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- 2025-12-19 19:08:16
- Opinion
- The Minister should be appointed to lead policy continuity
- by Lee, Hye-Kyung May 20, 2022 06:11am
- On the 13th, the Yoon Seok-yeol government announced the appointment of vice ministers, ministries, and commissioners. However, as the head of the Ministry of Food and Drug Safety was excluded from the list of appointments, many talks were exchanged about the background. The most credible argument was that the appointment of the head of the affiliated agency would not have been easy at a time when the appointment of the MOHW was not made. Candidate for Minister of Health and Welfare Chung Ho-young has yet to be appointed since the personnel hearing. Some say they are trying to trade for the confirmation of Prime Minister nominee Han Duck-soo and the resignation of Minister of Health and Welfare candidate Chung Ho-young. In this situation, attention is also being paid to who will become the head of the regulatory agency, the MFDS. Oh Yoo-kyung, dean of Seoul National University College of Pharmacy, Kim In-kyu, former head of Gyeongin Office, Yoon Hyung-joo, and Seo Kyung-won, head of safety evaluation, were mentioned as candidates for his successor. All candidates seem to have the advantage of being able to maintain policy continuity and consistency as internal personnel of the MFDS. It is unclear whether the head of the MFDS, who is first appointed by the Yoon Seok-yeol government, will also be able to exceed the average tenure. The MFDS is a regulatory agency for pharmaceutical and food safety management, and frequent replacement of the head of the MFDS does not seem desirable to maintain continuity and consistency. Yoon Seok-yeol, the first head of the government's MFDS, who will be appointed soon, should be empowered to lead policies such as rapid approval of medical products such as medicines and support the development of COVID-19 treatments.
- Opinion
- [Reporter’s View] New govnt signals expanded PE exemptions
- by Eo, Yun-Ho May 18, 2022 05:52am
- The inauguration of a new government brings hope and anticipation to each and every industry. The same goes for multinational pharmaceutical companies. In the pharmaceutical industry, hopes are rising for the expanded eligibility of the pharmacoeconomic evaluation exemption scheme. Although many agendas remain in need of resolution, such as improvement of drug prices for each indication and the pre-listing post-evaluation scheme, etc., the industry believes the improvement of the PE exemption system is most realistic. This seems plausible from the third person's perspective as well. In fact, Yoon Suk-Yeol’s administration plans to promote the accelerated listing of anticancer drugs and treatments for severe and rare diseases that have no alternatives to improve patient access to such treatments. However, due to the conservative stance held by the relevant ministries such as the Ministry of Health and Welfare, Health Insurance Review and Assessment Service, and the National Health Insurance Service in improving drug prices for each indication and the application of the pre-listing post-evaluation system, no drastic change may be possible even with the administration change. But there still lies hope for improvement in the PE exemption system, as this special system that was introduced as an exception by the Korean government is still being well utilized, and the request for its improvement has been continuously raised for some time. Strangely enough, new drugs with low profitability due to a small number of eligible patients and drugs that have difficulty demonstrating cost-effectiveness even after overcoming developmental difficulties are becoming a trend and being actively introduced to the market. It may be due on one part because drugs for almost all other diseases have already been released, but still, the addition of these new treatment options cannot be bad for mankind. The industry has been requesting expanding eligibility of the pharmacoeconomic evaluation exemption scheme. The industry requested a more flexible application of the system, under which the PE exemption system is applied to drugs with no alternatives that have been approved with placebo-controlled data or be applied the same eligibility standards for the patients, etc. However, from the government’s perspective, it is difficult to open up its pockets upon every request as it has to pay the expenses from a limited budget. This is why the rumor that the PE exempted drug’s price will be set at ‘80% of the lowest A7-adjusted price’ had turned the industry upside down last year. PE exemptions are the only option for necessary drugs deemed difficult to receive pharmacoeconomic evaluations. It contains various fiscal management devices and has incorporated the ‘expenditure cap’ design ever since its implementation to protect fiscal sustainability. It’s just that with more drugs introduced to the market, more flexible management of the system may now be required for the right treatment to be prescribed to patients at the right time. In this context, on what picture the new administration has prepared to address this issue remains a focus of attention.
