In a push to prevent medicine shortages across Europe, Czechia is advocating for a more coordinated approach to medicine stockpiling.
Czech Deputy Health Minister Jakub Dvořáček has emphasised the need for a system that balances national interests with European solidarity, particularly as some countries – like Germany – have taken measures that could affect the availability of medicines across the EU.
“We are not saying that Germany is wrong, but the way they are managing their stockpiles is creating unintended consequences for other EU countries,” Dvořáček told Euractiv. He was referring to the six-month stockpiling requirements that Germany imposes on pharmaceutical companies.
National stockpiling v. European solidarity
The issue of national stockpiling has been debated within the EU for several months. As Euractiv reported, Czechia, with a coalition of other EU member states, warned that excessive stockpiling could damage the single market.
Medicines for Europe, the association representing the European generics and biosimilar sector, warned in April 2024 that uncoordinated stockpiling could have unintended consequences, including additional costs for manufacturers, or the inability to relocate stocks from one EU state to another to mitigate potential shortages.
Czechia has also been vocal about potential downsides.
For smaller EU member states, like Czechia, the risk is that larger countries stockpiling medicines could leave others without essential supplies. “In Europe, medicines are being stockpiled, but nobody knows what is stored and in what quantities. There is no central point where this information is collected,” Dvořáček explained.
He again cited Germany as a primary example of how national stockpiling can disrupt the balance. Under German law, pharmaceutical companies must maintain a six-month stockpile of medicines under certain tenders.
Czechia offers new approach
Czechia is trying to offer an alternative – a dynamic system that could serve as a model for the rest of the EU.
“We developed a system where we are not stockpiling medicines ourselves, but we have established a reservation system that allows us to access supplies as needed,” said Dvořáček. The Czech State Material Reserves Authority (SSHR) operates this system by tendering distributors who hold medicine stocks, ensuring the supplies can be updated and refreshed regularly to avoid waste.
“The medicines are not owned by the state or SSHR, which means we can react quickly if there is a shortage,” Dvořáček noted. “If a manufacturer reports a supply interruption, we can request a reduction in reserves, covering the gap without patients or pharmacies noticing any difference.”
This system, he explained, is designed to be flexible and to prevent overstocking or the expiration of medicines. “We do not need to wait for a disaster to use these medicines,” he said, adding: “The key is to avoid the panic that often comes with stockpiling discussions.”
In Dvořáček’s view, the EU needs a clear overview of ongoing stockpiling schemes and to gather information on who is stockpiling what and in what quantities. He advocates for the creation of a dynamic, EU-wide system based on the Czech reservation model, where medicines are not centrally owned but can be quickly mobilised and replenished.
“If the whole of Europe is holding an extensive supply of penicillin, for example, it does not make sense because we will never need this drug in such large quantities. We need to think about how to distribute the stock so that it is actually usable when it is needed,” Dvořáček explained.
The stockpiling issue is discussed within the Critical Medicines Alliance (CMA), established under the Health Emergency Preparedness and Response Authority (HERA). The CMA brings together EU member states, industry, and civil society to tackle the challenges of medicine shortages and supply chain vulnerabilities.
The CMA is expected to provide recommendations by the end of the year on how the EU should approach stockpiling and the production of essential medicines.
These recommendations could be integrated into the planned Critical Medicines Act, set to be proposed by the new European Commission.
Optimistic views
The Critical Medicines Act is intended to address more than just stockpiling. It will also include support for manufacturing, procurement, and distribution across the EU.
“The past few years have shown us just how fragile our supply chains are. It’s not just about stockpiling; it is about ensuring that Europe has the manufacturing capacity and flexibility to respond to crises,” he said.
The Czech initiative has garnered broad support among EU member states.
“We have seen a lot of willingness from other countries to collaborate on this,” Dvořáček said, noting that even Germany, which was initially singled out for its stockpiling practices, has been open to adjusting its approach in light of a broader European strategy.
Looking ahead, Dvořáček remains optimistic that Europe can find a path forward that balances national needs with European solidarity. He sees the Czech system as a potential model for others.
“What we are doing in Czechia could be transferable to other countries. It gives flexibility, avoids waste, and ensures that medicines are available when and where they are needed most,” he remarked.
[Edited by Vasiliki Angouridi, Brian Maguire]