呂正鉉

呂正鉉

  • 律师
  • T. +82-2-3404-6928
  • F. +82-2-3404-7686
  • E. junghyun.yeo@bkl.co.kr

介绍

Junghyun Yeo focuses his practice mainly on healthcare including medicines and medical devices, administrative litigation, and legislative work. Mr. Yeo provides professional legal service in the areas of government regulation and healthcare based on his public service experience at the Ministry of Health and Welfare directing policies on rebates and sales practices of the medical/pharmaceutical industry and handling administrative act/litigation concerning medical professionals as well as his work experience as a pharmacist at a pharmacy and a hospital.

Mr. Yeo graduated from the College of Pharmacy, Yeungnam University and obtained his pharmacist's license in 2009. He later graduated from Yeungnam University Law School and was admitted to the Korean Bar in 2016. He started his work in the public sector at the Ministry of Government Legislation and has worked as a deputy director of the Ministry of Health and Welfare until 2023 before joining Bae, Kim & Lee LLC.

履历

2023-至今 Bae, Kim & Lee LLC
2021-2023 Deputy Director, Division of Pharmaceutical Policies, Ministry of Health and Welfare
2019-2020 Deputy Director, Division of Child Abuse Response, Ministry of Health and Welfare
2017-2019 Expert Advisor, Healthcare Resource Policy Division, Ministry of Health and Welfare
2016 Attorney in Legal Affairs, Legislation Innovation Division, Ministry of Government Regulation
2010-2011 Pharmacist, Yeolin Pharmacy
2009-2010 Pharmacist, CHA University Gangnam Medical Center
其他经历
2025-至今 Member, Self-Regulatory Deliberation Committee on Labeling and Advertising, Korea Food Industry Association
2018-2019 Investigation Commissioner, Ministry of Health and Welfare's Medical Training Environment Review Committee
2017-2018 Advanced Intellectual Property Strategy Program (AIP, 4th), Korea Advanced Institute of Science and Technology (KAIST)

主要业务案例

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

学历

2016 Yeungnam University Law School (J.D.)
2009 Yeungnam University (B.S.)

主要社会活动

著作
Precedents Explained, Pharmacist Act (Shinil Books, 2021)
Precedents Explained, Medical Service Act (Shinil Books, 2020)
活动
Lecturer, Department of Pharmacy, Sookmyung Women's University (2025–Present)
Speaker, KIMES Seminar on Compliance Issues to Establish a Medical Device Supply Order (2026, Korea Medical Devices Industry Association)
Lecturer, Recorded Initial and Refresher Training Programs for Medical Device Contract Sales Organizations (CSOs) (2025, Korea Medical Devices Industry Association)
Speaker, KMDIA Ethics Committee Regular Workshop - Fair Competition Rules in Medical Device Distribution Transactions (2025, Korea Medical Devices Industry Association)
Speaker, Aesthetic Medical Device Expo & 51st Autumn International Conference - Response Strategies to “Black Consumers” (2025, Korean Society for Laser, Dermatology and Trichology)
Lecturer, Recorded Initial and Refresher Training Programs for Pharmaceutical CSOs (2024–2025, Korea Pharmaceutical and Bio-Pharma Manufacturers Association)
Lecturer, Capacity-Building Training for Seoul Metropolitan Government Officials in Charge of Medical and Pharmaceutical Affairs - Recent Case Law under the Pharmaceutical Affairs Act, Q&A on the Pharmaceutical Affairs Act, and Understanding of CSO (2024–2025, Seoul Metropolitan Government)
Speaker, KPBMA Ethics Management Workshop (First Half, 2024) - CP Monitoring and Audit Techniques: Demonstrating Supervisory Duties (2024, Korea Pharmaceutical and Bio-Pharma Manufacturers Association)
Speaker, KRPIA Ethics Management Workshop - Key Issues in Recent Amendments and Implementation of the Pharmaceutical Affairs Act (2024, Korea Research-based Pharmaceutical Industry Association)
Speaker, KPBMA-KRPIA Ethics Management Academy - Dispute Response Strategies Related to Disclosure of Expenditure Reports (2024, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Research-based Pharmaceutical Industry Association)
Speaker, KMDIA Ethics Committee Regular Workshop - Anticipated Disputes and Response Strategies under the Expenditure Report Disclosure Regime (2024, Korea Medical Devices Industry Association)
Speaker, KIMES Seminar on Compliance Issues and Practice in Medical Device Distribution Order (2024, Korea Medical Devices Industry Association)
Speaker, KMDIA Ethics Committee Regular Workshop - Compliance Issues in Medical Device Agency Agreements and Legal Issues between Manufacturers/Importers and Distributors (2023, Korea Medical Devices Industry Association)
奖项
Citation (Minister of Education, 2019)
Citation (Minister of Health and Welfare, 2018)

资格

2016 Korea
2009 Pharmacist (Korea)