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- 2026-04-16 08:12:13
- Company
- KDDF invests KRW 263 bln for 9 years but goal unachieved
- by Chon, Seung-Hyun Sep 09, 2020 05:52am
- The three government ministries’ first project to provide all-around support on new drug development, the Korea Drug Development Fund (KDDF) has ended its nine-year program. Although the goal of ‘developing 10 global new drugs’ was unachieved and the initially planned budget fell short, the project resulted in 50 license-out deals and it was evaluated to have implemented a new paradigm for government R&D support. The second project launching next year is expected to allocate more than five times of the first project’s budget, as well as an improved systematic support. ◆KDDF ending nine years of program, 50 license-out deals signed According to industry sources on Sept. 9, KDDF has finished their entire program as of Sept. 8. Started from September 2011, nine years of the R&D support program was wrapped and the foundation was dismissed. KDDF was the first and only pan-government pharmaceutical R&D support project in South Korea. The Ministry of Science and ICT (MSIT, formerly known as Ministry of Science, ICT and Future Planning at the time of establishment), the Ministry of Trade, Industry and Energy (MOTIE), and the Ministry of Health and Welfare (MOHW) have jointly invested 1.6 trillion won (530 billion won by government, 530 billion won by private) for over 10 years through R&D investments to seek 10 global new drugs. It was the first project to support that backed the entire life cycle of new drug development from candidate medicine exploration to commercialization. Experts evaluate KDDF has laid out a new paradigm for supporting R&D at a pan-government level, as their own R&D capability was well-incorporated to establish an effective R&D support system. For nine years, KDDF has supported 162 projects after reviewing 590 projects claiming for their R&D support. At the end, 50 projects were licensed out. The overall deals are valued at approximately 13.7 trillion won. KDDF official said, "The outcome is seen as a milestone in the history of new drug development in South Korea." In fact, momentous R&D outcomes in the Korean pharmaceutical and bio companies have been supported by KDDF. Some of major deals worth over 1 trillion won, such as Janssen licensing the technology of Yuhan’s anticancer treatment 'Lazertinib,' Alteogen's ‘hyaluronidase’ platform technology transferred to a global company and Hanall Biopharma licensing out autoimmune disease treatment technology to Roivant. However, most of the deals have not been paid out completely. For the Lazertinib deal, Yuhan has received a total of USD 85 million (about 100 billion won) including a down payment of 50 million dollars. Supported by KDDF from the initial R&D phase, SK Biopharmaceutical's anti-epileptic drug XCOPRI successfully won the U.S. Food and Drug Administration (FDA)’s approval last year. Major performance review on Korea Drug Development Fund (Source: KFFD) KDDF official noted, "Beyond the R&D support, the foundation also offered various programs and consulting to leverage the potential of Korean new drug development." KDDF’s BRIDGE Track sought after early stage license-out opportunity to bridge the translational gap between university, research labs and the industry. And Advancing Clinical Trial (ACT) program gave consulting on clinical trial for nonclinical research and pre-clinical trial phase. When selected as a supported R&D pipeline, the main research institute and KDDF constructed an organic joint development system for consulting specific to development stage and monthly joint meeting to discuss the direction of R&D pipeline. CEO of KDDF Muk Hyunsang noted, “The nine years of the foundation’s program has come to an end after researching and developing 162 projects with 91 research institutes, while expanding experience and skills and training outstanding researchers in the process.” ◆Failed to achieve the initial goal of ’10 global new drugs,’ only about halfway done Nevertheless, some experts say KDDF's outcome did not meet the initial expectations. When KDDF was launched, it declared the goal of ‘developing 10 global new drugs’, but there has not been a drug worthy of the title, ‘global new drug,’ yet. As the whole process of new drug development from candidate medicine discovery to R&D completion takes approximately two decades, the experts criticize the government has set the bar too high to begin with. In 2013, KDDF revised its goal from 'developing more than 10 global new drugs by 2020' to 'licensing out more than 10 global new drugs by 2020.’ Moreover, KDDF's R&D support budget was far short of the original plan. The plan was to put down a budget of 530 billion won, for the beneficiary companies to match the investment to reach over 1 trillion won in R&D investment. However, KDDF's R&D support was totaled at 263.2 billion won, investing almost 70 billion won per year. The foundation’s annual R&D support budget was not fixed, but appropriated according to the expenditure. Unused budget in a year also meant budget deduction in the following year. An industry insider pointed out, “It is difficult to predict the amount of financial support for the next year due to the system of setting the amount based on the nature of the pipeline.” Vision by Korea Drug Development Fund (Source: KFFD) ◆New state-led new drug development program to kick off next year, budget expands significantly