The Health (Miscellaneous Provisions) Bill 2024 recently passed Second Stage in the Dáil. The Bill was published last year and has been progressing through the Houses of the Oireachtas since. The Bill, when enacted, will amend current legislation to enhance the Minister’s power to make regulations for the management of, and access to, medicinal products. In this article, IPU Editorial Manager Siobhán Kane provides an overview of the debate at Second Stage.
The Health (Miscellaneous Provisions) Bill 2024 passed Second Stage in the Dáil on 22 February, and the Minister for Health, Stephen Donnelly TD, used the debate to discuss his ambitions for expanding the role of pharmacists. Speaking when he proposed the Bill for Second Stage on 21 February, Minister Donnelly said the Bill, “is an important step in providing a new legislative basis to tap into (pharmacists’) very substantial expertise and their real appetite for doing more and more in terms of healthcare provision right across the country”. In this article, we set out the main provisions of the Bill, and the debate contributions from both the Minister and those Opposition Members who spoke on issues pertaining to pharmacy.
Minister Donnelly outlined the three main aims of the Bill:
Minister Donnelly used the debate to set out his “ambitions for pharmacy as a profession”, saying “pharmacists are highly trained professionals who can support a greater level of access to care for all of us in our own communities.” He said enhanced pharmacies are a commitment in the Programme for Government, and Government is aware that pharmacists can and want to, do more: “My Department is in discussions now with the Irish Pharmacy Union about a broad-ranging agreement.”
Part of his ambition for pharmacy, is with regard to the provision of services “that previously required a trip to the GP”: “As we rollout a minor ailments scheme, there are other things — for example, conjunctivitis — where a pharmacist can very easily spot the problem but cannot provide the product because it requires a prescription. We are looking at those kinds of things to make sure that pharmacists can do more and more. We will tap into their expertise in terms of substituting certain medicines. We know there are medicines shortages around the world and we need to become more agile. There are therefore many steps we are taking with the pharmacists.”
He also cited the Pharmacy Taskforce, which Minister Donnelly said will “support this goal and its work is progressing well”.
Minister Donnelly outlined changes to the Irish Medicines Board Act 1995 (IMB Act), which will clarify regulatory powers concerning the supply and administration of medicinal products.
The IMB Act makes broad provision for arrangements for the control of medicinal products, including in relation to their manufacture, sale and distribution. Minister Donnelly said, “Notwithstanding amendments that were made in 2006, updates of some provisions are advised to ensure the Act is more in line with the current needs of public health and of our health services.” There are three amendments proposed to the IMB Act, which will allow for the following:
Access to certain approved prescription medicines
The cohort of those who supplied and administered vaccines was widened during the COVID-19 pandemic. This will be retained and extended and will give clarity on the professions who may administer medicinal products including, but not limited to, vaccinations. It will explicitly include “pharmacy” as a named location where the administration of medicinal products may take place.
Allow pharmacists to sell and supply approved medicines without the need for a prescription
This primary legislative amendment will be subject to appropriate regulation and controls, to be set out in secondary legislation. This amendment also provides for the expanded provision of vaccinations by pharmacists. On this point, Minister Donnelly said; “It is my intention that regulations will be put in place to facilitate the sale and supply of oral contraceptive pills by pharmacists in the absence of a prescription.”
Medicine shortages
Regarding changes to the IMB Act concerning medicine shortages, Minister Donnelly said his proposals will help to “mitigate medicines shortages nationally, and to complement work happening at EU level on medicines availability”: “These measures will introduce medicines substitution protocols, MSPs, and related actions which will help to mitigate the impact of medicines shortages. MSPs allow pharmacists to supply a specified therapeutic alternative medicinal product in limited circumstances where there is a shortage of a prescribed medicine. This will be done in strict compliance with approved protocols specific to a known or anticipated shortage and for a limited time. It will enable us to be agile in our response to emerging shortages and further utilise the expertise of pharmacists.”
During the Second Stage debate, Minister Donnelly also signalled to his colleagues that he intends to introduce a further measure, which will be included in the Bill, but will not be introduced until Committee Stage. He said, “This will take the form of a further amendment of section 32 of the IMB Act to introduce reporting obligations for actors in the medicines supply chain and to allow for this information to be used in national medicinal planning systems. These reporting requirements, which are in line with European obligations, seek to improve visibility of the medicines supply chain to Ireland and help the management of medicines availability in Ireland. These measures will support the national system for the management and security of medicines supply and will facilitate a more proactive system for the management of medicines shortages.”
The Bill was welcomed and supported by all Opposition and Government backbench TDs who spoke during the Debate.
Sinn Féin
Sinn Féin’s Health Spokesperson, Waterford TD David Cullinane, said Sinn Féin will support the Bill. He particularly welcomed “the provisions relating to medicines substitution protocols, which will improve the availability of products through pharmacies without a prescription”. Citing the priority and oral questions he has raised on this issue over recent years, he welcomed the steps being taken in the Bill, but said, “I believe we are still only dipping our toes into the water with regard to what we can do with pharmacies”: “I see GPs and pharmacies as comprising one of the most important gateways for people getting into healthcare. They are really important in terms of taking pressure off acute hospitals. I have always held this view.”
