- LOGIN
- MemberShip
- 2025-12-17 14:30:15
- Policy
- Bill bans remote narcotics and hair loss drug prescriptions
- by Lee, Jeong-Hwan Sep 17, 2025 06:10am
- A partial amendment to the Medical Service Act was introduced in the National Assembly on the 16th, mandating that physicians check the Drug Utilization Review (DUR) system when prescribing via telemedicine. The rule applies to high-risk drugs such as narcotics, psychotropics, anti-obesity drugs like Wegovy, hair loss treatments, and isotretinoin acne drugs that are prone to misuse. The bill stipulates that physicians must confirm the DUR system when prescribing any drugs designated by the Ministry of Health and Welfare as prohibited for telemedicine. Violations will result in administrative fines of up to KRW 3 million. Rep. Sunmin Kim (Rebuilding Korea Party), who proposed the bill as representative, explained, “In telemedicine, physicians cannot prescribe government-banned drugs once they check DUR at the time of prescription. This legislation codifies the existing safeguard into law.” If enacted, the bill is expected to close loopholes where telemedicine could otherwise be exploited as a channel for prescribing high-risk, non-reimbursed drugs. The bill amends Article 18-2 (“Confirmation of Drug Information”) of the Medical Service Act, adding a clause requiring physicians and dentists providing telemedicine to check DUR before issuing prescriptions or dispensing medicines themselves. Terminology adjustments include renaming “telemedicine” (Article 34) to “non-face-to-face cooperative care,” while defining “telemedicine” in a new Article 34-2. The definition covers patient monitoring, consultation, education, diagnosis, and prescribing using computers, laptop computers, video conferencing, outside of medical institutions. Also, the bill limited telemedicine subjects to returning patients, residents in medically underserved regions (islands, remote areas), inmates in correctional facilities and military personnel, and patients eligible for proxy prescription pickup. Effectively, first-time patients cannot use telemedicine unless under special circumstances, being restricted access to telemedicine. Specifically, for patients eligible for limited initial telemedicine, the Minister of Health and Welfare can now legally prescribe the types of medications that cannot be prescribed and set appropriate prescription durations, thereby establishing legal safeguards to prevent adverse effects from initial remote consultations. Also. the MOHW minister may designate specific disease groups requiring non-face-to-face telemedicine consultations via video communication for clear diagnosis. Patients with burns are expected to fall under this category. The bill also newly establishes provisions for telemedicine platforms, specifying the authority and responsibilities of the platform industry within the Medical Service Act. To provide or operate a non-face-to-face medical care intermediary platform, one must report to the Minister of Health and Welfare according to standards set by the Minister of Health and Welfare. Compliance requirements for telemedicine platforms are also newly established as separate provisions, and platform management and supervision standards are included in the law. The bill prohibits platforms from interfering with a physician's medical judgment, encouraging the misuse or abuse of medical services or pharmaceuticals, or engaging in acts that undermine healthcare order or harm patient health. Specifically, telemedicine platforms shall not arrange, induce, or instigate collusive acts as defined by the Pharmaceutical Affairs Act. Platforms must not, either directly or through third parties, introduce, arrange, or lure patients or individuals holding prescriptions to specific medical institutions, medical practitioners, pharmacies, or pharmacy owners/employees, and in return, provide, demand, or promise money, goods, benefits, labor, entertainment, or other economic advantages, nor receive such from medical institutions or similar entities. Platforms are also prohibited from inducing users to recommend or select specific medical institutions or pharmacies. Platforms are required to report quarterly to the Minister of Health and Welfare on the number of users of telemedicine platforms and the medical specialties involved, for the purpose of surveying the status of such telemedicine intermediaries. The Minister of Health and Welfare may order platforms to provide necessary data for this purpose. Additionally, platforms must submit quarterly reports to the MoHW on telemedicine use, including number of users and medical departments involved. The Minister may also request further data as needed. If platforms violate service standards or fail to comply with corrective orders, the Minister may restrict or suspend facility or equipment use. Non-compliance with such orders can result in license cancellation or suspension of business operations for up to one year. These provisions establish legal grounds for cancellation of platform registrations and suspension of operations in cases of regulatory breaches.
