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- 2025-12-25 21:24:36
- Policy
- Hanmi’s generic for Galvus is aiming for release next year
- by Lee, Tak-Sun Oct 23, 2020 09:44am
- Galvus by NovartisHanmi applied for item approval again three months after withdrawal of the DPP-4 inhibitory diabetes treatment 'Galvus' (Novartis, Vildagliptin) salt-modifying drug. Indications were not removed unlike existing products, and combination drugs were applied for permission. According to the MFDS and pharmaceutical industry on the 21st, Hanmi applied for item approval for a single drug for Vildagliptin HCl on the 29th of last month and a combination drug for Vildagliptin HCl /Metformin HCl on the 16th of this month. In January, Hanmi obtained an item license for Vildagliptin HCl. At the time, it was licensed to exclude two of the original drug uses. The company tried to obtain insurance benefits, but the Intellectual Property Trial and Appeal Board dismissed the request from Hanmi. Accordingly, as of July 6, Hanmi voluntarily withdrew the item. The item applied for permission this time contains the same six original uses unlike the previous case. It seems that it is now aiming for release on August 30th next year. Although it failed to split the indications, Hanmi and Ahn-Gook succeeded in invalidating Galvus' material patent duration extension period of 187 days. Accordingly, the product can be released on August 30 next year. However, in response to the Intellectual Property Trial and Appeal Board trial decision, Novartis has filed a lawsuit to cancel the trial decision to the Patent Court of Korea. The judgment of this lawsuit is scheduled for the 29th this month. It will be difficult to launch in August next year if the court takes the side of Novartis, then, it will be available only in March 2022, a year later. Hanmi applied for permission for the Metformin combination drugs at this time. Currently, Hanmi is the only generic company that has applied for a combination drug. Although it failed to launch this year, it can dominate the market with Ahn-Gook even if it is released next year. However, Ahn-Gook did not apply for a combination drug. It is analyzed that if Hanmi introduces a single drug and a combination drug at the same time, it will be more advantageous in the competition for market share of generic companies. According to UBIST in the first half of this year, the outpatient prescription sales of the original, Galvus and the combination drug, Galvusmet were ₩4 billion and ₩17.9 billion, four times larger in the combination drug market.
- Policy
- Saxenda must be prescribed thru outpatient Rx
- by Lee, Jeong-Hwan Oct 23, 2020 09:44am
- The MFDS stated that the principle is to issue outpatient Rx by applying the principle of separation of prescribing and dispensing drugs for self-injectable medicines such as obesity drug, Saxenda. Unless a doctor directly injects, according to the purpose of separation of prescribing and dispensing drugs, medical institutions such as hospitals and clinics should not directly prescribe or dispense self-injection drugs, but rather must dispense them at a pharmacy. On the 20th, the MFDS unveiled an agreement with the MOHW regarding self-injectable medicines in a written inquiry by Nam In-soon, a member of Democratic Party of Korea. She inquired about the need for safety management and prevention of drug abuse for self-injectable medicines. It was pointed out that self-injectable medicines should be reinforced during the national audit last year that the safe use measures for patients should be strengthened due to side effects such as bleeding, infection, and pain. In particular, she asked about the results of consulting the MFDS’ Central Pharmaceutical Affairs Review Committee in January this year to support measures to support the safe use of self-injectable medicines and the contents of consultations with the MOHW regarding the mandatory outpatient Rx. She clarified that self-injectable medicines is subject to separation of prescribing and dispensing drugs, and urged that the outpatient Rx be made mandatory and consulted with the MOHW so that the public can use it safely. The MFDS stated that based on the discussion of the MOHW, self-injectable medicines should be prescribed through outpatient Rx, unless the doctor injects directly. She said that she would discuss the details of outpatient Rx with the MOHW. The MFDS said, "To support the safe use of self-injectable medicines, we have created patient-participated information and planned patient education with experts." Saxenda has improved the packaging unit from the current 5 packaging to unit packaging." She added, “I confirmed the position of the MOHW that Issuing outpatient Rx for self-injectable medicines is a principle unless the doctor injects directly.” And she also said that outpatient Rx for self-injectable medicines is a task under the jurisdiction of the MOHW, and I will discuss the details in the future."
