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- 2026-04-29 06:35:07
- Opinion
- [Reporter’s View] Amid hopes for K-drugs, beware
- by Eo, Yun-Ho Dec 13, 2023 05:38am
- It is not only the patients that are now interested in the research and development of new drugs. The interest in high-value-added industry and aspirations for the development of the domestic industry has never been hotter. Industry development is good. New drugs? Even better. However, the rise of the stock market bubble that stirs investment interest in the sector is potentially detrimental to the advancement and success of the industry and new drug discovery. New drug development would not have risen as a trend if it was easy. Due to rising interest in Korea's biopharmaceutical industry grows, information about the pharmaceutical industries’ clinical trial failures, discontinuation, or efficacy issues are being constantly covered online. When successful, reports on these clinical trials make it into the headline news. The current trend is understandable. Biosimilars from companies like Samsung and Celltrion are increasingly gaining recognition in the US and Europe, and the Korean government is coming up with a favorable drug pricing policy for domestically produced new drugs, based on the government's premise of devising a measure to foster the biopharmaceutical industry. Let’s get one thing clear. Suceeding in new drug development is far from easy. According to an analysis conducted by the Biotechnology Innovation Organization (BIO) in the US, which examined data from 9,985 clinical trials either completed or underway by the U.S. Food and Drug Administration (FDA) from 2006 to 2015, the success rates were 63.2% for Phase 1, 30.7% for Phase 2, and 58.1% for Phase 3 clinical trials. When these rates are calculated to determine the probability of a new drug reaching the commercialization stage, the number renders to a mere 9.6%. Development discontinuation and clinical trial failures in the pharmaceutical industry are common; it would rather be odder if they didn't occur. However, the issue lies in transparency. It's a fact that numerous pharmaceutical companies have jumped on the new drug development bandwagon, trying to take advantage of the rising tide. Clinical data on candidate substances and presentations made at international conferences are being often distributed indiscriminately without adequate drug information. Its phrases, "shows superior effectiveness compared to drug X," "the first treatment for X cancer," or "significantly improves survival duration," seem to be primarily aimed at influencing investor psychology, Such headlines do seem attractive, but the articles frequently lack basis. Detailed information, such as the number of patients involved in clinical trials, the duration of the research, and quantitative data from comparing different cohorts on the drug's effectiveness and safety, are not provided. Moreover, drug descriptions are frequently oversimplified to terms like ‘good drug’ stated by a company personnel. Keep in mind that drug discovery is science and has patients as the end-customers. Any success in new drug development by Korean companies are encouraging news. Therefore, other companies should embrace the transparency and open up information for a fair evaluation. They must stop worrying about IR (Investor Relations). Just as they addressed the rebate issue, it is now the time for the companies to dispel any doubts about stock price manipulations.
- Opinion
- [Reporter’s View] CSO is a double-edged sword
- by Kim, Jin-Gu Dec 07, 2023 05:47am
- Over the past few years, small mid-sized pharmaceutical companies and contract sales organizations (CSOS) have developed a strong symbiotic relationship. Small and mid-sized pharmaceutical companies have provided work for CSOs, and CSOs have repaid the companies by improving their performance. Due to this, many companies, especially small- and mid-sized companies, have partnered with CSOs. Over the past few years, CSOs have become "the trend" for small- and mid-sized pharma companies, as their performance varied depending on whether they used CSOs. Also, CSOs have expanded their role by specializing in sales for specific products or regions. They have been praised for improving cost-effectiveness and profitability through flexible sales activities, but they have also been criticized that it has become a ‘breeding ground for rebates.’ It was constantly pointed out that CSOs were being utilized as a rebate delivery channel, hiding in the blind spots of the system. Then, the CSO Reporting System emerged to address this issue. A bill to amend the Pharmaceutical Affairs Act to require CSOs to report to the government and local governments passed the National Assembly in the first half of this year. The revised Pharmaceutical Affairs Act will come into effect on October 19 next year Once implemented, the government will be able to hold pharmaceutical companies that signed contract sales agreements with CSOs accountable for the CSO’s deviant activities. This means when rebates are made, not only the CSO but also the pharmaceutical company involved could be criminally punished as an "accomplice". Even if the company avoids criminal penalties, it will be difficult to avoid administrative penalties because criminal penalties and administrative penalties are imposed separately. The administrative penalty imposed on a Korean pharmaceutical company that was finalized in July this year is a good example. Although the company was acquitted by the prosecution due to insufficient evidence for the rebate case that was discovered in 2016, the Supreme Court made the final ruling to impose a 3-month suspension on the sales of 14 items. Therefore, cases of rebates made through CSOs may also be judged similarly. Even if the companies avoid criminal penalties, they may still face strong administrative penalties. Moreover, if multiple rebate cases are found at the same time, the administrative penalties may be accrued or raised. For small- and mid-sized pharmaceutical companies, such rulings will be a hard blow. In this sense, CSOs are now a double-edged sword for small- and mid-sized pharmaceutical companies. They can improve performance but the companies will have to also bear the risk. The time has come for pharmaceutical companies that have already built a symbiotic relationship with CSOs to make a choice. Will the companies continue to work with CSOs that deliver high performance, or reduce the role of CSOs to mitigate risk? The companies will need to make their decision quickly, as just over 10 months remain until the CSO reporting system comes into effect.
- Opinion
- [Reporter's View] Covid-19, endemic is not 'The End'
- by Eo, Yun-Ho Dec 06, 2023 06:00am
- ‘Endemic’ doesn’t mean THE END. Covid-19 has transitioned to an endemic after a long-fight against the virus for three years. Accordingly, each country is making an adjustment to the health protocol in a bid to meet domestic needs. The Korean government had announced that it will work to list Covid-19 treatments for reimbursement within the first half of 2024 through the Covid-19 risk level management roadmap. And the public’s sense of crisis has dropped with the eased restrictions. Covid-19 transitioned from pandemic to endemic. Yet, the continued introduction of new Covid-19 variant make high-risk patients, particularly those with underlying diseases and senior patients, all the more vulnerable. Up until now, excess deaths associated with Covid-19 is continuing, according to the KDCA report citing KOSTAT data submitted to the office of Rep. Jung Chounsook, a member of the Democratic Party of Korea and a member of NA's Health and Welfare Committee. The Covid-19 associated excess deaths toll over 65,000 people, and in this case, ‘excess deaths’ are typically defined as the difference between the observed numbers of deaths in Covid-19 periods and expected numbers of deaths in the same time periods. Be prepared for battle yet again. We should not forget the times when all people worn masks and had restricted gatherings. Continued supply of vaccines and patient management would be the most important part of the preparation. However, a sense of crisis is hard to achieve once lowered. A lowered crisis-level would result in the transition of reimbursement of Covid-19 treatment to non-reimbursement. After initiating phase 2 of the COVID-19 risk level management roadmap, Covid-19 will be treated as level 4 infectious diseases similar to influenza (flu). In other words, drugs such as Gilead Sciences Korea's ‘Veklury’ and Pfizer's ‘Paxlovid’ will now only be available through the regular reimbursement scheme. Although the government promised to continue providing oral Covid-19 drugs without charge, it can just as well abruptly discontinue provision. As a solution to the problem, pharmaceutical companies have submitted insurance reimbursement applications for drugs in October and are in discussion with HIRA. Yet, no progress has been made. Time is ticking for the upcoming crisis-level adjustment deadline. If we were to treat people with non-reimbursed drugs, copayment rate would be skyrocketed. The problem is that people would start to think, ‘Why should we pay this much for the treatment?’ due to a lowered sense of crisis. We are running out of time. The government should promptly proceed with the debate, and the pharmaceutical companies should consider proposing reasonable drug pricing in preparation for a long fight against COVID-19.
