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- 2026-05-11 19:39:25
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- SGLT-2 combo Qtern awaits release in Korea
- by Eo, Yun-Ho Mar 27, 2023 05:56am
- With reimbursement extensions to combination therapies that use SGLT-2 inhibitors imminent, the combination drug ‘Qtern’ is rapidly landing at general hospitals in Korea. According to industry sources, AstraZeneca’s DPP-4i+SGLT-2i Qtern (saxagliptin+dapagliflozin) which is being solely distributed by Ildong Pharmaceutical in Korea, has passed the drug committee (DC) reviews in tertiary hospitals such as Seoul National University Hospital, Seoul St. Mary’s Hospital, Seoul Asan Medical Center, Sinchon Severance Hospital, and other general hospitals including Gangwon National University Hospital, Korea Anam University Hospital, Nowon Eulji Medical Center, Ewha Womans University Medical Center, Inje University Ilsan Paik Hospital, Chonnam National University Hospital, Jeju National University Hospital, Chungnam National University Hospital, and Hanyang University Guri Hospital. Although the drug had been approved in March 2017, it was not released in Korea due to the non-resolution of the reimbursement issue for antidiabetic combination therapies in Korea. However, However, Qtern may finally be released in line with the progress made regarding the government’s discussions on antidiabetic combination drugs and the reimbursement standards being expanded for antidiabetic combination therapies from next month (April). Qtern is currently undergoing reimbursement listing in Korea. Other DPP-4+SGLT-2 combination drugs that are approved in Korea include Boehringer Ingelheim’s ‘Esglito (linagliptin+empagliflozin)’ and MSD’s ‘Stegluzan (sitagliptin+ertogliflozin).’ These drugs are also awaiting the revitalization of the combination market that will come with the resolution of the reimbursement issue. Generic versions of antidiabetic combos are also awaiting entry into the market. The post-marketing surveillance period for DPP-4i+SGLT-2i combos is soon to expire, until which application for generic drugs is blocked. Meanwhile, in a Phase III trial that studied adding dapagliflozin or placebo to the saxagliptin+metformin two-drug combination therapy for 52 weeks, results showed that patients that used the three-drug combination showed an improvement in terms of lowering blood sugar level and achieving glycosylated hemoglobin (HbA1c) target level over the two-drug combination therapy. No hypoglycemia side effects were additionally observed in the study.
- Policy
- Dupixent 200mg, newly listed
- by Kim, Jung-Ju Mar 27, 2023 05:55am
- Sanofi-Aventis Korea's severe atopic dermatitis treatment Dupixent PFS 300mg has expanded insurance coverage to pediatric and adolescent patients, and products with 200mg content will be newly listed next month with an expanded range. Taking this as an opportunity, the government is planning to expand the scope of benefits for special calculations based on eliminating blind spots in existing treatments for severe atopic dermatitis. Janssen Korea Erleada, which is used for the treatment of metastatic prostate cancer (mHSPC), will be newly listed as a risk-sharing contract (RSA) reimbursement type at around 20,000 won. According to the industry on the 21st, the Ministry of Health and Welfare plans to revise the 'drug reimbursement list and reimbursement upper limit table' and is pushing to apply it on the 1st of next month. There are a total of 4 new drugs being promoted, 1 drug that has been expanded in the scope of use (benefit), and 4 items that are under contract renewal negotiations with the NHIS due to the expiration of the RSA period. ◆Newly listed item = Erleada is newly listed next month at 20,045 won so that it can be applied for health insurance. This drug is used in combination with androgen deprivation therapy (ADT) for the treatment of patients with hormone-responsive metastatic prostate cancer. Currently, A7 is registered in a total of seven countries, including the United States, Japan, France, Germany, Italy, Switzerland, and the United Kingdom. The company applied for insurance listing to the Review and Assessment Service on November 30, 2021, a year later. proceeded. At the time, the committee judged that the cost-effectiveness ratio was included in the acceptable range as a result of the economic evaluation, but the reimbursement was appropriate when the drug price was lowered in consideration of the financial impact such as the possibility of an increase in market share. As the company accepted this result, the drug was put on the negotiating table of the NHIS, and immediately entered into negotiations on the drug price and expected billing amount, and was successfully registered in April. The corporation expects that this drug will be cheaper than alternative treatments, and actual additional finance will be insignificant when considering the RSA refund rate in the