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Policy
Guideline to be revised to prevent unintentional impurities
by
Lee, Hye-Kyung
Mar 04, 2024 05:52am
Amid the recent recall of sitagliptin combination products due to excess detection of impurities, the Ministry of Food and Drug Safety appears to be busy preparing a system to manage unintentional impurities at all times. The MFDS aims to revise the 'Guideline for Safety Management of Impurities in Drug Products’ within June to establish and advance a permanent pharmaceutical industry-led system for managing unintentional impurities in drugs. The revised guidelines will reflect the latest advances in Korea and abroad such as new impurity tolerance standards, causes, and reduction strategies, and measures such as information collection, risk assessment, testing, and reduction. Unintentional impurities have continued to occur, including those in the hypertension drug valsartan in 2018, gastrointestinal drugs ranitidine and nizatidine in 2019, and the diabetes drug metformin in 2020. In addition, last year, due to the detection of nitrosamine impurities, the government implemented safety measures such as submission of test results and recalls were implemented on domestically distributed drugs such as ‘perindopril,’ ‘tamsulosin,’ ‘nortriptyline,’ and ‘sitagliptin’ based on the evaluation results. In particular, in the case of sitagliptin, a number of sales recalls have recently been carried out by the companies as a precautionary measure due to concerns over the detection of excess impurities (NTTP). In January, Kyung Dong Pharma’s anti-ulcer drug ‘Zanitin Tab 150mg' was recalled due to concern over the detection of impurities, and in February, Alvogen Korea's ‘Genxiga S Tab 10/100mg', Hutecs Korea Pharmaceutical's ‘Nanudangxiga Tablet 10/100mg', KyungBo Pharmaceutical's ‘Janustin Duo Tab 10/100mg', Ahn-Gook Pharm’s ‘Adapasita Duo Tablet 10/100mg', and Nex Pharm Korea's 'Flosita Tab 10/100mg' were also recalled. An MFDS official, said, “We will strengthen drug quality control and contribute to public safety through preemptive management of impurities that may be unintentionally mixed into drugs."
Policy
Will the novel anticancer drug Enhertu be reimb in April?
by
Lee, Tak-Sun
Mar 04, 2024 05:52am
After going through two Cancer Disease Deliberation Committee meetings and two Drug Reimbursement Evaluation Committee meetings, the anticancer drug ‘Enhertu’ has finally started drug pricing negotiations with the National Health Insurance Service. As the drug has passed drug evaluations after repeated revisions, the negotiations are expected to go smoothly. In particular, it will be interesting to see if the government grants reimbursement within April, as there are analysts who believe that the government is using the scenario of coverage before the parliamentary election. According to the industry on the 28th, the Health and Welfare Ministry recently issued a drug pricing negotiation order to the NHIS for Enhertu, after which the NHIS has begun full-scale negotiations. Enhertu 100mg Inj (fam-trastuzumab deruxtecan-nxki, Daiichi Sankyo Korea) was granted marketing approval in Korea in September 2022. The company applied for reimbursement coverage in December of the same year. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. .As a HER2-targeted antibody-drug conjugate (ADC), Enhertu demonstrated clinical efficacy over existing agents .HER2-targeted antibody-drug conjugate (ADC) Enhertu reduced the risk of disease progression or death by nearly 50% compared with conventional chemotherapy, with an mOS of 23.4 months, which was a 6.6-month extension from the 16.8 months in the chemotherapy group .However, this high effect rather posed a hurdle during drug pricing evaluations .Due to the high survival rate, the duration of its use was expected to increase, making it difficult for the drug to pass the economic evaluation threshold .If the ICER value (incremental cost-effectiveness ratio) of a drug, which is used as an indicator for economic evaluation, exceeds the threshold, it makes it difficult for reviewers to recognize the adequacy of the drug’s reimbursement .Due to this, the Cancer Disease Deliberation Committee was held twice last year to set the reimbursement standard for the drug, and the Drug Reimbursement Evaluation Committee meeting, which makes the final judgment on the adequacy of reimbursements appropriateness of drugs, was held twice in January and February this year .Although the ICER value of Enhertu exceeded the threshold of KRW 50 million set for anticancer drugs, the threshold was reportedly lowered to a reasonable level after discussion with the authorities .The company is analyzed to have conceded a lot in terms of drug price .As the drug price and financial sharing have been somewhat clarified during the evaluation process, negotiations are expected to go more smoothly .This raises the possibility that the deal could be finalized earlier than the 60-day negotiation period and listed in April .As there is talk that the government may list Enhertu and promote it as an innovative new drug listing achievement before the general elections, this is expected to speed up the negotiation process .However, there is also an analysis that the MOHW’s negotiation order came later than expected, leaving insufficient physical time to complete negotiations before the Health Insurance Policy Review Committee meeting commences in March.
