Will silymarin reimb reversal be overturned?

Seoul High Court overturns lower court ruling, recognizes silymarin's clinical utility

Legalon retains reimbursement status... potential implications for other reevaluation lawsuits

In a lawsuit challenging the Ministry of Health and Welfare's decision to remove ‘silymarin (milk thistle extract)’ products from the reimbursement list following a reimbursement adequacy reassessment, Bukwang Pharmaceutical secured a reversal victory on appeal.

The case has drawn significant attention from the pharmaceutical and biotech industry as it marks the first instance where the Seoul High Court overturned a lower court ruling and recognized the clinical utility of an active ingredient that had failed a reimbursement adequacy reassessment.

Bukwang Pharmaceutical overturns first instance loss, successfully demonstrates ‘clinical utility

According to industry sources on the 19th, the 9-1 Administrative Division of the Seoul High Court ruled in favor of the plaintiff in the lawsuit filed by Bukwang Pharmaceutical against the Minister of Health and Welfare seeking the ‘revocation of the partial amendment notice of the drug reimbursement list and reimbursement ceiling price table’. This overturns the Seoul Administrative Court's first-instance ruling in favor of the Ministry of Health and Welfare, accepting Bukwang Pharmaceutical's arguments.

The key issue in this lawsuit was whether the ‘clinical utility’ of the silymarin component would be recognized. Silymarin was subject to a reimbursement adequacy reassessment in 2021 alongside ▲bilberry dry extract ▲avocado-soybean unsaponifiables ▲Vitis vinifera (grape seed extract) ▲Ginkgo biloba dry extract.

Following the reassessment, the government concluded that silymarin lacked reimbursement adequacy, citing insufficient academic evidence to support its clinical utility. In November of that year, the Ministry formally announced the removal of reimbursement coverage for silymarin products.

In response, pharmaceutical companies filed administrative lawsuits and sought injunctions to suspend enforcement. Bukwang Pharmaceutical, which markets the silymarin product Legalon, filed a separate lawsuit, while six other companies—including Samil Pharm, Suheung, Young Il Pharm, Korea Pharma, Hutecs Korea Pharmaceutical, and HanAll Biopharma—jointly filed a related suit.

After more than two years of litigation, the Seoul Administrative Court issued its first ruling in November 2023, finding the reimbursement removal lawful and ruling in favor of the government.

The pharmaceutical companies appealed, and the appellate court took a markedly different view. During appellate proceedings, Bukwang submitted additional evidence, including SCIE-indexed academic papers, to substantiate the clinical utility of silymarin. The court determined that this body of literature was sufficient to support the ingredient’s clinical utility.

First case where the court recognized clinical utility. … Industry interest rises

While multiple administrative lawsuits have challenged reimbursement adequacy reassessment outcomes in the past, no court had previously accepted a pharmaceutical company’s claim regarding clinical utility.

In a 2023 case involving bilberry dry extract, a pharmaceutical company prevailed at first instance; however, the court at that time cited procedural flaws in the reassessment process rather than recognizing clinical utility. Ultimately, bilberry dry extract failed to secure final recognition of clinical utility on appeal and was removed from the reimbursement list.

By contrast, the silymarin ruling directly addresses the substantive issue of clinical utility, rather than administrative procedure. It represents the first case in which a court explicitly acknowledged the effectiveness of a drug ingredient based on academic evidence submitted by a pharmaceutical company, overturning the government’s determination that the drug lacked sufficient efficacy.

Reimbursement for Legalon maintained… potential ripple effects on ongoing lawsuits

As a result of the appellate victory, Bukwang Pharmaceutical will be able to maintain reimbursement coverage for Legalon. While Legaron's reimbursement was preserved during the lawsuit due to the court's injunction, this ruling is seen as further solidifying its legal standing for reimbursement.

Industry observers expect the government to appeal to the Supreme Court to seek a final judgment. However, given that the appellate court explicitly acknowledged the value of the clinical evidence, analysts suggest that pharmaceutical companies may hold a stronger position in any further proceedings.

The ruling is also expected to influence other ongoing lawsuits involving silymarin products filed by companies such as Samil Pharmaceutical, as the legal issues at stake are essentially identical.

According to pharmaceutical market research institute UBIST, outpatient prescription sales of silymarin products increased by 45% over three years, from KRW 23.6 billion in 2019 to KRW 34.1 billion in 2022. However, following the failure of the reimbursement reassessment, many products were removed from the reimbursement list, leading to a contraction of the market. Currently, only products from seven companies involved in litigation with the government continue to receive reimbursement coverage. Cumulative prescription sales for these products reached KRW 17.5 billion in the third quarter of this year, representing a 5% year-on-year decline. For Legalon, cumulative third-quarter prescription sales fell 11%, from KRW 12.1 billion to KRW 10.8 billion.