do not substitute" notation is not in the handwriting of the prescribing GP. Somebody could devise a brand. Any number of other situations might present. We were invited to ask the Minister to outline what a pharmacist is supposed to do when presented with a prescription that says "do not substitute" in a form other than the handwriting of the prescribing GP. Should the pharmacist send the patient back to the GP if he or she questions the veracity of the message? If the pharmacist ensures the patient's needs are met, can the Minister ensure he or she will not be left open to sanctions from the Pharmaceutical Society of Ireland? It is understandable that such questions are arising in the pharmacy sector. Perhaps the Minister of State can respond to them.

Many different circumstances could arise. Section 13 clearly provides that in order to preclude substitution, the "prescriber shall write, legibly and by hand, "do not substitute" on the prescription". That could leave it open for the patient or someone else to write "do not substitute" on the prescription. I know that would be of concern. Is there a way of addressing that? Is a sanction being provided for? I would also like clarity on what will happen in the event of a pharmacist being unsure of the authenticity or veracity of a handwritten note that says "do not substitute". What mechanism will be available to the pharmacist to address such concerns? Will he or she be able to pick up the telephone and ring the prescribing doctor, or will the patient have to go back to the GP? I am asking these questions because it is clear that many people are attached to the medicines they are on. We all know people who only want the blue tablet or the green tablet and no other colour tablet will do them. If, after we include this provision in legislation, a doctor makes a clinical decision that the person's medicine is suitable for substitution, it will be very easy for a patient to write "do not substitute" on the prescription in nice legible handwriting to ensure no change is made. As the Minister of State knows, such handwriting is totally different from medical handwriting. Obviously, that should be an offence. I am concerned to ensure pharmacists who sense that a prescription has been amended will be able to take action to confirm the authenticity of the request. If they find it is not an authentic request while they have the prescription at hand, will they be able to override it by means of verbal contact with the prescribing GP?

Obviously, we all accept and acknowledge that human error can occur occasionally. We live in a human world where errors can occur. It should be emphasised, leaving aside this legislation completely, that the high degree of reliance we place on the professionalism of those involved in our prescriptions system - doctors, consultants, GPs and pharmacists - is well repaid. I think we can all agree that the instances of human error causing something bad, dangerous or worse to happen are few and far between. I have no reason to believe that will change under this regime. I would like to consider some of the issues that have been raised in a little more depth. Deputy Ó Caoláin asked about the recourse pharmacists might have in particular scenarios to which they might be exposed. I will consider that and revert to the Deputy. It is important to draw attention to section 15 of this Bill, which gives us some comfort in this regard. It states:

Nothing in this Part shall be construed to affect a pharmacist's discretion, when presented with a prescription, to not dispense, whether temporarily or permanently, a medicinal product in accordance with the prescription (including any substitute medicinal product) if, in his or her professional opinion as a pharmacist, the use of the medicinal product by the patient for whom the prescription was issued may be prejudicial to the health of the patient.

I have an amendment in this regard with which we will deal shortly. That gives, as it were, a statutory basis for the pharmacist to pause and say, "No. For a specific reason, I do not think it is appropriate to dispense a particular medication." That provides some comfort.

While I do not make little of the issue, there is always the risk of the falsification of a prescription in particular circumstances. To be honest, I do not know whether it is an offence, but I will risk saying that I imagine that, under the relevant legislation, it is unlawful to falsify a prescription. However, I will check for the Deputy.

The point comes back to the issue raised by Deputy Denis Naughten and others that we have a proper information campaign and a proper communications strategy in this regard in order that people will have the confidence to know this new system will work and contains protections.

I am not concerned so much about its lawfulness or otherwise. However, in the event that the pharmacist has a concern about a prescription, about the veracity of the signature or the “do not substitute” requirement, is the Minister of State suggesting section 15 will provide enough comfort for pharmacists?

We are dealing with section 13.

Yes, but I offered section 15 as a possible answer to some of the issues the Deputies reasonably raised. I have to be honest and say I had not considered the specific issue raised by the Deputy. It has just occurred to me that, on a reasonable reading of section 15, it is helpful in dealing with the issue he has raised.

The Minister of State might take note of it. I have raised the issue and may consider it again before Report Stage.

I will consider it.

