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- 2025-12-20 03:55:04
- Opinion
- [Reporter’s View] Haste makes waste
- by Dec 04, 2020 05:55am
- The commercialization of the COVID-19 vaccine is approaching. The UK has already announced that the Pfizer vaccine will be approved for emergency use for the first time in the world and will be supplied early next week. Excluding vaccines from Russia and China that are not internationally recognized, this is the fastest action. The British government has also secured a dose for 20 million people. Other countries are in a hurry as the UK preemptively commercializes vaccines. It is reported that the United States will also receive vaccines by Pfizer/Modena within this month. According to CNN, the United States will go through a meeting of the FDA (Food and Drug Administration) advisory committee on the 10th to decide whether to approve it, and receive Pfizer on the 15th and Modena vaccine on the 22nd. It will be vaccinated as soon as the vaccine is available. In addition, there are many opinions in Korea asking for a vaccine. Some say that in the third epidemic of COVID-19, the government must quickly approve, contract, and proceed with vaccination. Currently, the Korean government has completed a purchase contract with AstraZeneca, signed an MOU with Johnson & Johnson and Pfizer, and is known to be negotiating with Modena. I agree with the opinion that amid the COVID-19 pandemic that continues for the first year, the situation should be pacified with rapid vaccination. However, it seems that a more careful approach is needed at times like this. This is because the current vaccine is not the absolute thing to end COVDI-19. Rushing has no advantage in negotiations. Currently, the vaccine manufacturers hold all the cards. They said they demanded a 'side-effect immunity' from all countries that the manufacturer is not responsible for any side effects from those who received the vaccine. It is a condition that is unthinkable under normal circumstances, but in the COVID-19 outbreak, the development period, which took more than 10 years, had to be drastically reduced, so this demand can also be raised. In this situation, if the government is in a hurry, there is a possibility that negotiations will proceed on more unfavorable terms. Getting the vaccine quickly doesn't mean everything The confusion is even greater if unexpected side effects occur one after another or if the vaccine's effectiveness is less than expected. Rather, it is much more stable to proceed with vaccination while taking a closer look at the trends of other countries where vaccination was started. Currently, there are 400~500 confirmed cases in Korea every day, but the situation is not urgent enough to urgently introduce a new substance whose efficacy and safety are not fully guaranteed. In addition, there are not one or two guidelines to be established before the vaccine is introduced, such as distribution method, the institutions, and order of vaccination. We already had already suffered from an urgent vaccination schedule just a few months ago, and the flu vaccines were exposed to room temperature during delivery. The process of delivering about 10 million doses of the flu vaccine, which is said to be easy to manage, was also difficult. Can we safely deliver tens of millions of doses of a much more difficult mRNA vaccine? It is necessary to prepare the cold chain thoroughly over time. What makes the confusing situation worse is the unpredictable factor. We need to be able to put the new variable, the vaccine, into the most predictable range. Vaccines are neither absolute nor complete solutions to COVID-19 outbreak. "Vaccines are just one tool for controlling disease," said Albert Bourla, CEO of vaccine maker Pfizer. "We have to be on the lookout for absolute belief in vaccines," he said.
