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- 2025-12-19 14:19:21
- Policy
- New Divisions for Essential & Public Healthcare proposed
- by Lee, Jeong-Hwan Oct 15, 2025 06:11am
- Ministry of Health and Welfare Minister Eun-kyeong Jeong The Ministry of Health and Welfare has decided to establish a new director-level organization, the ‘Regional, Essential, and Public Healthcare Policy Office,’ to ensure the success of the Lee Jae-myung administration's national policy task of people-focused healthcare reform. It has been confirmed that this request has been submitted to the Ministry of Interior and Safety as a top priority. This effectively kicks off the organizational restructuring process, where the existing ‘Healthcare Policy Office’ under the Second Vice Minister will handle legislative and policy-based tasks, while the new ‘Regional, Essential, and Public Healthcare Policy Office’ will focus on practical healthcare reform initiatives such as the regional doctor system, public medical schools, and telemedicine projects. Alongside the separate establishment of the Regional, Essential, and Public Healthcare Policy Office, the Ministry also conveyed to the Ministry of the Interior and Safety its request for the creation of a director-general level organization (second priority) dedicated to the ‘Integrated Support Act for Regional Care, including Medical and Nursing Care,’ set to take effect next March, and the establishment of a director-level ‘Pharmaceutical and Bio Industry Policy Office’ (third priority). According to National Assembly and Ministry of Health and Welfare officials on the 14th, the Ministry is considering an organizational restructuring plan targeting successful healthcare reform, the smooth implementation of systems related to the Integrated Care Act, and the promotion of the domestic pharmaceutical and bio industry. The Ministry has conveyed its request to the Ministry of the Interior and Safety for the creation of a director-level organization and a bureau-level organization. It plans to accelerate the administrative process for organizational restructuring and expansion based on the Ministry of the Interior and Safety's decision. Currently, under the Second Vice Minister of Health and Welfare, there is one Office — the Healthcare Policy Office — and three Bureaus: the Health Insurance Policy Bureau, the Health Policy Bureau, and the Health Industry Policy Bureau. Additionally, three temporary organizations—the National Pension Reform Support Team, the Biohealth Innovation Promotion Team, and the Medical Reform Promotion Team—are operating separately. The Healthcare Policy Office is responsible for government legislative and administrative tasks concerning health and medical policy and health and healthcare finance overall. Ministry of Health and Welfare Minister Eun-kyeong Jeong has emphasized the need for a dedicated unit focused on regional, essential, and public healthcare operations while maintaining the existing policy-based Healthcare Policy Office structure. The rationale is that for the Lee administration to properly succeed with essential healthcare strengthening policies—which the previous Yoon administration failed to unilaterally implement, including plans to increase medical school enrollment by 2,000—a dedicated director-level organization for regional, essential, and public healthcare operations would be essential. Currently, the Ministry has the ‘Medical Reform Promotion Team,’ a temporary director-level organization established during the Yoon administration. Led by Director Gyeong-sil Jeong, this team is handling the transfer of related duties to the Public-Focused Medical Reform Committee following the launch of the Lee administration. Minister Jeong is expected to abolish this temporary team and establish the new director-level Regional, Essential, and Public Healthcare Policy Office. Furthermore, Minister Jeong reportedly holds the view that the Healthcare Industry Policy Bureau should be elevated to a director-level Pharmaceutical and Bio-Industry Policy Office to properly foster the domestic pharmaceutical-bio industry and biohealth industry. She has also asked MOIS to elevate the temporary unit under the Senior Policy Office for Population and Social Services, which currently handles elderly policy, into a full-fledged “Integrated Care Bureau for Medical, Nursing, and Community Services.” As strengthening regional, essential, and public healthcare, fostering a globally competitive pharmaceutical and biotech industry, and ensuring a smooth landing for a regionally integrated care system are all presidential campaign pledges and national policy tasks, attention is focused on how much the Ministry of the Interior and Safety will accommodate the Ministry of Health and Welfare's requests. Multiple officials from the National Assembly and the Ministry of Health and Welfare agree on the necessity of establishing a separate Regional-Essential-Public Policy Office alongside the Healthcare Policy Office. The prevailing view is that the Ministry of the Interior and Safety must also accept the establishment of a Pharmaceutical and Bio Industry Policy Office and the elevation of the Integrated Care Bureau to successfully advance these national policy tasks. An MOHW official stated, "The Healthcare Policy Office will operate as a policy and legislative foundation organization, while the Regional-Essential-Public Policy Office handles comprehensive administrative tasks by sector. We see no overlap or conflict in their duties. If the Regional-Essential-Public Policy Office takes charge of practical tasks related to regional healthcare, public medical schools, and advancing the healthcare delivery system, the work will be clearly separated. Other ministries, such as the Ministry of Trade, Industry, and Energy, also have director-level organizations structured as Policy Division, Infrastructure Division, and Business Division."
