- LOGIN
- MemberShip
- 2026-04-30 19:05:33
- Opinion
- [Reporter’s View]Rise of adjuvant therapies amid concerns
- by Eo, Yun-Ho Jun 05, 2023 05:37am
- Although it may not be the same, the concept of administering a drug for ‘prevention’ has been around for a while. Patients who have chronic diseases have been taking drugs to ‘manage’ their condition rather than treat it. Also, some drugs just exist to prevent a condition, like anticoagulants. The same has just recently been applied to anticancer drugs. Companies have been acquiring or seeking indications as adjuvant or neo-adjuvant therapy for early-stage disease with their various new anticancer drugs through various research. Even at the 'American Society of Clinical Oncology 2023 Annual Meeting’ that is being held in Chicago, USA, adjuvant therapy research data are pouring in for 'Keytruda (pembrolizumab)', 'Kisqali ( ribociclib)', 'Herceptin (trastuzumab)' and others. However, concerns have followed the uprise of adjuvant therapy, with the biggest burden being financial. As everyone knows, even after being cured, cancer can frightfully recur. Depending on the type of cancer, some cancers have a recurrence rate that nears 80%. In the current era of high-priced pharmaceuticals, prescribing anticancer drugs that are leading the high-priced trend as adjuvant therapy and granting insurance reimbursement would naturally pose a burden for the health authorities. Another fact is that the benefits of adjuvant therapy are also receiving attention from the academic world. Already, adjuvant therapy has begun to be listed in the guidelines of world-renowned academic societies, with higher and higher grades of recommendation. So this is now the time for all those involved to ponder. Carefully examine the necessity of adjuvant anticancer therapy for each drug, and weigh the practical benefits rather than the indistinct and vague worry about its 'burden.' Treating patients with recurrent cancer may be less cost-effective. Recurrence and metastasis are fatal factors that increase cancer mortality. Since there is no right answer, we have to weigh the good and the bad. It is not possible to leave the piling number of applications for drugs to be used as adjuvant or maintenance therapies unattended. It is not just about the profits and losses. The stakeholders should also consider the specificity of each drug and the patient's situation and find consensus that takes into account Korea’s unique health insurance system and the pharmaceutical industry’s ecosystem.
- Opinion
- [Reporter’s View] Please wait for policies to take effect
- by Lee, Tak-Sun Jun 01, 2023 05:39am
- The government is pushing to reform the drug pricing system to reduce the number of generics. It is said that the authorities are considering a plan that does not grant the premium price allowed for innovative pharmaceuticals to generics that exceed a certain number. The analysis is that the government's decision to regulate the number of generics was influenced by the large amount of Forxiga generics that entered the market at once in April. 57 generic drugs were released as soon as the patent term for Forxiga expired. However, this was possible because the generic drugs were approved before the consigned bioequivalence test restriction system was implemented. The amendment to the Pharmaceutical Affairs Act, which restricts consigned bioequivalence testing companies to 3, took effect in July 2021. Forxiga generics were first approved earlier last year, but the development of the drugs was carried out before the consigned bioequivalence test restriction policy was implemented. Therefore, at the time, there was no restriction on the number of companies that can receive consigned bioequivalence tests. Therefore, one consignor could share its bioequivalence test results with multiple consignees without restriction. The industry expects the number of new generics to gradually decrease due to the restrictions made for bioequivalence tests. In the midst of this, the government's plan to add price cuts for generic drugs is nothing but a clampdown on the pharmaceutical companies. It would not be too late for the government to wait for the restrictions on bioequivalence tests to take effect before making further judgments. Rather, if the bioequivalence restriction regulations contract the generic market and negatively affect not only the domestic pharmaceutical industry but also consumer accessibility, the government should even consider deregulations. It would be unreasonable, even reckless for the authorities to pull the reigns on the price of generics further before checking the effect of the policies it had implemented. If the government considers generics as just a means that deplete health insurance reimbursement finances, it is the same as giving up the domestic drug market. In order to maintain the fiscal health of Korea’s health insurance, more fundamental measures that recognize the proper function of generics and activate it should be prepared.