- Policy
- NA audit talks about pre-listing coverage on anticancer
- by Lee, Hye-Kyung Oct 23, 2020 09:44am
- At the National Assembly annual audit, a healthcare provider suggested the ‘pre-listing reimbursement and post-evaluation’ should be implemented and ‘incremental cost-effectiveness ratio (ICER) threshold’ should be adjusted to practically improve access to new drugs. Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital, treating cancer patients at the clinical treatment scene, elaborated about the patients struggling to receive treatment due the delayed new drug reimbursement listing. However, the insurer, or the National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) expressed a reserved view on the suggestion. At the NHIS-HIRA National Assembly annual audit session on Oct. 20, Professor Kang Jin-hyoung was summoned as a witness and stated, “A novel anticancer treatment takes a long time to receive NHI reimbursement even after getting approved for the market by the Ministry of Food and Drug Safety (MFDS),” and “Patients are in immense pain as an immunotherapy for lung cancer could not pass HIRA for three years.” Regardless of how greatly effective a new drug is, it is not easy for the patients to actually use those drugs without the reimbursement. Professor Kang explained, “MOHW and HIRA say the anticancer treatment listing takes 350 days, but it excludes the time for requesting and submitting supplementary evidence. The time should be shortened to within 180 days for the patients and healthcare providers to actually feel the improvement.” The professor also noted although the risk sharing agreement system (RSA) introduced in 2014 contributed in speeding up the new drug listing procedure initially, the effect of RSA implementation on shortening the time has been insignificant due to expensive anticancer treatment entering the market. The professor stressed, “The social controversy is that most of immunotherapies can hardly get to RSA signing. After RSA was implanted, a half of anticancer treatments were listed through RSA, but the actual effect of shortening the listing period was weak,” and “The new drug listing speed has slowed down due to scarce review meetings amid COVID-19. If RSA were the only supplementary boost for the positive listing system, we need to pursue new options from now on.” Professor Kang recommended the following agenda to improve the new drug accessibility; providing pre-listing reimbursement and post-evaluation option, adjusting ICER threshold, and seeking means to secure additional source of NHI income to enhance public-private access. Regarding the ICER threshold for severe and rare disease treatments, the professor noted the threshold should be flexibly adjusted in a ‘bracket’ range, instead of basing it on GDP per capita. An independent Lawmaker Lee Yongho, who summoned Professor Kang, commented that “The patients would be desperate to access those new drugs,” and “Only controlling the NHI finance would not grant a solution. We need a balanced approach.” NHIS President Kim Yong-ik (left) and HIRA President Kim Sun-min (Source: National Assembly Correspondent Organization) Instead of clearly giving their opinion, however, NHIS President Kim Yong-Ik and HIRA President Kim Sun-min both claimed implementing a new system should be approached, carefully.. President Kim stated, “We can only be cautious when listing a new drug. Negotiating with a pharmaceutical company from a disadvantageous position can put NHIS and the government at risk when setting the drug pricing. And higher drug price can then put the patients in a worse situation. This is why the problem is difficult to solve.” On introducing the pre-listing reimbursement and post-evaluation, President Kim said, “We would review the suggestion, but we would not make any hasty decision as with have imminent issues regarding drug pricing and NHI finance.” HIRA President Kim Sun-min also said the accessibility issue is regrettable from the point of patients, but the suggested agenda would be difficult to execute without a social consensus. President Kim explained, “ICER threshold has to be effective when adding more cost. Recently listed anticancer treatments require cost of over 1 billion won to extend life expectancy by average one year,” so “We need to consider other patients and pursue the social consensus through thorough discussions.” “Although we would further make efforts to expand access to new drugs for severe and rare disease patients, we are already providing pharmacoeconomic evaluation exemption system and pricing negotiation exemption system,” nevertheless, “We would continue to improve the access,” said President Kim. After hearing from Lawmaker Lee Yongho’s witness, People Power Party Lawmaker Lee Jongseong spoke to President Kim Yong-ik, “You sounded negative about providing support to access the novel immunotherapy, but the administration promised, with the Moon Care, that no one would be neglected from accessing treatments. The government needs more forward-looking review. It should consider making a cancer fund and other options.” President Kim then answered, “We are absolutely not negative about expanding access to new drugs. Surely the alternative options should be considered, but the previous answer was concerned more of the pricing negotiation.”
