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- 2026-04-09 06:29:31
- Company
- SCD accelerates EU approval of Eylea biosimilar
- by Nho, Byung Chul Oct 05, 2023 05:27am
- SCD announced on the 4th that it had decided to proceed with final negotiations after receiving confirmation of the details of the due diligence conducted for three days from September 6th to 8th by the Eylea biosimilar European partner company. Inspectors designated by the European partner company visited the SCD Eylea biosimilar CMO production site and inspected production facilities and GMP regulations for three days. As a result, it was concluded that there were no problems with the application for European EMA approval, and it was reported that the first result was confirmed on September 26th. An SCD official said, “This extension of the Binding Term Sheet deadline is not because there was a problem with due diligence or negotiations, and we have not yet received the final report on the due diligence results, so we have inevitably extended the signing of this contract.” SCD explained, “The inspectors are comprised of experts with more than 20-30 years of experience in the European EMA approval review process, so it is almost the same level as the approval inspection.” He added, “Now that all preliminary work for the contract has been completed, we will strive to achieve results within the targeted time.” In addition, it was confirmed that SCD received $3 million (approximately 40.8 billion won) in down payment related to the previous Eylea biosimilar supply contract in Canada.
- Company
- New drugs only account for 8.5% of all drug spending in KOR
- by Eo, Yun-Ho Oct 05, 2023 05:27am
- A study revealed that the expenditures spent on new drugs account for only 8.5% of Korea's total drug cost. On the 4th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) released the results of 'A study on the analysis and rationalization of drug expenditures for new drugs in Korea' conducted by Professor Jong-Hyuk Lee from Chung-Ang University’s College of Pharmacy. Study results showed that the expenditures spent on new drugs from the national health insurance finances accounted for 8.5% of total drug costs and 2.1% of the total national health insurance medical costs. In particular, the financial impact made by new drugs on national health insurance finances was among the lowest when compared with other OECD countries. This study was initiated in recognition of the growing need to strengthen coverage of innovative new drug treatments for domestic patients, and how the new innovative drugs were having difficulties being listed due to the perception that they are a significant burden on health insurance finances. Professor Lee's research team examined Korea's current drug expenditure structure by analyzing the expenditures made by 227 new drugs that were listed during the past 10 years (2012-2021). More specifically, the results showed that the annual drug expenditure spent per new drug product was about KRW 6.1 billion, with the total drug expenditure spent over the past 10 years being KRW 164.2 trillion. The study also analyzed the financial impact made by new drugs according to their cost-effectiveness verification method (economic evaluation, economic evaluation exemption, weighted average price, etc.), and the proportion of expenditures spent on new drugs listed under the risk sharing agreement (RSA) system, and the financial impact of new drugs according to their serious disease classification status. In this analysis, the financial expenditures spent on items that were waived pharmacoeconomic evaluation data submissions and were subject to RSA, which account for most of the new drugs used to treat serious diseases such as cancer and rare diseases, were low at 0.3% and 2.7%, respectively, of the total drug cost. In addition, when analyzing the financial impact of new drugs according to their serious disease classification status, drug expenditures spent on new drugs for severe and rare diseases (cancer, rare diseases) were found to be only account for 3.3% of the total drug costs, suggesting the low treatment access available for domestic patients with severe and rare diseases. Professor Lee said, “The 10-year financial expenditures spent on domestic new drugs that were analyzed in our study were lower than what was previously known, confirming that their impact on finances was lower than the general perception.” He added, "In particular, new drugs that are exempt from submitting from pharmacoeconomic evaluation data, which account for the majority of new drugs being introduced recently, not only have a low financial impact, but also have a low annual drug cost per item, and the ratio of finances spent for new drugs for severe rare diseases is also low. Therefore, the expenditure structure requires some improvement in terms of improving access to treatment." Meanwhile, PhRMA (Pharmaceutical Research and Manufacturers of America) also shared its report on the international comparison of accessibility and financial impact of new drugs in each country (based on IQVIA data) of 460 global new drugs approved in the U.S., Europe, and Japan over the past 10 years (2012-2021). According to PhRMA’s analysis results on the financial impact of new drugs of each OECD country, as of 2021, Korea's financial impact of new drugs was 4%, ranking 30th out of 32 countries, the third from the last, followed by Turkey, Greece, and Mexico. Korea’s financial expenditure structure for new drugs was at a similar level. In addition, compared to major developed countries, Korea had the lowest financial expenditure ratio for new drugs, with a 3~6 times difference from major countries such as the United States stands at 26%, Germany at 19%, the United Kingdom at 18%, and Japan at 14%.