- Policy
- Spray formulation of 'nicotine' wins nod in KOR as OTC
- by Lee, Tak-Sun Sep 16, 2025 06:10am
- Product photo of Nicorette QuickMist sold overseasA spray formulation containing nicotine, which is used as a smoking cessation aid, received its first approval in Korea. The nicotine spray was previously discussed for classification as a prescription drug in 2019, but this time it obtained approval as an over-the-counter (OTC) drug that is exempt from safety and efficacy review. Spray formulations are widely used as OTC products overseas. On September 15, the Ministry of Food and Drug Safety (MFDS) approved Johnson & Johnson Korea's 'Nicorette QuickMist Mouthspray (nicotine).' This drug is an adjunct therapy for smoking cessation and is used to relieve nicotine cravings and withdrawal symptoms. As a nicotine replacement therapy (NRT), it reduces cravings and withdrawal symptoms by allowing nicotine to be absorbed through the oral mucosa. This drug is used in three stages: In Stage 1 (weeks 1-6), one spray is used when a craving to smoke arises. In Stage 2 (weeks 7-9), the daily usage is gradually reduced, with the goal of using half the average number of sprays used during Stage 1 by week 9. In Stage 3 (weeks 10-12), if the usage has been reduced to 2-4 times a day, the use of this drug should be discontinued. Complete smoking cessation is required while using the oral spray. The method of use is to open the mouth, bring the spray nozzle as close to the mouth as possible, and press firmly on the top of the spray to dispense it, avoiding the lips. J&J's Nicorette is a leading brand of smoking cessation aids sold in pharmacies. In Korea, three formulations are currently sold: Nicorette Gum, Nicorette Lozenges Coolmint, and Nicorette Invisi Patch. While the spray formulation is sold overseas, it had not been launched in Korea due to concerns over potential misuse and abuse. It has reportedly been sold as an OTC product in the UK for nearly 20 years. In 2019, the MFDS Central Pharmaceutical Affairs Advisory Committee (CPAC), while discussing approval for the nicotine spray formulation, had shared the opinion that classifying it as a prescription drug was appropriate. At that time, 5 out of 7 committee members favored a prescription drug classification due to concerns about misuse by adolescents. Subsequently, the nicotine spray formulation was not approved. Six years later, with MFDS granting approval for this drug as an OTC drug, which offers good consumer accessibility, it is gaining attention whether this market will become more active. The approval process also excluded a safety and efficacy review.
- Policy
- US pressures MFNs to cut drug prices
- by Lee, Jeong-Hwan Sep 16, 2025 06:09am
- As the US Trump administration pushes hard for Most Favored Nation (MFN) drug pricing policies, voices are growing within the industry that Korea should mitigate trade pressure by expanding the “risk-sharing agreement (RSA),” the key tool used during drug pricing negotiations in the reimbursement process. Industry representatives are arguing that non-innovative pharmaceutical companies’ new drugs developed for export, as well as anticancer and orphan drugs introduced through open innovation, should also be included in the refund-type RSA scheme. The industry insisted that the dual pricing system—currently applied only to exported drugs to allow higher external list prices—should also be extended to imported drugs. This would increase Korea’s freedom from U.S. pharmaceutical trade pressure while improving patient access. The Ministry of Health and Welfare acknowledged that Korea’s current drug price disclosure system is excessively transparent, creating disadvantages in international trade and exports, and promised to actively consider reforms such as refund-type RSAs and the dual pricing system. This signals a green light for system improvements in line with industry demands. On the 15th, Democratic Party of Korea lawmakers Yoon Kim and Youngseok Seo co-hosted a National Assembly debate on “Future Directions for the RSA System.” Professor Jeonghoon Ahn (Ewha Womans University, Department of Convergence Health Policy) who presented at the debate, explained that Korea’s drug prices significantly affect global markets. Initially, Korean drug prices were unofficially referenced by Asian countries. In 2013, Saudi Arabia formally included Korea as a reference country, followed by Canada in 2019, which greatly expanded Korea’s global pricing influence. Given that the US. MFN drug pricing policy under the Trump administration undermines the profitability of Korean drug exports, Prof. Ahn stressed that RSA expansion is necessary to address the issue. Ahn said, “Limiting RSAs only to anticancer and orphan drugs is far too restrictive compared to many advanced countries. If export-bound Korean drugs were also eligible for RSA, they could benefit when entering the US market. It is time to consider RSA expansion given the changing external environment.” “Refund-type RSA should also be applied to non-innovative pharmaceutical company’s anticancer drugs and rare disease drugs” Hee-Sung Kang, Head of the External Affairs Team at