Mary Butler (Waterford, Fianna Fail)
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I thank the members for attending. This legislation, when enacted, will achieve a number of aims. First, it will provide for an exemption of rent-a-room income of up to €14,000 per annum to be disregarded from the medical card and GP visit card income assessment process. Second, it will amend current legislation to clarify regulatory powers concerning the supply and administration of medicinal products. Third, it will provide for the establishment of regulations to help deal with shortages of medicinal products by way of the introduction of a medicines substitution protocol, MSP. This will include a framework for therapeutic substitution by pharmacists in line with a clinically approved protocol, in other words, the supply of a specified therapeutic alternative medicinal product in limited circumstances, where there is a shortage of a prescribed medicine.

In addition to the amendments already proposed, we also wish to introduce a new amendment at this juncture that will further help us to prevent and manage shortages of medicinal products and improve security of supply. The proposed amendment, which I will outline later in further detail, introduces reporting obligations for actors in the medicines supply chain and allows this information to be used as part of our national approach to prevent shortages and where they occur, to mitigate their impact.

Having taken on board the comments previously raised at past meetings on this Bill, I wish to inform the committee that the Government is in the process of finalising a further amendment to facilitate pharmacist prescribing, which members will all welcome. This is to be introduced on Report Stage in order to be included in this Bill. This will take the form of a further amendment of the Irish Medicines Board Act 1995 to introduce a regulation-making provision that will enable the Minister for Health to make regulations that will enable pharmacists to prescribe.

As the committee is aware, in July 2023, the Minister, Deputy Donnelly, established the expert task force to support the expansion of the role of pharmacists in Ireland, whose first recommendation to extend prescriptions is now in operation. The task force is now addressing the introduction of pharmacy prescribing, of which part will encompass the capacity of pharmacists to assess a framework of agreed minor ailments, with underpinning protocols. By enabling pharmacist prescribing, we open doors for the healthcare service. We empower pharmacists to leverage their unique expertise, take on expanded roles in patient care and play a more integral role in our healthcare teams. We enhance patient access to vital medications, reduce healthcare costs and improve health outcomes for individuals and communities.

It is crucial to emphasise that the implementation of this amendment to introduce prescribing hinges on several key enablers, including education, training, guidance from our regulators and any additional necessary support systems. These foundational elements will be put firmly in place as part of the introduction of pharmacist prescribing. Behind every prescription, every medication and every healthcare decision lies a patient, a person in need of care, compassion and support. It is our duty to ensure they receive the highest standard of care possible.

This authority will be subject to the appropriate framework being in place and will operate in tandem with the safeguards provided for in other legislation, including the following: conferring authority for accreditation and quality assessment of the training; operating in conformance with the applicable standards of care expected and the current fitness to practice and code of conduct requirements as set out by the Pharmaceutical Society of Ireland; and providing for a defined regulatory governance structure to be applied to the settings within which the prescribing activity occurs.

David Cullinane (Waterford, Sinn Fein)
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This section proposes to exclude rent-a-room relief from the assessment of needs, which I support. I want to make a wider point that I also made in my Second Stage contribution. In my view, there is a need to look at the whole area of medical cards and where we are going from here. There have been some moves, which I recognise and support, in regard to providing additional free GP care for a section of the population but we have not reviewed medical card eligibility for nearly two decades.

The income thresholds are way too low. We can see that ourselves. We all see it in our clinics when people come to us about reviews of medical card entitlements and there are means assessments and so on. I believe it has to be the next phase of how we roll out free healthcare and reduce the cost of healthcare. My question is for the Minister of State, Deputy Butler, and to her officials here who may have responsibility for this area. Has this been looked at? What assessments have the Department and the HSE done regarding the eligibility criteria and the income thresholds? I asked for a report from the Secretary General of the Department on this issue in advance of our own pre-budget process and when I looked at the qualifying criteria and the income threshold, I was amazed at how low they are. Even somebody on a living wage may not fit into the category. The thresholds are far too low and have not been reviewed in a long time. A medical card is a gateway into primary care services and very important services for people beyond just seeing a GP, and for free medicines as well. I will leave it at that and will simply seek a reply from the Minister of State as to whether the Government has looked at this. Is it something we may see in the next budget, if indeed we get to a next budget? Have the Department and the HSE looked at and examined this?