- Company
- GSK Korea appoints Maurizio Borgatta as new General Manager
- by Oct 05, 2023 05:27am
- On the 4th, GSK Korea announced it appointed Maurizio Borgatta, former General Manager of GSK Portugal as its new general manager. After joining GSK in 2015, the new GM is known to have successfully launched and sold GSK’s treatments and vaccines in the European region, including Belgium, Spain, Italy, and the UK. Also, he contributed to increasing patient access to treatments in various countries including the United States, Japan, and Germany by launching a treatment for severe eosinophilic asthma and expanding indications. Since 2021, he served as general manager of GSK Portugal, where he successfully achieved the expansion of indications for 8 innovative drugs and enabled the market entry of 2 new vaccines. He said, “With employees and executives at GSK Korea, we will strive to strengthen access to GSK's broad vaccine portfolio and other innovative treatments for Korean patients and ensure stable supply to stay ahead of disease and contribute to improving the quality of life of patients in Korea.” Rob Kempton, who led GSK Korea since 2020 until recently, was appointed Head of the Vaccines Market in Europe.
- Company
- The reimbursement process for Cosentyx and Taltz
- by Eo, Yun-Ho Oct 05, 2023 05:27am
- The insurance reimbursement registration process for IL-17A inhibitors as first-line treatment for ankylosing spondylitis has been at a standstill for a long time. As a result of the investigation, the two IL-17A inhibitors approved in Korea, Cosentyx of Novartis Korea and Taltz of Lilly Korea completed discussions on expanding the HIRA level of coverage in February, but the application has not yet been implemented. These drugs simultaneously submitted applications for reimbursement expansion based on the ‘ASAS-EULAR axSpA treatment recommendations 2022’ in July last year. Interleukin drugs are already available for prescription as first-line treatment for ankylosing spondylitis in more than 30 countries. In Korea, both drugs are approved for reimbursement only as second-line therapy after a prescription for a TNF-α inhibitor. According to the ASAS-EULAR guidelines revised last year, IL-17A inhibitors were upgraded to the same recommendation grade (A) and level of evidence (1a) as TNF-α inhibitors. It was mentioned that both agents are currently being used as first-line biological agents for the treatment of ankylosing spondylitis, and it was officially confirmed that the therapeutic positions between the two agents are the same. Additionally, in the case of TNF-α inhibitors, there are concerns about tuberculosis. For this reason, treatment for latent tuberculosis must precede the use of TNF-α inhibitors. However, despite anti-TB treatment, the occurrence of tuberculosis due to the use of TNF-α inhibitors is still reported in several studies. Therefore, for some patients who are at high risk of infection, such as tuberculosis, or who have comorbid conditions, such as heart failure, for which it is difficult to prescribe TNF-α inhibitors, other treatment options are needed. Hong Seung-jae, insurance director of the Korean Society of Rheumatology (Department of Rheumatology, Kyung Hee University Hospital), said, "IL-17A inhibitors are already widely used as first-line treatments overseas, and the 2022 overseas treatment guidelines also state that for patients with ankylosing spondylitis accompanied by skin diseases such as psoriasis, IL-17A inhibitors are already widely used as first-line treatments overseas. “As 17A inhibitors are recommended with priority over TNF-α inhibitors, we hope that coverage for IL-17A inhibitors will be expanded in Korea as soon as possible so that we can provide customized treatment tailored to patient characteristics,” he said. Meanwhile, the number of ankylosing spondylitis patients has rapidly increased by nearly 50% over the past 10 years (35,592 in 2013, 52,616 in 2022). It is a disease that mainly develops at a young age, and domestic patients go through a waiting period of about 40 months until they receive an accurate diagnosis. In addition, the disability level of ankylosing spondylitis is the highest level 2, making it a serious disease that qualifies people with severe disabilities and even exemption from military service. Among domestic ankylosing spondylitis patients, 72.6% are male, and one in two male patients are in their 30s and 40s, and are most socially active, so there are concerns about a decline in occupational ability due to symptoms. In fact, in a study targeting domestic patients, patients were absent from work due to their symptoms, and the annual cost of lost productivity time due to this was approximately 14 million won, and this increased as disease severity and functional limitations increased.
