Joint Committee on Health debate -
Wednesday, 8 Nov 2023

General Scheme of the Health (Miscellaneous Provisions) Bill 2023: Discussion

An Cathaoirleach

Apologies have been received from Senators Hoey and Black. I am told some of the members will be attending a Private Members' Bill and I think Deputy Durkan is next door at the finance committee meeting. I therefore apologise if people leave, come and go, but that is the nature of these meetings. Before we get to the main item on today's agenda, the draft minutes of the committee meeting of 24 October 2023 have been circulated to members. Are they agreed? Agreed.

The purpose of today's meeting is for the joint committee to consider a waiver for pre-legislative scrutiny on the health (miscellaneous provisions) Bill 2023. The objectives of the Bill are to provide for the exemption of rent-a-room income from medical card and GP-visit card assessment criteria and necessary amendments to the Irish Medicines Board Act 1995 to enhance the existing powers of the Minister for Health to make regulations for the sale, supply and administration of medicinal products and management of medicine supply chains and shortages. The Minister for Health, Deputy Donnelly, wishes to secure the enactment of the legislation as soon as possible in order to ensure the early and timely implementation of this Government policy. He has requested a waiver of pre-legislative scrutiny in this regard. I am pleased to welcome from the Department of Health, Mr. Paul Flanagan, principal officer, Ms Anne Marie Seymour, principal officer, Ms Adedolapo Odukoya, assistant principal, and Ms Bevin Doyle, assistant principal.

Witnesses are reminded of the long-standing parliamentary practice that they should not criticise or make charges against a person or entity by name or in such a way as to make him, her or it identifiable or otherwise engage in speech that might be regarded as damaging to the good name of the person or entity. Therefore, if their statements are potentially defamatory in relation to an identifiable person or entity, they will be directed to discontinue their remarks. It is imperative that they comply with any such direction.

Members are also reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the Houses or an official either by name or in such a way as to make him or her identifiable. I also remind members of the constitutional requirement that they must be physically present within the confines of the Leinster House complex to participate in public meetings. I will not permit members to participate where they are not adhering to this constitutional requirement. Therefore, any member who attempts to participate from outside the precincts will be asked to leave the meeting. In this regard, I ask any members taking part via MS Teams to confirm, prior to making their contribution to the meeting, that they are on the grounds of the Leinster House campus.

To commence our consideration of a pre-legislative scrutiny waiver for the health (miscellaneous provisions) Bill 2023, I invite Mr. Flanagan to make his opening remarks on behalf of the Department of Health. He is very welcome.

Mr. Paul Flanagan

I thank the committee for the invitation to discuss the general scheme of the health (miscellaneous provisions) Bill 2023. I am a principal officer in the primary care performance and oversight division of the Department of Health and I am joined by my colleagues Ms Anne Marie Seymour, principal officer in the medicines, controlled drugs and pharmacy legislation unit of the Department, Ms Adedolapo Odukoya, assistant principal, and Ms Bevin Doyle, assistant principal.

I would like to briefly outline the background and rationale behind this draft legislation, in the first instance, before briefly addressing some of its main provisions. The general scheme of the health (miscellaneous provisions) Bill 2023 consists of two main parts. The purpose of part one of the Bill is to provide for an exemption of rent-a-room income of up to €14,000 per annum from the medical card and GP-visit card income assessment process.

The second purpose is to provide for an amendment of current legislation to enhance the Minister for Health’s power to make regulations for the management of, and access to, medicinal products.

With reference to Part 1, Housing For All - a New Housing Plan for Ireland is the Government’s housing policy to 2030. The plan’s overall objective is to ensure that everyone in the State has access to a home to purchase or rent at an affordable price, built to a high standard and in the right place, offering a high quality of life. Action 17.1 of the Housing for All action plan commits to removing potential barriers to use of the rent-a-room scheme to increase its potential as a source of student accommodation by reviewing the assessment of rent-a-room income within the medical card assessment process.

Rent-a-room tax relief is a measure put in place by the Revenue Commissioners in 2001 to increase the availability of accommodation for rent in the State. The relief allows participants on the scheme to earn up to €14,000 per year tax-free if they rent out a room, or rooms, in their home for use as accommodation by others.

Separately, eligibility for a medical card is primarily based on residency and a financial assessment that is conducted by the HSE in accordance with the Health Act 1970. The HSE assesses each application on a qualifying financial threshold. This is the amount an individual can earn per week and still qualify for a card. The HSE medical card assessment guidelines outline certain incomes that are not included within the assessment process, primarily social welfare payments and some compensation payments that can be disregarded. At present, income derived from the rent-a-room scheme would be assessed under the medical card assessment process. In such cases, this income will be a contributing factor, along with other income and expenses, as to whether a person qualifies for a medical card.

The objective of Government is to provide for a disregard of up to €14,000 income for persons who have been granted rent-a room relief by the Revenue Commissioners such that the income will not be assessed within the medical card assessment process. In this context, the rent-a-room scheme may have some potential to assist in addressing the shortage of accommodation in the State by making more efficient use of housing stock to stimulate supply for both students and other renters.

With reference to Part 2, the Department of Health is committed to expanding the role of pharmacists in the State to enhance access to services and to reduce pressures across health services. Expanding the scope of pharmacy practice aligns with the principles of Sláintecare - delivering the right care, in the right place, at the right time - and offers the opportunity to alleviate pressures across the health service, particularly in primary care, and to make care more accessible closer to home.

Pharmacists are health care professionals who are expert in the use and management of medicines. They were, and continue to be, an essential part of the response to Covid-19 and have been playing an expanded role in the delivery of seasonal influenza vaccinations for some years now. There are various strands of work under way in the Department to build on the increasing contribution of pharmacists to health service provision and to further optimise the scope of this profession.

Committee members will be aware that shortages of medicinal products have become a problem in recent years. Ireland is not unique in this regard and many other countries face similar challenges. Ireland is heavily involved in the many European work programmes aimed at preventing and mitigating the impact of shortages. At a national level, the Department is working with stakeholders to put in place a protocol for the management of shortages of medicinal products governed by regulations.

The Department of Health has been advised that an amendment to section 32 of the Irish Medicines Board Act 1995 could be made to enable pharmacists to sell and supply approved medicines without the need for a prescription. The proposal will not confer prescribing powers on pharmacists but clarifies that registered pharmacists are a class of person for whom the Minister may make specific regulations, pursuant to the Minister’s existing power under section 32 of the 1995 Act, to make regulations for the prohibition of, or exceptions to the prohibition of, the sale and supply of medicinal products.

Following preliminary drafting work undertaken by officials in the Department to progress these objectives, the Minister for Health recently received Government approval to publish the general scheme of the Health (Miscellaneous Provisions) Bill 2023. This Bill is also on the Government’s autumn legislative programme 2023 and it is intended to progress the Bill for priority publication in the current Oireachtas session.

Following publication of the general scheme, officials from the Department of Health are now working with the Office of the Attorney General to progress priority drafting of the legislation, subject to finalising a position on pre-legislative scrutiny. In this context, officials from the Department of Health will continue to engage with colleagues in the Departments of Housing, Local Government and Heritage, and Further and Higher Education, Research, Innovation and Science, regarding the rent-a-room component as the legislation is further developed and finalised.

In conclusion, a core purpose of the Bill is to deliver on Government’s policy objective to disregard rent-a-room income up to €14,000 per annum for the purpose of medical card eligibility. It must be noted also that, on 29 March this year, the Dáil passed a motion which included the commitment to extend the disregard as follows: “the Government will extend the rent-a-room scheme disregard for social welfare recipients and extend the disregard into medical card criteria”. The Bill will also ensure that regulations to manage medicines shortages, and to support current and expanded activity by pharmacists, can be put in place.

Given that the core objectives represent positive actions intended to benefit students, renters, patients and families, especially in the context of the current cost of living crisis and existing accommodation challenges being experienced by the State, it is hoped to publish and enact the legislation as soon as possible to ensure early and timely implementation.

I thank the committee for giving its time today and we look forward to the opportunity to further discuss the proposals.

Deputy Bernard J. Durkan

I think the witnesses for appearing before the committee and giving information on very important issues.

