June 2011 Lester 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

Objectives1. 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 25-30 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 10-12 who should be able to comply with WHO requirements within a shorter timeframe of 1-3 years

June 2011

Company segmentationCategory Description

A1 currently engaged with PQP

Supplying to national markets, some tenders, wish to increase exports interested in PQSome require TA

A2 Experience of PQP

Require TA

A3 Not yet applied

Require TA

B Supplying to national and/or regional markets, not interested in PQ

C Intend supplying to USA and/or other regulated markets

D Not currently capable and/or willing to raise standards

June 2011

Categories Company Country Comments

Category ASupplying to national markets, some tenders, wish to increase

exports interested in PQ

A1 Currently engaged with WHO 1 Note a) AQAS study – phase 1/2/3

2 AQAS study, no response

3

4

5 AQAS study – tech support

6 AQAS study, no response

A2 Experience of WHO-PQP 7 China AQAS study - unprepared

8 Indonesia AQAS study, no response

9 India AQAS study – phase 1 & 2

10 Indonesia AQAS study, no response

11 Indonesia AQAS study, no response

12 Indonesia AQAS study – phase 1 & 2

A3 Not yet applied 13 Thailand AQAS study – phase 1/2/3

14 Thailand AQAS study – phase 1/2/3

15 India AQAS study - unprepared

16 China AQAS study – phase 1/2/3

17 Bangladesh AQAS study – phase 1/2/3

18 Mexico

June 2011

Category B Supplying to national and/or regional markets, not interested in PQ

19 Brazil AQAS study, no response

20 Brazil

21 Brazil AQAS study, no response

22 Chile AQAS study, no response

23 Uruguay

Category C Intend supplying to USA and/or other regulated markets

24 South Africa AQAS declined

25 Oman AQAS deadline expired

26 India AQAS 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

Objectives3. 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 25-30 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 10-12 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 30-50 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 2011 Lester Chinery

Thank - you