- Opinion
- [Desk’s View] On resolving the stock shortage of drugs
- by Lee, Tak-Sun Dec 05, 2023 05:49am
- As a parent, I feel like I've been visiting hospitals after the endemic than I did during the COVID-19 pandemic. At the height of the pandemic, I only had to worry about COVID-19, but after the pandemic has passed, children with weak immunity are suffering from various viral diseases including colds, flu, and adenovirus. When my older daughter got sick, my younger one also got sick, and us parents were no exception. After going through a series of these vicious cycles, I pulled out my mask again and wondered whether I had removed my mask too soon. With this increase in hospital visits, drug shortages are quite understandable. However, as a healthcare consumer, I don't understand the seriousness of it. It's not as bad as when I had to go from pharmacy to pharmacy seeking acetaminophen fever reducers for my COVID-19 vaccination. I never had to go to another pharmacy because the prescriptions written by my local pediatrician or ENT were not available at one site. However, when I look at the prescribed drugs, I see the ingredients of the “drug with unstable supply" that are often mentioned in recent articles. Although these are not the items that are being discussed for price hikes, they contain the same active ingredients. This shows that there may be differences in demand for different products even within those that contain the same ingredients. Also, in one corner of the pharmacy, I saw a lot of over-the-counter fever reducers. Although the supply of prescribed fever reducers is running low, the over-the-counter ones still seem to be available. The government's response to the ‘unstable supply of medicines’ seems to have been successful to a certain extent, as consumers are not feeling any inconvenience yet. If the consumers had felt and experienced the drug shortage firsthand, the anger against the government would have been extreme, as people become most emotional when they are sick. However, I am disappointed that the government's solution seems to be focused on 'increasing production.’ Even the most effective card the government has played, the drug price increase, is aimed at increasing production. If only certain products are out of stock and other drugs with the same ingredient are available, efforts should be made to diversify prescriptions. It would be best if the system allows full utilization of the substitution system, but it is unlikely to have an effect under the current system, as the pharmacies need to bear the inconvenience. In this case, why not amend the enforcement decree to temporarily exempt pharmacies from notifying the medical institutions about the substitutions for drugs that are in unstable supply? In the long run, we can also expect to alleviate the concentrated prescription of certain ingredients by removing reimbursement of general medicines used for mild illnesses such as the common cold. However, as such options are not even being considered as a way to solve the supply and demand instability of drugs, this further narrow the options that the government can take. The government should seriously monitor the market first, and consider measures to diversify prescription if other drugs with the same ingredient are left for immediate utilization.
- Opinion
- [Reporter's View] Non-face-to-face treatment pilot project
- by Lee, Jeong-Hwan Dec 04, 2023 05:12am
- Starting December 15th, ’24-hour non-face-to-face treatment’ will be available to the public following the legalization of revised non-face-to-face treatment pilot project by the Ministry of Health and Welfare. The project will extend the non-fact-to-face treatment benefit that had been previously limited to returning patients to new patients. Patients will be able to request non-face-to-face treatment for all types of diseases, whether acute or chronic, at a clinic where they have made an in-person visit within 6 months. A dramatic increase in the number of non-face-to-face treatment is expected due to the updated policy, which has allocated the responsibility of sorting the non-face-to-face treatment eligibility at the sole discretion of the physicians, regardless of severity of disease. Physicians and pharmacists registered with the Korean Medical Association (KMA) and the Korean Pharmaceutical Association (KPA) have voiced concerns against the newly updated non-face-to-face treatment policy. Their primary view regarding the policy is that the government has forcefully implemented the pilot project without a thorough assessment of its side effects. Shortly after the MOHW's announcement, physicians and pharmacists' associations small and large have all issued statements opposing the revised pilot project. On November 30th at 8:00 a.m., a day before the MOHW released the revised plan, a conference had been held between the advisory panel regarding the non-face-to-face treatment pilot project. Although the KMA, KPA, and the Korea Alliance of Patients