The Oireachtas Health Committee met to consider the Health Bill at the end of March. In this article, IPU Editorial Manager, Siobhán Kane provides a report on the hearing.
The Health (Miscellaneous Provisions) Bill 2024 received cross-party support when it passed Second Stage in the Dáil in February, and a detailed report on the debate was carried in the March 2024 IPU Review. The three main aims of the Bill are:
On 21 March the Oireachtas Select Committee on Health convened to consider the Bill. Minister of State at the Department of Health, Deputy Mary Butler (Waterford Fianna Fáil) attended the meeting with officials from the Department of Health.
Minister Butler informed the Committee that the Government intended on bringing forward an additional amendment to the Bill to facilitate pharmacist prescribing at the Report Stage. This addition will involve a further amendment to the Irish Medicines Board Act 1995 that will provide for the Minister for Health to make regulations that will enable pharmacists to prescribe.
Referencing the Expert Taskforce to support the expansion of the role of pharmacists in Ireland, Minister Butler said the Taskforce is now addressing the introduction of pharmacy prescribing, which will allow pharmacists to assess a framework of agreed minor ailments, with underpinning protocols. Minister Butler said; “By enabling pharmacist prescribing, we open doors for the healthcare service. We empower pharmacists to leverage their unique expertise, take on expanded roles in patient care and play a more integral role in our healthcare teams. We enhance patient access to vital medications, reduce healthcare costs and improve health outcomes for individuals and communities.”
Minister Butler also said it was “crucial” that “foundational elements” are in place in advance of these provisions being introduced, as; “the implementation of this amendment to introduce prescribing hinges on several key enablers, including education, training, guidance from our regulators and any additional necessary support systems. These foundational elements will be put firmly in place as part of the introduction of pharmacist prescribing.”
Minister Butler said the authority to prescribe “will be subject to the appropriate framework being in place and will operate in tandem with the safeguards provided for in other legislation”. She specifically listed the following:
Sinn Féin’s Health Spokesperson, Deputy David Cullinane, reiterated his support for the Bill, which he had previously expressed at Second Stage, and welcomed “some of the advances made in pharmacy and the role of pharmacists in recent months”. He said that while enabling pharmacists to extend a prescription for 12 months “is really important as it makes repeat prescriptions a reality . . . there is an awful lot more that can be done”. Deputy Cullinane specifically referenced that, “the Irish Pharmacy Union has campaigned for some of these measures for a long time as well as many more measures, including what it calls a ‘pharmacy first’ model and a minor ailment scheme”.
He asked Minister Butler for an update on this, and also said; “If we look at the network of community pharmacists we have, there are a number of pharmacists in almost every town and village. I strongly believe they could play a much greater role in taking pressure away from GPs. The fact some moves have been made in recent times proves that point.”
Deputy Cullinane referenced a recent Dáil motion Sinn Féin proposed on relieving pressure on acute hospitals, saying many people end up in hospitals who, “are not in the right place or getting the right care and they are in the emergency departments because the alternative care pathways do not exist”. He also said that; “We are still way behind other European countries as regards the role of pharmacists, particularly in the area of minor ailments”.
Deputy Butler said the Health Minister had taken on board the comments raised at previous meetings related to this Bill, and “the Government is in the process of finalising a further amendment to facilitate pharmacists prescribing. It will be introduced at Report Stage to be included in this Bill.” She said that, “by enabling pharmacists to prescribe, we will open doors for the healthcare service and empower pharmacists to leverage their unique expertise, take on expanded roles in patient care and play a more integral role in healthcare terms.”
Deputy Cullinane then asked Minister Butler to clarify if the Minister would have to set out specifically what medicines a pharmacist potentially could dispense, at which point Deputy Butler asked Muiris O’Connor, Assistant Secretary, Research and Development and Health Analytics Division at the Department of Health, to respond. Mr O’Connor said the Expert Taskforce, “is working very intensively on the detail of the scope, the safeguards, education, what ailments and established medicines will be in scope . . . that will all be determined and the Taskforce is expected to report to the Minister by mid-June. We recognise now that legislation will be needed to support the implementation of the recommendations.”
