Drug shortages remain a persistent challenge across the European Union (EU), with PGEU data showing 400–800 medicines in short supply in many countries between November 2024 and January 2025.
When national alternatives are unavailable, shortages can become critical, triggering EU-level intervention and putting pressure on patients and health systems.
According to a September European Commission report, root causes include supply chain vulnerabilities linked to offshore manufacturing and the inconsistent enforcement of companies’ obligations to maintain supply.
Proposed reforms include stronger monitoring and mandatory shortage reporting to the EMA, as well as an "EU-level stockpile."
However, uncoordinated “reshoring” and unilateral stockpiling done previously have worsened shortages elsewhere, underscoring the need for careful design and coordinated EU action.
So, what do industry players think will actually work? Manufacturing Chemist speaks to MM Pharma, Cold Chain Technologies and Testo Saveris to find out.
What’s driving these medicine shortages?
Though shortages are now less frequent than they were a few years ago, they are still noticeable.
Companies are running down their pandemic-era stock, having held unusually high levels to protect themselves from supply disruptions, export bans and spikes in demand.
According to MM Pharma, as these inflated inventories return to more typical levels, companies are ordering only what they need and doing so closer to the time of use.
Ataa Elfaquih, Quality and SC Director at MM Pharma & HC Packaging, explains: “What we observe is a shift in customer behaviour: many are coming out of a period of high stock levels and are now reducing inventory, leading to shorter planning horizons.”
This can create much less tolerance for disruption anywhere else in the supply chain and production bottlenecks can emerge much faster.
At the same time, frequent regulatory updates, tender-driven artwork changes and packaging variations between markets have put pressure on production slots and packaging capacity, Elfaquih warns.
“Combined with frequent artwork and version changes because of tenders or safety updates, this creates pressure on production slots, especially when multiple markets require differentiated packs.”
The demand for certain medicines varies by season, making seasonal drugs regular pressure points for the pharmaceutical industry.
Paediatric medicines also present additional difficulties owing to their intricate booklet-format requirements.
“These are harder to resolve quickly as substrates, inks, adhesives and foil lacquers require prior qualification and print capacity is not always flexible enough to absorb sudden changes," Elfaquih concluded.
Could an EU-wide stockpile work?
Some countries, such as Finland, Estonia and the Czech Republic, are known to stockpile goods already.
However, as demonstrated during the pandemic, countries that choose to stockpile can cause a "domino effect" and worsen shortages in others when there is a failure to coordinate.
A more comprehensive, EU-wide stockpile has been floated by the European Commission, whereby member states would be part of an EU Stockpiling Network.
Here, countries could coordinate national stockpiles and have access to critical supplies during crises.
Programmes such as rescEU, which provides a reserve of medical equipment, generators and other supplies, would fill gaps in essential goods.
However, those in the industry believe the plan can only work if it is designed intelligently.
“Although there are many potential benefits to a centralised stockpile, it is only viable if proper storage conditions are maintained,” said Dr Fabio A.S. Leite, Subject Matter Expert for Pharma at Testo Saveris GmbH.
Incorrect storage conditions can degrade medicines, cause regulatory non-compliance and jeopardise patient safety.
Effective stockpile management, therefore, demands both accurate initial calibration and ongoing monitoring.
“Temperature mapping is the first step in creating a safe and compliant medication stockpile.’
“The precise recording and environment of factors such as temperature and humidity in these spaces is essential, as is an intelligent alarm system to anticipate and guard against critical events.”
From a packaging perspective, industry stakeholders believe a centralised stockpile could work if designed as a rotating stock of semi-finished goods instead of finished medicines.
“A practical model would include neutral cartons on standard dielines, multi-language booklets and pre-approved labelling templates stored in humidity-controlled EU hubs,” explains Elfaquih.
“Final country-specific elements could be printed or applied late in the process.”
“Logistics providers would manage FEFO rotation, version control and rapid release, minimising expiry risks and adapting more easily to regulatory changes.”
Using data to optimise the supply chain
Pharma companies are increasingly turning to predictive analytics and AI-driven supply chain optimisation to increase efficiency.
Predictive analytics can be used to forecast demand, manage inventory, predict and mitigate risks and enhance real-time tracking and temperature control for cold-chain products, allowing companies to detect potential disruptions before they occur.
“There will doubtless be ongoing refinements to the supply chain and the use of smart platforms can facilitate data-driven decisions, for example, using historical data to optimise routes, minimise delays and boost reliability,” says Natalie Robinson, Global Head of Operations at Cold Chain Technologies.
As the EU attempts to bring pharma manufacturing back to Europe, data-driven supply chains could be deployed alongside other strategies to reduce disruption risks and keep products moving efficiently.
“This technology can help ease the reshoring transition, with real-time visibility allowing for the prevention or rapid resolution of supply chain hiccups before product quality or delivery timelines are impacted.”
Multisourcing vs consolidation
CDMOs are increasingly adopting dual or multisourcing of materials to build a more resilient and reliable supply chain.
However, experts across the sector are split on whether this is the correct road to be going down.
Elfaquih argues that when planned proactively, multisourcing can work: “Effective multisourcing involves dual-qualifying sites and materials on identical specs, maintaining shared dielines and colour masters and validating once to cover all alternates.”
“What doesn’t work is reactive qualification under time pressure, which often triggers new artwork and delays.”
Robinson, however, disagrees: “Whereas multisourcing may seem like a way of spreading risk, the reality is that it can cause unnecessary complications and dilute supply chain accountability.”
Therefore, she says, CDMOs should choose a single-source strategy for unified data and insights.
“Choosing dedicated partners for the most crucial elements of the cold chain — logistics and temperature-controlled packaging — offers both intelligence and reassurance.”
She argues that, from an intelligence standpoint, centralising shipment data provides actionable insights that can streamline operations and address issues before they escalate.
“The security and trust that comes from a single-source relationship is crucial, especially during a complex transition such as relocation.”
“The most advanced cold chain container providers invest in highly specialised technical advisory teams capable of offering neutral, context-driven guidance around packaging selection, risk management, regulatory compliance and thermal strategy — all in the best interests of the customer.”
What needs to happen next?
Europe’s medicine shortage problem is unlikely to be solved by a single measure.
Instead, industry experts are pointing to a combination of smarter stockpile strategies, stronger data infrastructure and earlier collaboration between regulators, CDMOs and logistics providers.
They say that resilience will depend on collaboration. Without shared data, unified standards and coordinated production models, shortages will remain.
The EU’s goal of building a supply chain that can anticipate disruption rather than merely reacting to it will most likely be achieved only if it listens to experts in the field.
As it prepares legislative reform, the EU’s next phase will depend on how effectively the ideas discussed in this article are turned into operational reality and whether Europe can do this proactively rather than waiting for the next crisis, such as another pandemic, to force its hand.