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Policy
The government are in full swing discussing support
by
Lee, Jeong-Hwan
Nov 24, 2022 05:50am
The ruling party and the government's move to expand access to patients with severe and rare diseases, which was President Yoon Suk Yeol's presidential pledge, is notable. On the 21st, the People's Power, the Ministry of Health and Welfare, and the Ministry of Strategy and Finance will hold a policy meeting at the National Assembly to prepare measures to support the treatment of severe and rare diseases. The move is aimed at collecting opinions from private experts on the establishment of nursing hospitals specializing in severe and rare diseases and supporting medical expenses for new drugs for rare diseases and reflecting them in related policies and budgets. The policy meeting will be attended by People's Power figures, including Sung Il-jong, chairman of the policy committee, Lee Chul-kyu, secretary of the Special Committee on Budget and Accounts, and Lee Jong-sung, a member of the Health and Welfare Committee. In the government, Park Min-soo, the second vice minister of welfare, Hwang Soon-kwan, the Ministry of Economy and Finance, and the director of chronic disease management at the Korea Centers for Disease Control and Prevention will attend. In the private sector, the co-CEO of the Seungil Hope Foundation, permanent directors, and chief-level officials will be present. Ahead of the review of the Special Committee on Budget and Accounts, the People's Power announced that it would set up a regional specialized institution to deal with rare diseases of children and adolescents, establish a nursing hospital for rare incurable diseases such as amyotrophic lateral sclerosis(ALS), and increase the budget by 34.5 billion won to support medical expenses for non-reimbursed new drugs. Analysts say that it is unusual for the ruling party's policy committee to directly mention medical expenses for new drugs for severe and rare diseases. It is interpreted as a move to fulfill President Yoon's presidential campaign pledge and meet the demand for access to new drugs for incurable diseases raised by the private sector. President Yoon has made a pledge to resolve policy blind spots on treatments for severe and rare diseases and inject finances where practical guarantees are needed.
Policy
Gov’t to increase drug price reference countries
by
Lee, Tak-Sun
Nov 23, 2022 06:04am
The Health Insurance Review and Assessment Service made a preannouncement of a revision plan to expand the number of reference countries used to evaluate new drugs from 7 to 9 (US, UK, Germany, France, Italy, Switzerland, Japan, Canada, Australia·A9). After opinion inquiries, the revised plan will take effect in January next year. Although the reference countries are used to evaluate the adequacy of reimbursement of new drugs that are waived submission of pharmacoeconomic evaluation data, domestic pharmaceutical companies that own more generics than new drugs are also voicing opposition due to concerns over the next step HIRA will take afterward. According to industry sources on the 22nd, HIRA is also preparing reevaluations on listed drugs based on the revised plan to expand the number of price reference countries. Therefore, it is analyzed that reevaluations will be carried out sequentially from 2024 at the earliest after making preparations next year. The industry had expressed concerns about the very low price of generic drugs in Australia, which was added as a drug price reference country in the revision. Australia is known to introduce the cheapest drugs through competition. According to research, some generic drugs in Australia are set at one-fifth of the price in Korea. Therefore, using the drug price of 9 countries including Australia when conducting reevaluations on the adequacy of listed drugs will likely reduce the price of listed drugs in Korea. In other words, it will have the same effect as the unilateral price cut that had been made in 2012. Another industry concern is that such reevaluations are also being driven by policies after the ruling party pointed out that generic prices in Korea are high at the last NA audit. An industry official said, “If the expanded reference countries are used not only for pricing of new drugs but also reevaluations of all listed drugs, the price of generic drugs will inevitably be cut.” The reevaluation plan of listed drugs was also discussed with the expansion of pricing reference countries at the public-private working group meeting that had been held previously. Thus, HIRA is expected to start preparations after including the reevaluation plan for listed drugs in the 2nd Comprehensive Plan of National Health Insurance according to the expansion of reference countries. As a result, the industry believes that the criteria will be set next year and the drug price of listed drugs adjusted after sequentially receiving reevaluations from 2024.
