In 1985, Ron Woodroof, a Texas cowboy played by Matthew McConaughey in “Dallas Buyers Club,” contracted HIV at a time when a diagnosis was almost a death sentence. The disease mainly affected gay men, sex workers and drug users, who suffered brutal discrimination: they were thrown out of their homes, classrooms, jobs and even hospitals. In desperation, Ron turned to antiretroviral drugs not approved in the U.S., acquired illicitly in Mexico, Japan, Israel and the Netherlands. Thus began the Dallas Buyers Club, the local version of an international network of drug distribution services for thousands of patients who otherwise would not have access.

Today, HIV/AIDS is a chronic but manageable disease in high-income countries, thanks to access to effective antiretroviral drugs. Even in middle-income countries such as Colombia, access is possible because most health systems have included these drugs in their health benefit plans, making them a theoretically available option for all. However, this does not completely solve the access problem, as States must face the challenge of negotiating fair prices for these drugs.

Colombia has taken an important step on the road to ensuring access to vital HIV treatment drugs by granting a compulsory license for Dolutegravir (DTG), an easy-to-use and effective antiretroviral drug for the treatment of HIV. This move came after the government declared the drug to be in the public interest in 2023, highlighting the effort to make this treatment accessible to all people in need. Compulsory licenses are a legal tool that, in emergency situations or for reasons of public interest, allows the production and use of generic drugs without the need for the patent holder’s consent. Although they are not new at the global level, these licenses have allowed several countries to collaborate with the pharmaceutical industry and adapt their legal frameworks to facilitate access to medicines, seeking to balance public health with intellectual property rights.

To better illustrate this point, this article presents some emblematic cases and the example of Colombia, which can serve as a precedent for the region in terms of equity in health.

Compulsory licensing pioneers: South Africa, Brazil and India

The experiences of South Africa, Brazil and India, as well as the recent experience of Colombia, show the usefulness of this tool. Through licenses, these countries have controlled the price of antiretroviral drugs, guaranteeing access to those who need them.

In the 1990s, South Africa faced one of the most severe HIV crises in the world, with approximately 3 million people affected by the epidemic. As the situation worsened, access to effective antiretroviral treatment became a national priority. The high costs of these patent-protected drugs made them inaccessible to the majority of the population. In response, the South African government decided to take a bold step: to issue a compulsory license to allow the production of generic versions of these essential drugs in their country.

In 1997, South Africa passed the Medicines and Related Substances Control Amendment Act, which granted a compulsory license for HIV drugs. This law allowed the importation and sale of generic versions of the drugs, a move that had not been seen before anywhere else in the world. The South African government’s decision was driven by a combination of factors: growing pressure from civil society organizations, the pressing need to save lives, and ineffective negotiations with pharmaceutical companies to reduce prices.

In 1998, thirty-nine pharmaceutical companies sued the South African government in the Pretoria High Court in an attempt to overturn the law. The pharmaceutical companies and their advocates argued in their lawsuit that patents were not the problem, that weakening patent monopolies threatened innovation, and that South Africa lacked the infrastructure to distribute and control HIV drugs. Strong national pressure and global solidarity with South Africa forced the pharmaceutical companies to withdraw their lawsuit in 2001. This move not only saved countless lives, but also set a crucial precedent for other developing countries.

Brazil also played a crucial role in using compulsory licensing to improve access to medicines. In 2007, the Brazilian government issued a compulsory license for Efavirenz, an essential antiretroviral, after negotiations with Merck Pharmaceuticals failed to reduce the price of the drug. This measure allowed local manufacturers to produce generic versions, reducing costs and improving access for thousands of people living with HIV in the country.

India, known as the “developing world’s pharmacy,” has strategically used compulsory licensing to ensure access to medicines. In 2012, India issued a compulsory license for the anti-cancer drug Nexavar, allowing the production of generic versions at a fraction of the original cost. This move not only made the drug more accessible to Indian patients, but also set an important precedent for other developing countries.