Organization have stated their opposing views on the extension of the policy at the meeting, their opinions have not been taken into consideration. Therefore, the panels expressed that the advisory panel for the pilot project was held for formality, wherein the government had not planned to regard any of the opinions proposed at the meeting and the extension of the plan was already a done deal. The Yoon Suk-Yeol administration has been putting an emphasis on running the governmental operation based on ‘social consensus and scientific reasoning,’ especially regarding the major issues of national concern. However, no such consensus or reasoning was made in the process of the non-face-to-face treatment pilot project advisory panel meeting and the revision announcement. Neither scientific statistics nor research analysis data have been suggested for concluding extending the potential patient pool of the ongoing pilot project. It is truly questionable whether MOHW has ruled President Yoon Seok Yul’s comment that “parents of children have a hard time seeking non-face-to-face treatment late at night and on holidays” made in the Cabinet meeting a scientifically backed argument. In contrast, all the opposing voices of physicians, pharmacists, and patient organizations were left unheard. As for the revision, the scientific reasoning-based administration is non-existent and the societal agreement-based policy-making principle has been neglected. Because the non-face-to-face-treatment pilot project is a revision to the public health law and not to the medical law, there seems to be no regulation of MOHW's way of conducting an extension. Despite of opposing views by medical professionals, concerns by patient organizations, and major criticisms by the political party, the pilot project which allows ’24-hour non-face-to-face treatment’ will be accelerated. December 15th will be remembered as the date on which the omnipotent pilot project, which extends the scope of non-face-to-face treatment, overpowers the medical law.
- Opinion
- [Reporter’s View] 1 yr after Zerbaxa's release
- by Eo, Yun-Ho Nov 20, 2023 05:50am
- One year has passed since the new antibiotic ‘Zerbaxa’ has been listed for reimbursement in Korea. At the time, the drug was applied the special exemption of the pharmacoeconomic evaluation system as a National Essential Medicine. The government’s flexible response amid the rise of the global issue of antimicrobial resistance shone through. The drug’s need, although it is not for a ‘life-threatening disease,’ has been recognized. However, a more serious issue lies ahead. No other new antibiotic has been reimbursed since then. Even when taking into account how Zerbaxa was listed 5 years after its approval, this 1-year gap is a significant time when determining whether the government had continued to show resolve to address the antimicrobial resistance issue. At the time, when designating antibiotics as subject to the PE exemption system, the government limited the scope of beneficiaries to antibacterial drugs like Zerbaxa. This is why Cresemba, another antibiotic, remains non-reimbursed, due to difficulties in passing pharmacoeconomic evaluations. Medically, antibiotics refer to 'antimicrobial medicines' that include antibacterial drugs (for the treatment of bacterial infections), antifungal drugs (for the treatment of fungal infections), and antiviral drugs (for the treatment of viral infections). The increase in antimicrobial resistance (AMR) is being regarded as one of the most serious public health issues worldwide. The World Health Organization (WHO) has defined AMR as a global health and development threat as it threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses, and fungi. Also, finding a new therapeutic alternative to carbapenem is another public health issue that has been announced by the WHO. The rise in the incidence of multidrug-resistant Gram-negative bacteria has also been causing serious issues in terms of healthcare-related infections. In particular, the WHO has designated carbapenem-resistant Pseudomonas aeruginosa infection as one of the highest-priority pathogens in need of research and development for new antibiotics. In this context, ‘Zavicefta,’ which can benefit from the PE exemption waiver system and receive reimbursement, has passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in September and is undergoing drug pricing negotiations with the National Health Insurance Service. The drug has been gaining attention as a new antibiotic option for severe infections in which drug resistance poses a serious problem, such as multidrug-resistant Pseudomonas aeruginosa infections, carbapenem-resistant Gram-negative pathogens, extended-spectrum β-lactamases (ESBL) producing Enterobacteriaceae, etc. In With its reimbursement listing nearing thanks to the efforts of the pharmaceutical company and government, this is now the time to look back on the antibiotics issue that lingers as a threat to public health.
