HPRA End of Year Review

Written by Lorraine Nolan, Chief Executive, Health Products Regulatory Authority (HPRA)

Embracing a Unified Approach to Shared Challenges

This year was another busy period for the HPRA as it focused on delivering its planned programme of work across each of the health product areas it regulates. As with most years, the HPRA was also faced with managing a wide variety of emerging issues spanning the full spectrum of its regulatory remit. Some of these were familiar developments in the regulatory world, such as adaptations to the way we work due to changes in legislation. Others arose in response to continued advancements and innovation across the sectors we regulate. The year started with a global surge in demand for antibiotics, which brought new challenges in the area of medicines shortages, not only in terms of their numbers, but also the impact on our health system.

Medicines shortages and availability

Over the course of 2023, medicines regulatory authorities across the globe reported higher instances of medicines shortages than had been experienced in previous years. This is believed to be the result of a complex combination of multiple contributory factors, including the impact of the COVID-19 pandemic on medicines supply chain resilience, geopolitical events, rising costs, and increasing frequency of major weather events.

The HPRA continued to focus its efforts on initiatives to respond to and mitigate shortages as and when they arise. Additionally, a great deal of work was undertaken to build greater resilience in the medicines supply chain with a view to identifying and preventing potential shortages before they occur. At a national level, this included the work of the national Medicines Shortages Framework, through which the HPRA coordinates and oversees a multistakeholder response to medicines shortages. At the EU level, the HPRA participates in two groups coordinated by the European Medicines Agency (EMA), both of which have important roles in the monitoring and management of medicines shortages across Europe. As part of this work, the European medicines regulatory network has carried out supply and demand modelling for key antibiotics used to treat respiratory infections in advance of the 2023/2024 winter season. This led to the publication of recommendations for actions to avoid shortages of these antibiotics to ensure sufficient supply to meet the needs of EU patients. Additionally, the network is compiling an EU list of critical medicines, the purpose of which will be to ensure that medicines most critical to EU health systems are available at all times.

Perhaps the greatest strategic opportunity in relation to medicines availability lies in having the capacity to take pre-emptive actions to prevent the occurrence of shortages. With this in mind, the HPRA met with the Minister for Health and his Department and agreed a number of strategic focus areas to build greater resilience in the national supply chain.

The HPRA, across many areas of its work, values its interaction and collaboration with healthcare and other professionals working in the hospital setting. Throughout 2023, medicines availability has been a key focus area for that interaction. We look forward to working with the Department of Health and all health stakeholders that have a role in this area, in building greater resilience in medicines’ availability.

Legislative changes to health product regulation

Over the course of 2023, we continued to embed new processes arising from changes to legislation introduced in the preceding years. The end of January 2023 saw a significant milestone in the implementation of the Clinical Trials Regulation, as it marked the point at which use of the new Clinical Trials Information System (CTIS) became mandatory. Efforts to strengthen the system brought improvements that supported its users and will help us to realise the aims of the Regulation, including centralisation of key regulatory activities and increased transparency. Further information, including for trial sponsors, is available on the CTIS website: euclinicaltrials.eu

In relation to medical devices, it is no secret that implementation of the Medical Devices Regulation and In Vitro Diagnostics Regulation has presented significant challenges. However, a lot has been achieved, and throughout the past year the HPRA continued to work with other EU regulators, industry, healthcare professionals, and patients to explore what is possible within the existing framework and implementing legislation. It is only through unified and collaborative action that we can achieve the aims of the legislation, which is to create a robust, transparent, and sustainable regulatory framework that improves clinical safety and enables availability of state-of-theart treatments for EU citizens.

In April of this year, the European Commission published its proposal to review the EU’s pharmaceutical legislation. The revision, which will be the most extensive update to EU medicines legislation in over 20 years, includes proposals for a new Directive and a new Regulation, which revise and replace the existing pharmaceutical legislation. Some of the key focus areas of the legislation will be improving access to and availability of medicines, supporting innovation, and tackling antimicrobial resistance. Work is already underway to review the proposal, both nationally and across the European medicines regulatory network. This is with the goal of ensuring the final legislative package helps foster a modern, patient-focused pharmaceutical sector, while also supporting innovation.

Communication and engagement

Under the HPRA’s current strategic plan, key areas of focus for the organisation include communication and engagement, as well as health system partnerships. The HPRA is undertaking numerous initiatives to develop its information resources and communication platforms to strengthen its partnership with, and contribution to, the health system. One such initiative that illustrates these efforts is the ongoing project to redevelop the HPRA’s website. As part of this project, the layout of the website will be modernised, with accompanying improvements in readability and accessibility of the site’s content. In tandem, the manner in which the website interacts with the HPRA’s other digital systems will be modified to optimise how information is presented to website users. This is one of the largest projects undertaken by the HPRA in 2023, requiring significant input and collaboration from across the organisation. The outcome will be an improved website that better serves the needs of the HPRA’s diverse range of stakeholders, including professionals working across our hospitals nationally.

Looking ahead to 2024

While we can be certain that many of the developments that emerged in 2023 will continue into the new year and beyond, I look forward to seeing how the HPRA will continue to rise to these challenges and meet them head on. The issues facing regulators are increasingly experienced on a global scale, and it is evident that the strongest approach to shared challenges is a unified approach. The HPRA remains committed to working in partnership with colleagues across the national health system, as well as the international regulatory network, to deliver for the benefit of public and animal health.

Read the full magazine: December HPN

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