- Opinion
- [Reporter's view] Are you ready to use
- by Lee, Hye-Kyung May 18, 2023 05:45am
- The 'Act on the Safety and Support of Advanced Recycles and Advanced Biomedicines' will be in effect for three years in August. The Advanced Recycled Bio Act prepares a system for securing the safety of advanced renewable medicine, provides a plan for technological innovation, and practical use, and stipulates the necessary matters to secure the quality, safety, and effectiveness of advanced biopharmaceuticals, and to support commercialization.The Advanced Recycled Bio Act has been implemented, and 36 cell treatment facilities and 32 human cell management institutions have been approved in Korea. Cell therapy is made in Korea to export technology to foreign countries, or the CMO/CDMO business of biopharmaceuticals is actively underway. As if proof of this, 'BioKorea 2023', which was held from May 10th to 12th, was presented by a high-tech renewable medical center for the first time, and various sessions were held on the theme of revitalizing clinical research on advanced renewable medicine and exploring the direction of the development of the high-tech biopharmaceutical industry. A speaker who attended the site at the time said that the regenerative medicine session was formed for the first time in Bio Korea, and that it was time to seek industrial development as well as domestic advanced regeneration bio research. However, it has only been three years since the High-Tech Recycled Bio Act was implemented, so it seems that there is still a long way to go. The Ministry of Health and Welfare has expressed its will to improve regulations to revitalize clinical research on cutting-edge bioregenerative medicine treatment technology. It is said that the clinical research application target will be expanded and the clinical research results can be linked with approval, but the position of the researchers conducting the actual research was a little different. It is said that it is urgent to prepare a legal basis for the activation of clinical research data based on the Temple of Heaven's Regenerative Bio Act. In fact, there have been various attempts to utilize the health care big data platform, but the linkage rate between each institution is low as it still hits the wall of personal information. Even if you use data from multiple platforms, you have no choice but to hit the limits of using it with your gender, name, and date of birth alone. In the end, this phenomenon seems to be bound to occur in the use of advanced regeneration bio clinical research data. There is a provision in the Advanced Recycled Bio Act that 'if you need a head of a safety management agency, you can request the provision of data such as unique identification information', but it is not enough to expand it to pharmaceutical companies and clinical research practitioners. In accordance with the Advanced Recycle Bio Act, the basic plan for advanced renewable medicine and advanced biopharmaceuticals is established every 5 years. Three years are coming, and the time is coming soon to come up with a second basic plan. When you try to take advantage of the accumulated endless health care big data, you have to remember the many hurdles. Data from high-tech regeneration and biopharmaceuticals that have just crossed 2/3 of the first basic plan is being collected one by one. In order to actively conduct clinical research with this data, it is necessary to come up with various strategies that can utilize individual unique identification information.
- Opinion
- [Reporter’s View] Bitter ERPs following spin-offs and sales
- by Eo, Yun-Ho May 17, 2023 05:38am
- The operation of Early Retirement Program (ERP) schemes following sales of business units has been frequenting as an issue in the pharmaceutical industry. Although the spin-off and sales by multinational pharmaceutical companies aim at ‘separation of innovation and legacy, ‘this premise of ‘selecting and focusing’ on its strengths inevitably entails the negative situation of ‘layoffs.’ Also, the layoffs that occur from sales of businesses are different from general ERPs. Despite the notion of ERPs being a ‘voluntary retirement,’ ERPs that occurs during such situations are much less ‘voluntary.’ This is why such ERPs bring about labor-management conflict. Of course, multinational pharmaceutical companies provide immense compensation for their ERPs. In particular, the ERPs offered after spin-offs or sales offer industry-leading compensation. For employees that were considering whether to change jobs, ERPs can even be a fortune. However, there is no guarantee that there will be new jobs for everyone. Also, for some, a company is more than a place to earn a living but is also a place of value and pride. If layoffs are unavoidable, the company should focus on providing maximum compensation and ensuring succession of employment. The coercions being made under the word ‘voluntary ERP’ must be addressed, and the size of the layoffs should not be determined by a rule of thumb. There is no such thing as good layoffs. Only a few leave satisfied. Some will feel a sense of loss and separation just by the fact that they were being laid off as 'legacy'. As the companies that were the pride and hope of their employees, the companies should work to live up to their employee's expectations, whether those are being laid off as ‘legacy’ or not, and actively work to persuade its head office and take responsibility for the future course of the employees, if there is even the smallest room for improvement.