- Policy
- Gov't to unveil New drugs·Generic Drug Pricing System Rev.
- by Lee, Jeong-Hwan Oct 14, 2025 06:40am
- Director General Lee Jung-kyu The Ministry of Health and Welfare (MOHW) has announced plans to release the drug pricing system revision next month (November), including both new drugs and generics. It is drawing the attention of Korean and international pharmaceutical companies. The MOHW plans to disclose the timing of the re-evaluation of reimbursement appropriateness for listed drugs, along with the new drug pricing improvement plan. The reform is expected to include significant measures that will impact the Korean pharmaceutical industry, including enhancing patient access to new drugs, strengthening the stability of essential medicine supply, standardizing the post-market drug price reduction system, and improving the conventional generic drug pricing structure. On October 12, Lee Jung-kyu, Director General of Health Policy of the MOHW, shared some of the direction for the new drug pricing improvement plan, including reimbursement re-evaluation, during a meeting with the Korea Special Press Association. Lee stated that the re-evaluation of reimbursement appropriateness is currently under review as part of the overall drug pricing system revision plan. Lee explained that the delay is due to efforts to align the re-evaluation's direction with the new improvement plan, following earlier subcommittee discussions. The 'actual transaction price-based drug price reduction system' will proceed as scheduled, as its implementation timeline was recently announced. However, the MOHW plans to discuss it with revisions under review, including post-market drug price management. Furthermore, the MOHW's drug pricing revision plan for next month is expected to include items discussed at the World Bio Innovation Forum, which President Lee Jae Myung attended on the 5th of last month. At the forum, a plan to expand the application of a dual pricing system was stated. The dual pricing system is one in which the actual price of a medicine differs from its officially listed price. The goal is to provide Korean pharmaceuticals with a competitive advantage when exported overseas, thereby facilitating drug price negotiations. The MOHW has already implemented a form of dual pricing through a drug pricing system revision in March. This revision allows the National Health Insurance Service (NHIS) to enter into a separate contract with a manufacturer, contract manufacturer/seller, or importer if the drug is deemed necessary after assessing its impact on public health and if the company wishes to pursue strengthening global competitiveness. The MOHW is now considering expanding the application of this provision to other medicines. The system for concurrently processing approval, evaluation, and negotiation (Concurrent Approval-Evaluation-Negotiation) is currently in a pilot phase and is expected to transition to a formal system. The integration of post-market drug price management, such as price reductions, is being discussed to align the currently separate price adjustment systems (the drug price cap adjustment system) so they are implemented on a single date and time. This would unify the timing and application of systems like the NHIS's price-volume agreement (PVA)-linked reduction and HIRA's reimbursement re-evaluation and actual transaction price reductions. While the MOHW emphasizes that post-market management and re-evaluation have distinct goals and objectives for each system, it has commissioned policy research in response to demands from pharmaceutical companies and local pharmacies to enhance the predictability of drug price reductions. The MOHW also conducted policy research on the integration of drug price cap adjustment mechanisms in March of this year, to finalize specific plans and financial impact analyses based on the results of the preceding research. Regarding preferential drug price regulations, new provisions are expected to be established, such as preferential pricing for drugs that contribute to the supply of essential medicines, executing the government's national goal of stable supply for drugs with unstable supply. Lee said, "Last year's research service analyzed the current situation," and added, "Based on that data, it has been analyzed that further research is needed on how to improve the system, and that additional research will be commissioned soon."
