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Policy
100 billion won more for new drug 500 billion won megafund
by
Lee, Hye-Kyung
Jun 19, 2023 06:00am
The government plans to create an additional fund of 100 billion won this year following the creation of a 500 billion won 'mega fund' last year to strengthen investment and export support for the pharmaceutical and bio industries. However, since a proper drug price valuation must necessarily accompany first-in-class development support, it was suggested that the system should be improved for this purpose. Kim Yong-woo, head of the Korea Health Industry Development Institute, explained the 3rd 5-year comprehensive plan to nurture and support the pharmaceutical and bio industries in a session on 'Government Policy and Industrial Strategy for Creating a New Bio-Health Market' held at the KFDC Spring Conference held on the 16th. Director Kim said, "The Ministry of Health and Welfare created two investment institutions at the end of last year to create a mega fund worth 500 billion won." The creation of the megafund is part of the 3rd plan to nurture and support the pharmaceutical and bio industries from this year to 2027 and was prepared to strengthen financial support and support start-ups in the pharmaceutical and bio sectors. Director Kim said, "We are paying attention to infrastructure creation so that we can bring in a lot of money to the biopharmaceutical field by creating mega funds and strengthening policy finance investment links." prepared,” he explained. In addition to mega funds, financial support such as technology guarantee funds, preferential loans to expand private investment and attraction support, and incentives to attract domestic and foreign investments were included in the 3rd comprehensive plan. Looking at the 3rd Comprehensive Plan in detail, 10 key tasks (investment in global blockbuster R&D, R&D investment in response to health security and social needs, AI promotion of new drug development, digital conversion support, finance and start-up support, export industrialization, core talent cultivation, human resources development ecosystem, support for innovative new drug development system, support for strategy to achieve global No. 3 in clinical trials, and strengthening of infrastructure by pharmaceutical value chain). Looking at the investment strategy for creating global blockbuster new drugs, support is provided for expanding public and private investment in new drug development, establishing a first-mover strategy to secure super-gap technologies, and investing in vitalizing open innovation. Director Kim explained, "In order to support the first-in-class development system, it is necessary to improve the system for proper drug price evaluation." He emphasized, “Efforts must be made to shorten the period of new drug development through an expedited approval system and simultaneous reimbursement review for each drug characteristic.”
Policy
Awareness of Korean pharmaceuticals, ranked 7th out of 13
by
Lee, Hye-Kyung
Jun 16, 2023 05:55am
In an awareness survey conducted on overseas consumers in countries leading the world's bio-health industry, they ranked 7th out of 13 countries in the pharmaceutical sector, 7th out of 15 countries in the medical device sector, 3rd out of 12 countries in the cosmetics sector, and 3rd out of 12 countries in the medical service sector. It was ranked 5th out of 14 countries. In the case of pharmaceutical respondents, 75.3% were aware of Samsung Biologics. Daewoong Pharmaceutical 34.2%, Hanmi Pharmaceutical 33.8%, GC Pharma 31.7%, Celltrion 30.3%, SK Bioscience 29.9%, Yuhan Corporation 26%, Hugel 23.5%, Seegene 18.2%, Donga ST 15.1%. All companies in each sector were selected as the top companies in terms of manufacturing exports in 2021, and it is a figure that confirms whether or not they are each company, rather than selecting companies known to them in terms of ranking. On the 14th, the Korea Health Industry Development Institute (President Cha Soon-do) announced the '2022 Korean Bio-Health Industry (Manufacturing and Medical Service) Overseas Awareness Survey' with these contents. The countries surveyed were 19 countries (25 cities), including the United States, China, Japan, India, and Germany, with a focus on countries where Korea's health products are exported a lot. the survey was conducted on the subject. As a result of the survey, awareness of Korea as a manufacturer of health products was 75.1%, up 