- Policy
- Patients taking more than 10 drugs exceeded 2 million
- by Lee, Jeong-Hwan Oct 22, 2020 06:45am
- The number of multi-drug-drug patients who took more than 10 drugs at once exceeded 2 million last year. Korea ranks the highest among seven OECD countries that submitted statistics on multi-drug consumption, and the situation is serious. On the 20th, In Jae-keun, a member of Democratic Party of Korea, analyzed the national control data submitted by the NHIS and made this announcement. When taking multi-drugs, there is a high risk of drug effects or side effects due to drug interactions. According to a study by the NHIS, if older people 65 years of age or older take 5 or more drugs, they increase their risk of hospitalization by 18% and death by 25% compared to taking 1 to 4 drugs. The reality of taking multi-drug drugs in Korea is at a serious level. Last year, the OECD published the percentage of 75-year-old patients (as of 2017) who chronically take five or more drugs for 90 days or more, and Korea was the highest among the seven countries that submitted statistics. The proportion of Korea was 68.1%, and the average of 7 countries was 48.3%. The multi-drug prescription rate in Korea is increasing every year from 3.3% in 2016 to 3.5% in 2017, 3.8% in 2018, and 4.2% in 2019. The higher the age, the higher the multi-drug prescription rate was, and as of 2019, the multi-drug prescription rate of the 75-year-old or older population reached 23.6%. The multi-drug prescription rate is the number of people who took 10 or more drugs for 60 days or more in the year divided by the number of people who received the prescription at least once in the year. The number of patients taking multi-drugs is also increasing. The number of multi-drugs users from 1,548,000 in 2016 increased every year to 2,012,000 last year. During the same period, the multi-drug taking rate also increased from 3.0% to 3.8%. Looking at multi-drugs users by age, as of 2019, 841,000 people aged 75 and over (22.4% dose rate), 600,000 people aged 65-75 (12.2% dose rate), and 401,000 people aged 55-65 (4.8%), 127,000 people aged 45 to 55 (1.4%), and 43,000 people under the age of 45 (0.2%). There was also a difference in the status of multi-drugs users by income. As of last year, the first quintile was the highest at 5.8%, followed by the 10th (4.2%) and the ninth (3.7%). The 2nd to 8th quartiles showed similar figures around 3.0%. This means that those with higher income levels than those with intermediate income levels and those with the lowest income level than those with higher income levels had a higher rate of taking multi-drugs. In particular, in the case of medical benefits, the multi-drugs use rate reached 19.4%, requiring special attention. She said, "The current state of multi-drugs use in Korea is another aspect of an excellent pharmaceutical system," and pointed out that "the government needs attention for improvement." She stressed that it is urgent to manage multi-drug products for the elderly and low-income groups, including medical care recipients, to promote it as an official project.
