The Swedish Medical Products Agency is pushing for the creation of a state-run pharmaceutical production company to deal with shortages of critical medicines.

If the proposed law revisions pass, in future, a state-owned firm and private manufacturers could receive state orders to produce medicines to be reserved on standby.

Sweden needs to have a stable contingency function for the national supply of drugs, the nation’s Medical Products Agency says in a recent article, outlining its positions on how to deal with medicine shortages.

Early this summer, Euractiv reported that the regulator was seeking a stronger mandate to deal with the challenges of drug shortages. For example, the agency wants to be able to redistribute medicines across the country if there are shortages in some regions.

This time around, it says that mandatory stockpiling is necessary and would create a buffer against so-called stock-outs.

Moreover, there is another measure that would be needed – and not only in times of war or a crisis – but also in peacetime and everyday life, Luisa Becedas, the agency’s head of medicine availability, told Euractiv.

Public-private partnership

The agency reveals that it is actively seeking a mandate to be able to order the production of critical drugs that are in short supply or have run out of stock. This means changes to Swedish law.

The Medical Products Agency is pushing the idea “of an established government control for a smooth production transition nationally or in the neighbouring area, where private actors and also state-owned pharmacy production & laboratories (APL), if necessary, should be able to produce on standby to cover a shortage situation,” the agency states in the article.

According to Luisa Becedas, the agency’s main focus is to establish a collaboration with the state-owned Swedish company Apotek, Production & Laboratorier (APL).

“We are in a dialogue with the APL on the matter of support manufacturing, but we are also in discussion with some large private players,” she said.

According to Becedas, the regulator is also in talks with the Ministry of Social Affairs on the issue.

The proposal would mean a completely new and expanded role for APL, which currently has a public assignment to manufacture individually tailored extemporaneous drugs and produce batch-manufactured stock formulations. At the same time, APL also offers contract manufacturing to the life sciences industry.

EU-supported idea

The idea of creating a standby production capacity is not new in Sweden, but it is now being promoted by the EU4Health programme, the Critical Medicines Act and the Critical Medicines Alliance – EU initiatives aiming to address medicine shortages.

As Luisa Becedas explained, one of the EU4Health’s joint actions should lead to support for an enhanced medicine production capacity and a more stable supply of around 200 “active pharmaceutical ingredients”, or APIs, within the EU.

The Swedish medicines regulator has significantly increased its EU involvement in the field of medicine availability over the past year.

Becedas also said that the state-run “support manufacturing” would not aim to compete with pharma companies in the production of medicines.

The drugs that could be produced this way on demand would be carefully selected by the agency from the EU’s list of 200 critical drugs, as well as from lists of critical medicines drawn up by the WHO and the Swedish National Board of Health and Welfare.

As an example of a critical drug that could be selected, she mentions acetylcysteine, the antidote to paracetamol poisoning. “This is a great example of a drug that can prove lethal not being available in Sweden,” she said.

“Not a silver bullet”

In 2023, the agency mapped the pharmaceutical production and its capacities in Sweden and in the Nordic countries. It shows that Sweden has 61 facilities for authorised medicines and 12 for taking oPIs.

The initiative of the regulator is more or less welcomed by Swedish stakeholders.

“I am glad the regulator is opening up and looking into this auxiliary production. But this is not a silver bullet, as APL is a small player. Such manufacturing could be helpful, though, in some situations,” said Bengt Mattson, policy manager at LIF, the association of research-based pharmaceutical companies in Sweden.

Some of LIF’s members, larger players, are in talks with the Medical Products Agency about backup production.

“However, I think it is also important to follow the new government investigation, set to propose new conditions for emergency production for the Swedish industry in general on October 31, as this will also affect the pharmaceutical industry,” Mattson said.

Mattson explains that LIF’s member companies sometimes may have production overcapacity, which could be used for backup production. He also points out that the government would have to pay for such manufacturing.

“To think that, for example, the giant Astra Zeneca in Södertälje, which has an export value of more than €15 billion every year, could convert and only produce drugs for Swedish needs would be a challenging thought,” he added.

Wider support

Lena Ring, CEO of the Swedish Pharmaceutical Society, believes that upping drug production in Europe is a necessity.

“We believe that the European ambition to increase the production of APIs (active pharmaceutical ingredients) in our neighbourhood is necessary. We also believe that it is important to improve the opportunities for Sweden to be a leader in terms of research and expertise in product development up to a finished product,” she told Euractiv.

Björn Ehlin, president of the Swedish Diabetes Association, also supports the idea of backup manufacturing for critical drugs but says it needs to be surrounded by a clear regulatory framework.

There are more than 600,000 people with diabetes in Sweden. In a survey conducted by the association this summer that included 3,700 people with diabetes, four out of ten (41 %) said medicines they needed were not available at the pharmacy, says Ehlin.

“The drug regulator is right. We really need to speed up the way we deal with drug shortages. The government is waiting for a lot of investigations to be completed, but these take a long time, and we know that people are suffering from a lack of medicines right now.”

[Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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