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- 2026-04-13 03:17:15
- Policy
- There were no applications for Ultomiris·Soliris benefits
- by Lee, Hye-Kyung Jan 06, 2022 06:09am
- In November last year, it was confirmed that there was no pre-application for Ultomiris and Soliris benefits for new patients with paroxysmal night hemoglobin (PNH). There were only two applications for pre-approval of Soliris and one application for re-examination approval for new patients with atypical hemolytic uremic syndrome (aHUS), all of which were rejected. In the case of Spinraza, a treatment for Spinal Muscular Atrophy (SMA), two applications for new patient benefits have been approved. The HIRA conducted deliberation on 11 items, including ventricular adjuvant therapy (VAD), short-term hospitalization (2–4 days) with neuroblocking treatment, including Soliris and Ultomiris, short-term hospitalization with percutaneous epidural ganglion neoplasty (2–4 days), short-term hospitalization (2–4 days) with neuroblocking treatment, short-term hospitalization due to trauma (2-5 days), short-term hospitalization for pain control (2–4 days), mid- to long-term hospitalization (13 days), long-term hospitalization (27th~40th), Spinraza, and hematopoietic stem cell transplantation. Soliris costs 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. Ultomiris was listed at 5,598,942 won per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris and Ultomiris are ultra-high-priced new drugs, so they implement a pre-approval system to determine whether they are eligible for medical care benefits, and the agency must administer Soliris or Ultomiris within 60 days from the date of notification of the results of the pre-approval application. If it is intended to be administered after 60 days, it must be re-applied. Medical institutions approved for medical care benefits by Soliris or Ulromiris must submit monitoring reports every 6 months, and in the case of aHUS, additional initial monitoring reports must be submitted at 2 months after treatment commencement. Spinraza is an ultra-high-priced new drug with 92.35 million won per bottle of 5ml, and medical institutions that want to take it must apply for pre-approval and submit a monitoring report every four months after approval of benefits. Details of the deliberation can be found on the website of the HIRA (biz.hira.or.kr) or the medical institution's business portal (biz.hira.or.kr>examination criteria>standard>examination criteria>public deliberation cases).
- Policy
- Companies obtain generic for exclusivity in proportion
- by Lee, Tak-Sun Jan 06, 2022 06:08am
- Among pharmaceutical companies that use generic for exclusive in the licensed patent linkage system that took effect in 2015, it was found that companies with large sales are more likely to obtain generic for exclusivity. As a result, it was suggested that small and medium-sized pharmaceutical companies need more support such as consulting. Sungkyunkwan University's Industry-Academic Cooperation Group made the remarks in the "2021 Pharmaceutical Patent-approval linkage system Impact Assessment Research Service Result Report". The result report was released by the MFDS on the 29th of last month. This study is conducted annually to establish a stable patent-approval linkage system and minimize side effects, which has been fully implemented since March 2015, as a revision of the Pharmaceutical Affairs Act to implement follow-up measures to the FTA. Through research, the relevant status and status are identified, and the impact of the implementation of the system is analyzed and evaluated annually. The basis for the impact assessment is specified in Article 50-11 of the Pharmaceutical Affairs Act. As of 2020, the analysis targets the current status of obtaining generic for exclusivity of 171 domestic pharmaceutical companies with finished products. As a result of the evaluation, when other variables were controlled, companies with large sales were more likely to obtain generic for exclusivity. As of 2019, 20 pharmaceutical companies with annual sales of more than 300 billion won applied for generic for exclusivity (28.7%), 31 pharmaceutical companies with sales of more than 100 billion won (40.2%), 22 pharmaceutical companies with sales of more than 50 billion won to less than 100 billion won (17.1%), and 31 pharmaceutical companies with less than 50 billion won (14.0%). If the sales of the applied pharmaceutical company are more than 300 billion won, the average number of applications is 11.0, and the average number of applications tends to increase as sales increase. There was a high probability that a company with a large number of items would obtain generic for exclusivity. Through this, the researchers analyzed that companies with large sales and a large number of items are more likely to obtain generic for exclusivity. In response, the researchers said, "As large-scale pharmaceutical companies tend to gain generic for exclusivity, it is required to strengthen SMEs' capabilities in first-generation development. Consulting support for SMEs is needed to encourage SMEs to obtain patent challenges and approval." The researchers also analyzed the impact of generic for exclusivity on generics before and after the introduction of the parent-approval linkage system (March 14, 2015) in terms of market share. As a result of the evaluation, the number of items significantly decreased due to the introduction of the system. However, there was no significant change in the duration of generics' entry into the market. However, it was found that the period of entry into the market was shortened in the case of generic for exclusivity. The researchers said, "Unlike concerns at the time of introduction, stable operation continues, and it is evaluated to have a slight positive effect on health policies and employment in the pharmaceutical industry."
