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- 2025-12-18 12:21:13
- Opinion
- [Desk View] Can NHI alone cover the costs of cancer drugs?
- by Lee, Tak-Sun Aug 20, 2025 06:23am
- The reimbursement claim amount submitted for anti-cancer drugs has been increasing robustly every year. According to the '2024 Pharmaceutical Reimbursement Claims Data' published by the Health Insurance Review & Assessment Service, drug expenditure for cancer diseases in 2024 amounted to KRW 4.1372 trillion, a 7.4% increase from KRW 3.8506 trillion in 2023. The rate of increase in cancer drug expenditures is steeper than the 4.5% increase for overall drug expenditures (KRW 26.9897 trillion). These data indicate that the costs of anti-cancer drugs are rising with the emergence of expensive drugs like immunotherapies and targeted therapies. The problem lies in what comes next. If the anti-cancer drugs currently awaiting reimbursement approval are approved, an additional KRW 2-3 trillion is expected to be added soon. The national health insurance, which is accumulating financial deficits, may no longer be able to cover these rising costs of anti-cancer drugs. Global pharmaceutical companies are increasingly combining new anti-cancer drugs or expanding investments in more expensive first-line treatments. As a result, cancer treatment is evolving. However, the latest high-cost anti-cancer drugs are waiting in a long queue for reimbursement, putting a burden on national health insurance finances. Some are suggesting that the 5% patient co-payment rate for anti-cancer drugs should be slightly increased. However, adjusting a patient's co-payment rate once it has been lowered is not an easy task. The government and politicians probably refrain from such a move, as it could cost them votes. For this reason, there is a growing argument that South Korea should also establish a separate fund for anti-cancer or rare disease drugs, similar to the UK, to save national health insurance finances and improve access to new drugs. However, the government does not seem to be acknowledging the seriousness of this issue yet. During the candidacy confirmation hearing, Jeong Eun Kyeong, Minister of Health and Welfare, expressed the view that expanding reimbursement coverage should be prioritized over creating a separate fund for patients with rare and severe diseases. The issue of national health insurance drug expenditures is not new, but the current instability differs from past patterns. In particular, merely adjusting the prices of drugs with expired patents, as in the past, has limited effectiveness in alleviating the financial pressure caused by the entry of high-cost drugs, such as innovative new anti-cancer drugs. It is also difficult for the government not to permit the entry of new, more effective anti-cancer drugs. The financial losses caused by these innovative anti-cancer drugs are, therefore, unavoidable. In this situation, it isn't easy to solve both financial stability and access to new drugs with past methods of drug cost reduction or reimbursement expansion. We hope that the new government realizes the seriousness of the cancer drug expenditure problem and prioritizes its policies.
- Opinion
- [Reporter's View] Innovation exists in treating all diseases
- by Eo, Yun-Ho Aug 20, 2025 06:23am
- When discussing Korea’s insurance reimbursement system, the qualifier “life-threatening” has long been a source of frustration. It is no exaggeration to say that, for the pharmaceutical industry, this phrase has been the number one target for removal since the very beginning. This was the case in determining eligibility for the Risk Sharing Agreement (RSA) and the exemption from pharmacoeconomic evaluation, and recently, even the preferential treatment for innovative drugs that allow the application of a flexible ICER threshold—another long-standing aspiration—has seen the phrase “life-threatening” implicitly applied in a different form. However, it is now necessary to question the very notion that a disease must be life-threatening to be considered serious. In particular, new drugs for chronic diseases, which are indirect causes of death for a large number of people due to comorbidities and complications, have long been left neglected in Korea’s reimbursement system. Although there are already many old drugs on the market and the number of new drugs being developed has decreased, the new drugs that represent a paradigm shift are being neglected. The breast cancer treatment Trodelvy was the first innovative drug to receive preferential treatment and ICER benefits, and was added to the reimbursement list in June. According to reports, the threshold for Trodelvy was set at KRW 70 million. This is an unprecedented amount. The Health Insurance Review and Assessment Service has stated that it does not use explicit thresholds, but it is well established that since the pharmacoeconomic evaluation system was first introduced in 2007 that the ICER threshold has been set at KRW 25 million for general drugs and KRW 50 million for anticancer drugs, based on the per capita GDP of KRW 25 million at the time, and has remained since for 18 years. In fact, according to HIRA's announcement last year, the ICER values for drugs submitted for pharmacoeconomic evaluation from 2019 to 2023 ranged from KRW 12.06 million to KRW 36.1 million for general drugs and KRW 25.88 million to KRW 47.92 million for anticancer drugs. This is why Trodelvy’s reimbursement listing is a significant milestone. However, such milestones should not become extremely rare cases. Providing benefits that cannot be applied in real life is meaningless. The criteria for receiving ICER benefits include three requirements, one