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- 2025-12-18 03:04:58
- Policy
- Petition filed urging expedited reimbursement of Livmarli
- by Lee, Jeong-Hwan Jun 17, 2025 06:00am
- A national petition has been filed to urge for the health insurance reimbursement of Livmarli (maralixibat), which is used to treat pruritus (itching) in patients with Alagille syndrome. The petition period runs until the 12th of next month, with over 1,600 signatures signed as of the 16th. Alagille syndrome is a condition in which the intrahepatic bile duct becomes significantly reduced in number (bile duct paucity), preventing bile from being excreted from the liver. This leads to its accumulation in the liver and is often accompanied by complications affecting the cardiovascular system, skeletal system, eyes, and skin. The drug is indicated for “biliary pruritus in patients with Alagille syndrome aged 1 year or older,” in Korea, and is imported by GC Biopharma. Livmarli is the first treatment in Korea for pruritus in patients with Alagille syndrome and is expected to be of great help to patients suffering from itching skin and other symptoms. According to data from the Health Insurance Review and Assessment Service, as of 2021, there are 136 patients with Alagille syndrome in South Korea. Livmarli obtained domestic marketing approval in February 2023, but it is not yet covered by health insurance. A petitioner who identified herself as Kim, a mother of a child with Alagille syndrome, wrote that her child is receiving treatment at Severance Hospital but is facing difficulties in treatment due to the lack of health insurance coverage for Livmarli. Kim explained that medical staff suggested participating in a clinical trial for another treatment, Bylvay Cap (odevixibat), but that this was not possible due to the child's young age. She added that there is a medical necessity to prioritize the use of novel drugs over liver transplantation for infants who have passed their first birthday and that the medical staff recommended Livmarli as an effective treatment option for such. This is why Kim launched a petition calling for the immediate reimbursement of Livmarli. Kim said, “The itching and skin damage (caused by Alagille syndrome) are destroying my child's daily life,” adding, “Xanthomas are not merely a cosmetic issue, but a serious indicator of how much bile and fat are accumulating in the body.” “For such a young child like mine, the opportunity and choice to alleviate symptoms with medication rather than undergoing a major surgery like a liver transplant is desperately needed. Rare diseases are not something families can face alone. It's heartbreaking that treatments exist but must be given up simply because they are not covered by insurance.”
- Policy
- Atopic dermatitis drug Ebglyss reimbursed from next month
- by Lee, Tak-Sun Jun 16, 2025 06:03am
- With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ‘Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)’ complete, the drug is expected to be listed for reimbursement next month in Korea. Once listed, the number of biological agents available for atopic dermatitis will increase from two—Dupixent (dupilumab) and Adtralza (tralokinumab)—to three. According to industry sources on the 13th, the NHIS recently updated its website with news of the agreement made on Ebglyss Autoinjector. In August 2024, the Ministry of Food and Drug Safety approved this drug as a treatment for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older (weighing at least 40 kilograms) who are inadequately controlled by topical therapies or for whom such treatments are not recommended. In February, the drug’s reimbursement application was approved by the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service. At the time, the condition was attached that the adequacy of its reimbursement would be recognized if the company accepted the price below the initially assessed value. Lilly Korea accepted such a price and began negotiations with the National Health Insurance Service in March." It is highly likely that Ebglyss waived drug price negotiations as it accepted a price below the weighted average price of existing atopic dermatitis drugs covered by the national health insurance, and would only have negotiated the estimated claims amount with the NHIS. Ebglyss demonstrated its clinical efficacy and safety profile in a pivotal Phase III clinical trial and is expected to become a first-line treatment option for patients with atopic dermatitis in Korea. The clinical studies on which the approval was based on are the Phase III ADvocate-1, ADvocate-2 and ADhere trials. The trials evaluated the clinical efficacy and safety of Ebglyss in 1062 adults and adolescents with moderate-to-severe atopic dermatitis. In ADvocate-1 and ADvocate-2, which evaluated Ebglyss as a monotherapy, Ebglyss improved outcomes, with 58.8% and 52.1% (16.2% and 18.1%, respectively in the placebo arm) achieving Eczema Area and Severity Index (EASI) 75; and 38.3% and 30.7% (9% and 9.5%, respectively in the placebo arm) achieving EASI 90 during the induction period (weeks 0-16) compared to placebo. Also, after one year of maintenance therapy (Week 52), 81.7% of the Ebglyss arm achieved EASI 75 (vs. 66.4% in the placebo arm) and 66.4% achieved EASI 90 (vs. 41.9% in the placebo arm), demonstrating significant symptom improvement in the long term. The most commonly reported adverse events following treatment with Ebglyss were conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eye (1.4%), with the majority of adverse events being mild or moderate and not leading to treatment discontinuation. Recently, the government has applied reimbursement for cross-administration of biological agents and JAK inhibitors used to treat severe atopic dermatitis, and Ebglyss is expected to benefit from this as well. Patients are also expected to benefit from the increased biological agent options and lower drug prices.
