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- 2025-12-17 11:50:37
- Policy
- Revaluations for herbal medicines begin in earnest
- by Lee, Tak-Sun Dec 10, 2025 08:48am
- Some herbal preparations are entering comparative clinical trials for equivalence reevaluations.This comes one year after the Ministry of Food and Drug Safety announced the reevaluation of herbal preparations’ reimbursement last December, indicating how long it took for clinical trial protocols to be approved.According to industry sources on the 9th, the MFDS recently approved two clinical trial protocols submitted by manufacturers of Pelargonium sidoides extract tablets for equivalence reevaluations.The original brand for Pelargonium sidoides is Hanwha Pharma’s Umckamin, used for acute bronchitis.The approved clinical trials are reportedly led by Dasan Pharma and Genuone Sciences.Currently, 30 Pelargonium sidoides tablet products maintain marketing authorization (excluding export-only products). Of these, 28 are subject to the equivalence reevaluation. Dasan Pharma’s trial is said to have the largest number of participating products.The clinical trial is expected to proceed to submit a final report in two years. The MFDS granted an additional six months beyond the initially planned duration. However, depending on trial progression, the submission deadline may be shortened or delayed.Unlike Pelargonium sidoides tablets, the generic versions of the gastritis treatment ‘Stillen Tab and the osteoarthritis reliever ‘Layla Tab, which are also subject to reevaluation, are reportedly still undergoing revisions to their clinical trial protocols.The herbal medicine equivalence reevaluations began upon the MFDS’ announcement in December last year. The MFDS stated that proving bioequivalence through standard BE testing was unsuitable for these formulations, and that comparative clinical trials would be required instead. This marks the first time equivalence reevaluation will be performed through full clinical trials.Comparative clinical trials are considered the most burdensome form of equivalence testing for companies, costing tens of billions of won and requiring more than two years. As a result, about half of the original 212 products subject to reevaluation have already withdrawn their marketing authorization or converted to export-only status.Upon the MFDS review announcement, companies submitted clinical trial protocols by June. A total of seven trials will be conducted (three for Stillen generics, three for Umckamin generics, and one for Layla generics). Poonglim Pharmatech will be conducting 2 trials for 2 Stillen generics; Mother’s Pharm 1 for Stillen generic and 1 for Layla generic; and Dasan Pharma and Genuone Scinces, Korea United Pharm will each lead 1 Umckamin generics trial.However, due to MFDS requests for revisions and companies’ extension requests, approvals for the trials have been repeatedly delayed.Consequently, the first trial plan approval came a full year after the announcement. The Umckamin generic companies whose plans were approved this time must submit their result reports by December 2027 to demonstrate equivalence with the original product.
- Policy
- First batch of Korean anthrax vaccine Barythrax Inj released
- by Lee, Jeong-Hwan Dec 10, 2025 08:48am
- GC Biopharma announced on the 8th that Barythrax Inj., the world’s first recombinant-protein anthrax vaccine that it had co-developed with the Korea Disease Control and Prevention Agency (KDCA), has been released domestically for the first time.This comes about 8 months after receiving marketing approval as Korea’s 39th homegrown new drug last April, marking the country’s transition from full reliance on imported anthrax vaccines to enabling self-sufficiency.The first batch shipped from the Hwasun plant will be supplied as reserve vaccines for the KDCA.Unlike existing vaccines that directly use non-pathogenic anthrax bacteria, Barythrax expresses and purifies only the Protective Antigen (PA) protein, a key component of anthrax toxin, offering a higher safety profile.Preclinical and clinical studies demonstrated Barythrax’s excellent safety and strong immunogenicity, and the platform allows rapid large-scale manufacturing when needed.Barythrax is produced at GC Biopharma’s vaccine plant in Hwasun, Jeonnam, which has the capacity to manufacture up to 10 million doses annually, sufficient for approximately 2.5 million people based on a four-dose regimen per person.GC Biopharma particularly emphasized that Barythrax is a vaccine developed entirely with domestic technology, making it highly significant in terms of securing national vaccine self-sufficiency.The KDCA expects this shipment to help secure the stable supply of essential national medicines. As a core material in the bioterrorism response system, anthrax vaccines have previously relied on overseas products, raising persistent concerns about supply disruptions.The KDCA's position is that securing a domestic production base strengthens vaccine sovereignty and enables a more systematic response to infectious disease and bioterrorism.KDCA Commissioner Seung-Kwan Lim said, “The first shipment of the domestically produced anthrax vaccine is an achievement made through close cooperation between government agencies and private companies. This case will serve as a turning point to elevate the technological capabilities and production base of Korea’s vaccine industry to the next level.”He added, “We will continue to pursue the domestic production of essential national vaccines and build a more robust vaccine stockpiling system for infectious diseases and bioterrorism preparedness.”GC Biopharma CEO Eun-chul Heo remarked, “We are pleased to be able to ship the first supply of a domestically developed anthrax vaccine that we jointly developed with KDCA. GC Biopharma will continue to strive to strengthen Korea’s disease prevention capabilities and achieve vaccine self-sufficiency.”