Although KDDF will be dissolved as the program ends, the new state-led new drug development program would kick off from next year. The new national new drug development program that passed the preliminary feasibility evaluation in June, in accordance with the National Finance Act, would provide support on all phases of new drug development. The inter-ministerial program would bring precedent programs by MOHW, MSIT and MOTIE together to support R&D pipelines, resembling much of the KDDF business structure. The national new drug development program would consist of four projects: research on expanding the technological base of new drugs, research on establishing a new drug R&D ecosystem, new drug clinical trial development, and support for new drug R&D commercialization. The feasibility of national new drug development program was approved with allocation of budget totaling at 2.18 trillion won for 10 years from 2021. The state funding of 1.47 trillion would be provided. If the program fully delivers the budget for a decade, fivefold of what KDDF presented for R&D support (263.2 billion won) would be accessible. Initially, the supervising ministries suggested injecting 2.80 trillion for the new drug development program (1.95 trillion won by state funding, 83.1 billion won by private capital), but the overall budget was decreased by 600 billion won as preliminary feasibility evaluation recommended. The preliminary feasibility evaluation recently disclosed by the Korea Institute of S&T Evaluation and Planning (KISTEP) reported the participating ministries suggested the goal of the program to license out 75 cases of global technologies, valued at over 20 billion won each, and 45 cases valued at over 100 billion won. It has set more detailed objectives of receiving five new drug approvals in the U.S. and Europe by 2030, and eight approvals by 2015. Also the ministries aims to develop two new global drugs valued at 1 trillion won per year. The government bodies’ goal also included obtaining 1,859 overseas patents, winning 269 IND approvals, signing 100 license-out deals, receiving seven orphan drug designations, and generating 100 billion won worth of an annual import substitution effect. A MSIT official stated, "The national new drug development program has only passed the preliminary feasibility evaluation, and the ministries are still in process of drawing up detailed action plan and organization structuring plan, which would be finalized before the program kicks off next year."
- Policy
- Kang Do-tae & Jeong Eun-Kyeong were promoted
- by Kim, Jung-Ju Sep 09, 2020 05:49am
- Kang Do-tae, the current head of the Planning and Coordination Office (51, Seoul National University, Master of Public Administration), was appointed as the first multiple vice minister to lead the health sector of the Ministry of Health and Welfare. The next Vice Minister, Kang Do-tae, the first multiple Vice Minister of the MOHW, is in charge of all areas of the health sector encompassing the pharmaceutical industry within the Ministry of Health and Medicine, including health care and medicine. In addition, the first director of the Korea Disease Control and Prevention Agency (KDCA), who is promoted to a central administrative agency, succeeds and continues the head of the Korean Centers for Disease Control and Prevention Jung Eun-kyung (56, MD & Ph.D Preventive Medicine of Seoul National University ) Through a briefing on the afternoon of the 8th, Cheong Wa Dae announced the new members of the Ministry of Health and Welfare and the KDCA, which are reorganizing the government in accordance with the partially amended laws of the Government Organization Act. First, Kang Do-tae was appointed as the second vice minister of the Ministry of Health and Welfare, the current head of the Planning and Coordination Office. Vice Minister Kang was a graduate of the 35th Public Administration Examination, and has been in charge of policy practices in various fields in the field of health, including the Welfare Administration Support Officer, the Health and Medical Policy Officer, and the Health and Medical Policy Officer at the Ministry of Welfare. When the new Vice Minister Kang is appointed, the Ministry of Health and Welfare plans to reinforce the health care policy capacity by reinforcing 3 departments and 44 people to implement more active health care policies. As expected, the first head of the KDCA, which is promoted from the headquarters unit to the central administrative agency, is Jeong Eun-Kyeong, the current head of the KCDC. She was from Department of Medicine, Seoul National University and worked as a health researcher at the Ministry of Health and Welfare to gain administrative experience. Afterwards, she served as the head of the emergency medical department and the head of the disease policy department of the MOHW, and then served as the head of the KCDC and the Head of the Emergency Situation Center, gaining high knowledge and experience in responding to infectious diseases. It is evaluated that the rapidly evolving performance was remarkable while promptly and accurately commanding the response to the COVID-19 incident. As a result, she is the head of the organization that conducts full-cycle management from Korea's infectious disease monitoring and research, health crisis response and prevention, while leading a total of 1,476 personnel from the 5 Bureaus 3 Offices and 41 divisions at the National Disease Administration, which will be launched in earnest on the 12th.
