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- 2026-07-22 11:58:23
- Opinion
- [Reporter's view] Expensive vaccine sovereignty
- by Apr 15, 2021 05:56am
- The cervical cancer vaccine is Gardasil 9, and the rotavirus vaccines RotaTeq and Rotarix. Vaccines that are considered essential vaccinations, but consumers are less accessible. Foreign pharmaceutical companies are raising prices all at once. Gardasil 9 and RotaTeq's supply prices rose by 15% and 17%, respectively, from this month. RotaTeq will also become about 12% more expensive from next month. As supply prices rise, consumer vaccination prices also rise. Already, some hospitals are demanding additional costs from consumers who have made a prepayment. Gadasil 9 is already a vaccine that was burdensome at ₩450,000~600,000. Since 2016, women and adolescents aged 12 have been vaccinated free of charge for cervical cancer, but men and women born before 2003 have to get the vaccine at their own expense. Parents who have to give their newborns the rotavirus vaccine are also feeling not good. Due to the increase in supply prices, most hospitals have increased their vaccination prices since April, resulting in an average increase of 50,000 to 60,000 won for parents. Rotavirus vaccine is considered an essential vaccine for newborns, but in Korea it is not included in the national vaccination (NIP) program, so it is unconditionally non-reimbursement benefit. It should be inoculated with. The price of cervical cancer and rotavirus vaccines are rising, which is causing consumer dissatisfaction. In the case of Gardasil 9, even a national petition against the price increase appeared. There is a growing recognition that the cervical cancer vaccine is a vaccine that men as well as women should get. MSD Korea, a manufacturer, also announced the need for male vaccination by using male comedians such as Jo Se-ho and Yoo Byung-jae as advertising models. It is unreasonable to pay more than ₩600,000 and hope that the male vaccination rate will increase. Unfortunately, there is no basis for restricting pharmaceutical companies from raising the price of non-paid items. However, from the perspective of public health, the nation can expand NIP and support localization of vaccines. The former is the most obvious way to directly reduce the cost of the public, but the fiscal burden is high. In addition, the former has a problem that it is not possible to make a virtuous cycle in domestic demand because the invested finances go only to foreign companies. There is also an indirect method of inducing price cuts by increasing supply by supporting commercialization of domestic vaccines. Of course, it is difficult to predict how much the price cut effect will be in the market, but when a domestic vaccine is released, supply and demand and management are more stable. This is the same opinion as the government that it will secure'vaccine sovereignty' by increasing the self-sufficiency rate of domestic vaccines. Currently, both cervical cancer vaccines and rotavirus vaccines are only products from multinational pharmaceutical companies, so there is no way to deal with them even if prices rise or sell out. It is necessary for the government to make active efforts so that a domestic vaccine can appear as soon as possible and help improve the health rights of the people.
- Opinion
- [Reporter’s Eye] MNC CEOs' response to ‘Korea passing'
- by Eo, Yun-Ho Apr 05, 2021 05:52am
- MNC CEOs’ response to the ‘Korea passing’ phenomenon “Have you ever received pressure from corporate headquarters to consider ‘Korea passing’?” This question was asked to every multinational pharmaceutical company CEO interviewed by the reporter. Although the answer differed for each company and CEO, all the answers shared one common sentiment – a sense of burden. With the idea that ‘new drugs come from multinational pharmaceutical companies’ yet firmly established in Korea, it would have been difficult for them to say that “the company will not sell drugs to Korea because Korea sets prices low.” Such a response would imply that the company disregards ‘patients' that are so integral to the system. In addition to the burden, a sense of ‘crisis’ was also ingrained in their responses. “Our company has never chosen ‘Korea passing’ as an option yet," said the CEOs. ”However, Korea’s influence on China, the U.S., and other countries may impact future decisions.” The seemingly simple proposition, ‘better drugs enable people to live longer,' has now become a complicated issue that the government, pharmaceutical companies, doctors, patients, and even the general public can hardly be free from. Even now, highly effective but costly drugs, the special ‘commodities’ that are directly related to human health that cost hundreds of millions of won are waiting in line to enter our society. Although Market Access is responsible for such drugs, the CEOs are the real point of contact when it comes to communicating with headquarters. Therefore, their thoughts and even their philosophy may affect access to new drugs in Korea. That Korea is a good country for reference with a small market is a dilemma that we must bear. Despite pressure from civic groups, it is encouraging that the government has taken the first steps to expand the Risk Sharing Agreement (RSA) system. However, more must be done to minimize the risk of ‘Korea passing.’ as the pressure adds on with the possibility that the U.S. may also consider using Korea’s drug price as a reference. Nevertheless, in the process of improving policies, as well as discussing and persuading headquarters to release the company’s drugs in Korea, those in charge should bear a sense of responsibility for the commodity - the drug itself. Responsibility is one value that ‘those who bring their company’s drugs to Korea’ should cherish at all times. The ‘Korea passing’ phenomenon should not be abused as a pretext for easier listing in Korea. Our eyes will be on those who manage the Korean subsidiaries of MNCs, to see which companies choose to sideline Korea after detecting the slightest unfavorable element and whether management is doing their part to persuade their headquarters while pushing for systemic improvement in Korea.
