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- 2026-05-11 17:34:32
- Policy
- Sama Pharm’s formoterol to receive clinical reevaluations
- by Lee, Hye-Kyung Jan 12, 2023 04:29am
- After the authorities issued a notice on conducting clinical reevaluations for the active ingredient formoterol fumarate, Sama Pharm, the only company that maintained its authorization for the ingredient, was found to have submitted a clinical trial protocol for its acute bronchitis indication among its 3 approved indications (bronchial asthma, acute bronchitis, asthmatic bronchitis). The Ministry of Food and Drug Safety ordered clinical reevaluations to be conducted for 16 tablet and syrup products that contain formoterol fumarate on December 23, 2020 and requested companies to submit their clinical trial protocols by March 31, 2021. However, all companies that own items other than the 3 items that were the first to receive marketing authorization in 1986 – Sama Pharm’s Atock Tab. Sama, and Sama Atock Tab. 20μg – have voluntarily withdrawn their licenses after the notice. According to the minutes of the advisory meeting of the Central Pharmaceutical Affairs Council that was recently disclosed by the MFDS, the CPAC approved the adequacy of Sama Pharm’s clinical trial protocol (its scope of effect·efficacy, trial period) but requested the company to submit data that adequately describes the basis for calculating the number of trial subjects. The minutes also showed that Sama Pharm first submitted clinical trial protocols for bronchial asthma and acute/chronic bronchitis but received administrative disposition for non-submission of supplementary materials, and then resubmitted a clinical trial protocol only for its acute bronchitis indication. Also, the company set the efficacy endpoint for the reevaluation as the 'improvement of wheezing,’ and the MFDS determined the endpoint reasonable in consideration of the pharmacological action of the active ingredient, the age of the test subjects, and expert advice from the Korean Academy of Tuberculosis and Respiratory Diseases. However, to address concerns about bias due to subjective judgment on the improvement of wheezing in the evaluation index, the CPAC ordered trial objectivity to be secured through a clinical trial design (placebo-controlled, double-blind). Regarding the validity of the scope of efficacy and effect verification in the clinical trial, one committee member pointed out, "As the trial will only prove efficacy and effectiveness in pediatric patients with acute bronchitis, its actual scope of use in the field will be different” Another member said, “The drug has been long used in the field, therefore, the drug is expected to be used for indications other than acute bronchitis even though the clinical trial is conducted only for acute bronchitis.” Meanwhile, the MFDS had recommended against the use of long-acting beta-agonists (LABAs) such as formoterol as monotherapy in asthma patients based on the US FDA’s analysis. The FDA had also issued such a guideline based on a study that showed that using LABA alone may increase the risk of exacerbation of severe asthma symptoms.
- Company
- Dupixent to be reviewed by DREC for reimb after 2 years
- by Eo, Yun-Ho Jan 12, 2023 04:29am
- The atopic dermatitis treatment ‘Dupixent’ has taken a step forward in extending reimbursement to children and adolescents. According to industry sources, the low-dose formulation (200mg) of Sanofi-Aventis Korea’s Dupixent (dupilumab) will be deliberated by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee today on the 12th. This progress has been made 2 years after the company applied for the reimbursement extension in April 2021. It first took 7 months for expert opinion inquiries to begin on extending reimbursement of Dupixent to pediatric and adolescent patients, and the reimbursement standards for the indication were set in May last year. Being a high-priced new drug, the drug, which had difficulty being approved for reimbursement the first time, is having difficulty extending reimbursement as well. Although the specific indications may differ, the difference in speed of progress is evident when compared to other JAK inhibitors that applied for reimbursement extensions in atopic dermatitis, such as Lilly Korea’s ‘Olumiant (baricitinib),’ Abbvie Korea’s ‘RInvoq (upadacitinib)’ etc. The price of JAK inhibitors is also relatively lower than that of Dupixent, and the two drugs were both listed for reimbursement in May last year. Therefore, whether Dupixent will be able to pass DREC review and be extended reimbursement remains the focus of attention. However, the remaining journey will not be so easy for Dupixent. Being an RSA (Risk Sharing Agreement) drug as well as the addition of the separate 200mg dose, the drug will have to pass HIRA’s cost-effectiveness review process and complete drug pricing negotiations with the National Health Insurance Service. Meanwhile, the 300mg dose of Dupxient is currently reimbursed for adult patients aged 18 years or older with chronic severe atopic dermatitis who have had the condition for over 3 years and satisfy all three of the following criteria: ▲ who are unable to control their symptoms after receiving topical treatment for over 4 weeks, and ▲ unable to use systemic immunotherapies due to side effects or saw no response (50% or more decrease in EASI, EASI 50) after receiving treatment with systemic immunotherapies, and ▲ had an EASI score of 23 or higher before administering Dupixent.