- Policy
- Roche’s SMA drug Evrysdi Tab approved in Korea
- by Lee, Hye-Kyung Jun 16, 2025 06:03am
- The table formulation of Roche's blockbuster drug for spinal muscular atrophy (SMA), Evrysdi (risdiplam), has received marketing authorization in Korea. On the 13th, the Ministry of Food and Drug Safety approved Roche Korea's ‘Evrysdi 5 mg (risdiplam).’ With the approval, SMA patients in Korea may now be prescribed the 5 mg tablet formulation in addition to the existing liquid oral solution, enabling easier intake. Evrysdi is the first oral treatment for SMA and has the advantage of self-administering without location restrictions. In addition, the newly approved Evrysdi Tab is the first tablet formulation for SMA treatment. The 5mg tablets can be swallowed whole or dispersed in water and may be stored at room temperature. The existing liquid solution will continue to be available, and patients weighing 20 kg or more and aged 2 years or older are eligible to take the tablet formulation. Spinal Muscular Atrophy (SMA) is a systemic disorder caused by a deficiency of the Survival Motor Neuron (SMN) protein, which is essential for motor function. The disease affects not only neuromuscular systems but also respiratory muscles, cardiac rhythm, skeletal muscles, joints, and the autonomic nervous system. Evrysdi is a splicing modifier that binds to the immature pre-mRNA of the SMN2 gene, increasing and maintaining the levels of Survival Motor Neuron (SMN) protein throughout the patient's body. It can cross the blood-brain barrier, allowing for even distribution across the entire body, including the central nervous system. In February, the U.S. FDA approved Evrysdi based on the results of a bioequivalence study. In the trial, Evrysdi 5 mg Tab and the existing liquid formulation demonstrated equivalent absorption of the active ingredient risdiplam. Meanwhile, in Korea, Evrysdi Dry Syrup 0.75 mg/mL (risdiplam) was approved in 2020 and has been reimbursed since October 2023, three years later. Evrysdi is currently reimbursed for the treatment of 5q Spinal Muscular Atrophy in patients who received a genetic diagnosis of 5q SMN-1 deficiency or mutation that ▲ have 3 or fewer copies of SMN2 even before the onset of symptoms, and are less than 6 months old at the time of treatment initiation; or ▲ have SMA types 1-3 with clinical symptoms and signs related to SMA and are not on permanent ventilation.
- Policy
- Ruling party proposes bill for free HPV vaccination
- by Lee, Jeong-Hwan Jun 13, 2025 06:02am
- Rep Lee Su-Jin (Democratic Party of Korea) The Democratic Party of Korea has submitted a bill to the National Assembly to significantly expand the scope of Korea’s National Immunization Program for human papillomavirus (HPV) vaccines. The bill proposes to provide free HPV vaccinations to all males and females aged 12 to 26, regardless of gender or income level. This legislation is in line with President Lee Jae-myung's campaign pledge to expand the National Immunization Program (NIP) for HPV vaccines. On the 12th, Rep. Lee Su-Jin (Seongnam City) of the Democratic Party of Korea submitted a bill titled “Partial Amendment to the Infectious Disease Control and Prevention Act” as representative. The bill aims to expand HPV vaccination coverage to all men and women aged 12 to 26, regardless of income or gender, for the prevention of HPV infection. The current law stipulates that the government shall provide NIP for HPV prevention to “female adolescents aged 12 to 17” and “low-income women aged 18 to 26.” However, Rep. Lee pointed out that individuals who are not eligible for government support are equally exposed to the risk of HPV infection, yet receive no assistance at all. Depending on age, two to three doses may be required, and each dose costs over KRW 150,000, placing a financial burden on individuals who must cover the expense themselves. President Lee included the expansion of the HPV NIP support program in his campaign pledge for the 21st presidential election, and Rep. Lee has proposed a corresponding legislative bill. Rep. Lee stated, “By providing HPV vaccination to all individuals aged 12 to 26, regardless of income or gender, we can prevent HPV infection and cervical cancer. I pledge to spare no legislative support to ensure women's right to health through proactive prevention.”
