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- 2026-03-10 00:56:55
- Policy
- Rebate penalty in innovative pharma certification reform
- by Lee, Jeong-Hwan Jan 05, 2026 10:39am
- The pharmaceutical industry's attention is drawn to the Ministry of Health and Welfare's (MOHW) proposed reform of the Innovative Pharmaceutical Company certification system.The MOHW is considering a transition from the current 'cancellation of innovativeness certification' rule for illegal rebates to a points-based scoring system.While the MOHW initially announced a shift toward a scoring system, which would give incentives towards new drug development from pharmaceutical companies rather than a penalty disqualifying the certification, it has faced significant pushback from those expressing concerns.On January 2, the pharmaceutical industry is currently anticipating an administrative measure related to rebates concerning innovative pharmaceutical company certification system reform that can sufficiently encourage R&D investment.Even if the current disqualification rules for illegal rebates are maintained without a transition to a scoring system, the industry's demand is for a reasonable reform that prevents certification cancellation for cases that occurred long ago.The industry argues that for R&D plans to be maintained, regulations should be established to ensure that certification is not revoked for extremely old rebate cases or for instances where court rulings determined the company did not actively participate in the illegal activity.The MOHW plans to issue a legislative and administrative notice within January after receiving feedback from both domestic and international pharmaceutical companies. The MOHW noted that the original schedule for the notice was delayed due to the process of gathering diverse opinions from stakeholders.An official from a domestic pharmaceutical company explained, "The MOHW seems to be considering various administrative directions regarding the transition to a scoring system," and "It is crucial that the unreasonable cancellation rules be updated rather than a focus on transitioning to a score system. The goal of the certification is to provide preferential treatment to companies that are dedicated to new drug R&D."
- Policy
- 'Platform wholesaler ban law' forum faces backlash over bias
- by Lee, Jeong-Hwan Jan 02, 2026 08:00am
- Rep. Hankyu Kim of the Democratic Party of Korea (center) hosted an emergency forum titled 'Asking the Venture Industry's Opinions on the Pharmaceutical Affairs Act Amendment' on December 16.Rep. Hankyu Kim of the Democratic Party of Korea received criticism from the healthcare and medical communities for openly opposing a bill that would prohibit platforms from also serving as pharmaceutical wholesalers. Rep. Kim opposed this bill, which passed the Health and Welfare Committee and theLegislation and Judiciary Committee with agreements reached by both parties, during an emergency National Assembly forum that he hosted.During the forum, Rep. Kim reportedly voiced strong opposition to the statement from a division head from the Ministry of Health and Welfare (MOHW), the primary department responsible for the proposed amendment to the Pharmaceutical Affairs Act. Some in the medical community expressed concern that the "host lawmaker appeared to be targeting the official by demanding an immediate change in stance or a revision to the legislative proposal". Objections have been raised that the forum was operated with a coercive manner, essentially ordering the ministry to draft an amendment in favor of platform industries and startups for a bill that is already awaiting a final plenary session vote.During the emergency forum on December 16, Rep. Kim stated, "Today’s seminar was co-hosted by 10 members of 'Unicorn Farm', but if the MOHW does not listen to the opinions [of startups and VCs], I will gather 20 members next time for a seminar. If that is still insufficient, I will gather 30 members for discussion."On December 17, representatives from the medical community and bipartisan officials from the National Assembly’s Health and Welfare Committee evaluated Rep. Kim's remarks