future. Dupixent, which is used for severe atopic skin disease in adults, is also listed as a 200mg product with reduced content. Similar to the 300mg content product already registered and covered by insurance, RSA refund type, total amount limit type, and initial treatment cost refund type were applied to this content product in combination. In addition, Bukwang Pharmaceutical's Zaledeep 5mg and 10mg content products, which have stepped on the track of skipping drug price negotiations with the NHIS, are also listed at 102 won and 153 won per capsule, respectively. ◆ Expansion of scope of use = The scope of reimbursement for Dupixent 200mg, which is already registered, will be expanded from adults currently applied to children and adolescents in the future. Currently, it is estimated that 5,000 Korean adults with atopic dermatitis are receiving benefits. The government plans to broaden the reimbursement standard so that the drug can be widely used for children (6-11 years old) and adolescents (12-17 years old) with atopic dermatitis. The number of these patients is estimated to be 2550. The drug's benefit for children and adolescents is being applied to all A7 countries, and it is also being applied to adults in Korea, so its clinical usefulness has already been proven. Following the increase in benefits this time, the company negotiated with the NHIS again and set the price at 696,852 won per share, a 1.5% cut. At the same time, the government expands the scope of application of special calculations accordingly. It is to adjust the benefit standard while expanding the benefit from the existing adult target to children and adolescents. This is because if the current registration standards for calculation special cases are maintained, pediatric patients fall under the pharmaceutical reimbursement standards, but cannot meet the registration standards for calculation special cases, creating a blind spot where special cases are not applied. ◆ RSA Expiration Evaluation Items = Negotiations were made to renew contracts for 4 items of drugs covered by insurance through RSA. The target is Cabometyx, a renal cell cancer drug from Ipsen Korea, and Erbitux Inj. 5mg/mL (cetuximab), colorectal cancer, and head and neck cancer treatment from Merck. Before the contract period of the RSA drug expires, the government has the Pharmaceutical Review Committee evaluate the drug's clinical usefulness and cost-effectiveness, and proceed with contract renewal negotiations with the NHIS. The types of negotiations include lower drug prices, expected billing amounts, reimbursement rates, and caps. The target drugs for this time were contracts with Cabometyx or Erbitux, which limit the amount of use per patient, and as the companies expressed their intention to renew the contract, the procedure was followed. As a result of the negotiations, Cabometyx will be cut by 2.5% for each content, and Erbitux will be cut by 8.5%. In the case of Erbitux, the new drug price will be applied as of May 1 due to the renewal of the contract.
- Policy
- Forxiga patent is about to expire
- by Kim, Jung-Ju Mar 24, 2023 05:48am
- As the patent for Dapagliflozin, the original drug (Forxiga), is about to expire, domestic generics of this drug will be released early next month. Accordingly, the government is swiftly proceeding with the process of calculating the drug price and additional negotiations so that the drug can be listed immediately. According to the industry on the 21st, the Ministry of Health and Welfare is planning a revision of the drug reimbursement list and the maximum reimbursement amount table and is pushing to apply it on the 1st of next month. The application date is April 8, the day after the patent expiry date of Forxiga. Forxiga is an antidiabetic drug, and its price dropped to 734 won, or 3.4%, after negotiations with the NHIS for PVA type "Na" was concluded on the 13th. Domestic generics, which are taking a breather to secure market share, are 89 single drugs and 78 combination drugs. The Ministry of Health and Welfare has calculated generic drug prices based on 734 won, which was set as a result of PVA negotiations, in order to quickly register these drugs. If the original drug expires, the generics are automatically given a price calculation of 53.55%. Currently, companies ahead of the launch of Forxiga's generics are currently in the process of negotiating with the NHIS for stable supply and quality control while preparing for enlistment on the 8th. The deadline for negotiations is the 30th of this month. Governments and authorities expect generics to quickly capture half of the claims once they hit the reimbursement market. The estimated size of fiscal savings is expected to be around 1.1 billion won per month. Estimated on an annual basis, it is about 13.2 billion won. As the share of domestic products increases, the reduction in health insurance finances is proportional to that amount, so the government has no choice but to be busy.
