- LOGIN
- MemberShip
- 2025-12-19 22:53:54
- 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.
- Opinion
- [Editor’s View] The key to Xofluza pricing negotiation
- by Nho, Byung Chul Jan 26, 2021 06:00am
- A novel breakthrough influenza treatment Xofluza (baloxavir) by Roche is in a deadlock. Due to COVID-19 pandemic and conditional non-reimbursement status, the flu drug is struggling with the sales dip and marketing. Even before the launch, the drug was expected to easily take over Tamiflu’s market with significantly improved administration convenience, but it only generated maximum 100 million won last year. IQVIA projects the drug’s quarterly sales marked 360,000 won, 1.4 million won, 29 million won and 50 million won in last first quarter through the fourth. The market experts point out the sales were disappointing last year, presumably because the influenza patient size plummeted last year due to the strict mask-wearing order given amid COVID-19 pandemic. The argument is supported by a household name Type A influenza treatment Tamiflu (oseltamivir) barely making 3.5 billion won last year. Moreover, Roche’s strategy to launch the new flu drug without the healthcare coverage in last March also seems to have backfired on the limited patient access. The non-reimbursed Xofluza cost ranges from 70,000 won to 75,000 won. Pushing aside the unexpected COVID-19 pandemic factor, the product launch without the reimbursement greatly hindered the drug from absorbing the market share. The drug sales plateaued already from the point of receiving the coverage with evidence development from the first reimbursement listing threshold, the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC). The coverage with evidence development means the applicant company may start the projected claim amount negotiation with the National Health Insurance Service (NHIS) after accepting the pricing lower than HIRA’s evaluated pricing. However, Roche stated it would not accept the pricing suggested by the government agency. The industry suspects HIRA suggested a reimbursed pricing of around 20,000 won to 30,000 won for Xofluza, whereas the company offered a range of 45,000 won to 60,000 won. In other countries, where the drug is approved, it is priced at USD 90 (99,152 won) in the U.S. for both 20 mg and 40 mg, and also at JPY 1,535.4 (16,349 won) and 2,348.8 yen (25,961 won) for 10 mg and 20 mg, respectively in Japan. Based on the global pricing and weighted average pricing, Roche would highly unlikely to accept the pricing below 50,000 won for the healthcare reimbursement. Even if the company takes the pricing under 50,000 won, it would cause confusion among the A7 and other countries complain. The key to Xofluza’s pricing negotiation is in the pharmacoeconomic evaluation. In other words, Roche would have to convince and make HIRA understand how much of economic efficiency Xofluza can achieve compared to Tamiflu. 75 mg of Tamiflu is priced at 1,662 won in South Korea with the healthcare coverage. It would cost 16,620 won when taking two capsules daily for five days. Meanwhile, 40 mg of Xofluza could alleviate the symptoms of influenza with a single dose. Basically, one capsule of Xofluza can replace 10 capsules of Tamiflu. The key outcomes of CAPSTONE-1 with healthy adult and adolescent patients aged 12 to 64 years found Xofluza’s median time to symptom alleviation was 26.5 hours faster than the placebo. Also, Xofluza showed faster virus shredding than placebo. In about 24.0 hours, Xofluza halved the viral shedding, which was significantly shorter than placebo (96.0 hours) and Tamiflu (72.0 hours). During the CAPSTONE-2 study with high-risk influenza patient groups including senior and chronic disease patients, the high-risk patient group treated with Xofluza demonstrated median symptom alleviation time of 73.2 hours, which was about 29 hours faster than the placebo group (102.3 hours). In the same study, Xofluza halved the viral shedding in 48.0 hours, improved by approximately 50 percent than the placebo (96.0 hours) and oseltamivir (96.0 hours). In short, Xofluza can treat and alleviate the influenza symptoms about one to two days faster than Tamiflu. Also the vastly improved administration convenience to replace 10 capsules for five days with one single dose is great news for those who have dysdipsia. Now for the pricing negotiation, it is up to Roche to persuade and HIRA to acknowledge how much of economic value a 24-hour-faster recovery can make for a working person making 100,000 to 300,000 won a day.
