A Q&A guide to life sciences in South Korea.
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.
To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.
This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.
Pharmaceutical products are regulated by the Pharmaceutical Affairs Act (PAA). The PAA contains, among other things:
Comprehensive provisions relating to the manufacture, import, sale and advertising of pharmaceutical products.
The conditions for licensing, establishing and operating pharmacies.
The PAA categorises pharmaceutical products as follows:
Drugs.
Herb medication.
Therapeutic devices.
The manufacture, import, sale and advertising of medical devices are regulated by the Medical Devices Act (MDA). Under the MDA, medical devices are classified into four classes based on the intended use and the risk that the device poses to the patient:
Class I. Devices with rare potent risk.
Class II. Devices with low potent risk.
Class III. Devices with medium potent risk.
Class IV. Devices with high risk.
Medical products are regulated by the PAA and MDA (along with their Presidential Decrees and Enforcement Rules), as well as the guidelines and notifications of the Korea Food and Drug Administration (KFDA) (see box, Regulator details).
The reimbursement price of medical products (that is, pharmaceutical products and medical devices) is regulated by the National Health Insurance Act (NHIA).
The main administrative authority overseeing the enforcement of the PAA and MDA is the KFDA, which is a branch of the Ministry of Health and Welfare (MOHW). The KFDA can:
Accept reports or applications to manufacture, import or sell medical products.
Assess safety and effectiveness of new medical products.
Approve clinical trials.
Set categories or standards for medical products.
Issue corrective administrative orders and fines.
Biologicals are treated as "drugs", as defined under the PAA. Additionally, the KFDA has issued specific good manufacturing practices (GMP) for biologicals.
At the core of the national health system is the national health insurance under the NHIA. Any South Korean citizen with an income must subscribe to the national health insurance, and make insurance payments based on his level of income. A foreign national residing in South Korea who meets certain requirements can become a subscriber or a dependant of a subscriber to receive benefits.
If the insured contracts a disease, he is entitled to insurance proceeds under the NHIA until he makes a full recovery, regardless of the amount of insurance payments he has previously made. The funds administered under the NHIA consist of government subsidy and insurance payments from the insured.
There are no direct restrictions on the price of medical products. However, reimbursement prices of medical products are strictly regulated if the costs of the products are reimbursed under the NHIA. In principle, reimbursement ceilings for new products are determined through negotiations with the medical product producer and the National Health Insurance Corporation (NHIC). The NHIC determines a lower reimbursement price for generic products pursuant to the MOHW Regulations (for example, generic pharmaceutical products will have a reimbursement price, which is 53.55% of the new pharmaceutical products).
Medical product prices are generally set at reimbursement ceilings as listed and publicised by the MOHW.
The insurance proceeds are reimbursed to the medical institutions and pharmacies that provide medical products to insured patients. The medical institutions and pharmacies:
Buy medical products from the pharmaceutical companies to treat insured patients.
Administer or provide these medical products to insured patients, in exchange for a limited amount paid by the insured patient under the NHIA.
Subsequently receive reimbursements in the form of insurance proceeds from the NHIC, within the limit under the NHIA.
For medical products bought outside medical institutions, the ratio between the amount paid by the insured patient and the NHIC is about 30:70.
For medical products bought within medical institutions, the percentage paid by the insured patient varies from 20% to 60%, depending on the type of medical institution or whether the patient is hospitalised.
To operate a medical products manufacturing business, an application for a manufacturing business licence must be submitted to the KFDA under the PAA (in case of pharmaceutical products) and MDA (in case of medical devices).
In addition, a manufacturer must obtain a product licence to manufacture a medical product, under both the PAA and MDA (see Question 8).
To receive a manufacturing business licence for pharmaceutical products or medical devices, the following must be obtained:
A manufacturing facility.
A laboratory for managing the quality of ingredients, materials and products.
Storage for ingredients, materials and products.
Facilities and equipment necessary for manufacturing and maintaining quality.
Further, the MOHW has established GMPs for pharmaceutical products and medical devices.
