As part of our IPU Review special this month on medicine shortages, we asked a number of key stakeholders the same questions in relation to medicine shortages. The replies we received are printed over the following pages.
Over the following pages, we provide the responses received from the Department of Health, Irish Pharmaceutical Healthcare Association and Medicines for Ireland, in addition to a statement from the PSI.
In your agency/organisation’s view of medicine shortages in Ireland, do you think the situation is improving or not?
The work of the Department, HPRA, and indeed the wider European medicines network in the area of medicines shortages has increased dramatically in the number of years.
Ireland has increased infrastructure and systems in place when responding to shortages via established lines of cross-health service stakeholder groups, and the already established Medicine Shortages Framework.
The Department recognises that shortages of medicines at a pharmacy level can cause concern for patients and healthcare providers alike. Issues surrounding security of supply of medicinal products have become increasingly well characterised and are thusly the subject of several workstreams within the Department.
What solutions would your agency/organisation be in favour of to address the impact of shortages on patients, prescribers, and pharmacists?
The Department of Health will continue to liaise with stakeholders to improve our existing structures to manage and mitigate shortages. Additionally, the close and positive working relationships and engagements between the Department and IPU and regulatory bodies enables solution focused discussion and information exchange. Access to timely and accurate information in relation to shortages has proven to be very beneficial to targeting solutions, for example, via the Department’s Medicines Criticality Assessment Group.
The introduction of the European Shortages Monitoring Platform in February of this year will provide an additional resource to national competent authorities in this respect.
With your unique perspective of the Irish medicine supply chain, which solution in the question above would you think has the most potential to resolve the current issues?
As above.
Pharmacists have noted a significant increase in the number of Exempt Medicinal Products (EMPs) that they are having to dispense in the place of licensed product in short supply. Do you have any data that outlines this increased use, and do you have an opinion on how we could become less reliant on EMPs for patients in Ireland?
The Department does not collect data in relation to the volume of exempt medicinal products (EMPs) used. Such competence would lie with other health service stakeholders, such as the HPRA.
An EMP may not be prescribed or supplied in situations where an authorised or registered equivalent (i.e. same active substance(s), strength and dosage form), is available in Ireland.
“MFI believes we need resilient and forward-thinking strategies that counteract escalating inflation and effectively address the evolving challenges within the market landscape.”
Community pharmacists are advocating for therapeutic substitution by pharmacists. Is your agency/organisation in favour of facilitating this, and allowing pharmacists to practice to full scope?
Yes. The Department is engaging with a number of stakeholders to expand the role of pharmacists and utilise their professional and technical expertise to the fullest extent possible. Additionally, the Health (Miscellaneous Provisions) Act 2024 provides the legislative framework to develop additional potential solutions within the scope of pharmacy practice.
Community pharmacists are calling for a national stockpile of critical medicines to ensure continuity of care, are you in favour of this call? And if so, how best could this be managed to ensure waste is minimised and costs are managed?
Ireland does not mandate holding of contingency stocks. Work on mitigating shortages of ‘critical medicines’, as included in the European Union List of Critical Medicines is ongoing in various fora at a European level, such as via the Critical Medicines Alliance. The Department of Health is engaged in numerous initiatives for the management of medicines supply issues and bolstering security of supply. The Department will continue to closely monitor updates to the Critical Medicines List.
In your agency/organisation’s view of medicine shortages in Ireland, do you think the situation is improving or not?
Shortages is a complex issue, driven by multiple factors, including manufacturing, regulatory, commercial, quality, as well as supply and demand. IPHA member companies take the issue of medicines shortages very seriously. When they do occur our member companies give the matter the highest level of attention by national management, seeking to ensure that patients’ care is not interrupted. We are aware that specific, international supply chain issues can lead to delays and shortages and IPHA member companies work closely with the HPRA on these.
What solutions would your agency/organisation be in favour of to address the impact of shortages on patients, prescribers, and pharmacists?
IPHA believes that the issue can be dealt with at European level, through the proposed revision of the European Pharmaceutical Legislation which includes a number of measures to mitigate shortages. In particular, greater use can be made of the information in the European Medicines Verification System to help anticipate and therefore mitigate shortages.
With your unique perspective of the Irish medicine supply chain, which solution in the question above would you think has the most potential to resolve the current issues?
Supply chain requirements need to be proportionate and fit for purpose. Policy measures should focus on the demand side, improving visibility over local patient needs so we can anticipate changes. We would support a European harmonised approach to tackling shortages which allows for better EU coordination, that avoids duplication and streamlines reporting particularly through the European Shortages Monitoring Platform.
