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- 2026-05-02 11:39:33
- Policy
- Reimb extension discussions for Kyprolis break down
- by Lee, Tak-Sun Dec 06, 2024 05:57am
- The proposal to extend reimbursement coverage for the multiple myeloma drug Kyprolis (carfilzomib, Amgen) has failed to make it past the negotiating stage with the National Health Insurance Service. The negotiations, which began last October, have broken down. The National Health Insurance Service announced the news of Kyprolis' negotiation failure on the 4th while updating the list of drugs that have completed drug price negotiations on its website. Kyprolis was set reimbursement standards by the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee in April as a ‘combination therapy used with daratumumab and dexamethasone (DKd regimen) for the treatment of multiple myeloma patients who have received one or more prior therapies’. However, the coinsurance rate for daratumumab is set at 100%, for the patient to pay in full as out of pocket price. Since then, the agenda has passed the Drug Reimbursment Evaluation Committee review and was in negotiations with the NHIS since October. In February 2018, Kyprolis was successfully listed on the reimbursement list as part of the RSA (risk-sharing agreement, refund type) scheme. The reimbursed therapies at the time were KRd therapy (Kyprolis+lenalidomide+dexamethasone) and Kd therapy (Kyprolis+dexamethasone). With the reimbursement, the out-of-pocket cost for the patients was reduced from KRW 10 million to KRW 500 to 600 thousand. The DKd regimen had shown evidence that it was effective in patients exposed to lenalidomide, which is why it is expected to be beneficial to patients if reimbursed. However, the breakdown in negotiations means it will take longer for the drug to be reimbursed. The drug will have to undergo another review by HIRA DREC before it can be re-negotiated with the NHIS. As a blockbuster drug that recorded sales of KRW 32.2 billion last year (IQVIA), it will be interesting to see how Amgen will respond to its negotiation breakdown.
- Policy
- Expanded clinical use of orphan drug 'Joenja' in children
- by Lee, Hye-Kyung Dec 06, 2024 05:56am
- Product photo of Joenja. The administration·dosage in children for a clinical trial of 'Joenja (leniolisb),' an APDS treatment designated as an orphan drug in South Korea, is expected to be expanded. The meeting record of the Central Pharmaceutical Affairs Advisory Committee (CPAC), released by the Ministry of Food and Drug Safety (MFDS) on December 4, indicates that there has been a consultation regarding the application for approval of a medication on clinical trial intended for therapeutic use, which is currently undergoing clinical trials in a foreign country. It was reported that the medication is Joenja, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). In June, Joenja was designated as an orphan drug. APDS is caused by mutations in one of the genes encoding PIK3CD or PIK3R1 that is needed for the development and function of immune cells. The disease occurs in 1 in 1-2 million people. Patients exhibit autoimmunity and inflammatory symptoms. Symptoms include ears infections, paranasal infections, and upper·lower respiratory infections. Lymph nodes or the spleen may enlarge, and patients have increased risk of developing cancer, such as lymphoma. The approval of Joenja was based on the results of multinational, triple-blinded, placebo-controlled, randomized clinical 2/3 trials. The clinical trial involved 31 APDS patients over 12 years old. At the recent CPAC meeting, discussions were held on the age range eligible for approval based on pediatric administration·dosage and predicted through pharmacokinetic (PBPK) modeling data and case studies from a compassionate use program (10 patients). The CPAC concluded that approval could be granted for patients aged four years and older, with further discussions required for those under four. Regarding the PBPK modeling data, one committee member stated, "Metabolism is proportional to body weight and liver volume, with differences of about 20% observed even among adults, making application in children reasonable." "However, since kidney function, liver function, and body composition become similar to adults only after two, predicting results for patients under two years old is challenging." Most committee members state that the submitted modeling document presents no significant issue. One committee member commented, "FDA reports indicate that medication use in ages 4-11 will not pose any problem based on the modeling result. However, the applications below the age of 4 or 2 must need further discussion." Another committee member stated, "The CYP cell maturity is similar after age 2, larger liver size and hepatic clearance. We believe that this has been incorporated in the modeling." Once patients start taking medication, they are likely to continue treatment. Therefore, concerns have arisen that administration should only begin after safety results are reviewed. However, the committee chair noted that data collection could be challenging since the target population comprises children with rare diseases. Regarding this, "The medication has been designated as an orphan drug in both the U.S. and Korea, with four additional approved cases," the MFDS stated. "We need consultation on whether the clinical trial data from U.S. approval, submitted as evidence of safety and efficacy, along with the modeling data and case studies from 10 patients, can substitute for therapeutic confirmatory or exploratory clinical trial results." Consequently, it was concluded that CPAC must give a green light, as the unapproved status in South Korea and CPAC's opposition to access would deny Korean patients treatment opportunities. Meanwhile, since the currently available 70 mg product is a film-coated tablet that children may be unable to swallow, the company plans to provide the medication in 10 mg and 30 mg tablets.