- Policy
- Dual punishment for CSO rebates passes NA committee
- by Lee, Jeong-Hwan Mar 24, 2023 05:48am
- A provision that stipulates the prohibition of doctors from receiving rebates offered by contract sales organizations (CSOs) and a plan to amend the Medical Service Act to advance regulations on medical advertisements and allow the Ministry of Health and Welfare to intervene in the Medical Advertisement Deliberation Committee passed the plenary meeting of National Assembly’s Health and Welfare Committee. Also, a proposal to amend the Pharmaceutical Affairs Act, which includes a clause prohibiting illegal hospital subsidies in exchange for prescriptions between hospitals and pharmacies that are preparing to open, and a clause that allows pharmacists to refuse to dispense poor or counterfeit narcotics prescriptions was passed in the same the plenary meeting. Also, the bill to manage the harm from cigarettes, which was merged as an alternative by the NA Chair after the bill was separately presented by NA Rep. Hye-Young Choi of the Democratic Party of Korea and Ki-Yoon Kang of the People Power Party, also crossed the threshold set by the Health and Welfare Committee. On the 23rd, the NA Health and Welfare Committee. held a plenary session and voted on the bills that were reviewed by the 1st and 2nd legislation subcommittees. A bill that adds drug CSOs to the scope of rebates such as money and valuables that doctors should not receive and obligates the medical device CSOs to report to the government and local governments passed the Health and Welfare Committee deliberations. Therefore, these agendas will go through legislative procedures with the drug CSO reporting system that had been pending at the Legislation and Judiciary Committee level. Changes are expected in the review of medical advertisement deliberations in the future as the Medical Advertisement Deliberation Committee, which consists of functional groups of medical professionals such as those from the Korean Medical Association, passed the bill to improve MDAC deliberations and allows the Ministry of Health and Welfare the right to intervene. Also, the Pharmaceutical Affairs Act, which prohibits prospective hospitals and pharmacies from exchanging hospital subsidies for prescriptions, is subject to review by the NA’s Legislation and Judiciary Committee. Furthermore, legislation of the Tobacco Hazard Control Act, which includes disclosure of the types and amounts of harmful substances contained in e-cigarettes as well as leaf tobacco is expected to accelerate progress. Also, an amendment to the Narcotics Control Act that stipulates that pharmacists at pharmacies may refuse to dispense drug prescriptions issued by medical institutions that poorly entered patient information or are suspected a forgery also passed the Health and Welfare Committee. Whether to present the bills at the plenary session will be determined by the Legislation and Judiciary Committee after considering the agenda seriatim.