- Policy
- Request for non-reimbursed use of Pahtension in Loop's pts
- by Lee, Hye-Kyung Jan 06, 2022 06:08am
- Application for Pahtension 20mg was rejected for non-reimbursed patients with systemic erythema lupus accompanied by immunosuppressants, vasculitis that does not improve even with antibiotics, and peripheral ulcers. The HIRA is receiving applications in advance for use exceeding the MFDS' permission to prevent the use of drugs that lack medical evidence or are concerned about safety. According to the details recently released by the HIRA, a total of 237 cumulative cases were rejected due to insufficient medical evidence for the submitted data, including Pahtension. Cases added this time include Previmis 240mg tab, Previmis 480mg tab, and Previmis inj, which will be non-reimbursed to pediatric and adolescent patients receiving hematopoietic stem cell transplantation. The request to prescribe My-Rept 250mg to Sjogren's syndrome patient with steroid dependence that recur during steroid loss after diagnosis of MCD and renal syndrome was also rejected. After hematopoietic stem cell transplantation, prescriptions of R-A 10mg and R-A 20mg were also rejected for patients with BK virus-related hemorrhagic cystitis who did not respond to existing antiviral drugs or could not be used as side effects of existing antiviral drugs. All attempts to prescribe Premina 0.625mg and Premina 3mg to patients with hemorrhagic cystitis who do not respond to existing treatment after hematopoietic stem cell transplantation or after high-dose cyclophosphamide treatment have not been approved. Among patients with circular hair loss, frontal hair loss, or systemic hair loss aged 8 years or older, it was also rejected to prescribe Xeljanz to patients with severe intractable skin lesions or interstitial pneumonia who do not respond to SALT score changes of less than 25% or high dose glucocorticoid and at least two immunomodulatory treatment. Approval to prescribe Previmis 240mg and Previmis 480mg was also rejected if there was no improvement in the use of other antiviral drugs for more than two weeks due to giant cell virus infection and peripheral organ disease after hematopoietic stem cell transplantation. Among children with persistent tachycardia after heart transplantation, approval to prescribe Procoralan 5mg was also rejected to patients with tachycardia persistent tachycardia despite the use of drugs such as beta blockers.
