This session will explore the latest developments in the application and impact of the SPC Manufacturing Waiver. Since its implementation, the waiver has shown a significant influence on the pharmaceutical industry, particularly in terms of manufacturing within the EU. Points of discussion will include:

• Analyzing who is utilizing the SPC Manufacturing Waiver, how it’s being used, and if there’s any evidence of misuse
• Addressing the practicality of the waiver, especially the stockpiling exception, and the mixed feedback from industry participants
• Discussing potential areas of emerging litigation arising from the waiver’s use and examining the disputes related to the waiver regulation
• Analyzing how different entities in the pharmaceutical sector are strategically using the SPC Manufacturing Waiver, and what best practices can be advised to clients in light of recent experiences and legal challenges
• Assessing the case for reforming the SPC manufacturing waiver regime during its upcoming 2024 review period