- Policy
- No companies apply for domestic API pricing premium
- by Lee, Jeong-Hwan Oct 13, 2025 06:07am
- Although the Ministry of Health and Welfare has implemented a policy since March this year offering a 68% pricing premium on essential medicines made with domestic APIs, it has been confirmed that as of October—7 months after implementation—not a single pharmaceutical company has benefited. Criticism is mounting that the Ministry's overly stringent criteria for applying the pricing premium to domestically produced raw materials severely undermine the policy's effectiveness and hinder the development of the domestic API industry, which is directly linked to public health and national security. According to the ‘Status of Domestic API Drug Price Preferential Treatment’ submitted to People Power Party lawmaker Jong-heon Baek by the Ministry of Health and Welfare on the 10th, despite several months since the policy's implementation, not a single pharmaceutical company has applied for the preferential treatment. The MOHW stated that since the relevant regulations were revised last December and the policy took effect this March, the number of applications for the ‘68% pricing premium for domestically produced active pharmaceutical ingredients used in national essential drugs’ and the number of drugs receiving the benefit are both zero. Although the system aims to promote the use of domestically produced APIs, reduce dependence on foreign APIs, and foster the development of the pharmaceutical industry, it has effectively failed 7 months after its implementation. The domestic pharmaceutical industry is voicing concerns that unless the Ministry revises the relevant price discount regulations, the policy will become a dead letter, effectively meaningless. Reasons behind the domestic API price preferential policy fail National Essential Medicines are defined under the Pharmaceutical Affairs Act as ‘medicines essential for public health, such as disease management and radiation disaster prevention, but for which stable supply is difficult through market mechanisms alone, which are designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation with the heads of relevant central administrative agencies.’ As of August this year, 473 drugs are designated as National Essential Drugs in Korea. Despite how a policy is in place that adds 68% to the drug price when domestic APIs are used to manufacture these National Essential Drugs, with the benefit lasting up to 10 years, domestic pharmaceutical companies claim the reason there are no applicants or items is because the Ministry of Health and Welfare's standards are excessively stringent. The domestic pharmaceutical industry has long demanded that the 68% drug price advantage be applied even to pharmaceutical companies already producing essential medicines using domestic APIs. They are also calling for regulations to be established that would allow the benefits to be applied retroactively to drugs manufactured before the pricing premium policy was implemented this March. Notably, compound drugs that use both domestic and imported APIs from multiple sources, not just one, are excluded from the 68% price discount. The MOHW currently requires that all major active ingredients contributing to pharmacological efficacy must be individually recognized as domestic APIs to qualify for the price advantage. Pharmaceutical companies criticized that such conditions are unrealistic, warning that very few medicines could ever meet the 68% incentive criteria under the current framework. Politicians agree on the need to improve drug pricing system regulations Some political circles also agree with the domestic pharmaceutical industry's arguments and are urging the Ministry of Health and Welfare to improve the system. Rep. Jong-heon Baek plans to summon Ssang-Soo Han, CEO of Inist ST, as a witness during the upcoming National Assembly audit of the Ministry of Health and Welfare on the 15th. He intends to question him about the inadequacies of the domestic API drug price premium policy and measures to foster the domestic API drug industry. Baek emphasized that in the wake of the COVID-19 pandemic, global protectionism in pharmaceutical supply chains has intensified, and the Korean government must treat the domestic API sector as a matter of public health and national security, not merely industrial policy. Accordingly, Rep. Baek urged the Ministry to prepare countermeasures against the risk of the domestic API preferential pricing policy becoming obsolete. The Ministry has only stated a general position, indicating it will seek solutions by thoroughly gathering opinions from the industry, experts, and the field regarding the demands of the pharmaceutical sector and Rep. Baek. This includes exploring new measures such as retroactive application rules or preferential regulations for compound drugs. Rep Baek pointed out, “The fact that not a single pharmaceutical company has applied for the preferential pricing as essential medicines with domestically produced APIs for 7 months is proof that this is a nominal system. Despite ongoing complaints from the pharmaceutical industry that the application criteria are excessively stringent, if the Ministry of Health and Welfare does not move to make the regulations more realistic, the policy to foster the domestic API drug industry will fail.” He added, “During the NA audit, I plan to question the Minister of Health and Welfare's perception of the API industry and demand that the system be revised, viewing it as an issue concerning public health and national security.”