Daewoong Pharmaceutical, who participated as a panelist, expressed the opinion that expanding the scope of drugs eligible for the refund-type RSA would benefit domestic pharmaceutical companies pursuing export-focused strategies. When included as price reference countries in China, Southeast Asia, and BRICS nations, refund-type RSAs would allow higher list prices to be maintained while controlling domestic budget impact. This strategy would improve both domestic and global access to new medicines. “The March 2023 revision of the Drug Decision and Adjustment Criteria limited refund-type RSAs to innovative drugs developed by innovative pharmaceutical companies. But considering the reality of Korea’s pharmaceutical industry, new drugs from non-innovative pharmaceutical companies developed for export, as well as anticancer and orphan drugs introduced through open innovation, should also be eligible.” He added: “This would help maintain high list prices at the time of local reimbursement, reduce concerns about reference pricing by overseas developers, and ultimately expand treatment options for domestic patients. Even in cases of post-marketing price cuts, if companies can choose refund-type RSAs, companies can preserve list prices while securing market trust.” “Applying dual pricing system to imported drugs could resolve U.S. trade issues” In-Hwa Choi, Director of the Korean Research-based Pharmaceutical Industry Association (KRPIA), stated that the Trump administration's push for MFN drug pricing and the increased likelihood of high tariffs should not be viewed merely as external pressure. Instead, she urged using this as an opportunity to supplement and innovate the structural weaknesses of the domestic drug pricing system. Most importantly, Choi called for revising the refund-type RSA system, which distinguishes between list price and actual price. She noted that Korea’s drug price disclosure system is highly transparent, which is advantageous in some respects but creates structural disadvantages in international negotiations. As a solution, she proposed extending the dual pricing system—currently applied only to exported drugs—to imported drugs as well. “Korea introduced the dual pricing system in March to allow higher list prices for exported drugs to prevent the risk of unfavorable, low drug pricing abroad. If we extend this system to imported drugs as well, we can partially resolve supply stability risks that may arise under the MFN trade environment.” Choi also suggested rebranding the dual pricing scheme under a new name, such as “Korean-style refund system,” to avoid misunderstandings associated with the term. “Other countries also use alternative terms like MEA or claw-back system,” she said. She concluded: “The K-refund system could become a strategic innovation model that helps Korea manage trade uncertainties while improving both patient access and industrial competitiveness. Patients would benefit from timely and stable treatment; the government would gain fiscal efficiency; and the industry would strengthen global competitiveness—a true win-win solution.” MOHW “RSA, U.S. MFN, and other external changes in addition to industry demands necessitate improvements and development” Yeon-Sook Kim, Director of the Division of Pharmaceutical Benefits at MOHW, emphasized that the ministry's principle for national health insurance reimbursement of pharmaceuticals is ‘timely reimbursement of effective drugs’. Kim acknowledged that the RSA system is at a point where development is needed in response to changes in the external environment and the pharmaceutical industry's demands. She also agreed on the need to closely monitor and respond swiftly to the significant domestic impact of the Trump administration's trade pressure regarding most-favored-nation (MFN) drug pricing. Yeon-Sook Kim, Director of the Division of Pharmaceutical Benefits at MOHW She admitted that Korea’s single-payer national insurance system, with its fixed patient co-payment model, has limited flexibility. This, combined with high transparency in drug pricing, has sometimes caused “unintended disadvantages” for pharmaceutical companies. Regarding whether South Korea's new drug prices are truly low, Kim mentioned there is much debate among experts and responded with the intention to partially improve the transparent drug price disclosure system. Kim said, “Operating within a robust public health insurance system inevitably leads to a lack of flexibility. Consequently, while a highly transparent system has been established, we understand that pharmaceutical companies experience unintended harm and unfairness. AS a result, the current drug price disclosure system is transparent, but it must be improved to address the inherent risk of being unreasonably disadvantaged.” Kim added, “While there was much initial debate about RSA, it is now making a significant contribution to Korea’s national health insurance. However, it is time for it to evolve in response to changes in the external environment. Various terms like RSA or dual drug pricing systems are being discussed, and the government will actively and promptly review the drug pricing system.”