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy for the question. The Deputy raises a valid question around people having access to medical cards and doctor visit only cards. Currently 50% of people living in the State have either a medical card or a GP visit only card. It is approximately 50% and I remember those figures from the Bill in relation to private care that we do every year. As to the Deputy's specific question, it is my understanding that those threshold rates have not been increased since 2009. I stand open to correction on that but I do believe it was 2009. Officials in the Department will carry out a strategic review during 2024 of eligibility for health services. The overall objectives of the review are twofold, namely, to review the existing framework to clearly assess what is working well and to inform policy options and proposals to enhance eligibility and access to services based on robust evidence. This is really welcome.

The Deputy will be aware that in my role, I put in place the strategic workforce advisory group trying to support more carers to come into the role of caring. We have an ageing population and one of the recommendations was around the people who might agree to do X number of hours caring but they would not lose their social welfare supports such as a medical card. If people had the opportunity to work 12, 14 or 16 hours a week potentially - for example the majority of people who do this work are female when the kids are in school - and if they did not lose their social welfare entitlements we believe this would be an open door to push to get more people caring. We are actually exploring this with the Department of Social Protection.

David Cullinane (Waterford, Sinn Fein)
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What are the current income thresholds to qualify for a medical card for a single person?

Mary Butler (Waterford, Fianna Fail)
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I do not have that detail here this morning.

David Cullinane (Waterford, Sinn Fein)
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The Minister of State's officials may have.

Mr. Paul Flanagan:

I can speak to that point. In broad terms firstly, there are two cohorts of persons who qualify for medical card eligibility: those persons who are over the age of 70 and those who are under 70. We spoke at length in the committee prelegislative scrutiny session we had in November around medical cards and medical card eligibility generally. The point we made at that time was the thresholds for persons over 70 increased last in November 2020 and the general thresholds for persons under 70 - to which the Deputy refers - are in the region of €184 for a single person as the financial viability criteria.

David Cullinane (Waterford, Sinn Fein)
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That is €184 a week.

Mr. Paul Flanagan:

Yes, €184.

David Cullinane (Waterford, Sinn Fein)
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If somebody was on a living wage would that qualify them under those criteria?

Mr. Paul Flanagan:

I am not aware of what the current living wage is. I can track that for the Deputy and get a note for him.

David Cullinane (Waterford, Sinn Fein)
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It is certainly not €184 week. It is probably double that.

Mary Butler (Waterford, Fianna Fail)
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It is €13.10 per hour.

David Cullinane (Waterford, Sinn Fein)
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I will come back to the Minister of State. A threshold of €184 week is a very low income threshold bar, which is the point I am making, given it has not been reviewed since 2009. Notwithstanding the over 70s, we are talking about the general population.

Mary Butler (Waterford, Fianna Fail)
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Yes.

David Cullinane (Waterford, Sinn Fein)
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I am simply making the point. It is not attacking the Government. I am saying that the political system and all of us have to look at that as the next step to reducing the cost of healthcare.

Mr. Paul Flanagan:

As the Minister of State has outlined, there is a programme of work planned by the Department working in conjunction with HSE during 2024 to review the overall eligibility framework, which includes medical card thresholds and medical card eligibility. It is a point we are addressing. We acknowledge the point raised by the Deputy and the need to reappraise and review the medical card administration system. It is absolutely within our focus and we will be looking at it in the coming months.

Mary Butler (Waterford, Fianna Fail)
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It was something we discussed last year. The Minister for Health, Deputy Stephen Donnelly, and I discussed it and I am glad it is being reviewed at the moment. We all deal with people in our constituency offices every day of the week who are finding it difficult to secure a medical card and especially when they have an illness. That is one of the challenges. It is important that it would be reviewed. I do not disagree with the Deputy's point at all. I also want to put on the record that we have expanded the amount of people who can have the doctor visit only cards. Almost 50% of people in the State either have a medical card or a GP visit only card. We will look forward to that review and the recommendations from it.