- Policy
- 9 non-reimbursement vaccines could save ₩40 billion
- by Lee, Jeong-Hwan Oct 22, 2020 06:43am
- It was argued that expanding the National Immunization Program (NIP) and including non-reimmbursement vaccines in the scope of health insurance coverage would be effective in reducing socioeconomic losses and strengthening health insurance finances. It is pointed out that it is possible to reduce the socio-economic cost of ₩39.9 billion by ₩3.65 billion for adult vaccination against nine diseases such as pneumonia and mumps. On the 20th, Jung Choun-sook, a member of Democratic Party of Korea, announced this through the Korea Disease Control and Prevention Agency and the HIRA submission data. According to data from the Centers for Disease Control and Prevention (CDC) submitted by the Korea Disease Control and Prevention Agency, the cost of vaccines compared to hospitalization costs was only 0.02% to 3.78%. Specifically, the cost of hospitalization for tetanus was $102,524, while the cost of the vaccine (based on children) was only $16.34 to $61.65. Hospitalization costs for pneumococcal disease ranged from $3,798 to $25,848. Looking at the treatment status of these nine diseases over the last three years, the number of pneumococcal disease patients from 2018 to June 2020 was 10,588, and the total amount of medical care benefit expenses was about ₩18.945 billion. The number of patients for mumps was 33,464, the cost of medical care benefits was about ₩2,964 million, the number of patients for chickenpox was 194,700, and the cost of medical care benefits was about ₩14,87 billion. On the other hand, even though the cost of the vaccine is not covered, the cost of the vaccine will be ₩61,501/person at a hospital for pneumococcal disease, and if all 10,588 patients are vaccinated, the cost of the vaccine will be ₩651 million. For mumps, the vaccine cost is ₩11,390/person, and if all 33,464 patients are vaccinated, the vaccine cost will be ₩381 million. Chickenpox amounts to ₩13,020, and ₩2,535 billion, if 194,700 people are vaccinated. It is much more economical if the disease is prevented by vaccination. She believes that vaccination is the most effective public health intervention tool in terms of cost/benefit, and if NIP is expanded through national health insurance reimbursement, and that it will ultimately help finance health insurance by reducing socioeconomic losses and reducing medical costs. As of this year, the nationally supported NIP include 'Children's NIP' for children under 12 years of age (17 types of vaccines eligible for free vaccination such as tuberculosis, hepatitis B, diphtheria, tetanus, whooping cough, etc.), 'Healthy Women's First Step Clinic Project' targeting female adolescents aged 12 years, 'Influenza NIP' targeting seniors 65 years of age or older, 6 months to 12 years old, and pregnant women, and 'Elderly pneumococcal disease NIP' targeting seniors 65 years of age or older. 정춘숙 의원은 "예방접종은 비용 대비 편익 측면에서 가장 효과적인 공중 보건 중재 수단"이라며 "국민건강보험 급여화를 통해 예방접종사업을 확대하면, 사회경제적 손실을 줄이고 의료비용 절감을 통해 궁극적으로 건강보험 재정에 큰 도움을 줄 수 있다"고 강조했다. 한편 예방접종 비용을 국가가 지원하는 국가예방접종 사업은 올해를 기준으로 만 12세 이하 어린이를 대상으로 한 '어린이 국가예방접종 지원사업'(결핵, B형간염, 디프테리아, 파상풍, 백일해 등 무료접종 대상 백신 17종), 만 12세 여성 청소년을 대상으로 한 '건강여성 첫걸음 클리닉사업', 만 65세 이상 어르신, 생후 6개월~12세 어린이, 임신부를 대상으로 한 '인플루엔자 국가예방접종 지원 사업', 만 65세 이상 어르신을 대상으로 한 '어르신 폐렴구균 예방접종사업' 등이 있다.
