In the past, large domestic pharmaceutical companies in South Korea have focused primarily on the manufacture and distribution of generic products. In recent decades, investment in new drug development has risen steadily. In the case of biosimilar companies, there is not only growth in product development but also in consignment manufacturing for global bio-pharmaceutical companies. There is also a sharp increase in new drug and digital health device development activities by start-ups with growing investment in this sector.

Private funds as well as government-driven funds are being established for investment in the bio and digital health sector. The government announced in July 2022 that it plans to develop, in co-operation with the private sector, funds of KRW500 billion for investment in biopharma companies and grow this amount to KRW1 trillion. The government also announced the Comprehensive Plan (2023 to 2027) for the Promotion of BioPharma Industry in March 2023, under which it will invest KRW4 trillion in the Biopharma research and development sector.

Bio-related research is very active in university labs and many researchers are now involved, establishing start-ups in the bio sector. Academic and private sector research in digital health devices is also very active, with increasing research collaboration between university hospitals/large general hospitals and domestic and global pharmaceutical, biopharma, and medical device companies. According to data released by the Ministry of Food and Drug Safety (MFDS), it approved a total of 711 clinical trials for drugs in 2022 (595 sponsor-initiated trials and 116 investigator-initiated trials).

Start-ups tend to focus on venture capital investment but private equity funds have also (separately and with the government) participated in forming investment funds. Once a start-up is recognised for its growth potential, listing on the stock market through an initial public offering is an important funding source for research and development.

South Korea has a single payer system, so that all contributions are paid into (and reimbursements paid out from) the National Health Insurance System (NHI system).

The NHI system is managed and operated by the Ministry of Health and Welfare (MoHW), the National Health Insurance Service (NHIS), and the Health Insurance Review and Assessment Service (HIRA).

The MoHW decides health care policies and the NHI system and the NHIS manage overall operational tasks. As the insurer of the NHI system, the NHIS carries out tasks such as managing applicant qualifications, charging and collecting insurance fees, and paying reimbursements to health care providers. The HIRA reviews reimbursement claims billed by health care providers.

Health care delivery relies heavily on the private sector, though some public health facilities provide medically necessary services at the central, regional, and municipal levels.

In South Korea, all citizens are enrolled in the national health insurance programme and all medical institutions must provide medical services under this system.

For medicines prescribed by a physician, the drug price is reimbursed according to the National Health Insurance Act. The HIRA determines whether a drug can be covered by national health insurance. Drug prices are determined in principle by negotiations between the NHIS and the relevant pharmaceutical company (see Question 4).

The market price of a medicinal product is ultimately determined by the MoHW, which publishes the maximum reimbursement price (MRP) for that medicinal product under the NHI system.

The price and reimbursement for a medicinal product is based on the National Health Insurance Act and the Rules on the Standards of National Health Insurance Benefits.

There are no particular restrictions on the price of drug products not covered under the NHI system (so that health care providers can determine the price to be charged to patients for these products).

Pricing of a new drug product is determined as follows:

Among these steps, the HIRA review stage is the most important. The HIRA review includes health technology assessment (HTA) appraisal, based on a full review of the following:

Treatment for life threatening or rare diseases can be subject to risk-sharing agreements, which can include various reimbursement schemes such as refunds, expenditure caps, conditional treatments, and use caps.

Insurance proceeds are reimbursed to medical institutions and pharmacies that provide covered medicinal products to insured patients. The medical institutions and pharmacies:

Pharmacists are restricted from earning any sales margin on products subject to reimbursement by the NHI system. For these products, pharmacists are paid a dispensing service fee for the relevant product by the NHIS and the patient under the National Health Insurance Act.

Unless the prescribing physician explicitly restricts dispensing of substitutes for clinical reasons, a pharmacist can replace the prescribed product with an alternative product determined by the MFDS to be bioequivalent (an approved generic).

Except for some designated household medicines, the Pharmaceutical Affairs Act imposes strict restrictions on selling medicinal products. In principle, only licensed pharmacists can sell medicinal products to consumers. Importers and manufacturers can sell their imported/manufactured medicinal products to wholesalers, pharmacists, medical institutions, and other manufactures. Wholesalers can sell medicinal products to pharmacists, medical institutions, or other wholesalers.

Over-the-counter drugs can be purchased at a pharmacy. Purchasing prescription drugs requires a prescription from a physician.

The Pharmaceutical Affairs Act prohibits online sales of medicinal products to patients. However, online sales to wholesalers are permitted.