- Opinion
- [Reporter’s View] Now is the time for drug reclassification
- by Lee, Tak-Sun May 06, 2022 05:46am
- 10 years have already passed since the heated discussion arose on the drug reclassification and sale of over-the-counter drugs in non-pharmacy venues. As the Korean saying goes, even nature can change in one decade. In that not-so-long but also an epoch of a period in terms of change, many drugs have established safety profiles and await better patient access. In other words, the time has now come for discussions on drug reclassifications, just as we have done in 2012 a decade ago. Above all, we need to make an opportunity to discuss reclassifications because no system that regularly reclassifies drugs exist in Korea. The Ministry of Food and Drug Safety announced that it would establish a regular system at the time of the reclassification in 2012, but the switchings based on overseas and safety data are not being performed smoothly. There are cases where the reclassification process itself is at a standstill despite rising social demand, such as in the case of the morning-after pill. This is mainly due to the absence of an applicant, but this doesn’t mean that the government should just let go of the matter. The government should actively come up with a plan and have applicants such as pharmaceutical companies, medical/pharmaceutical associations, and consumer groups fill out application forms. The environment and timing are also set for reclassifications, as 10 years have passed since the full reclassification and the people who led the reclassification at the time have returned with the administration change. Of course, opposition from medical and pharmaceutical groups such as the Korea Medical Association and the Korean Pharmaceutical Association is expected. KMA is opposed to the reclassification plan, and the KPA is also passive in reclassification to avoid increasing the number of over-the-counter drugs. Also, civic groups are much less interested in enabling reclassification than a decade ago. The pharmaceutical companies that rely on insurance prices are less likely to request reclassification on their part. However, it is negligence on the government's part to let go of the drug classification issue due to fear of conflict. The authorities must do what is needed despite the expected turmoil. Update the overseas cases and collect the new safety data to reform the outdated system. Just firmly withhold the set principles during the reform. Allow easier access for drugs with verified safety, if not, tighten access. Stop walking on eggshells in fear of the medical and pharmaceutical groups and gather the experts who are aware of the gravity of the situation and hear their opinions.
- Opinion
- [Reporter’s View] Use of maintenance and adjuvant therapies
- by Eo, Yun-Ho May 04, 2022 06:03am
- Continuous administration of a drug for ‘prevention.' This is not a new concept. Patients have been taking drugs to ‘manage’ their chronic condition for a long time, and drugs such as anticoagulants exist for the purpose of prevention. This only became an issue after the concept of maintenance and adjuvant therapies were introduced in cancer treatment. The introduction has been less welcomed undoubtedly because of its high price. Everyone fears the risk of recurrence after being cured of cancer. Depending on the type of cancer, some cancers have a recurrence rate of up to 80%. But in the era of high-priced drugs, prescribing the industry-leading high-priced anticancer drugs for preventive purposes, and providing insurance benefits for such can come as a burden for the health authorities. On the other hand, the introduction of such therapies has become the trend in the pharmaceutical industry. Existing therapies have been continuously adding maintenance and adjuvant therapy indications, and new anticancer drugs with their initial indication approved as adjuvant therapy are also being introduced into the field. This shows for sure that we now need to seriously consider the use of maintenance and adjuvant therapies. It is time for the authorities carefully examine the necessity of administering anticancer drugs as a preventive measure by each drug and consider the practicality rather than the indefinite ‘burden' they may bring. Paying out drug costs for the relapsed patients may be less cost-effective than reimbursing maintenance and adjuvant therapies. Recurrence and metastasis are fatal factors that increase the mortality rate of cancer. We now need to weigh the pros and cons of the drugs as the accumulating adjuvant and maintenance therapy drugs cannot be left unattended anymore, fully recognizing that there is no right answer. The drugs have to be considered not only by their profit and loss but also by the specificity of each drug and patient situation. All the interested parties including the health authorities and the pharmaceutical industry must make an effort to reach an agreement that takes into account Korea's health insurance system and the pharmaceutical industry’s ecosystem.