- Opinion
- [Reporter's view] AI drug development, should face reality
- by Hwang, Jin-joon May 16, 2023 05:39am
- "Artificial intelligence (AI) drug development will be useful, but there is a problem with only talking too much hope. Domestic AI drug development is still at an early stage, so more R&D is needed." These are the words the representative of an AI drug development company attending a recently held event related to digital healthcare threw to the debaters in the audience. It seems to point out that although new drug development using AI is being carried out in various parts of the world, companies that have achieved tangible results in Korea have yet to be seen. According to the Ministry of Science and ICT, new drug development is one of the projects that take an average of 10 years or more for a new drug to come to the market. It takes about 5 years to discover 5,000 to 10,000 promising candidates. Among the discovered candidate substances, 10 to 25 substances are entering preclinical trials. Of these, nine substances are approved for phase 1 clinical trial plans. The success rate is so low that there are only 5 in Phase 2, 2 in Phase 3, and only 1 in the market. In order to overcome the low success rate of new drug development and entry barriers that require long-term and high costs, a plan to utilize AI in the early R&D stage has been proposed. For traditional new drug development, a method of selecting a target disease and searching for a candidate substance by a research team reviewing about 400 to 500 related papers is used. AI is expected to have the advantage of being able to search for more than 1 million papers and hundreds of thousands of chemicals so that dozens of researchers can do the work that they have to do for 1 to 5 years more quickly. The AI drug development market is estimated to have high growth potential. The AI drug development market is expected to grow from 636.2 billion won in 2019 to 4.7693 trillion won by 2027, growing at an average annual rate of 28.63%. Global pharmaceutical companies such as AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, GSK, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sanofi, and Roche have also actively collaborated with AI drug developers to discover candidate substances. In 2021, a candidate substance for the treatment of pulmonary fibrosis discovered and designed through AI by Insilico Medicine in Hong Kong entered clinical trials. In October of last year, Verge Genomics, a US AI drug developer, started clinical trials of candidate materials for amyotrophic lateral sclerosis (ALS, Lou Gehrig), which were secured using AI's new drug discovery platform Converge. Verge Genomics is a biotech company that has received investments from Eli Lilly, MSD, WuXi AppTec, and BlackRock. In Korea, the Ministry of Science and ICT invested 25.8 billion won for three years from 2019 to 2021 to develop new AI drugs. The main goal was to build a customized AI platform for each stage of new drug development. It aimed to lead the development of three areas: candidate substance discovery, drug re-creation, and smart pharmacovigilance. Through a three-year support project in the field of AI new drug development, it developed an AI model that can be applied to neurodegenerative diseases and new anticancer drugs. The developed AI model is loaded into the public platform KAIDD and is openly operated so that researchers from industry, academia, and research institutes can utilize it. As a follow-up project that started in September of last year, the company plans to improve the data sharing and utilization environment by advancing the AI new drug development model by 2026. We plan to develop new drug candidates that can be applied for a clinical trial plan. There are several areas that need improvement in clinical prediction and targeting of clinical patient groups. It is also an important issue to establish social consensus and specific action plans that can utilize personal medical data classified as sensitive information. It is problematic that the AI drug development industry is not securing tangible results such as sales while talking only about the ideal use of technology, overseas cases, and the growth potential of the global AI market. It is necessary to face reality and solidify internal stability to be competitive.