- Policy
- Linking 'Prior review-performance evaluation-reevaluation'
- by Lee, Tak-Sun Dec 06, 2024 05:56am
- HIRA The Health Insurance Review and Assessment Service announced that it has been reviewing a measure that links preliminary review, performance evaluation, and reevaluation for newly listed high-priced drugs. In other words, for newly listed high-priced drugs, the authorities will conduct a proper cost-effectiveness evaluation through a preliminary review process. In this way, the new system will build a virtuous cycle with the existing preliminary review system. HIRA's Healthcare Review and Assessment Committee (HCRAC)’s Review Department and Review Division explained so at a press conference with press corp reporters on the 3rd. The Review Department and the Review Division are TF-type departments that were established this year to improve HIRA’s review standards. Min-Sun Kim, Head of the HCRAC Department, said, “The HCRAC Department was newly established earlier this year when a new task of overseeing and improving the general review standards was added to the committee’s preliminary review task.” Kim explained that the HCRAC's key achievements this year were the voluntary efforts it had made to improve the review standards and the establishment of a virtuous cycle of the preliminary review system. “As the need for preliminary review has increased with the increase in the number of high-priced drugs, we have established and operated a monitoring and return system that switches items that have been under review for a long time to post-review and quickly introduce newly listed high-priced drugs through preliminary review,” explained Kim. Of the 12 preliminary review items, 5 items, including a treatment for paroxysmal nocturnal hemoglobinuria, were stably transitioned to items for post-review, and a new treatment for the inherited retinal disease was introduced. In addition, the committee improved and expanded the reimbursement standards for 6 items through analysis of the review status and expert discussions. This year, HIRA switched the preliminary review status of Strensiq, Soliris Inj (paroxysmal nocturnal hemoglobinuria), Ultomiris Inj, ICD (implantable cardioverter-defibrillator), and CRT (cardiac resynchronization therapy) as subject to post review. Kim added, “In the case of preliminary review, we will promote the introduction of high-priced new drugs, and consider ways to utilize data that can be linked from preliminary review to performance evaluation and re-evaluation for a solid reimbursement management system of high-priced drugs." Jung Gu Kang, President of HIRA who also attended the conference, added, “Drugs whose data has not been verified at the time of their introduction should be objectively verified for cost-effectiveness through post-evaluations. Newly introduced drugs should undergo preliminary review to reduce unnecessary spending.” However, he said there are no plans to move the atypical hemolytic-uraemic syndrome treatment, which has been receiving many requests to transition the item to post-review due to its low pre-approval rate. “The reason we switched paroxysmal nocturnal hemoglobinuria treatments to post-review is because they are stable in terms of reimbursement coverage, but atypical hemolytic uremic syndrome treatments are not so,” added Kim, ”The Anti-Corruption & Civil Rights Commission did not recommend abolishment of the drug’s preliminary review status.” In addition to the reorganization of the preliminary review system, the HCRAC’s review office said it has improved the review standards for 114 applications. Kim explained, “At the end of last year, we reviewed a total of 410 cases, including spine surgeries that clinical societies and associations filed appeals and opinions on improving the review criteria and revised and reflected their opinion on 114 cases into review guidelines and notices, and improved the review process. We met and discussed with academic societies and held advisory meetings more than 50 times.” “Of the 410 cases, 58%, or 238 cases, were resolved within the year. For 124 cases where the medical community misunderstood the review and criteria, we provided detailed guidance to clinical societies and associations for better understanding of the medical community, and 114 cases with medical grounds were reflected in the review guidelines and notices.” “For the other 172 cases that have not yet been resolved, some cannot be resolved immediately due to lack of clinical evidence, while others need to be improved, but may take several months to a year or more to resolve due to equity issues between medical departments or financial requirements. We have shared these situations with clinical societies and associations, and we ask for the understanding and cooperation of the medical community and the government for their resolution.”
