Swedish medicines regulator seeks stronger mandate to combat drug shortages

The Swedish Medical Products Agency is seeking a new mandate to address drug shortages. Among other responsibilities, it wants to be in charge of redistributing critical medicines to pharmacies and setting up a situational awareness system based on stock and sales data. 

In a recent interim report to the government, the Swedish Medical Products Agency, Läkemedelsverket, calls on the government to give the agency a clearer and stronger national role with more powers to deal with future medicine shortages.

Overall, the Swedish pharmaceutical supply system works well, with 93 per cent of marketed medicines available in Sweden. But the missing seven per cent is causing major problems for patients and healthcare workers, according to Veronica Arthurson, the agency’s head of division.

“At the moment, we have some challenging residual situations for some cancer drugs like fluorouracil, some antibiotics like amoxicillin and diabetes drugs in the form of GLP-1 analogues, that is Ozempic,” she told Euractiv.

Decisions of allocation to one actor

Arthurson explains that the reasons for the shortcomings are mainly manufacturing-related problems but also an increased demand and a more widespread just-in-time (JIT) inventory management, according to which the exact number of products needed are supplied the moment they are requested.

“There is a need for a national actor that brings together issues and has the ability and mandate to take quick decisions on the necessary actions in situations of drug scarcity,” Arthurson says.

The agency, for example, wants to have the legal power to make binding decisions on the redistribution and allocations of medicines to pharmaceutical actors under its supervision, such as pharmacies, wholesalers and pharmaceutical companies.

“Yes, we are proposing that we should have the power to redistribute drugs between pharmacies and to ask wholesalers to supply medicines to particular pharmacies, or only to hospitals, for example, in the event of a critical shortage of medicines,” Veronica Arthurson added.

Lessons learned during the pandemic

Such a measure was actually temporarily assigned to the agency during the pandemic when community and hospital pharmacies were asked to share critical drugs like the much-needed anaesthetic propofol.

“This kind of redistribution is not possible today due to Swedish laws, but the pandemic showed the need for a national actor that could take on such work, Bengt Mattson, policy manager at LIF, the association of researched-based pharmaceutical companies in Sweden, explained to Euractiv.

Mattson said he’s pleased that the Swedish Medical Products Agency is now stepping forward.

“Swedish healthcare is fragmented, so it’s great that the Medical Products Agency now wants to take on this overall and greater responsibility as a national actor,” he said, adding, “We have to make sure that medicines get where they are needed.”

According to Bengt Mattson, the issue is also discussed within HERA, the European Health Emergency Preparedness and Response Agency.

Situational awareness reports

In addition, the agency would like to have broad access to stakeholders’ stock and sales data to establish system support for producing situational awareness reports on drug supplies inspired by a Danish systematic working model.

This aims to allow the agency to better monitor when medicines are running out. It would also improve Sweden’s reporting of shortages to the European Medicines Agency (EMA), the report says.

Bengt Mattson says LIF has no objections to such an approach: “However, we believe that for such a system to be really valuable, it would be best to include not only the pharmaceutical industry but also pharmacies and healthcare stockholding.”

Learning from other countries

The agency has also mapped measures taken by Norway, Denmark, Finland, Iceland, Ireland, Great Britain, Germany and France to handle drug shortages.

Its survey shows that the number of medicines in shortage has increased in all these countries, but no comprehensive solution has been found. However, according to Arthuson, Sweden can learn from certain approaches.

“Our analysis shows that in some of these countries, it seems easier to find substitutes when regular medicines are out of stock.”

In the UK, for example, community pharmacists can use a “serious shortages protocol” to dispense a substitute without the prescribing doctor’s consent.

This is something the Swedish agency is interested in and will continue to investigate. At the same time, the agency is working with centres of excellence in Sweden to help develop clinical recommendations for use when drugs are lacking, Arthurson told Euractiv.

The CEO of the Swedish Pharmaceutical Society, Lena Ring, is positive about the proposed new changes. 

“During the COVID-19 pandemic, there were temporary provisions to redistribute medicines between pharmacies, and we welcome the proposals on how existing stocks can be used in other situations, as we have called for in the past,” she told Euractiv.

A balanced approach

Lena Ring said the new report includes proposals on several levels to improve access to medicines.

Another proposal from the Medical Products Agency is to introduce a legal obligation for individuals working with shortages to provide the agency with information on medicine in short supply, but only if the information would be necessary for the agency to have.

“When it comes to requirements to disclose data needed to address medicine shortages, we agree with the importance of a balanced view,” Lena Ring told Euractiv.

[By Monica Kleja, edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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