Pharmacovigilance BMGF Perspective. Raj Long Bill & Melinda Gates Foundation

Transcription

1 Pharmacovigilance BMGF Perspective Raj Long Bill & Melinda Gates Foundation

2 Overview 1. Key challenges -Recap Safety Surveillance Working Group (2012/2013) 2. Overall BMGF strategy and approach 3. Key priorities/areas of work for the foundation moving forward 2

3 SAFETY SURVEILLANCE WORKING GROUP 3

4 WHERE TO INVEST: RISK-BASED ASSESSMENT Given pressing needs and limited resources, investments need to be prioritized and coordinated Geographic distribution of product launches, assessed by relative risk ( ) Moldova (1) Georgia (2) Armenia (2) Risk-based assessment 1.Anticipated product pipeline 2.Anticipated or potential postmarket safety risk 3.PV capacity in launch countries 4.Timing of launch Honduras (1) Kiribati (1) (not to scale) Puerto Rico (1) Cape Verde (1) (not to scale) Sao Tome & Principe (2) (not to scale) Senegal (4) The Gambia (6) Guinea-Bissau (3) Guinea (2) Sierra Leone (4) Liberia (2) Burkina Faso (4) Ghana (2) Equatorial Guinea (1) Gabon (1) Congo Rep. (3) Lesotho (2) Seychelles (1) (not to scale) Comoros (3) (not to scale) Yemen (1) Togo (4) Benin (4) Rwanda (5) Burundi (5) Eritrea (3) Djibouti (2) Malawi (4) Reunion (1) Mauritius (1) Sri Lanka (2) Kyrgyzstan (2) Tajikistan (3) Bhutan (3) Bangladesh (5) Laos (2) Cambodia (5) Viet Nam (3) Malaysia (1) Philippines (3) East Timor (3) Solomon Islands (2) Low risk Medium risk High risk

5 PHARMACOVIGILANCE LANDSCAPE IN LMICS Overview of PV landscape in LMICs Limited Safety Reporting from LMICs Main strengths Most LMICs with established national PV center for data collection and upload to WHO Safety Database Strong willingness to improve PV systems AEFI 1 reports by 10,000 births Main challenges / limitations A. Limited reporting: Spontaneous reporting methodology used in developed countries not helpful / appropriate in LMICs B. Low local capacity / capability to analyze data collected C. Low NRA capacity / capability to take action from alert signals received: (3 in 55 NRAs per 2008 survey by WHO took action). 10 Eastern Mediterr. 5 Western Pacific Europe Americas SE Asia Millions of Safety Reports in WHO database (VigiBase ( VigiBase) LMICs HICs Africa AEFI Adverse Events Following Immunization SOURCE: Safety Surveillance Working Group report, WHO, Uppsala Monitoring Centre 2012 Bill & Melinda Gates Foundation 5

6 EVOLVING PRODUCT LANDSCAPE INCREASES URGENCY IN ADDRESSING EXISTING PV CHALLENGES Evolving product landscape New vaccines, drugs, and diagnostics specifically developed for LMICs LMICs no longer able to rely onpostmarket safety surveillance from HIC economies as not launched there Implications/Risks Product Risk Limits therapeutic efficacy Licensure withdrawal Systemic Risk to Public Health Products, undermining patient confidence / trust Delayed access to market ( e.g.rmp 1 ) Reputational/Ethical Risk Patient Risk 1 RMP -Risk Management Plan 6

7 CONCEPT OF AN END TO END SAFETY SURVEILLANCE SYSTEM Action? Data review Data review Data review Patient w/ Adverse Event Push Investigator / health care worker AE Report Push Local / national database Push Pull Regional Database Pull Global Database Pull Development Safety Baseline Database Stakeholders National Regulatory Authorities Health Care System Sponsor / Manufacturer National PV Collaborating Centers Regional Centers (e.g. WHO, African RECs) Final Facility (WHO CC UMC) Main challenges A. Limited reporting B. Limited local analysis C. Limited action on signals impacting patients 7

8 KEY CONCEPTS of the PROPOSED APPROACH Vision Proposed Principles Lookouts Timely & Adequate Reporting Review, & Meanigful Action Safeguard Patients who receive Priority Global Health Products Adopt a stepwise approach with initial pilots. New medicine (NCE) New vaccine Develop holistic plan (established guiding principles, infrastructure & resources) Collaborate with existing resource WHO, WHO CCs, NPV centers, Regions/NRAs and other Parties (leverage existing infrastructure) Support the development of an integrated strategy to engage key interested stakeholders Grant to WHO(Sept 2016) -advocate for other partnerships Increase Transparency Avoid Duplication in activities/reso urces All levels of engagement Coordinated Platform is Crtical 3S Smart Safety Surveillance 8

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10 Thank you Bill & Melinda Gates Foundation 10