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- 2026-05-06 15:45:55
- Policy
- Did Mooncare truly reinforce coverage for rare diseases?
- by Eo, Yun-Ho Dec 01, 2021 05:57am
- The voice requesting expanded coverage for patients with rare diseases had been exceptionally high this year in the 4th year of Mooncare. Starting with NA discussions held to enhance coverage of innovative new drugs for rare genetic disorders in May by the NA Health and Welfare Committee member Sunwoo Kang, NA members Byungwon Kang, Woni Kim, Young Seok Seo, Hyunyoung Shin held a public hearing to discuss ways to resolve the medically unattended areas, continuing on the effort to foster a policy environment that in which patients with rare diseases are not marginalized. The main contents that were discussed included the need to apply special exemption of calculation to diseases that are not being covered due to non-designation as a rare disease, and the strong proposal on the need to expand patient access to new rare disease treatments. The discussion continued to the NA Audit, where the NA Health and Welfare Committee member Sunwoo Kang, and members of the ruling and parties including JaeKeun In and Jongseong Lee all unilaterally urged improvement. ◆100% reimbursement rate for rare disease treatments in 2020? However, the public hearing revealed the different views held by the Health Insurance Review and Assessment Service. At the public hearing in May, HIRA presented that the reimbursement rate for rare disease treatments was 85.3%(2016~2020) and 100% in 2020. The numbers indicate that patient access to rare disease treatments is perfect. But if this is the case, why is the voice to expand reimbursement for rare disease treatments continuing to rise? 출처: 희귀유전질환 혁신신약 접근성강화를 위한 국회 토론회The results announced by HIRA were the reimbursement rate of drugs that went through the review and assessment process, not the actual reimbursement rate among all rare disease drugs. In other words, HIRA’s result excluded various factors including rejected and voluntarily withdrawn items. Data studied by the Korean Research-based Pharma Industry Association and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association showed that only 50% of the pharmaceuticals that were designated orphan drugs over the past decade were listed on the reimbursement list. ◆Industry "Need to expand the pharmacoeconomic evaluation exemption system" The two associations joined forces to address the issue. Dailpharm found that KPBMA and KRPIA saw consensus on the need to expand accessibility to rare disease treatments and submitted a statement on the need to expand the pharmacoeconomic evaluation exemption system for rare disease treatments. In the statement, the two associations pointed out the existence of many rare diseases that greatly affect households with indirect medical costs and deteriorate the quality of life of patients but are not qualified for the ‘life-threatening (less than 2 years of life expectancy)’ condition that needs to be fulfilled to be able to utilize the current special exemption system (RSA and pharmacoeconomic evaluation exemption system) Therefore, the associations insisted that evaluating the ‘clinical need’ only with life expectancy does not take into account the characteristics of rare diseases, and diseases that do not meet the ‘less than 2-year life expectancy’ part of the clinical need requirement should also be allowed PE exemption if it is authorized through expedited approval processes abroad (US BTD, EU PRIME). The government had said that it would make efforts to improve access to rare disease treatments in the several public hearing and NA audits, but no specific plan or goal seems to be in place. An industry official said, “The government had recently adjusted the price evaluation criteria of PE exemption drugs by 20% from the lowest A7-adjusted price to improve the price transparency of PE exemption drugs. If the authorities decided to reduce the risk factors in price as such, they also should increase its scope of benefits.”
- Policy
- 30 new drug items reimbursed or extended coverage this year
- by Kim, Jung-Ju Nov 30, 2021 05:52am
- 30 new drugs were newly listed on the reimbursement list or extended reimbursement standards from January this year to this month. Among these, 25 were newly listed new drugs, and 5 were already-listed new drugs that have extended their scope of reimbursement and increased coverage. The reinforced coverage of new drugs this year benefited only 107,000 patients in Korea until last month, but the new listing of Bronpass Tab had increased the number of beneficiaries sevenfold to record 781,725. First, 30 drugs (based on representative dosages) were enhanced coverage being newly listed on the reimbursement list or extended reimbursement standards from January to November. Drugs that were newly listed as of the 1st this month are the severe neutropenia treatment Rolontis Prefilled Syringe inj and acute bronchitis treatment Bronpass Tab. No drugs were extended reimbursement standards this month. The two drugs that were newly listed differ greatly in the expected number of patients in Korea and annual financial requirements. Reimbursement for Rolontis Prefilled Syringe inj is expected to be applied to 4,000 people, costing ₩10 billion. On the other hand, Bronpass Tab is reimbursed for 670,000 people and will be applied to the most amount of patients among all newly listed drugs this year, however, its annual fiscal spending is relatively small, by ₩2.9 billion. This is interpreted as a result of comprehensively reflecting to flexibly expand coverage even for expensive drugs required for a small number of rare diseases and the social maturity to accommodate them. The number of beneficiaries greatly varies due to policies that now allow flexible expansion of NHI coverage to high-price drugs that are used for a small number of rare diseases, that were established based on the increased social maturity that can now accept such policies. The government and payer expect the new listing and extended reimbursement standards to cost ₩256.4 billion and grant access to 781,725 people.