Bernard Durkan (Kildare North, Fine Gael)
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I welcome the provisions already referred to. I have similar concerns as my colleague-----

David Cullinane (Waterford, Sinn Fein)
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In more ways than one.

Bernard Durkan (Kildare North, Fine Gael)
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We can progress that as the day moves on. We shall see.

David Cullinane (Waterford, Sinn Fein)
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I was supporting you for the leadership but I am taking it back now Bernard.

Bernard Durkan (Kildare North, Fine Gael)
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I am upset now but I cannot take it up at the moment as I am otherwise engaged. However, there are a couple of things we need to keep in mind. The threshold is too low at the moment. It needs to be shifted. As my colleague has said, it has not been moved for many years. For example, a person with a disability may be on an invalidity pension. That person is disqualified and does not get it, as he or she is above the limit. There is a problem there. I am glad to see it is being dealt with or is under discussion.

There are several other cohorts of people affected as well, and the Minister of State has made reference to this with regard to carers and encouraging more carers into the system who are willing to carry out the caring provisions. The point is that there are many people who are on the verge all the time and who are worried . If anything goes wrong or if they get an illness of one description or another, it pushes them into the zone they cannot control. They are worried about that and I can understand that. This does not have to be older people. It is anybody of any age that has a particular illness that puts them in the area where they cannot work, their work is limited, they cannot get an income, their income is limited, and they cannot qualify for a medical card and other services in order to alleviate the burden they see upon themselves. That burden can best be evaluated by people who are in that particular category because nobody else can. One must put oneself in their shoes. They see themselves as being vulnerable and they are. The vulnerability comes from a number of things, including being dependent on all around them and being dependent on the rest of society coming to their aid at a time when they most need it. It is about recognising that in many of these cases these are people who have given all of their lives so far in employment in the private and public sectors. They feel that if there is a delay - and there have been delays in the allocation of medical cards - this then becomes something that increases what they see as a threat to them having a sufficient budget to survive reasonably well. It is also about recognising that more people providing care for more people means less of a burden on services, hospitals, the HSE and so on. I strongly support those recent provisions.

On the rent-a-room scheme, it would be ironic if the rent-a-room provision was made on the one hand, and with the other hand the money was being taken away. This is where the State moves in with the one hand and then with the other hand says "You get nothing or nearly nothing". In this regard it is a welcome provision and I strongly support it.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputies. I will respond to the point, which was made very clearly and especially in relation to discretionary medical cards. There are currently some 180,000 discretionary medical cards, which take into full account the difficult circumstances in the case of applicants who may be in excess of the income guidelines.

They exercise discretion and will grant a medical card, for example, to patients with significant medical expenses who do not satisfy the means test. Emergency medical cards are issued to patients who are terminally ill. I know there are times when somebody can fall just outside the threshold, which can be very difficult. These are the people who come to our constituency offices looking for supports. It can be especially difficult at times for people who have cancer but do not have a terminal diagnosis.

I am glad this review is under way. Everybody will welcome it because when people are ill they should not need to worry about the cost of medical supports.

David Cullinane (Waterford, Sinn Fein)
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I will make a few points on this section. I welcome what this section does. It is important to reiterate what the Bill does and does not do. It does give clarity as to the professions that may administer medical products but it states very clearly that it does not confer new powers or scope of practice on any profession. It is important to make that point.

I support what the Bill intends to do. On Second Stage, in a discussion with the Minister for Health, Deputy Stephen Donnelly, I welcomed some of the advances made in pharmacy and the role of pharmacists in recent months. Their being able to extend a prescription for 12 months is really important as it makes repeat prescriptions a reality. That will be beneficial to patients and pharmacists and will also take pressure off GPs. I fully support that. However, there is an awful lot more that can be done. The Minister of State may know that the Irish Pharmacy Union has campaigned for some of these measures for a long time as well as many more measures, including what it calls a "pharmacy first" model and a minor ailment scheme. Where are things in that regard? There was some talk that funding for a minor ailments scheme would be provided for in budget 2024. That obviously did not happen and it may have been a casualty of the lack of funding for new measures in budget 2024. If we look at the network of community pharmacists we have, there are a number of pharmacists in almost every town and village. I strongly believe they could play a much greater role in taking pressure away from GPs. The fact some moves have been made in recent times proves that point.