- Policy
- Measures to reduce industry burden for stronger GMP
- by Lee, Hye-Kyung Jun 12, 2025 06:04am
- With the Ministry of Food and Drug Safety set to enforce the revised GMP standards for aseptic drugs reflecting the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards from December, measures are being prepared by the industry to reduce its burden. Ahead of its rejoin into PIC/S in 2023, the MFDS announced the “Regulations on Drug Manufacturing and Quality Control (MFDS Notice)” which outlines a risk-based, systematic contamination control strategy to enhance the quality assurance of aseptic pharmaceuticals. At the time, in consideration of the need for sufficient preparation time for all pharmaceutical companies to establish contamination management strategies, the government decided to implement the regulations first for aseptic finished pharmaceutical products until 2 years after the announcement, and then for aseptic active pharmaceutical ingredients until 3 years after the announcement. The implementation of measures such as PUPSIT (Pre-Use Post-Sterilization Integrity Testing) for verifying the integrity of sterilizing filters has been granted a uniform grace period—up to three years from the date of the revised GMP regulation—considering the need for additional preparation time for revalidation of aseptic processes and administrative procedures for GMP compliance determinations under the current guidelines. However, as the implementation of certain requirements for sterile finished pharmaceutical products approaches, including ▲the obligation to establish and implement a systematic contamination control strategy for the manufacture of aseptic drugs, ▲ the establishment of individual manufacturing and quality control standards (GMP) for advanced biopharmaceuticals, and ▲ the clarification of detailed specifications for the types of formulations subject to GMP compliance assessment, as well as the procedures and methods for such assessments, some pharmaceutical companies are halting or withdrawing their aseptic product manufacturing operations on itself. Particularly, following the announcement by Ildong Pharmaceutical that it would discontinue production and supply of its ‘Ativan Inj,’ which has experienced repeated supply instability over the past 3 years since 2022, speculation has emerged that the ripple effects of the strengthened GMP standards for aseptic drugs may have begun. Jung-yeon Kim, director of the MFDS In response, Jung-yeon Kim, director of the MFDS's Pharmaceutical Quality Division, said at a briefing with reporters on the 10th, “There have been ongoing issues with the supply of Ativan, and we have been in constant communication with the manufacturer since the end of last year. The company did not decide to withdraw from the market due to the stricter GMP standards, rather, there were internal circumstances, such as product profitability and drug price issues.” It is known that a similar sentiment was conveyed at a meeting between the MFDS and the heads of aseptic drug manufacturers on April 30. Kim explained, “About 20 companies participated in a factory manager meeting last month. At the time, the MFDS conveyed its position that it had no choice but to apply the same standards used by the 52 PIC/S member countries. Manufacturers also expressed difficulties in the preparation process, and that the MFDS should prepare supporting data through a research platform to reduce the burden on the industry and provide technical and regulatory support.” Instead of implementing the PIC/S-level GMP strengthening measures for aseptic preparations as scheduled in December, the MFDS plans to establish guidelines for large-volume IV solutions, contamination control strategies (CCS), and PUPSIT, referring to the results of the “Study on the Harmonizing the GMP Regulations on Aseptic Drugs” currently being conducted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) Kim added, “In the case of large-volume IV solutions, strengthening GMP standards to comply with EU Annex 1 would require establishing a contamination control strategy for each batch, which companies find most burdensome. We are conducting research with three companies— HK Inno.N, JW Pharmaceutical, and Dai Han Pharm— and KPBMA to establish grounds that show there will be no changes in GMP quality even with eased standards.” The three companies participating in this study account for 90% of the large-volume IV solution market, and since November last year, they have been meeting with the KPBMA and MFDS to develop a research protocol and have completed kick-off meetings and preliminary workshops. Cheon-Woon Cheon, a research committee member at the KPBMA Cheon-Woon Cheon, a research committee