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- 2026-05-09 17:28:01
- Policy
- Unpaid medical benefits “fully solved next month”
- by Kim, Jung-Ju Dec 26, 2019 06:31am
- The government reflected the unpaid medical benefits in the budget of ₩100 billion in next year's budget. Most of this year's unpaid payments have been resolved, and the unpaid payments of nursing institutions, which appeared at the beginning & the end of the year, are being resolved somewhat. However, dues are reflected in next year's budget, and may occur partially in some regions. The MFDS said in a recent question by the Professional Reporters Council that the unpaid medical benefits to be received by nursing homes this year have been resolved by supplementary budget, and the budget has been secured by reflecting the expected unpaid payments next year. The medical care budget for next year is about ₩7 trillion, an increase of ₩600 billion from ₩6.4 trillion this year. The reimbursement per capita has increased by more than 16%, the MFDS said that it was first reflected in the budget to prevent unpaid payments. Looking at the budget by year, it is increasing by ₩4.59 trillion in 2015, ₩4.81 trillion in 2016, ₩5.24 trillion in 2017, and ₩5.61 trillion in 2018. Nursing institutions, including pharmacies and other hospitals, have complained of difficulties in management due to the delayed payment of medical benefits for several months at the beginning & the end of the year. According to the MFDS, Ministry of Health and Welfare Committee Seung-Hee Kim's report presented at the National Audit, the unpaid medical benefit in 2018 was ₩869.5 billion, the highest ever. This is an increase of ₩430.9 billion (98%) compared to 2017, which is doubled compared to last year. As a result, the unpaid amount reflected in next year's medical benefit budget amounted to ₩108.7 billion. However, the MFDS explained that due to the portion reflected in next year's budget, the unpaid amount may be partially generated in some attempts. The Ministry of Health and Welfare said, “We expect little delay in payment every year, and the nursing institutions like pharmacies and hospitals would take a breather”.
- Policy
- Moon Care on new drug and generic pricing in 2019
- by Kim, Jung-Ju Dec 26, 2019 06:29am
- The Moon Jae-in administration’s ambitious Moon Jae-in Care has directly affected the drug pricing system, essential to the insurance coverage. The healthcare coverage enhancement policy lowered the threshold of new drug listing standard, but further complicated the post-marketing drug pricing system. Also Ministry of Health and Welfare’s (MOHW) had its pharmaceutical benefit sector to concentrate their drug pricing capability on the designing of the technicalities of the healthcare policy. Lowered threshold, but complicated post-marketing evaluation for all-around management of generic and new drug The impact of the groundbreaking insurance coverage enhancement program by the Moon Care has struck down on the general drug pricing system this year. In the beginning of the year, the government, as previously notified, presented generic pricing and new drug listing system revision, listed drug reevaluation and pharmaceutical expense management all at once. For the bigger frame of enhancing healthcare coverage and reducing the people’s medical bills, the government has decided to progressively reinforce coverage on new drug while strictly managing already-listed new drugs and generics. To better manage quality of generic after the valsartan contamination issue, the government has decided to link approval and drug pricing system under the name of ‘3+1 System.’ Ministry of Food and Drug Safety (MFDS) revised the generic approval system and pricing system to gradually lower pricing of items depending on the number of listed items. In July, MOHW issued an administrative notice on partially revised regulation of ‘Pharmaceutical Affairs Decision Making and Approval Criteria’ with the said changes, and plans to finalize it by the end of the year. On the other hand, the barrier of new drug listing has been alleviated. The RSA eligibility and scope have been expanded for high-cost new drugs as constantly demanded by the industry. But for an item to choose the option, it has to pass the three following conditions; a drug used for treating cancer or disease either recognized by ‘Special Case Standard for Partial Copayment Benefit’ or ‘Special Case Benefit for Patients with Rare Disease and Chronic Disease’; drug with clinical efficacy proven to improve quality of life or recognized so by a related committee; drug recognized as Breakthrough Therapy Designation (BTD) or Priority Medicines (PRIME) by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), respectively, or recognized as equivalent by Drug Reimbursement Evaluation Committee (DREC). But some have raised an issue about the regulator turning Health Insurance Policy Deliberation Committee (HIPDC) on-paper reimbursement listing review into a face-to-face review for new drug exempted from negotiation. They claimed it would cripple the system’s effectiveness and accessibility. Meanwhile, the government plans to establish a listed drug reevaluation standard and to elaborate