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- 2026-07-22 11:58:23
- Opinion
- [Reporter's view] The MFDS shouldn't selectively explain
- by Lee, Tak-Sun Jul 26, 2021 05:50am
- In a recent series of incidents, the MFDS did not properly explain, causing confusion. It wasn't a big issue, but it's not something to skip. The issue of whether the RNA-based QTP104, which was approved for phase 1 clinical trial on the 20th, was initially marked as "domestic development" on a site where approval status can be checked, but it was changed to "foreign development." A reporter raised a question through an article, and this time it was changed to "domestic development." As a result, there was confusion among reporters. The vaccine could not be clearly processed because it was not distinguished whether it was the first RNA-based or overseas vaccine. As of 4 p.m. on the 22nd, it is marked as "domestic development," so it seems to be a domestic development vaccine, but there is no clear answer from the MFDS. It is the government's long-cherished project to localize the RNA vaccine that Pfizer and Moderna monopolized. As there is also a great interest in the public, it was important to understand the reality of phase 1 clinical approval of QTP104. However, the MFDS has changed its mark from "domestic development" to "foreign development" again, making it difficult to identify the reality. I also asked the MFDS. Even now, the MFDS should quickly answer whether QTP104 is a vaccine developed in Korea. It seems necessary to explain the use and capacity change of the 31st new drug "Leclaza" developed by Yuhan. The MFDS said it was legally changed at the request of the company, but the usage and capacity were changed a day before the benefit confirmation this month. .Moreover, it is necessary to clarify why the dosage and indications have been changed because the diagnosis method is different compared to Leclaza's competitive drug Tagrisso .The MFDS should not just announce on its website the cancellation of the item license of Daewoong's Albis D, but explain it more actively .Previously, the Fair Trade Commission and the Korea Intellectual Property Office detected data manipulation during the patent registration process of this product .The cancellation of item permits is the strongest disposition that the MFDS can make .It should be explained whether the disposition is an extension of the disposition of the Fair Trade Commission and the Korean Intellectual Property Office, or is part of the GMP investigation .Watching this series of events, I suspect that the MFDS is deciding what to explain .It also seems that there is no problem with procedural justification or neglects explanation if it does not become an issue .Even though the method of storing the Pfizer vaccine was changed last time, journalists of daily and economic newspapers raised questions because they did not notify it .Since the MFDS has not explained each and every change in permission, the reporter thought it would not be a big issue .However, As the MFDS' lack of objectiveness continues, it may not have been recognized as a public communication problem.
- Opinion
- The patient's life comes first
- by Lee, Jeong-Hwan Jul 15, 2021 07:06pm
- On March 5, the MFDS approved Kymriah(Tisagenlecleucel), the world's first treatment for CAR-T, as the first advanced bio-medicine under the Advanced Regenerative Bio Act. Targets are patients with B-cell acute lymphocytic leukemia and submicrobial giant B-cell lymphoma under the age of 25 who are recurrent and nonresponsive. Kymriah was already licensed in August 2017 by the U.S. FDA and in March 2019 by the Ministry of Health, Labor and Welfare of Japan, where there was no further treatment due to recurrence or non-compliance, resulting in treatment for late-stage blood cancer patients. Emily Whitehead, who was diagnosed with acute lymphocytic leukemia at the age of five and failed to treat it, has been living in good health since joining the first clinical trial of the CAR-T drug Kymriah in 2012. However, in Korea, there was news of Eun-chan who recently died while preparing for Kymriah treatment. Emily Whitehead's experience is touching around the world, but we are facing sad news that we are not being treated in time. Eun-chan's mother left a wish on her blog, saying, "It will be a lifelong regret that Eun-chan was not able to receive CAR-T treatment, but I hope that other patients in similar cases will not lose their lives like Eun-chan." Kymriah has been given only once in a lifetime, or "one shot," to allow for near-cure treatment and long-term survival. Therefore, if the existing treatment does not work, or if patients with multiple recurrences of blood cancer can rely on it for the last time.In acute lymphocytic leukemia, 82% and lymphoma 39.1% show Complete Response Rate. The effectiveness of treatment above a certain level can be verified. When Kymriah was licensed in Korea, not