Policy
Patients bear 100% of Imfinzi cost for biliary tract cancer
by
Lee, Tak-Sun
Feb 28, 2024 05:50am
Reimbursement standards have been prepared for the use of combination therapy in biliary tract cancer in Korea. However, in consideration of health insurance finances, patients are required to the full cost of the high-priced immuno-oncology drugs. The Health Insurance Review and Assessment Service recently added the combination of immuno-oncology Imfinzi (durvalumab) with gemcitabine and cisplatin to the biliary tract cancer reimbursement standards after an opinion survey on the amendment to the notification on medicines prescribed and administered to cancer patients. This is the first time an immuno-oncology drug regimen has been added for biliary tract cancer. HIRA said that the cost of the Imfinzi+gemcitabine+cisplatin combination is too high relative to its clinical benefit to cover the entire regimen, therefore patients will need to bear a 100% copayment rate for Imfinzi and a 5% copayment rate for the other drugs, gemcitabine + cisplatin. In terms of eligibility, reimbursement standards are limited to histologically confirmed adenocarcinoma and exclude ampulla of Vater cancer. Currently, the drug price (upper limit) of Imfinzi is set at KRW 3,347,202 per vial (10 ml). The use of immuno-oncology drugs, which attack cancer cells by activating the body's immune system, is being applied to various cancer types. In Korea, it is being used in lung, head and neck, stomach, breast, and cervical cancers, and the use has now been extended to biliary tract cancer. In addition, the immuno-oncology drug Keytruda applied for reimbursement extensions to 13 cancer indications last year. Meanwhile, in the amendment to reimbursement standards for anticancer drugs, the use of FOLFIRINOX (oxaliplatin+irinotecan+leucovorin+5-FU) therapy (neoadjuvant chemotherapy) was newly added for pancreatic cancer and capecitabine monotherapy (adjuvant therapy) for biliary tract cancer. In addition, the phrase that restricts the use of enzalutamide (Xtandi soft capsules)+ADT and abiraterone acetate (Zytiga)+ADT regimens for prostate cancer has been removed. In acute myeloid leukemia, reimbursement for Xostapa is now approved without limiting the duration of treatment, regardless of their eligibility for hematopoietic stem cell transplantation As a result of the negotiations with the NHIS, the expected claims amount for Xostapa was set at KRW 124.1 billion, and an additional KRW 83.8 billion was with the reimbursement extension. However, the actual financial expenditure is expected to be less than this when considering the risk-sharing agreement. Xostapa agreed to a drug price of KRW 190,704, a 6.2% reduction from the current upper limit, starting in March.