- Company
- Botulinum share in domestic market is 93%
- by Chon, Seung-Hyun Sep 09, 2020 05:47am
- Among domestically produced and imported botulinum toxin preparations, products developed by Korean companies accounted for more than 90%. Following Medytox, Hugel, and Daewoong Pharmaceutical, Huons Global and Pharma Research joined. The three types of Meditoxin, whose license was decided to be canceled, recorded ￦82.2 billion in production last year. According to the MFDS on the 7th, the domestically produced and imported botulinum toxin formulation last year was ￦213.5 billion. It decreased by 0.3% from ￦214.2 billion in 2018, but increased 2.5 times in 4 years from ￦85.5 billion in 2015. This is the result of a survey of products that reported production and import performance to the MFDS. For imported products, an exchange rate of ￦1,200 per dollar was applied. The botulinum toxin formulations registered last year's production and import records are a total of 10 products including Meditoxin, Botulax, Nabota, Innotox, Botox, Xeomin, Liztox, Rientox, Coretox, and Dysport. A domestic company, Medytox, has three products, including Meditoxin, Innotex, and Coretox, and the remaining companies are selling one product each. Yearly Botulinum Toxin Production Performance (Unit: ￦million, Source: the MFDS) Among the total production and import of botulinum toxin products, the proportion of products from domestic companies overwhelmed the imported products. The production of botulinum toxin preparations of domestic companies such as Meditoxin, Botulax, Nabota, Innotox, Liztox, Rientox, and Coretox last year was ￦198.5 billion, accounting for 92.2% of the total. The proportion of domestically developed botulinum toxin production decreased slightly from 95.2% in 2018, but considering that Allergan and Ipsen entered generic maraket, the share of over 90% is an unusually high proportion. Some of the products produced by domestic companies are sold in overseas markets, but even if exports are excluded, they dominate the original imported products. Market share of domestically produced botulinum toxins by year (Unit: %, Source: the MFDS) Not only existing companies such as Medytox, Hugel, and Daewoong Pharmaceutical, but also Huons Global and Pharma Research Bio recently jumped into the botulinum toxin market as generics and made results. Production performance of Meditoxin was ￦104.1 billion last year, accounting for nearly half of the total production and imports, but decreased by 13.9% from ￦120.8 billion in 2018. However, Innotox and Coretox, generics for Meditoxin, are recording high growth with production values of ￦10.5 billion and ￦2.5 billion respectively last year. In the case of Meditoxin, the license was canceled in June due to the suspicion of manipulating documents, except for 200 units out of the four doses of 50, 100, 150, and 200 units. Last year's production of the three products that were canceled last year amounted to ￦82.2 billion, or 78.9% of the production of Meditoxin. While the court cited an application for suspension of execution of the three types of Meditoxin's license cancellation, collection, and disposal orders last month, it became possible to sell even the main lawsuit. If sales are finally banned, it is expected that a significant loss in sales will be inevitable for Medytox. Botulinum toxin production and import performance by item (Unit: ￦million, %, Source: the MFDS) Production performance of Hugel's Botulex increased 5.4% from ￦55.7 billion in 2018 to ￦58.7 billion last year, while production performance of Nabota by Daewoong last year decreased 26.9% from the previous year. Huons Global recorded ￦5.8 billion in production of Liztox, a botulinum toxin drug developed last year. After recording production of ￦2.3 billion for the first time in 2016, it has increased every year, including ￦3.2 billion in 2017 and ￦3.5 billion in 2018. Huons Global received a license for export under the brand name Hutox in October 2016, and then received an official license under the product name Liztox in April 2018. Phamar Reserch BIO’s “Rientox” recorded the first production performance of ￦4.1 billion last year. Phamar Reserch BIO is a company that changed its name after BioC&D, a bio company, was acquired by Phamar Reserch Product in January 2018. It obtained a permit for export in February of last year, and although it has not yet been released in Korea, it seems that sales have occurred in overseas markets. Allergan's Botox imports last year stood at ￦7.3 billion, up 69.2% from the previous year, but it was far short of domestically developed products. The report of Xeomin by Mertz and Dysport by Ipsen also posted only ￦6.2 billion and ￦1.6 billion last year.
- Company
- Jung-Jin Seo, COVID-19 tx will be applied within this year
- by An, Kyung-Jin Sep 09, 2020 05:46am
- Jung-Jin Seo, Chairman at Celltrion is giving a keynote lecture on the first day of GBC Jung-Jin Seo, Chairman at Celltrion announced that he will apply for approval for emergency use of COVID-19 antibody treatment within this year. The strategy is to finish early phase I clinical trial of the COVID-19 antibody treatment, which started at the end of July, and start an integrated phase II and III clinical trial at the end of this month to complete the effectiveness and safety verification. It will also start commercial batch production this month to enable mass production as soon as it obtains emergency use approval. He gave a keynote lecture on the theme of 'Post COVID-19 Era, Crisis is an Opportunity' at the 2020 Global Bio Conference (GBC) online event hosted by the MFDS, and introduced the current status of COVID-19 antibody development. According to the announcement on the day, the Phase I clinical trial of the antibody 'CT-P59' for the treatment of COVID-19 developed by Celltrion has recently been administered to healthy subjects. It is a policy to end phase I clinical trial in Korea early, and to discuss with regulatory agencies to simultaneously proceed with phase II and III clinical trials from the end of this month. Celltrion believes that it will be able to apply for an emergency use approval at the end of the year if its efficacy and safety are verified in the Phase II clinical phase. If phase III clinical trial is completed in May next year as planned, the world's first COVID-19 antibody treatment will be developed. He said, "We hope to start an integrated phase II and III clinical study this month through cooperation with regulatory agencies. We plan to start large-scale production from this month in order to respond to global demand, centering on domestic COVID-19 patients. It is also progressing without a hitch.” He predicted that it would be difficult for the neutralizing antibody formation rate to exceed 50% with only the gene-recombined and protein-recombined vaccines that are currently being developed. Since it is difficult for the vaccine under development to have a complete preventive effect, the company is in a position to put all efforts into accelerating the time of development of the treatment. He said, "At this stage, the best way to lower the mortality rate of COVID-19 patients is early diagnosis and early treatment," he said. "Korea is developing antibody treatments and blood system drugs as a world leader. The production capacity is unrivaled enough to account for 15%,” he emphasized. It is evaluated that it has high competitiveness as a production base even if the leading position in the development of COVID-19 treatment or vaccine is lost to advanced countries such as the United States. He also said, "Korea is developing the world's leading antibody treatments and blood system treatments. If the protein-recombined COVID-19 vaccine being developed overseas succeeds in commercialization, we will suggest securing the quantity of vaccines for domestic use as the top priority in the consignment production contract process. He said, "Celltrion will play at the forefront to turn the national crisis caused by COVID-19 into an opportunity."
