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- 2025-12-18 05:17:18
- Opinion
- [Reporter’s View] Time to verify K-radiopharmaceuticals
- by Son, Hyung Min Jul 10, 2025 06:09am
- Radiopharmaceuticals are special preparations that combine drugs with radioactive isotopes for diagnostic or therapeutic use. In particular, radioligand therapy (RLT), which delivers radiation directly to tumor cells, is known for its high precision, being referred to as "moving radiation surgery." As beta particle-based radioligand therapy enters the commercialization stage, the global industry is shifting its focus to alpha particle-based therapies, which offer higher energy, shorter range, and more precise killing power. Leading candidates include actinium-225 and astatine-211. These agents, which have a shorter range and higher linear energy transfer (LET) than the existing beta-particle-based lutetium-177, are gaining attention as next-generation targeted therapies for their ability to precisely target cancer cells while minimizing damage to surrounding tissues. Multinational pharmaceutical companies are also making bold investments. Novartis, which developed Lutathera and Pluvicto, acquired a radioligand therapy developer Mariana Oncology last year. AstraZeneca has begun joint development with Actinium Pharmaceuticals. The United States, Canada, and Europe have already incorporated the development of actinium production and purification infrastructure into their national strategies. In contrast, Korea is still in its early stages. Although the Korea Atomic Energy Research Institute (KAERI) and the Korea Institute of Radiological & Medical Sciences (KIRAMS) have isotope production and some research platforms, vertical integration encompassing isotope purification, labeling technology, ligand design, and clinical development has not yet been achieved. Above all, the connection between hospitals, nuclear power, and pharmaceutical companies remains weak. While platforms exist, they rarely lead to the development of pharmaceuticals. Radiopharmaceuticals for diagnostic use have been commercialized, but the development of therapeutic agents is still lagging behind. Nevertheless, companies in Korea have also begun to explore this field. Currently, Cellbion is completing Phase II clinical trials for prostate cancer and is expected to apply for approval. They expect therapeutic effects comparable to or better than those of the already commercialized Pluvicto. FutureChem has completed a Phase II clinical trial for prostate cancer and plans to proceed with Phase III trials. The company plans to apply for conditional approval as soon as it receives authorization for the Phase 3 Investigational New Drug (IND) application. In this sense, the rumored development of K-radiopharmaceuticals is finally beginning to show some tangible results. However, the companies’ pipelines still have gaps in key technological elements such as target protein design, clinical strategy, and formulation optimization compared to global standards. Therefore, structural government support is necessary to secure independent competitiveness. Radiopharmaceuticals are a complex technology with a high barrier to development. However, as the entry barriers become extremely high, some experts believe that successful localization could enable market dominance even beyond that of antibody-drug conjugates (ADCs) once a company enters the field. The solution for domestic production of radiopharmaceuticals lies not in isolated technologies but in “strategic integration.” It is now time to establish a “Korean RLT Alliance” that encompasses everything from target proteins to hospital networks, clinical design, and isotope supply. Otherwise, domestically produced radiopharmaceuticals will remain mere objects of technology transfer rather than becoming market leaders.
- Opinion
- [Reporter's View] The revision of the Commercial Act
- by Kim, Jin-Gu Jul 09, 2025 06:08am
- The bill on revising the Commercial Act has passed the National Assembly. The bill expands the fiduciary duty of directors to include not only the “company” but also “shareholders,” mandates the introduction of electronic shareholder meetings for listed companies with assets of KRW 2 trillion or more, and changes the title of “outside directors” to “independent directors.” The bill also includes a provision limiting the voting rights of the largest shareholder and related parties to 3% when appointing audit committee members. The pharmaceutical and biotechnology industry has been keenly eyeing the change. This is because many companies in the industry have traditionally been owner-managed. Owner-managed companies have the advantage of being able to make quick decisions and establish long-term strategies. Nevertheless, the absence of proper oversight mechanisms has often led to abuses such as unilateral decision-making and the pursuit of private interests. In fact, there are countless cases where internal transactions with special-related companies controlled by the owner's family are approved by the board of directors without any significant opposition. Many companies have not paid dividends for several years while the owners' compensation increases every year. The second and third generations of owners are appointed to key positions without any verification of their expertise, but the board of directors, which should serve as a check on them, fails to fulfill its role. Even when facing major business decisions such as changes in clinical strategies or whether to apply for approvals, management often unilaterally sets the direction without prior explanation or communication with shareholders. There have also been repeated controversies where clinical results are intentionally delayed or distorted information is leaked to boost stock prices, followed by the sale of shares held by owners or management at that time. These structural limitations are also evident in ESG