- Policy
- Changes to DUR criteria for pack unit drugs
- by Jung, Heung-Jun Dec 10, 2025 08:48am
- The changes to the drug utilization review (DUR) system criteria for pharmaceuticals sold in packs will be applied to duration of use, starting on December 11. The issue concerning confirmation of the actual duration of use due to the characteristics of pack units is expected to be improved.New regulatory standards will apply to 39 drug items involving 18 active ingredient codes, including treatments for allergic rhinitis, hormonal preparations, and COVID-19 therapies.On December 9, the Health Insurance Review and Assessment Service (HIRA) informed medical institutes of changes to the Drug Utilization Review (DUR) criteria. By incorporating the total duration of use, duplicate checking will become more thorough.For example, if a prescription for Climen is written for 1 tablet once daily for a 28-day supply, the pharmacy dispensing claim will now record as dose per administration: 0.0356 (1/28), times per day: 1, and total days of Supply: 28.DUR system checks for duplication only for a single day. However, there have been differences in unit size for cases such as a 21-tablet pack or a 30-tablet pack.From now on, the actual period of use will be displayed next to the total days of supply. For example, if the unit is a 28-tablet pack, the period of use will be recorded as 28. This change will make duplication checks easier for the actual 28-day duration of the pack-unit drug.Regarding the rationale behind the improvement, HIRA stated, "For pack-unit drugs, improvements to the review criteria were necessary to accurately reflect the actual duration of use, as unclear prescribing or packaging unit descriptions resulted in inaccurate monitoring."Furthermore, the change is also aimed at preventing drug misuse and abuse through accurate duplication checks of the same active ingredient.HIRA requested cooperation from healthcare institutions, asking them to "accurately record the total days of supply in accordance with the guidelines to ensure the supply of safe use information for pack-unit drugs."The total days of administration will also be reflected in claims for both treatments and dispensing. For example, if a prescription for Climen is written for 1 tablet once daily for a 28-day supply, the pharmacy dispensing claim will now record as dose per administration: 0.0356 (1/28), times per day: 1, and total days of Supply: 28.
