Overview

The government has implemented a national health system that provides healthcare services to all citizens and residents, regardless of their income or social status.  Total health spending represents 9 percent of the GDP, with the public sector accounting for 70 percent of it.  Experts predict a strong growth driven by both the public and private sectors, which is projected to reach 10 percent of the GDP by 2027, amounting to 11 billion dollars.  To ensure a successful entry and long-term business growth it is recommended to have a local partner. 

In 2007, the National Integrated Health System was established to integrate public and private providers.  It is funded through a Fund called FONASA in Spanish, a unique, public, and mandatory fund that collects contributions from employers, employees, and government.  Employers contribute an equivalent of 5 percent of the employee’s nominal wage, while workers contribute between 3 and 8 percent of their salary, depending on their income and family size.  In return, the workers, their children, and spouse receive comprehensive health coverage.  Individuals who do not contribute to social security (approximately one million people) receive coverage through the public hospital system called “ASSE.” They receive the same benefit plans as those affiliated with FONASA.  These who contribute, have the option to choose a private healthcare provider.  Most opt for one of the over 40 private Mutualista plans, which function as membership plans to private hospitals, without deductibles or lifetime caps.  On top, there’s a small percentage of the population who pay additionally a private insurance to have access to premium services and hospitals.  These institutions invest heavily in technology and modernization.

Uruguay’s doctor/population ratio stands at second place in Latin America and number 17 in the world.  However, the small population does not allow doctors to be exposed to a diversity of clinical cases and specialize in complex or rare pathologies.  Therefore, there are opportunities for specialized training, and for second-medical opinion services.

All diagnostic reagents, therapeutic devices, and medical equipment must be registered with the Ministry of Public Health.  This process is typically undertaken by the local representative as it must be initiated by a local company that is pre-registered with the Ministry.  It is important to note that having FDA approval alone is not sufficient for product registration.  Additional documentation, including a letter from the manufacturer designating the local company as the authorized representative/distributor, is required.  The registration process is often complex and time-consuming.  Once obtained, the record belongs to the company that initiated the request.  If multiple-authorized distributors operate in the market, each one must register the product with the Ministry.  The registration is valid for five years and can be renewed upon paying a fee.

Procurement by the public sector follows a competitive tendering process.  All offers are published online at the state’s procurement agency platform called “SICE.” 

Pharmaceutical

Source:  Transaction database – USD million / Uruguay XXI Reports.

*Including Free Trade Zones.

HTSUS:  2936, 2937, 2939, 2941, 3001, 3002, 3003, 3004, 3005, 3006 (pharmaceutical products).                 

Total Market Size = (Total Local Production + Total Imports) – (Total Exports).

Pharmaceuticals are the leading industry in the life science sector.  Uruguay has a long history in pharmaceuticals and has over 30 pharmaceutical facilities.  Approximately 61 percent of the national production is produced for the domestic market and 39 percent for export markets.  The workforce is highly skilled and knowledgeable, and the government has established a transparent regulatory framework in which companies and laboratories operate.  International firms have raised concerns about Uruguay’s pharmaceutical intellectual property regime, which can take up to 10 years to grant intellectual property rights to international pharmaceutical producers.  According to Uruguay XXI, in 2022, Uruguay’s pharmaceutical exports amounted to USD $183 million by 17 companies (more than half of them were exported from free trade zones, more specifically form Zonamerica and Parque de las Ciencias), representing 1.4 percent of the total amount of exports of the country.  Exports of veterinary products totaled USD $103 million.  Both products of human and veterinary use were predominantly sold to other Latin American countries, primarily Argentina.  Additionally, Uruguay’s pharmaceutical industry exports vaccines and serums, primarily for veterinary use and packaged for retail sale.  Pharmaceutical laboratories are dependent on imported raw materials, mainly from China, because Uruguay and other countries in the region do not produce these chemicals.

