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Executive Summary
The country’s annual healthcare expenditure amounts to approximately 5.2% of Chile’s GDP. President Piñera’s administration took office on March 11, 2018. His announcements for the healthcare sector include: reform of the private healthcare insurance (ISAPRES) system, reform of the Primary Attention System, modernization of the public-sector healthcare insurance system (FONASA), and amendments to the “Ley Farmacos II” still being discussed in Congress.
Chile’s Universal Access to Healthcare government program, ex “Plan AUGE”, currently known as “GES” (Garantias Explicitas en Salud), was started in 2005 and currently consists of government-subsidized healthcare coverage for 85 diseases considered to be high-incidence. However, expenditure in the private sector has doubled in the last 10 years. Private clinics have increased their number of outpatient centers and number of beds, mainly due to three factors: a) increase in demand, b) an aging Chilean population, and c) state-of-the-art technology available for diagnosis and treatment.
FONASA, the government-run healthcare insurance system, covers 69% of the population; of the remaining 31%, approximately 5% lacks any type of insurance, 3% has insurance under the Ministry of Defense (for armed forces and police), and 23% (bordering on 2.6 million people) pay into the private sector insurance system provided by ISAPRES. There are 12 ISAPRES providers currently operating in the Chilean market.
In terms of regulation, pharmaceuticals have mandatory registration at the Institute of Public Health. Currently, medical devices that need authorization include contraceptives, gloves, needles, and syringes. However, there is a law - Ley Farmacos II - that has been in Congress since 2015, which may impose additional regulations to pharmaceuticals and medical devices.
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Market Entry
U.S. medical equipment and devices are well regarded in Chile. A strategy that has proven successful for market entry is to appoint a qualified agent or distributor. Chilean distributors in the medical sector are usually knowledgeable, experienced, and have a good network of sales people throughout the country. Reliable after sales support is a priority in this market. Local distributors/representatives should be experienced in selling to the public sector through the government portal: www.mercadopublico.cl.
The metric system of weights and measures is standard in Chile. The electric power supply is 220V 50Hz. Since the implementation of the U.S.-Chile Free Trade Agreement in 2004, medical devices/equipment and pharmaceuticals enter Chile duty-free, provided a U.S. certificate of origin is presented to Chilean Customs. Imports to Chile from foreign countries, as well as domestic products, are subject to Chile’s 19% VAT (Value Added Tax).
Currently, mandatory registration at the Institute of Public Health is required for all pharmaceuticals and quality testing authorization is required for contraceptives, gloves, needles, and syringes.
There are 1,002 clinical laboratories throughout Chile. 303 are government-owned through municipalities or health centers and the rest are privately owned. In Santiago, there are 312 laboratories and 22 blood centers, which account for 31% of the private centers that assist 40% of the population.
There is no local production of laboratory equipment other than some refrigerators, cold chambers and blood banks, so the market size is estimated based on imports. In 2017 the US had a 28% market share for laboratory equipment followed by Germany with an 11% share. In the case of reagents, the market share was 37% for United States followed by 24% for Germany.
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Current Market Trends
U.S. state-of-the-art medical technology has good market potential in Chile, especially in the private sector as the Chilean private healthcare system is well regarded in the region. Private hospitals receive foreign patients for treatment on a regular basis. Some of these private hospitals have Joint Commission accreditation, and therefore maintain high standards as a permanent goal. Many Chilean physicians have U.S. post-graduate degrees and maintain regular contact with important U.S. healthcare institutions.
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Best Prospects
Leading sub-sectors include healthcare information management systems, telemedicine, and remote monitoring systems for chronic diseases.