- Policy
- "Gov't actively supports the development of new drugs"
- by Lee, Jeong-Hwan Sep 16, 2025 06:08am
- Ministry of Health and Welfare (MOHW) The Ministry of Health and Welfare (MOHW) explained that its establishment of a first-ever 'Phase 3 Specialized Fund' as one of its budget projects for next year is the result of government's commitment to creating innovative new drugs in Korea. The MOHW also announced that it would first design a specific business model for the 'Loan System for New Drugs Based on Success' by next year through a research project, and then begin selecting pharmaceutical and bio companies to receive benefits from 2027. A MOHW official, in a recent meeting with the Korea Special Press Association, explained, "The establishment of a specialized fund by the government to support pharmaceutical companies with the will and capability to develop new drugs in Phase 3 is the first of its kind, and it holds significant meaning." The MOHW has allocated KRW 60 billion in new costs for the establishment of the Phase 3 specialized fund next year. The goal is to establish a total fund of KRW 150 billion by combining the MOHW's contribution and investment from a fund of funds. This fund will then be used to select and support pharmaceutical and bio companies that have innovative new drug and Bio-Better pipelines and the intention to pursue Phase 3 clinical trials. Once the fund is established, the MOHW will not be directly involved in the selection of pharmaceutical companies or new drug candidates, entrusting that responsibility to investment firms. The MOHW also allocated KRW 500 million for a research service budget to design a Korea model for the 'Loan System for New Drugs Based on Success.' Given that it is rare to invest such a large amount, such as millions of KRW, into a research budget, it demonstrates a strong will to design a proper loan model for Korea. The Loan System is a policy that exempts or partially reduces the loan repayment responsibility for pharmaceutical companies that receive government investment and support for new drug development, even if the new drug ultimately fails to be created. If next year's budget is approved by the National Assembly, the MOHW plans to do its utmost to ensure that domestically developed new drug and bio companies can receive tangible benefits. A MOHW official said, "The Phase 3 specialized fund requires consultation with policy banks and other institutions. It's difficult to proceed with just government contributions, so we need to raise external investment." He stressed that, "While a KRW 150 billion fund may not be large when you consider the costs required for Phase 3, the fact that this is the first time the government is establishing a specialized fund to provide customized support for Phase 3 clinical trials is what makes it meaningful." The official added, "This is a demonstration of the government's strong will to discover new drugs." He continued, "The fact that this is the first time we are providing such support is impressive, and if the project is successful, we can increase its size, which makes it a crucial budget." And added, "For the Loan System, we will only be conducting research next year. We've allocated KRW 500 million, which is a significant amount for a research budget." He added, "We will design a specific implementation plan and a practical loan model for new drugs. After completing the research next year, we plan to reflect the actual project support budget in the 2027 budget plan." Finally, He said, "The Loan System requires collecting many opinions from the pharmaceutical and biotech industry during the research process," and added, "We need to discuss details, including pharmaceutical companies willing to support, the number of new drugs, and the criteria for success. We decided that we need such a system to encourage challenging investments in new drug development, which has a high probability of failure, and the Ministry of Economy and Finance agreed to include it in the budget plan."