the post-marketing evaluation procedure. The three reevaluation types—external reference pricing, listing contract expired drug, and performance-based post-marketing evaluation—would be categorized by literature-based reevaluation and real world evidence (RWE)-based reevaluation. But the industry is firmly opposing on the notion of reevaluation, as the result of the reevaluations would eventually either reduce reimbursed price or adjust the general pricing lower. Reevaluation procedure on reimbursed drugs (summarized by Daily Pharm) The government also finalized the ‘7.7 Pricing System’, which raised both Korean and global pharmaceutical companies’ eyebrows, as its initial version and enforced it from this year. First it started from the KORUS FTA renegotiation agenda, but technically the government dropped both benefit for Korean-made new drug exporting to global markets and the U.S.-based multinational pharmaceutical companies’ demand for new drug pricing benefit. Considering the government had its agenda behind it, the industry reprehended the government last year for its concerning and unfair action. The Drug Pricing Benefit for companies states the manufacturer and suppliers of WHO-recommended essential drug or National Essential Drug as designated by Article 2 of the Pharmaceutical Affairs Act should be confirmed to manufacture and supply without an issue. And the government would strip the pricing benefit of the companies, if they have issues supplying drugs on the Reimbursed Drug List, or were imposed with administrative penalty or convicted by a court for providing illegal rebate, according to Paragraph 2 of Article 47 of the Pharmaceutical Affairs Act. But there are exceptions. A company that suspends the supply of the drug with following reasons would be exempted from the penalty; in case manufacturing plant is shut down or closed; manufacturing, import or sales approval is suspended or canceled; new issue of safety or effectiveness arises; manufactured or imported supply shortage occurs due to surged demand (except when the demanded amount is within the predicted billing amount); when the company is faced with inevitable natural disaster. The government is also continuing on with the rebate prevention policy. The so-called ‘K-Sunshine Act’ was enforced and required pharmaceutical companies to file, archive and submit financial profit provision record (within the allowed amount by Pharmaceutical Affairs Act), or the expenditure report. At the moment, the government is reviewing the submitted expenditure reports. The government is focusing on analyzing and investigating expenditure types to set the system down. However, the companies may undergo investigation by prosecution when correlation between their expenditure and rebate are clearly found. The insurance coverage enhancement policy implemented this year constructed with substance-by-substance reimbursement, expanded listing of high-cost drug, and listed drug reevaluation would base even more specified drug pricing policy for next year. The industry is expected to see the effect in the field. Moon Care ploughs on with coverage enhancement with selective reimbursement This year was the first year for the first National Health Insurance Comprehensive Plan. Last year the government was sketching out the technicality of the Moon Care, and this year it was busy executing the detailed policy actions in the set order. Starting from the first pilot program of primary healthcare-based chronic disease management (initiated from December 2018), the government gradually increased healthcare coverage on ultrasound scan, essential check up and treatment for lower abdomen (rectums and anal passage) and urinary system (kidney and bladder). Moreover, coverage on cavity treatment for children under 12, thoracoabdominal MRI scan and Korean medicine treatment has been granted this year. In addition, the government started the pilot program for Community Care that integrated healthcare and welfare, providing customized benefit by each region across the country. On July 2, President Moon Jae-In presented the importance of National Health Insurance, performance of coverage enhancement and prospective plan at the ‘Second Anniversary Briefing of NHI Coverage Enhancement Initiative Implementation’ convened at NHIS Ilsan Hospital. The healthcare coverage statistics presented by the government in July found the coverage rate in general hospital was increased from 62.6 percent in 2016 to 67.2 percent in 2018. But with the figure, the public is skeptical about the government raising the National Health Insurance premium by 3.2 percent. The skepticism is not only about the premium increase, but also about ultimately reducing the people’s medical bills by fixing insurance income source and increasing rate of the government funding. Both industrial organizations and civic groups are urging the National Assembly to push up the government funding rate up to 20 percent to keep the moderate balance of medical service fee and coverage rate. Currently, Ministry of Economy and Finance has promised MOHW to provide the government insurance funding of 14 percent for next year, which MOHW would utilize on reinforcing insurance coverage programs.
