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- 2026-05-15 21:38:31
- Company
- 1 in 3 don't know the right dose of antipyretic drugs
- by Apr 20, 2022 06:05am
- With COVID-19, 9 out of 10 consumers have purchased antipyretic drugs within the past six months, but one in three still does not know the appropriate dosage, indicating that appropriate medication guidance is needed. Johnson & Johnson Korea announced the results of a survey conducted on 1,000 consumers aged 20 to 49 in Korea on the 18th through Open Survey, a domestic research company. The survey was designed to find out whether consumers are aware of the right dosage and information, and what factors affect purchase frequency, purchase purpose, and purchase as the demand for home remedies, including antipyretic analgesics, increases due to COVID-19 home treatment. According to the survey results, 9 out of 10 consumers (90.5%) of consumers aged 20 to 49 had experience purchasing antipyretic drugs (including emergency medicines such as comprehensive cold medicines) within the past six months. More than half (57.6%) of them felt that the frequency of purchasing antipyretic painkillers increased this year when home treatment began in earnest. As for "Who is the most recently purchased antipyretic pain reliever (including OTC cold medicine) for?" more than half, 50.3%, said they purchased it for "the whole family." 31.7% of the respondents said they did not know the appropriate dosage of antipyretic analgesics they usually take. Young people tended not to purchase specific brands. Six out of 10 (61.9%) said they did not know whether the antipyretic drug brand they usually buy was an original or generic drug. In addition, 78.7% of the respondents said they considered the "effect" the most important thing when purchasing antipyretic drugs, followed by safety (49.2%), brand (33.5%), ease of purchase (20.7%), and price (16.5%). As a result of the survey on "What is the original drug antipyretic pain reliever you know", 89.8% chose "Tylenol". 58.6% of the respondents chose "intention" to buy original medicines for those who have purchased antipyretic drugs within the past six months. Among the reasons for thinking that way (multiple responses), "safety data accumulated as long as they were sold (72.7%)" and "confidence given by original" (70.4%) were the most common. In particular, 78.9% of them said that originality is more important when purchasing medicines than general foods. The intention to purchase the original medicine was especially evident from consumers aged 20 to 49 who said they had purchased antipyretic drugs. An official from Johnson & Johnson Korea said, "The antipyretic pain reliever such as comprehensive cold medicines, has become a must-have item in the home, with 90.5% of consumers aged 20 to 49 saying they have purchased within six months." He said, "It is encouraging that interest in proper dosage is increasing as the demand for antipyretic drugs increases, but one in three people still say they do not know the proper dosage, so we will continue to work hard to provide consumer information such as medication guidance." Source: Johnson & Johnson, Korea
- Company
- Hanmi leads the outpatient prescription market in Q1 2022
- by Chon, Seung-Hyun Apr 19, 2022 05:53am
- Hanmi Pharmaceutical’s performance stood out in the outpatient prescription market with its solidified lead heralded by the introduction of its new combination drug. Daewon Pharmaceutical’s prescription volume has also soared vertically due to the boom in anti-inflammatory and cold medicines following a surge in the number of confirmed COVID-19 cases. Other major pharmaceutical companies also showed an increase in sales performance due to an increase in demand for COVID-19 symptom relief medications According to the pharmaceutical research institution UBIST on the 18th, Hanmi took the sole lead among pharmaceutical companies in Korea and abroad in outpatient prescriptions with ₩194.3 billion in Q1 this year. This is an 11.8% growth from the ₩173.89 billion in Q1 last year, and a ₩45.5 billion difference from the