2016/LSIF/FOR/004 Policies to Promote Patient Access to Innovative Treatments and Combat Antimicrobial Resistance

Transcription

1 2016/LSIF/FOR/004 Policies to Promote Patient Access to Innovative Treatments and Combat Antimicrobial Resistance Submitted by: Merck Sharp & Dohme Policy Forum on Strengthening Surveillance and Laboratory Capacity to Fight Healthcare Associated Infections and Antimicrobial Resistance Ha Noi, Viet Nam December 2016

2 Policies to promote patient access to innovative treatments and combat AMR Silas Holland, Global Public Policy Director, MSD APEC Policy Forum: Strengthening Surveillance & Laboratory Capacity to Fight Healthcare Associated Infections and Antimicrobial Resistance 14 December 2016

3 AMR has tremendous human and economic costs Deaths attributable to AMR every year compared to other causes of death Road traffic accidents now 1.2 million Measles now 130,000 Tetanus now 60,000 AMR in million Cancer now 8.2 million Cholera now 100, , million people dying every year Reduction of 2% to 3.5% in GDP, costing the world up to 100 trillion USD. Diarrheal disease now 1.4 million Diabetes now 1.5 million The Review on AMR Chaired by Jim O Neill

4 The most severe impact of AMR is in Asia Deaths attributable to AMR every year by 2050 North America 317,000 Europe 390,000 Asia 4.73 million Latin America 392,000 Africa 4.15 million Oceania 22, > Mortality per 100,000 population Number of deaths The Review on AMR Chaired by Jim O Neill

5 High rates of resistance in some APEC economies Prevalence % ESBL producing E.Coli Extreme high rates of ESBLs in AP (up to 70%) PACTS Pseudomonas AP data

6 Meeting the Challenge of AMR Speed up antimicrobial discovery and development New research and targets Novel vaccines, antibiotics, and alternatives Diagnostics Slow down the emergence of resistance Coordinated global effort - Infection prevention - Diagnosis and surveillance - Antimicrobial stewardship - Prevent transmission OneHealth + Ecological approach 5

7 Global attention to AMR can drive important policy change Asia Pacific One Health Initiative on AMR (Tokyo Communique, April 2016)

8 Multi-stakeholder efforts will be needed to deliver on the challenges outlined in the WHO Global Action Plan on AMR IMPROVE AWARENESS AND UNDERSTANDING OF AMR STRENGTHEN SURVEILLANCE AND RESEARCH REDUCE THE INCIDENCE OF INFECTIONS OPTIMIZE USE OF ANTIMICROBIAL AGENTS ENSURE SUSTAINABLE INVESTMENT

9 Industry is engaged on AMR and is recognized as a key partner Davos Declaration (January 2016) over 100 companies and associations committed to: Increase investment in R&D Reduce resistance through appropriate stewardship Improve access to antibiotics and vaccines Called on governments to create a sustainable and predictable market Roadmap on Progress on Combatting AMR (September 2016) 13 leading companies committed to : Reduce the environmental impact from the production of antibiotics Help ensure antibiotics are only used by those who need them Improve access to antibiotics globally Explore new opportunities for collaborations between the industry and public sector 8

10 Decreased Activity in Antibiotic R&D Active Corporate Antimicrobial Programs 9 Adapted from: Kinch MS et al. Drug Discov Today 2014; 19(9):1283-7

11 Antibiotic development presents significant challenges SCIENTIFIC Bacteria are resilient and constantly evolving Narrow therapeutic window DEVELOPMENT & REGULATORY Complex regulatory pathways Non-inferiority clinical trials ECONOMIC Limited returns relative to other therapeutic areas

12 Policy changes can facilitate access to effective antibiotics and stimulate R&D R&D: Public-Private Partnerships to address unmet needs BARDA (US) and IMI (EU) Reimbursement: Valuebased reimbursement that reflects societal benefits of novel antibiotics Reimbursement reform in the US France, Germany Novel incentive model pilots in UK and Nordic countries Regulatory: Priority review pathways for novel antibiotics Philippines, Malaysia, Singapore, Vietnam (New Pharma Law) US: 21 st Century Cures Appropriate use: Patientcentered stewardship to optimize treatment Broader use of surveillance data and diagnostics Hospital-based stewardship partnerships

13 The Way Forward Capitalize on the current global momentum to deliver concrete action on AMR for patients Include all key stakeholders governments, industry, civil society and others in domestic action to combat AMR Explore opportunities to facilitate access to effective antibiotics and ensure continued investment in antibiotic R&D: public/private partnerships, priority regulatory pathways, value-based reimbursement, appropriate use 12