- Policy
- ‘Lowest-ever’ number of drugs approved in 4 years
- by Lee, Tak-Sun Jan 05, 2022 05:59am
- The year 2021 is likely to be remembered as the year of reduced marketing authorizations for drugs. This was greatly influenced by the changes in the market and the new regulations that were introduced last year. In particular, the pricing penalty imposed on indirect bioequivalence tested drugs and the restrictions set on consigned bioequivalence tests had greatly contracted the development of consigned generic drugs, significantly decreasing the number of approved items compared to the previous year. ◆ In 2021 = a total of 2,057 items were approved, recording the lowest-ever number of approvals during the past 4 years. 2,112 items were approved in 2018, 4,893 items in 2019, and 3,350 items were approved in 2020. In the case of prescription drugs, the number of approvals is on a decline for 2 consecutive years since 2019. After reaching the peak of 4,193 in 2019, the number of approved prescription drugs decreased to 2,614 in 2020 and to 1,596 in 2021. The situation had worsened significantly due to the introduction of the penalty system that additionally discounts the price of drugs that did not directly conduct bioequivalence tests. Moreover, the so-called "1+3 restriction” system that was introduced in July regulates the number of pharmaceutical companies that can share a company’s bioequivalence test to three other pharma companies, greatly reducing the foothold of CMO generics. Therefore, the number of incrementally modified new drugs and generics that conduct their own bioequivalence tests is expected to increase greatly. OTC drugs are at greater peril. Compared to the past when OTC development increased when stricter drug pricing regulations were imposed on the industry, the number of approved items decreased to an unusual extent this year. By month, approvals peaked in February with 441 with a flood of generics of the hyperlipidemia combo ‘Atozet Tab’ being approved. Since then, the average number of approvals remained in the 100 range, dipping to 88 in September. ◆OTC = Among the 461 OTC drugs that were approved in 2021,6 were data submission drugs, 63 were herbal medicines, and 211 were drugs subject to the Standard Manufacturing Criteria for Drugs, and others including generics accounted for 181. The drugs ‘subject to the Standard Manufacturing Criteria for Drugs’ that accounted for 46% of the OTC drugs approved this year were allowed sale after simply reporting to the Ministry of Food and Drug Safety. The MFDS designates the type, standard, and limit of the ingredients, formulation, dosage·regimen, efficacy·effect, and precautions for such drugs so that they may be easily sold. It is the most preferred type of drug for pharmaceutical companies as it saves development costs. The reality is that companies cannot invest so much into R&Ds of OTCs that have a small market size and require immense marketing costs. ◆Prescription drugs = Although generic drugs account for a substantial amount of the 1,596 prescription drugs that were approved in 2021, the number of new drugs and data submission drugs are also on the rise. Among the 45 new drugs that were approved last year, 3 were advanced biological drugs that were newly approved other than reregistered drugs, and 304 were data submission drugs. These accounted for 22% of all prescription drugs approved in 2021. The trend was also evident in new drugs approvals. A record-high number of new active ingredients in 4 years was approved last year. Many new drugs and vaccines were introduced due to the DOVID-19 pandemic, and 4 homegrown new drugs were also approved last year. Starting with Yuhan Corp’s anticancer drug ‘Leclaza’ in January, Celltrion’s COVID-19 treatment ‘Regkirona’ in February, Hanmi Pharmaceutical’s neutropenia treatment ‘Rolontis’ in March, and Daewoong Pharmaceutical's ‘Fexclu’ was approved in December. Also, under the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ that was implemented in 2020, 3 new advanced biopharmaceutical drugs have entered the market. These cell therapy and gene therapy products would have been categorized as new drugs in the past. All three advanced biopharmaceuticals that were newly approved this year are Novartis’ products. The first advanced biopharmaceuticals ‘Kymriah’ was approved in March, followed by ‘Zolgensma’ in May and ‘Luxturna’ in September. Novartis’ advanced biopharmaceuticals are all ‘one-shot’ treatments that are leading the pharmaceutical revolution. However, the drugs have a long way to go before receiving health insurance benefits in Korea as these one-shot treatments for rare diseases are very expensive.
