Colombian civil society’s fight for access to affordable medicines

Civil society groups in Colombia have long championed greater accessibility of patented medicines, culminating in a historic move by the country to break the patent monopoly on a key HIV drug.

Juliana López Méndez

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COLOMBIA has a significant track record in using the flexibilities established under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to ensure access to medicines.

The TRIPS Agreement in the World Trade Organization (WTO) obliges all WTO member states to recognise patents in respect of medicines, thereby enlarging and entrenching the rights of patent holders at the expense of consumers. The effect of such all-encompassing patents has been to confer monopoly rights on international drug companies in the production and distribution of their patented drugs. By shutting out competition, the TRIPS Agreement gives drug companies the ability to charge high monopoly prices for their drugs.

The crux of the issue is how to make medicines more affordable to more people who need them. HIV/AIDS drugs are just one high-profile example. Many other drugs for tuberculosis, malaria, cancer, asthma, diabetes and rare diseases, among others, are made unaffordable simply because drug companies have been able to block competition from other firms and products through the use of patents.

While the TRIPS Agreement obliges WTO members to provide patent protection for drugs, it also allows them to take certain measures (e.g., government use of patents, compulsory licensing, parallel importing and exceptions to patent rights) which override or limit patent rights under certain conditions. These measures have, in fact, been introduced as a means of balancing patent rights with the public interest of encouraging competition, consumer protection and, in the case of drugs, access to affordable medicines.

Developing countries also pushed for an interpretation of the TRIPS Agreement which guaranteed the right of WTO members to use measures such as compulsory licences and parallel imports. The result is the Ministerial Declaration on the TRIPS Agreement and Public Health, adopted by the WTO members at the Doha Ministerial Conference in November 2001. The Doha Declaration states that the TRIPS Agreement ‘does not and should not prevent members from taking measures to protect public health’. It also reaffirms the right of members to issue compulsory licences (and the freedom to determine the grounds on which the licences are granted) and confirms their right to make use of parallel importing. The Doha Declaration is significant because it recognises the negative impacts of an inflexible implementation of the TRIPS Agreement, and therefore, the need to balance commercial interests in patent rights with public interest in ensuring access to medicines.

In this context, in Colombia, civil society organisations such as the IFARMA Foundation have played a key role in leading or backing several requests for declarations of public interest to support compulsory licensing. Under Colombian law, such declarations enable the Superintendence of Industry and Commerce (SIC) to then issue compulsory licences for the relevant patented products.

The first of the civil society initiatives dates back to July 2008, when a declaration of public interest was requested for the HIV/AIDS drug Kaletra. At that time, the SIC returned the file, arguing its lack of competence according to Decree 4302 of 2008, which establishes the procedure for issuing declarations of public interest. Additionally, Kaletra’s patent holder, Abbott Pharmaceuticals, filed a right of petition and a tutela action requesting (a) the rejection of the request and (b) its participation in the process in case the request was successful.

Subsequently, in March 2010, IFARMA, Fundación Misión Salud and Mesa de Organizaciones con Trabajo en VIH/SIDA filed a direct request before the SIC with the purpose of initiating an administrative procedure to obtain a compulsory licence for Kaletra, invoking reasons of social emergency in health. However, the SIC reiterated its incompetence to suspend granted patents or intervene in pending applications related to products involved in the declaration of social emergency.

In September 2012, the Administrative Court of Cundinamarca ordered the Ministry of Health to regulate the price of Kaletra and urged the SIC to open investigations to determine whether Abbott had respected the reference prices. As a result of these actions, the SIC sanctioned the pharmaceutical company for marketing the drug at above the maximum price allowed. This pressure resulted in the inclusion of Kaletra in the direct price control regime.

In November 2014, several civil society organisations filed a request for a declaration of public interest in relation to the cancer drug imatinib, produced by the Swiss pharmaceutical firm Novartis under the Glivec brand name. In March 2015, the Ministry of Health notified that the process was underway. However, towards the end of May, the Swiss government sent an official communication opposing the measure. In response, IFARMA, together with other organisations, issued an open letter to the Swiss government, supporting the right of the Colombian state to grant compulsory licences in accordance with international law. As a result of these actions, imatinib became the first drug to be declared of public interest by the Ministry of Health and a significant reduction in its price was achieved.

