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- 2026-05-01 14:44:57
- Policy
- New price adj guidelines set for drugs with unstable supply
- by Lee, Tak-Sun Dec 06, 2023 06:00am
- On the 5th, the National Health Insurance Service established the ‘Pricing adjustment negotiation guidelines for insurance ceiling price of drugs.’ The guideline gained attention for specifying the negotiation content for drugs that have an unstable supply. The guideline also includes the submission of pre-negotiation materials for drugs with unstable supply and premium pricing measures. The NHIS explained that the purpose of the Pricing adjustment negotiation guidelines is to stabilize the supply and demand of drugs that are essential for patient care but do not have smooth supply due to low profitability. The pricing adjustment negotiations are conducted for drugs that have received a negotiation order from the Ministry of Health and Welfare as deemed necessary based on the NHIS Drug Reimbursement Evaluation Committee’s evaluation results of submitted pricing adjustment applications. After receiving the negotiation order, subject companies need to submit evidence of drug cost for the drug subject to negotiation and data on the contract production (import) volume that would be produced (imported) after adjusting the upper price limit. The new guideline requires drugs that need prior discussion to speed up the negotiation period by submitting the abovementioned data prior to negotiations. Therefore, if the MOHW requests prior consultation, the company is required to submit evidence of drug cost for the drug subject to negotiation and data on the contract production (import) volume that would be produced (imported) after adjusting the upper price limit. In addition, if there is an urgent request from the public-private consultative body on the need for a specific drug with unstable supply, the estimated contract production (import) volume data after adjusting the upper price limit must be submitted within 5 days of request. The guidelines set for drugs with unstable supply and demand show the government’s plan to first discuss the contracted production volume amount that will be produced after pricing adjustments to speed up production. Also, drugs with unstable supply and demand will be granted a premium when raising the upper price limit. One percent of the price will be additionally raised if the drug satisfies 1 of the 10 items in the list of policy-related premium pricing conditions, which include cases evaluated as ‘exceptional cases such as infectious disease crises or urgent supply shortages, for which central administrative agencies request cooperation related to drug supply.’ In other words, pricing adjustments requested by the public-private consultative body for drugs with unstable supply and demand will be granted a premium. However, the policy-added benefit is not to exceed a maximum of 7%. The guideline also specified a follow-up plan conditional on production expansion. The NHIS and the company can contract a certain amount of mandatory production (import) volume as needed for a certain period of time, which the company must produce (import) and supply faithfully according to the contract. It also prohibits companies from applying pricing adjustments again for 3 years after receiving pricing adjustments but leaves the door open for cases of medical necessity for the public, such as the spread of infectious diseases. Specifically, negotiations and pricing readjustments are allowed for drugs deemed necessary by the Drug Reimbursement Evaluation Committee. According to the formula, only up to 22% of Selling, General and Administrative Expenses (SGA) will be recognized, and non-operating profits and losses will not be recognized. In addition, a maximum of 17% of the total cost is recognized as reasonable profit, and the distribution margin of 3.44% will be applied to high-priced drugs and 5.15% to low-priced drugs. Hae-Min Jung, Deputy Minister of NHIS Pharmaceutical Management Department, said, “We created the new guideline because it took a long time for pharmaceutical companies to prepare data required for the previous adjustment negotiations, and issues such as sales and administrative costs had hindered prompt negotiations. The NHIS will conduct prompt negotiations per the new guidelines and actively sign and manage supply volume contracts to ensure that essential drugs are supplied to the front line." Meanwhile, the government is actively reviewing drug price increases for drugs with unstable supply and demand and is considering including them eligible for adjustment applications. In line with the government's policy, the guidelines for pricing adjustment negotiations also include exceptional negotiation clauses for drugs with unstable supply and demand. Only this year, prices of magnesium hydroxide, pseudoephedrine budesonide, suspension for nebulizer were granted price hikes through pricing adjustment negotiations, and acetaminophen fever reducer syrups and cefditoren pivoxil Fine Granule and constipation treatments that contain lactulose are being reviewed for pricing adjustments.
