- Head of BfArM tells Spiegel that he is consulting with legislators
- Says EU market rules mean hurdles are high
- Several EU countries have already banned outbound Ozempic trade
- It is not clear when the new Lilly drug will help meet the demand for weight loss
FRANKFURT, Nov 15 (Reuters) – Germany’s drug watchdog BfArM is considering an export ban on Novo Nordisk’s ( NOVOb.CO ) diabetes drug Ozempic, which is in high demand for its weight-loss benefits as European health systems struggle to stem supply shortages.
Ozempic is approved to treat type 2 diabetes when more established treatments have failed, but it has increasingly been prescribed “off-label” to treat weight loss because it has the same active ingredient as Novo’s hugely popular but rare anti-obesity drug Wegovy.
“We are currently in talks with legislators about what we will do if the current measures and the public messages do not show an effect,” BfArM president Karl Broich told Spiegel magazine.
“We would then consider imposing an export ban so that there is enough left in the country for the patients who need it,” Broich said, adding that the drug was destined for other European countries and the United States.
Use of Ozempic for weight loss has caused shortages across Europe. The UK and Belgium have temporarily banned its use for weight loss to ensure availability for diabetics.
Novo’s launch of weight-loss drug Wegovy, a high-dose version of Ozempic, in the UK, Germany, Norway and Denmark has so far done little to dampen the craze for Ozempic, as the supply of Wegovy has been limited due to production bottlenecks.
Novo Nordisk, which has earmarked $6 billion to increase production in Denmark, said last week that the industry was far from being able to produce enough weight-loss drugs to meet global demand.
More drugs are coming on the market, but it is not clear when supplies will be large enough to satisfy the growing demand.
WEIGHT LOSS PROMISE
Eli Lilly’s ( LLY.N ) drug tirzepatid, also known as Mounjaro, has shown even greater weight-loss potential in trials than Wegovy, and last week was approved for wider anti-obesity use, in addition to earlier approval for diabetes, in the United States and Britain.
The EU’s medicines regulator has recommended approval, but the EU Commission’s final word is still awaited.
BfArM’s Broich said some Ozempic was moved out of the country because it is cheaper there than elsewhere and demand was driven by use for weight loss.
Broich warned that export restrictions could only rarely be used and that legal hurdles were high due to the EU’s single market.
The German association of pharmaceutical wholesalers PHAGRO said in a statement that there was no certainty that exports were the cause of the shortage.
“Export control measures, which are a less invasive option, should be preferred to an export ban as long as there is no evidence that exports are a direct cause of non-availability,” the group said.
However, several countries in the EU have already stopped Ozempic exports, according to data from Affordable Medicines Europe, a lobby group of drug wholesalers that operates parallel trade in drugs between EU countries.
Countries that have introduced such bans are Austria, France, Greece and the Czech Republic. Portugal, Poland, Romania, Belgium, Slovakia and Spain, on the other hand, have regulations in place that are likely to make it impossible to export the drug, Affordable Medicines said.
In a statement on its website, Germany’s BfArM reiterated a call for doctors to only prescribe drugs from the class of GLP-1 receptor agonists, which includes Ozempic and Eli Lilly’s ( LLY.N ) Trulicity, for their approved use against diabetes.
It has also encouraged pharmacies to only fill prescriptions that list diabetes as an indication.
It added that the availability of the drugs had been limited since the spring of this year, despite efforts by drug manufacturers to increase production. It also urged “all relevant actors” not to export the drugs.
($1 = 0.9203 euros)
($1 = 6.8636 Danish kroner)
Reporting by Ludwig Burger in Frankfurt and Miranda Murray in Berlin; additional reporting by Patricia Weiss; editing by Matthias Williams and Sharon Singleton
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