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- 2025-12-18 10:42:58
- 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.
- Opinion
- [Reporter's View] GMP standards for sterile products
- by Lee, Hye-Kyung Jun 17, 2025 05:58am
- The Ministry of Food and Drug Safety (MFDS) is devising measures to reduce the burden on the pharmaceutical industry ahead of the implementation of the 'Revised PIC/S Good Manufacturing Practices (GMP) Guide for Sterile Medicinal Products (guidelines on manufacturing and quality control of medicines)' in December. Following the administrative announcement of revised guidelines in 2023, the MFDS has granted a two-year grace period. Therefore, the MFDS has planned a solution to lessen the burden, rather than an extended grace period as requested by several pharmaceutical companies. Strengthened GMP standards for sterile medicinal products include ▲systemic establishment·implementation of contaminant management methods for sterile medicinal products ▲establishment of separate GMP for cutting-edge technology biotechnology medicines ▲specifying detailed formulation and selection process·methods for products meeting GMP standards. Establishing contamination-control strategies is most important, but establishing a strategy for each lot number requires substantial manpower and investment. Approximately 100 companies in South Korea are reportedly manufacturing sterile products. In fact, since late last year, news of sterile production halts has been circulating, primarily among some manufacturers. For instance, Ildong Pharmaceutical's 'Ativan,' which had experienced years of supply halt and re-production, recently announced a final halt to both supply and production. According to the MFDS, this is due to the company's internal circumstances. It is also rumored that the decision to withdraw was made due to a combination of existing supply concerns, such as the cost-effectiveness of reinvesting in facilities, given the strengthened GMP standards. MFDS's consistent response when asked has been 'no further grace period.' Then, on the 11th, the MFDS Quality Management Division proactively requested a meeting with reporters. The MFDS explained that they had met with factory managers from approximately 20 manufacturers of sterile products last month. The reason they couldn't hold a press briefing immediately was their desire to jointly explain the ongoing 'Research on the GMP Guide for Sterile Products Implementation Plan' with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. MFDS has been conducting research jointly with the association since last year to alleviate the industry's burden related to the strengthened management of GMP for sterile products, aiming for standard relaxation. They are already in the mid-phase of research with three companies, HK inno.N, JW Pharmaceutical, and Daehan Pharmaceutical, which produce over 90% of large-volume intravenous fluids. If this research is successful, standards for large-volume intravenous fluids are expected to be relaxed first. From a quality perspective, they were preparing technical support measures to alleviate the industry's burden resulting from the actual implementation of the strengthened standard. However, a question arises here. While technical and regulatory support measures are being prepared to apply GMP standards at the same level as PIC/S member countries to domestic sterile product preparation manufacturers, has an alternative plan been prepared for cases where smaller companies, facing difficulties in facility and personnel investment despite this support, decide to abandon sterile product preparations? The disappointing part was the Quality Management Division's ambiguous response, suggesting that the Biopharmaceutical Management Support Team might handle supply-related issues rather than the Quality Management Division. It sounded like, 'GMP standards are our division's responsibility, but supply is another division's responsibility, so we don't know.' MFDS expresses concern that it might appear as if companies are abandoning the supply of sterile products, such as injectables, solely due to the strengthening of GMP standards. However, these two issues are inseparable. Many sterile product preparations are designated as shortage prevention drugs (SPD) or national essential medicines. This designation implies that the government intends to manage them because they are not profitable. Now, a situation has arisen where companies must invest anywhere from several billion to tens of billions of KRW in facilities and manpower for sterile product preparations that yield almost no profit. Consequently, it's inevitable that cases will emerge where companies decide to withdraw products after weighing investment costs against profitability. Therefore, instead of considering the issues of standards and supply separately, we hope that they will be addressed together, and solutions will be devised to reduce the burden on the pharmaceutical industry and alleviate public anxiety caused by supply instability.