evaluations. Pharmaceutical and biotech companies have consistently received lower ratings in the governance (G) category compared to the environmental (E) and social (S) categories. This is because the board of directors has lost its oversight function, and internal audits are often conducted merely as a formality. In the process of repeated closed and arbitrary decisions being made, general shareholders are pushed out of the decision-making structure. Such closed decision-making increases the risk of business failure, and its impact is not limited to the losses of the company concerned. It also leads to losses for investors, a decline in overall market confidence, increased risks for partner companies, and ultimately impose a burden on patients waiting for new drugs. The recent revision of the Commercial Act addresses these issues. The revision aims to expand the scope of directors' duties to include shareholders, clarify the status of independent directors, and strengthen shareholder participation through electronic shareholder meetings. Although issues such as cumulative voting and mandatory separation of audit committee elections remain as future tasks, the revision is analyzed as providing a clear direction for frontline companies. The pharmaceutical and biotechnology industry must now recognize shareholder oversight and participation not as a “burden” but as a “responsibility.” Owner-centric quick decision-making is not always the right choice. Especially in industries like new drug development, which require extensive time and resources, the initial direction of decision-making can determine success or failure. A governance structure with checks and balances and transparency is the only way to minimize the costs of failure. In the realm of corporate decision-making, direction is more important than speed. Though change is often uncomfortable, it is essential — and the pharmaceutical and biopharmaceutical sectors are no exception.
- Opinion
- [Reporter’s View] NHI finances and reimb expansions
- by Lee, Jeong-Hwan Jul 04, 2025 06:06am
- Striking a balance between improving the financial sustainability of the national health insurance system and enhancing patient access to drugs for rare and intractable diseases is a national issue. The two issues that repeatedly come into conflict have long occupied the attention of all political parties in their search for solutions, yet a clear and definitive answer has remained elusive. With ample finances, there would be no need to agonize over finding concrete solutions. The problem is that the surplus funds available for drug expenses within the health insurance budget are becoming increasingly scarce. The global paradigm for new drugs is rapidly shifting from chemical drugs to biopharmaceuticals. Global big pharmas are focusing on developing ultra-high-priced one-shot treatments for severe and intractable diseases for which there are no effective drugs, and the number of biopharmaceuticals approved in Korea is increasing accordingly. This in turn is increasing the health insurance authorities' concerns. There are an increasing number of cases where expensive drugs with therapeutic effects proven through clinical trials are being developed, but there are insufficient financial resources to ensure patient access to each and every drug that emerges with health insurance coverage. Another issue is that the entry of ultra-high-priced drugs for severe and intractable diseases developed by global big pharmas into the Korean market poses an unintended threat to domestic pharmaceutical companies. In order to increase reimbursement for ultra-high-priced drugs within the limited national health insurance budget, the easiest measure is to reduce the insurance ceiling price (drug price) of existing drugs to create financial leeway. This means that the prices of drugs manufactured by most domestic pharmaceutical companies that maintain their business with generic drugs are likely to fall. Drug price experts often describe the repeated administrative practice of lowering prices of already approved drugs to fund high-cost drugs as a zero-sum game. This expression metaphorically describes the reality of having to balance two conflicting priorities: expanding treatment opportunities for patients with severe and rare diseases while also supporting the domestic pharmaceutical industry, both of which are inextricably linked to the limited national budget. As such, the new administration is tasked with the challenge of reducing or eliminating the conflict zone between two zero-sum goals: “enhancing the sustainability of the national health insurance finances” and “improving access to new drugs.” Among the many ways to solve this problem, this reporter has two suggestions for the new administration based on the opinions of drug price experts. First, I ask the government to take the courage to pursue a new agreement on the allocation of health insurance drug expenses and consider the establishment of a separate fund for severe and intractable diseases, targeting high-cost drugs, as an additional funding source. This means reducing health insurance drug costs for mild diseases (by increasing patient copayments) and launching a process to gather opinions and reach a consensus across society and the public on expanding reimbursement for severe diseases, while at the same time securing additional financial resources with the mission of improving access to high-cost drugs. Both are expected to face significant challenges in implementation, but given the recurring zero-sum nature of the issue, it is an issue that cannot be ignored any longer. President Lee Jae-myung has repeatedly pledged to design a true Korea. We hope that the process of deriving a social consensus on a genuine health insurance policy aligned with the principles and philosophy of the National Health Insurance System will take its first steps in tandem with the design of a true Korea.
