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- 2026-03-10 07:55:27
- Opinion
- [Reporter’s View] Reliability Verification Review Committee
- by Lee, Hye-Kyung Jun 20, 2024 05:48am
- The Ministry of Food and Drug Safety has formed a Reliability Verification Review Committee. In the 'Guideline for Drug Manufacturing, Sales, and Import Marketing Authorizations and Labeling Change Authorizations,' which was revised by the MFDS on the 17th, a procedure was added for the Reliability Verification Review Committee to verify the reliability of the permit data submitted by companies during the drug approval and review process. In the past, if data with questionable reliability was submitted during the approval and review process, nothing happened if the applicant withdrew the data. Unreliable data is data that is false or falsely presented data. In other words, if false data was submitted intentionally or unintentionally and detected, it was possible for the applicant to just withdraw the application in a ‘no harm no foul’ sense. However, in the future, the data submitted to MFDS will not be nullified even if the company 'voluntarily withdraws’ or 'voluntarily cancels’ the data. The reliability of all the data submitted will be verified without exception. If the committee determines that the submitted data is not credible, it will notify the headquarters and the follow-up department to initiate pharmacovigilance. This process will be applied to all data that are currently under review, even before the committee is formed. What should not be overlooked is that a suspicion of the reliability of an item in the approval/review stage can taint the reliability of the entire drug manufacturing plant during pharmacovigilance. The MFDS said that if the reliability of a single data in the early stages of review is questioned, it is possible to suspect "falsehood" and "falsity" of the entire manufacturing process. Therefore, if data submitted during the approval/examination stage is even slightly wrong, whether intentionally or unintentionally, this one issue can lead to 'revocation of the GMP certificate’ in the pharmacovigilance process. The MFDS also said that it "cannot be said that it is irrelevant" that the "questionable data" submitted by companies that do not follow the principle of good faith may be subject to future disposals up to the revocation of their GMP certificate. Although it may seem like just the MFDS reorganizing, launching a new committee, and refining its procedures, the launch of the Reliability Verification Review Committee seems to be one of those serious regulations that can even lead to the revocation of GMP certificate.
- Opinion
- [Reporter’s View] Finances limit reimbursement of drugs
- by Eo, Yun-Ho Jun 07, 2024 05:51am
- Insurance reimbursement standards and indications for a drug can differ. This is because the government’s pockets are not infinite under the National Health Insurance System. This is why there are always complaints in the field. Not all complaints can be resolved but there are some that evidently require resolution, that were made for incomprehensible “financial” reasons that are difficult to understand. Restrictions on age, duration, and switching drugs are typical examples. In the case of the age restriction, the standard is simple. For the same condition, infants, young children, or elderly patients may be excluded from coverage, or only certain age groups may be included due to concern about financial exhaustion. In this case, reimbursement is often extended later through reimbursement expansion measures. However, some drugs remain inaccessible for the patients. Restrictions set on the duration of use are a little different. Generally, reimbursement standards limit a drug's dosing interval based on the drug's clinical studies or authoritative international guidelines. However, there are also cases where reimbursement is restricted for "financial" reasons without any specific grounds for limiting the dosing interval. Restrictions on switching are the most frequent. Autoimmune diseases are the next big thing in the pharmaceutical industry after anticancer drugs, and numerous classes of drugs and same-class drugs with the same mechanism of action compete in the market. In the case of these drugs, the government often does not allow patients to be reimbursed for the first drug if they switch to another, meaning that if a patient is given a new drug with the expectation that it will work better than the first drug, but experience worse prognosis, he or she cannot go back to the old drug. The same situation was applied to drugs that were introduced long ago, and it took a long time before switching was granted reimbursement. In Korea, drug reimbursement has a significant impact on prescribing practices. Even if a patient needs a drug, doctors will often refuse to prescribe it if it is not reimbursed. This is why restrictions for financial reasons can be detrimental in fields where prescribing is essential. We ask the health authorities to trust the field’s judgment a little more.
- Opinion
- [Reporter's View] Expectations for new Alzheimer's drugs
- by Son, Hyung-Min Jun 05, 2024 05:47am
- Last month, a new drug for Alzheimer's disease, Leqembi, was approved in Korea. Leqembi, which was developed by Eisai and Biogen, targets the amyloid beta (Aβ) protein in the brain, which is considered one of the most likely causes of Alzheimer's disease. The industry welcomed Leqembi’s arrival because there had been no promising new drugs to treat Alzheimer's disease until now. Until now, donepezil, galantamine, rivastigmine, and memantine were used for Alzheimer's, but all were only able to relieve symptoms such as cognitive impairment and do not fundamentally treat dementia. Since then, a number of brain function improvement drugs have been introduced to prevent Alzheimer's disease but failed to prove their effectiveness. In 2022, acetyl-L-carnitine, which was used as a brain function enhancer, failed to prove its efficacy during clinical reevaluations, which led to its indication being removed. Oxiracetam also failed to prove its efficacy during clinical reevaluations last year and was removed from the market. Choline alfoscerate formulations also remain mired in controversy. The reason for the market exit of these drugs that had been used to improve brain function is lack of efficacy. The main problem with these drugs is that they have a jagged effect, which means that they may or may not improve the patient’s condition, depending on how the patient is feeling that day. Side effects have also slowed the development of Alzheimer's disease treatments. Alzheimer's is one of the leading causes of dementia, and it is believed that abnormal proteins such as amyloid beta protein and tau protein build up in the brain, causing nerve cells to die slowly. However, in the case of amyloid-targeted therapies, amyloid-related imaging abnormalities(ARIA), which are abnormal signals such as brain edema or microhemorrhage observed on MRI scans, may occur with their use. Aduhelm, which came close to commercialization before Leqembi also failed due to high rates of side effects in addition to its lack of efficacy. The good news is that other treatments have emerged that have shown promise in early Alzheimer's disease, including Leqembi and Lilly's donanemab. Both treatments target the amyloid beta protein, which is responsible for the development of dementia, and have shown efficacy in clinical trials with manageable side effects. In clinical trials, Leqembi improved a composite measure of cognitive function. This allowed patients with mild cognitive impairment to return to daily life to conduct day-to-day activities. Just as it is meaningful to extend the number of survival days of cancer patients by administering chemotherapy drugs, administering Leqembi is expected to have a similar effect. As we severely lack treatment options for Alzheimer's disease, new drugs are needed to expand treatment opportunities for patients. After the history of failures recorded in the development of Alzheimer's disease treatments, it would be interesting to see if the new Alzheimer's drugs can reverse the fate. It is the reporter’s hope the new drugs will be able to address the dire unmet needs of Alzheimer's patients in Korea.
- Opinion
- [Reporter’s View] An open talk on improving the GMP system
- by Lee, Hye-Kyung Jun 05, 2024 05:47am
- Last month, CEOs of biopharmaceutical companies submitted a statement to the Ministry of Food and Drug Safety (MFDS) requesting an improvement to the 'Cancellation of the GMP compliance decision (GMP One strike-out).' They asked that if non-compliance with GMP has been unintentional, a different set of measures be applied instead of one strike-out. On December 11, 2022, the MFDS initiated a GMP One strike-out act. According to this act, when a company is found to be in violation of the Good Manufacturing Practices (GMP) for medicinal products, their GMP compliance approval may be revoked. This measure has been established due to past incidents in which more than ten companies, including Binex, Vivozon Pharmaceutical, Hanall Biopharma, Dongindang Pharmaceutical, Hansol Pharm, Samsung Pharm, and Medica Korea, altered ingredients without authorization, falsified documents, and provided false information on approval documents. The GMP One strike-out act states that if a company violates GMP compliance, such as obtaining GMP compliance decisions based on false information or illegally and repeatedly falsifying GMP records, action will be taken. This year, there was a case of canceling the GMP compliance decision, and some items will soon be withdrawn. When a company receives a GMP One strike-out, manufacturing the offended item and the same formulation will be stopped. The system was implemented one year and six months ago. During this period, Hutecs Korea Pharmaceutical received a disposition and is pursuing a trial. The companies expecting a disposition may not readily accept the MFDS’s disposition. Consequently, there should be an opportunity to hear the opinions of biopharmaceutical companies CEOs regarding their statement for revising the GMP One-strike out system. The MFDS has reviewed the CEO’s statement regarding the GMP One-strike out system. However, the MFDS has not publicly discussed this matter or announced its official opinion. The MFDS may open a session with the CEOs if the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), which represents biopharmaceutical companies in South Korea, officially submits a statement. However, the MFDS prefers to discuss this matter unofficially. The GMP One-strike out system has been implemented as part of revising the Pharmaceutical Affairs Act Article 38-2 (Standards of Manufacture and quality control). Since this system was established by the National Assembly, the MFDS, an administrative agency, feels certain pressure to discuss measures for revision. However, this policy has been implemented over one year and six months ago. There is a need to conduct a public review of the system. If the KPBMA proposes a clear agenda regarding this system, the MFDS official should provide an opportunity for official discussion.
- Opinion
- [Reporter’s View] We don’t know the fate of rivoceranib
- by Kim, Jin-Gu May 30, 2024 05:50am
- On the 17th, The US Food and Drug Administration issued a complete response letter (CRL) for HLB and Chinese Jiangsu Hengrui Pharmaceuticals’ frontline camrelizumab plus rivoceranib as a treatment for those with unresectable or metastatic hepatocellular carcinoma (HCC). Immediately after the news broke, HLB's stock price plummeted. The stock price, which was KRW 95,800, hit the floor for two days in a row, halving to KRW 47,000. Its market cap evaporated by more than KRW 630 billion in 2 days. As investors had high expectations for the company, which once recorded the second-largest market cap on KOSDAQ, the disappointment was as great. However, its stock has since rebounded, especially on the 27th and 28th, rising by more than 10% for two consecutive days and recovering to the KRW 63,500 level. The analysis is that HLB's strong claim that the FDA's approval was only delayed due to the facility issue at Jiangsu Hengrui Pharmaceuticals and that there is no problem with its final approval, has brought back the investors' attention again. Interpretations of the companies’ CRL receipt had been mixed. Some have said that the FDA "denied" the approval or that the companies have "failed," while others say the approval was just "delayed" or "pending. There is no special meaning to a CRL. It doesn't mean that the possibility of an FDA approval is long gone or that your approval is assured. Receipt of a CRL literally means that the FDA has requested a supplement to the application. Of course, as HLB claims, many new drugs have crossed the FDA threshold after receiving a CRL. HLB and Jiangsu Hengrui Pharmaceuticals plan to reapply for the FDA’s approval. They plan to resolve the facility issues that were pointed out as the reason for the CRL and try again. The exact time of the reattempt was not disclosed, but the industry expects the companies to reapply 'soon.’ We cannot predict whether the reattempt will end a success or failure. While many factors favor a positive outcome, there are also clear factors that point to a negative outcome. According to HLB claims, the CRL was unrelated to the efficacy and safety of the combination therapy. If so, this means that the combination therapy’s longest overall survival (OS) data compared to competing drugs is acceptable. In this case, the reapplication would only need to address the Jiangsu Hengrui Pharmaceuticals’ facility issues that caused the CRL. However, it is different if there are other causes besides the facility issue. In the past, the pharmaceutical industry has criticized the camrelizumab plus rivoceranib combination trial for not being double-blinded and for having a disproportionately large number of Asian patients. There are also other variables beyond the clinical and facility issues. One risk is that the US has been slow to approve new drugs from China for political reasons. The US recently passed the Biosecure Act, which actively restricts activity by Chinese pharmaceutical companies. Furthermore, the imminent release of clinical data of a potential competitor, the Opdivo plus Yervoy combination as a first-line treatment for liver cancer, also renders it difficult to be optimistic about the outcome. HLB Chairman Yang Gon Jin called the CRL a "double hit" for the company. However, it's too early to assess whether it's a double or a triple hit based solely on the FDA’s rejection or delay of approval. The ball hit by the HLB is still in flight. At this point, the ball could go over the fence or be out. Even if the FDA approves the product, the approval by itself would be hard to call a success. While it's clear that crossing the FDA's threshold is very difficult, it shouldn't be the ultimate goal. It’s as important to have a vision of how to commercialize the product after approval. So from various aspects, it is clear that it is too early to call rivoceranib a success or a failure, just based on the receipt of the CRL.
- Opinion
- [Reporter’s View] Lung cancer but also a 'rare disease'
- by Eo, Yun-Ho May 27, 2024 05:48am
- What appears to be the same 'cancer' type can be classified based on different numbers. Cutting-edge, targeted anticancer therapies are being developed to target an extremely small number of patients within a specific category of cancer. The cancer types we refer to as liver cancer, gastric cancer, and lung cancer are major categories, and they are classified as different subtypes. Even if a tumor originates from the same organ, treatment difficulty and the number of patients differ among these subtypes. The transition of medicine’s prescription criteria to the focus on 'genetics' is expected as precision medicine is already being developed. It is knocking on our door, yet we still need time to acclimate. These cutting-edge, targeted anticancer therapies can be used once patients’ genetic mutations are confirmed. However, the South Korean system is having difficulty accepting this type of therapy. Let’s examine the cases of lung cancer, which many anticancer therapies currently target. Anticancer therapies, such as RET-targeted medicines 'Gavreto (pralsetinib)' and 'Retevmo (selpercatinib),' MET-targeted medicines 'Tabrecta (capmatinib),' 'Tepmeko (tepotinib),' and 'Rybrevant (amivantamab),' attempted for reimbursement listing in the past years but they all failed. Although these anticancer therapies fall under the top category of 'lung cancer,' their subject category falls under for the number of patients with orphan drugs. Furthermore, previously listed targeted anticancer therapy and immunotherapy for cancer face hurdles in expanding reimbursement coverage. These drugs need value re-evaluation and prediction of the usage volume because the prices and the expanded usage are high. Such strictness is required to maintain the National Health Insurance system of South Korea. We cannot simply blame the government authorities. However, a transition of approach seems necessary considering one of the characteristics of recently developed novel drugs is that the number of patients, in other words, the number of mutations of a certain genetic, is quite few. As mentioned earlier, novel drugs only target a few patients. Out of the total solid cancer population in South Korea, less than 1% of patients have such rare disease, and less than 200 patients are diagnosed. Furthermore, the experts explain that these patients do not respond well to conventional therapies (previously used medicines). Because of these reasons, the industry has lately advocated for re-establishing the definition of a rare disease. The disease should reflect the number of patients per treatment option rather than the number of patients for the entire disease. Of course, such changes may require more detailed discussion. It’s time to put together ideas on how to have targeted anticancer therapies, which have expanded usage but are targeting fewer patients, to be covered by reimbursement. It’s true that there is an increased number of 'medicines available in the market but cannot be used' in South Korea. Now, the pharmaceutical companies need to be resolute, and the government needs to act.
- Opinion
- [Reporter’s View] Drug Review Coordination Council
- by Kim, Jin-Gu May 16, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS) has launched the Drug Approval and Review Coordination Council. The council will directly receive coordination requests from complainants when matters for supplemental measures arise during the drug approval and review process. With the Director-General of the Drug Safety Division heading the council, director-level officers at MFDS and 4-5 external experts will be coordinating the issues at hand. In other words, the council will coordinate issues that the MFDS has requested supplementation for under the leadership of the Director-General of the Drug Safety Division. Although it is a 1-year pilot program, the pharmaceutical industry has high expectations. This is because a significant portion of the pharmaceutical industry's complaints related to approval and review arose during the process of handling the supplementary measures. There always has been a discrepancy between the data requested by the MFDS and the data submitted by the pharmaceutical companies, and the process of closing the gap has always been fraught with complaints. The pharmaceutical industry was constantly thirsty for communication in this area. As the MFDS voluntarily offered to meet this need in this situation, the pharmaceutical industry welcomed the decision with open arms. In particular, the industry expressed expectations over the fact that the coordination process will be handled by the Director-General of the Drug Safety Division. The industry’s hope is that the complaints, which had become an ongoing hassle between working-level staff members of the MFDS and companies, will be adjusted more flexibly from a larger direction. However, no system, no matter how good, can satisfy 100% of the complainants who have expressed concerns over MFDS’s plan. The biggest concern is that the approval and review period could increase. With so many complaints focused on the processing of supplemental measures, the fear is that handling a large number of coordination complaints with limited manpower will create a kind of bottleneck phenomenon, increasing the time required for approval and review. As if acknowledging these concerns, the MFDS announced that it will exclude complaints for which there are clear regulations or have already gone through Central Pharmaceutical Affairs Council review. Furthermore, the MFDS is also planning to limit the number of coordination applications to '1 case per product by company'. Some in the industry are disappointed with this decision regarding the restriction. There were also concerns about equity. As the criteria for determining the coordination subjects is not clearly laid out, there is a possibility that complaints may arise on how the MFDs are only responding to the needs of certain pharmaceutical companies. The MFDS’s decision to open up a communication channel that the pharmaceutical industry has long awaited for is great news. Some industry insiders have complimented that the “MFDS has changed for the better.” However, this is the crucial moment. In order for the acclaimed MFDS’s plan to avoid becoming a ‘nothingburger,’ the authorities now need to prepare substantive sub-regulations, such as criteria for selecting coordination subjects, coordination procedures, and on how to apply the coordinated results.
- Opinion
- [Reporter’s View] MFDS’ Regulatory Innovation 3.0
- by Lee, Hye-Kyung May 14, 2024 05:48am
- The Ministry of Food and Drug Safety (MFDS)’s announcement of the regulatory innovation tasks is now an annual event. The Regulatory Innovation 1.0, announced just two months after Oh Yu-kyoung’s appointment as the minister, focused on regulations that need system improvements. Since 1.0 was criticized for not considering citizens’ opinions, 2.0 announced tasks, including managing digital safety, increasing consumer and small business benefits, and supporting future businesses. What about the implementation rate? The Regulatory Innovation 1.0, which included 100 tasks in three fields as part of the 'Improvement of Safety and Enhancement of Convenience for Health Functional Food,' had 88% implementation rate. 'Regulatory Innovation 2.0 Tasks for Food and Drug' solved 65 out of 80 tasks in five fields, showing 81.3% implementation rate. Both projects achieved over 80% implementation rate in a year. On May 2, the Regulatory Innovation 3.0 was announced. Unlike previous regulatory innovation announcements that felt like a mandatory annual event, 3.0 was different. Previous announcements lacked innovative tasks related to pharmaceuticals despite their intentions to include both food and drugs. While 1.0 and 2.0 merely updated old regulations, 3.0 aimed to solve regulations essential to the field. 3.0 included regulatory innovation tasks that would meet the needs of the pharmaceutical industry. After the Regulatory Innovation 3.0 announcement, the MFDS also provided a separate session for the pharmaceutical industry, sharing 3.0’s policy and agenda related to the field of pharmaceuticals. This year, there will be significant changes to the GMP evaluation policy, the department of approval, the clinical trial system, and the post-management of drugs. After the 3.0 announcement, there was significant interest from the pharmaceutical industry regarding the revision of requirements for registering APIs. The GMP evaluation for APIs will be replaced with documents proving the country of origin and PIC/S countries. The MFDS is already discussing internally to revise the regulation related to GMP within this year. They will announce the legislation this month and set a goal to implement the revision by December after hearing experts’ opinions and the review by the Office for Government Policy Coordination. The revision will be made so that facility audits will be substituted with submitting documents for GMP evaluation of APIs starting next year. There were doubts when Regulatory Innovation 1.0 was announced three years ago, but now the industry looks forward to the announcement of 4.0.
- Opinion
- [Reporter’s View] The dark side of the coveted MNC jobs
- by Eo, Yun-Ho May 10, 2024 05:47am
- Multinational pharmaceutical companies have become the wannabe companies for job seekers. With high salaries that are comparable to those of large companies and the flexible working arrangements that allow remote work, generous vacation days, generous in-house benefits, and a horizontal corporate culture, it seems anyone would jump at the chance to join these companies. However, there is a catch. For such a good foreign pharmaceutical company, labor conflicts are not uncommon. Layoffs that accompany various changes, such as divestitures, spin-offs, and reorganizations, are not a big deal in the industry anymore. Some people refer to labor unions in foreign pharmaceuticals as labor aristocracy and elite unionism, but there are definitely conflicts. Although the layoffs are coined differently in each company – including the Early Retirement Program (ERP), and Volunteer Separate Program (VSP) - these retrenchment programs all serve the same purpose and offer a substantial compensation compared to other Korean companies. Some joke that "you must have done well in your previous life to get ERP". For those nearing retirement age and those who can find another job, an ERP from a multinational can be an opportunity. The problem is that despite the compensation, many just feel despair. The medical representatives are affected the most. More recently, also the marketing staff, which were once the crown jewels of the pharmaceutical industry, are now the companies’ No.1 candidate for retirement. The irony is that the current era of new high-priced drugs is what is pressuring these business units. Contrary to how the drugs that the company sells have become better and more expensive, the departments that make the profits are subject to the layoffs. The reason is simple: the drugs that pharmaceutical companies are selling are no longer "competition-based.” Drugs these days are sold as long as they receive reimbursement, so are “reimbursement-based.” There are no longer 4 or 5 new drugs competing for the same mechanism of action for diabetes, hypertension, high cholesterol, etc. This is an era where a petition for reimbursement of a single drug gains 50,000 consents, an era of all-purpose drugs with characteristics as unique as their high price that are expanding indications like an octopus, an era where only 1-2 competitors exist for each condition, rendering the speed of reimbursement key. Market access (MA), Government Affairs (GA), and Patient Advocacy (PA) are the hottest positions right now. And the traditional commercial staff are feeling the pinch. Multinational companies are replacing the names of their sales personnel with terms such as "medical assistant," "expert information providers.” These vague and general terms were coined by the reporter to avoid referring to a specific company. on. They have drastically reduced their numbers and given them new tasks and motivations as literal “supporters,” but this new culture has not settled well. Global Big Pharmas are driven by profit. There's nothing wrong with that, but the workforce that has become irrelevant in the new era has done no wrong either. It remains regrettable that the wannabe companies don't seem to have the foresight to evolve and foster the unique talents of their employees.
- Opinion
- [Reporter’s View] Patients are left to suffer amid dispute
- by Lee, Jeong-Hwan Apr 29, 2024 05:50am
- It has been 3 months since the doctors and the government failed to see eye to eye on the government’s plan to expand medical school admissions by 2,000 students. The prolonged dispute has intensified animosity towards each other. The doctors have criticized the Minister and Vice Minister of Health and Welfare, Kyoo-hong Cho and Minsoo Park for their absurd remarks and called for their resignation, and even called for the resignation of the administration itself ahead of the general elections. The presidential office and the government condemned the act as a "cartel of interests" by doctors who were only worried about protecting their own interests and chose to enforce the policy instead of seeking further communications. Amid the patients’ deepening grievance and suffering, the doctors and the government continued to fight without retreat, and the ruling and opposition parties that were intent on winning the 22nd general election held an indifferent eye to the issue at hand. Three weeks have passed since the general elections, but there is no sign of the ruling and opposition parties planning to discuss or resolve the doctor-government conflict at the National Assembly level. The 21st National Assembly and the 22nd National Assembly are both sitting on the sidelines as the former is nearing the end of its term, and the latter is yet to start its term. Maybe the medical gap, as well as the grievances and fear felt by the neglected patients, do not seem so urgent or serious to the National Assembly. Doctors and the government are continuing to repeat their own explanations for why they are unable to engage in a dialog. At this rate, it's easy to assume that the two will continue to spew the same slanderous messages day after day. The Special Presidential Committee on Healthcare Reform, despite being "operated directly under the president," convened on the 25th without a doctor. This is like operating a vehicle with its doors open, which is illegal under the current Road Traffic Act and falls under the 12 acts of gross negligence according to the Act on Special Cases Concerning The Settlement Of Traffic Accidents. In this sense, the doctors who did not participate and the government who started without closing its doors are both guilty of gross negligence. The Special Presidential Committee on Healthcare Reform that convened without doctors will discuss policies to strengthen local and essential healthcare without reflecting the voices in the medical field without knowing whether the medical community would accept them. This increases the probability of establishing an impractical healthcare policy that is nothing more than rhetoric. Patients are suffering amid the endless doctor-government conflicts, parliamentary indifference, and the shaky launch of the healthcare reform task force. The patient’s pain and suffering will only grow greater if the conflict continues. When a child's temperature rises greatly at night, or a child's skin is scratched and torn by a laceration one day, or the condition of an elderly patient hospitalized in a nursing home suddenly deteriorates due to illness, patients and their caregivers have to experience the dreaded medical crisis. They come face-to-face with the 'emergency room rush' they've only seen in the news. The negative effects of the doctor-government conflicts are not limited to emergency and serious illnesses. Patients and their caregivers who are unable to receive a timely diagnosis on whether their bleeding abrasion is minor or serious are left to suffer their injury in pain in addition to medical confusion. Moreover, patients who receive some abnormal findings in medical health screenings are unable to visit a higher-level hospital at their desired time for further diagnosis because the medical system, except for emergency and severe cases, has been shut down. There's no telling what diseases that have slipped through the cracks will quickly take hold and eat away at the patients' lives. Doctors and the government need to stop their needless arguments and start tending to the patients. They should sincerely listen to each other's arguments and try to understand the underlying implications. The doctors need to decide to get back to the front lines of medicine and get to work on crafting a unified government-to-physician deal of their desire, including the size of the medical school expansions. Rather than just calling for a return to the drawing board, the doctors should participate in closed-door meetings and the health reform task force to exchange negotiation cards with the government. The government should also prepare a proposal that can motivate doctors to stop their collective action and return to the field. The government has conceded a point, transitioning next year’s admission quota to voluntary expansions, but it should be willing to yield further to open the dialogue. This is all for the sake of the patients. Our patients can't afford to wait any longer. Why should the patients be terrorized and sacrificed in a battle between the doctors and the government? It's time for the parties to end their ego games and deferral of responsibilities and start creating a medical normalization plan to resolve the conflict proactively. The National Assembly should also make a bipartisan move to end the conflict and bring about reconciliation. It is the raison d'être and duty of the National Assembly to reconcile conflicts between stakeholders over national policies, both large and small, and lead them to rational administration and national affairs. We hope that the 21st National Assembly leads the two parties to reach a consensus before the end of its term for ‘one last hurrah.’