However, Deputy Cullinane also cautioned on the funding levels available for health this year: “we have very limited additional funding for health in 2024. It is important to reinforce that at each and every opportunity we have this year to talk about expansion of healthcare. If the additional resources and funding are not there, then there are very limited options available to the Minister to expand services.”
Deputy Cullinane’s Party colleague Donnchadh Ó Laoghaire TD (Cork South-Central), echoed his support for the Bill, but again reiterated that “pharmacies have been underutilised”: “We have a network of pharmacies that are willing to do more.”
Deputy Thomas Gould (Sinn Féin, Cork North-Central), also wished to put on the record, “the great work done by pharmacists in my constituency and right across the State”: “They are often a person’s first port of call. They provide compassionate, educated advice on many issues. This is invaluable.”
Fellow Sinn Féin Deputy, Limerick City TD Maurice Quinlivan, also said, “The Bill and its ambitions are positive”: “The proposal to allow the Minster for Health to make regulations that could enable pharmacists to sell and supply approved medicines without a prescription are positive, if minimal, moves that can contribute to alleviating our healthcare crises. Any move that seeks this outcome should be welcome.”
The Labour Party
The Labour Party’s Health Spokesperson Deputy Duncan Smith (Dublin Fingal) also welcomed the Bill, saying provisions to enable pharmacists to sell and supply approved medicines without the need for prescriptions, “is a positive step in addressing the increased pressure that is placed on GPs and GP services”. He said pharmacists are the first port of call for many people when they have a medical issue, and “they have the knowledge and expertise to provide expert care either over-the-counter or in the consultation rooms that some of them have on-site”. Deputy Duncan drew on research from the IPU on a minor ailments scheme, showing the overwhelming support for expanding the role of pharmacists. Citing “the financial benefit involved” for pharmacists, Deputy Smith said, “it is the public benefit I am interested in”: “Again, it is just about trying to get access to services and to make it easier for people who are sick or who are running to the pharmacy for someone in their family who is sick to be able to get the medication they need as soon as possible. The public appetite for an expanded role for pharmacists is there. Whatever negotiations need to take place between the IPU and GP services, through the Minister and the HSE, must be brought to fruition . . . The IPU feels, as I do, that the full expertise of Ireland’s community pharmacists has long been an untapped resource.”
However, Deputy Smith also cautioned that any additional services being provided by pharmacists will result in, “significant additional work for pharmacists”, and highlighted that pharmacies have already faced a 16-year pay freeze: “During that time, the rate paid to dispense medicines under the community drug scheme decreased by 24%, from €6 to €4.58, while the revenue generated by pharmacies under the community drug scheme decreased by 29%. That is not a sustainable trend, nor is it a sustainable model.”
Social Democrats
The Social Democrats Health Spokesperson, Róisín Shortall TD (Dublin North-West), also voiced her Party’s support for the Bill, and again welcomed the provisions to enhance the role of community pharmacists. Deputy Shortall provided a detailed overview of the “struggle to get any expansion of pharmacy services over the line”: “When it was first proposed that pharmacists would start to administer the flu vaccine, it was a real battle for them to be allowed to do that. That was the first battle. The second battle was for them to be paid fairly in line with what GPs were being paid. Thankfully, that was resolved in time.” Deputy Shortall highlighted the “huge capacity within community pharmacies”, saying, “It does not make sense not to exploit that capacity as fully as possible. At a time when we are struggling with recruitment and different issues in respect of the health service, it makes absolute sense to ensure that pharmacists have an expanded role. They also have the huge benefit of being located in every town and village throughout the country.”
Deputy Shortall said, “As is so often the case with healthcare policy, existing interests resisted any change to the status quo. I am very glad that the plan for the rollout of the flu vaccine came to fruition. We saw the huge benefits of that in the context of COVID vaccines . . . I urge the Minister to seize on the opportunity to unlock their full potential.”
In terms of pharmacists extending prescriptions, “the overriding concern must be patient safety”: “While it is accepted that pharmacists are highly trained healthcare professionals and that they require flexibility to use their professional judgment, the Taskforce did recommend regulatory guidance and supporting educational materials to facilitate the safe application of this new process. It also recognised that it may not be appropriate to extend the prescription of certain categories of medication and that any extension should be subject to person-centred criteria.” Deputy Shortall said, “these are very welcome and necessary safeguards”.
Referring to the IPU’s appearance in March 2023 before the Oireachtas Health Committee, and the minor ailment scheme as outlined by the IPU then, Deputy Shortall said, “One would hope that the Expert Taskforce will recommend a similar proposal, and I urge the Minister to act on those recommendations soon after they are published”.