- Policy
- Take the burden off the hospital bills
- by Lee, Tak-Sun Jan 12, 2023 04:29am
- The NHIS announced that it had expanded the scope of particular calculation for rare diseases and chronic kidney dialysis patients subject to particular calculation of health insurance from January 1 this year to ease the burden on the medically vulnerable. The expansion will significantly reduce the burden on patients by lowering the burden on them from 20% of hospitalization and 30% to 60% of outpatients to 10% of both hospitalization and outpatients. First of all, it is expected that about 4,000 people with the disease will benefit from medical expenses reduction as special calculation cases will be applied to 42 new rare diseases, including "polycystic kidney, common chromosome dominance." The NHIS has been working with the Korea Centers for Disease Control and Prevention, which manages rare diseases, to collect opinions from patient groups and experts, and has been reviewed and resolved by the Ministry of Health and Welfare and the Corporation. With this expansion, the number of rare diseases subject to the particular calculation will increase to 1,165. Accordingly, patients with new rare diseases will pay 10% of their own charges for treatment of diseases registered for particular calculation and complications with clear medical causality with the disease, and health insurance subscribers with a median income of less than 120% (less than 130% for children) can receive 10% of their own charges through the Korea Centers for Disease Control and Prevention. In addition, special cases for calculating patients with chronic renal failure apply to outpatient treatment on the day of dialysis and inpatient treatment related to the procedure. Previously, failure to receive dialysis on the same day due to unavoidable reasons such as blood vessel surgery or bleeding after hemodialysis may cause excessive dialysis or financial burden. Based on expert advice and medical evidence, the system has been improved to allow dialysis vascular procedures and surgery. The improvement of the system is expected to further benefit artificial kidney dialysis patients, who have not been subject to special cases due to failure to perform dialysis after vascular procedures and surgery for dialysis. Lee Sang-il, senior executive director of the corporation, said, "The NHIS will continue to work with related agencies such as the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention to strengthen essential medical coverage for the vulnerable by continuing to find and calculate rare and severe incurable diseases that require long-term treatment."
- Policy
- Erbitux deal is in renegotiation
- by Lee, Tak-Sun Jan 12, 2023 04:29am
- MerckThe third Risk Sharing Agreement (RSA) contract for Erbitux, a treatment for metastatic direct bowel cancer and cranial cell cancer, is being prolonged. It is known that renegotiations have been underway since the first round of negotiations with the National Health Insurance Service broke down. Erbitux's second RSA contract period has ended as of June last year. According to the corporation and the industry on the 7th, Merck and the NHIS are negotiating for a third contract as Erbitux's renewal of RSA has ended. Erbitux signed its first RSA for Refund contract in 2014. And after four years of the contract, he succeeded in renewing his contract in 2018. It was the first case of renewal as an RSA drug. The renewal period ended in June last year, and negotiations have been underway for a third contract. The first round of negotiations broke down in August of that year, and it was found that renegotiations were currently underway after going through the HIRA Drug Benefit Evaluation Committee again. The renegotiation period is 60 days. As negotiations are currently underway, the effectiveness of the existing RSA contract is maintained. However, in the worst case, if the renewal fails, the burden on patients is expected to increase. Erbitux is currently supplied at an upper limit of 222,325 won per bottle. When a refund contract is signed, the pharmaceutical company will refund a certain percentage of the insurance claim to the NHIS. However, the refund rate is not known. Erbitux recorded sales of 42.4 billion won as of IQVIA 2021. Meanwhile, as of July 2022, a total of 60 RSA contracts were counted. Among them, 18 items were maintained to renew their contracts, 24 items were initially maintained, and 18 items were expired. RSA was introduced in 2014.
