Several German states have suspended trips by their quality-control inspectors to Chinese pharmaceutical companies over tightened espionage laws.
ADVERTISEMENTThe German pharmaceutical industry has warning of possible drug shortages after China tightened its espionage laws.
Four out of Germany’s 16 states have now cancelled routine quality control trips to China by their inspectors as they’re concerned they could fall foul of the law.
The states say they can no longer guarantee the safety of their inspectors on visits to Chinese pharmaceutical factories.
« Some active ingredient certificates have already expired or are threatening to expire in the next few months, which will lead to a standstill in the supply chain for various drugs, » the German Pharmaceutical Industry Association warned in an article in Germany’s Pharmaceutical Newspaper.
Europe imports a high number of active pharmaceutical ingredients and antibiotics from China, which is one of the world’s largest suppliers.
In Germany, almost 90 percent of all antibiotics come from China, according to the German Pharmaceutical Industry Association (BPI).
All drugs made in China must meet EU quality control standards, and European inspectors have to issue certificates to confirm that the manufacturing process meets EU standards.
« No one can afford additional drug shortages, » BPI spokesman Andreas Aumann told Pharmaceutical Newspaper.
The decision to cancel trips by auditors has been supported by the German pharmaceutical industry.
« They go into the companies and look around, they take notes, they collect data and they are simply afraid of reprisals or, in the worst case, of arrests if they travel there and inspect the factories, » Dorothee Brakmann, CEO of the country’s largest pharmaceutical associations Pharma Germany, told German broadcaster Tagesschau.
The BPI has appealed to the German government for confirmation that China’s anti-espionage law would not impact the work of German pharmaceutical auditors.
But Germany’s Ministry of Health has minimised concerns for inspectors on behalf of the pharmaceutical industry, saying that even before the espionage law was tightened there had always been an element of risk due to the « unpredictable actions » of the Chinese authorities.
« The Federal Ministry of Health is in close contact with the Foreign Office and the states in order to minimise possible concerns and risks in future inspection trips, » said a spokeswoman for the BMG » the Pharmaceutical Newspaper reported.
Beijing downplays risk
China has also downplayed the pharmaceutical industry’s fears, insisting that the law only targets a handful of espionage activities and won’t interfere with normal business activities.
« As long as the relevant companies and personnel can act in accordance with the law, there is nothing to worry about,” Mao Ning, China’s Foreign Ministry spokesperson, said.
ADVERTISEMENTFirst introduced in 2014, China’s anti-espionage bill intends to « prevent, frustrate and punish » acts of espionage, giving the country a broad mandate to crack down on activities perceived to be a threat to China’s national interests.
Changes to the law enacted last year included a ban on the transfer of information related to national security.
Additional changes in February broadened the scope of the law to include « work secrets », a vague term that may not relate to state secrets but could still cause « adverse effects » if revealed.
Several foreign business organisations have called for greater clarity over Beijing’s revisions to the law, particularly on what data is safe for foreign businesses to collect.
ADVERTISEMENTIn 2023, a senior employee of a Japanese pharmaceutical manufacturer Astellas Pharma was arrested in China on charges of espionage.