In addition, anyone distributing drug products must comply with the Korea Good Supply Practice established under the Drug Safety Regulation.

Under the Pharmaceutical Affairs Act, wholesalers can sell medicinal products to pharmacists, medical institutions, or other wholesalers. A wholesaler cannot directly import or manufacture medicinal products without obtaining separate relevant licences (for example, a drug manufacture or import licence).

To obtain a wholesaler licence, the applicant must meet certain personnel and facility requirements, have at least KRW500 million of capital, and apply to the local MFDS office in the relevant jurisdiction. The capital requirement is reduced to KRW200 million if the wholesaler only deals with imported drugs, safety emergency drugs (drugs specifically allowed to be distributed outside pharmacies), drug materials, or traditional Korean medicine.

The MFDS is responsible for supervising the distribution of medicines, and both administrative and criminal sanctions can be imposed for violating medicine distribution laws.

In addition, the MOHW and local governments can conduct on-site inspections of wholesalers. Depending on the result of the inspection, the wholesaler can be subject to administrative sanctions (for example, business suspension or licence cancellation) and/or criminal sanctions.

To carry out medicinal product import business, an importer must obtain from the MFDS an import business licence and marketing authorisation for each product to be imported and distributed.

Under the Pharmaceutical Affairs Act, to apply for an import business licence, an importer must have at least one product for which it is applying for marketing authorisation. In other words, to submit an import business licence application, an importer must also submit a marketing authorisation application for at least one product.

To qualify for a drug import business licence, the applicant must meet certain personnel and facility requirements and procure laboratory and necessary facilities and equipment for drug testing.

No international mutual recognition arrangements apply to South Korea for the approval of medicinal products. Even if a product is approved in another jurisdiction, it must fully satisfy the separate requirements in South Korea.

The Pharmaceutical Affairs Act does not explicitly prohibit parallel imports. However, in effect, parallel import of medicinal products is not allowed because a marketing authorisation must be obtained to sell medicinal products in South Korea, and only the marketing authorisation holder can import and sell those products.

The Fair Labelling and Advertising Act governs advertising activities in general and the Pharmaceutical Affairs Act regulates advertising of medicinal products. The MFDS enforces advertising restrictions under the Pharmaceutical Affairs Act.

The Voluntary Code on Labelling and Advertising for Drugs issued by the Korean Research-based Pharmaceutical Industry Association also applies to member companies advertising medicinal products in South Korea.

Under the Fair Labelling and Advertising Act, advertising is defined as the act of broadly informing consumers of a particular business or its products through periodicals, newspapers, broadcasting, telecommunications, pamphlets, samples, tickets, the internet, posters, signs, balloons, videos, records, books, movies, plays, the products of other businesses, and other similar media.

There are no specific provisions defining advertising under the Pharmaceutical Affairs Act. Under the MFDS Guidelines for Drug Advertisements and Providing Prescription Drug Information 2019, drug product advertising is defined as drug manufacturers, marketing approval holders, and importers using media described in the Pharmaceutical Affairs Act for the purpose of widely making known the name, manufacturing method, efficacy, or performance of a drug to a large number of unspecified people, including general consumers and medical and pharmaceutical experts.

Additional restrictions apply to drug advertising, depending on the type of the product. Specifically, direct-to-consumer advertising is prohibited for:

There are no legally mandated internal procedures on advertising. However, most companies establish these policies for compliance purposes. These policies typically govern the internal management and approval of drug advertising.

Under the Pharmaceutical Affairs Act, all direct-to-consumer advertisements must undergo a preliminary review by the Korea Pharmaceutical and Bio-Parma Manufacturers Association (KPBMA), which is assigned this task by the MFDS, and have the review cleared. There is no mandatory timeline for this review. In practice, it is carried out each week for advertisements submitted in the preceding week.

While the Pharmaceutical Affairs Act does not explicitly restrict comparative advertising, it prohibits advertisements that "criticise or imply criticism of other products without regard to its truthfulness." The MFDS tends to take the view that negative comparative advertisements violate this restriction.

In principle, the Pharmaceutical Affairs Act prohibits the advertisement of a medicinal product before the product is authorised. However, scientific discussions of these medicinal products or indications are permitted subject to limitations (for example, the information must be based on scientific evidence and the information should not be an advertisement). As such, a case-by-case compliance review should be made to review information disseminated as a scientific discussion.

While a case-by-case review is necessary in the above circumstances, in principle, advertisements for off-label use and compassionate use can also be deemed a violation of the Pharmaceutical Affairs Act. Press releases are also subject to restrictions if deemed to be an advertisement for unapproved products.