- Policy
- Health plans expected to be implemented after NA audit
- by Lee, Jeong-Hwan Oct 05, 2023 05:27am
- The preferential drug price policy plan that reflects the value of new drugs and the 2nd comprehensive national health insurance plan, which the pharmaceutical and bio-industry are closely eyeing, is expected to be unveiled after the National Assembly audit this year. The amendment to the Instructions for the Biohealth Innovation Committee under the direct control of the Prime Minister is also expected to be promoted after the National Assembly audit. The schedules have been delayed compared to the original plan, and the government plans to complete the practicalities after collecting opinions from each sector after the completion of the National Assembly audit. The results were revealed on the 4th when the Press Corp covered the Ministry of Health and Welfare’s plans on the innovative drug pricing system reform plan and the 2nd Comprehensive National Health Insurance Plan. According to the original plan, the final results of the agenda were scheduled to be announced within September or October. The reform of the drug pricing system that reflects the innovative value of new drugs and health security seeks to provide preferential drug treatment for values of new drugs such as clinical superiority essential drug status, and use of domestic APIs. The MOHW originally intended to specify the policy direction by operating a public-private consultative body for preferential pricing of innovative new drugs and announce it before the NA audit, the announcement is likely to be made after the audit due to delayed operations of the consultative body. The announcement of the 2nd Comprehensive National Health Insurance Plan is also being delayed compared to the original plan. The pharmaceutical and bio-industry is paying close attention to the direction of the pharmaceutical policies that will be included in the 2nd Comprehensive National Health Insurance Plan. This is because the pricing systems for new drugs, incrementally modified drugs, and generic drugs depend on the direction of health insurance policy operation. The MOHW said that its researchers are seeking advice from the Health Insurance Policy Deliberative Committee and that it plans to hold a public hearing after the National Assembly audit to collect a broader range of opinions for the 2nd Comprehensive National Health Insurance Plan. A MOHW official said, “We are currently establishing plans after collecting various opinions. We plan to establish the 2nd Comprehensive National Health Insurance Pla within this year at the latest for disclosure.” The launch of the Biohealth Innovation Committee which will be directly controlled by the Prime Minister, is also being delayed. The committee was being prepared as a government control tower to foster Korea’s pharmaceutical bio industry. The establishment of the Biohealth Innovation Committee, a domestic pharmaceutical and bioindustry development organization that was set to be directly operated by the Prime Minister, is expected to be announced and operated through a presidential order. The MOHW is preparing to issue a notice on the order and appoint members to the Innovation Committee, and plans to launch the committee as soon as possible. According to the proposed regulations, the Biohealth Innovation Committee will consist of less than 30 members. The government plans to appoint the Prime Minister as the chair and 30 members including 12 ministers from each ministry and 17 civilian members. The 12 ministerial members will include Ministers of the Ministry of Health and Welfare, Ministry of Strategy and Finance, Ministry of Education, Ministry of Science and ICT, Ministry of Trade, Industry and Energy, Ministry of Foreign Affairs, and Ministry of SMEs and Startups, as well as the minister for the Office for Government Policy Coordination, the Chairperson of the Personal Information Protection Committee Commission, the Minister of Food and Drug Safety, Commissioner of the Korea Intellectual Property Office, and the Commissioner of the Korea Disease Control and Prevention Agency. The committee secretariat is scheduled to be established as a department called the ‘'Biohealth Innovation Promotion Team' under MOHW’s Bureau of Health Industry Division of Health Industry Policy. The MOHW’s Health Industry Policy Director will concurrently serve as the head of the Biohealth Innovation Promotion Team. The Biohealth Innovation Committee will seek to efficiently deliberate and adjust policies and tasks to comprehensively and systematically support the development of Korea’s health industry, including products and services related to pharmaceuticals, medical devices, and health technology, and their convergence and integration with cutting-edge technologies. The committee is also expected to be launched after the National Assembly audit.