Policy
AbbVie Korea will discontinue supply of Kaletra
by
Lee, Tak-Sun
Feb 27, 2024 05:45am
The HIV drug Kaletra, which was used as a first-line antiviral treatment during the COVID-19 outbreak, will be withdrawn from the domestic market. The decline in domestic demand is cited as the reason. On the 23rd, AbbVie Korea reported to the Ministry of Food and Drug Safety that will stop supplying Kaletra Tab(lopinavir + ritonavir) in Korea. The company explained, "In light of the decrease in demand for Kaletra and the fact that improved substitute options are well in supply, we plan to discontinue its supply." The company added that the impact on patients is expected to be minimal as improved alternatives are already well-established in the market. In consideration of the available improved alternatives to Kaletra, AbbVie said it will work to ensure that patient care is not disrupted through notifications and guidance to long-term care organizations and their patients. With the notification, Kaletra will be available only until October of this year. Kaletra was used as an antiviral drug during the first outbreak of the COVID-19 virus in February 2020. However, in August of that year, the National Medical Center’s Central Clinical Committee for New Infectious Diseases removed Kaletra from recommendations in the clinical practice guideline for the antiviral treatment of COVID-19. Instead, remdesivir was added in its place. The reasoning was that Kaletra seemed to have no or limited effect against COVID-19. At the time, the committee explained, "HIV-protease inhibitors, including Kaletra, are not generally recommended for COVID-19 and may be considered cautiously in very limited circumstances, such as in clinical studies.” Kaletra gave up the rights to its patent in early 2020, allowing generics to be developed around the world, but no generic versions have been released in South Korea since. Currently, Pfizer's Paxlovid and MSD's Lagevrio are the only officially authorized COVID-19 treatments in Korea.
Policy
Expedited domestic supply of suspended essential medicines
by
Lee, Hye-Kyung
Feb 27, 2024 05:45am
The timelines for domestic distribution of supply-disrupted essential medicines will likely be shortened to two months from four months starting this year. The Korea Orphan & Essential Drug Center (KOEDC) announced on the 27th their plans to ensure a stable supply through monitoring the supply and demand of orphan drugs and essential medicines in Korea and overseas, according to its ‘2024 Business plan.’ If supply monitoring indicates medical needs and urgency of medicines, the center will shorten the timelines for domestic supply through a preliminary survey of overseas medicines for expedited supply. Previously, the Ministry of Food and Drug Safety (MFDS) was responsible for confirming the expedited supply of essential drugs that had been suspended, and the center handled business related to imports and distribution. The plan for expedited supply of suspended essential drugs: the center will be responsible for implementing preliminary measures of expedited supply, such as independently conducting surveys of overseas medicines and domestic demands. Then, the MFDS will undertake administrative management of the expedited supply. From now on, the center will conduct preliminary measures of expedited supply, such as independently conducting surveys of overseas medicines and domestic demands. Then, the MFDS will undertake administrative management of the expedited supply. Furthermore, the center aims to strengthen the domestic self-sufficiency of suspended essential medicines by expanding consignment manufacturing (a new item per year). If a stable supply of the previously ordered items is achieved, the production will be transferred to private companies. The center will diversify their sources for purchasing (manufacturer, overseas wholesale business) drugs, especially for orphan drugs, to improve the system of imports and distribution of orphan drugs and essential medicines that are not available domestically. Furthermore, the center plans to shorten import timelines and reduce drug prices by discussing estimated demands with a distributor beforehand and obtaining three months of stock. Besides these plans, the center will strengthen its supportive measures. This includes improving the environment related to safe use of medicines and reducing patients’ financial burden by adjusting drug prices. The center will continue to offer support related to regular surveys of overseas medicines and adjustment of drug prices by reducing importing costs, tariff refunds via tariff and tax exemption, low-income funding projects for purchasing medicines (90 million won), and patient support (free supply) programs. “KOEDC will continue to survey and provide information related to the development of orphan drugs and put our efforts into providing patients with medicines that are necessary but unavailable domestically,” KOEDC President Jinseok Kim stated
Policy
Delayed actual transaction price cuts slash expected savings
by
Lee, Tak-Sun
Feb 26, 2024 05:25am