- Opinion
- [Reporter’s View]Recall the purpose of regulating biologics
- by Apr 27, 2022 06:04am
- The Ministry of Food and Drug Safety visited 3 pharmaceutical distributors on the 21st to prepare a new guideline that reflects voices in the field and the realistic difficulties of the industry in preparing to comply with regulations on the distribution of biological products. The government is resetting the guideline after the revised version of the ‘regulation on the Manufacture and Sales Management of Biological Products’ was implemented in January last year faced with strong opposition from the pharmaceutical distribution industry on the sudden rise in the distribution standards of biological products without considering the cost or preparation period. The raised standards increased the cost of transporting biologicals that already have low distribution fees to the extent that many companies decided rather not to distribute them. Also, the industry pointed out the difficulties in managing the temperature of biological products that have to be frequently shipped in small amounts to pharmacies like insulin. Under the revised regulations, it is necessary to maintain 2-8 degrees at all times using transport containers equipped with automatic temperature recording devices when delivering biological products, and the record must be kept for two years. Unlike the regulations that forbid even a single deviation from the designated temperature, there are times when the temperature may suddenly jump out of the reference range for unknown reasons in reality. Although this has no effect on the efficacy of the drug because the temperature does not deviate for a long period of time, they are subject to punishment under the regulations. This is why the distributors are struggling with the issue. A representative of a company has been testing various transportation containers every day, including custom-made containers, but has not been able to find a solution even now. It also depends on which and how many refrigerants are added. This is why the industry is making complaints and requesting that the MFDS should suggest the type and number of refrigerants and containers used that are not too heavy, not too expensive, and have good temperature control for 24 hours. This is the result of overlooking the fact that it takes a lot of money and a long preparation period to prepare a perfect cold chain. More than 90% of pharmaceutical distributors are small and medium-sized enterprises (SMEs) that cannot afford to spend a lot of money on the cold chain of biologics. However, the government implemented the revised regulations in just 6 months since it was announced, in a hurry to implement the regulations within the year. Faced with backlash from the industry, the authorities granted a 6-month guidance period, but the end of the guidance period is now less than three months away. The MFDS said it will include the details in the guidelines, but the problem is time. If the companies do not abide by the regulations, they will be subject to punishments starting on July 17th. There is not enough time for the authorities to rewrite and announce the guidelines and for the companies to complete preparations accordingly. The original purpose of strengthening the regulations for the transport of biological products was to enable the safe delivery of drugs that are directly related to the people's right to health. However, such hasty measures that are focused on administrative procedures and written deadlines leave much room for issues in the regulations that were made with good intentions. This is why the government should show patience and take the right steps step by step so as not to defeat the purpose of strengthening the regulations.
- Opinion
- [Reporter’s View] 1st oral abortion pill approval difficult
- by Lee, Hye-Kyung Apr 21, 2022 06:03am
- A year has passed since the decriminalization of the abortion ban has taken effect. The Korean Health and Medical Workers’ Union distributed a press release on the 11th on ‘ensuring safe abortion of the people 1 year after the decriminalization of abortion in Korea.’ The press release contained the request for marketing authorization of the oral abortion inducer Mifegymiso (Mifepristone·Misoprostol) and the preparation of an alternative legislation following the decriminalization of abortion under the criminal law in Korea. On April 11, 2019, the Constitutional Court made a constitutional discordance adjudication on the provision on abortion under the Criminal Act. The ruling took effect on January 1st, 2021, after which Hyundai Pharm applied for the marketing authorization of Mifegymiso in July of that year. Hyundai Pham has signed an exclusive marketing and distribution agreement for the supply of Mifegymiso in Korea with the UK-based Linepharma International. The drug is being used in 75 countries after the World Health Organization designated the drug as an essential medicine in 2005, The Ministry of Food and Drug Safety had assured expedited review of the drug to Hyundai Pham before the company applied for the marketing authorization of Mifegymiso. Since then, the drug went through a preliminary review process for 4 months from February last year, during which it was implied that the drug may be commercialized within the year with an expedited review. The Mifegymiso that Hyundai Pharm applied for is a combination pack that contains one 200mg Mifepristone tablet and four Misoprostol 200ug tablets. 10 months have passed since the marketing approval, but there is still no news of its approval in Korea, with the drug still under review. The MFDS is known to have requested supplementary data to Hyundai Pharm in the review process, but the company requested a postponement of the deadline for submitting supplementary data, which has rendered the approval schedule unpredictable. In addition, the need to create a legislative environment in which abortion drugs can be used stably was emphasized. As controversies continue to arise over the approval of the abortion drug, the MFDS is having trouble promptly proceeding with the approval of the product. In November last year, the MFDS and MOHW held an expert advisory meeting on the issue, but the meeting ended fruitlessly due to strong objections by obstetricians and gynecologists. While civic groups are urging for the prompt approval of Mifegymiso, the medical community, mainly the Korean Association of Obstetricians and Gynecologists, is pointing out the dangers of Mifegymiso and insisting that it must undergo a bridging study in accordance with the principle of drug introductions in Korea. In addition, it seems difficult for domestic pharmaceutical companies to expedite the marketing of abortion drugs in the absence of revisions to legislation such as the Criminal Act and Maternal and Child Health Act that would contain specific conditions and regulations for allowing abortions. Ultimately, it seems that the approval of the first abortion drug in Korea will not be granted until all controversies in legislation and safety are revised and resolved.