- InterView
- There shouldn't be any patients who can't receive new drugs
- by Eo, Yun-Ho Jan 05, 2022 05:59am
- Global pharmaceutical companies, which can be said to be the mainstay of the supply of new drugs. The KRPIA, which represents these companies, is also raising expectations in 2022. Multinational pharmaceutical companies' attention is more focused on the "appropriate value of new drugs" than ever before. With the advent of the so-called "high-priced drug era," it is becoming increasingly difficult to find a point of contact between the government and the pharmaceutical industry. There are still many discussions and suggestions regarding the drug price system, such as expanding the scope of application of the PE system, introducing pre-registration & post-evaluation, and adding drugs subject to negotiation and calculation. Dailypharm met with Lee Young-shin (64 yrs old), a full-time vice chairman of KRPIA, and heard about KRPIA's future plans for a period of expectation and transformation. -The regime will change in 2022. What is there to ask for a new government? Vice Chairman Lee Youngshin = In the new government, it is hoped that patients will not be able to receive treatment or health insurance coverage for severe disease treatments due to low income. In other words, it is expected that policies will be prepared and implemented so that there are no patients who are alienated and discriminated against from necessary treatments due to income and disease. The government is expanding its role as a global leader and has announced several plans to become a biopharmaceutical industry powerhouse. This seems to have originated from the belief that economic scale, public awareness, and potential technology have aspects of advanced countries. In order to become a biopharmaceutical powerhouse, one must not stay in "vaccine sovereignty" but have "new drug sovereignty," and sovereignty is being created. From a global perspective, Eco-systems and infrastructure in the pharmaceutical industry should be established, and open innovation should be established with an open mind. - What is the current issue or vision that the KRPIA wants to focus on the most this year? = In the new year, the KRPIA will also make efforts to help the pharmaceutical bio-industry take responsibility for public health and contribute to economic development. First of all, new drugs with new therapeutic paradigms such as state-of-the-art biopharmaceuticals are being released. We will actively participate in the improvement of policies and systems related to drugs and new drugs that allow domestic patients to access quickly, and promote the improvement of patients' access to new drugs as a top priority. - Then, what do you think was the biggest achievement of the KRPIA last year? = In the face of COVID-19 Pandemic, which is suffering worldwide, it was rewarding to secure the stability of the supply of imported medicines as a measure for the health rights of the people. The expected issues were identified in advance, discussions with regulators, and alternatives were presented, and continued to cooperate. As a result, it was able to receive active government support, such as replacing document screening of overseas surveys, utilizing online due diligence, allowing electronic documents, and activating counseling through video conferences, and stably supplying medicines without major problems. It is also proud that the COVID-19 vaccine developed by our member company contributed to the quarantine. What was the most regrettable issue as an association last year? = Last year, there was great progress and improvement in the regulatory environment to quickly develop and introduce COVID-19 vaccines and treatments, and we appreciate the government's efforts to do so. It is necessary for the government and industry to proactively prepare and discuss after post-Corona to prepare for the introduction of products due to the development of new technologies, patient access to new treatments, and electronic product manuals that can quickly provide the latest drug information. I hope there will be a lot of progress this year, and the association will continue to make efforts. - When talking about the contribution of multinational pharmaceutical companies to Korea, it is true that the investment of research funds in Korea was focused on phase 3 research. Is there a plan for basic research support? = According to the results of the annual R&D survey conducted by the Association on member companies, the growth rate of phase 1 and phase 2 corresponding to the initial clinical trial has recently increased significantly compared to the growth rate of phase 3. I know that many member companies are actively cooperating in various forms with domestic research institutes, schools, and bio-ventures to support basic research. However, since basic research is in the very early stages of research and development, the contents and progress cannot be disclosed.
