Improved early warning systems needed to reduce medicines supply risks, says ABPI

A new report from the Association of the British Pharmaceutical Industry sets out the leading causes of medicine supply shocks, alongside a plan to further strengthen UK medicines supply chains to protect patients when disruptions occur.

While medicine supply issues remain comparatively rare, their impact can be serious and distressing for patients when they do happen, and concerns about disruptions to global medicines supply chains have been increasing.

Shortages of raw materials, manufacturing constraints, geopolitical instability and sudden surges in demand all increase the pressure on global supply chains, with the potential to affect patient access to medicines.

A new ABPI report, ‘Building a resilient medicines supply chain together’, developed with input from across the healthcare sector, explains how medicines supply chains work and offers practical recommendations to strengthen and make the system more resilient.

The report shows that the UK has around 14,000 licensed medicines, supplied through highly complex global networks that are closely monitored and actively managed. In the past year, 264 medicines were monitored under shortage protocols, with just a handful of product supply disruptions classified as critical. [1] Most issues are resolved within 28 days, although more complex cases can take longer.

Ross Maclagan, ABPI Head of Supply and Distribution Policy, said: “Medicines supply issues are very serious for patients, and our industry takes the security and resilience of supply chains extremely seriously.

“Systems to manage supply were stress tested like never before during the pandemic, as well as by the recent conflicts in Ukraine and now the Middle East. While the industry has met these challenges, global pressures are growing, and we cannot be complacent. That is why this report sets out practical recommendations to make an already resilient system even stronger, so patients can continue to get the medicines they need when they need them.”

Most potential supply issues are identified and addressed before patients are affected. Planning production, sourcing raw materials, manufacturing medicines and supplying them to patients can take up to 36 months, requiring companies to predict demand far in advance in a volatile global environment.

Pharmaceutical companies deem continuity of supply to be of the highest priority and spend significant amounts of time in local, regional and global teams on forecasting, supply planning and stock management for the UK market alone. This investment helps ensure potential issues are spotted early and managed before patients notice any impact.

The report also highlights the pressure supply issues can place across the wider health system. More than a quarter of pharmacy teams (26 per cent) report spending over two hours a day trying to obtain stock or source alternative medicines.

Disruptions are most common in generic medicines, which account for 75 per cent of NHS prescriptions, with generic stock issues identified as the most frequent cause of supply chain disruption.

Setting out how pharmaceutical companies, the Department of Health and Social Care, the NHS, regulators, wholesalers, pharmacists and others can work together to keep medicines available for patients, the ABPI recommends: 

1. Improve early warning of supply issues: strengthen reporting systems so risks can be identified earlier and addressed before patients are affected.
2. Proactive sharing of data to improve forecasting: enable clearer, two-way data sharing between industry, the NHS and government.
3. Strengthen collaborative planning across the system: improve communication, notice periods and coordination between pharmaceutical companies, the NHS, government and patients, particularly during disruptions and major contract changes.
4. Support innovation and digital transformation: encourage the appropriate use of digital tools and artificial intelligence (AI) to improve forecasting, visibility and coordination across the medicines supply chain.
5. Enable regulatory flexibility: use proportionate regulatory flexibilities, including faster approvals and temporary use of alternative packs or imports.