A foreign manufacturer of medical products without a Korean manufacturing business licence must distribute its products through an authorised operator with an address in South Korea. A foreign manufacturer with either a Korean affiliate or a subsidiary can produce medical products through toll manufacturing (that is, outsourcing the manufacture of medicinal products to a qualified company using a manufacturing business licence (see above, Conditions)).
Close co-operation with any KFDA order and/or decision in a timely manner during the application procedure is very important. After filing an application, there is usually an opportunity to discuss the application with a KFDA official and correct any shortcomings in the application. The KFDA also conducts an on-site inspection of the applicant's facility. It generally takes 25 days from the date of filing the application for the KFDA to decide applications for manufacturing business licences for pharmaceutical products or medical devices.
For both pharmaceutical products and medical devices, the fee is KRW280,000 if the application is submitted in person, and KRW252,000 if the application is submitted online. Information about KFDA fees can be found on its website.
Authorisation is not subject to any time limit. When an authorisation is issued, it continues to be in effect unless it terminates (for example, due to cancellation) or if it is revoked as a result of the company's failure to comply with post marketing surveillance conditions (see Question 8, Post-marketing commitments and pharmacovigilance obligations).
The KFDA is the principal regulator of manufacturing authorisations (PAA and MDA). The KFDA can conduct an on-site inspection of a manufacturing facility to ensure that regulations and the GMP are satisfied (PAA and MDA).
If a violation is found, the KFDA can issue an order for:
Correction.
Disposal.
Suspension or cancellation of the manufacturing licence.
Criminal sanctions, such as imprisonment or a fine, can be imposed. The person liable and also the company for which the person works can be fined.
The PAA and MDA govern the clinical trials of medical products. The overseeing authority is the KFDA (see Question 1, Regulatory authorities).
To conduct a clinical trial, a clinical trial protocol must be approved by the KFDA. For this purpose, the following must be submitted to the KFDA:
A plan for the clinical trial.
Supporting documents or data proving the relevant medical products have been manufactured in compliance with medical product manufacturing and quality management standards. For biomedical materials, biomedical product manufacturing and quality management standards must be included.
Self-evaluation standards and testing methods, and the documents requested by the Commissioner of the KFDA relating to safety and effectiveness.
The following must be explained to the trial subject to obtain their prior informed consent to the trial:
The contents of the clinical trial.
Possible adverse effect on the health of the trial subject.
Compensation amount and procedure.
Before a clinical trial begins, the protocol must be reviewed in advance by an institutional review board (IRB), and a written contract must be concluded between the sponsor (for example, a medical product manufacturer) and the medical institution.
Clinical trials must be conducted in accordance with the standards under the Good Clinical Practices for pharmaceutical products and medical devices, relating to the:
Test method.
Qualifications of testing institution and test supervisor.
Safety plan.
Test period.
Preservation of related data.
A product licence must be obtained from the KFDA to manufacture, import or market a medical product (PAA and MDA).
For pharmaceutical products, an application with supporting documents (including clinical data and a GMP certificate) must be submitted to the KFDA for approval. However, some products are exempt from the KFDA approval procedure (for example, products set out under Korean pharmacopoeia, an official compendium or a book of medical products recognised by the KFDA). In these cases, a report must be submitted to the KFDA before the manufacture, importing or marketing of such products. The KFDA will review the report to ensure that the exemption requirements are satisfied.
For medical devices, an application with supporting documents (including clinical data, dimensional specifications, technical drawings and a GMP certificate) must be submitted to the KFDA for approval. Class I generic products (see Question 1, Legislation) are exempt from this approval process but a report must be submitted to the KFDA for it to confirm this exemption applies.
The KFDA mainly considers whether the following factors have been satisfied, in accordance with the standards set out for each medical product:
Safety.
Efficacy.
Quality.
For imported products, information on production and sale in the country of origin.
Other relevant information.
Pharmaceutical products can only be distributed and sold by licensed wholesalers or pharmacists (PAA).