- Policy
- Korea’s Drug expense management to settle on ‘trade-off’
- by Lee, Hye-Kyung Dec 24, 2019 06:10am
- Apparently, the government is to redirect finance saved by dropping drug with unproven clinical efficacy from reimbursement listing and adjusting drug price to provide coverage on new drugs for treating severe and rare disease. It would mean that the ‘trade-off’ strategy kept mentioned by Korea’s Ministry of Health and Welfare (MOHW), as a part of the National Health Insurance Comprehensive Plan, would be implemented soon. The technicality of the trade-off strategy and the tentatively named ‘Severe Disease Drug Expense Account’ would be included in the ‘Pharmaceutical Listing and Adjustment Standard’ MOHW is to publicly notify soon after the pre-announcement period started from September. Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW reiterated the notion of ‘money pot’ when describing the trade-off strategy at a policy seminar convened on Dec. 19 about insurance coverage on immunotherapy by Lawmaker Kim Kwang-soo. The deputy director pointed out, “England has Cancer Drugs Fund (CDF) that sets a road map to manage National Health Service (NHS)-covered drug and its annual action plan, but it has a limitation on the ‘money pot’”. The government official indirectly mentioned of the Korean ministry planning to reallocate saved drug reimbursement to cover severe disease drug expense as a trade-off. Deputy Director Choi stated, “Whether it be a household or a state, they need to get an access to money when need be. But there are not many pots of money available, realistically. We need to reevaluate drugs to sort out drug underperforming and ineffective than expected and even considered valueless in other countries”. Recently, Health Insurance Review and Assessment Service (HIRA) held a public hearing on pharmaceutical reimbursement reevaluation standard and procedure, and stated it would conduct a post-marketing review on high-cost anticancer and rare disease treatments with uncertainty in clinical efficacy based on foreign government insurance listing status, usage frequency, and ratio of claimed reimbursement. In short, the government is to revisit pharmaceutical expense increase rate and reimbursement claim cost. Deputy Director Choi stressed, “The ministry is trying to create a pot of money, or an account, by reevaluating listed drugs and reusing saved finance on anticancer or rare disease treatment. Only when we save money from the reevaluation, we would be able to use it as resource to cover anticancer or rare disease treatment”. A so-called trade-off or money pot is a tentatively named Severe Disease Pharmaceutical Expense Account as stated the National Health Insurance (NHI) action plan. The action plan aims to generate an account from adjusted and saved NHI expense according to pharmaceutical reevaluation to utilize it on enhancing coverage over high-cost severe disease treatments. The government is considering various means to operate the Severe Disease Pharmaceutical Expense Account without revising statute, but by having National Health Insurance Service (NHIS) to manage the account separately like the National Health Promotion Fund. In September, Song Young-Jin from the Pharmaceutical Benefits Division published an article in the September issue of HIRA Policy Report and also stated “The government plans to differentiate evaluation style or gradually apply evaluation model, taking in account of unique pharmaceutical quality, on selectively reimbursed drug, high-cost severe disease treatment, conditionally approved drug, evaluation-exempted drug or drug underperforming than expected.” The government official also has mentioned of establishing future reevaluation initiative by reviewing past pharmaceutical reevaluation cases and similar cosigned research, and also set pilot program for year 2020 to expand reevaluation system gradually.