- Opinion
- [Reporter's View] Yuhan's Open Innovation Success Model
- by Kim, Jin-Gu Jan 20, 2021 06:02am
- Until only five years ago, Yuhan was the No. 1 pharmaceutical company in Korea, but it was criticized for being a company that sells foreign drugs and only acts as a wholesaler. The company had very few pipelines. However, since President Lee Jung-hee took office in 2015, Yuhan's new drug pipeline has increased to 29 as of the end of last year. The sales share of R&D expenses also increased from 5.7% to 10.8%. This year, Yuhan plans to invest more than ₩130 billion in R&D. Yuhan's Leclaza (Lazertinib mesylate) received conditional marketing authorization on the 18th. Leclaza's rival drug is Tagrisso (Osimertinib), which generates about ₩4 trillion in sales globally. Considering that Tagrisso enjoys a dominant position in the third-generation non-small cell lung cancer treatment market, Leclaza's competitiveness in the global market is highly evaluated. According to the published data so far, it is said that the efficacy is similar to that of Tagrisso, while the safety is more superior. Global Data, a global pharmaceutical market research firm, predicts that Leclaza will generate annual sales of about ₩600 billion. Leclaza's approval is noteworthy in that it has established a relationship between bio-ventures, Yuhan and global pharmaceutical companies. It is evaluated that it has established a business model that licenses a promising candidate substance from a bio-venture and then licenses it out to a global pharmaceutical company. Many biopharmaceutical companies are actively involved in open Innovation. However, there were no successful commercialization cases until receiving Leclaza's CMA. There were also many opinions that were unsure about the Korean open innovation model. Leclaza's approval is an evaluation that gave substance to Korean open innovation. The Korean open innovation model proposed by Yuhan is expected to instill confidence in the direction of new drug development to other pharmaceutical bio companies targeting another Leclaza.
- Opinion
- [Reporter's View] Activation of the Generic Substitution
- by Kim, Jung-Ju Jan 14, 2021 01:23pm
- At the beginning of the year, small shops and large companies make actionable plans for the next year. The government plans the budget as well. In addition, the government divides and executes policy projects more detailed and strategically because administrative procedures and processes are more demanding than private enterprises. According to the detailed schedule of the “2021 Comprehensive Health Insurance Plan” released by the MOHW, it is quite encouraging that the government decided to make and finalize an improvement plan within this year for the Incentive system for reducing drug costs for prescription and dispensing. As planned, it is presumed that the consensus was formed by the government, the National Assembly, and the pharmaceutical community to solve the post-notification problem, which has been the biggest issue in the activation of generic substitution, with a computerized system (DUR). However, in more detail, it can be fully assumed that the government is currently facing issues of sustainable health insurance operation and fiscal savings. The government knew that there was a generic substitution activation system as a way to reduce the cost of drugs. Despite the short period of about three months, the results were very meaningful and implications were drawn on the possibility of reducing drug costs. Physicians go through at least two or three selection processes when choosing a drug for prescription. It is the selection of categories, ingredients, and items. Except for the case where the original item is single listed among innovative therapeutic new drugs, the selection of drugs is left to the doctor's medical and subjective judgment. In addition, as the reimbursement standards vary from monotherapy, combination therapy, or three-drug therapy, and there are many generics, the number of cases that can be selected increases. Reduction of drug costs in hospitals can only be achieved by expanding outpatient drug costs. The activation of generic substitution is also directly connected to the problem of financial efficiency management of health insurance and strengthening of coverage in the long term. When the government came up with a comprehensive health insurance plan, it was the same as aiming for a method of investing the amount saved by reinforcement of follow-up management into strengthening coverage. Even if only one side of the hot water balloon is squeezed, the total amount of water never decreases. It is noteworthy that this year's generic substitution system can be activated through the improvement of the incentive system for reducing drug costs for prescription and dispensing.
- Opinion
- [Reproter's View] Have you forgotten what the MFDS does?
