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 [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
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
2010.
- Undertaken by a Quality Medicines for RH subcommittee of MDAWG, using existing resources, as
agreed by the MDA and SS Working Groups.
UNFPA Brussels Office
March 2010