- Opinion
- [Reporter's View] Fostering BD talent requires tech·strateg
- by Whang, byung-woo Jun 12, 2025 06:04am
- Recently, the role of business development (BD) in the pharmaceutical and biotech industry has been rapidly advancing. Previously regarded simply as a sales task, BD changed to one of the core strategic teams that oversees the success of new drug development. BD is responsible for key discovery and execution of various opportunities for new drug commercialization, including domestic and overseas market analysis, candidate product entries, license-out (L/O) agreements, strategic collaborations, and joint research. Now, BD is an essential expert team required for the success of new drug development. However, it was once seen as simply a sales team. Recently, as the importance of BD has been highlighted, BD's role expanded, and the industry often says that 'BD is the competitiveness.' There are cases where the achievement of new drug L/O (technology transfers) has significantly changed the corporate value. Therefore, a BD team is no longer considered simply a subordinate team but a strategy team responsible for determining the success of new drug development. This aligns with major pharmaceutical companies in Korea that run convergent R&D and BD teams, keeping commercialization in mind from the early stages of research. Their goal is to create synergy between research and BD. Park, Yeong-Min, Business Head of the National New Drug Development Division, emphasized, "A precise commercialization strategy is necessary from the early stages for successful new drug development." However, despite such changes, clinical practices are challenged with BD talent shortages. A biotech company head stated, "Talents with both technological understanding and business communication skills are difficult to find. Therefore, collaborations and supplementation are mandatory." It is challenging to find BD talents who simultaneously possess technical expertise, negotiation skills, and an understanding of the global market. To address this talent shortage, organizations like the Korea Drug Development Fund (KDDF) are running programs such as 'Young BD' workshops to strengthen the practical capabilities of young professionals. However, these initiatives are criticized for still being insufficient for effective talent development, as they cannot replace real-world experience and face structural limitations such as short training periods and limited enrollment. The global competitive environment further emphasizes the importance of BD talent training. With Chinese biotech companies recently surpassing those in South Korea in securing large-scale technology exports, many analyses suggest that soft skills, such as business strategy and negotiation prowess, are crucial beyond just technical excellence. Several experts said, "It's difficult to be competitive in global partnering by only emphasizing technological prowess," and added, "Strategic capabilities to accurately convey the value partners seek are desperately needed." With the new government taking office, attention is also being drawn to potential changes in bio-industry policy. The industry anticipates practical support measures from the government for nurturing BD professionals across the entire cycle, from R&D to commercialization. The Korea Pharmaceutical and Bio-Pharma Manufacturers Association also recently emphasized, "We must expand support for late-stage clinical trials and companies closer to the commercialization phase," adding, "The government's pharmaceutical and bio R&D policy should be restructured to focus on achieving tangible results." Fostering BD talent is no longer an issue for individual companies but a challenge directly linked to the competitiveness of the entire industry ecosystem. Only when the harmonious development of R&D personnel, who drive technological innovation, and BD personnel, who connect this to success, is supported can South Korea truly leap forward as a new drug powerhouse. It is time for companies, academia, and the government to collectively gather their wisdom to bridge the gap between technology and communication.
- Opinion
- [Reporter's View] Biotech policy must be consistent
- by Jun 04, 2025 06:17am
- What's the most critical factor in corporate management? It's challenging to pinpoint whether it's capital, talent, or technology. However, for all these elements to function, a prerequisite must be established: predictability. A company must be able to foresee the future to invest and endure risks to recruit and conduct R&D. South Korea is often evaluated as lacking predictability in its systems and policies. Industrial nurturing strategies and regulatory directions change dramatically with every government, and policy consistency between different ministries also tends to be inconsistent. It's common to see ministries offering different interpretations of the same issue or administrative decisions varying depending on the timing and the official in charge. The biotech industry is no exception. The Yoon Suk Yeol government began establishing control towers by launching organizations directly under the Prime Minister and the President; however, there some criticized that these two committees lost momentum after the presidential impeachment. A similar problem is found in the capital market, which drives the growth of the biotech industry. Listing criteria for public offerings change with every government transition. Such uncertainty is particularly detrimental to industries like biotech that require long-term investment. For companies, it becomes difficult to formulate long-term plans. Attracting investment is challenging when regulations and policies frequently change. Cases where existing strategies must be revised due to policy shifts also arise, and the efficiency of budget allocation and human resource management decreases. Ultimately, companies are but to adopt a conservative management approach, which leads to a slowdown in the overall pace of innovation within the domestic biotech industry. In the long term, there is a high probability of a downturn in the industrial ecosystem and weakened competitiveness in the global market. In other words, the lack of trust in policies and systems hinders the potential for industrial growth. The world has entered competition centered on 'biotech sovereignty.' China is rapidly expanding its presence on the global stage by investing massive national budgets. In response, the United States has moved to strengthen regulations, including securing domestic production capabilities. It's now imperative for South Korea to establish a system that allows biotech policies, separate from politics, to be pursued long-term within a neutral and stable structure. A new government will be launched. The government must promise consistency and predictability in policies not only to the public but also to the business sector. While governments may change, the principles and strategies for viewing the industry should remain consistent. These elements will establish the foundation for foreign companies to trust Korea and for domestic companies to develop long-term visions, ultimately sustaining the competitiveness of Korea's biotech industry.