- Company
- The effect of government regulation
- by Chon, Seung-Hyun Jan 11, 2023 05:59am
- More than 7,000 Rx drugs have withdrawn from the market over the past 3 years, the report showed. It is analyzed that this is due to the fact that the item license renewal system, which regularly checks the safety and efficacy of drugs, has been established and a series of market withdrawals due to continuous clinical re-evaluation. Some point out that the government's pressure to re-evaluate generic drug prices also encouraged the market to withdraw. According to the Ministry of Food and Drug Safety on the 11th, a total of 2,167 cases were withdrawn from the market last year, including the withdrawal and cancellation of Rx drugs. The number of Rx drugs permits was 93.8% higher than 1118. This means that there were about twice as many professional drugs in which market withdrawals entered the market as new markets last year. The number of withdrawals and cancellations of Rx drug licenses surged 68.1% from 1,600 in 2019 to 2,690 in 2020. In 2021, 2,595 Rx drugs were withdrawn, and more than 2,000 Rx drugs disappeared for the third consecutive year until last year. A total of 7452 Rx drugs have been withdrawn from the market over the past three years due to the withdrawal and cancellation of permits. A total of 3,796 Rx drugs returned permits over the three years from 2017 to 2019, with the number of products withdrawn from the market doubling over the next 3 years. It is analyzed that the number of products disappearing from the market has increased due to the combination of government regulatory movements such as drug item license renewal, clinical re-evaluation, and price of generic re-evaluation. It is pointed out that the withdrawal of expired drugs from the market has increased due to the establishment of the item license renewal system. The key to the drug item renewal system, which was based on the revision of the Pharmaceutical Affairs Act in 2012, is that drugs approved by health authorities must be re-certified every five years to maintain their licenses. Existing drugs on the market have been verified for safety and efficiency once every 16-20 years through a procedure called reevaluation. However, the renewal system was introduced because it was deemed necessary to operate a reasonable evaluation system according to rapid scientific development. Drugs licensed from January 1, 2013 are maintained only after submitting data related to safety and efficacy every five years and being judged suitable by the Ministry of Food and Drug Safety. If a drug whose item license expires does not submit data for renewal, the license will be canceled. An industry official explained, "After the implementation of the item license renewal system, even if there are no safety and efficiency problems, the practice of withdrawing products with low sales volume from the market has been established." The government's continuous revaluation policy is also cited as a factor that accelerates the product cleanup phenomenon. In the case of clinical re-evaluation, which rechecks efficacy and safety, it often leads to the withdrawal of the drug from the market. For example, in the case of Choline alfoscerate, a brain function improvement drug, more than half of the licensed products left with the start of clinical re-evaluation. In June 2020, the Ministry of Food and Drug Safety requested the submission of clinical trial data for Choline, and 57 pharmaceutical companies were approved for re-evaluation clinical plans. Initially, the Ministry of Food and Drug Safety ordered a total of 134 companies to re-evaluate Choline's clinical trials, but less than half of 57 companies were approved for re-evaluation clinical trial plans. This means that 77 companies gave up the re-evaluation of Choline and chose to withdraw from the market. Recently, some diagnose that the withdrawal from the Rx drug market has increased due to the re-evaluation of generic drug prices. In June 2020, the Ministry of Health and Welfare announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price if Generic, which does not meet the highest price requirements, submits BA test and registered raw material drug data by February 2023. The re-evaluation of the generic drug price is a policy to apply the new drug price system, which took effect in July 2020, to the original generic. Each time one requirement is not met, the upper limit is lowered by 15%. Pharmaceutical companies should choose strategies to accept drug price cuts for consignment generics or avoid drug price cuts through additional investments. Requirements for the use of registered raw materials can be met through the replacement of raw materials and medicines. Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through conducting BA tests. Accordingly, pharmaceutical companies are actively conducting BA tests on licensed generics. The goal is to avoid lowering drug prices through permission to change the drug price by making generics through pharmaceutical research, conducting BA tests, and obtaining equivalent results. At this time, if the permission is changed while converting consignment manufacturing to its own manufacturing, the company is using a strategy that meets the requirements for 'BA test implementation'. For pharmaceutical companies, if additional investment is burdensome, they have no choice but to accept a reduction in drug prices. It is known that many generics often choose to withdraw from the market rather than accept drug price cuts. Some analysts say that reckless entry into generics, which did not take into account marketability before the government tightened regulations on generics, may have led to a withdrawal from the market after stricter regulations. In 2018, 175 items containing Valsartan, a hypertension treatment, were banned from selling due to the detection of excess impurities. At that time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety set up a "consultative body for improving the generic drug system" and began to come up with measures to curb the generics crisis. As the government hinted at the government's move to tighten regulations, pharmaceutical companies moved to install generic products in advance, temporarily increasing generic permits. The number of Rx permits reached 1,562 in 2018, which surged to 4,195 and 2,616 in 2019 and 2020, respectively. 374 of the Rx licensed in 2019 returned their permits. In other words, it withdrew from the market less than three years after it was approved by the government's move to tighten regulations. There are also more products that disappear from the market due to unexpected variables such as impurities. The Ministry of Food and Drug Safety decided in September 2019 to ban the sale of all products containing Ranitidine, citing excessive detection of NDMA, a carcinogenic substance.
- Policy
- NHI coverage rate 64.5% in 2021...Fell 0.8% YOY
- by Lee, Tak-Sun Jan 11, 2023 05:59am
- The National Health Insurance Service announced that Korea’s health insurance coverage rate in 2021 had fallen slightly from the previous year to 64.5%. On the 10th, the NHIS announced so through the ‘NHI Patient Medical Expense Survey 2021’ report on the 10th In 2021, the NHI coverage rate decreased by 0.8%p YoY to record 64.5%, and the non-reimbursement burden rate increased by 0.4%p YoY to record 15.6%. The NHI coverage rate is calculated by dividing the insurer’s reimbursement expenses by the sum of the insurer’s reimbursement expenses, legal copayment amount, and non-reimbursed medical expenses. The total coverage rate in medical institutions has decreased due to decreased coverage rates in clinics despite the increased coverage in general or higher-level hospitals. The expanded scope of reimbursement for ultrasounds [chest (amended in April 2021), heart (Sep 2021)] and the reduced use of advanced hospital wards (single-bed ward) led to a 0.5%p increase in the coverage rate in general or higher-level hospitals to 69.1%. The coverage rate in clinic-level institutions fell 4.1%p due to the increase in the proportion of non-reimbursed medical services (+4.8%p) such as manual therapy (rehabilitation and physical therapy expense), and multifocal intraocular lenses for cataract surgery (treatment material). However, the coverage rate for severe and high-cost medical treatments has increased continuously. The coverage rate for the 4 major diseases was 84.0%(+0.1%p), and the coverage rate of the Top 30 severe and high-cost diseases (leukemia, pancreatic cancer, lymphoma, etc.) was 82.6% (+0.5%p), and Top 50 diseases (Top 30+dementia, pulmonary tuberculosis, etc.) was 80.3% (+0.2%p). The coverage rate of those that belong to the age group - ‘5 years or younger (71.0%),’ and ’65 years or older (70.3%)’ - was higher than other age groups. However, in the case of those in the ’65 years or older' group, their coverage rate in tertiary hospitals, general hospitals, and hospitals has increased, but their coverage rate in clinic-level institutions has fallen by 0.9%p from the previous year due to their increased use of manual therapy and multifocal intraocular lenses for cataract surgery, etc. By income level, the NHI coverage rate (including the effect of the copayment ceiling system) of those in the lower-income bracket was higher than that of those in the higher-income quintile group (as classified by quintile of health insurance premiums), and the effect of the copayment ceiling system was found to be greater in the lower-income quintile group.