- Product
- Halted fight between government vs. doctors damages both
- by Kang, Shin-Kook Sep 09, 2020 05:46am
- The Korean Medical Association (KMA) has decided to temporarily halt but revisit their discussion with the government and the ruling party on increasing the quota for medical school and establishing public medical school, until COVID-19 is contained. The junior doctors are most likely to return for their duty after the last discussion on Sept. 7. Instead of revoking the policy, the government made up a pretext for re-discussing the medical reform policy, whereas the medical community paved their way to intervene in the future medical policy making process. With COVID-19 spreading relentlessly, the talks on medical reform plan saw no clear winner or loser. Ultimately the medical community also had to settle on a middle ground as they were to face the angry public, if the strike continued. ◆So did the ruling party ‘lose’ the battle?: Even within the ruling party, criticisms were made on the result of the ruling party and medical organization agreement. Democratic Party Lawmaker Representative Lee Su-jin posted a comment on her social media on Sept. 4, "We are now supposed to re-discuss expanding the medical school quota and establishing public medical school from square one, and obviously we are putting a pin on introducing the regional doctor system, indefinitely.” Lee continued and evaluated, “The doctors used medical strike to maneuver their say in the medical reform policies the public is highly interested in.” Lawmaker Yun Kun-young firmly defended the ruling party’s decision and responded to the criticism on the agreement between the ruling party and the Korean Medical Association (KMA), saying, "Even if the government couldn’t save its face, and the ruling party feels humiliated, there is nothing we can do,” because “saving the people’s lives come first amid COVID-19.“ Democratic Party Policy Committee Chair Han Jeongae, who led the mediation between the government and the medical community, also refuted the criticisms that the government and the ruling party had surrendered to the medical community. Lawmaker Han said, "The policy will be revisited again through persistent communication and discussion to resolve the unfair distribution of medical service in different regions, strengthen essential medical care and reform medical care system for the public. Also the ruling party would endeavor to deliver the agreement signed between KMA and the Democratic Party.” The medical community is also still torn from the result. KMA President Choi Dae-zip’s executives clashed with the interns and residents, who are already calling for President Choi’s impeachment. Resisting against the agreement, the medical interns, residents and fellows demanded the strike to continue, but they declared the strike would be over without a justification to continue as KMA signed the agreement. ◆Private clinic and hospitals were calmer, but junior doctors arose: The most unique part of the medical strike was medical interns, residents, fellows and students taking the action together. KMA President Choi Dae-zip signed an agreement with the ruling party and the government. The medical reform plan to increase the medical school quota and opening public medical seemed to have stirred the young doctors more than private hospital doctors. During the nationwide strike from Aug. 28 to 29, only about 6 percent of private hospitals and clinics went on a strike, but up to 84 percent of the medical interns and residents participated. The private hospital strike participation rate went down over time, but the junior doctors’ participation rate continued to rise. The medical community and the National Assembly analyze reaching the agreement would have been impossible without the participation and solidarity the young doctors showed. The government also took Korean Intern Resident Association (KIRA), instead of KMA, as a negotiation counter partner. This is the reason the ruling party agreement added a clause stating ‘fostering and supporting essential medical care, and practically improving medical interns and residents’ training environment.’ A National Assembly official commented, "It is true that the medical interns, residents and fellows play a significant role in the medical field," and “their absence in response against the pandemic would have pressured the government tremendously.” What the government feared the most was the actions taken by professors, interns and residents at tertiary hospitals. Amid the epidemic, dysfunctional tertiary hospitals would be detrimental. Specifically, the government was concerned with the inconvenience the patients requiring urgent care or fighting against severe diseases would experience. This proved the role of private hospitals and clinics is weaker than that of tertiary hospitals amid COVID-19. During the junior doctors’ fight against the government policy plan, KMA secured their seat in re-discussing the key agendas, such as the Health Insurance Policy Deliberation Committee structure, medical care delivery system reform, pilot program for Korean herbal medicine coverage, and non-contact medical service. The government and the ruling party would have realized by now that fighting with doctors is never easy. And the doctors now have the ‘strike’ as their open option whenever an unfavorable policy is on the table.