Pharmacists have noted a significant increase in the number of Exempt Medicinal Products (EMPs) that they are having to dispense in the place of licensed product in short supply. Do you have any data that outlines this increased use, and do you have an opinion on how we could become less reliant on EMPs for patients in Ireland?
No, we do not have data in this regard. We are however aware of the issue at the overall level through our membership of the Irish Medicines Verification Organisation alongside the IPU and others.
Community pharmacists are advocating for therapeutic substitution by pharmacists. Is your agency/organisation in favour of facilitating this, and allowing pharmacists to practice to full scope?
This would need very careful consideration by the regulatory authorities (HPRA, PSI), taking into account the very great differences across medicines of different types.
Community pharmacists are calling for a national stockpile of critical medicines to ensure continuity of care, are you in favour of this call? And if so, how best could this be managed to ensure waste is minimised and costs are managed?
As identified by the EU Commission study Future-proofing pharmaceutical legislation, stockpiling, together with exports bans and hoarding, have “the negative effect of creating additional risk of shortages”. IPHA believes that contingency stocks should therefore focus on a limited number of critical products of major therapeutic interest that are at risk of shortages and the stocks should be kept at regional level. Any volumes requested should be proportionate and limited in time buffering a specific risk, to ensure this does not lead to unfair and unintended negative consequences that would limit patient access in other countries. Any contingency stock requirement should be implemented in collaboration with Marketing Authorisation Holders.
IPHA agree that the resolution of shortages requires in the first place a common approach to define (critical) shortages and setting up a list of critical medicines and critical shortages. These lists should be transparent, concise, based on clear/objective criteria and on risk, considering the therapeutic indication of the medicines as well as the availability of alternatives. Their adoption and review should require a dialogue with the medicine developers and other relevant stakeholders in the supply chain. The lists should avoid duplication and multiple/ contradicting lists such as national and HERA lists.
In your agency/organisation’s view of medicine shortages in Ireland, do you think the situation is improving or not?
In our view, the situation regarding medicine shortages in Ireland is not improving and can be more pronounced at certain times of the year or with particular types of medicines, such as older molecules. Persistent global supply chain disruptions, rising energy and transport costs, and inflation continue to exacerbate the problem. Current pricing strategies in Ireland (and in Europe), which rely on downward only pricing mechanisms/price reductions via reference pricing for generic medicines, or at best flat pricing, have resulted in some medications becoming unviable, leading to market consolidation, increased shortages, and a growing reliance on Exempt Medicinal Products.
What solutions would your agency/organisation be in favour of to address the impact of shortages on patients, prescribers, and pharmacists?
MFI believes we need resilient and forward-thinking strategies that counteract escalating inflation and effectively address the evolving challenges within the market landscape. There is an urgent need to stop the race to the bottom via complementary reforms at the EU and national levels. There are a number of solutions that can help the Irish market mitigate against the current supply issues. Flexible pricing is the core solution for many medicines, including lower cost medicines. Automatic indexation would also assist in offsetting higher costs resulting from inflation or increased regulatory burden by automatically adjusting prices based on a predetermined index value. Additionally, engagement is required to ensure that biosimilar medicines have a fair opportunity to gain market share, ensuring a sustainable market for new biosimilars to launch. Changes in regulatory practices, such as the introduction of an electronic Product Information Leaflet (E-PIL), could assist in allowing more timely manufacture and transport of medicines without the challenge of having to print and pack a market-specific PIL in the pack. This measure would have the added benefit of ensuring that patients receive the most up-to-date product information as changes are approved. The EU Pharmaceutical Package has the potential to facilitate earlier launches of generic and value-added medicines. Greater investment and support from the EU to expand the production of API in Europe could also assist in addressing some of the supply chain challenges that impact on shortages. Furthermore, we need to ensure that we prevent shortages from worsening, and this requires all legislation, both at home and in Europe, to be viewed through this lens. The recent Urban Wastewater Treatment Directive (UWWTD), passed by the EU institutions, is likely to significantly impact the supply of medicines. This directive is designed to remove micropollutants from all urban sewage treatment centres in the EU; this ambition is something that all MFI member companies fully agree with. However, the way that this is being funded presents real challenges for the continued supply of many important medicines being used to treat Irish patients. The introduction of the directive will lead to the introduction of direct costs for companies supplying almost every dose of medicine used to treat Irish patients. For MFI companies who supply the largest volumes of medicines at low costs this naturally presents a substantial challenge. We will continue to work with colleagues across Europe to highlight this issue and call on the Irish government and the EU institutions to reassess the impact of this directive on the availability of essential medicines for patients.
