UNFPA Brussels Office March 2010 Ensuring Access to Quality Reproductive Health Medicines [particularly generic products] Reproductive Health Supplies Coalition Benedict Light, Senior Technical Adviser, UNFPA Brussels Kampala, Uganda, 26 May 2010

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: DC meeting issues Consensus on scarce supply of quality HC products and need to promote WHO PQ; Recommendations for RHSC discussion Market issues: limited products; lack of supplies interest in meeting PQ; Risk that PQ supplier might leave market Supplier issues: lack of info re quality; need to prescreen [AQAS] Phased risk management strategy needed to: assess non-PQ products; incentivise PQ & maintain standards; determine product quality [GMP, API]; test product procured by partners

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: setting the scene Hormonal Contraceptives: OCs, EC, Implants, Injectables Hormonal LS-MH medicines: Oxytocin, Magnesium Sulphate, Availability OR Quality to Availability AND Quality “Quality” : SRA approved or WHO pre-qualified Without “quality” no guarantee of safety and efficacy RHSC Bonn Consensus, October 2006 – principle of procuring only SRA approved or WHO pre-qualified products

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: stakeholder groups Procurers – critical; everyday problem; quality & availability Donors – crucial facilitator of moves to PQ; quality costs WHO – normative body; slow progress to HC PQ [learn from other PQ schemes?]; Can RHSC assist? National Drug Regulatory Authorities – Collaborating to encourage improved national standards; Which ones? Testing laboratories – key role to raise, maintain standards Manufacturers – What has to change for PQ to work for them?

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: Quality issues Assuring quality Quality/Safety and Efficacy Demonstrating Quality: GMP / API / BE GMP – Good Manufacturing Practice API – Active Pharmaceutical Ingredient BE – Bioequivalence Strengthen/systematise QA mechanisms and procedures to mitigate risks of non-PQ products – and move to PQ

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: Regulatory issues Strengthen/systematise QA mechanisms and procedures Need to show acceptable quality now – build incentives to move toward better quality and PQ Procurers – build good practices into procedures [QA, scope to harmonise]; improve coordination; testing info with NDRAs NDRAs – key issue is product registration at national level Scope to link PQ to fast tracked in-country registration? Select NDRAs [which?] and develop strategy?

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: business rationale Issues relating to motivation of generic producers to raise standards AQAS initiative [and earlier work] scoping out market size, potential, etc. in order to incentivise producers Also found that for generic producers there are issues of: lack of management support; problems with quality issues [GMP, API; BE]; [mis-]understanding of PQ process So is PQ worth it for generic HC manufacturers? Big investment of time & money – with no guarantees. Already have a reasonable market [national, international at lower standards]? Also, with PQ’s higher costs, might lose existing markets…

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: key DC recommendations Mindful of the quality, regulatory and economic issues outlined above, as a result of the DC meeting, a number of action points are recommended with regard to: Risk Management when buying non-certified products Product Registration Issues TA to continue to build economic rationale for PQ

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH meds: Risk Assessment and Management To assist risk management of procurers, one interim mechanism is to create an Expert Review Panel to promote—and transition to— PQ, [note GFATM example] ERP would sanction 12-month temporary approval ERP mechanism would incentivise PQ – though risks would be higher than with PQ products THIS IS NOT AN ALTERNATIVE TO PREQUALIFICATION, IT IS A TIME-LIMITED ACTIVITY TO MEET IMMEDIATE DEMAND

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH meds: Sub-group to address concerns Create Quality of RH Medicines sub-committee of the MDA WG, to ensure procurers’ concerns addressed. Use the sub-group to consider, for example: Joint demand planning to help incentivise moves to prequalification; Development of LTAs with unit price premiums and orders spread among a range of suppliers to nurture market Ideal opportunity to promote and use AccessRH

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: Registration Issues DC meeting participants felt that efforts could be made to: Encourage acceptance of SRA/WHO PQ as way to meet national registration requirements: For PQ products, registration process could be waived or fast-tracked by the NDRA. Work with countries/regions on reciprocity agreements: encourage countries to develop regional joint product registration; work with groups harmonising drug lists – to harmonise or do joint registration Gather Information: Comparative study on registration [to include requirements for registration in donated commodities/or non commercial products]

UNFPA Brussels Office March 2010 Ensuring Access to Quality RH medicines: : TA to help PQ Use existing initiatives such as AQAS and, as necessary, develop new Technical Assistance mechanisms to: Provide TA to selected manufacturers to aid moves to PQ. Determine share of public procurement in the total OC market; Advocate for PQ to suppliers and list suitable producers for ERP; List HC producers close to PQ standards, not in public markets; Identify candidates, time, and cost to prequalify [to help producers become WHO PQ and attract suitable suppliers to the public market]

UNFPA Brussels Office March 2010 Assuring Access to Quality Hormonal Contraceptives: conclusions Moving to a situation of consistent availability of hormonal contraceptives with assured quality takes time Much real progress has been made in this area in recent years but efforts must be redoubled – success will depend on different stakeholder groups working together The RHSC—particularly the donors—needs to: Recommit to the RHSC’s Bonn Consensus on quality [ ] Underline that quality is about safety and efficacy and cannot—in good faith—be equated with protectionism Acknowledge that quality costs – and budget accordingly

UNFPA Brussels Office March 2010 Quality medicines for RH Commitment of Coalition members to procure products of internationally accepted quality standards by: Reaffirming the consensus reached at Bonn 2006 meeting that products procured should be either be prequalified by WHO or approved by a stringent regulatory drug agency. Moving towards a harmonized procurement and quality assurance strategy.

UNFPA Brussels Office March 2010 Quality medicines for RH Moving forward requires: Support of WHO’s PQ programme through: advocacy; building capacity of manufacturers; ensuring quality testing; defining mechanisms to incentivize suppliers; ensuring necessary resources. Interim mechanisms to meet immediate demand while aiming towards achieving overall PQ vision, such as: an expert review panel; harmonized approaches to assessing manufacturers. Understanding of, and cooperation on, related agendas, such as: National registration and harmonisation of regulatory requirements; and other external activities impacting on quality RH medicines.

UNFPA Brussels Office March 2010 Quality medicines for RH Immediate action: -Develop a Framework Strategy to include an activity plan and resources required, for completion by 31 July Undertaken by a Quality Medicines for RH sub- committee of MDAWG, using existing resources, as agreed by the MDA and SS Working Groups.