- Opinion
- [Reporter's View]Drugs fluctuating prices should be excluded
- by Lee, Hye-Kyung Nov 24, 2020 09:01am
- The lawsuit for canceling eye drops’ price ended with the Supreme Court's ruling. Recently, the Supreme Court did not accept the appeal of 20 pharmaceutical companies, including Kookje, filed against the government to cancel a lawsuit for canceling the disposition of lowering the upper limit on the reimbursement of eye drops. After the defeat of the Supreme Court by eight pharmaceutical companies including Daewoo in September, the government won all of the remaining trials. The lawsuit for lowering the drug price for eye drops was conducted by pharmaceutical companies who opposed the enforcement of the government's notice in August 2018. It started with a trial divided into Kookje and Daewoo. It took place over only two years. The problem is that drug price cuts and recovery were repeatedly performed in this process. About 12,000 pharmacies were subject to confirmation in the '2020 Secondary Medical Institution Purchased Drug Price Periodic Check' in August, which corresponds to the '4th quarter of 2018', when the actual eye drop drug price cut and the drug purchase drug price and billing unit analysis time were combined. The HIRA compares the billed unit price with the weighted average of the purchase price of eye drops during the drug price cut period, resulting in inconsistent claims in the majority of pharmacies handling eye drops. Regular confirmation of the price of purchased drugs at pharmacies resumed from May 2018. The reason for the resumption of regular confirmation was that the discrepancy between the purchase price and the billed unit price continued to increase, but the pharmacy suffered damage from the government's drug price cut and the drug company's lawsuit. Of course, if the pharmacy updates the billing software every day and constantly checks the drug price file, it can avoid false claims, but it can be an administrative burden for pharmacists who operate single pharmacies. Therefore, in the case of items such as eye drops, which have a wide range of insurance drug prices due to administrative lawsuits between the government and pharmaceutical companies, there seems to be a need to exclude them from the regular confirmation of the purchased drug price or subject to field investigation. However, if the HIRA establishes 'advance drug price verification system', the pharmacy should also actively make an effort such as checking the weighted average price at the same time as billing.
- Opinion
- [Reporter’s View] The sluggish shift in stepped pricing
- by Eo, Yun-Ho Nov 18, 2020 06:34am
- In June, South Korea’s Ministry of Health and Welfare (MOHW) issued an administrative notice to withdraw the plan to apply the stepped drug pricing reduction on drugs transferred by business restructuring. And it has been three months since the ministry completed collecting the public opinion in August. But the finalized notice has not been disclosed. When the decision was made, the pharmaceutical industry seemed relieved and also complimented the government for swiftly changing the policy to reflect the public opinion. Daily Pharm also praised the MOHW’s action as an example of a ‘Smart healthcare administration.” However, the companies, who were relieved about the change and pushing on with their product transfer along with the business restructuring, are now idling. Some even assumed the final notice was issued and proceeded with the healthcare reimbursement listing procedure, which they ended up withdrawing. Initially, the stepped drug pricing, in effective from August, sets the upper limit pricing of a drug, regardless of qualifying two criteria for top-level pricing, at 85 percent of either the lowest pricing or 38.69 percent of the first-in-class drug, if the number of listed same-substance drugs exceeds 20. However, the Pharmaceutical Decision and Adjustment Criteria amended in last February opened up a room for the stepped pricing to be used on a product that succeeds business status due to corporate restructuring—for example in case of M&A, corporate split or license sell-off. Accordingly, companies like Pfizer Pharmaceutical Korea (Upjohn) and MSD Korea (Organon) preparing for multiple transfer of original products to the respective split off companies, fear of the possible pricing reduction. Takeda Pharmaceuticals Korea that recently sold off an antidiabetic treatment pipeline to Celltrion could not be completely free from the same fear. The controversy seemed to have died out as the ministry decided to set the upper limit price as before, according to the Pharmaceutical Affairs Act Article 89 notified to be enforced in June, when a drug is transferred by inheritance, business transfer or merge; a manufacturing license is switched to an import license or vice versa; and license is dropped and receives license as a same-substance drug due to Pharmaceutical Affairs Act, MFDS notice or the corporate status change. When a government body admits finding an error or side effect in a policy and decides to take a change, speed also becomes an integral part. Surely, the government body has to take time to carefully consider consequences. Taking numerous reconsiderations, even after accepting the public opinion, makes sense for such major policy shift like reviving the stepped drug pricing system. Regardless, the pricing reduction on the transferring original product should be a minor amendment. The speed is crucial for the significant shift in policy. Affected companies are already missing the business schedule. The bigger problem is that they still cannot fathom when it would be finalized. When there are companies waiting and the precious time is ticking away, the companies at least deserve an explanation.
- Opinion
- [Reporter's View] Did they have to sell that day?
