Colombia – Access to Medicines

For nearly two decades, Colombian activists, experts and academics have been fighting to expand equitable access to medicine across the country by deliberately challenging pharmaceutical monopoly power. Since 2008, Colombia’s access campaign has helped reduce medicine prices, increase public scrutiny of medicine price abuses, and reinstated parallel importation — a means to reduce medicine prices by shopping on the world market. Colombian organizations have expanded their campaign nationwide and found new ways to challenge Big Pharma greed. Public Citizen’s Global Access to Medicines Program has supported Colombian health groups throughout this journey.   

A brief history of work in Colombia is outlined below.

Dolutegravir

In June 2023, Global Humanitarian Progress Corporation (GHP Corp) and Public Citizen, along with more than 120 other organizations and prominent individuals worldwide, voiced strong support for the Ministry of Health’s move to authorize price-cutting generic competition with the critical patented AIDS drug dolutegravir.  In a letter to Minister of Health Guillermo Alfonso Jaramillo, they urged him to proceed with the proposal to issue compulsory licenses allowing Colombia to make or import generic dolutegravir without permission from the patent owner, ViiV Healthcare. Generic dolutegravir is available to millions of people worldwide through licenses with the Medicines Patent Pool, a Swiss foundation. However, ViiV excluded Colombia and many populous middle-income countries from the license, maintaining its high-price monopoly.

On October 3, 2023, Colombia’s Ministry of Health released a Declaration of Public Interest for dolutegravir. The Declaration is a commendable show of political will and a key step toward the issuance of a compulsory license, a mechanism to authorize generic affordable generic competition with expensive medicines.

On January 31, 2024, the government of Colombia took a historic step towards issuing its first-ever compulsory license to overcome patent barriers to HIV treatment and import less expensive generic versions of the HIV medicine dolutegravir. The step by Colombia’s Secretariat of Trade and Industry invites applicants to make use of the compulsory license for dolutegravir for generic supply, meaning that, within the next ten days, manufacturers need to express an interest to supply the drug to Colombia under this compulsory license.

On April 24, 2024, Colombia’s Secretariat of Trade and Industry issued a compulsory license to the Ministry of Health for dolutegravir. Public Citizen, MSF, and Global Humanitarian Progress Corporation welcomed the landmark news in a release.

• See here for Public Citizen & MSF’s July 2023 press release showing support for the move to expand access to dolutegravir
• See here for Public Citizen & MSF’s October 2023 press release welcoming the declaration
• See here for Public Citizen & MSF’s February 2024 press release welcoming the step by Colombia’s Secretariat of Trade and Industry to invite applicants to make use of the compulsory license for dolutegravir

Paxlovid (nirmatrelvir-ritonavir) 

In response to Colombia’s exclusion from the Pfizer-Medicines Patent Pool licensing agreement for COVID treatment Paxlovid, GHP Corp and other civil society organizations submitted a request to the Colombian government for government use of Paxlovid on March 14, 2022. The Colombian government refused to take up the request in their May 2022 response.  

After the 2022 Colombian presidential election, the civil society organizations filed another petition for government use of COVID treatments Paxlovid and molnupiravir to the new Colombian government. Again, the Colombian government responded, but the petition for government use was ultimately unsuccessful. 

COVID-19 vaccine contract transparency

In May 2021, following a petition by the Instituto Anticorrupcion and subsequent judicial review, the Colombian Government was ordered to make its COVID-19 vaccine procurement contracts public. The court concluded that COVID-19 vaccines were a global public good and that maintaining contract secrecy would infringe upon the right to access information.

Amid the controversy over contract transparency in Colombia, Pfizer was accused of “bullying” Latin American governments in COVID-19 vaccine negotiations in a story by the Bureau of Investigative Journalism. 

In an October 2021 report, Public Citizen analyzed Pfizer contracts with various countries, including Colombia. The report highlights ways the contracts shifted risk and maximized profits, including through nondisclosure provisions, requiring dispute settlement in secret arbitration courts, and giving Pfizer unilateral authority over contract revisions.

• See here for the International Commission of Jurists’ briefing paper on the Colombian contract transparency case 

Glivec (imatinib)

In November 2014, Colombian non-governmental organizations CIMUN, IFARMA, and Misión Salud submitted a petition to issue a compulsory license for the cancer drug Glivec. The drug was priced in Colombia at nearly double the country’s GDP per capita.  

After more than a year and a half, protracted talks broke down with the Swiss pharmaceutical company Novartis over the price of the drug. In June 2016, the Colombian health minister issued a declaration of public interest for the drug. 

The declaration came after months of government deliberations and negotiations with Novartis regarding imatinib, along with international pressure. For example, the Secretariat for Economic Affairs of Switzerland wrote a letter to the Colombian Ministry of Health to express concern over the compulsory license application, equating a compulsory license to “an expropriation of the patent owner.” Concerns over pressure from the United States Trade Representative and the Senate Finance Committee were also eventually raised by the U.S. House of Representatives.

• See here for academics and advocates’ May 2016 letter to President Santos of Colombia affirming Colombia’s right to issue a compulsory license on cancer medicine imatinib
• See here for Colombian civil society organizations’ June 2016 statement on the declaration
• See here for public health, human rights, and faith organizations’ June 2016 letter questioning State Department pressure against global access to medicines initiatives 

Kaletra access campaign

In April 2008, with prices for Abbott’s monopolized HIV treatment Kaletra in the several thousands of dollars per person per year, Fundación IFARMA, the Colombian Network of People Living with HIV (RECOLVIH), Misión Salud and the Group of NGOs working on HIV/AIDS (la Mesa) requested a license from Abbott to facilitate generic competition. When Abbott did not respond, the health groups petitioned the Colombian government and launched a public access to medicines campaign. One year later, the government issued an order establishing a price ceiling for Kaletra, which Abbott ignored. In September 2009, the groups filed a lawsuit, seeking a compulsory license to inaugurate competition. In January 2010, Colombia announced a financial emergency in its health system and strengthened the powers of the medicines pricing commission. Abbott finally complied with the price order. The price reductions, initially around 54-68%, were projected to save Colombia’s HIV programs approximately US$12 million in the first year alone. 

In February 2012, a Colombian administrative judge ruled that Abbott Laboratories and the Ministry of Health threatened and violated collective rights to public health by maintaining the price of an HIV medicine above the reference price, flouting a government order. The court’s decision was a groundbreaking condemnation of Big Pharma pricing abuses and a precedent for health rights in Colombia.  

These activists’ work building a coalition of health advocates and challenging the Colombian Government on exorbitant drug pricing laid the foundation for an access movement that has only grown. A leading force of this early movement, Javier Leo Varon of RECOLVIH, sadly passed away in 2013 due to complications related to AIDS. Mr. Varon and others brought access conversations to the fore, making pricing abuses impossible to ignore. Their work has led to the growth of a broader access movement, to more campaigns, and greater access to lifesaving medicines.

• See here for an English translation of Colombian civil society’s statement on the Supreme Administrative Court’s decision 
• See here for a backgrounder on Colombia’s Kaletra access campaign