Member states scrambling to secure steady flow of diabetic drug

Germany is considering an export ban on Ozempic, an antidiabetic medicine that has been flying off the shelves in pharmacies not only for its effectiveness in managing glucose levels of people living with Type 2 Diabetes but also for its weight-loss properties.

Short supply is impeding access for patients in Sweden, off-label use is causing headaches in Czechia and Slovakia, while thousands of packs of the drug lay in storage in Greece. 

Countries like Bulgaria, Greece (which had a ban on parallel trade of the medicine up until September), and Czechia have further restricted prescription of Ozempic to tackle shortages, but according to the manufacturer, intermittent shortages are expected throughout 2024. 

Off-label use

While the discussion on European drug shortages due to production limits and import bottlenecks is nothing new, for certain types of drugs, an additional factor puts a strain on their availability: unattended use.

This is the case, in particular, with Ozempic, manufactured by Danish pharma company Novo Nordisk.

A GLP-1 analogue medication containing the active substance Semaglutide, Ozempic has been authorised for use by the European Medicines Agency as a medicine designed to manage Type 2 Diabetes. 

However, weight loss has emerged as a noteworthy additional effect of the medication, and the drug started to be used off-label – that is, for a different indication than approved – to treat obesity.

The dual application of Semaglutide presents an especially tricky situation with prescriptions in Slovakia. The rising demand is partially driven by patients for whom it is not indicated – healthy individuals wanting to lose a few kilos, with the surge leading to problems for patients who rely on the medicine to manage their diabetes.

Additionally, with the drug’s growing popularity also came fears of illegal online trading and falsified Ozempic pens.  

Germany considering an export ban

In Germany, the shortage of Ozempic is so severe that the Federal Institute for Drugs and Medical Devices (BfArM) is “considering imposing an export ban so that enough remains in the country for patients who need it”.

A lack of supply, however, is not an issue in Germany’s case. Even though the drug needs to be imported, the “quantity of goods produced and placed on the market is significantly higher than the average demand,” the BfArM told tagesschau.de.

Instead, the problem is two-fold: For one, the demand increased drastically due to the weight loss craze, and then, the drug turned out to be cheaper in Germany than in other countries, causing an outflow of Ozempic shortly after it is imported to other European countries or the USA.

Patients in Sweden in “a hunt to track down” their medicine

Shortages were also reported in Sweden. “Most of the packages or concentrations, are back-listed. This doesn’t mean there is nothing at all, but that the manufacturer can’t fully accommodate the demand,” Johan Andersson, head of the department at the Swedish Medical Products Agency, told Euractiv.  

But it is the people who depend on the medicine that are affected the most.

“In Sweden, there was a shortage of Ozempic since the sharp global demand increased. For some individuals, there might be alternatives to Ozempic, but that doesn’t count for all people living with Type 2 Diabetes,” Björn Ehlin, the president of the Swedish Diabetes Association, told Euractiv.

On top of that, doctors aren’t warned through their electronic prescription system when a drug is in short supply in order to avoid prescribing them if they are not available in pharmacies.

“Patients have to chase after their medicine from pharmacy to pharmacy,” Ehlin said adding also that the healthcare personnel has to administer new prescriptions for drugs that are lacking.

Quantities of Ozempic stuck in stock in Greece

Greece has also battled with shortages of Ozempic. Around six months ago, the National Medicines Organisation (EOF) decided to order through the Institute of Pharmaceutical Research & Technology (IFET) and its mechanism of emergency import around 9,000 packs of the GLP-1 analogue medicine.

Part of those quantities was made available to pharmacies, but quite a big amount has been left sitting on refrigerator shelves in storage since then. The precise number is unclear, but it seems to vary from 3,500 to 5,500, according to reports.

“Because of a week’s delay by the board of EOF to green light the purchase of all the Semaglutide packs, a part of the order was bought with a price difference, not a particularly high one, to be frank”, Christos Daramilas, president of the Panhellenic Federation of People with Diabetes, told Euractiv. 

As a result of the difference in purchase price and the price approved by the board of EOF, it was decided not to issue codes and labels needed to distribute those packs. “That was given as the excuse, verbally,” Daramilas explained.

The National Organisation for the Provision of Health Services (EOPYY), which operates as a unified health insurance fund, requested to know the reasons behind the decision to not distribute all of the available medicine but got no official answer from EOF, as EOPYY’s president Theano Karpodini recently told mentioned journalists.

On top of that, the storage of the Semaglutide packs costs extra. As Daramilas pointed out, “GLP-1 analogue medicines need to be stored in refrigerators, and since the IFET hasn’t enough refrigerated storage for such quantities, it has been paying rent to a storage facility”. 

Euractiv has asked IFET for a comment but none has been provided by the time of publication, citing the transitional period, as both IFET and EOF have newly appointed temporary heads of their respective boards.

Novo Nordisk’s reaction

According to an official communication by Novo Nordisk to the European Medicines Agency (EMA), the company has decided to temporarily reduce the supply of another diabetic treatment to facilitate increasing supply of Ozempic. 

“For Ozempic, intermittent shortages are expected throughout 2024”, Novo Nordisk reported.

It also stated that the supply of the starting dose for Ozempic (0.25 mg) will be limited, “which is expected to limit the initiation of new patients, to mitigate the increasing demand on the higher maintenance doses. It is recommended to limit initiations of new patients during the shortage and until the supply situation improves, which is expected in Q1 2024”.

The company has also decided to boost production, announcing plans to invest more than 42 billion Danish kroner to expand its manufacturing facilities in Kalundborg, Denmark, and more than 16 billion kroner (2.1 billion euros) to expand the production site in Chartres, France.

[By Filip Áč, Monica Kleja, Kjeld Neubert, Vasiliki Angouridi | Edited by V. Angouridi/Zoran Radosavljevic]

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