By Dr Ian Weatherhead, Senior Director, Public Affairs, EMENA

Over recent years, the healthcare sector has faced serious challenges due to demand-driven shortages of essential medicines. For example, in 2022/23, there was a surge in demand for oral antibiotics like amoxicillin and common pain relief medications such as paracetamol and ibuprofen, which continued through 2024. These shortages were especially pronounced for paediatric formulations, causing difficulties across the EU and the UK.

These events highlighted the need for secure and reliable supply chains that can handle sudden increases in demand.

The Critical Medicines Act

In July 2024, the re-elected president of the European Commission, Ursula von der Leyen, outlined proposals for a Critical Medicines Act, the principal aim being to tackle the issue of drug shortages through a number of mechanisms, including making the EU more robust and self-reliant in terms of medicines supply chains.

In response, later this year the EU will introduce the Critical Medicines Act, a policy aimed at reducing shortages and improving self-reliance. Central to the preparation for the Act has been the work of the multi-stakeholder Critical Medicines Alliance (CMA) which ran through 2024, the outputs of which will help to inform the forthcoming new Act. The CMA has brought together many stakeholders, including industry leaders, to address the weaknesses in our supply chains. Its work includes strengthening manufacturing capacity within the EU, enhancing public procurement processes, and developing international partnerships to secure the supply of critical medicines.

The CMA’s recommendations will help shape the Critical Medicines Act, which is set to be enacted later in 2025.

Benefits to the UK

Although this is an EU initiative, the UK stands to benefit from its outcomes. Despite no longer being part of the European Union, the UK remains closely linked to European supply chains, and any improvements in their stability directly influence the availability of medicines in the UK. Medicines supply chains are global, and any improvements in Europe’s capabilities will have a ripple effect. By addressing supply vulnerabilities, the Act could help to stabilise medicine availability in the UK pharmacy network, reducing the risk of shortages that directly impact patient care.

The off-patent medicines sector

The role of the off-patent medicines sector in achieving this vision is central. This sector already provides 4 out of 5 medicines to the NHS, including 40% of branded treatments. Notably, 90% of the medicines identified as ‘critical’ in the EU are supplied by the off-patent sector.

Manufacturers like Accord, as key players in this industry, will play an essential role in strengthening supply chains and addressing vulnerabilities. By collaborating across the pharmaceutical ecosystem, we can ensure that essential medicines remain accessible to those who need them most.

In the UK, the sustainability of the generics marketplace is just as important. Generic and biosimilar medicines save the NHS billions each year, offering treatments at a fraction of the cost of originator products. However, the absence of dedicated government policies supporting the off-patent sector has been a missed opportunity. Alongside the British Generic Manufacturers Association (BGMA), we have been advocating for policies that encourage healthy competition and investment in sustainable supply chains. Such measures would not only benefit the NHS financially but also provide stability for the sector and the communities it serves.

Encouragingly, there have been steps in the right direction. Strengthening local manufacturing and securing stable supply chains provide a foundation for greater resilience in the delivery of medicines. These efforts signal a more prepared and reliable system, capable of meeting future challenges with confidence.

Date of prep: January 2025 Job bag number: UK-Gen-NP-01517