- Company
- Discussion of reimbursement for Vyndamax is running in place
- by Eo, Yun-Ho Mar 24, 2023 05:48am
- It seems that discussions on registration of transthyretin (TTR) amyloid cardiomyopathy drug 'Vindamax' for insurance benefits are at a standstill again. As a result of the coverage, Pfizer Korea's ATTR-CM (ATTR amyloidosis with cardiomyopathy) treatment Vyndamax, (Tafamidis 61mg) passed the HIRA last year, but the schedule for presentation to the Pharmaceutical Reimbursement Evaluation Committee has not yet been set. there is. In fact, it is judged that the discussion has ceased. The passage of the standard subcommittee itself was the result of only the fourth challenge, but it disproves that the gap between the government and pharmaceutical companies remains. Vyndamax failed to designate an essential drug in its first reimbursement challenge in early 2021. Afterward, an economic evaluation was conducted in the first half of the same year and a second challenge was reached through a Risk Sharing Agreement, but the results were the same. And in April of last year, it failed to exceed the standard subcommittee again, but in the second half of last year, it barely made a step forward. However, it is judged that there were still difficulties in finding a point of agreement in terms of financial sharing. It remains to be seen whether Vyndamax will be able to supplement the data again and continue discussions on salary listing. Meanwhile, Vyndamax is virtually the only ATTR-CM treatment option. ATTR-CM has been regarded as a disease with poor treatment results because it is misdiagnosed as simple heart failure or has no treatment, even though it is fatal enough that the survival period is only 2 to 3.5 years if not treated appropriately. In this situation, Vyndamax is a drug that has been shown to reduce the occurrence of cardiovascular events in CM patients through the phase 3 ATTR-ACT study and to improve the 6-minute walking test. In the ATTR-ACT study, 441 patients have randomized to Tafamidis 80 mg, Tafamidis 20 mg, and placebo in a 2:1:2 ratio. The main secondary endpoints of the study were the change in the 6-minute walk test from baseline to 30 months, the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the KCCQ-OS score, where higher scores mean better health. As a result of the study, the Tafamidis-administered group showed a statistically significantly lower risk of all-cause death and cardiovascular-related hospitalization compared to the placebo-treated group.
- Company
- 5th time the charm for Tagrisso’s reimbursement extension?
- by Jung, Sae-Im Mar 24, 2023 05:48am
- After five attempts, the EGFR mutation-positive non-small cell lung cancer (NSCLC) treatment ‘Tagrisso (osimertinib)’ finally crossed the first hurdle to receiving reimbursement as a first-line treatment. Although other procedures such as deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee remain, the fact that it had overcome the highest barrier to reimbursement, the Cancer Disease Deliberation Committee review, 4 years after its indication was expanded to the first line, is regarded an achievement. HIRA’s CDDC held its second 2023 Reimbursement Standard Deliberation Meeting for Anticancer Drugs on the 22nd and established reimbursement standards for Tagrisso. The CDDC determined it was appropriate to set reimbursement standards for Tagrisso as a ‘first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.’ With the decision, the drug was able to pass the first gateway for third-generation EGFR-targeted anti-cancer therapies to receive reimbursement as a first-line treatment. ◆Passes CDDC review after 5 attempts...sees fruition 4 years after indication expansion Tagrisso is a third-generation targeted anticancer therapy that targets the EGFR mutation. It inhibits both the EGFR mutation and T790M mutation that are represented by L858R and Exon 19 deletions. As the drug has a high blood-brain barrier (BBB) permeability than first and second-generation EGFR-targeted therapies, Tagrisso has shown a superior effect in patients with brain metastasis. Tagrisso, which added its first-line indication in December 2018 in Korea, attempted to extend its reimbursement to the indication in 2019. However, the drug was unable to receive reimbursement as a first-line treatment for over 4 years. AstraZeneca had attempted reimbursement for Tagrisso at the CDDC level 4 times since 2019 and failed every attempt. When Tagrisso’s reimbursement to the first line first emerged as an agenda in the second half of 2018, the government had been in favor of extending reimbursement. However, the favorable stance faltered with the release of the Asian subgroup analysis results from a global Phase III trial in 2019. The FLAURA trial assessed the efficacy