Head of BfArM tells Spiegel he is consulting with lawmakers
Says EU market rules mean that hurdles are high
Several EU countries have already banned outbound Ozempic trade
Not clear when new Lilly drug will help meet weight-loss demand
(Adds trade group comment in paragraphs 15-16)
By Ludwig Burger
FRANKFURT, Nov 15 (Reuters) - German regulator BfArM is considering banning Ozempic exports as Europe's health systems grapple with shortage of the diabetes drug, which is in high demand for its weight-loss benefits.
Use of Novo Nordisk's Ozempic for weight loss has caused shortages across Europe, where Britain and Belgium have temporarily banned its use for weight loss to secure availability for diabetics.
Novo's launch of anti-obesity 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.
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 hugely popular but scarce 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," said Broich, adding that the drug was going to other European countries and the United States.
Novo, which has earmarked $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 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 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.
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.
Affordable Medicines Europe, a lobby group of drug wholesale companies that run parallel trades of pharmaceuticals between EU countries, said that exports are not the cause of Ozempic shortages and that countries should instead consider measures to regulate off-label prescription.
Beyond Ozempic, German patients and medical insurances are among the main beneficiaries of drug parallel trade in the European Union because the country is the larget inbound market for EU drug trading, a spokesperson for the association said.
Several countries in the EU, however, have already stopped Ozempic exports, Affordable Medicines data shows. 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.
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 and urged "all relevant actors" not to export the drugs. ($1 = 0.9203 euros) ($1 = 6.8636 Danish crowns) (Reporting by Ludwig Burger in Frankfurt and Miranda Murray in Berlin; additional reporting by Patricia Weiss; Editing by Matthias Williams, Sharon Singleton and Alexander Smith)