- Policy
- Demands for expanded reimbursement for NMOSD
- by Jung, Heung-Jun Oct 13, 2025 06:02am
- The demand to improve reimbursement to enhance treatment accessibility for Neuromyelitis Optica Spectrum Disorder (NMOSD) is anticipated to heat up again in this year's parliamentary inspection. During the parliamentary inspection of the Health Insurance Review & Assessment Service (HIRA), on October 17, a NMOSD will attend as a testifier, urging improvements to reimbursement for new drug insurance. NMOSD treatments are gradually receiving reimbursement and expanded criteria. The scope of reimbursement for Roche Korea's Enspryngg (satralizumab), listed for reimbursement in 2023, was expanded in August this year after the symptom relapse criteria had been eased. Uplizna (inebilizumab) recently received conditional reimbursement decision from the Drug Reimbursement Evaluation Committee (DREC) on the 2nd and is awaiting drug price negotiation. AstraZeneca Korea's Soliris (eculizumab) has been covered by reimbursement since April of last year, and Ultomiris (ravulizumab) added the NMOSD indication in July last year but is not yet covered by reimbursement. While access to pharmaceuticals is gradually improving with expanded reimbursement coverage, there are ongoing demands to relax the stringent criteria associated with expensive orphan drugs. In August, a caregiver of an NMOSD patient had requested a lowering of reimbursement hurdles, such as the relapse criteria, through a National Assembly petition. Rep. Seo Mi-hwa of the Democratic Party last month also pointed out the unreasonableness of the new drug reimbursement criteria being conditional on relapse and being preconditioned. Furthermore, there were several arguments that accessibility must be increased for drugs that could prevent relapse. The reimbursement criteria are based on symptom relapse for Enspryngg and Soliris and they also include a conditional clause requiring the administration of MabThera (rituximab) with reimbursement. Since Rep. Seo has requested a NMOSD patient as a testifier for the upcoming parliamentary inspection, more attention is likely to be paid to requests for expanded reimbursement and criteria improvement. Strengthening access to orphan drugs is a key issue that has frequently been raised during the Health and Welfare Committee's parliamentary inspection. Following last year's criticism of the low prio-approval rate for Soliris, the prior-review criteria for its use in Atypical Hemolytic Uremic Syndrome (AHUS) were improved this month.
- Policy
- Ozempic nears reimb approval…next is Mounjaro
- by Jung, Heung-Jun Oct 13, 2025 06:02am
- With Novo Nordisk’s GLP-1 injectable Ozempic (semaglutide) deemed adequate for reimbursement for diabetes, attention is now turning to whether Eli Lilly’s Mounjaro (tirzepatide) will be reviewed next by the Health Insurance Review and Assessment Service (HIRA). At the same time, voices are growing in favor of extending insurance coverage—at least partially—to high-risk obesity treatment, based on body mass index (BMI) criteria. On the 2nd, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee recognized the appropriateness of coverage for Ozempic 2mg/1.5mL and 4mg/3mL, used for diabetes patients. Following price negotiations, the final listing procedure will be complete.. Lilly Korea’s Mounjaro, which was being prepared for reimbursement evaluation simultaneously with Ozempic, was not included in the list of drugs submitted to DREC this time. However, Lilly has reportedly been actively pursuing reimbursement for Mounjaro as a diabetes treatment since before its launch, submitting supplementary data. The key question is whether Mounjaro will be submitted to the next DREC meeting while Ozempic undergoes the price negotiation process. Apart from the push for the drugs’ reimbursement as a diabetes treatment, calls for the drugs’ reimbursement as an obesity treatment continue. A reimbursement plan limited to high-risk obesity treatment was mentioned in review materials on GLP-1 reimbursement that Representative Mi-hwa Seo of the Democratic Party of Korea received from the National Assembly Research Service. The review contained an opinion suggesting restricting the target population to patients with severe obesity and those at risk of complications. Furthermore, Representative Seo emphasized the need for public support, citing the higher obesity incidence rate among low-income groups compared to higher-income groups. The Korean Society for the Study of Obesity is also pushing for coverage. At a symposium on health insurance policies for obesity management last September, the society proposed a tiered coverage system based on BMI. Their stance is to prioritize improving treatment access for severe obesity, not cosmetic concerns. However, opinions on introducing coverage remain divided, citing concerns about misuse of obesity drugs and the current state of Korea’s health insurance finances. Furthermore, even if a phased coverage approach based on severity is implemented, challenges remain, including establishing appropriate criteria.
