Major countries including Japan, the United States and those in Europe manage the outsourcing of pharmaceutical sales by tightening qualifications for sales staff, strengthening drugmakers' responsibilities and imposing strict penalties for violations, a report has found.
According to a report titled "Strengthening the Management and Supervision System for Pharmaceutical Promotion and Sales," submitted to the office of Rep. Kim Yun of the Democratic Party by the Ministry of Health and Welfare on the 25th, in Japan a contract sales organization (CSO) commonly dispatches medical representatives (MRs) to a drugmaker, which then directly directs and supervises them. MRs go through a private certification system involving more than 300 hours of training and examinations, and 98.2% of active MRs hold the certification, effectively making it an industry standard. Some medical institutions use MR certification as a condition for entering their hospitals.
The United States imposes heavy penalties on illegal promotional practices while also encouraging whistleblowing. A willful violation of the Anti-Kickback Statute (AKS) can bring up to 10 years in prison or a fine of $100,000 (about 139 million won), as well as exclusion from federal health insurance programs. When illegal rebates lead to false or fraudulent claims to federal health insurance, the False Claims Act (FCA) applies, imposing damages equal to three times the government's actual loss along with per-claim fines.
The country also operates a "qui tam" system, under which whistleblowers file lawsuits on behalf of the federal government. Whistleblowers receive up to 30% of the amount the government recovers over corporate misconduct, and protection provisions bar the dismissal of or discrimination against those who report violations. According to the report, there were 1,297 qui tam lawsuits in 2025.
The United Kingdom and the European Union are spelling out the responsibility of contracting drugmakers to manage and supervise CSOs. The code of practice of the Association of the British Pharmaceutical Industry (ABPI) holds drugmakers responsible for the conduct, training and compliance of contract sales staff, while the Bribery Act requires preventive procedures such as due diligence, training and monitoring to keep third parties from providing improper benefits. In the EU as well, under codes of conduct including that of the European Federation of Pharmaceutical Industries and Associations (EFPIA), drugmakers are required to verify the eligibility and compliance capabilities of CSOs and to conduct training, record-keeping and monitoring even after signing contracts.
An industry official explained that "in Korea too, drugmakers can be subject to criminal liability or administrative sanctions for a CSO's illegal conduct, but the current Pharmaceutical Affairs Act does not specifically set out how and to what extent an entrusted CSO should be inspected and supervised."
