Slides

Country Income Groups (World Bank Classification)

  • Country income classification as outlined by the World Bank:

    • Low Income: $1,045 or less

    • Lower Middle Income: $1,046 - $4,125

    • Upper Middle Income: $4,126 - $12,735

    • High Income:

    • Non-OECD: $12,736 or more

    • OECD: $12,736 or more

  • Year of data: 2016

  • Source: The World Bank Group

Importance of Drug Development Despite Challenges

  • Motive Behind Drug Development:

    • The best interests of both public health and the pharmaceutical industry.

  • Globalization Factors:

    • Trade:

    • Clinical Trials: Essential for evidence of drug efficacy and safety.

    • Supply Chain: Critical for the distribution and accessibility of medicines.

    • Health Investments:

    • Global funding is necessary to ensure the quality and safety of medicines.

    • Pre-Market Approval: Processes required to validate the safety and efficacy of drugs prior to market release.

    • Drug Lag: A situation where newly developed drugs take longer to reach certain markets.

    • Post-Market Surveillance: Monitoring drug performance and safety after approval.

    • Regulatory Science: The study and development of regulations governing drug approval processes.

Challenges in Drug Development

  • Challenges highlighted through specific examples:

    • Panama Cold Medicine Incident:

    • Issues regarding supply chain and quality assurance.

    • Clinical Trials in Africa:

    • Focus areas include:

      • Infectious diseases: meningitis, malaria, and HIV/AIDS.

      • Public health concerns impacting drug accessibility and confidence.

  • Global Health Challenges:

    • Drug lag contributes to public health crises, particularly in low- and middle-income countries.

    • Ethical dimensions of drug adherence and the ongoing loss of public confidence in vaccines and medicines.

Regulatory Systems and Challenges

  • Regulatory Gaps Identified by WHO in Africa:

    • Legal Framework: Absence of robust laws governing drug approval and management.

    • Regulatory Standards: Lack of established guidelines for drug safety and quality.

    • Capacity Issues:

    • Insufficient training, recruitment, and retention of regulatory professionals to manage clinical trials effectively.

Causes of Drug Lag

  • Regulatory Barriers that slow drug approval progression:

    • Requirement for Western Approval: Drugs must often meet standards set by Western countries, delaying local adaptations.

    • Need for Local Clinical Trials: Often a requirement before allowing drug sale in local markets.

    • Certificate of Pharmaceutical Product (CPP): A validation document required for foreign drug registrations.

    • Good Manufacturing Practices (GMP): Essential certifications that ensure quality production processes.

    • Pricing Certificates: Documents verifying fair pricing for medications.

    • Document Authentication: The necessity for confirming the legitimacy of manufacturing documents.

    • Harmonization: The effort to align regulatory practices across borders to ease market access.

Counterfeit Medicines

  • Statistics on Counterfeit Drugs:

    • Counterfeit drugs often require chemical analysis for definitive identification.

    • Characteristics of counterfeit drugs may include:

    • Deviations in size, shape, color, and packaging quality.

    • Fake drugs often resemble their genuine counterparts.

    • Prevalence of counterfeit drugs is higher in:

    • Low and Middle-Income Countries: 9% - 41% of medicines sold are counterfeit.

    • High-Income Countries: Less than 1% of sold medicines are counterfeit.

Prequalification of Medicines by WHO

  • Purpose and Significance:

    • Billions of dollars' worth of medicines are procured annually for distribution in resource-limited countries (e.g., by UNICEF, Global Fund).

    • WHO Prequalification of Medicines Programme (PQP): Ensures that medicines meet strict standards of quality, safety, and efficacy since its inception in 2001 focusing initially on HIV, TB, and malaria.

  • Prequalified Medicines List:

    • As of 2012, the WHO list included 316 medicines for priority diseases, guiding international procurement.

    • PQP also evaluates Active Pharmaceutical Ingredients (API) and quality control laboratories.

Prequalification Process Steps

  1. Expression of Interest Invitation:

    • WHO calls on manufacturers to express interest in product evaluation.

    • Inclusion criteria include:

      • Listing on WHO’s Model List of Essential Medicines.

      • Submission of applications for assessment by the WHO Expert Committee.

      • Recommendations from WHO treatment guidelines.

  2. Dossier Submission:

    • Manufacturers provide comprehensive data on:

      • Ingredient purity,

      • Finished product stability,

      • Bioequivalence test results.

  3. Assessment:

    • Teams evaluate data including WHO staff and regulatory experts worldwide.

  4. Inspection:

    • Inspectors verify compliance with WHO Good Manufacturing Practices (GMP).

    • Compliance of Clinical Research Organizations (CROs) with WHO Good Vigilance Practices (GVP) and Good Laboratory Practices (GLP).

  5. Decision Making:

    • Products that meet requirements are added to the WHO prequalified list.

Timelines and Maintenance of Prequalification

  • Timeframe for Prequalification:

    • Can take as little as 3 months; longer if data is incomplete or inadequate.

  • Post-Qualification Maintenance:

    • Continuous monitoring and random quality checks on prequalified products.

    • Evaluations of any variations to specifications or manufacturing processes.

  • Follow-Up Procedures:

    • Regular re-inspections and reporting requirements to ensure ongoing compliance and safety.