- Opinion
- [Reporter’s Eye] How was working from home for a year?
- by Kim, Jin-Gu Mar 31, 2021 06:09am
- A year has passed since the COVID-19 has bled into people’s daily lives. The pharmaceutical industry also has faced big changes and working from home was one the biggest changes. Although it was forcefully introduced, the work from home system, unlike the beginning of the outbreak, became a norm—the office staffs have been working from home and the sales at site for a long time. After spending some time to get used to it, the companies are now seeing some positive side of the system. A team lead at a multinational pharmaceutical company commented, “The company struggled a bit in the beginning, but the work productivity has improved significantly compared against pre-COVID-19. Now we are rather worried about post-COVID-19.” Of course, there is an opposite side to it. Another company’s team lead said, “Because work tends have its inertia, the high productivity would be maintained for a while. But for a long-term, working from home would not help. There are definitely limitations in creativity and team work.” Both sides are right. The evaluation on working from home would vary depending on the company and team’s ambiance, workload, and position within the organization. Also the evaluation would be based on the work habit, distance from the office, and private issues like child care. Surely, the problem has no definite answer. The U.S., already preparing for the end of COVID-19 before South Korea, is taking interesting stance. Recently, major companies in the U.S. are having heated dispute over whether to continue work from home after the end of COVID-19. Netflix CEO Reed Hastings apparently called work from home a “pure negative.” Meanwhile, Apple CEO Tim Cook sees the outcome of working from home was impressive. And other companies are also contemplating on the pros and cons of working from home. South Korea should also consider the life after COVID-19. As the vaccination has been initiated, the end of COVID-19 is seemingly getting closer. The government anticipates achieving the herd community in coming November. Around early next year, the COVID-19 pandemic that has been draining the South Koreans over a year would finally mark the end. Also the time is coming for the pharmaceutical company to make a decision on either to continue working from home or go back to the office. Working from home was never an option in the beginning. Pharmaceutical companies were forced to work from home as the outbreak spread nationwide. But the companies can decide to stop working from home. And the decision has to be quick and bold. They should avoid the confusion they caused in the beginning at all cost. If some of the companies decide to continue working from home, they would need to be well-prepared. A simple guideline would not cut it. A well-designed remote working system should be established and organizational culture and personnel evaluation system should be entirely reformed. They should be aware the work from home guideline from the bygone days ordering ‘only the essential staffs to report to office’ has a clear limitation.
