Ireland is taking a more coordinated approach to medicines shortages and supply risks. The Strategic Medicines Access and Availability Group (SMAAG), established by the Department of Health in 2025, will help shape national policy on access to and availability of medicines.
Medicines Supply Strategy Led by the Department of Health
SMAAG is a cross-sectoral working group bringing together relevant government, regulatory and healthcare bodies. Its role is to examine the strategic issues that can affect whether patients and healthcare providers can obtain medicines in Ireland.
The group will assess evidence on medicines usage, including the use of exempt medicinal products (EMPs), while identifying gaps in the data. It will also examine vulnerabilities involving medicines that are unauthorised or not marketed in Ireland, alongside opportunities to improve the supply of authorised products.
Why medicines availability matters
Medicine shortages can arise from supply-chain disruption, market conditions, procurement challenges or limited availability of authorised products. SMAAG will consider these pressures in an Irish and European context, with the aim of supporting a more secure and sustainable medicines supply.
How SMAAG Will Assess Medicines Access
The group’s work will include collaboration across public bodies and healthcare organisations. Sub-groups may be created when more detailed analysis is needed in specific areas.
Its approach will involve:
- Reviewing available data on medicines use and identifying important evidence gaps.
- Identifying medicines linked to vulnerability or a demonstrable unmet need in Ireland.
- Examining market conditions that could increase the risk of shortages nationally or across Europe.
- Considering national and European policy developments that may improve availability.
- Exploring procurement and shortage-prevention measures.
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Supporting Authorised and Critical Medicines
A key part of SMAAG’s remit is encouraging the marketing and continued supply of authorised medicines in Ireland. Where no authorised product is available, the group will consider suitable supports for critical unauthorised or non-marketed medicines.
The group will also support appropriate access to authorised and marketed medicines, including products listed on the European Union’s critical medicines list. This work is intended to strengthen resilience while recognising the importance of regulation, clinical need and sustainable supply arrangements.
Coordinating Ireland’s public health response
The initiative complements the wider responsibilities of the Health Service Executive (HSE) and the Health Products Regulatory Authority (HPRA), while the Department of Health remains responsible for national health policy. Reliable information and cooperation between these bodies will be important when responding to emerging supply risks.
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What Happens Next?
SMAAG’s published terms of reference set out its responsibilities and expected areas of work. Its outputs will focus on practical measures that can improve medicines access, prevent shortages and strengthen long-term supply security.
The group will consider procurement approaches, market dynamics, European cooperation and potential policy responses. Its findings may help inform future decisions on medicines planning and availability in Ireland.
Conclusion
Ireland’s Strategic Medicines Access and Availability Group provides a structured framework for tackling medicines shortages and supply vulnerabilities. By bringing together government, regulatory and healthcare expertise, the medicines supply initiative aims to improve access to critical treatments and build a more sustainable system for patients.
Article/Image Courtesy: gov.ie