only were it already licensed in more than 30 countries, but there are also many countries that have health insurance registered, including Japan. What if Kymriah's domestic approval had progressed a little faster? In Korea, it would have been a medical environment where CAR-T treatment could be done as quickly as in Japan, and health insurance coverage would have been carried out as quickly as in Japan. If that were the case, Eun-chan might have been able to receive Kymriah treatment by now. A sad situation like Eun-chan should not be allowed to happen again. Korea also needs a system that can quickly register new drugs directly related to life without alternatives and has more than a certain level of therapeutic effect like Kymriah. The scope of the "new drug directly related to life" should be set through social discussions, and the MFDS should set a "temporary drug price" at the same time as the approval and apply health insurance to save the patient's life first The HIRA's Cancer Drugs Benefit Advisory Committee and Pharmacological Benefit Advice Committee, the NHIS negotiations, will be carried out quickly to ensure that the "final drug price" is finalized. Afterwards, the government shall actively engage in the introduction of a new drug health insurance rapid registration system directly related to life by post-settlement. The reason why pharmaceutical companies developed new drugs is to save people's lives, and the reason why the government creates and operates a health insurance system is to prevent patients from losing their lives because they have no treatment costs. Pharmaceutical companies and governments should put priority on patients' lives over profits and health insurance finances. Novartis Korea should actively cooperate with the government to quickly provide health insurance benefits by preparing a socially acceptable rational CAR-T treatment Kymriah financial sharing plan.
- Opinion
- [Reporter’s view] Request for suspension of execution
- by Kim, Jin-Gu Jul 05, 2021 05:54am
- The MOHW has announced that it will improve the system so that drug costs paid during the suspension of the enforcement of the drug reduction can be recovered. The plan calls for improvements to numerous revocation litigation and request for suspension of execution. request for suspension of execution in drug prices includes a lawsuit filed by pharmaceutical companies to cancel the reduction after the MOHW announced a reduction in the upper limit of insurance benefits. Pharmaceutical companies request for suspension of execution in the reduction of the drug price until the results of the lawsuit are released. The court accepts the request for suspension of execution. It follows the outcome of Lawsuit on the Merits. Each time the request for suspension of execution is repeated. The court accepts as well. This process takes up to five years. The court cites most of the request for suspension of execution because the outcome of lawsuit on the merits is unclear. So far, the only case in which the application for suspension of execution has been rejected is the case of a reduction in eyedrops. For pharmaceutical companies, the suspension of investment citation is as important as drug price reduction. The drug price maintained during the proceedings is much higher than the cost of the lawsuit. If pharmaceutical products with annual performance of ₩50 billion are subject to a reduction due to the launch of generics, they can keep more than ₩70 billion for five years during the lawsuit. Even if a pharmaceutical company loses at lawsuit on the merits, it already benefits enough. The pharmaceutical industry opposes the government's announcement of system improvement. It is argued that it is unconstitutional for the administration to effectively restrict the rights guaranteed by the judicial system. It is argued that the MOHW should not arbitrarily judge whether pharmaceutical companies abuse the disposition of the reduction of drugs. In April, the Supreme Court sided with the original company in patent suit of Eliquis. Generics were released based on the verdict of the first trial, and the reduction of drug price was taken accordingly. The MOHW is aware of this situation. "We are considering compensation for damages and recovery at the same time. "If it is not systemized, we will consider more ways to respond to the lawsuit results." The pharmaceutical industry should look at why the MOHW is worried. The MOHW believes that there are too many applications for suspension of execution. It is judged that pharmaceutical companies are abusing their rights guaranteed by the judicial system. The pharmaceutical and distribution industries believe that there is a lot of confusion in this process. The MOHW stresses, "So far, the government has never lost in a drug-price lawsuit." The pharmaceutical industry should think about why the MOHW is even reforming the system by limiting its jurisdiction.