I recognise what was intended to happen on the medical card qualification and the extent to which that is affected by the rent-a-room scheme. However, I bring to the attention of the committee again what I have said previously. A very tight regimes runs for income levels for qualification for medical cards. Out of four or five cases I have had one resolved. That was an unfortunate case, but it is only temporary. A very peculiar thing I have noticed though is in the event of a hospital mishap I am dealing with, I would have thought that it would be urgent to ensure that the person involved be accommodated in any way possible. This has not happened and it has been dragging on for months and will continue to drag on. I am going to bring it up at a different level. It is an embarrassment and it should not have happened. Details have been with the medical card section for quite a long time. I strongly object to the way the patient is being treated because there are extenuating circumstances. These are the responsibility, in the first instance, of the health services. I ask that this matter be looked at as a matter of urgency. I will not name the patient as I am sure they are well known to the medical card system.

The other issue I want to raise is that of new medicines becoming available and the extent to which they are being processed and whether they will be processed on time. I want to point out the issue of the pharmaceutical sector and the drop in taxation levels as a result of a reduction in volumes and a knock-on effect on profits. I cannot quite understand it because much of the manufacturing is done here, as we know. It is a strong sector that we very much rely on. I cannot understand why there has been a drop-off because the demand for pharmaceuticals is ever-increasing. The two situations have to be addressed. Whatever measures necessary have to be taken to ensure an adequate supply in the marketplace, now, not in six months or a year, but now. The other one is to ensure that the new drugs coming onstream, which can make a huge contribution, should be made available as quickly as possible by the health service. It is not acceptable that we wait until the end of the winter when the bugs have descended upon us to find out what the answer is. The answer has to be provided now. We need the supply now. We need access to the new drugs now. We need them processed as quickly as possible and we need the patients of the country who depend on them to be able to access them . Some of these drugs are as basic as penicillin. It is a vital drug, which is manufactured in this country as well. We should not have to apply anywhere for it.

I listened to a representative of the Pharmaceutical Society of Ireland on radio a few days ago.

She said we are a very small blip on the European map. That may well be the fact but we are part of the internal market, the Single Market, and we are entitled to the same entitlements in every aspect of industry, medicine and everything else as everybody else throughout the European Union. There can be no exceptions made or explanations put forward to counter that. Although the representative on the radio was only reflecting what she was told, that is not the case. Every part of this country, even the most remote parts, has the same access to the Single Market as Paris, Brussels or anywhere else. No situation can arise where we can become subject to an explanation that we are only a small blip on the map with a small population in a small country and so on and so forth, and it is the bigger market that has to be looked at. This is the bigger market. We are in it. It is the Single Market. Every single citizen in this country is entitled to their fair access to what is going on and what is available in the Single Market, with no exceptions. If there are exceptions, we want to know about it and we want to discuss them as soon as possible. That is my contribution. I will take an answer if there is an answer forthcoming. If not, I want action in any event. One could say I am an angry old guy at the moment. That is correct.

Deputy Neasa Hourigan

We would never say that.

An Cathaoirleach

There is a lot in there. Do the witnesses want to respond to one or two of those?

Mr. Paul Flanagan

There are certain parts to which we can respond. I thank the Deputy for his contribution. Regarding the medical card query, it is difficult for me to comment on specifics given that I do not have the details of the queries involved but I am happy to take receipt if the Deputy wishes to contact me directly-----

Deputy Bernard J. Durkan

I will email them.

Mr. Paul Flanagan

-----and we will engage on his behalf with the HSE medical card unit to ascertain what is going on and get him some details. Regarding the aspects mentioned around pharmacy and prescribing more generally, I invite my colleague Ms Seymour to speak to the issues raised.

Ms Anne Marie Seymour

I made a short list of the points the Deputy raised and if I miss anything he can come back to me.

On the first piece around new medicines, my understanding is that in Ireland it is not always the finished product. Many of the medicines can be exported but I will engage with our colleagues in the Department of Enterprise, Trade and Employment on that and come back to him. Regarding new drugs coming on stream, there is a lot of work going on at European level for all European citizens at the moment. The pharmaceutical strategy and legislation was published in April. A working group has been developed across Government agencies and Departments looking at Ireland's position on that. The sole purpose of that is access, affordability and availability of medicines. That is something in which we are really actively involved and there is a huge body of work going on at European level in which we are heavily involved. There has been the Mazars report around new drugs coming on stream and their approval and that is a key deliverable for the Department at the moment. It has been given additional resources to progress work in that area.

On shortages of medicines, we are not the only country impacted. We do not have any evidence that suggests Ireland is more impacted than any other country in Europe. Unfortunately, there has been a big increase in shortages but it has been seen across Europe and the world in recent years. There are various factors to that. We are still recovering from the Covid-19 pandemic and the impact on supply chains. There are the geopolitical factors such as the war, the energy crisis and the cost of medicines. Again, there is a huge body of work being done in trying to address that and to enhance the security of supply of medicines for Irish citizens. Some of the proposals are included in this Bill to allow us to develop better systems for oversight of the medicines we have and to act faster when we know there are shortages coming, and there is also then that huge body of work being done at a European level in which we are heavily involved and with our medicines regulator, the Health Products Regulatory Authority, HPRA. It has a medicines shortages framework which it manages on behalf of the Minister. That framework has been replicated in Europe and was the base for the system they use in Europe for assessing and managing medicine shortages. The Commission published a statement just last week on how we can work better at managing medicine security at a European level. There is a lot of work coming out of that in which we are really engaged.

On the pharmacy piece, the Minister is very supportive of the expansion of the scope of the practice of pharmacy access for everybody regardless of where they live in the country. Most citizens in Ireland live within approximately 5 km of a pharmacy. We have a large number of pharmacies and they are very accessible. Ireland had one of the biggest uptakes in vaccinations because people could access those through pharmacies. These are the kinds of things on which we want to build to enhance access to medicines and medical care in the primary care setting. If I have missed anything, the Deputy can advise.

Deputy Bernard J. Durkan

I note the points made. I see visible signs of shortages that should not be happening at this time. This has come to my family's attention by virtue of having to call on pharmacies in recent times. I ask that an urgent re-evaluation be done of the availability of various medicines on which people depend and that they be dealt with as quickly as possible. This must happen now because it is no good dealing with this in two or three months. It will be all over at that stage. I thank our visitors. They will be glad to know I am due at another meeting now.

Deputy David Cullinane

I welcome our witnesses and thank them for their work on the Bill. I doubt very much that there will be a need for any further scrutiny beyond today. The Bill is fairly simple in what it aims to do.

On the first element and the exemption of the rent-a-room income, a maximum of €14,000 is what is being recommended. This is already the most rent that can be disregarded anyway. It is obviously the purpose of the Bill to ensure that is not taken into account in the financial assessments for GP and medical cards. Is that, in essence, what that part of the Bill seeks to do?

Mr. Paul Flanagan

That is absolutely correct.

Deputy David Cullinane

It gives us a timely opportunity to look at that income threshold because we have discussed this at the committee several times. In fact, we said we would possibly have a session on it at some point in the new year. My reading of the income thresholds for medical cards is that they have not been changed in a long time and they are very low. For a single person under 66 years of age, what is the current income threshold for eligibility for a medical card?

Mr. Paul Flanagan

I thank the Deputy for his contribution. To address the initial query, I will explain the medical card assessment process very broadly, which is based primarily on means and residency in this State. When we look at current income thresholds for medical cards, we can look at them as being categorised across two main cohorts. The first is income thresholds for persons who are over the age of 70 and the second is income thresholds for persons under the age of 70. Income thresholds for those over the age of 70 have increased in recent years. From memory, November 2020 was the last increase for that cohort. The current rates are somewhere in the region of-----

Deputy David Cullinane

Yes. I am talking about people under 66. I am aware of the over 70s.

Mr. Paul Flanagan

Absolutely. I am just acknowledging that point. The under 70 thresholds have not changed in quite a number of years. The Deputy is correct on that.

Deputy David Cullinane

What is the current threshold?

Mr. Paul Flanagan

I will invite my colleague Ms Odukoya to speak to the threshold limits.

Ms Adedolapo Odukoya

Is the Deputy is looking for the thresholds for people under 66?

Deputy David Cullinane

For single people.

Ms Adedolapo Odukoya

The threshold for a single person under 66 living alone is €184 per week.

Deputy David Cullinane

It is shockingly low for most people who work. Even on very low incomes, there is no chance of them availing of a medical card.

Ms Adedolapo Odukoya

It includes qualifying expenses as well, so many expenses are disregarded in the assessment.

