Ensuring Access to Quality Reproductive Health Medicines [particularly generic products]

1. 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

2. 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 Ensuring Access to Quality RH medicines: DC meeting issues

3. 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 Ensuring Access to Quality RH medicines: setting the scene

4. 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? Ensuring Access to Quality RH medicines: stakeholder groups

5. 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 Ensuring Access to Quality RH medicines: Quality issues

6. 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? Ensuring Access to Quality RH medicines: Regulatory issues

7. 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… Ensuring Access to Quality RH medicines: business rationale

8. 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 Ensuring Access to Quality RHmedicines: key DC recommendations

9. 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 Ensuring Access to Quality RH meds: Risk Assessment and Management

10. 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 Ensuring Access to Quality RH meds: Sub-group to address concerns

11. 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] Ensuring Access to Quality RH medicines: Registration Issues

12. 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] Ensuring Access to Quality RH medicines: : TA to help PQ

13. 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 [10 2006] Underline that quality is about safety and efficacy and cannot—in good faith—be equated with protectionism Acknowledge that quality costs – and budget accordingly Assuring Access to Quality Hormonal Contraceptives: conclusions

14. 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. Quality medicines for RH

15. 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. Quality medicines for RH

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