- Opinion
- [Reporter’s View] MSD Korea ‘Calm before the storm’
- by Jung, Sae-Im May 11, 2023 05:46am
- “There were rumors from a month ago, but they proved true. I am at a loss for words at the announcement that the department will be closed down." With the news that MSD Korea’s blockbuster antidiabetic treatment ‘Januvia Series’ will be handed over to Chong Kun Dang, the employees at MSD Korea received the crushing news that the company’s General Medicine Business Unit that used to sell Januvia will be shut down. Blinded by the unexpected blow, the employees are currently at a loss for words. Although the company refrained from directly using the term, ‘closure of a department,’ the notice included phrases such as ‘we are deeply grateful to MSD Korea’s GM employees who have shown dedication and worked hard to fulfill their responsibilities’ and that the company is ‘preparing a competitive voluntary retirement and external career support programs,’ indicates the imminent abolishment of the business unit. No more drugs are left for the GM unit to sell. When MSD spun off Organon 3 years ago, it handed over a large number of its off-patent drugs to Organon including Atozet, Cozaar, and Singulair. Only the Januvia series whose patent term remained and the company’s new SGLT-2 inhibitor drug ‘Steglatro’ had survived the spinoff. From July, all rights to Januvia will be transferred to Chong Kun Dang, and Steglatro and its combination therapy Steglujan will also be sold independently by Chong Kun Dang. No follow-up drugs await release either. The reduction of the GM unit had been expected to some extent due to the company’s shift in focus to anticancer and personalized vaccines. However, no one would have imagined that a department with about 100 employees would disappear so suddenly. Moreover, MSD Korea currently does not have a leader to oversee the company's business affairs. MSD Korea's Managing Director’s spot has remained vacant ever since Kevin Peters, who had actively engaged in communication with the labor union, took office as the Managing Director of the German branch in January. David Peacock, president of the Asia-Pacific region, is temporarily serving as the manager of MSD Korea as well. This is why concerns are rising on whether the voices of Korean employees will be well conveyed amid the change with no head in place to lead the company. The company had always chosen to go with the most profitable decision for the company so far. At the time of the Organon spin-off, the company did not hand over Januvia as it was bringing in profit then and then chose to hand it over now because the patent is scheduled to expire this year. By keeping Januvia, the company had earned more than KRW 200 billion in sales over the past 2 years from June 2021. Employees in the GM unit who will now be eligible for voluntary retirement would also want to make the most profitable decision for themselves. Therefore, the key question is, how well will the company compensate the employees? For employees who may wish to remain, the company should also actively consider ways to relocate personnel. The livelihood of as many as 100 employees and their families is at stake. Employees are not products that can be handed over when it’s of no use to other companies at an appropriate price. MSD Korea said, “The company will use all its available resources to help employees adapt to the new circumstances and prepare for another opportunity for growth. We will have individual meetings with each employee to sincerely discuss their career plans and concerns." It is our sincere hope that the company will hold true to its statement and that it is not just a brief excuse to calm the confusion.
