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- 2026-05-01 18:28:08
- 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.
- Opinion
- [FOCUS]Government sophistication to generic regulations
- by Chon, Seung-Hyun Nov 25, 2019 06:21am
- A few years ago, a multinational pharmaceuticals announced “high quality” by launching generics in the domestic market. It is the aspiration to show good quality generics based on strict production management, product monitoring and quality assurance system that have long been recognized in the global market. At the time, the head of the licensing review department of the Ministry of Food and Drug Safety, who got the news, rejected that "the quality of generic products is meaningless." Generics must pass strict standards from drug substances to finished product manufacturing facilities. In addition, a conformity test should be made in a bioequivalence study demonstrating that the generics are equivalent to the rate and concentration of original drug absorption. "Generic products that have passed all government-set standards and have been approved for sale should be regarded as equal in quality.“ The MFDS is trying to tighten restrictions on generics after last year's issue of Valsartan impurity. The MFDS announced the legislative draft of the “Revision of Partial Rules on the Safety of Pharmaceuticals,” etc. on the 18th. It contains a significant tightening of the licensing requirements for all fair commissioned manufacturing generics. It means that the GMP evaluation data, standards and test method data, which have been exempted from the consigned generic permit screening data, must be submitted. It is noteworthy that MFDS referred to “high quality generics” as the background for strengthening generic regulations. According to the Regulatory Impact Analysis Report of the revised regulations, the MFDS said that they will secure the trust of the people providing 'high quality' medicines and improving the soundness of drug distribution through the quality improvement of generics for each clause that strengthens the regulation of generics. The intention is to supply high-quality generics by strengthening generic regulations. It also means that there is differences in quality between generic products. This is contrary to the conventional view that "quality is equal if it passes the strict licensing process." It seems possible that even with the MFDS, there may be some low quality generics. It is also ambiguous to see how the strengthening of permit standards is related to quality improvement. Submission of GMP assessment data by authorized generic means re-release of data that has already been verified by the MFDS. GMP assessment data need not be submitted when consigning a product that is identical to a previously approved generic. However, one year after the proclamation of amendment, the authorized generics will also be required to produce three manufacturing units (batch) and submit relevant GMP data for approval. The submission of GMP evaluation data by authorized generics disappeared just five years ago. The MFDS implemented ‘the GMP Compliance Certification System’ in 2014, which permits Pharmaceutical production that all factories producing pharmaceuticals requires passing the standards set by the MFDS every three years. At this time, regulations for mandatory production of licensed drugs were relaxed. It was made possible for the establishment within the validity period of the conformity assessment to replace the data on the evaluation of the GMP implementation with the conformity assessment. They have already laid the foundation for strengthening quality management by introducing the ‘Certificate of GMP Compliance of a Manufacturer', and in the situation where the approved facility has determined the suitability of licensed drugs, it is decided that it is redundant regulation to receive the GMP evaluation data of the authorized generics again. The same applies to co-bioequivalence regulations currently underway. On April 15, the MFDS announced a partial revision of the “Regulations on the Authorization, Declaration, and Review of Pharmaceuticals,” which includes tightening regulations on co-bioequivalence regulations. According to the amendment, regulations will be tightened so that up to three authorized generic manufacturers are allowed to one original manufacturer one year after the notification. This means that up to four generics will be granted for each bioequivalence test. After three years, consiged bioequivalence is completely banned. Four years after the notification, only one generic may be approved in one bioequivalence study. As a result, after four years, the same product from the same manufacturing facility must be tested for bioequivalence separately. I don't know what it is related to run separate bioequivalence tests on the same product with ‘high quality generics’. Goal of the MFDS is clear that it tightens regulations of generics. Because of the serious difficulty of generics, the intention is to reduce the number of generics in the market by raising licensing barriers. It is clear that the overflow of generic manufacturing contractors is the cause of generic upheaval. It is also clear that generic upheavals were triggered by changes in government permit regulations. Wouldn't it be better to admit that the government's policies encouraged generic upheaval and try to persuade the reasons for changing the policy stance? Rather, the cause of “quality improvement,” which is not related to the regulations, can lead to confusion in the industrial field. This leads to distrust in government policy. Of course, the government may adjust the regulatory intensity in response to changing market conditions. However, companies need to be able to believe and follow only by providing a clear justification and justification for the new policy. If the government produces a policy without justification and changes the policy stance, in the turn of a hand, credibility falls.
