Mr. Woo-Soon Jang is a Senior Advisor at Shin & Kim, and provides advisory services on drug reimbursement pricing in the pharmaceutical and bio industries and compliance.

Mr. Jang has performed major policy-related duties for relevant industries at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, including those related to drug reimbursement pricing, compliance, external cooperation, global business affairs, AI-driven drug development and the fostering of talented manpower, conducting policy coordination between the industry and the government.

In particular, Mr. Jang has performed practical duties with respect to changes in the regulatory environment of the pharmaceutical industry, including overhauls of the drug reimbursement pricing system, responses to the introduction of the dual punishment system and two-out system, and the operation of the administrative surcharge system for rebates. He has also performed duties relating to the amendment of the Fair Competition Code, overhaul of corporate codes of ethics and by-laws, introduction of the compliance management system, etc. for the establishment of compliance systems for pharmaceutical companies

Based on such substantial experience as above, Mr. Jang currently provides his clients with advisory services on regulatory responses and the establishment of policies and strategies for the pharmaceutical/bio industries.

• Advisory on Insurance Drug Pricing, Pharmaceutical Policies, Regulatory Response, Rebate Regulations, Compliance, Pharmaceutical Distribution, AI-Driven New Drug Development, and Global Cooperation

Drug reimbursement price system and drug pricing policies

• Contributed to the introduction of the price premium system for fixed-dose combination incrementally modified drugs (2013), improvement of the cost calculation standards for new drugs and drugs for prevention of market withdrawal (2014), abolition of the low-price purchasing incentive system (2014) and the introduction of the price premium system for domestically developed new drugs (2017)
• Made policy responses to the measures for the rationalization of drug costs (2006), across-the-board drug reimbursement price reduction (2012), improvement of the actual transaction price-based drug price reduction system (2016) and the establishment of grounds for the implementation of the foreign price comparison-based drug price reevaluation system (2020)

Establishment of compliance systems and policies to ensure transparent distribution

• Responded to the introduction of the dual punishment system for rebates (2010) and the two-out system (2014)
• Established regulations limiting distribution transaction prices of drugs for prevention of market withdrawal to prevent instability in supply and demand and market withdrawal (2017)
• Led the 3rd, 4th and 5th amendments of the Fair Competition Code, establishment of the corporate ethics codes and by-laws and the implementation of compliance management initiatives (introduction of ISO 37301)
• Supported the introduction of a reporting system on the details of disbursement of economic benefits (K-Sunshine Act), the CSO declaration system and a mandatory training program

AI-driven drug development, global engagement, fostering of talented manpower

• Secured the order for K-MELLODDY project, provided education on AI-driven drug development and established an eco-system (advisory group, consultative council, competition, forum)
• Advanced into the Boston cluster, revised the Vietnam bidding ratings, dispatched the Central and South American health and medicine delegation and led cooperation between Korea and Japan and Korea and China
• Established the CP academy (CSO education), LMS-based education platform, project for commemoration of 80th anniversary of incorporation and Vision 2030