runner-up Chong Kun Dang. Also, this is an ₩80 billion difference with the No.3 Daewoong Pharmaceutical. Hanmi Pharmaceutical took this lead in the prescription drug market using its new combination drug. Prescriptions of Hanmi’s combination drug for hyperlipidemia, Rosuzet, increased 13.1% from Q1 of the previous year to record ₩32.7 billion. Rosuzet is a combination of ezetimibe and rosuvastatin that was released at the end of 2015. Rosuzet has made rapid growth every year since recording ₩24.3 billion in sales in 2016. Rosuzet has recorded a ₩10 billion range of prescriptions for 10 consecutive months since June last year. Hanmi’s leading new combination drug, the Amosartan family, has also shown continued growth. Hanmi has been selling its amlopidine and losartan combination Amosartan as well as Amosartan Plus, Amosartan Q, and Amosartan XQ. Amosartan Plus is a combination of three drugs, amlodipine, losartan, and chlorthalidone. Amosartan Q is a combination of Amosartan and the hyperlipidemia treatment rosuvastatin. Amosartan XQ is a combination of Amosartan, rosuvastatin, and ezetimibe that was released last year. Prescription sales of Amosartan, Amosartan Plus, Amosartan Q, and Amosartan XQ have increased 5.8% from the previous year to record ₩31.9 billion. Prescription performance of Amosartan rose 2.4% from the previous year to ₩21 billion, and Amosartan Plus rose 3.8% to ₩7 billion. Amosartan Q, Amosartan XQ also recorded ₩2.8 billion and ₩1.1 billion each. Sales of the antiulcer drug Esomezol rose 12.0% to ₩13.5 billion in Q1 this year. Prescription of Hanmi’s drugs that were used to relieve COVID-19 symptoms such as Clari, Suspen 8 hours, and Maxibupen has also increased greatly. Chong Kun Dang has ranked No.2 with prescriptions of ₩148.8 billion in Q1. However, its gap with the No.1 in the ranks had widened with its performance reduced by 4.7%. Daewoong Pharmaceutical has ranked No.3 with prescriptions of ₩114.1 billion, which was a 6.5% increase from the previous year. Prescriptions at major pharmaceutical companies have generally increased from Q1 last year. 15 of the 20 top companies have shown growth in prescriptions compared to the same period last year. In particular, Daewon Pharmaceutical's growth stood out among the companies. Daewon Pharmaceutical's outpatient prescription sales in the first quarter amounted to ₩83.8 billion, up 25.5% from the previous year. It surpassed the ₩82.8 billion recorded in Q4 2019 for the first time in 9 quarters and made a new record. The increased demand for anti-inflammatory and cold drugs due to the recent surge in the number of confirmed COVID-19 patients has led to this upward trend in prescriptions for Daewon Pharmaceutical. The anti-inflammatory analgesic Pelubi’s sales grew 22.0% from the previous year to record ₩9.5 billion in Q1. This is the largest record made since its release in 2007. Daewon’s original new drug Pelubi is a non-steroidal anti-inflammatory analgesic used for osteoarthritis and back pain. The upsurge in the number of confirmed COVID-19 cases has increased the demand for anti-inflammatory analgesics, increasing prescriptions of Pelubi as well. Prescriptions of Daewon’s cold medicine Codaewon have also increased greatly. Prescriptions of Codaewon S in Q1 this year were ₩6.4 billion, a 253.6% increase from the ₩1.8 billion recorded last year. Codaewon Forte’s sales have also increased twofold from the ₩2.9 billion last year to ₩5.6 billion in Q1 this year. Codaewon S is used to improve signs and symptoms of acute bronchitis and Codaewon Forte is indicated for coughs and sputum. Celltrion Pharm, Daewoong Bio, Hutecs, Boryung, and United Pharma Korea’s prescriptions have increased by over 10% in Q1 compared to the same period of the previous year. The surge in demand for COVID-19 symptom relief drugs such as cold drugs and anti-inflammatory analgesics are analyzed to have led to the improvement in prescription performance. On the other hand, the prescription volume of Chong Kun Dang, Viatris, Dong-A ST, Jeil Pharm, and Il Dong Pharmaceutical had decreased from the previous year.