Yesterday, in my contribution on a Dáil motion Sinn Féin proposed on this issue and similar issues, I said that we have to look at primary care and community care services as a way to take pressure from our acute hospitals. Unfortunately, if we look at the attendance in many of our emergency departments, many people are not in the right place or getting the right care and they are in the emergency departments because the alternative care pathways do not exist. It still amazes me that in major urban areas we do not have 24-7 pharmacy available. It strikes me as bizarre that this service is still not available in the 21st century. We are still way behind other European countries as regards the role of pharmacists, particularly in the area of minor ailments. If we were to expand community pharmacy, it would do a number of things. It would take pressure off GPs who are being asked to do an awful lot more and need to do more in and of themselves to take pressure away from hospitals. It would also play a role in and of itself to take pressure away from hospitals.

Is the Government committed to a minor ailment scheme being rolled out by pharmacists? Where is that commitment? Has any funding been made available, or does funding need to be made available, to make that a reality? I understand there was a working group but I do not know whether it has reported with recommendations in this area.

Mary Butler (Waterford, Fianna Fail)
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I thank the Deputy for his questions. Further to the discussion we had last night during Private Members' business, the Deputy may have stepped out of the Chamber when I stated that the Minister, Deputy Stephen Donnelly, had taken on board the comments raised at previous meetings related to this Bill. The Government is in the process of finalising a further amendment to facilitate pharmacists prescribing. It will be introduced on Report Stage to be included in this Bill. That addresses the point the Deputy raised last night and just now. This will take the form of a further amendment that can be discussed on Report Stage. It will be very welcome because by enabling pharmacists to prescribe, we will open doors for the healthcare service and empower pharmacists to leverage their unique expertise, take on expanded roles in patient care and play a more integral role in healthcare terms.

The implementation of this amendment to introduce prescribing hinges on several key enablers, including education, training, guidance from our regulators and any additional necessary support systems. These foundation elements will be put firmly in place as part of the introduction of pharmacists prescribing. Behind every prescription, medication and healthcare decision, there is a patient, a person in need. This change is very welcome.

With regard to-----

David Cullinane (Waterford, Sinn Fein)
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I will make a point of clarification. I welcome that important move. I assume the Minister would have to set out specifically what medicines a pharmacist potentially could dispense?

Mary Butler (Waterford, Fianna Fail)
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I will hand over to Mr. O'Connor.

Mr. Muiris O'Connor:

The Deputy referred to the expert task force. Its first recommendation was to facilitate the extension of prescriptions and the issuing of 12-month prescriptions. That was adopted, implemented and is in effect right now. The second phase of the work, as was described in earlier discussions of this Bill, was to move to explore an expansion of the scope of pharmacy and that it is supported. The Deputy articulated extremely well why that makes good sense. It is proposed that on Report Stage, while the task force is working very intensively on the detail of the scope, the safeguards, education, what ailments and established medicines will be in scope, that will all be determined and the task force is expected to report to the Minister by mid-June. We recognise now that legislation will be needed to support the implementation of the recommendations.

David Cullinane (Waterford, Sinn Fein)
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It is a pre-emptive move.

Mr. Muiris O'Connor:

It is a pre-emptive move. It creates-----

David Cullinane (Waterford, Sinn Fein)
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That is fine.

Mr. Muiris O'Connor:

-----an amendment to the Irish Medicines Board Act which will mention pharmacists among a list of prescribers and give the Minister authority to regulate and implement the recommendations of the task force. We were told to explore how we could-----

David Cullinane (Waterford, Sinn Fein)
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The modalities of the extension of prescribing are being worked out.

Mr. Muiris O'Connor:

The detail of the amendment to come on Report Stage-----

David Cullinane (Waterford, Sinn Fein)
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It will be a legislative enabler.

Mr. Muiris O'Connor:

It will be a legislative enabler that will give the Minister power to regulate for the details, scope and safeguards to facilitate this.