- by Lee, Tak-Sun Jan 08, 2021 06:21am
- It was expected that the politics and media would put pressure on the introduction of COVID-19 vaccine, but it is too blatant. They only emphasize rapid introduction forgetting the role of the MFDS in verifying the safety and effectiveness of vaccines. From the time President Trump pressed the US FDA, the independence of the MFDS was expected to be affected. In recent years, the European EMA is also under pressure from each country, and it is in a situation where it is advancing the recruitment of the review committee to approve COVID-19 vaccine, so it is obvious that the drug regulatory authorities in each country are suffering. The MFDS was presented with a deadline altogether. In foreign countries, after urgently approving COVID-19 vaccine, the deadline was officialized in February as politics and the media urged rapid introduction every day. The MFDS seems to have to approve one company’s COVID-19 vaccine after completing the review before February. It is understandable that the current situation is not good, so it is possible to introduce it as early as possible, and this can be considered a special case. However, there was no MFDS in the process of discussion. They don't seem to know that the vaccine can only be approved by the MFDS through systematic screening. No confidence in the regulatory authorities was shown. Some media have ignored the MFDS, asking if the MFDS can review and approve vaccines that are not approved by the US FDA. These reports only dampen the will of the MFDS, which is showing its willingness to independently screen by abolishing the obligation to submit CPP (manufacturing and sales certificates in importing countries). It is difficult to apply the same situation in the UK and the United States, which initially approved COVID-19 vaccine. In that country, the vaccine has undergone clinical trials and has been reviewed through a preliminary review. Nevertheless, the FDA was the first to grant EUA for the vaccine. Chloroquine, COVID-19 treatment that was urgently approved by the FDA, was also withdrawn. As such, emergency approval drugs cannot be fully guaranteed for efficacy and safety like formal approval. Korea does not have an Emergency Use Authorization System (EUA). In case of an emergency, there is a special import or special manufacturing system, but it is difficult in situations where there is no data to verify at all, such as a vaccine developed overseas for COVID-19. This is because clinical trials have never actually been conducted in Korea. It is impossible to get vaccination while skipping the MFDS. Nevertheless, some politicians and the media are misleading as if they could inoculate the people immediately after signing a supply contract. In the future, the MFDS should not be condemned even if the MFDS is delayed in approving COVID-19 vaccine. If the MFDS is pressed as it is now, drug approval is difficult to ensure transparency and national security. Now it depends on the MFDS. Let's first trust the MFDS so that COVID-19 vaccine can be thoroughly verified and brought in.
- Opinion
- [Reporter's View] Pharmaceutical dept. needs independence
- by Lee, Hye-Kyung Dec 18, 2020 06:06am
- The 'Rules on the Standards for National Health Insurance Medical Care Benefits' revised and implemented by the MOHW on October 8 became the basis for negotiating all reimbursed drugs with the NHIS. At the time, the pharmaceutical industry could not realize the 'power' of the rule amendment, but the NHIS emphasized that all drugs that need to be listed on the drug reimbursement list will go through a negotiation process through meetings with the pharmaceutical industry. The specific basis is that Article 11-2, Paragraph 7 of the Rules, 'All drugs evaluated as having appropriate benefits shall be determined after negotiation within the range of 60 days'. All drugs for which the HIRA has evaluated reimbursement adequacy, so-called all drugs that are about to be listed, must be negotiated with the NHIS. The pharmaceutical industry realized the power of this revised rule through the start of generic drug negotiations. When the HIRA's drug price calculation is complete, the NHIS negotiations have been added to the generic registration process in which the registration was made. Conditions for implementation such as risk-sharing drugs, ▲ confidentiality, ▲ other matters necessary for stable medical care benefits and financial management of health insurance, etc., must be discussed in order to be listed on the list. Small and medium-sized pharmaceutical companies that have not participated in new drug price negotiations or Price-Volume agreements are the first to negotiate with the NHIS. The NHIS says it cannot negotiate a stable supply or quality control for drugs that have not yet been produced. Following the generic negotiations and non-listing of drugs that have not yet been produced, the NHIS also took over the contract for reimbursement of benefits for listed drugs, including 'Choline alfoscerate' formulation, which is about to undergo clinical re-evaluation of the MFDS. The NHIS will sign a payback contract for 230 items of clinical reevaluation drugs by February 9th next year. Drugs subject to additional reevaluation, which will be implemented on January 1 of next year, will also go through the negotiation process of the NHIS. The NHIS drug-related department, which had been the main task of follow-up management such as additional revaluation of clinical reevaluation drug benefits and additional reevaluation drugs will be carried out. The NHIS is in charge of the management of all reimbursed drugs, and pharmaceutical companies feel that the 'power' of the drug department of the NHIS is weaker than the NHIS. Currently, among the NHIS's salary strategy office, the pharmaceutical department consists of four departments: Drug Price System Improvement Department, Drug Price Negotiation Department, Drug Price Post Management Department, and Generic Negotiation Management Department. The HIRA's pharmaceutical department, which started with 3 teams with the introduction of the positive list system in 2006, has grown to 14 teams as of October this year. Of the 107 employees in the Benefit Strategy Office, 62 (54 currently employed, 22 pharmacists) are occupied by the drug-related department. It can be said that the pharmaceutical department has sufficient conditions for the workload and capacity to be independent. The possibility of independence of the pharmaceutical department became an issue every time as the size of the organization increased. The NHIS has been examining the organization this year and reviewing organizational improvement to enhance its status as an insurer. This included expansion of the organization and coordination of work between departments, and it was also discussed that the drug department should be promoted to a management group to form a separate organization. It will be 14 years since the drug price negotiation system between the NHIS and pharmaceutical companies was introduced next year. As the workload related to drugs increases, the number of pharmacists is also increasing. The independence of the department with professional manpower is expected to expand the status of the NHIS pharmacists with the strengthening of the organization's status in the future.