- Company
- The prolonged slump in IPO of pharmaceutical bio
- by Kim, Jin-Gu Apr 19, 2022 05:52am
- Amid the prolonged sluggish trend in the IPO market in the pharmaceutical bio industry, attention is being paid to whether newly challenged companies will be able to draw a turnaround. According to the pharmaceutical industry on the 19th, there are two pharmaceutical bio companies that have been listed in the second quarter of this year, Wonteg and RP BIO. On top of that, Immunemed, Lunit, and Shaperon have proposed listing on KOSDAQ within the first half of the year. However, they have not yet been approved for a preliminary screening of the listing. RP BIO passed a preliminary review for listing on KOSDAQ on the 14th. It has been about four months since it filed a preliminary review in December last year. RP BIO is a manufacturer of soft capsule-type medicines and health functional foods. Its sales and operating profit last year were 114.9 billion won and 5.8 billion won. The largest shareholder is Yoon Jae-hoon, the second son of honorary chairman Yoon Young-hwan, founder of Daewoong Pharmaceutical. Prior to this, On the 31st of last month, Wonteg received approval for a preliminary review. It submitted a securities report on the 1st of this month. Wonteg is pushing for listing on KOSDAQ through a merger and acquisition of SPAC. Wonteg is a company that manufactures and sells laser and ultrasound medical devices related to skin beauty. On the 25th, Wonteg is raising the mood by announcing IR events related to listing. The pharmaceutical bio industry is paying attention to whether the two companies will be successful in IPO. Given that the IPO of pharmaceutical bio companies failed to make a hit in the first quarter, attention is growing on whether it will continue its sluggish trend in the second quarter or succeed in reversing the atmosphere. Three pharmaceutical bio companies listed this year are said to have failed to make a hit. Ad Biotech, which was listed in January, and Noul, which was listed in March, were decided to have a lower public offering price than Hope Band. BiofDNC, which was listed in February, has remained lower than the public offering price until recently after its stock price plunged on the first day of listing. As the pharmaceutical bio IPO market shrinks, more and more companies are giving up listing in the middle. In March, Boronoi submitted a report to the Financial Supervisory Service to withdraw its listing. Boronoi even received approval for listing, but temporarily suspended its listing plan as it failed to predict demand. KMRI, Finemedix, and FutureMedicine also voluntarily withdrew at the preliminary screening stage for listing. In the first half of last year alone, eight companies were newly and previously listed through corporate disclosure. Starting with PBPharma, Prestige Biologics, NeoImuneTech, Biodyne, SK Bioscience, HPO, GeneSystem, and ADM Korea debuted. Most of them were successful in box office. SK Bioscience succeeded in publicizing 1.4918 trillion won when it was listed on the securities market in March last year. Institutional investment conducted prior to listing recorded a competition ratio of 1275.47 to 1. In the subscription for general investors, more than 63 trillion won of evidence was collected. The industry believes that the sluggish IPO market has been affected by a combination of rising U.S. interest rates, the sluggish domestic stock market atmosphere due to the Ukrainian war, and weak investor sentiment in the bio industry. Another reason is that there are no large pharmaceutical bio companies that are about to be listed. This is in contrast to the consecutive listing of large pharmaceutical bio companies such as SK Biopharm two years ago and SD BioSensor, Inc·HK inno.N last year.
- Product
- Immunity products fare better “targeting the long COVID mkt
- by Apr 19, 2022 05:52am
- The OTC drug trend at pharmacies is changing. Compared to February and March when the Omicron variant had wielded power over the country and sales at pharmacies increased due to a surge in demand for antipyretic analgesics and sore throat treatments, etc., sales of products related to long-term effects of COVID-19 are now increasing due to more and more people complaining about COVID-19 aftereffects. Purchase and requests for general OTC drugs at pharmacies for coughs, chest pain, loss of appetite, fatigue, lethargy, and nutritional supplements have increased among patients who overcame COVID-19. Pharmacist A said, “With the COVID-19 wave subsiding, sales from prescriptions for confirmed patients and sales of OTC drugs have decreased significantly. The number of prescriptions for confirmed patients has drastically decreased to 1/5-1/6, and the number of customers purchasing related OTC drugs has also decreased significantly. These days, more and more patients visit pharmacies to buy drugs or consult about their COVID-19 aftereffects. The number of new confirmed cases has decreased to 47,743 on the 17th, with the number of patients treated at home falling under a million as of midnight on the 18th to 742,367. Pharmacist A said, “Since many patients complain about continued sore throat or coughs, OTD drugs such as Yonggaksan, Troche products, and herbal medicines are relatively popular.” An official from a pharmaceutical company that produces herbal medicines said, “Sales of our products surged in February and March due to COVID-19 sore throat symptoms and continue to stay strong in April. I think the interest in herbal medicine has increased due to the need for long-term intake.” Also, pharmacist A explained that inquiries and counseling on nutritional supplements or nutritional tonics also continue with some younger and many older people complaining of fatigue, lethargy, and sleep disorders, Pharmacist B said, just like some clinics and oriental clinics have recently increased focus on COVID-19 recovery treatments, there are differences in products recommended by age and various products ranging from nutritional tonics and arginine that can provide instant symptom recovery to comprehensive nutritional supplements that can be taken long-term are being sold at the pharmacy." B continued, “Since the aftereffects experienced by patients vary greatly, patients with more severe symptoms purchase more expensive products such as Gongjin-dans and Kyungo-gos. We have also been recommended health functional foods related to long COVID symptom relief to our customers.” Also, YouTube videos related to long COVID are recording more views recently. From instructions on taking high-dose vitamins to specific videos that recommend products directly purchased from overseas, lots of drugs and health functional foods are being presented as being good for COVID-19 after-effects in the media, and pharmacists voicing that “it is important to properly know about each drug for proper intake.” Pharmacist Ji-Hyan Lee recently said in YTN Radio's ‘Wise Radio Life’ corner, "Being infected with COVID-19 is like catching a big fire. Even if it is incinerated, fire residues and debris remain. You have to take care of yourself for at least 3 months, and above all, it is important not to overwork and pace yourself well.” Pharmacist C said, “Symptoms such as cough and phlegm can improve relatively quickly, but recovery from dizziness or lethargy can be slow or difficult. Therefore, it is important to raise your immunity on a daily basis, and manage your hygiene and immunity as well as tend to your lifestyle and dietary habits.”