- Policy
- Medical expenses exceed ₩1 trillion
- by Lee, Tak-Sun Oct 04, 2023 05:35am
- The number of lung cancer patients has steadily increased, and health insurance medical expenses exceeded 1 trillion won last year. The NHIS (Chairman Jeong Ki-seok) announced this by using health insurance treatment data to promote the status of health insurance treatment for lung cancer patients from 2018 to 2022. The number of patients treated increased by 25,236 (27.7%↑) from 91,192 in 2018 to 116,428 in 2022, and the average annual increase rate was 6.3%. The number of men will be 70,564 in 2022, an increase of 22.5% (↑12,969) compared to 57,595 in 2018, and the number of women will be 45,864 in 2022, an increase of 36.5% (↑12,267) compared to 33,597 in 2018. Looking at the composition of medical staff by age group, of the total medical staff (116,428 people), those in their 70s accounted for the most at 34% (39,541 people), those in their 60s accounted for 32.2% (37,516 people), and those in their 80s or older accounted for 17.8% (37,516 people). 20,704 people) followed. For men, those in their 70s accounted for the highest proportion at 37.3%, followed by those in their 60s at 31.1% and those in their 80s or older at 18.8%. For women, 33.9% were in their 60s, 28.8% were in their 70s, and 16.2% were in their 80s or older. Health insurance medical expenses for lung cancer patients increased by 39.9% (364.8 billion won) compared to 2018, from 915 billion won in 2018 to 1.2799 trillion won in 2022, with an average annual increase rate of 8.8%. Looking at medical expenses per person over five years, it increased by 9.6% from 10.03 million won in 2018 to 10.99 million won in 2022. Lung cancer refers to a malignant tumor that occurs in the lung and can be divided into 'primary lung cancer' in the tissues that make up the lung and 'metastatic lung cancer' in other organs and spreads to the lung. It is said that smoking is the leading cause of lung cancer known to date, with results showing that approximately 80% of deaths due to lung cancer are due to smoking. Lee Sang-cheol, a professor in the Department of Respiratory Allergy at National Health Insurance Ilsan Hospital, said, "More than 70% of the causes of cancer are due to environmental factors and lifestyle habits such as smoking, high-fat diet, drinking, and exposure to carcinogens. As we age, these risk factors decrease. “The amount of exposure increases,” he said. He explained, “The gradual increase in the elderly population due to aging is also the cause of the increasing cancer incidence rate in elderly patients.”
- Company
- Price cuts for 35 generics suspended…only 0.5% of all
- by Chon, Seung-Hyun Oct 04, 2023 05:35am
- The second case of suspension of execution of price cuts among 7,000 generic drugs emerged on the 5th. The price cuts for 12 generic items from Hutecs Korea will be suspended for 9 months. The number of products for which drug price reductions have been suspended, including the 17 drugs whose price cuts have been temporarily suspended, has increased to 35. However, the number of items that received a stay of execution is so small that it only accounts for 0.5% of all the generics that received price cuts. According to the Ministry of Health and Welfare on the 25th, the price cuts for 13 Hutecs Korea’s items will be suspended until June 30 next year. The prices of A Cet SR Tab, Alzpezil Tab 5mg, Lyreca Cap 75mg·25mg·50mg, Exforte Tab. 5/160mg, Amolvikar Tab 5/20mg·5/40mg·1/40mg, and Crestibe Tab. 10/5mg·10/10mg have been reduced by up to 15% on the 5th, but their prices will be kept at the level before the price reduction for 9 months. The MOHW announced price cuts for about 7,000 drugs from the 5th through a partial amendment announcement of the ‘drug reimbursement list and reimbursement ceiling price table.’ However, Hutecs Korea filed an administrative lawsuit and suspension of execution, claiming that it could not accept the drug price cuts for 13 items, after which the court decided to put the drug price cuts on hold. As a result, price cuts for 17 items from two companies received a stay of execution for 7 to 9 months after filing an administrative lawsuit. Previously, the Seoul Administrative Court decided to suspend Medica Korea's drug price cuts for 5 items, including Telmisartan Tab 40mg, until April 30, 2023. In the case of Hutex Korea, this is the first case where the drug price cut was reverted due to a lawsuit after the drug price cut had been implemented. Not only Medica Korea, but also Abbott Korea, SS Pharm, NBK Phparm, and Youngil Pharm filed a lawsuit to cancel the drug price cut, which resulted in a temporary suspension of execution before the drug price cuts were