- Opinion
- [Reporter's view] The Korean bio-health industry in Anomie
- by Lee, Jeong-Hwan Nov 20, 2019 11:50pm
- World-class standards of medical technology is Korea's long-standing pride. Advanced bio-new drugs are the future growth fuel that the world pursues, and the Korean pharmaceutical industry is gradually shifting its development focus from generics to new drugs with technology. Expectations and concerns coexist in the public's spotlight toward the medical and biopharmaceutical industries that will affect the future of Korea. It is rare to oppose the achievement of 'high-tech medical and bio-new drugs' that will lower regulatory barriers, speed up the introduction of new technologies, and ultimately directly benefit society and the public. On the other hand, the question of whether to agree to the provision of personal health information necessary for the development of advanced medical and biologic new drugs is not easily nodded in assent. The order to make high-tech medical and new medicine without medical big data is to offer the best dinner without high quality and abundant raw materials. In this respect, The Korean bio-health Industry fell in Anomi. New norms and social values appropriate for advanced medical and biologic drugs and the fourth industrial revolution must be established, but it is the current status of our society that existing traditional norms and values rarely innovate. In other words, the social values, which are essential for the high-level medical care and advanced new drug industrialization, are in a state of confusion and irregularity. Recently, the 4th Industrial Revolutionary Committee urged the government to advance laws and regulations, and to strengthen the capacity for review and licensing. Specifically, the government said that it would reduce social unrest by strengthening public relations about the objective scientific achievements that the biohealth industry would bring along with the revision of the Personal Information Protection Act, medical law, and bioethics law. KIET stated that the Korean bio, IT, and AI industries with excellent technology have fallen into ‘the prisoner's dilemma’, pursuing their own interests among medical world, civil society, and the government. It is a diagnosis that civil society, which has high technology development and government-industrial distrust, is not able to agree on providing sensitive health and medical personal information, and is hindering the development of telemedicine or biomedicine. After all, how to rescue Korea's bio-health industry in an anomalous state is the solution for advanced medical and biomedicine drugs. Citizen anxiety is likely to grow as regulatory innovations take place, and it can create fear that personal information is being used by government or some industries for other purposes. The government should work with expert groups to make concrete plans to break down civil distrust, and quickly resolve the public's lack of cutting-edge bio-information through various public participation external events. Regulatory innovation and industrial development should not be focused on keywords, it made The public, the government, and the industry struggling with each other, and darken the state-of-the-art medical and biopharmaceuticals the future We should be able to explain transparently and specifically how my medical information is used and protected in the development of the biohealth industry and how the individual can finally benefit. Also, it is time to break down chaos and anomie by creating a way for individuals to participate in the biohealth industry.
- Opinion
- [Column] Imposing fine enough to prevent rebate?
- by Kim, Jung-Ju Nov 13, 2019 01:09am
- Korean government’s plan to revise illegal rebate penalty regulation and replace insurance reimbursement suspension with fine on an accused drug product came under fire. However, the government is committed to protect drug access considering patient’s safety and convenience. For the justification of rebate regulation against rebate, the government points its finger on financial factor, other than pure objective of treatment, intervening the process of selecting and purchasing drug products, and negatively affecting on patient’s health, National Health Insurance (NHI) and general medical expense. The objective of rebate regulation is to induce adequate use of drug and transparent trading. The execution of rebate regulation should be able to achieve the objective, and the regulators should maintain fairness when executing it. The existing penalty against rebate is to revoke NHI reimbursement listing and to impose fine depending on the number of committed offenses. The proposed revision of the regulation starts from lowering of upper limit healthcare expense (drug price) to suspension of healthcare reimbursement, as well as imposing of fine, depending on the number of committed offenses. The major differences are utilization of drug price reduction, increase in amount of fine, and excluding revocation of reimbursement listing. It seems appropriate not to remove the responsible drug product from reimbursement listing for the sake of patient’s stable drug access, because it would be far-fetched to correlate illegal practice and quality of the drug. Furthermore, the