member at KPBMA who is leading the study, said, “We have held meetings with the MFDS and companies to clearly set the direction of the project, and our goal is to produce results by October so that they can be reflected in the policy.” Cheon added, “The revision of Annex 1 has placed a significant burden on manufacturers of sterile products. We are seeking ways to reduce this burden and are currently researching the appropriate level of validation required for processes such as formulation, filtration, filling, and sterilization.” In this regard, Kim said, “There is no single correct answer in GMP. What matters is having a technically and scientifically justified rationale that achieves the intended goal. I hope that the research findings will provide a sufficient basis to support the level of aseptic control expected by PIC/S.” Through this study, the MFDS expects not only to relax the standards for large-volume IV solutions but also to establish guidelines for CCS and PUPSIT. Cheon said, “Small companies lack experience and have difficulty just approaching CCS. Our goal is to establish guidelines by the end of the year that small companies can follow by conducting research through large companies.” In the case of PUPSIT, which is scheduled to be implemented in December next year, a separate project team has been formed to establish its guidelines. Kim said, “In principle, each company is responsible for implementing GMP issues per the system, but the MFDS has tried to provide assistance through industry communication. Since November last year, we have been meeting with associations and industry representatives to ask them to follow the international standards, and we have formed a consensus on common research tasks.” Kim added, “While direct financial support is difficult at this time, we are exploring ways to reduce industry burdens through regulatory or technical support. Once research results are available, we aim to establish GMP management measures with a clear direction, which should also lead to cost savings.”
- Policy
- Qlaris starts Phase II trial for its glaucoma drug in KOR
- by Lee, Hye-Kyung Jun 12, 2025 06:03am
- Qlaris Bio, a US biotech company, is conducting a Phase II clinical trial in Korea for 'QLS-111,' a drug candidate for primary open-angle glaucoma (POAG) and ocular hypertension (OHT). On the 5th, the Ministry of Food and Drug Safety approved a randomized, active-controlled, multicenter, double-blind, preliminary study to evaluate the safety and tolerability of QLS-111 versus preservative-free 0.5% timolol maleate ophthalmic solution in subjects with normal-tension glaucoma (NTG). QLS-111 is a novel therapeutic agent that targets episcleral venous pressure (EVP), which reduces intraocular pressure by relaxing the vascular and vascular-like tissues in the trabecular meshwork to lower EVP. As there are currently no glaucoma treatments that reduce EVP (episcleral venous pressure), a successful clinical outcome would likely expand treatment options for patients. According to Qlaris, its two Phase II clinical trials conducted in the U.S. – the Osprey and Apteryx trials - met all primary and secondary endpoints. The Osprey study was a randomized, double-blind, placebo-controlled trial evaluating the safety, tolerability, and intraocular pressure (IOP) lowering efficacy of QLS-111 compared to placebo in 62 adult patients with POAG or OHT across a range of doses. Study results showed that QLS-111 at a concentration of 0.015% administered once daily in the evening (QPM) resulted in the greatest reduction in intraocular pressure, with a mean reduction of 3.7 mmHg compared to the average intraday IOP of 23.0 mmHg. The Apteryx study was a randomized clinical trial evaluating the safety, tolerability, and additional IOP-lowering efficacy of QLS-111 when added to latanoprost in 32 patients aged 12 years or older with stable POAG or OHT using latanoprost monotherapy. When latanoprost monotherapy was administered, the mean intraday baseline IOP was 19.8 mmHg. QLS-111 0.015% administered in combination with latanoprost induced additional mean IOP reduction compared to latanoprost monotherapy, with a reduction of 3.2 mmHg with QLS-111 QPM administration and 3.6 mmHg with QLS-111 BID (twice daily) administration. Qlaris stated, “We are satisfied with the efficacy QLS-111 demonstrated in the Phase II Osprey and Apteryx trials. These results from our preservative-free new formulation reinforce our confidence that QLS-111 has the potential to become the first-in-class EVP selective targeted therapy.” Qlaris was founded in 2019 with a primary focus on the development of treatments for ophthalmic diseases. Last year, the company successfully secured $24 million in funding.