- Opinion
- [Reporter's View] Addressing drug shortage, healthcare
- by Lee, Jeong-Hwan May 30, 2025 05:57am
- Ahead of Korea's early presidential election, scheduled for June 3, leading candidates have prioritized pledges to strengthen government support for essential medicines·address drug shortages. Lee Jae-myung, the candidate for the Democratic Party of Korea, included the resolution of a supply shortage of essential medicines in his top 10 pledges, suggesting the possibility of a partial introduction of generic name prescribing for drugs such as flu treatments and cold medicines. Kim Moon-soo, the candidate for the People Power Party, also promised to create a system for detecting drug supply shortages, establish a public electronic prescription system, and set up a drug supply management committee. Lee Jun-seok, the candidate for the Reform Party, also acknowledged that frequent drug shortages are a pressing concern for pharmacists, indicating his intention to establish an independent channel with the Korean Pharmaceutical Association (KPA) to discuss related solutions. Likewise, the inconvenience faced by pharmacies and patients due to shortages of frequently sought-after essential medicines has remained unresolved for several years, becoming a nationwide headache to the extent that presidential candidates have uniformly listed it as their top pharmacy-related pledge. While pharmacists review their drug shortage checklists every morning and respond to the chaos by exchanging drugs with nearby pharmacies through local communities and KakaoTalk, they are frustrated that the process remains haphazard. These are the reasons the KPA proposed to the presidential candidates the establishment of a government-level drug shortage management system. The aim is to advance beyond merely sharing information about some drug shortages through the Drug Utilization Review (DUR) service and for the government to establish a system that assumes social responsibility. The newly appointed president, following the election, and the new government need to design and implement policies with a mission to find fundamental solutions to drug shortage issues, thereby strengthening national health security and pharmaceutical sovereignty. The drug shortage problem arises due to the instability of active pharmaceutical ingredient (API) supply due to accelerating drug nationalism. To domestically produce APIs that have low profitability, the government must provide sufficient incentives. In other words, the government must exert its public role to the fullest, encouraging domestic approval and manufacturing of essential drugs by pharmaceutical companies to improve self-sufficiency rates and also advance the distribution lines of produced medicines. Suppose a system is also created that can quickly promote the supply of the relevant active ingredient/product or alternative drugs when sudden shortages occur in local pharmacies. In that case, the frequent occurrence of drug shortages being raised at the annual national audit will decrease. We anticipate the election of a president who will operate the existing public-private consultative body for drug shortages, thereby implementing policies and budgetary solutions into actual systems to ensure organic cooperation among the pharmaceutical industry, the pharmacy community, and drug distribution.
- Opinion
- [Reporter’s View] Reimbursing the only RET-targeted therapy
- by Eo, Yun-Ho May 29, 2025 05:52am
- News of a new drug failing to be listed for insurance reimbursement always upsets patients. The blow is even harder when it is the only treatment option available. Such was the case in 2023 when the National Health Insurance Service and Lilly failed to reach an agreement on the price of the RET-targeted anticancer drug Retevmo (selpercatinib). This was the only case of a drug price negotiation failure that year. This drug was the first treatment option for patients with RET fusion-positive non-small cell lung cancer and thyroid cancer, and the only drug that was being reviewed for reimbursement in Korea. With the reimbursement listing of Retevmo falling through, patients were left to endure an indefinite wait. Then, this year, the developer, Lilly Korea, finally reaffirmed its commitment. Lilly recently submitted a reimbursement application for non-small cell lung cancer along with an indication for thyroid cancer. This is the company’s third attempt. Prior to the approval of Retevmo, there were no targeted treatment options available for patients with RET-mutated NSCLC or thyroid cancer. Therefore, the Ministry of Food and Drug Safety approved Retevmo through a fast-track review for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. Among the A7 countries that are used as Korea’s drug price reference countries, Retevmo is covered and used in 6 countries (US, Germany, Italy, UK, Switzerland, and Japan) other than France. However, despite the considerable time that has passed, it is still not reimbursed in South Korea. The MFDS has been operating an expedited review system to promptly launch and supply highly innovative drugs for life-threatening or serious conditions to the market and patients. However, only a handful of the 23 approved through the fast track is currently being reimbursed by insurance. This means that even after the drugs receive accelerated approval through fast-track review, it is difficult for cancer patients to receive treatment benefits without reimbursement. While regulatory authorities often determine that rapid introduction is necessary, it is frequently the case that insurance authorities remain cautious and conservative. When it comes to the introduction and improvement of systems, ‘effectiveness’ is always a top priority. This reporter hopes that policies aimed at improving patient access to innovative new drugs can achieve the intended effect.