Deputy David Cullinane

I know there are exemptions and so on. I accept all of that. I refer to the income thresholds. Do we know the last time they were changed for those under 70? Mr. Flanagan said it was quite a long time.

Mr. Paul Flanagan

It would be some time in the region of 20 years ago. However, the point I was making is that we should not focus on the medical card thresholds alone. We need to look at the broader suite and range of measures that the Department, the Minister and the Government have introduced in recent years around the provision of healthcare generally. In that context, we should look at GP visit cards as kind of a necessary key-----

Deputy David Cullinane

Will Mr. Flanagan hang on a second? I am not asking about GP visit cards. I accept they have been extended. What we are talking about here is medical cards. The reason I am asking the question is because I accept what we are trying to do with the rent-a-room exemption and the logic for it. We have a housing crisis and students need accommodation. I fully accept it and I will be supporting the Bill 100%. I do not have a difficulty with it. However, we are doing it at a time when the income threshold to qualify for a medical card has not changed in as long as 20 years.

I accept that there has been movement on free GP cards. We collectively as an Oireachtas signed up to moving towards universal healthcare and more people not just having free GP cards but also medical cards. Giving more medical cards is the logical next step as we expand entitlement if we want to get to universal healthcare. However, there seems to be an awful lack of information within the Department. This point is important. If we were to extend the income thresholds by increments of €10,000 a year, is there a sense in the Department of how many additional people would then qualify for a medical card and what that would cost? In other words, is that modelling and work being done? Can that information be provided to this committee?

Mr. Paul Flanagan

“Yes” is the short answer. That information can be provided to the committee. We have the basis to provide for modelling scenarios that can determine the impact in both cohort coverage terms and financial terms from moving the income thresholds from where they current sit.

Deputy David Cullinane

Could that information relating to increasing the income thresholds right across the board by increments of €10,000 be provided following this session today?

Mr. Paul Flanagan

We could. We could absolutely endeavour to provide that information to the committee after today’s meeting.

Deputy David Cullinane

In whatever format Mr. Flanagan thinks is-----

Mr. Paul Flanagan

I wish to make one point. As the Deputy was talking about universal healthcare and moving towards a pathway to universal healthcare, it goes to the issue of medical cards and the broader range of measures we are looking at as an overall package of providing care to our citizens in this State. Aside from the medical income thresholds piece, the Government, the Department and the Minister have been extremely active in the past two to three years in expanding eligibility for access to healthcare generally. I refer to budget 2022 measures for affordability and access to services, such as the abolition of inpatient charges, for children, for example, the provision of free-----

Deputy David Cullinane

I know and accept that. I do not need to hear a long list of what was done in other areas because I am aware of that. I accept it and I supported every additional measure that has been put in place. I am talking specifically about medical cards. I want to move on to the issue of pharmacies. If Mr. Flanagan can provide that note, that would be useful.

Mr. Paul Flanagan

We will.

Deputy David Cullinane

As I said at the start, I certainly welcome the provision in the Bill in respect of the rent-a-room scheme and the exemption from the financial assessment. That is worthwhile.

On the pharmacy part of the Bill, if you want to call it that, I imagine that the core purpose of this is to expand the role and scope of how we manage medicines. It is essentially giving the Minister more power to introduce regulations by amending the Act. Is that essentially what we are trying to do?

Ms Anne Marie Seymour

Yes, it is dual purpose in terms of expanding the scope of practice of pharmacy and then oversight and better strategic management of our medicines supplies in our supply chains, which will be a little bit outside of the scope of practice of pharmacy. There is an overlap in the medicine substitution protocol that-----

Deputy David Cullinane

One of the issues that has come up a lot over the past year – possibly longer but certainly the past 12 months – is there has been much more of a focus on medicine shortages and the possibility or need for what is called in other European countries a “serious shortage protocol”. No reference to that was made in the opening statement. How far advanced are we in respect of the possibility or the concept of a protocol or a protocol coming into existence?

Ms Anne Marie Seymour

We are very far advanced on that. It would require secondary legislation. Because of the nature of what a medicines shortages protocol would do, you would want it to be able to be enacted very quickly. The idea is to give the Minister power to make that provision in this Act.

Deputy David Cullinane

This Bill is a necessary prerequisite to being able to put the protocol in place.

Ms Anne Marie Seymour

Yes. Medicines shortages is not included in the Irish Medicines Board Act at the moment. We are working on secondary legislation. We have engaged with the relevant stakeholders in developing the framework. The idea is that the secondary legislation will lay out the framework of what needs to be done. Then, every time a serious shortage is declared, legislation would not have to be passed.

Deputy David Cullinane

For example, let us say a person is prescribed product A and product A is not available. Product B was not prescribed but is a similar type of product. Is it that we would then give flexibility to pharmacists to be able to prescribe similar products that ordinarily a person would have to get a prescription for but in that instance, that person would not? Is that essentially what-----

Ms Anne Marie Seymour

That is essentially it. In our current legislation, we can do much more than other countries. We can swap it out if it is a similar brand or if it is the same brand but a different quantity needed. This will be for when there is no other alternative available but there is a medicine that can deliver the same result. It is allowing pharmacists to do that without the need to go back for the prescription.

Deputy David Cullinane

I have two more questions. I imagine all of this is in the context of making better use of community pharmacy, and I support all of that. The Minister spoke about a minor ailment scheme several times last year. I know there was no additional funding in the budget to provide for it but I am not sure if it is something that can be delivered next year. Is it advanced and has it been costed? Can it realistically be put in place for next year?

Ms Anne Marie Seymour

It is encompassed in the body of work that the pharmacy task force that was established in July-----

Deputy David Cullinane

I know the task force recommended it. I am talking about delivery.

Ms Anne Marie Seymour

Regarding extension of prescription, the first recommendation was just received at the end of October, which is to allow for prescriptions to have a legal validity of 12 months. Pharmacists can extend prescription. We have a plan of action of how to implement that and the implementation date will be 1 March 2024.

Deputy David Cullinane

The minor ailment scheme that was being looked at was broader than that.

Ms Anne Marie Seymour

Some medicines there will entail pharmacists prescribing and that is the next piece of work. On 21 November, the pharmacy task force is reconvening, and now they are moving on to looking at pharmacists prescribing and how that could be delivered. Some of the early deliverables of that would be something like a minor illness scheme in a community pharmacy under that framework.

Deputy David Cullinane

I welcome the work of the task force. What was really welcome was how quickly it did its work and reported back with very strong recommendations that I think we would all support. One of the things that the Pharmacy Union has been calling for for a long number of years is the concept of chief pharmaceutical officer. If we had a chief pharmaceutical officer, one could argue that we would not have needed a task force. We had a task force and it made recommendations but an advocate or a chief officer could give cohesion and make sure we actually deliver. Is that being or has that been looked at?

Ms Anne Marie Seymour

At present, there is no plan for a chief pharmaceutical officer. There are a number of pharmacists working within the Department. There are experts on medicine. There are also very close relationships with our pharmacy regulator, our medicines regulator and in the task force itself. It is not seen as something that is critical to deliver these changes in the scope of practice-----

Deputy David Cullinane

Who made the judgment it is not critical?

Ms Anne Marie Seymour

That would be done at senior management board level.

Deputy David Cullinane

At the moment, there is no Government plan or policy to do it.

Ms Anne Marie Seymour

No, not to appoint a chief pharmaceutical officer.

Deputy Róisín Shortall

I thank the witnesses for their presentation. On the exemption for the rent-a-room scheme, the witnesses quoted from the Housing for All document, which talks about the potential for student accommodation. Is that the only reference in terms of the rent-a-room scheme? The quote used would seem to confine it to accommodation for students.

Mr. Paul Flanagan

That is one quote and that is one source for the reference in the Housing for All action plan. The focus initially was on student accommodation particularly but that has since been broadened out to include student accommodation and accommodation more generally across the State. That is on foot of both progressive work under way on the Housing for All action plan, as I understand it, led by the Department of Housing, Local Government and Heritage but also the Dáil motion and discussion in March this year, which encompasses all accommodation to be brought within the scope of the rent-a-room scheme expansion.

Deputy Róisín Shortall

I was just curious as to why the witnesses used that quote.

