June 2011Lester Chinery Accessing Quality Assured Supplies (AQAS) An MDAWG Initiative Addis Ababa, June 2011

June 2011 Project summary The AQAS Initiative was undertaken - December 2009-February 2011 through a grant from the RHSC Innovation Fund The project goal; To identify a group of hormonal contraceptive manufacturers with the capacity and intention to apply for prequalification of products by WHO within two years, and are willing to provide low- cost, products of assured quality to less developed country markets. 27 companies surveyed

June 2011 Objectives 1. To assess the current status and capability of selected hormonal contraceptive manufacturers to achieve prequalification of products by WHO and provide products of assured quality for public and social marketing programmes in less developed countries Outcome-a group of companies exists whom, with support, have the potential to achieve PQ for 1 or more of their products over 1-5 to years. The timeframe for each will depend upon - level of support, investments required, speed of action and perceived value of WHO PQ. Of these, there are who should be able to comply with WHO requirements within a shorter timeframe of 1-3 years

June 2011 Company segmentation CategoryDescription A1 currently engaged with PQP Supplying to national markets, some tenders, wish to increase exports interested in PQ Some require TA A2 Experience of PQP Require TA A3 Not yet applied Require TA BSupplying to national and/or regional markets, not interested in PQ CIntend supplying to USA and/or other regulated markets DNot currently capable and/or willing to raise standards

June 2011 CategoriesCompanyCountryComments Category A Supplying to national markets, some tenders, wish to increase exports interested in PQ A1 Currently engaged with WHO1Note a)AQAS study – phase 1/2/3 2AQAS study, no response 3 4 5AQAS study – tech support 6AQAS study, no response A2 Experience of WHO-PQP7ChinaAQAS study - unprepared 8IndonesiaAQAS study, no response 9IndiaAQAS study – phase 1 & 2 10IndonesiaAQAS study, no response 11IndonesiaAQAS study, no response 12IndonesiaAQAS study – phase 1 & 2 A3 Not yet applied13ThailandAQAS study – phase 1/2/3 14ThailandAQAS study – phase 1/2/3 15IndiaAQAS study - unprepared 16ChinaAQAS study – phase 1/2/3 17BangladeshAQAS study – phase 1/2/3 18Mexico

June 2011 Category BSupplying to national and/or regional markets, not interested in PQ 19BrazilAQAS study, no response 20Brazil 21BrazilAQAS study, no response 22ChileAQAS study, no response 23Uruguay Category CIntend supplying to USA and/or other regulated markets 24South AfricaAQAS declined 25OmanAQAS deadline expired 26IndiaAQAS deadline expired Cat D – not capable

June 2011 Objectives 2. To identify the outstanding process and manufacturing challenges/deficits of each company in relation to CGMP, the additional requirements for bioequivalence, and the provenance/suitability of Active Pharmaceutical Ingredients used. To document the cost and time of remedial/additional actions required Outcome-the project provided in-depth technical support to 12 companies, including on-site assessments and assistance to 6. The current status of these companies is known; the action required identified and costed and forward action plans in place. All of this information has been documented and provided to the individual manufacturers

June 2011 AQAS – technical challenges Main technical challenges Understanding/approach to GMP/quality assurance Quality and provenance of the API/excipients used in finished products Production constraints - batches of 100,000 units or less. Demonstrating appropriate process validation. Bioequivalence – suitable comparators, protocols, number of subjects, relevance of existing studies Identification and use of suitable Clinical Research Organizations (CROs) for bioequivalence that comply with Good Laboratory Practices and Good Clinical Practices (GLP/GCP). In adequate or incomplete stability data/studies Facilities and manufacturing environment for highly potent substances – hormones.

June 2011 Objectives 3. To raise awareness of WHO-PQP among companies, the benefits of participation, through the development of a guide for manufacturers in collaboration with WHO. To inform members of the RHSC of the current challenges in ensuring a continual supply of quality assured products for country programmes Outcome-31 manufacturers were provided with information on the WHO programme and its requirements, 13 received the Frequently Asked Questions document and updates to guidelines and new WHO Technical Report Series alerts 25 copies of the FAQ were distributed at the WHO Prequalification Stakeholders and Manufacturers meeting FAQ document available on PQP website

June 2011 Objectives (3 continued) Direct face to face discussions about the programme was provided to senior managers/owners and technical staff of 11 companies RHSC publication – Medicines for RH, Ensuring Access to Quality Assured Products was developed

June 2011 Objectives (3 continued) RHSC-MDA Working Group meeting - November 2009, Washington DC. RHSC-SS Working Group meeting - December 2009, Copenhagen. RHSC-MDA Working Group meeting - May 2010, Kampala. RHSC – Annual Meeting (as part of the Quality Medicines for RH session) - May 2010, Kampala. International Consortium for Emergency Contraception (ICEC) Annual Meeting - Sept 2010, New York RHSC-MDA Working Group meeting - November 2010, Washington DC UNFPA- PSB staff briefing - January 2011, Copenhagen Various briefing meetings with WHO, BMGF and UK DFID- 2010/11

June 2011 Main findings A group of companies exists whom, with support, have the potential to achieve PQ for 1 or more of their products over 1-5 to years. Of these, there are who should be able to comply with WHO requirements within a shorter timeframe of 1-3 years Some potential “good” candidates have minimal interest in PQ and serving less developed markets Incentivizing manufacturers is a key issue – assisting with understanding market dynamics & achieving an equitable purchasing platform for those who invest Increased harmonization of QA approaches – at international and national levels – incentivize the willing Better communication, clarity and linkages between PQP and those willing to engage/are engaged. Registration at the country level is, and will remain a critical factor

June 2011 Conclusions It is feasible to establish a competitive roster of companies providing quality assured products over next 2-3 years. These products could offer a price advantage over existing QA offerings A critical mass of companies are currently/ prepared to raise standards There is a significant issue re incentivizing manufacturers Some companies do not feel under pressure from customers to increase standards More clarity is required on the PS market-pace, conditions, scope and segmentation for business planning and decision-making Communication/information gap between PQP and industry Bringing new manufacturers through would ideally be a coordinated multi-agency interim strategy

June 2011Lester Chinery Thank - you