and safety of Tagrisso in the first line, and the Asian subgroup analysis results of this global trial had risen as a barrier to its reimbursement as its hazard ratio (HR) was 0.995. An HR of 0.995 indicates that the difference between Tagrisso and the control group is 0.005, which could be interpreted as the difference being insignificantly small. After such results were disclosed, the CDDC in October 2019 decided to defer its decision until the full data from the Phase 3 FLAURA trial was released. The company made its second attempt, submitting the overall OS data of FLAURA in 2020. However, due to the rapid spread of COVID-19, the CDDC meeting that was set for February of the year had been pushed back and canceled several times and finally held at the end of April. The reimbursement standards for the drug had not been set then either. Although AstraZeneca expressed their will to accept most of the cost-sharing plan proposed by the government in consideration of the Asian subgroup data, the reimbursement fell through due to strong opposition from committee members that raised the issue of the drug’s clinical efficacy. In September of the same year, the company made its third attempt powered by results from the FLAURA China study that confirmed improved OS in Asians. The FLAURA China trial data analyzed a cohort of 136 Chinese patients that included 19 Chinese patients from the global FLAURA trial as well as 117 patients from a trial that had been separately conducted. Results showed that the median PFS of the Tagrisso group was 17.8 months, which was comparable to the results from the global study. Median OS in the Tagrisso group was 33.1 months, 7.4 months longer than the 25.7 months in the control group. This is a higher OS improvement than the 6.8 months identified in the global trial. The third reimbursement extension discussions for Tagrisso were made in April 2021. The third attempt also resulted in failure. At the time, CDDC members concluded that the OS value from the FLAURA China trial lacked statistical significance. After the third attempt failed, patient groups rose to the occasion. After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent a joint statement to the government imploring the government to extend Tagrisso’s reimbursement to the first line as in many major countries. Academic societies also criticized how only Tagrisso is not being reimbursed as first-line treatment in Korea. 3 months after its third setback, AstraZeneca applied for the 4th time to extend reimbursement. This time, the company adopted a strategy of narrowing part of its reimbursement standards. The company excluded Exon 21 mutation from the 'EGFR exon 19 deletion or exon 21 (L858R) mutation NSCLC’ it had been indicated for. The company narrowed the criteria to 'first-line treatment for patients with EGFR exon 19 deletion and brain metastases' and reapplied for reimbursement. The plan was to increase the clinical value of the drug by excluding the patient group that showed a relatively small difference in efficacy from the control group. However, Tagrisso’s reimbursement extension was rejected at the CDDC meeting that was held in November 2021. Real-world study on first-line Tagrisso use in Japan. OS results according to gene mutation status (Data: ESMO) This reluctant sentiment on Tagrisso’s reimbursement extension was reversed at the end of last year with the release of large-scale real-world data on Tagrisso’s use in the first line in Asia and Europe. Analysis of real-world data on 660 Japanese patients confirmed a longer progression-free survival period (20.0 months) and an overall survival period of more than 3 years (40.9 months) than those identified in the Phase III trial. With this data, the company put an end to Tagrisso’s efficacy controversy in Asia. AstraZeneca took on its 5th challenge with this new data and a plan to lower drug prices as supplements. The patient organizations’ petition requestion reimbursement extension also added support. The 'Petition regarding the request for first-line treatment of the lung cancer treatment Tagrisso’ that was uploaded to the e-People website in February was sent to the National Assembly Health and Welfare Committee for deliberation after receiving over 50,000 consents. As a result, after 5 attempts in the course of the past 4 years, Tagrisso finally made it through the first barrier to its reimbursement and passed the CDDC review. ◆Can it be reimbursed within the year? Depends on DREC progress Although it has passed the high barrier of CDDC review, many procedures still remain for its reimbursement extension. For anticancer drugs, CDDC review is only the first step of many. The agenda has to pass HIRA’s Drug Reimbursement Evaluation Committee (DREC), and then undergo