- Policy
- Jardaince patent expires Oct 23…over 400 generics expected
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- Product photo of Jardiance As the substance patent for Jardiance (empagliflozin, Boehringer), an SGLT2 inhibitor for the treatment of diabetes, is expiring next month (October 23), over 400 generic drugs are expected to be introduced to the market. Notably, domestic pharmaceutical companies in Korea have developed empagliflozin + metformin extended-release tablets and are launching the first type of combination therapies, such as empagliflozin + sitagliptin. They are expected to revitalize the sales market. According to industry sources on September 14, Korean pharmaceutical companies announced the launch of Jardiance generic drugs next month and began pre-marketing. Along with Forxiga, which was withdrawn from the Korean market, Jardiance is among the top two SGLT inhibitors for the treatment of diabetes. Based on last year's UBSIT, outpatient prescription sales for Jardiance monotherapy amounted to KRW 66.3 billion and for Jardiance Duo (empagliflozin + metformin) recorded KRW 41.8 billion, accounting for a market exceeding KRW 100 billion. Esgliteo, a combination of empagliflozin and linagliptin, also recorded KRW 12.1 billion and became a blockbuster drug. Domestic pharmaceutical companies that seized the opportunity for the Forxiga patent expiration in April 2023 are also entering the Jardiance market, which is a KRW 100 billion market, with their generic drugs. A total of 412 empagliflozin monotherapy and combination products have been approved so far. Pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical are expected to receive higher prices by entering the generic drug market with their independently developed data-submission drugs. Several generic products were developed before the implementation of the joint bioequivalence test regulation, which meant they could not meet the self-developed bioequivalence test conditions. Among the generic monotherapies, only Dongkoo Bio & Pharma and Huons have met the requirements. Consequently, Dongkoo Bio & Pharma, which contract-manufactures generic drugs for over 20 pharmaceutical companies, is expected to receive the highest price among generics due to the innovative pharmaceutical company premium. With this premium, a cost of KRW 396 for the 10mg dose and KRW 518 for the 25mg dose is set, which corresponds to a 68% markup of the highest-priced drug. Among the generic drugs for the empagliflozin + metformin combination, there is also an extended-release film-coated tablet formulation that is taken once daily. The original product does not have an extended-release formulation. Additionally, Chong Kun Dang and Daewon Pharmaceutical have developed combination therapies that combine empagliflozin with the DPP-4 inhibitor sitagliptin, which they will be the first to introduce to the Korean market. An unprecedented level of competition is expected due to the entry of these generic drugs, which circumvented the joint bioequivalence test regulation. In addition, there are also drugs from pharmaceutical companies like Hanmi Pharmaceutical and Daewon Pharmaceutical, which have developed their products using in-house technology and new extended-release formulations. Related to this, a fierce competition is anticipated to create new prescriptions, with pharmaceutical companies pursuing independent sales and numerous CSOs joining in, offering high commission rates. In response, Boehringer Ingelheim, which holds the original Jardiance that recently succeeded in obtaining expanded reimbursement to cover chronic kidney disease, is expected to defend its existing accounts while also actively expanding into new ones for a year, during which it will be granted a 70% premium on the highest price. Jardiance is co-promoted in Korea with Yuhan Corporation.
