Sweden: Failing to report drug shortages could now lead to heavy fines

Pharmaceutical companies may be gradually improving at notifying drug shortages to the Swedish Medical Products Agency on time, but delays are still common and the agency is now examining suspected violations, which could result in fines of up to almost €9 million.

Like many parts of Europe, Sweden is struggling with drug shortages. Currently, alarms have been going off concerning paracetamol for babies and young children, neurological medicines, female hormones, insulin, and other drugs.

In Sweden, the number of medical products reported by the pharmaceutical industry as “out of supply” or “potentially out of supply” has risen sharply since the summer of 2022.

“The increase is related to the war in Ukraine, high inflation, increased transport costs and energy prices, production conditions and a weak Swedish krona”, Johan Anderson, head of department at the Swedish Medical Products Agency, told Euractiv.

This year could be the one when the number of notifications will reach an all-time high.

The reasons are twofold and related to production planning and/or capacity, and increased demand, according to the agency’s statistics.

For more than ten years, pharmaceutical companies have had to notify the agency two months before a drug might be out of stock. This gives the agency time to act and, together with pharmacies and the healthcare sector, find a solution.

But compliance with the rule has been weak for years, according to Andersson.

In July this year, a new law came into force allowing the authority to impose fines for late notifications of potential drug shortages. The penalties range between 2,200 euros to 8,7 million euros (25,000 SKR to 100 million SKR).

“As a result, we have seen companies reporting earlier and more often, which is good,” Andersson said.

The real picture needs monitoring

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.

“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”, Bengt Mattson, a senior expert at LIF, told Euractiv.

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 shortages and for the agency and doctors to work together to recommend alternatives in good time,” he said.

Earlier this autumn, LIF also set out its view on the drug shortages in an action plan, including a guide for companies on how to notify the authorities of the risk of shortages.

Fines ahead

Despite the improvements made by the pharma companies, Andersson said delays are still common. Around 35% of the notifications arrive 1-30 days in advance instead of the stipulated two months ahead, according to the agency, which is now going to take action.

“We are investigating and preparing a small number of cases with solid evidence of infringements that can lead to fines,” Andersson said.

However, he told Euractiv, such cases can only be made if the agency can prove that a company had actually received timely information about an impending shortage – but then failed to notify the agency on time.

“This could be challenging for us,” Andersson said.

Patients ‘hunting down’ medicines

Meanwhile, patient groups, such as the Swedish Diabetes Association, pointed out that doctors need accurate and up-to-date information about the supplies.

When prescribing a drug, most doctors in Sweden do not receive notification from their electronic prescription system if a medicine is out of stock, which can cause trouble for patients on life-saving medicines.

“You have to call different pharmacies and try to get two doses here and three doses there. In the long run, this is not a life you can survive”: These are the words of a female pancreatic cancer patient in a letter to Health Minister Acko Ankarberg Johansson (Christian Democrats), in which the woman refers to the situation as “drug chaos”.

The letter, seen by Euractiv, is one of many others sent to the minister by desperate patients needing help to get insulin or female hormones which are out of stock.

They would then get an official reply from the Social Affairs Ministry that various stakeholders are working to improve the supply of medical products using policy measures. For example, pharmacies must now adjust stock levels to better cope with potential shortages.

At the same time, the Swedish authorities are taking part in discussions on shortages within the European Union, where the European Medicines Agency, EMA, is also going to get a stronger role in monitoring and reporting shortages.

[By Monica Kleja – Edited by Vasiliki Angouridi/Zoran Radosavljevic – Euractiv.com]

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