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Access to ART in a context of increasing patent protection:. an analysis of ARV drug price evolution and determinants in Brazil C Meiners , L Sagaon - Teyssier , F Orsi , R Lopes, MP Carrieri , B Spire, L Hasenclever , JP Moatti AIDS 2010 Vienna. Presentation outline.
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Access to ART in a context of increasing patent protection: an analysis of ARV drugpriceevolution and determinants in Brazil C Meiners, L Sagaon-Teyssier, F Orsi, R Lopes, MP Carrieri, B Spire, L Hasenclever, JP Moatti AIDS 2010 Vienna
Presentation outline • Context • Issues and objectives • Data and methods • Results • Case analysis • Main conclusions
Context HIV/AIDS & HAART in Brazil • PLWHA : 730 th (UNAIDS, 2008) • Prevalence: 0.61% since 2004 • Treatment coverage: almost 200 th patients • Free and universal access to HAART • Decentralized and individualized care • 2009: 19 ARVs and 1 FDC (32 formulations)
Context ARV market structure • Demand-side: monopsony (MoH) • Supply-side: patented and off-patent drugs • Branded segment - 9 proprietor/licensed MNCs - 13 ARVs • Non-branded segment - Local production (6 gov & 1 priv lab) - 8 ARVs and one FDC (AZT+3TC)
Issues and objectives • Local production + assertive pricenegotiations »»access to state-of –the-art HAART in Brazil • ↑drugresistance + toxicity »»↑ adoption of patenteddrugs • Objectives: • Study ARV priceevolution • Identify main price determinants
Data and methods • Object: adult ARV transactions (2009 USD) • Analysedperiod: 1996 - 2009 • Data: transaction, drug and marketcharacteristics • Source: Dept of STD, AIDS and VH, MoH • Descriptive analysis: QYD and PYD evolution • Regression analyses: pricedeterminants (log PYD) • Variables: therapeutic class, log QYD, drug age, patent status, transaction year, patient weight
Results Coverage and mean expenditure 5 100 1 350 N=607
Results PYD according to supply type ↓52% 2 000
Results ARV supply share (QYD) N=491 55% 20%
Results Expenditure share (2009 USD) N=491 80% 80% 68%
Results N=491 ^ ^ ^ * Significantat 10%; ** Significantat 5%; ***Significantat 1%
Case analysis I. 1st-line NRTI PYD evolution 927 313 95
Case analysis II. Compulsory license of EFV 1 163 ↓74%
Main conclusions • ARV price decrease has been mainly pushed by non-branded drug competition; • Falling price trend came to a halt after 2004; • Patent protection, due to its effect on prices, constitutes an important obstacle to the access to new generation ARVs; • Increasing ARV costs help impose a double standard of HIV care in the world; • TRIPS flexibilities may provide an important means for decreasing costs, yet their full application faces important limits and high political pressure.
Acknowlegments: ANRS, Sidaction, Dept. of STD, Aids and VHs (BMoH), UMR 912 Inserm & IE/UFRJ. Contact: constance.meiners@inserm.fr