- Opinion
- [Editor’s View] One year after the pandemic
- by Chon, Seung-Hyun Mar 25, 2021 05:58am
- A year has passed since COVID-19 hit the world. About this time last year, when the World Health Organization (WHO) declared a global pandemic of COVID-19, the KOSPI index dropped to the 1400 line. But suddenly, the KOSPI index recovered to 3000. On March 19 of last year, the KRX healthcare index, composed of major pharmaceutical and bio companies, fell to 2,187.22 and rose to 4,569.86 in one year. Over the past year, vaccines and treatments have become the most powerful weapons to overcome the unexpected infectious disease crisis. Many domestic pharmaceutical bio companies have announced the development of vaccines and treatments. After one year of the pandemic, pharmaceutical bio companies also developed COVID-19-related drugs. However, domestic companies are not able to produce very satisfactory results. Last month, Celltrion received a conditional marketing authorization (CMA) for the first domestically developed COVID-19 treatment, but it is difficult to predict how effective it will be at the actual prescription site. Many domestic companies are accelerating clinical trials by proclaiming the development of COVID-19 treatments, but there are cases in which the superior clinical trial results are not obtained one after another. COVID-19 treatment approval has also been denied. Covid-19 vaccination has begun around the world, but domestic companies' vaccine development is still ongoing. Over the past year, the stock prices of companies delivering news of vaccine and treatment development have soared. They even used the pandemic crisis as a stock price. Press releases were pouring out, as if a great achievement was imminent, but no news was heard afterwards. In the context of ending COVID-19 through collective immunity around the world, it is time to verify the results of the development of corona drugs by domestic companies. The later the development of COVID-19 drug is, the less valuable the drug is. Companies developing COVID-19 treatments or vaccines can be verified with data whether their promises to patients or investors over the past year have been properly fulfilled, and can be judged by commercial outcomes through government approval. The efforts of most pharmaceutical bio companies to conquer COVID-19 should not be dismissed. It is unavoidable even if it failed by mobilizing all of its R&D capabilities with a large amount of money. This means that the failure to develop new drugs should not be blamed. In 2019, as many domestic bio companies failed clinical trials for new drugs in succession, there were some doubts that the clinical data were intentionally distorted and released. The time is approaching when the promises of pharmaceutical bio companies to conquer COVID-19must also be verified over the past year. Even if companies have failed to achieve their goals, they should inform them honestly in terms that the people can understand. It is time to verify the COVID-19 R&D as well.
- Opinion
- [Reporter’s Eye] For unbiased KPBMA ethics committee
- by Mar 19, 2021 06:28am
- Industry-representing associations are often perplexed among various opinions of businesses of all sizes. Unlike small and medium-sized companies urging the regulation to be versatile for the survival of many companies, large corporations focus more on industry support and advancement. Often, the companies express contrasting opinions on a same regulation. The industry association, supposed to generally cover all member companies, gets into an internal dispute when it loses balance among them. And pharmaceutical industry associations were no exception. When the industry was sensitive with the drug pricing system revision in early 2019, many of small and medium-sized companies talked of collectively leaving the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) as they complained the association has turned its back on the small and medium-sized companies and represented the large corporations’ benefit. The association’s ethics committee has to maintain a fine balance as well. The association consists of 10 committees to research for or deliberate about businesses, and the ethics committee reviews misdemeanor by a member company and takes appropriate disciplinary action. In other words, the penalty on a member company’s misconduct imposed by the ethics committee provides an opportunity for the industry to self-reflect on itself. The committee’s disciplinary action would not hurt a company financially, but it would take a detrimental hit on the corporate image. For instance, the ethics committee imposed a penalty of disqualification on Pharma King for the charge of providing illegal rebate in 2016. The same disciplinary action was taken on Binex and Vivozon lately for manufacturing drugs for not following the authorized label. Since the news broke out on Mar. 8 of the allegation, the association moved fast. On Mar. 11, it issued an official statement that the companies would be “strictly penalized to set an example,” and convened an emergency ethics committee a week after. But the issue with the ethics committee is that it distances itself from consistency. The ethics committee seems to be biased towards small and medium-sized companies, compared against large corporations. Back in October 2019, Dong-A ST was sentenced for illegal rebate and decided to voluntarily leave the association. In the case of Parma King, Binex and Vivozone, the association, which preemptively opened the ethics committee before the results of the trial came out, waited patiently until the Supreme Court sentence was confirmed in the Dong-A ST case. At that time, Dong-A ST was the chairman company of the association. A year after the incident, Dong-A ST rejoined the origination in November 2020. On top of everything, the company was once again designated as a chairman company. Currently, the JW Group, under an investigation for the allegation of providing illegal rebates, is also favored by the association. Some cases of misconduct are dealt by the ethics committee, while others do not. Even for the same issue, smaller scale of misdemeanor faces worse penalty. The reason for the inconsistent standard is because the ethics committee is convened without clear regulations. .Members committing misconduct may or may not be penalized .Reprimanding a member charged with the wrongdoing is also a duty the association has .However, the committee should clarify the grounds when taking a disciplinary action .Only when everyone is on the same page as to when the ethics committee is convened for what kind of misconduct and in what scale, the penalty on the responsible member would be agreeable and acceptable .Based on the precedents, it feels like the ethics committee, firmly conservative on large corporation, tends to open promptly for small and medium-sized companies .Hopefully, the association to become more well-trusted by the pharmaceutical and bio industry and better represent the whole of the industry .