- Policy
- DREC deems 42 drugs appropriate for reimbursement
- by Jung, Heung-Jun Dec 09, 2025 08:28am
- According to the Health Insurance Review and Assessment Service (HIRA), the Drug Reimbursement Evaluation Committee (DREC) deemed reimbursement appropriate for 42 drug items during the 12 meetings held this year.Among them, 30 cases involved new drug listings or expanded reimbursement indications, averaging about 2.5 approvals per month. Another 12 were approved for reimbursement when accepted at or below the evaluated price.Based on the results of the twelve meetings held by HIRA’s DREC on the 7th, Dailypharm examined the status of reimbursement appropriateness approvals by the DREC this year.Although final listing requires successful price negotiations with NHIS and subsequent review by the Health Insurance Policy Deliberation Committee, passing the DREC remains the most critical hurdle toward reimbursement listing in Korea.This year, Janssen Korea and Eli Lilly Korea appeared most frequently among the 42 approved items. Janssen led with four products, followed by Lilly with three, marking strong performance.Janssen Korea secured reimbursement approval for Balversa (erdafitinib), a targeted therapy for urothelial carcinoma. Darzalex (daratumumab) for multiple myeloma and Erleada (apalutamide) for prostate cancer were recognized as appropriate for reimbursement expansions.Additionally, Opsynvi (macitentan/tadalafil) for pulmonary arterial hypertension received conditional approval, making drug price negotiations critical.Lilly Korea received positive evaluations for Jaypirca (pirtobrutinib), a treatment for mantle cell lymphoma, and Mounjaro Prefilled Pen (tirzepatide) as an adjunct therapy for diabetes. Also, Ebglyss Autoinjector Inj (lebrikizumab) was conditionally approved at or below the evaluation price.Other multinational companies, including Novartis Korea, AstraZeneca Korea, GSK, and Sanofi, had 2 items approved each, including conditional approvals.Among domestic companies, Hanmi, Jeil Pharmaceutical, JW Pharmaceutical, HLB Pharma, GC Pharma, Shinpoong Pharm, and Samoh Pharmaceutical all received reimbursement adequacy approvals from DREC.Notably, Handok is the only domestic company with two items approved. Its bile duct cancer treatment, Pemazyre Tab (pemigatinib), received reimbursement adequacy approval, while its thrombocytopenia treatment Doptelet Tab (avatrombopag) received conditional approval. Both drugs were listed after price negotiations with the National Health Insurance Service.
- Policy
- Application submitted for salt change generic to 'Jakavi'
- by Lee, Tak-Sun Dec 09, 2025 08:28am
- Novartis' rare blood cancer treatment 'Jakavi'The first applications for a generic to Novartis's 'Jakavi (ruxolitinib phosphate)', used for rare blood cancers, have been filed in South Korea. Jakavi is facing generic competition ahead of the expiration of its domestic substance patent on January 14, 2027. Currently, Daewoong Pharmaceutical and Chong Kun Dang are actively seeking to circumvent a composition patent.According to the Ministry of Food and Drug Safety (MFDS), applications for different dosage variants of a salt form-changed generic to Jakavi were filed on the 24th and 27th of last month. In response, the MFDS notified the original patent holder, who had registered patents on the drug listing, of the generic applications, in accordance with the Patent-Approval Linkage System.The generic drug has a different salt form from the original Jakavi. While Jakavi is the phosphate salt, the generic drug uses the hemifumarate salt. This change in salt form is interpreted as a strategy to circumvent the patent.Currently, Daewoong Pharmaceutical and Chong Kun Dang are also working to circumvent the composition patent by filing suits for negative confirmation of the scope of right with the Korean Intellectual Property Trial and Appeal Board. If these suits are successful, they will be able to launch their generic drugs immediately after the substance patent expires on January 14, 2027.Another key characteristic of the generic drug applications is that they exclude the Graft-versus-Host Disease (GVHD) indication, which still has a remaining Post-Marketing Surveillance (PMS) period.Jakavi is indicated for the treatment for Myelofibrosis (MF), Polycythemia Vera (PV), and Graft-versus-Host Disease (GVHD). However, the GVHD indication was added in 2022 and has a remaining PMS period until May of next year (2026). During the PMS period, the filing of generic drug applications is generally prohibited.Generics to Jakavi are reportedly under development, besides those form Daewoong and Chong Kun Dang. Jakavi is a global blockbuster product, with worldwide sales reaching KRW 6.6 trillion as of 2024. Its sales in South Korea are rapidly rising after successfully securing reimbursement coverage for MF and subsequently for GVHD in 2023.Given that rare disease drugs often lack alternatives and carry high costs, analysis suggests that companies succeeding in an early launch of a generic drug can secure a stable sales performance.
