Uruguay’s new left-wing coalition government took office in March 2025, under President Yamandu Orsi. Part of his new agenda has been to enhance the country's regulation of pharmaceuticals. Uruguay is currently the only country in Latin America that lacks an independent drug regulatory body, putting it at a disadvantage to other nations in the region that already have specialised regulatory frameworks. Creating a medicines agency would be a major modernisation of Uruguay's healthcare system, aligning the country with global standards.
The initiative for this agency is not new, and working groups of professionals have pursued its creation for almost two decades. Since 2008, the Association of Chemistry and Pharmacy of Uruguay has played an active role in promoting a National Health Surveillance Agency, and in 2020 the government attempted to launch a similar agency but it ultimately failed. Since this setback, the pharmaceutical sector has continued to operate with limited restrictions.
To date, the drug evaluation and approval process is centralised within Uruguay's Ministry of Public Health (MSP); however, the current structure has limitations. The MSP is less focused on pharmaceutical regulations, and the absence of a drug regulatory agency has negatively impacted healthcare system users. Uruguayans report facing high costs for medications not included in the Integrated Health Care Plan, forcing patients to pay expensive bills or even resort to legal modalities to obtain essential treatments. This current system has exposed the overall structural weakness of the healthcare system. The government therefore is advocating for the creation of the new drug regulatory agency to expedite economic growth, streamline drug approvals and attract international pharmaceutical companies to invest in the country. The new agency will absorb the existing MSP’s pharmaceutical regulatory functions, including drug licensing, quality control and price regulation.
To proceed with this major modernisation of the health system, Uruguay’s MSP has tasked a working group to plan the agency, and a 40-page proposal has been created by the Faculty of Chemistry at the University of Uruguay and submitted. It should be emphasised that this proposal is still in the early stages, and it has not been released by the government; however, a copy was published online on June 14 by Uruguayan newspaper El Pais.
The proposal revealed that the future agency will be named the Agency for the Evaluation, Regulation and Surveillance of Health Technologies (AUVISA), and that it will operate under the leadership of the country's health ministry, but independently, without political or financial interference. AUVISA is expected to become self-sustaining after an initial investment by the state, supported by user fees and taxes on exports and sales. It will therefore be included in the country’s five-year budget under the guise of a non-state public official agency. AUVISA's annual budget for salaries would be $13 million for 250 employees.
The proposal demonstrates that the country is aligning its new agency with requirements established by the World Health Organization, which require exporting countries to have an autonomous and robust health agency to guarantee international quality and safety standards. Additionally, while developing the proposal, the working group conducted an analysis of regulatory agencies in the region: Argentina's regulatory body the National Administration of Medicines, Food, and Medical Technology, Brazil's National Health Surveillance Agency, Chile's National Medicines Agency, Cuba's Center for State Control of Medicines, Equipment and Medical Devices and Colombia's National Institute for Drug and Food Surveillance, as well as one agency from Europe, the Spanish Agency for Medicines and Health Products. The objective of this analysis was to evaluate their organisational structures, the connection with their respective Ministries of Health and their level of economic autonomy, to identify models applicable to the characteristics of Uruguay.
Advocates for the agency believe that independent health regulatory agencies strengthen the integrity of a country's health system, protect patients and improve ability to respond to innovations and global health challenges. However, opponents of the agency claim that the proposal is costly and redundant. Opposing lawmakers propose an alternative process by which Uruguay would automatically ratify approvals by trusted foreign agencies. These lawmakers claim that Uruguay lacks the resources to regulate medicines effectively and should instead rely on decisions by established international bodies such as the European Medicines Agency. Critics also describe the proposed salary and bureaucratic burden as not seeming reasonable, and the salary scale proposed in the bill includes much higher salaries than those of the current Ministry of Public Health.
Advocates for the agency argue that while the opposing approach would streamline drugmakers' access to the local market, it would not affect drug pricing, improve pharmacovigilance, bolster local manufacturing capacity or advance specific public health priorities. Supporters continue to emphasise that the creation of a regulatory agency could improve the traceability of medications and ensure that the most up-to-date medicines are available at affordable prices.
Uruguay’s new government believes that the vitality of the pharmaceutical industry and the growing complexity of innovative treatments require new institutional tools that allow the country to adapt to the challenges of the 21st century. Nevertheless, the creation of the agency and the successful transition will depend on government funding and political support.