- by An, Kyung-Jin Nov 16, 2020 06:03am
- The whole world was excited when the news about COVID-19 vaccine developed by Pfizer last week was delivered. This is because Pfizer announced an interim result that the mRNA vaccine, which is being developed jointly with BioNTech in Germany, showed more than 90% prevention effect. The company recruited about 44,000 participants in clinical trials from five countries, including the United States, and divided them into two groups, receiving COVID-19 vaccine on one side and a placebo on the other. Among them, as a result of analyzing 94 people who were diagnosed with COVID-19, participants who received the vaccine twice had an infection rate of less than 10%, and no serious side effects were observed. Uğur Şahin, CEO of BioNTech, said in an interview with foreign media, "I believe that this vaccine can end COVID-19 outbreak." As the spread of COVID-19 across the United States is accelerating, including the tightening of blockade measures in major cities such as San Francisco and Chicago, starting with New York, it is expected that the current level of data alone will provide dramatic protection effects. Albert Bourla, CEO of Pfizer, said, "We will apply for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) in the third week of November." and he added,"Vaccines can be manufactured in quantities that can inoculate 15 to 20 million people within the year." In the long term, Pfizer is planning to increase the dose of vaccine to 1.3 billion doses per year. Although it has been pointed out that detailed clinical data has not been disclosed and there are many issues to be solved, such as the distribution process, the good news that came after a long time moved the market. As the anticipation for the development of a COVID-19 vaccine and economic recovery was reflected, the New York Stock Market continued to rise overall, and Pfizer's share price rose about 15%. However, Pfizer CEO Albert Bourla sold a large number of stocks on the day of the announcement of the interim results of COVID-19 vaccine clinical trial. On that day, CEO Albert Bourla sold 62% of Pfizer's shares he owned and made a profit of ₩6.19 billion. Pfizer's vice president Sally Susman is also reported to have sold 44,000 treasury shares for $1.8 million (₩2 billion) on the same day. Of course, there is no legal problem with their selling. Pfizer said, "The sale of this stock is part of Bulla's personal financial plan and a pre-determined plan." The stock sale was approved on August 19th (local time), and the sale was made in accordance with the insider trading regulations, but there are no matters that violate the regulations. Nevertheless, public opinion is not good about this. There are also criticisms that it was inappropriate for Pfizer to announce the interim results of the clinical trial on the day the CEO decided to sell the treasury stock. As a result, doubts about the effectiveness and safety of the vaccine, which are still not established, have been raised. Moreover, this is not the first time such a controversy. Controversy arose as US pharmaceutical company Modena executives sold their stocks and earned profits after announcing the results of the interim phase I clinical trial of COVID-19 vaccine in May of this year. Even at this time, the company held a position that there was no legal problem with the executives' stock sales. The development of COVID-19 vaccine and an end to the pandemic are the wishes of not only investors who own Pfizer shares, but also the people around the world. Could they have acted more carefully if they were conscious of their responsibility for such aspirations? We hope that the stock sale will end in controversy as the remaining vaccine development and supply schedules proceed smoothly.
- Opinion
- [Reporter’s View] ERP should be kept ‘voluntary-basis’
- by Nov 12, 2020 06:19am
- The pharmaceutical industry is bracing themselves as winter is coming with the management offering early retirement program (ERP). Lilly Korea, a South Korean branch of the U.S.-based Eli Lilly’, has presented the ERP plan to reduce a quarter of its sales force. It is its first ERP after three years since 2017. Only Lilly Korea has officially announced the ERP plan, but the industry sources hint many more multinational pharmaceutical companies are preparing for the program as well. But what should be highlighted is that these multinational companies’ ERP is not local specific, but rather a part of reorganization trend apparent throughout the world. The global pharmaceutical companies are unfolding the strategy of focusing on selected key resources. Pfizer split off the off-patent drug business as a whole, while MSD is also planning to spin off female healthcare and off-patent products. Sanofi has announced its major downsizing plan to vastly shrink the antidiabetic and other chronic disease treatment business. Instead, the company is focusing on autoimmune disease and anticancer therapies. The wave of reorganization occurring outside of South Korea is now impacting the Korean branches as well. There is no reason for the executives to keep the employees under the departments to be closed. In the process of reorganization in Europe, Sanofi has notified its plan to lay off about over 400 employees under the chronic disease department. Moreover, the novel coronavirus (COVID-19) has been worsening the situation. As the sales and marketing activities have turned noncontact-focused online events, the company has a justifiable reason to downsize the sales force. The real motivation of ERP, the voluntary-basis retirement, seems to be out of reach for the employees in the multinational companies. The management claims they are only accepting voluntary applicants. However, the employees, especially the ones in the targeted department, would feel immensely insecure. They predict the management would eventually pressure the specific departments’ employees, when the management does not see a satisfying number of volunteers. This is why the labor unions in the multinational companies are constantly demanding the management to disclose transparent ERP procedure and to promise to provide the program without pressure. Reorganization and downsizing could be inevitable for a company to survive and relentlessly seek for changes. But a company is an organization that a board of executives cannot take a full control over the employees. If the employees are not taking the ERP offer as expected, than the management should follow legal procedure and offer more favorable options or change the objectives accordingly. Hopefully the approaching winter would not be so harsh, so the ‘voluntary retirement’ does not turn into a ‘pressured retirement.’