Both the Fair Labelling and Advertising Act and Pharmaceutical Affairs Act regulate internet advertising. In particular, the Pharmaceutical Affairs Act prohibits public advertisement of prescription drugs, including internet advertising.

Non-prescription drugs can only be advertised after a preliminary review by the KPBPMA (see Question 12).

The MFDS, local governments, and the Korean Fair Trade Commission monitor internet advertisements, to see if there are any Fair Labelling and Advertising Act and Pharmaceutical Affairs Act violations.

Violations of the Pharmaceutical Affairs Act advertising regulations can result in:

Violations are often detected by advertisement monitoring by the MFDS or the local provincial government or due to reports to the MFDS by competitors.

Advertising of medicinal products, over-the-counter drugs, and prescription drugs are regulated differently under the Pharmaceutical Affairs Act. Direct-to-consumer advertising is prohibited for:

Direct-to-consumer advertising is only possible for general over-the-counter drugs and vaccines. However, all advertisements must first undergo review by the KPBMA (see Question 12).

The Pharmaceutical Affairs Act prohibits the provision of free samples to the public. Providing samples for the purpose of advertising is strictly prohibited.

There are no specific rules and principles on engagement with patient organisations. It is necessary to review the laws and regulations that can apply to each specific activity and event. For example, when conducting events about a specific disease, care must be taken to ensure that no direct-to-consumer advertising occurs in breach of the Pharmaceutical Affairs Act.

In addition, the KPBMA ethics code sets out that pharmaceutical companies should:

There is no law or regulation that specifically defines the term health care professional.

The Medical Service Act states that physicians, dentists, oriental medical doctors, midwives, and nurses are "medical service providers", and persons engaged in diagnosis or medical chemical tests under the instruction of physicians or dentists are classified as "medical service technologists". All are subject to eligibility requirements under the Medical Service Technologists Act.

Generally, physicians, dentists, oriental medical doctors, nurses, and pharmacists are viewed as health care professionals. On a case-by-case basis, medical service technologists can also be deemed a health care professional.

The Medical Service Act also defines "medical institutions" to include clinics, hospitals, and general hospitals, and these are generally understood to be health care organisations.

No provisions under applicable laws require certain information to appear in advertisements to health care professionals or health care organisations. However, the MFDS guidelines for advertisements state that information provided to health care professionals about prescription drugs must be verifiable, medically approved, and objectively true, and that any information about a medicinal product should be accompanied with information identifying the supporting source.

Offering money, goods, convenience, services, entertainment, or any other economic benefits to pharmacists, oriental medicine practitioners, health care professionals, founders, or employees of medical institutions is prohibited for sales promotion purposes (such as inducing selection or prescription of pharmaceutical products or maintaining prior business relations with marketing authorisation holders, importers, and wholesalers of drugs). The Pharmaceutical Affairs Act and the Medical Service Act punish both a provider and recipient of illegal economic benefit. However, there are certain exceptions to this prohibition under the Pharmaceutical Affairs Act, including:

The Medical Devices Act sets out similar exceptions.

In addition, the following laws are relevant:

To ensure transparency in the pharmaceutical and medical device market, the expenditure report system requires pharmaceutical companies and medical device companies that offer permissible types of economic benefits (specified in applicable laws and regulations) to prepare expenditure reports and retain relevant books and evidentiary materials for five years. These must be submitted to the MoHW if requested.

The amended Pharmaceutical Affairs Act, effective as of 21 July 2023, requires providers of medicinal products to disclose their expenditure report under the terms set out in the MFDS administrative order (which has not yet been issued).

Providing kickbacks to health care professionals, unless specifically permitted under applicable laws, is prohibited under the Pharmaceutical Affairs Act (which prohibits the provision of economic value for sales promotion purposes) and the Monopoly Regulation and Fair Trade Act (which prohibits unfair inducement of customers) (see Question 21).

If the prohibition is violated, the Pharmaceutical Affairs Act imposes penalties including administrative fines, sales suspension, revocation of marketing authorisation, and criminal punishment for both the wrongdoer and the company or its management of up to three years in prison or KRW30 million in fines.

In addition, the National Health Insurance Act provides for a reduction or suspension of the reimbursement price by the National Health Insurance Service for kickbacks in breach of the Pharmaceutical Affairs Act.