- Opinion
- [Reporter’s view] Confusion by 1+3 bill must be minimized
- by Lee, Tak-Sun Jun 30, 2021 05:56am
- Sharing the results of the biological equivalence test with other companies and obtaining permission is restricted by the revision of the law. The National Assembly passed the pharmaceutical affairs law amendment on the 29th, which included 1+3 bill. Accordingly, a trustee who manufactures medical supplies may share permitted data and supply medical supplies only within three consignment companies. Therefore, it is expected that this will greatly reduce generic items that are easily licensed only by data sharing. Trustees are expected to suffer a setback in their projects due to a decrease in consignment production. Overall spending costs are also expected to increase as the number of medicines manufactured by pharmaceutical companies increases. The 1+3 bill was revised by the MFDS in 2019 by reflecting it in the screening regulations due to numerous generic drugs. However, the office for government policy coordination's Regulatory Reform Committee decided to withdraw the system, and the regulations were not amended. The National Assembly said that the number of generics should be limited when impurities were detected in preparations such as Ranitidine following Valsartan. As a result, it was re-promoted with the Pharmaceutical Affairs law, and despite opposition from small and medium-sized pharmaceutical companies, the MFDS, the KPBMA, and lawmakers from the ruling and opposition parties were generally in favor. Now, when the law is promulgated in July, it will be restricted from new medicines received from the future. Since the law takes effect immediately, pharmaceutical companies may suffer unfair damage due to the application of products prepared before that. Regulations can be avoided by proving joint development within one month of the enforcement date of the law. However, there may be complaints over the targets of exceptions, evidence, and procedures. Consequently, failure to make the exception correctly can be confusing. The MFDS should establish detailed rules after passing the law to minimize complaints from pharmaceutical companies and to ensure that the law is settled quickly. The 1+3 bill was effective and any debate became meaningless. The MFDS, which is in charge of ensuring that the law is applied fairly and quickly. It is up to the MFDS now.
- Opinion
- [Reporter's view] Tylenol is out of stock
- by Jun 02, 2021 06:10am
- As vaccinations began in earnest, the Tylenol crisis broke out in pharmacies. The Tylenol crisis has become inevitable as vaccinations for people aged 75 or older and those aged 65-74 have been implemented following preferential vaccinations for essential social workers. The government and the media are instructing people to take Tylenol if they have a fever after the inoculation. If pharmacists order Tylenol through wholesale, only the quota amount is supplied, so there are always times when the stock is tight or out. "Do you have Tylenol in stock?" "No, but we have the same active ingredient as Tylenol." "Oh, never mind." "Do you have any masks in stock?" "There are no more masks any more" This situation is similar to the mask crisis of the past. Pharmacies with relatively stable supply and demand through Jansen direct transactions do not mean that the situation is better. It is exhausting to guide dozens of consumers to take "after vaccination." Pharmacies are innocent, but it's as if they've become sinners. The pharmacy said this. "The moment I took out Tacenol, the patients looked different. That's exactly where I am going to do business. I don't know why I have to be a merchant, not a pharmacist, with a same pill." The Korean Pharmaceutical Association also urged the government to take Tylenol. The reason why patients only look for Tylenol at a time when many APAP are in sufficient stock is that health authorities have mentioned Tylenol directly since the beginning of the vaccine, causing confusion in their choice of fever reducer. Through the KCDA, the Korean Pharmaceutical Association asked each district health center to guide them to take APAP such as Suspen, Bukwang's Tacenol, and Penzal when fever symptoms occur after inoculation. The government, which authorizes the people to "Tylenol," should correct this issue. The situation has already deteriorated to persuade patients that pharmacies have the same ingredients and that other pharmacies do not have Tylenol. The MFDS has unveiled 70 items that have the same efficacy and effect as acetaminophen preparations, but pharmacists question their effectiveness. Since Tylenol has already been so deeply established in the public's perception, it is necessary to come up with effective measures, saying that the release of 70 products will not be much help unless campaigns and advertisements are combined. The target will also be expanded sequentially. Pharmacies say there will be a bigger problem in the future than it is now. It seems necessary to come up with measures quickly before vaccinations for the entire country are implemented in earnest.
