The Healthcare Law Review: South Korea
The healthcare industry of South Korea is mainly governed by the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS). These government authorities are concerned with the healthcare service at large, including the enforcement of healthcare-related laws and regulations, administrative review of healthcare professionals, certification of medical institutions, mediation of medical disputes, sanctions on illegal rebates involving pharmaceutical products and medical devices, national health insurance, pricing and reimbursement, safety management of pharmaceutical products and medical devices, and the overall management of clinical trials. The MOHW and the MFDS work together with related organisations, including the National Hospital, the National Health Insurance Service (NHIS), the National Medical Center, the Korea Institute of Drug Safety and Risk Management, and the Health Insurance Review and Assessment Service (HIRA).
Healthcare services can be provided by a variety of healthcare providers, including clinic-level medical institutions and hospital-level medical institutions, and citizens can choose the providers from which they wish to receive their healthcare services. The licensing, establishment and operation of healthcare providers are also governed by the MOHW pursuant to relevant laws and regulations.
National health insurance is the central component of the operation and funding of healthcare services in South Korea. Within the national health insurance system, insurance enrolment and payment of insurance contributions are mandatory, and the amount of the insurance contributions is determined based on the income level of the relevant insured.
The healthcare economy
Healthcare related laws in South Korea include (1) the Pharmaceutical Affairs Act (PAA), (2) laws and regulations relating to medical devices, (3) the Medical Service Act (MSA), and (4) laws and regulations relating to health insurance.
There are various stakeholders involved in the healthcare industry in South Korea, including the following:
- medical institutions;
- healthcare professionals;
- manufacturers, importers and sellers of medical devices and pharmaceutical or biotechnology products;
- insurance companies;
- government authorities, including the MOHW, the NHIS, the HIRA and the MFDS; and
- academic institutions for healthcare professionals.
The roles played by the various government authorities in relation to national health insurance are as follows.
The MOHW: the MOHW is ultimately responsible for making policy decisions regarding the national health insurance system. For example, the MOHW determines the insurance contribution rate, the standards for the imposition of insurance contributions, and the scope of healthcare benefits subject to insurance. The MOHW also approves the budget and regulations of the NHIS, which is the authority managing and operating the national health insurance system.
The NHIS: as the insurer of the national health insurance system, the responsibilities of the NHIS include:
- the management of qualification criteria of health insurance subscribers and their dependants;
- the imposition and collection of insurance contributions;
- the management of insurance benefits;
- the implementation of national health check-ups, disease prevention and health promotion related work;
- payments to medical institutions;
- the determination of drug prices through negotiations with pharmaceutical companies; and
- the execution of pricing contracts with pharmaceutical companies.
The HIRA: the responsibilities of the HIRA include (1) the assessment of medical care costs and the appropriateness of the healthcare benefits and (2) the development of these review and assessment criteria.
The Health Insurance Policy Deliberative Committee: as a committee under the MOHW, the Health Insurance Policy Deliberative Committee makes decisions on long-term comprehensive planning for the national health insurance system, the implementation, timing and method of these comprehensive plans, and the various standards applicable to benefit qualifications and the level of insurance contributions and benefits.
ii The role of national health insurance
National health insurance under the National Health Insurance Act
The national health insurance programme in South Korea is a public insurance system that spreads the burden of medical expenditure to all residents under the mandatory National Health Insurance coverage. The resources required to run the national health insurance programme are derived from insurance contributions paid by the insured and their employers (as applicable), government subsidies and other income (such as fees for delinquent payments and other penalties).
The national health insurance programme is governed by the National Health Insurance Act and the key features of this statute are as follows:
- the national health insurance programme is compulsory when certain legal requirements are met, and the payment of insurance contributions becomes mandatory;
- insurance contributions are imposed according to ability to pay (i.e., depending on income level); and
- regardless of the level of the insurance contributions paid, insurance benefits are paid equally with regard to the scope and level of insurance coverage.
Non-resident foreign patients are not eligible for national health insurance coverage under the National Health Insurance Act.