- Opinion
- [Reporter’s View] Doctors agree Korea’s reimb is too slow
- by Eo, Yun-Ho Jul 02, 2025 06:09am
- Even prescribing physicians believe that the pace of new drug reimbursement listing in Korea is too slow. This is an issue not only for doctors or patients, but obviously for pharmaceutical companies as well. Recently, the Korean Research-based Pharmaceutical Industry Association (KRPIA) released the results of a survey of 100 medical professionals in Korea. In January, a global polling agency Ipsos Research surveyed domestic clinical experts from various medical departments to ask their opinions on access to new drugs in Korea. According to the survey results, all medical professionals unanimously answered that the period required for MFDS approval to health insurance coverage is “long,” with 74% stating it is “too long.” Regarding the appropriate period from approval to health insurance coverage, 81% of medical professionals answered “up to 10 months,” with 41% deeming “within 6 months” as appropriate. As of 2022, it took an average of 608 days (approximately 20 months) for innovative new drugs to be approved by the MFDS and listed for health insurance reimbursement in Korea. This is twice the appropriate period (10 months) cited by most medical professionals and significantly longer than what is required for other major countries such as Germany (281 days), Japan (301 days), and France (311 days). Furthermore, experts who directly treat patients on-site responded that the widespread introduction of innovative new drugs would be of practical help in treating patients. Eighty-three percent of medical professionals expected that “if drugs already in common use overseas are covered by health insurance in Korea, patient treatment outcomes will improve significantly.” A large proportion of medical professionals (85%) also responded that “if reimbursement criteria are relaxed to enable early or wider scope of use, even for drugs already covered by health insurance, this will significantly improve patient treatment outcomes.” In addition, 95% of medical professionals urged the MOHW to introduce a “fast-track listing procedure or system” for health insurance coverage, similar to the MFDS's Global Innovate Products on Fast Track (GIFT) system, which shortens the drug approval review period for severe or life-threatening diseases by up to 75%. Medical professionals who participated in the survey also expressed concerns about Korea's low access to new drugs. Ninety-four percent pointed out that “access to new drugs in Korea is lower than overseas,” and 97% answered that “the government must set appropriate and reasonable drug prices to prevent the ‘Korea Passing’ phenomenon, where multinational pharmaceutical companies abandon the launch of innovative new drugs due to domestic regulations on pharmaceuticals.” Although this is a recurring issue, the criticism carries more weight as it comes from the front lines of medical care. Of course, the government is not without effort. Every year, health authorities introduce various systems to improve the speed of drug listing. The “parallel approval-evaluation-negotiation pilot project” is already in its second phase. In addition, the deadlines for regulations of drugs that go through the general listing process are being shortened in general, in both the evaluation and negotiation stages of the Health Insurance Review and Assessment Service and the National Health Insurance Service. However, whether the process is really speeding up remains in question. The problem lies in the process of enforcing regulations. No matter how well the system supports prompt reimbursement of drugs, there are always factors that can cause delays. Ultimately, patients are the ones left to suffer. They are left to wait anxiously, without a clue about what will happen next. Measures to shorten the process of listing drugs for insurance reimbursement must be accompanied by greater transparency and disclosure.