implemented. The products for which the companies filed lawsuits to cancel the drug price cuts had their drug prices reduced due to procedural inadequacies even though they submitted data that met the highest price requirements, such as conducting bioequivalence tests, and thus pursued legal action. For example, there was one case where a drug’s price was reduced after a bioequivalence test was performed and the conversion was completed because the company did not submit the change permit. There are also cases where the company conducted bioequivalence tests that cost hundreds of millions of won, but permit changes were not completed due to schedule delays. Also, even though companies proved that they fulfilled the requirements for the use of registered APIs, some have been classified as being subject to drug price cuts by raising issues over other ingredients listed in the authorization permit. However, among the total 7,355 drugs whose prices have been reduced, the number of products whose execution of price cuts has been suspended accounts for only 0.5%. There are a total of 179 pharmaceutical companies subject to drug price cuts, and only 3.4% of them filed administrative lawsuits. As there is no legal justification to claim unfairness in the drug price reduction process, the number of administrative lawsuits filed by pharmaceutical companies is expected to be minimal. Hutecs Korea filed a lawsuit to cancel only 13 of its 153 products that received drug price cuts, which amounts to only 8.5%. Hutecs Korea reduced the price of three dosage forms of Exforte tablets but filed a lawsuit to cancel the price cut for only one, 10/160mg dose, product. Medica Korea filed a lawsuit to cancel only 5 of the 91 products that were set to receive drug price cuts, which amounts to only 5.5%. This means that it accepted drug price cuts for 86 of its items. However, it is highly likely that the number of products for which drug price cuts will be suspended will continue to increase. The temporary stay of execution of price cuts made for the 15 items from 3 companies may receive a formal stay of execution before the end of the provisional suspension period. The execution of drug price cuts for 3 items, including Abbott Korea's Lypsta Plus Tab 10/5mg, has been suspended until the 28th of this month. The drug price reduction for 9 items including SS Pharm's S-nofen Tab, 2 items including NBK Pharmaceutical's Cebicox Cap 200mg, and 3 items including Youngil Pharmaceutical's Necfo Tab 5/160mg will be put on hold until the 29th. With cases of drug price cut suspensions rising, there is a possibility that other pharmaceutical companies may also file additional administrative lawsuits. This is because the companies can reduce financial losses during the suspension of the execution period, regardless of the success or failure of the drug price cut cancellation lawsuit. For example, the 35 items for which drug price cuts were suspended did not incur any losses due to price reductions.
- Company
- New urothelial cancer drug Padcev attempts reimb in KOR
- by Eo, Yun-Ho Oct 04, 2023 05:35am
- Padcev, the first targeted antibody-drug conjugate (ADC) for urothelial cancer, is attempting reimbursement in Korea. According to industry sources, Astellas Pharma Korea recently submitted a reimbursement application for its Padcev (enfortumab vedotin), its antibody-drug conjugate (ADC) that is directed against Nectin-4. The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet. The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. Therefore, the industry’s eyes are on how well Padcev can fare in Korea’s drug reimbursement process this year. Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 39% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group. Mi-so Kim, Professor of the Department of Oncology at Seoul National University Hospital, explained, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later line therapies after using immunotherapy in the second-line due to the lack of a standard later line treatment option. Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and will open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.” Urothelial cancer is the most common type of bladder cancer that accounts for around 91% of all bladder cancers. 8 of 10 patients are over the age of 60, and due to its prevalence in the elderly and its frequent recurrence and metastasis, it is a fatal disease with a 5-year survival rate of around 5%. It had been considered a representative disease that has a large unmet need due to its limited treatment options and the low quality of life caused by accompanying urinary disorder symptoms such as hematuria, frequent urination, and residual urine.