The medical benefits system is a public assistance system that provides support with respect to medical problems of low-income citizens. It is a social security system that works together with the national health insurance system to support public health. Specifically, the MOHW has responsibility for the medical benefits system, and provides medical costs assistance to those on low incomes pursuant to the Medical Care Assistance Act.
In principle, the medical benefits system provides support for medical expenses for items specified in the National Health Insurance Medical Benefits Criteria published by the MOHW. Certain co-payment requirements may apply, as well as restrictions on the number of days during which medical benefits or treatment procedures can be received.
Citizens may also enrol into private insurance in addition to the national health insurance system. Private insurance differs from public insurance in that (1) enrolment is optional, (2) insurance contributions are imposed by the private insurance provider based on the provider's risk analysis, (3) the insurance benefits paid out vary according to the level of insurance contributions made by the insured, and (4) the collection of insurance contributions is governed by private contracts rather than by laws and regulatory requirements. In South Korea, insurance companies offer a variety of insurance products, such as cancer insurance, death insurance and co-pay medical expenses insurance.
iii Funding and payment for specific services
Under the national health insurance system of South Korea, the insured usually pays a part of the healthcare expense as co-payments, and the insurance proceeds are reimbursed directly to the medical institutions and pharmacies that provide healthcare services to insured patients. The co-payment rate of the insured is affected by multiple factors, such as the type of treatment (for example, inpatient services or outpatient services) and the nature of the medical facility providing the treatment.
Certain treatments are non-benefit items, which are not covered by the national health insurance programme. These include medicines, medical materials, or medical services that are provided or used for a disease that does not seriously affect a patient's daily life, and residents must pay for the cost of such non-benefit items, either personally or through enrolment in private insurance. Medicines, medical materials or medical services that do not improve essential bodily functions such as cosmetic surgery, freckle treatment and snoring treatment are examples of non-benefit items that are not covered by the national health insurance programme.
Primary/family medicine, hospitals and social care
i Classification of medical institutions
Medical institutions are classified as follows:
- Clinic-level medical institution:
- outpatient care for simple and common diseases;
- patient care for those who do not need to be hospitalised for a chronic disease requiring long-term treatment;
- simple outpatient surgical operation or treatment; and
- treatment of patients who have returned after treatment of general care at a general hospital or tertiary hospital (advanced-care general hospital).
- Hospital or general hospital:
- general hospitalisation and surgical treatment;
- patient care that requires more specialised management by area;
- patients with chronic disease requiring long-term care and hospitalisation;
- patients who have been hospitalised at the medical institution concerned and need direct observation of progress at the medical institution after discharge; and
- medical treatment for patients requiring long-term hospitalisation.
- Tertiary hospital (advanced-care general hospital):
- treatment of serious diseases that require highly specialised treatment techniques;
- treatment of patients with a condition carrying a high risk of mortality and complications;
- treatment for patients involving multiple areas of medical speciality and the use of special facilities and equipment;
- treatment of patients with a rare or incurable disease;
- operation of specialised medical treatment centres for specialised medical services for severe diseases;
- treatment of patients who have been hospitalised at the medical institution concerned and need direct observation of progress at the medical institution after discharge; and
- performance of medical training of healthcare professionals and research and development of medical services.
Although, in principle, a patient should be transferred to a general hospital or a tertiary hospital following a referral from a physician at a clinic, there are no direct restrictions preventing a patient from initially visiting a general hospital or tertiary hospital without such a referral from a clinic. That said, if the subject treatment is covered by the national health insurance system, the patient's co-payment may increase following such a direct visit to a general or tertiary hospital.
ii Primary/family medicine
In Korea, a family doctor or individual doctor system is not prevalent. The proportion of specialists is very high, and doctors who open clinics are either specialists or those who practise medicine for only certain diseases. Therefore, patients choose their doctor according to their symptoms and receive primary care from the clinic with the relevant specialisation.
