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

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