- Policy
- Review period & material improved for COVID-19 Txs, etc.
- by Lee, Jeong-Hwan Nov 29, 2021 05:58am
- The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals. The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anticancer drugs, orphan drugs, and infectious disease treatments such as COVID-19 drugs. On the 25th, Prime Minister Boo-Kyum Kim held the 137th State Affairs Inspection and Coordination Conference and announced “the 8th measure for regulatory innovation to address difficulties in the new industry” The regulatory innovation that will directly affect the pharmaceutical industry is the measures made for the bio-health industry. In line with the Ministry of Food and Drug Safety, the Office for Government Policy Coordination had agreed on the need to improve the priority review system for pharmaceuticals. Currently, the MFDS has an expedited review process in place during marketing authorization for the prompt introduction of new drugs such as new drugs, anticancer drugs, orphan drugs, and infectious disease treatments. However, unlike the US FDA, the system does not specify the review period or the scope of materials submitted in detail, which undermines the administrative effectiveness and predictability of the system. On this, the Ministry of Food and Drug Safety decided to prepare specific standards on the review period and scope of submitted materials by revising the Pharmaceutical Affairs Act & Regulation on Safety of Drugs, Etc. The pre-announcement of legislation was issued on October 19th, and the revised Regulation on Safety of Drugs will be in full effect from January 21st next year. The scope of submitted materials will be specified to define the evidence data, development process, manufacturing method, dosage/administration, efficacy/effect of drugs subject to priority review. The MFDS expects the regulatory innovation to preemptively respond to the need for pharmaceuticals and promote the protection of national health. The regulations on chemical materials used for pharmaceutical manufacturing and quality inspections will also be alleviated. The MFDS exempts import requirements for raw materials that are essential for drug manufacturing when importing chemicals for drug manufacturing or quality inspection. The problem is, the MFDS reviews the cases case-by-case, only after the importer inquires to the ministry whether its chemical material is applied the exemption of import requirements. Due to this, criticism arose that the lack of criteria within the system is causing inconvenience for the importers. Accordingly, the MFDS decided to provide detailed criteria for determining substances subject to the exemption of import requirements and provide detailed case examples to aid better understanding among civilians and improve administrative processes for its employees. More specifically, the ministry plans to revise the ‘Tacts for recommending pharmaceuticals among those subject to import requirement confirmation exemption’ guidelines for business conduct in the coming December.
- Policy
- A new pre-approval system for Ultomiris was established
- by Lee, Hye-Kyung Nov 29, 2021 05:58am
- The pre-approval application system for Ultomiris, a treatment for night hemoglobin (PNH) in Handok, has just been established. The HIRA recently established a new Ultomiris pre-approval application system in the nursing institution business portal. The application for pre-approval of Ultomiris is in the same position as Soliris, which is previously prescribed in the benefit certificate. Nursing institutions that want pre-approval of Ultomiris and Soliris can register their applications after selecting the drug name from the pre-approval of medical standards management → Eculizumab and Ravulizumab on the nursing institution portal. Monitoring application data can also be submitted through the same menu. Monitoring data should be submitted for each subject every six months after treatment begins. In accordance with Article 6 of the Method and Procedure for Pre-Approval, etc., approval application and monitoring data related to pre-approval, such as Ultomiris and Soliris, shall be submitted from the 1st to the 10th of the even month in accordance with the subject's deliberation period. Meanwhile, Ultomiris was listed at KRW 5,598,942 per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris is an insurance cap of 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price alone reaches 400 million won per year. Both Ultomiris and Soliris were expensive new drugs, and pre-approval and monitoring were essential for registration. Since the registration of Ultomiris in June, pre-approval has been steadily made since July, and in August, one Soliris and four Ultomiris were approved for new PNH patients during the deliberation of the HIRA Medical Review and Assessment Committee.