- Policy
- 'Low-price purchase incentive ineffective and detrimental'
- by Lee, Jeong-Hwan Oct 10, 2025 06:05am
- Rep. Joo-young Lee There is growing criticism that the government’s low-price drug purchase incentive policy should be overhauled due to its structural contradictions and low effectiveness. The low-price purchase incentive, which is linked to the market-based actual transaction price reduction system, focuses on price rather than quality. From the pharmaceutical companies’ perspective, the lower the actual transaction price (purchase price), the higher the likelihood of a price cut, rendering it difficult for them to actively participate in the policy. Some critics have also raised concerns that the system could be exploited for illegal drug rebate practices, calling for a review of whether it should be fundamentally reformed or even abolished. On the 3rd, Rep. Joo-young Lee of the Reform Party, who is also a member of the National Assembly’s Health and Welfare Committee, said, “The low-price purchase incentive system was designed to enhance the financial soundness of the national health insurance and reduce patient drug costs, but it has become an outdated policy that no one welcomes anymore.” Rep. Lee emphasized that if the government wants to establish a reasonable drug pricing system that both strengthens the pharmaceutical industry and ensures the stability of health insurance finances, it must first abolish policies that do not function in the actual healthcare field, such as low-price purchasing incentives. Under Article 22 of the Enforcement Decree of the National Health Insurance Act, the Health Insurance Review and Assessment Service (HIRA) currently operates the incentive system that pays medical institutions (hospitals, clinics, and pharmacies) 70% of the difference between the reimbursement ceiling price and the actual purchase price when they buy drugs of the same ingredient, dosage, and formulation at a lower price than the insurance ceiling. The program aims to reduce national health insurance expenditures, expand the use of generic drugs, curb excessive use of high-priced medications, and lower patient out-of-pocket costs. It has been in effect since 2010. However, Korean pharmaceutical companies and wholesalers argue that the system has failed to achieve these goals and contains inherent contradictions. They have consistently demanded major reforms or the abolition of the policy. Rep. Lee saw eye to eye on these concerns, urging the government to make substantive policy changes. At the industry level, critics argue that low-price purchasing incentives risk promoting an industry structure that prioritizes price over quality. This is because such incentives reward companies based on how cheaply they can procure drugs, rather than rewarding them for the quality of the drugs themselves. As long as the government maintains a policy that rewards cheaper supply, manufacturers will be incentivized to cut production costs and quality to produce low-cost drugs, sustaining a downward spiral in the market. The pharmaceutical industry and drug wholesalers argue that the low-price purchase incentive system inherently contains a contradiction, as it links incentives to reductions in actual transaction drug prices. They point out that the lower the actual transaction drug price becomes to qualify for the low-price purchase incentive, the greater the likelihood it will later be targeted for price reduction. Consequently, no one is willing to trade at lower drug prices. Healthcare institutions have long pointed out that for small and medium-sized hospitals, neighborhood clinics, and pharmacies—not large tertiary hospitals—the actual volume of low-price purchases is too small, resulting in a low perceived incentive effect. Critics note that over 80% of incentives are concentrated in large tertiary hospitals and mid-sized facilities, often benefiting institutions engaging in “one-won bidding” practices. Rep. Lee stated, “Both the low-price purchase incentive and the actual transaction price reduction systems are built on a price-based structure, not on generic drug quality. They contradict the government’s stated goal of fostering the pharmaceutical industry as a national growth engine and supporting global expansion.” Lee also warned of potential abuse of the system through illegal rebates or manipulation of prescription volumes to maintain sales of specific drugs. Rep. Lee concluded, “If the system has neither achieved its original goal of reducing health insurance expenditures nor contributed to the development of the pharmaceutical industry, the government should not leave it as is. Rather, the government should actively consider abolishing it. There is no reason to maintain a policy that no one supports and that only invites calls for reform or repeal.”