My point is that illegible writing by a doctor should not necessarily be a problem because he or she could print his or her name rather than use a signature. How is a pharmacist meant to know in such cases? If a pharmacist has a suspicion, is there some method he or she could use to contact the prescriber to find out whether the request is correct, or does he or she have to send the patient back again?

Have consultations taken place with the members of the IPU? We met them individually, though not in committee, and they raised issues in this regard, as Deputies Billy Kelleher, Denis Naughten and Caoimhghín Ó Caoláin have mentioned.

I strongly disagree that section 15 will provide comfort for pharmacists.

I ask the Deputy to stick to this section. There is an amendment to follow.

The Minister of State made the link. It is my strong view that section 13 will not comfort pharmacists. It comes back to the myriad situations that can present. It is important, in giving effect to their professional judgment, that there be a degree of cover or comfort for pharmacists in order that, in the event that something is other than what was intended, they would be covered. If we are trusting their professional opinion, on which we do not have a question, any number of situations might present in meeting the “do not substitute” requirement. Section 15 only refers to adverse consequences, which is not what we are talking about here in regard to generic substitution, apart from the very important exception of epilepsy which we have spent a lot of time discussing.

I have referred to section 15 which I respectfully suggest is relevant. However, perhaps more relevant to what the Deputy is raising is what is included in section 12 which provides that there be no liability on the part of the pharmacist with regard to substitution in the circumstances set out in the section. That is highly relevant in terms of the concern raised by the Deputy. We will consider the issues raised. We have had contact with the IPU on these matters and------

The IPU briefed members before this meeting on its concerns which are being addressed.

We will certainly revisit these issues with the IPU.

There is a straightforward issue on payment. Pharmacists may have concerns where they do not dispense the medicine included in the prescription and overrule owing to sound professional judgment. What will be the position on payment under the reimbursement scheme?

Section 12 gives protection in respect of any liability or action conceivably being taken against the pharmacist or the prescriber. I repeat that section 15 is relevant in that it gives discretion to the pharmacist when presented with a prescription.

We will deal with section 15 shortly.

SECTION 15

Question put and agreed to.
Section 14 agreed to.

I move amendment No. 7:

In page 22, to delete lines 19 and 20 and substitute the following:

"prescription ought not to be dispensed because to do so may be prejudicial to-

(a) the health of the patient for whom the prescription was written, or

(b) the health or safety of members of the public.".

Pharmacists have a concern which I have expressed and the Minister of State has dealt with, although perhaps not to my satisfaction. In the dispensing of medicines a pharmacist may have concerns when a person with a “do not substitute” request arrives at the pharmacy. They may not have to do with the authenticity of the “do not substitute” request but with the medicines listed on the prescription. Can the pharmacist overrule the prescription of the doctor based on sound clinical professional judgment? What mechanism is in place for reimbursement?

We are dealing with section 15 and I am not sure whether I should deal with my amendment now.

Yes, the Minister of State should.

As we have been discussing, the purpose of section 15 is to ensure requirements regarding generic substitution do not affect a pharmacist's discretion not to dispense a medicinal product. As drafted, the section is explicit in its expectation that the pharmacist's professional opinion will inform the decision to dispense on the grounds of the health of the patient. However, in practice, under the current regulatory regime, one of the most common situations where a pharmacist might refuse to dispense a prescription is where the pharmacist has a concern that the person presenting the prescription may be planning to sell or supply the medicines to other individuals or on the street. In this case, the pharmacist would usually refuse to dispense the prescription, not necessarily on the basis of a concern for the health of the person named on the prescription but on the basis of concern for the safety of others and the integrity of the supply chain.

The pharmacy regulator, the Pharmaceutical Society of Ireland, expressed concern that the scope of section 15 ought to be broadened to explicitly provide that a pharmacist would not dispense a prescription if he or she had a genuine concern that dispensing the prescription might put others at risk. I am, therefore, proposing to amend the section to broaden its scope to take into account the obligation of the pharmacist not to dispense a medicine included in a prescription on the basis that it may cause harm to the health of the patient named on the prescription or the health and safety of any member of the public.

