Germany's Drug Supply At Risk, Warning Over Potential Shortages from China

The German pharmaceutical sector is facing potential drug shortages following China's recent tightening of espionage regulations. As a result, four of Germany's 16 states have halted their routine quality control inspections in China. The states are worried that their inspectors could inadvertently breach the new laws, raising concerns about their safety during visits to Chinese pharmaceutical facilities.

The German Pharmaceutical Industry Association issued a cautionary statement in an article published in Germany's Pharmaceutical Newspaper, “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.”

Europe relies heavily on China for active pharmaceutical ingredients and antibiotics, with China being a major global supplier. In Germany, nearly 90% of antibiotics are sourced from China, as reported by the German Pharmaceutical Industry Association (BPI). To ensure compliance with EU regulations, all pharmaceuticals produced in China must adhere to EU quality standards, and European inspectors are responsible for certifying that these manufacturing processes meet EU requirements.

Dorothee Brakmann, CEO of the country's largest pharmaceutical association Pharma Germany, told German broadcaster Tagesschau that "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,"

The BPI has requested assurances from the German government that China's anti-espionage law will not interfere with the duties of German pharmaceutical auditors. However, Germany's Ministry of Health has downplayed these concerns, stating that the potential risks for inspectors have always existed due to the "unpredictable actions" of Chinese authorities, even before the recent tightening of the espionage law.

The pharmaceutical newspaper mentioned that a spokesperson for the BMG said, "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.”