3.5%p from 2021 (71.6%). Specifically, the awareness rate in the pharmaceutical sector was 68.6% (▲4.8%) and the medical device sector was 68.6% (▲3.9%), and awareness rose significantly in Japan, Australia, and France. Among Korean bio-health products, the number of consumers who are aware of a specific product stood at 67.1%, a slight increase from 65.8% in 2021. The proportion of people who are aware of specific medical device products in Korea was 63.8%, an increase of 4.2%p compared to 2021. When using Korean bio-health products for the first time, about 8 out of 10 (82.2%) knew that they were Korean products and used them, a slight increase compared to 2021 (81.5%). As a result of asking 507 respondents who later recognized that it was a Korean bio-health product, the degree of change in perception after brand recognition, the average score of 100 was 67.2 points. Respondents who used it for the first time before (67.1 points) before the outbreak of COVID-19 (67.2 points) had a higher opinion that 'positive changes' had taken place, and South America (76.9 points), Southeast Asia (72.7 points), and medical devices (69.1 points) The average score of 100 users was high. By country, in Thailand, India, and France, Korean brand awareness before using the product was relatively low, while in Brazil, Kazakhstan, and Vietnam, there was a high change in positive awareness among post-recognizers. After using Korean biohealth products, the overall satisfaction rate was 75.3 points, a decrease of 0.3 points compared to 2021. By factor, quality, and efficacy satisfaction was the highest at 75.8 points, and the positive evaluation for product diversity (75.0 points) increased compared to the previous year. In the field of medical devices, it was found that satisfaction with the diversity of Korean medical devices increased. As a result of asking about the intention to recommend Korean bio-health products regardless of experience, active recommendation (voluntarily recommended) was 61.4 points and passive recommendation (not voluntarily, but recommended if someone asks) was 62.8 points, indicating active and passive recommendation. All intentions increased year-on-year. As for the reason for recommendation, the opinion that the efficacy of the product was ranked first (87.7%). The willingness to recommend Korean bio-health products by 265 foreign experts was high at 60.1%, and cosmetics experts showed a willingness to recommend 83.3%, and the entire bio-health product industry showed a high willingness to recommend. General consumers' overseas awareness of Korea's first medical service was 61.3%, and awareness was high in countries with many foreign patients visiting Korea, such as Vietnam, China, and Mongolia. In addition, after Corona 19, the national brand and power awareness of Korean medical services has been strengthened, and it was high in countries such as Vietnam, Indonesia, UAE, and Saudi Arabia. As a result of analyzing perceptions between Korean bio-health products and medical services, Vietnam, China, Thailand, and Indonesia all showed high awareness of manufacturing and medical services, while Kazakhstan, UAE, and Russia had higher awareness of Korean medical services than manufacturing. investigated. As a result of a correlation analysis between foreign patient attraction performance and medical service awareness by country, Korean medical services in China (1st place, 83.3%), Mongolia (5th place, 80.8%), and Vietnam (7th place, 91.7%) ranked high in foreign patient attraction. Awareness of the service was very high. In the Middle East, the UAE (10th, 74.2%) and Saudi Arabia (14th, 71.7%) showed a high level of awareness of Korean medical services compared to the performance of attracting foreign patients. Han Dong-woo, head of the Health Industry Innovation Planning Division at the Promotion Agency, said, "This survey is significant in that it has been expanded not only to Korea's bio products, but also to the medical service sector, such as attracting foreign patients." Director Han said, "It is possible to objectively grasp overseas consumers' perceptions of our products and services in major bio health-related exporting countries and to analyze the differences and causes of awareness between our bio health products and medical services in the same country. It is expected that our bio health industry will be highly utilized in establishing strategies for overseas expansion tailored to each foreign country."