- Opinion
- [Reporter’s View] Can new drug listings really be accelerat
- by Eo, Yun-Ho Jan 11, 2023 05:59am
- The measures to accelerate reimbursement listing of new drugs is expected to be implemented in earnest this year. However, the practicality of the measure – on whether it will really accelerate drug listings – remains in question. The health authorities made a preannouncement on the amendment of the pharmacoeconomic evaluation exemption guidelines and drug pricing negotiations to expedite the listing of anticancer drugs and severe disease treatments as promised by the Yoon Suk-Yeol administration for implementation next year. Through this, the reimbursement listing of new drugs with no alternatives will be reduced by 60 days at most. Reducing the reimbursement listing period of drugs has been a regular agenda that had been discussed every year. With every discussion, the regulatory deadline was reduced incrementally. This applies to both the evaluation and negotiation process conducted by the Health Insurance Review and Assessment Service and National Health Insurance Service. However, this deadline is only the term set for the authorities to review reimbursement after someone (a pharmaceutical company) applies for reimbursement listing. The fault is on both parts. Quite a lot of pharmaceutical companies spend a considerable amount of time before applying for reimbursement after approval to discuss strategies with their headquarters. In other words, the companies take their time to thoroughly calculate their strategies and options. In the process, the companies weigh the timing of reimbursement to receive a higher price or forgo some indications in consideration of competition with other products. Companies really deliberately defer pricing negotiations waiting to be included in the government’s coverage reinforcement measure or decided to cancel the introduction of their drugs determining that Korea's marketability is poor. The decision to pass Korea, the ‘Korea passing’ phenomenon of “deciding to enter Korea after OO country” has become too common. The government's stance to “take discussions to the Drug Reimbursement Evacuation Committee after addressing most issues in the front end” has also played a role. When tracing back the listing process of drugs that have long exceeded the review deadline, applications for many of these drugs have been voluntarily withdrawn by the company after experiencing delays at the Drug Reimbursement Standard Subcommittee level. However, many companies have spoken out on how this voluntary withdrawal is not so ‘voluntary.” The deferral decision is very common during drug pricing negotiations between the NHIS and pharmaceutical companies. However, we need to remember that the 60-day deadline set for negotiations is a promise, and a deadline is a deadline. Also, the NHIS has referred to the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. The problem is that there is no transparency in the progress made in that 60-day period. Nothing is disclosed on what happened to the drugs that exceeded the listing review deadlines. As a result, only the patients are left to suffer in endless await. No answer nor explanation on the direction of progress is provided to those that wait in dire need. This new year, all the stakeholders involved should make collaborative efforts to reduce the period to actual reimbursement listing.
- Company
- Rx Drugs permits have fallen by 73% in 3 years
- by Chon, Seung-Hyun Jan 10, 2023 05:35am
- Stair-type drug price systems and joint development regulations have dampened the entry power of generics Last year, the number of Rx drug permits decreased significantly. The number of market entries has been reduced by more than 70% compared to three years ago. Analysts say that the government's all-around regulatory pressure, such as the reorganization of the drug price system and regulations on joint development, has greatly reduced its entry into the generic market. According to the Ministry of Food and Drug Safety on the 9th, a total of 1,118 Rx drugs were approved last year. It decreased by 30.1% in a year from 1,600 in 2021. Last year, the number of Rx drug permits was less than half of the 2616 two years ago. Compared to 4,195 in 2019, it decreased by 73.3%. The number of Rx drug permits has decreased by 3077 compared to three years ago. The number of Rx drug permits averaged 130 per month to 1,562 in 2018, but more than doubled to 4,195 per month in 2019. In May 2019, 584 professional drugs were approved for a month. However, since 2020, the number of Rx drug permits has gradually decreased and seems to have regained the previous year's level. From October 2018 to July 2020, more than 100 Rx drugs were poured out every month, and in August 2020, Rx drug permits fell to less than 100 in 23 months. Last year, there were only four Rx drug licenses per month. It is analyzed that the number of generic permits, which account for the largest proportion of Rx drugs, has decreased. The reorganization of the drug price system is cited as a major factor in the decrease in the number of generic permits. The