Colombia A Strategic Choice For Medtech Clinical Trials

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By Julio G. Martinez-Clark, CEO, bioaccess

Colombia, one of the top three economies and most populous countries in Latin America, with its vibrant culture, diverse landscapes, and rapidly growing economy, is a promising destination for medical device clinical trials and other advanced medical technologies. Colombia actively promotes foreign direct investment (FDI) within a welcoming and secure business environment.1 Colombia is a middle-income nation of 52 million people and one of the oldest democracies in Latin America; it established ties with the United States in 1822 and, since then, it has become one of the closest U.S. allies in Latin America and receives the most U.S. aid in the region through a multifaceted approach that includes financial support, trade agreements, military aid, and humanitarian assistance.2,3 This support aims to promote peace, prosperity, and security within Colombia and address broader regional challenges.4 This article explores the critical aspects of conducting clinical trials for medical devices in Colombia.

The Healthcare System In Colombia

Colombia has demonstrated its commitment to global health by offering comprehensive coverage to its citizens based on a mixed model combining the public and private sectors. The country has well-equipped private hospitals with modern technology and highly skilled physicians, contributing to its reputation as one of the best healthcare systems in Latin America.

The Colombian healthcare system embraces the idea that access to quality medical services is a fundamental constitutional right for all citizens, and this approach has led the country to stand out internationally. Among 40 countries, Colombia scores highly in several categories of The Economist’s 2023 The Health Inclusivity Index: measuring progress towards good health for everyone.5

Despite achieving nearly universal coverage and making significant strides toward equitable health access for its population, the Colombian healthcare system faces several critical challenges threatening its sustainability and effectiveness. These challenges can be categorized into issues related to financial sustainability and systemic inefficiencies.7

While Colombia has made remarkable progress in expanding coverage, there remains a gap between formal and material health coverage. Despite being formally insured, many individuals lack material access to healthcare services, leading to thousands of citizens filing lawsuits against health insurance companies.8 Despite the universal coverage in Colombia, patients have challenges accessing care and complain about low-quality services, very long waiting times, and difficulty accessing high-cost procedures. The lack of material access to healthcare services attracts patients who see clinical trials as a vehicle to overcome these challenges in the healthcare system.

Colombia’s Hospital Infrastructure

Colombia's hospital infrastructure is among the best in Latin America, supported by its significant representation in regional rankings. Colombia has 57 nationally quality accredited hospitals and is one of the only three Latin American countries in the Newsweek World’s Best Hospital 2024 ranking, a prestigious international listing that ranked 2,400 hospitals across 30 countries.9 These hospitals comply with the minimum legal quality conditions required by their respective health authorities and also have obtained international recognition.10 Another popular annual regional ranking shows that Colombia has 41%, or 19, of the 46 hospitals in the ranking, which is to say that Colombia has the most top-ranked hospitals in Latin America.11

Colombia has the highest density of for-profit privately owned hospitals per million population in Latin America, with 167 hospitals per million as of 2021. Mexico is the next leading country in Latin America with 31.6 for-profit hospitals per million population.12 Corruption and bureaucracy present significant challenges in business dealings with public not-for-profit hospitals in Latin America.13

Most of the population of Latin America (e.g., Mexico, 70.9%; Brazil, 75%; Argentina, 50%; Chile, 76.5%; Panama, 90%; and Costa Rica, 91%) receive healthcare services mainly through public not-for-profit hospitals that are part of the public healthcare system.14–19 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 in Latin America to prefer private hospitals over public hospitals when selecting research sites for their studies. Contrary to most countries in Latin America, Colombia’s national government doesn’t own hospitals. This situation gives Colombia an advantage over most Latin American countries since over 95% of the Colombian population receives healthcare services through private for-profit hospitals. This means that CROs in Colombia don’t have to choose between activating a public not-for-profit hospital as a research site with high patient volume or a private for-profit hospital with low patient volume.