Policy
RMP evaluation cycle Up to 3 yrs What items can be changed?
by
Lee, Hye-Kyung
Jun 16, 2023 05:55am
Items that can change the risk management plan (RMP) cycle up to three years have been determined. The Ministry of Food and Drug Safety recently enacted an amendment (draft) to the 'drug risk management plan guidelines and specifically included the targets for changing the RMP reporting cycle, related documents, and procedures for reviewing the feasibility of the change. In the case of RMP-submitted drugs, safety evaluation or benefit/risk evaluation, such as clue analysis, is conducted every 6 months from item approval until 2 years, and every 1 year after 2 years have elapsed, and the results are submitted after the expiration of the relevant period. It must be reported to the Ministry of Food and Drug Safety within one month. However, in the future ▲Items that have completed re-examination in accordance with Article 32 of the Pharmaceutical Affairs Act ▲Items for which additional pharmaceutical surveillance activities (post-marketing surveillance) have been completed ▲Items for which 4 years have elapsed since marketing if other pharmaceutical surveillance activities are not established ▲RMP after product approval In the case of drugs designated for submission, the RPM evaluation cycle can be changed to a maximum of 3 years or less for items for which 4 years have elapsed since the date of change of approval following the RMP submission. However, the plan may be changed if essential changes have occurred to the relevant item, such as the addition of new indications or changes in usage and dosage, or if evaluation and reporting of RMP implementation results are required at a shorter cycle than the changed cycle due to pharmacovigilance, etc. If it is judged that it is necessary to shorten the evaluation cycle due to issues such as safety, the RMP plan can be changed. In the case of drugs with high safety concerns, such as anticancer drugs, antibiotics, drugs for the nervous system, narcotics, orphan drugs, and biological products, whether they fall under the review of changing the evaluation cycle and the need for the change must be separately considered. The Ministry of Food and Drug Safety ▲occurrence or change of important clue information, benefit/risk analysis/evaluation results, etc. ▲clinical characteristics of established safety review items and types and characteristics of bad information ▲deletion or change of safety review items and additional risk mitigation measures ▲ The RMP cycle can be changed by reviewing the appropriateness of the implementation of the risk management plan that has been implemented so far ▲ the characteristics of formulations with low risk of safety problems ▲ consideration of the overseas safety information evaluation cycle and differences. When changing the periodic reporting period, the change of evaluation start point is not applicable except in unavoidable circumstances. The Ministry of Food and Drug Safety said, "The change in the evaluation cycle of the RMP is to review the feasibility of the target item and change the implementation result evaluation cycle period to a maximum of three years or less." "he said.
Policy
Why Vyndamax and Tabrecta’s reimb were unable to pass DREC
by
Lee, Tak-Sun
Jun 15, 2023 05:38am
# i1 The reasons why Vyndamax and Tabrecta, the two drugs that had high reimbursement demand, were unable to pass the Health Insurance Review and Assessment Service’s review were revealed. The two drugs were determined to be ineligible for reimbursement by HIRA’s Drug Reimbursement Evaluation Committee (DREC) at its meeting that was held in April, and the results of the relevant meeting were disclosed recently. According to the industry sources on the 14th, Vyndamax and Tabrecta were reviewed by the DREC on April 6. Vyndamax Capsule (tafamidis, Pfizer), a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), was reviewed by the DREC in April, 9 months after passing the Drug Reimbursement Standard Subcommittee deliberations in July last year. The drug was deemed to be eligible for the Risk-Sharing Agreement scheme due to its lack of alternative treatment options, disease severity, social impact, and impact on public healthcare. However, the authorities failed to close the gap with the pharmaceutical company on the terms of the RSA. DREC requested the refund plan proposed