Germany’s drug regulator BfArM is considering an export ban on Novo Nordisk’s NVO-N diabetes drug Ozempic, which is in high demand for its weight-loss benefits, as European health systems grapple to stem a supply shortage.
Ozempic is approved to treat type 2 diabetes when more established therapies 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 scarce anti-obesity drug Wegovy.
“We are currently in talks with lawmakers about what we will do if the current measures and the public messages don’t show an effect,” BfArM President Karl Broich told Spiegel magazine.
“We would then think about imposing an export ban so that enough remains in the country for the patients that need it,” Mr. Broich said, adding that the drug was going to other European countries and the United States.
Use of Ozempic for weight loss has caused shortages across Europe. Britain and Belgium have temporarily banned its use for weight loss to secure availability for diabetics.
Novo’s launch of weight-loss drug Wegovy, a high dose version of Ozempic, in Britain, Germany, Norway and Denmark, has so far done little to temper the craze for Ozempic as volumes of Wegovy have been limited due to production bottlenecks.
Novo Nordisk, which has earmarked US$6-billion to boost production in Denmark, said last week the industry was far from being able to produce enough weight-loss drugs to meet global demand.
More drugs are coming to market but it is not clear when supplies will be large enough to satisfy soaring demand.
Eli Lilly’s LLY-N drug tirzepatide, also known as Mounjaro, has shown even greater weight-loss potential in trials than Wegovy, and was last week cleared for wider use against obesity, in addition to a previous approval against diabetes, in the United States and Britain.
The EU’s drugs regulator has recommended approval but the EU commission’s final word is still pending.
BfArM’s Mr. Broich said some Ozempic was being moved out of the country because it is cheaper there than elsewhere, and demand was driven by use for weight loss.
Mr. Broich cautioned that export restrictions can only be rarely used and legal hurdles were high because of the European Union’s single market.
The German association of drug wholesale distributors PHAGRO said in a statement that there was no certainty that exports were causing the shortages.
“Measures of export control, which are a less invasive option, should be preferred over an export ban for as long as there is no proof of exports being a direct cause for non-availability,” the group said.
Several countries in the European Union, however, have already stopped Ozempic exports, according to data from Affordable Medicines Europe, a lobby group of drug wholesale companies that run parallel trades of pharmaceuticals between EU countries.
Countries that have imposed such bans are Austria, France, Greece and the Czech Republic. Portugal, Poland, Romania, Belgium, Slovakia and Spain, in turn, have rules in place that likely make it impossible to export the drug, Affordable Medicines said.
In a statement on its website, Germany’s BfArM reiterated a call for physicians to only prescribe drugs from the class of GLP-1 receptor agonists, which include Ozempic and Eli Lilly’s Trulicity, for their approved use against diabetes.
It has also called on pharmacies to only fill prescriptions that state diabetes as the indication.
It added that availability of the drugs had been limited since the spring of this year despite efforts by drugmakers to ramp up production. It also urged “all relevant actors” not to export the drugs.