Over the past decade, Colombia has become an increasingly popular destination for medical tourists, particularly for cosmetic surgery, dental care, cardiac, bariatric, orthopedics, and fertility procedures. Colombia is among the fastest-growing medical tourism destinations in the world. Medical tourists flock to Colombia for its high-quality healthcare services, advanced technology, and well-trained medical professionals offering various healthcare services at competitive prices. The medical tourism industry is experiencing growth, with the country establishing itself as a leading destination for medical tourism in Latin America. Furthermore, the Colombian Ministry of Industry and Tourism regulates medical tourism in the country and forecasts at least 2.8 million health tourists and a revenue of at least $6.3 billion by 2032, indicating a significant role for medical tourism in Colombia's economy.20,21

The State Of Clinical Research In Colombia

The globalization of clinical research has brought about substantial changes in the pharmaceutical and medical device industries, with Latin America emerging as a prime destination for international clinical trials. Colombia stands out as a noteworthy hub for clinical research, offering many advantages that make it an attractive choice for medtech companies.

According to ClinicalTrials.gov, 240 clinical studies in Colombia are recruiting and not yet recruiting. ClinicalTrials.gov data also shows that Colombia, with 4.65, is the fourth country in Latin America for recruiting and not-yet recruiting studies in Latin America per million people (after Chile, with 17.03, Argentina, with 13.14, and Brazil, with 5.39).22

Here are some critical aspects of the country’s clinical trial landscape:

Rapid Subject Recruitment

One of the crucial factors in any clinical trial is the ability to recruit subjects efficiently.23 As the third most populated country in Latin America, Colombia boasts a large population, with most of the population covered by its universal healthcare system. The nation's well-established healthcare system and robust hospital infrastructure further facilitate recruitment, ensuring a large and diverse pool of potential study participants. Also, most of the Colombian population lives in urban areas, making patient recruitment easier in Colombia than in less urbanized countries.

Experienced Clinical Research Sites

Colombia has a rich history of clinical research, with foreign pharmaceutical companies having conducted trials in the country for over three decades. Since 2010, medtech companies also have begun to choose Colombia for early-phase clinical trials. To ensure the adequacy of research centers, subject safety, and data quality, the Colombian regulatory agency (INVIMA), a dependency of the Ministry of Health, is proactive by certifying and auditing research sites every five years. Colombia is the only country in Latin America with a stringent ICH/GCP institutional quality certification process. Currently, the country has approximately 150 ICH/GCP-qualified certified research sites.24

Efficient Regulatory Approval

Concerns about regulatory approval timelines are common among companies planning clinical trials. Fortunately, in Colombia, a typical institutional review board (IRB) (also known in Colombia as a research ethics committee) evaluates and approves a research study in 15 to 30 calendar days. INVIMA’s medical device committee typically evaluates studies every 30 days during their monthly meetings (after IRB approval), a unique meeting schedule in Latin America, and is open to having pre-submission meetings with sponsors. At their scheduled meeting, INVIMA approves or issues requests for corrections on the submission.25 The timeline for approval might vary depending on the number of rounds of questions and answers involved in the process. Still, generally, it is a streamlined and efficient process that takes 60 to 90 calendar days.26

Cost-Competitive Environment

Colombia presents a cost-competitive environment for clinical trials, including for medtech companies. The savings a medtech can expect by going to Colombia for experimental medical procedures compared to the U.S. can be substantial, depending on the specific procedure. In general, medical procedures in Colombia can be 40%–75% lower than rates in the U.S.27 The country's cost-effective environment allows for more extensive and comprehensive studies, benefiting patients and advancing medical knowledge without compromising quality.