- Opinion
- [Reporter's View] BINEX & NDMA Phobia
- by Lee, Jeong-Hwan Mar 12, 2021 06:21am
- It was said that it should never be done and it was malicious because it was deliberate. This is a concern from the National Assembly, the government, and the pharmaceutical industry looking at the situation of BINEX, which violated the pharmaceutical affairs law due to suspicion of manufacturing method and dosage manipulation, which is also a bad thing for the global prestige of domestic drugs. The confidence in the quality of domestic drugs, which only recovered after the detection of NDMA, a suspected carcinogen, has been broken again. In this case, the violation of the Pharmaceutical Affairs Law, such as the intentional manipulation of the manufacturing method of a specific pharmaceutical company, rather than the incorporation of impurities (NDMA) caused by unknown external factors, sparked the incident. Since the detection of NDMA such as Valsartan and Ranitidine is an overseas drug quality incident and is a common international issue, the impact on the quality and reliability of domestic drugs was not significant. The impact was further mitigated as no fatal safety issues were identified in the NDMA detection survey by the MFDS. This BINEX incident is very different from the NDMA incident. As one pharmaceutical company was suspected of manipulating the manufacturing method and the dosage of the active ingredient, it had a negative impact on the reputation of domestic generics. The MFDS, which is the main ministry, was also unable to escape responsibility. The MFDS has introduced a GMP system and an item approval renewal system and is operating a management system after marketing approval. BINEX violated the post-regulation system of the MFDS and the Pharmaceutical Affairs Act, ignored ethical management and pursued only profit. On the 8th, the MFDS issued the same disposition to 32 items from 24 generic companies made in the same factory following the suspension of manufacturing and sales of 6 drugs that violated the Pharmaceutical Affairs Act manufactured at BINEX Busan Plant 1 and voluntary recovery. Confidence in the consignment manufacturing generic system has collapsed. "If a pharmaceutical company decides to cheat, it will be impossible for the MFDS to detect violations of the Pharmaceutical Affairs Act one by one," experts in the pharmaceutical industry say. Medicines that treat sick patients should be perfect. Drugs are sometimes poisonous in that they can have unexpected side effects. The NDMA impurity crisis drove the public into drug phobia and stopped prescribing and dispensing in pharmacies at front-line medical institutions. The BINEX crisis is highly likely to re-create the national turmoil caused by the NDMA crisis. Some media reported the response to BINEX's case. Among the numerous reports, BINEX's explanation of 'violation of the Pharmaceutical Affairs Act due to a change in manufacturing method rather than a major dose manipulation' is so much ridiculous. The intention is to clear the company's position that it acknowledges the manipulation of the manufacturing method, but does not manipulate the dosage of the active ingredient, thereby removing some unfair accusations. However, violation of the Pharmaceutical Affairs Act is another matter. Since it is difficult for the general public to know the professional pharmacist law and drug information, it does not seem important that the manufacturing method was manipulated and the dose manipulated. It is illegal to change the manufacturing method without permission from the MFDS, which can cause distrust in the pharmaceutical industry. The National Assembly Health and Welfare Committee's attitude toward the BINEX situation is strict and serious. This is because it is true that they deliberately tricked the people and the government into distributing and selling medicines, and negatively affecting the reliability of domestic and foreign medicines. The BINEX incident made subsequent legislation in the National Assembly inevitable. The illegality and deviation of a pharmaceutical company may increase the burden by strengthening the overall post-regulation of the pharmaceutical industry, including the good pharmaceutical companies who are properly complying with the law. BINEX must repeatedly reflect on the violations it has committed. The MFDS should prepare measures to prevent recurrence of BINEX as soon as possible. The National Assembly, which is in charge of legislative responsibility on behalf of the people, must consider a reasonable legislation without unnecessary over regulation. A reflection of illegal pharmaceutical companies, a transparent investigation by regulatory authorities, and smart and delicate legislation of the National Assembly are required.