of which states, “Significant clinical improvement must be recognized in final outcome measures such as extended survival.” Although the term “survival” implies “life-threatening,” it was not explicit. And in November last year, Kook-Hee Kim, Director of the Pharmaceutical Management Division at HIRA, said, “If innovativeness of a drug needs to be recognized in consideration of the severity of the disease and the social burden of the disease, the ICER threshold can be raised even if all three requirements are not met,” suggesting the possibility of flexible screening. In July, Minister Eun-kyung Jeong, who was appointed as the new Minister of Health and Welfare under President Jae-myung Lee’s administration, also mentioned the case of Trodelvy during her confirmation hearing in the National Assembly and expressed her agreement with the need for policy changes to recognize innovation. Under these circumstances, Mounjaro, which has been attracting public attention as a treatment for obesity, recently submitted a reimbursement application for its diabetes indication. While its weight-loss effect is well-known, Mounjaro's achievements in the diabetes field are also significant. Beyond blood sugar control targets, 6 out of 10 patients achieved normal blood sugar levels without an increased risk of hypoglycemia, reaching the ultimate treatment goals of preventing cardiovascular complications and reducing mortality. It even demonstrates the potential for “remission” in diabetes. However, assuming that the normal listing process is followed, it seems extremely unlikely that Mounjaro will be granted reimbursement for diabetes. As mentioned earlier, chronic diseases are already mainly treated with off-patent drugs. Given that these drugs are the comparators, it is difficult to predict a bright future for the entry of a new biopharmaceutical in the area. New drugs and drug prices are currently facing a critical turning point. Amidst the Trump administration's pressure on South Korea's drug pricing policy and the flood of high-priced drugs, concerns about “Korea passing” are growing, and future policy directions could have a significant impact on public health. With Korea already a foot into a super-aged society, it is crucial to make policy decisions from a long-term perspective to build a sustainable society capable of overcoming future health crises. We place our hopes in the Lee administration's pledge to “create a country where no one worries about illness.”
- Opinion
- [Reporter's View] Clarify support for unstable supply drugs
- by Lee, Hye-Kyung Aug 19, 2025 06:11am
- The Ministry of Food and Drug Safety is reportedly preparing support measures to stabilize the supply of national essential medicines and other items with unstable supply. The MFDS initially announced its intention to specify the urgent measures required by the industry to stabilize supply, such as emergency imports, custom manufacturing, and administrative support, within the first half of this year. However, it was not specified within the first half of the year, and it is said that the authorities are still considering how to specify and disclose the measures. Support for stabilizing the supply of drugs is provided by the Pharmacuetical Management Support Team of the MFDS. The team was newly established in March 2024 after the tasks previously handled by the Pharmaceutical Policy Division within the Pharmaceutical Safety Bureau were transferred due to the growing need to respond to public health crises caused by COVID-19. The Pharmaceutical Management Support Team will operate on a temporary basis until January 31, 2027, and is currently responsible for securing a stable supply system for essential medicines, ensuring the swift and stable supply of medical products in crisis situations, as well as other related tasks. In particular, it is responsible for tasks such as the designation of essential medicines, reporting on supply disruptions or shortages, monitoring supply and demand, providing administrative support and communicating with companies, and taking measures to maintain the supply of discontinued items. In this process, the pharmaceutical industry has consistently requested that administrative support measures be clearly stipulated in writing. Support measures are necessary to ensure the continued supply of essential medicines in cases of supply disruptions, as there have been instances where price increases were implemented for certain items. Therefore, there is a growing demand for the sharing of individual cases to clarify what support can be provided for which specific items. The MFDS is also preparing guidelines that include various administrative support measures, but the problem is that it is struggling with whether to use these guidelines internally or disclose them externally. If the guidelines are disclosed externally, administrative support may be applied to all items, which would inevitably increase the administrative burden. In the case of stabilizing the supply of pharmaceuticals, support measures may vary by product, and if the guidelines are made public, some companies may raise issues regarding the varying standards. However, formalizing administrative support could be one of the most effective measures to help companies stabilize supply. Companies may need to bear the burden of administrative costs and continue producing items that could otherwise be discontinued, so it is crucial for the government to clarify the specific support it can provide. Therefore, if guidelines are established, they should be publicly disclosed rather than kept internal, and administrative support measures should be properly established through a case-by-case approach.