- Opinion
- [Reporter's View] Divisional restructuring needed
- by Lee, Hye-Kyung Jun 30, 2025 06:06am
- During his candidacy, President Lee Jae-myung pledged to designate the biotech industry as a cutting-edge sector and build it as the future growth engine, aiming to position South Korea as one of the world's five strongest biotech countries. Based on an analysis that the previous government was short on investment in the pharmaceutical and biotech industry, President Lee will likely plan to implement policies geared at establishing special funds and fostering talents with expertise to strengthen national investment and responsibility in the pharmaceutical and biotech industry. Firstly, there will be expanded support at the R&D center, focusing on venture technologies. To achieve this, regulatory support is crucial. To set a goal of becoming a strong biotech country, aggressive R&D must be pursued. Additionally, supporting measures for venture firms with less regulatory experience are also necessary. Celltrion, for instance, which successfully overtook the No. 1 place in exporting biopharmaceuticals in South Korea, was established in 2002 as a biotech venture company. Therefore, when aggressive R&D takes place, there will be more venture firms with fewer years of regulatory experience that will robustly grow. The problem lies in whether the Ministry of Food and Drug Safety (MFDS), which is responsible for providing regulatory support to make South Korea one of the top five global biotech powerhouses, can properly fulfill its role. In particular, the division responsible for pharmaceutical approvals is operating as a temporary task force (TF), with a fixed staff of only seven people managing all approval-related tasks for biopharmaceuticals, Korean traditional medicines (han-yak), and quasi-drugs. Although the current government has promised active investment in biotech, it remains uncertain to determine how much will be allocated for pre-registration or applications for new drug approval. Furthermore, the government implemented an innovative measure to shorten the new drug approval duration from 420 to 295 days this year, which also includes biopharmaceuticals. According to the number of approved new drugs by year, the number of chemical medicines decreased from 29 in 2023 to 11 in 2024. In contrast, the number of biopharmaceuticals increased during the same period, from 8 to 12 cases. For biopharmaceuticals, which are often high-priced, cutting-edge therapies for rare·intractable diseases or cancers with significant medical demand, the approval process is complex. If the approval division isn't functioning properly, it becomes challenging to ensure swift internal and external communication or make highly reliable decisions based on scientific·legal reviews. Related to this, it's puzzling why the Pharmaceutical Approval Management Division remains a task force (TF). This bio approval TF was established in May 2024 when the Vice Minister's direct reporting divisions for overall approval management and advanced product approval were reorganized and redistributed across three bureaus: Pharmaceutical Safety Bureau, Biopharmaceuticals and Herbal Medicines Bureau, and Medical Device Safety Bureau, to strengthen the linkage between medical product approvals and policy. While this reorganization converted two existing divisions into three, resulting in 'Approval Divisions' for pharmaceuticals and medical devices, only bio approvals were structured as a "team"-based TF. Reportedly, MFDS faced limitations in creating new official divisions under its organizational regulations, leading to the establishment of permanent divisions for pharmaceuticals and medical devices, which handle a relatively higher volume of public complaints and regulatory support). Yet, it's difficult to comprehend. At the same time, the bio-related function was set up as a temporary task force. This is particularly difficult to understand given that becoming a biotech powerhouse has been a national priority since the previous administration, and it's a commitment significant enough to be a presidential pledge in the current government. The Pharmaceutical Approval Management Division serves as the manager for the entire approval process and acts as a communication channel between external stakeholders and the MFDS. Operating as a temporary organization with only seven full-time staff means that even the absence of a single employee can jeopardize the swift processing of applications and approvals. If the approval department doesn't function properly, it becomes difficult to ensure quick internal and external communication or make reliable decisions based on scientific and legal reviews. While the current proportion of pharmaceuticals in the overall medical product industry in South Korea may still be low, there's significant potential for further growth, depending on the role of the President Lee government. To accelerate the commercialization of domestically developed biopharmaceuticals and secure a leading global position, the MFDS will likely need to reorganize its structure to provide proactive regulatory support.
- Opinion
- [Reporter's View] For local gov't seeking biotech diplomacy
- by Whang, byung-woo Jun 30, 2025 06:05am
- 'BIO USA,' held in Boston, U.S., is the world's largest biotech industry conference. Notably, this year's conference was attended by officials from Korea's local government. The attending officials aimed to promote local biotech clusters and seek potential investment partners. Through this event, they intended to establish a gamer-changer to their regional growth. However, some industry officials showed both anticipation and concern. Korean local governments attending this year's BIO USA strived to meditate on biotech diplomacy. For instance, Nowon District of Seoul hosted a press conference near the event location and presented plans for 'Seoul-Digital Bio City (S-DBC).' Currently, Nowon District is reportedly discussing investment opportunities with two biotech companies in South Korea to build a biotech cluster in Chong-dong Training Depot. Daejeon City, as a key bio-cluster holding local government, also sought technology transfer and joint research partnerships through MOU signings with overseas research institutions and IR events targeting investors. Furthermore, Siheung City, Gyeonggi Province, which is promoting a biotech-cluster through an investment agreement of approximately KRW 2.2 trillion with Chong Kun Dang, also visited the event. Although the enthusiasm of these local governments was evident, accomplishments have not yet been achieved. Some local governments have only just begun their steps into the pharmaceutical and bio-industry, so news of significant investment attraction or contract signings is scarce. An industry official pointed out, "While local government's interest and investment in the bio-industry are welcome. However, if the focus is solely on trying without deliveries, it will ultimately be judged as mere showmanship." Ultimately, if local governments' overseas efforts do not lead to effective investment exchanges, they may not yield tangible results despite significant time and budget expenditure. While various local governments view the pharmaceutical and biotech industries as a future growth engine and actively engage with them, not all have a favorable view. This is partly because there are precedents of bio-clusters located across the country. Currently, there are between 20-30 large and small bio-specialized complexes established in Korea, but questions remain about whether all these clusters are functioning. Recently, the focus has shifted to improving efficiency and enhancing the competitiveness of existing bio-clusters instead of merely creating new ones. Local governments also view that it's necessary to clarify their position and strengths within this larger picture, and strive to build complementary ecosystems by avoiding redundant investment or competition. The choice of local governments to invest in the biotech industry, seeing it as a key opportunity for job creation, is not necessarily deserving of criticism. However, there are negative view regarding the aspirations of some local governments to attract global big pharma's offices and R&D centers. A biotech industry official advised, "Ultimately, to attract global big pharma, clusters in South Korea must grow to a level that makes them desirable. It's not a problem that can be solved by local governments merely providing buildings and land. They must create a self-sustaining ecosystem where excellent research personnel and companies gather." Ultimately, proper direction and cooperation are needed. For the local government's efforts in Boston to yield tangible results rather than empty echoes, industry stakeholders and policymakers need to work as a unified team, drawing a larger picture, rather than pursuing individual goals, self-serving efforts by the central government, local governments, and private companies.