- Policy
- Winner of pricing suits will be compensated for damages
- by Kim, Jung-Ju Nov 26, 2021 05:54am
- The countless litigations between government and companies regarding reimbursements such as drug price cuts or reduced scope of reimbursement are causing wasteful losses to both parties. On this, the government and the National Assembly have been proposing various solutions to prevent excessive stay of executions. The NA has proposed an amendment to the National Health Insurance Act which allows government authorities to recover the reflective profits the companies accrued during the suspension of execution period if it wins the main lawsuit, and refund them to companies when vice versa after a pharmaceutical company applies for administrative litigation and suspension of execution in opposition to the disposition of drug price cuts. The bill passed the plenary session after passing the Health and Welfare Committee's bill review subcommittee. The biggest contributor to the implementation of this refund system was the stay of execution the companies filed with their drug pricing lawsuits. The stay of execution is filed by a pharmaceutical company to suspend execution of the government’s drug price cut disposition based on the presumption of innocence. In general, the court cites or accepts the stay of execution request because of ‘irrecoverable damages’ that may occur from the company’s aspect. Since 2018, 36 out of 38 stays of executions were accepted, with the other two suits withdrawn. Most of the litigations have resulted in favor of the government. The problem is that the company’s only option during the suit to defend its drug price is to use the stay of execution and minimize damage or maximize profits during the litigation period. In this case, any cost that arises from the non-change in the drug price during the trial period results in a loss in health insurance finances. The government estimates that the financial loss caused by the suspension of drug price cuts since 2018 amounts to nearly ₩400 billion. Broadly applied to price cuts, reimbursement suspensions, selective reimbursement, etc. Will include added interest… price-cut drugs may choose either a lump-sum payment or price raise The refund system will be used to reduce such side effects. The system will be applied when a stay of execution filed by the pharmaceutical company is dismissed at the administrative ruling or litigation, but accepted in the original suit. In other words, the system will be applied when the government loses and the pharmaceutical company wins the suit. The compensation for damages will be applied to all pharmaceutical dispositions that are directly related to pharmaceutical sales, such as pricing adjustments, reimbursement suspensions or exclusions, reduced scope of reimbursement, selective reimbursement (changed copayment rate), etc. If these requirements are met, the NHIS needs to pay the pharmaceutical companies for the losses as a “binding act,” meaning that the government must compensate for losses. The government has decided to announce the standard rules and amendments to the medical insurance benefit criteria next month. Considering the administrative procedures such as legislative notice, regulatory review, legislative review, and public announcement, the amendment is expected to be implemented within the first half of next year.
- Policy
- Cost bearer in debate ahead recall of some losartan products
- by Lee, Tak-Sun Nov 26, 2021 05:53am
- The MFDS has mentioned ‘re-prescribing or re-dispensing' some items at meetings with medical, pharmacist, and pharmaceutical associations while discussing measures to recall some of the antihypertensive ‘losartan’ products that were found to contain azido impurities during inspections. The re-prescribing or re-dispensing measures are prepared for cases when patients cannot exchange their drugs at pharmacies, and all lot numbers of some losartan items are highly likely to be recalled. In other words, some items will be subject to full recalls. Previously, the valsartan and ranitidine products that were fully recalled due to impurities had also been re-prescribed or re-dispensed. At the time, the patients’ out-of-pocket cost was borne by medical care institutions for valsartan, and by the National Health Insurance Service for ranitidine. The NHIS had later filed a suit to claim the re-prescribing and re-dispensing cost borne to the pharmaceutical companies. However, as medical and pharmaceutical associations believe the patients’ out-of-pocket cost should be borne by pharmaceutical companies, the issue is expected to raise much controversy this time. According to the industry on the 25th, the MFDS had held a series of meetings with doctors, pharmacists, and pharmaceutical associations on the 24th. At the meetings, the MFDS had mentioned the possibility of re-prescribing and re-dispensing some losartan items, upon which the associations expressed the position that pharmaceutical companies should bear the patients’ out-of-pocket costs that arises from prescribing and re-dispensing while minimizing product recalls. In summary, it seems that full recall of some losartan items will be inevitable. If re-prescribing or re-dispensing measures take place, conflict may arise over who pays for the patients’ out-of-pocket cost and NHIS cost. The government, as well as the medical and pharmaceutical groups, believe that pharmaceutical companies should bear the cost, whereas the pharmaceutical industry is reluctant to bear the cost as this is an unintentional impurity event. However, the analysis is that the companies may accept bearing the out-of-pocket cost of patients. If only a few products are subject to exchange or re-prescriptions, there is the possibility that the recall will proceed without much confusion like in the case of the last AZBT losartan recalls. Therefore, the attention is focused on how many items will be recalled, and what proportion of the products will be re-prescribed at the official announcement made by the MFDS. The MFDS announcement is highly likely to come in early December after the MFDS receives and aggregates pharmaceutical companies’ product impurity test results at the end of this month. The MFDS also plans to hold a meeting soon with pharmaceutical companies that possess products subject to recalls.