- Opinion
- [Reporter's View] 'Samsung Epis' as independent firm
- by Whang, byung-woo May 23, 2025 05:51am
- Samsung Biologics officially announced on May 22 that its shareholders determined to conduct a spinoff of Samsung Bioepis and establish 'Samsung Epis Holdings.' The business independence of Samsung Bioepis, which expanded its focus on biosimilars, was conducted earlier than anticipated. It has been two years since Samsung Biologics acquired Biogen's entire share in Epis. The current spinoff is meaningful in a way more than simply reorganization of the firm. This indicates Samsung Bioepis' performance over 10 years, future market changes, and efforts to achieve the technological leap. Samsung Bioepis was established as a joint venture between Samsung Biologics and the biotech firm Biogen in 2012. In 2022, Samsung Biologics acquired 49.9% of the U.S.-based Biogen's share in Samsung Bioepis for approximately USD 2.3 billion, acquiring Epis as a 100% subsidiary. After that, Samsung Bioepis established a partnership-based collaborative structure that is flexible and strategic rather than simply a shareholder relationship. Its performance in the past two years can be seen as a period of testing the firm's 'independent survival.' Samsung Bioepis will become a completely independent entity after the spinoff. At the same time, Samsung Epis Holdings will strengthen its role in Samsung Group's biotech business. Samsung Bioepis' performance in the global market is notable. According to IQVIA, Samsung Bioepis ranked No.2 in the market share of Humira biosimilars as of 2023. However, the company's competitors are fiercely rising. For instance, Celltrion has established a competitive ground as it obtains approval and distributes new products in addition to existing biosimilars. Samsung Bioepis' new project is 'new drug discovery,' preparing beyond biosimilars. Whereas the past performance focused on proving equivalence against original products and expanding market presence, the company will likely focus on securing a proprietary new drug pipeline for the next 10 years. Samsung Bioepis has already started investing in R&D of proprietary new drug discovery. It has begun searching for next-generation technologies, such as establishing an AI-based new drug discovery platform and antibody-drug conjugate (ADC). However, the company's new drug pipeline for clinical trials has not been officially announced. The company will likely seek an R&D model that could balance profitability and risk rather than delving into new drug discovery, requiring time and funds but carrying low success. This approach has both pros and cons. This means there is an opportunity to choose and focus on an area with a high probability of success rather than taking risks and being reckless. Celltrion employs a similar strategy. Samsung Epis Holdings' establishment can be seen as Samsung Group entering a new stage of 'comprehensive biotech strategy' beyond biosimilars. This is likely to be followed by efforts to expand into fundraising, co-development with global big pharma, and the rare disease and vaccine sectors. There's still a long way to go. Their experience in new drug discovery remains in the early stages, and there are many challenges to overcome, such as securing high-value pipelines, navigating the regulatory environment, and securing talent. The company's journey was like 'starting from scratch' and turning question marks from external and internal sources into exclamation points. Conversely, it was also an expression of pride in leading the company to its current level with a relatively minor organization compared to large entities like Samsung Electronics and Samsung C&T. The launch of Samsung Bioepis Holdings signifies confidence in past achievements and represents a bold first step toward new challenges and responses. We anticipate Samsung Bioepis' continued strong presence in future competition, leveraging their 'original vision' and proven competitiveness in the biosimilar industry.