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Market Size
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Healthcare spending (including investment)
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… as percent of GDP
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7.8 % (2014)
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Hospitals, Procedures, Healthcare Professionals UN:
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Number of hospitals
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363 in 2015
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…Public
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46%
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…Private
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54%
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Number of hospital beds
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38,496 in 2015
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… available beds per capita
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21 per 10,000 population in 2010
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Number of surgical procedures
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5,540 per 100,000 population in 2012
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Physicians
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1.03 physicians/1,000 population (2009)
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Demographics
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Population
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17,650,114 in 2016
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Life expectancy men/women
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75.7 men
81.9 women
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Infant mortality
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6.7 deaths / 1000 live births
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Percent of population older than 65
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10.51%
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…projection, 2030
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20.2 million
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Annual deaths
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101,943
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…caused by [highest disease burden]
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Ischemic heart disease
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…caused by [second highest]
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Cerebrovascular disease
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Prevalence of [fastest growing disease burden]
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Chronic kidney disease
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Main Competitors
In 2018, medical device imports amounted to US$ 695 million with the following market share: The United States has approximately 39%, followed by Germany with 23%, and China with 10%. Price is an extremely important factor, especially in the public sector where limited funds cover a large segment of the population. The private sector is also price sensitive but is far more likely to consider recognized brands that have good quality and a strong reputation for after-sales service.
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Current Demand
The following list of equipment is currently in demand in Chile: autoclaves, surgical tables, non-disposable and disposable surgical instruments, cardiology equipment including pacemakers, monitors (low and medium complexity), central monitors, ventilators, aspiration pumps, imaging equipment, trauma equipment, anesthesia instruments and appliances, and hospital furniture.
The following equipment/devices continue to have market potential: surgical tables, surgical lamps and flash lights, disposable and non-disposable surgical instruments, central monitors, trauma equipment, emergency equipment, and hospital furniture.
Since the implementation of the U.S. Chile Free Trade Agreement in 2004, medical devices with U.S. Certificate of Origin enter Chile duty free. However, a 19% Value Added Tax is levied over the CIF value of the merchandise. Sub-sector best prospects include modern senior home care equipment products and assistive devices, modern orthotics, modern orthopedic devices, trauma equipment, central monitors, incubators, surgical tables, disposable and non-disposable surgical instruments.
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Registration Process
In general, there is no health-required registration imposed on medical devices except for contraceptives, gloves, needles, and syringes, which do need an authorization/quality control assessment to certify their safety. X-Ray equipment or nuclear medicine equipment needs special authorization from other government agencies. Pharmaceuticals have mandatory registration that is granted by the Institute of Public Health.
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Reimbursement
Employees under contract are mandated by law to designate 7% of their monthly net wages to healthcare. However, freelance workers are not obliged to do so. Contracted workers must choose to use this 7% towards public or private healthcare.
In the public sector, workers are classified into three different categories depending on the contribution, which means that there are some workers who will pay for healthcare services and others who will not. Currently in Chile the minimum monthly wage is approximately US$458. Therefore, workers who earn less than this monthly amount do not pay. Wages above the minimum monthly wage must pay around 10% of the healthcare service, depending on their contribution.
The private sector, on the other hand, is different. Private healthcare insurance is called ISAPRES. The insurance is held by a contract that is renewed on an annual basis. For a new contract with a company, a healthcare declaration of all existing diseases must be provided. In some cases, an insurance company may decide to not include healthcare for previously diagnosed chronic diseases within the proposed plan. The contracted plan is paid on a monthly basis and the cost is calculated depending on the chosen benefits. In general, the healthcare service is paid according to the contracted plan and prior to any healthcare services provided. Insurance plans also have a limit on certain services they provide and once the annual limit is reached, the rest of the cost of healthcare must be paid out of pocket.
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Barriers
Chile has a favorable import climate. There are no known barriers to U.S. medical equipment, devices, pharmaceuticals, laboratory equipment, or diagnostic testing equipment.
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U.S. Commercial Service Contact Information
Name: Veronica Pinto
Position: Commercial Specialist
Email: veronica.pinto@trade.gov
Phone: (56-2) 2330-3369
Industries: Pharmaceuticals, medical devices/equipment, dental devices/equipment, biotechnology, and healthcare services
Name: Claudia Melkonian
Position: Commercial Assistant
Email: claudia.melkonian@trade.gov
Phone: (56-2) 2330-3312
Industries: Laboratory/testing equipment, veterinary equipment/products/pharmaceuticals.