Medical devices can only be distributed and sold by the licensed seller or pharmacist (MDA).
It usually takes at least six months to obtain a product licence to manufacture and market pharmaceutical products from the KFDA. The key stages are as follows:
Safety and efficacy review: 70 days.
GMP evaluation: 120 days.
For medical devices, it usually takes at least five months to obtain a product licence to manufacture and market a Class II, III or IV product from the KFDA. The key stages are as follows:
Safety and efficacy review: 80 days.
Review of technical documents: 65 days.
Fees payable to the KFDA vary from KRW27,000 to KRW4.14 million for pharmaceutical products and KRW35,000 to KRW447,000 for medical devices. This depends on whether:
The filing is an application for approval or a report.
Safety and efficacy evaluations are required.
Evaluations on data for medical product equivalency tests are required.
For new drugs and new medical devices, the product licence is subject to re-examination requirements (PAA and MDA, respectively) (see below, Post-marketing commitments and pharmacovigilance obligations).
Post-marketing surveillance focuses on the efficacy and safety of new medicinal products, indications and devices. The minimum number of reports required to be submitted to the KFDA depends on the type of product and varies from 600 to 3,000. For example, the following are subject to post-marketing surveillance during the following re-examination periods, starting from the date of the product licence approval:
New drugs: six years.
Pre-approved prescription drugs with a new indication (that is, a new application for an existing approved drug): four years.
New medical devices: four to seven years.
The PAA has simplified the application procedure for authorisation of certain medical products. If a product is subject to approval, the approval procedure can also be simplified as follows:
Information or materials relating to safety and efficacy need not be submitted if the product (other than new drugs) both:
is not a biological product, gene recombination product, cell culture product, gene treatment, cell treatment, or other similar product;
corresponds to the manufacturing standards publicised by the KFDA, or is listed in the Korean pharmacopoeia or book of medical products recognised by the KFDA.
Pills, capsules or suppository drugs that contain the same ingredients as those already approved for manufacture and sale are exempt from safety and efficacy evaluations, but data on biological equivalency must still be submitted.
If the product is an orphan drug that requires immediate introduction, information or materials relating to manufacture, quality standards, and test methods need not be submitted.
For generic drugs, the KFDA's review focuses mainly on the bioequivalence test.
Foreign marketing authorisations are not recognised (see Question 5, Restrictions on foreign applicants).
The MOHW and the KFDA can effectively monitor whether products are manufactured, imported, distributed and sold according to the PAA and MDA.
The KFDA can issue an order of:
Correction.
Disposal.
Recall.
Suspension or cancellation of the manufacturing licence.
Further, the KFDA can file a criminal report with the public prosecutors' office for criminal prosecution.
South Korean law does not specifically prohibit parallel imports. However, the parallel import of medical products is not allowed, in that an import business licence and a product licence must be obtained to sell foreign medical products in South Korea (see Question 8).
Amendments made in 2010 to the PAA, MDA and Medical Services Act (MSA) introduced the Dual Punishment System, which prohibits the provision and receipt of any economic benefits for the purpose of promoting the sales of medical products. This restriction applies broadly to healthcare professionals, including:
Doctors.
Pharmacists.
Nurses.
Medical institutions and their administrative staff.
Pharmaceutical companies, medical device companies, wholesalers and their employees.
The following activities are not prohibited:
Provision of samples.
Sponsoring the organisation or attendance of academic congresses.
Sponsoring clinical studies.
Product presentations.
Early payment discounts.
Post-marketing surveillance.
Accumulation of procurement credit card points.
Violation of the amended PAA, MDA and MSA results in:
Monetary fines.
Suspension or cancellation of business or practice licences.
Criminal charges up to two years imprisonment.
The Monopoly Regulations and Fair Trade Act (MRFTA) also prohibits offering and receipt of kickbacks (that is, benefits offered to healthcare professionals to induce recommendation or prescription to their clients). In case of violations of the MRFTA, the Korea Fair Trade Commission (FTC) can issue a corrective order, impose monetary fines and file a criminal report with the public prosecutors' office.