- Policy
- MFDS requested supplementary data of Mifepristone
- by Lee, Hye-Kyung Apr 19, 2022 05:52am
- 'The MFDS is conducting a comprehensive review including the need for Bridging Study data. A year and four months have passed since the abortion crime was abolished, but drugs that have been applied for permission by domestic pharmaceutical companies are still being reviewed. According to the press release of the MFDS on the 18th, the MFDS requested the submission of supplementary data of Mifepristone applied by Hyundai in July last year. The MFDS said, "We asked the company to submit supplementary data because we needed to supplement some data during the screening process, and the company has requested a postponement of the deadline for submitting supplementary data." At the Central Pharmaceutical Review Committee held last year, the need for a Bridging Study clinical trial to verify safety and effectiveness by conducting clinical trials on Koreans again was discussed, but the MFDS has yet to give specific opinions. At the time, the Korean Association of Obstetrics and Gynecology said that the Bridging Study should be conducted, but most members reportedly concluded that the Bridging Study clinical trial was unnecessary. Accordingly, the MFDS said, "We are comprehensively reviewing the data submitted by the company, including whether or not bridging study data is necessary," adding, "It is difficult to answer because the approval schedule cannot be predicted." Regarding the criticism that obstetricians and gynecologists were excluded from the committee, the committee held last year said that obstetricians attended the committee as members The MFDS explained, "When the Central Pharmaceutical Center was held, obstetrics and gynecology specialists were also present as members in accordance with related regulations, and the Korean Association of Obstetrics and Gynecology attended and submitted opinions." Regarding the drug item license and safety use plan, the MFDS said, "Check safety, effectiveness, and quality, and use it safely during the examination process, and we will come up with measures such as educational materials for experts and patients and post-marketing investigations to ensure that abortion drugs can be used in a legally stable environment, and we will actively support the National Assembly's law revision process. On April 11, 2019, the Constitutional Court made a constitutional nonconformity decision on the abortion of the criminal law to respect women's right to self-determination of the body, and the abortion crime has been invalidated since January 1 last year.
- 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.
- Company
- Pharmaceutical industry starts face-to-face marketing
- by Kim, Jin-Gu Apr 18, 2022 05:58am
- As the government decided to completely lift social distancing measures from today (18th), the pharmaceutical bio industry is also actively planning offline marketing events. As large-scale offline events have been virtually impossible for nearly two years, marketers are raising expectations for changes caused by the move. ◆ Abolish social distancing in 2 years On the 15th, Prime Minister Kim Boo-kyum announced that social distancing will be lifted from the 18th through a meeting of the COVID-19 Central Countermeasure Headquarters held at the Seoul Government Complex. After today, the limit on the number of private gatherings and restaurant business hours will be removed. It is the first time in two years and one month that the social distancing guidelines are completely lifted. The pharmaceutical bio industry welcomes this measure. This is because offline marketing events have been virtually impossible due to restrictions on the number of private gatherings. There are also notable places that are preparing for a large-scale event next month. Boryung is planning a symposium on the launch of 'Dukarb Plus' next month. Dukarb Plus is the seventh product of Boryung's Canarb Family. An official from Boryung said, "We are preparing for a launching symposium at a hotel in Seoul next month," adding, " we are planning various offline symposiums and seminars for each business headquarters." The offline Dukarb Plus launch symposium contrasts with the online launch symposium when Dukaro and Akarb were released two years ago. Boryung held the Dukarb launch symposium online for the first time in the industry in March 2020. This web symposium was a great success with 2,500 medical staff accessing at the same time. In September, Akarb was released and similarly opened a web symposium. ◆ Pharmaceutical industry