David Cullinane (Waterford, Sinn Fein)
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That is okay.

Mr. Muiris O'Connor:

The Minister and the Department will be more ready to receive and implement those.

Bernard Durkan (Kildare North, Fine Gael)
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Another one of concerns raised was the supply and continuity of medicines. I welcome the provisions in the Bill. I do not want to get into the arguments we had over the years of there being a difference between branded medicines and their alternatives. However, continuity of supply is important. The Irish Pharmacy Union acknowledged that there was a difficulty because Ireland accounts for only a small proportion of the population of Europe and, as such, although it did not say this but we are led to believe it, we have to take our place in the queue. I emphasise again that we do not have to take our place in the queue. The queue is a European one that is available to everybody and every part of the European Union is entitled to have the same supply as it would have if it were the main street of Berlin or wherever. We should also keep in mind that Ireland is a significant manufacturer in the pharmaceutical sector. We need to assert that the theory that this country is a minuscule part of the population of Europe and, as such, has to take second, third or fourth place in a queue for supply, is not correct. We should take whatever steps are needed to ensure the suppliers recognise the fact they have obligations to every country in Europe, big and small, without exception and at the same time.

Mr. Muiris O'Connor:

We very much support the Deputy's comments.

We feel that the European Union and Europe working together on these matters is important and there is a pharmaceutical regulation emphasising access to, and the availability and affordability of, medicines. It benefits us to operate as a proactive partner in that European approach, but the Deputy is correct in that we are an island beyond an island and may be at the end of some supply lines. Nevertheless, that absolutely does not undermine our entitlement to a fair share of what the EU proposes. We are wary of instincts towards stockpiling, which we think are a bit simplistic, and are nervous that large member states might be tempted to move in that direction because the European medicine supply lines are dynamic and need to flow to operate effectively. We will support wherever Europe lands in respect of buffering, but we will try to encourage a recognition of our interdependence within the global arena and the importance of the flow of medicines. We have arrangements nationally to monitor drugs going into a shortage of supply and this legislation will absolutely strengthen the information base we will have for that.

Mr. Warren might wish to come in on the shortages framework.

Mr. Kevin Warren:

To add to what Mr. O'Connor said, the amendment Bill aims to strengthen what we are trying to do to oblige people involved in the supply chain to inform us of any shortages that occur in order that a timeliness will be attached and we can plan and mitigate that. In addition, the medicine substitution protocol, which was part of the earlier stage, is another piece of that jigsaw.

There is a complex journey for medicines to get to the patient, and we are putting together the blocks to ensure Ireland is not regarded as an outlier and does not have to take a place in the queue. That is part of it, and the conversations we have at European meetings assist in that when we are discussing it with colleagues from other countries. We are fully engaged with it to ensure we will get our fair share and will not be left lagging behind in any fashion, because we regard that as crucial as well.

Bernard Durkan (Kildare North, Fine Gael)
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I might add one point to that. It would be ironic if matters were to develop such that countries outside of the European Union were able to benefit from a continuity of supply to a greater extent than a country inside the European Union. We need to have that as our headline and goal. By all means, we should supply whatever is required, but in the pecking order we have to supply those within the European Union first, and thereafter we can supply whatever else we can supply. We should not leave shortages at home while supplying other jurisdictions.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 3:

In page 11, line 27, to delete “supply.”.” and substitute “supply.”.

This is a technical amendment to correct a typographical error.

David Cullinane (Waterford, Sinn Fein)
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I will support the amendment but I just want to make a point about the substance of the section, which relates to having medicine shortage protocols in place. I have been looking for this for some time and have engaged with the Minister of State on it. If I am correct, the provisions relate to medicinal product shortages by facilitating the implementation of a framework for medicine substitution protocols. That is obviously important given the discussion we had earlier. Mr. O'Connor was talking about supply chains and the relationship between us and the European Union and how all that is interconnected. This is very worthwhile and is long overdue. There is an issue at the moment with the supply chain for medicines, as we know. The Irish Pharmacy Union has been lobbying all of us for some time to put in place such a protocol, and the quicker it is in place, the better.