When kickbacks are discovered, a 20% decrease in drug reimbursement prices can be imposed under the NHIA (see Question 1, Legislation).
The extraterritorial enforcement clauses of MRFTA, PAA, MDA and the Penal Code apply to foreign entities if they offer or provide kickbacks to Korean healthcare professionals.
The PAA and MDA impose strict restrictions on the marketing of medical products. Only licensed pharmacists and pharmaceutical or medical device sellers (including manufacturers and importers) can sell pharmaceutical products or medical devices in principle.
Further, pharmacists and pharmaceutical/medical device sellers can only sell medicinal products or medical devices in their pharmacies or shops. Therefore, online sales of medicinal products or medical devices are illegal.
Since November 2012, certain household medicines designated by the MOHW can be sold in 24-hour open convenient stores, as the PAA was amended.
Advertising of medicinal products is subject to the PAA and MDA. The KFDA is the main regulatory authority (see Question 1, Regulatory authorities).
Under the PAA and MDA:
Advertising is only allowed for KFDA-approved products.
Advertising must comply with the KFDA's approved indications, efficacies and other conditions.
False, deceitful, exaggerating or slanderous advertising is prohibited.
Absolute expressions such as "the best" cannot be used.
Individual healthcare professionals cannot be recommended.
Direct-to-consumer advertising must be reviewed in advance by the KFDA or its designated body.
Direct-to-consumer advertising for prescription drugs is not allowed.
Additionally, the Fair Labelling and Advertising Act generally prohibits false, deceitful, exaggerating or slanderous advertising.
Neither the PAA nor the MDA specifically regulate internet advertising. Therefore, the same principles apply to internet advertising (see above, Restrictions).
The Promotion of Information and Communications Network Utilisation and Information Protection Act regulates e-mail advertising and requires the following details to be disclosed when sending out mass advertising e-mails:
Type of information and main message.
Name and contact information of the sender.
The source(s) used to collect the recipient's e-mail address.
Steps to easily indicate whether to accept or refuse to receive the e-mail. If recipients reject an e-mail, the sender must not resend the e-mail to the same recipients (opt-out method).
Packaging and labelling of medicinal products are subject to the PAA and MDA. The KFDA is the regulatory authority.
Packaging and labelling rules for medicinal products differ depending on the types of medicinal products.
The following information (among others) must generally be indicated on the container or packaging of medicinal products:
Name and address of the approved manufacturer or importer.
Name of the product.
Manufacture number and expiration.
Quantity (weight, volume or number).
Method of storage and other matters to be indicated on the labelling, for certain specially designated medicinal products.
Name of the ingredients.
Indication of prescription drug or over the counter (OTC) and price.
All labelling of medicinal products must be in Korean. Foreign language or Chinese characters in the same size as the Korean language can be used together with Korean.
Traditional herbal medicinal products, which are not mere herbs, qualify as pharmaceutical products under the PAA. Accordingly, they are also subject to the PAA.
Simple herbs are deemed to be food products and are regulated under the Food Sanitation Act (health supplements that are manufactured or processed from functional ingredients determined by the KFDA must be reported to the KFDA).
The sale of food products that are hazardous to health is prohibited, and food products must satisfy certain standards and specifications (Food Sanitation Act). The Food Sanitation Act provides separate standards for labelling.
The following must be satisfied for patentability (Patent Act):
Novelty.
Inventiveness.
The Patent Act does not explicitly require inventions to be capable of industrial application. However, a patent application must contain a plausible method of implementing the invention. So, in that sense, the capable of industrial application requirement is indirectly contained in the Patent Act.
The requirements for patentability must be satisfied as at the filing date.
Patents can be issued for medical devices, medicine, and methods for producing these products. However, patents cannot be issued for the method of diagnosing, treating or operating on a human being.
Patents cannot be issued if there is either:
A prior filing based on the claims.
A prior filing based on the specifications.
