WEAE01 - The future of affordable ART: trends in patents and prices

Session summary

Major changes in global trading rules have occurred in the past decade while countries were struggling with price negotiations on first-line then second-line ARV drugs. This session summarized what happened globally and at country level in this recent period and shed some light on the successes achieved so far as well as the many challenges emerging now.

Viegas et al described the smart use Brazil made of the compulsory license mechanism for efavirenz. A comprehensive legal framework was put in place in 2007 and renewed in 2012. The cost reduction was almost immediate and quite drastic after the adoption of the compulsory license, allowing a rapid and massive increase in the number of patients treated and leading to an estimated 58% in savings. This flexibility in the TRIPS should be used more broadly as it clearly serves to improve access without impairing economics.

Park et al reported the findings of an international survey performed by the Medicines Patent Pool on the use of voluntary licensing, a non-exclusive license granted to generic producers by an originator company. Industry practices varied widely in geographic scope, number of licensees and many terms and conditions although transparency was limited, a problem encountered by Villardi also when critically reviewing the pharmaceutical patenting and sanitary registration of ARV drugs in Brazil. Companies must be encouraged and scrutinized to adopt “maximize access” terms and conditions.

Moatti et al explored the trends in ARV drug prices and their determinants at a global level by analyzing a large international database of donor-funded ARV transactions set under the auspices of UNITAID. Treatment prices seemed to have reached the marginal cost level for first-line drugs but reductions of 50% or more are certainly possible for second- and third-line treatments. Quantities purchased have now become a clear driver of drug costs, like in any mature market, with a positive correlation with GDP per capita. Generic competition has clearly been a driving force for ARV price decreases. Brand firm strategies remain however the major source of higher prices, including when patents expire.

Bhardwaj specific analysis of the situation in middle-income countries was somewhat alarming as universal access is likely to be seriously impaired by such categorization of countries. Indeed, they must now fund themselves their treatment programs and have different negotiation rules imposed by the pharmaceutical industry. Furthermore, the Global Fund has not totally clarified its position on the matter.

Overall, there is a risk to loose the progress made in the past ten years, at least in some countries and certainly for drugs other than those currently used first-line. The goal set of an HIV-free generation and the plea for maximum efficiency appear somewhat contradictory with the global policies on international property supported by some big donor countries as well as their own relative inefficiency in health system organization.