- Opinion
- [Reporter's View] Sales dilemma of newly listed bioventures
- by Whang, byung-woo Aug 12, 2025 06:15am
- “Off to a fair start” was the market’s assessment regarding the stock prices and performance of biotech companies that went public on the KOSDAQ this year. However, upon closer inspection, some point out that the strengthened scrutiny of financial figures following the Fadu incident (accounting and revenue recognition controversy) has increased the importance of sales indicators, resulting in an ‘optical illusion’ that the listed samples generated favorable results. While there's a prevailing view that the bio industry is experiencing a positive wind of change, there's also a conflicting view that primarily companies that were inherently favorable to the industry are going public. Not all bio companies that have gone public have relied solely on sales. Some have proven their success through clinical progress or partnerships. Nevertheless, the consensus within the industry is that the growing influence of sales metrics is undeniable. In fact, sales are the most intuitive defense mechanism from an investor protection perspective. However, the biotech industry inherently has a longer time horizon than other industries. Research and development, clinical trials, regulatory approvals, and technology transfer negotiations may signal future sales, but they are difficult to fully capture in current income statements. This gap could fuel concerns about more conservative reviews and demand forecasts for R&D-focused companies. In other words, caution is needed in interpreting the current “good performance” as a structural recovery. As post-listing management requirements and external pressures increase, some are discussing attempts to strengthen the company's external image, which is not closely related to its core business. This is evaluated as a potential distraction from the company's core business and an opportunity cost that could ultimately slow down the pipeline development process. Of course, considering cases where some companies have received delisting warnings, it is difficult to blame measures that raise the threshold for new listings based on sales. The need for investor protection is clear. However, considering the purpose of technology-based special listings, the side effect of reducing opportunities for pure new drug development companies that do not generate immediate sales is ongoing. This is not unrelated to the phenomenon of using ancillary businesses to offset sales to meet sales targets. The reason why newly listed biotech companies seem to be performing well this year is due to the sales-centric filter. While this is not inherently problematic, it does not fully reflect the pace of the biotech industry. Ultimately, it is necessary to adjust the balance between regulations and evaluations to avoid overly narrowing the pathway for new drug development companies. Sales metrics are important for investor protection and corporate continuity. However, considering the purpose of the technology-based listing exemption and the unique characteristics of the biotech industry, a perspective that “also” considers sales may be more just.
- Opinion
- [Reporter's View] Can NA resolve the drug shortage issue?