regulators should contemplate on how effective the revised penalties would be to eradicate the illegal practice, compared to the revocation of reimbursement listing. The purpose of the regulation should not only stress on punitive aspect, but also stress on preventive aspect. Reduction of drug price and increased fine are undeniably punitive. However, the issue is the severity level of the penalty sufficient enough to bring preventive effect. When the level of penalty is bearable, then companies with agenda would rather take the chance of committing offense. Other issues are drug price reduction, reimbursement suspension period and the unclear definition of the ‘period’ when imposing fine. Positively speaking, they could be seen as ‘flexibility’ in administrative measure, but negatively speaking, ‘voluntariness’ of the administrative measures are questionable. It is easy to predict who would exploit and abuse the regulatory standard (interpretation of the term). Also, the term ‘one year-worth of reimbursement cost’ addressed in the regulation summing the amount of fine is ambiguous. Depending on the point of the ‘year’, the accused company’s absolute amount of fine and countermeasure differ vastly. At the moment, dual penalty system is applied on the rebate giver, a pharmaceutical company, and the receiver, a doctor or healthcare institute. But the off-balance between regulations against the giver and the receiver, as addressed by the National Health Insurance Act, are under fire. The regulators are reinforcing financial penalty on rebate-giving product, instead of imposing regulation on the product itself to maintain access to the treatment. On the other hand, regulators suspends license of the rebate-receiving healthcare provider, and also confiscates illegally obtained financial gain. How about some more attention on re-evaluating the fairness between reimbursement revocation on a drug product and suspension of doctor’s license? Or between drug price reduction and reimbursement cost refund, and financial gain confiscated from healthcare providers? Effective execution and fair penalties of rebate regulation should be revisited at this point in time. Moreover, we should not forget to contemplate on revising the regulation to prevent rebate practice in long-term and fundamental fashion, taking the unique qualities of the pharmaceutical industry’s rebate practice and distribution environment into account. Although the ultimate consumer of a drug product is patient, it is undeniable that doctors are in control over the pharmaceutical options. Keeping in mind that a drug is also a commercial product, the regulators would also have to face the reality of marketing without some form of rebate. The point is to bring down healthcare provider’s openness of receiving rebate and the level of rebate provision. Besides the problem within rebate practice, National Health Insurance’ payment system and healthcare provision system should be reformed to achieve fair and good healthcare.
- Opinion
- [Reporter's view] DC the absolute power behind hospital
- by Eo, Yun-Ho Nov 11, 2019 11:08am
- When each hospital’s Drug Committee (DC) is convened, pharmaceutical companies starts a fierce war to land a favorable drug deal. Just like any war in the world, the ‘DC war’ has a winner and a loser. Unfortunately, not always do the winners deserve a win or the losers deserve their defeat. To land a ‘drug code-in’ deal at some general hospitals, ‘inappropriate backdoor dealing’ is more important than outstanding evidences of a drug’s indication and efficacy. Such phenomenon is prevalent when an original’s patent is expired and new generic is released. A hospital’s DC mostly consists of doctors from each department and chief pharmacist. However, sometimes unheard-of drugs get their codes in and push out existing drugs, thanks to hospital foundation’s influence. To this date, a hospital with significantly influential DC brings in representative of a pharmaceutical company and demands for so-called ‘drug code maintenance fee’ on an original drug with expired patent. In fact, the hospital removed well-known original hypertension, hyperlipidemic and antithrombotic items for last two to three years. Their codes were removed, simply because the drug companies refused to pay the ‘maintenance fee’. The illegal rebate paid by drug companies is never handed straight to the foundation. Pharmaceutical industry insiders hint that the money is rerouted and laundered through separate corporations owned by the foundation or distribution companies with a close relationship, and finally gets to the foundation. DC lobbying exists between originals when there is a new generation or type of drug is launched. So for pharmaceutical companies to get a drug code-in deal, they need to coax foundation and doctors. Of course, the effort of Dual Penalty System and Fair Competition Agreement has brought some fairness to the business. Unless solid evidence of a drug is available, growing numbers of hospitals are not guaranteeing DC’s approval, regardless of a good connection between a healthcare provider and a pharmaceutical company. However, hospitals still associate DC with an absolute power. Even though it should be given that hospital’s drug coding depends on fair evaluation.
