- LOGIN
- MemberShip
- 2026-07-22 13:35:22
- Opinion
- [Reporter’s view]Dilemma of salesperson suicide & reporting
- by Eo, Yun-Ho Feb 03, 2020 06:23am
- Sad things happen constantly. In the past year, four salespeople who worked for a multinational pharmaceutical company took their own lives. This is the minimum number known and confirmed. The circumstances of the company and the extreme choices are different. However, the common point was that the reason for suicide was 'the company they worked for'. The reporting of suicides is tricky and uncomfortable for the media and journalists. The media needs to be cautious in reporting. Dailypharm also did not cover all four incidents. Even if reported, the first article is written with a level of communication that excludes interpretation and presumption. Nevertheless, the dilemma for the report itself remains. This is because of the heart of the bereaved family after the deceased. Of course, there are many cases where the bereaved family wants to be articled with appeal. Rather, the indifference of the press sometimes hurts them. On the other hand, but if they don't want their family to be exposed to someone they don't know about, or that someone around them might be able to guess the deceased, apart from the legitimacy of reporting, I think that ethical consideration is necessary. Certainly we shouldn't 'use' death badly, but if they have a 'reason' of extreme choice and a story they want to tell, we should listen to it. In addition, the media should add strength in raising awareness to prevent such tragic accidents from recurring. Suicide is linked to sorrow and interests. Confrontation between the union and the company intensifies, They continue to fight who is responsible for death. Even if the choice of the deceased was caused by performance pressure and staff reduction, it is another story to conclude this with the company's "imputation". So the press should be an observer. Based on the story of death, the media should listen to the labor and management's arguments and let them know that there are media that watch the fighting's conclusions and follow-up. Once again, I pray for the deceased's condolences and hope that suicide in the pharmaceutical industry will never happen again.
- Opinion
- [FOCUS] 10 ‘global new drugs’ promised 10 years ago
- by Chon, Seung-Hyun Jan 15, 2020 06:28am
- In 2011, the government formed Korea Drug Development Fund (KDDF) to provide inter-ministerial level support for developing new drug. Ministry of Science and ICT (MSIT), Ministry of Trade, Industry and Energy (MOTIE) and Ministry of Health and Welfare (MOHW) laid down a plan to develop more than ten global-level new drugs by investing on R&D together. The initial plan was to invest 1.6 trillion won for ten years until 2020 (530 billion won by the government, 530 billion won by private investment). According to the plan, Korea should be able to release ten new drugs by the end of this year. But it seems unrealistic at the moment. Considering Korea’s pharmaceutical and bio industry’s reality, the barrier of global market was too high. When Hanmi Pharmaceutical signed a series of giant license-out deals on investigational technology in 2015, the Korean pharmaceutical and bio industry was exhilarated. Everyone celebrated the advancement Korea has achieved in pharmaceutical and bio sector. But the excitement did not last long. For a long while, no other news of notable out licensing deals was reported. And when a few of licenses were returned to Hanmi Pharmaceutical, the industry’s rosy dream subsided. In fact, many were skeptical about the exaggerated expectation on the industry. Only then, more voices spoke out about keeping the head cool. In hindsight, more realized the Korean pharmaceutical and bio industry’s landscape has not been progressing, except for the exceptional performance by Hanmi Pharmaceutical. Since then, not only traditional pharmaceutical companies, but also bio ventures, such as Dong-A ST, Yuhan, SK Chemicals, SK Biopharmaceuticals, Legochem Biosciences, BridgeBio Pharma, Alteogen, and iNtRON Biotechnology, inked out licensing deals. Global pharmaceutical giants like AbbVie, Janssen, and Boehringer Ingel Heim shook hands with Korean companies. And Celltrion and Samsung Bioepis are now leading the global biosimilar market. Now the Korean industry is yet again dreaming on about drawing level with global pharmaceutical powerhouses. But the truth is we still have a long way to go. Last year, the U.S. Food and Drug Administration (FDA) cleared two new drugs by SK Biopharmaceuticals, but only five investigational drugs developed with Korean-made technology have passed the U.S. health authority so far. None of them reached the level, what would be viewed as ‘global commercialization success.’ Finished pharmaceutical product export in 2018 generated 3.40 trillion won, which was not even 20 percent of overall manufactured volume of 18.54 trillion won. Contrastingly, 4.89 trillion won of overseas finished products, significantly higher than the export, were imported in the same year. Finished product made in Korea used in Korea has gone down lower than the previous year to 75.6 percent. Some of Korean pipelines transferred to other global companies were dropped before reaching the commercialization stage. And in the near future, more out-licensed technologies are likely to be returned than successfully made into a finished product. Recent global drug development trend has more progressive new drugs proceeding faster than Korean pipelines. In some cases, technology development partner companies have lost interest in pursuing Korean companies’ pipeline with other similar candidate medicines available. Even worse, many Korean bio companies reported disappointing news of failed pipeline and clinical trials to their investors last year. Stock market was shaken by rumors spreading with mixed facts and hopes. Share price fluctuated from maximum to minimum limit for days. Obviously, it is possible for a Korean company to soon bring surprise news of making a big global success. But even so, it would mean outstanding performance of the company and not the whole Korean corporate R&D landscape’s. For last few years, Korean pharmaceutical and bio industry has experienced a series of trial and error. The ‘world’s first gene therapy’ turned out to have switched out active ingredient in production and its approval was revoked. Such ridiculous ‘trial and error’ should not be repeated again. Hopefully, this year would be the time for the industry to grow further based on the rough experiences. This year, probably, Korean companies would hear many stories of hopes and failures. And the entire industry should not be agitated or swayed by them. Instead of heightened anticipation, what we need is keeping it calm and moving forward.
- Opinion
- [Reporter’s View] At least a guideline for ‘class effect’
- by Eo, Yun-Ho Jan 03, 2020 06:33am
- ‘Recognizing expected efficacy of drugs with same mechanism of action.’ It is definitely an unresolved conundrum. Experts have clashing opinions and each pharmaceutical company has different interests. In the end, what it comes down to is ‘case by case.’ Not that it needs an answer key, but obviously the prescribing doctor’s decision based on experience and medical knowledge is important. The problem is consistency in applying healthcare insurance reimbursement. For some classes, the effects are recognized regardless of the approved label and equivalent reimbursement criteria are applied, but some other classes have different scope of labels approved. Reimbursement expansion on combination therapy of sodium-glucose cotransporter-2 (SGLT-2) inhibitor, currently pending without much of progress from 2018, would be a good example. As Korean Diabetes Association (KDA) failed to settle a dispute over expanding reimbursement on off-label anti-diabetic combination therapies including SGLT-2 inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione (TZD), the government that initially had intention to expand reimbursement on the off-label use, is now hesitant to take a further step. An odd phenomenon of the doctors opposing on expanding reimbursement is happening because of the dispute over class effect. Originally, it was the medical industry that started the discussion of providing reimbursement on anti-diabetic combination therapy. Apparently, doctors had experiences of confusion in prescribing as each drug in same class had different indications, and eventually had reduced reimbursement. In 2013, expanding reimbursement on combination therapy with DPP-4 inhibitor and TZD went through the same ordeal. However, the results were different. The medical industry valuing clinical evidence and expert’s judgment over approved label and financial impact was unprecedented as well. Class effects of DPP-4 inhibitor and SGLT-2 inhibitor, as stated by Korea’s reimbursement standard on orally taken anti-diabetic treatment, have been polarized so far. However, the possibility is still out there. Some expects positive outcome of a former professor at Seoul St. Mary’s Hospital, Yoon Kun-ho, elected as the president of KDA. The former professor used to actively demand for reimbursement on the combination therapy in 2013. We are talking about prescription drug. It doesn’t hurt to be careful. Some might say it better be rather careful. But, if their agenda is to recognize the class effect, then they should set a guideline on ‘required time for properly building up prescription experience, or prescription volume.’ There may be an expectation in the current situation, but there is no promise. If properties of disease are different, then a manual on class effect by each disease is essential. There is no need for the government to worry about the industry getting too confident about class effect and lazy on clinical trial. They know very well that abundant academic data is more powerful in the field than qualifying for reimbursement criteria.