- Policy
- Speculation high over the new Minister of Health and Welfare
- by Lee, Jeong-Hwan Jun 10, 2025 06:05am
- (clockwise from the upper left) Former KDCA head Eun-kyung Jeong; former MOHW vice minister Sung-il Yang; Democratic Party of Korea’s Health and Medical Care Special Committee chair Cheong-hee Kang; lawmakers In-soon Nam, former lawmaker Hyun-young Shin, lawmaker Yoon Kim, lawmaker Hyun-hee Jeon Speculation is rife over who will become the first Minister of Health and Welfare in Lee Jae-myung's administration. Eun-kyeong Jeong, former Commissioner of the Korea Disease Control and Prevention Agency, who served as the chief campaign advisor for Democratic Party candidate Jae-myung Lee, is widely expected to be appointed as the next Minister of Health and Welfare. However, no official nomination has been confirmed as of yet. As a result, several names are being mentioned for the position of Minister of Health and Welfare, ranging from former public officials to former and current members of the Democratic Party of Korea. According to political circles on the 8th, the candidates for the position of MOHW include former KDCA head Eun-kyung Jeong; former MOHW vice minister Sung-il Yang; Democratic Party of Korea’s Health and Medical Care Special Committee chair Cheong-hee Kang; lawmakers In-soon Nam, Hyun-hee Jeon, and Yoon Kim, and former lawmaker Hyun-young Shin. Former KDCA head Jeong is credited with contributing to the Moon Jae-in administration's success in fighting COVID-19 on the front lines as well as to the election of Jae-myung Lee as president. Jeong, who has been consistently mentioned as the next MOHW minister before and after the presidential election, has stated that she will return to her position as a clinical professor of family medicine at Seoul National University College of Medicine after the election. During the presidential election period, Jeong herself repeatedly reaffirmed that her participation in the election was driven by the intention to contribute to the nation and its people amidst the turmoil caused by the declaration of martial law. In addition, Sung-il Yang, who entered public service after graduating from Seoul National University with a degree in social welfare and passing the 35th civil service examination, is also mentioned as a candidate. During the recent presidential election, he was active in Lee Jae-myung's think tank and, and served as the co-chair of the welfare policy subcommittee, devising strategies for the health insurance system reform and promoting the health industry. Specifically, Yang is considered to have played a key role in Lee’s campaign as chair of the Economic Growth Committee's Pharmaceutical and Bio Health Committee, chair of the Basic Social Policy Committee's Basic Care Subcommittee, and head of the Special Committee on Citizens with Disabilities. Cheong-hee Kang, Chair of the Democratic Party of Korea’s Health and Medical Care Special Committee who has practical experience as an insurance reimbursement director at the National Health Insurance Service and president of the Korea Public Tissue Bank, was also actively involved in Lee’s presidential campaign. Kang, who is a doctor by profession, ran for office in the 22nd general election in the Gangnam district of Seoul. Among the current members of the National Assembly, In-soon Nam, a four-term Democratic Party lawmaker; Hyun-hee Jeon, a three-term lawmaker; and Yoon Kim, a first-term lawmaker and medical doctor, have been mentioned as potential candidates for Minister of Health and Welfare. Nam served as the head of the functional headquarters in Lee Jae-myung’s presidential campaign, Jeon as a co-chair of the campaign committee, and Kim as the deputy head of the policy headquarters, all contributing significantly to the campaign’s victory. Hyun-young Shin, a former lawmaker who was elected as the Democratic Party of Korea’s No.1 proportional representative in the 21st National Assembly, is also being mentioned as a potential candidate. Shin, a former doctor who served on the NA Health and Welfare Committee, served as the spokesperson for the General Election Headquarters during the presidential election.