- Opinion
- [Reporter's View] Suspension of drug price cut
- by Kim, Jin-Gu May 08, 2023 05:41am
- The price of Forxiga, an SGLT-2 diabetes drug, remains unchanged despite the release of a generic version. AstraZeneca applied for suspension of drug price cut execution along with an administrative lawsuit, and the court accepted it. AstraZeneca cited the reason that Forxiga's indications include not only diabetes but also heart failure and kidney disease. A generic Forxiga was released as a treatment for diabetes, and the government's price cuts that affect other indications are unreasonable. Unlike the US, Switzerland, and Australia, Korea does not differentiate drug prices by indication. In other words, unless the current drug pricing system changes in a broader framework, it is very likely that the administrative lawsuit filed by AstraZeneca will not be accepted by the courts. There is no way that AstraZeneca did not know about this situation. Nevertheless, AstraZeneca applied for a suspension of execution of Forxiga's drug price cut. It is a very clever decision from AstraZeneca's point of view. Considering that it usually takes more than three years for the Supreme Court to make a final decision, it can prevent expected losses of tens of billions of won every year for more than three years. However, at the same time, it cannot be free from criticism that it abused the suspension system. Coincidentally, the day Forxiga's drug price cut enforcement suspension was cited was the day the 'Drug Price Cut Refund and Refund Act' passed the National Assembly. This law is about the collection and refund of pharmaceutical expenses paid or unpaid during the period of suspension or execution of drug price cuts. The government has emphasized the necessity of this bill. Biopharmaceutical companies complained that the judiciary's decision to suspend the execution of drug price cuts caused a loss in health insurance finances. The biopharmaceutical industry criticized that it was concerned about violating the constitutional right to sue. Regarding the government's claim that the pharmaceutical industry abuses the judiciary's suspension of execution, he protested that it was only a "partial problem." The face of the biopharmaceutical industry, claiming the injustice of the drug price reduction/refund law, has become meaningless. Rather, it has strengthened the government's argument that has emphasized the necessity of the bill. According to the government's logic, health insurance financial losses of tens of billions of won are expected over the next few years. Neither the government nor the biopharmaceutical industry can view this positively. On the day the bill to correct the problem was passed, he did that very problematic act. Criticism comes from the pharmaceutical industry that the degree of cleverness is too much. The bill will come into effect six months after promulgation. After 6 months, such an application for suspension of execution is burdensome. If the Forxiga drug price cut had been six months later, would AstraZeneca have made the same decision as it is now?
- Opinion
- [Reporter's View] Patent expired original
- by Lee, Tak-Sun May 03, 2023 05:38am
- For original drug patents that have expired, the upper limit is adjusted under the authority of the Ministry of Health and Welfare when a generic drug with the same product appears. Original drugs will be reduced to 70% of the previous price for one year, and from the second year onwards, the price will drop to the same 53.55% level as generic drugs. If the price drops by half, sales are likely to drop in proportion to him. That's what we call performance cut in half. Therefore, from the company's point of view, it is necessary to devise a strategy to prevent generics from being produced. First, it is to delay the expiration of the patent. In order to further guarantee the validity of a 20-year substance patent, the patent period can be extended by requesting an extension of the duration. In Korea, there is no limit on the extension of the duration. Therefore, pharmaceutical companies have been delaying the expiration of patents by extending the duration in consideration of the drug registration period. Another is to register subsequent patents. Commonly referred to as an evergreening strategy, it is to delay the release of generics by additionally registering salt patents, formulation patents, composition patents, and use patents. Domestic pharmaceutical companies sometimes make salt-modified drugs to avoid extending the duration or subsequent patents. However, as the Supreme Court disallowed it as a means of avoiding extending the duration, it is now widely used to neutralize subsequent patents. However, the salt-modified drug is not the same drug as the original drug because the salt is different. Therefore, even if a salt-altering drug comes out, the upper limit of the original drug does not fall. Maybe the original drug's evergreening strategy worked. Last year, generics were also released