Korea to adopt compliance scoring system on pharma kickbacks in 2026

Starting in 2026, the government is likely to implement a new “rebate scoring system” as part of the criteria for retaining certification as innovative pharmaceutical companies.

In Korea, “rebate” refers to illegal financial kickbacks provided by pharmaceutical firms to healthcare providers.

The new system will allow firms with a history of rebates to maintain their designation as long as their scores remain below a set threshold.

Kim Kang-seop, director of the Health Industry Promotion Division at the Ministry of Health and Welfare, explained the progress of the rebate scoring system during a meeting with journalists on Wednesday.

The Innovative Pharmaceutical Company Certification System provides benefits such as preferential drug pricing and tax incentives to firms with high R&D investment ratios, aiming to stimulate new drug development among Korean pharmaceutical companies.

Earlier, the ministry stated in its “2025 Key Task Implementation Plan” that it would strengthen the certification criteria for innovative pharmaceutical companies as part of core regulatory reforms. The rebate scoring system was reviewed as one of the proposed improvements.

Currently, innovative pharmaceutical companies face strict disqualification rules reflecting the system’s original intent to uphold high ethical standards. Companies that violate the Pharmaceutical Affairs Act within three years and receive two or more administrative penalties totaling over 5 million won ($3,600) are excluded from the designation.

However, the pharmaceutical industry has argued that using past rebate violations as a basis for disqualification is excessive. The ministry accepted this view and is moving forward with improvements.

Under the revised plan, the rebate scoring system will assign points for disqualification factors—such as the number of administrative penalties or the total rebate amount. The key principle is that companies will retain their innovative status unless their scores exceed a set limit, even if rebate violations are recorded.

“We plan to announce the notice regarding the introduction of the rebate scoring system in October for implementation in January 2026,” Lim said.

The plan will also include separate certification standards for multinational companies and a review of the rule that prohibits re-certification for three years after losing innovative pharmaceutical company status.

“We have prepared distinct certification standards for multinational firms. Regarding the current three-year ban on re-certification after cancellation, industry voices have said this is excessive, so we are reviewing it,” Lim explained.