Under the Monopoly Regulations and Fair Trade Act, penalties imposed by the Korea Fair Trade Commission include an administrative penalty surcharge of up to 4% of the revenue from the relevant product during the period of the violation, and criminal punishment of up to two years in prison or KRW150 million in fines.

Repeated violations can lead to harsher penalties.

Under the Patent Act, for an invention to be patentable it must be:

Any person applying for a patent for a micro-organism must deposit it in the Korean depository institution or international depository institution. Micro-organisms subject to deposit mean all biological material including genes, vectors, bacteria, fungus, animal cells, fertilised eggs, plant cells, and seeds.

Patents can be issued for medical devices, medicines, and methods for producing them.

Patents cannot be issued for a method of diagnosing, treating, or operating on a human being.

The following among others are not patentable:

General principles under the Patent Act apply. However, it is understood that patent rights in the biotech and pharmaceutical sector can be separately recognised for identical substances based on differences such as administration dosage or method, toxicity, side effects, or efficacy.

Patent applications are handled by the Korean Intellectual Property Office (KIPO). Its website provides guidance on the application procedure.

Application fees and examination fees must be paid and, if registration is accepted, a registration fee must be paid. Details of fees are on the KIPO website.

The following process and timing typically applies:

Any person can submit information outlining reasons to reject a patent application to the Commissioner of the KIPO.

A patent term starts once the patent is issued and ends 20 years from when the application is filed.

For divisional patents and amended patents, the patent right expires 20 years after the date of the original application.

For pharmaceutical patents, the patent term can be extended for the time (up to five years) required for the relevant product to be approved by relevant authorities under applicable laws (for example, the Pharmaceutical Affairs Act). This ensures that the applicant can use the patented invention for the duration it would have enjoyed but for the period required for approval from the other authorities.

To extend a pharmaceutical patent an application must be submitted to the Commissioner of the KIPO within three months of the date of approval under the Pharmaceutical Affairs Act. An application cannot be made within six months of the date of expiration of the 20-year patent term.

The patent owner has the exclusive right during the patent term to exercise the patent rights or license it to a third party.

A patent is infringed when a third party copies the patented invention and carries on a business without authorisation.

When patent infringement occurs, the patent right holder can:

The main defence is that the alleged infringement does not fall under the scope of the claimed invention.

Research or clinical trials of a medicinal product is not deemed to be patent infringement.

The act of prescribing or dispensing two or more medicinal products under the Pharmaceutical Affairs Act does not infringe a patent for medicinal products manufactured by combining two or more medicinal products or methods for combining two or more medicinal products.

IP exhaustion is recognised only for copyright and trade marks.

South Korea is party to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

South Korea is party to the Patent Cooperation Treaty 1970 (PCT).

South Korea is party to the:

To register a trade mark, the mark cannot be identical or similar to a previously registered trade mark for identical or similar products and the mark must be capable of distinguishing goods from those of others.

The Trade Mark Act regulates trade mark registrations.

A medicinal product brand can be registered as a trade mark when the requirements under the Trade Mark Act are met. In registering a medicinal product brand as a trade mark, terms describing the quality, ingredient, effect, or general terms are not registrable.

The KIPO registers trade marks. Its website provides guidance on the application procedure and trade mark fees.

If the applicant is preparing to use or is using the trade mark, priority examination can be requested where the examination can be concluded within two to three months.

If there are no grounds for rejection, the application is published. If there are grounds for rejection, the KIPO issues an office action requesting the applicant to correct them. If they are overcome, the application is published.

An opposition can be filed within two months from the date of publication of the application.

If an opposition is filed, the KIPO reviews the opposition. The opponent provides grounds for the opposition and the applicant is given an opportunity to rebut it. An opposition process takes about four months. The KIPO decision cannot be appealed.

If no opposition is filed or the opposition is dismissed, the KIPO issues a registration decision and the applicant must pay the registration fee within two months from that date. The trade mark becomes registered immediately on payment.

It takes about eight to ten months from the filing date for KIPO to decide whether to register the trade mark. It can take up to four more months if an opposition is filed.

Prohibition on unfair collusive activities. Under the Monopoly Regulation and Fair Trade Act (MRFTA), the Korean Fair Trade Commission (KFTC) prohibits and can impose a cease-and-desist order and/or administrative fines against cartel activities.

Cartel activities are defined as an agreement, arrangement, or resolution with other enterprises that unfairly restricts competition, relating to:

Criminal sanctions such as imprisonment or a fine can be imposed. The person liable and the company for which the person works can be fined.