- Opinion
- [Reporter's View] Silent efforts pay off in the market
- by Son, Hyung Min Jun 25, 2025 06:02am
- In the first half of this year, South Korean pharmaceutical and biotech companies achieved notable success through technology exports. A series of major licensing deals were signed based on the companies’ innovative drug development platforms and clinical trial results the companies steadily developed and accumulated over the years. In April, ABL Bio signed a technology licensing agreement with GlaxoSmithKline (GSK) for its blood-brain barrier (BBB) shuttle platform, ‘Grabody-B,’ for the development of new treatments for neurodegenerative diseases. Through this deal, ABL Bio received approximately KRW 73.9 billion as a non-refundable payment. The total contract value is estimated at around KRW 4 trillion. This is ABL Bio's seventh technology export deal. Previously, the company had successfully licensed its technology to major pharmaceutical companies such as Sanofi and Yuhan Corp. Alteogen has transferred its subcutaneous (SC) formulation change platform ‘ALT-B4’ to MedImmune, a subsidiary of AstraZeneca. Alteogen has signed two licensing-out deals with MedImmune's US and UK subsidiaries. The two contracts are worth KRW 65.5 billion, with the total contract value, including milestone achievements, exceeding KRW 2 trillion. Alteogen has also signed licensing deals with leading global pharmaceutical companies such as MSD and Daiichi Sankyo. Through the agreements, the company’s formulation change technology will be applied to major immuno-oncology drugs like Keytruda and the antibody-drug conjugate (ADC) Enhertu. In February, Olix Pharmaceuticals successfully exported its technology for OLX75016, a new drug candidate for obesity and metabolic dysfunction-associated steatohepatitis (MASH), to Eli Lilly. OLX75016 is a MASH and obesity treatment candidate based on siRNA technology, a short double-stranded RNA genetic material that plays a key role in RNA interference. OLX75016 is being developed as a subcutaneous (SC) formulation obesity treatment that can be administered once every three months. The common thread among the three companies lies in their long-standing pursuit of innovative drug development platform technologies. ABL Bio's blood-brain barrier (BBB) shuttle technology, Alteogen’s SC formulation conversion technology for anticancer drugs, and Olix's siRNA platform for obesity treatments are the result of repeated animal studies and early-phase clinical trials—achievements compelling global pharmaceutical companies to initiate deals. The upfront payments alone amount to hundreds of billions of won, with total contract values exceeding the trillion-won mark. These technology export cases are not simple pipeline transactions. It holds significance in that global pharmaceutical companies are knocking on Korean companies’ doors, recognizing the platform itself as a technological asset. Platform technology is not limited to a single substance but can be expanded to the development of multiple candidate substances, which is an option that reduces long-term risk for partner companies. In particular, these achievements are not one-time contracts. They have great potential to lead to subsequent pipeline expansion, joint development, and long-term commercialization partnerships. This demonstrates the power of a ‘technology platform’ that goes beyond simply selling a single technology that enables a future together with partners. Developing a model that can prompt a series of technology exports to multiple partners based on a single platform is the direction that the domestic pharmaceutical and bio industry should seek. It is time to move away from licensing out just a single pipeline and adopt a platform-based approach that has scalability and repeatability. Once again, the recent licensing out deals have shown how technology with ‘sustainability’ and ‘consistency’ rather than those that chase the latest R&D trends will ultimately be chosen by the market. Clinically validated technologies, rather than optimistic projections for investor appeal, are increasingly emerging as the true standard of competitiveness on the global stage.