- Policy
- Eplerenone was first approved in Korea
- by Lee, Tak-Sun Oct 22, 2020 06:31am
- Pfizer’s Inspra (Eplerenone) The drug for hypertension and chronic renal failure, which was not introduced in Korea, was first approved by a small and medium-sized pharmaceutical company in Korea. The MFDS approved a drug for data-based re-evaluation of two doses of Theragen Etex's Eplerenone formulation on the 21st. Eplerenone is generic for Inspra, which was approved by the US FDA for hypertension treatment in 2002. It was approved as a treatment for congestive heart failure in 2003. Inspra is a drug developed by Pharmacia before the acquisition of Pfizer. It is known as an Aldosterone antagonist, such as Spironolactone, as a potassium-sparing diuretic agent. Pfizer did not introduce Inspra instead of launching 'Aldactone film coated tab' with spironolactone component in Korea. It is known that Inspra did not achieve sales performance as expected due to Spironolactone formulation overseas. Pfizer did not introduce Inspra while launching 'Aldactone film coated tab' containing Spironolactone in Korea. It is known that Inspra failed to achieve as much as expected due to the Spironolactone formulation overseas. Pfizer has its best-selling drug, Norvasc which is a calcium channel blocker that dilates blood vessels and improves blood flow. Pfizer acquired Pharmacia in 2002 and secured famous pipelines such as Celebrex. Since it was not introduced in Korea, there are no licenses or patents on the Orange book of the MFDS. Therefore, there is no difficulty for generics to enter the market because the original has not been introduced in Korea. Theragen Etex also recognized this and belatedly started to approve the item. Eplerenone from Theragen Etex can be used for hypertension and chronic heart failure (when receiving basic treatments such as angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, β blockers, and diuretics). The amount of outpatient prescriptions for Aldactone, was ₩2.8 billion last year. Although the market size of drugs for hypertension and chronic heart failure is large, new drug competition is fierce, so the sales volume of Eplerenone, which was introduced lately in Korea, will only be known after time.
- Policy
- Competition for generics for Tenelia M SR is fierce
- by Lee, Tak-Sun Oct 21, 2020 06:35am
- Tenelia M SR Following Handok's DPP-4 inhibitory diabetes treatment 'Tenelia', the generics for 'Tenelia M SR', a combination drug combined with Metformin, are also actively developing commercialization. According to the MFDS on the 20th, this year, Kyung Dong and Kolmar Korea were approved for a phase I clinical trial to compare the equivalence of their developed drug and Tenelia M SR. Kyung Dong received approval of two clinical trial protocols in July and August, and Kolmar in August and October. The reason for the two trials is that Tenelia M SR is a drug that controls blood sugar both before meal and after meal by taking once a day. Therefore, Kyung Dong and Kolmar Korea conduct a test to compare the bioequivalence of healthy adults in two situations before and after meals. Previously, Mothers Pharm was also approved for clinical trials in two situations before and after meals in October last year. Until now, Tenelia salt modification single drug product approval and application for permission are continuing, but it is known that there is no approval procedure for the combination drug Tenelia M SR. It is still in the stage before commercialization. A single drug was applied for the first approval of a product containing Teneligliptin HCl, a salt-modifying drug, in April, and Kyungdong received the first approval of 'Teneritin Tablet 20mg' with the same ingredient last month. In addition, five additional Teneligliptin HCl hydrates have been applied for permission, and two cases of 'Teneligliptin tosylate hydrate'' have been applied for permission. Both drugs were reportedly developed by Kyung Dong and Mothers Pharm. The ingredient name of Tenelia is Teneligliptin hydrobromide hydrate. Teneligliptin's substance patent expires on October 25, 2022, so generics cannot be sold until then. In addition, a separate composition patent for Tenelia M SR is scheduled to expire on December 23, 2034. There are still no generics for composition Patent. Tenelia is a product introduced by Handok by 'Mitsubishi Tanabe Pharma' in Japan. However, Tenelia M SR is a product developed by Handok as a combination drug after the introduction of Tenelia. The combination drug Tenelia M SR outperforms the single drug Tenelia. Based on UBIST, Tenelia M SR's outpatient prescriptions in the first half of this year were ₩10.8 billion and Tenelia’s sales were ₩9.5 billion.