Therefore, the following are not patentable:
Academic and experimental inventions.
Inventions that clearly cannot be implemented in reality.
Inventions without safety or danger prevention measures.
Patent applications are handled by the Korean Intellectual Property Office (KIPO). The KIPO website provides guidance on the application procedure (www.kipo.go.kr).
Application fees and examination fees must be paid and, if registration is accepted, a registration fee must be paid.
As at 1 January 2013, the application fee consists of both:
A basic fee of KRW38,000 for electronic applications and KRW58,000 for paper applications.
KRW1,000 per page for a paper application that goes beyond 20 pages, including specification, drawings, and summary.
The examination fee consists of both:
A basic fee of KRW130,000.
An additional fee of KRW40,000 per claim.
The registration fee consists of:
A basic fee of KRW15,000 per year.
An additional fee of KRW13,000 per claim.
If the patent is for 13 to 25 years, a basic fee of KRW360,000, with an additional fee of KRW55,000 per claim.
More detailed information is available on the KIPO's website.
If the application is accepted by the KIPO, it is processed and the filing date is fixed. Priority is established from the filing date.
An application is generally accepted and an application number assigned to it. However, if the application is defective and a correction of the defect is not possible, the application is rejected. If the defect can be corrected, the KIPO can issue an office action, requesting the applicant to correct the defect.
An application is generally published after one and a half years from filing. After that, the applicant must file a request for examination of his application within five years from filing the application (a request for examination can also be filed before publication of the application). If the request for examination is not filed within this five-year period, the application is deemed withdrawn.
The KIPO provides for a speedy examination of patents relating to green technology, to support growth of low-carbon green technology.
Registration of a patent can take from one and a half years to two years from filing or even longer, depending on a number of factors such as the nature of the invention.
The term of a patent right starts once the patent is issued and ends at the expiry of 20 years from filing of the application. In the case of divisional patents and amended patents, the patent right expires after 20 years from the date of the original application.
The term of a patent cannot usually be extended.
In medical or agricultural pesticide patents, the term of the patent can be extended for the length of time (up to five years) required for the relevant product to be approved by other relevant authorities under applicable laws (for example, the PAA and the Agrochemicals Control Act). This is to ensure that the applicant can use his patented invention for the duration he otherwise would have enjoyed, but for the period required for the approvals from the other authorities.
The validity of a patent can be challenged in proceedings before the KIPO by an interested party or the KIPO patent examiner. A patent can be subject to invalidation (as if the patent never existed) if the:
Invention lacks novelty or inventiveness.
Patent application was filed after the filing of an identical invention.
Patent does not specify the purpose, structure or effect of the invention, so that a person of ordinary skill in the art cannot easily perform the invention.
Scope of the patent claims is not clear and concise, or the claims are not supported by the written specifications.
Patent application fails to identify joint ownership when the right to patent is jointly owned.
A patent is infringed when a third party performs the patented invention as a business without authorisation.
When patent infringement occurs, the patent right holder can:
In a civil proceeding, file an action for a restraining order or a preliminary injunction, and/or file an action for a permanent injunction and damages.
In a criminal procedure, file a report with the investigating authorities for criminal prosecution, and the infringer can be imprisoned or fined if found guilty.
A six-year marketing exclusivity period is recognised for new drugs (PAA).
The most basic requirement for registering a trade mark is that it cannot be identical or similar to previously registered trade marks on identical or similar specific products. In addition, the mark must be capable of distinguishing goods from the goods 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 medical product brand as a trade mark, terms describing quality, ingredient, effect, or general terms are not registrable.
Trade mark applications are handled by the KIPO. The KIPO website provides guidance on the application procedure.
The official filing fee is KRW56,000 for electronic applications, and KRW66,000 for paper applications. An additional KRW2,000 is imposed for each additional designated good, in excess of 20 designated goods in a class.
The registration fee is KRW211,000. An additional KRW2,000 is imposed for each additional designated good, in excess of 20 designated goods in a class.
