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Will Argentina Be The Next Medtech Clinical Trial Destination In Latin America?

With a population surpassing 44 million, Argentina presents a compelling proposition for medtech clinical trials, bolstered by its robust healthcare system, modern facilities, and a cadre of experienced medical professionals.1

The country's position in the global arena is further underscored by its rank of 20th out of 46 in the 2020–2021 Medical Tourism Index, highlighting its healthcare system's high doctor-patient ratio, top-notch medical facilities, and substantial healthcare investments. This underlines Argentina's emerging prominence in the medtech sector, particularly in cosmetic and reconstructive surgeries, regenerative medicine, cardiology, and other medical procedures, offering competitive expertise and pricing advantages.2

As stakeholders in the Argentina clinical research landscape, including contract research organizations (CROs), navigate the expeditious clinical trial approval timeline, positive developments in the local clinical research industry continue to unfold. These advancements, alongside a robust clinical trial hospital infrastructure, underscore the nation's potential ascendancy as the next major hub for medtech clinical trial activity, poised to attract increased foreign sponsorship and partnership. From 2018 to 2022, Argentina's clinical trial industry's market size increased by 126.6%, from $7.2 million to $88.9 million.3 This article will explore Argentina's medical device clinical trial landscape. It will explore why this South American country is now one of Latin America's top clinical trial destinations.

Clinical Trials Landscape And Oversight

The potential of Argentina as the next medtech clinical trial destination is magnified by its steadfast adherence to international quality and safety standards. This attribute aligns with the stringent nature of clinical trial regulatory approval processes. The clinical trial landscape is also enriched by local and international seasoned CROs, a competitive clinical trial approval timeline, thorough regulations, and an advanced hospital infrastructure conducive to medtech clinical trials. These elements, combined with Argentina's unique cultural and linguistic offerings, position it as a promising hub for clinical research, offering vast opportunities for global research organizations and participants.

Medtech clinical trials are pivotal in assessing the safety and efficacy of innovative medical technologies and procedures. Argentina emerges as a compelling destination for these trials, thanks to its substantial and varied population, cutting-edge medical infrastructure, and comparatively lower costs relative to the U.S. This setting, underpinned by the oversight of the Argentine National Administration of Drugs, Foods, and Medical Technology (ANMAT), positions Argentina advantageously in the global clinical trial regulatory approval process, promising alignment with ethical guidelines and international standards.4 ANMAT, established in 1992, controls and monitors drug products, medical devices, and more. As of 2019, the Pan American Health Organization (PAHO) has recognized eight national regulatory authorities of regional reference (NRAr). These authorities are recognized for their regulatory capabilities in the region. ANMAT is one of them.5

Argentina’s Contributions To Medical Device Innovation

Argentina has made significant contributions to medical device innovations, with several notable inventions that have had a global impact. Here are some of the most prominent medical device innovations from Argentina:

  1. Finochietto Rib Spreader: This is one of the most famous surgical instruments invented in Argentina by Enrique Finochietto. The Finochietto rib spreader, or thoracic retractor, is a critical tool used in thoracic surgery to provide access to the chest cavity by retracting the ribs. Enrique Finochietto created 67 surgical instruments, including his eponymous retractor.6,7
  2. Coronary Artery Bypass: The surgical intervention to treat heart blockages, known as the coronary artery bypass, was created by Dr. René Favaloro in 1967. This method revolutionized heart surgery and remains the most practiced surgical treatment for heart disease worldwide.8
  3. Total Artificial Heart Transplant: Domingo Liotta, an Argentine inventor, and his North American colleague Denton Cooley performed the first total artificial heart transplant in 1969. The artificial heart they developed was made of plastic fiber and polyester, marking a significant milestone in cardiac surgery and artificial organ development.9
  4. Coronary Stent: Invented by Dr. Julio Palmaz, the coronary stent has revolutionized the treatment of coronary heart disease. The Palmaz-Schatz stent, developed in the late 1980s, was the first successful coronary stent. It reduced the risk of artery closure after angioplasty and improved blood flow. The stent received FDA approval in 1994 and has had a profound impact on the treatment of coronary artery disease.10,11

These inventions highlight Argentina's rich medical technology innovation history and contributions to global healthcare advancements.