- Policy
- MOHW will expand drugs subject to price adjustments
- by Lee, Tak-Sun Dec 05, 2023 05:48am
- To ensure higher drug prices for medicines in short supply, the Ministry of Health and Welfare (MOHW) announced its plan to revise the evaluation standard for drugs eligible to apply for pricing adjustments to increase the upper limit price (list price). Accordingly, national essential drugs and those selected by public-private consultative bodies as having unstable supply will be eligible to apply for price increase adjustments. According to industry sources on December 4th, the MOHW is reviewing a plan to include national essential drugs and drugs suggested to be in short supply by its public-private consultative body as subjects in its evaluation standard to adjust the upper limit price. The current evaluation standard allows drug pricing adjustments to be made for drugs ▲with no alternative drugs are available; ▲absolutely necessary for treatment; ▲necessary for treatment, and the cost of medication is cheaper than its alternative but the administration and ingredients are the same, and there is only 1 manufacturer produces the drug. A drug essential for treatment should meet the following criteria, ▲have no available alternative therapies (including medicines) ▲is used for serious diseases with low survival rates ▲is used for rare diseases that affect a small group of patients ▲has demonstrated clinically significant improvement such as a substantial extension of survival time, and other cases where the committee evaluates it absolutely necessary for the patient’s treatment. The drugs that have recently had supply shortages and raised concern in pharmacies, often do not meet the current evaluation criteria. To resolve the current issue, the government is considering revising the evaluation criteria to include national essential drugs and drugs deemed necessary for price increase by the public-private consultative body to resolve the supply instability issue. The Ministry of Food and Drug Safety recently added 6 types of 7 pediatric medicines, including acetaminophen syrup and tulobuterol transdermal patches to the list of national essential drugs. The industry views this as a step towards adding the qualification for drug price increase adjustment requests for national essential drugs. The industry views the proposed revision is a measure to quell potential disputes over criteria that may arise in the future, as the government is considering the drug price increase as part of measures to address the supply shortage of particular drugs. Consequently, there is speculation that drugs that do not qualify for adjustment requests will still go through the price increase process, with their legitimacy being granted through subsequent revisions of the criteria. On December 7th, HIRA's Drug Reimbursement Evaluation Committee will review pricing adjustment requests for 5 pharmaceutical products that have supply shortages. The candidate products include Sama Pharm's 'Setophen Suspension', Johnson & Johnson Korea’s 'Children's Tylenol Suspension', Boryung's ' Meiact Fine Granule Boryung', Kukje Pharm's 'Ditoren Fine Granules', and JW Pharmaceutical's 'Dulackhan Easy Syrup', among others.
- Policy
- Tagrisso and Leclaza complete drug pricing negotiations
- by Lee, Tak-Sun Dec 04, 2023 05:13am
- The National Health Insurance Serivce was found to have completed pricing negotiations with the companies for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as first-line treatments for non-small cell lung cancer through the risk-sharing agreement (RSA) system. However, as the two were applied different types of RSA, the actual reimbursed prices of the two drugs are expected to differ somewhat. According to industry sources on the 1st, AstraZeneca, which owns Tagrisso, and Yuhan Corp, which owns Leclaza, recently completed drug price negotiations with the NHIS. The pricing negotiations had been ongoing with the NHIS since late September for Tagrisso, and since late October for Leclaza, but the authorities had reportedly treated the two drugs as a single set for reimbursement deliberations. Yuhan Corp has been providing Leclaza as a first-line treatment to patients free of charge through an Early Access Program (EAP) until its reimbursement, without limiting the number of patients. This was why the initial treatment refund type RSA was not applied during its pricing negotiations., Initial treatment refund-type RSA is a risk-sharing approach that takes into account uncertainties such as the effectiveness of the drug during the initial treatment period. Instead, Leclaza was applied 2 types of RSA during negotiations – Refund type and Expenditure Cap type RSA. On the other hand, Tagrisso was applied initial treatment refund type, refund type, and expenditure cap type RSA. Due to differences in the type of RSA applied, the NHIS seemingly has balanced the prices of the two drugs by setting different refund rates. As such, the refund rate for Leclaza, which was not applied the initial treatment refund-type RSA, will be higher than that of Tagrisso. As such, the actual price of Leclaza is also likely to be somewhat lower than that of Tagrisso The list price is also expected to decrease slightly with the increase in the reimbursement rate. Currently, the insurance price ceiling (list price) is set at KRW 68,964 per tablet for Leclaza, while Tagrisso (80 mg) is set at KRW 212,148 per tablet. As Leclaza is taken three times a day, and Tagrisso once a day, the total drug cost is slightly cheaper for Leclaza. However, depending on the refund rate, the actual difference in price may increase further.