- Policy
- All agreed to the legislation of the CSO reporting system
- by Lee, Jeong-Hwan Nov 26, 2021 05:53am
- The MOHW, as well as KPBMA, KRPIA, and Korean Pharmaceutical Association, approved the mandatory government and local government reporting bill by CSO. Except for the opinion that the regulations related to the CSO reporting system should be tightened compared to the legislation pending in the National Assembly, no organizations opposed it. Depending on the results of this month's subcommittee's review, the legislation is expected to be completed within this year and implemented as early as early as next year due to the government's fear. This is the result of confirming the review data of the National Assembly's Health and Welfare Committee's bill 1 subcommittee on the revision of the Pharmaceutical Affairs Act and Medical Device Act on the introduction of the CSO reporting system for medicines and medical devices on the 23rd. The bill, proposed by Rep. Kim Sung-joo of the Democratic Party of Korea, requires CSOs to report to the heads of cities, counties, and districts as prescribed by Ordinance of the MOHW. Pharmaceutical companies, which are pharmaceutical suppliers, can entrust drug promotion work only to CSOs who have been reported. Consignment of drug promotion work to unreported CSOs was sentenced to up to three years in prison or fined up to 30 million won, and CSOs were prohibited from re-consigning drug promotion work. Violation of this will result in imprisonment for up to three years or a fine of up to 30 million won. In addition, CSO representatives, executives, and workers were obligated to complete the drug sales order training. Violations will be fined up to 1 million won. All KPBMA, KRPIA, and Korean Pharmaceutical Association agreed Both organizations representing the domestic and foreign pharmaceutical industries and pharmacist organizations, including the government, approved the bill. Rather, it submitted an opinion to further specify the CSO reporting method or raise the level of regulation. The MOHW predicted that the CSO reporting system will clarify those subject to CSO for medicines and medical devices and incorporate them into the legal system so that administrative authorities can manage and supervise them. The MOHW agrees with Rep. Kim Sung-joo's proposal to eventually strengthen the management of the distribution order of medicines and medical devices by blocking indirect illegal rebates through CSO by establishing the obligation to prohibit rebates. KPBMA also approved the bill. However, it urged pharmaceutical companies to clarify the purpose of the law by adding content that imposes management obligations for CSOs. KRPIA demanded stricter regulations against the bill, asking pharmaceutical companies to specify legal grounds for CSO to request information such as whether to report under the Pharmaceutical Affairs Act and whether representatives, executives, and employees complete rebate prohibition training. The Korean Pharmaceutical Association also said the bill could contribute to preventing illegal rebates by identifying the current status of CSO and ensuring transparent distribution networks. The Korean Pharmaceutical Association further proposed the introduction of a punitive fine in consideration of the reality that it is difficult to eradicate illegal rebates. Only the provisions for re-consignment of CSO in the validity of the bill are changed. Hong Hyung-sun, an expert at the National Assembly's welfare committee, also agreed with the purpose of the bill to make the distribution order of medicines and medical devices correct. It did not prohibit re-consignment between CSOs, but expressed an opinion on changing the provisions so that the consignment route could be identified. In order for the CSO to re-consign drug promotion work to another CSO, it is to stipulate that the original drug provider is informed of the facts as prescribed by the MOHW. In addition, pharmaceutical companies and CSOs presented revised opinions on the contents of the promotion work consignment and the clause requiring the other party to prepare a "consignment report" within one month from the contract date and keep it for five years with evidence. Violation of this would result in imprisonment for up to one year or a fine of up to KRW 10 million, and the CSO definition would include cases where drug promotion work was re-consigned. In addition to preparing grounds for cancellation of designation by CSO educational institutions, Hong also proposed an incidental amendment to establish a hearing procedure in case of cancellation of designation.