- Policy
- Reimbursement review is underway for 'Ozempic'
- by Lee, Tak-Sun Sep 15, 2025 06:02am
- Ozempic 'Ozempic (semaglutide, Novo Nordisk),' a diabetes treatment with the same active ingredient as the injectable Wegovy, has been reapplied for National Health Insurance reimbursement. Novo Nordisk submitted a reimbursement application for Ozempic to the Health Insurance Review & Assessment Service (HIRA) in the first half of this year, and the review is reportedly now underway. Ozempic is garnering attention regarding whether it will be successfully added to the reimbursement list this time, as its previous attempt in 2023 was halted just before it could be listed. According to industry sources on September 11, Novo Nordisk recently submitted supplementary documents related to Ozempic's reimbursement to HIRA. A review of Ozempic's reimbursement appropriateness is reportedly underway, and it is expected to be considered by the Drug Reimbursement Evaluation Committee (DREC) within the year. Ozempic had already passed the DREC in February 2023. At that time, the DREC recognized the appropriateness of sOzempic's reimbursement on the condition that the company accept a price below the evaluated amount, which the company agreed to. The Korean Diabetes Association and the Korean Endocrine Society had submitted their opinion to the PBEC, stating that it was appropriate for Ozempic, a long-acting GLP-1 receptor agonist, to have a reimbursement scope similar to that of Trulicity, which is in the same class and has also been the subject of a comparative clinical study. Subsequently, it entered drug price negotiation with the National Health Insurance Service (NHIS), but the reimbursement application was withdrawn due to the company's internal circumstances. Industry sources report that the company halted the reimbursement process at the time because the explosive demand for semaglutide products, such as Wegovy, in the global market made it difficult to supply the drug in Korea. The company's decision to re-pursue reimbursement this time is analyzed as being influenced by the full-scale entry of Mounjaro (tirzepatide, Lilly), Wegovy's competitor, into the Korean market. Mounjaro received domestic approval as an obesity treatment last September, and a reimbursement application for its diabetes indication was submitted in July. The Korean academic community also views the reimbursement of Ozempic and Mounjaro positively. This year's '2025 Diabetes Clinical Practice Guidelines' present both drugs as having a significant blood sugar-lowering effect. Currently, the only reimbursed product among drugs that bind to GLP-1 (Glucagon-like Peptide-1) receptors to lower blood sugar, like these two drugs, is Lilly's Trulicity (dulaglutide).
- Policy
- HIRA to disclose all off-label drug approval/disapprovals
- by Lee, Tak-Sun Sep 12, 2025 06:19am
- All approval decisions regarding off-label drugs will be disclosed on the official website from now on. Currently, only non-approved general drugs are listed publicly, but going forward, both approved and non-approved cases will be made available in order to reduce the administrative burden on medical institutions submitting applications. On the 10th, the Health Insurance Review and Assessment Service (HIRA) pre-announced a partial amendment to its regulations governing the approval of non-reimbursed off-label use of drugs beyond their authorized or reported indications, and will collect industry opinion until the 16th. Applications for non-reimbursed off-label drug use must first be reviewed by a hospital or academic society with an Institutional Review Board (IRB). Among these, general drugs are referred by HIRA to the Ministry of Food and Drug Safety (MFDS) for evaluation of safety and efficacy, while anticancer drugs are reviewed monthly by the Cancer Disease Deliberation Committee. The issue has been that for off-label general drugs, only non-approved cases were published on the website, making it difficult for medical institutions to prepare applications due to a lack of information. By contrast, for off-label cancer drugs, both approved and non-approved cases are disclosed, raising concerns over fairness when only non-approved cases were listed for general drugs. A HIRA official stated, “With the disclosure of both approvals and non-approvals for all off-label drugs, we expect that medical institutions will face less administrative burden when preparing applications.” Industry voices are also calling for the relaxation of current approval criteria. In particular, they argue that the IRB review requirement should be abolished and the clinical data requirements eased. One industry insider pointed out, “For infectious disease treatments like COVID-19, it is difficult to conduct clinical trials due to the nature of the disease. Yet, off-label non-reimbursed use requires clinical literature similar to that for general drugs. This is an unreasonable measure that fails to account for the urgent characteristics of infectious disease treatments.” HIRA has also shown willingness to improve the system, having commissioned an external research project last year on “Improvement Measures for the Use of Drugs and Medical Devices Beyond Approved Indications,” and hosting an international symposium on the issue on the 29th of last month. This regulatory amendment marks the first step toward system improvement,, with further reforms are expected to be discussed in the future.