- Opinion
- [Reporter's View] Telemedicine in a 5-sided tug-of-war
- by Lee, Jeong-Hwan Jun 19, 2025 06:02am
- With the election and inauguration of President Lee Jae-Myung, the Democratic Party of Korea, which successfully changed the administration, submitted a bill to revise the Medical Service Act that narrows the scope of telemedicine’s initial consultation in the current pilot program to the National Assembly. As a result, the eyes of the ruling and opposition parties, public opinion, the health and medical community, and the platform industry are all focused on the bill. Specifically, six key stakeholders — the ruling and opposition parties, the government (Ministry of Health and Welfare), telemedicine users (patients), doctors, pharmacists, and platform companies — are all closely monitoring the Democratic Party’s proposed telemedicine legislation. The biggest issue is the scope and eligibility for initial non-face-to-face medical care stipulated in the bill proposed by Representative Jeon Jin-sook of the Democratic Party of Korea. Rep. Jeon Jin-sook's bill allows minors under 18 and seniors over 65 to apply for telemedicine from the initial consultation, while adults over 18 can only apply for follow-up consultations with telemedicine. This has led to differing arguments among legislative stakeholders. This is why the legislative battle over telemedicine, which erupted once in the 21st National Assembly, is likely to be repeated in the 22nd National Assembly. Two major differences from the 21st National Assembly are that the Democratic Party of Korea, which was the opposition party at the time, has moved onto the ruling party position, and that the number of patients using telemedicine has increased rapidly due to the unrestricted pilot project. In this context, the key stakeholders in the legislation surrounding telemedicine can largely be grouped into five categories: the government, patients, doctors, pharmacists, and platform companies. The National Assembly, which is responsible for reviewing the revision of the Medical Service Act, must gather all the different opinions of these five stakeholders, find common ground, and then persuade and consult with each other on points of disagreement before reaching a consensus between the ruling and opposition parties. The problem is that even before the bill was submitted to the National Assembly for review, the five stakeholders had such different positions that conflict constantly arose. First, the MOHW had to maintain the pilot program for unrestricted telemedicine while holding party-government consultations with the ruling Democratic Party of Korea on the new administration’s plan. During the Yoon Suk-yeol administration, the MOHW took the position that it would utilize the institutionalization of telemedicine as a means to resolve essential and regional medical shortages and promote the health and medical industry. However, the Lee Jae-myung administration is likely to pursue a different policy. The original bill proposed by Representative Jeon Jin-sook aims to conservatively legislate telemedicine as a supplement to face-to-face medical treatment, rather than as a means to promote the health industry. Doctors and pharmacists are both in a symbiotic and adversarial relationship concerning this legislation. While doctors and pharmacists share the same interests in minimizing the scope of telemedicine, they are busy attacking each other over the delivery of prescription drugs, with doctors in favor and pharmacists opposed. For now, doctors and pharmacists are likely to maintain a cooperative stance, opposing telemedicine and prescription drug delivery under the pretext of in-person medical care and in-person dispensing, while also agreeing that intermediary platforms must be prevented from disrupting the healthcare delivery system and pharmacy ecosystem and causing medical institutions and pharmacies to become dependent on platforms. Public opinion is divided regarding the legislation, but there is growing support for allowing telemedicine without restrictions, provided that safety is guaranteed. Patients who have experienced the gradual expansion of telemedicine since February 2020 have grown accustomed to the convenience of telemedicine. If legislation suddenly restricts access to telemedicine services they have been using, it is inevitable that there will be backlash. In particular, public opinion is likely to maintain its stance that the current scope of telemedicine pilot programs should be maintained or minimally reduced, citing reasons such as improving medical access for children and adolescents during late-night hours and enhancing the right to medical care for disabled individuals and the elderly with mobility difficulties. The platform industry is strongly advocating for the institutionalization of telemedicine through a negative list approach and the allowance of prescription drug delivery by courier in the 22nd National Assembly, as it had been during the 21st National Assembly. The argument is that telemedicine should be prohibited only in cases where specific risks have been identified and that telemedicine should be available without age restrictions in all other cases, in order to maintain the platform business that has been in business for 6 years. Ultimately, legislation on telemedicine will be reviewed by the National Assembly