How Sweden will improve its pharmaceutical preparedness

When the EU and the Critical Medicines Alliance mapped the supply chains for selected, particularly critical medicines in 2025, significant vulnerabilities emerged – including the fact that large parts of production are concentrated among individual players and often located outside the EU. This could have serious consequences for Swedish patients when the next crisis hits.

Streamlined supply chains lead to fragile medicine supplies

“During the pandemic, we saw an effect. There was a very high demand for certain medicines, such as vaccines, which led to shortages in some places. Countries began to hold on tightly to their own supplies,” says Denny Mahlin, a researcher in pharmaceutical formulation at RISE.

But it doesn't have to be a war or a pandemic for a shortage to occur. The pharmaceutical industry has long been driven by the just-in-time principle – small inventories and streamlined supply chains that drive down prices, but at the same time make the systems fragile.

”Much of the manufacturing of active substances is located in China or India and is often single-sourced, meaning that there is only one manufacturer in the supply chain. This means that if a single factory is affected by, for example, a fire, everything comes to a halt. Then there are political aspects: what happens if a country in a shortage situation prioritises the larger markets and chooses to no longer export to Sweden?” says Denny Mahlin.

The goal is not to become self-sufficient – but to be prepared

The goal is not for Sweden to become self-sufficient – that is neither practical nor economically feasible.

"But we could be better prepared, conduct more analyses of where the risks lie and what different scenarios might look like," says Nicolaas Schipper, production manager at RISE and responsible for the pharmaceutical testing and demonstration environment in Södertälje.

Emergency stockpiles are part of the solution – both of finished medicines and of certain active substances that cannot be manufactured in Sweden. But there are limitations.

”If all countries build their own stockpiles, it will affect the market and may create shortages in itself. In addition, stockpiles must be rotated constantly, as medicines have a limited shelf life,” says Nicolaas Schipper.

Another option is to be able to quickly switch production when needs change. This could involve agreements with Swedish companies on emergency production, or enabling healthcare providers to manufacture certain medicines locally.

However, switching to manufacturing medicines is far more complicated than a manufacturer of vacuum cleaner bags starting to make face masks, which is what happened during the pandemic.

”In order to be able to produce antibiotics in a factory, for example, documentation, processes and trained personnel must be in place. You even have to produce regularly, under normal circumstances, to maintain the knowledge. It becomes very costly," says Nicolaas Schipper.

Countries can help each other to create resilience in the supply of medicines

In the longer term, there are opportunities in small, modular pharmaceutical factories – flexible units that only operate when needed.

”But that is much further in the future; a lot of development and research is needed in this area,” says Denny Mahlin.

To create resilience in the supply of medicines, countries need to be able to help each other. However, there are several problems that need to be solved, including the harmonisation of doses and packaging.

“In the Nordic region alone, doses and how they are described differ. It is not so easy to simply send a package from Denmark to Sweden in the event of a shortage,” says Denny Mahlin.

At EU level, work is underway to strengthen production within the Union. But here too, competition, financing and market dynamics must be taken into account.

All in all, the supply of medicines is a complex issue. Many actors with different roles are involved, and the boundaries of responsibility are not always clear.

“There is a lack of clarity about who does what. That organisation needs to be established now,” says Nicolaas Schipper.

RISE can take on a coordinating role

Here, RISE, as an independent actor, could take on a coordinating role.

”Our technical expertise and leadership, as well as our contacts with industry and authorities, are valuable in the work to find solutions for flexible manufacturing and conversion in the event of crises and shortages,” says Nicolaas Schipper.

RISE can also contribute with analysis of how these situations arise – and at the same time be an important party in the research and development of technical solutions that can enable everything from better storage stability to transport.

”We also have the expertise to quickly develop manufacturing processes,” says Denny Mahlin, who also highlights quality assurance as an important issue.

"What is absolutely critical in order to be able to distribute medicines in a crisis? In such a situation, there may be regulatory flexibility, but if we want to be flexible, we must have preparations and guidelines in place for this.”