The implementation of the actual transaction price system intended to reduce the drug price has been postponed. Since the system was initially scheduled to take effect in January, the price monitoring investigation reached conclusion. However, the price adjustments are being delayed for various reasons. Pharmaceutical companies may benefit from the delay, but it results in financial loss for the National Health Insurance Service (NHIS) due to reduced effects of financial savings. According to industry experts on the 22nd, the price cutting of the actual transaction prices of drugs has been repeatedly delayed. It is unlikely to be implemented in March as it has not been included in this year’s Health Insurance Policy Review Committee agenda. Since the post-listing price cuts following the re-evaluation of the upper price limit are scheduled to begin in March, price cutting of the actual transaction prices of drugs is expected to be postponed. This delay is intended to allow the payer to take effective management of returns and budgets into account. However, it is unclear whether the policy changes will take effect in April. Financial savings may be negatively affected due to the delay in policy implementation. The government implements an actual transaction price system biannually. This system investigates the actual prices of drugs distributed in hospitals, except for national and public hospitals. If a drug’s actual price distributed is lower than the upper limit price, it is subject to a discount rate of 10%. The investigations exclude low-priced drugs and drugs that have been listed as shortage prevention drugs (SPD). The NHIS can expect financial savings through the system. The 2019 actual transaction price investigation resulted in price cutting of 3900 drugs, leading to annual financial savings of 42.1 to 112.9 billion won in 2020 and 2021, according to ‘Research on the comprehensive improvement of the actual transaction price system based on the effectiveness evaluation (P.I: Professor Kim, Jinhyun of Seoul National University).’ According to government data, adjusting the upper limit price of 3829 drugs based on the actual transaction price investigation resulted in a net estimated financial savings of 79.6 billion won in 2022. Since a price cutting of drug prices based on the actual transaction price investigation saves a minimum of 40 billion won annually, 10 billion savings in the first quarter are estimated to be lost due to delays in the implementation. The Ministry of Health and Welfare (MOHW) stated that the price cuts of the actual transaction price have been delayed because their review of National Essential Drugs and drugs in short supply is incomplete. The implementation timeline will be decided later, according to the MOHW. Every month, the price of drugs on the drugs shortages list has been increasing. In March, The prices of 49 items of tulobuterol patch are expected to increase by an average of 13.9% of the upper limit price. An additional designation of National Essential Drugs is planned for the first half of the year. However, critics argue that the NHIS is causing financial losses by delaying the price cuts not only for drugs under investigation but also for those where investigations have already concluded. The point is that the drugs in short supply or National Essential Drugs represent only a small fraction of the items investigated for actual transaction prices, and these can be adjusted during post-management. Another point is that the government is refraining from taking risks before the upcoming general election. The government may proceed with implementation cautiously because price cutting of drugs in short supply may lead to public criticism. “Is the government reluctant to take risks before the upcoming general election, despite their goal of efficiently managing finances by assessing the financial structure of national insurance?” a pharmaceutical industry representative emphasized. “If the government continues to delay the implementation, their expected financial savings will be reduced,” a representative added.
Policy
Competition intensifies in 3-combo drug mkt for COPD·asthma
by
Lee, Tak-Sun
Feb 23, 2024 05:48am
GSK’s triple therapy for COPD, Competition in the market for three-drug combinations used to treat COPD (chronic obstructive pulmonary disease) and asthma has become somewhat complicated. Kolon Pharma’s Trimbow, which was introduced in January, triggered the competition, and GSK’s Trelegy Ellipta, which had enjoyed its sole lead in the market till then, strengthened its line-up in response. According to industry sources on the 22nd, GSK Trelegy Ellipta will be reimbursed for the treatment of asthma in addition to COPD starting next month. The Ministry of Health and Welfare issued a pre-announcement of the amendment to the revised drug reimbursement standards that Trelegy Ellipta will be reimbursed for the treatment of "severe asthma that is not adequately controlled with a combination of moderate-or high-dose inhaled corticosteroids and a long-acting inhaled beta-2 agonist,” starting on March 1st. With the reimbursement, Trelegy Ellipta’s competitivity in the market will increase further as it will be available for severe asthma in addition to its existing indication for moderate-to-severe COPD in adults. Trelegy Ellipta had been dominating the Korean market with its low drug price but is now facing competition with Kolon Pharm's Trimbow inhaler which was introduced in January. Moreover, the new inhaler can be used for both asthma and COPD. With Trelegy