An applicant must file a trade mark application with the KIPO.
It takes about eight to ten months from the date of filing an application for KIPO to decide whether to allow registration of the trade mark. However, it can take four more months if an opposition is filed (see below).
If the applicant is preparing for use or is using the trade mark, priority examination is permitted. If priority examination is requested, the examination can be concluded within two to three months.
If there are no grounds for rejection, the application is published. However, if there are grounds for rejection, the KIPO issues an office action requesting the applicant to correct the grounds for rejection. If it overcomes the grounds for rejection, the application is published.
An opposition can be filed within two months from the date of publication of the application. If no opposition is filed during that period, the trade mark is registered. However, if an opposition is filed, the KIPO reviews the opposition and this cannot be appealed. (The opponent can provide the grounds for opposition through a third party observation process, and the applicant is given an opportunity to rebut the opposition.) The opposition process takes about four months.
If no opposition is filed after publication 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.
Trade mark protection lasts for ten years.
For renewal, the applicant must file an application for renewal with KIPO within one year before expiration of the protection period, and pay trade mark registration fees.
A registered trade mark can be invalidated (as if the trade mark was never registered) if there are grounds for invalidation, for example failure to satisfy the conditions for registration because the trade mark is either:
Identical or similar to a prior registered trade mark.
Composed of only general, descriptive or geographic terms.
A registered trade mark can be cancelled (the trade mark right no longer exists from the date of cancellation) if the trade mark either:
Was used improperly by the trade mark owner or trade mark licensee (causing misconception or confusion).
The trade mark has not been used for more than three years without just cause.
Trade mark infringement occurs when there is use of a trade mark that is identical or similar to the registered trade mark, in a product that is identical or similar to specific products of the registered trade mark without authorisation of the trade mark right holder.
When a trade mark is infringed, the trade mark right holder can file a claim for:
Injunction.
Destruction of infringing products, equipment used in producing the infringing products, and other measures necessary to prevent infringement.
Damages.
In criminal proceedings, the trade mark right holder can file a criminal report with the investigating authorities for trade mark infringement, and the infringer can be imprisoned or fined if found guilty.
There is no such requirement in South Korea.
South Korea is a signatory to the following:
WIPO Paris Convention for the Protection of Industrial Property 1883.
Trade mark Law Treaty 1994.
WIPO Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989.
WIPO Nice Agreement Concerning the International Classification of Goods and Services for the Purpose of the Registration of Marks 1957.
WTO Agreement on Trade-Related Aspects of International Property Rights 1994.
The main provisions are:
The Product Liability Act.
Principles of tort outlined in the Civil Code.
Contract principles of non-performance of obligations and compensation for damages outlined in the Civil Code.
Product Liability Act. The claimant bears the burden of proving the following:
Defect in the product (manufacturing defect, design defect or labelling defect).
Life, bodily or property damage.
Causal relationship between the defect and damage.
Tort. The claimant bears the burden of proving the following:
Intentional or negligent act.
Damage suffered by the claimant.
Causal relationship between the act and damage.
Contract. The claimant bears the burden of proving the following:
Non-performance of contractual obligations.
Damage suffered by the claimant.
Causal relationship between the non-performance and damage.
Product Liability Act. Product liability claims can be brought against manufacturers, which include:
Persons engaged in the business of manufacturing, processing, or importing the product.
Persons who represent or misrepresent themselves as persons identified in the above bullet point by putting their name, trade name, trade mark or any other identification markings on the product.
Tort. There is no limit on who can be liable. If the substantive requirements are met (see above, Substantive test) any involved party can be liable, including manufacturers, processors, importers, sellers, doctors, nurses, and pharmacists.
If a government official has wilfully or negligently granted approval for the sale of medicinal products that have defects, the state employing the government official may be required to compensate for damages (State Compensation Act).
Contract. A breach of contract claim can only be made against a party which has a contractual relationship with the claimant. Hospitals, doctors, pharmacists and other medical professionals that are parties 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.