as biased. They noted that holding a division head responsible for follow-up measures regarding a bipartisan agreement that has already cleared the Welfare and Judiciary committees is likely to draw criticisms of partiality.Medical industry insiders and committee officials argued that the operational direction of the forum, titled "Asking the Venture Industry's Opinion on the Doctor Now Prevention Act," could be perceived as an attempt to intimidate the MOHW administration, which is working to protect public health and the drug distribution ecosystem.Jun-Hyuk Kang, Director of the Pharmaceutical Policy Division at the MOHW, stated during the event, "The Pharmaceutical Affairs Act amendment is different from the 'Tada Ban Law.' The expression 'Doctor Now Prevention Act' is also incorrect, and it is not a law that hinders innovation." He explained, "If a platform operates a wholesaler, it cannot be free from the incentive to drive the prescription and dispensing of its own distributed medications. This law is designed to prevent such conflicts of interest."Kang's statement implied that the delay in passing the bill, which has stalled despite clearing committees, must be resolved to prevent telemedicine platforms from abusing the system for private profit.Immediately after Kang's statement, Rep. Kim continued with remarks that appeared to demand an immediate revision of the bill.Rep. Kim said, "Just because the MOHW says I shouldn't call it a 'Tada Ban Law' doesn't mean I can't. Because many people see it that way, I call it the second 'Tada Ban Law,' and I believe 'Doctor Now Prevention Act' is an accurate term." He added, "The MOHW seems to question why companies enter the platform wholesale business, but what business a company chooses to conduct should be a matter of corporate freedom."Rep. Kim continued, "It is unreasonable for the MOHW to judge whether something constitutes innovation. While the ministry wants to separate the dispensing and prescription of drugs from wholesaling, the correct legislative approach would be to regulate specific conduct, such as penalizing a wholesaler or platform that negatively influences a pharmacist’s prescription or forces generic substitution, rather than banning the wholesale business itself." He argued, "It is strange to insist on this amendment just to block a wholesaler that distributes 90 types of drugs, as Doctor Now does."Rep. Kim further challenged the official, saying, "I could offer a rebuttal to every single point the MOHW makes. I am questioning the procedural legitimacy. I believe the ministry should state its willingness to seek alternatives to the venture industry's opinions. What is most disappointing is that, based on the division head's words today, the MOHW seems to have no intention of changing its position or engaging in further discussion. Is it the official position of the department that no further discussion is possible?"As these remarks became public, the healthcare community questioned whether the emergency forum was intended solely to pressure the MOHW.A pharmaceutical industry official noted, "I heard that Rep. Kim openly pressured the ministry for a revision. Why demand a modification from the MOHW for a bill that secured bipartisan agreement and is awaiting a plenary vote? Remarks about gathering 20 or 30 lawmakers if the ministry doesn't comply sound like a threat."The official added, "The delay in the Pharmaceutical Affairs Act amendment is a matter that could shake the domestic healthcare system and the public health safety net," and added, "Dismissing doctors and pharmacists as focused on protecting their own turf, while framing platforms and startups as the 'weak' party to block the bill, is an act that ignores people’s right to health and life."The official said, "Despite numerous explanations for the legislation and reports of illegal platform activities during the pilot project, Rep. Kim’s insistence on protecting specific corporate interests through a distorted frame is difficult to understand," and concluded, "This attempt to modify the bill will only increase the burden on the Democratic Party, the government, and the President."