We are concentrating on the issue of anti-epileptic drugs, AEDs, but there is a broader issue in regard to benzodiazepines and many other drugs. The country is awash with these drugs and there is over-prescribing. Let us be clear. They are being prescribed legally, but they then find their way into the underworld where people sell them on. This is an issue of huge concern.

I have made this point before. Pharmacists have spent seven years in college and are highly qualified professionals. As a society, we do not trust them enough.

We always have to look to the GP who prescribes and whose view is sacrosanct. This is fine. Let there be a pecking order, but I passionately believe that pharmacists should have a greater role to play in the health of the nation. They are in every town and village and are a great resource and highly professional and qualified. I am very concerned that medications such as benzodiazepines are being slushed around society at a fierce pace. Documentaries have covered this, but as practising politicians, we are all aware that it is clearly a major issue. Anything that can put checks and balances on prescriptions is a good thing because it might discourage some GPs from over-prescribing, and there is a propensity among some GPs to over-prescribe these medicines, particularly benzodiazepines.

The Minister of State's observations on section 12 and my previous concerns are acknowledged. The case relating to this amendment is valid and stands on its merit. I wish to record my acceptance of it.

Deputy Kelleher is right in that we as a nation and society need to look at over-prescribing. If a survey was carried out in every house, it would probably find cupboards full of half-used bottles of tablets or prescription medicines. I am not a pharmacist but the people with which I deal in Cork are the most professional, thorough and caring people and a huge resource within society that is perhaps undervalued, as Deputy Kelleher said. An individual I know who works in a pharmacy takes time to deal with people. I would love if the Government would look at the issue of over-prescribing.

I totally agree with the Chairman. I received a worrying text. When we talk about a prescriber in respect of epilepsy-----

Is this on section 15?

Yes, it is. Are we talking about GP prescribers? I spoke in particular about neurologists, but when a GP writes that a prescription cannot be substituted, does that hold the same weight as a prescription written by a neurologist? I received a text saying that it did not. Could the Minister of State clarify matters?

It most certainly does. "Prescriber" includes a GP.

Persons with the power to prescribe include GPs. I share Deputy Kelleher's concern about benzodiazepines, which Deputy Ó Caoláin and others share. In respect of the Chairman's comments about pharmacists, we are enhancing the role and strengthening the hand of the pharmacist. With regard to pharmacists declining to dispense, there was a concern that this would affect the health of the individual patient tendering the prescription, but we are now expanding the basis upon which the pharmacist can decline to fill the prescription where there is a broader concern about the health and welfare of others. That comes back to the point about benzodiazepines.

Section 15, as amended, agreed to.

Amendment agreed to.
Sections 16 and 17 agreed to.
SECTION 18

Amendment No. 8 was discussed with amendment No. 1.

I move amendment No. 8:

In page 24, subsection (3)(b), lines 33 and 34, to delete all words from and including "the" in line 33 down to and including "run" in line 34 and

substitute the following:

"the running of the period of 180 days referred to in subsection (2) is, upon the giving of the notice referred to in paragraph (a) to the applicant, suspended".

Amendment agreed to.
Section 18, as amended, agreed to.
SECTION 19

Amendments Nos. 9 and 10 are related and will be discussed together.

I move amendment No. 9:

In page 25, subsection (1), line 27, after "decision" to insert "and to prescribers and pharmacists".

If the Minister of State cannot accept this amendment now, he should go away, take some advice and consider it for Report Stage. I do not mean that in a disparaging way. There is no reference to prescribers and pharmacists in this section. For example, if something is removed from the list, there is an obligation for the Health Service Executive to notify the manufacturer, but it has no obligation to notify prescribers or pharmacists. This could present difficulties. For example, a prescriber or pharmacist may be blissfully unaware that a product has been removed from the list and may continue to prescribe or stock it. Surely they should be informed at the same time as the manufacturer, as a matter of logistics? Pharmacists would need to secure other types of medication similar to that item and hold them in stock. If they are not informed they may not do that, so patients going to their local pharmacists on a regular basis may have to wait a number of days or go elsewhere if the pharmacist is unaware that this product has been removed from the list. That is the primary purpose of this very logical amendment. I hope that if he cannot accept it today, he will consider it in the broader context of Report Stage.