Mr. Paul Flanagan

Because it is sourced and referenced in the Housing for All action plan. That is an iterative document, as I understand it. It has changed, the actions within have changed and, presumably, the terminology-----

Deputy Róisín Shortall

I was just curious about the use of that quote.

How does verification of entitlement to the scheme work? How long does it take to get that verification from, presumably, Revenue?

Mr. Paul Flanagan

That level of detail will need to be worked through with the HSE in finalising the operational arrangements for provision of the scheme. We are currently drafting broad parameters of the legislation to enable the provision to take place. With regard to timeframe, we envision concluding the drafting process with the Attorney General’s office will take place in the coming months, hopefully to facilitate enactment of the legislation in quarter 1 or early quarter 2 of next year. What we need to do before-----

Deputy Róisín Shortall

Have Department officials not discussed this with the primary care reimbursement service, PCRS?

Mr. Paul Flanagan

We have, of course. We have had preliminary discussions with the PCRS.

Deputy Róisín Shortall

What is its view on that and the likely delay?

Mr. Paul Flanagan

It would be based in broad terms on the rent-a-room scheme, as it is currently incepted and provided by the Revenue Commissioners. That is done on the basis of a tax credit and confirmation of the tax relief provided on an end-of-year basis. When a person is availing of, and confirmed to be a participant in, the rent-a-room scheme, that automatically feeds into the medical card eligibility process. Our challenge and focus will be in further engagement with the HSE PCRS on ensuring absolute operational simplicity and a streamlining of operational practices as best we can to ensure there is no lag or delay for persons who have availed of the rent-a-room scheme, to then feed that link into the medical card assessment process.

Deputy Róisín Shortall

I am not sure how the scheme works exactly. Did Mr. Flanagan say there is a credit at the end of the year?

Mr. Paul Flanagan

Yes.

Deputy Róisín Shortall

That is from the point of view of a person claiming that exemption entitlement but from the point of view of entitlement to a medical card, what kind of documentation will people need to provide and will Revenue be in a position to provide that prior to the end of the year?

Mr. Paul Flanagan

That is precisely the level of detail we are engaging with HSE PCRS on at the moment. There are a number of ways of tackling that particular operational challenge, one of which would be for people who apply for a medical card eligibility to potentially self-declare or self-evidence their participation in the rent-a-room scheme. In doing so, they would then become automatically eligible to gain the exemption from the rent-a-room scheme, rather than waiting upon the tax relief exemption confirmation from the Revenue Commissioners.

Deputy Róisín Shortall

There would not be any verification of that.

Mr. Paul Flanagan

That is part of the broad discussions that are ongoing at the moment with the HSE, the Revenue Commissioners and the Department of Finance as part of the stakeholder engagement to finalise the legislation.

Deputy Róisín Shortall

Revenue is engaged in that at the moment.

Mr. Paul Flanagan

It is, yes.

Deputy Róisín Shortall

It will be interesting to see how that will work.

On the question Deputy Cullinane raised, I just want to probe a bit further the general approach to entitlement to medical cards. It is extraordinary that the income limits have not increased for 20 years, at a time when we are supposed to be extending access to people. I am particularly concerned about people under 70 and under 66. It is in their 50s and 60s that people tend to develop chronic illnesses and need access to services. There seems to be a tendency to steer people away from medical cards to GP visit cards, which are fine for providing access to GP visits but there is a whole range of other services that people require, such as access to public health nurse services and therapies and so on. What is the rationale for just funnelling people towards free GP care rather than the full range of services? It is generally recognised that a GP may be the gatekeeper but what people need generally need is access to other medical services, from therapists and public health nurses in particular.

Mr. Paul Flanagan

It is important that we look at medical card provision in its totality, that is, medical cards and GP visit cards together.

Deputy Róisín Shortall

Sorry-----

Mr. Paul Flanagan

I will focus on the medical card specifically for one second. The core objective of the medical card system is obviously to support citizens in this State to access care when they need it most and to ensure that people who experience undue financial hardship can access that care. There are two important points to make in that context. The first is that overall numbers of medical cards would indicate that the medical card system is broadly operating effectively and fulfilling its objective. Some 1.6 million medical cards have been issued and administered to citizens of the State. I would also look at the additionality of GP visit cards and the role they play over and above that very significant cohort of the population who are benefiting from medical card administration. That is just one piece.

The second piece is that when we look at medical card income thresholds generally, we obviously have cases where people are on the margins of those income thresholds and may fall out and not receive a medical card eligibility because they exceed the current existing thresholds. It is important to note that the HSE has significant discretion and flexibility to address that case-----

Deputy Róisín Shortall

I am not talking about discretion. It is a question of entitlement. For some reason, a decision was taken at some point in the past that the emphasis was going to be on access to GP care. Access to GP care is important but people need access to the whole range of care, particularly people with a chronic illness. There is a huge cohort of people who are being denied that access free at the point of use. It is actually putting more pressure on GP services and precluding people from getting free access to the range of other services they require when they have a chronic illness. I just cannot understand that thinking.

Mr. Paul Flanagan

The point I would make is that I would not consider that we are funnelling persons away from medical card eligibility towards GP visit cards. Both work holistically together as a composite piece. We have still retained very significant numbers of medical card eligibilities while building upon expanding-----

Deputy Róisín Shortall

It is not about retaining significant numbers. It is about extending and expanding. That is what we should be at. Mr. Flanagan made a point about modelling. I had enormous difficulty, as I am sure representatives from other parties had, in trying to get access to some modelling on extending income limits for people under 70 and under 66 when preparing an alternative budget. I also saw from searching parliamentary questions that many other parties have done the same and were refused. The types of answers that were provided very much steered people away from the whole question of medical cards and told us about GP visit cards, just as Mr. Flanagan is doing here this morning. It is partly a political decision but there also seems to be a view within the Department about limiting access to medical cards. I do not think it is fair for a start and I do not think it makes sense either in terms of ensuring we use a wider range of care services for people rather than just GP visit cards. I am very interested in seeing the modelling Mr. Flanagan referred to because it was not provided by way of parliamentary question replies. I do not know why that is. That is something we need to pursue thoroughly.

Many of us are interested in the principle of extending access to medical cards. What we are doing here is fine but arguably, people who have accommodation to spare in their homes and can let that out without any tax implications and without any implication for access to a medical card are in a far more privileged position than, say, a 63-year-old who has a chronic illness and is in a single-room flat. There is an inequality of treatment inherent in what is happening. That is also inherent in the very significant trend towards concentration on GP visit cards as opposed to medical cards. Of course there is a range of other entitlements that would come if a person had a medical card. I am concerned. I want to see the modelling the Department has been doing.

I am out of time, unfortunately. I would like to ask some questions on the pharmacy issue but we might come to those. We might get a chance before I have to leave.

Mr. Paul Flanagan

To reiterate, we commit to coming back with the modelling work as best we can and outlining the implications, as I said earlier to Deputy Cullinane. We will provide that to the committee.

Deputy Neasa Hourigan

I want to put some questions about pharmacies myself before the end of my time. While I broadly accept the requirement for this legislation, it is useful for us to be clear about what we are talking about when talking about the rent-a-room scheme. While it is good that we are encouraging people to make the best use of their homes, we are also encouraging a system where people are not in any way covered by the legislation that usually protects renters. There are no minimum physical standards the property must comply with and there is no legal requirement for the landlord to provide the tenant with a rent book. The restrictions on rent increases on other private rental accommodation do not apply. The landlord can end the tenancy at any time. If there is a complaint, it is not covered by the RTB. Tenants are not covered by the Equal Status Acts, which prohibit discrimination on the grounds of gender or civil status. The rent can be increased without restriction and the tenant's only option is to negotiate with the landlord. We are promoting something and through this legislation we are locking it in. I know it is not an issue for the Department of Health but it is important to read into the record how utterly unprotected people are when they rent a room. By locking that down further in legislation like this, we are accepting that that is the standard but across the EU, that is not the standard. The EU has a two-tier version of renters' rights whereby if a tenant is living with somebody in their owner-occupied home, they also have rights.

In Ireland one has zero rights, is in no way protected and there are no minimum standards. One can see that from the quality of some of the homes which, particularly students, are living in at the moment. It is important to put that on the record.

I want to focus, however, on some of the expansion issues, or the proposals for expansion. I am interested in that idea around the further work which is happening on the serious shortage of protocols because I know that has been in operation in the UK for four years, or has it?