- Opinion
- [Reporter’s View]Year of regulations, principle vs practice
- by Kim, Jin-Gu Jan 05, 2022 05:57am
- As in every other year, regulations imposed on the pharmaceutical and biopharmaceutical industry are again expected to be further reinforced this year. In particular, GMP-related regulations will be strengthened even further. Starting this month, the government may impose punitive fines on the arbitrary manufacture of pharmaceuticals by companies. In addition, the government and the National Assembly are pushing to amend the law so that an assigned GMP investigator could conduct on-site investigations on drug manufacturing plants. Also, a bill to revise the law to allow business suspension dispositions up to one year and license revocations in case of GMP violations is pending at the National Assembly. Some may complain that such excessive regulations hinder the development of the pharmaceutical and biopharmaceutical industry. However, the regulations did not appear out of nowhere. There were always events that triggered the tightening of regulations. The GMP regulations were reinforced due to the series of arbitrary manufacturing events that occurred last year. The arbitrary manufacturing of pharmaceuticals that were once considered rare incidents conducted by one or two companies was identified in several companies last year. The industry thus lost the public’s trust. In depth, the ruling may indeed have felt unfair for some pharmaceutical companies. However, their protests failed to gain public sympathy as their argument, in essence, is an excuse that they did not follow the 'principle' in the name of customs and practice. And this is not an issue that just arose last year. The license of Kolon’s ‘Invossa’ was canceled in 2018, Medytox’s botulinum toxin in 2019 because they were found to have manufactured their product differently from their approved specifications. This would not have happened if the companies stuck to the basic principles. This new year, the industry should look back on itself. Companies should look back and examine whether they have chosen practice rather than principle in other areas of their business as well. If so, they must remedy their ways immediately as these small incidents are what intensify to become serious issues. The MFDS should also review its ways to become an institution that is faithful to principles. This does not mean that the ministry should adhere to principles on every issue that arises. Punishing pharmaceutical companies based on pure principle is not a fundamental solution. If deviations of front-line pharmaceutical companies have become a practice, the ministry should more deeply look into the background on why it became so. As the regulatory authority, the MFDS’s role is to establish principles in the direction that can protect the public’s health and further develop the industry. In other words, if the regulations are causing the issue, it is the MFDS’ role to establish “new principles.”
- Company
- Exports of the biohealth industry surpassed 19 trillion won
- by Jan 05, 2022 05:57am
- Exports of the domestic biohealth industry hit a record high last year due to soaring demand for biosimilars, COVID-19 diagnostic kits and medical devices. Exports in related sectors reached $16.2 billion last year, exceeding $15 billion for the first time. It is expected that strong performance will continue this year due to the release of new biosimilars and the export of Omicron diagnostic kits. According to Ministry of Trade, Industry and Energy on the 3rd, domestic biohealth exports amounted to $16.2 billion last year, up 16.9% from $13.9 billion the previous year. It surpassed $10 billion for the first time in 2020, followed by $15 billion last year. In December last year, it showed an upward trend, recording $1.9 billion in monthly exports (2.2619 trillion won) for the first time in history. The biohealth sector has become one of top 15 major export engines as exports have increased for 23 consecutive years. Biohealth exports increased 2.2 times over the past five years from $7.5 billion in 2017. This is due to the fact that domestic biosimilars are on a roll in global markets such as the European Union (EU), and exports of medical devices such as ultrasound imaging devices and dental implants have steadily increased. In particular, biohealth exports amid the epidemic of infectious diseases shone as global demand for domestic COVID-19 diagnostic kits increased. By country, exports to the EU region rose 9% year-on-year to $4.8 billion. Exports to the U.S. rose 22.9% to $2.1 billion, while ASEAN rose 92.8% to $1.9 billion. In addition, Japan's biohealth exports are insignificant, but they have been increasing for the past nine consecutive months due to the demand for medicines and medical devices caused by the spread of COVID-19 mutations. Expectations are high that biohealth exports will continue to be strong this year. Due to the spread of Omicron mutations, the demand for domestic diagnostic kits that can diagnose Omicron infection in a short period of time is increasing. Domestic diagnostic device companies such as Seegene, Bioneer, and Kogen Biotech have released diagnostic kits that can determine Omicron mutations within 3-4 hours, respectively. Last month, Seegene signed an export contract to supply 2.8 million and 1.7 million new kits to five European countries and Israel, respectively. Exports of domestic diagnostic kits are expected to increase once again as the number of COVID-19 confirmed patients around the world is soaring again with Omicron. Domestic biosimilars will be released in the global market with the approval of new products. In August and September last year, Samsung Bioepis received product permits for Lucentis' first biosimilar Byooviz in the EU and the United States, respectively. Celltrion's Yuflyma, Humira's biosimilar, is expected to expand its European market and enter North America.
- Policy
- Combination drugs of PPI+ antacid have also been released
- by Lee, Tak-Sun Jan 05, 2022 05:57am
- In the anti- ulcer drug market, combination drugs of PPI+ antacids have been released. This time, it is a drug that combines Rabeprazole and sodium bicarbonate. The PPI+ antacids, which started with Chong Kun Dang's Eso Duo (Esomeprazole Magnesium Trihydrate+Sodium Bicarbonate), continues to develop new products. The MFDS approved Youngjin Pharmaceutical's Rabenew, Ildong Pharmaceutical's Rabietduo, Dongwha's Rabeduet, Samjin's Rabeol Duo, Whanin's Rabemore, and Dong-A ST Rabiduo on the 31st. These products are combination drugs that combine the PPI formulation Rabeprazole Sodium and the antacids Sodium Bicarbonate. Youngjin is in charge of all production. The new combination drugs are used fir ▲ gastric ulcer/duodenal ulcer, ▲ erosive or ulcerative GERD, ▲ relieving symptoms of GERD, and ▲ for long-term maintenance therapy for GERD, and can be taken once a day. The usage is similar to the existing Rabeprazole only indication. However, the use of PPI+ antacids in the prescription market is expected to change as they complement the side effects of night acid secretion and late drug effects, which are disadvantages of PPI single drugs that are weak against stomach acid. It is already the third time this year that combination of PPI+ antacid has been used. Yuhan Corporation, GC Pharma, and Kyung Dong were approved in February, and Hanmi Pharmaceutical in October. This is the first drug that combines Rabeprazole and antacids. Analysts say that the successive development of new PPI+ antacid products is due to the popularity of Chong Kun Dang's "Eso Duo," which was launched in 2018. As soon as Eso Duo was released, it grew into a blockbuster worth 10 billion won a year, recording 7.8 billion won in outpatient prescriptions based on UBIST in the first half of this year. The new product is expected to further strengthen Ildong Pharmaceutical's market competitiveness. Ildong has the number one generic called Rabiet in the single Rabeprazole market. This is because it recently decided to start selling co-promotion of Nexium, the original PPI sales top. Competition in the anti- ulcer drug market is expected to heat up next year as Daewoong Pharmaceutical is releasing new products such as Fexuclue (Fexuprazan HCl), a new P-CAB drug, on the 30th.
- Company
- Only 14% of Pharmas plan to increase jobs due to COVID-19
- by Chon, Seung-Hyun Jan 04, 2022 05:56am
- The prolonged COVID-19 pandemic is expected to bring personnel reshuffling changes to the pharmaceutical and biopharmaceutical industry. CEOs in the pharma industry said that they plan to maintain or reduce the size of new employments in their companies. In addition, 7 out of 10 CEOs predicted that while the companies will maintain the number of jobs, they expect reshuffling to occur within. According to a business strategy survey conducted by Dailypharm on 51 CEOs from pharmaceutical and biopharmaceutical companies, only 13.7% (7) of the CEOs who participated in the survey said they plan to expand the number of new employments this year compared to the previous year. 9.8% (5) responded that they will reduce the number of new employments, and 76.5% (39) said they will maintain the size as is. In other words, 86.3% of the companies will not be expanding the number of new employments this year. Such a trend, where only a few companies decided to scale up new employment, is quite unusual in this industry with the pharmaceutical and biopharmaceutical industry making strong growth every year. This reluctance was evident in the industry in general, regardless of company size. Only 4 of the 32 CEOs (12.5%) of companies with more than 300 employees had responded that they will increase new employment this year. Among companies with less than 300 employees, only 3 out of the 19 companies (15.8%) expected to increase new employment this year. 78.1% and 73.7% of the CEOs in companies with 300 or more employees and 300 employees or less said they will be hiring at a similar level as the previous year. The companies had not increased hiring last year as well. 70.6% (21) CEOs said that they had hired at the same level last year as that of the previous year. 13.7% of the respondents said that they reduced the size of the recruitment compared to the previous year. Survey results showed that many CEOs are expecting