- Policy
- Gvn’t ‘Drug reform benefits Korean companies’
- by Lee, Jeong-Hwan Dec 05, 2025 08:33am
- Ki-hyun Bae (Deputy Director) and Yeon-sook Kim (Director) of the Ministry of Health and Welfare’s Pharmaceutical Benefits Division explain the intent behind the new generic drug pricing reform. The ministry’s position is that the focus should be on significantly expanding price incentives for innovative pharmaceutical companies, firms with strong R&D, and manufacturers that ensure a stable supply of essential or exit-prevention medicines, and on advancing the post-listing price-reduction management system.The Ministry of Health and Welfare has emphasized that the purpose of this reform of the generic drug pricing system is to encourage domestic pharmaceutical companies' new drug research and development (R&D) and ensure the stable supply of essential medicines. It also stated that the advancement of the post-listing price-reduction management system reflects efforts to minimize unnecessary confusion or administrative burdens for pharmaceutical companies and establish a predictable environment for drug price reductions.This is a follow-up measure to the domestic pharmaceutical industry's strong resistance to the reform, which includes a substantial reduction in the generic drug pricing calculation rate from 53.55% to the 40% range.The Ministry of Health and Welfare stated that it intends to send a clear signal through this drug pricing system reform: both domestic and international pharmaceutical companies should strengthen their commitment to obtaining Korea Innovative Pharmaceutical Company certification, and even non-innovative pharmaceutical companies can receive preferential drug pricing if they invest in R&D or contribute to the production of essential medicines and drugs, preventing market withdrawal.On December 3, Director Yeon-sook Kim and Deputy Director Ki-hyun Bae met with the press corp and explained that the new pricing structure aims to reinforce the environment for new drug R&D and comprehensively overhaul the post-listing pricing evaluation and reassessment system.Kim stated, “The core of this reform is enhancing access to new drugs and establishing a clinical evidence-based reevaluation system. It's regrettable that this aspect seems largely unknown to the domestic pharmaceutical industry.”The drug pricing system improvement plan reported by the Ministry of Health and Welfare to the Health Insurance Policy Deliberation Committee last month includes applying preferential price increases of up to 68%, 60%, and 55% to innovative pharmaceutical companies and companies with high R&D investment ratios, respectively, and extending the existing one-year price premium period to three years or more.In particular, the ministry plans to overhaul post-listing reassessment into a unified, evidence-driven system focused on clinical utility, and to establish a fixed biannual schedule (April and October) for post-management.The Ministry of Health and Welfare states that this aligns the timing of drug price adjustments for frequently occurring reasons like ‘expanded usage scope’ and ‘price-volume linkage pricing’, enhancing predictability. This fully reflects the domestic pharmaceutical industry's demands.Kim stated, “The most important direction of this reform is not prioritizing health insurance savings, but minimizing policy judgment factors and shifting to an evidence-based approach. We will strengthen predictability by uniformly standardizing the post-approval management cycle, procedures, and evaluation items.”Furthermore, the Ministry clarified that the adjustment lowering the generic drug ceiling price to the 40% range in 2012 is a phased approach, starting sequentially with items already on the reimbursement list that have maintained a calculation rate of 50% or higher for over 13 years.While interpretations vary within the pharmaceutical industry regarding whether this applies only to drugs listed in the 2012 reimbursement list, Kim emphasized, “The approximately 3,000 items that are priced between the 53.55% and 50% level, and the approximately 4,500 items between 50% and 45% level are based on the 2012 reimbursement list criteria.”According to the government roadmap, approximately 3,000 items will be adjusted over 3 years starting in the second half of next year (2026). From the second half of 2027, the 1,500 items that maintained a rate of 45% or higher will be sequentially adjusted (reduced).Regarding the industry’s biggest concern—whether generics listed after April 2012 will also face price cuts—Kim explained, “We will gather industry feedback, and as outlined in the reform plan, we intend to establish a periodic reassessment framework, which may be discussed in connection with this issue. No immediate reduction or specific schedule has been finalized.”Kim further stated, “This restructuring should be viewed not as a policy differentiating global and domestic companies, but as a structural reorganization to ensure a stable supply of new drugs and essential medicines. Measures such as raising the designation criteria for exit-prevention drugs, adjusting the cost-compensation method, and providing incentives for using domestically produced raw materials are actions that broadly incorporate the pharmaceutical industry's research service results. Savings generated from the price cuts will ultimately return to benefit the domestic pharmaceutical industry.”Kim concluded, “For areas not yet finalized, we will make decisions after collecting further opinions. For this, we will continue communication and consultation with pharmaceutical associations and experts.”