- Opinion
- [Reporter's view]Double regulation of penalties for rebates
- by Lee, Jeong-Hwan Nov 02, 2020 06:12am
- Rebates in the Pharmaceutical Industry's trick to `ship to pharmacies' has been repeated for decades. Some of them are established as practice and are taken for granted. During the two-week grace period given by the MFDS prior to the suspension of sale, pharmaceutical companies are actually making total sales by releasing drugs that cannot be sold for three months (6 months of second detection) to pharmacies. The grace period given to alleviate discomfort for patients taking medication is rather abused as a intensive promotion period for disposal items of Rebates in the Pharmaceutical Industry. Moreover, the inconvenience of pharmacists who have to pre-order stocks in order to dispense drugs that will be temporarily sold out due to the suspension of sales is also aggravated. The 21st National Assembly Health and Welfare Committee urged the MFDS to realize regulations as a result of eradicating disease. Kang Seon-woo, a member of Democratic Party of Korea focused on current regulations that do not directly punish pharmaceutical companies which have committed illegal administrative dispositions for rebates. The target of the disposition is pharmaceutical companies, but as they regulate medicines, the damage is transferred to patients who take medicine for disease treatment and to pharmacies in charge of dispensing. The sales of eight pharmaceutical companies, which were caught in rebates last year, sold items for sale within the two-week grace period was four times that of the previous month (the average sales growth rate of eight companies increased by 396%). The current regulation is a trickery that advances the timing of drugs to be sold during the disposal period within the grace period, and the effectiveness of suspension of sale is extremely low. Pharmacists are very embarrassed when they face a patient who gives out a prescription including out-of-stock drugs. In preparation for this, if a pharmacy pre-orders inventory as a temporary action, the nature of the ban on rebates is completely lost. Therefore, pharmacists are saying that the suspension of sales of rebate drugs should be replaced with punitive penalties imposed on pharmaceutical companies, or the prescription itself should be prevented by suspension of benefits. Earlier at the time of the parliamentary inspection, Lee Eui-kyung, Director of the MFDS, was reluctant to respond to the proposal that it was necessary to replace the suspension of sales with a fine. As the Health Insurance Act regulates lowering the rebate drug price and the Fair Trade Act also imposes penalties on rebate pharmaceutical companies, she is concerned that the collection of additional penalties under the Pharmaceutical Affairs Act may act as a double regulation. However, it was not appropriate as an answer to the improvement in the sale of illegal rebate drugs. In the case of illegal rebate violations prohibited by the current pharmacist law, the administrative disposition is 3 months suspension of sales at the first detection, 6 months suspension of sales at the second detection, and cancellation of the license for the third time. The fact that pharmacies and pharmacies and wholesalers of rebate items can be sold out without economic damage until the second detection, when the sale is suspended for six months, can trigger an unfair result of allowing two rebates. The eradication of illegal rebates is an obligation that the MFDS must take the lead. It is also the duty of the MFDS to make invalid sales suspensions ineffective by collecting a penalty surcharge. If the Health Insurance Act's drug price cut and the Fair Trade Act penalty are not in place of the suspension of rebate sales, shouldn't the imposition of the substitute penalty for the Pharmaceutical Affairs Act be viewed as a legitimate and legitimate punishment rather than an overlapping or excessive regulation?