- Opinion
- [Reporter's View] Strengthening GMP for sterile drugs
- by Kim, Jin-Gu May 19, 2025 05:56am
- The government has reaffirmed its existing position on strengthening GMP standards for sterile finished drug products in December. The Ministry of Food and Drug Safety recently met with sterile drug factory managers and stated that there will be no postponement of the enforcement of the “Regulations on Drug Manufacturing and Quality Control” in December. Under these regulations, facilities producing sterile drug products must implement the following measures: ▲Establish and implement a systematic contamination control strategy for the manufacture of sterile drug products; ▲Develop individual good manufacturing practices (GMP) for advanced biopharmaceuticals; ▲Clarify the details of the specific dosage forms, evaluation procedures, and methods for determining compliance with the good manufacturing practices (GMP). The MFDS has been preparing for the implementation of these measures since joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014. The MFDS believed that it was necessary to strengthen GMP standards for sterile products in line with international standards. To this end, the MFDS has provided the pharmaceutical industry with sufficient time. When revising relevant regulations in 2023, the MFDS required manufacturers of sterile finished drug products to replace outdated equipment within 2 years after the revision of the notice, and manufacturers of sterile APIs to do so within three years. Additional grace periods were granted for certain provisions. However, as the deadline for implementing the new regulations approaches, an increasing number of pharmaceutical companies are refusing to replace their outdated equipment. Instead of halting production of sterile drug products, they plan to shift production to contract manufacturing facilities. This is because replacing outdated equipment could cost tens of billions to hundreds of billions of won, depending on the facility. At first glance, this seems as if aseptic drug manufacturers are considering production halts to save equipment replacement costs. Additionally, given the sufficient timeframe provided, it seems that they have not been reacting for the past two years and only decided to halt production as the deadline for stricter regulations approaches. However, the story of sterile drug manufacturing plants is different. Their common claim is that the productivity of sterile drug manufacturing itself has become too low, regardless of the need to replace outdated equipment. In a situation where profits are almost nonexistent due to excessively low drug prices, they argue that they have no choice but to halt production, as additional costs of up to hundreds of billions of won would be required for replacements. For this reason, the pharmaceutical industry requested support for facility investment costs and improvements to the drug price structure during several recent meetings with the MFDS. However, the MFDS has drawn a line, saying that it will not provide investment support as it has already provided a sufficient grace period. Discussions on pricing sterile drugs have also stalled. If this situation continues, there are concerns that the supply shortage of sterile drug products will worsen by the end of the year. Already this year, 22 cases of injection supply discontinuations or shortages have been reported. It is known that about 10 sterile drug factories are seriously considering discontinuing production. If they discontinue their product supply by the end of the year, there are concerns that it will lead to a large-scale supply shortage. I agree with the policy direction that GMP should be strengthened to meet international standards. However, before doing so, we must first address the fundamental problem of low productivity. The MFDS must not dismiss the demands of sterile drug product manufacturers as “lack of preparation.” Unless the fundamental problems of excessively low drug prices and the resulting low productivity are resolved, it will be difficult to encourage sterile drug product manufacturers to participate, no matter how long the grace period is.
- Opinion
- [Reporter's View] Korea’s vaccination space: ups and downs
- by Eo, Yun-Ho May 15, 2025 06:23am
- Vaccines are at the forefront of localized pharmaceuticals in Korea. Leading domestic companies such as GC Biopharma and SK Bioscience are now responsible for vaccine production and supplying preventive vaccines for various diseases, including influenza. The commercialization of so-called “premium homegrown vaccines,” such as pneumococcal protein vaccines, cervical cancer vaccines, and shingles vaccines, is also progressing steadily and is set to be completed soon. However, despite the improvement in vaccine competitiveness, the vaccination fee cartel among doctors in South Korea remains unchanged. For example, if the purchase price of a vaccine (the price at which doctors buy vaccines from pharmaceutical companies) is KRW 100,000, the implicitly accepted appropriate inoculation fee among doctors is around KRW 200,000. However, after some time passes, some local clinics lower the vaccination fee to as low as KRW 150,000 in an attempt to sell more at lower prices. Some even abandon their margins altogether, offering even lower prices through promotional events. These clinics then face criticism from neighboring doctors. They are labeled as traitors who betrayed their colleagues for their own gain. Such controversies can escalate into disputes between different medical specialties. The medical society of the relevant specialty may launch a campaign claiming that people should be vaccinated by specialists in their respective field. The interesting point lies in the margins. For vaccines, the difference between the inoculation fee and the purchase price, minus approximately 30% tax, constitutes the doctors' income. If they receive the “appropriate price” they claim—KRW 200,000 per vaccination—the actual income may vary depending on tax reporting, but amounts to roughly 70,000 won. For some workers, this is equivalent to a day's wage. Even if they receive KRW 150,000, approximately KRW 35,000 margin remains. This is by no means a small amount. Private practitioners claim that after including vaccination fees and labor costs, nothing remains. Meanwhile, during the flu season, they engage in fierce competition to secure supplies of flu vaccines, where the purchase price is KRW 10,000, and an approximately KRW 12,000 margin remains per inoculation. Private practice doctors are self-employed. This is a fact. Therefore, it is understandable that they want a high income that commensurates with the effort they put into obtaining their medical license. Additionally, since vaccine prices are not fixed, they have the right to set their own prices. However, they should refrain from claiming that twice the purchase price is the “appropriate price” and form a cartel. I earnestly hope they will finally “recognize” that the era when doctors' words were unquestioningly accepted is now over.
