Aperçu sur lévolution récente du prix des ARVs Benjamin CORIAT.

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1 Aperçu sur lévolution récente du prix des ARVs Benjamin CORIAT

2 Background on the TRIPS and Public Health The TRIPS (1994) : sets out minimum standards for IP protection derived from industrialised countries including patent on pharmaceutical products One exception (under some conditions and complex protocols): the use of compulsory licence, but to supplypredominantly the domestic market Even after the Doha declaration s trong limitation for countries without sufficient manufacturing capacities to use CL (ie. Strong restriction on export and import under CL

3 La période TRIPS pre-2005 Rappel sur le rôle déterminant des génériques dans laccès aux ARV au Sud

4 Competition as a catalyst for price reductions** The fall in the price of first-line combinations of stavudine (d4T), lamivudine (3TC), and nevirapine (NVP), since 2000 (MSF, 2010).

5 Changes in the legal context … End of the transitional period (Indian Amended Patent Act) Spread of TRIPS plus Agreements Changes in the scale of population under ART… Relevant increase in the number of patients under ART (5 millions in 2009 and 14 millions in need) Changes in the therapeutic recommendations (WHO) with inclusion of new much more costly ARVs, most often protected by patents (TDF, LPV/r…) Rapid acceleration of people in need of 2nd and 3rd line treatments within the national therapeutic programs yearly, 10 % of each cohort has to pass to 2sd line regimen New hindrances to the Sustainability of HIV/AIDS Programs in Southern Countries Since 2005 : The new Framework

6 Prices and regimen change in USD in 2008 ( WHO Global Price Reporting Mechanism) 4 000 3 000 Low incomeMiddle income 2 000 1 000 94 5 000 100 610 1599 1100 4767 X16 X48 D4T/3TC/NVP – 1 st line TDF/3TC/EFV – substitute ABC/ddI/LPVr – 2 nd line

7 Understanding TRIPS Flexibilities Bolar Exception for scientific use Parallel Imports Pre-Grant Oppositions Compulsory Licenses different alternatives provided by article 31 of the TRIPS agreement, including : Governmental Use, National Emergency, Public Interest … Initiatives from emergent countries towards IP Flexibilization

8 The Price of Newer, Improved First-line Regimens in 2010.** Generic competition has allowed newer, improved first-line regimens recommended by WHO to fall in price, but in some countries, patent protections means prices stay at unaffordable levels.

9 Des transactions très concentrées Tenofovir EffectifsPourcentage Pourcentage valide Pourcentage cumul é Abbott Laboratories Ltd.1,2 Anspec Pty Ltd.1,2,3 Aspen Pharmacare Ltd.17927,2 27,5 Aurobindo Pharma Ltd.2,3 27,9 Cipla Ltd.324,9 32,7 Gilead Sciences Inc.22133,6 66,4 Gilead Sciences, Inc.1,2 66,5 Hetero Drugs Ltd.2,3 66,8 IDA Warehouse6,9 67,7 IDS Marketing Ltd4,6 68,3 Matrix Laboratories Ltd.20431,1 99,4 Traphaco Joint Stock Company1,2 99,5 Tridem Pharma3,5 100,0 Total657100,0

10 The treatment timebomb: the impact of switching to second- and third-line regimens on the price of ARV treatment.**. The price of a possible third-line regimen may cost at least 23 times more than the most affordable first-line regimen, and close to seven times more than the most affordable second-line regimen. Patients and treatment providers are once again faced with the prospect of drugs being priced out of reach (MSF, 2010).

11 Les enjeux Montée des accords de commerce bilatéraux et limposition de normes TRIPS + « Data exclusivity » Capacité des pays à développer un recours systématique au LO – La position de lInde notamment en terme de licence obligatoire Lévolution de lindustrie pharmaceutique indienne (I.e mouvement de rachat par multinationales) Le développement de modèles alternatifs au monopole et blockbuster – Patent pool pour laccès et pour la R&D : UNITAID Initiative – Partenariat Public/privé pour linnovation à moindre cout : DnDi initiative for malaria