- Opinion
- [Reporter's View] It's up to pharmaceutical companies
- by An, Kyung-Jin May 17, 2021 05:53am
- Drug quality management is at stake. Over the past two months, four companies, including Binex, Vivozon, Chong Kun Dang and Hanall Biopharma, have been caught violating drug quality control. A total of 62 products are under administrative disposition due to violations of quality control by four companies. Including pharmaceutical companies in consignment contracts, the impact is even greater. Thirty-four pharmaceutical companies that have entrusted production to four companies are also focusing to whether the MFDS will dispose of them further. A total of 38 companies are on the verge of being kicked out of the market because of the trustee's deviant behavior. The pharmaceutical industry fears it will spread to distrust of consignment generics. It is only a matter for some companies, and the consignment act itself should not be a problem. In July 2018, the Valsartan crisis, which shook the global pharmaceutical market, was unprecedented in overseas countries as carcinogenic substance N-Nitrosodimethylamine (NDMA) was detected in Valsartan manufactured by China's Zhejiang Huahai. NDMA was not originally subject to standard checks on Valsartan. Until Zhejiang Huahai reported that more NDMA was detected than the standard, no pharmaceutical company in the world cared about NDMA detection. The FDA and the EMA were not aware of the need for inspections, but rushed to investigate and come up with measures to determine the cause. It was just an unexpected accident. Chinese raw medicine and generic are starting to be blamed as if they were the causes of "low quality." It is also from this time that regulations on consignment generic have been tightened in Korea. Health authorities set up a "Generic Drug System Improvement Council" and began to come up with measures to curb generic disorder. The MFDS has removed all deregulation granted to Entrusted generic. From next year, mandatory production of licensed products, which had been exempted from consignment generics, will be implemented again. It is also pushing to exclude consignment generics from generic exclusivity. Following the reorganization of the drug price system, which took effect in July last year, the standard for calculating the drug price of consigned generic has also been lowered. The 53.55% upper limit price can be maintained compared to the original drug before the patent expires only when all requirements are met to conduct biological equivalence tests directly and use registered raw material drugs. The regulation on joint development of drugs under discussion at the National Assembly is also key to restricting the permission of consignment generic. Some amendments to the Pharmaceutical Affairs Law, which limits the number of drugs licensed in one clinical trial, passed the Health and Welfare Committee, leaving procedures for future plenary sessions, the Legislation and Judiciary Committee, and the plenary session. The government's justification for tightening regulations on generic seems to be somewhat out of standard. The MFDS defines "generic" as a officially licensed drug based on the same quality as the original developed drug. It is not appropriate that the large number of generic drugs authorised by the Government is of low quality. Nevertheless, pharmaceutical companies are largely to blame. If unreasonable regulations and misunderstandings are unfair, they should prevent repeated violations and come up with self-rescue measures to improve competitiveness in drug quality. The drug quality control agenda has already been controversial, although it was not originally due to generic. It is up to pharmaceutical companies to restore generic drug reputation.
