The Brazilian Interdisciplinary AIDS Association (ABIA), an advocacy group in Rio de Janeiro, has called on the Ministry of Health to issue a compulsory license (CL) for the antiretroviral (ARV) dolutegravir (DTG). According to the World Health Organization (WHO), it is “more effective, easier to take and has fewer side effects than alternative drugs.”
The CL will pave the way for more affordable generic versions by overriding the drug’s patent, by allowing governments to use patented inventions without the permission of patent holders and is a public health safeguard under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) — a WTO agreement that prescribes minimum standards for intellectual property regulation.
“What we are seeing here in Brazil is an abuse of the patent system and a high price for DTG,” said Susana van der Ploeg, the coordinator of the Working Group on Intellectual Property, and project assistant at ABIA. “We believe that to combat the abusive pricing, the Ministry of Health should issue a compulsory license for DTG.”
Affordable ARVs are essential for Brazil, which is home to the highest HIV prevalence in Latin America – nearly a million people are living with HIV — and a steadily rising rate of new HIV infections, which reached 51,000 in 2022. ABIA, a partner of the Make Medicines Affordable campaign, states that the Brazilian government can save money by acquiring more affordable generic medicines, which would make its funding go further. Currently, Brazil currently spends nearly two-thirds of its HIV budget on treatment, leaving prevention and testing programs underfunded.
Today, a single tablet in Brazil costs R$4.40, when it could be at 0.70 cents. In 2023, the government purchased 180 million units of DTG at a price of R$4.40.
“If the Ministry of Health were to adopt a firm public policy to combat the abuse of prices and the patent system, we would have the possibility of expanding not only access to medicines but also other measures to fight the HIV/AIDS epidemic,” van der Ploeg said.
According to Bloomberg, nearly two-thirds of Brazil’s HIV budget is spent on buying medicine. As a result, HIV preventative programs and tests are underfunded. The country is home to nearly one million people living with HIV according to UNAIDS.
DTG was patented by ViiV Healthcare, a multinational pharmaceutical company, which initially priced the drug at $3,606 USD per person, per year in Brazil. Between January 2015 and September 2016, ABIA conducted strategic dialogues with, and outreach to the Brazilian government and other stakeholders, to prioritize increasing access to DTG.
As a result of ABIA’s efforts, the government changed its treatment guidelines to include DTG as part of first-line treatment, thus increasing demand for the drug. The government also negotiated a 75% price reduction with ViiV Healthcare (from $3,606 USD to $558 USD, per person, per year).
ABIA and the Working Group on Intellectual Property (GTPI), launched three patent oppositions (pre-grant oppositions in September 2017, August 2019, and a post-grant opposition in January 2021) along with local generics manufacturer Blanver. The final decision from the patent office, INPI, was to grant the patent. Nonetheless, the issue is currently subject to judicial proceedings for patent nullification, and the final decision regarding the patent’s invalidation remains pending in court.
The pressure from ABIA delayed ViiV’s patent monopoly on DTG, enabling Brazil’s government to sponsor local production of generic DTG. This provided Brazil with a more sustainable — and affordable — source for DTG, and allowed more people to access this important drug. In 2022, the government purchased 79.5 million doses of locally produced, generic DTG at a reduced price — but the patent poses a real risk in preventing the ongoing local production of generic DTG. According to van der Ploeg, removal of the patent will be an act of defense of the Public Health System, Sovereignty and the guarantee of continuity of treatment for people living with HIV whose lives are placed on the line due to expensive and inaccessible treatment.
“A compulsory license is bound to give local manufacturers a legal backbone and such a commitment will guarantee access to critical and life-saving products,” added Veriano Terto, ABIA’s executive director.
In Colombia, Brazil’s northern neighbor, HIV cases have increased by 31%, leading its Ministry of Health to declare its interest in DTG. The Minister of Health and Social Protection, Guillermo Alfonso Jaramillo, said people living with HIV were paying $100 USD per month for the drug – a price that is 50 times higher than the generic versions available through the Pan American Health Organization. In October 2023, the country’s patent office was directed to issue a CL for DTG, setting a precedent for the South American region, that would potentially allow Colombia to provide 28 people with generic DTG for the same cost as treating one person with the patented drug.
Humanitarian organizations including the U.N. Office for the Coordination of Humanitarian Affairs (OCHA) and UNAIDS have hailed the decision by the Colombian Ministry of Health, stating that it is a “proactive approach” to pursuing public interests.
“This fully legitimate action by the Colombian government is the first of its kind from Colombia and is a significant act of leadership that clearly puts people and public health over corporations’ profits,” stated Francisco Viegas, Medical Innovation Policy Advisor from Doctors Without Borders (known by its French acronym MSF), in a statement.
According to ABIA, this sets an inspiring precedent that Brazil can soon follow.
“Colombia has shown us what is possible,” said Terto. “We are hopeful that Brazil will follow in their footsteps, enabling sustainable production of generic DTG and challenging the status quo of pharmaceutical profiteering from HIV.”