It could be argued my next point is unrelated to the Bill but I would like to get a steer on it from either the Minister of State or her officials. An important European Union directive, regarding intellectual property rights in respect of medicines, is the subject of debate at the moment. The proposal, as I understand it, is to reduce the period of data exclusivity of IP for new products and medicines from eight years to six years. The industry, obviously, has its view and we as a State have to take our view. I understand that in all these issues, we have to look through a wider lens. The industry will look at it through its own lens but we have to look at it through a wider lens. I would imagine the logic of the directive is to have greater access to generic drugs, which we also need, but there is a need for caution on the part of the State. The pharmaceutical sector, as we know, is very important to the Irish economy. It creates a lot of jobs and a lot of high-tech drugs are produced in Ireland, as we know. The industry would say a great deal of investment goes into producing these drugs in the first instance and, obviously, it wants to protect what is there. I am not giving a view at this stage in terms of what I would like to see but I would like some sense from the officials or the Minister of State, if she is in a position to give it, as to what the Government's approach is because my understanding is this could very quickly reach the floor of the European Parliament. Industry has, as I said, been raising serious concerns about it and I am interested in hearing the response of the officials.

Mary Butler (Waterford, Fianna Fail)
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I move amendment No. 4:

In page 11, after line 27, to insert the following: “Reporting of information to support the security of supply of medicines

32I. (1) The Health Products Regulatory Authority may require a relevant person to provide to the Authority, in such form and manner and within such period as may be prescribed by regulations made by the Minister, such information in relation to medicinal products within the possession or control of the relevant person as the Authority considers necessary for the purpose of the management of the availability of medicinal products in the State, including—

(a) the monitoring of the current and future supply of medicinal products, and

(b) the identification and management of medicinal product shortages.

(2) A relevant person shall comply with a requirement set out in regulations made under subsection (1).

(3) In this section, ‘relevant person’ means the following persons involved in the manufacture or supply of a medicinal product:

(a) the holder of a manufacturer’s authorisation granted under Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007);

(b) the holder of a marketing authorisation granted in accordance with the Medicinal Products (Control of Placing on the Market) Regulations 2007;

(c) the holder of a community marketing authorisation within the meaning of the Medicinal Products (Control of Placing on the Market) Regulations 2007;

(d) the holder of a wholesaler’s authorisation granted under Regulation 9 of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007);

(e) a retail pharmacy business within the meaning of the Pharmacy Act 2007;

(f) a hospital;

(g) such other persons or legal entities, being persons or entities authorised or entitled to supply medicinal products, as may be prescribed in regulations made by the Minister.”.”.

As committee members will be aware, issues surrounding the security of medicines supply have been increasingly well characterised, both nationally and internationally, in recent years. The causes of such supply issues are multifaceted, ranging from pandemics to geopolitical events and potential shortages of raw materials. Medicine availability is complex and involves the interface of the medicine regulatory system, clinical policies, national policies, pricing, and reimbursement policies. While the temporary unavailability of a medicine, that is, a shortage, is one potential consequence, supply chain security and sustainability are broader issues.

Because of the interlocking challenges facing the world, medicine shortage management requires constant development to achieve the best outcomes for patients. For this important and complicated work, Ireland needs to implement policies focusing on what feasible solutions can be achieved.

Now is the time to implement an update to Ireland's medicine shortages framework to utilise how it can be more effective prior to and when a shortage occurs and to accelerate learning and improvement cycles. Improved information and early notification will be vital in the management of our medicines shortages.

The amendment would mandate "relevant persons" to provide information on medicinal products in their possession or control to the Health Products Regulatory Authority, as requested by it as the medicines regulator. It is envisaged that this information, while simple in theory, will yield multiple benefits for our national management of medicines availability. This reporting obligation will allow for additional visibility of the presence of medicines in Ireland, increase our ability to mitigate the impact of shortages and increase our capacity to prevent them occurring at all, while allowing us to feed into European shortages mitigation measures such as the European shortages monitoring platform, which is to be functional in February 2025.

These measures will support the national system for the management and security of medicines supplies and will facilitate a more proactive system for the management of medicines shortages. I will ask Mr. O'Connor to answer the second part of the question.

