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Aperçu sur l’évolution récente du prix des ARVs

Aperçu sur l’évolution récente du prix des ARVs. Benjamin CORIAT. 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

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Aperçu sur l’évolution récente du prix des ARVs

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  1. Aperçu sur l’évolution 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 onpharmaceutical products One exception (under some conditions and complex protocols): the use ofcompulsory licence, but to supply “predominantly the domestic market” • Even after the Doha declaration strong limitation for countries withoutsufficient 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 l’accès 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) ABC/ddI/LPVr – 2nd line TDF/3TC/EFV – substitute D4T/3TC/NVP – 1st line 5 000 4767 4 000 3 000 X48 2 000 1599 1100 1 000 610 X16 94 100 Low income Middle income

  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

  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 l’imposition de normes TRIPS + « Data exclusivity » • Capacité des pays à développer un recours systématique au LO • La position de l’Inde notamment en terme de licence obligatoire • L’évolution de l’industrie pharmaceutique indienne (I.e mouvement de rachat par multinationales) • Le développement de modèles alternatifs au monopole et blockbuster • Patent pool pour l’accès et pour la R&D : UNITAID Initiative • Partenariat Public/privé pour l’innovation à moindre cout : DnDi initiative for malaria

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