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Global Supply Chains for Medicines

Secure, reliable access to medicines is best supported by a diverse and agile global supply chain designed to respond quickly to evolving needs. No country can make every medicine it needs, and no medicine is made in every country. Protectionism and localization will not improve overall supply resiliency; policies supporting strong global supply networks are needed.

Security of Medicines Supply

The global availability of safe, effective, and affordable medicines is threatened by systemic issues causing supply disruptions and medicine shortages. Stakeholder collaboration and policy action is urgently needed, and solutions must be targeted to the root causes of shortages. There is potential for misguided unilateral responses, such as supply chain localization requirements, to exacerbate supply vulnerabilities.

Improvements to Existing Medicines

Improvements to Existing Medicines covers products based on known molecules that address healthcare system needs and deliver relevant improvement for patients, healthcare professionals, and payers. A dedicated regulatory pathway for abbreviated development should be established for improvements to existing medicines that encompasses drug repurposing, drug reformulation, and drug combinations. Further, improvements to existing medicines should be recognized as a separate category of innovation with the appropriate incentives, including appropriate and proportionate exclusivity protections and pricing & reimbursement frameworks that recognize the value differentiated products offer to improve patient access and health outcomes while reducing health system costs.

Protecting Access to Antibiotics

Antimicrobial resistance (AMR) is a growing public health concern. Access to the right antibiotic at the right time is crucial in the fight against AMR, yet supply is threatened by the unsustainable market dynamics of off-patent antibiotics. Short- and long-term policy action is needed to safeguard access.

Global Regulatory Efficiencies

Streamlining regulatory frameworks that support the development, approval, and post-approval changes of medicines worldwide optimizes the use of both industry and health authority resources to create more efficient regulatory assessments, ultimately accelerating and expanding access for patients. Streamlining can be accomplished through harmonization, reliance, and agility, which expedites medicine approvals and enhances availability while upholding rigorous safety and efficacy standards.