Ellipta’s reimbursement also extended to COPD, the two drugs will now be fully engaged in a one-on-one competition. The price of Trelegy Ellipta is slightly less expensive. Its price remains the same at KRW 45,602 per box even with the coverage expansion. Trimbow is only KRS 1,000 more expensive, at KRW 46,669. However, Trimbow seems to have scored a win by obtaining a higher price than Trelegy Ellipta. Trimbow has both asthma and COPD indications, and was regarded as an alternative to Novartis’s triple therapy ‘Enerzair Breezhaler 150/50/160μg’ (upper limit price KRW 65,502) for asthma and ‘Trelegy Ellipta (upper limit price (upper limit price KRW 45,602)’ for COPD, and was priced below 90% of the weighted average price of the two drugs. If Trimbow only owned an indication for COPD, its price would have been set lower than that of Trelegy Ellipta, however, owning the two indications allowed for the drug to receive a price higher than that of Trelegy Ellipta. Therefore, the competition between the two drugs are likely to begin in earnest due to their similar indications and prices. In addition to adding the asthma indication Trelegy Ellipta, GSK was successful in receiving reimbursement for its higher-dose Trelegy 200 Ellipta Inhaler to the list this time. However, Trelegy Ellipta 200® Inhaler is only used for asthma. Therefore, its alternative, ‘Enerzair Breezhaler 150/50/160μ (upper limit price KRW 74,115)’ became the basis for its pricing negotiations. As a result, Trelegy Ellipta 200® Inhaler was listed at KRW 65,500 per box, after accepting a price below 90% of its alternative. With the reimbursement extension for its Trelegy Ellipta and the new listing of the Trelegy Ellipta 200®, GSK will now be able to adopt a two-track strategy in Korea’s asthma inhaler market. Industry analysis is that the new additions will contribute to broadening the choice for patients in Korea, with the lower-priced Trelegy Ellipta and the higher-priced, higher-dose Trelegy Ellipta 200. Also, GSK voluntarily reduced the price of its 2 inhaled single-agent products to help ease the financial burden of the patients. The price of Arnuity 100 Elipta (fluticasone furoate) for asthma was reduced from KRW 19,973 to KRW 17,376, and Incruse Elipta (umeclidinium bromide) for COPD was reduced from KRW 38,438 to KRW 34,978. The measure is considered to have been made in strategic response to the introduction of Kolon’s triple therapy product. Going forward, a key question for the triple combination market is whether AstraZeneca will introduce its Breztri Aerosphere in the market. The drug received conditional approval from the Drug Reimbursement Evaluation Committee in May of last year, that its reimbursement would be adequate if it is priced below the assessed value. The company has since applied for reevaluation to DREC, but no results have been disclosed since. However, when listed, it would be difficult for Breztri Aerosphere, which only has an indication for COPD, to receive a price higher than that of Trelegy Ellipta, which currently has the lowest price.
Policy
Gov't 'Too soon to price immune-oncology drugs by indication
by
Lee, Jeong-Hwan
Feb 22, 2024 05:49am
MOHW Director Chang-Hyun Oh(left) and NHIS Deputy Minister Hae-Min Jung is explaining the administrative procedures for the indication-specific drug pricing system The Ministry of Health and Welfare has reaffirmed its stance that it will use the health insurance finances saved by the follow-up management measures, including reevaluation of benefit adequacy and reevaluation of the reimbursement standards and conditions, to reimburse drugs that have proven their innovativeness, such as immuno-oncology and targeted-anticancer drugs. Regarding introducing a differentiated drug pricing system for immuno-oncology drugs by indication in Korea, the NHIS said that more social consensus is needed and that it would first need to gather patients' opinions on paying different prices for the same drug by cancer type and spend the administrative costs required to change the health insurance claims system, such as assigning separate billing codes. Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, and Hae-Min Jung, head of the Department of Drug Management at the NHIS, made such comments at a forum discussion on the 10-year achievements and challenges of the introduction of immuno-oncology drugs that was hosted by Rep. Jong-sung Lee of the People Power Party on the 20th. Regarding the future insurance coverage of anti-cancer drugs, Oh said that he would focus on strengthening patient access, especially for cancer types with no reimbursed treatment. To this end, Oh urged pharmaceutical companies seeking reimbursement to thoroughly prepare a financial sharing plan. The implication is that immuno-oncology drugs are relatively expensive, so pharmaceutical companies need to take on a drastic range of financial sharing in order to get their drugs reimbursed quickly. In particular, Oh promised to operate the reimbursement system with the concept that reimbursing immuno-oncology drugs strengthens essential medical care. "We have already announced an essential medical care policy that saves healthcare finances that are being leaked or overused for use as additional resources. In the pharmaceutical field, we will also mobilize follow-up management systems such as