- by Kim, Jin-Gu Aug 06, 2025 06:09am
- Whether the four bills presented for amendments to the Pharmaceutical Affairs Act aimed at resolving the shortage of medicines will be discussed at the National Assembly's Health and Welfare Committee in August is gaining attention. The amendments to the Pharmaceutical Affairs Act were proposed by Rep. Jeong-ae Han, Rep. Yoon Kim, and Rep. Mi-hwa Seo of the Democratic Party of Korea, and Rep. Sun-min Kim of the Rebuilding Korea Party. Rep Jeong-ae Han’s bill proposes the establishment of a supply management committee involving both the public and private sectors, as well as the designation of “medicines with unstable supply” and the establishment of regulations for emergency production and import orders. Rep Yoon Kim's bill includes medicines with temporary supply shortages or sudden increases in demand as “medicines subject to stable supply management,” and allows medical professionals and relevant institutions, and organizations to participate in the National Essential Medicines Supply Stability Council. Rep. Mi-hwa Seo's bill focuses on including medications without alternatives as National Essential Medicines and implementing constant monitoring. Rep. Sun-min Kim’s bill includes medications with temporary supply shortages or sudden increases in demand in the “stable supply management targets” category and seeks to allow medical professionals and institutions/organizations to participate in the National Essential Medications Supply Stability Council. All four amendments were positively received as they presented their own solutions to stabilize the supply of medicines. Considering the repeated medicine shortages and supply disruptions that arose over the past few years, they were also deemed timely. If the bills are submitted and pass the Health and Welfare Committee review, they are likely to be processed through the Legislative and Judiciary Committee and handled during the September regular session of the National Assembly. If this process is realized, it is expected to provide a significant boost to resolving the medicine supply shortage that has been recurring for several years. Resolving the medicine supply shortage was a common campaign pledge made by both the ruling and opposition parties in the last presidential election. Furthermore, except for the extent to which the international nonproprietary name prescriptions should be allowed, there does not seem to be much disagreement between the parties. This means that now is the optimal time to discuss measures to resolve the medicine supply shortage. However, it is necessary to carefully review whether there are any aspects that have not been included in the revised bill. In particular, the pharmaceutical industry has consistently demanded fundamental solutions for increasing the self-sufficiency rate of domestically produced raw materials for pharmaceuticals and strengthening incentives for the production of low-profit essential drugs, which require urgent attention. There are calls for the need to establish practical supply chain strengthening policies that go beyond simply expanding the scope of items subject to supply instability and forming a consultative body. Fundamental measures are needed to overcome low productivity and a weak supply structure. The government should also consider expanding public reserves and establishing a digital-based real-time monitoring system. Overseas cases are also worth noting. The United States operates a Drug Shortage Task Force to maintain an early warning and supply substitution system. The European Union (EU) operates a system to jointly manage and stockpile about 200 essential drugs. Japan is known to operate a system to reevaluate the prices of low-profit products that cause deficits, focusing on essential drugs. These countries share the common feature of active government intervention to expand supply and promote corporate participation. The current parliamentary discussion presents an opportunity to address critical issues that can no longer be postponed. It must serve as the starting point for developing practical solutions. This rare opportunity must not be wasted. Instead of half-hearted measures, a clear direction that ensures supply stability that both citizens and the pharmaceutical industry can feel must be presented this time.
- Opinion
- [Reporter's View] KRPIA opts for 'maintain' over 'change'
- by Eo, Yun-Ho Aug 01, 2025 06:15am
- The Korea Research-based Pharma Industry Association (KRPIA) has chosen continuity over change. The KRPIA recently confirmed the appointment of Vice Chairman Lee Young-shin (68) to the position of Executive Vice Chairman, who is currently leading the association. This decision was made after amending the articles of incorporation to address the appointment of the Executive Vice Chair. Initially, the articles of association permitted only one re-appointment to the Vice Chair. Vice Chair Youngshin Lee had already been re-appointed once since his initial appointment in 2019. Therefore, a change in Vice Chair was highly probable upon the expiration of his term, but the association decided to amend its articles of incorporation and maintain the existing system. Historically, KRPIA has favored former government officials for the position of Executive Vice Chair. Given the nature of multinational pharmaceutical companies, whose core business is the supply of new drugs, communication with ministries related to the drug pricing system is crucial, and government connections are indeed crucial. Due to various reasons, the association has not appointed any former government officials since the resignation of former Vice Chair Lee Sang-seok, and Vice Chair Youngshin Lee 's second re-appointment has been confirmed. There must be a reason for this unusual decision. KRPIA has seen significant changes in its personnel composition over the past few years. While the reduction in the number of board members is an unavoidable consequence of the reassignments inherent in multinational company CEO positions, the frequent departures of government relations personnel, including former Policy Director Min-Young Kim, have led to substantial personnel gaps. Additionally, since February of last year, In-hwa Choi, the current Executive Director of Policy and External Affairs, has been appointed, and other vacant positions have been filled, resulting in the current state. New drugs and drug pricing are currently at a more critical juncture than ever before. Amid concerns about 'Korea Passing' due to the Trump administration's pressure on South Korea's drug pricing policy and a flood of high-priced drugs, the future policy direction could significantly impact public health in Korea. South Korea's drug pricing system, including that of generics, could face significant challenges. Moreover, a new government has just taken office. KRPIA's role will undoubtedly be paramount. The decision has been made, and now it's time to move forward. Beyond merely defending drug prices, we look forward to the association operating with rational and sharp judgment to find common ground with health authorities and lead to agreement on the overarching premise of 'improving patient accessibility.' This, along with a re-evaluation of the priorities for past government activities and policy proposals.