Following further questions from Deputy Cullinane, Mr O’Connor clarified that the amendment to come on Report Stage, “will be a legislative enabler that will give the Minister power to regulate for the details, scope and safeguards to facilitate this”.
” We are still way behind other European countries as regards the role of pharmacists, particularly in the area of minor ailments.”
In addition to the amendments already proposed, Minister Butler also sought to introduce a new amendment, which she said would seek “to prevent and manage shortages of medicinal products and improve security of supply”. The proposed amendment introduces reporting obligations for actors in the medicines supply chain and allows this information to be used as part of the national approach to prevent shortages and where they occur, to mitigate their impact.
Deputy Bernard J. Durkan (Kildare North, Fine Gael) again welcomed the provisions in the Bill and began by discussing the importance of continuity of medicine supply, saying “every part of the European Union is entitled to have the same supply as it would have if it were the main street of Berlin or wherever”. Deputy Durkan said, “We should take whatever steps are needed to ensure the suppliers recognise the fact they have obligations to every country in Europe, big and small, without exception and at the same time.”
Mr O’Connor responded saying; “We very much support the Deputy’s comments. We feel that the European Union and Europe working together on these matters is important and there is a pharmaceutical regulation emphasising access to, and the availability and affordability of, medicines.” Mr O’Connor continued; “we are an island beyond an island and may be at the end of some supply lines. Nevertheless, that absolutely does not undermine our entitlement to a fair share of what the EU proposes.”
He said the Department of Health is “wary of instincts towards stockpiling, which we think are a bit simplistic, and are nervous that large member states might be tempted to move in that direction because the European medicine supply lines are dynamic and need to flow to operate effectively.” He said encouraging recognition of our interdependence and the importance of the flow of medicines, is important.
He then asked Kevin Warren, Principal Officer, Medicines, Controlled Drugs and Pharmacy Regulation at the Department of Health, to contribute. Mr Warren said the Bill; “aims to strengthen what we are trying to do to oblige people involved in the supply chain to inform us of any shortages that occur in order that a timeliness will be attached and we can plan and mitigate that. In addition, the medicine substitution protocol, which was part of the earlier stage, is another piece of that jigsaw.”
He said the medicines journey to the patient is complex, “and we are putting together the blocks to ensure Ireland is not regarded as an outlier and does not have to take a place in the queue”.
Continuing the conversation on medicine shortages, Deputy Cullinane said he has been looking for medicine shortage protocols to be put in place, saying, “the Irish Pharmacy Union has been lobbying all of us for some time to put in place such a protocol, and the quicker it is in place, the better”.
Minister Butler said; “Now is the time to implement an update to Ireland’s medicine shortages framework to utilise how it can be more effective prior to and when a shortage occurs, and to accelerate learning and improvement cycles. Improved information and early notification will be vital in the management of our medicines shortages.”
Explaining the amendment, Minister Butler said it would, “mandate ‘relevant persons’ to provide information on medicinal products in their possession or control to the Health Products Regulatory Authority, as requested by it as the medicines regulator. It is envisaged that this information, while simple in theory, will yield multiple benefits for our national management of medicines availability. This reporting obligation will allow for additional visibility of the presence of medicines in Ireland, increase our ability to mitigate the impact of shortages and increase our capacity to prevent them occurring at all, while allowing us to feed into European shortages mitigation measures such as the European shortages monitoring platform (ESMP), which is to be functional in February 2025.”
All amendments put to the Committee were accepted. The debate can be viewed in full at Oireachtas.ie > Debates > Committee Debates, and search for the Health Committee debate on 21 March.
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.
Siobhán Kane
Editorial Manager, IPU
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