- Opinion
- [Reporter’s View]Encouraging healthy competition in NSCLC
- by Son, Hyung-Min Nov 16, 2023 05:46am
- Although it might be frustrating for those competing against each other, healthy competition often leads to beneficial results on the whole. This is the case for the EGFR-mutated non-small-cell lung cancer treatments, Yuhan Corp’s Leclaza (lasertinib) and AstraZeneca’s ‘Tagrisso (osimiertinib).’ Both drugs are third-generation tyrosine kinase inhibitors (TKIs) targeting EGFR-mutated non-small cell lung cancer, and are currently used as first- and second-line treatment in the field. The two are same-generation drugs that own the same indications. Both have proven their effect in terms of brain metastasis, efficacy, and safety, which are important factors in treating cancer patients. Yuhan Corp and AstraZeneca, which developed the two drugs, have continued to engage in competition with combination therapies using their respective drugs. At the 2023 European Society for Oncology (ESMO) Congress that was held last month, results of Janssen’s main MARIPOSA study that evaluated the combined use of Janssen’s ‘Rybrevant (amivantamab)’ and Leclaza were disclosed. Results showed that Leclaza+Rybrevant improved the primary efficacy endpoint of progression-free survival (PFS). A favorable trend was also observed in overall survival (OS), the secondary endpoint. Also, results of the FLAURA2 study showed that Tagrisso extended PFS by pulling forward the use of platinum-based chemotherapy, which is currently used as a second-line treatment for EGFR-positive NSCLC. Due to the high interest in the 2 treatments, the results for the combination therapies received great attention, raising discussions on which treatment was more effective . The competition further intensified in Korea after Yuhan Corp announced that it would provide Leclaza for free until the drug was reimbursed. Although there was concern that AstraZeneca may object to the measure, the company did not, referring to how it would benefit patients. The movements to extend the patient's survival through the use of combination therapies, offering free treatment to patients, and not raising objections as the other company’s programs will benefit the patient, are all efforts on the companies’ part to put patients first. This deserves applause. Yuhan Corp and AstraZeneca are both separately in pricing negotiations with the National Health Insurance Service to receive reimbursement for Leclaza and Tagrisso as a first-line treatment for EGFRm NSCLC. It is difficult to say which treatment is superior. Ultimately, both drugs would need to be reimbursed if the patients and HCPs are to receive equal benefits in terms of choice. The cost of a single cycle of the two drugs when prescribed without reimbursement exceeds KRW 5 million. So it is this reporter’s wish that the two treatments will be approved for reimbursement so as to reduce the financial burden borne by patients with NSCLC. In this sense, we support the healthy competition between the two companies that can produce beneficial results for the patients.
- Opinion
- [Reporter’s view] Successive large-scale technology exports
- by Kim, Jin-Gu Nov 10, 2023 05:19am
- There is some good news coming from the pharmaceutical and bio industry. Chong Kun Dang and Orum Therapeutics have signed large-scale technology export contracts with global pharmaceutical companies. On the 6th, Chong Kun Dang signed a technology export contract with Novartis worth a total of $1.305 billion (about 1.7 trillion won). This is a transfer of global development and commercialization rights, excluding Korea, for ‘CKD-510’, a new drug candidate in the HDAC inhibitor class. On the same day, Orum Therapeutic, an unlisted bio venture, signed a contract with BMS to transfer the technology of ‘DRM-6151’, a new drug candidate for leukemia. The total contract size is $180 million (approximately 230 billion won). What attracts more attention than the total contract size is the down payment. Chong Kun Dang received $80 million (approximately 100 billion won) as a down payment, and Orum Therapeutic received $100 million (approximately 130 billion won) as a down payment. The down payment is money that does not need to be returned even if the rights to develop new drugs are later returned. The down payment is evaluated as an appropriate tool to objectively reflect the value of the candidate material. The total contract size is filled with an optimistic outlook. If a candidate material does not meet detailed contract conditions such as development or approval, it will not be received. In general, it is considered a good condition if the down payment ratio is more than 5% of the total contract size. Chong Kun Dang received 6.1% of the total contract size, and Orum Therapeutic received 55.6% as a down payment. In terms of down payment, it is the largest in four years since 2019. In February 