key to the revised drug price system, which took effect in July 2020, is to maintain the upper limit of 53.55% of the original drug before the expiration of the current patent only when generic products meet both the direct BA test and the use of the registered raw drugs. The reorganized drug price system includes a stepped drug price system in which the upper limit decreases as the salary registration period is delayed. If more than 20 generics are listed in the specific ingredient market, the upper limit of newly listed items will be up to 85% of the existing lowest price. Analysts say that the permission for the entire process of manufacturing consignment generics has decreased significantly due to the structure in which drug prices fall significantly if pharmaceutical companies do not develop generics themselves and conduct BA tests. Since more than 20 generics have already entered most markets with high marketability, late generics will inevitably lose their motivation to enter new markets as drug prices fall significantly due to the application of the step-type drug price system. Some say that regulations on the joint development of drugs, which took effect in July last year, have promoted the decline in generic permits. The revised Pharmaceutical Affairs Act, passed at the plenary session of the National Assembly in May last year, calls for limiting the number of improved new drugs and generics that can be approved as a clinical trials. If all manufacturing processes are manufactured the same way with the same prescription and manufacturing method at the same manufacturing plant as the pharmaceutical company's drug that directly conducted the BA test, the use of BA data is limited to three times. This means that only four generics can be approved for one BA test. Clinical trial data can also be agreed to only three items other than drugs from direct-performing pharmaceutical companies. In the past, dozens of pharmaceutical companies often received consignment generic licenses with the same data if certain pharmaceutical companies were approved for generics through BA tests, but joint development regulations have made it impossible to "unlimited generic replication." Critics point out that the government provided the cause of the surge in Rx permits in 2019 and 2020. The government's move to tighten regulations on generics has led to a surge in generics permits. In 2018, 175 items containing valsartan, a hypertension treatment, were banned from selling due to the detection of excess impurities. At that time, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety set up a "consultative body for improving the generic drug system" and began to come up with measures to curb the generic crisis. As the government's move to tighten regulations showed, pharmaceutical companies moved to install generic products in advance, temporarily increasing generic permits. The number of generic permits surged due to the government's move to tighten regulations and returned to the previous level after the system was reorganized.
- Company
- HIV drug Pifeltro may be prescribed at hub hospitals in Kore
- by Eo, Yun-Ho Jan 10, 2023 05:35am
- ‘Pifeltro,’ a single-ingredient drug used for HIV, can be prescribed at general hospitals in Korea. According to industry sources, MSD Korea’s HIV treatment Pifeltro (dovavirine) passed the Drug committees of tertiary hospitals such as the Seoul National University Hospital and Sinchon Severance Hospital as well as local hub hospitals (national and public hospitals) that are in charge of HIV treatment in Korea, including the Kyungpook National University Hospital, National Medical Center, Pusan National University Hospital, Soonchunhyang University Hospital, Ulsan University Hospital, Chonnam National University Hospital, and Hanyang University Hospital. MSD’s fixed-dose combination drug ‘Delstrigo (dovavirine, lamivudine, tenofovir disoproxil) also contains the main active ingredient in Pifeltro, dovavirine. Both Delstrigo and Pifeltro were listed for reimbursement in October 2021. The final listed price was set at KRW 7,975 per tablet for Pifeltro, and KRW 19,491 per tablet for Delstrigo. Delstrigo is already being prescribed at major medical institutions in Korea. Both drugs are indicated for the treatment of HIV-1 infection in patients without prior antiretroviral therapy (ART) treatment history in Korea. The efficacy of the drugs was identified through the DRIVE-AHEAD trial, in which Delstrigo demonstrated noninferiority to efavirenz·emtricitabine·tenofovir(EFV/FTC/TDF). In the trial, the proportion of patients who sustained viral suppression through 48 weeks (viral suppression of HIV-1 RNA
- Policy
- “Will dvlp blockbusters and systemize non-F2F treatment”
- by Lee, Jeong-Hwan Jan 10, 2023 05:35am