Mr. Muiris O'Connor:

Deputy Cullinane set out very well the dynamics at play at European level. There is a lot under way in terms of the EU pharmacy regulations being formulated and the pharmacy directives. There is a proposal from the Commission, as Deputy Cullinane said, to reduce the period of data exclusivity. It would go from eight years to six years, as the Deputy said, but the companies could buy them back with commitments that correspond with European policy objectives. We are speaking about an expectation that a product would be made available in all member states. A commitment to this market access would grant an extra two years' exclusivity. A commitment to clinical trials beyond launch, of which there are not half enough in terms of testing the efficacy of drugs in the real world, would buy six months' exclusivity in the proposals. There would also be some incentivisation of drugs that might not be greatly profitable but are vital, such as antibiotics that are capable of managing antimicrobial resistance and some paediatric drugs that might not have a large market.

As members know very well, we have a lot of interest in pharmaceuticals. We have a large and very vibrant pharmaceutical industry. The Department of Health shares the policy objectives of the Commission in ensuring affordability, access and relevant medicines. To navigate and develop the Irish position in a way that corresponds with all of these interests, we are part of an interdepartmental group that also involves the Departments of the Taoiseach and Enterprise, Trade and Employment. We bring our perspectives from each of these sectors and we formulate and develop the Irish position.

One of the things we really want, and what industry always says to us, is that whatever way it lands, we want it to land in an environment that is clear and has certainty for the industry to produce medicines and develop new medicines. Certainty is important. We do not want this bumbling on indefinitely. There are differences of opinion between the Parliament, the Commission and the Council. We have a nuanced position whereby we want it settled in a pragmatic way and we can get on with progressing the objectives of access while also protecting the competitiveness of the pharmaceutical industry in Ireland and in Europe more generally.

David Cullinane (Waterford, Sinn Fein)
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I would like clarification on what a settled pragmatic decision or position of the Government might be.

Mr. Muiris O'Connor:

We do not have a full position. We have a working position that we bring to the working group. This is where we push for resolution of the discussions and a settling down to something that industry can work with. We are considered to have a good understanding of the industry perspective. There are quite pragmatic difficulties with some of the recommendations of the Commission. The pharmaceutical industry tells us a simultaneous launch in 27 markets is very difficult. There could be quite superficial moves in this direction, whereby something is nominally launched but the price point is-----

David Cullinane (Waterford, Sinn Fein)
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Is there provision for an opt-out, or perhaps not an opt-out but that a member state could have a derogation to make a decision, as opposed to this being a one-size-fits-all approach across the European Union? If the proposal is to reduce data exclusivity from eight years to six years, albeit with the caveat that Mr. O'Connor has given on the buyback, whatever about where it eventually lands, is it possible the State could seek a derogation in this area and state we want to make this call?

Mr. Muiris O'Connor:

No. It is a Single Market for medicines and it is regulation that will prevail across the full market.

David Cullinane (Waterford, Sinn Fein)
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This is the concern that is being shared by the industry. It states the US will be watching this with regard to anything that makes it more difficult for a company to protect its intellectual property, particularly when there is large investment in high-tech drugs, and we all know how important that is for patients and the industry. I get that there is a balance to be struck. I get all of these points. I fully understand the issues relating to affordability and access. There is a balance to be struck and this will play out. What is Mr. O'Connor's understanding of the process? We are being told by industry that this will end up on the floor of the European Parliament.

Mr. Muiris O'Connor:

Yes.

David Cullinane (Waterford, Sinn Fein)
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I assume the proposal came from the Commission, went through a committee and will end up on the floor of the Parliament. Is that the process?

Mr. Muiris O'Connor:

That is my understanding. The Parliament has published some very differing views. It has tried to abandon all of the buybacks and added to the period of exclusivity. The pharmaceutical industry is certainly being represented very well in the Parliament.

David Cullinane (Waterford, Sinn Fein)
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If the Parliament rolls back on the buybacks, and it is even worse than we could imagine, there is nothing we could do.