Hospital Infrastructure

Argentina has a robust hospital infrastructure that supports clinical trials, making it an attractive location for such research. As of 2023, hospital infrastructure in Argentina encompassed a wide range of facilities capable of supporting various healthcare needs, including clinical research.12

According to a 2023 Latam Business Conference (LBC) ranking, two Argentine hospitals are among the top 10 best in Latin America. The Hospital Italiano de Buenos Aires is ranked seventh, and the Hospital Universitario Austral is ranked ninth. The rankings are based on the best hospitals in Latin America over the past year.13 The 2021 rankings from Statista also named the Hospital Italiano de Buenos Aires as the highest-quality hospital in Argentina, with a quality index score of 82.3. The rankings consider seven dimensions: patient safety, human capital, capacity, knowledge management, reputation, efficiency, and patient dignity and experience.14  According to Global Health Intelligence, Sanatorio Güemes is the best-equipped hospital in Argentina for hosting patients, with 1,162 points. Hospital San Bernardo is ranked second, with 897 points, and Hospital Dr. José María Cullen is ranked third, with 357 points.15 Almost 80% of the clinical research activity in Argentina happens at hospitals in the greater Buenos Aires metropolitan area.3

Moreover, Argentina's Ministry of Health has taken steps to improve patient experiences and healthcare delivery by establishing a national digital health network. This network allows care centers to access patient data securely, facilitating standardized provider integration and supporting medical data sharing for millions nationwide.16 Such advancements in healthcare infrastructure and digital health initiatives further enhance Argentina's capacity to host clinical trials by improving data management and patient tracking.

Argentina's hospital infrastructure, supportive policies, and digital health initiatives provide a solid foundation for conducting clinical trials, making it an attractive destination for international and local research sponsors.

Demand For Medical Device Clinical Trials

The global medical device CRO market is expected to grow at a compound annual growth rate (CAGR) of 8.8% from 2023 to 2030. Given the global nature of this growth rate, it can be inferred that Latin America, and particularly Argentina (as part of the global market), may experience similar growth trends, especially considering the region's increasing role in clinical trials and the broader CRO market.17 As one of the largest medical device markets in Latin America, Argentina is an attractive destination for such trials due to several factors:

  1. High Prevalence of Chronic Diseases: The rising number of clinical trials in Argentina is driven by the high prevalence of chronic diseases, which necessitates developing and testing new medical devices.18
  2. Import-Driven Market: Argentina's medical device market is significantly import-driven, with a substantial portion of medical devices imported from the U.S., Germany, China, and Brazil.19 This creates opportunities for international manufacturers to test and introduce their products in the Argentine market. The Latin American medical devices market was valued at $42.89 billion in 2023 and is projected to grow at a CAGR of 5.79% from 2023 to 2028, reaching $56.84 billion. Argentina and Mexico are expected to be the fastest-growing regions, with Argentina growing at a CAGR of 11.2%, making it one of the fastest-growing medical device markets in the region.20
  3. Regulatory Environment: For Class III and IV medical devices, manufacturers must submit clinical trial results demonstrating the safety and efficacy of the device. This regulatory requirement encourages the conduct of clinical trials within the country.21
  4. Healthcare Expenditure: Healthcare expenditures in Argentina traditionally account for approximately 9% to 10% of GDP, among the highest in the region.1 This indicates a substantial investment in healthcare, including adopting and testing new medical technologies.
  5. Highly Trained Healthcare Professionals: Argentina boasts high academic training among healthcare professionals and remarkable hospital capacity.1 This provides a conducive environment for conducting clinical trials with skilled personnel and adequate facilities.
  6. Economic Factors: Despite economic challenges such as high inflation and currency controls, there is still high demand for imported essential and specialized medical equipment.21 This suggests that there is room for growth and experimentation in the medical device sector, including clinical trials.