I support amendments Nos. 9 and 10. I do not know if the phrase should go immediately after "decision"; I would opt to put it in after the reference to the supplier of the item. The case is irrefutable. Maximum dissemination of information is hugely important. Prescribers and pharmacists are key players in all of this. We are talking about maintenance and ongoing amendments. Decisions are made in respect of either new medications or other medications that for whatever reason are to be removed. Strengthening and improving the legislation is a requirement. The IPU has made the case strongly in support of these amendments. The Minister of State should be aware of that from his engagement with it. The purpose of this is to help ensure maximum awareness and the greatest safety not only for those who are prescribers and pharmacists but, most importantly, for end users.

I propose to take amendments Nos. 9 and 10 together. Part 4 of the Bill sets out statutory procedures concerning the supply and reimbursement of medicines and other items to patients under the general medical scheme and community drugs schemes. Section 19 of the Bill sets out the action to be taken by the HSE where it makes a relevant decision under section 18 of the Bill, namely, 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 the list. Section 19(1) provides that, as soon as is 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 that is the subject of the relevant decision. Section 19(2) provides that where the HSE has used any expert opinion or recommendation in reaching such a decision, it shall attach a copy of all such expert opinions or recommendations to the notice of the decision provided to the supplier under section 19(1).

Deputy Kelleher is proposing to amend section 19(1) to provide that notice of a relevant decision in respect of an application from the supplier of an item which is the subject of the relevant decision be also supplied to prescribers and pharmacists. Deputy Kelleher is further proposing to amend section 19(2) to provide that any expert opinions or recommendations provided to the supplier under this subsection should also be provided to prescribers and pharmacists.

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 listed item which is the subject of said decision, I consider that Deputy Billy Kelleher's proposed amendments are not really relevant to section 19. In such circumstances, I do not propose to accept them. I draw the committee's attention to the fact that 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 prescribers and pharmacists. What we are dealing with in section 19 is a slightly narrower part of the regime where when an application is made by a supplier, there are certain requirements on the HSE to revert, within particular time periods, to that supplier in respect of any decision it makes. I am not sure whether the amendments relate to what is proposed in the section.

I differ with the Minister of State in his interpretation. Section 19 relates to the action to be taken by the HSE in circumstances where it makes decisions in respect of the provisions contained in section 18 which relates to the maintenance of the reimbursement list. That list will be updated from time to time and products will be added to, retained on or deleted from it. There are myriad reasons products may or may not be on the list. There are certain products which may have been on the list but which will now be removed from it. Prescribers and pharmacists should be informed when particular products are removed from the list and they should be made aware of the reasons for their removal. Let us consider the case of a person who is normally prescribed a particular medicine and may go to his or her GP, obtain a prescription and present it to the pharmacist to be filled. The pharmacist will then give the individual involved the relevant medicine while remaining blissfully unaware that it has been removed from the list. Surely there must be some mechanism by means of which prescribers and pharmacists can be informed. Am I completely missing something?

I accept that there will be a list. However, prescribers and pharmacists should be informed when a product is being taken off or added to it. Will GPs and pharmacists be required to go online each morning or afternoon to see what has been added to or deleted from the list? The list of various products to which we are referring is huge. In order to ensure there will be a full flow of information, when products are added to or deleted from the list, the HSE should issue - probably by electronic means - a circular advising dispensers and prescribers of the changes made. That would make absolute sense.

While it is not contained in the wording of Deputy Billy Kelleher's amendments and in order to guarantee the full dissemination of information, the IPU and the IMO should also be informed of any change. These are normal steps which should be taken in this regard. I have no particular knowledge of the extent of items being added to or deleted from the reimbursement list. However, I am well aware that many medical card holders were seriously discommoded when the decision to remove from the list all coeliac targeted products - that is, those which are gluten free - was taken last year. It is all very well to state it was cheaper for those who did not have medical cards to purchase such products in supermarkets, but what was done had an extremely serious impact on medical card holders in straitened circumstances in accessing gluten free products. The consequence has been that many pharmacies with which I am familiar have significantly reduced the number of such products they stock. The products to which I refer were sold in pharmacies for a purpose. I accept that they may not appear on the shelves of pharmacies in the future and that supermarkets may corner this part of the market. However, the decision to which I refer is continuing to have a serious impact on coeliacs throughout the country.