Mr. Muiris O'Connor:

We can contribute to the formulation of the European positions but we will have to live with the settlement. One of the key things we want is that it settles in a reasonably short space of time and the industry operating throughout Europe has a clear understanding of the parameters. As Deputy Cullinane knows, we have a very strong genetic pharmaceutical industry that has an interest quite contrary to the new drug developers. The genetic pharmaceutical industry has an interest in shortening the period and then the production at scale of drugs that prove effective in genetic format.

David Cullinane (Waterford, Sinn Fein)
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Would it be possible to get a note on this, given that it will be an important issue and the Parliament will have to make decisions on it? Perhaps a note can be given to members of the committee to inform us as best the Department can on the process so far, what has been proposed and the position of the Government or the Department. Mr. O'Connor said a number of Departments are meeting.

Mary Butler (Waterford, Fianna Fail)
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That is a reasonable request.

Mr. Muiris O'Connor:

Yes, that is fine. We will do that.

Bernard Durkan (Kildare North, Fine Gael)
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The issue being discussed is important. The Commission is subject to the Single Market also. It cannot decide that it will ignore the Single Market here because there is immediate provision for more influential countries and we have to kowtow to them. We do not. The Single Market stands and on that we will stand or fall. If we allow it to be established that particular circumstances might need a change in the Single Market, we should go back before Europe on that one again. The Single Market is sacrosanct.

If we allow any watering down of what it contains in any area, not just in the pharmaceutical area but any area, we are narrowing and going into a smaller circle where we are liable to end up in the same position as we started before the Single Market came, and that would not be a nice place to be.

Mary Butler (Waterford, Fianna Fail)
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I thank the Cathoirleach and all the members who attended today.

Bernard Durkan (Kildare North, Fine Gael)
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This issue is not relevant to the meeting we just had, but it has come to my attention a couple of times recently. I refer to waiting lists for cataracts, which are very acute, particularly if people live alone, and they do. Their sight diminishes at an alarming rate having been on a waiting list for two or three years. Suddenly, they panic, and the family come together and decide to go private and get it done in a week. Why can we not get it done in a week? What is the answer to that question? The facility is there. We have the purchase scheme available to us. We can and should use it because we do not have to travel anywhere out of the country to get an available facility. The sad part about it is that we will not countenance a request for any kind of contribution from the patient at all. That is archaic and old-fashioned. That is old-style business that we should not have to put up with at all. If the patient is entitled to and needs the surgical treatment or laser treatment or whatever it is and needs it now, we should be compassionate enough to say that this person cannot see, drive, walk or go anywhere. He or she might live alone and be dependent on everything around them unless somebody leads them around. We should be able to make an exception in those circumstances and say that under ordinary circumstances, if we did not have a long waiting list, we would have been able to do this in the first instance and we should have done it. I strongly urge that we take that into account and make provision for this. Friends of mine since we were all teenagers together were waiting for a couple of years for something that is very simple and readily available. The Minister of State is here and I will ask her to take account of this She is an expert in the field she is in. I ask, if it is at all possible, to ensure that we take account of those particular cases with a view to allowing some payment to be made. It does not have to be the whole lot or the full contribution, but it should be at least a recognition of the plight they were in due to the waiting lists.

Mary Butler (Waterford, Fianna Fail)
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It is a very valid point. For older people especially who need their cataracts done, it makes such a huge improvement on their ordinary day-to-day living when their cataract is sorted and their sight improves immensely. We are running waiting list initiatives at the moment for cataract procedures. I take on board the point the Deputy is making, however. Many people who avail of the treatment abroad scheme have to travel outside the jurisdiction which, for some people, is not always possible. I discussed this with the Minister, Deputy Donnelly, previously. There is a hi-tech lab in Ballincollig. We also have one now in University Hospital Waterford. We are taking 60 people per week off the waiting list. We are seeing huge improvements. We will certainly look into it. If the Deputy wishes, we can come back with a note to the committee in that regard. There are certainly waiting list initiatives in place, however, and it does improve the quality of people's lives dramatically when they have the cataracts sorted. I do not disagree with anything the Deputy said.

Bernard Durkan (Kildare North, Fine Gael)
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I thank the Minister of State.