Prequalification Programme of Medicines (PQP): Introductory messages EMP TBS, 3 November 2011 Dr Lembit Rägo

Background 2000 - Differences in procurement QA policies mapped Started 2001 in conjunction with the UN general response to HIV/AIDS pandemic Was expanded to other groups of products gradually: TB, malaria, reproductive health, influenza, Zn, diethylcarbamazine Sub-programme for prequalification of QC labs added

Principles Transparency Based on international standards - WHO, ICH and NRAs Close cooperation with NRAs Open to regulators from all countries Capacity building since beginning important component No duplication of efforts Harmonization of requirements and using best practices

PQ of Medicines Programme (PQP): messages WHO’s standing in global healthcare provides the most inclusive and effective regulatory pathway for the needs of developing world PQP is the most trusted source of quality medicines for major international funding/procurement organizations and other parties (NGOs, national procurement, regulators) Global supply capabilities have been strengthened and expanded because of the PQP Independent surveys show that pharmaceutical manufacturers are satisfied with and highly value PQP

PQ of Medicines Programme (PQP) PQP has been very effective “engine” for pulling the quality of Essential Medicines Agenda Promoting quality of Essential Medicines (no poor quality medicines for poor people!) Promoting and facilitating harmonization of quality assurance policies and strategies of funding and/or procurement mechanisms – impact at country level Offering new effective ways of regulatory capacity building (hands-on training, doing it with the countries for countries) and harmonization (level playing field)

PQP: Past and Future PQP has come a long way since its inception but… …the global health arena is changing fast…and… …significant challenges remain To be more responsive and accountable to stakeholders, PQP Holds meetings with manufacturers and enabling partners manages External Review Panel (ERP) process, working on risk-based approach for EM, prequalification of selected APIs Provides technical assistance based on the input from stakeholders PQ conducted a series of internal and external evaluations and research to: …become more efficient and effective e.g. targeting, IT trace and track solutions …develop new models of service to stakeholders, and …continue to advocate and build upon our position of quality medicines for all

NRA capacity building* Part of the programme from the very beginning Unique rotational post for developing country regulators 2010 – 76 countries represented in WS (always sub-regional, regional or interregional) – regulators and manufacturers Each assessment session – average 15 assessors from developing countries Inspection – host country inspectors always invited, inspectors from recipient countries also involved 22 prequalified QC laboratories covering all 6 WHO regions, +33 in different stages Joint assessment with EAC countries * This is integral part of many WHO at activities at HQ, regional and country level. Other medicines programmes are also involved.

Funding: past, present and future Past funding – Canada, France, Germany, Ireland, Norway Breakthrough – BMGF grant in 2006 Present and future Most significant – UNITAID BMGF for RH products Cost sharing/recovery Support from GF, co-financing Charging for service built into procedures Internal issues

Existing benefits for future development As the world’s convener of medical and technical capabilities and moderator of major issues and stakeholder positions, WHO can give more people greater access to quality medicines The programme has a solid technical foundation with a strong record of accomplishment Of all “regulatory pathways” PQP has the greatest upside potential of meeting the challenges of access to quality Essential Medicines