- Opinion
- [Reporter’s View] Patience is a virtue...for drugs?
- by Eo, Yun-Ho Apr 20, 2022 06:05am
- Price falls when supply increases. The same goes for the pharmaceutical market. Although the government can reduce fiscal spending by inducing competition between pharmaceutical companies, this would lead to a delay in NHI reimbursement listing. As we enter the era of high-priced drugs, the government has been exercising the ‘art of waiting.’ If new drugs of the same class apply for listing and the approval of its latecomer(s) is expected soon, it is not uncommon for the authorities to concurrently conduct reimbursement deliberations for the two, even three new drugs at once. The combination therapy using 'faslodex’ for breast cancer that was approved in 2019 was one example, and JAK inhibitors in atopic dermatitis and CGRP inhibitors in migraines are also being discussed in groups despite the different dates of their application submission. Due to the high price of the drugs, the government can let the market play its positive function and trigger pricing competition between the pharmaceutical companies. Fiscal savings through such measures under the NHI system can open up new opportunities as the savings can be used to improve coverage for the patients. But for drugs, time is of the essence. It would be optimal for all drugs of the same class to be approved and apply for listing at a similar period, but the reality isn’t so clear-cut. The application period often differs by 6 months to even 1 year at the most. Delays due to other factors can also play a role, but this difference in the ‘application submission period’ itself is also important. Also, the position of each pharmaceutical company may be sharply different. Companies that applied in advance desire independent evaluations as preoccupying the market by entering first is advantageous, apart from the price. Also, the clinical data issue remains. Even new drugs with the same mechanism of action can have different values depending on their indication and clinical results. The drugs' indications influence reimbursement standards and the value demonstrated by clinical data affects drug prices. Therefore, there is no real right answer to this issue. The government needs to well weigh the pros and cons. It’s not all about the numbers - the profits and losses – and the specificity of each drug needs to be considered. Therefore, all the stakeholders need to work together to reach a consensus on a rational solution that takes into account Korea's health insurance system and the ecosystem of Korea’s pharmaceutical industry.
- Opinion
- [Desk] R&D capabilities and Moonshot
- by Chon, Seung-Hyun Apr 19, 2022 05:52am
- Pfizer CEO Albert Bourla introduced Pfizer's COVID-19 vaccine development process through a recently published book called "Moonshot." Every step from the decision to develop a COVID-19 vaccine to clinical trials, large-scale production, and transportation was close to impossible, and it created a miracle with prepared R&D capabilities and judgment. In April 2020, Pfizer's researchers shared an aggressive plan to complete phase 3 clinical trials of the COVID-19 vaccine by the second half of 2021. But CEO Albert Bourla told employees, "We have to make a vaccine by October this year. And by next year, hundreds of millions of times, not tens of millions, should be able to be vaccinated," he said, calling for faster development of the COVID-19 vaccine. In a pandemic situation that the world has not experienced in 100 years, the CEO's bold drive alone did not produce successful results. The long-established R&D capabilities led to successful results in adventures that were considered near impossible. Pfizer has partnered with BioNTech two years ago to develop a flu vaccine using mRNA technology. It made bold investments in adventures that were not guaranteed success. Pfizer promised to pay $72 million in advance to BioNTech, an additional $563 million (680 billion won) depending on its performance, and purchased some of BioNTech's shares for $113 million (140 billion won). Pfizer and BioNTech agreed to share all development costs and profits from commercialization in half, but Pfizer decided to pay the entire development cost first. If the development of the mRNA COVID-19 vaccine fails, Pfizer is responsible for all losses, but if the vaccine development succeeds, it was an exceptional condition that BioNTech returned the development cost to Pfizer in the future. Pfizer's entire staff mobilized all their capabilities. In order to increase the success rate and speed of the development of the COVID-19 vaccine, clinical trials were conducted on various candidate materials at the same time, and the first inoculation was achieved 269 days after the development began. Pfizer