FDA Clinical Trial Data Acceptance

A crucial concern for companies conducting clinical trials outside the United States is whether the FDA will accept the data collected. The FDA will readily accept Colombian clinical data if it adheres to ICH/GCP guidelines and provides evidence of such adherence to the FDA.10

Proctor Participation in Procedures

Representatives of medtech companies can scrub in and participate in clinical procedures conducted on study subjects in Colombia. Most Colombian investigators are honored and delighted to have a U.S. physician proctor scrub in the operating room. This collaboration and engagement with in-country investigators help ensure the smooth and effective transfer of knowledge and execution of the trials. Foreign medtech company physician proctors can quickly obtain a temporary medical license to perform procedures at research sites in Colombia.28

Accessibility and Safety

Traveling to Colombia is both quick and easy. Direct flights from major U.S. cities provide convenient accessibility to the country.1 Furthermore, Colombia has become a safe and welcoming destination for tourists and business travelers. The nation’s dedicated efforts to improve safety over the past decades, such as signing a peace deal with the largest guerrilla group and tackling drug trafficking, have successfully made Colombia a secure place to visit, live, and conduct business. Between 2021 and 2023, tourism in Colombia experienced significant growth. The number of non-resident visitors arriving in Colombia during the first nine months of 2023 was 4,198,801, which already surpassed the number of visitors during the same period in 2022 (3,247,698), indicating a 29.3% increase in tourism.29

Generous R&D Incentives

Colombia offers generous research and innovation (R&D) tax incentives among the Organization for Economic Co-operation and Development (OECD) and partner economies. In 2021, the marginal tax subsidy rate for profit-making (loss-making) small and midsize enterprises (SMEs) in Colombia was estimated at 0.67 (0.50), well above the OECD median of 0.20 (0.18).30 This means that medtech companies looking to run a clinical trial in Colombia can create a local entity and claim a 50% tax rebate from their investment in their research projects.

For medtech companies that create a local entity in Colombia, the country also offers a fast-track way to sell their innovations in the local market before obtaining FDA approval. Colombia allows foreign manufacturers of non-FDA-approved medical devices to partner with a local contract manufacturer compliant with good manufacturing practices (GMP) to assemble devices and package them for sale through a distributor in the local market. The Colombia medical devices market was valued at $1.42 billion in 2022. Colombia is Latin America's third-largest medical device market after Brazil and Mexico. A significant rise in the prevalence of chronic diseases, rising market authorizations by INVIMA, and favorable reimbursement scenarios for high-end devices in Colombia are projected to boost market growth.

Medtech Success Cases In Colombia

Many medtech companies have successfully conducted studies in Colombia, attesting to the nation’s favorable environment for clinical trials. Companies like Mitralign, Avinger, Cook Medical, Avantec Vascular, ReGelTec, Imperative Care, Watershed Therapeutics, enVVeno Medical, PAVmed, Sparta Biomedical, B2M Medical, Watershed Therapeutics, Perceptive Technologies, and eyeFlow are just a few examples of those who have experienced success in the Colombian clinical research landscape.

Conclusion

Latin American countries are indeed making strides toward becoming knowledge societies, with countries like Uruguay, Brazil, and Colombia taking active roles in this transformation by following the Knowledge Societies Policy Handbook initiative, developed under the auspices of UNESCO's Information for All Programme (IFAP). Colombia houses a substantial global business community of numerous reputable and well-established medtech companies dedicated to maintaining a lasting presence. These companies include Johnson & Johnson, Siemens, 3M, Medtronic, General Electric, B Braun, Boston Scientific, and many other top global medtech companies.31 Colombia’s combination of a large and diverse population, experienced clinical research sites, efficient regulatory processes, a cost-competitive environment, a regionally respected association of clinical research professionals (AVANZAR) working with the government to increasingly attract more foreign investment in clinical research, and a track record of successful medtech clinical trials since 2010 make it an attractive choice for U.S. medical device companies looking to conduct clinical research to obtain cost-effective clinical data for proof-of-concept or FDA submissions for a larger pivotal trial in the U.S. As Colombia continues to lead in clinical research, it exemplifies how innovation and opportunity converge to advance healthcare globally. With accessibility and safety considerations also in favor of Colombia, this Latin American nation is becoming a strategic choice for medtech clinical trials.

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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).

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Source link : https://www.meddeviceonline.com/doc/colombia-a-strategic-choice-for-medtech-clinical-trials-0001 Author : Publish date : 2024-03-21 03:00:00 Copyright for syndicated content belongs to the linked Source .