- Opinion
- [Reporter’s Eye] Needs transparency in Cancer Committee
- by Eo, Yun-Ho Mar 08, 2021 06:20am
- The cases of healthcare reimbursement expansion on novel drug in South Korea has plummeted last year. The drug use has diversified but the actual use volume has not been increased. A survey on pharmaceutical reimbursement status found the increase in reimbursement expansion for each item in 2020 compared to 2019 has plunged by 70 percent, and by 75 percent for each indication. The figure includes the reimbursement expansion in off-label use as well. In 2019, total 107 items had their coverage expanded. However in 2020, only 35 items succeeded expanding the coverage. 104 indications had their coverage expanded in 2019, whereas it was only 30 indications last year. Regardless of the drop in expanded coverage, the number of coverage expansion application was not so different in 2020 compared to 2019. The biggest cause of the drop seems to be the COVID-19. Respective reimbursement deliberation committees including the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) and Cancer Deliberation Committee had to postpone their meetings multiple times, which is an essential step prior to reimbursement listing. To improve the situation, the South Korean government alleviated the related regulation and allowed on-paper review from September. But besides the COVID-19 pandemic, some of the pharmaceutical industry associates point out the reimbursement expansion barrier has gotten higher over the year. The fingers are pointing at the Cancer Deliberation Committee. Originally, specialist doctors used to discuss the practicality of the drug by reviewing the drug’s clinical efficacy. But from last year, the committee started to also evaluate the financial impact of a drug. Since last year, the Cancer Deliberation Committee became the impossible river to cross. More and more drugs are pending for reimbursement expansion due to the committee. Some company goes as far as to submit a pharmacoeconomic analysis to the committee. It is possible, that many companies could have been too greedy with the pricing or had so many clinically ineffective drugs specifically in last year. But the issue is transparency. Currently, the Cancer Deliberation Committee does not disclose the result. The applicant company sometimes finds out about the listing close to the effective date. The DREC was like that in the past. An applicant company had to either pull their strings to confirm the result immediately after each meeting or wait for healthcare news media to publish an article on it. The companies continued to file complaints and now the DREC results are disseminated to news media with clear reasoning behind the decision. The same old situation is occurring within the Cancer Deliberation Committee. As the Cancer Committee started reviewing the financial impact, the number of cases where a drug is rejected by DREC after passing the Cancer Committee has drastically dropped. Basically, the Cancer Committee is playing the role of DREC. It is clear the Cancer Committee has to disclose all result clearly as DREC has. Only when the Cancer Deliberation Committee provides the clear reason behind the disapproval, a company can be reprimanded for its greediness or seek for the middle ground. While COVID-19 is an emergency state to be handled carefully, the South Korean health authority should not forget the cancer patients are also waiting desperately.