Policy
MFDS recruits companies to develop 6 National Essential Drug
by
Lee, Hye-Kyung
Nov 23, 2022 06:04am
The government is busy recruiting institutions to develop domestic manufacturing technology for items that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines. The Ministry of Food and Drug Safety had recently selected 11 products, including 5 raw materials and 6 finished products, as candidates for Stage 1 development after deliberation by the Product Selection Committee, and posted an open recruitment for developers on the webpages of research institutions including Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The government will additionally recruit developers for items only a single company had applied for, which include 2 finished products (‘Amiodarone Inj,’ ‘stiripentol Cap’) and 4 APIs (‘amiodarone (amiodarone tablet, injection),’ ‘ibuprofen (ibuprofen injection 5mg/ml),’ ‘ketoconazole (ketoconazole tablet),’ ‘benserazide (levodopa, benserazide tablets)’). Although there is no limit to the number of development projects each institution may apply for, if the same applicant applies to develop the APIs that are candidates for a stable supply of national essential drugs and use them for the development and production of the finished drugs, the items will be recognized as two separate items and be supported separate R&D expenses. The MFDS selected drugs that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines and has been carrying out the ‘Research Project for Managing Stable Supply of National Essential Drugs’ from this year until 2026. Despite the need to maintain a stable supply of national essential drugs at all times, there recently has been a shortage of raw materials as well as finished drugs internationally due to the COVID-19 outbreak. In particular, Korea is heavily dependent on imported drugs, therefore criticism had been raised on the need to prepare a supply chain for essential drugs in case of the rise of public health crises in the future. in The MFDS will invest a total of KRW 5 billion for 5 years - KRW 1 billion each year- to build a stable supply system for national essential drugs that have supply concerns and will aim to develop raw materials and finished drug production technology for domestic production. In the first stage (first-second year) of the project, the development targets will be selected and over 40% of the technology for the target drugs will be developed. In the second stage (third-fifth year), the remaining technology will be developed and be subject to comprehensive assessments. The MFDS said, "In addition to developing the technology for the localization and self-sufficiency of API manufacturing, we will also expand the recognition of multiple specifications of APIs when adding API manufacturers to diversify the supply chain for APIs. Also, if a disruption in supply is expected, we will promptly handle related complaints including adding drug substance manufacturers, etc."
Policy
Forxiga Prodrug will be reimbursed for five months
by
Lee, Tak-Sun
Nov 23, 2022 06:04am
ForxigaProdrug of Forxiga, an SGLT-2 diabetes treatment drug that Dong-A ST succeeded in avoiding patents through the development of drugs, will be listed on the 1st of next month. It is five months before the expiration of the patent. Earlier this month, it was possible because it succeeded in avoiding the duration of the material patent, which ends in April next year. The Ministry of Health and Welfare recently disclosed this fact through an administrative notice of the revision of some details on the criteria and methods for applying for medical care benefits. Dong-A ST's "Dapapro 10mg" will be newly registered on the 1st of next month and added to the standard for diabetes treatment. Dapapro was granted permission on 23 August. At that time, it was unclear whether Dapapro would be released before the expiration of its patent. This is because Dong-A lost the second trial of a patent suit against AstraZeneca, a patent holder of Forxiga, in February. Dong-A challenged the patent that Dapapro, a prodrug with a different chemical structure from the original, was not within the scope of Forxiga's material patent rights, but it was blocked in the second trial. The Korean Intellectual Property Tribunal, which is the first trial, decided that it was not within the scope of rights as requested by Dong-A. The ruling could have put Dong-A ST's early launch efforts in vain. This is because there is not much time left until the patent expires. However, Dong-A succeeded in avoiding patents on the 2nd of this month through a new patent lawsuit. This time, it was argued that Dong-A ST products were not included in the rights on the 917th day of the duration added to a material patent for Forxiga. For now, Dong-A ST is reportedly coordinating internally with the goal of releasing it before February next year if it is paid on the 1st of next month. Currently, the Ministry of Food and Drug Safety has approved 225 products containing Dapagliflozin. However, among them, only seven items from AstraZeneca, the original company, are on the market. It is virtually difficult to sell the remaining items until the patent expires in April next year. Dong-A ST is launching early alone. It is the first SGLT-2 generics in Korea. However, there is a possibility that the direction of patent litigation will emerge as a variable. It is not known whether AstraZeneca, who lost the patent tribunal, will appeal. If AstraZeneca expresses her intention to appeal, it will have to fight again in the patent court. If the ruling is overturned in the patent court, the sale of the product must be stopped. If there is a record of selling before then, AstraZeneca can also file a compensation suit based on this. It is highly expected that Dong-A ST will not miss this opportunity to dominate the market. Although it actively responds to patent lawsuits, it is expected to focus its efforts on marketing to preoccupy the market regardless of the outcome. It is reported that Dong-A ST believes that the patent issue has been resolved and judges the early release before the expiration of the patent.