This is one of the footprints in time of our very being as a people. This is a very serious matter and it is most regrettable that the Government did not accept the arguments to the effect that it should not have proceeded with the change to which I refer. I instance this matter only to illustrate what can happen. I suggest, not through a further amendment but rather in the context of the common sense of what Deputy Billy Kelleher is arguing for, the IPU and the IMO be included.

I retain my respectful view that section 17 deals with the maintenance of the list. The Deputies may well have raised an issue in respect of which I could perhaps seek further clarification between now and Report Stage as to precisely the technical process by which changes are made to the list. Deputy Billy Kelleher inquired as to whether prescribers and dispensers would be obliged to consult the list online each day. It would make some sense if the relevant website issued automatic notifications of changes to the list, rather than it just being a case of the list being changed.

I understand the point. However, section 19 deals with the process by which the HSE will make decisions and revert to suppliers on such decisions. I respectfully suggest that what Deputy Billy Kelleher proposes in his amendments is excessive and unnecessary, particularly if he is advocating that all prescribers and pharmacists and, as Deputy Caoimhghín Ó Caoláin recommended, the IMO and IPU be individually notified, either by post or e-mail, of any changes which occur. I accept and understand the fair point which has been made on people being notified that the list has changed rather than being obliged to continually to check to see if changes have been made. Perhaps a specific notification might be included on the website, to which people would be periodically referring, to draw attention to the fact that changes have been made. I will certainly consider the matter before Report Stage. However, I am not minded to accept the amendments.

I have no wish to be divisive in this matter and thank the Minister of State for his commitment to the effect that he will consider it prior to Report Stage. However, section 19(2) states:

Where the Executive has made a relevant decision based on any expert opinions or recommendations, it shall attach copies of all such opinions and recommendations to the notice concerned under subsection (1) to be given to the supplier of the item or listed item the subject of the relevant decision.

That is fine, but the relevant information should be available to prescribers and pharmacists. In other words, they should be alerted to the fact that certain products have been added to or removed from the list. The information to which I refer should be made available online or disseminated in some other way. I have made my case. I accept that the Minister of State may have concerns about the volume of information involved, but when a product is removed from the list, people should be notified. At the very least, there should be an alert system on the website to indicate that certain products are no longer on the reimbursement list. Let us ignore for one moment the fact that pharmacists and doctors will be discommoded and concentrate on circumstances where a particular product might be prescribed and the GP or pharmacist involved is not aware of its removal from the list. The very fact that these professionals have not been informed will give rise to difficulties for the consumer. I ask the Minister of State to re-examine this matter.

Amendment put and declared lost.

I move amendment No. 10:

In page 25, subsection (2), line 32, after "decision" to insert "and to prescribers and pharmacists".

Amendment put and declared lost.

I move amendment No. 11:

In page 25, lines 33 to 36, to delete subsection (3) and substitute the following:

"(3) The Executive may—

(a) in the case of a relevant decision which falls within paragraph (a) or (e) of the definition of "relevant decision" in subsection (8), specify a date, or the occurrence of an event, from which the relevant decision shall take effect, and

(b) in the case of a relevant decision which falls within paragraph (d) of that definition, specify a date, being a date after the expiration of the period of 28 days immediately following the Executive's compliance with subsection (1) in respect of the relevant decision decision, from which the relevant decision shall take effect.".

As drafted, section 19 provides that the HSE shall give notice in writing to the supplier of the item of relevant decisions it makes on the reimbursement list.

Subsection (3) provides that the HSE may specify a date for the implementation of decisions to add items to or remove items from the list. I am proposing to amend this subsection to provide for a minimum notice period of 28 days before items are removed from the list. I consider that this is a reasonable notice period that will facilitate both patients and the pharmaceutical supply chain.

Amendment agreed to.
Section 19, as amended, agreed to.
Section 20 agreed to.
SECTION 21

I move amendment No. 12:

In page 27, subsection (2), lines 28 to 30, to delete paragraphs (d) and (e) and substitute the following:

"(d) the potential budget impact of the item if it were to become a listed item,

(e) the ability of suppliers of the item to meet patient demand for the item if it were to become a listed item,

(f) the resources available to the Executive, and

(g) the terms of any agreement in place (whether entered into before, on or after the commencement of this section) between the Executive and any representative body of the suppliers of drugs, medicines or medicinal or surgical appliances where the agreement relates, whether directly or indirectly, to the price of the item.".

