Today (24/7), hundreds of treatment advocates attending AIDS2024 in Munich protested against the companies with “Drop The Case Slogans” to denounce GSK and ViiV’s decision to challenge the compulsory license issued by Colombia. This dangerous move prevents thousands of people living with HIV from accessing optimal treatment.
Munich, Germany, 24 July 2024: In a groundbreaking move to ensure access to dolutegravir (DTG), the Colombian government issued Colombia’s first-ever dolutegravir-related compulsory license (CL) on April 23rd, 2024. The government’s action paves the way for the entry of manufacturers of generics, which will slash the price of DTG by 27-fold, from US$102 per person, per month (PPPM) to just US$3.70 per month.
But GSK and ViiV Healthcare supported by the Colombian pharmaceutical association AFIDRO, have challenged the CL in the court, which may freeze its validity. Pharma’s legal manoeuvres are a direct threat to ensuring wider availability of DTG in Colombia.
Colombia is home to 190,000 people living with HIV. With this many people needing lifelong and life-saving HIV treatment, access to affordable, effective and safe ARVs is essential. DTG is the WHO-preferred treatment for HIV, due to its superior clinical outcomes, high resistance barrier – meaning people can take it for years – minimal adverse effects, and lower risk of drug interactions. However, DTG access is severely limited in Colombia by its exorbitant price.
“In Colombia, GlaxoSmithKline/ViiV hold a monopoly on dolutegravir’s active ingredient until 2026 which prevents generic competition and keeps DTG out of reach” according to Juliana Lopes, from iFarma, Colombia, “GlaxoSmithKline/ViiV’s patent monopoly has led to a staggering price disparity between the branded version, priced at US $102 PPPM vs. generic alternatives, which are priced as low as US $3.70 PPPM. The Colombian government is spending a significant amount of money on procuring DTG. Procuring it from generics manufacturers would result in significant savings, enabling Colombian government to provide DTG to more people, and to fund more comprehensive, higher-quality HIV prevention and treatment services.”
“Colombia, similar to Brazil, was excluded from the voluntary license for dolutegravir granted by ViiV to the Medicines Patent Pool (MPP). ViiV’s attempt to prevent the compulsory license is a step back from its commitment in the voluntary license that allows supply to countries when compulsory licenses are issued. We call upon GSK/ViiV and AFIDRO to cease their litigation efforts in Colombia and withdraw the lawsuit challenging the validity of the CL on DTG,” said Susana Van der Ploeg from ABIA, Brazil. “It is imperative that they refrain from any actions that hinder the implementation of this first ever compulsory license on dolutegravir, which is essential for advancing HIV treatment access in Colombia and prioritizing the well-being of individuals over profit.”
“A CL is an established legal tool, defined in international agreements such as the TRIPS Agreement of the World Trade Organization,” says Othoman Mellouk, Access to Diagnostics and Medicine Lead at ITPC Global. “It enables governments to address critical public health needs by overriding patent monopolies. Colombia has full right to use a such mechanism to ensure affordable generic versions of DTG are procured and provided to those in need. ViiV’s attempts to block this is unacceptable. They should Drop The Case.”
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