compared the challenge of developing a COVID-19 vaccine to Moonshot, which originally means launching a lunar probe. This means that the development of the COVID-19 vaccine was an adventure that deserves to be evaluated as the greatest challenge in history. Last year, Pfizer's global sales nearly doubled from the previous year to $81.3 billion. It raised 44 trillion won only with COVID-19 vaccines and treatments. Multinational pharmaceutical companies that have succeeded in developing COVID-19 vaccines such as Moderna, AstraZeneca, and Johnson & Johnson have also realized high performance. R&D capabilities were compensated by financial performance. In Korea, SK Bioscience's long-standing know-how in vaccine development led to improved performance. SK Bioscience's sales amounted to 929 billion won last year, more than quadrupled from 225.6 billion won in 2020. Operating profit soared 12 times from 37.8 billion won to 474.2 billion won. SK Bioscience has invested a total of 400 billion won since 2008 to develop vaccines. L HOUSE, a vaccine factory built in Andong, Gyeongsangbuk-do in 2012, is a key infrastructure for SK Chemical's next-generation vaccine business. Since its launch, Samsung BioLogics has also built the world's largest biopharmaceutical factory with vigorous investment and has achieved the results of consignment production of Modena's COVID-19 vaccine as well as antibody treatments from multinational pharmaceutical companies. Of course, domestic companies did not achieve phenomenal results such as Pfizer and Moderna, but they also contributed to the domestic supply of COVID-19 vaccines and were compensated for their performance through prepared biopharmaceutical manufacturing know-how. Many domestic pharmaceutical bio companies are still focusing their R&D capabilities on developing global new drugs as well as COVID-19 vaccines and treatments. If R&D capabilities are quietly expanded and efficient investments are made, it is hoped that domestic companies will be able to achieve Moonshot someday.
- Opinion
- [Reporter's eyes] Despite Tessentrick's high sales
- by Apr 15, 2022 06:03am
- According to Roche audit report, the company recorded sales of 343.9 billion won and operating losses of 69.6 billion won last year. Sales fell 22.5% year-on-year, and operating losses increased. This is the first drop in sales in 10 years for Roche Korea, which has increased its sales every year. It is the largest deficit in 10 years. Roche Korea has blockbuster products like anti-cancer drugs. Based on IQVIA, a pharmaceutical research institute, two of the top 10 best-selling drugs in Korea last year were Roche products. Avastin recorded 112.3 billion won in sales and Perjeta 93.9 billion won in sales. Sales of Tecentriq, an immuno-cancer drug, also amounted to 67.2 billion won, and Herceptin's sales amounted to 65.3 billion won. Roche Korea has a risk-sharing contract with the NHIS for Kadcyla, Perjeta, Herceptin, and Tecentriq. It is a contract in which the company refunds the amount of medication equivalent to the excess amount to the corporation during the agreed period. Each year, the company calculates the estimated amount of the risk-sharing refund as unpaid expenses and deducts it from sales. Last year, the estimated risk-sharing refund set by Roche Korea was1942 billion won and the amount paid was 77.2 billion won. An additional 200 billion won in refunds was incurred alone. The remaining amount of refunds at the end of the year reached 178.5 billion won, including 61.6 billion won, the basic amount. In terms of figures alone, they have to pay more than half of Korea's total sales. The refund amount of Roche was not large from the beginning. It was enough to cover 9.4 billion won at the end of 2017, 31.7 billion won at the end of 2018, 49.9 billion won at the end of 2019, and 61.6 billion won at the end of 2020. Then, the amount of refunds increased sharply last year, increasing the company's burden. How the pharmaceutical company set the ratio of refunds with the government is private. However, the industry views Tecentriq's influence highly. The government accepted the government's proposal to share Tecentriq, generic for immuno-cancer drugs, to quickly enter the market, which may have made it difficult for Roche. At the time of Tecentriq's registration, Roche Korea was the only company with immuno-cancer drugs to accept the government's proposal to "burden pharmaceutical companies for the initial three-cycle medication cost." It also accepted the proposal of an "initial treatment refund type" that refunds the administration for an initial period of time depending on whether or not the patient responds to the expansion of the benefit. Therefore, there was also a story about Tecentriq that "the more you sell, the more you