- Opinion
- [Reporter’s Eye] Be aware of fake news trampling the hope
- by An, Kyung-Jin Mar 05, 2021 06:26am
- Recently, the South Korean media industry is intensely disputing over a bill imposing punitive damages. Democratic Party Lawmaker Noh Woong-rae issued a legislative notice on a bill to include general media and portal websites as subjects for the punitive damages, which awards compensation valuing maximum of triple the damages to a prevailing plaintiff of a libel case, where damages are caused due to intentional distribution of false and distorted information. Reportedly, the media industry is strongly resisting against the bill. The opposition party and the media labor union are criticizing that “The new bill is shackling the media in the name of media reform.” The public opinion survey result disclosed a day after the Democratic Party announced the bill would be brought to the National Assembly provisional session showed contrasting reactions. A South Korean public opinion survey firm Realmeter surveyed 500 adults aged over 18, as requested by Oh My News, about applying the punitive damages on media outlets, where 61.8 percent approved of it, which more than doubling the opposing opinion (29.4 percent). The distribution differed depending on the political view and supporting party, but the approving opinion was higher than the opposing opinion throughout most of the regions and age groups. Regardless of supporting or opposing the bill, the outcome was shocking. Basically, it portrayed how low the people’s trust in media has gotten. Issues with fake news were apparent even from the early stage of the novel coronavirus infection outbreak (COVID-19). Hateful comments burst out when the outbreak was out of hand for a while in Daegu, and misinformation of confirmed patients and their routes was shared through Youtube, KakaoTalk and online communities fast causing a massive damage to the affected ones. Since the MERS outbreak in 2015, the information technology has developed rapidly and the people’s dependency on social media hiked and fired up the fake news spreading. Concerned of the rapid distribution of the fake news, the World Health Organization (WHO) has warned of infodemic, a portamanteau of “information” and “epidemic,” and unfolded a relevant management plan. And a year has passed since. How are we doing amid COVID-19? The treatment and vaccines that used to feel unobtainable have been developed, and the COVID-19 vaccination started from Feb. 26 in South Korea as well. The government plans to achieve the herd immunity by coming November, and inoculate the first dose of COVID-19 vaccine to 70 percent of the people by September. However, the fake news creating insecurity is still found around every corner. What’s worse is that it is not spreading only by social media or individual media channel. Some of articles and their provocative headlines published by news outlet are implying a specific company’s vaccine could cause more adverse reaction. Without a proper investigation outcome in the cause of death, the public is thrown into turmoil with news articles reporting the death of COVID-19 vaccine recipients. Healthcare providers urge, “The vaccination is essential for us to end the COVID-19 pandemic.” Besides the government, Korean Society of Infectious Diseases (KSID), Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) and Korean College of Rheumatology are raising their voices and plead “Do not get confused by fake news and participate in COVID-19 vaccination.” Looking back now, I am reflecting on myself with the thought of ‘what have I been doing as a reporter amid pandemic?’ The South Korean media should take COVID-19 as an opportunity to reflect back on themselves and regain the public’s trust.
- Opinion
- [Reporter’s View] KDCA’s dilemma on using AZ vaccine
- by Kim, Jin-Gu Feb 17, 2021 05:39am
- The last call is to be made by the hand of Korea Disease Control and Prevention Agency (KDCA). On Feb. 10, South Korea’s Ministry of Food and Drug Safety (MFDS) finalized the authorization on AstraZeneca’s COVID-19 vaccine. The ministry included a warning for inoculating an age group over 65 that ‘the vaccination should be carefully considered for the specific age group.’ It was a clever decision. But also at the same time, now KDCA has to make the hard decision. In the afternoon of Feb. 15, KDCA announced the final inoculation plan including the vaccination for the elderly age group. Initially, the government was planning to prioritize inoculating AstraZeneca’s vaccine on long-term nursing hospital occupants and elderly age group. If KDCA decides not to recommend using the vaccine on 65-and-up group, the entire change in the plan is inevitable. Basically, every government in the world has conflicted stances on inoculating the 65-and-up age group with AstraZeneca’s vaccine. Germany, France, Sweden, Norway, Denmark, the Netherlands and Spain are recommending the vaccine for the 65-and-up age group. Whereas, Italy and Belgium recommend the vaccine only to age 55 and under. The two countries do not see that the vaccine has sufficient evidence to confirm the efficacy. In fact, a clinical study with the vaccine showed only 660 people aged 65 and over, or 7.4 percent of the total, responded to the vaccine. Meanwhile, the U.K., India and Argentina recommend using AstraZeneca’s vaccine on all age groups. The World Health Organization (WHO) also approves of inoculating the elderly age group with the vaccine. They consider the potential benefit of the vaccine outweighs the risk. They elaborated the immune response on the vaccine by the elderly group has been confirmed through documents, which was apparently on par with other age group. The most challenging decision is now given to KDCA to make. Both options could be criticized by each side. However, KDCA should not be swayed by those criticisms. This is the time for the agency to strictly follow the principle. Based on the preceding vaccination cases, they should make a firm decision focusing on the safety and efficacy only. Postponing the decision on the 65-and-up age group vaccination could be an option, if need be, until other countries like the U.K. unveils further clinical data. Most of all, the agency should steer away from a political decision, keeping the April by-election in mind. The inoculation plan may be constantly changing and delayed, but it would be better than risking people’s health with an unconfirmed vaccine. And this is why the KDCA’s decision holds a grave meaning to it.