- Policy
- GLP-1 drug Ozempic passes reimbursement review
- by Jung, Heung-Jun Oct 10, 2025 06:05am
- Novo Nordisk’s GLP-1 receptor agonist Ozempic (semaglutide) has passed review by the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee, which acknowledged the drug as adequate for reimbursement. Ozempic contains the same active ingredient as the obesity drug Wegovy, but is indicated for diabetes. Meanwhile, the reimbursement scope for Janssen Korea’s prostate cancer drug Erleada (apalutamide) will be expanded. In addition to the existing indication of “metastatic hormone-sensitive prostate cancer (mHSPC),” the new coverage will include treatment for “high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).” On October 2, HIRA held its 10th Drug Reimbursement Evaluation Committee meeting of 2025 to review applications for new drug reimbursement and expanded indications for drugs under risk-sharing agreements. Three drugs - Novo Nordisk’s Ozempic pre-filled pen (semaglutide 2 mg/1.5 mL, 4 mg/3 mL); Shinpoong Pharm’s Hyalflex Inj (hexamethylenediamine dihydrochloride bridged sodium hyaluronic acid gel) for knee osteoarthritis; and Mitsubishi Tanabe Pharma Korea’s Uplizna Inj (inebilizumab) for neuromyelitis optica spectrum disorder (NMOSD) – were reviewed. Ozempic was recognized as adequate for reimbursement “as an adjunct to diet and exercise for adults with type 2 diabetes inadequately controlled by existing therapies (in combination with other antidiabetic agents).” This marks the second time the drug has cleared reimbursement evaluation since 2023. While the first approval included a condition to accept a price below the assessed value, this latest decision carries no such condition. Novo Nordisk reportedly made substantial efforts by submitting supplementary data to HIRA for reimbursement and will now proceed to price negotiations with the National Health Insurance Service (NHIS). Uplizna was recognized as adequate for conditional reimbursement – allowed reimbursement when the company accepts a price below the assessed value—for treating “adult patients positive for anti-aquaporin-4 (AQP4) antibodies with neuromyelitis optica spectrum disorder.” The final listing will follow after the company completes price negotiations with the NHIS. Erleada’s reimbursement will expand to include “high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).” The drug has been reimbursed since April 2023 for “metastatic hormone-sensitive prostate cancer (mHSPC).”
- Policy
- "Why are pharma developing salt changes called innovative?"
- by Lee, Jeong-Hwan Oct 01, 2025 06:10am
- Professor Yong Jin Kwon "There are no developed countries that provide public funds and National Health Insurance resources to pharmaceutical companies for simply changing salt formation. South Korea is the only country in the world that recognizes incrementally modified drugs as having the value of innovative new drugs. (If we want to call incrementally modified drugs innovative new drugs), The government should establish the concept of a super-innovative new drug and allocate funds to companies that develop truly innovative treatments. The National Health Insurance authorities shouldn't be worrying about Korean pharmaceutical companies; they should be preparing to spend hundreds of millions, or billions, of KRW from the NHI budget when a genuine domestic innovative treatment is developed." Criticism calls for a major shift in perspective among domestic pharmaceutical companies in Korea, the Ministry of Health and Welfare (MOHW), and the National Health Insurance Service (NHIS) to foster the Korean pharmaceutical industry and develop new domestic drugs into global blockbusters. The argument is that to produce domestic new drugs that meet the standards of the global market, the NHI authorities must establish an environment that invests limited national budgets and NHI funds into genuine new drugs, rather than salt-changed, incrementally modified drugs. Pharmaceutical companies must step up their investments in New Drug Research and Development (R&D). Immediately after the parliamentary forum, held on September 26, on improving NHI financial management, Professor Yong Jin Kwon of the Public Healthcare Center at Seoul National University Hospital met with DailyPharm and sharply criticized the government's new drug administration and the R&D direction of domestic pharmaceutical companies. Professor Kwon asserted that the current innovative new drug support policy of the Korean government is fundamentally flawed. He pointed out that Korea is the only country in the world to support these efforts with national budgets and NHI funds, recognizing the value of incrementally modified drugs based on salt changes. Professor Kwon emphasized that the Korean pharmaceutical industry must deeply reflect on the fact that it has grown significantly over the past 25 years, driven mainly by public health insurance premiums, yet failed to produce innovative new drugs during that period. "I believe that the presidential pledge for a drug price premium based on innovative new drug value is someone's lobbying work," Professor Kwon stated. "We need to have a conversation with the public about whether there is any developed country that gives NHI funds to companies that just change salt formation. I don't think (the domestic pharmaceutical industry) should be operating this way." He further pointed out, "Twenty-five years ago, when the National Health Insurance Act was introduced and the separation