- Policy
- New pharmaceutical data protection system begins
- by Lee, Jeong-Hwan Oct 04, 2023 05:35am
- Legislation is being promoted to abolish the drug reexamination system, establish a separate legal basis for the drug data protection system, encourage research and development in the pharmaceutical industry, and strengthen the monopoly on the IMDs market. It also includes provisions to reduce the burden on pharmaceutical companies due to the reexamination system and overlapping operations by integrating the drug post-marketing safety management system into the risk management system. On the 3rd, Jeon Hye-sook, a member of the Democratic Party of Korea, announced that she had proposed a partial amendment to the Pharmaceutical Affairs Act to this effect. The Ministry of Food and Drug Safety has been insisting on the necessity of this legislation since 2020, and it is expected to be passed in the 21st National Assembly. The key to Representative Jeon Hye-sook's bill is to abolish the drug reexamination system and establish a separate legal basis for the drug data protection system. We encouraged domestic pharmaceutical companies to actively conduct clinical trials by expanding the scope of application of the law so that drugs approved by submitting new clinical trial data in addition to drugs under the existing reexamination system can also be subject to the data protection system. Looking at the data protection system contained in Representative Jeon Hye-sook's bill, 'orphan drugs' are 10 years from the date of product approval, 'new drugs' are 6 years, and 'the type of active ingredient is changed to improve the safety, efficacy, and usability of drugs that have already received product approval.' The protection period for clinical trial data was set at 6 years for 'medicines that require submission of new clinical trial data, such as 'for drugs that require submission of new clinical trial data to obtain product approval', and up to 4 years for 'other drugs that require submission of new clinical trial data to obtain product approval.' This is expected to lead to the effect of granting a 4-year data protection period to pharmaceutical companies that developed a new phase 3 clinical trial, allowing them to have market exclusivity for a certain period of time. This means that the current re-examination system has improved the irrationality of failing to grant a re-examination period to some IMDs. Rep. Jeon Hye-sook explained, “The drug re-examination system is intended to ensure post-marketing safety, and it has been pointed out that it does not fit the purpose of the data protection system.” She explained, "We will improve the pharmaceutical industry's research and development capabilities by submitting new clinical trial data in addition to drugs under the existing reexamination system so that approved drugs can also be subject to data protection."
- Policy
- Legislation to prevent reverse-payment agreements
- by Lee, Jeong-Hwan Oct 04, 2023 05:35am
- Legislation is being promoted to eradicate the so-called 'generic reverse-payment agreements’ that prevent the launch of generic drugs by delaying or suspending the price cuts made on new drugs. If passed, the legislation will stipulate the reduction in the reimbursement price or suspension of reimbursement of drugs that took part in unfair collusion, such as reverse-payment agreements. Rep. Young-Seok Seo of the Democratic Party of Korea announced on the 27th that he proposed a bill for the partial amendment to the National Health Insurance Act that contained the contents above. The current law sets the price of the original drug that is currently listed for reimbursement in Korea at 70% of its current price, and the price of the generic at 59.5% of the original drug’s price when the first generic version of the original drug is released. When the third generic drug is released, the price of the original and the generic drugs are set at 53.55% of the previous existing drug price. Rep. Seo believes that although the launch of generic drugs is what leads to the price reduction of the original drug, the issue is that some companies are employing expedient measures to avoid lowering the price of their drugs with collusion. The Fair Trade Commission had uncovered acts of collusion between companies, where pharmaceutical companies producing and releasing generic versions agreed not to produce or release their respective generic versions in return for receiving exclusive domestic distribution rights from the original company. In this regard, Rep. Seo proposed a bill to prevent pharmaceutical companies from making unfair profits through collusion by reducing the reimbursed insurance ceiling price or suspending reimbursement of drugs that took part in unfair collusion. Rep. Seo explained, “If generic drugs are not released due to collusion between pharmaceutical companies, it is the patients that suffer the burden of drug cost and the health authorities that bear the increased financial leakage burden. The bill can establish a fair drug sales order and prevent waste of Korea’s health insurance finances.”