On the other hand, Korean medicines are classified as either over-the-counter drugs, which do not require the prescription of a doctor, or ethical drugs that require prescription by a physician. Additionally, medicines can be sold only by pharmacists in principle; however, certain over-the-counter drugs designated as home emergency drugs under relevant regulations can be sold in 24-hour convenience stores.
iii Social care
According to the Regional Public Health Act, public health centres are established in municipal units and form a part of government agencies. Doctors and nurses at these public health centres are in charge of vaccination, treatment and patient education in the local community. A patient must pay a prescribed fee to visit a public health centre, but this fee is less than the cost of visiting a private clinic or hospital.
Medical assistance is provided to the low-income class pursuant to the Medical Care Assistance Act. If you are covered by the Medical Care Assistance Act, this fee for visits to public health centres may be exempted or discounted under the National Health Insurance Act.
The licensing of healthcare providers and professionals
The MOHW regulates the social welfare and healthcare systems through the enforcement of relevant laws, such as the MSA, the PAA, the Medical Care Assistance Act, the National Health Insurance Act and the National Basic Living Security Act. For reference, the government authorities working together with the MOHW include the MFDS, the NHIS, and the National Medical Center, and institutions under the MOHW include the National Hospital for each district, and the Korea Centers for Disease Control and Prevention.
The MFDS enforces the PAA together with the MOHW, and the enforcement of the Medical Devices Act is also under the responsibility of the MFDS. Institutions under the MFDS include the Medical Device Information Support Center.
ii Institutional healthcare providers
According to the MSA, medical institutions in South Korea are classified under the following categories: (1) clinic-level medical institutions, (2) midwifery clinics, and (3) hospital-level medical institutions. Clinic-level medical institutions consist of medical clinics, dental clinics, and oriental medical clinics, and hospital-level medical institutions consist of hospitals, dental hospitals, oriental medical hospitals, intermediate care hospitals, mental health hospitals and general hospitals.
On the other hand, if classified by function, medical institutions can be classified as general hospitals or advanced care hospitals, as explained above.
Establishment of medical institutions
A healthcare professional cannot engage in healthcare service business without establishing a medical institution and, except for certain specified exceptions, all medical services must be performed within that medical institution. The qualification criteria of those who can open a medical institution in accordance with the MSA are limited. Medical institutions can be established only by licensed healthcare professionals, local governments or entities of a public nature specifically permitted under the MSA.
The procedure for opening a medical institution can be roughly classified into filing a 'report of establishment' for medical institutions at the clinic level, and the application for an 'establishment permit' for medical institutions at the hospital level. Any person who intends to open a medical institution must file a report of establishment or apply for an establishment permit, as applicable, to the relevant local municipality depending on the type of medical institution. A healthcare professional can open and operate only one medical institution at a time.
Prohibitions on the establishment of medical institutions
Non-healthcare professionals are prohibited from establishing medical institutions. The penalty for violating this restriction may include the invalidation of relevant contracts and administrative as well as criminal sanctions.
iii Healthcare professionals
The MSA defines healthcare professionals as (1) doctors, (2) dentists, (3) oriental doctors, (4) midwives, and (5) nurses who received a licence from the Minister of the MOHW. The MSA prohibits, in principle, any person who is not a healthcare professional from engaging in medical activities and any medical professional from engaging in medical activities other than those for which the professional is licensed. A person who violates this prohibition may be subject to criminal sanctions, and if a healthcare professional has caused a non-healthcare professional to perform medical activities, the healthcare professional may be disqualified. To become a healthcare professional, a person must pass a national examination and obtain a licence from the MOHW after completing their studies in the relevant healthcare field at a qualified institution.
The MSA sets out instances where a healthcare professional's licence may be suspended or revoked. Grounds of suspension or revocation include the violation of relevant laws and regulations and ethical rules.
As regards claims for medical negligence, case law provides that, to be liable for breach of the duty of care in medical practice, a causal relationship between the breach of duty of care in medical practice and the damage incurred must be found. Case law further provides that, to establish that causal connection, the plaintiff has the burden of proving that (1) medical malpractice has occurred, and (2) there are no causes for the damage in question other than the medical malpractice.