reevaluation of reimbursement adequacy and reevaluation of reimbursement standards and conditions to rationalize expenditures and reduce unnecessary finances, and reflect them in innovative drug prices." He added, "Foreign countries would not have applied immuno-oncology reimbursement at once either. Korea is also just going through the due process. Due to their high price, the companies need to take special care in submitting the financial-sharing plan to accelerate their reimbursement. We are expanding coverage of cancer types for immuno-oncology drugs, and will prioritize patient access to immuno-oncology drugs.” Jung explained that to enable the indication-specific drug pricing system, changes would need to be made to Korea’s health insurance claims system, such as assigning a separate billing code and preparing a separate refund plan for differences in patients’ out-of-pocket expenses. In other words, consultations with relevant organizations and social consensus are further needed to introduce the indication-specific drug pricing system. Jung also raised the need to collect patients' opinions, as insurance drug prices may increase when additional cancer types are added to the reimbursement list. "If the indication-specific drug pricing system is introduced, drug prices may increase when other cancers are added for reimbursement. We also need to consider whether patients will be willing to accept different out-of-pocket costs for different cancers. The patient-specific flexibility and price opacity when signing risk-sharing agreements need to be considered.” Jung added, "The single price-weighted average price method also requires separate codes for each indication, and it is difficult to predict usage, which can lead to the need for later settlement of prices. Multi-year multi-indication systems are also quite rare overseas. Therefore, some uncertainties lie in indication-specific contracts, so it is important to consider whether the industry will be willing to accept these variables.” "The realization of the multi-indication reimbursement system should be a collaborative effort between relevant organizations, patients, and the government; It requires discussions on ensuring patient access to care, as well as the clinical innovativeness of the drug, the financial capacity of national health insruance, and administrative costs associated with the separate billing codes."
Policy
‘Gavreto’ withdrawn from KOR amid reimb rejection
by
Lee, Hye-Kyung
Feb 21, 2024 05:45am
BPM made a decision to discontinue selling and developing Gavreto in all countries except the United States and China. ‘Gavreto Cap. 100mg (pralsetinib),’ previously managed by Roche Korea, will be withdrawn from the Korean market. In February 2023, Roche announced its decision to terminate the global partnership agreement with Blueprint Medicines Corporation (BPM), the drug’s original developer. Furthermore, Gavreto did not clear the reimbursement hurdle, leading to the voluntary withdrawal of its Biologics License Application (BLA). Gavreto will no longer be available in South Korea as BPM, the original developer of Gavreto, does not hold a division in Korea, and a search for a new partner has been unsuccessful. “Gavreto has not been prescribed since June 2023, and there are currently no patients using the drug,” Roche Korea said reporting to the Ministry of Food and Drug Safety (MFDS) recently. “The company has 134 in stock, with the last import date being April 11th.” Gavreto was granted a BLA approval in South Korea for its use as a treatment for non-small cell lung cancer (NSCLC) on March 29th, 2022. As targeted therapies for RET(REarranged during Transfection) gene mutation, Gavreto and ‘Retevmo Cap. (selpercatinib)’ were expected to be competitors in the market. However, the two drugs went different paths in Korea. Retevmo was deemed suitable for reimbursement by the Cancer Drug Review Committee of the Health Insurance Review and Assessment Service (HIRA). Gavreto, on the other hand, received a non-reimbursement decision. However, Retevmo failed to be listed for reimbursement due to unsuccessful drug pricing negotiations with the National Health Insurance Service (NHIS). Currently, there are no RET-targeted therapy that are eligible for reimbursement. RET, which is one of the essential imaging biomarkers for cancer, can cause malignant tumors by a fusion with another gene or point mutations. Certain types of cancers, including lung cancer, breast cancer, and colorectal cancer, are associated with RET mutations. The frequency of RET mutations in NSCLC is about 2-6%, while RET fusion mutations in thyroid cancer are reported to be up to 40%. “While there is no identical drug to Gavreto available, a similar formulation called Retevmo with the same indication is available in the market,” Roche stated. “Considering the small number of eligible patients for this indication, it appears appropriate to use targeted therapy for RET gene mutations within the same class.” The withdrawal of Gavreto is not limited to South Korea. “On January 8th of this year, BPM made a decision to discontinue selling and developing Gavreto in all countries except the United States and China,” said Roche. “(In South Korea), we plan to voluntarily withdraw the BLA after completing the import discontinuation reporting process.”