- Opinion
- [Reporter’s View] Next year wishes for the industry
- by An, Kyung-Jin Dec 30, 2019 09:47pm
- “Last year, not one of Korean-made new drug was approved by the U.S. Food and Drug Administration (FDA). Ever since hemophilia treatment Aftyla was passed in 2016, Korean drugs have not been able to get a green light from the U.S. health regulator for two consecutive years. However, the industry is expected to bring a series of good news this year about Korean drugs entering the U.S. market.” In the beginning for the year, Daily Pharm had opened an article with the lead. And as predicted, Korean pharmaceutical and bio companies had a year filled with good news. Starting from Yuhan closing a license-out deal with Gilead Sciences on candidate medicine for non-alcoholic steatohepatitis (NASH), SK Biopharmaceuticals, OliX Pharmaceuticals, LegoChem Biosciences, Bridge Biotherapeutics, JW Pharmaceutical and Alteogen also scored license-out deals. Total nine license-out deals from January to November this year were closed by Korean pharmaceutical and biotechnology companies for 290 billion won. Also, other good news reported new pipelines developed with Korean-made technology have been approved in global markets. The U.S. FDA gave a nod respectively on treatment for excessive daytime sleepiness associated with narcolepsy, Sunosi (solriamfetol), and for partial-onset seizure, Xcopri (cenobamate) that SK Biopharmaceuticals licensed out to Jazz Pharmaceuticals. Led by botulinum toxin medicine Nabota developed by Daewoong Pharmaceutical, Samsung Bioepis and Celltrion’s biosimilars also had a notable achievement of grabbing foreign regulators’ approval this year. Although they were not first-in-class breakthrough drugs, Nabota and the biosimilars have been making profits from global markets in competition against other blockbuster drugs. Celltrion Healthcare has generated total of 800 billion won up to the third quarter with three biosimilars, Resima, Truxima and Herzuma. The volume surged by 60 percent from the same time last year. Samsung Bioepis selling three biosimilars—Benepali, Flixabi and Imraldi—in European market is expected to turn around for the first time in the year with accumulated net profit of 97.2 billion won up to the third quarter. Unfortunately, the industry had to endure a number of setbacks as well. Following the sales ban on Kolon Life Science’ Invossa, emerging biotechnology companies like Sillajen, Helixmith, and HLB Life Science released regretful news of failed clinical trials and left the public doubtful of the pharmaceutical and bio industry. Hanmi Pharmaceutical with the most aggressive R&D investment strategy in Korea had to give up on two R&D milestones from its license-out deal, whereas botulinum toxin companies like Medytox and Hugel stagnated with litigation over the source of strain and regulation on Chinese resellers. In contrast, the sluggish bio stocks growth having to turn around recently gave a hint of hope for next year. Investors are expecting the J.P. Morgan Healthcare Conference 2020 in January to be a catalyst to drive up the bio stocks. The J.P. Morgan Healthcare Conference is the one of the world’s most renowned conferences for the bio sector. It has been reported major pharmaceutical and biosimilar companies from Korea, such as Hanmi Pharmaceutical, Yuhan, Daewoong Pharmaceutical, JW Pharmaceutical, Dong-A ST, Celltrion and Samsung Biologics, as well as other bio companies like Medytox, Hugel and ABL Bio are planning to participate in the event. Moreover, the industry predicts SK Biopharmaceuticals going public in the first half of next year would also boost investors’ confidence. Hopefully, Korean pharmaceutical and bio industry would achieve even more R&D milestones in year 2020.