- Policy
- Astellas’s Xtandi Tab 40mg and 80mg approved in KOR
- by Lee, Hye-Kyung Dec 05, 2024 05:53am
- Pic of Xtandi Soft Cap Astellas, the original company of the oral androgen receptor inhibitor (ARTA) class prostate cancer treatment, became the first company to receive marketing authorization for the tablet formulation of Xtandi in Korea. The Ministry of Food and Drug Safety approved two dosage forms of Astellas' Xtandi Tab - 40 mg and 80 mg – on March 3. Since Astellas received approval for ‘Xtandi Soft Capsules 40 mg (enzalutamide)’ in Korea in 2013, the company has only been supplying the soft capsule formulation until now. Soft capsule formulations have a disadvantage in that increasing the dose increases the size of the capsule itself, which can reduce patient convenience, making it difficult to develop higher-strength products. Astellas has been developing Xtandi Tab since 2020, increasing the dose to 80 mg and selling them alongside its soft capsule product after receiving approval for the tablet formulation in the US and Europe. However, in Korea, only the soft capsules have been released due to delays in approval, and domestic pharmaceutical companies have been developing tablet formulations of enzalutamide, the main ingredient of Xtandi. Recently, Ildong Pharmaceutical and Boryung Pharmaceutical have been developing tablet formulations of enzalutamide. However, Astellas registered its patent technology for Xtandi’s tablet formulation with the Korean Intellectual Property Office in July, and then recently received approval for Xtandi Tab. According to IQVIA, domestic sales of Xtandi Soft Capsules have increased from KRW 29.1 billion in 2022 to KRW 43.2 billion in 2023, accounting for one-fifth of Astellas' sales. Xtandi's growth has been largely driven by the drug’s reimbursement extension. In August 2022, Xtandi was granted reimbursement for patients with advanced prostate cancer with distant metastases when used in combination with androgen blockade therapy (ADT), and in November last year, it became reimbursable regardless of the patient’s prior use of other ADTs. In addition, the reimbursement was extended to non-metastatic hormone-sensitive prostate cancer (nmHSPC) in June, leaving room for further growth. Meanwhile, Astellas Pharma Korea's sales reached KRW 251.1 billion last year, up 7.5% from KRW 232.2 billion in 2022.
- Policy
- 30-day negotiation window for essential medicines
- by Lee, Tak-Sun Dec 04, 2024 05:57am
- The National Health Insurance Service (NHIS) has started revising guidelines related to the government's initiative to improve the drug pricing system to 'reflect on the new drug innovative value.' First, the NHIS announced to introduce Risk Sharing Agreement (RSA) types and has reduced the time required to negotiate pricing adjustments for national essential medicines. The NHIS has recently drafted a revision to the guidelines for drug price negotiations and detailed matters for RSA drug price negotiations, collecting public opinions. The deadline for submitting opinions is December 4. Regarding revision to the guidelines for drug price negotiations, the NHIS established a basis for shortening the time required for drug price negotiation and pre-negotiating the national essential medicines. In detail, the NHIS decided that the negotiating period for drugs evaluated at the Drug Reimbursement Evaluation Committee (DREC) to require assistance from the central administrative agency for drug supply issues, such as crisis for infectious diseases or emergency drug shortages, will be 60 days instead of 30 days. Also, pre-negotiation is possible, and the pre-negotiation application will be the same as a submitted document to the Health Insurance Review and Assessment Service (HIRA). For detailed matters for RSA drug price negotiations, the NHIS announced introducing an early-stage treatment cost refund type and an achievement-based refund type. The early-stage treatment cost refund type is for applicants seeking refunds from NHIS for a portion of the initial administration cost. Also, the achievement-based refund type is for applicants requesting refunds of a portion of the total claim amount of the drug from NHIS when an individual does not meet the predetermined treatment effects after a follow-up·monitoring for a specified time. Recently, these two types have been applied to high-priced drugs. With the newly added types, contract additions·changes will be permitted during negotiations, and post-management procedures will be officially incorporated. Additionally, the current revision will simplify the procedure required at RSA termination. Previously, the NHIS requested an evaluation of the RSA-approved drug's clinical usefulness and cost-effectiveness before the contract termination. The current revision will skip the drug procedure under the third contract for RSA. Also, the NHIS will request confirmation from the HIRA director related to changes to RSA drugs, including substitute drugs or reimbursement criteria. "The revision has been established to bring improvements to the drug pricing system to reflect on new drug innovative value and to ensure healthcare security," the NHIS explained regarding the current revision. "To promote innovative new drug value and incentivize innovative growth, the NHIS aims to support sustainable, innovative systems for the