- The government will reinforce R&D support in the pharmaceutical industry to develop 2 new global blockbuster drugs by 2027, by increasing public-private investments and expanding customized policy support. The government also selected the institutionalization of non-face-to-face treatment and increasing the admissions quota of medical schools as key policies required to reinforce essential healthcare, and expressed its will to promote the policies promptly through the operation of a permanent consultative body. On the 9th, the Ministry of Health and Welfare announced the above as part of its 2023 major task plan. ◆Full-fledged support to fostering the biohealth industry and exports=The MOHW will be preparing measures to train 110,000 manufacturing and research personnel by 2027 and lay the foundation for fostering the biohealth industry. Also, through the operation of the WHO training hub for mid to low-income countries, the authorities promote partnerships between vaccine and raw material companies in Korea and abroad to support overseas expansions of Korean companies. It will also promote a pre-entry/post-evaluation system through an integrated review system for innovative medical devices and extending deferment period for new health technology assessments, etc., and promote the expansion and commercialization of treatment opportunities for advanced regenerative medicine Also, a pan-ministerial governance body called the ‘Pharma-Bio Innovation Committee’ will be organized to provide efficient and borderless support ranging from basic R&D to commercialization. Biohealth exports will also be strategically supported. In Korea, biohealth exports have been growing 19.5% on average annually from USD 12.5 billion in 2017 to USD 25.4 billion in 2021. The Comprehensive Plan for Healthcare Exports contains measures to support the creation of 2 global blockbuster new drugs by 2027 and systematic measures for Korea to achieve the 5th place in medical device exports. To this end, a plan for the pharma-bio industry and the medical device industry will be established by January next year. More specifically, the authorities will public-private investments and reinforce customized support. This year, it will expand R&D by investing KRW 3.8 trillion in the pharmaceutical industry and KRW 1.6 trillion in the medical device industry. At the same time, the government will invest in the K-Bio vaccine fund in earnest and create an additional fund worth KRW 1 trillion by 2025. In line with the movement to strengthen licensing and regulations in major countries, the government will actively respond to protect Korea’s industry and implement strategic support by industry and region to develop new markets. ◆Strengthening welfare for the weak and essential healthcare= The MOHW will also operate a permanent consultative body to promptly implement policies including the systemization of non-face-to-face treatment and increasing the admissions quota of medical schools. In the mid-to-long term, the MOHW will present a comprehensive healthcare vision in consideration of its relation and consistency with various other policies, such as the reform of the healthcare delivery system. The healthcare development plan will be prepared by the second half of this year. Specifically, in order to expand essential healthcare, which was a topic of focus last year, the first stage will be to establish a reinforced system for severe, urgent, childbirth, and pediatric treatments. Also, the pediatric treatment support plan will further be supplemented by reflecting opinions from public hearings. In the second stage, MOHW will provide support for essential healthcare, in areas that have difficulty providing proper treatment due to lacking medical environment or a lack of professional manpower. In order to resolve the imbalance between regions and areas of treatments that remain, compensation in fields that lack supply will be strengthened, and public policy fees such as regional fees will continue to be developed. Also, eligibility for catastrophic medical expenses will be lowered, the amount raised, and applicable diseases expanded. ◆ Establishing health security and driving entry to new markets with advanced technology = The MOHW will also prepare for the rise of future pandemics and rare diseases by investing in new technologies in the bio sector. To prepare for infectious diseases, the government will localize essential vaccines that are import-dependent and also develop next-generation vaccines and treatments. By 2029, the MOHW will support KRW 215.1 billion to localize essential vaccines, support KRW 21 billion for the development of mRNA vaccines, and KRW 46.4 billion for the development of antivirals. To advance technology for disease control, prevention, and medical safety, the MOHW will invest KRW 85.7 billion by 2027, and KRW 28.8 billion by 2027 with the goal of developing non-face-to-face treatment technology for use in future pandemics. Also, it will prepare a 'Korean ARPA-H' that supports target-oriented strategic R&D tasks such as technologies for treating rare diseases to its success. In order to prepare for the transformation into a digital and data-oriented medical paradigm, the MOHW will develop the MyData service model as well as pioneer models for digital transformation such as smart hospitals, while operating transformation expansion support centers to provide customized support for the smartization of public-private hospitals.
