Lee & Ko's Healthcare Practice Group focuses on providing legal services expertly tailored to meet the needs of clients with specific concerns relating to healthcare and related matters, including (among other things) medical devices, food and beverage products and cosmetics. In addition to their outstanding credentials and experience as legal professionals, the practice group's members are attorneys who have specialized backgrounds in various relevant fields, such as medicine, pharmacology and chemical engineering. The practice group also includes a number of members who have special expertise and prior experience as persons who have been directly or indirectly involved in the regulatory enforcement of healthcare-related laws and policies in positions of responsibility at relevant governmental agencies. The excellent professional capabilities available within the Healthcare Practice Group ensure that clients will benefit from the highest levels of expertise and receive the most effective legal assistance and advice possible in connection with any healthcare-related issues or matters that may concern them.

Legal issues of particular relevance in the general healthcare field include strict regulatory restrictions that apply to medical devices, food & beverage products, cosmetics and medical service businesses. While existing regulatory restrictions are continually revised and updated, new regulations are also being frequently introduced pursuant to legislation and regulatory policy-making to accommodate the fast changing social environment in response to evolving social demands and awareness as well as the increasingly rapid pace of technological innovation. The members of our Healthcare Practice Group provide accurate, effective and practical advice to clients based on extensive experience and knowledge in the relevant industries as well the ability to draw upon cordial and constructive relationships and channels of communication maintained vis-a-vis various relevant experts in the regulatory sector.

Lee & Ko's Healthcare Practice Group not only provides advice on traditional healthcare practice matters, such as approvals and permits, labelling, trademark and patents, but is also at the forefront in providing effective legal solutions in new areas such as cross-border business expansions by medical service providers and the integration of IT and healthcare. Many members of the practice group also actively participate in related legislative and regulatory policy-making matters in advisory capacities that include providing input on the drafting of healthcare-related laws and regulations, as well as consultation on enforcement-related issues and approaches.

Expertise

Medical Devices

The Healthcare Practice Group has been very active in this heavily regulated industry, providing advice to numerous clients regarding a full range of legal issues, including such things as product approvals, import procedures, and distribution and clinical trials for medical devices. As increasing emphasis is put on compliance relating to fair trade and anti-corruption regulations, the Healthcare Practice Group has been providing clients with comprehensive legal advice addressing issues arising under Korean fair trade and anti-corruption laws, as well as foreign anti-corruption laws (such as the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act) and foreign industry codes

The Healthcare Practice Group has also been active in providing legal services relating to new types of medical devices such as diagnostic applications and wearable devices

Medical Services

Lee & Ko’s Healthcare Practice Group has been very active in advising many healthcare institutions in connection with clinical trials, medical litigation, medical service advertising and other long-standing areas of concern in the medical services sector. Additionally, in light of a dramatically increased focus on compliance in recent years in the medical services sector, the Healthcare Practice Group has developed an excellent reputation for the quality of its in-depth compliance advice and assistance. In recent years, the Group has been at the forefront in providing legal services in new areas, such as cross-border business expansion by medical service providers, integration of medical services and IT, and medical tourism.

Food & Beverage Products and Cosmetics

The Healthcare Practice Group provides clients with highly effective and practical legal solutions based on many years of experience with import procedures, labelling and advertising requirements, and consumer protection restrictions for various food & beverage products. Since the 1980s, the Healthcare Practice Group has been active in advising clients in connection with the importation and marketing of food and beverage products, as well as cosmetics, into Korea. The Group also has extensive experience as legal advisors for domestic as well as cross-border M&A transactions involving food and beverage products and cosmetics.