“Medicines Shortages - Industry Perspective” Maura Kinahan, PhD MPSI 2013 INTERNATIONAL SUMMIT ON MEDICINES SHORTAGE Toronto 20th-21st June 2013 Overview 1 Setting the Scene 2 Challenges Faced 3 Ideas to Improve Availability 4 Conclusion Setting the Scene (con’t) API or Excipient Shortage Manufacturing (e.g. Quality Issue, Contamination) Regulatory Action (e.g. Enforcement) Why External Economic Environment Shortages Occur? Product Recall Demand Increase Trading of Medicines Product Discontinuation Lifecycle of a Medicine Discovery Innovator Continues to Supply Development Filing No New Market Entrants Approval Exclusivity Period Loss of Exclusivity New Market Entrants Innovator’s Volumes Decrease Innovator Decreases Capacity Commercialisation Supply Chain Complexity Product A (Norm Becoming the Exception) Product B (Becoming the Rule) DP Mfg Pack US US DP Mfg Pack US US DP Mfg Pack EU EU DP Mfg Pack EU EU Asia Canada US Mexico API Mfg API Mfg US DP Mfg Pack DC’s US US Various Europe LA Asia (1) API Mfg Asia (2) NA Pack ME Innovator Site Spain, France 3rd Party Site Pack Asia DP Mfg Pack EU EU ROW Pakistan Japan Turkey Even Administration Tools Can Be Complicated 7 Global Supply Chain Network Ireland Belgium Michigan France China 35K SKUs supplied globally 150 markets 89 Pfizer manufacturing sites > 500 external suppliers 175 logistic centres Overview 1 Setting the scene 2 Challenges faced 3 Ideas to Improve Availability 4 Conclusion Supply Disruption Example Leading to Drug Shortages… Competitor Supply Disruptions Started Second Quarter 2011… And Increased Demand for Pfizer-Outstripping Capacity 16 12.0 13.0 13.5 14.5 15.0 12 8 4 0 2011 Contract site 2012 2013 Perth Wuxi 2014 2015 Forecast Demand 9 Pfizer’s Response 16 12.0 13.0 13.5 14.5 15.0 12 Managing Constrained Supply (2011–2012) • Cross functional Sales and Operations planning (S&OP) identified supply gaps by market and potential mitigation 8 4 • Allocation decisions based on medical need and availability of alternative products 0 2011 2012 Contract site 2013 Perth Wuxi 2014 2015 Forecast Demand • Drug Shortage Review Team (DSRT) assessed shortages and made recommendations 18 14 12.0 13.0 13.5 14.5 15.0 Addressing Long Term Capacity (2013–2015) 10 6 • Capacity expansion in internal sites 2 -2 2011 Contract site 2012 2013 Perth Wuxi 2014 2015 • Transfer of manufacturing activities to leverage additional capacity and re-optimize the new network Forecast Demand 10 Drug Shortage Reporting (EU) Global Logistics & Supply Global Logistics & Supply Commercial Business Unit Quality Operations or Regulatory Affairs Drug Shortage Review Team (DSRT) Supply Interruption is identified (last > 2 weeks) Drug Shortage Review Team (DSRT) meeting (GLS lead) Review Impact e.g. Is Pfizer the sole supplier? •Duration of shortage •Is this a medically necessary drug? •Is this a centrally authorized product? •Other information Local mkt reporting requirements? Yes Report the drug shortage to the HA Shares results, recommendations & comments from the HA with DSRT GLS closes DSRT report Drug Shortage – When a Drug Product Is Unavailable to Patients Close the shortage report and communicates this to the HA and internally to DSRT EPBU Executive S&OP Meeting Dashboard (KPI’s) (Example Only) Stock (%) Target No of Supply Interruptions * 98.0% Target 0 May 99.2% May 2 June 98.7% June 12 July 99.4% July 2 August 98.0% August 3 Months on Hand Target Forecast Error (FE) 3.2 Target 20.0% May 3.0 May 25% June 3.8 June 37% July 4.0 July 27% August 3.6 August 20% * Supply interruption in Pfizer warehouse of greater than 1 day Local Management Engage with Regulatory Agency Local Response Team Communicate with DoH Manufacturer Rework if Necessary Update Customers Source Stock from Other Markets Allocations Overview 1 Setting the Scene 2 Challenges Faced 3 Ideas to Improve Availability 4 Conclusion Ideas to Improve Availability • Culture of quality and compliance embedded in manufacturing and distribution network and with supply partners – In Pfizer, we are continuously investing to ensure our sites and partners meet contemporary regulatory standards • Assess risks in supply chain and put plans in place to minimize • Streamline communication between manufacturing and markets from global perspective to quickly identify and mitigate potential supply issues • Critical care products prioritised • Address manufacturing complexity to improve overall efficiencies • Sales & Operational Planning (S&OP) and end-to-end supply chain teams in place Ideas to Improve Availability (con’t) Industry-Regulator collaboration • As we build early warning and contingency planning, we need to work closely together to maintain supply in a pragmatic and flexible way: • Opportunity to simplify processes? • Fast-track variations? • Derogation from regulatory process? 16 Overview 1 Setting the Scene 2 Challenges Faced 3 Ideas to Improve Availability 4 Conclusion Conclusion • Medicines supply chain is highly complex • Many challenges to maintaining supply • Each out of stock situation is unique and needs to be dealt with on a case by case basis • All stakeholders need to work together to streamline processes and procedures to enable the safe and secure supply of medicines • We must all remember the impact on the patient However, in spite of these challenges, Pfizer is committed to maintaining supply