- Policy
- Preferential pricing plan will be further discussed by HIPDC
- by Lee, Tak-Sun Dec 04, 2023 05:12am
- The government’s announcement of the plan to improve Korea’s drug pricing system to properly compensate for the innovation value of new drugs (hereinafter referred to as the New Drug Preference Pricing Plan) is expected to be made around the end of this month. The plan was originally set to be presented for deliberation at the general meeting of the Health Insurance Policy Deliberation Committee (HIPDC) on the 8th of this month, but the Health Insurance Policy Deliberation Subcommittee decided that the agenda requires further discussion. According to the industry on the 3rd, the New drug preference pricing plan had been presented as an agenda for deliberation on the 22nd, but the subcommittee decided to continue further discussions. As such, another subcommittee meeting is expected to be held around the middle of this month. Prior to this, the contents of the New drug preference pricing plan will be shared at a meeting with the pharmaceutical industry. This is also expected to be held in the middle of this month, ahead of the subcommittee meeting. The New drug preference pricing plan has been discussed with the pharmaceutical industry since January this year. The government has been working on a plan since the end of last year to strengthen the competitiveness of homegrown new drugs and foster the pharmaceutical and bio industries. The industry has also consistently called for drug pricing incentives for homegrown new drugs that have proven non-inferiority to existing drugs, saying that more practical measures are needed to encourage innovative pharmaceutical companies. As such, the ministry held 5 public-private consultative body meetings and 6 working-group level meetings with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the Korea Biomedicine Industry Association, and the Korean Research-based Pharmaceutical Industry Association until June this year. Since then, the Ministry of Health and Welfare has taken time to organize the final draft, collecting opinions from related organizations in consideration of the financial soundness of insurance finances and feasibility. In addition, the MOHW had added other measures, such as adding drug price preservation plans for drugs with unstable supply and demand. Currently, the most promising plans include ▲ Flexible application of ICER thresholds by prioritizing innovation for pharmacoeconomic evaluation of innovative new drugs ▲ Preferential drug pricing for domestically developed innovative new drugs (apply highest price among alternative drugs) ▲ Preferential drug pricing for natural drugs at the same level as cell therapies ▲ Expansion of drugs for severe diseases that deteriorate the quality of life to be allowed exemption from pharmacoeconomic evaluative and applied RSA ▲ Application of RSA (dual drug pricing) for homegrown new drugs planned for exports. If the plan is finalized, the industry expects that the preferential pricing of homegrown new drugs and eased post-marketing management will improve the competitiveness of the drugs overseas and allow faster listing of innovative new drugs developed abroad that are urgently needed for patient treatment.
- Policy
- Novavax’s COVID-19 vaccine receives EUA in KOR
- by Lee, Hye-Kyung Dec 01, 2023 05:35am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced that it had granted emergency use authorization (EUA) for Novavax’s ‘Novavax COVID-19 Vaccine 2023-2024’ to respond to the Omicron subvariant (XBB.1.5). The Minister of Food and Drug Safety grants emergency use authorization when the head of relevant central administrative agencies requests a medical product that is not approved in Korea to appropriately respond to public health crises such as infectious disease pandemics, and allows the manufacturer or importer to manufacture or import medical products not approved in Korea. The EUA was granted after a review of the clinical and quality data submitted by the company, consultation with experts in various fields, then deliberation and resolution by the Medical Product Safety Management and Supply Committee. The Korea Disease Control and Prevention Agency had requested the use of Novavax’s vaccine in accordance with its national vaccination plan to prevent COVID-19 in the 2023-2024 winter season which is imported and supplied by SK Chemicals in Korea. Novavax's vaccine directly injects an antigenic protein made by genetic recombinant technology into the body to induce the production of antibodies that eliminate the virus The Pfizer and Moderna vaccines that are currently available are mRNA-based vaccines that express antigenic proteins to induce the body’s immune response. The Novavax vaccine has been granted EUA in the United States and is being used with formal approval in Europe. The Ministry of Food and Drug Safety said, "The introduction of Novavax’s vaccine in Korea holds significance as it expands the types of vaccines that can be used in the field. We will continue to strengthen the safe management of COVID-19 vaccines by carrying out thorough quality control measures and collection of adverse event reports to ensure that the public can receive the vaccination with peace of mind.”