- Policy
- Gvn’t to invest over ₩1T in Medical AI, Pharma, and Biohealth in 2026
- by Lee, Jeong-Hwan Jan 02, 2026 07:43am
- The Ministry of Health and Welfare (MOHW) will invest more than KRW 1 trillion in healthcare research and development (R&D) in the new year (2026).On the 31st, the ministry announced its integrated implementation plan for next year's R&D projects and simultaneously issued the first integrated call for research proposals for 19 healthcare R&D projects. The budget allocated for new projects is KRW 171.5 billion, while KRW 62.5 billion will be invested across the 19 projects in the first call.The MOHW’s total R&D budget for 2026 amounts to KRW 1.0652 trillion, representing a 12.6% increase year on year.Of the 83 total R&D programs, KRW 1.0014 trillion has been allocated to 69 ongoing programs, while KRW 63.8 billion will be invested in 14 new programs. Over the past five years, the ministry’s R&D budget has grown at an average annual rate of 11.1%.The Ministry will pursue this R&D investment centered on four key strategic pillars: technological innovation for public health, securing future growth engines in biohealth, AI-based digital and medical innovation, and establishing a foundation for biohealth innovation.The total scale of new projects for 2026 is KRW 171.5 billion. A first integrated call for proposals will be conducted for projects scheduled to begin in April (19 projects, KRW 62.5 billion).The application period runs from December 31, 2025, to 2:00 PM on January 30, 2026. Research institutions will be selected in April to commence research. Projects scheduled to begin in July (6 projects, 15.9 billion won) will be recruited through a second consolidated call in April 2026.Key new programs included in the first integrated call are dementia medical technology R&D, patient safety technology development, technology development to address suicide-related social issues, translational clinical research in anti-aging and reverse-aging regenerative medicine, establishment of an AI-based surgical robot innovation lab, structure-based AI drug discovery, advanced bio convergence talent cultivation, recruitment of top-tier overseas talent, K-MediST support, and the Health and Medical R&D Core Technology Early Boost Program.In addition, new projects will be selected and supported under nine ongoing programs, including global physician-scientist training, translational research linked to clinical field demand, and technology development to address low birth rates. Starting with new projects in 2026, researchers must submit a research data management plan when applying for a project, and data obtained during the research process must be managed according to a standardized format.Eun-young Jung, Director General of the Bureau of the Health Industry Policy at the Ministry of Health and Welfare, stated, “The role of healthcare R&D is critical for the development of sustainable medical and care technologies and the expansion of biohealth exports. We look forward to active participation from researchers in the new projects for 2026.”Soon-do Cha, President of the Korea Health Industry Development Institute (KHIDI), said, “We will do our utmost to support researchers so that R&D outcomes translate into tangible benefits for the public.”
- Policy
- Third vitamin-based acne treatment approved in KOR
- by Lee, Tak-Sun Jan 02, 2026 07:43am
- Dongwha Pharmaceutical’s nicotinamide-based acne treatment, “Sevita B Gel”Since the first vitamin-based acne treatment was launched in Korea in 2022, other pharmaceutical companies have begun turning their attention to the market. Following Dongwha Pharmaceutical, Chong Kun Dang, and Dong-A Pharmaceutical have now also secured product approvals.On the 29th, the Ministry of Food and Drug Safety (MFDS) approved Dong-A Pharmaceutical’s “Acvita Gel” (over-the-counter drug). Acvita Gel contains nicotinamide and is used for the topical treatment of mild to moderate inflammatory acne.The recommended dosage is to apply a sufficient amount to the affected area twice daily, morning and evening. Each tube contains 30 grams.Nicotinamide is known as the active form of vitamin B3. It helps improve acne symptoms through its anti-inflammatory action.The acne-fighting effects of nicotinamide have already been confirmed in numerous studies and papers. Consequently, products containing nicotinamide, such as Nicomed Cream and Prederma Gel, have long sold overseas.In Korea, the ingredient was first introduced in June 2022, when Dongwha Pharmaceutical launched “Sevita B Gel,” a product containing the same active ingredient.Subsequently, in October last year, Chong Kun Dang received approval for ‘Dermagram Gel’, a pharmaceutical product with the same ingredient. Now, with Dong-A Pharmaceutical's ‘Acvita Gel’ added, three products have been listed.Dong-A Pharmaceutical expects Acvita Gel to generate synergies with its steady seller, “Noscarna Gel.” Noscarna Gel is used for the treatment of hypertrophic and keloid scars, acne scars, and post-surgical scars, and has established itself as a leading acne scar treatment with annual sales exceeding KRW 10 billion.The nicotinamide-based acne treatment also offers advantages over existing prescription drugs, having the advantage of not inducing resistance and being conveniently available as an over-the-counter drug. Dongwha Pharmaceutical's Sevita B Gel recently recorded high growth rates among the company’s OTC products, further boosting expectations for other products containing the same ingredient.