- Policy
- MOHW will reform system for certifying innovative companies
- by Lee, Jeong-Hwan Sep 12, 2025 06:18am
- The Ministry of Health and Welfare (MOHW) plans to announce a legislative notice in October for reforms to the Korea Innovative Pharmaceutical Company certification system, aiming to implement the changes in January next year. The reform plan includes converting the certification system into a point-based structure and establishing separate certification criteria for multinational pharmaceutical companies. Regarding whether to abolish the current penalty clause—which bars companies whose certification has been canceled from reapplying for three years—the MOHW responded that it is “under review.” An MOHW official explained so during a meeting with the MOHW press corp on the 10th. The delay in announcing and implementing the reform plan that was originally scheduled earlier, appears to have been influenced in part by the change of administration and the launch of the new government. At the core of the reforms is a shift from the current system—where certification is immediately revoked if illegal practices such as pharmaceutical rebates are uncovered—to a point-based system. The ministry aims to enforce the anti-rebate rule while moving to a flexible, point-based certification system. The MOHW official stated, “The reform plan for Korea Innovative Pharmaceutical Company Certification includes converting to a point-based system covering acts such as illegal rebates, and establishing separate certification criteria for domestic versus multinational pharmaceutical companies. We are aiming to publish the legislative notice in October and implement it in January next year.” The official added, “We are still reviewing whether to lift the rule that prevents companies whose certification was canceled due to illegal rebates from reapplying for certification for three years.”
- Policy
- Improvement to the post-marketing management for pharma
- by Lee, Tak-Sun Sep 11, 2025 06:11am
- A comprehensive discussion regarding the post-marketing management program of pharmaceuticals, including actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement, is anticipated once research results become available at the end of this year. Improvement plans to the actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement programs have already been discussed with the pharmaceutical industry. However, with the release of the 'Research on a Unified Mechanism for Post-marketing Drug Price Management,' commissioned by the Ministry of Health and Welfare, scheduled for the end of this year, the policy is to conduct a comprehensive discussion based on results. On September 9, the Ministry of Health and Welfare officially announced the detailed operational guidelines for adjusting the ceiling price based on its actual transaction price survey, which is conducted once every two years. The survey will target 19,588 drugs and inspect 104,275 medical institutions from July 1 of last year to June 30 of this year. However, as before, public and national hospitals will be excluded from the survey. Additionally, low-priced drugs, discontinuation-prevention drugs, narcotics, orphan drugs, radiopharmaceuticals, artificial perfusion solutions, and oxygen·nitrous oxide are excluded. Oxygen and nitrous oxide were added to the list of excluded items this time. Discussions on improving the actual transaction price reduction program began late last year. Based on the 'Research on Improving the Actual Transaction Price-Based Drug Price Reduction System' (led by Professor Kim Jinhyun of Seoul National University), which was commissioned by the Health Insurance Review & Assessment Service, a consultative body was formed with the pharmaceutical industry to gather opinions until the first half of this year. The consultative body discussed issues such as abolishing the 10% price reduction cap and including public and national hospitals in the survey. The proposal to include public and national hospitals in the survey is a matter that the pharmaceutical industry strongly opposes, as drug dumping is a structural problem in public hospital bidding, where drugs are often awarded for as low as KRW 1. Although the process of gathering opinions from the pharmaceutical industry has been completed, the actual transaction price survey will proceed as before, excluding public and national hospitals. Only oxygen and nitrous oxide were included in the list of excluded items. An industry official said, "We understand that the improvement plan for the actual transaction price-based drug price reduction program will be discussed as part of a discussion with other post-marketing management programs after the unified post-market mechanism research is released at the end of the year." He added, "At that time, the issue of including public and national hospitals may be re-discussed." The improvement plan for the re-evaluation of drug reimbursement appropriateness is also scheduled for re-discussion after the unified post-market management research. The plan was discussed at a subcommittee meeting of the Health Insurance Policy Deliberation Committee last month, but it was not included on the review agenda for the main session. The details of the re-evaluation improvement plan are to change the selection criteria from the existing average claim amount of 0.1% or more over three years (approx. KRW 20 billion) to KRW 10 billion or more, and to expand the condition for not being listed in other countries from fewer than two A8 countries to fewer than three countries. Notably, seven ingredients, including ginkgo leaf extract, were selected for next year, which is the first year of the second re-evaluation phase under the comprehensive health insurance plan. However, with the discussion delayed, the progress of the re-evaluation next year itself is now uncertain. An industry official said, "If the confirmation of the re-evaluation targets is delayed, it may be difficult to proceed next year, considering the time needed to prepare materials like textbooks," and added, "It will be necessary to wait and see how the discussion proceeds after the post-marketing unified mechanism research is released at the end of the year."