amid a five-way conflict of interests between the government, patients, doctors, pharmacists, and platforms. Currently, there are 3 bills (proposed by Rep. Choi Bo-yoon, Rep. Woo Jae-Joon, and Rep. Jeon Jin-sook, in order of proposal) to institutionalize telemedicine, but there is ample room for additional bills reflecting the positions of stakeholders to be proposed in the future. The Democratic Party of Korea, medical associations, and the platform industry are already at odds over the scope of telemedicine for initial consultations. In the 21st National Assembly, telemedicine bills failed to reach a consensus due to differing interests and were not passed. After that, doctors and medical students opposed the increase of 2,000 medical school enrollment quotas and took collective action, and the MOHW has been implementing unrestricted telemedicine under the pretext of alleviating the medical shortage. Some analysts say that the unconditional opposition of doctors to telemedicine and the opposition of pharmacists’ prescription drug delivery created a synergy effect, which led to the blocking of relevant bills. The 22nd National Assembly must not repeat the legislative turmoil experienced by the 21st National Assembly. The institutionalization of telemedicine is a common presidential campaign pledge of both ruling and opposition parties and an unstoppable trend. Unlimited telemedicine without legal grounds cannot be maintained. If legal loopholes are left unaddressed as they are now, it will inevitably create opportunities for illegal and irregular practices to proliferate. This is why the ruling and opposition parties must work together to minimize disagreements among stakeholders and establish legislation that reduces public inconvenience and prevents confusion. It is now time for the sharply divided stakeholders to gather in the National Assembly and engage in intense yet reasonable legislative discussions to achieve the stable domestic implementation of telemedicine.
- Opinion
- [Desk View] Disclosing drug reimb info must be done properly
- by Lee, Tak-Sun Jun 18, 2025 06:00am
- Due to concerns about the non-transparency of the selection process for medicinal product reimbursement, the Health Insurance Review & Assessment Service (HIRA) and the National Health Insurance Service (NHIS) are disclosing partial processes and candidates. HIRA discloses, through press releases, the review results from the Cancer Drug Reimbursement Committee, which discusses reimbursement criteria for anticancer agents, as well as review results from the Drug Reimbursement Evaluation Committee (DREC) regarding new drugs and the expanded usage scope of drugs under a risk-sharing agreement (RSA). NHIS updates the initiation of the negotiation process for drugs that have passed the HIRA review and the agreement status on its website. However, the problem is user-friendliness. Information disclosure is intended for public knowledge in the best interest of patients, yet it does not take the user's perspective into account. For instance, in February, HIRA released press reports of the results from the DREC review on the conditional appropriateness of expanded reimbursement criteria for 'Cabometyx.' According to the detailed report, "The efficacy·effectiveness of Cabometyx 20, 40, 60mg (cabozantinib, Ipsen Korea) are for clear cell renal cell carcinoma (ccRCC). Cabometyx is deemed appropriate for expanded reimbursement scope if Cabometyx's company were to accept a price below the evaluated amount." Cabometyx was initially listed for reimbursement in February 2019 as a 'monotherapy for patients with advanced renal cell carcinoma who had previously received VEGF-targeted therapy.' DREC's press release indicates that this drug, reimbursable for treating advanced renal cell carcinoma, can also be appropriate for reimbursement for treating ccRCC. However, ccRCC is the most common type of advanced renal cell carcinoma. Patients with ccRCC are already eligible for reimbursement, so expanding the reimbursement scope does not make sense. The expanded usage scope for this drug was recently reported following the NHIS's update of its website in May, which included news of ongoing negotiations. The negotiation outcome was 'failed.' However, even here, it's impossible to discern for which indication the negotiations were conducted and subsequently fell through. The NHIS only discloses the success or failure of drug negotiations in an Excel file. According to the HIRA press release, the negotiation for expanded reimbursement coverage could have been for 'ccRCC.' However, as previously mentioned, the scope for 'ccRCC' is broad, and it is already reimbursed. Ultimately, the information disclosed by both agencies makes it impossible to know for what specific indication the reimbursement scope of this drug is being expanded. The pharmaceutical company later confirmed that the drug was undergoing reimbursement expansion for 'treatment not only after VEGF-TKI-based first-line therapy but also after immunotherapy-based first-line therapy (ipilimumab+nivolumab or IO+TKI) in ccRCC.' Before the final indication was confirmed, some public even suspected that the HIRA might have mistakenly used 'clear cell renal cell carcinoma (ccRCC)' instead of 'non-clear cell renal cell carcinoma (nccRCC)' in their press release. This suspicion arose because there's