German pharmaceutical companies warn that China’s tighter laws could mean drug shortages

Germany’s pharmaceutical industry is sounding alarms about potential drug shortages following China’s tightening of its espionage laws. Four of Germany’s 16 states have now stopped routine quality control inspections in China over concerns that their inspectors could inadvertently violate these new laws.

These states have expressed that they can no longer ensure the safety of their inspectors during visits to Chinese pharmaceutical facilities. 

China is a major global supplier of active pharmaceutical ingredients and antibiotics, with nearly 90% of Germany’s antibiotics sourced from the country, according to the German Pharmaceutical Industry Association (BPI).

Under EU regulations, all drugs manufactured in China must adhere to strict quality control standards, which European inspectors must verify. 

However, the cancellation of these inspection trips has received backing from Germany’s pharmaceutical industry. Andreas Aumann, a BPI spokesperson, stressed the importance of avoiding further drug shortages, telling Pharmaceutical Newspaper, “No one can afford additional drug shortages.”

Dorothee Brakmann, CEO of Pharma Germany, the largest pharmaceutical association in the country, explained the growing fear among inspectors: “They enter the companies, observe, take notes, collect data, and now they fear reprisals or even arrests during their inspections.”

The BPI has urged the German government to clarify whether China’s anti-espionage law will impact the work of German pharmaceutical auditors. 

However, Germany’s Ministry of Health has downplayed these concerns, noting that risks associated with Chinese inspections were present even before the law was tightened due to the “unpredictable actions” of Chinese authorities.

China has responded by saying that the law targets only specific espionage activities and will not disrupt legitimate business operations. “As long as relevant companies and personnel act in accordance with the law, there is nothing to worry about,” said Mao Ning, a spokesperson for China’s Foreign Ministry.

China’s anti-espionage law, initially introduced in 2014, aims to “prevent, frustrate, and punish” espionage activities, granting the government broad authority to address perceived threats to national security. 

Recent amendments to the law, including a ban on sharing information related to national security and the inclusion of “work secrets,” have raised concerns among foreign businesses about what data is safe to collect.