Prohibition on unfair inducement of customers. The MRFTA also prohibits offering and receiving kickbacks (that is, benefits offered to health care professionals to induce recommendation or prescription to their clients). For violations of the MRFTA, the KFTC can issue a corrective order, impose monetary fines, and file a criminal report with the public prosecutors' office.

The person liable and also the company for which the person works can be fined.

Prohibition of retail price maintenance. The MRFTA also prohibits coercing another undertaking in the distribution channel to sell goods or services at a certain price subject to binding conditions. This also applies to the sale of medicinal products. The KFTC can issue a corrective order, impose monetary fines, and file a criminal report with the public prosecutors' office. The person liable and the company for which the person works can be fined.

The KFTC is the main competition authority (see above, Competition Law and Main Provisions).

KFTC investigations into the pharmaceutical sector have focused on unfair trade activities, particularly illegal kickbacks to medical institutions/HCPs by pharmaceutical companies. As a result, the Medical Service Act, the Pharmaceutical Affairs Act, and the Medical Device Act were amended in 2011 to include anti-kickback provisions.

The KFTC has also investigated bid collusions and reverse payment (pay-for-delay) issues. This is less common, with only two cases resulting in sanctions for reverse payment, one of which is pending court review.

Under the South Korea-US Free Trade Agreement 2012, South Korea introduced the Patent Approval Linkage System, similar to the US Hatch-Waxman Act, where the relevant patent owner can apply for a sales stay of generic drugs.

The KFTC and the Supreme Court hold that pay-for-delay agreements are illegal. In GSK v Dong-A Pharmaceutical 2014, the claimant, GSK, acquired a patent for the manufacturing method of ondansetron, an antiemetic drug, marketed as Zofran. Dong-A Pharmaceutical independently developed ondansetron and launched its antiemetic drug, Ondaron, containing the same active ingredient as Zofran. GSK filed a patent infringement suit against Dong-A Pharmaceutical. The two companies ended the lawsuit by signing a drug licensing agreement that included a pay-for-delay settlement. The KFTC determined that this collusion between the two companies would exclude the cheaper generic drug (Ondaron) from the antiemetic drug market and prevent competing drugs from entering the market. As a result, the KFTC issued a corrective order and imposed a KRW5.173 billion penalty on GSK.

The Supreme Court upheld the KFTC order, holding GSK's action (to prevent the launch of a competing product by providing economic benefits greater than the patent litigation costs) as an act not considered a legitimate exercise of patent rights and therefore subject to the Fair Trade Act. Such an act may appear to exercise a patent right but its substance is contrary to the fundamental purpose of the patent system. The Court held that this can be determined by considering various factors, such as the purpose and intent of the Patent Act, the content of the patent right, and the impact the activity has on fair and free competition.

Article 69-3 of the Pharmaceutical Affairs Act was subsequently enacted on 13 March 2015. This requires details of a settlement of a drug patent dispute between a patent holder and a generic applicant to be reported to the MFDS and the KFTC.

The KFTC recently found an unfair refusal to deal violation in the pharmaceutical sector and imposed a cease-and-desist order. This related to an enterprise that manufactures and sells medicinal products for which it is the exclusive supplier in South Korea. The enterprise unfairly refused to trade with a particular wholesaler.

South Korean law does not specifically prohibit parallel imports. However, in practice parallel import of medicinal products is not possible because only the product marketing authorisation holder can import the medicinal products into South Korea. Prohibiting parallel imports could be an unfair trade practice under the MRFTA. However, no unfair trade practice issues arise for medicinal products because parallel import is not possible.

The KFTC sets out standards for fair business in its Review Guidelines on Undue Exercise of Intellectual Property Rights.

Unfair exercise of intellectual property rights is handled by the Korean courts and the KFTC according to these laws and guidelines.

This is not a requirement in South Korea.

An institution funded by the government that develops national core technology must obtain approval from the Minister of Ministry of Trade, Industry, and Energy to export the national core technology. The Act on the Prevention of Divulgence and Protection of Industrial Technology also applies.

The MFDS or the competent local government body can order the manufacturer, importer, or wholesaler of a medicinal product to recall, dispose of, or take other appropriate measures relating to a medicinal product in circulation, if it determines that it causes or may potentially cause harm to public health.

If the order is not complied with, or if urgent action is needed for public health, the MFDS or the competent local government body can order a public official to recall or dispose of the product if necessary. The manufacturer, importer, or wholesaler of the medicinal product must then notify the public of these measures.

The following can be imposed for a violation of an order to recall or dispose of a product under the Pharmaceutical Affairs Act:

Sanctions can be imposed on the person liable for the violation and on the company for which the person works.