- Opinion
- [FOCUS] There is no reliability of cluless government policy
- by Chon, Seung-Hyun Dec 26, 2019 06:29am
- The impurity issues that started in Valsartan last summer led to Ranitidine and Nizatidine, and many drug products were discontinued. This year, the domestic pharmaceutical industry suffered greatly due to impurity risk all year round. Using a stigma called "carcinogen", a huge amount of medicines were recovered, and pharmaceutical companies suffered huge losses. So far, the government's follow-up on impurity drugs has been a fear to pharmaceutical companies. From the Valsartan to Nizatidine, the pharmaceutical industry continued to report that the domestic measures were strong. Valsartan immediately suspended the sale of products using the company's drug substance when recalls were received in Europe. Since January 2015, the Ministry of Food and Drug Safety has stopped selling all drug products that used the ingredients in question. It has been criticized that losses have increased and confusion has increased as the problem-free products have been recovered. It has been concluded that impurity-containing Valsartan medicines are not harmful to humans in both Korea and the United States. In Korea, Ranitidine has been inspected for the collection of finished drugs and drug substances, and all products of Ranitidine have been suspended. Not all Ranitidine has been removed from abroad. In the United States and Europe, companies made their own recovery. The US Food and Drug Administration (FDA) issued an official statement last month stating that "the hazards of NDMA detected in Ranitidine are comparable to those exposed when eating roasted or smoked meat". 13 products of Nizatidine was discontinued. No products have been issued a recall order in the US and Europe. Mainly older products were classified as subjects of recovery, and pharmaceutical companies complained that they were forced to sacrifice while stopping the sale of trouble-free products. The MFDS is currently investigating the presence of impurities in Metformin. Singapore's Ministry of Health (HSA) recently retrieved 46 items of Metformin sold locally and recovered three. N-nitrosodimethylamine (NDMA) was detected above the daily allowance. Unlike Valsartan, Ranitidine, and Nizatidine, Metformin investigations are cautious. The MFDS said they are investigating an Metformin, but has not yet conducted a collection test. The MFDS set out to conduct collection tests after Metformin's NDMA test was established this year. In this situation, the MFDS ordered pharmaceutical companies to submit data on the production of pharmaceuticals containing Metformin hydrochloride and the system of active drug substance investigation. Pharmaceutical companies are questioning whether “products using raw materials recovered from Singapore have been brought into the country”. Metformin's drug product recovered from Singapore has never been imported into Korea. However, the MFDS has not yet made an official position on whether the drug substance used in the product is imported into Korea. In the case of Valsartan, products that use the same raw material pharmaceuticals as those recovered as impurities from overseas must be discontinued in Korea. If it is confirmed that the same drug substance as Metformin recovered in Singapore is imported into Korea, it may be decided whether to discontinue the sale. In fact, it is reasonable to take follow-up measures through collection inspection even if the drug substance and the same manufactory that were recovered overseas are imported into Korea. It is reasonable to recover only the serial number in question even for the same product. This is a lesson already learned from the Valsartan issue. Rather, the bold policy to relieve the anxiety of the people encouraged anxiety. It caused a lot of social cost waste. It would be even more frustrating if they were reluctant to disclose transparent information because they were afraid of criticism that the MFDS would be in conflict with public insecurity or past policies. If they have experienced trial and error in the past, it is the government's role to honestly admit and implement an evolved policy. Then they should ask for understanding why it should have been. Only then they can gain trust. We want a "cool" government that can reflect on their mistakes.
- Opinion
- [Column] Self-injectable drug abuse, is SPD the answer?