The demand for medical device clinical trials in Argentina is supported by the country's significant healthcare expenditure, the prevalence of chronic diseases, a regulatory environment that mandates the demonstration of device safety and efficacy, and the presence of highly trained healthcare professionals. These factors make Argentina an attractive location for conducting medical device clinical trials.

Healthcare System

Argentina's healthcare system comprises three main sectors: public, social security, and private.22,23

  • Public Sector: This includes a network of public hospitals and primary healthcare units that provide care to the poor and uninsured population. It is financed with taxes and payments made by social security beneficiaries who use public healthcare facilities. Currently, about half of the population uses the public system.22,24
  • Social Security Sector: Also known as Obras Sociales, this sector covers all formal economy workers and their families. It operates through contracts with private providers and is financed with payroll contributions from employers and employees. The social security sector is managed by labor union-run health insurance schemes, with over 300 Obras Sociales in Argentina.22,23
  • Private Sector: This includes private providers offering services to individuals, beneficiaries of Obras Sociales, and those with private health insurance. The private sector also includes prepaid medicine enterprises, financed chiefly through premiums paid by families and employers. About 13.6% of the population is covered by the private system, and 10.4% has more than one type of coverage.24

The Ministry of Health (MSAL) oversees all three subsectors of the healthcare system and is responsible for setting regulations, conducting evaluations, and collecting statistics.22 The healthcare system in Argentina is known for its high-quality services, especially in major cities, and it is accessible to both residents and foreigners. Public health services provide free hospital, medical, dental, and palliative care. In contrast, private health services offer a higher level of care with reduced waiting times.25

Most of the population of Latin America receives healthcare services mainly through public not-for-profit hospitals that are part of the public healthcare system.26–31 Most clinical research experts in Latin America agree that conducting clinical trials at public not-for-profit hospitals is challenging due to bureaucracy, delays in institutional review board approvals, and contract negotiations and signing. This forces most CROs and sponsors in Latin America to prefer private for-profit hospitals over public hospitals when selecting research sites for their studies. Contrary to most countries in Latin America, only about 50% of the Argentinian population uses public sector hospitals.22 This situation gives Argentina an advantage over most Latin American countries since, in Argentina there’s a larger patient pool (50% of the 44 million) in private hospitals than in most other countries in Latin America. Recent government findings report that 88% of the clinical trial activity in Argentina happens in private for-profit hospitals.3

Clinical Trials Growth

The medical device clinical trial market is growing in Latin America. According to the provided sources, there was a significant increase in medical device trials in the region, with a 138% increase from 17 trials in 2017 to 31 trials in 2020.32 Additionally, the Latin America Clinical Trials Market is projected to reach $2.76 billion by 2027, growing at a CAGR of 8.20% from 2022 to 2027, indicating a positive growth trend in the market for clinical trials, which includes medical device trials.33

The remarkable growth in clinical trials in Argentina and substantial foreign sponsorship delineates a promising trajectory for the nation's role in global medical research. This growth encompasses several vital factors:

  • According to a report from the Argentinian Ministry of Sciences and Technology, foreign manufacturers sponsor 91.8% of clinical trials in the country.3
  • According to ClinicalTrials.gov, from 2010 to 2021, clinical trials in Argentina saw a 61% increase, evidencing the country's expanding research capabilities and attractiveness to international sponsors. Argentina now averages about 200 new clinical trials annually, which positions the country after Chile as the second highest recipient of foreign-sponsored clinical trials in Latin America per million population.34,35
  • As of March 2024, Argentina hosted 3,935 clinical studies with diverse phases, indicating a robust clinical trial ecosystem.35
  • According to the data, as of 2017, the urban population of Argentina represented 92% of the country's total population, making it one of the most urbanized countries in the world and surpassing both European and United States averages.36 This level of urbanization places Argentina among the highest in Latin America, with the region being the most urbanized region globally, where about 80% of the population lives in cities.37 This data suggests a high concentration of potential trial subjects and qualified medical professionals, as well as low dropout rates.38
  • The country's qualified and reliable medical professionals contribute to low dropout rates and strong enrollment and compliance rates. This has led to excellent quality data being seen in all FDA and EMA audits.38