pharmaceutical and biotech industry. This includes ensuring stable drug supplies by setting reasonable drug prices for essential pharmaceuticals required by patient treatments and establishing a foundation for essential healthcare." The current revision is a follow-up to the 'Specific evaluation criteria of new drugs and medicines in consideration for negotiation,' which was established by the HIRA in August, and the 'Pharmaceutical Approval and Adjustment Criteria,' which was announced in October. The government plans to promote new drugs' innovative value and to improve the drug pricing system to ensure healthcare safety by favoring the national essential medicine. The government will expand the number of pharmaceuticals for RSA and provide benefits for the drug pricing of the national essential medicines that use domestic raw materials. An NHIS employee explained, "We plan to implement the revised draft by hearing public opinions alongside the announced draft by the Ministry of Health and Welfare (MOHW).
- Policy
- Legislation of ‘INN prescriptions’ for drugs begin
- by Lee, Jeong-Hwan Dec 04, 2024 05:56am
- The government is promoting legislation to recommend international non-proprietary name prescriptions for national essential medicines and drugs with unstable supply and demand and to encourage the use of 'product name and the international non-proprietary name’ when obtaining a marketing authorization. The bill also includes a provision that requires the government to establish a policy to resolve stockouts by legislating the definition of unstable drugs and giving them the same status as national essential medicines. The legislation recommends that the government prescribe and approve the use of ingredient names only for drugs with unstable supply and national essential medicines, which are frequently out of stock and cause inconvenience to pharmacies and patients. On the 2nd, Rep. Yoon Kim, a member of the Democratic Party of Korea, introduced a bill as representative to amend the Pharmaceutical Affairs Act. First, the bill defines an unstable supply drug as a drug designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation as a drug that needs to secure a stable supply due to unstable supply and demand. The amendment puts unstable drugs on the same level as national essential medicines. The Minister of Welfare and the Minister of Food and Drug Safety are obligated to carry out support tasks to promote the production and utilization of drugs with the same ingredients as drugs with unstable supply and demand. The Minister of Welfare and the Minister of Food and Drug Safety are required to establish and promote comprehensive measures to stabilize the supply of drugs with unstable supply and demand and to support the establishment of a stable supply base, research and development, and safe use. Recommendation of international non-proprietary name prescriptions and approving ingredient-containing product names In particular, the law recommends doctors prescribe ingredient names for national essential medicines and drugs with unstable supply and demand and encourages pharmaceutical companies to receive marketing authorization based on ingredient-containing product names. Specifically, the Minister of Welfare is required to establish a policy to activate the use of ingredient names for nationally essential medicines and drugs with unstable supply and demand in prescriptions. This provision has the effect of encouraging the prescription of nationally essential medicines and drugs with unstable supply and demand. In addition, the Minister of Food and Drug Safety recommends the use of international non-proprietary names for those who intend to sell or import national essential medicines and drugs with unstable supply and demand. The Minister of Food and Drug Safety can provide administrative and financial support for those who want to sell and import nationally essential medicines, etc. Through the provision, the government recommends pharmaceutical companies planning to sell and import drugs with domestic marketing authorizations to include the names of ingredients in the product names. The law also stipulates that the MFDS National Council for Stable Supply of Essential Drugs shall consult on matters related to national essential medicines. The Korea Orphan & Essential Drug Center will manage drugs with unstable supply along with national essential medicines. The amendment is expected to create a government organization dedicated to drugs with unstable supply and demand. “In recent years, the problem of unstable supply and demand of certain drugs has not been easily resolved and is often prolonged,” said Rep Yoon Kim. ”This causes problems within the drug supply process, from distribution to consumer purchases, such as stockpiling, issuing long-term prescriptions, and over-the-top trading between pharmacies.” “Therefore, the government will establish a stable supply mechanism for drugs with unstable supply and demand and promote the use of international proprietary names for nationally essential medicines to lay the foundation for stable and timely supply of drugs to consumers.” Yoon Kim was joined in the bill by Democratic Party members Gi-Pyo Kim, Nam-Geun Kim, Nam-Hee Kim, Seung-won Kim, In-soon Nam, Ji-won Park, Hae-Cheol Park, Hee-Seung Park, Seung-A Bak, Hoon-Gi Lee, and Mi-ae Lim.