- Policy
- 10th DREC members to be appointed next year
- by Jung, Heung-Jun Dec 05, 2025 08:33am
- The appointment of members for the 10th term of the Drug Reimbursement Evaluation Committee (DREC), which assesses the appropriateness of drug reimbursements, is expected to be delayed until next year.The 12th committee meeting held today (4th) will see the existing 9th-term members participate as usual. The Health Insurance Review and Assessment Service (HIRA) is currently conducting personnel verification procedures, including checking administrative disciplinary records, prior to appointing the 10th-term members, with appointments expected soon.Although the 9th-term members' official two-year term ended last September, their tenure has been extended due to delays in recommending and appointing the 10th-term members.DREC members are appointed after receiving around 70 recommendations from professional medical societies and organizations. The Korean Pharmaceutical Association may also recommend one member.The committee consists of approximately 105 members. Once the HIRA appointments are finalized, various subcommittees, such as the Pharmacoeconomic Evaluation Subcommittee and the Risk-Sharing Agreement Subcommittee, will also be newly reorganized.Seventy-six members were appointed for the 9th term. For the monthly DREC meetings, 20 members are randomly selected to participate.Among the recommended DRED members, the following are excluded: ▲Those currently performing pharmacoeconomic evaluation-related services for pharmaceutical companies ▲Officers, employees, or practicing physicians/pharmacists of the recommending medical/pharmaceutical organization ▲Those deemed unable to perform duties impartially during the pre-appointment ethics screening ▲ Individuals with administrative sanctions or legal penalties within the last 5 years under the Medical Service Act, Pharmaceutical Affairs Act, National Health Insurance Act, or Medical Benefit Act ▲ those who have served as a DREC member for two or more consecutive terms.Since HIRA is currently reviewing candidates’ administrative sanction histories, the committee may be fully reorganized with new members as early as January next year. The term of office is 2 years.Additionally, HIRA revised the Drug Evaluation Committee regulations last July, changing the chairperson election method from an election by committee members to appointment by the HIRA Director. The authority to form subcommittees and elect subcommittee chairs was also transferred from the committee chair to the HIRA Director, an issue criticized during the National Assembly audit.The number of individuals each organization (KMA, KPA, KSHP, etc.) can recommend for the candidate pool was also reduced from two to one..
- Policy
- MFDS announces revision to the ODD regulations
- by Lee, Tak-Sun Dec 05, 2025 08:32am
- From now on, Orphan Drug Designation (ODD) can be expedited without the need to submit documentation of significant improvement in safety and effectiveness compared to substitute drugs.The Ministry of Food and Drug Science (MFDS) (Minister Yu-Kyoung Oh) announced on December 4 that it has issued an administrative notice for the amendment to the 'Regulations on the Orphan Drug Designation' (MFDS Notice), expanding the criteria to provide diverse treatment opportunities for patients with rare diseases.The amendment is part of the 'The Top 50 Food and Drug Safety Tasks' and it will allow drugs used to treat or diagnose rare diseases to receive expedited designation as orphan drugs without having to submit data proving 'significantly improved safety and efficacy compared to alternative medicines.'A rare disease is one with a prevalence of fewer than 20,000 people, or one whose prevalence is unknown due to diagnostic difficulty, as designated and publicly announced by the Korea Disease Control and Prevention Agency (KDCA).The amendment enhances predictability by clearly specifying the documentation requirements that companies must submit when applying for Orphan Drug Designation, aligning them with the specific designation criteria.Since July of this year, the MFDS has been operating a 'Consultative Body for Improving the ODD System' to discuss various improvement measures, including the ease of designation criteria.The MFDS anticipates that this revision will help foster an environment in which patients with rare diseases can receive stable treatment and will contribute to the government's national agenda to fulfill a 'A Strong Welfare Nation Built on Solid Foundations'.Detailed information on the administrative notice for the regulation amendment can be found on the MFDS official website (www.mfds.go.kr) → Legislation/Data → Legislation Information → Legislation/Administrative Notice.
