Healthcare & Life Sciences
“They grasp the client’s needs quickly and provide accurate and thorough feedback within the timex-frame. Plus, their interdepartmental collaboration is hugely helpful.”
- Chambers & Partners Asia-Pacific
Overview
BKL’s Healthcare & Life Sciences Group offers a full spectrum of legal services to both international and domestic clients across the healthcare, pharmaceutical, and life sciences industries. With a multidisciplinary team of experts, BKL specializes in key sectors including medical service, pharmaceuticals, medical devices, animal drugs, food and cosmetics. Our team provides strategic guidance in areas such as regulations, patents and licensing, litigation, government investigations, fair trade, M&A and initial public offerings (IPO).
BKL has a distinguished track record in addressing complex regulatory and compliance issues. Our services include obtaining product approvals, navigating Good Manufacturing Practice (GMP) surveillance, handling violations of the Act on Fair Labeling and Advertising, advising on relevant regulations including inclusion on the National Health Insurance benefit list. We have also achieved landmark victories in litigation involving government administrative actions such as sales suspension, drug price reductions, and impurity-related disputes.
As the healthcare sector evolves into a next-generation industrial driving force, BKL continues to pioneer innovative solutions to support its growth and globalization. Our expertise extends beyond traditional legal services, providing tailored advice on M&A, IPO, overseas expansion, technology licensing, and new business model designs for pharmaceutical and medical device companies and healthcare institutions. In today’s rapidly advancing technological landscape, BKL is at the forefront of addressing emerging challenges and opportunities. We deliver cutting-edge legal and strategic support in areas relating to medical records, use of big data, use of AI and cutting-edge technology, telemedicine, and new drug development.
Key Services
Regulatory Advice and Litigation on Healthcare Industry Regulations
Handle investigations by health authorities such as the Ministry of Food and Drug Safety and the Ministry of Health and Welfare.
Advise and represent clients in cases concerning the national lot release system.
Manage cases involving temporary manufacturing/sales/use suspension orders, business suspension orders, and other regulatory sanctions.
Legislative and Government Relations Support
Advise on healthcare-related laws such as the Medical Service Act and the Pharmaceutical Affairs Act.
Assist with government legislation and policy consultation.
Monitor health authority trends, obtain authoritative interpretations, and manage interactions with administrative agencies concerning amendments to laws and regulations.
National Health Insurance Advice and Litigation
Provide guidance on the application of healthcare benefits for pharmaceuticals and medical devices, as well as claims for such benefits.
Advise on drug pricing and reimbursement standards, including those related to the launch of biosimilars.
Represent clients in litigation seeking:
Digital Healthcare Support
Advise and represent clients on the use and management of personal medical data.
Provide legal counsel on telemedicine, digital therapeutic devices, and related technologies.
Compliance and Risk Management
Assist in establishing internal regulations and conducting compliance diagnoses for domestic and international companies.
Conduct internal investigations and employee training to enhance compliance practices.
Technology Licensing and Intellectual Property Rights
Advise and represent clients in cases involving patent and trademark infringement, invalidation, and employee inventions.
Provide counsel on licensing agreements for new drugs and drug candidates.
Healthcare Business Strategy and Corporate Legal Services
Advise on joint ventures, M&A, equity investments, and business transfers between domestic and international pharmaceutical companies.
Represent clients in cases involving the acquisition of foreign hospitals by domestic corporations.
Counsel on contracts such as joint development agreements, exclusive sales agreements, and consignment manufacturing agreements.
Operation of Medical Institutions
Represent clients in litigation related to the establishment and operation of foreign medical institutions, including cancellation or revocation of permissions.
Provide legal support for sanctions, such as suspension of healthcare benefit payments and recovery of benefits.
