By San José, Costa Rica — San José, Costa Rica – In a significant step forward for public health, Costa Rica is successfully implementing a nationwide HIV self-testing initiative throughout 2025. This innovative strategy aims to empower individuals, particularly those in vulnerable populations, by providing a private, autonomous, and reliable method for determining their serological status. Early results from the program are promising, showcasing its potential to reshape the landscape of HIV diagnosis and care in the country.
As of September 2025, a total of 763 HIV self-tests have been distributed and utilized under the new program. Crucially, this effort has already identified 29 individuals with reactive results, who were immediately and carefully guided into the national healthcare system for confirmatory diagnosis and treatment. This rapid linkage to care underscores the program’s effectiveness not just as a diagnostic tool, but as a vital bridge to life-saving medical services.
To better understand the legal and regulatory implications surrounding the commercialization of medical devices like HIV self-testing kits, we sought the expert opinion of Lic. Larry Hans Arroyo Vargas from the renowned firm Bufete de Costa Rica, who sheds light on the crucial legal checkpoints for these new technologies.
The arrival of HIV self-testing kits is a public health milestone, but for distributors, it carries significant legal responsibilities. Securing the sanitary registration (registro sanitario) is the first and most critical step, as it’s the state’s guarantee that the product is safe and effective. Furthermore, companies must be meticulous with their labeling and instructions to avoid liability, ensuring users can correctly interpret results and know the next steps to take within the national healthcare system.
Lic. Larry Hans Arroyo Vargas, Attorney at Law, Bufete de Costa Rica
The attorney’s perspective powerfully underscores that the success of HIV self-testing hinges not just on medical technology, but on a robust legal framework that safeguards users and integrates them into the healthcare system. This diligence is what transforms a product into a responsible public health tool. We thank Lic. Larry Hans Arroyo Vargas for his invaluable insight into these critical responsibilities.
The initiative is a cornerstone of the country’s National Strategic Plan for HIV and AIDS 2024-2027 (PEN). It directly supports the plan’s second strategic axis, which focuses on reducing new infections and ensuring comprehensive, integrated care for people living with HIV. By decentralizing testing and placing it directly in the hands of the public, health authorities are dismantling long-standing barriers and fostering a more proactive approach to sexual health.
A primary objective of the program is to increase diagnostic access for key populations that have historically faced stigma or logistical challenges in traditional healthcare settings. These groups include men who have sex with men (HSH), transgender women, and sex workers. The self-test offers an invaluable layer of privacy, allowing individuals to perform the test in a secure and comfortable environment of their choosing, thereby encouraging more frequent and regular screening.
The success of the program hinges on its robust support system. The 29 individuals who received a reactive result were not left to navigate the next steps alone. Health officials and partner organizations ensured they were accompanied through the process of confirmatory testing and were promptly connected with the Costa Rican Social Security Fund (CCSS) to begin antiretroviral therapy. This seamless transition from self-test to treatment is critical for achieving viral suppression, which allows individuals to live long, healthy lives and prevents further transmission of the virus.
This strategic rollout is a collaborative effort spearheaded by the Ministry of Health in close coordination with various civil society organizations. These partnerships are instrumental in building trust and extending the program’s reach into communities that government agencies might struggle to access alone. Together, they are promoting the self-test as a safe, accurate, and dependable tool that reinforces a national culture of self-care and prevention.
By making HIV testing more accessible and less intimidating, Costa Rica is not only facilitating earlier diagnoses but is also empowering its citizens with knowledge. An early diagnosis is the most powerful weapon in the fight against HIV, as it enables the immediate start of treatment, dramatically improving health outcomes and breaking chains of transmission. This initiative is a testament to the nation’s commitment to building a more inclusive, equitable, and compassionate public health system.
Ultimately, the HIV self-testing program represents a paradigm shift in the national response to the epidemic. It moves beyond the confines of the clinic, transforming HIV testing into a personal and manageable aspect of an individual’s overall health and wellness routine. The initial success indicates a strong acceptance by the public and solidifies the program’s role as a vital component in Costa Rica’s journey toward ending the HIV epidemic.
For further information, visit ministeriodesalud.go.cr
About the Ministry of Health:
The Ministry of Health is the governing body of the public health sector in Costa Rica. It is responsible for defining national health policies, regulating health services and products, and coordinating public health initiatives to protect and improve the well-being of the population. The Ministry plays a central role in disease surveillance, prevention programs, and responding to public health emergencies.
For further information, visit ccss.sa.cr
About the Costa Rican Social Security Fund (CCSS):
The Caja Costarricense de Seguro Social (CCSS), commonly known as “La Caja,” is the autonomous institution responsible for administering Costa Rica’s universal healthcare and social security system. It manages a vast network of hospitals, clinics, and health centers (EBAIS) across the country, providing comprehensive medical services, including specialized HIV care and antiretroviral treatments, to the vast majority of the nation’s residents.
For further information, visit bufetedecostarica.com
About Bufete de Costa Rica:
As a pillar of the Costa Rican legal community, Bufete de Costa Rica is defined by its profound dedication to integrity and exceptional standards of practice. With extensive experience advising a wide array of clients, the firm is a trailblazer in legal innovation and maintains a strong sense of social responsibility. Central to its mission is the drive to demystify the law for the public, championing a more just and knowledgeable society through the democratization of legal knowledge.