Deputy Shortall also mentioned contraception, saying, “Not only would increasing (pharmacists’) role in the dispensing of birth control medication ease the burden on overstretched GPs, it would also make contraception more accessible.” She also highlighted chronic illness management, saying “Given their expertise and the shortage of GPs, there is no reason our community pharmacists could not assist greatly in these areas.”
Deputy Shortall finished her contribution by asking the Minister for an update on the review of pharmacy fees.
Fianna Fáil
Carlow-Kilkenny Fianna Fáil Deputy Jennifer Murnane O’Connor said allowing pharmacists to sell and supply approved medicines without the need for a prescription, “is really good judgment”. She particularly commended her own community pharmacist in Carlow, Kevin Kelly, saying, “I would put all my trust in him, as I know others do. He gives advice regularly and is always very positive. I also know there are many more pharmacists around the country doing the same . . . This will be a great help and I will absolutely support this Bill.”
Her Party and constituency colleague Deputy John McGuinness also voiced his “support for the Bill and the measures contained within it”. However, he voiced his concern that pharmacies, “are also overcome with the amount of prescriptions with which they are dealing and the amount of customers, if you like, that they have. Far greater investment is needed for both the primary care element of the Bill and for the pharmacies. We cannot put stuff into a Bill and then not match it with the amount of money that is required to make it happen.”
Deputy McGuinness said he would like to, “again emphasise to the Minister that I have seen many pharmacists being put to the pins of their collars to deliver the extra services they provide. I appeal to the Minister to look at those on the frontline, including GPs and pharmacists, and ensure there is an appropriate level of investment to allow them to develop the services, develop their own skills and talents, and serve the local communities that all of us serve. Those on the frontline are under dire pressure.”
Fine Gael
Fine Gael Dublin Fingal Deputy Alan Farrell welcomed the Bill and commended the Minister for Health on bringing it forward, “because I believe it will make access to medicine and to healthcare easier, with such care being provided in the community by people known to the individual. This is particularly important given the current pressure on accessing GP appointments across the country.” He said by facilitating an increase in the period during which pharmacists can renew prescriptions, “we can ease pressure on services and provide better and quicker access for patients. I commend pharmacists on taking on this extra work, something I know they have indicated for quite some time they are prepared to do.”
He also emphasised the importance of expanding who can administer vaccines, saying: “We do not have to cast our memories back too far to see how an expanded number of vaccine administrators can contribute to immunising the population or vulnerable groups. Indeed, recent attention has rightly been given to the potential for a measles outbreak.”
Deputy Farrell concluded his contribution by highlighting the IPU’s call for adequate resources for pharmacies.
Independents
The debate rested on 21 February, and when it resumed on 22 February, Independent Galway West TD Catherine Connoly welcomed, “that we are extending the powers of pharmacists based on recommendations of the Taskforce”: “Any of us run to the chemist and beg them to renew a prescription and put pressure on them to do so. It is something we want but we want it under supervision. We want to ensure, particularly with regard to mental health, that prescriptions are not renewed without proper supervision or monitoring.”
The Second Stage debate concluded when the Bill was passed on 22 February. Minister of State at the Department of Health, Mary Butler TD (Waterford, Fianna Fáil), put forward the Bill on behalf of the Government on this day, and again welcomed the Bill and the provisions contained therein. The Bill then passed at Second Stage.
When contacted by the IPU Review regarding the next steps for the Health Bill, the Department of Health responded that Minister Donnelly hopes to secure full passage of the legislation in the coming months: “This legislation will lay the ground for an enhanced role for pharmacists in Ireland, with further developments to follow via secondary legislation. The Bill intends to amend the 1995 Irish Medicines Board Act to enable pharmacists to sell and supply certain approved medicines without the need for a prescription, subject to appropriate regulation and controls to be set out in secondary legislation, and subject to further clarification and consultation with stakeholders.” The Department spokesperson also said, “the Minister for Health is committed to expanding the role that pharmacists play in our health services”.
Further updates on the Health Bill will be available in the IPU Review and in the IPU newsletter, as the Bill progresses through the Houses of the Oireachtas.
During the Health Bill debate in Dáil Éireann on 21 February, Health Minister Stephen Donnelly TD said the following in praise of pharmacists and their staff during the COVID-19 pandemic:
“Essentially, I believe that pharmacists can do a lot more than they are currently allowed do under the law. They stepped up during the COVID pandemic. I insisted at the time that the COVID vaccine programme be expanded to pharmacists. There were some who believed they would not step up; they were magnificent in stepping up. They cleared the decks through Christmas. There was one particular wave of COVID during which we had a matter of days, maybe a week or two, to get the most vulnerable vaccinated before that wave hit. If we had not been able to vaccinate those more vulnerable people, many people would have died. The GPs stepped up and the pharmacists stepped up. They were magnificent.”
Siobhán Kane
Editorial Manager, IPU
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