Ms Anne Marie Seymour

It may be a little bit longer in the UK. Their system is different in that they do not have this generic substitution. If there is a different brand but it is the same product, they are not entitled to do this substitution. Our Health Act already allows for that. What is proposed here is specific expansion of where the product is therapeutically different. This is where, for example, the main ingredient is different but one gets the same result for the patient. It is to manage that piece and that is where we will see the use of this medicine substitution protocol. A good example would be something like an antibiotic. Last winter, when we had issues with access to antibiotics, work was done by the HSE with regard to clinical guidance which would enable a pharmacist to change the antibiotic without sending somebody back to their prescriber to get a new prescription. That is the kind of area in which this will deliver.

Deputy Neasa Hourigan

When the review was done in the UK, it found that the most common substitution was in the area of things like selective serotonin reuptake inhibitors, SSRIs.

Ms Anne Marie Seymour

Again, we have generic substitution-----

Deputy Neasa Hourigan

The Department of Health has that capability already.

Ms Anne Marie Seymour

-----in our Health Act already so it would be different from what is in place in the UK.

Deputy Neasa Hourigan

What is the level of communication with pharmacists in dealing with patients or customers because SSRIs, even generic substitutions, might affect people differently? Could Ms Seymour talk me through what the communication is from the Department to pharmacists on how they deal with that issue with patients?

Ms Anne Marie Seymour

On specific generic substitution, there is no communication from the Department. Pharmacists are the medicines experts. They have spent five years studying in this area and they use their professional judgment in making that decision around a patient. There is legislation around what a pharmacist is required to do and it is part of their code of conduct. It would be the regulator who would issue specific guidance in that kind of space.

If we are moving out to therapeutic substitution, which is this medicines substitution protocol, the framework would be built where we would call a shortage, there is clinical guidance and there are clinical experts to look at it. They will identify things like what questions one should ask a patient, what are the risks of this substitution, what one needs to do, how one needs to document it, and the timeframe of it, because hopefully it would be for a short period of time. That would be clearly called out and would be done for each case. The secondary legislation would just lay out what needs to be done but then in each case, that process will be followed to ensure patient safety, and to make it easier for the patient to access these.

Deputy Neasa Hourigan

For the sake of clarity, is it the Department or is it a specific body which is issuing guidance to pharmacists around the particular substitution in the case of a shortage?

Ms Anne Marie Seymour

The Minister will be the final approver in the process we have proposed but there would be a role across the service with regard to ourselves, the HSE, the Health Products Regulatory Authority, HPRA, and then our regulators - the Pharmaceutical Society of Ireland and the Medical Council - with regard to the communication around the final protocol. It needs ministerial approval.

Deputy Neasa Hourigan

The Minister is the final arbiter and is where the buck stops, which is fair enough, but are all of the groups or people listed out by Ms Seymour in the room when the Department is deciding?

Ms Anne Marie Seymour

No, they are not. It would be the responsibility of the Health Products Regulatory Authority to call the shortage and it would be for the HSE, then, to develop the clinical guidance and assess the issue because it would need to pull in different expertise based upon what the shortage is.

Deputy Neasa Hourigan

It is the HSE, then, which goes to the Minister with the recommendation.

Ms Anne Marie Seymour

Yes. This is the secondary legislation we are working on.

Deputy Neasa Hourigan

Yes, I know as I am just trying to understand how it might work.

Ms Anne Marie Seymour

This is the proposal. We have been speaking with Dr. Colm Henry and his team around how could it could be delivered from the HSE and that is the current proposal.

Deputy Neasa Hourigan

I notice in the UK that it has included a requirement - under what I believe is a separate piece of legislation - for the pharma industry to advise if shortages are imminent. Is that something we are looking at?

Ms Anne Marie Seymour

That is included in this Act here. Very good relationships have already been built across the system but what we see across Europe is that countries are now legislating for that. As I mentioned earlier, the work across Europe to manage shortages is better and we are looking at developing systems that-----

Deputy Neasa Hourigan

Could Ms Seymour outline for me how that communication might work or happen?

Ms Anne Marie Seymour

Is that from the manufacturer to the HPRA?

Deputy Neasa Hourigan

Yes.

Ms Anne Marie Seymour

There would be a legal requirement to report. There is already an obligation in European legislation.

Deputy Neasa Hourigan

What is the timeline for that?

Ms Anne Marie Seymour

It is two months in current legislation and there are changes proposed in the pharmaceutical legislation which is under review at the moment. In Ireland we would like to see what would be for the best here. What is proposed in the current Bill is that the Minister can make regulations around the reporting. It will go a little bit broader than that because if we have a shortage, we do not have good oversight in Ireland at the moment as to what stocks we have. This is looking holistically at the system to see how we can enhance the security of supply in a better way.

Deputy Neasa Hourigan

My apologies to Ms Seymour for interrupting as I only have a couple of minutes left.

Ms Anne Marie Seymour

My apologies to the Deputy.

Deputy Neasa Hourigan

When Ms Seymour says "as to what stocks we have" does she mean within the HSE or by the manufacturers?

Ms Anne Marie Seymour

I mean across the whole system of manufacturers, wholesalers, hospitals and pharmacy.

Deputy Neasa Hourigan

We find it difficult in this country to say that we have this many units gross, altogether.

Ms Anne Marie Seymour

Yes.

Deputy Neasa Hourigan

Is there, or has there been, a concern, even with that European requirement, with regard to the interaction with the competitiveness of particular products? Pharma is a private industry and if it is reporting shortages I can only imagine that that might have an impact. Is there a concern in terms of the legislation as to how it interacts with the pharma industry's private operation as profit-driven companies?

Ms Anne Marie Seymour

This is a requirement already so if the pharma company supplies and has a licence in a country, it is required to report shortages and potential shortages.

Deputy Neasa Hourigan

Have there been failures of that?

Ms Anne Marie Seymour

There have been, yes.

Deputy Neasa Hourigan

Could Ms Seymour expand on that little bit, please?

Ms Anne Marie Seymour

Ideally, one can react better, the more notice one has. Sometimes, if a notification comes quite slowly, or if medicine will be in short supply within a short period of time, it does not give us the same powers to be able to react in a better way because we would work with the HSE, with the medicines authority, with the Pharmaceutical Society of Ireland and the Medical Council, with regard to clinical guidance and how to manage a shortage. There have been cases where if we had known earlier, and if the Health Products Regulatory Authority had been informed earlier that there was a shortage coming, then things could have been done in a better way. Clinical guidance just talks about something one cannot do overnight.

Deputy Neasa Hourigan

These companies, therefore, have not fulfilled the two months requirement, let us say.

Ms Anne Marie Seymour

Not in every case, no.

Deputy Neasa Hourigan

Has any punitive action being taken?

Ms Anne Marie Seymour

No, there is no power at the moment in legislation to take action on that.

Deputy Neasa Hourigan

As a legislator, when there is no punitive or follow-up power, one questions then the efficacy of the legislation. Is it something that the Department is exploring that there would be some follow-up? Pharma is a very profitable industry and I can only imagine that even fines would not be particularly useful.

Ms Anne Marie Seymour

Yes. This is something that can be considered in the development of the secondary legislation.

Ms Anne Marie Seymour

Is the Department considering this?

Ms Anne Marie Seymour

It is something we are considering but we have not reached that full level of assessment as to what we want to do there.

Deputy Neasa Hourigan

Are there any examples within the EU that we can look to?

Ms Anne Marie Seymour

Yes, some countries have powers if things are not complied with. Some countries have just legislated about further reporting but not what happens when they do not report.

Deputy Neasa Hourigan

I thank Ms Seymour.

An Cathaoirleach

I thank Deputy Hourigan and Ms Seymour.

Deputy Gino Kenny

I thank the Cathaoirleach and good morning everybody. I have a number of questions. I generally welcome the broad base of the Department's statements. On the rent-a-room scheme, how many people have taken up the scheme at this moment in time?

Mr. Paul Flanagan

Approximately 11,000 people currently avail of the rent-a-room scheme. That is based on the latest data from 2021 is provided by the Revenue Commissioners.

Deputy Gino Kenny

Some 11,000. With this change in legislation, does the Department envisage that that number will go up?