- Policy
- KPA counters oppositions on need for INN prescribing
- by Kim JiEun Dec 04, 2025 09:15am
- Sujin Noh, General Affairs/Public Relations Director, KPA The Korean Pharmaceutical Association has fully refuted concerns raised by some quarters on how the introduction of international nonproprietary name prescribing will not generate the expected healthcare cost savings and infringe on physicians' prescribing rights.At a media briefing on the 1st, Director of General Affairs and Public Relations Soo-jin Noh discussed the association’s advocacy efforts regarding international nonproprietary name prescribing and introduced portions of the final report from the Korea Institute for Pharmaceutical Policy Affairs ‘INN Prescribing Model Development’ that was completed last October. The KPA also announced that it recently issued an advocacy booklet titled ‘A Citizen-Centered INN Prescribing System: Why It Is Absolutely Necessary,’ to strengthen outreach to government bodies around its INN Prescription Task Force and to support lobbying activities by regional branches and sub-branches.This booklet, focusing on why the system is beneficial for the public, highlights: ▲ Definition of INN prescribing ▲Benefits for improving public health ▲ Reducing the burden of drug costs ▲ Addressing drug supply instability ▲ Strengthening patients' right to know and choice of medications ▲ Safety considerations ▲ Phased and stable implementation plans.The booklet particularly drew attention by including the KPA's position on issues and questions raised by some sectors regarding the INN prescribing system.This is interpreted as a counter-rebuttal to the Korean Medical Association's strong opposition to the legislative amendment currently proposed in the National Assembly regarding the introduction of generic name prescribing for out-of-stock drugs, which counters some of the KPA's arguments.The KPA first countered the claim that INN prescribing infringes on doctors' prescribing rights and undermines the principle of separation of medical and pharmaceutical practices, stating, “It is, in fact, a system that aligns with the intent of separating prescribing and dispensing practices.The KPA emphasized, “Physicians hold the core authority in patient treatment to determine the active ingredient, dosage, administration method, frequency, and duration. Pharmacists guide and dispense medications, enabling rational selection based on drug supply conditions and the patient's economic situation. INN prescribing aligns with the principle of rational drug use inherent in the separation of medical and pharmaceutical practices.”The KPA also countered the KMA’s recent objections to its claim, based on research by the Korea Institute for Pharmaceutical Policy Affairs, that introducing INN prescribing could save KRW 7.9 trillion in medical costs.The KPA stated, “Even under the current system, dispensing based on the lowest price criterion could save KRW 7.9 trillion annually, and including socioeconomic costs, we can expect savings exceeding KRW 9 trillion. If drug price system improvements and INN prescribing are implemented together, the savings will be even greater.” Regarding the criticism that INN prescribing cannot resolve the root cause of drug supply instability, the KPA emphasized, “This is an issue that remains unresolved despite attempts at various measures, including drug price increases, distribution improvements, and cooperation from pharmaceutical companies to increase production.” It stressed, “The most effective solution on the ground is for pharmacists to assist patients in exercising their right to choose the correct medication, ensuring patients can take government-guaranteed therapeutically equivalent drugs on time.”The KPA announced plans to produce additional materials for public outreach beyond this advocacy booklet.Director Noh stated, “We initially printed about 1,000 copies of this document, which will be distributed to provincial branches nationwide, the Korean Pharmaceutical Association's board members, and lawmakers. We also plan to produce additional public awareness leaflets and distribute them to local pharmacies and hospital pharmacists to explain the necessity of INN prescribing to the public." Director Noh also disclosed part of the results from a citizen survey included in the final research report on ‘‘INN Prescribing Model Development’ completed last month by the Korea Institute for Pharmaceutical Policy Affairs.Noh stated, “In a survey of 3,000 adults regarding awareness of INN prescribing, 83.8% of respondents agreed with the practice. Notably, citizens with prior experience of generic substitution showed higher positive perceptions of INN prescriptions. Reasons cited included improved access to dispensing and enhanced understanding of medication information.”Noh added, “It appears the public is choosing their preference based on individual convenience rather than professional disputes like conflicts between doctors and pharmacists. As drug shortages persist, overall public awareness and positive sentiment toward generic substitution and prescribing drugs with the same active ingredient seem to have increased.”