Policy
Reimb standards will be newly established for Coagadex
by
Kim, Jung-Ju
Nov 22, 2022 06:04am
Reimbursement standards for the hemophilia treatment Coagadex (Human coagulation factor X) that had been granted urgent introduction in Korea have been newly established. Also, oral eperisone hydrochloride as well as oral and ophthalmic solutions that include syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy will be applied new reimbursement standards according to their reevaluation results. The Ministry of Health and Welfare announced its partial amendment to the ‘Details on the standards and methods for application and method (pharmaceuticals)‘ and is opinion inquiry until the 24th. The new reimbursement standards are set to be applied on December 1st. First, the MOHW recognized the need for reimbursement for the hemophilia treatment Coagadex (Human coagulation factor X) in patients confirmed with hereditary Factor X deficiency and willy newly establish reimbursement standards. Patients with hereditary Factor X deficiency will be allowed the administration of Coagadex. In terms of a single administration (single dose), 40 IU/kg in patients aged less than 12 years, 25 IU/kg in patients aged 12 years or older will be allowed, with up to 4 courses recognized per visit. Under the doctor’s discretion, such as when the patient's condition is stable, up to 8 courses of administration will be reimbursable if a patient visits once every 4 weeks. If Coagadex is administered in the hospital, those administered in hospitals are also counted. However, if bleeding occurs in the patient even after administering 8 courses for 4 weeks, an additional 2 courses per visit may be covered, but the doctors’ medical opinion in the medical record needs to be attached. Also, oral eperisone hydrochloride, oral, and ophthalmic solutions including syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy this year will be applied new reimbursement standards according to their reevaluation results. Eperisone hydrochloride drugs including CHodang Pharm’s Mulex Tab will be reimbursed for painful muscle spasms associated with musculoskeletal disorders such as cervicobrachial syndrome, periarthritis, and lower back pain. Sodium alginate preparations including Taejoon Pharm’s Lamina-G solution etc will be granted reimbursement for improving subjective symptoms of reflux esophagitis. For ophthalmic solutions including syrup and oral suspension forms, a new reimbursement standard will be set under oral sodium alginate products according to the reimbursement reassessment results, and be deleted under general principles for ophthalmic solutions. The restrictions set on the number of administrations for Hanmi Pharmaceutical’s Maqaid Inj (triamcinolone acetonide) will be deleted based on approvals in Korea and abroad, textbooks, clinical practice guidelines, clinical literature, and opinion from related societies, but readministration will only be applied reimbursement when administered in intervals that exceed 3 months. Also, Hanmi Pharmaceutical’s Esomezol Cap 10mg (oral esomeprazole 10mg) will be newly listed next month and be added to the list of proton pump inhibitors. Reimbrusement standards for oral proton pump inhibitors include omeprazoles like Yuhan Losec Cap, lansoprazoles like Lanston Cap, pantoprazole like Pantoloc Tab, rabeprazoles like Pariet Tab, and esomeprazoles like Nexium Tab. However, as Esomezole DR Cap 10mg was not approved for the treatment of H.pylori infections, this indication is off-label and excluded from reimbursement. Reimbursement for Kyowa Kirin Korea’s Romiplate Inj 250μg (Romiplostim) will be extended to the treatment of refractory or relapsed aplastic anemia following immunosuppressive therapy based on approvals in Korea and abroad, textbook, clinical practice guidelines, and clinical literature. Reimbursement standards for vedolizumab injections that are applied to Takeda Pharmaceuticals Korea’s Kynteles Inj (vedolizumab) will newly include Kynteles refilled Pen Inj to account for its new listing. However, in consideration of the differences between existing formulations and the approvals (dose and usage), the evaluation method for ulcerative colitis will be changed and new standards for self-injection and long-term prescription will be set. According to the new details, considering how Kynteles Prefilled Pen Inj is a self-injection formulation, the patient should fill out a 'patient dosing diary' to monitor the administration period of the drug for the management of medical care institutions. Also, for long-term prescriptions of Kynteles Prefilled Pen Inj, a single prescription period shall be up to 2 weeks upon discharge from the hospital and up to 3 weeks for outpatient prescriptions and shall be prescribed in hospitals in principle. Patients who show no side effects and stable disease activity 24 weeks since initial administration.