In October 2015, IFARMA requested that all direct-acting antivirals for the treatment of hepatitis C – including telaprevir, boceprevir, sofosbuvir, simeprevir, daclatasvir, faldaprevir and ledipasvir – be declared of public interest, arguing that their high prices threatened the financial sustainability of the health system. However, pressures exerted by the international pharmaceutical industry caused an unusual delay in the process. Only in 2019 did the Technical Committee meet to analyse the request and issue its recommendation. Finally, the Ministry of Health opted to implement an alternative mechanism: centralised purchasing through the Strategic Fund of the Pan American Health Organization (PAHO).

Compulsory licence for dolutegravir

The above developments can be seen as paving the way for the landmark achievement in 2023 when Colombia navigated a complex web of legal, political and industry hurdles to become the first country in the Americas to issue a government use license (a form of compulsory licence). The licence was for the HIV treatment dolutegravir.

Dolutegravir is a cornerstone in modern HIV therapy due to its superior efficacy, tolerability and resistance profile compared with older treatments. However, its high cost has historically limited access in many low- and middle-income countries, including Colombia.

According to the Colombian government, the estimated cost of treatment with dolutegravir, as sold by ViiV under the brand name Tivicay, was approximately $1,224 per patient per year in 2023 in Colombia. The international medical humanitarian organisation Médecins Sans Frontičres (MSF) said this was an exorbitant mark-up when compared with the price of $22.80 or $44 per patient per year for generic versions of dolutegravir offered in 2023 through the Global Fund and PAHO respectively.

Now, under the government use licence, the price available to the Ministry of Health, $44 per patient per year, has enabled affordable access to generic dolutegravir.

Formal implementation of the government use licence materialised with the issuance of Resolution 20049 of 2024, which establishes the regulatory framework for its execution. With the licence, and through a centralised purchasing process, 819,346 vials of the pharmacological combination dolutegravir 50 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, produced by APL Health Care Limited (India), were acquired. This acquisition was financed with resources from the Global Fund and managed by the Administradora de los Recursos del Sistema General de Seguridad Social en Salud (ADRES).

The direct beneficiaries of this measure include Venezuelan migrants living with HIV, recently diagnosed patients, as well as people requiring post-exposure prophylaxis. In operational terms, the distribution of the medicine by the Ministry of Health is currently in the logistical conditioning phase. However, the units assigned to the territory have already begun to be distributed to the target populations.

The issuance of the government use licence by Colombia has been widely praised by global health advocates and organisations such as MSF, Public Citizen and Global Humanitarian Progress Corporation Colombia. The World Intellectual Property Organisation (WIPO) has stated that Colombia’s pursuit of a compulsory licence for dolutegravir shed light on the complexities of intellectual property licensing schemes and pricing of medicines globally.

However, the implementation of the compulsory licence has encountered obstacles: on the one hand, pressure from pharmaceutical companies who argue that this licence may discourage innovation, and on the other hand, they consider the issuance of the licence illegitimate and illegal, which has generated intense debate in the country. The measure has faced strong opposition from the pharmaceutical industry trade body AFIDRO, as well as from the patent holders – ViiV Healthcare, GlaxoSmithKline and Shionogi – who have filed multiple legal and administrative actions in different institutional settings in order to reverse the decision. In this context, IFARMA has taken a leading role in defending the compulsory licence and the legitimacy of its implementation in accordance with the principles of international public health law.

Further, there is a lack of clarity about the regulations on the use of compulsory licences, which has created uncertainties for both healthcare providers and patients. The Benefit Plan Administration Companies (EAPB) in Colombia have taken advantage of this lack of knowledge to set up additional administrative barriers that have resulted in patients not being able to access even the treatments covered by the licence.

The EAPB act as intermediaries between the state, citizens and providers for the country's universal health coverage system. They are responsible for managing public health resources and ensuring that the services under the Health Benefits Plan (PBS), a public social security health insurance plan, are provided to users.

Although the Ministry of Health has encouraged the necessary dialogues with healthcare providers, they have been reluctant to implement the changes necessary to facilitate the delivery of treatment. This state of affairs lays bare the lucrative and privatised nature of the current system, which perpetuates the vision of health as a business.

The Colombian health system faces numerous challenges, which require responses that prioritise equity and access to affordable treatment. The implementation of compulsory licensing for dolutegravir represents a crucial step towards guaranteeing access to antiretroviral drugs, but strong political commitment is needed to overcome current obstacles. In any future strategy, guaranteeing the right to health for all Colombians should be the main goal.                

Juliana López Méndez is a social worker and epidemiologist with 10 years of experience in community work and human rights advocacy. As director of the IFARMA Foundation, she has led research projects related to the Foundation's objectives and, together with her team, has monitored the implementation of the compulsory licence for dolutegravir.

*Third World Resurgence No. 363, 2025/2, pp 34-36