of prescribing and dispensing was implemented, domestic pharmaceutical companies made enormous net profits, eliminating all their debt until generic prices were cut in 2013." He criticized, "That's why structural reform of the pharmaceutical industry failed. There are no studies on how much of the R&D funding provided to pharmaceutical companies, which includes high generic drug prices paid by the public and government support from the MFDS, actually led to tangible results, and no one is looking into it." Professor Kwon said, "The R&D support budget for pharmaceutical companies is public tax money and insurance premiums. So, how much has the domestic pharmaceutical industry truly developed over the past 25 years?" He added, "We need to evaluate this before talking about developing the pharmaceutical industry. The NHIS shouldn't be worrying about domestic pharmaceutical companies. The NHIS should be pushing them to create proper rare disease drugs (new drugs)." Professor Kwon also proposed improving the financial soundness of the NHI by rationalizing the prices of generic drugs. It is to lower generic drug prices to an appropriate level relative to the original price and use the saved resources to support and expand investment in innovative drug development. Specifically, Professor Kwon suggested unilaterally reducing generic drug prices, which currently account for 53.55% of the original drug price, to a level of 30% to 40%, and mitigating the market shock through phased adjustments. It is believed that this redistribution of NHI finances could expand investment in innovative new drugs by two to three times without increasing the total medical expenditure. Professor Kwon said, "I strongly disagree with the NHIS's remark that we should reconsider the structural reform (reduction) of generic drug prices. The NHIS is the public's agent. If they look into where the public's NHI money has been wasted, I absolutely want to tell them that this is not the time to worry about domestic pharmaceutical companies," he asserted. "The Korean government and pharmaceutical companies must raise the competitiveness of the domestic pharmaceutical industry and be prepared to spend hundreds of millions, or billions, of KRW from the NHI budget when an innovative new drug is developed." Finally, Professor Kwon said, "How long will we continue to out-license all our new drug candidates and then have to slash prices when we bring them back from overseas markets? We are a developed country now." He added, "(The government) should improve the system by modifying the current actual transaction price reimbursement system and introducing a dual pricing system so that our new drugs can command high prices when exported to foreign markets."
- Policy
- First lot of returning nasal spray flu vaccine approved
- by Lee, Tak-Sun Sep 30, 2025 06:12am
- FluMist labelThe nasal spray flu vaccine ‘FluMist Intranasal Spray (AstraZeneca Korea)’ has received shipment approval from the Ministry of Food and Drug Safety (MFDS) and is preparing for sales. This product was previously sold by GC Biopharma, but it did not gain significant popularity at the time. With expected demand from children who dislike injections, attention is on whether it will avoid repeating its past failure. On the 26th, the Ministry of Food and Drug Safety granted shipment approval for FluMist Intranasal Spray (live attenuated influenza vaccine), lot number YK2763C (expiration date January 8, 2026). This is the first shipment approval since it was licensed in April this year, signaling the start of full-scale supply ahead of the flu season. FluMist Intranasal Spray is a trivalent vaccine preventing three viruses (influenza A H1N1, H3N2, and influenza B Victoria). It can be administered to children and adults aged 24 months to 49 years. Safety has not been established for children under 24 months. For those aged 50 and older, administration is prohibited in high-risk groups with underlying conditions, as the incidence of pharyngitis was higher compared to placebo. Nevertheless, this vaccine is gaining attention because it offers convenience in administration, particularly for children who dislike injections. This vaccine is a spray product that delivers the solution into the nose, which is expected to improve acceptability among children and make administration easier for providers. At a press conference celebrating the vaccine’s approval in June, Professor Yoon-Kyung Kim (Pediatrics, Korea University Ansan Hospital) said, “FluMist is a painless vaccine delivered by nasal spray that can contribute to increasing flu inoculation rate among children.” However, as it is not included in the National Immunization Program (NIP), demand is expected to fluctuate depending on pricing. When GC Biopharma launched the product in 2009, demand was low because it cost KRW 5,000–10,000 more than injectable vaccines. As a result, its license was revoked in July 2020 after the validity period expired. Another barrier is that intranasal vaccines are not yet familiar to the public, which could also affect uptake. Still, expectations remain that it could raise pediatric flu vaccination rates and contribute to herd immunity, thereby protecting the elderly from infection. A pharmaceutical industry official said, “Ultimately, pricing will impact sales volume. But unlike in the past, there is now demand for non-reimbursed vaccines that emphasize quality, so if the price gap is small, FluMist could gain a foothold in the market.”