Policy
Phase 3 of Fitusiran, an all-around tx for hemophilia
by
Lee, Hye-Kyung
Nov 22, 2022 06:04am
Phase 3 clinical trials of Fitusiran, a treatment candidate substance that is effective for both hemophilia A and B, are also being conducted in Korea. The Ministry of Food and Drug Safety approved a phase 3 clinical trial of Sanofi-Aventis Korea on the 18th. This clinical trial is a phase 3, single group, multi-organ, multinational clinical trial to investigate the efficacy and safety of Fitusiran prevention therapy in male severe type A or type B test subjects over the age of 12 with or without inhibitory antibodies to coagulation factor VIII or IX. In phase 3 of multinational clinical trials targeting 75 male hemophilia patients around the world, Korea has been approved for clinical trials in five patients. Clinical trials are conducted at Kangdong Kyung Hee University Hospital, Severance Hospital, and Inha University Hospital. The Fitusiran global clinical trial was voluntarily suspended by Sanofi in October 2020 after non-fatal symptoms of thrombosis were found in phase 3 clinical trial participants. Sanofi also stopped all studies in September 2017 when one patient died of thromboembolism in the brain during phase 2 clinical trials. Hemophilia is a congenital hemorrhagic disease caused by a lack of blood clotting factors, and the incidence rate is estimated to be around one per 10,000 people. Depending on the type of insufficient coagulation factors, it is divided into two types: hemophilia A and hemophilia B, with type A accounting for 80% of the total and type B accounting for the remaining 20%. Fitusiran is a small interference RNA (siRNA) treatment that targets antithrombin, which is a treatment for hemophilia type A and type B patients and promotes thrombin production by lowering the level of antithrombin to prevent hemophilia's hemostasis and bleeding. Currently, Hemlibra, which is used for hemophilia type A, ranks first in the hemophilia treatment market, and Sanofi and Novonordisk's Concizumab are the development treatments used for both hemophilia type A and type B patients.
Policy
Gov't declines preferential pricing for innovative drugs
by
Lee, Jeong-Hwan
Nov 21, 2022 05:56am
Complaints are rising in various areas of the pharmaceutical industry with the Ministry of Health and Welfare maintaining its position that preferential pricing for new drugs manufactured by Korea Innovative Pharmaceutical Companies cannot be introduced in practicality due to issues including trade conflict, NHI finances, etc. The industry is complaining that the Ministry of Health and Welfare taking too much of a protective stance rather than focusing on preparing preferential pricing measures based on the fact that not only domestic pharmaceutical companies but US and UK companies are accredited as Korea Innovative Pharmaceutical Companies. On the 20th, MOHW reiterated its position that authorities must play caution in providing preferential pricing measures for Korea Innovative Pharmaceutical Companies and drugs that use domestically manufactured APIs, etc, virtually reaffirming its plan on the non-introduction of such policies. Although a clause for providing preferential pricing to Korea Innovative Pharmaceutical Companies had been prepared as of December 11th, 2018 under the Special Act On Fostering and Support of Pharmaceutical Industry, the government had also expressed practical difficulties in its implementation as providing pricing support for specific pharmaceutical companies, despite its legal basis, can lead to trade conflict. Regarding the enactment of subordinate statutes, the MOHW said it agrees with their necessity, but would need to consider whether it conforms to the international trade order. The ‘Premium drug pricing system for global innovative new drugs,’ which had been announced on July 7th, 2016 to provide preferential treatment for drugs developed by such companies, had been deleted in December 2018 as a discriminatory factor as a result of negotiations on amendments and modifications of the US-Korea (KORUS FTA). However, the domestic pharmaceutical industry stressed the need to promptly introduce a preferential pricing policy for innovative new drugs based on the fact that the criteria for accrediting innovative pharmaceutical companies are not limited to domestic companies. Also, the demand for preferential pricing of innovative new drugs by domestic pharmaceutical companies has been increasing further as MOHW Minister Kyu-Hong Cho stated that “further phased price cuts are deemed necessary as the price of generics are more expensive in Korea than overseas” regarding price cuts for generic drugs that are considered the basis of Korea’s pharmaceutical industry at the NA audit this year. The main reason