Policy
President Yoon asks doctors to 'stop collective action'
by
Lee, Jeong-Hwan
Feb 21, 2024 05:45am
President Yoon, President Seok-Yul Yoon said, "Doctors should not hold the lives and health of the people hostage and take collective action, no matter what,” in response to doctors who submitted a collective resignation letter and medical students who decided to take a collective leave of absence in protest to the government’s plan to increase medical school admissions. President Yoon made it clear that increasing the number of medical school seats by 2,000 is the minimum amount necessary to fill essential and regional medical gaps and to train medical scientists and medical entrepreneurs for the advanced bio-healthcare industry. In other words, the president has directly expressed the position that there is no turning back, such as reducing the number of medical school admissions through collective action by doctors. However, he also reaffirmed his commitment to continue government investment and support for essential fields, rural areas, and medical education, and that he will build an environment of trust by reducing judicial risks for doctors. At 2 p.m. on the 20th, President Yoon presided over the 9th Cabinet Meeting and made the above remarks regarding the increase in medical school admissions. President Yoon pointed out that despite the government meeting with doctors' organizations 28 times to explain the inevitability of healthcare reform and promising measures such as reducing judicial risks for doctors, strengthening the compensation system for essential doctors, and supporting investment in regional healthcare, the public's health has been threatened by the resignation of doctors. He criticized that by submitting resignations, which led to the cancellation of surgeries and postponement of cancer patients' operations, the doctors have abandoned their responsibilities and put the public's health at risk. "Protecting the life and safety of the people is the reason for the existence of the state, along with national security and public safety. It is the most basic constitutional responsibility of the government. The state must protect the lives and health of the people by efficiently managing medical resources. Doctors may not be public servants like soldiers or the police, but they must never deny care as a group.” The president also added that the need for healthcare reform in Korea has been long overdue. He cited the case of a nurse at one of the Big 5 hospitals who collapsed on duty in July 2022 and died without being able to receive surgery due to the lack of doctors. From President Yoon's view, the incident demonstrates the serious situation of essential medical care in Korea, and the urgent need for medical reform to train doctors for essential medical care, but 30 years have passed without any government being able to propose a solution. "The demand for medical services is growing rapidly, but the supply is not keeping up with the demand. The number of essential medical personnel has decreased even more significantly, and medical care in rural areas has collapsed accordingly. This collapse of local essential medical care puts the health and safety of those living in rural areas at serious risk.” "Until now, the government has continuously failed to increase the medical school enrollment quota by even a single student. Even if we increase the number from next year, the first medical school graduates will not graduate until 2031, and it will take at least 10 years to produce specialists to strengthen essential medical care. It will not be until 2035 that the increase of 2,000 essential medical doctors will be realized." "Increasing the medical school enrollment quota is the need of the hour. The arguments and fears that the quality of medical education will decline are not correct. The government will continue to invest in and support medical education. We are committed to the people and healthcare reform. For local doctors who excel in cancer surgery and critical care, the government will publicize their performance and achievements widely and correct the blind preference for medical services in Seoul." He added, “Korea's medical capabilities are among the best in the world, but the reality of healthcare in rural areas is miserable. Please join us in carrying out the healthcare reform that cannot be delayed. We will create an environment where doctors can treat with confidence by fairly compensating local essential and serious medical care and reducing judicial risks. Expanding medical schools is also essential to train medical scientists and medical entrepreneurs for the advanced bio-healthcare industry."
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