Additionally, the European Federation of Pharmaceutical Industries and Associations has argued that the cause of delays in each region varies — in Western Europe it’s a result of value assessment processes, while in Eastern Europe, it’s due to health system constraints, they said in an April report.

“The fundamental problem is that paying for medicines is not within the remit of the European Union itself.” Catherine Drew Partner, Pinsent Masons

“This shows that there is no one-size-fits-all-solution to fix access issues, and regional or country-specific solutions are needed,” it argued in the report.

Drug shortages

Inflationary pressures, rising energy costs and a suite of other challenges this winter caused worsening drug shortages across the EU. A report by the Pharmaceutical Group of the European Union found that 100% of member countries reported shortages in 2022, with a quarter of countries reporting more than 600 drugs in short supply.

To prevent a similar situation from arising again, the EU Commission outlined a procedure in the pharma update requiring companies to notify the EMA about looming shortages six months before they happen, create shortage prevention plans and hold larger stocks of medicines.

Industry groups, however, have argued that it’s impossible to predict supply chain issues months in advance, and if they could, they’d fix the problem before it arose. A compromise, they say, is creating digital infrastructures that track the consumption of medicines across the EU, which could help them forecast surges in demand.

“The integration of electronic patient information (ePI) along with harmonized forms and presentations for medicines has the potential to revolutionize the way stocks are managed across Europe, effectively avoiding stock-outs and ensuring swift distribution of medications,” Guntern said of the potential policy.

The EU proposal does suggest plans to implement “increased digitalization,” but it remains unclear if policymakers are open to applying digital infrastructures to the drug shortage problem.

And although it is “still in the early stages of negotiations,” Guntern said she is “optimistic that the pharma review will bring positive changes, enabling a more streamlined and digitized approach to healthcare,” when all is said and done.