- Policy
- Imfinzi's 3-drug combo burden reduced despite nonreimb
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- An unprecedented decision was made at the Cancer Disease Review Committee meeting that was held on the 22nd. At the meeting, AstraZeneca failed to establish reimbursement standards for its Imfinzi Inj (durvalumab) as part of a three-drug combination therapy for biliary tract cancer, but the CDDC decided to grant reimbursement for the gemcitabine and cisplatin used in the combination. Accordingly, the economic burden of the non-reimbursed Imfinzi + gemcitabine + cisplatin combination as first-line treatment for biliary tract cancer will be reduced to some extent with partial reimbursement approval. A HIRA official explained, "The CDDC decided to recognize part of the patient's out-of-pocket cost spent on gemcitabine and cisplatin that is used in combination with durvalumab. We plan to weigh the cost-effectiveness and report the results to the Ministry of Health and Welfare." If the MOHW recognizes the cost-effectiveness, it will amend the anticancer drug reimbursement standards so that only 5% of the drug cost for gemcitabine and cisplatin will have to be borne by the patient when used in combination with durvalumab. Gemcitabine’s insurance price ceiling is set at KRW 200,000 per vial, and cisplatin is also not expensive, costing less than KRW 20,000 per vial, so it seems likely that the reimbursement standards will be revised without complicated procedures. However, because Imfinzi, which is priced at KRW 3.34 million per vial, is non-reimbursed, the burden borne by the patients has not been completely resolved. Imfinzi’s biliary tract cancer indication was approved by the Ministry of Food and Drug Safety in November last year, as a first-line treatment for locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin. With the approval, Imfinzi became the first new standard therapy introduced to the field of biliary tract cancer in 12 years. The approval was demonstrated through Phase III TOPAZ-1 which was conducted on 685 treatment naïve patients with unresectable locally advanced or metastatic biliary tract cancer. The Phase III trial results showed that the Imfinzi arm (Imfinzi+gemcitabine+cisplatin) showed a survival rate in the Imfinzi arm was 24.9% compared with 10.4% in the placebo arm at 2 years. The median progression-free survival (PFS) was 7.2 months for the Imfinzi arm, which was a 25% improvement compared to the 5.7 months in the placebo arm. Since obtaining the indication, the non-reimbursed three-drug regimen has been widely used in the field for the primary treatment of biliary tract cancer. AstraZeneca applied for extended reimbursement in August in consideration of the burden borne by the patients, but failed at the first gate to reimbursement, at the CDDC level. However, the CDDC accepted the reimbursement for the other two drugs used in the combination in consideration of the patient burden and the high frequency of their use. An AstraZeneca official said, “We would like to express our gratitude to the government for showing the will to ease the burden of treatment costs for patients with biliary tract cancer, who are relatively elderly, have a poor prognosis, and have a progressive disease. Regarding the CDDC results, we have been conducting internal discussions to devise a measure to extend Imfinzi’s reimbursement to patients suffering from biliary tract cancer and the medical staff who work tirelessly day and night for their treatment.” “Considering the many HCPs and patients waiting to use Imfinzi, the first new standard treatment option and immunotherapy for biliary tract cancer that was introduced in 12 years, the company will continue to work with health authorities to expand its reimbursement in the future.” AstraZeneca is now left to decide whether to be content with the results or to reorganize the data and apply for reimbursement again.
- Policy
- External ref price reevals will be carried out as planned
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- The Health Insurance Review and Assessment Service decided to thoroughly discuss its external reference price reevaluation plan with the industry. Although the government’s original plan of preparing a final draft by December is also expected to be postponed somewhat due to the prolonged discussions, HIRA explained that there is no change to its policy in starting the reevaluations next year. According to industry sources on the 29th, at the 2nd meeting on the external reference price reevaluation held on the 24th, HIRA accepted the pharmaceutical industry's opinion to continue working-level discussions until February next year when the final plan is set. Due to prolonged discussions, the final plan is expected to be prepared after February next year. Initially, HIRA planned to prepare final guidelines by December after several discussions with the industry. An industry official said, "At the meeting, the industry raised the opinion that more time was needed, so we decided to continue discussions until February. Specific details will likely come out after further meetings are held." Although the preparation of the final plan has been delayed, the government has confirmed that its policy of starting reevaluations next year remains unchanged. A HIRA official explained, “If we prepare well while gathering industry opinion, there will likely be no problem in conducting the first evaluation next year even if the final reevaluation plan is released after February.” Starting next year, HIRA plans to sequentially conduct reevaluations on the price of listed off-patent drugs, mainly chronic disease drugs, based on their overseas drug price. The price adjustments made through the reevaluations are planned to be applied from January of the following year. At the first meeting, the government had only disclosed the principle of comparing the highest price of each drug in the A8 countries (USA, UK, Germany, France, Italy, Switzerland, Japan, Canada) with the highest price in Korea, and decided to discuss further details in further meetings. The HIRA official added, “We plan to decide on subject drugs for the first year and other specifics after discussing with the industry. Internally, HIRA has already prepared a plan.”