Section 21 sets out the criteria to be taken into account by the HSE when it is considering the proposed price of an item for inclusion on the list of reimbursable items. To address concerns regarding the need for the HSE to safeguard continuity of supply when setting prices, I am proposing to amend section 21(2) to add "the ability of suppliers of the item to meet patient demand for the item if it were to become a listed item," to the list of criteria to which the HSE must have regard when setting a price for an item. I am satisfied that this amendment is necessary, given the difficulties experienced by some countries in securing an adequate supply of necessary medicinal products following price reductions. This proposed amendment brings section 21 into line with section 24, which already provides that the HSE must have regard to this criterion when setting a reference price for a group of interchangeable medicinal products. In addition, I am also proposing to amend this section to include a reference to agreements such as those recently agreed with the Irish Pharmaceutical Healthcare Association, IPHA, and the Association of Pharmaceutical Manufacturers in Ireland, APMI, to ensure that the State can continue to benefit from price reductions contained in those agreements.

Amendment agreed to.
Question proposed: "That section 21, as amended, stand part of the Bill."

I have a question. I ask the Minister of State to tell us why the welfare of the patient is not included in the criteria listed in section 21.

I refer to paragraph (c), which deals with the potential therapeutic benefits of the item for patients likely to use the item if it were to become a listed item. It seems to me that this addresses the issue.

I do not know that it does what the Minister of State suggests. I refer to the therapeutic benefits of the item for patients who are likely to use the item, as against the welfare of the patient.

We are considering the aspect of the patient's welfare with regard to the effect or impact of particular drugs. It is the potential therapeutic benefit of the item for the patient who is likely to use it.

As I have raised this issue now, if the Minister of State has no further comment to make on it, an amendment may be tabled on Report Stage if a member was of the opinion that this would be helpful.

I draw the attention of the Deputy and the committee to Part 3 of the Schedule setting out general criteria, wherein it is stated that the executive shall have regard to the health needs of the public.

Question put and agreed to.
Sections 22 and 23 agreed to.
SECTION 24

I move amendment No. 13:

In page 28, subsection (3), lines 39 to 41, to delete paragraphs (d) and (e) and substitute the following:

"(d) the relevant prices of therapeutically similar listed items,

(e) the resources available to the Executive, and

(f) the terms of any agreement in place (whether entered into before, on or after the commencement of this section) between the Executive and any representative body of the suppliers of drugs, medicines or medical or surgical appliances where the agreement relates, whether directly or indirectly, to the price of one or more of those items.".

Section 24 outlines the criteria to be taken into account by the HSE when it is setting or reviewing a reference price. As already proposed for section 21, I propose to amend section 24(3) to include a reference to agreements such as those recently agreed with the IPHA and the APMI to ensure that the State can continue to benefit from price reductions contained in those agreements.

SECTION 26

Amendment agreed to.
Section 24, as amended, agreed to.
Section 25 agreed to.
Question proposed: "That section 26 stand part of the Bill."

An issue has been brought to my attention recently with regard to UK citizens who are holders of medical cards. What are the implications, if any, for UK holders of medical cards in terms of their access to the general medical service? Will they be liable for the same charge as anyone else? I ask the Minister of State to clarify the agreement between Ireland and the UK. Is a person who is in possession of a medical card on foot of the agreement liable for the prescription charge? Such people are currently being charged.

I can reply in the affirmative to both questions.

The circumstances will be same for UK citizens. At the moment they are legally liable for the prescription charge, just as everyone else is.

That is my understanding.

Question put and agreed to.
Sections 27 to 31, inclusive, agreed to.
SECTION 32

I move amendment No. 14:

In page 34, lines 1 to 4, to delete paragraph (c) and substitute the following:

"(c) in section 35(1) by inserting the following after paragraph (e):

"(ea) a failure to comply with Chapter 2 or 3 of Part 2, or Part 3, of the Health (Pricing and Supply of Medical Goods) Act 2013,

(eb) a failure to comply with any duties referred to in section 18(1A) imposed on the pharmacist by regulations made under section 18.",

and

(d) in section 36(1)—

(i) in paragraph (a), by deleting "and 2006, or" and substituting "and 2006,",

(ii) in paragraph (c)(ii), by deleting "paragraph (b)." and substituting "paragraph (b)," and

(iii) by inserting the following after paragraph (c):

"or

(d) the pharmacy owner has failed to comply with any of the duties referred to in section 18(1A) imposed on the pharmacy owner by regulations made under section 18.".".