by the subcommittee, ‘full refund for the initial treatment through a Refund-type RSA, then and simple refund rate Refund-type RSA and Expenditure Cap-type RSA,’ should be applied for Vyndamax’s reimbursement to reflect the uncertainties including its effect during the initial treatment period. However, as the suggested refund plan was not implemented, and the pharmacoeconomic evaluation results were deemed to be cost-ineffective, the committee decided on its non-reimbursement. Regarding its clinical efficacy, the committee pointed out that the drug had reduced all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo in adult patients with hereditary or wild-type ATTR-CM, but the degree of clinical improvement varied depending on the type and stage of the disease, and there are limitations in that there is no study with a sufficient number of patients or observation period to analyze the varying effect. In the case of Tabrecta (capmatinib, Novartis), the lack of evidence to judge its clinical usefulness acted as an obstacle to its reimbursement. DREC determined the drug to be non-reimbursable as the drug is approved drug for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations, but there is insufficient evidence to determine its clinical usefulness, and the cost required is higher than its alternative drugs. DREC selected the pembrolizumab+pemetrexed+platinum therapy and pemetrexed+platinum therapy as alternatives to Tabrecta. For patients who have previously used immune checkpoint inhibitors and failed first-line platinum-based therapy, DREC selected docetaxel monotherapy as the alternative option. Based on these selections, the 3-week administration cost required for Tabrecta was higher than its alternative therapies. The survival period of patients with ATTR-CM is only 2 to 3.5 years if not treated properly, and known for its poor treatment results due to a lack of treatment options. Tabrecta is the only treatment for ATTR-CM, which brought out the high demand for its insurance reimbursement. However, due to the large number of expenses required, the industry opinion is that it will be difficult to receive reimbursement if the pharmaceutical company lets go of its terms for risk-sharing in the future. Tabrecta also drew attention as the first NSCLC treatment that confirmed the MET exon 14 deletion mutation. In addition to Tabrecta, Tepmetko (Tepotinib, Merck), which is in the same class, is also undergoing a reimbursement review, with no progress. Therefore, without providing more evidence to support its clinical usefulness, it seems unlikely that Tabrecta will be covered and reimbursed in Korea.
Policy
Handok's Imported Monjuvi Licensed
by
Lee, Hye-Kyung
Jun 13, 2023 07:39pm
The Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) announced on the 9th that it had approved Monjuvi, an orphan drug used to treat diffuse large B-cell lymphoma. For adult patients with relapsed or refractory diffuse large B-cell lymphoma who are unsuitable for autologous hematopoietic stem cell transplantation and who have failed one or more prior therapies, use this drug in combination with lenalidomide, and then use it as monotherapy. Monjuvi provides a new treatment opportunity for diffuse large B-cell lymphoma by binding to CD19, a B-cell surface antigen protein, and inducing direct apoptosis, antibody-dependent phagocytosis, and antibody-dependent cell-mediated cytotoxicity, resulting in B-cell depletion. For reference, this drug is an immunoglobulin (IgG) subtype humanized monoclonal antibody drug that targets CD19, a cell surface antigen protein on the surface of B-cell lymphocytes. Monjuvi was designated for expedited review on January 18 last year as a treatment for life-threatening or serious diseases (improving efficacy). If designated as an expedited review target, the Ministry of Food and Drug Safety shares the overall review schedule, such as prior planning for approval review schedules, along with close consultation on the preparation of data in consideration of item characteristics. The time required to review is shortened to within 75% of the general review period through 'additional accompanying review', in which prepared materials are reviewed. It is approved and used in the US and Europe and was designated as an orphan drug in December 2021 in Korea.
Policy
When will the innovative generic price system be improved?