- Opinion
- [Contribution]Which is the first among COVID tx & vaccine?
- by Kang, Shin-Kook Dec 16, 2020 06:14am
- As vaccination has begun in foreign countries and the approval of antibody treatments in Korea is imminent, the need to establish strategies for quarantine is urgently emerging. Will the vaccination aim for population immunity, or will it aim for the effect of preventing severe disease and preventing spread by administering early treatment along with early diagnosis? Seo Jeong-jin, Chairman of Celltrion, is proposing a method of early administration of the treatment based on the fact that the safety of the vaccine has not been secured. This argument is a matter that urgently needs to make decisions in our society. It seems necessary to compare the treatment and vaccination in terms of not only the health damage caused by the side effects of vaccination, but also the effect of preventing the spread of infectious diseases. In general, preventing infectious diseases as a treatment is ineffective, so vaccination is chosen without the need for comparison. However, it is necessary to consider it as an alternative to a vaccine, as Celltrion and others are developing the same as antibody formation, which is the target of a vaccine as an antibody treatment. In the early stages of COVID-19 infection, even before or after the explosive growth and release phase of the virus, the vaccine can be replaced with a therapeutic agent if it can be prevented by the administration of antibody therapy. If it is possible, outpatient treatment (or very short-term facility isolation) instead of hospitalization may be possible for asymptomatic patients, so self-treatment from administration of antibody therapy from early diagnosis can be used to replace vaccines. There is currently no basis for confirming such an effect. However, it will be very realistic if clinical data such as Celltrion are positively aggregated. Chairman Seo Jeong-jin said in an interview with YouTube that he has already finished producing antibody treatments for 100,000 Koreans. It seems to be sufficient considering that the number of confirmed patients currently in need of treatment is around 10,000. For the antibody treatment of 100,000 people, about 8 million tests are needed, considering that the cumulative COVID-19 positive rate is 1.2%. In this case, a cost of about ₩1.6 trillion is expected when the price of a diagnostic kit of about ₩20,000, specimen collection cost of about ₩160,000, and the treatment price of about ₩400,000 as announced by Chairman Seo. This is advantageous compared to the estimated vaccine administration cost of ₩1.3 trillion (AstraZeneca) and ₩2.5 trillion (Modena), taking into account the cost of vaccine and treatment to receive a vaccine for 25 million Koreans. However, the costs not included are uncertainties about the cost of adverse effects of the vaccine and the possibility of failure or delay in quarantine of the antibody therapy. Such a judgment will be possible only when the clinical results of antibody therapeutics and the ability to block transmission are revealed. However, if very promising results come out, new test guidelines and behavioral guidelines for early preemptive testing and outpatient treatment for COVID-19 must be prepared urgently in response to them. It would be said that prompt and flexible policy responses from government authorities are required.