- Policy
- 17 drugs receive essential medicine designations
- by Lee, Hye-Kyung Dec 03, 2024 05:53am
- Seventeen medicines that are essential for pediatric patients, cancer patients, and others, but require government support due to unstable supply, have been newly designated as national essential medicines. The Ministry of Food and Drug Safety (MFDS, Yu-Kyung Oh) announced on the 29th that it held a meeting on the stable supply of national essential medicines and newly designated 17 items (ingredients and formulations) as national essential medicines. Newly designated national essential medicines include cisplatin injection, an anti-cancer drug used for testicular and bladder cancer; clofarabine injection, a treatment for pediatric leukemia; and citric acid-sodium citrate-glucose mixtures, which prevents blood from clotting in blood donations. Newly designated national essential medicines Formoterol dry syrup, a cold medicine used to relieve bronchitis symptoms, whose designation has been discussed since last year at the 'Public-Private Consultative Committee that Responds to the Unstable Supply and Demand of Drugs' jointly run by the Ministry of Food and Drug Safety and the Ministry of Health and Welfare, was also newly designated as a national essential medicine. This new designation brings the total number of National Essential Medicines to 473, an increase of 17 from 456. The National Council for Stable Supply of Essential Medicines, which discusses issues related to the stable supply of medicines at the pan-governmental level, has been establishing comprehensive measures for the stable supply of essential drugs and discussing important matters necessary for the operation of the system, such as the designation or removal of new essential drugs. At this meeting, they shared information on the stable supply system of national essential medicine and discussed ways to collaborate between organizations to operate the national essential medicine system more efficiently. The MFDS said it will continue to actively cooperate with related ministries and medical sites to ensure a stable supply of nationally essential drugs, and will do its best to provide institutional and administrative support to ensure the timely and stable supply of drugs essential for patient treatment. "The National Essential Medicine Designation System, which designates and supports medicines that require stable supply, is essential for securing national health security," said MFDS deputy minister Yumi Kim, who chairs the council. "We will work together to create an environment where people can use medicines with peace of mind without supply insecurity."
- Policy
- Janssen’s Tremfya’s price cut 2yrs due to increased use
- by Lee, Tak-Sun Dec 03, 2024 05:52am
- The upper limit price of Tremfya, Janssen's autoimmune disease treatment, is expected to be reduced under the price-volume agreement system for the second consecutive year. According to industry sources, the National Health Insurance Service and Janssen recently finalized PVA negotiations for the reimbursement of Tremfya on the 1st. In December last year, Tremfya’s upper price limit was also lowered from KRW 1.59 million to KRW 1.55 million under the price-volume agreement Type I negotiations. If the price of the drug is reduced again this year, it will be the second consecutive year that the upper limit has been adjusted under the PVA system. As the first interleukin-23 inhibitor, the drug was approved as a treatment for adult patients with plague psoriasis in April 2018. In September of the same year, the indication was applied to reimbursement benefits. The drug has been increasing its indications and expanding its market size. The drug’s reimbursement was extended to cover pustular in adults in May 2021, and psoriatic arthritis in May 2022. The Ministry of Food and Drug Safety had previously approved the drug to treat active psoriatic arthritis in adult patients who had responded inadequately or were intolerant to disease-modifying anti-rheumatic drugs (DMARDs). Also, Tremfya is reimbursed in patients with active or advanced psoriatic arthritis who show an inadequate response to TNF-α inhibitor or IL-17 inhibitor or need to discontinue the use of such drugs due to contraindications or adverse events. The reimbursement extension has been driving domestic sales. According to IQVIA, domestic sales of Tremfya increased from KRW 6.1 billion in 2019 to KRW 12.5 billion in 2020, KRW 18.2 billion in 2021, and then KRW 24.3 billion in 2022. In May 2021, the upper price limit of Tremfya was first lowered through Type A of the price-volume agreement. At that time, it was reduced by 4.5% from KRW 1.6364 million to KRW 1.589 million. Type A negotiations are triggered when a drug’s insurance claims increase by over 30% more than the expected amount, so it is expected that Tremfya’s insurance claims have already exceeded expectations in 2020. After the Type A negotiations last year, the drug was again subject to Type B negotiations this year and became a regular in the PVA system. Drugs are subject to Type B negotiations if the claims amount increased by more than 60% from the previous year after a drug’s insurance ceiling price was adjusted through Type A negotiations, or if the increase was more than 10% and the amount over KRW 5 billion. This is a testament to the year-over-year growth of Tremfya’s domestic sales.