by
Lee, Tak-Sun
Jun 12, 2023 05:42am
As announced, the government-pharmaceutical working group for PVA improvement plans started on the 1st with the first meeting and got on track. The industry is complaining of frustration as there is no news about the plan for preferential drug prices for innovative new drugs whose working group has already ended or the reorganization of the generic drug price system that is being pursued together. According to the industry on the 7th, the PVA improvement plan working group will be held from the first meeting on the 1st to November. Originally, this working group was scheduled to run from May to August, but instead of being delayed by one month, the entire period was extended. The government plans to promote institutional improvement next year through a working group. The external research service, which is the basis for the improvement plan of the usage-drug price linkage system, has already been disclosed. The 'PVA Performance Evaluation and Improvement Study' participated by Bae Seung-jin, professor at Ewha Womans University Pharmacy, was also disclosed to the outside world in April. Looking at the main content, in the case of type Ka, currently, only cases where the billing amount increases by 30% or more are included in the negotiation target, but like Na and Da types, a plan to include items with a 10% increase in billing amount & 5 billion won or more presented. It also proposed a plan increase the efficiency of negotiations and system acceptance by raising the exclusion standard from the current claim amount of 2 billion won to 3 to 5 billion won. The core of the study results is to include more expensive drugs with high claims in the PVA negotiation target and to expand the exclusion of low-priced drugs. In the industry, different opinions are expressed depending on the size of the company. Rumor has it that the one-day meeting ended with sharing the results of the research service and simply listening to the opinions of the industry. The NHIS plans to have its staff members travel abroad to France, Japan, and Taiwan to come up with improvement plans. It has already been brought to Taiwan and is known to be planning to visit France and Japan this month. The industry is calmly participating in the fact that the PVA improvement plan has already been disclosed and the operation of the working group was scheduled. Rather, they are looking forward to a meeting to discuss the government's final plan for improving innovative new drugs, which ended in the first half of this year, and plans to improve the generic drug price system. The public-private consultative body to improve innovative new drugs ended after the 5th meeting in March, and the government is waiting for the final draft. The government never met with the industry in a situation where only the media reported that the government was promoting a plan to improve the generic drug price system. Some predict that there will be a face-to-face meeting with the industry after the government plans to prepare an internal draft for improving the generic drug price system by June. An official from the industry said, "This year, not only PVA but also various consultative bodies such as measures to improve the actual transaction price system are scheduled." He said, "The industry is interested in preferential treatment for innovative new drugs and reform of the generic drug price system, but the government's plan is not clear, so the industry is in a frustrating situation."
Policy
Adtralza is about to be approved in Korea
by
Lee, Hye-Kyung
Jun 09, 2023 05:35am
Domestic product approval for an adult atopic dermatitis treatment developed by LEO Pharma, a Danish pharmaceutical company, is imminent. According to the pharmaceutical industry on the 8th, the Ministry of Food and Drug Safety completed the safety and efficacy review of 'Adtralza 150mg (tralokinumab)', which Leo Pharma applied for. As the safety and efficacy review of the Ministry of Food and Drug Safety has been completed, it is expected to enter the item approval process soon. This drug is a component of tralokinumab and is sold under the trade names of Adbry in the US and Adtralza in Europe. Adtralza is the first biological agent that specifically binds to and inhibits IL-13 cytokine, a key trigger, and symptom of atopic dermatitis, and can be used in combination with topical corticosteroids or as monotherapy. In December 2021, the FDA first approved the IL-13 family of atopic dermatitis treatments and became famous. Adtralza proved effective in three ECZTRA 1-2-3 trials conducted on a total of 2,000 adult patients with moderate to severe atopic dermatitis. In the ECZTRA 1 and 2 clinical trials, the group administered with tralokinumab showed a 50% higher rate of achieving an IGA score of 0 to 1 (completely resolved to almost eliminated dermatitis) than the control group administered with a placebo. In the two clinical trials (ECZTRA 1 and 2) in which only Adtralza effects were judged, the rate of reaching an IGA score of 0 to 1 (completely to almost no dermatitis) was more than 50% higher in the drug-administered group than in the placebo-administered control group. The 75% improvement rate of the Eczema Area and Severity Index (EASI), another primary endpoint, was 33% in the tralokinumab group, much higher than 10% in the control group. The rate of improvement of at least 4 points on the 11-point numerical rating scale for itch was 20% in the tralokinumab group and 10% in the control group. The ECZTRA 3 clinical trial results, in which corticosteroid ointment was added to tralokinumab, were also similar to the ECZTRA 1 and 2 clinical trial results. Side effects included eye and eyelid inflammation, injection site reaction, and eosinophil (a type of white blood cell) increase.