- Company
- The government is worried about the generic exclusivity
- by Kim, Jin-Gu Sep 08, 2020 06:12am
- The generic exclusivity system is about to change in the fifth year of its introduction. Until now, the industry has been criticized for 'free ride' over this system. The core of the system is the grant of monopoly rights, and the contradictory situation in which monopoly was impossible was repeated. The discrimination power was lowered by the process of acquiring the generic exclusivity by anyone, which led to a reduction in substantial benefits. As a result of the Dailypharm analysis, the average benefit per item that has acquired the right so far has reached an average of ₩400 million. For the pharmaceutical company that led the patent challenge and generic development, it was a collapse. It is said that the MFDS, the main ministry in charge, agrees to such criticism from the pharmaceutical industry. It is from the same reason that they have come up with improvements one after another in the fifth year of the generic exclusivity system. However, in the pharmaceutical industry, there is no change in ‘the requirements for first trial', which is the core cause of the problem. In this regard, it is reported that the government intends to separate this part and promote it in the form of legislative legislation. ◆The first improvement plan by the MFDS excluding the right of consignment items Let's take a look at the proposals made by the MFDS. First of all, this is the result of the 'Public-Private Council for Reinforcing International Competitiveness of Generic Drugs' announced on July 16th. As one of the measures to strengthen the competitiveness of generics, the MFDS has decided to ``exclude consignment generics from the generic exclusivity''. The permission of the right for consigned items was another reason for the scattering of right along with the initial request for trial. In fact, there were frequent cases of receiving only the right without developing generics. As many as dozens of companies boarded the train for the generic exclusivity at the same time. For example, in the case of “Sarpogrelate SR,” 23 companies received the generic exclusivity, but manufacturers are only Sinil and Kukje. 22 companies entrusted the production of generics to Sinil. Generic for ‘Alitoc (Alitretinoin)’ is more biased. Thirteen companies received the right for the generic exclusivity, all of which are produced by Donkko. The same is true of Stillen 2X and Layla. For generics for Stillen 2X, all 14 companies that received the generic exclusivity were assigned to Richwood (Poonglim), and for generics for Layla, all 10 companies left to Mothers Pharmaceuticals. Most of the major large items had similar circumstances. 10 companies each entrusted the production of Januvia (Sitagliptin) and Janumet (Sitagliptin + Metformin) to three consignors. Excluding Chong Kun Dang, Hanmi Pharm, and Dasan Pharm, Kyungdong Pharm, SCD Pharm, Samjin Pharm, Jeil Pharm, Youngjin Pharm, Yuyu Pharm, and Korea Prime Pharm received the right without direct production of generics. Generic production from 21 pharmaceutical companies for Amosartan (Amlodipine + Losartan) was concentrated in three consignment companies, and production of 'Viread (Tenofovir)' from 13 companies was concentrated in five consignment companies. These are the cases in which a pharmaceutical company recruits dozens of Consignment companies to file a patent lawsuit when they devise a formulation development and patent strategy. From the consignee's point of view, it is a strategy that can maximize consignment production income while reducing the risk of patent litigation. This is the reason why some point out that pharmaceutical companies have invited free rides for generic exclusivity by sharing patent strategies. ▲ The number of companies that acquired the right for major items and the number of consignment manufacturers The number of companies that acquired the right copyright for major items and the number of consignment manufacturers This resulted in a feeling of relative deprivation. This was because the efforts for product development and patent overcoming were in vain. Criticism came out that it did not fit the purpose of the generic exclusivity system. Additionally, it was pointed out that the excessive number of unnecessary lawsuits increased social costs, and that the burden of complaints on the original company, the patent holder, was increased. The improvement plan requires revision of the Pharmaceutical Affairs Act. Currently, the published proposal is the opinion of the public-private council. Even if an amendment to the Pharmaceutical Affairs Act containing these contents is legislated, the gateway to the passage of the National Assembly remains. Taking this into account, it is an observation that at least one year remains before this alternative is actually applied to the field. ◆The MFDS Improvement Proposal Second'Unable to delete trick patents The second is the content contained in the 'Partial Amendment to the Pharmaceutical Affairs Act', which was announced on August 20th. The key is to prevent the 'trick' of the patent holder (original company) in advance. The main point is to restrict the deletion of patents in the case of medicines that have received the generic exclusivity. Under the current regulations, the patent right registered in the patent list can be deleted upon request by the patent holder. In this case, the company that received the generic exclusivity cannot exercise the right. It is possible to enter the market without restrictions, not only for items that have received the right, but also for other generics. This is because the right qualification automatically disappears as the patent right is deleted. It is reported that after the actual generic exclusivity system was implemented, several original companies made such an attempt to check the items of right . However, it is explained by the MFDS that there has been no instance of a patent right being deleted after acquiring the right. The industry explanation is a little different. It is explained that there have been no cases of deleting a patent since the right was acquired, but there were often cases where a patent was deleted during the patent evasion process before the right was obtained. Accordingly, there is an opinion in the industry that the timing of the patentee's discretionary restriction of deletion of patents should be set to “the point of filing a patent trial” rather than “after