Mr. Paul Flanagan

We would but it is difficult to specify or forecast with absolute accuracy what the additionality might be with regard to numbers coming into the scheme. We can build in some working assumptions against the bedrock of 11,000 current participants. For costing purposes, we can take some examples around perhaps a 10% increase, which obviously yields in excess of 1,000 new additional units becoming available to the rent-a-room process. That allows us then to cost what the cost to the Exchequer and to the State might be, overall, as a package of care and as an outcome of the process. Our bedrock is the current participants on the scheme of 11,000. That number has increased marginally over the past number of years, as I understand it. Our focus in bringing through this objective would be to further increase that number, although, as I say, it is difficult to determine accurately at this point what that precise number be.

Deputy Gino Kenny

Could Mr. Flanagan gave me a breakdown of that 11,000 householders with regard to locality, or possibly of geographical areas?

Mr. Paul Flanagan

I do not have that detail readily available this morning but we can make an inquiry on behalf of the Deputy to the Revenue Commissioners and see what we can get by way of a breakdown with regard to household units, families and geographical location across the country.

I am not sure if it is available, but we can make that inquiry for the Deputy.

Deputy Gino Kenny

What is the tax liability for somebody renting a room out to an individual or individuals as regards the Revenue?

Mr. Paul Flanagan

My understanding is that that is beyond the scope of the Bill. It is not an area that is within my remit of responsibility. My understanding is that the income is generally taxable unless the person has signed up and become an eligible participant in the rent-a-room scheme. If the Deputy would like further detail on the practicalities of how the scheme is administered, we can certainly get it for him. As I said, however, it is beyond the scope of the Bill and beyond the remit of the Department of Health. It is policy elsewhere in Government. We can source detail on it for the Deputy.

Deputy Gino Kenny

My final questions are about the second part of the Bill as it relates to pharmacists. It is good that pharmacists are broadening their services to many individuals. We have seen that during the Covid pandemic. How does the Irish Pharmacy Union feel about the possible legislative change in this regard?

Ms Anne Marie Seymour

We have engaged with the Irish Pharmacy Union and it sees this very positively and is happy to support any new initiatives that are developed. We spoke to it just in advance of the pharmacy task force's announcement last week about the expansion of prescriptions. The union was very encouraged by that and is happy to engage in and support the further work of the pharmacy task force and any of the changes discussed here.

Deputy Gino Kenny

If this legislation were enacted tomorrow, what would it look like as regards what pharmacists could do after the legislation that they cannot do now?

Ms Anne Marie Seymour

A lot of aspects of this clarify what is already in place as regards pharmacists. The legislation refers to the locations where medicines can be supplied and refers to a hospital, a nursing home or other. The Attorney General has spoken about future-proofing the legislation, particularly if there were another pandemic in the morning. It is a matter of referring to pharmacists specifically as a profession that can supply medicines. It is about strengthening what is in the Irish Medicines Board Act. Any further action would have to involve secondary legislation. Decisions made on the supply of medicines by pharmacists would entail the development of secondary legislation. This involves not only pharmacists but also other healthcare professionals as regards the vaccination programme. We had a really good vaccination programme in Ireland during the Covid pandemic. Other healthcare professionals were brought in to administer vaccinations who had not been used before. We would really like to build on that and learn from the benefits. We had such a good uptake of vaccinations. The inclusion of that in this Bill will provide for the retention of those other healthcare professionals, again within a framework such that the right training and the right regulation are required. This involves pharmacists and others as regards certain aspects such as the State vaccination programme.

Deputy Gino Kenny

The unions that represent GPs, I think, would be relatively happy about this legislation in that it frees their work to a degree.

Ms Anne Marie Seymour

Yes. We are very cognisant of that engagement as regards the work of the pharmacy task force. We have representation from the Irish College of General Practitioners, ICGP, on the pharmacy task force. We engaged directly with the Medical Council, the Irish Hospital Consultants Association and various other medical bodies on the work of the pharmacy task force. That will continue as we go through this, looking at the expansion of the scope of practice of pharmacists.

Deputy Gino Kenny

I have never heard of the European voluntary solidarity mechanism before. It is a European mechanism for the regulation of medicines that could become unavailable in certain European countries. Is that the purpose of the mechanism?

Ms Anne Marie Seymour

It is kind of one of the suite of measures that I mentioned the European Commission came out and spoke on last week. The solidarity mechanism allows member states to support one another such that if there were a specific issue in Ireland, we might support France or vice versa. Unfortunately, we do not have a full single market for medicines in the same way we have one for other products. The goal of the European Commission is to have a single market for medicines. The voluntary solidarity mechanism is sort of an interim piece whereby countries can support one another in times of shortages of their medicine supplies. It could be the case that a medicine is not packaged for a certain country. The packaging could be in a different language. In exceptional circumstances it could be used.

Deputy Gino Kenny

Has that happened before?

Ms Anne Marie Seymour

Yes, it happens. The voluntary solidarity mechanism is quite new. It has been established just in recent months. As regards medicines being used, the leaflets for some of the earlier Covid vaccinations may not have been in the English language. I think they came from Switzerland but I can double-check that.

Deputy Gino Kenny

Are there any examples in, say, the European Union of pharmacists being able to prescribe particular drugs to customers? Is there any mechanism in Europe whereby that can happen?

Ms Anne Marie Seymour

Yes. I will ask my colleague, Ms Doyle, to speak about other European countries.

Ms Bevin Doyle

Not necessarily within the EU, but I remind the Deputy that, in the context of health being a national competency, different countries will have different arrangements in place for different medications. I am sure we have all experienced situations in which we have been abroad and have been able to get something over the counter that one cannot get over the counter here. There are differences in the scope of practice and what might be available to pharmacists. We would note that, despite the fact that they are no longer part of the European Union, pharmacist prescribing is in place in Northern Ireland, Scotland and England. Wales is on its pathway towards it. Most of that work was achieved before Brexit. Certainly, there was precedent there in our nearest neighbour. Elsewhere, I think the scope of practice varies. Pharmacist prescribing would not be usual across the EU, I think it is fair to say.

Deputy Gino Kenny

Can the witnesses give an example of what these medicinal products would be to the average person who goes into a pharmacy to collect them?

Ms Anne Marie Seymour

I apologise. Can the Deputy clarify the context?

Deputy Gino Kenny

How would medicinal products be classified? These are drugs that do not need to be prescribed by a doctor but can be obtained in a pharmacy.

Ms Anne Marie Seymour

As regards current examples, under European legislation it is a prescription or not a prescription. Not a prescription is your over-the-counter, Panadol-type product. Then there is supply by a pharmacist. When you get your flu vaccination, your pharmacist does not have a prescription, so that is supply. There are emergency situations. In the emergency context you can go into your pharmacy and the pharmacist can give you medication without a prescription. It is that kind of thing.

Deputy Gino Kenny

What example would that be?

Ms Anne Marie Seymour

Any medication-----

Deputy Gino Kenny

Contraception?

Ms Anne Marie Seymour

Emergency contraception has moved to being an over-the-counter product in Ireland. Again, there are different things in different countries. You can go into a pharmacy for any medication, really.

Another piece of work ongoing in the Department is looking at the emergency supply of controlled drugs, which can be an issue at times when people need access, even in palliative care-type situations, where there is a need for an emergency supply for a couple of days for somebody. That is another work stream we are delivering on as regards access to medicines for patients.

Deputy Gino Kenny

Would, say, methadone come under that guise?

Ms Anne Marie Seymour

As regards methadone, I think that on the emergency supply any controlled drug would be included.

Ms Bevin Doyle

Yes, absolutely. On an emergency basis pharmacists may provide an emergency supply until such time as the person can get to his or her prescribing medical practitioner.

Deputy Gino Kenny

That could be applied to all drugs, could it?

Ms Bevin Doyle

The intention is be very broad in the scope of what pharmacists can supply in an emergency. In fact, this was already in place as regards the Covid-19 pandemic, during which it was a measure taken to make sure that continuity of care was available to people.

Deputy Gino Kenny

Would that even apply to, say, antidepressants?

Ms Anne Marie Seymour

It will apply to any medicine but the professional practice of the pharmacist is key. He or she will assess every single patient, person and case on a one-to-one basis. They are experts in medicines and can assess a situation. It is not creating a broad scope. It is very much patient-centred.

Deputy Gino Kenny

In theory, a pharmacist could give somebody anti-depressants without a prescription. Is this possible?