These elements collectively position Argentina as a burgeoning hub for clinical trials, attracting significant foreign investment and sponsorship and contributing to the global advancement of medical science.

The Regulatory Framework For Medtech Clinical Trials In Argentina

Clinical trials for medical devices in Argentina must adhere to specific requirements set forth by the Ministry of Health (MoH) Regulation No. 969 of 1997 and ANMAT Regulation No. 6,777 of 2010. These regulations mandate that ANMAT and an accredited ethics committee within the country approve the clinical trial protocol.19 These are the steps to approve a medical device clinical trial in Argentina:

  • Institutional Review Board/Ethics Committee Approval: Approval from an independent ethics committee and the medical institution where the trial will be conducted is required. According to local industry experts, this approval can take 15 working days.
  • Submission of Documentation to ANMAT: Sponsors must submit a comprehensive set of documents to ANMAT for review. This includes the clinical trial protocol, informed consent forms, medical device and investigator information, and details about the trial sponsor.4,39
  • Review by ANMAT: Upon receiving the documentation, ANMAT conducts a thorough review to ensure compliance with regulatory requirements and good clinical practices. This includes evaluating the study's scientific validity, the participants' safety and rights, and the adequacy of the informed consent process.4
  • Validation Period: A "validation period" of three working days is established, during which only complete packages will move forward to the evaluation process.38
  • Technical and Administrative Evaluation: The evaluation process is expected to take 60 working days for technical evaluation plus an additional 10 working days for administrative aspects, totaling 70 working days.38
  • Registration at ReNIS: Sponsors must register their study at the National Registry of Health Research (ReNIS), the national registry for clinical trial disclosure.4

Effective June 5, 2017, these guidelines were designed to streamline regulatory timelines and promote greater efficiency, economy, transparency, and predictability while adhering to strict international guidelines for patient safety. These regulatory changes have aimed to accelerate the evaluation process from longer durations to the current timelines. Regular reviews and updates of regulations facilitate the adoption of new clinical trial designs and more agile marketing approvals for new medical products in Argentina. These changes reflect Argentina's commitment to improving the efficiency of its clinical trial regulatory environment.40,41

Conclusion

Argentina is one of the top economies in Latin America. According to the International Monetary Fund's October 2023 World Economic Outlook database estimates, the country ranks as the third-largest economy in Latin America by gross domestic product (GDP) at purchasing power parity (PPP), following Brazil and Mexico.42 This is further supported by the World Bank, which notes that with a GDP of approximately $650 billion, Argentina is one of the largest economies in the region.43 Additionally, Argentina is recognized for its vast natural resources in energy and agriculture, which contribute significantly to its economy. Challenges in Argentina's medical device field include strict currency controls, high inflation, and low foreign investment. Despite these economic hurdles, the demand for imported essential and specialized medical equipment remains high, offering business and clinical trial opportunities for medical device manufacturers.21 The country is now poised to become a significant hub for medtech clinical trials due to streamlined regulatory processes, a large and diverse population, a robust medical infrastructure, lower hospital fees, and a thriving clinical trial landscape. As Argentina navigates the clinical trial industry's complexities, it fosters an environment ripe for scientific advancement and collaborative international research efforts. The potential for growth and innovation and realizing Argentina's full capabilities for medical device clinical trials remains exciting.

References

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About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).

Source: Med Device Online.

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