- Policy
- Moon Jae-in Care needs speed control
- by Lee, Hye-Kyung Dec 23, 2019 06:29am
- There were voices of concern that the government's policy to strengthen health insurance guarantees could weaken domestic economic growth potential and national competitiveness. The Korea Employers Federation (Chairman of KEF, Kyung-sik Sohn) held a session on the 19th to evaluate the 1st National Health Insurance Comprehensive Plan (2019 ~ 2023) under the theme of 'National Health Insurance, Sustainable?'. The debate was held in the public's concern about the financial crisis of health insurance due to the overlap of policy factors such as increased measures to the medical use due to aging. In the past 10 years (2008 ~ 2018), Korea's medical expenses growth rate is 6.9% per year, three times the OECD average of 2.3%, and the fastest rate among 36 member countries. In the case of National Health Insurance, which accounts for the largest proportion of medical expenditures, which have increased by 8% every year for the past five years (2014 ~ 2018), are expected to increase by more than 13% this year. Yong-geun Kim, the Vice President of the KEF, said, “Recently, medical expenditures are rapidly increasing, which raises the public's concern about the financial crisis of health insurance, at the current rate of increase in medical expenses, it will soon become a factor that weakens growth potential and national competitiveness as excessive national resources are put into the medical sector”. Mr. Kim said, “Expansive radical guarantees will entail excessive insurance premiums, which will eventually lead to a vicious cycle of lowering private investment and consumption and reducing economic vitality, and it needed to adjust the speed of security measures”. The government plans to raise the rate of health insurance premiums by 3.2% annually to cover the cost of expanding the coverage, but this also means that in the era of low growth with an economic growth rate of around 2%, the burden on the people and businesses is beyond. Mr. Kim said, “Companies paying 43% of the total health insurance income cannot afford to pay premiums anymore due to the deteriorated business environment and poor performance, we need to focus on improving fiscal soundness by rationally improving health care spending while minimizing premium rate hikes”. He also called for a full reform of the health insurance system to make more efficient use of limited resources, and he cited the resolution of moral hazards in the medical field, revitalization of private insurance subscribers, the introduction of incentives for reducing medical expenses, the expansion of comprehensive budget system, the reduction of drug costs, and the introduction of the primary doctor's system. In addition, he urged a preemptive reform of the committee's operating system so that the opinions of companies (labor-management) and community members who are responsible for health insurance can be reflected in a greater proportion. Professor Hee-kyun Yang, Kyung Hee University, who was in charge of the first presentation, predicted that the burden of subscribers would increase because there is no way to solve the overuse of medical services due to the expansion of the guarantee coverage. Therefore, in case of excessive anticipated medical use (MRI, ultrasound, anticancer drugs, treatment materials, etc.) and services (elderly outpatient’s flat sum system, copayment limit, long-term hospitals, upper ward benefits) The government said that it is necessary to prepare a management plan for discounts and surcharges. As a plan to alleviate the phenomena of large hospitals, it was required to establish a four-stage medical delivery system (clinics-hospitals-advanced hospitals-nationalwide hospitals), including the establishment of a nationwide hospital using the total contract method. The second speaker, Seong-in Chang, a professor at Yonsei University, predicted that the cumulative reserves, which amounted to ₩20.8 trillion in 2017, will be exhausted in 2022. Professor Chang said, “To secure financial health of health insurance, we must break away from the stereotype of solving all things with one health insurance and establish a hybrid medical security system that properly connects social security and market economy principles, we need to consider introducing a lifetime health account that manages parts as an individual account”. Seok-yong Chang, a professor of Eulji University, the third speaker, pointed out that despite the establishment of the 1st National Health Insurance Comprehensive Plan, there is still no high-level health development plan. Professor Chang said, “As the rules of the game need to be carefully reviewed, we need a social consensus on strengthening the representation and professionalism of members and the formation of public interest committees in decision governance such as the Health Insurance Policy Review Committee and the Financial Steering Committee, and considering the enormous amount of financial operations, it is necessary to establish a pre-control mechanism of the National Assembly”.