- by Kim, Jung-Ju Dec 17, 2019 01:40am
- Self-injectable obesity treatment Saxenda has been under fire constantly, because the obesity treatment has been abused as a weight management injection generating not only safety concerns but also questionable profit for the interest group. Apparently, the government said it would provide answer to it in November. Some likely suggestions are individual unit packaging and separation of prescription and dispensing (SPD) system. Undue profit generated from abusing Saxenda? Demands for Saxenda has soared when the words got out that the injection is great option for controlling obesity. Accordingly, frequency of prescription and administration showed steep growth since then. However, it is questionable if the users in need of Saxenda are taking appropriate procedure to acquire the treatment at a moderate price. Before a medical profession makes a decision on the necessity of Saxenda administration and dose, user’s demand can make decisions first. As a result, inappropriate prescription of the injection raises concern of adverse reaction and safety. Other than the user’s demand, it also has been meddled with prescriber’s interest in profit. Abnormal amount of financial profit has been generated when prescribing and dispensing the injection, and such push in profitability has been pointed out as a reason for the abuse. Also it is problematic that some of the healthcare institutes and drug distributors are illegally supplying the treatment for the sake of financial gain. Besides making illegal profit, illegal supply of drug could bring serious safety issues. Is Saxenda abuse preventable? Plenty of reasons can be suggested for the abuse. But the user’s perception is the biggest reason. Drug users seeing Saxenda as a weight loss tool for esthetic purpose, rather than a health condition treatment, is one of the main reasons. And doctor’s perception is as problematic. The doctors are the ones to judge the necessity of the treatment use, and a drug prescription and frequency are decided by them as well. The doctor could be prescribing the treatment to the users to increase patient visit frequencies and profit. The user’s abuse can be shifted or prevented by educating and raising awareness of the risk. But doctors need more than a mere training and public service announcement; they need proper regulatory management. The health regulator could intervene doctors with insurance-covered medical service fee review, and pharmacist with the SPD system. Illegal drug supply can worsen the situation and its severity level. Countermeasure on illegal distribution is necessary not only to prevent drug abuse, but also to secure the order in distribution process and to stabilize medical expenditure in the National Health Insurance. Is SPD the answer to prevent self-injectable drug abuse? There are a number of suggestions to prevent drug abuse. Preventing and managing drug abusing by changing the perceptions of user and prescriber has limitations. This is why the regulatory management is needed. Besides the review procedure of insurance-covered medical service fee, the regulator could take account of SPD system as one of options for the regulatory management. The purpose of SPD system is to appropriately integrate economic feasibility and safety of drug use. Moderate use of drug consists of economic feasibility, safety and convenience. And it is the reason the injection was exempted from the SPD system. If an injection were to be dispensed at a pharmacy, the user would have to take it to a healthcare institute to get a shot. But self-injection is an exception and it can be shot either by a medical profession or the user themselves. However, the dual option of administration has become a loophole and it has created a side effect of drug abuse. Therefore, the regulator should positively consider applying SPD system on self-injectable items as well. The treatment was labeled ‘self-injectable’ for the sake of convenience, given the safety is guaranteed. To keep safety and economic feasibility from drug abuse, a handful of drug users should deal with inconvenience of administering the injection at a healthcare institute. The SPD system is not the only measure to prevent and manage self-injectable drug abuse. The government and insurer should endeavor to educate users and prescribers to change their drug use behaviors, while regulatory amendments on review and evaluation, and illegal distribution management are made, simultaneously. The interest group may additionally demand for increased dispensing fee and other means of compensation for SPD. But we should count on the interest groups to logically and reasonably handle the situation.
- Opinion
- [Reporter's view] Illegal Rebate CSO
- by Lee, Jeong-Hwan Dec 11, 2019 06:40am