- Policy
- Generic dispensing, collusion ban pass legislative committee
- by Lee, Jeong-Hwan Sep 11, 2025 06:11am
- On September 10, the National Assembly’s Legislation and Judiciary Committee passed two amendments to the Pharmaceutical Affairs Act. One expands the post-notification method for generic substitution at pharmacies to include information systems operated by the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service; the other expands the scope of essential medicines and elevates the legal basis for operating the Stable Supply Council from presidential decree to law. The National Assembly's Legislation and Judiciary Committee has also passed an amendment to the National Health Insurance Act, which allows for the reduction of drug prices or the suspension of reimbursement for unfairly traded drugs when reverse payment agreements are detected. These agreements involve originator and generic drug companies colluding to delay the launch of generics, thereby avoiding price reductions for the original drug. Once these bills are passed in the plenary session, they will complete the necessary legislative process and take effect on the enforcement date stipulated in the addenda following government promulgation. Bill to simplify the post-notification of generic substitution notifications#eB (Partial Amendment to the Pharmaceutical Affairs Act) establishes a new Article 27-2 (Establishment and Operation of a Substitution Information System) in the Pharmacuetical Affairs Act, enabling the MOHW to establish and operate an information system to support post-substitution notification. Specifically, the bill allows the Minister of Health and Welfare to delegate this task to the Health Insurance Review and Assessment Service (HIRA), with the necessary details to be stipulated by MOHW ordinance. The bill retains the existing obligation that when a pharmacist substitutes a drug listed on a prescription with an item recognized by the Ministry of Food and Drug Safety as having bioequivalence, the pharmacist must inform the patient of this fact and notify the prescribing physician or dentist within one day (or three days if unavoidable circumstances exist). National Essential Medicines definition expansion bill(Partial Amendment to the Pharmaceutical Affairs Act) allows medicines without substitutes or facing supply instability to be designated as National Essential Medicines. The basis for the composition and operation of the National Essential Medicines Stable Supply Council, previously established by Presidential Decree, has been elevated to the Pharmaceutical Affairs Act. The chairmanship of the council was revised: instead of appointing a single Vice Minister of MFDS as chair, it now requires adding one ‘senior public official designated by the Minister of Health and Welfare of the MOHW’. Generic drug collusion prohibition bill (Partial Amendment to the National Health Insurance Act) mandates that if the Fair Trade Commission detects collusive reverse payment agreements between originator and generic drug companies, the prices of the unfairly traded drugs must be reduced or their reimbursement suspended. Specifically, it stipulates that cases violating Article 40(1) or Article 45(1) of the Monopoly Regulation and Fair Trade Act, where the violation was committed “for the purpose of increasing or maintaining the upper limit of drug reimbursement costs,” the insurance drug price can be reduced or reimbursement suspended. When a reverse payment agreement violation is first detected, drug prices can be reduced by up to 20%. If another reverse payment agreement is detected within five years of the price reduction, drug prices can be reduced by up to 40%. If another illegal reverse payment agreement is detected within five years after the second price reduction, drug reimbursement can be suspended for up to one year.