- Policy
- BMS’s next-gen targeted drug repotrectinib approved in KOR
- by Lee, Hye-Kyung Jun 09, 2025 05:51am
- BMS Pharmaceuticals' ‘Augtyro Cap (repotrectinib),' which is regarded a next-generation targeted therapy for lung cancer, has been approved in Korea. On the 5th, the Ministry of Food and Drug Safety granted marketing authorization for 2 items - Augtyro Cap 40 mg and 160 mg. Specifically, repotrectinib is indicated as: ▲treatment for patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) ▲ treatment for pediatric patients 12 years and older and adult patients with locally advanced or metastatic solid tumors that are unsuitable for surgical resection due to high risk of severe complications and harbor an Neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Augtyro was first approved by the US FDA in November 2023 as a treatment for non-small cell lung cancer and was designated as an orphan drug in Korea last May. Since August last year, it has been prescribed to patients after receiving initial approval for its use in Korea for therapeutic purposes. The drug’s efficacy was confirmed through the multinational Phase I/II TRIDENT-1 trial. The trial results showed that the primary endpoint, the objective response rate (ORR), was 79% for repotrectinib in 71 TKI treatment-naïve patients. Progression-free survival (PFS) was nearly double that of previous targeted therapies. The ORR was defined as the proportion of patients treated within a specific time frame who either had a decrease in tumor size (partial response) or no further signs of cancer (complete response). The median duration of response was 34.1 months. In 56 ROS1 TKI–naïve and chemotherapy-naïve patients, the objective response rate was 38%, and the median duration of response was 14.8 months. The trial also examined the drug’s efficacy in treating patients with resistance to existing targeted therapies. In the 56 patients with resistance to existing therapies, repotrectinib showed an ORR of 38% and a PFS of 9 months, and 17 patients who had acquired a baseline G2032R resistance mutation showed an ORR of 59% and a PFS of 9.2 months. The results of the TRIDENT-1 trial were published in the New England Journal of Medicine (NEJM) (IF 176.082), with Byoung-Chul Cho, Director of the Lung Cancer Center at Yonsei Cancer Hospital in Korea, participating as a corresponding author. ROS1-positive NSCLC accounts for 2% of all lung cancers. The standard of care is to use targeted anti-cancer therapies that target the mutated gene. Commonly used drugs include ‘crizotinib’ and ‘entrectinib,’ and repotrectinib is gaining attention as a next-generation drug.
- Policy
- Lee 'will strengthen public nature of medical sector'
- by Lee, Jeong-Hwan Jun 05, 2025 06:10am
- With the election of President Lee Jae-Myung, the legal community predicts that the government will strengthen its public policy in the healthcare and pharmaceutical biotechnology sectors. The areas of AI-based digital healthcare industry, rare and intractable disease coverage, and regional essential medical infrastructure will see new opportunities. There are also predictions that the medical industry and related platform technology industries will be revitalized as the institutionalization of non-face-to-face medical care (telemedicine) and home visits will expand the provision of medical services beyond geographical limitations. There are also analyses that public support for the pharmaceutical industry will expand, increasing opportunities for pharmaceutical and biotechnology companies. On the 4th, Shin & Kim LLC announced this in a special report on the results and impact of the 21st presidential election. President Lee Jae-Myung announced in his campaign pledge that he would strengthen the public nature of the medical and pharmaceutical industries. According to Shin & Kim LLC analysis, the new government will strengthen the public return support system through national R&D investment to foster the pharmaceutical and bio industries. In particular, it is expected that the government will establish a public consignment production and distribution system for essential medicines and promote the construction, public acquisition, and conversion of public hospitals. With the expansion of public support for the medical and pharmaceutical sectors, opportunities will rise for relevant companies, and the industry recommended parties to closely monitor the new government's efforts to achieve the two goals of strengthening public nature and fostering industry growth. To resolve supply instability and establish a stable supply system for essential medicines, the report suggested that policy measures should be developed with a focus on providing incentives to pharmaceutical companies and promoting limited International Nonproprietary Names (INN) based prescriptions. With the promised establishment of a regional essential medical care fund, policies to strengthen regional essential medical care infrastructure centered on regional medical schools and national university hospitals are expected to be promoted, which is seen as an increase in opportunity for regional medical institutions. Shin & Kim LLC stated that in terms of strengthening health insurance reimbursement coverage for medicines, particular focus will be placed on treatments for rare and intractable diseases. It is anticipated that the door to health insurance coverage for high-priced innovative drugs targeting rare and intractable diseases will be expanded and that the threshold for new drugs to enter health insurance coverage will be significantly lowered through the expansion of the Risk Sharing Agreement (RSA) scheme. In line with the pledges to institutionalize telemedicine and expand home visits and primary care physician systems, it is analyzed that policies for medical services that transcend geographical limitations will activate the medical industry and related platform industries. The Lee Jae-myung administration's medical reform plan sets out to organize a public debate committee as central governance, where medical professionals, experts, patients, and citizen representatives participate. Shin & Kim LLC diagnosed that it is necessary to closely monitor the direction set for the medical delivery system that starts from outpatient clinics to tertiary hospitals, regional medical infrastructure, and medical personnel supply to predict and respond to changes in the industrial landscape. Shin & Kim LLC explained, “The strengthening of the public nature of the medical and pharmaceutical industries will increase corporate social responsibility and alter the structure of market competition,” emphasizing the need for proactive measures in response. It added, ”The importance of profit management for medical institutions and related companies will increase due to the strengthening of price management for non-reimbursed medical services to stabilize Korea’s national health insurance finances.”