a strong demand within the medical community to extend reimbursement coverage for Cabometyx to patients with nccRCC. The two agencies' unhelpful disclosure of information regarding drug reimbursement isn't limited to this instance. Recently, the NHIS announced the initiation of negotiations for Darzalex solution via a website update. However, simply looking at the website doesn't reveal the nature of these negotiations. Confusion arises because the NHIS lists all drugs, whether they are new drugs, drugs with waived price negotiations, or drugs with expanded usage scope, regardless as subjects for drug price negotiation. One can infer that Darzalex solution is undergoing negotiations for an expanded usage scope, given that this drug was mentioned in the HIRA deliberation results from a press release distributed in May, under the section for review results regarding the appropriateness of expanding the usage scope for RSA drugs. But even this doesn't clarify which indication the usage scope is being expanded for. The press release merely states its efficacy and effect as 'multiple myeloma.' Darzalex solution is a well-known drug used for multiple myeloma. Since several reimbursement criteria for multiple myeloma are already established, it remains unclear for which indication reimbursement is being expanded this time unless one directly asks a HIRA or NHIS official. The consumers of drug reimbursement information are generally patients with relevant diseases who are often in desperate situations. This type of information does not gain widespread public interest. Maybe because of this reason, HIRA's and NHIS's information disclosure is unilateral, unhelpful, and, at times, even irresponsible. It's as if they're implying, "You can figure it out with just this much information?" If information disclosure is initiated due to patient demands, then an extra degree of helpfulness should be added. If HIRA and the NHIS intend to continue providing drug reimbursement information in the future, they must do it properly. HIRA and the NHIS should accurately specify the scope of reimbursement coverage for the target diseases of the respective drugs. We are not asking them to disclose the background of their review outcomes or agreement results. We want them to at least, inform us why a particular drug is undergoing review, evaluation, or negotiation. In the future, we hope that those responsible for disclosing drug reimbursement information will adopt a more responsible approach.
- Opinion
- [Reporter’s View] Expectations for the second pilot project
- by Eo, Yun-Ho Jun 17, 2025 05:59am
- Several drugs that were undergoing concurrent regulatory approval and reimbursement evaluations for improved patient access are now approaching commercialization. However, whether these drugs will actually receive reimbursement coverage remains uncertain despite expedited approval timelines. Since 2023, the Ministry of Health and Welfare has been running a pilot program integrating the drug approval, reimbursement evaluation, and pricing negotiation processes specifically for drugs treating life-threatening conditions and rare or intractable diseases. The aim was to accelerate the timeline for new drug reimbursement under Korea’s National Health Insurance system. In October last year, the government selected the first two candidate drugs under the initial pilot program: ‘Qarziba’ (dinutuximab), a pediatric rare disease treatment, and ‘Bylvay. However, Bylvay failed to pass the Health Insurance Review & Assessment Service’s Drug Reimbursement Review Committee review. Even Qarziba, which was eventually listed for reimbursement, faced a temporary setback during the review process. Ten drugs applied for the second round of the pilot program in 2024, and three were selected: MSD Korea’s sotatercept (Winrevair) for pulmonary arterial hypertension, UCB Pharma Korea’s fenfluramine (Fintepla) for Dravet syndrome, and CuroCell’s anbal-cel (Rimqarto) for large B-cell lymphoma. All three are expected to be commercialized in Korea within this year. Eligibility criteria for the second round of the pilot program were as follows: ▲ drugs that can apply for both approval and reimbursement by June 2025, ▲ treatments for rare or life-threatening conditions with a life expectancy of less than one year with sufficient efficacy, ▲ drugs with no current alternatives or those that offer clinically significant improvements, and ▲ drugs designated or eligible for expedited approval under the GIFT program (Global Innovative Drug Fast Track) by the Ministry of Food and Drug Safety. The criteria clearly specify drugs urgently needed in clinical settings. While streamlining the reimbursement timeline for innovative drugs has long been discussed, and some procedural deadlines have indeed been shortened, doubts remain: Has the process truly become faster? Even for Qarziba, the first pilot drug, it took over one year for the drug’s reimbursment listing. The concurrent approval and pricing review system does not guarantee smooth or timely outcomes. In other words, transparency and speed remain key concerns for the system. New drugs must not be left in regulatory limbo – left to blindly await the government’s decision. As the second pilot program unfolds, this reporter hopes that the combined efforts of all parties will result in a clearer and shorter listing process.
