Quality of Reproductive Health Medicines programme

Since 2005, members of the Reproductive Health Supplies Coalition (RHSC), which includes major procurers for international programmes; public and private donors, governmental representatives, manufacturers and technical agencies, have been actively seeking to identify manufacturers of reproductive health medicines to provide products that meet international quality assurance criteria to national programmes worldwide. In October 2006, WHO launched its Prequalification Programme for Essential Reproductive Health Medicines. In the same month members of RHSC 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”

Although few products had been prequalified, in 2010 in Kampala the membership of RHSC reassessed the issue of quality, reaffirmed its commitment to the Bonn 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 (ERP) more robust interim, time-bound mechanisms for 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

Starting in August 2011, the UK Department for International Development (DFID) funded the (RHSC) to undertake a major programme intervention entitled “Quality of Reproductive Health Medicines” (QuRHM). This programme is being managed by Concept Foundation, which is directly undertaking the technical support activities to manufacturers to submit dossiers to WHO/PQP as required under output 1; and is working with partners, particularly with UNFPA and WHO, to achieve the outcomes required under outputs 2-4. The outputs of and indicators for the programme, to be achieved by 31 March 2014, are:

Output 1		Substantially increase the availability of affordable, quality assured RH medicines for supply to less developed countries. Indicator - A total of 34 products (including 26 new products) are prequalified under the WHO prequalification scheme for RH medicines and support is continuing to be provided to a further 21 products with the aim of getting product dossiers accepted by WHO. In addition, 11 APIs will be prequalified and support is continuing to be provided to a further 7.
Output 2		Harmonize policies and practices among the international procurement organizations being members of the RHSC. Indicator - UNFPA and up to 6 procurement organizations (including social marketing organizations), which are members of RHSC, agree and adopt common policies and practices for purchasing essential RH medicines.
Output 3		Adopt internationally accepted policies and practices in selected countries having significant generic penetration, including strengthening national procurement and regulatory criteria and capacities in collaboration with UNFPA and WHO. Indicator - Situation analyses completed and Ministries of Health or other entities responsible for procurement of RH medicines adopted internationally accepted criteria into their purchasing practices and tenders for essential RH medicines, in at least four countries.
Output 4		Raise awareness of the QuRHM programme and related quality issues among donors and other high-level stakeholders within the RHSC membership. Indicator - Donors and other RHSC high level stakeholders have an increased awareness of the issues around quality assurance, the potential impact on RH commodity security and are able to utilize the knowledge gained for consideration in grant-making and strategic planning mechanisms and decisions.