With your unique perspective of the Irish medicine supply chain which solution in the question above would you think has the most potential to resolve the current issues?
MFI believes this year will be critical to introducing systems that can mitigate against shortages through the new Framework Agreement on the Supply and Pricing of Medicines. Implementing flexible pricing mechanisms that address the current downward-only pricing model while encouraging competition will be critical to addressing many of the shortages we currently experience in Ireland. Stopping the race to the bottom on pricing is crucial to ensure a sustainable and resilient supply of essential medicines.
Pharmacists have noted a significant increase in the number of Exempt Medicinal Products (EMPs) that they are having to dispense in the place of licensed product in short supply. Do you have any data that outlines this increased use, and do you have an opinion on how we could become less reliant on EMPs for patients in Ireland?
While MFI does not produce data on this matter, the data from the IPU Medicines Shortages Survey 2024 indicates a continued rise in pharmacists’ dispensing of EMPs. The current arduous model of pricing and reimbursement means it can take significant time for generic suppliers to secure a suitable price for their licenced products. This is particularly a concern in the low-cost medications space — the difficulty for suppliers in achieving viable pricing coupled with the lack of transparency over pricing and length of reimbursement timelines means that Ireland may not have a sufficient risk/reward balance to support launches of these medications. This can be seen in the number of areas where there are limited low-cost therapeutic options for patients.
Community pharmacists are advocating for therapeutic substitution by pharmacists. Is your agency/organisation in favour of facilitating this, and allowing pharmacists’ to practice to full scope?
Medicines for Ireland does not currently have a position on this, however we recognise evidence from other jurisdictions that suggests that any such program should involve robust consultation with prescribers to ensure best implementation.
Community pharmacists are calling for a national stockpile of critical medicines to ensure continuity of care, are you in favour of this call? And if so, how best could this be managed to ensure waste is minimised and costs are managed?
MFI recognises that a national stockpile could be seen as one possible solution to ensure continuity of supply. However, we have seen that when individual countries implement national stockpiles, they can negatively impact supply in other countries. As a result, MFI opposes the introduction of stockpiles in Ireland and in Europe. Stockpiling poses a significant problem for medicines with limited manufacturing capacity. Instead of distributing these essential medicines in accordance with patients’ needs, they will be held in stockpiles in a single country. This misallocation of products, particularly for medicines already at higher risk of shortages due to high market concentration, risks exacerbating the shortage issues, particularly in smaller countries. Such measures place further stress on supply chains for these medicines, undermine manufacturers’ ability to respond to shortages efficiently, and offer solidarity, as stocks would be held within individual national markets. In the case of antibiotics, Germany’s annual consumption, together with the six-month stockpile, would amount to one-quarter of the EU’s total consumption. As a small country on the edge of Europe, Ireland would likely suffer the greatest if all other EU countries were to put a similar stockpile into place. Medicines for Europe has suggested an effective alternative to national stockpiling could be the creation of a European Strategic Reserve at the EU level. Coordinated by the European Commission through HERA (Health Emergency Preparedness and Response Authority), this approach could offer significant benefits during crises while preserving the normal functioning and sustainability of the internal market. To succeed, the model would need to ensure efficient stock management, adhere to the principle of EU solidarity, and maintain economic sustainability.
As pharmacy regulator, we are aware of the ongoing challenges facing pharmacists, prescribers and patients in relation to the availability of medicines. We know that pharmacists and pharmacies are going to significant lengths to manage these shortages to ensure continuity of access to medicines and treatments for their patients.
We work together with the Department of Health, Health Products Regulatory Authority and the HSE as part of the Medicines Criticality Assessment Group that is convened by the Department.
While our remit is not to manage medicines shortages, working as part of the broader healthcare system, we strive to ensure that the appropriate information and guidance is available to those we regulate, and that the pharmacy profession is supported in their role and responsibilities, ensuring appropriate care is provided to the public.
Pharmacists play a crucial role in ensuring the safe and appropriate supply of medicines. In the event of a shortage of a specific medicine, we know of the extent of effort that can often be required to manage and source medicines and alternatives, to communicate with prescribers, patients and carers, and to reassure those who are worried about getting their medicines on time. We recognise the challenge of ensuring continuity of treatment for patients, and the valuable expertise of pharmacists in assessing the appropriate and safe alternatives that may be available.
We are aware of the proposal in the recently published draft Programme for Government to, “Support pharmacists to adopt a proactive approach to managing medicine shortages.” Our responsibility will be to ensure a framework of regulation is in place that supports initiatives that are agreed under this objective, in line with our continued promotion of patient safety and professional accountability.