- Opinion
- [FOCUS] Uncomfortable co-development regulation of medicines
- by Chon, Seung-Hyun May 11, 2021 05:59am
- There is a growing possibility that a bill will be implemented to regulate joint drug development by pharmaceutical companies. Recently, the National Assembly's Health and Welfare Committee held a bill subcommittee to pass a partial revision to the pharmaceutical practices law that limits the number of drugs that can be licensed through a single clinical trial. It allows up to four drugs that can be licensed with one biological equivalence test or clinical trial data. It does not apply to biopharmaceuticals or generic drugs. Biological equivalence testing is a kind of clinical trial for generic development, which effectively limits drug co-development by pharmaceutical companies. In fact, regulating the number of pharmaceutical companies participating in joint drug development by law is hard to find even in foreign countries. Sharing strategies for drug development through cooperation among pharmaceutical companies is an area of free business activities. The government does not directly intervene by law. If regulations on biological equivalence testing are applied, additional social costs may arise because the same drugs produced in the same manufacturer must be tested separately. This is why the Regulatory Reform Committee has opposed it. At a meeting of the Regulatory Reform Committee in October 2010, the restriction of biological equivalence tests was called a strange system, saying that "unscientific and logical regulations should be abolished." As the government pushed for the regulation again, the Regulatory Reform Committee opposed last year, saying, "Restricting pharmaceutical companies to enter the market also has low direct improvement in drug quality and safety and minimal R&D promotion." IMD's joint development regulations are also seen as the government's involvement in pharmaceutical companies' R&D strategies. There have been many ways to jointly develop new improved drugs while sharing clinical costs with small and medium-sized pharmaceutical companies that do not have enough funds. If development costs are divided and paid, this is to reduce risks caused by failure of development or sluggish sales after commercialization. In other words, the government restricts voluntary R&D cooperation of pharmaceutical companies. The MFDS, which is in charge of the project, is also burdened with regulations on joint development. According to the minutes of the bill subcommittee, Kim Jin-seok, deputy director of the MFDS, said, "I think mentioning the same part as joint R&D in pharmaceutical law exceeds the legal scope." Like Rx drugs, OTC can be cloned indefinitely through consignment, but it is hard to understand that only specialized drugs are subject to regulation. The KPBMA, one of the leading interest groups in the pharmaceutical industry, is welcoming the bill immediately after it is passed by the subcommittee. It is somewhat unusual for the industry to express its support for tightening regulations. It is undeniable that the "limit on the number of joint drug developers" is a strange system in science or common sense. What is even more uncomfortable, however, is the deformed environment of the domestic pharmaceutical industry, which led to the introduction of a strange system. More than 100 pharmaceutical companies are entering the large generic market and are excessively competing. As of December last year, according to the HIRA. A total of 139 pharmaceutical companies released Atorvastatin products. It increased by 40 from 99 in 2015. It has increased from 118 in 2018 to 133 in 2019 and 139 companies in recent years. In 2015, there were 91 domestic pharmaceutical companies that released Clipidogrel, but five years later, it increased to 133 companies, increasing to 42 companies. There were 112 pharmaceutical companies that released Atorvastatin in 2018, and 21 more joined in two years. The number of companies that released Donepezil reached 134 in two years from 89 in 2018. The value of generic is also gradually decreasing. In foreign countries, when the patent of the original drug expires, cheap generic dominates the market. The situation in IMD is similar. The joint development of IMD is seen as trying to curb generics' entry into the market. The new generic drug price system, which took effect in July last year, includes a stair-type drug price system in which the upper limit is lowered as the benefit is registered late. If more than 20 generic items are listed in the specific ingredient market, the upper limit for newly registered items will be up to 85% of the existing lowest price. If a certain pharmaceutical company develops IMD through clinical trials and recruits more than 20 delegated generics, the generic price will drop significantly. Doubts have been raised that many pharmaceutical companies may be trying to reduce the motivation for entering generics through sharing IMD clinical data. As a result, it led to the introduction of a strange system that also limits IMD clinical data sharing companies. With the reorganization of the drug price system, IMD infinite cloning of delegated generics has emerged to preempt high drug prices, and side effects of "intentionally registering drugs at low prices to induce competitors to receive lower prices." It is hard for anyone to understand the recent unprecedented phenomenon of drug production. Whenever regulations are made to solve urgent problems such as the general crisis, it is likely to backfire in the market. Overseas, inexpensive generic drugs are encouraged, and at some point, generic drugs have been ignored in Korea. It is time to reflect on where it went wrong and what responsibilities the government and pharmaceutical companies have and gather wisdom.