Ms Anne Marie Seymour

For a very short period of time; if it was a Friday evening emergency where-----

Deputy Gino Kenny

If that person goes to a pharmacy and says he or she has finished his or her prescription and cannot see his or her GP, could the pharmacist provide a week's supply of that drug?

Ms Anne Marie Seymour

It is possible. We are looking at a maximum of five days around emergency supply but, again, it would be a case of judging the particular situation.

Deputy Colm Burke

I thank the witnesses for their presentation and for their work in this area. I will return to the issue of the medical card because I know the income limit not increasing was mentioned. I have dealt with the medical card division and have found it to be extremely approachable as regards dealing with difficult circumstances. Can we get an idea of the number of discretionary cards that have issued? This is where somebody has a particular health issue and is above the income threshold but, because of the medical issue, what we call a discretionary card is issued. I understand that more than 1.8 million people have medical cards. How many of these are discretionary medical cards? I am thinking of someone with cancer or a medical issue where they need to constantly go for medical care.

Mr. Paul Flanagan

We have those numbers. From memory, the number of discretionary medical cards awarded by the HSE is in the region of 180,000. I mentioned in our presentation how where people are on the margins of breaching the income thresholds, the HSE has discretion to recognise the particular individual circumstances of applicants, be it on the basis of illness, undue financial hardship or an illness that has very high cost-incurring expenditure attached to it. In that scenario, the HSE is very active in using its flexibility and providing discretionary medical cards.

Deputy Colm Burke

Am I correct about there being 1.8 million medical cards in existence or is the number higher?

Mr. Paul Flanagan

My understanding, and I will come back to correct the record if I am incorrect, is that the number is 1.6 million, which is the totality, including discretionary cards.

Deputy Colm Burke

So we are really talking about nearly 15%. I have not done a quick calculation of it but roughly around 15% are discretionary cards.

Mr. Paul Flanagan

That is correct.

Deputy Colm Burke

One of the issues that comes up with regard to medical cards is where someone has a medical condition and is over the threshold but, the only unit providing the kind of care that person requires is with the HSE and he or she cannot get access to it without a medical card. Has this come up quite a bit with regard to particular types of illnesses, where the person needs medical care, but that person can only get it in a hospital setting he or she would not get access to unless he or she had a medical card? I have come across quite a number of those cases.

Mr. Paul Flanagan

I am not quite clear about the circumstances to which the Deputy is referring. Is it where the person has a particular illness and has not qualified?

Deputy Colm Burke

The person has an illness and needs ongoing care but does not qualify for a medical card because of his or her income levels, whereas the level of care that person requires involves access to public clinics to which he or she would not have an entitlement without a medical card.

Mr. Paul Flanagan

This speaks to the qualifying criteria for medical cards in the first instance, which, as I mentioned earlier, is based primarily on residency and means. Medical card eligibility on the basis of specific illness was examined in 2014 by an HSE expert advisory group, which examined the context and the possibility of providing medical cards to recognise particular illnesses. That expert advisory group process shone a light on the complexities around that approach, not least the ethical decisions around what illnesses should be in the scope for medical card eligibility.

Deputy Colm Burke

I met a young man with multiple sclerosis whose wife was working so he was totally over the income limit. Initially, he could not get access to particular treatment unless he had a medical card. We got it over the line. He was refused initially. In fairness to the medical card division, it reviewed it and gave him a card, but this is the kind of thing I am talking about, where someone could not get access to the treatment he required because it was only through a HSE facility.

Mr. Paul Flanagan

In the case of specific circumstances, it is entirely appropriate that the HSE would analyse the totality of the person's situation and circumstances. That this individual got the access and care he needed in time is a good news story-----

Deputy Colm Burke

Yes, but he was turned down initially. Many people would have walked away once they were turned down but in fairness to him and through my office, we did fight the issue and, in fairness to the HSE, it came on board. I am concerned there might be others with a similar medical condition who may decide, after being turned down, not to deal with it.

Mr. Paul Flanagan

The issue of illness as a defining criterion for medical cards has been examined by a HSE expert advisory panel. The complexities around which illnesses are defined for medical card eligibility and how the hierarchy of illnesses and their importance are defined throw up a swathe of justifiable ethical concerns. It is because of that expert group advisory process in 2014 that we hold means as the bedrock of assessment on a continuing basis.

Deputy Colm Burke

I will move on to the second part of the Bill, which is about pharmacists being able to provide medicines without a prescription. Are we not behind the times regarding the way we deal with this? I have a bank card and can go anywhere in the world with it and get access to my bank account. If I go into three different hospitals in Cork, there is a paper file for me in each of them. When are we going to have a card whereby if I go into a pharmacy, the pharmacy can check that I have not already gone into five, six or ten other different pharmacies? That is the danger of allowing pharmacies to provide medication without a prescription. I know pharmacists will be very careful about this but why can we not have a card system? I have been talking about this, as have others, for the past ten years. Denmark introduced it in 1996 and we still do not have a system whereby somebody has a patient medication card when he or she goes into hospital or pharmacy or to a GP. We are doing nothing about it. Why is this the case?

Ms Anne Marie Seymour

The e-health and e-prescribing project is very active. It is doing a lot in this space. I know it is not-----

Deputy Colm Burke

I know that but say I go into ten different pharmacies and get the same medication from each of them, there is no way the pharmacist can check where I have purchased them.

Ms Anne Marie Seymour

What is being done on the e-health side-----

Deputy Colm Burke

I am just asking. That is the position.

Ms Anne Marie Seymour

I am not saying we are there yet-----

Deputy Colm Burke

When are we going to get there? Having one central file for each person has been proved to have produced a significant saving in Denmark. Remember that 1.6 million people are already on the system so why has it been long fingered for the past ten, 15 or 20 years? When are we going to move forward on this issue?

Ms Anne Marie Seymour

That is being actively progressed. A team is working on e-health, which will provide that oversight. Similarly, some of the provisions in the-----

Deputy Colm Burke

We introduced it in five maternity hospitals so that all of the files of any patient admitted to any of those hospitals were computerised, but we have not done anything with any of the other 14 maternity hospitals. That is a good place to start off with. When can we put it into the other 14 hospitals?

Ms Anne Marie Seymour

This is not my area of responsibility but my understanding is that the approach is to develop this system that will deliver-----

Deputy Colm Burke

I know, but it comes back to the issue about pharmacists being able to manage this area. If we had a central card system, we could devolve a significant amount of work to pharmacists in the morning because we would then have checks and balances. There are no checks and balances at the moment. Pharmacists will do their best.

However, that does not prevent the situation arising where the same person can go to different pharmacies in different parts of the country or the city and get the same drug.

Ms Anne Marie Seymour

That supply is the emergency situation, and it or any other supply of a medicine is already tightly managed in the legislation. It is not this broad opening that pharmacists can give out what they want.

Deputy Colm Burke

I understand that, but does Ms Seymour understand the point I am making? We want to expand what pharmacists can do. If we had a card system in place for everyone just as they have bank cards, the pharmacist could open a person's file and see a person already got a drug in another pharmacy.

Ms Anne Marie Seymour

In the work of the pharmacy task force we recognised where the electronic systems are and where they need to be in terms of the kind of thing the Deputy is talking about. However, the decision and the recommendation of the group was that progress should not be halted while waiting for e-health.

Deputy Colm Burke

I accept that but when are we going to have the card system? Denmark started it in 1986. Here we are, not even at the starting block.

Ms Anne Marie Seymour

Work has been going on for a number of years.

Deputy Colm Burke

Exactly, but it has not delivered.

Ms Anne Marie Seymour

They have a very clear project plan.

Deputy Colm Burke

What is the timeframe of that project?

Ms Anne Marie Seymour

I would not like to comment exactly because it is not my area of responsibility but I could provide that to the Deputy.

Deputy Colm Burke

Would Ms Seymour accept that we already have information on 1.6 million people through the medical card system so we could use that as a base to start off with as regards computerising the medical records of the population? If someone is suddenly admitted to hospital through accident and emergency, if there is any information from when that person was in another hospital, the admitting hospital has to wait until the paper file is sent over.

Ms Anne Marie Seymour

Rather than tackling it in a piecemeal way, this delivery will include the e-prescribing system and the e-health records. That is where the energy is being focused.

Deputy Colm Burke

Will Ms Seymour come back to me about when it is envisaged?

Ms Anne Marie Seymour

I can.

Deputy Colm Burke

When is it intended for maternity hospitals? I understand five are done. When is it proposed to have the other 14 up and running?