- Policy
- Lee Jae-Myung elected as president of South Korea
- by Lee, Jeong-Hwan Jun 05, 2025 06:10am
- Lee Jae-myung, the 21st President of South KoreaWith the election of Lee Jae-myung of the Democratic Party (Candidate No. 1) as the 21st President of South Korea, momentum is expected to build for key healthcare policies. These include the establishment of a National Medical Reform Public Opinion Committee to resolve conflicts between the medical community and the government, the promotion of limited International Nonproprietary Names-based prescriptions and generic substitutions to address drug supply instability, and the institutionalization of telemedicine with a standardized public e-prescription system. In particular, President Lee Jae-Myung has pledged to establish a system for telemedicine that complements in-hospital care, adheres to the principle of follow-up visits, and centers on neighborhood clinics, while halting indiscriminate pilot projects and establishing a management and supervision framework for intermediary platforms, is expected that the current unlimited telemedicine pilot project will be reasonably scaled back. From the pharmaceutical and biotech industry’s perspective, insiders are expecting a comprehensive overhaul of the drug pricing system, including granting higher drug prices to pharmaceutical companies that have invested heavily in R&D for innovative new drugs and strengthening mechanisms to remove generic drugs from the market if they fail to properly prove their efficacy. President Lee Jae-myung is expected to immediately begin implementing his campaign pledges on healthcare, pharmaceuticals and biotechnology, and health insurance without forming a transition committee. National Medical Reform Public Opinion Committee, Resolution of the medical-political conflict remains a challenge President Lee Jae-myung has decided to immediately begin work on establishing a National Medical Reform Public Opinion Committee that will involve the public, healthcare professionals, and experts from various fields. This is to resolve the ongoing issues triggered by the Yoon Suk-Yeol administration's policy to increase the number of medical school enrollment quotas by 2,000, which led to collective action by resident doctors and medical students in February last year and a medical staffing shortage. However, the Democratic Party has stated that it will not provide additional benefits to the resident doctors who participated in the collective action to resolve the conflict between the government and the medical community. Ultimately, it is likely that the committee will discuss solutions to the collective action by doctors and medical students. In addition, the policy to increase the number of medical school enrollment quotas is likely to be decided based on the results of the review by the Committee on Medical Manpower Planning, which was passed by the National Assembly with the agreement of both the ruling and opposition parties. This is because the Democratic Party of Korea's policy was to decide on the number of medical school enrollment quotas for the 2027 academic year and beyond through an objective and transparent deliberation process by the the Committee on Medical Manpower Planning, as the number of medical school enrollment quotas for the 2026 academic year has been set to return to 3,058. Furthermore, it is expected that Cho Kyoo-Hong, Minister of Health and Welfare, and Park Min-Soo, Second Vice Minister, who were at the forefront of the policy to increase the medical school enrollment quota, will be held accountable. As part of measures to strengthen regional and essential medical care, the government has promised to introduce a regional doctor system, establish public medical schools, and promote public medical academies. The government also plans to assign national university hospitals the role of base hospitals and expand public medical infrastructure by medical service area. Solutions to the drug shortage crisis, stronger government intervention, and INN-based prescriptions The solution to the supply instability of medicines pledged by the president involves strengthening government intervention in all stages of the process, from the supply of APIs for medicines that are frequently out of stock to the production of finished medicines and distribution to pharmacies. The government is expected to establish a list of frequently out-of-stock medicines and provide incentives for pharmaceutical companies to take an interest in producing APIs that are difficult to produce in Korea. The Democratic Party of Korea's policy is to increase profits for pharmaceutical companies that produce finished drugs using domestically produced raw materials show improved self-sufficiency rates and strengthen the public drug consignment manufacturing system for drugs in short supply. At the same time, the government will allow limited use of generic drug prescriptions for essential medicines with unstable supply. The government plans to resolve issues that caused significant inconvenience to the public during the COVID-19 pandemic, such as the shortage of acetaminophen for prescription drugs, by allowing limited INN-based prescriptions. President Lee also promised to promote substitute prescriptions as a solution to drug shortages. In response, there is a possibility that the current administration will go beyond allowing pharmacies