- Policy
- Bill banning pharma wholesale platforms
- by Lee, Jeong-Hwan Dec 03, 2025 08:47am
- Minister of Health and Welfare Jeong Eun Kyeong, Rep. Kim Yoon of the Democratic Party of Korea, and Rep. Seo Young-kyo of the Democratic Party of Korea (from left)"This bill is not a second 'Tada Ban Law,' as mentioned by Rep. Shin Dong-uk in the press. It is not intended to prohibit the non-face-to-face healthcare platform itself, but rather to impose restrictions to solve problems arising when a platform operates a pharmaceutical wholesale business. Currently, the establishment of medical institutions and pharmacies is also currently prohibited from engaging in wholesaling."With the formal legislation bill for non-face-to-face healthcare and the bill banning intermediary platforms from establishing pharmaceutical wholesale (the so-called 'Doctor Now Bejin Pharm Prevention Act') passing the National Assembly's Legislation and Judiciary Committee, the evaluation is that "the government has achieved results in legislation that guarantees the safety of public pharmaceuticals."Minister of Health and Welfare Jeong Eun Kyeong addressed questions from both ruling and opposition party members in the Legislation and Judiciary Committee on the afternoon of November 26. It is reported that the Minister said, "The platform wholesale prohibition act is not a second 'Tada Ban Law,' with a firm stance, remaining calm, and giving logical and clear explanation of the potential side effects if the bill failed to pass led to its passage by the Committee.The ruling Democratic Party of Korea also played a major role, directly proposing the regulatory bill (Rep. Kim Yoon) and endorsing the Minister's philosophy and concerns through supportive questioning (Rep. Seo Young-kyo). This combined effort pushed through the necessary legislative act to establish a comprehensive non-face-to-face healthcare environment.The government and the ruling party effectively collaborated to proactively block the potential criticism of having a 'impractical non-face-to-face care bill,' which they would have faced if the platform wholesale prohibition act had not passed.The amendment to the Medical Service Act (institutionalizing non-face-to-face healthcare) and the amendment to the Pharmaceutical Affairs Act (prohibiting intermediary platforms from establishing wholesalers) are expected to be put to a vote and processed in the National Assembly plenary session on November 27.If approved by the plenary session without issue, all necessary parliamentary procedures for the legislation will be complete. Following government transfer and Cabinet Meeting approval, the laws will be announced next month (December). The implementation dates for both the Non-face-to-face Care Act and the Doctor Now Bejin Pharm Prevention Act are set to "one year from the date of government promulgation," meaning they will officially take effect in December 2026.Minister Jeong's firm stance... "Medicine is a public good, platform must not be abused"Throughout the Legislative and Judiciary Committee meeting, Minister Jeong logically persuaded the National Assembly, explaining why non-face-to-face healthcare intermediary platforms must be prohibited from engaging in wholesaling and detailing the anticipated side effects if it were allowed.Minister Jeong's core argument was that the bill prohibiting the concurrent operation of a platform and a wholesale business is not intended to regulate the non-face-to-face care intermediary industry, which is a new and innovative sector. Instead, it is a preventive law designed to prevent platforms from abusing their immense authority to control the distribution, prescribing, and dispensing of pharmaceuticals, which are considered a public good, for unfair profit.In explaining this, Minister Jeong pointed to the precedent of the domestic market-leading platform, Doctor Now, which had already caused controversy by establishing the pharmaceutical wholesaler Bejin Pharm as a subsidiary and by entering the drug distribution market.Doctor Now's operation of Bejin Pharmacy was strongly opposed by the pharmacists' community and caused public controversy over fair pharmaceutical distribution. It ultimately served as a critical justification for the Legislation and Judiciary Committee's amendment to the Pharmaceutical Affairs Act."Platform operators possess far greater influence than doctors or pharmacies," Minister Jeong explained. "They can use their affiliated pharmacies or medical institutions to influence the prescribing or dispensing of