is planning to hold offline events in earnest in the second half of the year Other companies have similar situations. Although the timing of the resumption of offline symposiums, seminars, and product briefings are different, expectations are high that more active offline events will be possible by lifting social distancing measures. A marketing manager at a large pharmaceutical company said, "Since the beginning of this year, social distancing measures have been loosened little by little, and small product briefings have been sporadic," adding, "If the distance disappears, offline events will be more active." Another official from a large pharmaceutical company said, "We have focused on online marketing so far," and predicted, "Marketing activities such as symposiums, seminars, and product presentations will be carried out in a way that combines online and offline." Small and medium-sized pharmaceutical companies are even more pleased with the move. A marketing manager at a small and medium-sized pharmaceutical company said, "In the case of large pharmaceutical companies, they created their own online platform and carried out marketing activities, but small and medium-sized pharmaceutical companies failed to do so," adding, "We plan to actively carry out offline marketing events from the end of this month." ◆The workshop that has been postponed for two years is also moving to resume, "following the company's guidelines Internal events such as workshops and company dinners are also being resumed. However, it is confirmed that it is approaching somewhat more carefully than offline marketing events. An official from the pharmaceutical industry said, "Most of the workshops over the past two years have been replaced online or canceled altogether." Although no official company-level guidelines have been issued yet, offline workshops and dinners are expected to resume soon, he explained. An official from a multinational pharmaceutical company said, "It was like that before, but we will carry out offline activities according to the company's guidelines," adding, "Until now, offline events, whether internal or external events, have been completely banned. In the future, it is expected that it will be changed in a way that combines online and offline." Another multinational pharmaceutical company official said, "There is no immediate change," and predicted, "However, as distancing has been lifted from the second half, restrictions are expected to disappear in the stage of preliminary review or preparation."
- Company
- DHP Korea faces reimb. reevaluations for its HA eye drops
- by Nho, Byung Chul Apr 18, 2022 05:58am
- How DHP Korea, a company specializing in eye drops, will be establishing a strategy to defend its sales ahead of the upcoming reimbursement reevaluations for its HA (hyaluronic acid) products next year is drawing attention. In particular, this upcoming risk is highly likely to serve as a testbed to verify the company’s newly appointed CEO Eunyoung Park’s ability in crisis management and the creation of new growth engines. Eunyoung Park, who was formerly the SSK business unit head of Zuellig Pharma, was appointed head of DHP Korea last month. One key point of concern is whether the Health Insurance Reimbursement and Assessment Service’s reimbursement reevaluations would result in partial reimbursement cuts or large-scale reimbursement deletions, depending on which the company’s loss in sales would vary significantly. DHP Korea made sales of ₩57.3 billion in 2021, among which ₩34.1 billion was from reimbursed eye drop products. The other ₩23.1 billion was from CMOs and other deals. The external growth of HA eye drops accounted for ₩25.1 billion, 43% of the company’s total sales and 73% of the company’s sales from eye drops. This concentration on HA eye drops is why the reimbursement reevaluation of sodium hyaluronate eye drops by HIRA that is scheduled next year is foreshadowing a huge blow to DHP Korea's performance, regardless of whether it results in reimbursement cuts or deletions. DHP Korea’s key product, HA eye drops, had recorded its peak sales in 2020 at ₩30.4 billion, then fell to ₩5 billion last year. Other than Tearin F (₩1.2 billion→₩2.4 billion), Tearin S (₩2.8 billion→₩2.2billion), Tearin Free (₩14.3 billion→₩8.8 billion), and Tearin P (₩11.9 billion→₩11.5 billion) all showed negative growth. DHP Korea said, “Nothing has been determined yet on whether the reimbursement evaluations on sodium hyaluronate eye drops will be deleted or reduced. We will seek a strategic breakthrough after examining how it goes."