to notify the Health Insurance Review and Assessment Service after dispensing substitute drugs, which is currently pending implementation, and introduce additional policies to increase the rate of substitute prescriptions. Legalization of telemedicine centered on local clinics and repeat patients gains momentum The possibility of legalizing telemedicine pilot projects within this year has also increased. President Lee promised to institutionalize telemedicine while ensuring safety and effectiveness. It is particularly noteworthy that the Democratic Party of Korea is preparing legislation to institutionalize telemedicine centered on “clinic-level” medical institutions and “repeat” patients. This is because the Democratic Party of Korea, which holds a majority of seats, has succeeded in changing the administration, greatly increasing the likelihood of the Democratic Party-led legislation of telemedicine. The Democratic Party of Korea is preparing a bill that would allow telemedicine to be used primarily by medical institutions at the clinic level, but also allow hospitals to provide telemedicine in special cases. In particular, the bill is expected to include provisions allowing telemedicine for initial consultations only for patients under 18 years of age and those over 65 years of age, while patients in other age groups would only be able to apply for telemedicine for follow-up consultations. In this case, the scope of eligible recipients for telemedicine would be significantly reduced compared to the current pilot program. Of course, since the amendment to the Medical Service Act to legalize telemedicine must undergo parliamentary review, the Democratic Party of Korea cannot make a unilateral decision on the matter. Unlike the 21st National Assembly, the 22nd National Assembly will see the ruling party change from the People Power Party to the Democratic Party of Korea, and it is expected that the Democratic Party's proposal will be reflected in the government's proposal to a considerable extent. The establishment of a public electronic prescription system will also be implemented along with the institutionalization of telemedicine. The Democratic Party of Korea plans to utilize public electronic prescriptions as a means to prevent the falsification and misuse of prescriptions and to prevent errors in the entry of prescription information during telemedicine. Pharmaceutical industry announces restructuring and advancement of drug pricing system President Lee announced a policy pledge to actively promote the pharmaceutical and bio industry as a new future growth engine for South Korea. As a measure to promote the pharmaceutical and bio industry, President Lee announced plans to revise the drug price system to focus on new drugs and strengthen the mechanism for removing generic drugs that have not been verified their effect from Korea’s health insurance reimbursement list. The most notable pledge is “drug price incentive linked to new drug R&D investment rates.” The vision is to create an environment where pharmaceutical and biotechnology companies can focus on developing new drugs by setting higher drug prices for medications produced by pharmaceutical companies that contribute significantly to innovative new drug R&D. This pledge was one of the policies proposed by multiple domestic pharmaceutical and biotech companies led by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The government also promised to establish a more predictable drug pricing system to serve as a catalyst for new drug development and a cash cow for domestic pharmaceutical companies. The vision is to integrate drug price reduction mechanisms to establish a drug pricing system that encourages investment in new drug R&D. The president has also outlined a plan for the government to take the lead in establishing an R&D investment system and forming large-scale funds (megafunds) to promote industry development. In addition, the candidate's campaign promises include advancing the certification system for Korea Innovative Pharmaceutical Companies to expand R&D tax credits for certified innovative pharmaceutical companies, establishing a governance system that combines AI and big data technologies for the development of new drugs targeting global markets, and expanding risk-sharing agreements (RSA). To secure health insurance funds for these initiatives, the candidate proposed removing non-verified generic drugs from the market. In other words, the intention is to create some health insurance funds by more actively reevaluating the reimbursement of generics that have been approved for a long time but are not effective, thereby narrowing the scope of health insurance coverage. On the morning of the 4th, when his election was certain, the president-elect took the stage in front of the National Assembly and said, “The responsibility of a president in a united country is to bring the people together. I will never forget that my duty is not to be a great ruler, but to greatly unite the people.” Meanwhile, President Lee began his term as president immediately after the National Election Commission officially confirmed his election as president at 7 a.m. on the same day. President Lee held a brief inauguration ceremony at the National Assembly at 11 a.m. that day, after which he immediately appointed the Chief of Staff and began forming his Cabinet, including the Prime Minister.