- Opinion
- [Reporter’s View] Support domestic COVID-19 vaccine first
- by May 10, 2021 05:56am
- The U.S had expressed support for waiving intellectual property (IP) protections for COVID-19 vaccines. Such support can induce the production of copies of Pfizer and Moderna’s COVID-19 vaccine, ultimately increasing vaccine supply. The U.S administration’s support was received with expectations, concerns, support as well as opposition. It is not an exaggeration to say that the key to mRNA vaccines -such as Pfizer’s and Moderna’s vaccines – lie in its patent. A sophisticated lipid nanoparticle (LNP) technology is required to deliver mRNA, which is vulnerable to the surrounding environment, well into the body. This technology has been preemptively patented by many companies. Moderna has also been paying another company for the LNP technology used in its COVID-19 vaccine. Therefore, if the production of mRNA-based COVID-19 vaccines is possible without employing patent avoidance strategies, many more companies may make the attempt to produce COVID-19 vaccines. However still, the prominent opinion among experts is that this is not the right solution for addressing the current vaccine crisis. According to foreign media, Scott Gottlieb, a former F.D.A. chief had said, “The production of COVID-19 vaccines requires a complex process and difficult materials. Allowing other manufacturers to use the patented technology will not increase supply immediately.” Chad Landmon, the chair of Axinn, Veltrop & Harkrider’s Intellectual Property and FDA practice groups, pointed out, “IP has not been the barrier to the production — it’s really been the technology and how complicated” it is to manufacture COVID-19 vaccines. He continued, “Also, the issues in the supply chain, such as shortage of raw materials will also be a challenge.” Without the cooperation of big drug companies, patent waivers are unlikely to expand the global supply of coronavirus vaccines, said “Vaccines are difficult to make because they use biological systems which are much more difficult than small molecules. Patents are only codified information. To make it work, the multinational pharmaceutical companies would need to share their actual technological know-how, quality control, manufacturing process. It is like a 3-Michelin Star restaurant. Even if the restaurant shares its recipe, it cannot be simply replicated. “ Rather than follow the false demand for IP waiver, experts advise that the government should listen to the voices of people with abundant drug development experience and implement practical support measures to increase vaccine supply. For example, Gottlieb suggested cooperating with vaccine developers rather than confronting them by increasing manufacturing capacity by assisting in the production of raw materials and purchasing special equipment. So how would this apply to Korea? Even if the controversial IP waiver passes through, the overall opinion stays that it will be difficult for the Korean industry to develop a generic mRNA vaccine. Rather, the focus should be on supporting the development of domestic COVID-19 vaccines that are already in progress. 5 domestic companies - SK Bioscience and Celid, Genexin, Eu Biologics, Cellid – have started clinical trials for their vaccines. It would be more effective for Korea if the government set specific guidelines for their Phase III trial and support the smooth operation of their clinical research.
- Opinion
- [Reporter’s View] Interest in the role and vision of GAs
- by Eo, Yun-Ho Apr 26, 2021 05:51am
- Multinational pharmaceutical companies have been eagerly hiring employees for Government Affairs (GA). Even companies that originally had no such position have newly created the position. Until now, the distinction between areas covered by Market Access (MA) and GA was unclear, and GA's target 'government institutions’ were limited to directly relevant ministries such as the Ministry of Health and Welfare (MOHW), Health and Insurance Review & Assessment Service (HIRA), and National Health Insurance Service (NHIS). This was why in quite many companies, the MA managers also took care of GA. However, such industry practices have changed much over the past few years. Many multinational pharmaceutical companies including Novartis, Takeda Pharmaceuticals, Roche, AstraZeneca, Pfizer, BMS, and MSD have been reinforcing their policy area. Also, other companies including Boehringer Ingelheim, Viatris, and Organon have hired or are in the process of hiring GAs. This change is largely due to the trend of new drugs. With the advent of the ‘'high-priced drug era,' the government and pharmaceutical companies are finding it increasingly difficult to see eye to eye on the price of such drugs. As a result, whether and when the government would list a drug for reimbursement became the determinant that makes or breaks the success of a new drug. However, as issues that cannot be resolved through communication with only ‘directly related ministries’ began to accumulate, the pharmaceutical companies started to seek new solutions such as the National Assembly. This raised the need for experts from various backgrounds including the National Assembly, the government, and the media. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has also been paying more attention to strengthen its GA-focused HC Policy committee. However, internal and external conflict regarding this increased interest in GAs exists. Contrary to MAs who are typical pharmaceutical industry experts that have a high understanding of drugs and drug pricing systems, GAs are often not from the industry. Therefore, the perception that ‘GAs do not know the industry well' does exist within the industry. Externally, although MAs and GAs both deal with government authorities, the specific authority targeted by each is different. For example, from the MOHW’s perspective, it is natural that it would feel uncomfortable if a drug-related issue is raised by the National Assembly. In such situations, if MA represents the MOHW and GA represents the National Assembly, friction is due to arise. Therefore, only companies that achieve synergy between MAs and GAs may succeed in using GAs. The internal message needs to be integrated first before taking further steps. However, one warning to bear in mind is that companies should not simply use GAs for the generation of profit in the ‘‘'high-priced drug era.’ Publicizing drug issues is like a double-edged sword. Bear in mind how the COVID-19 vaccine issue became embroiled in a political battle.
- Opinion
- [Reporter's view]Controversy over Novavax vaccine
- by Lee, Tak-Sun Apr 16, 2021 06:02am
- The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June. The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad. Eventually, the conservative opposition party criticized using the people as clinical maruta. As the controversy continued, the government was controversial over the introduction of the ax vaccine before approval the day after the announcement. The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June. The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad. Eventually, the conservative opposition party criticized using the people as clinical subject of experiment. As the controversy continued, the government refuted the day after the announcement that it had never considered pre-licensing the Novavax vaccine. After reading this controversial article, I couldn't help but laugh. It is not possible at all for Korea to introduce a vaccine developed abroad first. There has not been a case of using overseas drugs developed first under the approval of Korean health authorities. All drugs can be sold only after obtaining approval from the MFDS. The same goes for vaccines. However, the MFDS has so far required to attach a certificate of manufacture and sale of the exporting country when applying for a new drug for import. This is to refer to the case of approval of the exporting country. In early April, the MFDS revised the regulations so that the approval results from exporting countries are not attached when applying for a permit for biological products such as vaccines. The reason is that the MFDS can also be independently screened. According to the regulations, domestic permits were possible without the need for overseas approval. However, there is no possibility that an overseas development company such as Novavax will first apply for a license in Korea instead of in large markets such as the US or Europe. SK Bioscience, which has transferred the technology, can also be approved if it has data from a clinical trial conducted by Novavax. Prior to application for overseas approval, clinical trial results are not shared with other companies in which the technology has been transferred. Among the COVID-19 vaccines, the only basis for the special import of Pfizer vaccine was the case of overseas approval such as the United States and Europe. In order for Novavax vaccine to be introduced in Korea before overseas approval, Novavax should prioritize the small market in Korea, and health authorities or experts must approve the introduction of the vaccine without referencing overseas approval. It is unlikely that this will happen. Health authorities are conservative. If safety or effectiveness is uncertain, it will not be introduced. The safest way is to consult foreign cases, especially FDA or EMA. Pfizer and AstraZeneca vaccines will be the same, and will be introduced in the future. Through this controversy, I feel that the media and politics are too concentrated on the success or failure of the government vaccine introduction. Anyway, in a situation where vaccine development with our technology has not been made, it is inevitable to be attracted to foreign companies. Japan, which has a lot of Big Pharma, does not have a vaccine developed in-house, so it is the same situation as Korea. Accordingly, the timing of the introduction and the overall supply and demand issue are uncertain. It seems pointless to question whether the policy is successful or not. The government should also be honest about the current situation and demand patience from the people. The media should also not criticize the government's policy of introducing vaccines. And we have to reflect on why we didn't make the vaccine on time.