obtaining the right”. ◆What is the improvement of the'initial request for trial requirements? Although there are some disagreements, the domestic pharmaceutical industry is generally welcoming the two institutional changes. With regard to the exclusion of generic exclusivity for consignment items, most of them agree to the purpose of the fact that free rides are greatly reduced. Many of the positions that the patentee's discretionary measures not to delete a patent are also welcomed in that it protects the rights of generics. However, there are many opinions that it is unfortunate when it comes to the entire system. This is because the 'initial request for trial', which can be said to be the cause of the abuse of right. Taking generic for Amosartan as an example, if only the measures to exclude the rights of consignment items are applied, the number of pharmaceutical companies that can acquire rights will be reduced from 21 to 3. On the other hand, if the requirements for the initial request for trial are improved, only one place can receive the right copyright. The case of 'Trajenta' is similar. When only consignment items are limited as specified by the MFDS, 12 companies receive the right, but if the initial request for a trial is improved, one will receive the right. ▲ Trajenta's copyright holders An official from a domestic pharmaceutical company said, "As long as the requirements for the initial request for trial stipulated on 14days, we cannot fundamentally prevent the abuse of right." A patent attorney in the pharmaceutical and bio field also said, "There is a requirement for an initial request for a trial in the background that the generic exclusivity system has fallen to the level of a generic ticket. The exclusion of the generic exclusivity for consignment items will have some effect, but it is more active in order to properly recognize the price of the effort. Institutional change is necessary." ◆"First request for trial, promoting legislative legislation rather than government legislation, In this regard, according to the results of Dailypharm, it is reported that the MFDS is trying to improve the requirements for initial request for trial through the legislation rather than the government legislation. Several officials from the pharmaceutical industry and the National Assembly gathered saying, "We know that the MFDS is pursuing the government legislation to exclude the right of generic exclusivity of consignment items, and the improvement of the initial request for trial in the form of a legislative legislation." Government legislation and legislative legislation are customarily clear in their strengths and weaknesses. In the case of government legislation, it takes a long time for the legislation to pass, but the passing rate is high. The bill is thoroughly reviewed in the process of pre-evaluation, legislative notice, public hearing, consultation with related ministries, and deliberation by the city council. On the contrary, the time for legislative legislation to be initiated is short. A joint motion of 10 or more members of the National Assembly is a prerequisite. However, the passing rate tends to be slightly lower than that of government legislation. In view of this, the MFDS is pursuing a more conservative and reliable method, the exclusion of the generic exclusivity of consignment items, while the improvement of the initial request for adjudication is undertaken by a two-track strategy that speedily promotes through the legislative legislation. It is not yet known exactly what the bill will contain in relation to the improvement of the initial request for trial. However, instead of deleting the 14-day rule in question, it is effective to eliminate the requirement for the initial request for trial. In this case, the requirements for obtaining the right are reduced from three to two. An official in the pharmaceutical industry said, "If only the 14 days rule is deleted, there is a possibility that the number of requests for trials will increase. By allowing applications to be made, transparency is secured and free rides are also expected to decrease.”
- Policy
- How Tenelia latecomers lost chances in preferential sales
- by Lee, Tak-Sun Sep 08, 2020 06:11am
- Although Kyungdong Pharmaceutical first received approval on antidiabetic Tenelia’s incrementally modified drug (IMD), the drug is apparently not eligible for the preferential sales right given to the generic market. Regardless of the preferential right, any Tanelia IMDs that successfully evaded the original’s salt base patent can be launched at the same time. And as the stepped drug pricing system stipulates, the first 20 items approved would also receive premium pricing benefit. According to the industry sources on Sept. 7, the first IMD to have applied for the government approval after evading Tenelia's salt patent and the expiration of the original’s post-marketing surveillance (PMS) period, was not eligible for the preferential sales right to begin with . In order to win the preferential sales right, a drug first has to either request for the first patent trial (or requested within 14 days from the first trial date), or to conclude the patent trial before the first company to request the trial. The second prerequisite condition is to win the patent challenge, and the third is to be a first to apply for the item license. Kyungdong Pharmaceutical’s IMD ‘Teneritine 20 mg tablet,’ approved as of Sept. 4, has met the second and third conditions. But it turns out that the drug has failed to meet the first condition. The original Tenelia has a substance patent, expiring on Oct. 25, 2022, and a salt-base patent, expiring on Feb. 17, 2026. Besides the substance patents the Korean pharmaceutical companies lost at a trial, the follow-on drug companies attempted to challenge the salt-base patent. The first patent challenges were made by Hana Pharm and Intro Biopharma. Hana Pharm first filed a patent trial on Apr. 10, 2015 to nullify Tenelia’s salt-base patent. The two Korean companies are currently developing drugs identical to Tenelia with same active pharmaceutical ingredients and salt base. Meanwhile, pharmaceutical companies with IMDs filed their first patent challenge on Oct. 19, 2018, three years after Hana Pharm’s trial. Kyungdong Pharmaceutical requested for a negative confirmation of patent right scope to evade the original’s patent. In order to acquire the preferential sales right, the IMD companies have to fulfill the prerequisite conditions. The