The Swedish Medical Products Agency is examining suspected violations of its rules which could result in fines of up to almost €9 million as Sweden struggles with drug supply problems that are also afflicting other parts of Europe.

The areas of concern in Sweden are the supply of paracetamol for babies and young children, neurological medicines, female hormones, insulin, and other drugs.

The European Medicines Agency (EMA) this month laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. The medicines on EMA’s list include basic antibiotics such as amoxicillin, plus painkillers like paracetamol and morphine, as well as vaccines for diseases like measles, rabies and the flu.

The European Commission is also setting up a Critical Medicines Alliance—due to come online in early 2024—that will enable national authorities to cooperate with the industry and the EU to counter shortages and supply chain vulnerabilities.

In Sweden, pharmaceutical companies have had to signal two months before a drug might be out of stock for the last decade to allow the Agency to try and find a solution.

However, the Association of Research-based Pharmaceutical Companies in Sweden, LIF, warns that companies may now be over-reporting as a precautionary measure in order to avoid being fined.

To date, 1,250 medical products have been reported as in danger of running out of stock. Many of them are exchangeable, but in about 6 to 7% of the notified products, there are no clear alternatives for the patients, according to the agency.

In a bid to tighten control of the situation, a new law came into force in July allowing the authority to impose fines for late notifications of potential drug shortages. The penalties range between 2,200 euros to 87 million euros (25,000 SKR to 100 million SKR).

There are concerns the number of notifications is set to reach an all-time high and they revolve around production planning and/or capacity, and increased demand, according to the agency’s statistics.

Johan Anderson, head of department at the Swedish Medical Products Agency, told Euractiv. “The increase is related to the war in Ukraine, high inflation, increased transport costs and energy prices, production conditions and a weak Swedish krona. As a result, we have seen companies reporting earlier and more often, which is good.”

However, over reporting is a concerning situation according to Bengt Mattson, a senior expert at LIF, who told Euractiv: “It is important to remember that the list doesn’t mean that the products are actually in critical shortage. The media image of empty shelves in pharmacies is not a true description of the reality”.

The association hopes that the government will assign the Medical Products Agency and the eHealth Agency in Sweden to set up a system to monitor the national situation of supply and critical needs. “This would make it easier to identify critical shortage and for the agency and doctors to work together to recommend alternatives in good time:” added Mattson.

Patient groups are voicing their concerns as doctors in Sweden do not receive notification from their electronic prescription system if a medicine is out of stock.

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