- Policy
- Who holds the key to end financial toxicity?
- by Lee, Hye-Kyung Dec 22, 2019 09:52pm
- (From left) Professor Kim Hee-jun of Chung-Ang University Hospital, Professor Lee Dae-Ho of Seoul Asan Medical Center Department of Oncology, Professor Park Ji-hyun of Konkuk University Medical Center Department of Hemato-oncology, Professor Suh Dong-Churl of Chung Ang University College of Pharmacy, Baek Jin-young Korea Kidney Cancer Association, and Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW Doctor: “Although it’s non-reimbursed, the immunotherapy option is recommended for kidney cancer. But it’s expensive” Patient: “How much is it?” Doctor: “It’s about 10 million won per month”. Patient: “Can I get fully recovered”. Doctor: “It’s not guaranteed”. Patient: “It’s too expensive”. Doctor: “Discuss and decide with your family after checking the price, if you have a private insurance.” At a policy seminar convened on Dec. 19 about enhancing coverage for immunotherapy, President Baek Jin-young Korea Kidney Cancer Association enacted a common conversation between a doctor and kidney cancer patient. The seminar was organized by Lawmaker Kim Kwang-soo at a seminar room in the National Assembly Member’s Office Building. President Baek said, “During the three-minute counseling time, cancer patients have to listen to a doctor talk about financial toxicity first than the severity of their own health. It happens quite often.” Professor Kim Hee-jun of Chung-Ang University Hospital and Professor Park Ji-hyun of Konkuk University Medical Center Department of Hemato-oncology nodded their heads at President Baek’s story. Professor Kim stated, “It’s dishearteningly relatable. Once when a colleague visited and listened to a conversation between my patient and me, she commented it sounded like I was selling a private insurance. I have to ask patients about their private insurance status and limits. And even if I show a survival rate graph after the talk, I know they are not paying an attention anymore.” She added, “When Obdivo announced its launch in Korea in 2015, I was excited. But it’s disheartening that I cannot use it for all patients.” President Baek and Professor Kim proposed that the special case benefit applying five percent patient copayment rate from first-line therapy could be raised. President Baek claimed “Cancer patients should also stop being stubborn about the five percent copayment rate, but embrace the opportunity to choose different options with higher copayment rate. It is also crucial for pharmaceutical company, patient and government to share the initial risk of uncertainty in treatment efficacy, and to establish reasonable standard of reimbursement.” Professor Kim also added, “At first, I was grateful for the five-percent copayment rate. But the more new drugs were launched, the longer patients had to fight against cancer. Back in the day, cancer patients had about less than a year to survive. But the survival period has gotten longer. We need to carefully consider raising the copayment rate a little bit for all cancer patients to benefit from the system.” Professor Lee Dae-Ho of Seoul Asan Medical Center Department of Oncology pointed out, “The root of all problem is money.” The professor elaborated, “We need to consider if the people would be happy to enhance coverage on four major severe diseases, and if they would be happy to spend their tax money on cancer patients,” and “I also don’t mean to reduce the price of drugs for those pharmaceutical companies trying to bring new drugs to Korean patients.” “It’s skeptical if profit-seeking pharmaceutical companies are truly for the patients,” because it is “unconvincing for insurer paying for the health insurance expenditure [to expand coverage on anticancer treatment], when the companies demand for improved access on new drug, but don’t put an effort to lower their drug price,” the professor added. New drug reimbursement application, it’s up to pharmaceutical companies After a series of criticisms from the panels, Ministry of Health and Welfare (MOHW) defended their position with vulnerable financial situation. Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW urged, “Besides people’s overestimation of immunotherapy as a miracle elixir, it is still an unknown territory as an insurer who has to pay for the insurance expenditure. We need at least a tool to confirm its response rate to grant insurance reimbursement”. Accordingly, Health Insurance Review and Assessment Service (HIRA) is conducting a RWD research for post-marketing evaluation, and National Health Insurance Service (NHIS) is conducting a study on expenditure efficiency for financial feasibility. Deputy Director Choi noted, “We always feel sorry for patients and their family, and we are regretful that we cannot provide the right weapon for medical profession to fight against cancer with. However, it is also regretful that all the responsibility for the unfortunate state is blamed on the government”. The government basically pointed out the public thinking the government is keeping the last key back to end the pharmaceutical company’s tug-of-war against the government, insurer and NHIS with the new drug pricing negotiation. Deputy Director Choi elaborated, “The government is not the one with the last key. MOHW, NHIS and HIRA exist to keep health insurance expenditure justifiable. As the insurance finance is not from a bottomless pot, the ministry set the drug pricing regulation for pharmaceutical companies to apply for reimbursement with according to their drug’s financial impact and patient protection measures and to have negotiation with government for the reimbursement listing.” Deputy Director Choi Kyung-ho of Pharmaceutical Benefit Division at MOHW “Negotiation does not proceed with a unilateral yielding, but it is rather a process of reaching an agreement and seeking a way within the system. The government asks for new drug’s response rate, financial toxicity, and clinical data to base reimbursement decision. But some companies don’t even speak a word. We are not to name names, but the pharmaceutical companies are the ones holding back the key”, the deputy director reprehended. The government official also mentioned of a foreign financial support system, Cancer Drugs Fund. Deputy Director Choi said, “Some have suggested a sort of ‘money pot’ is needed when setting up the National Health Insurance Comprehensive Plan. So we are trying to make an individual account to cover anticancer and rare disease treatments with money saved from reevaluating drugs with low efficacy or not delivering expected effect”. Regarding the five-percent special case reimbursement rate, the official said “We are considering on expanding selective reimbursement scope.” “We are contemplating a realistic solution like preliminary pricing reduction for a limited number of cancer patients. Although monotherapy exists, also having a combination therapy makes the situation complicated. We would do our best to improve patient’s new drug accessibility,” said the deputy director.
- Policy
- Only one case of non-tumor initial human administration test
- by Lee, Tak-Sun Dec 20, 2019 06:35am
- Among the clinical trials conducted by multinational pharmaceutical companies in Korea, the first human-administered trial was found to be very rare. According to the Korea Clinical Trial White Paper No. 2 published by the Korea National Enterprise for Clinical Trials (CEO Dong-Hyun Ji, KoNECT) on the 18th, there was only one initial human dosing study in non-tumor fields conducted by multinational pharmaceutical companies from 2016 to 2018. The initial human administration study mainly examines the pharmacological effects and side effects of the human body in healthy adults and determines the tolerated dose. It will also identify pharmacokinetic properties. Proceeding with the patient will explore the potential for effectiveness. Clinical progress and analysis is known to be difficult because it determines the direction of successful commercialization of the drug. Activation of Phase I clinical trials by multinational pharmaceuticals, such as the first human administration trial, is essential for raising the domestic clinical level. In addition, it means that commercialization of new drug development will be carried out from the beginning, which is related to the activation of new drug development in Korea. In the case of new drugs developed in Korea, Phase I clinical trials are often conducted overseas. Table 63. Characteristics of Phase 1 Clinical Trials in Non-tumor Fields (206-2018) In the first phase clinical trials of the tumor field, the first human trial of multinational pharmaceutical companies was rare. The white paper explained that at least six were approved. During the same period, Korean pharmaceutical companies undertook 28 trials of the first human trial in the non-tumoral field. This is only 7.9% of all phase I nonclinical trials. Even if it was not the first human trial, multinational pharmaceutical companies (including multinational CROs) accounted for only 4.5% of the phase I clinical trials. Tumor field was 23.3%. However, the share of multinational pharmaceutical companies increase as they move to Phase II clinical trials. In Phase II, multinational drug makers accounted for 32.3% of non-tumors and 33.6% of tumors.