Policy
Voluntary price reduction of Diacomit/Olpadine up to↓40%
by
Lee, Hye-Kyung
Jun 05, 2023 05:37am
The drug prices of Diacomit, a treatment for Dravet syndrome, and Olpadine, a treatment for hereditary tyrosinemia, which is a rare essential drug, fell by up to 40%. The KOEDC said in a press release on the 1st, “In the case of Diacomit and Olpadine, insurance prices were voluntarily reduced on April 1 and May 1, respectively.” As a result, the price of Diacomit per capsule was reduced by about 23% from 19,160 won to 14,700 won. This is due to the fact that overseas wholesalers can reduce transportation costs by importing directly from the manufacturer, and as export certification by the manufacturer becomes possible, tariff exemption is possible under the Korea-EU FTA. Olpadine cut the price by about 40% from 37,386 won per capsule to 22,420 won to adjust for the difference between the cost of import and insurance drug price. As a drug subject to tariff exemption, the insurance price of Enhertu, a breast cancer treatment, was cut from 5.4 million won to 5 million won, and the Alzheimer's drug, Aduhelm, was cut from 3.44 million won to 3.2 million won. The Korea Customs Service imposes a basic tariff rate of 8% when importing medicines from abroad, but no duty is imposed on immune products. The KOEDC took note of this and reduced drug prices through tariff reductions on Enhertu, a breast cancer treatment, and Aduhelm, an Alzheimer's treatment. Enhertu applied for a preliminary review to the Korea Customs Service in June 2022 and was notified of the result in August 2022, and the drug price per vial was reduced from 5.4 million won to 5 million won through tariff reduction. Aduhelm applied for a preliminary review to the Korea Customs Service on March 7, 2023, and was notified of the result on March 20, 2023. Through tariff reduction, the drug price per vial increased from 2.04 million won to 1.9 million won for 170 mg, and 3.44 million won for 300 mg was reduced to 320 million won. In the case of Quinidine, a rare arrhythmia treatment, an attempt was made to import and supply it as an Epic Pharma drug due to Sandoz’s suspension of supply in June 2022, but the cost of the drug was 75 times higher than the existing drug price (50,000 won/bottle), adding to the patient’s burden. The KODC announced that it has been able to supply Nisco Quinidine, which can be imported directly from the manufacturer, by lowering the price to 35,000 won through continuous efforts.
Policy
Evrysdi, a tx for Roche's spinal muscular dystrophy, passed
by
Lee, Hye-Kyung
Jun 05, 2023 05:37am
Roche Korea's oral 5q spinal muscular atrophy treatment Evrysdi Dry Syrup has been recognized for its benefits and has crossed the insurance threshold. The HIRA released the results of the '2023 6th Pharmaceutical Reimbursement Evaluation Committee' deliberation on the 1st. Ace Pharma's Megval 50mg and H.I.Pharm's Melpspal 50mg, both of which are Evrysdi and Melphalan Hydrochloride-component multiple myeloma treatments, were all approved for reimbursement. Evrysdi is a liquid formulation that is taken orally once a day and can be applied to patients who have difficulty in spinal treatment. The effect of improving motor function and the safety profile was confirmed in patients with a wide range of disease types, including patients of a wide age range from 2.2 months to 25 months of age and patients with scoliosis-related surgery experience. Since self-administration is possible at home, it reduces not only the additional direct medical costs related to hospitalization and visitation, which occurred during the existing intrathecal injection treatment, but also the burden of indirect medical costs such as study and work interruption, transportation costs, and nursing care, which are accompanied by this, reducing insurance finance It is evaluated that it can produce the effect of reducing the socio-economic burden. In addition, it is a customized prescription according to age and weight, and the liquid formulation corresponding to the recommended dose can be taken once a day. Megval and Melpspal 50mg, whose main ingredient is Melphalan Hydrochloride, have been approved for multiple myeloma treatment. The dosage is 0.4 mg per kg of body weight (16 mg/m2) intravenously over 15 to 20 minutes for adults, and for patients with renal impairment (BUN > 30 mg/dL), reduce the dose by half.