- Opinion
- [Reporter’s View] AI-assisted diagnosis and its hurdles
- by Whang, byung-woo Jul 28, 2025 06:08am
- Advanced technologies such as AI-assisted diagnosis and robotic surgery are being actively introduced into the domestic medical field more than ever before. Robotic surgery, which was first introduced 20 years ago, has now become the standard treatment in many fields. For example, the Da Vinci Robotic Surgical System, introduced in 2005, has since performed a cumulative total of approximately 370,000 robot-assisted surgeries in Korea, and currently, more than 200 systems are in operation in Korea. This quantitative growth is the result of the efforts of medical professionals and their willingness to embrace innovation. In fact, robotic surgery has demonstrated clinically significant benefits, such as a 75% reduction in blood transfusions during surgery, a 44% reduction in postoperative complications, and a 46% reduction in mortality, and is recognized as one of the global standards for minimally invasive treatment. AI-assisted diagnostic technologies are also being developed, with domestic medical AI startups such as Lunit, Vuno, and Neurophet gaining prominence. The global medical AI market is rapidly expanding, with the market size expected to grow from approximately USD 1.3 billion in 2023 to USD 3.7 billion by 2028. In Korea, innovative medical devices such as AI software for early cancer diagnosis are garnering attention as a potential next-generation industry. Although resistance to innovative technology has decreased compared to the past, conservative views still remain in the medical community. In other words, the view is that advanced technology should only play a supporting role rather than a leading role. In fact, at a briefing held by a global medical device company that this reporter attended, while emphasizing the company's achievements, the company was cautious in answering questions about the possibility of such devices completely replacing doctors. In particular, the word “assistant” was mentioned in the press material, highlighting how robots would play an “assistant role” rather than replacing doctors. "Even with cutting-edge technologies, the company’s approach reflects the industry’s cautious stance, which emphasizes that technology should not overtake the role of physicians, given the unique nature of medicine." Behind this cautious attitude in the medical field lie concerns about safety and reliability. In fact, when AI is applied to actual clinical practice, there are cases where its accuracy falls short of expectations. For example, there is a domestic report that an AI diagnostic solution, which was evaluated with an “excellent” rating with a sensitivity of 91.7% and a specificity of 88.6%, had a sensitivity of only 54.9% in actual field diagnosis. In addition, the possibility of AI misdiagnosis, vague anxiety about the replacement of medical personnel, and the unclear accountability in the event of a malfunction are some of the key concerns raised by the medical community. Such discrepancies between laboratory performance and actual clinical outcomes inevitably lead to a lack of trust among medical staff, which explains why a degree of skepticism remains. However, there are also opinions that we should not miss opportunities for innovation due to vague fears about technology. Although concerns about AI doctors replacing human doctors have been raised since the beginning, AI introduced into clinical practice has been proven to improve the quality of medical care and benefit more patients as an auxiliary tool. By serving as an extension of doctors' hands and eyes, AI is bringing about better outcomes for patients. Ultimately, the key lies not in the technology itself, but in the attitude and approach toward accepting it. Innovation and conservatism are always in a tense balance, even more so in the field of medicine, where human lives are at stake. However, for the sake of a better future for patients, it is sometimes necessary to take bold steps toward change. It is this reporter’s hope to see a future where innovation is embraced, but only with the wisdom to thoroughly evaluate and mitigate its risks."