first condition was to complete the legal proceedings before Hana Pharm. The possibility was still open as the Intellectual Property Trial and Appeal Board prioritizes the negative confirmation of patent scope. Unfortunately, however, the final decision on the IMD’s patent evasion was made on the same day as the patent invalidation trial with Hana Pharm and Intro Biopharma. Both trials on patent evasion and invalidation were concluded on Dec. 31 last year. Immediately after trial, the IMD companies applied for both item approval and preferential sales rights, but the Ministry of Food and Drug Safety (MFDS) reportedly denied the application due to the incomplete fulfillment of the prerequisite conditions. If the IMD trial decision was made even a day earlier, Kyungdong Pharmaceutical and other IMD companies would have acquired the preferential sales rights effective from Oct. 26, 2022. Although Hana Pharm and Intro Biopharma have requested the first patent challenge and met the requirements for a successful patent challenge, they failed to apply for the government approval on the day after when Tenelia's PMS ended on Apr. 29. As a result, none of Tenelia's latecomers would have the preferential sales rights. Nevertheless, the first 20 items to be licensed would receive premium pricing, according to the stepped drug price system. The said Korean companies may have failed to win the preferential sales rights through patent challenge, but at least the follow-on drugs would obtain the premium pricing benefit as long as their development speed is fast enough. Meanwhile, Tenelia is a seventh dipeptidyl peptidase 4 (DPP-4) inhibitor released in the South Korean market. Developed by the Japanese-based Mitsubishi Tanabe Pharma, Handok has licensed the sales rights in the Korean market. UBIST reported the drug has made 9.5 billion won from the outpatient prescriptions in the first half of this year.
- Policy
- NA burdened as dispute continues despite Gov-KMA agreement
- by Lee, Jeong-Hwan Sep 08, 2020 06:11am
- As the dispute among medical community is deepening regardless of South Korea’s Ministry of Health and Welfare (MOHW) and Korean Medical Association (KMA) settling on an agreement, the National Assembly is now burdened with a grave responsibility to deliver the agreed terms and to fairly execute the medical reform plan. The Young Doctors’ Emergency Committee representing medical interns, residents and fellows initially intended to protest against the government-medical organization agreement and to continue the collective strike. But they decided to temporarily suspend the strike and return to their jobs on Sept. 6. Nevertheless, the committee stresses the possibility of the young doctors going on a strike again at any time, if need be. The ruling and opposition parties have agreed on establishing a Special Medical Reform Committee under the National Assembly. Now, the both parties are expected to fully implement the agreement, and to calm the public and patient concerned about the agreement impeding the medical reform policy. On Sept. 6, the National Assembly seems to be carefully observing the medical community’s reaction to the agreement signed between the government and the medical organization. Especially, Chair Han Jeongae (Democratic) of Health and Welfare Committee, leading the mediation between the government and the medical professionals, is inevitably trying to read the air in political parties, civic and patient advocacy groups, as well as the medical community. Some of the Democratic Party lawmakers have criticized KMA won the battle against the government, while civic and patient groups are reprimanding the ruling party for waving the white flag to doctors on strike that took patients as hostage. Lawmaker Han said, "I disagree with the criticism that the ruling party raised the white flag. Rather, the party has raised the white flag to the people and patients," and “The lawmakers would continue to discuss the issues regarding the medical reform. And we would do our best to improve policies and regulations to execute measures stated on the government-KMA agreement.” The Young Doctors Emergency Committee, centering the Korean Intern Resident Association (KIRA), has decided to temporarily hold back on the resistance against the agreement and to report back for duty. However, the committee is firmly expressing its intention to take the collective action again as they would closely follow up with the lawmakers’ further support for the agreement. The young doctors are willing to go on the nationwide strike again immediately, if the government and the National Assembly fail to keep their promises with the medical community. The National Assembly is ultimately relieved the doctors halted the strike, but at the same time they now have serious task in their hands. Particularly, the public’s attention would be focused on the Special Medical Reform Committee’s prospective approach as it would consist of both the ruling and opposition parties. The initial implication the Special Committee would face is whether the committee would operate centering the ruling and opposition parties, or include the government and medical representatives. An official from a ruling party lawmaker's office noted, “The ruling party was taken back for a moment as the medical interns, residents and fellows opposed so strongly, when KMA, Democratic Party and the government signed the agreement," but “with the agreement, the government, medical community and the lawmakers can now come together to overcome the COVID-19 epidemic. The discussion on the medical reform can start from the scratch after we overcome the crisis.” The same official elaborated, "What the National Assembly can do right now is to form the Special Medical Reform Committee to sufficiently collect opinions from the medical community and the government." An official from the opposition party lawmaker also stated, "The party believes the lawmakers have done their job. The ruling and opposition parties have agreed on the urgency of halting the medical reform talks and returning the doctors for their duty. And also we are seeing eye-to-eye on arbitrating between the government and the medical community.” The official added, "The National Assembly cannot do anything about the conflict within the medical community escalated since KMA signed the agreement. It is the medical community's job to arbitrate the conflicted community. There is limitation to what lawmakers can do for them."