- Policy
- 8 items, including Infanrix, will be discontinued next year
- by Jung, Heung-Jun Dec 29, 2025 08:55am
- Product photo of GSK's Infanrix-IPV+Hib Inj, Yuhan Corporation's Bambec Tab, and Hanall Biopharma's Cortisolu InjectionEight items, including GSK's hexavalent combination medicine (included in the National Immunization Program (NIP)), will be discontinued for supply starting next year. On the 2nd of next month, the list of items subject to supply suspension, along with their scheduled dates, will be shared on the drug utilization review (DUR) system.The Health Insurance Review and Assessment Service (HIRA) the list of items reported to be suspended for next year's production, imports, and supply shared with relevant organizations and associations.According to the relevant association on December 26, eight items from seven companies, including Eisai Korea, GSK, and Hanall Biopharma, will be discontinued for supply next year.The included items are ▲Hanall Biopharma's Cortisolu Injection (hydrocortisone sodium succinate) ▲Daewoo Pharm's Tobeson Eye Drops (tobramycin, dexamethasone) ▲Tai Guk Pharm's Hyrosone Cream (hydrocortisone) and Gammarin D Liquid ▲Yuhan Corporation's Bambec Tab 10mg (bambuterol hydrochloride) ▲Genuone Sciences' Pencivir Cream (penciclovir) ▲GSK's Infanrix-IPV+Hib Inj ▲Eisai Korea's Plegridy Pen Inj Starter Pack (peginterferon beta-1a, recombinant), among others.Infanrix-IPV+Hib is a hexavalent combination vaccine supplied for the NIP for infants. It is a vaccine that simultaneously prevents meningitis, pertussis, and polio.The relevant vaccination market has been split between Sanofi's Pentaxim and Infanrix. Following the discontinuation of Infanrix on June 30 of next year, demand is expected to shift to Pentaxim from the second half of the year.The list of pharmaceuticals subject to discontinued supply (January 2026): ▲Hanall Biopharma's Cortisolu Injection (hydrocortisone sodium succinate) ▲Daewoo Pharm's Tobeson Eye Drops (tobramycin, dexamethasone) ▲Tai Guk Pharm's Hyrosone Cream (hydrocortisone) and Gammarin D Liquid ▲Yuhan Corporation's Bambec Tab 10mg (bambuterol hydrochloride) ▲Genuone Sciences' Pencivir Cream (penciclovir) ▲GSK's Infanrix-IPV+Hib Inj ▲Eisai Korea's Plegridy Pen Inj Starter Pack (peginterferon beta-1a, recombinant), among others.Eisai Korea's Plegridy Pen Inj is a new drug for relapsing multiple sclerosis that received domestic approval in 2016 and was listed for reimbursement in 2017. As a recombinant treatment for a rare disease, the decision to discontinue supply was made approximately 10 years after its introduction. Supply will be discontinued starting June 30 of next year, the same time as Infanrix.Hanall Biopharma's Cortisoru Inj will be discontinued starting July 1 of next year. As a corticosteroid, it is expected to be replaced by more than 20 other drugs available in the same therapeutic class.With AstraZeneca’s decision to withdraw Bambec Tab. from the market 31 years after its domestic approval, Yuhan Corporation will also cease sales and supply after December of next year.Bambec Tab is a long-acting beta-adrenoceptor agonist (LABA) used to treat asthma, chronic bronchitis with bronchospasm, emphysema, and other lung diseases. Since combination therapies have been increasingly used for asthma treatment recently, the decline in market competitiveness is considered the reason for the withdrawal.The HIRA plans to provide information on the eight items scheduled for discontinuation next year to physicians and pharmacists through the DUR system on the 2nd of next month.
