ECCK urges Korea to fast-track drug reimbursement and update pricing rules

The European Chamber of Commerce in Korea (ECCK) on Thursday urged Seoul to close what it calls a years-long gap between approval and insurance coverage and to modernize the way Korea prices innovation. 

Ana-Maria Boie, who chairs the ECCK’s healthcare committee and leads Boehringer Ingelheim Korea, called for a defined fast track to reimbursement in life-threatening conditions, a higher recognition of innovation in pricing, expanded EU cooperation to curb duplicate quality controls, and fixes to risk-sharing rules that can undercut access.

Boie said Korean patients “wait about four years,” far longer than in many developed markets. She said the lag discourages companies from prioritizing Korea and slows patient access to breakthrough therapies.

The government has begun a pilot program that evaluates reimbursement in parallel with regulatory review and shortens formal price negotiations. The chamber wants those changes made permanent.

The ECCK White Paper 2025 backs up the argument with new data and a specific fast-track design. It cites a survey of 100 healthcare professionals in which “all respondents” said the process from approval by the Ministry of Food and Drug Safety to coverage by the National Health Insurance Service is too long, and they urged shorter insurance hearings for innovative medicines.

The paper says the reimbursement rate for new drugs is “22 percent in Korea, 61 percent in Germany, 48 percent in Japan,” and that Korea’s average time from global first launch to local listing is 46 months, compared with four months in the United States, 11 in Germany, 17 in Japan, 27 in the United Kingdom and 34 in France. 

On pricing, Boie said recognition of the “value for innovation” is a “long-standing issue” and that “Korea’s ICR threshold has remained unchanged since 2007.” She was referring to the incremental cost-effectiveness ratio (ICR), the benchmark used to judge how much the health system will pay for an extra year of good-quality life from a new treatment. The white paper argues the static bar undervalues novel medicines even as per-capita GDP has risen by more than 90 percent since then. 

It notes that new drug spending represents 13.5 percent of Korea’s pharmaceutical outlay versus an OECD average of 33.9 percent and lower-teens to mid-20s percentages in A8 peers. 

The committee recommends raising the threshold to reflect current economic conditions, clarifying how flexible assessments will account for disease severity and social value, and piloting indication-based pricing so multi-indication drugs are not forced into a single price that ignores clinical differences.

Supply-chain friction is another focus. Boie said ECCK “urge[s] the expansion of mutual recognition agreement particularly with the European Union” to speed registration and supply by avoiding duplicate quality checks on EU-made medicines. 

For rare diseases, the paper says Korea’s Ministry of Food and Drug Safety has at times been reluctant to accept orphan-drug designation applications if foreign approvals are not yet in hand, despite complete dossiers.

It recommends reviewing those applications “regardless of the approval status in foreign countries” and setting a consistent standard based on ICH, the International Council for Harmonisation’s global rules on drug quality, safety and efficacy.

Risk-sharing agreements (RSA), which Korea uses to cover some high-cost cancer and rare-disease medicines, have widened access but carry structural problems, the chamber says.

The white paper states that “VAT is included in the refund amount” from a company perspective, effectively taxing the list price even when refunds lower the net, and that “after generic entry, the RSA contract automatically expires,” creating concerns about the continuous supply of the original drug.

It recommends excluding value-added tax from refunds so taxes reflect the real post-refund price, treating re-evaluation as a decision about extending a contract rather than a tool for price cuts, allowing different contract types when indications expand and maintaining agreements after generic entry through renegotiated net prices.

Boehringer’s experience in Korea illustrates both progress and pressure points. Jardiance (empagliflozin), a diabetes medicine now used to slow kidney decline, won insurance coverage for chronic kidney disease this summer. 

Ofev (nintedanib), a drug for lung scarring and fibrosis, was added to reimbursement lists in May, about nine years after approval, just as cheaper copycat versions entered the market -- the kind of timing industry groups say better pricing rules are meant to avoid.

Abroad, the company’s oncology push is moving faster than Korea’s market. The FDA granted accelerated approval to Hernexeos (zongertinib) in August for HER2-mutant non-squamous lung cancer, with Japan and China following; no Korean approval has been announced. That gap, approvals and coverage abroad, silence at home, is the pattern the ECCK says reforms aim to break.

Boie also urged earlier deployment of “on-site use of multiplex molecular diagnostics in the primary care setting” for rapid, accurate detection of infectious disease, part of the same access logic: earlier decisions, fewer duplications, clearer economics.