- Policy
- MFDS, GLP-1 obesity drug + diabetes med combo hypoglycemia↑
- by Lee, Tak-Sun Sep 30, 2025 06:11am
- GLP-1 obesity drugs Wegovy(left) and Mounjaro.The Ministry of Food and Drug Safety (MFDS) announced that patients with diabetes using GLP-1 obesity treatments, which have recently become popular, must consult with their healthcare provider, as the co-administration of these drugs with diabetes medication significantly increases the risk of hypoglycemia. The MFDS also stressed that the use of obesity treatments must be avoided during pregnancy and lactation. Popular GLP-1 obesity drug brands include 'Wegovy' and 'Mounjaro.' The MFDS (Minister Yu-Kyoung Oh) and the Korea Institute of Drug Safety and Risk Management (KIDS)(President Soojung Sohn) announced on September 29 that they have distributed a 'Guidelines to Safe Use of GLP-1 Obesity Treatments' to regional medical associations and drug safety centers nationwide. This guide contains information on ▲the diseases for which the obesity treatments are used ▲correct administration methods, storage and disposal ▲precautions for use ▲reporting of adverse reactions (side effects). GLP-1 obesity treatments are prescription drugs prescribed to: obese patients with an initial Body Mass Index (BMI) of 30kg/m2 or higher, or overweight patients with a BMI of 27kg/m2 to less than 30kg/m2 who have one or more weight-related comorbidities. The MFDS emphasized that patients taking diabetes medication who are also taking GLP-1 obesity treatments are at a higher risk of hypoglycemia and should consult with their healthcare provider about whether to adjust drug dosages. They also added that the use of obesity treatments is prohibited during pregnancy and lactation, and it is advisable to plan pregnancy considering the drug's residual period in the body. Depending on the specific obesity treatment, contraception may be necessary for at least 1-2 months after discontinuing the medication. Obesity treatments should not be started at a high dose immediately. Instead, patients should initiate treatment with the dose specified by their physician, according to the approved regimen, and gradually increase it, strictly adhering to the dosage and administration instructions provided by both the physician and pharmacist. When administering the obesity treatment, patients should inject into the abdomen, thigh, or upper arm, whichever site is most convenient, and rotate the injection site with each dose. Patients must inform their healthcare professional before administration about ▲any known drug hypersensitivity ▲all currently administered medications, medical history ▲whether they are pregnant or breastfeeding. Additionally, obesity treatments should be stored in the refrigerator away from light. If the medication is frozen, contains particles, or has changed color, it should not be used and must be disposed of. The MFDS stressed that even when GLP-1 obesity treatments are used within the approved scope, adverse events such as gastrointestinal disorders, injection site reactions, fatigue, and dizziness can commonly occur. More clinically significant adverse events, such as hypersensitivity reactions, acute pancreatitis, cholelithiasis, and cholecystitis, may also occur. In such cases, patients should notify their healthcare team or visit the hospital. The MFDS stated that GLP-1 obesity treatments, as prescription drugs, must be used strictly following a physician's prescription and a pharmacist's dispensing and guidance, ensuring safe use within the authorized indications for obesity treatment. It was also stressed that purchasing or distributing these drugs through overseas direct purchases or person-to-person sales online should be avoided, as the product's safety cannot be guaranteed. An MFDS official said, "We hope this guide helps patients using GLP-1 obesity treatments to administer their medication safely." The educational material is available on the MFDS website (www.mfds.go.kr) → Law/Data → Promotional Materials → General Promotional Materials section, on the KIDS website (www.drugsafe.or.kr) → Education/Promotion → Resources section.