The claimant must prove the following:

However, the Product Liability Act relieves this burden of proof on an injured claimant by presuming liability if the claimant can prove the following:

The burden of proof then shifts to the manufacturer to prove that the damage arose from a cause other than product.

Under the punitive damages provisions in the Product Liability Act, if a manufacturer has knowledge of a product defect, but fails to implement measures to address it, the manufacturer can be subject to triple damages if the defect results in death or serious bodily injury (see Question 40).

Under the principles of tort in the Civil Code, the claimant must prove the following:

Under contractual principles of non-performance of obligations and compensation for damages in the Civil Code, the claimant must prove the following:

The Relief Scheme for Drug Side Effects came into force in December 2014, which lightens the burden of proving causality. If it is proved that use of the relevant drug caused harm, disability, or death, the following will be paid out to the claimant from relief funds:

Product liability claims can be brought against manufacturers, which include:

Any party whose intentional or negligent act is proven to have caused the damage suffered by the claimant can be liable, including manufacturers, processors, importers, sellers, doctors, nurses, and pharmacists.

If a government official is proven to have wilfully or negligently granted approval to the sale of defective medicinal products, the claimant can claim damages from the government which is responsible for the government official.

A breach of contract claim can only be made against a party with a contractual relationship with the claimant. Hospitals, doctors, pharmacists, and other medical professionals that are a party to a medical services contract can be liable.

Due to the lack of a contractual relationship, consumers and patients cannot generally bring breach of contract claims against manufacturers or importers.

The Relief Scheme for Drug Side Effects provides relief funds to claimants from funds collected from manufacturers, importers, and marketing authorisation holders of medicinal products through the Korea Institute of Drug Safety and Risk Management. The reserve funds consist of:

Manufacturers of medicinal products can be exempt from liability if they can prove any of the following:

However, if appropriate preventive measures are not taken to prevent damage on discovering or becoming aware of a defect in the product, manufacturers cannot assert defences in the second, third, and fourth bullet points above.

The Korean Supreme Court often relieves the claimant's burden of proving the causal relationship between the defect and damages, and a prima facie case may be established. In this situation, the defendant must prove that the damage was caused by something other than the defect.

A claim can be defended if it is proved that the non-performance of contractual obligations was not intentional or negligent.

Under the Relief Scheme for Drug Side Effects, the manufacturer, importer, or marketing authorisation holder can only submit the requested documents necessary to assess the amount of relief. They cannot participate in the process in terms of contesting the complaint. While there is no mechanism to contest liability, the manufacturer, importer, or marketing authorisation holder can contest the assessment of additional funds with the MFDS.

Product Liability Act. The limitation period to bring a claim is both:

In relation to latent damage, the symptoms of which appear after a certain period has lapsed, the ten-year limitation period starts from the date on which the symptoms appear.

Tort. The limitation period for bringing a tort claim is:

Contract. The limitation period for a claim is ten years from the date when the injured party is first able to make the claim.

Pharmaceutical Affairs Act. The limitation period to apply for payment of benefits for relief of harm is:

In a regular civil lawsuit, the consumer claims damages against the business operator and the Civil Procedure Act allows joinder of parties' claims if they are made on identical or similar grounds. Most product liability actions take this form. Class action lawsuits are not allowed under Korean law, except for securities-related lawsuits. However, in September 2020, the Ministry of Justice issued a legislative notice of a draft statute allowing class action suits for all types of lawsuits (without sector limitation) if there are 50 or more claimants. If this law is passed, class actions for medical product liability claims will be possible.

In a consumer group action, a group of consumers who have suffered damage due to a purchased product can bring an action through a consumer organisation against the relevant company. The only remedies available are corrective orders (for example, stop sale orders and correction of labelling). To obtain damages, a civil lawsuit must be brought. Only eight such actions have been carried out as of April 2020, so this system is not commonly used.

Monetary compensation can be sought for damages that usually arise from the defect.

For damages that have arisen due to special circumstances, compensation can be awarded if the liable party was aware of, or could have reasonably foreseen, the special circumstances. Loss of future earnings, medical expenses, and consolation money (mental suffering) are generally compensated.

Punitive damages for product liability were introduced in 2018. If a manufacturer causes serious damage to the life or body of a person due to not taking necessary measures against a defect in a product despite the manufacturer's knowledge of the defect, the manufacturer is liable for up to three times the damage sustained by the person. In these cases, the court considers the following factors when determining damages: