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- 2026-04-29 06:35:04
- 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.’
- Opinion
- [Reporter’s View] Decreased vaccine funding during endemic
- by Son, Hyung-Min Apr 24, 2024 05:44am
- K-bio and Vaccine Fund No.3 is soon to be launched. Considering the recent contraction of the investment market, the entire amount of KRW 40 billion of investment money from the government and the government-run bank has been invested, regardless of the formation size. Once the initial formation of KRW 70 billion is raised, early investment will be possible. In August 2022, the Ministry of Health and Welfare (MOHW) announced the establishment of the K-Bio and Vaccine Fund as part of the government’s policy commitments. The MOHW stated that it had invested KRW 50 billion and KRW 100 billion each in two funds, with additional investments of KRW 100 billion from the government-run banks (Korea Development Bank, Korea Eximbank, and Industrial Bank of Korea) and KRW 300 billion of private capital. These funds will be used to support companies that engage in vaccine development. However, the investment amount in the fund has gradually decreased. Few companies invest in funds due to a frozen private investment market. While the government raised KRW 261.6 billion through the K-Bio and Vaccine Funds No.1 and No.2, the investment size has now reduced to KRW 70 billion in No.3. In fact, this trend is not irrelevant to the end of the COVID-19 pandemic. In 2022, various Korean pharmaceutical and biotech companies like GC Biopharma, Ilyang Pharmaceutical, Genexine, and Shin Poong Pharm challenged the COVID-19 vaccine and treatment. However, with the shift of COVID-19 to the endemic phase, many of them either suspended clinical trials or withdrew development plans. With the waning interest from the government, the pharmaceutical and biotech industry, and citizens, the presence of the vaccine fund is now in question. The size of the vaccine fund is also raising concerns. Industry experts argue that an investment size of trillions of Korean won is necessary to develop new domestically developed drugs. However, the government reduced the fund’s size to KRW 1 trillion. Since the fund has not reached KRW 1 trillion, it is anticipated that Fund No.3 is expected to end with the formation of less than KRW 100 billion. When combining the sizes of Funds No.1, No.2, and No.3, the total is less than KRW 500 billion. In particular, the current fund size of KRW 300 billion is insufficient to support even late-phase clinical trials for a single pharmaceutical and biotech company. Many companies that develop new drugs domestically are abandoning development due to the high costs involved in phases 2 and 3. Most companies are unable to progress to phase 2 clinical trials. In the end, it may be difficult for President Yoon Suk Yeol to secure the vaccine and treatment technology to prepare for the Next Pandemic, as he has advocated since his inauguration. The vaccine fund is now non-commital due to the COVID-19 endemic and insufficient funds. There is a prevailing sentiment in the industry that instead of having high expectations for policies, the focus is on the government designating biotech as a promising industry and showing interest and support. Despite the heavy impact of the COVID-19 pandemic on Korean citizens, the government’s efforts to secure vaccines and treatment are waning with the announcement of the endemic. Doubts are emerging about whether the government plans to increase vaccine funds if infectious diseases like COVID-19 occur again. During this period, there are concerns regarding the course of government policies.
- Opinion
- [Reporter’s View] Additions to the post-management system
- by Eo, Yun-Ho Apr 12, 2024 05:41am
- “The introduction of the post-management system aims to secure additional evidence related to medicines of uncertain safety and efficacy. The system is intended to improve healthcare by reverifying those medicines with medical knowledge.” Although the intention seems reasonable, some are voicing concerns. The concern is that reinforcing the system could eventually result in 'drug price reduction.’ During the 48th Dailypharm Future Forum, which discussed ‘Directions for appropriate system improvement of Post-management System,’ Korean pharmaceutical companies, global companies, and academics all shared a unanimous skepticism toward the system. The prevailing opinion questioned the system’s necessity and whether RWE (Real-world evidence) would be utilized. Their opinion is well-founded. According to the analysis titled ‘A study on the analysis and rationalization of drug expenditures for new drugs in Korea,‘ the expenditures spent on new drugs from Korea’s health insurance funds only represent 8.5% of the Korea’s total drug expenditure. This figure accounts for 2.1% of the total medical service fee covered by Korea’s health insurance. Compared to other OECD countries, the impact of new drugs on Korea's health insurance funds appears to be among the lowest-ranking levels. The expenditures spent on items of Economic Evaluation exemption and RSA drugs, which include new drugs for severe diseases like cancer and rare diseases, are similarly low, accounting for 0.3% and 2.7% of total drug expenditures, respectively. The system’s requirement for RWE (Real-world evidence) appears to be inadequate. Typically, the hierarchy of evidence includes meta-analysis, literature reviews, randomized controlled trials (RCT), clinical and observational studies with control groups, observational studies without control groups, case reports, and expert opinions. The system's RWE requirement falls under 'observational studies without control groups-case reports.' Adjusting insurance drug prices based on data with a high bias probability could be an unreasonable approach. Additionally, if such document submission is reinforced, pharmaceutical companies will bear the burden of allocating a separate budget to conduct research. The industry is concerned that if the system leads to a reduction in drug prices, pharmaceutical companies will essentially be generating data that could contribute to a decline in sales. This aligns with the concerns of Korea-passing. However, the response of the Health Insurance Review and Assessment Service (HIRA) was encouraging. While maintaining the stance that additional evidence is needed for most drugs with uncertain efficacy and safety, as they are essential medicines in clinical practice and are subject to Economic Evaluation exemption, they agreed on RWE's limitations and concerns regarding the requirement of evidence in the data used for analysis. The post-management system will probably be further reinforced. A drug performance evaluation committee within HIRA Research is also postulated. There should be ‘further discussion.’ It’s crucial to determine whether the system will act as another method of reducing drug prices or if it will serve the government’s stated purpose of ‘alleviating uncertainty.’
- Opinion
- [Reporter’s View] Delays in reimbursement listing
- by Lee, Tak-Sun Apr 09, 2024 05:50am
- Last January, the Health Insurance Review and Assessment Service (HIRA) posted a document explaining the delay in listing and related press reports. The message was that the HIRA strives to implement faster listing, but pharmaceutical companies must cooperate. “Pharmaceutical companies must submit relevant documents for drugs subjected to the cost-effectiveness evaluation waiver system because cost-effectiveness of the drug may be determined vague,’ the HIRA said. “To shorten the evaluation period, proactive cooperation from pharmaceutical companies by submitting comprehensive data demonstrating the clinical utility and cost-effectiveness of drugs is necessary,” the HIRA emphasized. During the National Assembly audit in October last year, swift reimbursement orders for the cancer drug 'Enhertu inj' and the orphan drug 'Ilaris inj' emerged, and there have been numerous press releases related to the issue. In January, media coverage asking for swift reimbursement peaked as Enhertu inj and Ilaris inj were not yet under review by the Drug Reimbursement Evaluation Committee (DREC). The press primarily focused on the HIRA’s assessment delay. None of the articles demanded that pharmaceutical companies swiftly submit comprehensive documents. In January, HIRA’s explanatory document included such complaints and resentments. “During the early stage of reimbursement assessment, some pharmaceutical companies leave out important documents,” an official from the HIRA explained. Again, in the February DREC review, Enhertu received reimbursement appropriateness following the January DREC review. In March, negotiations for drug prices were completed. Starting in April, Enhertu is reimbursed for the upper limit amount of KRW 1,431,000 for patients with HER2 expression-positive metastatic breast cancer or gastric cancer who have received prior treatments. On the other hand, reimbursement for Ilaris is still under review. In March, the DREC conditionally recognized the reimbursement appropriateness pending further submission of evidence by the pharmaceutical company. After the pharmaceutical company raised objections, it was reviewed again in April. However, the DREC review delivered the same conclusion. Now, the pharmaceutical company has to make its decision. There has been a lot of media attention recently on medications that are intended for patients with low numbers or severe conditions. While insurers want to provide reimbursements quickly to address patients' urgent needs, they need to consider both the effectiveness and cost of the medication. Therefore, a thorough evaluation is necessary from the insurer's perspective. Recently, media reports urging swift reimbursement put psychological pressure on the HIRA. “There is significant pressure to accommodate patient community demands through media coverage. HIRA handles these issues through informal complaint-handling rather than formal procedures, leading to increased workload and stress for staff,” according to a recent report on ‘Comparison of Reimbursement Management Systems for High-cost Drugs in Korea and Overseas (researcher Kim Yoo-jung).’ The media often blames the HIRA for delays in the reimbursement assessment of drugs, hindering its normal operations. Recently, the HIRA announced its intention to expedite the inclusion of high-cost anticancer drugs and orphan drugs through a "pre-entry, post-assessment" policy. This means that even for Ilaris, the assessment results may follow a post-evaluation format for prioritized entry. While HIRA has played its card, whether the market is mature enough to accept this approach remains uncertain. Criticism accusing HIRA of passing on responsibility for insufficient data from pharmaceutical companies may not be entirely justified. According to HIRA, achieving swift reimbursement requires the cooperation of both HIRA and pharmaceutical companies. It's the responsibility of both parties to ensure swift inclusion. Pressuring for speedy inclusion through public opinion can cause more disruption instead of facilitating the process. Establishing formal administrative procedures that allow patients to participate in decision-making, as demonstrated in the recent HIRA study, is essential. This will clear up misunderstandings around current assessments and ensure impartial evaluations. Advocating for reimbursement through the National Assembly or the media is not legitimate.
- Opinion
- [Reporter’s View] Results needed for ‘Ilaris’ on hold
- by Eo, Yun-Ho Apr 01, 2024 05:29am
- It made its third attempt, but Ilaris faced another challenge. ‘Ilaris,’ a drug for about ten patients in South Korea, has not cleared the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) and is on hold. Novartis Korea’s Ilaris (canakinumab), a drug used to treat periodic fever syndromes (PFS), passed the review under condition by the DREC in February, causing anticipation. However, the ‘appropriateness of reimbursement’ decision was postponed after Novartis did not accommodate the additional documents requested by the government. Novartis requested that the government reconsider the requirements for submitting documentation. The HIRA replied that it would consider the request and re-introduce Ilaris for a review to the DREC between April and May. Typically, the DREC suggests conditions such as ‘accepting below the evaluation price.’ It is uncommon to have to submit additional documentation for clearing the DREC. Considering the circumstances, the company may not be able to accept all the terms required by the government. It remains to be seen whether Novartis will accept the requested documentation, whether HIRA will approve only the documents deemed doable by Novartis and not the whole and accept the reevaluation application. We hope for a speedy reimbursement process for Ilaris. Ilaris was approved in South Korea in 2015 but failed the second attempt at securing reimbursement. The patients have been awaiting approval for more than eight years. The drug targets only a few patients and has complicated indications. Only a few patients meet the Ilaris’ number of indications. Some Ilaris’ indications are missing disease codes and were recently registered. Thus, patients’ unmet needs are unimaginable. Currently, Ilaris is not covered by reimbursement, which means patients have to resort to alternative treatments with limited options. For treating CAPS, patients use 'Kineret' available through the Korea Orphan & Essential Drug Center (KODEC). The use of Kineret has limitations due to unclear communication methods and supply issues because it is imported through the center and has not been officially approved by the Ministry of Food and Drug Safety (MFDS). Ilaris's priority is DREC's review instead of an uncertain listing schedule. Currently, blaming the government or company is not necessary.
- Opinion
- [Reporter’s View] Let Enhertu’s case guide new listings
- by Eo, Yun-Ho Mar 19, 2024 05:44am
- The reimbursement listing of the advanced ADC anti-cancer drug Enhertu is imminent. The company completed drug pricing negotiations with the National Health Insurance Service at a ‘superfast’ speed when considering the slow progress it had made during previous procedures. At this pace, Enhertu is likely to be reimbursed in April this year. After passing HITA’s Cancer Disease Deliberation Committee last year, Enhertu’s reimbursement agenda was rejected by the Drug Reimbursement Evaluation Committee 8 times and was unable to cross the threshold until February this year. But its pricing negotiation took less than one month. This is both encouraging and unusual. Adding on to the wonder, the ICER threshold that the government had set for Enhertu is likely above KRW 50 million. Due to its superior efficacy, the company had difficulty calculating Enhertu’s cost-effectiveness. This is also the reason why it took a long time for the drug’s reimbursement agenda to be submitted to DREC, because the Economic Evaluation Subcommittee was unable to conclude on cost-effectiveness for a long time. The fact that this good drug with a high threshold passed the DREC review signifies that the government set an ICER threshold to pass the drug. Although there is no documented figure, it is generally accepted that the maximum ICER granted for reimbursement in Korea is KRW 50 million. And even the KRW 50 million threshold is known to have been granted very few times. Raising the ICER threshold has been a long-standing desire of the pharmaceutical industry. In a study published last year in the online edition of the medical journal Springer, "An Industry Survey on Unmet Needs in South Korea's New Drug Listing System," the ICER threshold was the No.1 improvement desired by market access managers in the industry. 93% of the respondents chose so. Improving the ICER threshold also topped the list of benefits the government promised to provide as preferential drug pricing measures for innovative new drugs last year. Enhertu’s case rose to attention amid such a trend. Other factors did take part in the incredibly rapid progress made in its drug price negotiations. When considering the given conditions, the pricing negotiation for Enhertu could not have gone so easily. This is why some analysts have been suggesting that the political pressure had played a role ahead of the general elections. However, regardless of the pace, Enhertu has set a promising example for other companies that need to pass pharmacoeconomic evaluations. Enhertu’s case should not end as a one-time event; rather, it should serve as a milestone for other cases to come.
- Opinion
- [Reporter’s View] 'Tylenol,' no longer produced,
- by Lee, Hye-Kyung Mar 18, 2024 05:49am
- Twelve years have passed since the government desginated over-the-counter emergency medicines. On November 15, 2012, the government implemented 13 over-the-counter (OTC) emergency medicines, including antipyretic analgesics, gastrointestinal medicine, and patches. When designating 13 OTC emergency medicines, the government based its evaluation primarily on consumer ‘brand awareness,’ meaning medicines with high name recognigtion and a long history of use, allowing consumers to choose the brand. The current list of OTC emergency medicines includes Tylenol Tab 500 mg, Tylenol Tab 600 mg, Children's Tylenol Suspension, Brufen Syrup for Children, Pancol A Sol, Panpyrin-T Tab, Bearse Tab, Dr. Bearse Tab, Festal Gold Tab, Festal Plus Tab, Jeil Cool Pap, and Sinsin Pas Arex. Since the initial designation of OTC emergency medicine, the list has not been updated once. In July 2012, the Ministry of Health and Welfare (MOHW) stated they would make an interim evaluation after six months and re-organize the pharmaceutical items after a year. Additionally, if necessary, there can be a withdrawal of designation or additional designations according to the Pharmaceutical Affairs Act, which states that OTC emergency medicine can include ‘less than 20 items, not fixed to 13 items. However, the list still includes the drugs that can no longer be manufactured in South Korea as the manufacturing plant shutdown, and the government is reviewing on the withdrawal of those OTC emergency medicines for eight months. The Ministry of Food and Drug Safety (MFDS) approved discontinuances of ‘Children's Tylenol Tab 80 mg’ and ‘Tylenol Tab 160 mg’ on March 21, 2022. The reason for discontinuance is the manufacturing plant shutdwon due to relocation to overseas. Previously, the MOHW stated that despite the MFDS’s approval of withdrawal, they can not decide to withdraw OTC emergency medicines because the stocks are still in the market. As the stocks ran out in convenience stores last October, the MOHW has organized an expert advisory group. Two years have passed since two OTC Tylenol emergency medicines were voluntarily withdrawn. We hope that the expert advisory group will discuss not only the withdrawal of Tylenol from the list but also the designation of alternative medicines and the reorganization of the OTC emergency medicines list.