On the other hand, if a medical treatment may result in negative consequences to the patient, physicians have an obligation to explain the symptoms of the disease, details of the treatment method, the necessity for the treatment and the risks associated with the treatment to the patient (or the legal representative of the patient), such that the patient is able to sufficiently compare the necessity for the treatment and the risks inherent, and make an informed decision whether or not to receive the medical treatment. In the event of a serious negative consequence of a treatment, the possibility of which the relevant physician failed to properly inform the patient, the physician may be liable for damages. In this situation, if the patient claims only damages for the lost opportunity to make a choice, the patient is only required to prove that the opportunity to make a choice was lost because of lack of explanation by the physician. If the patient claims compensation for damage or harm as a result of the serious negative consequence, the patient has to prove causality as well. In practice, patients are required to sign a prior consent form describing, for example, the details of treatment and the risks associated with the treatment.
There have been instances where physicians were held to be criminally liable when found to have committed medical malpractice. For this reason, it is quite common for patients who have had negative treatment results to file simultaneously both a criminal claim and their civil claims against the relevant physician. However, civil liabilities and criminal liabilities are differentiated under relevant laws, and the courts view criminal liability as being subject to a much higher burden of proof.
ii Notable cases
Recently, the Supreme Court confirmed once again that a physician is not relieved of his or her duty to inform just because the risk of after effects or side effects occurring after a medical act is very low. In this case, the patient had a history of a herniated cervical disk, and had received open-chest coronary artery bypass surgery and subclavian artery bypass surgery. However, the physician did not inform the patient that if a patient with a herniated cervical disk lies down with their chest elevated and head down for an extended period of time during anaesthesia and surgery, it could exacerbate the patient's herniated disk and possibly result in cervical myelopathy or quadriplegia. After the operation, the patient suffered from quadriparesis, such as delicate functional impairment in both hands and decreased muscle strength in both lower extremities. The Supreme Court recognised that the physician violated the duty to inform and found the physician liable for damages.
Ownership of healthcare businesses
i Medical institutions
Both private parties and public parties (entities) can establish medical institutions such as hospitals and dental clinics, but as mentioned above, the qualifications of those who can establish medical institutions are limited pursuant to the MSA. In other words, medical institutions can be established only by licensed healthcare professionals, local governments or entities of a public nature specifically permitted under the MSA and private companies cannot establish medical institutions for profit.
Similar restrictions apply to pharmacies. That is, according to the PAA, no person other than a pharmacist or oriental medicine pharmacist can establish a pharmacy. According to the above provision, it can be construed that only a pharmacist or oriental medicine pharmacist who is a natural person can open a pharmacy and that a corporation or an entity cannot open a pharmacy. In this regard, the Constitutional Court explained that, while the above provision does not permit the establishment and operation of a pharmacy by a general person or by a regular corporation that is not a pharmacist, applying the prohibition on establishing a pharmacy to a corporation whose members are all pharmacists would unduly violate the freedom of occupation of those pharmacists. However, despite this Constitutional Court decision, the fact of whether a corporate pharmacy is permitted is still subject to debate.
Commissioning and procurement
In Korea, all citizens are enrolled in the national health insurance programme, and all medical institutions must provide medical services under this system. However, there are also medical services that are not covered by national health insurance. In the case of these services the patient either pays directly or, if the patient has private health insurance coverage, a private insurer bears the costs. However, in the case of medical services covered by the national health insurance system, the patient pays a small co-payment to the medical institution and the remaining amount is paid directly to the medical institution by the NHIS. In the case of medical services covered by national health insurance, the price is controlled by the government, and although prices are determined through negotiation between the government, medical organisations and civil groups, there is always conflict between stakeholders over their respective interests.