2019, SK Biopharmaceuticals received $100 million (total contract size of $530 million) and signed a technology export contract for an epilepsy new drug with AVELOS Therapeutics. Since then, several technology export contracts have been signed with a total contract size in the trillions, but it is true that looking at the contract amount alone, it was disappointing. In some quarters, controversy arose over the discrepancy between the total contract size and the down payment. However, a series of contracts were concluded with a down payment of over 100 billion won. In the pharmaceutical industry, expectations are growing whether large-scale technology export contracts concluded one after another will be able to reverse the recent slump. Recently, the pharmaceutical and bio-industry has been facing an investment cliff due to the high-interest rate situation that has continued since the coronavirus pandemic. In particular, bio ventures that focused on R&D without consistent sales were pushed into crisis as external investment plummeted. In this situation, it is ultimately R&D, the core asset of the biopharmaceutical industry, that leads to a change in the atmosphere. It is time for another R&D performance. We succeeded in revitalizing the atmosphere through a series of technology export contracts. In order to completely change the atmosphere, new R&D results must be released in the near future. I look forward to hitting consecutive hits following Chong Kun Dang and Oreum.
- Opinion
- [Reporter's view] Preferential pharmaceutical alternative
- by Lee, Jeong-Hwan Nov 07, 2023 05:34am
- The government appears to be slow to announce a plan to reform the drug pricing system, which includes measures to give preferential prices for drugs that reflect the value of innovation. Although we have already held several consultative meetings with representatives of domestic and foreign pharmaceutical and biopharmaceutical companies, it is becoming increasingly late to present results on how to specifically evaluate innovation value and provide preferential drug prices. Initially, it was expected that the government would announce a plan to improve the drug price system in September last September for new drugs. The Ministry of Health and Welfare's plan was to make a final announcement as soon as possible based on the results of five public-private consultations on drug price system reform from February to June of this year. However, since there was no specific plan, the release was further delayed due to reasons such as a government audit. The establishment of preferential drug price regulations that reflect the value of innovation is an issue that the National Assembly has also proposed for several years, raising the need for improvement. The special bill on the pharmaceutical industry, proposed by People Power Party lawmaker Seo Jeong-sook, is the core of the bill, which establishes a pharmaceutical and bio innovation committee under the Prime Minister's direct control and mandates additional preferential treatment of the upper salary limit for drugs manufactured by innovative pharmaceutical companies. Park Min-soo, Second Vice Minister of Health and Welfare, has promised to establish and implement a practical system since the beginning of this year since taking office in relation to the plan to reform the drug price system to reflect innovation values. At a meeting held in person with the Professional Journalists Association in February of this year, Vice Minister Park Min-soo said, "Like the U.S. bio executive order, our country will create an incentive system to convert essential medicines and medicines using domestic raw materials to domestic production and reflect them in drug prices." It was revealed. Even during the review of Rep. Seo Jeong-sook's bill, Vice Minister Park expressed concern over converting the drug price preferential clause for innovative pharmaceutical companies into a mandatory/mandatory regulation and announced plans to clearly create and implement a policy of preferential drug prices for drugs that have proven their innovative value even if not converted. there is. Furthermore, this year's National Assembly inspection is reviewing a plan to improve the drug price system to appropriately compensate for the innovation value of new drugs in order to prevent 'Korea passing' and promote the overseas expansion of new domestic drugs and has responded that it will create a policy of preferential drug prices for drugs using domestic raw materials. In the end, the Ministry of Health and Welfare has announced throughout this year that it will prepare a plan to reform the drug price system to reflect innovation values, but it is regrettable that it is still difficult to examine the specific implications. In the past, in response to criticism that the drug price system needed to be reformed, the Ministry of Health and Welfare repeatedly stated