- Policy
- Parliament pushes for drug revocation bill w/o sales record
- by Lee, Jeong-Hwan Dec 20, 2019 06:35am
- A bill was proposed by the National Assembly to prohibit the renewal of drug items without sales records. The legislative goal is to minimize damage to Valsartan-Ranitidine impurities (NDMA) by eliminating drugs that some pharmaceutical companies produce only the minimum quantity and do not sell in order to update the product, which is a prerequisite for permit maintenance. On the 18th, Sang-hee Kim, a memeber of the National Assembly's Health and Welfare Commission announced that she proposed a partial amendment to the pharmaceutical affairs law. Current legislation requires the renewal of a drug license and declaration in order to sell the drug after the expiration of the drug product approval and the validity date. Drugs that are not manufactured or imported during the expiration date cannot be renewed Recently, NDMA has been detected in drugs such as high blood pressure treatment, Valsartan and antacid drugs, Ranitidine. It was pointed out that a drug that manufactured and imported only a minimum quantity for the item update and was not actually sold or distributed. Representative Sang-hee Kim pointed out the problem that the drug can be renewed without submitting the data. When renewing a drug product, it is necessary to submit data such as side effects collected during the expiration date, quality control and improvement measures to confirm safety and effectiveness. Drugs that are not actually sold can be renewed without submitting data. In order to protect the public health, it is necessary to check the status of safety and quality control of all medicines when updating drug products. Representative Kim said, “It is the core of the bill to restrict the renewal of product licenses and notifications for drugs that are not manufactured or sold within the validity period, I will build a foundation to provide safe and effective medicines”.
- Policy
- Swiss companies to benefit from mutual recognition of GMP
- by Lee, Tak-Sun Dec 19, 2019 11:20pm
- A mutual recognition agreement of Good Manufacturing Practice (GMP) with Swiss pharmaceutical regulator Swissmedic would not only invigorate pharmaceutical trade between two countries, but also it is expected to be a meaningful step towards Korea earning recognition of international level of regulation. The mutual GMP recognition agreement would bring significant influence on Korea, as Switzerland is one of A7 countries, which the Korean regulators refer to when deciding new drug pricing, and is also a pharmaceutical powerhouse with headquarters of Novartis, Roche and other major global companies. Korea’s Ministry of Food and Drug Safety (MFDS) announced on Dec. 18, it would be officially signing a Mutual Recognition Agreement (MRA) of GMP with Swissmedic. When the agreement comes in effect, GMP evaluation when applying for new drug approval in either country would be exempted. GMP certificate from either country would be validated in the other country. As a result, local due diligence, written review and other review procedures would be eliminated and ultimately accelerate the drug approval process. Korean pharmaceutical and bio companies would be able to reduce commercialization preparation period in Switzerland with the mutually recognized GMP certificate. The same goes for Swiss pharmaceutical and bio companies. Their new drug would be exempted from MFDS’ GMP evaluation. Actually, Korea has more drugs importing from Switzerland than exporting to them. Pharmaceutical powerhouse Switzerland houses major global pharmaceutical companies like Novartis and Roche. To this date, MFDS reviewers paid a visit to the local manufacturing plant and conducted GMP due diligence when reviewing Swiss pharmaceutical products. The MRA would drop GMP due diligence and other written review, which would reduce Swiss drug’s approval period in Korea by three to four months. It would be remarkable benefit for Novartis, Roche and other Swiss pharmaceutical companies. Targeting the Korean market, the Swiss companies now have the upper hand against other U.S. or European pharmaceutical companies. Although Korea exports less volume of pharmaceutical products to Switzerland, the intangible value generated from the MRA would shine through for the Korean industry later in the future. Signing of the MRA could mean that such a major pharmaceutical powerhouse recognizes Korea’s regulatory capability. The GMP recognition agreement MFDS signed with Ecuador in 2014 only applies to Korean drugs applying for approval in Ecuador, and it does not apply on Ecuadorian drug in Korea. MRA can only be signed by two countries when their regulatory standards are mutually recognized as equivalent level. Accordingly the signing of the MRA proves Switzerland also thinks highly of Korean regulatory standards. This could be favorable for Korea when negotiating with other countries. MFDS is currently seeking for opportunities to negotiate MRA on GMP with countries that have joined Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/s). Increasing number of countries with high faith in Korean regulatory system would simplify local new drug approval process for Korean-made drugs and also positively influence the industry’s business. MFDS official explained, “As Switzerland is not part of EU, it had an independent regulation apart from EMA and Korean companies had to go through another set of review process. The country is a home of global companies like Roche and Novartis, and CMO companies like Lonza. Korea has been recognizing Switzerland as one of A7 external reference pricing countries with their outstanding review capability that other advanced countries also approve of”. “MRA with Switzerland on GMP would be an opportunity for Korea to raise awareness of Korea’s trustworthy regulatory capability to other countries”, the official added.