- Opinion
- [Reporter’s View] Investors’ money, who is it for?
- by An, Kyung-Jin Oct 21, 2020 06:33am
- The public is giving the cold shoulder to the South Korean bio companies and their recent investments. A number of bio companies have apparently invested in Optimus fund that caused loss of about 500 billion won from an alleged fraud. And as the public found out about the fraud, the bio companies could not avoid their harsh reproach. Once valued at 5 trillion won, Helixmith came under fire from the investors as it was uncovered to have invested a large sum of over 200 billion won. This is not to criticize a private company investing on a high-risk hedge fund. Like any other individual investors, companies can carry out diverse investment models to multiply their assets. However, the problem is that these companies have injected a part of their investors’ money, received to improve R&D and relevant facility, to the high-risk hedge fund. The criticism on their ‘moral hazard’ would be inevitable, when they technically ‘gambled’ with the shareholders’ money. Most of the listed bio companies source their finance from the stockholders as they increase capital by issuing new stocks. Many of them generate insignificant sales volume, but they raise capital by ten-fold of the sales profit from the shareholders’ investment. For instance, Helixmith’ annual sales profit marked around 4.5 billion won last year, but it offered new stocks worth of total 281.7 billion won to the shareholders last month. Their plan is to secure over 60 times of their annual sales as capital by simply asking for investors’ money. The same company has also received total 300 billion won from increasing paid-in capital twice, each in 2016 and 2019. Superficially, their objective of follow-on offerings to the shareholders is to develop new drug. To let the shareholders to invest the finances for the new drug development, those companies would offer an opportunity to buy new stocks for inexpensive price. But a large-scale paid-in capital increase is not good news for the shareholders. Typically, the value of the stock gets diluted and drops when the rights issue is announced. For the shareholders, who cannot buy new stocks with their tight financial situation, the company’s decision to issue more stock cannot be pleasant. Also, the participating shareholders would have to take in even worse damage, if the stock value falls further after the rights issue. Whenever a company is offering a large-scale rights issue, the company has to report in detail regarding a specific objective of using the injected capital. The companies usually state the additional capital would be used on achieving the company’s vision like in new drug R&D, production facility expansion and debt repayment. A company receiving finances from investors is making a promise with the investors. The investors give their capital to the bio companies, believing that the executives of the companies would reach the vision as proposed. Statistically speaking, not all bio companies would be able to get to where it intended. The South Korean investors have also learned of difficulties the companies have to undergo in recent years. In the end, their hopes and dreams of a successful new drug leveraging the company as a global company lead the investors and the company executives to continue invest in R&D. A company instigating investment by manipulating the investors cannot be tolerated—it would disturb the order in the stock market. We would have to be concerned of certain company executives’ moral hazard influencing the investors’ distrust in the bio industry.