- Opinion
- [Reporter's View] Denmark's corporate model, Wegovy success
- by Jul 25, 2025 06:10am
- I recently had the opportunity to visit the biotech industry in Denmark. I toured facilities like Novo Nordisk, which rose to stardom with its GLP-1-based obesity treatment Wegovy, as well as LEO Pharma, with its 117-year history, and Lundbeck, a powerhouse in the central nervous system field. What struck me was that all these companies, without exception, cited their 'foundation-owned governance structure' as the secret to Denmark's biotech industry competitiveness. Denmark has Europe's most structured foundation-owned model. Approximately 1,300 companies in Denmark operate under a foundation-owned structure. Pharmaceutical companies like Novo Nordisk, LEO Pharma, and Lundbeck, as well as the toy company Lego, brewery Carlsberg, and shipping giant Maersk, all adopt governance structures where a foundation is the largest shareholder. Examining the governance structure of these companies reveals that non-profit foundations run them. A foundation controls an intermediate holding company, which is also a professional investment firm. This holding company, in turn, oversees various operating companies. It can be summarized as 'Foundation → Holding Company → Operating Company,' where the foundation indirectly controls its subsidiaries through a holding company-style investment firm. Foundations support the life sciences field in all-in efforts. The Novo Nordisk Foundation boasts one of the largest asset sizes globally, with Assets Under Management (AUM) reaching approximately $140 billion (KRW 194 trillion). Thisfigure is more than twice the AUM of the Bill & Melinda Gates Foundation, North America's largest private foundation, which stands at $69 billion. Such investment strengthens Denmark's scientific foundation nationwide and effectively attracts top talent from around the world to Denmark. A unique aspect of the Danish foundation-owned model is that the founding family does not serve as the largest shareholder of the operating company, nor do they directly hold equity. While some foundations may have founding family members play a symbolic role on the board, they do not exercise substantial control over the organization. Denmark has thus created a corporate ecosystem that perpetuates the founder's philosophy through a foundation while separating equity ownership from operational management. Due to this clear separation of ownership and management, companies can consistently pursue long-term strategies without being influenced by short-term performance. Being free from the pressures of short-term profits from external investors or shareholders creates an environment where companies can concentrate on long-term research and development (R&D) while delivering public value. Unlike private equity funds, which seek short-term returns based on profit, foundations can respond flexibly regarding equity maintenance or exit timing. In my opnion, this Danish case could offer significant implications for the direction the Korean pharmaceutical industry should take as it faces a transition in its governance structure. With the succession to the 3rd or 4th generation of founders gaining momentum, many Korean pharmaceutical companies are seeking solutions that simultaneously satisfy transparency in governance and continuity in management. Listed pharmaceutical companies find themselves in a situation where they must find a 'sustainable governance' middle ground between companies seeking to continue family management and succession, and shareholders demanding accountability and transparency. It doesn't imply that owner-management or professional management is better, or that the Danish model is superior. Korean companies cannot simply replicate the Danish model. Denmark has a highly sophisticated legal framework for foundation-owned companies, whereas South Korea lacks clear public interest foundation laws or a tax incentive structure. In Korea's case, a strong perception exists that public interest foundations are often a means for illegal succession, due to past instances of irregular successions by some companies. However, the Danish model can serve as a meaningful reference point for the Korean pharmaceutical industry when redesigning its governance structure. The key is to reinterpret the Danish model and integrate it into a feasible structure that aligns with Korean culture, institutions, and management realities. In the pharmaceutical industry, where a long-term vision is essential, the sustainability of the entire industry could be jeopardized without careful consideration of governance. New ideas and discussions about new structures are urgently needed for the development of "K-made Wegovy."