- Policy
- Mandatory evaluation of MFDS when using all off label drugs
- by Lee, Jeong-Hwan Dec 19, 2019 06:35am
- A bill is piloted to require government assessments when using 'off-labeled drugs' in patients that go beyond the indications that have been proven in clinical trials, which are phases of drug marketing. Representative Sang-hee Kim of the National Assembly on Health and Welfare on the 18th proposed the partial revision of the Pharmaceutical laws and regulations. Off-labeled use of current drugs differs from individual use procedures, such as those subject to reimbursed benefits and non-reimbursed, over-the-counter and anticancer drugs. Representative Sang-hee Kim said that the pharmaceutical industry is passive in research and development of medicines that meet the medical needs such as rare and severe diseases, children, and pregnant women, and encourages the use of off-label. It is pointed out that the use of off-labeled drugs with different efficacy, effect, indications, and dosage is not frequently recognized by the Ministry of Food and Drug Safety, which is a drug approval authority. Representative Kim criticized that MFDS conducts off-label use evaluation only for non-reimbursed generic drugs according to the Ministry of Health and Welfare, so systematic safety management of over-licensed drugs is not possible. Representative Kim said, “To prevent this, we need to establish a legal basis for the safety and effectiveness evaluation of MFDS for all use of off-label drugs, we will promote public safety by establishing a systematic evaluation environment for non-permission use”.
- Policy
- First Samsca generic submits approval application
- by Lee, Tak-Sun Dec 19, 2019 06:34am
- 오츠카 The first generic to follow Korea Otsuka Pharmaceutical’s Samsca (tolvaptan), indicated for treating euvolemic hyponatremia, has submitted an approval application to Korean Ministry of Food and Drug Safety (MFDS). The industry believes Myung In Pharma would be the one to grab the approval as it has been challenging the patent and developing the follow-on drug. According to MFDS on Dec. 17, a tolvaptan-containing drug submitted an application for approval. The drug in 15 mg dose is administered once-daily to treat patients with hyponatremia. As stated by the Drug Approval-Patent Linkage system, MFDS notified Otsuka, the patentee, about the submitted application. Otsuka’s Samsca is protected by a patent on solid preparation and its manufacturing method of the medicine including bezoazepine, which is to be expired on June 20, 2028. In last May, Myung In Pharma evaded infringement of Samsca’s drug patent with Intellectual Property Trial and Appeal Board’s ruling. The company filed a defensive confirmation trial for the scope of a right, which then was affirmed. And in the same month, the company’s bioequivalence test protocol was cleared. Based on the clues, the industry is convinced Myung In Pharma has probably applied for the approval. The original Samsca is the first-and-only hyponatremia treatment approved by MFDS in September 2011. Hyponatremia is an electrolyte-associated adverse event commonly found in hospitalized patient, which can cause serious neurologic complications. Before Samsca was available, intravenous fluid with high concentration of sodium was given to the patients, but it did not treat the cause. Recently, Samsca was granted with reimbursement approval on indication for treating patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). If Myung In Pharma snatches the first generic title in the market, it is expected to earn a significant commercial success with minimum competitors.