- Opinion
- [Reporter's View] Generic substitution is necessary
- by Lee, Hye-Kyung Oct 21, 2020 06:32am
- The activation of generic substitution was a daily issue at the National Assembly Health and Welfare Committee's national audit held on the 7th to 8th and 13th. It has been a long time since 2015 that the National Assembly has been interested in revitalizing alternative preparations as much as this year. This is also the reason why Young-Seok Seo, a member of Democratic Party of Korea initiated the 'Pharmaceutical Affairs Law Amendment Bill', which allows post-notification to the prescriber or the HIRA after generic substitution. According to the announcement of The MFDS, Pharmacists can make a generic substitution with an item recognized as bioequivalence by the MFDS or a bioequivalence reference drug which is cheaper than the drug prescribed by a doctor. At this time, a 'generic substitution incentive for low-priced drugs' system is also being implemented for pharmacists to receive 30% of the difference in drug price as usage incentives. However, the average of the generic substitution ratio for the five years from 2016 to August 2020 was 0.26%, of which more than 2.3 billion claims were made, in 603 million cases. This means that although the government has implemented an incentive system for the activation of generic substitution, the policy was not effective in the field. Over the past five years, it has saved ₩6,645 million by generic substitution. Excluding the incentives paid to pharmacists, it saved more than ₩4.6 billion in health insurance finances. As the drug cost increased every year, last year, ₩19,321.1 billion was spent as drug cost. The activation of generic substitution can capture some of the drug costs in health insurance medical bills. However, while pointing out the efficacy and side effects of the generic and original bioequivalence tests, doctors are opposed to the generic substitution. It's an old argument. The MFDS is promoting that generics can be taken with confidence because they are the same active ingredients as the original, Minister of Welfare Park Neung-hoo said, "There is no problem with the use of drugs from the patient's point of view as generic substitution is the preparation of drugs that have proven bioequivalence. Efforts are needed so that the people can trust in alternative drugs." The National Assembly proposed an amendment to the Pharmaceutical Affairs Act, and the Review Board said that the DUR system could be used to simplify the generic substitution process. The MOHW also expressed a willingness to improve the replacement dispensing post notification system. The government should create a forum for consultation with medical and pharmacists, and to build public trust in order to trust and take generics.
- Opinion
- [Editor’s View] Why still linger on bioequivalence test?
- by Chon, Seung-Hyun Oct 19, 2020 06:19am
- The South Korean government seems to be still lingering on the notion of restricting the joint bioequivalence test the Regulatory Reform Committee has put a brake on. At the recently convened National Assembly Annual Audit, Minister Lee Eui-kyung of Food and Drug Safety stated that she “fundamentally agrees with the restricting the ‘one-plus-three’ joint bioequivalence test.” The minister’s agreement was expressed on the regulatory bill introduced to the National Assembly to only approve of up to three generics using a single source of consigned bioequivalence tests. With the lawmaker’s boost, the ministry is rekindling the effort to legislate the restriction on joint bioequivalence test that was halted by the Regulatory Reform Committee. The restriction on joint bioequivalence test is viewed as a strict measure to prevent saturation of the generics market. When the number of consigned bioequivalence test per original test can be limited, the number of generic launched in the market could also be contained. Regardless of the Regulatory Reform Committee objecting to the restriction twice, the Ministry of Food and Drug Safety (MFDS) is relentlessly, and incomprehensibly, trying to reinforce the regulation without clear explanation as to why. Regarding the bioequivalence test restriction, the Regulatory Reform Committee concluded, “It is difficult to see it as an effective measure to achieve the objective of the regulation. And restricting pharmaceutical companies entering the market seems unlikely to directly improve the pharmaceutical quality and safety, or to promote R&D in the industry.” The committee also pointed out the restriction on joint bioequivalence test has been abolished by them in 2010, and no specific changes in the scene have been occurred to overturn their decision. MFDS is maintaining its stance on the toughening the joint bioequivalence test regulation without a clear justification, although the committee has reviewed that the restriction is an unfair regulation. The previous restriction on joint bioequivalence test was stipulated temporarily in distrust of Korean-made generics. When a number of drugs have been uncovered to have manipulated the joint bioequivalence test in 2006, total 307 items were revoked of approval. MFDS judged the heated competition in the generic market was also caused by the manipulated test results, and the ministry implemented the regulation on joint bioequivalence test from May 2007 to restrict the number of participating companies to two. But only after five years, in November 2011, MFDS removed the restriction on the joint bioequivalence test as recommended by the Regulatory Reform Committee. During the October Regulatory Reform Committee meeting in 2010, some criticized the unjustifiable restriction on joint bioequivalence test by claiming “Such non-scientific and irrational regulations should be abolished.” Also some argued, “Regulating the excessive competition is unreasonable, and besides the safety issue, the government intervening the market is a stretch.” And it is still a mystery if the restriction on bioequivalence test would hinder the generic market to get extremely saturated. The new drug pricing system has already demotivated new generics to enter the market. The newly revised drug pricing system effective from last July has put a lower cap on the generic pricing for those that did not individually conduct a bioequivalence test. Since the valsartan contamination incident, the Ministry of Health and Welfare (MOHW) put down the limitation on the drug pricing to solve the excessive generic competition. However, the unprecedentedly heated competition among the generic has already begun thanks to the South Korean government strengthening the regulation. As the government disclosed its plan to toughen the regulation, over 5,000 generics have been released to the market since last year. Some are even saying the government has instigated the excessive competition. Nevertheless, the government is still pointing its finger at the joint bioequivalence test for the cause of the phenomenon. About the regulation on joint bioequivalence test, a MFDS official at a Regulatory Reform Committee meeting stated, “Encouraging an individual bioequivalence test aims to raise the level of pharmaceutical quality and safety management.” Does it mean a generic that receives an approval based on results of consigned bioequivalence test has an issue? Could it mean the government granted an approval regardless of the risk of quality and safety management? For the government to set a policy, it needs its deserving justification. Moreover, it needs to persuade the stakeholders. And side effects of implementing a new policy should be checked beforehand. The voices from the industry should be heard to set an intricate policy. When it disregards the industry’s voice, the legitimacy of the policy is lost.