specific drugs. A case has already occurred where a platform operator, by concurrently operating a pharmaceutical wholesaler, induced affiliated pharmacies to source drugs through that wholesaler."Minister Jeong added, "This could become a form of unfair trade (illegal pharmaceutical rebates) and serve as an incentive to use specific drugs. The concern is that the platform, with its enormous power and influence, could impact physician prescribing and pharmacy dispensing. This power could be misused, for example, if the platform receives investment from pharmaceutical companies."Minister Jeong stressed, "We sought to address these issues preventively during the introduction of the new system because the misuse of the platform business could affect drug transactions, prescribing, and dispensing, all of which are considered a public good. It would ultimately have a negative impact on patients. This is consistent with the prohibition on medical institution or pharmacy founders from concurrently engaging in wholesaling."Following this explanation, Rep. Shin Dong-uk, who had raised the initial question, concluded his query by saying, "Yes, I understand," which led to the bill's passage by the Committee.Rep. Kim Yoon proposes the Bejin Pharm Prevention Bill...Rep. Seo Young-kyo questions the opening of a wholesale websiteRep. Kim and Rep. Seo of the Democratic Party also played crucial roles in the bill's passage.First, Rep. Kim proposed the amendment to the Pharmaceutical Affairs Act, representing the concern that Doctor Now's direct involvement in drug distribution and sales through the establishment and operation of Bejin Pharm could sharply increase the potential for new types of illegal activities (rebates) and significantly raise the probability of violating the Medical Service Act and Pharmaceutical Affairs Act by guiding patients to specific medical institutions and pharmacies. The legislative intent was to establish a fair pharmaceutical sales order.Immediately following the bill's proposal, Doctor Now publicly criticized the ban on platform-owned wholesalers as unfair legislation, expressing "regret that the bill was proposed despite policy authorities judging it difficult to be viewed as unfair trade."Prior to proposing the bill, Rep. Kim had summoned Doctor Now CEO Jeong Jin-woong to the Parliamentary Inspection last year to directly question him about the side effects of establishing and operating a wholesaler.Later, when the bill faced challenges during the National Assembly Health and Welfare Committee's plenary session, Rep. Kim, Rep. Park Hee-seung, and others strongly advocated for the legislative validity, arguing to their colleagues that the "Doctor Now Bejin Pharma Prevention Act is not a ban on non-face-to-face healthcare, but a regulation on illegal platform rebates."Rep. Seo emphasized the need for the legislation at the Legislation and Judiciary Committee hearing by publicly disclosing a text message that illustrated the potential problems if platforms were allowed to operate wholesale businesses alongside.Based on a text message Doctor Now sent to local pharmacies, Rep. Seo requested that the bill be passed. The Doctor Now text message announced the opening of a pharmaceutical wholesale website as a new function within its Doctornow-Web.The Doctor Now text included details that inventory would be linked based on the pharmacy's purchase history of specialized drugs distributed by Doctor Now, and upon linking, a 'Guaranteed Dispensing' badge would be displayed on the user application.Rep. Seo stated, "There are good startups and others that are not. This bill allows startups and the neighborhood pharmacies across the country to achieve a favorable coexistence."Thus, with Rep. Kim proposing the platform-wide prevention bill, Minister Jeong strongly asserting the legislative necessity, and Rep. Seo providing the final compelling evidence, the bill successfully passed the Health and Welfare Committee and the Legislation and Judiciary Committee, moving closer to final processing in the National Assembly plenary session.Regarding the legislation, Rep. Kim said, "Medical treatment for convenience should not be corrupted into dangerous distribution. The law is designed to prevent illegal rebates, as non-face-to-face platforms can influence the use and prescribing of pharmaceuticals through connections with pharmacies. If we allow non-face-to-face care without preventing this, there is a high risk of another new form of pharmaceutical rebates becoming a major issue, and we must stop it."