- Policy
- Imjudo, Imfinzi, Xpovio in reimb discussions with NHIS
- by Jung, Heung-Jun Dec 26, 2025 08:40am
- Imjudo (tremelimumab) and Imfinzi (durvalumab) are in price negotiations with Korea’s National Health Insurance Service (NHIS), bringing the drugs closer to reimbursement listing.Once they clear the final hurdle with the NHIS, Imjudo will be newly reimbursed for use in combination with Imfinzi in hepatocellular carcinoma, while Imfinzi is expected to secure a reimbursement expansion for use in combination with gemcitabine and cisplatin in biliary tract cancer.According to industry sources on the 26th, the NHIS is conducting price negotiations for three new drugs and two coverage expansion items.These drugs all passed the Drug Reimbursement Evaluation Committee in November. AstraZeneca Korea is negotiating the reimbursement of both Imjudo and Imfinzi simultaneously.If negotiations conclude as expected, Imfinzi will secure reimbursement for two combination regimens at once: combination therapy with Imjudo and the GemCis (gemcitabine + cisplatin) regimen.AstraZeneca is expected to expand Imfinzi’s use beyond its previous focus on lung cancer into liver cancer and biliary tract cancer.AstraZeneca is expected to expand Imfinzi prescriptions, previously focused on lung cancer, to include liver and bile duct cancers.Additionally, new drugs under negotiation include Janssen Korea's Balversa Tab 3, 4, 5mg (erdafitinib) and Takeda Korea's Takhzyro Prefilled Syringe 300mg (lanadelumab).Balversa Tab, a new targeted therapy for bladder cancer, received reimbursement adequacy approval for treating adult patients with locally advanced or metastatic urothelial carcinoma. Takhzyro Prefilled Syringe received reimbursement adequacy approval for preventing attacks of hereditary angioedema in adults and adolescents. Both products are now awaiting final price agreements.Xpovio 20 mg Tab (selinexor) from Antengene, which received reimbursement expansion approval alongside Imfinzi in November, has also entered price negotiations. Xpovio was approved for reimbursement expansion for use in combination with bortezomib and dexamethasone in adult patients with multiple myeloma who have received at least one prior therapy.However, unlike the other products, Xpovio’s approval came with a conditional clause stipulating that reimbursement expansion is deemed appropriate only if the company accepts a price at or below the evaluated price. If the company is unable to accept the proposed price, there remains a possibility that negotiations could break down.
- Policy
- Second generic for prostate cancer drug Xtandi approved
- by Lee, Tak-Sun Dec 26, 2025 08:40am
- Pharmaceutical companies are rapidly entering the generic market for the prostate cancer treatment ‘Xtandi (enzalutamide)’, which has a market worth approximately KRW 50 billion.Following Alvogen Korea's initial product approval last January, Daewon Pharmaceutical has also successfully obtained approval for its generic drug. These products are expected to establish patent strategies targeting launch after the substance patent expires next June.The Ministry of Food and Drug Safety approved Daewon Pharmaceutical's ‘Enzadex Soft Cap 40mg’ on the 23rd. This product is the second generic drug containing the active ingredient enzalutamide.The first generic was Alvogen Korea's ‘Anamide Soft Cap 40mg’, approved last January. A common feature of both Alvogen Korea and Daewon Pharmaceutical's products is that they import the finished drug from Taiwan.Enzadex Soft Cap is indicated for ▲ treatment of asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), ▲ treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel, ▲ treatment of patients with high-risk non-metastatic castration-resistant prostate cancer (mHSPC), ▲combination therapy with androgen deprivation therapy (ADT) for the treatment of patients with hormone-sensitive metastatic prostate cancer (mHSPC), ▲treatment of patients with high-risk hormone-sensitive non-metastatic prostate cancer (nmHSPC) who have experienced biochemical recurrence (BCR). These indications are identical to those of the original Xtandi Soft Cap 40mg.Xtandi’s formulation patent is set to expire on June 27 next year. However, a formulation patent valid until September 11, 2033, remains a key barrier to generic entry. As a result, multiple generic manufacturers have initiated legal actions to challenge or circumvent the formulation patent.Starting with Alvogen Korea in August, GL Pharma, Hanmi Pharmaceutical, Chong Kun Dang, JW Pharmaceutical, and Kuhnil Pharmaceutical have filed passive scope confirmation trials aimed at clearing the formulation patent hurdle.Industry analysts suggest that if the formulation patent is successfully overcome, generics could enter the market as early as June next year.Astellas' Xtandi competes in the first-line prostate cancer treatment market against drugs like Erleada (apalutamide, Janssen) and Zytiga (abiraterone, Janssen).Notably, since November 2023, the patient coinsurance rate has decreased from 30% to 5%, leading to increased usage. According to the pharmaceutical market research institution IQVIA, Xtandi's sales surged from KRW 23 billion in 2019 to KRW 43.2 billion in 2023.As the market expands, domestic pharmaceutical companies are also eagerly entering the prostate cancer treatment market. Hanmi Pharmaceutical has already moved aggressively by launching Abiteron Tab 500 mg, the first generic version of Zytiga, to secure early market share.With Xtandi’s patent expiry approaching, many generic manufacturers are now closely monitoring the opportunity. Generic companies are simultaneously advancing patent litigation strategies and regulatory approvals, aiming for early entry in June next year.Meanwhile, Astellas has preemptively obtained approval for Xtandi Tab, a new formulation last year, to counter the wave of emerging generic drugs. This appears to be a strategy to dilute the market impact of generic drugs by introducing a new formulation product.
- Policy
- PNH drug 'Piasky Inj' for adults·children wins nod
- by Lee, Tak-Sun Dec 26, 2025 08:39am
- The Ministry of Food and Drug Safety (MFDS), led by Minister Yu-Kyoung Oh, announced that it granted approval of 'Piasky (crovalimab)', a new orphan drug from Roche used for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and pediatric patients aged 12 and older who weigh 40 kg or more, on December 24.PNH is an acquired hematopoietic stem cell disorder characterized by hemolytic phenomena (hemoglobin escapes from red blood cells) that causes release of dark-colored urine during the night.'Piasky Inj' is an orphan drug that inhibits complement-mediated intravascular hemolysis in patients with PNH. Complement proteins assist the immune response by attacking pathogens such as bacteria and viruses.As a complement protein C5 inhibitor, this drug prevents the binding of C5 to abnormal red blood cells produced by hematopoietic stem cell disorders, thereby protecting the cells from lysis.Piasky is the first treatment approved for pediatric use in South Korea, and it is expected to significantly broaden the therapeutic landscape for both adult and adolescent patients (12 years and older).The MFDS stated that it will make every effort to ensure that new treatments for rare diseases are rapidly made available based on its regulatory science expertise, thereby expanding clinical opportunities for patients.
- Policy
- Expanded reimb for Keytruda·Dupixent
- by Jung, Heung-Jun Dec 24, 2025 08:08am
- As the review of expanded reimbursement for Keytruda (pembrolizumab) and Dupixent (dupilumab) has passed the Health Insurance Policy Review Committee (hereafter referred to as the committee) today (DEC 23), the out-of-pocket cost will drop by up to 95% starting next year.The committee also finalized a restructuring of the compensation system for clinical laboratory testing CDMOs, the formulation of an adjustment system for relative value units, and the launch of an 'innovative pilot project for community-based primary care', set for the second half of next year.The Ministry of Health and Welfare (MOHW) approved expanding health insurance coverage for Keytruda and Dupixent during the committee. While Keytruda was previously covered for four cancer types, including non-small cell lung cancer (NSCLC), coverage will now extend to 17 therapies across nine additional cancer types.Specifically, the expanded coverage includes head and neck cancer, gastric cancer, esophageal cancer, endometrial cancer, small bowel cancer, biliary tract cancer, colorectal cancer, triple-negative breast cancer (TNBC), and cervical cancer.For patients meeting the eligibility criteria for these expanded indications, the annual out-of-pocket cost per patient is expected to drop significantly, from approximately KRW 73.02 million to KRW 3.65 million (with a 5% co-payment for monotherapy).Dupixent, which was previously covered for chronic severe atopic dermatitis, will also be covered for severe Type 2 inflammatory asthma starting in January. The annual cost for severe asthma patients is expected to decrease from KRW 15.88 million to approximately KRW 4.76 million (based on a 30% co-payment).The committee also concluded this year's reimbursement re-evaluation for eight therapeutic ingredients. The reimbursement for spherical adsorptive carbon and artemisia herb extract will be maintained due to price reductions.2025 Reevaluation Results for Pharmaceutical Reimbursement Appropriateness: Reimbursement maintained for 1. olopatadine hydrochloride 2. Clematidis Radix-Trichosanthes Root-Prunella Spike 3. Bepotastine…Drug price reduced and reimbursement maintained for 7. spherical adsorptive carbon and artemisia herb extract (upon voluntary requests for drug price reduction by pharmaceutical companies).The oral formulation of