In 2022, the United States ranked as the fourth largest suppliers of pharmaceuticals to Uruguay after Argentina, Brazil, and Germany.  In 2022, Uruguay’s main imports were medicines followed by immunologic reagents.  Most pharmaceuticals imported from the United States were medicines, followed by immunological products.

Uruguay’s regulatory framework offers important advantages for logistics operations, with incentives for the installation of regional distribution centers to handle goods in transit (free trade zones, free port and airport, temporary admission, and deposits).  In 2022, the transit of pharmaceutical products in Uruguay reached $752 million, which is almost four times the amount exported by the sector.  This business model has grown over the last decade and has become an important option for companies serving the region.  The transit of pharmaceuticals through Uruguay shows an important flow of goods from the northern hemisphere, 50 percent come from Europe, 17 percent from the United States, and 30 percent from Mercosur (mostly from Argentina).  The final destinations are 47 percent to Mercosur, 27 percent rest of South America, 17 percent Central America, and 13 percent North America.

Prior authorization by the Ministry of Public Health is needed for import, representation, production, and commercialization of medicines of human use.  For veterinary products, prior authorization by the Ministry of Livestock, Agriculture and Fishing is required. 

Health Information Technology

In 2012, Government of Uruguay created the website, Salud.uy, which is an online healthcare platform shared by multiple government agencies.  Uruguay’s Presidency, the Ministry of Health, the Ministry of Economy, and the National Agency of Electronic Government (AGESIC) all coordinate the development of health IT initiatives on the platform. 

The Government of Uruguay approved Decree 242/017 in September 2017, which created the National Electronic Health Record platform (HCEN).  Resolution No.  1085 generated a staged-plan where forty-three healthcare providers created compatible electronic health records for their respective patients.  By the end of 2020, healthcare providers were to have registered 100 percent of patients (2.1 million people) and 90 percent of the healthcare activities such as medical studies, medical appointments, and others on the HCEN platform.

In 2019, Uruguay also implemented a National Digital Receipt, allowing patients to order prescriptions online and have the prescriptions delivered.  There is also a National Network of Image Diagnosis enabling doctors to check the results of imaging studies through any device connected to the network.

In March 2020, the government of Uruguay passed a telemedicine law to promote healthcare IT development in the country.  This law contains general regulations to support the implementation of telemedicine in Uruguay. 

Additionally, local medical technology distributors in Uruguay are interested in learning about U.S. solutions for digital health with the intention of representing these companies locally.

Medical Equipment

Source: Transaction database 

HS Codes: 9011;9012;9018;9019;9021;9022;9027

Total Market Size = (Total Local Production + Total Imports) – (Total Exports).

In 2022, U.S. products accounted for 32.5 percent of medical equipment imports in Uruguay, followed by China (11 percent) and Germany (9.7 percent). 

Opportunities and challenges

Private hospitals in Uruguay are investing in technology and modernizing their facilities, creating opportunities for U.S. manufacturers of hospital equipment and technology.  Some providers are working with U.S. Exim Bank’s loan Guarantee program and PNC Bank to provide this financing tool to local healthcare institutions to facilitate the acquisition of U.S. products and technologies.  U.S. companies are most successful in this market when offering price-competitive, high-quality, and innovative products.

Due to its geographical location, free trade zones, and legal and tax framework, Uruguay has positioned itself as a logistical hub for the pharmaceutical industry.  The free trade zones, free seaport, free airport, and warehouse regulations provide a complimentary framework for establishing distribution centers that supply medical goods to other locations in Latin America.  Additionally, Uruguay is an attractive innovation hub for the research divisions of international companies.  Uruguay offers government support that assist life science firms who invest in Uruguay.

On the other hand, in December 2020 the Uruguayan Congress issued Article 325 of Law No.  19924 which modified Article 99 of Patent Law No. 17164 regarding patent infringement protection occurring between the time of patent publication and the granting of the patent.  This change affects the protection of pharmaceutical products whose research occurred outside of Uruguay.  This is a concern to many international pharmaceutical producers because it can take up to 10 years to be granted intellectual property protection rights for pharmaceuticals.