- Policy
- BeiGene applies for reimb of its 2nd new drug after Brukinsa
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Chinese new drug developer BeiGene is working to quickly receive reimbursement for its 2nd new drug, Tevimbra (tislelizumab) following its first new drug, Brukinsa (zanubrutinib). According to industry sources, the company had immediately applied for reimbursement listing of its Tevimbra upon its approval on the 20th. Tevimbra is a PD-1 class immuno-oncology drug that received marketing authorization from the Ministry of Food and Drug Safety on the 20th as monotherapy for the treatment of adult patients with unresectable, relapsed, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy. The drug was also approved by the European Commission in September for the same indication. BeiGene had previously received approval for its 1st new drug, ‘Brukinsa’ in February last year. Brukinsa is the first drug developed by a Chinese company that received US FDA approval based on clinical trials in conducted China in November 2019. Brukinsa is indicated ▲as monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and ▲as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. The company had taken rapid steps for its reimbursement upon approval and was granted reimbursement in May, a year and 2 months since approval, as a ‘monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy.’ It was the moment when a new drug developed by a Chinese pharmaceutical company first entered the Korean market. Its insurance price ceiling was set at KRW 34,100 per capsule and was applied to an expenditure cap type risk-sharing agreement (RSA). At HIRA’s Cancer Diseae Deliberation Committee meeting that was held on the 22nd, Brukinsa’s reimbursement standards were set as ▲monotherapy for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, ▲ monotherapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and ▲ monotherapy for adult patients 65 years and older or adult patients below 65 years of age with comorbidities with naïve CLL or SLL previously treated with at least one prior therapy. The three indications that passed the CDDC review will become eligible for reimbursement once they pass HIRA’s Drug Reimbursement Evaluation Committee and the NHIS’s drug pricing negotiations. BeiGene has long been preparing to enter the Korean market, establishing a Korean branch in October 2019. Its entry is raising expectations as its immune-oncology drug may be distributed at a lower price than those sold by existing multinational pharmaceutical companies. However, it remains to be seen whether the second new drug, Tevimbra, will also succeed in promptly receiving reimbursement.
- Policy
- HIRA starts preparing for RWE-based reimb reevaluations
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Health Insurance Review and Assessment Service are accelerating the establishment of a plan to reevaluate Korea’s reimbursed drugs based on RWD (Real World Data)/RWE (Real World Evidence). The idea of RWD/RWE-based reimbursement reevaluations took shape at the public hearing for the ‘Performance-based reimbursement management plan for drugs using RWD/RWE’ that was held on the 21st. The plan is to reevaluate high-priced drugs or those that did not undergo pharmacoeconomic evaluations using RWD/RWE data. According to the industry on the 28th, HIRA's working-level officials will go on a business trip to Taiwan early next month as part of establishing the plan for RWD/RWE-based reimbursement reevaluations in Korea. Taiwan has been conducting RWD/RWE-based reimbursement reevaluations. Therefore, HIRA’s working-level officials plan to visit Taiwan's Ministry of Health and Welfare and benchmark Taiwan's RWE-based reevaluation system. RWD refers to a patient’s actual clinical data that is collected after reimbursement, such as health insurance claims data, hospital medical records, surveys, and post-marketing surveillance data. The clinical evidence based on such data is referred to as RWE (Real-World Evidence). At a public hearing that was held on the 21st, Ji-Hye Byun, associate researcher at HIRA presented the ‘Use RWE: reimbursement listing to reevaluation.’ Byun said, “For high-cost drugs that have submitted pharmacoeconomic evaluation data but have great uncertainty in its cost-effectiveness evaluation results (ICER), or for drugs that did not or cannot submit pharmacoeconomic evaluation data, we can conduct reevaluations after listing the drugs with RWD.” Associate researcher Byun is also known to be participating in the Taiwan business trip. Insurance authorities believe that there is a rising need for RWE-based reimbursement management based on RWD analysis due to the rising number of reimbursed high-priced drugs that have unclear treatment effects. Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access. So this is now the time a post-listing measure needs to be implemented. Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, added, “Addressing the uncertainty that follows the listing of high-priced drugs reimbursed with PE exemption is a pending task for all. As a tool, I expect RWD to become a good way to cover the uncertainties that remain in the area,” and expressed a positive attitude towards the introduction. The number of drugs that are exempt from submitting pharmacoeconomic evaluation data has been on the rise ever since the system was implemented in 2015. Last year, 87.5% of anticancer drugs and rare disease treatments reimbursed as new drugs were drugs that were exempt from submitting pharmacoeconomic evaluation data. In this context, RWE is rising as an alternative and appropriate follow-up management tool to verify cost-effectiveness. As HIRA held public hearings and has set out to conduct field surveys, an RWE-based reevaluation system is expected to surface soon in Korea as well.
