QUALITY REPRODUCTIVE HEALTH SUPPLIES Dr Hans V. Hogerzeil Director Essential Medicines & Pharmaceutical Policies

2 Part 1:Overview of the WHO / UN Prequalification Programme

3 Prequalification objectives  Produce list of prequalified products (for priority therapeutic areas), and of manufacturing sites, that meet international norms and standards for quality, efficacy and safety  Produce list of PQed medicine control laboratories that meet international norms and standards for quality, efficacy and safety  Ensure re-evaluation and maintenance of the list of PQed medicines, including assessment of variations and changes  Help national drug regulatory authorities build capacity in assessment, inspection and control  Develop local capacity in manufacturing production and clinical studies by offering customized technical assistance

4 Recent developments In addition to PQ of 241 medicines and 14 QCLs to date:  concept of medicines quality better and more widely understood by countries, partner agencies and manufacturers  increased access to quality-assured priority medicines products; more supplier security, more price competition  more rapid development of some quality products through provision of standards, technical assistance and training  faster regulatory approval of some products e.g. by making info about PQed products and evaluation/ inspection outcomes publicly available  monitoring and evaluation of the quality of medicines circulating on the market: large difference between PQ-ed and non-PQed

5 Products prequalified PQed 2010 to date: - 3 HIV/AIDS - 2 TB

6 Products prequalified, by therapeutic category

7 Number of inspections 2005 – 2009

8 Number of dossiers assessed 2007 – 2009

9 Training & capacity building 2007 – 2010

10 Technical assistance to manufacturers, CROs and QCLs by year 2006 – 2010 and WHO region

11 Quality control laboratories: Prequalified or interested in becoming prequalified Prequalified QCLs in:  Algeria  Canada  France  India  Kenya  Morocco  Singapore  South Africa  Ukraine  Vietnam

12 New directions  Survey of manufacturers of prequalified products: use the results to improve PQP services  Targeted outreach to potential new manufacturer applicants  Focus on improving quality of active pharmaceutical ingredients  Joint dossier assessments (between countries)  Assess value to manufacturers of WHO prequalification  Assess benefits to partners of WHO prequalification

13 Challenges  Increasing number of variations  Reducing timelines to prequalification  Funding for PQ of RH products ends on 31 May 2010  Procurement practices by agencies do not always follow and support WHO/UN prequalification  Lack of harmonized regulatory standards in countries; national authorities don't effectively use PQP's information for registration

14 Part 2:PQP's experience of prequalifying reproductive health products

15 Invitations to manufacturers of RH products to submit expression of interest for product evaluation (EOIs) 1st Invitation - October 2006 Oral and injectable hormonal contraceptives 2nd Invitation - December 2007 Prevention and treatment of post-partum haemorrhage and ecclampsia 3rd Invitation - May 2008 Extended to injectable hormonal contraceptives and oxytocics, implant 4th Invitation - July 2009 Extended to oral, injectable and implantable hormonal contraceptives 5th Invitation - May 2010 Deletion of lynestrenol, better specification for oxytocin and mifepristone

16 37 RH product dossiers submitted to PQP to date

17 RH medicines submitted, by country

18 Submissions by R&D and 'generic' companies

19 Reasons for rejections and cancellations Multisource Data in dossier do not demonstrate product quality - API or FPP data Bioequivalence is not demonstrated GMP standard is not acceptable (premises, QA) Common denominator: lack of experience, lack of technical skills and lack of co-operation R&D companies Product is not invited for prequalification Product is not identical as approved by stringent authority Product assessment is not documented by stringent authority

20 Workshops focused on therapeutic groups 2006 – 10

21 Benefits for manufacturers of participating in prequalification  Potential for increased financial profit  by meeting requirement of procurers and sponsors  participation in global market and international tenders  Enhanced reputation  Access to technical support – opportunity to save resources and to increase competitiveness  Facilitation of national registration in recipient countries and in "regulated" markets  PQP levies no charges for services

22 Manufacturers' reasons for not participating in PQP  The need to make human and financial investments  A lack of technical and regulatory skills  Not yet ready to participate globally  Differences between PQP and national regulatory requirements  Varying requirements and standards of procurers  Risk of losing traditional markets once defined as sub- standard !

23 How can we promote prequalification and quality among RH manufacturers?  Increases understanding of RH quality issues among procurers and international donors  Procurement agencies stop buying poor-quality RH products:  develop joint QA policy, harmonize requirements  make manufacturers aware of joint QA policy  publicly set target date for implementation of QA policy (i.e. deadline for suppliers to meet new QA requirements)  PQP analyses barriers to investing in improving quality and defines incentives for encouraging such investment  PQP secures donor funding for providing enhanced support to RH manufacturers aimed at prequalification !

24 Recommended actions for improving quality procurement Invest sufficient financial and human resources into quality assurance –Quality assurance costs % of procurement value –Procurement organizations are legally liable for the quality of the products Develop and publish an agency quality assurance policy –Define and confirm agency's long-term commitment and plan of action –Serves to inform consumers / recipients –Good example: the quality policy of the Global Fund (2009) Promote and use the WHO/UN Prequalification Programme –Inform and set deadline to manufacturers Make specific arrangements for the (temporary and exceptional) procurement of items neither prequalified or approved by SRA –WHO Expert Panel Review for risk-based advice on alternative suppliers Offer specific quality procurement training to key staff Hold meeting with WHO to discuss draft plan, define concrete steps