for diabetes treatment Tenelia, but the price ceiling did not fall because they were all salt-modifying drugs. Despite this patent strategy, generics are bound to come out. Last month, generics of Forxiga, a diabetes treatment, were poured out in heaps. Therefore, the original drug price was scheduled to be adjusted ex officio this month. The drug price cut was temporarily postponed because AstraZeneca, a pharmaceutical company, applied for suspension of execution to the court, and this was tentatively quoted. AstraZeneca applied for suspension of execution to the court because Forxiga, unlike generics, has indications other than diabetes. The company claims that it is unreasonable to cut drug prices that affect all other indications for which benefits have been applied, such as heart failure and kidney disease. It is interpreted that AstraZeneca pulled out a suspension card as a last resort when generics came out and drug price cuts became a reality. If the company suffers huge property damage, the possibility of suspension of collection increases. As mentioned earlier, the original drug's original drug price cut is halved, so property loss is inevitable. As a result, the rate of suspension of execution is also high. Once a suspension of execution is cited, price adjustments are not made until the outcome of the trial on the merits, so pharmaceutical companies can buy time for a long time. The longer the drug price adjustment period is, the more it will inevitably lead to financial losses for health insurance. As this problem has emerged, there is a movement to crack down on the door through revision of the law. The amendment to the Health Insurance Act, which provides for the recovery and refund of drug expenses paid or unpaid during the period of suspension of enforcement following the outcome of administrative litigation to cancel drug price cuts by pharmaceutical companies, passed the National Assembly on the 27th of last month. It is expected that if this law goes into effect six months after the government promulgation, the number of indiscriminate applications for suspension of enforcement by dissatisfaction with drug price cuts will decrease. A partial amendment to the Patent Act was proposed to limit the extension of the patent term to 14 years after approval and limit the number of patent rights that can be extended. If this law is passed, it is expected that generics will be more likely to be released earlier than before. I would like to think about introducing a more active reduction strategy, such as applying the ex officio adjustment condition limited to generics of the same product to late-release drugs with the same active ingredient after the expiration of the substance patent. There may be many things to consider, such as resistance from the pharmaceutical industry, laws and principles, and equity, but if the mechanism for adjusting authority is narrowly designed as it is now, strategies or tricks that abuse it will inevitably continue.
- Opinion
- [Reporter's View] Rise of patients and concerns
- by Eo, Yun-Ho Apr 18, 2023 05:37am
- Medicine is a product with strong public goods characteristics. It is a means of curing human diseases and maintaining health. In Korea, national health insurance is also applied. Another fact is that it is the company that makes and sells it. The purpose is to make a profit. Pharmaceuticals are high-value-added products that can make a lot of money. In this situation, the awakening of patients now exerts its power again, raising the popularity of prescription drugs. Their actions are influencing the decision-making itself for entitlement to benefits. These days, new drug development trends are anticancer drugs and rare incurable diseases. Innovative new drugs are emerging one after another in various cancer areas directly related to human life. There is also hope for patients with rare incurable diseases who have been suffering without proper treatment because only a small number of patients suffer from them. But those drugs are expensive. Most of these drugs are super-expensive. It's been a long time since it was approved by the Ministry of Food and Drug Safety, but prescriptions have not been made and the process for listing benefits has not been completed. The HIRA and the NHIS are bombarded with complaints from patients. Complaints even reach the National Assembly. The Ministry of Health and Welfare and its affiliated agencies are inundated with questions and criticism. Even without determining whether or not to receive reimbursement itself, cases, where the patient's power was clearly demonstrated in the speed of registration, are gradually accumulating. Pharmaceutical companies say that when they promote a drug, it is for the sake of patients. That is true, but there are times when there is no inspiration. It is thanks to companies that are inclined towards 'products' without a dilemma. That's why we hope that the industry's approach to patients will be accompanied by rigorous prudence.