- I suddenly thought that the trifoliate orange is innocent when I was covering the law revision extending medical and pharmacological expenditure reports to pharmaceutical CSOs. Pharmaceutical industry ethics management (CP) experts refer to CSOs based on drug expertise as tangerines, the CSO which was altered as an illegal rebate, as trifoliate orange Unlike tangerines that boil sweet and sour flesh, the trifoliate orange has a thick peel and a lot of seeds, so it has little flesh and a strong sour taste, making it suitable for comparing illegal CSOs. However, the pharmacological benefits of November’s trifoliate orange in season were excellent compared to the illegal CSO. Donguibogam (Principles and Practice of Eastern Medicine) says that the trifoliate orange is also effective for respiratory diseases and congestion such as relieving severe itching and detoxification of liver, relieving bloating and coughing. Even citric acid removes fat, which promotes nutrient metabolism in the body and helps with diet. Illegal CSOs, on the other hand, are all evil and no good to the health and pharmaceutical industry as well as to the health of normal CSO industries. The Korean version of Sunshine Act, launched from this year, is poised to expand the scope of application to pharmaceutical CSOs following pharmaceutical companies. It will be realized through the revision of the Pharmaceutical Affairs Law and the Medical Device Act, which contains the regulation on drug rebate, but it requires the efforts of the pharmaceutical industry and some altered CSOs. Korea's pharmaceutical industry, the future growth engine, is no longer able to stay in the generic drug structure. Generics that are already on the market and have expired major patents and poured out many of the same ingredients cannot lead the industry in the rapidly changing Fourth Industrial Revolution. It's been a long time since generics have lost their power as a cash cow, supporting the pharmaceutical industry and serving as a source of new drug research and development (R & D). There are numerous precedents that the generic fraudulent competition, which is hard to find market innovation, eventually leads to an illegal rebate war. Even in the case of generic competition, there is no argument against the need for a direction based on drug expertise through legitimate CSOs. The legislature and the Ministry of Health and Welfare soon agreed that they would embark on a complementary legislation that would include CSOs as drug companies in drug suppliers. This means a direct signal to the pharmaceutical industry and the CSO industry to initiate self-cleaning as a means of amending the law. The Welfare Ministry also believes that the revision of the law cannot be the magic bullet to eradicate all drug rebates. In the end, the rebate eradication can only be achieved if the pharmaceutical industry and the CSO themselves show their professionalism in the legal pharmaceutical competition market established by the government and the National Assembly, and then dig out the old and corrupt business. In addition to the yellow and coveted fruits, the trifoliate orange trees have been planted as a substitute for fences since ancient times, because of the stems of roses and oaks that are scary and thorny. Taking into account the medicinal efficacy and physical function of the trifoliate orange, which has been likened as an illegal CSO, we are dreaming of a future where the domestic CSO industry will grow into a strong and robust industry dedicated to pharmaceutical sales for medical and pharmacist experts.
- Opinion
- Both to blame of the rising Pharmaceuticals & Korea
- by Eo, Yun-Ho Dec 05, 2019 06:16am
- The pharmaceutical industry is a high value-added industry and Korea is now more interested in new drugs than ever before. As interest has increased, the names of pharmaceutical companies that have reported news such as clinical failures, discontinuations, or controversy about efficacy are very popular on the Internet. It is possible. Samsung and Celltrion's biosimilars are being recognized in the US and Europe, and the government is drawing blueprints for preferential treatment of new drug prices under the development policy of the pharmaceutical industry. But it should be clear. If success is easy, it is not a new drug in the first place. According to the analysis of 9,985 data performed or in progress by the US Food and Drug Administration (FDA) for 10 years from 2006 to 2015, the success rate of the phase I was 63.2%, the phase II was 30.7%, the phase III is 58.1%. If we calculate this and estimate the probability that a new drug will be commercialized, it is only 9.6%. Stopping development and failing clinical trials are strange not to happen. However, there is a herd effect and both to blame. It is also true that many pharmaceutical companies aimed at a bandwagon effect like striking while the iron is hot. The clinical entry and completion data of the developed materials and indiscriminately presented data of the development materials, which are distributed indiscriminately without any explanation of what the drug is, aims only at investor psychology. 'Excellent efficacy compared to OOO drugs', 'It is the first XXX cancer drug', 'Secured cardiovascular safety’. It is attractive but shows no evidence. As a result of how many patients were studied and how long the study was conducted, it is not known how the difference was shown in terms of efficacy and safety compared to the comparison group. There is even a case where a comment from a company official called 'Good Medicine' is all about the medicine. story of domestic drug development is encouraging. It should be duly evaluated. This is no time to care of IR (Investor Relations). Shouldn't the stigma of playing with stocks be free itself from restraints of rebates?