- Opinion
- [Reporter's View] Bio policy should remain consistent
- by Kim, Jin-Gu Jul 17, 2025 06:13am
- In November 2024, the Yoon Suk Yeol government officially announced the launch of the National Bio Committee. The government aimed to operate a 'presidential' governance body in a preparatory response to the global bioeconomy era. Considering that the previously established 'Bio-health Innovative Committee' was chaired by the Prime Minister, the National Bio Committee was regarded as an advancement in terms of its rank and role. The establishment of a governance body overseeing the pharmaceutical and biotech industries, directly under the President, has long been a goal of the pharmaceutical and biotech industries. Previously, the pharmaceutical and biotech industry operated with separate development strategies fragmented across different divisions. The wall between regulations and support policies, as well as the lack of a central coordinating point for strategic discussions, had been a long-standing concern for the industry. When the government took an initiative to 'unify policies scattered across divisions and manage them,' the industry welcomed it with open arms. There was great anticipation that a policy control tower would enable coordination of regulatory improvements, industrial support, and technological development at a governmental level. However, just about a month after the committee's launch plan was announced, a state of emergency was declared, followed by martial law. A continuous political chaos followed this. Former President Yoon Suk Yeol faced an impeachment trial. Ultimately, the Constitutional Court of Kora upheld his impeachment. Following an early presidential election, President Lee Jae Myung took office on May 4th last month. Even during the political turmoil, the National Bio Committee carried out two official schedules. At its launch ceremony in January this year, the committee unveiled the "Republic of Korea Bio Grand Transformation Strategy." In its second meeting in May, it selected 10 key R&D areas, including AI-driven drug discovery·radiopharmaceuticals·gene therapies, and discussed development strategies. However, there was insufficient time to yield accomplishments. With the new administration taking power, the committee's existence became uncertain. As an organization established by presidential decree, it is not an independent body under law. It lacks authority in terms of organization, budget, and personnel. In other words, it can be abolished at any time with the new government. It is not uncommon for presidential committees to be abolished with the new administration. New governments often introduce new slogans, and various committees have also disappeared with changes in power. Will the National Bio Committee follow the same path? This is a point of concern for the industry. Given that the pharmaceutical and biotech industry development strategies proposed by the National Bio Committee were recognized for their industrial validity regardless of the administration, the potential disappearance of this newly launched committee is frustrating. In the biotech industry, sustainability is more important than speed. It typically takes over 10 years to develop a new drug and bring it to the global market. This industry operates on a different timeline than a government's five-year term. If industrial strategies are reset every time the government changes, it will be difficult for the Korean pharmaceutical and biotech industry to advance its global competitiveness. Even if the government changes, the core axis of industrial strategy must be maintained. The direction of breaking down walls between ministries and consolidating public and private capabilities should not disappear. Even if a committee is renamed, its symbolism and status as a direct presidential committee should be preserved.
- Opinion
- [Reporter's View] Gov’t cooperation leads to a price cut?
- by Eo, Yun-Ho Jul 16, 2025 06:10am
- There are times when cooperation ends up causing losses. In an ironic twist, pharmaceutical companies that participated in the government's infertility support program have now found their products caught in the net of the Price-Volume Agreement (PVA) system, leaving them little choice but to face rapid drug price cuts. The government's infertility support program, aimed at addressing the low birthrate issue, has been steadily expanded over the past years. Last year alone, it was expanded 3 times, and in January 2024, the previous eligibility criterion of “household income at or below 180% of the median income” was abolished, and subsidies for in vitro fertilization and artificial insemination were provided regardless of income. In February, the number of reimbursements covered by national health insurance was increased from a maximum of 16 sessions per person for in vitro fertilization (9 times for fresh embryos and 7 for frozen embryos) to a maximum of 20 sessions per person (without distinction between fresh and frozen embryos). In November, the government also expanded the co-insurance rate for infertility treatments, which had previously been differentiated by age (30% for those aged 44 and under and 50% for those aged 45 and over), to a uniform 30% regardless of age. With the expanded infertility support, demand also increased significantly. The supply of infertility treatments could not keep up with demand, leading to supply disruptions and shortages. Follicle-stimulating hormone (FSH) preparations, which are essential for infertility treatment, are used to induce hyperovulation in assisted reproductive technology (ART) such as in vitro fertilization or artificial insemination. The issue is that most follicle-stimulating hormone preparations are hormone preparations (biological drugs) with complex manufacturing processes, making it difficult to increase production to meet the increased demand. From 2023 to the present, companies have reported supply disruptions or shortages for 7 follicle-stimulating hormone preparations to the Ministry of Food and Drug Safety. However, major FSH preparations that had expanded their supply to meet the rising demand have now been selected for PVA (Price-Volume Agreement) negotiations starting this July. The outcome will almost certainly lead to drug price reductions. Demand for infertility treatments is expanding globally beyond domestic markets. China has expanded public health insurance coverage for in vitro fertilization (IVF) in major cities like Beijing and other provinces starting in 2023 as part of efforts to address low birth rates. The United States is also expanding support policies, including the first federal-level executive order in February 2025 to enhance access to IVF, moving beyond previous state-level initiatives. In other words, it is not easy for any pharmaceutical company to ensure a smooth supply of the lacking IVF drugs in line with policy trends. The fact that many pharmaceutical companies are giving up is evidence of this. It is time for the government to provide appropriate compensation for those who cooperate with national healthcare initiatives.
