The challenge of compliance in the life sciences supply chain
The life sciences industry operates in one of the world’s most regulated environments. Global life sciences supply chains are lengthy and complex, shaped by many internal and external factors. Failures of any kind in the supply chain are hugely damaging to them in terms of immediate loss of revenue from delayed product launches, remediation costs and long-term reputational damage.
“Unravelling complexity. The challenge of compliance in the life sciences supply chain” is latest report by Deloitte Centre for Health care Solutions that elaborates on the challenges faced by life sciences supply chain.
The key challenges for the supply chain compliance are:
• Meaningful measurement – measuring compliance is complex and lacks comprehensive metrics to achieve visibility across the end-to-end supply chain
• Supply chain complexity – this highly complex environment is driven by the impact of intellectual property, tax structures and changing market access needs, as well as a growing reliance on third-party business partners, requiring effective governance and risk management
• The complexity of new product types and therapies – products are more diverse and have shorter product lifecycles, and there is a growing emphasis on outcomes and new models of healthcare delivery
• Implementing changes within existing regulatory frameworks – the management of regulatory and technical change presents a significant cost and operating challenge for life sciences companies
• Increased pace of regulatory changes – the proliferation of new regulations is set to continue, and regulators are increasing their compliance oversight and enforcement activities.