Maura Kinahan, PhD MPSI “Medicines Shortages - Industry Perspective” 2013 INTERNATIONAL SUMMIT ON MEDICINES SHORTAGE Toronto 20 th -21 st June 2013

Overview 1 Setting the Scene 2 Challenges Faced 3 Ideas to Improve Availability 4 Conclusion

Setting the Scene (con’t) Demand Increase Demand Increase Product Discontinuation Trading of Medicines External Economic Environment API or Excipient Shortage Regulatory Action (e.g. Enforcement) Manufacturing (e.g. Quality Issue, Contamination) Product Recall Product Recall Why Shortages Occur? Why Shortages Occur?

Lifecycle of a Medicine Discovery Development Filing Approval Innovator Continues to Supply Commercialisation No New Market Entrants No New Market Entrants Loss of Exclusivity Loss of Exclusivity New Market Entrants New Market Entrants Innovator’s Volumes Decrease Innovator’s Volumes Decrease Innovator Decreases Capacity Innovator Decreases Capacity Exclusivity Period

Supply Chain Complexity Product A (Norm Becoming the Exception) Product B (Becoming the Rule) API Mfg US API Mfg US DP Mfg US DP Mfg US Pack US Pack US DC’s Various DC’s Various Europe LA NA Asia API Mfg Asia (1) API Mfg Asia (1) API Mfg Asia (2) API Mfg Asia (2) DP Mfg US DP Mfg US DP Mfg US DP Mfg US DP Mfg EU DP Mfg EU DP Mfg EU DP Mfg EU DP Mfg EU DP Mfg EU Pack US Pack US Pack US Pack US Pack EU Pack EU Pack EU Pack EU Pack ME Pack ME Pack Asia Pack Asia Pack EU Pack EU Canada US Spain, France ROW Pakistan Japan Turkey Mexico Innovator Site 3 rd Party Site

Even Administration Tools Can Be Complicated 7

Global Supply Chain Network China Michigan Belgium Ireland 35K SKUs supplied globally 150 markets 89 Pfizer manufacturing sites > 500 external suppliers 175 logistic centres France

Overview 1 Setting the scene 2 Challenges faced 3 Ideas to Improve Availability 4 Conclusion

Supply Disruption Example 9 Competitor Supply Disruptions Started Second Quarter 2011… And Increased Demand for Pfizer-Outstripping Capacity Leading to Drug Shortages…

Pfizer’s Response Managing Constrained Supply (2011–2012) Cross functional Sales and Operations planning (S&OP) identified supply gaps by market and potential mitigation Allocation decisions based on medical need and availability of alternative products Drug Shortage Review Team (DSRT) assessed shortages and made recommendations Addressing Long Term Capacity (2013–2015) Capacity expansion in internal sites Transfer of manufacturing activities to leverage additional capacity and re-optimize the new network 10

Global Logistics & Supply Commercial Business Unit Quality Operations or Regulatory Affairs Drug Shortage Reporting (EU) Supply Interruption is identified (last > 2 weeks) Supply Interruption is identified (last > 2 weeks) Local mkt reporting requirements? Is Pfizer the sole supplier? Drug Shortage Review Team (DSRT) meeting (GLS lead) Review Impact e.g. Duration of shortage Is this a medically necessary drug? Is this a centrally authorized product? Other information Drug Shortage Review Team (DSRT) meeting (GLS lead) Review Impact e.g. Duration of shortage Is this a medically necessary drug? Is this a centrally authorized product? Other information Report the drug shortage to the HA Shares results, recommendations & comments from the HA with DSRT Close the shortage report and communicates this to the HA and internally to DSRT GLS closes DSRT report Drug Shortage Review Team (DSRT) Yes Drug Shortage – When a Drug Product Is Unavailable to Patients

EPBU Executive S&OP Meeting Target98.0% May99.2% June98.7% July99.4% August98.0% Target0 May2 June12 July2 August3 Target3.2 May3.0 June3.8 July4.0 August3.6 Target20.0% May25% June37% July27% August20% Stock (%) No of Supply Interruptions * Months on Hand Forecast Error (FE) Dashboard (KPI’s) (Example Only) * Supply interruption in Pfizer warehouse of greater than 1 day

Local Management Engage with Regulatory Agency Communicate with DoH Update Customers Allocations Source Stock from Other Markets Rework if Necessary Local Response Team Manufacturer

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

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