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German health ministry says Ozempic exports not a concern


By Ludwig Burger and Andreas Rinke

FRANKFURT (Reuters) -Large volumes of diabetes drug Ozempic are not being exported from Germany, its health ministry said on Thursday, quashing a suggestion by its drugs regulator that outbound trade in the drug, coveted for its weight-loss effect, may have to be banned.

The head of drugs regulator BfArM, which is subordinate to the ministry, in November suggested banning exports of Novo Nordisk’s Ozempic if other steps fail, as Europe’s health systems grapple with a shortage of the drug.

The ministry said in a statement there was “currently no evidence that larger volumes of diabetes medicines are being exported”.

“Shortages of certain pharmaceuticals, GLP-1 analogues in particular, exist in a number of EU countries because of high demand and limited production volumes,” a ministry spokesperson added, responding to a query by Reuters about any plans to restrict trade.

GLP-1 analogues are a class of drugs that include Ozempic and its high-dose version Wegovy, which is approved for weight loss.

A BfArM spokesperson said the ministry’s statement reflected the current situation and declined to comment further.

BfArM has had an Ozempic shortage declaration in place for about a year, saying that swings in availability are hard to predict, according to its website.

Among measures by manufacturer Novo to ease the shortage, it said in November it would ration starter kits of Ozempic in Europe and reduce supplies of another diabetes drug, Victoza, to prioritise Ozempic production.

Novo’s launch of Wegovy in Germany, as well as the introduction of rival weight-loss drug Mounjaro by Eli Lilly, has so far done little to temper the craze for Ozempic, partly because many users who have to pay for treatment themselves regard it as the most affordable weight-loss option.

Ozempic is approved to treat type 2 diabetes when more established therapies have failed, but has been increasingly prescribed “off-label” to treat weight loss.

In an interview with Spiegel magazine in November, BfArM President Karl Broich said the agency was in talks with lawmakers about imposing an export ban if other measures, such as cracking down on off-label use, don’t show an effect.

Affordable Medicines Europe, a lobby group of drug wholesale companies that run parallel trades of pharmaceuticals within the EU, said that member states Austria, France, Greece and the Czech Republic have imposed Ozempic export bans.

Other EU members have rules in place that likely make it impossible to export the drug, it added.

(Editing by Madeline Chambers, Mark Potter and Deepa Babington)

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