Policy
Non-face-to-face demonstration will be alternative relief ?
by
Lee, Jeong-Hwan
Jun 05, 2023 05:37am
While the non-face-to-face treatment pilot project started on the 1st, it is attracting attention that the government will "seek ways to use substitute drugs" as a way to prevent inconvenience caused by the lack of prescription drugs at the pharmacy near the patient after treatment. There is a lot of interest in whether the alternative treatment simplification method can be implemented within the pilot project period, such as exempting the follow-up notification of alternative treatment limited to non-face-to-face treatment. In particular, the government also announced that it will prepare guidelines such as banning automatic allocation of pharmacies after prescribing for non-face-to-face treatment platform management and regulation measures, and to induce improvement in case of problems after monitoring the platform by operating a pilot project advisory group such as the pharmaceutical society. On the 1st, the Ministry of Health and Welfare answered a question about the non-face-to-face treatment operation plan of Rep. Jeon Hye-sook, a member of the National Assembly Health and Welfare Committee. First, the government said that it would use alternative drugs to prevent cases of inconvenience because the medicines prescribed by medical institutions that have performed non-face-to-face treatment are not in pharmacies located near the patient's area. Starting from the pilot project, the method of receiving prescription drugs after the non-face-to-face treatment will be changed from delivery to the patient's (agent)'s direct visit to the pharmacy. The government's will to minimize the situation where the pilot project has a hard time because there is no medicine in the pharmacy through alternative medicine. In order to improve this inconvenience and lack, pharmacists are demanding that non-face-to-face treatment be allowed to 'simplify post-notification of replacement drugs' and 'prescribe ingredients'. However, the Ministry of Health and Welfare did not take a specific position regarding the exemption of non-face-to-face treatment substitutes, the introduction of simpletion, or ingredient name prescriptions. I answered only with the intention of using the alternative medicine system to solve the problem that occurs when non-face-to-face prescription drugs are not in pharmacies. The Ministry of Health and Welfare announced that it has prepared guidelines such as 'prohibition of automatic allocation of pharmacy' on ways to manage and control expedient, illegal, and deviant behavior of non-face-to-to-face treatment platforms. In particular, he said that he would monitor the platform through the operation of a non-face-to-face treatment pilot project advisory group in which health and medical organizations such as the Korean Pharmaceutical Society participate, and would demand improvement if there were any problems. However, the Ministry of Health and Welfare has made it clear that in order to impose legal obligations on platform laws, or to make effective regulations such as data submission requirements and corrective orders, it is necessary to legislate the institutionalization of non-face-to-face treatment. The Ministry of Health and Welfare said it would "promote amendments to the health care law based on the legislation proposed by the National Assembly" regarding platform regulation. The Ministry of Health and Welfare did not provide a specific position or method on the 'electronic prescription' that electronically transfers a prescription issued by a doctor to a patient-designated pharmacy after a non-face-to-face treatment. "The method of sending and delivering prescriptions from medical institutions to pharmacies is to deliver faxes, e-mails, etc. to pharmacies designated by patients," the Ministry of Health and Welfare explained. In addition, during the pilot project period, we reaffirmed our position that it is in principle to implement non-face-to-face treatment with video treatment rather than telephone consultation. He said that the principle of video treatment is to conduct non-face-to-face treatment as a 'means that can communicate with real-time video communication', not just by phone call or voice. "Elderly people who have difficulty making voice calls or do not have smartphones can have non-face-to-face treatment with voice calls," the Ministry of Health and Welfare said. It is read that even if a non-face-to-face patient lies that it is difficult to make a video call or does not have a smartphone, there is no way to specifically isolate or regulate it. When asked if the government plans to support the cost of building a video care system for medical institutions during the pilot period, the Ministry of Health and Welfare said, "there is no separate cost support plan."
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