L-aspartate-L-ornithine will remain covered, though its reimbursement criteria will be restricted to hepatic encephalopathy. For three other ingredients, including sulglicotide, the evaluation has been deferred on the condition that a portion of the reimbursement will be recouped if clinical trials fail to prove efficacy.Abolition of clinical lab management fees... new institution-specific fees establishedThe compensation structure for CDMO clinical laboratory testing will be reformed. The consignment fee, which overlaps with existing testing fees, will be abolished, and new fees specific to the CDMO institutions will be established. Furthermore, the billing and payment system will be improved to prevent diagnostic fee discounting.The CDMO fee criteria will be determined based on ▲the current management fee ▲the respective roles of the institutions ▲the financial impact during the regular RVU adjustment process. The KRW 240 billion saved from the abolition of the management fee will be reallocated to increase reimbursement for under-compensated areas, such as consultation fees.Examples of Lab Fee Adjustments: Examples of over-compensated areas, and actual adjustments will depend on finalized cost data. Under-compensated areas within clinical lab testing will not face fee cuts but will be prioritized for balance adjustments.The MOHW plans to revise relevant CDMO regulations in the first half of next year and implement the changes in alignment with the regular relative value unit adjustment cycle. Certification standards for clinical laboratory testing will also be updated.Regular adjustment of the relative value unit (previously updated every 5-7 years)To rationalize the fee compensation system, the government will formulate a regular adjustment model for the relative value unit. Previously, relative value unit restructuring occurred every 5 to 7 years, which critics argued failed to reflect rapid changes in medical practice.The government will review under-compensated and over-compensated services based on medical cost analysis and adjust them to balanced fees.In particular, funds from adjusting for over-compensation in areas such as clinical laboratory tests and imaging (CT and MRI) will be redistributed to under-compensated basic medical services, such as consultation and hospitalization fees at clinics and hospitals. Funds will also be directed toward strengthening compensation for essential healthcare, including surgeries and care that are severe·emergency and pediatrics·deliveries.Medical cost analysis results for relative adjustment...Low margins for drug administration and dispensingThe committee discussed the 2023 medical cost analysis results calculated by the Medical Cost Analysis Committee. These results will serve as the foundation for the 2026 regular RVU adjustments. The '2023 Fiscal Year Cost Analysis Report', which for the first time includes cost-to-revenue ratios by healthcare institution type and specific fee items, is scheduled for publication in the first quarter of next year.The analysis was expanded to include tertiary hospitals and clinics in addition to general hospitals. The report calculated the cost-to-revenue of reimbursements following the establishment of standardized medical cost calculation guidelines.Key findings regarding the cost-to-revenue ratio for covered services (based on tertiary hospitals) showed that clinical laboratory fees (192%), special radiologic imaging fees (169%), and radiation therapy fees (274%) had relatively high profit margins compared to costs.Conversely, drug administration and dispensing fees (11%), basic physical therapy (33%), and basic consultation fees (63%) generated significantly lower revenue than costs.'Innovative Pilot Project for Community-based Primary Care' to launch in JulyThe pilot project will launch next year, initially targeting patients aged 50 and older who require integrated management, with plans for gradual expansion.Under this project, registered patients can receive personalized preventive care, disease and medication management, and lifestyle coaching at their designated clinics, linked to their health check-up results. When necessary, patients can be referred to appropriate medical institutions or receive home-based primary care.Clinics that complete the required training are eligible to participate. Institutions capable of providing multi-professional, multidisciplinary team support can join as hub institutions.The government will introduce the 'Primary Care Functional Enhancement Integrated Fee', which compensates for 'patient registration and continuous management efforts' rather than traditional fee-for-service. The MOHW also plans to pilot multidisciplinary team-based service support and performance-based rewards.The pilot program is scheduled to run for three years, from July 2025 to 2028, with plans to expand its scope to additional regions and institutions starting in 2029.