- Opinion
- [Reporter's View] Vaccine's Cold Chain& Distribution System
- by Oct 17, 2020 06:36am
- Shinsung Pharm in charge of distribution of the flu vaccine at room temperature is being criticized. Shinsung Pharm itself has acknowledged the fault in the distribution process and is waiting for the disposal of the health authorities. The pharmaceutical distribution industry, which has been mainly dealing with synthetic drugs and OTC drugs, has not been very aware of the cold chain. So, even after putting vaccines that shouldn't be kept at room temperature in a paper box without any preservation devices and leaving them outside for hours, they didn't feel any problem. Will it be resolved if only Shinsung Pharm is punished? This incident is only a lack of awareness of cold chains for biological products. The importance of cold chains has emerged more than ever to distribute COVID-19 vaccine, which must be kept refrigerated and frozen due to COVID-19. In consideration of the health policy and the pharmacy network, the distribution of public masks was ultimately entrusted to the pharmaceutical distribution industry. The situation is different for the COVID-19 vaccine. Unlike a mask that can be carried in a paper box, it is essential to refrigerate or freeze COVID-19 vaccine. In particular, it is known that the mRNA vaccine under development by Moderna or Pfizer should be kept at -20℃ and as low as -70℃. Recombinant protein-based vaccine by Novavax needs to be refrigerated at 2-8℃. If the vaccine to be refrigerated falls below zero, problems such as foreign substances may occur, so it is necessary to separate the reference temperature for each manufacturer. It is considered a more important factor than the hospital network, whether the COVID-19 vaccine can be delivered by strict compliance with the reference temperature throughout the entire transportation process from the factory to the frontline hospital. In particular, if it is produced abroad, it must have the capability to check not only the road but also the air transport process. Can the current drug distribution industry's capabilities affect the level of shipping COVID-19 vaccines? Looking at the seminars and conferences surrounding the recent COVID-19 vaccine, FedEx Korea emphasized the strict cold chain system at BIOplus held last month. FedEx Korea said that it minimizes exposure to room temperature by identifying vehicle entry height restrictions, loading docks, and even forklifts through on-site inspection. In case of land transportation, it is prepared in case of a failure in temperature control with a double safety device, and the real-time temperature is checked through 24-hour monitoring. In the case of air transport, it is identified as a premium cargo so that pharmaceuticals can be managed, and it also prepares for sudden changes in flight. Although the general logistics industry is equipped with cold chains, the pharmaceutical distribution industry is still in its position in the past. The proportion of biologics is increasing rapidly, but changes in the distribution industry are slow. With a few temperature-controlled cars and a few warehouses as before, it cannot outperform the large logistics companies following the international system. In the future, if the drug distribution industry is no longer able to transport biopharmaceuticals due to lack of capacity, the damage may be passed on to the public. It is also the reason why the new distribution philosophy and legalization of the system must be updated due to the vaccine distribution crisis.