Section 32 of the Bill as drafted provides for amendments to the Pharmacy Act 2007 to ensure compliance with the relevant provisions of this Bill. Section 7 of the Pharmacy Act is amended to ensure that it will be a function of the Pharmaceutical Society of Ireland, PSI, to ensure that pharmacists operate generic substitution in accordance with the legislation. Section 18 of the Pharmacy Act is amended to allow for the making of regulations imposing duties on pharmacy owners and supervising pharmacists to supervise compliance by pharmacists with the generic substitution provisions. Section 35 of the Pharmacy Act is amended to include failure to comply with the generic substitution provisions as a ground for complaint against pharmacists.

I am now proposing to further amend section 35(1) of the Pharmacy Act 2007 to provide that a failure by a pharmacist to comply with regulations made under section 18(1A) of the Pharmacy Act, as inserted by section 32(b) of this Bill, will constitute a ground for complaint. I am also proposing to amend section 36 of the Pharmacy Act, which refers to complaints about registered retail pharmacy businesses.

The amendments at 36(1)(i) and 36(1)(ii), are technical amendments recommended by the Parliamentary Counsel. These are to ensure that the terminology here is in line with standard usage. The substantive amendment at subsection (d)(iii) provides that failure by a pharmacy owner to comply with any of the duties referred to in section 18(1A) of the Pharmacy Act 2007 will constitute a ground for a complaint. This provision addresses concerns that section 32 as drafted places an unfair burden on pharmacists when compared to pharmacy owners. This amendment will allow pharmacy owners to be held accountable for breaches of duties to supervise compliance with the generic substitution provisions of this Bill.

Amendment agreed to.

Question proposed: "That section 32, as amended, stand part of the Bill."

I may consider an amendment on Report Stage, although this may not be technically possible. I refer to section 14(1)(f) of the Pharmacy Act 2007, under which a bankrupt will be removed from the register of pharmacists. Is this absolutely necessary? While one may be bankrupt, it is not a corollary that one is incapable of dispensing medicines or seeking employment with another pharmacist. Why is it necessary to strike an individual off the register as a result of bankruptcy? A pharmacist will have spent seven years in college to earn his or her qualifications but his or her business may go pear-shaped. Why should a pharmacist lose the right to practise if declared bankrupt?

I want to examine the matter in the context of tabling an amendment to deal with the specific issue under section 32 and in view of the fact that the Minister of State referred to the Pharmacy Act 2007. It strikes me as bizarre. I presume that if a GP is declared bankrupt he or she is not struck off a register. Does it happen to a dentist? If a nurse goes bankrupt is he or she struck off the register of nurses?

It does happen if one is a Deputy.

There is a lot of stress in society because many people have gone bankrupt or will end up bankrupt for many reasons. Just because a pharmacist is bankrupt does not mean that he or she is incapable of dispensing medicines for somebody else. I understand why he or she might not be allowed to establish a business under company law but he or she should be allowed to take up employment.

I have not given prior consideration of the matter and the Deputy's point sounds relevant. No malpractice is suggested and that must be the clear critical determinant of whether somebody is suitable to practise as a pharmacist. It is without question that in times such as these situations can present that nobody could ever have planned for or catered to. It is within the bounds of possibility that a person could find himself or herself bankrupt. Pharmacy is a very competitive sector. There are a significant number of pharmacists in my home town yet a new one has opened in the past week. I was stunned because the new pharmacy is located next door to an existing outlet. The sector is almost at saturation point and not everybody can survive. Deputy Kelleher has made the reasoned argument that failure to succeed in an economic situation does not suggest inappropriateness to continue as a professional in the sector. A valid case must be considered here. The Minister of State probably knows more than me about the matter and he might consider the matter for Report Stage.