- Policy
- Gov't to enforce non-face-to-face care Medical Service Act
- by Lee, Jeong-Hwan Dec 24, 2025 08:07am
- Following a Cabinet meeting today (December 23), the South Korean government is set to announce an amendment to the Medical Service Act that formally institutionalizes non-face-to-face care. The Ministry of Health and Welfare (MOHW), led by Minister Jeong Eun Kyeong, is the primary department overseeing this transition.Currently operating as a pilot program, non-face-to-face care will officially take effect one year from the date of announcement, in accordance with the supplementary provisions of the Act. This means that December 24, 2026, will mark the official date when non-face-to-face care becomes a permanent, legalized system in South Korea.This legislative reform comes 15 years after the first amendment proposal was submitted during the 18th National Assembly in 2010.The core principle of the Act is that non-face-to-face care will be centered on returning patients and primary care clinics.First-time patients are also eligible for non-face-to-face care, but with specific caveats. Based on MOHW standards, they can only apply for services within their residential area and will be subject to restrictions on the types of drugs prescribed and the total number of prescription days allowed.For the first time, a provision for the delivery of pharmaceuticals outside of pharmacies will be legalized. This applies to specific groups, including residents of islands or remote areas, long-term care recipients, registered persons with disabilities, patients confirmed with Class 1 or 2 infectious diseases, and patients with rare diseases.Prescribing narcotics or psychotropic substances via non-face-to-face care is strictly prohibited. Additionally, the use of electronic prescriptions will be officially institutionalized specifically for non-face-to-face care services.The National Assembly maintained that while the principle of in-person treatment remains paramount, this legislation provides the legal grounds to supplement care via non-face-to-face care. It also establishes the Minister of Health and Welfare’s authority to manage and supervise non-face-to-face care services via online platforms.Those intending to provide or operate a non-face-to-face care platform must report to the MOHW. Furthermore, if the number of platform subscribers exceeds a certain threshold, the operator must apply for official certification from the MOHW Minister.The MOHW Minister reserves the power to revoke certification if a platform obtains it through fraudulent means or fails to meet the required certification standards.The platforms are prohibited from interfering with a physician’s professional medical judgment, encouraging the misuse or abuse of medical services or pharmaceuticals, brokering, inducing, or instigating collusion in violation of the Pharmaceutical Affairs Act.Furthermore, the platforms are prohibited from demanding or receiving financial incentives, goods, or other economic benefits from medical professionals or pharmacies in exchange for patient or prescription referrals.Prohibited provisions also include recommending or inducing patients to choose specific medical institutions, pharmacies, or medical devices.Both doctors and pharmacists are now mandatorily required to use and verify the Drug Utilization Review (DUR) system when prescribing or dispensing narcotics and psychotropic substances during both in-person and non-face-to-face care consultations. Failure to comply will result in a fine of up to KRW 1 million. This provision was institutionalized as a safeguard during the legalization of non-face-to-face care.Meanwhile, an amendment to the Pharmaceutical Affairs Act aimed at prohibiting non-face-to-face care platforms from concurrently operating as pharmaceutical wholesalers (which was expected to pass alongside the telemedicine bill) remains pending in the National Assembly. The timeline for its final approval remains uncertain.