Product Liability Act. The limitation period to bring a claim is both:
Three years from the date when the injured person became aware of the damage and the person liable.
Ten years from the date of supply of the product by the manufacturer.
In relation to latent damage, the symptoms of which appear after a lapse of a certain period, the ten-year limitation period starts from the date on which the symptoms appear.
Tort. The limitation period to bring a tort claim is:
Three years from the date when the injured person became aware of the damage and the person liable.
Ten years from the date when the unlawful act was committed.
Contract. The limitation period for a claim is ten years (five years for commercial contracts) from the date when the injured party is first able to make the claim. Under Korean case law, medical services contracts between doctors and patients are not generally considered to be commercial.
Class actions, except for stock-related suits, are not allowed under Korean law. The Civil Procedure Act allows for joinder of parties' claims if their grounds for bringing these claims are the same or similar.
Showing failure to satisfy the substantive elements (see Question 31, Substantive test), in whole or in part, is generally a defence. In addition, the following defences may also be possible.
Manufacturers of medicinal products can be exempt from liability if they can prove any of the following:
The manufacturer did not supply the product.
It was impossible for the manufacturer to discover the defect based on the level of scientific or technical knowledge available at the time of supply of the product.
The product defect is due to compliance with the applicable law at the time of supply of the product.
If raw materials or components of the product have the defect, the defect is produced by the design of the product or the manufacturing instructions from the manufacturer.
However, if appropriate preventive measures are not taken to prevent damages 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 case, 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.
Monetary compensation can be sought for damages that would 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 are not allowed under Korean law. Punitive damages are also not permitted in product liability claims.
There are no current proposals for reform.
Main areas of responsibility.
Matters related to the:
Food Sanitation Act.
Functional Health Foods Act.
Special Act on Children's Eating Habit Safety Management.
Pharmaceutical Affairs Act.
Medical Devices Act.
Cosmetics Act.
Safety and Management of Human Tissue Act.
Main areas of responsibility. Matters related to, among others:
Monopoly Regulation and Fair Trade Act.
Regulation of Standardised Contracts Act.
Fair Transactions in Subcontracting Act.
Act on Fair Labelling and Advertising.
Instalment Transactions Act.
Door-to-door sales.
Act on Consumer Protection in Electronic Commerce Transactions.
Fair Transactions in Franchise Business Act.
This is the official website maintained by the Ministry of Government Legislation. It provides up-to-date legislative information, including full texts of statutes together with notable case law in Korean.
This is the official website provided by the Korea Legislation Research Institute. It provides English translations of major acts and subordinate regulations. Information is potentially out-of-date and translations are for guidance only.
T +82 2 772 4379
F +82 2 772 4001
E hyeonggun.lee@leeko.com
W www.leeko.com
Professional qualifications. South Korea, 1994
Areas of practice. Healthcare law; M&A; general corporate law.
Non-professional qualifications. LLB, Seoul National University College of Law; LLM, Columbia Law School.
Recent transactions
Languages. Korean, English
Professional associations/memberships. Korean Bar Association.
Publications
A Practical Cross-Border Insight into Public Procurement: Korea Part, The International Comparative Legal Guide to Public Procurement, 2011.
Appraisal Rights of Dissenting Shareholders, BFL (vol. 38), Center for Financial Law at Seoul National University, 2009.
Korean Regulations on Business Combination involving Foreign Entities, Asialaw Corporate Finance Review, January 2008.
T +82 2 772 4711
F +82 2 772 4001
E jinhwan.chung@leeko.com
W www.leeko.com
Professional qualifications. South Korea, 2000; New York State, US, 2009
Areas of practice. Healthcare law; antitrust; general corporate law.
Non-professional qualifications. LLB, Seoul National University College of Law; LLM, Georgetown University Law Center
Recent transactions
Languages. Korean, English
Professional associations/memberships. Korean Bar Association; New York State Bar; American Bar Association.
Publications. The International Comparative Legal Guide to: Pharmaceutical Advertising – Korea Part, Global Legal Group, 2009.