- Policy
- There is no disadvantage in the long-term Rx due to COVID-19
- by Lee, Hye-Kyung Sep 08, 2020 06:11am
- It has been emphasized once again that there are no disadvantages for appropriate long-term prescriptions within the scope of medically recognized health authorities. It has been clarified that it will not cut down on necessary and appropriate long-term prescriptions so that medical institutions can actively respond to medical gaps due to doctor strikes. The HIRA's Drug Standards Department recently announced a request for cooperation in response to the spread of COVID-19. The amount of work of pharmacists following the preparation of long-term prescriptions for more than 91 days, published in a research report conducted by the pharmacist society In addition to active treatment for the prevention and spread of COVID-19 at each medical institutions, it was made possible for the public to receive health insurance coverage even in the event of an infectious disease crisis. In the request for cooperation, it was stated that there was no disadvantage in the case of long-term prescriptions necessary and appropriate within the scope of medically recognized, excluding drugs for which the number of days of prescription was determined in accordance with the relevant regulations (psychiatric solutions, etc.). Relevant regulations include notification of details on the application standards and methods of medical care benefits, notification of details on application standards and methods of medical treatment benefits for drugs prescribed and administered to cancer patients, and approval from the MFDS. On the other hand, although the health authorities recognize appropriate long-term prescriptions to strengthen coverage, there is no pharmacists' compensation for dispensing fees due to long-term prescriptions, so increasing the work of pharmacists will be inevitable. It has been pointed out that the current pharmacy dispensing fee limits the number of dispensing days to 91 days, so it does not reflect the increase in the pharmacy's workload due to the increasing trend of long-term prescriptions. In addition, with the spread of COVID-19 and face-to-face treatment, long-term prescriptions by medical institutions are rapidly increasing, but there is no discussion on an appropriate compensation system. Looking at the 'Work Volume Relative Value Development Study for the Third Relative Value Reorganization' conducted by the Korean Pharmaceutical Association through the external research service of the HIRA, it is prepared for 91 days or more by properly reflecting the form, scope, and level of the dispensing service. There is a need for a drugstore dispensing fee calculation system such as subdividing the number of days.
- Company
- The dismissal of an executive in Lundbeck Korea was unfair
- by An, Kyung-Jin Sep 08, 2020 06:11am
- The National Labor Relations Commission issued an order to reinstate the job, saying that the dismissal of former executives in Lundbeck Korea was unfair. According to related industries on the 7th, the National Labor Relations Commission held an interrogation meeting on July 30 and sided with Mr. A in the case of a ``unfair dismissal request'' filed against the company by former Lundbeck Korea executive A. The National Labor Relations Commission recently issued an award containing the contents. The National Labor Relations Commission acknowledged that the dismissal of Mr. A by Lundbeck Korea was unfairly dismissed, and ordered that Mr. A be reinstated to his original position within 30 days from the date on which he was served, and paid the equivalent of the wages he would have received if he worked normally during the dismissal period. In this regard, Lundbeck Korea held a disciplinary committee on April 13th, and Mr. A notified his dismissal in writing for violating Article 12 of the employment rules. ▲ Article 4 (duty of integrity) ▲ Article 9 (prohibited matters) 5 and 6 ▲ Article 27 (waiting order) Article 82 (Disciplinary) 3, 5, 8, 11, and 12. The company's explanation is that despite the violation of internal guidelines during the selection process of the contractor, and misconduct such as lies and non-cooperation in work, Mr. A did not reflect and his work attitude did not improve. and the dismissal was notified properly. Mr. A received a notification of 'dismissal' from the company on April 16, three days after the disciplinary committee was held, and filed a request for relief from unfair dismissal to the committee on June 2nd. The National Labor Relations Commission said, "The dismissal is an abuse of the disciplinary discretion of the employer due to an excessive amount of dismissal compared to the recognized disciplinary grounds." For example, it is pointed out that the problem of the open tendering process for a contractor is that it is not recognized as a misconduct by Mr. A because the CEO and the head office have the final decision authority and the duty of management and supervision. It was considered that the specific grounds for the claim that Mr. A failed to comply with the work order or disturbed the workplace order were insufficient. Among the multiple disciplinary grounds, it is the position that Mr. A only admits one act of attending the academic conference without approval from the management during the waiting period. According to this decision, Lundbeck Korea must reinstate Mr. A within 30 days of service of the decision and pay the wages for the dismissal period, or request a reconsideration with National Labor Relations Commission within 10 days.
