Advised multiple multinational pharmaceutical companies on drug pricing strategies, including the determination of reimbursement price ceilings, responses to the “Price-Volume Agreement (PVA)” mechanism, and expansion of reimbursement criteria
Advised a multinational pharmaceutical company on whether its Patient Support Program constitutes the provision of economic benefits under the Pharmaceutical Affairs Act
Advised a domestic pharmaceutical company on the implementation of the CSO (Contract Sales Organization) reporting regime, including reporting procedures, preparation of outsourcing agreements, and training obligations
Reviewed compliance issues regarding investigator-initiated trial (IIT) agreements for multiple domestic pharmaceutical companies, including the appropriateness of costs and potential rebate concern
Provided Government Relations (GR) support and follow-up legal advice for multinational pharmaceutical companies regarding the data protection system under the Pharmaceutical Affairs Act
Advised a domestic pharmaceutical company on the interpretation of Risk Management Plan (RMP) regulations for orphan drugs and the scope of submission obligations
Advised a domestic pharmaceutical company on the legality under the Pharmaceutical Affairs Act of ingredient advertising and disparaging advertising
Advised on regulatory requirements for the establishment of a pharmaceutical wholesaler in Korea and on applicable distribution structures
Advised on responses to search and seizure conducted by investigative authorities in connection with alleged violations of the Pharmaceutical Affairs Act (rebates)
Advised a domestic pharmaceutical company on pre-enforcement response to sanctions imposed by the Ministry of Food and Drug Safety (“MFDS”) for violations of pharmaceutical advertising regulations, including the submission of written opinions
Advised a domestic pharmaceutical company on pre-enforcement response to administrative sanctions imposed by the MFDS for failure to submit a Risk Management Plan (RMP) for an orphan drug
Advised a domestic pharmaceutical company on responding to MFDS administrative sanctions relating to a rebate case involving its sales representatives, including submission of written opinions to limit the scope of affected products
Represented a domestic pharmaceutical company in an administrative litigation seeking revocation of the MFDS's disposition cancelling an import drug marketing authorization
Advised a multinational medical device company on the legality of medical device advertising and provided Government Relations (GR) support and legal advice regarding the permissibility of disclosing a list of healthcare institutions handling its products
Assisted a multinational medical device company in drafting internal Standard Operating Procedures (SOPs) relating to donations, and provided compliance advisory services in both Korean and English
Advised a multinational medical device company on legal issues relating to a proposed reimbursement differentiation scheme based on the useful life of medical equipment
Advised on the review of ancillary agreements and legal compliance requirements in connection with the implementation of the medical device Contract Sales Organization (CSO) regime
Advised on the legality under the Medical Devices Act of a profit-sharing sales model and the provision of additional medical devices
Advised a food retailer on responding to an investigation into alleged violations of the Act on Labeling and Advertising of Foods, including the use of exaggerated claims for general food products and advertising based on consumer testimonials
Advised a home shopping company on the requirement to file a livestock product sales business registration under the Livestock Products Sanitary Control Act in connection with its online meat distribution business
Advised a pharmaceutical company on the legality under the Act on Labeling and Advertising of Foods of using health functional food-related expressions in marketing general food products
Advised a cosmetics company on follow-up measures in response to the contamination of foreign substances
Advised a cosmetics manufacturer and distributor on labeling and advertising regulations under the Cosmetics Act and measures relating to its products
Represented a large retail company in administrative litigation challenging sanctions imposed for violations of the Food Sanitation Act due to exceeding additive limits in packaged meat products
Advised a major distributor on responding to sanctions imposed by the MFDS for violations of cosmetics advertising regulations
Advised a healthcare institution on responding to on-site inspections and challenging administrative sanctions for alleged fraudulent claims for the costs of healthcare benefits, including claims for unperformed medical services and inflated patient visit days
Represented a healthcare institution in administrative litigation challenging a business suspension imposed for improper claims for the costs of healthcare benefits related to the nursing grade differentiation system