- Opinion
- [Reporter's View] Preferential price for innovative drugs
- by Lee, Jeong-Hwan Apr 06, 2023 05:54am
- Second Vice Minister of Health and Welfare Park Min-soo promised the National Assembly that he would make a rule that gives preferential prices to medicines made by innovative pharmaceutical companies over other medicines. This is in the same context as Vice Minister Park Min-soo clearly expressed his will to improve the drug pricing system, which includes specific drug price preferential treatment for innovative new drugs and essential drugs, at a meeting of the Ministry of Health and Welfare's press conference in February. Last month, at the Health and Welfare Committee of the National Assembly, Vice Minister Park asked that the preferential treatment policy for innovative drugs be made clear so that the mandatory drug price preferential legislation proposed by Rep. Seo Jeong-sook of the People’s Power of Innovative pharmaceutical companies should not be passed and the review suspended. To borrow the expression at the time, Vice Minister Park said, "(Within the Pharmaceutical Industry Promotion and Support Special Act), we will materialize the presidential decree and prepare a policy plan to improve the health insurance drug price system. Please keep an eye on it. Legislation of compulsory regulations is burdensome." When inquiries from Rep. Seo Jeong-sook, who proposed a bill to enforce preferential drug pricing in the 21st National Assembly, and Democratic Party lawmaker Nam In-soon, who first proposed a bill for voluntary drug price preferential treatment in the 20th National Assembly, Vice Minister Park stopped the legislation and confirmed the implementation of the policy. am. It is noteworthy that Vice Minister Park's promise to enact lower-level laws is in stark contrast to the Ministry of Health and Welfare's passive attitude in making lower-level laws, citing trade frictions. However, it is regrettable that Vice-Minister Park did not suggest a specific timing for establishing a preferential drug price policy. Even now, it should have set the exact time when the policy will be made and released so that it can be free from criticism that the enactment of the lower statute is very slow. In November 2018, the government promulgated legislation on preferential drug prices, including the addition of the upper limit on drugs manufactured by innovative pharmaceutical companies, after passing the plenary session of the National Assembly. However, even after four years, it is evaluated that the work of enacting sub-laws to support the effectiveness of drug price preferential treatment has not progressed forward. This is the background of Congressman Seo, who sympathized with the long wait and frustration of the pharmaceutical industry and introduced a bill to change the voluntary drug price preferential regulation into a compulsory regulation. The expert committee of the Welfare Committee also supported Congressman Seo's bill with the intention that the legislation was not unreasonable and the necessity and legitimacy were recognized. There was a movement for a sub-decree. In October 2021, the Ministry of Health and Welfare through the Korea Health Industry Development Institute ordered a 'research on drug price support policies for innovative pharmaceutical companies that conform to the international trade order'. However, even in this study, the original plan to announce the research results in May 2022 was not properly followed, and the vacuum in the lower statute has been walking in place so far. This is the reason why Rep. Seo and Rep. Nam did not hide their suspicious suspicions from Vice Minister Park, who revealed his will to legislate the rule of preferential drug pricing without fail. Fortunately, this time, along with the expression of Vice Minister Park's will, the Ministry of Health and Welfare's movement to enact substantive sub-statutes is accompanied by an atmosphere. The Ministry of Health and Welfare, along with NHIS, HIRA, and three pharmaceutical organizations, supervised a public-private consultative body to improve the drug price system. Vice Minister Park said, “Even if the law is changed to a mandatory regulation to prepare a preferential drug price clause, there is no problem when the Ministry of Health and Welfare does not comply with it, so it is ineffective.” It was explained that if the government's will and policy direction were firm, it could create a preferential treatment plan without amending the law. As the Ministry of Health and Welfare has virtually ended the work of collecting opinions from domestic and foreign pharmaceutical companies and bio companies, Vice Minister Park believes that he must directly roll up his sleeves and take the lead so that specific drug price preferential regulations can be completely unveiled at least within the first half of this year. If the enactment of sub-statutes is postponed again without a promise in the face of the temporary suspension of the National Assembly legislation, it will be difficult to be free from criticism that the Ministry of Health and Welfare is taking the legislative branch lightly. It is hoped that the enactment of the sub-statute by the Ministry of Health and Welfare will eliminate the need for review by the National Assembly for the enforcement of preferential drug price regulations ahead of the midsummer heat wave that will be approaching this year without fail. In addition, it is hoped that the sub-laws to be enacted will be filled with effective content to quench the thirst of the pharmaceutical industry, which has been waiting for five years and repeatedly complaining. It is important to carefully reflect on the preferential provisions that the industry really wants, not the formal administration of the National Assembly in preparing a plan for preferential drug prices. In order to nurture the biopharmaceutical industry and realize the creation of global blockbuster domestically produced new drugs, it is possible to achieve economic effects as well as realize policy goals by establishing sincere preferential measures by listening to the opinions of the industry.