That could only arise if we gave a broader consideration to the Pharmacy Act 2007 than we are here which is relatively narrow. We are talking about certain duties that pharmacists must undertake in order to comply with the provisions of the Bill. A failure to comply with the provisions of the Bill could be the subject of complaint made under the Pharmacy Act 2007.

The question of bankruptcy as grounds for being struck off is wholly unrelated to the legislation that we are dealing with today. It might be the basis for an interesting discussion on whether bankruptcy should be grounds for being struck off for any of the professions. The matter does not arise today.

Can the Minister of State make a technical amendment for same? He is amending the Pharmacy Act 2007.

It would not be germane to the legislation.

I can assure the Minister of State that I have seen stranger things happen when legislation passed through the House and over many years.

That may be so.

Was the Deputy party to those strange happenings?

I have been part of them. I am quite sure that people who were there were also part of them from time to time. I wanted to raise the matter because I wanted to examine the issue. It is not too often that we have an opportunity to raise an issue. The provision to have a pharmacist struck off merits exploration in view of the two points that were made.

To be clear, I do not propose to introduce an amendment to the Pharmacy Act 2007 regarding the issue of bankruptcy in the context of this legislation.

Question put and agreed to.
Sections 33 to 35, inclusive, agreed to.
SECTION 36
Question proposed: "That section 36 stand part of the Bill."

I wonder why the Irish Medicines Board is changing its name. Deputy Mitchell O'Connor drew my attention to the matter.

I raised the matter with the Deputy. Will the name change cost money? It costs money to change the headed paper and everything else.

The name is being changed to bring the board more in line with its extended functions. It will take account of the additional powers and requirements set out in the Act. It is more appropriate for the board to be known as the health products regulatory authority and thus take account of its new functions. It will include medical devices in general. The title "health products" has a broader remit.

I had not considered the costs but I take the point raised by Deputy Mitchell O'Connor.

Question put and agreed to.
SCHEDULE 1

I move amendment No. 15:

In page 36, between lines 33 and 34, to insert the following:

“5. In respect of medicines already included within a group of interchangeable medicines subject to an immaterial change, the materiality of which shall be determined by the Board, such medicines may be exempted by the Board from the notification requirements as set out at paragraph 2.”.

I await the Minister of State's reason for his non-acceptance of my amendment.

I was going to wait and listen to the basis for the Deputy's proposal because it was not entirely clear to me. Schedule 1 sets out procedural provisions relating to certain decisions of the IMB and HSE under the Bill.

Part 1 of the Schedule refers to the procedural provisions relating to the requirement, set out under section 6(1), that the IMB give notice in writing of a relevant decision made under section 5, together with the reasons for the decision to the relevant marketing authorisation holder, MAH. Paragraph 1 of Schedule 1 provides that where the board proposes to makes a relevant decision, it shall give notice in writing of the proposal to each person it would, if the proposal were implemented, be required under section 6(1) to give notice to. As a consequence, the board is obliged to give notice in writing to all authorisation holders of products already included in a group of interchangeable medicinal products of a relevant decision that proposes to change the composition of the group of interchangeable medicinal products. All proposals by the board in this context are therefore material decisions for the purposes of Part I of Schedule 1. It is unclear what would be an immaterial one, they are all material. In those circumstances, I do not propose to accept the amendment.

My amendment refers to material change, some of which would be so insignificant in terms of the broad thrust of what is required for modifications, etc. The Minister of State's power of persuasion knows no bounds.

Amendment, by leave, withdrawn.
Schedule 1 agreed to.
SCHEDULE 2
Question proposed: "That Schedule 2 be Schedule 2 to the Bill."

In terms of oversight in the Bill, the Taoiseach said in New York, or through his spokesperson, that he was now hands-on in the Department of Health. Is there a reference to the Taoiseach's obligations in the Schedule?

The Deputy's question is not relevant to the section but nice try.

Question put and agreed to.
Schedule 3 agreed to.
Title agreed to.
Bill reported with amendments.

I thank the Minister of State, Deputy Alex White, Ms Cody and Mr. Cregan for attending. I also thank Deputies Billy Kelleher and Caoimhghín Ó Caoláin and other members of the committee for their participation. I thank Deputies Robert Dowds and Mary Mitchell O'Connor for their patience and staying with us. I congratulate the Minister of State on bringing his first Bill before the committee.