that it would be difficult to come up with a drug price reform plan that would only give preference to domestic industries due to reasons such as WTO trade friction. However, after realizing that the pharmaceutical industry is directly linked to national security due to the prolongation of the COVID-19 pandemic, a signal was sent to protect the domestic industry without any trade friction and to provide corresponding compensation to medicines that showed innovative levels of efficacy and safety. Sent several times. Domestic and foreign biopharmaceutical companies that are manufacturing and importing pharmaceuticals in Korea may also have participated in public-private consultative meetings amid this signal. It is understandable at first glance that the Ministry of Health and Welfare is delaying the release of the inevitable reform plan in the process of designing a more detailed and practical drug price preferential policy based on the results of the consultative body discussions. However, from the perspective of the pharmaceutical industry, which is anxiously awaiting the improvement plan, the delay in the release of the Ministry of Health and Welfare's reform plan without any mention is hopeless. It can be torture. Complaints regarding pharmaceutical companies' drug price system reform have already been submitted to the Ministry of Health and Welfare after several meetings. The government's will to prepare a plan to reform the drug price system should not be weakened due to the end of the COVID-19 pandemic. We hope that the drug pricing system reform plan, which will encourage pharmaceutical companies to develop new and improved drugs, increase their chances of entering the global market, and motivate them to manufacture drugs using domestic raw materials instead of cheap Indian and Chinese raw materials, will be revealed before the end of the fall.
- Opinion
- [Reporter’s view] WLA Registration
- by Lee, Hye-Kyung Nov 03, 2023 05:32am
- WHO announced on October 26 that the Ministry of Food and Drug Safety was listed on the WHO Listed Authorities. The news became known in Korea on the afternoon of the 30th, when WHO posted a list of WLA-registered countries on its website and then suddenly deleted it. It was confirmed that the error was due to detailed coordination, and it was on the afternoon of the 31st that the Ministry of Food and Drug Safety officially heard the news of WLA registration. WHO also officially distributed a press release and announced that Korea was listed in the WLA. The good news about the Ministry of Food and Drug Safety's WLA is that although Korea is a full member of the ICH, it has not been listed on the WHO's SRA (Stringent Regulatory Authority), which means that the domestic pharmaceutical and bio industries have not been able to receive incentives in bidding for the procurement of medicines and vaccines from UN-affiliated organizations. In particular, in 2021, when COVID-19 was prevalent, Hong Kong limited the scope of countries recognizing vaccination certificates to countries listed in the SRA, raising controversy over the reliability of the regulatory level of domestic pharmaceuticals. This is a happening that occurred as the WHO has not been operating the SRA registration application process since 2015. WHO has been promoting WLA, in which WHO directly evaluates regulatory agencies, since 2016 to replace SRA, which is based on ICH membership requirements. Korea had no choice but to wait for an evaluation system to replace SRA since 2016, and submitted its first letter of intent for registration in 2021, when WHO began accepting letters of intention to register WLA. The news of the Ministry of Food and Drug Safety's WLA registration is a great achievement after two years. However, the specific incentives that the domestic pharmaceutical and bio-industry will experience once WLA registration is achieved are unknown. The Ministry of Food and Drug Safety also provides advantageous conditions by applying exceptions to WHO quality certification (Pre-qualification (PQ)) when SRA countries bid for the procurement of medicines and vaccines from UN-affiliated organizations, and WHO provides equivalent standards to countries listed in the WLA. The only announcement was that they expected to implement support measures. The pharmaceutical bio-industry is expecting WHO's PQ exception to be applied through this WLA listing. Although WHO is not a regulatory agency, it conducts PQ when procuring medicines and vaccines from UN-affiliated organizations, which includes data review, testing, and on-site inspection. In the end, it seems that domestic sites will only be able to realize the Ministry of Food and Drug Safety's WLA registration if they are able to receive exceptions to WHO's PQ. We hope that the Ministry of Food and Drug Safety will be able to announce in detail WHO's incentives for WLA registration as soon as possible.