the COVID-19 pandemic to bring personnel reshuffling within their companies. On the question asking about the changes in jobs due to changes incurred by the current COVID-19 environment, 68.7% (35) of Pharma CEOs said that “there will be no big change in the total amount of jobs, but there may be changes depending on job function, etc." 17.6% of the CEOs answered that ‘there will be no change’ and only 11.8% (6 people) answered that "there will be more jobs" in their respective companies. Only one CEO predicted job loss. On the other hand, 25.5% of the CEOs expected online security or IT jobs to increase. The expansion of non-face-to-face business such as online video conferencing due to the COVID-19 pandemic is expected to increase the attempts to establish and reorganize the system. Also, 25.5% of the CEOs expected jobs in approval and drug pricing to increase, and 15.7% expected jobs in sales and marketing to increase. On the other hand, 82.4% of the respondents said “no specific jobs in a certain area will decrease.”
- Policy
- Recovery Action held by the Legislation/Judiciary Committee
- by Lee, Jeong-Hwan Jan 04, 2022 05:56am
- The recovery system of drug prices bill, which drew attention from the government and domestic and foreign pharmaceutical companies, has been held by the National Assembly's Legislation and Judiciary Committee and is in trouble to deal with it. As it was excluded from the Legislation and Judiciary Committee agenda again during the extraordinary National Assembly in December last year, even the screening committee failed to rise, and there are concerns that it will not be passed even if it is barely introduced this year. The second subcommittee of the Legislation and Judiciary Committee, which is in charge of reviewing other standing committees' resolutions, tends to be rarely reviewed once handed over, so it is often called the "black hole in the bill" and the "tomb of the bill." On the 3rd, the National Assembly's Legislation and Judiciary Committee did not review the alternative of the chairman of the National Health Insurance Act on the resolution at a plenary session held within last year's extraordinary session. Some pharmaceutical and legal circles are strongly opposed to the review and processing of bills on the redemption and refund of drug prices, which reportedly affected the unknown agenda of the Legislation and Judiciary Committee. Some say that it will not be easy to deal with even if a plenary session of the Legislation and Judiciary Committee is held at the extraordinary National Assembly to be held in the new year and a revision to the Health Insurance Act, which includes a bill to return and refund drug prices, is on the agenda. It could be held by the Legislation and Judiciary Committee if some members of the Legislation and Judiciary Committee hold the bill at the plenary session or hand it over to a second subcommittee that examines other standing committee bills.If it is handed over to the second subcommittee on bills, it is not clear whether it will be able to obtain a proper opportunity for examination until the end of its 21st term in the National Assembly. The government and the ruling party plan to continue to urge the opposition party and the judiciary committee to review the agenda ahead of the need for a bill to recover and refund drug prices. The MOHW is expected to push ahead with the introduction of a refund system as planned through the revision of the health insurance care benefit rules and related notices reported to the Health Insurance Policy Deliberation Committee late last year. An official from the ruling party of the National Assembly's Health and Welfare Committee said, "The Pharmaceutical Affairs Committee and the opposition party are boycotting the agenda, even though the Restitution and Refund Act is a bill that settles and compensates for unnecessary damage to both pharmaceutical companies and the NHIS. Because of this, bills such as regulations on office managers' illegal hospitals, illegal pharmacies lending licenses, and mandatory identification of patient health insurance are also delayed." The official said, "The ruling party plans to select the revision of the health insurance law as an intensive promotion bill and continue to urge it to be processed. I understand that the MOHW is also repeatedly appealing to the Legislation and Judiciary Committee to pass the bill."