- Policy
- Concerns about National Bio Committee's foreign pharma exec
- by Lee, Jeong-Hwan Nov 29, 2024 05:54am
- President Yoon Suk Yeol has been appointed as chair of the National Bio Committee. The National Bio Committee, chaired by President Yoon Suk Yeol, is set to launch in December. However, reports indicate that a global pharmaceutical company executive has been included as a committee member, raising concerns. The committee comprises up to 40 members, including the chair, vice-chair, various ministers, and officials from the National Security Office. One of the appointed committee members is an executive from a foreign pharmaceutical company. Given that the committee's primary role is to formulate national strategies for the pharmaceutical and biotechnology industries, critics have argued that appointing an executive from a major multinational pharmaceutical company has the potential for government policies or confidential information to be leaked externally. According to the pharmaceutical industry on November 27, the list of committee members of the National Bio Committee included an executive from a multinational pharmaceutical company. President Yoon Suk Yeol was appointed as chair of the National Bio Committee, and Lee Sang-yeop, vice president of the Korea Advanced Institute of Science and Technology (KAIST), will serve as vice-chair. Civilian committee members include 20 experts, including Kim Bit-naeri, Director of the Institute for Basic Science, Koh Han-seung, CEO of Samsung Bioepis, and Kim Young-tae, President of Seoul National University Hospital. The first meeting is scheduled for next month. An issue has arisen from including an executive from a multinational company who has worked for nearly 20 years in a global pharmaceutical company. Criticism has been raised about including an executive from a foreign-based company representing global big pharma to the National Bio Committee for the Korean pharmaceutical industry is inappropriate. The National Bio Committee is responsible for reviewing South Korea's overall biotechnology policies, including research and development (R&D) and new drug approvals, to foster the high-tech pharmaceutical and biotechnology industry as a next-generation key sector. The committee comprises up to 40 members, including the President as Chair, a vice chair, ministers from various government departments, the senior secretary for Science and Technology, the Third Deputy Director of the National Security Office, and private experts from the field and academia. Criticism have been raised about including an executive from a multinational pharmaceutical company. Critics argue that such an appointment contradicts the committee's purpose of promoting domestic pharmaceutical innovation. They state that allowing a global "Big Pharma" executive to participate in discussions about policies shaping South Korea's pharmaceutical R&D, regulatory·pricing strategies undermines the committee's intent. Concerns also extend to potential security risks, as sensitive government policies or information on the pharmaceutical and biotechnology sectors critical to national security could be inadvertently·deliberately leaked externally. "The National Bio Committee is responsible for unveiling, formulating, discussing, and deciding on South Korea's R&D strategy in the pharmaceutical and biotechnology sectors. Including a multinational pharmaceutical company executive in a committee chaired by the President Yoon, where vaccine and pharmaceutical security issues may be discussed, is illogical. It is comparable to handing over our home territory," a representative from the domestic pharmaceutical industry said.