- Policy
- Losartan, which has a high proportion of consignment
- by Lee, Tak-Sun Nov 25, 2021 05:55am
- Concerns are growing as the proportion of consignment production is high in HBP treatment "Losartan" formulation, which is known to have excess Azido-based impurities. If it appears as an impurity problem at the raw material stage, there is a possibility that many pharmaceutical companies tied up with consignment will start collecting products. According to the Ministry of Food and Drug Safety on the 22nd, in the case ofLosartan 50mg, 16 companies in Korea manufacture it, but the number of licensed products is 88. 72 pharmaceutical companies are entrusting manufacturing to other companies. The factory that manufactures the most items is Withus Pharmaceutical's Anseong Plant 1, which produces a total of 21 items, and Youngil Pharmaceutical's Jincheon Plant 1 is followed by 18 items. Withus Pharmaceutical Anseong Plant 1 and Youngil Pharmaceutical's Jincheon Plant 1 also manufacture the largest number of items in combination of HCTZ+Losartan potassium (12.5 mg/50 mg) . Withus Pharmaceutical Anseong Plant 1 produces 15 items, and Youngil Pharmaceutical Jincheon Plant 1 produces 20 items. If there is a problem with the consignment factory product, it is highly likely that the consignment item will be the same problem. In particular, if the same raw material is used, there is a high risk of recovery at the same time. In the industry, this interpretation is possible as companies have recently temporarily suspended product shipments due to raw material problems. Withus Pharmaceutical, which produces the most items of Losartan potasium 50mg, has decided to voluntarily recover its Withus 50mg (2 lots) as of the 16th. Dasan Pharmaceutical's "New Cosar 50mg" (2 lots) produced in the same factory also decided to voluntarily recover as of the 15th. Currently, only two recovered items announced by the Ministry of Food and Drug Safety as Azido-based impurities are Withers Pharmaceutical and Dasan Pharmaceutical, but it is analyzed that there is a possibility of further increase in the future. In fact, the industry believes that more items have stopped selling or voluntarily took measures to recover them. Analysts say that if the Ministry of Food and Drug Safety collects the results of the investigation and turns out to be a raw material problem, it is likely to lead to a large-scale recovery.
- Policy
- Discussions began on the scope of Mifegymiso license
- by Lee, Tak-Sun Nov 24, 2021 05:53am
- Moon Eun-hee, head of the pharmaceutical policy division at the MFDSAn expert meeting was held on the 24th, and the review was conducted regardless of the revision of the criminal law. The MFDS, which is reviewing the product license of Mifegymiso, a drug for abortion, has begun a discussion process on the specific scope of use rights. It is a policy to decide through collecting opinions from all walks of life. Moon Eun-hee, head of the pharmaceutical policy division, said on the 23rd, "We are scheduled to hold a meeting with experts on Mifegymiso screening measures on the 24th. We are thinking about whether to limit prescription authority to obstetrics and gynecology and what capabilities we will describe." She added that Mifegymiso will basically be classified as Rx drug and compare preparation and administration cases in various countries to discuss whether it will be inpatient Rx or outpatient Rx. However, she mentioned that an agreement with all walks of life is needed. She stressed that she does not conduct a permit review on the premise of revising the criminal law related to abortion, but that she hopes the law will be revised as soon as possible so that licensed products can be used. It is found to be contrary to the opinion that Mifegymiso's approval review should be delayed due to the lack of criminal law by Seo Jung-sook and others. The abortion crime was abolished in 2018 when the Constitutional Court ruled against the Constitution. At that time, the Constitutional Court recommended that supplementary legislation be completed by the end of 2020, and five bills, including related criminal laws, were submitted to the National Assembly, but have not been processed. The criminal law contains specific conditions and regulations that allow abortion. The MFDS expects that abortion drugs will not violate the revised law and plans to examine them according to scientific procedures and methods. She explained, "I don't think that the termination of pregnancy in efficacy will apply to the revised Pharmaceutical Affairs Act related to the expression of abortion suggestion." She said, "Even in the revised criminal law, drugs, including drugs, are not considered to be applied to abortion conditions and grounds, but it seems that (related drug permission) is not desirable because it varies depending on interpretation." However, as collecting opinions from all walks of life is important, she plans to continue to discuss drug use. "I don't think it will be concluded by a single meeting on the 24th," she said adding, "There has been a process of collecting opinions from all walks of life, but we will continue to receive opinions if necessary." The plan is to determine whether the method of collecting opinions will be a consultative body of experts or a larger scale such as public hearings depending on the situation. For now, it is known that expert organizations such as Korean Association of Obstructors & Gynecologists, Korean Society of Obstetrics and Technology, and Korea Society of Health System Pharmacists will attend the meeting on the 24th. Regarding Mifegymiso's Bridging Study, the Central Pharmaceutical Review Committee also had a number of opinions on the exemption of Bridging Study, but it was not finally confirmed. Currently, the Mifegymiso review has been requested to supplement the data, but the data has not been submitted yet.