- Opinion
- [Column] Legal disputes over rebate penalty reducing price
- by Lee, Hye-Kyung Dec 05, 2019 06:12am
- This year would be a year to remember as various issues regarding drug pricing broke out, such as ‘lump-sum price reduction on single-use eye drops’, ‘revised generic pricing system’, and ‘litigation against pricing reduction penalty for providing rebate’. Currently the drug pricing system is geared towards paradigm shift, starting with abolished ‘same substance same pricing’ policy. Pharmaceutical companies would be helpless but to seek for other survival tactics in the coming year while the drug pricing ecosystem changes. There are many issues to be talked about regarding drug pricing, but today it would be about a few updates on meaningful court decisions made on pricing reduction as an illegal rebate penalty. However, it would mainly be summarized points of the issues as the lower court made the decisions and the issues are still open for long-running disputes. As I introduced in a column titled ‘Rebate and Kick-back’ published December last year, the Korean Ministry of Health and Welfare (MOHW) imposed maximum reimbursement price reduction on 340 items from 11 pharmaceutical companies accused of providing rebate. Currently, the most of affected pharmaceutical companies have filed administrative litigation against the matter. The pricing reduction penalty has not been imposed for years and related legal dispute has not been talked, either. So the recent legal disputes were raised since various issues occurred with MOHW imposing penalty of the massive scale. Going through each dispute issue, the first issue is about whether to consider nature or property of drug pricing reduction penalty as a sanction or not, according to the Item 12 of Paragraph 4 of Article 13 of Regulation for Criteria for Providing Reimbursed Services in the National Health Insurance, stating “a drug that has been confirmed as having disturbed trade orders by offering money or good for sales promotion, etc”, or also known as former rebate regulation. The distinction of the sanction is crucial, because the ministry’s jurisdiction could change depending on the recognition of the discretionary sanction. In other words, when the court recognizes the penalty as discretionary sanction, the judiciary would then decide the penalty was legitimate respecting the administrative agency’s judgment, if without a significant flaw, but if not then the court could revisit the issue. On the issue, the lower court decided drug pricing reduction penalty imposed based on the former rebate regulation ‘could not be seen as sanction, but rather the maximum reimbursement price adjustment should be judged as discretion of reasonable penalty.’ Therefore, the court meant that it would be considered as a legitimate penalty within the discretionary jurisdiction only when the jurisdiction is considered reasonable. With the said premise, the court ruling made decision on jurisdiction of discretionary authority for each specific disputed issue. First, the court ruled that the Minister of Health and Welfare was not obligated to lay down detailed basis of maximum reimbursement price calculation to affected companies, when imposing the price reduction penalty. The court did not see the legitimate reason as for the minister to consider the company as direct subject, because the regulation defines subjects for notice on reimbursed drug are mutually applied among healthcare institute, National Health Insurance Service (NHIS), policyholder, and dependent. Among drugs provided from Pharmaceutical Company B to Hospital A, should the price be reduced only for drugs prescribed by the rebate-received medical profession? Or should maximum reimbursement prices of all drugs supplied by Company B and prescribed by Hospital A be reduced? The court stated all drugs from Company B could be subject for the maximum price reduction. Rebate provision itself is highly likely to have been provided to promote sales of a specific company’s product, and there was no objective evidence to prove the rebate was provided for a specific product instead. So the court decided the Ministry of Health and Welfare’s penalty was within its jurisdiction of discretionary authority. Then what about a case of Hospital A providing both reimbursed and non-reimbursed drugs. How should the maximum reimbursement price reduction rate be calculated? Should the rebate on non-reimbursed drug be disregarded from the calculation of price reduction rate? The court decided proportionally dividing rebate amount on reimbursed drug, while completely disregarding non-reimbursed drug, was a faulty calculation of maximum reimbursement price reduction rate. The calculation formula for the price reduction rate was wrongful as rebate could have been provided for the non-reimbursed drug, and removing the amount provided to non-reimbursed drug from the calculation would have resulted in excessive reduction rate. Lastly, if the rebate provided to a pharmacist was for the cost of the provider’s prescription drug, would it be possible to reduce the maximum price including the rebate cost? Besides from violating Pharmaceutical Affairs Act, the court saw that the company’s act of providing rebate is difficult to relate back to prescription and sales of the prescription drug. The principle and the norm of dispensing and sales of prescription drug is decided by doctor’s prescription, so the court judged it is unlikely to see the correlation between rebate provided to pharmacist and ‘promotion of dispensing and sales of prescription drug’, except for a special occasion. Therefore, the court stated reduction rate should be calculated without the rebate cost provided to the pharmacist. As for the last decision, the court reviewed standard and process of imposing maximum reimbursement price adjustment penalty more specifically than other previous rebate decisions, which sets judging standard to see if the maximum reimbursement price reduction penalty was reasonable based on the ministry’s discretionary authority. The decisions were made during respective first trials and they are waiting for the appeal. Attention on the issues is heightened to see if the preceding decisions would be sustained in the appeal. In fact, there is a possibility of the change in decision during the appeal, and whichever decision is made at the Supreme Court later, the cases would definitely be the precedents setting a standard of the rebate-induced drug pricing reduction penalty. The heated legal disputes seem inevitable for the healthcare sector, as it is Korea’s new economic growth engine with visible rapid expansion in quality and quantity. Besides, the highly political and technical drug pricing is right in the center of the dispute. Previously mentioned drug pricing paradigm shift seems like it would bring more interesting topics on the table than just the rebate case. Surely the drug pricing policy would attract even more attention in the coming year 2020.