- Opinion
- [Reporter’s View] The transparency in COVID-19 drug review
- by Lee, Tak-Sun Feb 01, 2021 06:16am
- The public is keeping a close eye on the South Korean Ministry of Food and Drug Safety (MFDS) approving the COVID-19 vaccine and treatment. Especially because the pharmaceuticals and their efficacy have been controversial overseas, the public’s interest is heightened on the result of the health authority’s evaluation. To guarantee an objective assessment, MFDS is consulting with experts for three times. After the first verification, the Central Pharmaceutical Affairs Deliberation Committee and the Final Review Committee would conduct the second and third review on the drugs, respectively, for the final decisions Celltrion’s COVID-19 monoclonal antibody treatment candidate Rekirona has been passed by the Verification Council and the Central Pharmaceutical Affairs Deliberation Committee, and now it is waiting for the final decision by the Final Review Committee. AstraZeneca’s COVID-19 vaccine also has been under the Verification Council’s review for 30 days. Regardless of the thorough consultation with three groups of the experts, the public is still skeptic about the objectivity of the review. The public suspects the final decision has been made already, as the health authority addressed the projected approval date on those COVID-19 vaccine and treatment during a briefing session, and politicians are also commenting about the specific date. Now the people are concerned the groups of experts would not be able to make an objective decision as the government and politicians have built an environment strongly pushing for a positive result. In fact, Celltrion’s COVID-19 monoclonal antibody is apparently lacking sufficient data, and the efficacy of AstraZeneca’s COVID-19 vaccine on elderly population came under close scrutiny. But at this point any kind of decision could be made as the experts are disputing over split views. Apparently, some members of the Central Pharmaceutical Affairs Deliberation Committee are opposing against granting an official approval on Celltrion’s COVID-19 so much so that they suggested giving a special case authorization for manufacturing, instead of the approval. For the people’s rights to know and transparency, MFDS is weekly updating the evaluation news on the COVID-19 vaccine and treatment candidates. The ministry does realize the public’s demand for objectivity, independency and transparency on the COVID-19 vaccine and treatment are higher than ever. However, a fiery controversy would be unavoidable every time the expert bodies provide the review result. Even the experts struggle to make an unbiased decision on the drugs, torn between the treatment urgency and safety, as they were hastily developed for the urgent cause. To eliminate the public’s suspicion and ensure transparency, the ministry should fully disclose the Central Pharmaceutical Affairs Deliberation Committee’s meeting minutes. Although the ministry is supposed to disclose the meeting minutes by principle, they sometimes decide to keep the minutes confidential, causing the public to accuse the ministry of making decisions in their favor. Only giving a briefing of the Central Pharmaceutical Affairs Deliberation Committee’s meeting cannot possibly resolve the public’s curiosity. The public is highly suspicious of the expert groups reviewing the drugs with already-decided outcomes as the news articles are making accusations. The ministry would be able to shake off the accusations only if they unveil the Central Committee’s meeting minutes without concealing a word. Hopefully, MFDS would take a bold action on the matter.