- Policy
- Reimb. suspension on rebate drugs unconstitutional
- by Lee, Tak-Sun Apr 18, 2022 05:58am
- 박성민 변호사 A claim that applying the reimbursement suspension system on illegal rebate drugs that had been abolished in 2018 to acts that had been made before the law was revised can be unconstitutional has been raised. Due to unreasonable aspects of applying the existing law, the claim is that it is more reasonable to retroactively apply the law revised in 2018. Lawyer Seong-min Park at HnL law firm explained so at the monthly academic conference of The Korean Society of Law and Medicine that was held on April 16th. At the virtual conference, Park reviewed the ‘unconstitutionality of the insurance reimbursement suspension disposition applied under the National Health Insurance Act,’ and announced that the decision to suspend reimbursement for rebates caught before September 2018 violates the principle of prohibition of penalty surcharges or the principle of equality presented under the Constitution. The reimbursement suspension dispositions on drugs caught with illegal rebates had been first made in May 2017 after the system was introduced in 2014. However, due to concerns over hindered patient accessibility and side effects that arise from substituting drugs for non-medical reasons, the government revised the law to impose price cut dispositions rather than reimbursement suspensions in 2018. However, the government has applied the old law and issued reimbursement dispositions to acts of rebates that arose before September 2018, raising controversy. Park said, “The National Health Insurance Act revised as of 2018 does not stipulate which law to apply for rebates made before September 2018, however, the administrative agency has been issuing reimbursement suspension dispositions.” He added, “The retroactive application of the law, in particular, retrospective application of administrative laws is generally against the rule of law and therefore is not accepted as it unfairly infringes upon individual rights and freedoms and threatens the stability of living by the law. However, retrospective application of laws and ordinances is permitted as an exception in cases where there is no direct relationship to the interests of the general public or when the interest is rather advanced or eliminates disadvantages or suffering.” This is in accordance with the Supreme Court precedent that was made in May 2005 (Ruling No: 2004다 8630). He said, “We can’t definitively conclude that reimbursement suspensions are more advantageous than drug price cuts for the pharmaceutical companies. If the company clearly states it prefers price cuts over reimbursement suspensions, the protection of trust on the company’s part is rendered unnecessary, and the retroactive application of price cuts is therefore allowed as it can advance the interests of patients, doctors, pharmacists, health insurance finances, and pharmaceutical companies." In other words, the retroactive application of the revised law is reasonable even for rebates that occurred before September 2018. If the upper limit of fines is applied under the old law, the company may request a 40% penalty for one year of its sales rather than a suspension of reimbursement, and the authorities may exercise discretion. Park added that even if the law that was revised last year is applied, the company may request to receive a large fine that is applied for third violations under the current law rather than a reimbursement suspension, on which the authorities can also exercise discretion. Park said, “By substituting reimbursement suspensions to fines for lowest-priced drugs, the company may be subject to monetary sanctions through fines. Also, the price of drugs that are not lowest-priced can be effectively reduced by inducing voluntary drug price cuts, which can effectively result as same as drug price cut dispositions.”
- Policy
- Utilizing RWD for Re-evaluation of Old Drugs
- by Lee, Hye-Kyung Apr 18, 2022 05:58am
- Discussions were conducted at the Central Pharmacist Review Committee on the criteria for clinical re-evaluation of items licensed on the basis of foreign drug formulas without efficacy evaluation. The drug was Hanall Biopharma's "Blistop (p-Aminomethyl Benzoic Acid)" and was approved on May 16, 2001, and its efficacy expired on April 1. At the time of approval, Blistop was awarded to the eight major foreign drug formularies, allowing item approval without clinical data. However, with the recent revision of the permit regulations, it is impossible to permit drug formalities alone, and efficacy evaluation standard of "old drugs" used in the field for decades without efficacy evaluation has become controversial. According to the minutes of the committee's "Advice on the adequacy of drug item renewal" held by the MFDS on the 29th of last month, it was very difficult to prove its effectiveness through clinical re-evaluation. The MFDS said, "The items licensed based on foreign formularies have already been used in clinical sites for decades, and what to do with efficiency evaluation is a problem in the renewal of Old Drugs." "In consideration of not only clinical re-evaluation but also the use of RWD, we will only recognize the efficacy that can prove its validity through protocol review and approval procedures," he explained. Currently, the company has submitted opinions on clinical re-evaluation, and the MFDS is considering various methods such as clinical trials as well as post-marketing clinical trials. In this regard, a member said, "In the situation where there are differences in permission for each drug used for hemostasis, Blistop is well used so far in clinical sites," adding, "Since there is no significant adverse reaction, it is reasonable to give opportunities according to the company's will." Another member suggested, "It is difficult to objectively judge the validity of all drugs approved in the past. The MFDS needs to ease regulations on Old Drugs and prioritize safety evaluation over efficacy." It is unreasonable to impose restrictions on drugs that have been used for a long time since there is no safety problem, and the effectiveness is evaluated in the market, and drugs that are not effective will be eliminated in clinical practice. However, the MFDS agrees that the need and use in the market can naturally induce eviction, but there is a limit to maintaining permission as it is effective in the absence of clinical data as foreign formularies, the basis for licensed drugs, disappear. At the meeting that day, it was decided to renew the p-Aminomethyl Benzoic Acid item on the premise of validation.
