Market impact of WHO selection

and prequalification of priority medicines

Hans V. Hogerzeil, MD, PhD, FRCP Edin

Director, Essential Medicines and Pharmaceutical PoliciesWorld Health Organization, Geneva

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Second dimension of the concept of essential medicines:

WHO's list of not-existing essential medicines

No data Off-label use of adult medicines, for children No dosage data on children's FDCs, e.g. tuberculosis No efficacy/safety data, e.g. on new ATCs, children's formulations

No products No children's formulations, e.g. FDCs for HIV/AIDS, malaria No heat-stable insulin, oxytocin for tropical countries No new TB medicines in the last 30 years, few new antibiotics No new medicines for other neglected diseases March 2009: WHO Expert Committee accepts a proposed list

of missing FDCs for second-line ARV treatment

Patent pool !

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Why is WHO / UN Prequalification needed?Basically, because there are large budgets for medicines, inconsistent quality policies, and:

Tuberculosis: 10 DOTS products in various TB programs (2001) 6/10 products contain rifampicin that it is not resorbed in body

Repr.Health: 44 companies in 13 LIC/MIC screened (2008) All companies comply with national GMP standards; but only <30%

meet global GMP requirements of WHO, PIC/S, SRA; 20% could comply in future with quality investment and improvements; 50% would take years to comply (if at all)

Malaria: Recent quality survey in six African countries (2009) 73/184 (39·7%) samples of non-WHO prequalified antimalarials fail

quality testing, compared with only 3/83 (3·6%) of WHO-prequalified antimalarials

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WHO selection and prequalification guide innovation and speed up regulatory approval in countries

2002: WHO Model List of Essential Medicines (EML) linked to evidence-based WHO clinical guidelines. Renewed EML process defines standards for evidence on efficacy and safety

2003: WHO prequalification defines standards for quality

2006: WHO identifies missing essential medicines for children and missing paediatric formulations (e.g. ARVs); in 2009 WHO defines missing ARV/FDCs

Need for future EML listing and prequalification ensures early planning for R&D on clinical evidence, dosage, safety and regulatory requirements (e.g. medicines for malaria, neglected diseases, medicines for children)

Prequalification speeds up national regulatory approval and serves as basis for subregional harmonization (e.g. EAC)

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Market impact of the Prequalification ProgrammeBrenda Waning et al, Globalization and Health 2010; 6:9

Study based on 12.958 ARV purchase transactions 2002-2008

WHO guidelines of 2003 and 2006 strongly shaped demand 5 ARVs in WHO/2003 constituted 98% of ARVs purchased in 2004-2006 Price of major FDCs reduced from $484 in 2002 to $88 in 2008 (-82%) First generic ARV/FDC was WHO-prequalified in 2003; 8 FDCs by 2006 FDA approved first generic FDC in 2006; only then PEPFAR procured WHO/2007 change 40>30 mg d4T immediately shaped market: 30mg

from 54,000 to 300,000 pyear in 2008; price from $166 to $88/pp/yr Purchase volumes of new 2006-drugs increased 16-20x in 2006-2008

PEPFAR, GFATM and UNITAID cover 85, 88 and 88% of ARVs, FDCs PEPFAR is focusing large volume, 1-3 suppliers at lowest cost GFATM and UNITAID involve 4-5 suppliers, to maintain market diversity 85-90% of ARVs from SRA/PQed sources; rest through ERP

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Market impact of the Prequalification Programme (2)Discussion, recommendations

Markets for older ARVs are mature and efficient; markets for newer ARVs are not (generic competition severely restricted by TRIPS)

Certification programmes (FDA 2003-2006) can delay markets

WHO/2006 guidelines were too diverse; too many combinations created disincentive for the market; was corrected in WHO/2009

In 2002-2008, PEPFAR drove down the cost and GFATM/UNITAID maintained the competition

Large-scale procurement agents may decrease the number of buyers and sellers, making the market less competitive in the long term

Global policies must be developed with consideration of both short term (lowest cost) and long-term (supplier security, maintain competition and future development) impact on market dynamics