Also, in the case of medicines prescribed by a physician, the drug price is reimbursed according to the National Health Insurance Act. Whether or not the drug can be covered by national health insurance is determined by the Health Insurance Review and Assessment Service, and drug prices are determined based on negotiations between the NHIS and the relevant pharmaceutical company. Because drug prescription is not practicable unless covered by national health insurance, the original drug manufacturer pays great attention to national health insurance coverage and pricing negotiation.
Marketing and promotion of services
In South Korea, marketing and promotion of healthcare services and products are mainly regulated by the MSA, the PAA, the Medical Devices Act (MDA) and supervised by the MOHW and the MFDS. In addition, the Fair Labelling and Advertising Act, which governs advertising activities in general, and the Monopoly Regulation and Fair Trade Act, which governs fair competition in the market, both of which are supervised by the Korea Fair Trade Commission (KFTC), may also apply.
ii Medical services advertising
The MSA prohibits the advertising of medical services by a non-healthcare professional or non-medical corporation or institution. In addition, advertisements consisting of the following are prohibited: (1) guarantees of treatment effect; (2) comparisons of the quality of treatment with treatments by other medical institutions or professionals; (3) criticism of other medical institutions or healthcare professionals; (4) direct expositions of the treatment process; and (5) omission of important information. Further, a medical institution or healthcare professional intending to advertise using newspapers, outdoor advertisements, electronic signboards, etc. must obtain prior approval from the MOHW regarding the method and content of the advertising.
iii Pharmaceutical advertising
In the case of pharmaceuticals, the PAA prohibits false advertising or exaggerated advertising regarding the name, manufacturing method, effectiveness of the pharmaceutical product. In addition, the advertising of products that have not obtained MFDS approval, the use of news articles or media publications that may be misunderstood as providing a guarantee of the effectiveness of the drug by a healthcare professional, and advertising using photographs or articles that are suggestive of effectiveness or performance capabilities are all prohibited.
Furthermore, when a manufacturer, importer or the market authorisation holder of a pharmaceutical product intends to advertise the pharmaceutical product manufactured or imported by that person, review and approval of the advertising by the MFDS is required.
Finally, in the case of ethical drugs, direct-to-consumer advertising is prohibited.
iv Advertising of medical devices
The MDA regulates the advertising of medical devices. Specifically, the following information should not be indicated anywhere on the product or its packaging: (1) any false or misleading information; (2) information on the effectiveness or performance of the product for which approval or certification has not been obtained; and (3) information on the method of use or period of use that may cause health or hygiene issues. The following types of medical device advertisements are also prohibited: (1) false or exaggerated advertising of the name, manufacturing method, effectiveness or performance of the medical device; (2) advertising that uses news articles or media publications that may be misunderstood as suggesting that a healthcare professional is guaranteeing or recommending the medical device in relation to its effectiveness or performance; and (3) advertisements that use articles, photographs or drawings that are suggestive of the effectiveness or performance capabilities of the medical device. Those who wish to advertise medical devices are subject to approval by the MFDS.
v Marketing activities of pharmaceuticals and medical devices
Unless specifically permitted by the PAA or the MDA (such as sample provision, clinical trial, post-market surveillance, product presentation, sales call, sponsorship of academic congress or otherwise), the provision of hospitality or economic benefit for marketing purposes is prohibited.
The MOHW has the general authority under the PAA, the MDA and the MSA to regulate these marketing activities. However, the KFTC can investigate pharmaceutical companies, medical device companies and healthcare professionals under Article 23 of the Monopoly Regulation and Fair Trade Act, which prohibits unfair inducement of customers, such as the provision of kickbacks. In addition, given that certain criminal sanctions can be imposed, the Prosecutors' Office can also conduct an investigation into these activities.