- Policy
- Sneak peek into NHIS-HIRA audit centering new drug coverage
- by Lee, Jeong-Hwan Oct 21, 2020 06:32am
- An independent Lawmaker Lee Yongho (left) and People’s Power Party Lawmaker Lee Jongseong The National Assembly annual audit for National Health Insurance Service (NHIS) and Health Insurance Review and Assessment Service (HIRA) scheduled on Oct. 20 is predicted to address the issue of improving patients’ coverage on new drugs like high-cost anticancer treatment. The lawmakers would likely to talk about the necessity of legislating ‘pre-listing reimbursement and post-evaluation’ on rare disease treatments and establishing ‘cancer fund’ for cancer patients’ improved coverage. A renowned expert in immunotherapy, Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital, would be summoned as a witness to speak his opinion on new drug access and catastrophic medical expense. On Oct. 19, many of the lawmaker of the Health and Welfare Committee were reportedly preparing the audit agenda regarding the access to new drug. Particularly, an independent Lawmaker Lee Yongho and People’s Power Party Lawmaker Lee Jongseong are focusing on the financial impact burdened on patients using non-reimbursed and expensive anticancer treatment. In fact, the two lawmakers have been engaging with various activities in patient-centered new drug coverage enhancement. In last month, Lawmaker Lee Yongho convened an online discussion panel on improving patients’ access to new drug amid COVID-19, and Lawmaker Lee Jongseong also led a policy talk spotlighting the neglected health insurance benefit for cancer patients. Both talks shared a common theme of urging to implement the ‘pre-listing reimbursement and post-evaluation’ system to raise the reimbursement rate in all severe disease treatments. Lawmaker Lee Jongseong also proposed a realistic solution to source finance for coverage on expensive anticancer treatment by establishing a ‘cancer control fund.’ The lawmaker has already submitted a partial revision bill on the Cancer Control Act with the said notion. The independent lawmaker demanded Professor Kang Jin-hyoung at the Catholic University of Korea Seoul St. Mary’s Hospital to be summoned to the NHIS-HIRA audit session as a representative expert in immunotherapy. The lawmaker plans to publicly raise concern about the anticancer treatment coverage by questioning about new drug approval and catastrophic medical expense. Lawmaker Lee said, “This is the time to put our wisdom together in enhancing the access to new drug centering the people’s rights to health and making the news of new drug development a hope for the patients and their families.” “As a member of the Health and Welfare Committee, I would strive to reinforce the country’s medical system,” he added. Regardless, MOHW has also already expressed an opposing stance on the pre-listing reimbursement for expensive anticancer treatments For the extended questions by Lawmaker Lee Jongseog, MOHW official answered, The pre-listing reimbursement would make drug pricing adjustment difficult when the company refuses to accept the evaluation result, and it could also weaken the National Health Insurance Service’ (NHIS) negotiation power,” so “The issue needs to be reviewed thoroughly as we foresee the difficulties in practical system operation and reasonable pharmaceutical expense management.”