Since the 1970s, India has created a legal environment that protects the rights of generic manufacturers, enabling the development and distribution of essential drugs at affordable prices worldwide. For example, the Indian generics firm Cipla was able to produce its own version of the HIV drug at a significantly reduced cost, opening up markets that had been ignored by brand-name drug manufacturers.

Colombia: a commitment to equity 

In Colombia, HIV is a visible and urgent challenge that affects thousands of people and puts many more at risk. Despite World Health Organization (WHO) recommendations to use Dolutegravir as first-line treatment due to its high effectiveness and minimal side effects, the high cost of the drug prevented its access to a large part of the population.

The pharmaceutical industry, represented in this case by the multinational ViiV Healthcare, set prices that were beyond the reach of many patients.According to the Colombian government, the estimated cost of treatment with Dolutegravir (commercially available as TIVICAY® in a 50mg presentation) per patient, under the price reported in the Drug Price Information System (SISMED), was approximately $1,235 US dollars, compared to the cost offered by the Pan American Health Organization of approximately $45 US dollars per patient per year. This difference of $1,190 US dollars would allow 27 more people to be served with the generic compared to the commercial molecule.

Faced with this reality, the Colombian government resorted to several strategies before implementing the compulsory license. Initially, it tried to negotiate with ViiV Healthcare by requesting price reductions and proposing volume discounts. In addition, they proposed tiered pricing arrangements to make the drug more accessible. However, these proposals were not heard, and the company did not accept the conditions proposed by the government.

Finally, the Colombian government declared Dolutegravir to be in the public interest and approved a compulsory license for its production. This move was hailed as a significant advance in the fight against HIV and a firm commitment to health equity. The price available to the Ministry of Health under the compulsory license ($45 US dollars per patient per year) represents a major step towards affordable access to cheaper generic versions of Dolutegravir for all people in need.

Colombia’s decision had an immediate and positive impact, allowing the production of generic versions of DTG at significantly lower prices. This ruling will not only save the lives of Colombians, but also of thousands of migrants. The country is home to the largest number of Venezuelan migrants in the world (2.9 million as of August 2023). Recent studies have shown an HIV prevalence of 0.9% among this migrant population, almost double the 0.5% HIV prevalence among the country’s adult population.

Social and patient organizations have celebrated the news as a ‘historic step’ to expand access to affordable treatment for all those who need it. The decision also represents a powerful precedent for other countries in the Global South, considering that in the Latin American region only Brazil and Colombia have used this type of measures in the face of a continent-wide epidemic.

How do we keep the door open for essential medicines?

The implementation of compulsory licensing, while effective, is not without its challenges. Pharmaceutical companies often vehemently oppose these measures, arguing that they erode incentives for innovation and new drug development, even though the potential public health benefits are undeniable. Governments must carefully balance the need to protect innovation and intellectual property with the urgency of making essential medicines accessible to their citizens.

In the case of Colombia, the Association of Pharmaceutical Research and Development Laboratories (Afidro) was quick to react. They filed an administrative litigation lawsuit, opposing the implementation of the compulsory license for Dolutegravir. This lawsuit is currently in progress, which is evidence of the strong resistance of the industry to accept these measures. Despite these objections, the Colombian government’s decision to move forward with the compulsory license reflects a strong commitment to health equity and the urgent need to provide access to life-saving treatments.

For compulsory licensing to be effective globally, it is crucial that an international legal framework is in place to support and facilitate its implementation. This includes cooperation between countries, harmonization of health policies and promotion of agreements that prioritize public health over commercial interests. In addition, non-governmental organizations (NGOs) and civil society have a crucial role to play in promoting and supporting compulsory licensing. Through advocacy, education and community mobilization, these organizations can influence public policy and ensure that health rights are protected and promoted.

Just as Ron Woodroof found a way in the “Dallas Buyers Club” to ensure a better quality of life for himself and others, compulsory licensing today represents a struggle for equitable access to medicines that can save millions of lives. Colombia’s story is a powerful reminder that with political will and commitment to public health, it is possible to prioritize the well-being of the population over commercial interests. This narrative not only resonates regionally, but also provides a valuable precedent for other countries in their quest for justice and equity in health.