- Opinion
- [Reporter’s View] Notes on seeking for COVID-19 vaccine
- by An, Kyung-Jin Dec 14, 2020 05:59am
- The novel coronavirus disease-19 (COVID-19) is spreading at a concerning rate in South Korea. Although the social distancing level was raised to 2.5 two weeks after the government ordered the social distancing level 2 on Nov. 24, the third wave of pandemic seems to keep rising. The authority is even considering on raising the level up to 3, as the daily count of positive cases exceeded 1,000. Regardless, the hope for the end of COVID-19 is growing. A COVID-19 vaccine co-developed by Pfizer and BioNTech has earned the U.S. Food and Drug Administration (FDA) emergency use authorization on Dec. 11 local time. The authorization was made a day after the Vaccines and Related Biological Products Advisory Committee (VRBPAC) issued a recommendation to FDA, making the U.S. the sixth country to approve of COVID-19 vaccine use following the U.K., Bahrain, Canada, Saudi Arabia and Mexico. The U.S. government reaffirmed its strong determination to accelerate the vaccination speed by moving up the recommended vaccination schedule set by the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP). The nationwide COVID-19 vaccine distribution in the U.S. has started, and experts predict the vaccination can begin from Dec. 14 local time at the latest. Also the U.S. authority is highly likely to grant emergency use authorization on Moderna’s COVID-19 vaccine by the end of the month. Multiple factors played a part to turn around what seemed like the impossible ‘vaccination before Christmas’ and made it actually possible. Since the confirmation of the pandemic, the U.S. Federal Government has been conducting what is called the Operation Warp Speed. The program is an effort led by several U.S. government bodies to rapidly move the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics. A long-time Star Trek fan and a director of the Center for Biologics Evaluation and Research (CBER) at FDA, Peter Marks apparently suggested the particular name in April immediately after the Department of Health and Human Services (HHS) briefing. The chief operating officer for Operation Warp Speed, Gen. Gustave F. Perna is leading the program. Regardless of the speculation around the political intervention, the Trump administration aggressively funded the pharmaceutical companies seeking for COVID-19 vaccine by signing the pre-order contracts with the vaccine makers. When they were short of injection needles and other equipments, the U.S. Department of Defense reportedly flew the needed equipments within 48 hours. The super expedited COVID-19 vaccine commercialization was possible with the U.S. government’s full support backed by the Department of Defense and HHS with long history of developing and distributing vaccine. Fundamentally, the attempt to even accelerate the vaccine development and distribution was made, because the pharmaceutical giants, Pfizer and Moderna valued at KRW 250 trillion and KRW 68 trillion, respectively, were confident with their colossal capital and technology. The pandemic shortened typically a decade-long vaccine development process at unimaginable speed. Pfizer-BioNTech and Moderna’s vaccines are designed around a new technology involving messenger RNA (mRNA), which vastly differs from the conventional vaccine mechanism. A genetic substance of mRNA is injected to a human body to generate antibody and induce immune reaction. The threat of pandemic has opened up a new opportunity for the history of mankind. The regular healthy people have a long journey ahead to receive the COVID-19 vaccination. But the people exhausted from the COVID-19 would be full of hope to finally overcome the infectious virus—a thought of the day we return to the daily life without wearing masks. And hopefully, the South Korean government would also assess the vaccines swiftly but accurately, when COVID-19 vaccine makers apply for an approval.
- Opinion
- [Reporter’s View] Real reasons for disqualification?
- by Eo, Yun-Ho Dec 11, 2020 06:15am
- A multinational pharmaceutical company Sanofi Korea has failed to qualify as a certified innovative pharmaceutical company. Fairness aside, the transparency in the process seems questionable. Since its first certification won in 2014, the company lost its certification status after six years. Now, only three multinational companies—AstraZeneca, Janssen and Ostuka Pharmaceutical—are certified as innovative pharmaceutical companies in South Korea. The certification is definitely not permanent; if a certified company is disqualified, then the company’s benefit should be taken away. But the problem here is that there is no known reason behind the disqualification. An innovative pharmaceutical company is evaluated based on investment performance, manufacturing facility status, R&D vision and strategy, collaboration and partnership with local and overseas university and research institute, licensing contract, business ethics and business transparency. Reportedly, Sanofi has passed all the ‘quantitative criteria’ for the evaluation. In other words, the reviewers saw disqualifying factor in ‘qualitative criteria.’ But the details have not been disclosed. To Daily Pharm, the government official answered, “The innovative pharmaceutical company certification takes account of not only quantitative evaluation, but also quantitative evaluation.” However, Sanofi Korea has no clue on why they failed the qualification. Their answer of ‘qualitative evaluation is also used’ is not a justifiable answer. They need to state how the company’s qualitative factor scored lower than the passing score. The rumor has it that ‘the health authority was offended by Sanofi terminating the licensing contract with Hanmi Pharmaceutical,’ or ‘the government is trying to reduce the ratio of certified multinational companies.’ But the government lacking transparency has no rights reprimand the rumors. The innovative pharmaceutical company certification program allows the authority to officially certify and grant benefits to the qualifying companies. Fairness and transparency is essential to the program. At least the disqualified companies should have feedback to consider either prepare for the certification reapply or not. The poor reputation of ‘offending the authority is a surefire disqualification’ cannot be good. If such situation continues to happen, then Sanofi would not be alone in this. The relationship between multinational pharmaceutical companies and South Korea should not be overlooked. The country still does not have sovereignty over new drug. Without a clear guideline on the government’s key program for those companies bringing new drugs, the country and the companies’ headquarters could spark a conflict. Even private companies and universities are enforcing ‘blind interview’ to reinforce transparency in the application process. A head coach keeping a silence to a player asking why they are benched should not complain for being replaced.