- Policy
- Betmiga PR prices fluctuated 3 times Between 15 days
- by Kim, Jung-Ju Nov 24, 2021 05:53am
- It is a drug with a lot of stories. Betmiga PR (Mirabegron) of Astellas Pharmaceutical of Korea, which is in a lawsuit with the government to cancel the drug price drop, is a drug with a lot of price fluctuations. The drug has repeatedly filed lawsuits against the government's drug price cut, returning, cutting and raising drug prices as the results of the Price-Volume Agreement and additional calculations are added, with at least three drug price changes expected this month alone. In the aftermath, continued settlement and fluctuations in pharmacies and distributors are expected to follow, signaling chaos. According to the Ministry of Health and Welfare, the price of two Betmiga PR (Mirabegron) items, whose suspension of drug prices was lifted on the 14th, will rise slightly as of the 22nd as the price hike was adjusted this time. The increased price is KRW 314 for Betmiga PR and KRW 471 for 50mg of Betmiga PR. Up to two additional changes from the new generic registration to the new suspension of execution It is now common for drug price changes to occur frequently due to drug price lawsuits against the government. However, Betmiga PR is experiencing price hikes and cuts due to additional criteria, application and cancellation of the Price-Volume Agreement results, and price changes due to further litigation. Since the drug was lowered on the 14th due to the previous ruling of the administrative court (2021a 10434), the government has considered the additional application of the drug. This drug is subject to additional application. Therefore, it was raised to the 22nd by applying an additional calculation as of the standard from the 14th application at the time. In addition, the cancellation of the Price-Volume Agreement conducted earlier this year was reflected, making it different from the drug price (price before 14 days) at the time of the administrative court suit. The company is filing an appeal with the High Court. At the same time, the company raised a suspension to the effect of maintaining the actual initial price, but on the 12th, the High Court did not accept it unusually. However, since the suspension of execution can be carried out separately from the lawsuit on the merits of our law, the company immediately applied for a separate suspension of execution to the Supreme Court, and the results have not yet been released. If the Supreme Court results are decided to cite suspension of execution, the price will change again if the price changes to its original state Price fluctuations do not stop here. As Mirabegron's generic is scheduled to be additionally registered on December 1, the drug price change, which was expected to be adjusted to December 22, will change again in December. In other words, since there are three companies based on registered companies and the number of new generics exceeds three companies, the additional mechanism applied by the government will be lifted and the price will fall again. This is a change in drug prices that has progressed or is scheduled for only 15 days since the application of the administrative court results on the 14th, and the number of times alone is as many as three or up to four times. Confused by frequent fluctuations in drug prices and wholesale and retail prices of pharmacies and distribution prices As a result, the return and settlement of distributors and pharmacies, which are wholesale and retail branches of drugs, and confusion in face-to-face patients are inevitable. First of all, pharmacies should pay attention to discrepancies in claims if they miss the update of drug prices. In addition, it should be notified when facing the patient. In the case of distributors, they must make predictable plans for returns and settlements to check the volume with trading pharmacies and customers. Due to the nature of wholesale and retail dealing with tens of thousands of drugs, such confusion is expected to continue unless the system and law improve. In order to solve such a legal battle, the ruling party is currently pushing for a revision of the law aimed at banning and recovering corporate lawsuits, and the government and insurance authorities are also closely watching it. The MOHW said, "The part to be raised and adjusted as of the 22nd will end on December 1st," adding, "Astellas is appealing to the Supreme Court (related to suspension of execution), so if there is any change, additional information will be provided immediately."
