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The Quality of Reproductive Health Medicines Programme (QuRHM) was initiated in Addis Ababa in June 2011 by Lester Chinery to promote quality assurance. The program focuses on harmonized procurement, WHO's PQ program, and advocacy efforts to ensure access to quality-assured supplies. Stakeholders like manufacturers, international and national procurers, donors, and regulatory bodies support QuRHM's unique approach with distinct components. The program aims to raise manufacturing standards, reduce costs, and increase availability of essential reproductive health medicines globally.
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Quality of Reproductive Health Medicines Programme (QuRHM)An MDA/SSWG Initiative Addis Ababa, June 2011 Lester Chinery
QuRHM background • In 2006 Coalition members committed in principle to procure products that are either; prequalified by WHO or approved by a stringent regulatory drug agency - the so called Bonn consensus • In Kampala 2010, the membership reaffirmed this consensus and agreed to: • Move towards a harmonized procurement and quality assurance strategy • Support WHO’s PQ programme through: advocacy; building capacity of manufacturers; quality testing; defining mechanisms to incentivize suppliers; mobilizing necessary resources • Develop interim mechanisms to meet immediate demand while aiming towards achieving overall PQ vision, such as: expert review panel; harmonized approaches to assessing manufacturers • Gaining understanding of, and cooperation on, related agendas, such as: national registration and harmonisation of regulatory requirements; and other influences impacting on RH medicines quality
Development of QuRHM • Stakeholder meeting – Geneva – WHO, GFATM, UNFPA, Concept & RHSC Secretariat, July 10 • Strategy development – Aug-Oct 10 • Consultative meetings – Concept/UNFPA/WHO/RHSC Secretariat, Jan-Apr 11 • Briefing to MDAWG – DC Nov 10 • Draft proposal submitted – Dec 10 • Meetings with donors 2010/11 – DfID, BMGF • Development of business case and budget 2011 • Final proposal submission 2011
QuRHM approach • A quality assurance programme facilitated through the RHSC – a cross-cutting undertaking by MDA/SS Working Groups • Working with manufacturers and more! • Four distinct, but interrelated components: • Generic manufacturers/WHO PQP • International procurement • Country procurement and regulation • Advocacy/communication • Main implementing partners – Concept, UNFPA-PSB and WHO-PQP • Supported by a specially convened Advisory Committee
Output 1 – lead Concept Foundation • Expansion of technical team • Meetings with candidate FPP and API manufacturers • Development/revision of assessment tools and approach • Detailed planning for 1st year on-site assessments and TA • Consultations with key actors • Establishment of 20 NDAs – manufacturers and RH partners • Coordination of activities with WHO-PQP and scope of formal Collaborative Agreement
Output 2 – lead UNFPA • Development of new procurement policy based upon GFATM • Analysis of interim approach framework • Briefings to customers and suppliers • Meetings with WHO-PQP
Output 3 – lead UNFPA/WHO • To commence (year 1) with: • Selection of pilot countries (4) • Design of market studies • Detailed planning of country approach • Combine with WHO “Building the Business Case for PQ”
Output 4 • 1st year activities agreed – international • National-year 2, to be determined
Purpose? • What is the purpose or overall objective of the programme? • Ensuring access to quality assured supplies through raising manufacturing standards and harmonization • Reducing costs of key essential RH medicines? and/or • Enabling higher volumes of product by key procurement agencies? • Enabling higher volumes of product at country level?
Thank - you Lester Chinery