If a pharmaceutical company or medical device company provides undue economic benefit to healthcare professionals, administrative sanctions (which may consist of revocation of product approval of the drug or medical device at issue) or criminal sanctions can be imposed. Healthcare professionals who are provided with illegal rebates of this kind are also subject to criminal penalties and the economic benefits obtained through the rebate must be disgorged, and where disgorgement is not possible, the equivalent amount must be paid.
vi Korean Sunshine Act
Under the Korean Sunshine Act, drug providers (including market authorisation holders, importers and wholesalers of drugs) and medical device providers (including manufacturers, importers, and sellers or lessors of medical devices) are required to keep records of economic benefits provided to medical institutions and healthcare professionals through sample provision, clinical trials, post-market surveillance, product presentations, sales calls, academic congress sponsorship or otherwise. Companies must maintain these records for five years. Companies must maintain a template expenses form prepared by the MOHW for each expenses item, and must submit these records to the MOHW upon request.
After the outbreak of covid-19, the Infectious Disease Control and Prevention Act (IDCPA) was revised several times to ensure good crisis management of infectious disease. For example, the revised Act established a basis for managing infectious disease information through the use of information and communication technology, stipulated in detail the scope and procedure of information disclosure regarding tracing the route of an infected patient in an outbreak crisis situation, and strengthened the authority of local government, such as the city mayor or provincial governor, to respond to an outbreak crisis. The IDCPA also includes regulations that provide a basis for telemedicine if deemed necessary to protect patients, medical personnel and medical institutions from the risk of infection when an infectious disease crisis alert is issued (as explained below, telemedicine is normally not allowed under the Medical Service Act in Korea). In addition, the Korea Center for Disease Control (KCDC), a government agency that responds to infectious diseases, was upgraded to the Korea Disease Control and Prevention Agency (KDCA), and the current Central Disaster Management Headquarters and Central Disease Control Headquarters are carefully observing and briefing on related issues.
Regarding the development of covid-19 treatments and vaccines, the MOHW recently reported on the status of domestic vaccine development and future plans for the 'Third Covid-19 Response Special Quarantine Inspection Meeting' and announced that, in order to expedite covid-19 vaccine Phase 3 clinical trials, the government will launch a state-designated institutional review board and secure an R&D budget for the Phase 3 clinical trials. In addition, the MFDS is in the process of expediting approval for clinical trials on the treatment of covid-19, and has recently revealed that it will relax the standards for these Phase 3 clinical trials.
Telemedicine in Korea is restricted. This restriction is based on the requirement under the Medical Services Act that 'medical service must be provided by a licensed professional in a duly established medical institution'. Due to covid-19, however, the MOHW has issued administrative orders on 24 February 2020, which temporarily allow telemedicine until the covid-19 crisis is deemed concluded. Doctors are able to consult patients over the phone and also issue prescriptions remotely. And this telemedicine service is also reimbursed under national health insurance system. Drug delivery, which is prohibited in Korea, is also temporarily allowed under the MOHW emergency administrative order. This will serve as a national test case for the harms or benefits of allowing telemedicine.
Future outlook and new opportunities
Although telemedicine had been temporarily allowed in light of the covid-19 situation, the MSA restriction on telemedicine has not yet been revised. However, the government recently announced that it intends to allow telemedicine, remote prescription and drug delivery. The government had attempted to abolish telemedicine regulations in 2020, but was unsuccessful due to strong opposition from the Korea Medical Association. The prime minister recently announced that he would push for a 'regulation challenge' which would remove any domestic regulations considered excessive when compared to other countries, and include telemedicine, remote prescription and drug delivery as its initial review items. It will be important to closely monitor the extent to which patient–doctor telemedicine and remote prescription, neither of which had been allowed for a long time, will be permitted.
Government regulations affect various aspects of the healthcare industry in South Korea, including national health insurance coverage, commercial activities and advertising. There are therefore many cases in which regulations change according to government policy, and as a result, conflicts often arise between stakeholders such as healthcare professionals, patients, the NHIS and the government authorities. As discussed above, various issues relating to the current healthcare system, including dispute resolution in cases of medical accidents and the scope of health insurance coverage, are currently the subject of debate, and as a result, the healthcare system of South Korea may change considerably in the near future.
1 Eileen Jaiyoung Shin and Ji Hyun Yu are partners at Lee & Ko.