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Access, Quality and Pricing:
Innovation Challenges in
Low and Middle Income Countries
Muhammad H. Zaman
Departments of Biomedical Engineering and International Health
Howard Hughes Medical Institute
Boston University
June 14, 2018
1
INNOCENT
MOTHERS AND
CHILDREN DIE
EVERYDAY
Counterfeit and Substandard Medicines:
A Global Challenge
• Poor quality medicines make up
30 – 50% of drug sales worldwide
• Causes > 250,000 preventable deaths annually
• Poor quality medicines account for US$ 75
billion of US$ 962 billion global
pharmaceutical market
• Poor quality medicines contribute to drug-
resistant infection and disease
• Artemisinin resistant malaria on Thailand-Cambodia
border
4
Existing Field Solutions
GPHF MiniLab®
Field Standard
Spectrometers FDA CD3/4
• Chemical Analysis (TLC)
• Inexpensive
• Bulky (200 lbs) & labor intensive
• Qualitative results
• Chemical fingerprinting
• Non-destructive
• Semi-quantitative
• High batch variability
• Packaging Analysis
• Non-destructive
• Not analytical
• Counterfeit-oriented
5
PharmaChk: The Device
Accurately and affordably test the
quality of medicines in the field
through the quantification of active
pharmaceutical ingredient and
analysis of dissolution properties
Current Prototype: Test antimalarials and
antibitoics
6
PharmaChk
• Portable platform
• Optical quantification
• Specific chemistry
• No sample preparation
7Desai and Zaman, 2015 (Anal. Methods)
The Access-Quality-Pricing
Nexus
(Pakistan case study)
• The foundations of Drug
Regulatory Authority of Pakistan
• Current focus on pricing and not
access
• Impact on discovery, innovation
and manufacturing
• The tension between quality
and pricing
29 November 2018 8
Open Questions at Access-Quality-Pricing Nexus
• Innovation and the future of local manufacturing
• API versus finished product imports; biologics manufacture
• The tension between quality and pricing: perception and reality
• Quality as a metric of UHC
• Innovation and the road to UHC
29 November 2018 9

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Muhammad Zaman, "Access, Quality, and Pricing: Low and Middle Income Countries"

  • 1. Access, Quality and Pricing: Innovation Challenges in Low and Middle Income Countries Muhammad H. Zaman Departments of Biomedical Engineering and International Health Howard Hughes Medical Institute Boston University June 14, 2018 1
  • 3.
  • 4. Counterfeit and Substandard Medicines: A Global Challenge • Poor quality medicines make up 30 – 50% of drug sales worldwide • Causes > 250,000 preventable deaths annually • Poor quality medicines account for US$ 75 billion of US$ 962 billion global pharmaceutical market • Poor quality medicines contribute to drug- resistant infection and disease • Artemisinin resistant malaria on Thailand-Cambodia border 4
  • 5. Existing Field Solutions GPHF MiniLab® Field Standard Spectrometers FDA CD3/4 • Chemical Analysis (TLC) • Inexpensive • Bulky (200 lbs) & labor intensive • Qualitative results • Chemical fingerprinting • Non-destructive • Semi-quantitative • High batch variability • Packaging Analysis • Non-destructive • Not analytical • Counterfeit-oriented 5
  • 6. PharmaChk: The Device Accurately and affordably test the quality of medicines in the field through the quantification of active pharmaceutical ingredient and analysis of dissolution properties Current Prototype: Test antimalarials and antibitoics 6
  • 7. PharmaChk • Portable platform • Optical quantification • Specific chemistry • No sample preparation 7Desai and Zaman, 2015 (Anal. Methods)
  • 8. The Access-Quality-Pricing Nexus (Pakistan case study) • The foundations of Drug Regulatory Authority of Pakistan • Current focus on pricing and not access • Impact on discovery, innovation and manufacturing • The tension between quality and pricing 29 November 2018 8
  • 9. Open Questions at Access-Quality-Pricing Nexus • Innovation and the future of local manufacturing • API versus finished product imports; biologics manufacture • The tension between quality and pricing: perception and reality • Quality as a metric of UHC • Innovation and the road to UHC 29 November 2018 9

Editor's Notes

  1. Rethink strategy  new approaches;