for complaints raised by domestic pharmaceutical companies is that the Korean government is passive in preparing preferential treatment for innovative new drugs while concentrating on reducing the generic drug price. Also, the industry pointed out that as multinational pharmaceutical companies are also selected as Korea Innovative Pharmaceutical Companies in addition to domestic pharmaceutical companies, the policy should not be considered as being favorable for domestic pharmaceutical companies. Three multinational pharmaceutical companies – AstraZeneca Korea, Janssen Korea, and Korea Otsuka Pharmaceutical - have been accredited as Korea Innovative Pharmaceutical Companies. In other words, if the MOHW continues to solely pursue the plan to lower generic drug prices without specific preferential treatment or preservation measures, the concern of domestic pharmaceutical companies is likely to continue to deepen. A domestic pharmaceutical company official pointed out, “In every NA audit, the government had repeatedly promised policies to support drive new drug development, but no mechanism for preferential treatment for new drugs has been established as of now. The MOHW seems to have no plans to provide preferential treatment for drug prices and only have plans to lower generic drug prices." The official said, “If preferential pricing for Korea Innovative Pharmaceutical Companies may cause a trade dispute, the government should also separately contemplate measures to resolve the issue as well. Foreign pharmaceutical companies are also accredited as Korea Innovative Pharmaceutical Companies in addition to Korean companies.” Another official from a different pharmaceutical company in Korea also said, “The answer that the government would provide preferential treatment for new drugs after reviewing the international trade order and its financial impact on health insurance finances seems to mean that it will provide no preferential treatment. If this measure cannot be implemented, other measures to provide measures to preserve the drug price. The government has always been opposed to the request to preserve drug prices as well.” The official added, “If the government only formalizes the price cut of generic drugs and provides no response to the request for preferential treatment, reevaluation, or exceptions for the other drugs, domestic pharmaceutical companies will inevitably become more dissatisfied. The current response that no preservation or preferential treatment can be provided to domestic drugs because of NHI finances is quite irresponsible.” Meanwhile, members of the National Assembly's Health and Welfare Committee have also been demanding a drug price preservation policy every year, but it seems difficult for the NA to make further requests with the government continuing to repeat its principled answer. Following last year, members of the NA Health and Welfare Committee Rep. In-Soon Nam, Min-Seok Kim of the Democratic Party of Korea, and Rep. Jong-Seong Lee, Jong-Hean Baek, called for measures to provide preferential treatment for new drugs to foster Korea’s domestic pharmaceutical industry at this year’s NA audit.
Policy
Label for rosuvastatin to change following ticagrelor
by
Lee, Hye-Kyung
Nov 21, 2022 05:56am
The drug-drug interaction label for rosuvastatin drugs that are used to treat hyperlipidemia including AstraZeneca’s ‘Crestor’ will be changed. The drugs that affect rosuvastatin are ticagrelor drugs including AstraZeneca’s antiplatelet drug ‘Brilinta.’ The labeling change for ticagrelor has been preannounced by the Ministry of Food and Drug Safety in August and is set to be made on December 2nd. The labeling changes for rosuvastatin in line with the changes made for ticagrelor will also be applied after collecting opinions until December 2nd. According to the planned changes that will be made, the phrase ‘Ticagrelor can cause renal insufficiency and may affect renal excretion of rosuvastatin, increasing the risk for rosuvastatin accumulation’ will be newly added in the drug-drug interaction label of both the monotherapy and combination therapies of rosuvastatin. In some cases, co-administered ticagrelor and rosuvastatin led to a renal function decrease, increased CPK level, and rhabdomyolysis. Therefore, renal function and CPK control are recommended while using ticagrelor and rosuvastatin concomitantly. The MFDS prepared the label change based on European Medicines Agency’s safety review results on rosuvastatin. Items approved in Korea that contain rosuvastatin include 974 items including Crestor, Kuhnil Biopharm’s ‘Rosucande Tab,’ Kims Pharmaceutical’s ‘Rosuvac Tab,’ Ahngook New Pharm’s ‘Newsuvatin Tab,’ HK Inno.N’s ‘Vivacor Tab,’ Novartis Korea’s ‘Rosuco Tab,’ and Abbott Korea’s ‘Lypsta Tab.’