- Policy
- KIPO opposes to objections to new drug patent extended cap
- by Lee, Jeong-Hwan Nov 28, 2024 05:55am
- The Korean Intellectual Property Office (KIPO) The Korea Research-based Pharma Industry Association (KRPIA) and others have submitted an opinion disagreeing with the proposed legislation that would introduce a maximum cap for terms of patent protection for new drugs. The proposed legislation is intended to facilitate an earlier market launch for Korea-made new drugs. The Korean Intellectual Property Office (KIPO) stated its opposition to this issue at the 21st National Assembly. At that time, KIPO stressed that the original draft instead of a revised Patent Law that would limit the number of patents to a single (1 patent). A similar proposed legislation has been submitted to the 22nd National Assembly. Therefore, it is highly likely that KIPO would state an opinion agreeining with the original draft. On November 26, the Trade, Industry and Energy Small and Medium Venture Business Committee is scheduled to hold a small committee for legislative review. Rep. Koh Dong-jin, a member of the People Power Party, will review the draft of the revision to the Patent Law. Rep. Koh Dong-jin's proposal contains key messages, including ▲legislating a 14-year maximum (cap) on the effective duration of patent rights and ▲ limiting the number of patents eligible for extension to a single patent per drug. The proposed legislation is based on concerns that the current patent term extension system under Korean patent law differs from those in advanced countries such as the United States and Europe, potentially reverse discriminiate the domestic pharmaceutical industry. KRPIA "It worsens individual access to medications…disagreeing with the legislation" In Rep. Koh Dong-jin's draft of the revision, the Korean Research-based Pharmaceutical Industry Association (KRPIA), the Japan Pharmaceutical Manufacturers (JPMA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Biotechnology Innovation Organization (BIO), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and the Patent Information Initiative for Medicines (Pat-INFORMED) have shared opposing views. The opposing group argues that adopting only selective features of overseas practices regarding patent term extensions, rather than improving the entire system, could worsen public access to medicines and disrupt international collaboration. Specifically, regarding introducing a patent term cap, they highlight that South Korea recognizes only the 'domestic clinical trial period' for patent extensions, excluding the 'overseas clinical trial period' from the calculation of extension durations. They also argued that the scope of extended patent rights in South Korea is narrower compared to major countries. Specifically, there are conflicting court rulings on whether extended patent rights are limited to the indications approved at initial approval. It also remains to be seen whether the extended rights apply to all approved uses of the extended product. They also stated that there is almost no chance of appealing a rejection decision concerning patent term extension applications in South Korea. Before Rep. Koh Dong-jin's draft of the revision, KRPIA and others have previously opposed the bill proposed by Democratic Party Rep. Jung Il-young during the 21st National Assembly, which was abandoned because the legislative term expired. KIPO disagrees by citing U.S. examples During the 21st National Assembly, KIPO presented counterarguments to the objections raised against Rep. Jung Il-young's bill, advocating for the retention of the original proposal. KIPO will likely maintain the same position regarding Rep. Ko Dong-jin's proposal in the 22nd National Assembly. KIPO states that it cannot accept the opposing arguments, including the claim that South Korea does not include overseas clinical trial periods in calculating patent extension durations and the assertion that the scope of extended patent rights in South Korea is unclear compared to major countries. However, regarding the opposing argument that there is no opportunity to appeal rejection decisions on extension applications, KIPO partially accepted this concern, suggesting the need to review the introduction of a related system. KIPO disputed the claim that South Korea excludes overseas clinical trial periods and uniformly excludes the Ministry of Food and Drug Safety's (MFDS) approval supplementation period when calculating patent extension durations, stating, "Other countries do the same." KIPO explained, "The U.S. system, similar to South Korea's patent extension calculation method, includes only half of the clinical trial period and does not recognize overseas clinical trial periods." It emphasized that "maintaining the current practice for calculating extension durations is appropriate." "Considering the Supreme Court ruling, which excludes the applicant's compensation period during the MFDS's review of approval documents, we believe that the current method for calculating extension durations should remain unchanged," KIPO stated. "The length of the extension period is primarily influenced by variations in domestic clinical trial durations, which are affected by factors such as a country’s drug development capabilities and the size of its pharmaceutical market, rather than differences in extension systems." Regarding the opposition's argument that the scope of patent rights should be expanded to include the 'active ingredient' and included into patent law, KIPO countered by saying that the legislation should proceed as originally proposed. "The Supreme Court, considering the protection of patent holders and the purpose of the extension system, has ruled that the scope of extended patent rights should be determined based on the 'active ingredient and drug use based on the Patent Law,' similar to major countries," KIPO stated. KIPO partially agreed with the opposing view that there is no opportunity to contest rejection decisions on extension applications. "It is necessary to establish various concrete measures to contest rejection decisions to secure procedural rights for patent holders," KIPO stated. "However, these remedies should be introduced alongside measures to address rejection decisions related to delays in registration, which will require a more thorough review."