lose." Thanks to this, Tecentriq was able to quickly increase its market influence, but the company cannot be amused by the rapidly increasing amount of refunds. Since Roche does not make drugs by itself, but buys and sells finished products from its headquarters, the amount of refunds accumulated in hundreds of billions of won is a loss. Fortunately, Roche Korea's financial condition is very good. As of last year, cash and cashable assets amounted to 82.9 billion won, and retained earnings amounted to 135 billion won. In other words, the refund is still "at a level to cover." However, if the refund occurs nearly 200 billion won every year, financial stability is likely to falter. Last year, 1942 billion won was generated, and the debt ratio increased sharply. The debt-to-equity ratio of the company, which stood at 89% in 2020, stood at 203% at the end of last year. Roche Korea is trying to revise the refund conditions in the RSA renewal negotiations. However, due to the nature of immuno-cancer drugs, it is not easy to change the conditions already accepted once in favor of pharmaceutical companies at a time when there are many indications to negotiate the expansion of benefits. This is why Roche's concerns are deepening.
- Opinion
- [Reporter’s View] Deleting exemptions for industry dev.
- by Lee, Jeong-Hwan Apr 07, 2022 06:10am
- Until now, the pharmaceutical authorities had partially exempted the safety and efficacy review for ETCs and OTCs listed on drug formularies of 8 advanced countries – the US, Japan, UK, Germany, France, Italy, Switzerland, and Canada - for the prompt introduction of drugs to Korea. This special exemption system for drugs listed in foreign drug formularies was introduced and operated to promote domestic drug approval and production in 1970 in consideration of Korea’s relatively low drug development capabilities then. For the past several years, the system has been repeatedly criticized for impeding the development of the pharmaceutical industry and increasing unnecessary waste of health insurance finances, and there is little need to maintain the system. The Ministry of Food and Drug Safety accepted the National Assembly’s request for discontinuation of such special administrative measures and the regulation that exempts part of the data required for ETC and OTC drug approvals will be deleted from November this year. As a result, the safety and efficacy hurdle for OTC and ETC drugs listed on foreign drug formularies will be raised somewhat compared to now. The domestic industry and MFDS should use the amendment as a turning point to increase the quality and safety level of drugs in Korea. Breaking away from the past when the drugs were more leniently approved just because they were used in advanced countries, the regulatory environment should be restructured in which pharmaceutical companies directly generate and submit safety and efficacy clinical data, and the MFDS reinforces its review expertise in granting marketing authorizations. The Korean pharmaceutical industry today has secured competitivity by improving its own capabilities and even some global competitivity. In addition, the domestic pharmaceutical industry now bears the fate of needing to continuously evolve and develop as the new growth engine and national key industry. Based on the competitivity acquired in the pharmaceutical industry, experts believe that the government should generalize the verification process without exempting approval and review data for drugs taken by the people in Korea to further foster basic growth of the pharmaceutical industry and increase the possibility of development. In addition, more meticulous verification of the efficacy and safety of ETCs that are granted marketing authorization should be made for the more efficient management of health insurance finances. Some have raised the concern that non-essential regulations may be added due to the deletion of the special regulations for drugs listed on the foreign drug formulary, but it is predicted that the domestic pharmaceutical industry and approval and review authorities will be able to discover and approve effective and safe drugs based on the capabilities it had built until now. In 2020, in response to the NA’s criticism regarding the special exemption system for drugs listed in foreign drug formularies, the MFDS Minister at the time, Eui-Kyung Lee, had answered that “The domestic industry has enough expertise to conduct review and assessments..” With the revised regulations this time, it is the reporter’s hope that the pharmaceutical companies prepare data for pharmaceutical approvals based on scientific evidence, and that the MFDS strengthen the drug review environment through self-reviews to strengthen quality-based drug approvals and public trust.