Ms Anne Marie Seymour

I do not know the answer to that so I will look into it and send the information to the Deputy.

Deputy Colm Burke

It is so important if we want to make the health service system more efficient and get better value for money rather than delays in accident and emergency. The doctor will understand the person was in hospital previously but does not know what they were on. The person himself or herself is not able to give instructions and does not even know what medication he or she is on. It is very difficult for any nurse or doctor to try to manage a patient without even knowing what medication the person is on. If the person had a card, at least that could be put into the system and there would be immediate access to what medication he or she is on in the same way as bank account details can be accessed. We do not appear to be moving this fast enough.

Ms Anne Marie Seymour

We can come back to the Deputy with an update on that.

Deputy Colm Burke

Would Ms Seymour accept that if we had that system in place, we could then do a lot more with the pharmacies because the pharmacists would have the protection?

Ms Anne Marie Seymour

We do, and as I mentioned, the decision was to try to deliver what we can in line with what is there at the moment, so let us do what we can. We engage with the e-health teams quite regularly. It was a recommendation of the task force that engagement was strengthened, so they are cognisant of what is coming on the pharmacy side. When they are planning, they build it in.

Deputy Colm Burke

Have we a target date?

Ms Anne Marie Seymour

I do not want to comment on that.

Deputy Colm Burke

Should we not have a target date?

Ms Anne Marie Seymour

I know they have very detailed project plans and they have been delivering different things in terms of the formulae for drug files, but I do not want to say it here without double-checking. I can a get a briefing on that and send it.

Deputy Colm Burke

I look forward to that.

An Cathaoirleach

We have almost come to the end. Generally, there seems to be consensus that people are in favour of the Bill. The witness mentioned that, at the moment, 11,000 people are using this scheme. I am surprised we have not even done an assessment of those people in terms of encouraging others into this system. For anyone listening at home, we would encourage them, if they have accommodation, to join the scheme, despite some concerns raised by one of the members about it. In regard to the figure of €14,000, I know it is outside of the Department's remit but how did we come up with that figure? For many people who are trying to rent a room, €14,000 would be a relatively good price in today's market. Many people are paying a lot more. Given the current difficulties for people trying to get accommodation, how did the €14,000 figure come about? I understand it is outside the scope of the Department but have the witnesses any comments on whether there is flexibility down the road? I presume, if the Minister decides it is to be €16,000 or €17,000, it is just a matter of amending the legislation.

An area that some people will have a concern about is under head 8 whereby, during periods of medical shortages, pharmacies can therapeutically substitute another product in line with improved protocol. From my own experience and that of people in the system, when the product is changed, it creates a worry for people. People are used to a particular product and how their body reacts to it and so on. Changing it to a substitute product or a generic product means some people will say that affects them differently. Some people at home would certainly have concerns about that. Will the witnesses comment on that?

Overall people will welcome the Bill. This is similar to pre-legislative scrutiny. The Members decided we would bring this in. There were concerns about the roll-out of it. It makes sense that we give more powers to pharmacies, particularly having seen the challenges created by Covid-19. We do not know what is coming down the track but it makes sense that we spread the ability of people to be able to give out other medical products to patients.

The palliative care element was mentioned in the opening statement. Will the witnesses expand on that? In regard to some of the products, what general area will this legislation apply to? I presume there is quite regularly a shortage of antibiotics. That was one of the drugs people mentioned there is some shortage of. The area of big pharma whereby products come from all over the world was also mentioned. Are the shortages in particular countries? I presume that in the main we get products from within the EU or the greater Europe area. Are there particular countries where difficulties have arisen in recent years? I understand there were challenges with supply chains coming out of China, mainly due to some of the products that make up the drugs. Will witnesses identify countries where problems arose in recent years?

There are many questions but the witnesses might answer a few of them.

Mr. Paul Flanagan

To address the point on the rent-a-room income limits, as the Cathaoirleach rightly says that is an issue and the threshold is set beyond the Department of Health. It is as advised by the Revenue Commissioners. Interestingly, in providing for the exemption of that income, should that threshold increase in the future, that increased amount, whether it is €16,000 or €17,000, would automatically flow into the legislation we are drafting so that the exemption will continue to apply to the higher amount, not just to the €14,000 current limit. We are actively watching that space and trying to future-proof the legislation to take account of that.

The €14,000 threshold has increased in recent years. I am not sure from what base or over what timeframe but we will try to get that detail for the committee if it will be helpful.

An Cathaoirleach

I imagine Revenue has a ballpark figure for what it will use in that regard.

Mr. Paul Flanagan

That is absolutely the case. Importantly, as I say, the definition we are using for the rent-a-room relief will mirror any future changes that happen in this space and the exemption will carry automatically into medical card eligibility and, I hope, grow and expand the number of participants in the scheme overall.

Ms Anne Marie Seymour

The Cathaoirleach expressed concerns regarding substitution. That is an issues we recognise. We hear it is a concern of patients. There are two streams of work that can be done in that regard. The first relates to when a shortage has occurred or is occurring and how we can best support the patient. In that regard, under the medicine shortages framework, there are close relationships between us, the Health Products Regulatory Authority, the various streams in the HSE, including those involved in reimbursement, clinical guidance and supply for hospital and community pharmacies, and our regulators. What we have been doing and what we are doing for this winter is to meet quite regularly, every three weeks or so, to do a bit of horizon scanning as to what issues there are and what clinical guidance might be needed. Those are the kinds of things that can support communication to prescribers and pharmacists and allow them to know what is happening and to be better prepared to support patients when they come in. That is the patient-facing side of the matter.

Some of the legislation is intended to better prepare Ireland through the management of the supply of medicines. That will include reporting of the level of medicines we have and what the requirements are. If there were to be a pandemic or a particular issue in the morning, we would need a certain group to be convened quickly by the Minister. Developing a strategy around medicine shortages and the security of medicine supply would help to mitigate the impact on a patient in the first place. There are two pieces of work to that.

On the emergency supply of controlled drugs, a patient might leave hospital and a palliative care situation on a Friday evening. The reason for the emergency supply is to get such a patient over the day or two before they can access their GPs for a prescription. If things have changed and a patient needs medicine quickly, that is the idea of emergency supply.

The Cathaoirleach mentioned antibiotics and shortages thereof. That is an area where we would invoke the medicine shortage protocol. Work is already being done in the health service. Last year, the antimicrobial resistance and infection control, AMRIC, part of the HSE prepared guidance in the event that an antibiotic is not available and what should be substituted. That was updated on a daily basis over the winter. It prepared guidance for parents in the event of a paediatric antibiotic shortage and advised how they could get a child to take a tablet. Those kinds of things are intended to support patients. As medicine shortages occur, AMRIC will feed in, as required. Everything does not have to be in legislation but the purpose of this legislation is to allow us to build a framework. We can then engage with the various people in the HSE as we need to.

The Cathaoirleach asked about shortages in supplies coming from particular countries. Medicine supply chains are very complex and supplies come from here and there. Work is going on in respect of the security of supply chains. We engage regularly with our colleagues in the Department of Enterprise, Trade and Employment on Ireland's position on open strategic autonomy. The Irish position on the security of medicine supply chains is that we identify what medicines are critical and then look to monitor and enhance those supply chains. It is not a case of being able to say that we can make all medicines in Ireland, Belgium or France. We need the various pieces that are coming from different countries. The Irish position is that we examine which medicines are very important and consider how to monitor and support those supply chains to ensure the security of supply of medicines. It is not necessarily the case that one particular country causes the issues. The supply chains are so complex that it is about building the pieces together.

An Cathaoirleach

That is great. Perhaps at some stage we will bring in our guests again on the wider medical card issue. Eligibility and discretionary cards have come up on a number of occasions. It would be useful for the committee and for the people who are listening in at home. There is a public element to these committees and that might be useful for people.

I do not think there is anything else. Does Deputy Burke want to ask any further questions?

Deputy Colm Burke

I do not.

An Cathaoirleach

I again thank our guests for coming in today. It has been a useful engagement with the committee on the important matter of the general scheme of the health (miscellaneous provisions) Bill 2023.

Sitting suspended at 11.05 a.m. and resumed in private session at 11.07 a.m.

The joint committee adjourned at 11.07 a.m. until 9.30 a.m. on Wednesday, 15 November 2023.