- Policy
- MFDS evaluates documents for prolonged COVID-19 crisis
- by Lee, Tak-Sun Oct 21, 2020 06:32am
- The MFDS decided to skip the pre-GMP survey of imported drugs due to the prolonged COVID-19, and to evaluate the documents without exception. The MFDS postponed the survey after the massive outbreak of COVID-19 in February, and document evaluation was conducted for some items without the survey. However, as COVID-19 situation is prolonged, it is a policy to evaluate documents except when the factual survey should be omitted. The pharmaceutical industry is concerned that it is difficult to replace some items with documents without factual survey. According to the industry on the 19th, The MFDS recently prepared and implemented a pre-GMP evaluation plan for such imported drugs. The MFDS has temporarily prepared an evaluation plan when COVID-19 occurred in February of this year. It was decided to omit the factual survey if appropriate by submitting the PIC/s report, the due diligence report by the regulatory authority, and the result of action on the insufficiency of the inspection result. However, for civil complaints that cannot be omitted from the factual survey, the deadline for consultation will be extended until the end of this year, and on-site surveys will be conducted after COVID-19 situation is over. The MFDS, however, is likely to file complaints about the prolonged period of complaint handling due to the accumulation of items that have not been submitted and the prolonged situation due to the prolonged COVID-19. It is a policy to make an enemy or negative decision. This includes DMF complaints. Accordingly, document evaluation is conducted on all items including items not submitted such as PIC/s reports. However, it is a policy to first select the items that need to be subjected to factual surveys as'companies subject to post factual surveys at overseas factories'. In accordance with this full document review process, GMP evaluation essential data (11 types of data, etc.), which are not submitted as a reason for confirmation at the manufacturer factual survey, must also be submitted. Regarding this plan, an official in the pharmaceutical industry said, "If the cases that can be solved only by conducting a factual survey are replaced with documents, it is more difficult." Another official also said, "There are imported drugs that can be replaced with documents, and we are concerned that these items will become non-conformance cases." However, he explained, "If the MFDS only evaluates the documents, the burden on the pharmaceutical industry will be reduced."
- Policy
- The intervention in COVID-19 patents should be cautious
- by Lee, Jeong-Hwan Oct 20, 2020 09:16am
- The MOHW said that the government's intervention in a patent related to a vaccine and treatment for COVID-19 developed with public funds from the government should be carefully reviewed. Requesting nation share in patent rights or property rights of private companies just because vaccines and treatments were developed with government funding is the purpose of reviewing various legal grounds and social situations. On the 15th, the MOHW made this announcement in a written inquiry for Seo Young-seok, a member of Democratic Party of Korea. He asked the necessity of national intervention related to patents for COVID-19 vaccines and treatments with public funds. Accordingly, the MOHW said that government-sponsored R&D requires a balance between incentives to achieve performance and publicity. Specifically, the MOHW explained that the R&D performance technology license is granted to the host research institute, but it is collecting technology fees according to the proportion of the government-supported budget, and that the development of COVID-19 vaccines and treatments is applied equally. It means that the results, such as sales profits of COVID-19 vaccines and treatments developed by investing public funds, will be given to pharmaceutical companies, but will collect royalties according to the amount of budget input. The government's administrative basis is the Framework Act on Science and Technology and the Medical Service Technology Promotion Act. However, the MOHW affirmed that the participating pharmaceutical companies expressed their intention to consider national health, such as showing a willingness to provide them free of charge upon successful development. In fact, GC Pharma declared a free supply when it completed the development of plasma therapy in May, and Celltrion said it would not pursue profits with COVID-19 treatment in July. SK Chemicals is also supplying Alvesco, an asthma treatment drug, to 11 hospitals for free. In particular, the MOHW said that the Korean Intellectual Property Office is the supervisory authority for the issue of state intervention in patent rights, and that careful review is necessary. He also inquired about the need to prepare for the invocation of a compulsory license in case the supply of COVID-19 vaccines and treatments is not smooth or it is difficult to secure supplies due to high price. The MOHW said that the necessity of securing vaccines/treatments and initiation of compulsory licenses should be carefully reviewed. Organizations such as the WHO recognize COVID-19 vaccines and treatments as public goods, and the importance of international cooperation in development and distribution is emphasized, and the invocation of a compulsory license should not be decided prematurely. The MOHW said, "The technology license for R&D outcomes is given to the host company, but the provisions of the law to collect technology fees according to the support budget will also apply to COVID-19 vaccine and treatment system." Also it said that the Korean Intellectual Property Office should judge the intervention of the patent right through the law amendment, and a careful review is necessary. The MOHW said that since COVID-19 vaccines and treatments are public goods, international cooperation is important for development and dissemination, and the invocation of compulsory licenses such as manuals should be cautious. In addition, the MOHW added that the two-track strategy will be devoted to the introduction of overseas vaccines in Korea and the rapid development of domestic vaccines.