- Opinion
- [Column]GPP can’t be off anymore
- by Jung, Heung-Jun Nov 27, 2019 06:40am
- GPP is a hot potato in the pharmaceutical society. It is unlikely that a executive of the pharmaceutical association with experience in business would completely deny the introduction of GPP. This is because the government and the public have been asking the pharmaceutical association for decades. But the drive is making slow progress. This is because it is difficult for the Korean pharmaceutical society to roll their arms first for a policy that members are not happy with. Former Executive Committee, Chan-hui Cho held a debate to discuss the GPP, but the members' response was cold. The core of GPP is to elevate pharmacy's work level. This ranges from patient services related to medication to systematic and clean management of pharmacies. It is basic not to make unauthorized persons illegal activities, such as dispensing or selling generic drugs. This system aims to induce improvement by certifying excellent pharmacies through evaluation and to raise the level of work of all pharmacies. But members' response to the GPP is not favorable. They recognize the necessity, but they are not very active in accepting, or even view it as another unnecessary regulations. Some used to run a pharmacy at their convenience, but once the GPP is in place, they have to be more careful to meet the criteria and to include being assessed by an outside agency for certification. Nevertheless, the positive side of the GPP certainly exists. First, they can reduce underage pharmacies which do damage to the entire pharmacist society There are many pharmacies that operate in good faith in accordance with desirable pharmacists, but there are some that do not. Because of these pharmacies, the overall status of the pharmacist society falls. The protection of these pharmacies by the Korean pharmaceutical society is nothing less than the surrender of the rights of the whole members. Second, they can increase public confidence in pharmacies and pharmacists. Support of the public is essential for the pharmacist's petition project such as ingredient prescription. It is important to understand that the current situation with low confidence or expectation in pharmacies is the biggest obstacle to the development of pharmacist functions. Members often avoid GPP because of incorrect information or realistic concerns. The idea is that the GPP is tricky to implement a corporate pharmacy or objectionable because it will cost a lot of interior expense. In particular, there seems to be a misunderstanding that hardware elements such as interior and automatic dispenser are important conditions for becoming a pharmacy. Not like that. In order to provide good service, software factors such as pharmacist knowledge and careful care of patients are more important. And the certification system should be made to reflect these software elements well. This can lead to the development of the pharmacist's function, which is the true purpose of the system. In order for the GPP to be settled in a desirable manner, it is correct that the pharmacist society faithfully carries out these concerns and preemptively implements them. Recently, the Anti-Corruption and Civil Rights Commission recommends that the Ministry of Welfare undertake a study on the implementation of the GPP. It is a pity to respond aggressively to the changes of the times and to the demands of the people. We must abandon the current situation where the pharmacist society seems to stand up to the consumer's demands, and change to the stage where the pharmacists renew and gain the trust of the people. Change is always painful. But the power to change on its own is the driving force to open the future. Even now, we expect the pharmacist society to gather wisdom and courage to be on the right track of change.
