Strengthening European resilience of manufacturing and supply of medicines is required to secure patient health in the long-term
European Commission Vice-President for Promoting our European Way of Life Margaritis Schinas visits Centrient Pharmaceuticals’ sustainable antibiotic API manufacturing site in Barcelona, Spain, to discuss the importance of supporting the resilience of European medicine manufacture and supply. The meeting with Centrient Pharmaceuticals, the largest Cephalosporin antibiotic API manufacturer in Europe, is part of the Vice-President´s two-day visit to Barcelona to speak at the Medicines for Europe Annual Conference.
In the last 40 years, a significant share of generic pharmaceutical manufacturing companies, especially for APIs and intermediates, relocated or outsourced their manufacturing capabilities to Asia driven by comparative cost advantages. The COVID-19 pandemic and the economic consequences disrupted the global supply chains for all goods, including medicines. Inflation has risen in Europe to over 8.1%, transportation costs are increasing dramatically (up to 500%) while Manufacturing input costs have risen by between 50-160%. According to the European Parliament, the EU is increasingly dependent on non-EU countries - mainly China - when it comes to the production of active pharmaceutical ingredients, chemical raw materials, and medicines:
- 80% of active pharmaceutical ingredients come from India and China
- 40% of finished drugs sold in Europe are from China and India
These numbers raise many important questions about the political implications of supply chain resilience and possible shortage risks of drugs needed by European patients.
“Centrient’s manufacturing site in Barcelona, Spain, is one of the only two remaining manufacturing sites in Europe that produces Active Pharmaceutical Ingredients (APIs) for first-generation Cephalosporin antibiotics. Doctors prescribe Cephalosporins to treat skin and soft tissue infections and prevent hospital-acquired surgical infections. These antibiotics are classified on WHO’s Essential Medicines List and are given to patients allergic to penicillin,” Centrient’s Global Franchise Director for Semi-Synthetic Cephalosporins Robin Koenig noted. “The pressure on global supply chains caused by the disruptions due to COVID-19 and rapidly rising energy prices in Europe underline a growing need for a deeper collaboration between the European Union, the industry, and other healthcare stakeholders to secure European supply of essential medicines.”
"It is vital that the upcoming revision of the EU pharmaceutical legislation includes practical policies and incentives to strengthen the European industry. The visit of Vice President Schinas shows that the EU is serious and ready to engage with us to safeguard patient access to medicines and so I thank him for being here with us. We want to work together to develop clear procurement mechanisms that incentivise local, green production. This should be paired with access to EU emergency and recovery funds for the off-patent medicines industry, which counts for 70% of dispensed medicines to patients in Europe. added Elisabeth Stampa, President of Medicines for Europe.
The environmental footprint of antibiotic manufacturing at the Barcelona production facility is leading in industry both on limiting impact to antimicrobial resistance (AMR) and reducing carbon emissions.
High concentrations of antibiotic residue in factory wastewater can create hotspots of resistant bacteria which may lead to AMR. Centrient Pharmaceuticals recently reached a significant milestone in the clean production of its antibiotics by achieving 100% compliance with the stringent Predicted No Effect Concentration (PNEC) discharge targets set by the AMR Industry Alliance which minimizes the potential contribution to AMR. 700,000 people die yearly due to drug-resistant diseases, with the number forecast to reach 10 million by 2050 unless urgent action is taken. The World Health Organization recently declared antimicrobial resistance (AMR) as one of the top global public health threats facing humanity.
Further, Centrient’s Barcelona site is powered by renewable electricity and an innovative production process. “Our sustainable enzymatic manufacturing technology enables a 63% reduction in carbon footprint compared with the traditional chemical process. We produce the purest and most environment-friendly life-saving antibiotics for patients in Europe and beyond,” Alba Tiley, Centrient’s Director for Sustainable Antibiotics Program, said. “As a pioneer and expert in sustainable antibiotic API production, Centrient is ready to share our expertise in the fight against AMR and preserving the environment for generations to come.”