The COVID-19 pandemic and resulting economic crisis exposed the vulnerabilities of both domestic and global supply chains across multiple industries. Given the complexity and far-reaching global nature of their supply chains, pharmaceutical and biotechnology companies were required to diligently monitor CDMOs and internal manufacturing facilities, while enacting business continuity and risk mitigation plans to initiate the appropriate measures to safeguard the supply of medicines to patients throughout the pandemic. Long term, the pandemic has also triggered a turning point in how the biopharmaceutical industry needs to realign their supply chains in order to build resilience in the event of future disruptions.
Additionally, the pandemic revealed the limitations of increased dependence on overly globalized and geographically dispersed biopharmaceutical supply chains. Many of these supply chains have limited plans in place for supply redundancy and diversification. As a result, we witnessed delayed cGMP commercial production schedules, capacity reductions and production decommitments due to prioritization of COVID therapeutic product production at CDMOs, and a threat of temporary bans on raw material exports from China and India (two of the largest providers of key starting materials and active product ingredients). These examples, among others, sent shivers down the spine of the entire industry as they enable the potential for both near and long-term drug shortages.
With an intent to address these challenges and provide a framework for future biopharmaceutical supply chain resilience and risk management, the U.S. Congress passed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed into law on March 27, 2020. Tucked away in 335 pages of legislation, there are specific mandates and provisions to ensure biopharmaceutical companies implement proper measures to monitor and mitigate future supply chain risks and prevent potential future drug shortages.