Policy
Public policy fee for severely ill children is implemented
by
Kim, Jung-Ju
Nov 21, 2022 05:56am
The government will push for a pilot project for a new payment system for the sustainability of treatment for severely ill children and adolescents. The Ministry of Health and Welfare (Minister Cho Kyu-hong) announced that it will recruit participating institutions for about four weeks from today (17th) to December 15th, which will take effect in January next year. Participating institutions are Seoul National University Hospital, Asan Medical Center, Yonsei Severance Hospital, Samsung Medical Center, Chonbuk National University Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Chilgok Kyungpook National University Hospital, Yangsan Pusan National University Hospital, and Kangwon National University Hospital. The Ministry of Health and Welfare explains that this is a pilot project to prevent the collapse of medical infrastructure with groundbreaking support for severe childhood diseases, which are weakening due to a decrease in the child population. The pilot project is the first step in implementing the public policy fee presented as a national task. The government introduces a new payment system called a package follow-up method rather than an additional method for individual medical services to strengthen support for pediatric specialized care infrastructure. The Ministry of Health and Welfare explained that it aims to lay the foundation for pediatric patients and guardians to receive sufficient professional treatment even close by supporting the maintenance of essential medical infrastructure by region through pilot projects. The Ministry of Health and Welfare plans to operate the pilot project by adopting a new support method to operate a stable treatment system for severely ill children by region. The selected medical institution will expand essential manpower such as pediatricians and nurses to provide high-quality children's medical services and carry out key projects suitable for each center's characteristics such as short-term hospitalization and home medical services. The pilot project will be conducted for three years from January 2023 to December 2025, and the target of the application is an institution designated as a children's public medical center that wishes to participate. The participating institution will be selected by comprehensively evaluating the level of securing pediatric professionals and the quality of pediatric treatment. Minister of Health and Welfare Cho Kyu-hong said, "This pilot project is part of the public policy fee to strengthen the public role of health insurance," adding, "We hope that an environment will be provided for all children to grow safely and healthily."
Policy
The budget for Paxlovid's SE relief will be prepared
by
Lee, Jeong-Hwan
Nov 18, 2022 06:04am
The Welfare Committee approved a budget of 1.7 billion won. Payment can be made next year if the plenary session is passed. The budget for relieving abnormal cases and side effects of drugs being administered in Korea through the EUA system, which is not approved based on the current Pharmaceutical Act, is smoothly being secured. This is because the National Assembly's Health and Welfare Committee recently voted 1.79 billion won for next year's budget to relieve damage to EUA drugs such as COVID-19 treatments, and attention is focused on the results of the special committee on budget settlement. Given that the EUA drug damage relief budget is recognized by multiple lawmakers and professional committee members of the Welfare Committee, and the government is also actively encouraging the administration for COVID-19 prevention, calls for a side effect damage compensation budget are gaining momentum. As of November this year, a total of six drugs including Paxlovid, Remdesivir, Actemra, Lagevrio, Evusheld, and Comirnaty 2 are being administered in Korea as EUA drugs by the Ministry of Food and Drug Safety. There is no way to relieve the damage even if serious side effects such as abnormal reactions, deaths, and diseases are developed in patients who have taken six drugs approved for emergency use. This is because the drug and vaccine damage relief system is operated only for drugs and vaccines that are officially approved based on the Pharmaceutical Affairs Act. Choi Hye-young of the Democratic Party of Korea and Kim Mi-ae of the People's Power, who are members of the Welfare Committee, have proposed a bill to relieve the state from side effects caused by EUA drugs. Prior to the legislation, the Welfare Committee voted to increase the budget of 1.79 billion won to compensate for damages to EUA drugs during next year's budget review. If the budget bill passes through the Special Committee on Budget and Accounts and passes the plenary session, it will be able to compensate for side effects caused by the administration of EUA drugs such as Paxlovid from next year. Currently, the quarantine authorities are actively encouraging the use of EUA drugs such as oral COVID-19 treatments to prevent and treat severe COVID-19 and death, so there is a high expectation that the budget for damage relief will also pass the committee. There have been cases in which applications for relief from abnormal cases that occurred after taking Paxlovid have been received, and compensation for the cases will be possible only when the budget for next year is prepared. The Welfare Committee voted 271 million won, the same as this year, for the budget for the "relief from side effects of drugs" project.
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