Addressing IP barriers to the elimination of HCV as a public health problem in Latin America

Abstract

Treatment of HCV has evolved from injection-based regimens with severe side effects to DAAs with cure rates of 95%. However, due to patent monopolies high prices are charged and pose a major barrier to access, especially in Latin America, which precludes countries to access more affordable generic DAAs. While DAA patent holders have developed voluntary licensing schemes, with a view to offer more affordable prices to developing countries, too many middle income countries and most Latin America are excluded from it. As a result, countries are facing prices, that range from $12,000 to $6,212 for DAA treatment, which are unsustainable to reach HCV elimination targets. To face this challenge, DNDi has developed a HCV public health approach that, besides developing a new affordable and pangenotypic treatment, aims to seize the opportunity of the new DAAs available to advocate for its expansion of treatment widely. This strategy will require governments to take active steps to increase access and affordability, including by making use of IP flexibilities, allowed under international trade law, to overcome high prices and patent barriers. To enable this environment, DNDi seeks to work with governments, civil society, patients and other stakeholders to overcome IP and regulatory barriers to an affordable pan-genotypic treatment, particularly to countries in Latin America that are facing high prices and that are excluded from voluntary schemes. Recently, DNDi has welcomed Malaysiás leadership and example to developing countries facing high prices of DAAs to issue a government-use license to source generic sofosbuvir, in order to accelerate access to affordable sofosbuvir in its public hospitals. Seizing the public health potential of DAAs to ensure the elimination of HCV as a public health problem in Latin America will require strong leadership from Ministries of Health, governments, active involvement of treatment providers and patient's groups to advocate for the implementation and strengthening of pro-access policies, overcoming IP and regulatory barriers, to allow for scale up of diagnostic and treatment of HCV in Latin America.