- Policy
- DPM Choo ‘will finalize telemedicine plans this year'
- by Kang, Shin-Kook Nov 28, 2023 05:42am
- The direction of the government's policy to institutionalize non-face-to-face treatment has been set to institutionalize non-face-to-face treatment for overseas Korean nationals and prepare an improvement plan for the domestic non-face-to-face treatment pilot project within the year. Deputy Prime Minister Kyung-Ho Choo presided over the Emergency Economy-related Ministers' Meeting and Export Investment Measures Meeting on the 27th and finalized the regulatory innovation measures for new industries. Deputy Prime Minister Kyung-Ho Choo presides over the Emergency Economy-related Ministers Among the projects, the 4 regulatory innovation tasks in the field of bio healthcare field are ▲clarification of non-medical standards to foster the healthcare service industry; ▲institutionalization of non-face-to-face treatment; ▲allowing joint establishment and use of living modified organism (LMO) research facilities; and ▲expansion of subjects for rapid processing of advanced regenerative biopharmaceuticals. ◆Non-face-to-face treatment = The government plans to institutionalize non-face-to-face treatment for overseas Korean residents and improve the domestic pilot project for non-face-to-face treatment within the year. The government has decided to promote revision of the Medical Service Act to include Korean nationals residing abroad into the scope of eligible patients. The bill to amend the Medical Service Act (presented by Rep. Jong-Seong Lee) is pending at the National Assembly’s Health and Welfare Legislative subcommittee level. Furthermore, to resolve public inconvenience and improve access to medical care, the ministers decided to supplement and promote the pilot project by comprehensively reflecting opinions from various sectors, through discussion with the pilot project advisory panel, public hearings, etc. The goal is to contribute to improving medical accessibility and public health by improving and institutionalizing the pilot project for non-face-to-face treatment. Deputy Prime Minister Kyung-Ho Choo said, "We will institutionalize non-face-to-face treatment for Korean residents residing above, whose safety has been verified through the regulatory sandbox, and will improve the domestic pilot project for non-face-to-face treatment within the year." ◆Healthcare service = Due to the diversification of healthcare services, the government saw the need to clarify the uncertainties as to whether each service constitutes a medical practice (can only be performed by medical personnel) under the Medical Service Act. Accordingly, the government decided to clearly define whether certain medical services should be included or excluded from medical practice and expand the scope so that various healthcare services using new digital devices can be launched in line with technological developments. The goal is to create a foundation for revitalizing the development of new services by resolving uncertainty among non-medical healthcare service companies. The government decided to revise the 'Non-medical healthcare service guidelines and casebook' next year after conducting a pilot demand survey and collecting opinions in Q1 next year. ◆ LMO research facility = Companies had been burdened with high facility construction costs because the establishment and use of living modified organism (LMO) research facilities were prohibited. It was decided that a bill to amend to the ‘LMO Act' will be presented next year to improve this and allow joint establishment and use of research facilities to develop and test LMOs. The government predicted that this would contribute to revitalizing research by alleviating the cost burden of establishing separate facilities for relevant companies. ◆Advanced regenerative biopharmaceuticals = An expedited processing system (that reduces the review period from 115 days to 90 days) is in place for the accelerated approval and review of advanced regenerative biopharmaceuticals, but its scope of application was limited. Accordingly, the government decided to expand the scope of interpretation for 'cases where there is no alternative treatment' subject to expedited review. In other words, the scope will then include everything from ‘cases where there are no domestically approved drugs’ to ‘cases where the drug demonstrated improved safety and efficacy over existing drugs.’ The goal is to reduce the burden of approval and review on advanced regenerative biopharmaceuticals by reducing the time required for approval and improving public access to drugs.