pricing negotiation with the NHIS, then pass MOHW’s Health Insurance Policy Deliberation Committee (HIPDC) review to complete all the procedures required to extend benefits. Tagrisso is subject to the risk-sharing agreement (RSA) scheme and must pass the pharmacoeconomic evaluation. HIRA’s statuary evaluation period is set to 120 days or less, but it is common for HIRA to exceed the set deadline if the company is required to submit supplementary data. After completing discussions with HIRA and passing DREC review, the company has to conduct drug pricing negotiations with NHIS for up to 60 days. Within 30 days from the period, MOHW’s HIPCD will deliberate and then issue a notification on the new drug price and then list the drug for extended reimbursement. In other words, at maximum, Tagrisso’s reimbursement extension is set to be made by the end of this year. The decisive step in advancing or delaying this timing of Tagrisso's reimbursement is expected to depend on DREC’s stage, where the pharmacoeconomic evaluation takes place. If DREC requests supplementary data repeatedly, reimbursement listing may be delayed indefinitely. In fact, several anticancer drugs have not been deliberated for over a year at the DREC level after passing the CDDC review. In the case of MSD's Keytruda, which succeeded in extending reimbursement to the first-line treatment of NSCLC after 4 years, Keytruda’s reimbursement agenda was presented to DREC 6 months after passing the CDDC review in July 2021. Although the company showed a high willingness to negotiate the reimbursement of Keytruda, the process was only completed eight months after passing the CDDC review due to a delay in its schedule, such as an unsuccessful submission for the DREC review in November 2021. AstraZeneca plans to make the best efforts to extend Tagrisso's reimbursement within the year. The company said, "We welcome the CDDC’s decision and would like to express our thanks to the government and committee members for making efforts to enable this. We will continue to do our best to complete the procedures that remain and receive the reimbursement decision”
- Policy
- Rinvoq also succeeded in expanding youth atopy benefits
- by Lee, Tak-Sun Mar 24, 2023 05:48am
- Rinvoq 15mg will be covered from April as an adolescent atopy treatment. On the same day as the biologic drug Dupixent, the youth atopic treatment benefit is applied. It is the first among JAK inhibitors to obtain reimbursement for the youth indication before Cibinqo, a competitor drug. According to the industry on the 22nd, Rinvoq SR 15mg will be reduced by 5.1% from 21,085 won to 20,100 won by voluntarily lowering the upper limit of the salary. In addition to the reduction in the upper limit, benefits are also applied to the treatment of atopic dermatitis in adolescents. This drug was covered only for the treatment of moderate to severe atopic dermatitis in adults. As a result, it is expected that the treatment accessibility of adolescent atopic dermatitis patients will be improved. It is known that Rinvoq SR 15mg sought to lower the drug price according to the expansion of the range of use for the application of youth benefits. Although the upper limit of the range of use is adjusted within 5%, it is interpreted that the drug price cut was widened voluntarily, and the youth benefit was applied earlier than Cibinqo, a competing drug. From April, Dupixent will also be covered for atopic dermatitis in children and adolescents. The insurance authorities decided to apply Dupixent PFS 200mg and Dupixent PFS 300mg not only to adults with severe atopic dermatitis but also to children and adolescents aged 6 years or older through refund-type, total-limit, and initial treatment cost-reimbursement contracts. Pfizer's Cibinqo, a similar drug to Rinvoq, is currently negotiating with the NHIS to receive coverage as a treatment for atopic dermatitis in adults and adolescents. As the pediatric and adolescent atopic dermatitis treatment market expands, competition among related drugs is expected to intensify.
- Opinion
- [Reporter's view]Vaccine self-sufficiency rate to 80%
- by Kim, Jin-Gu Mar 23, 2023 04:45am
- In 2013, 10 years ago, the Ministry of Health and Welfare distributed a press release. The plan is to foster the domestic vaccine industry and raise the self-sufficiency rate of the National Immunization Vaccine to 80% by 2020. At the time, among the 28 types of National Immunization Vaccines, only 8 types of vaccines were self-sufficient, but the government's plan was to expand this to 22 types within 7 years. Only two years later, the plan to achieve 80% vaccine self-sufficiency was partially modified. The Ministry of Food and Drug Safety secretly delayed the target achievement from 2020 to 2022 at the Biopharmaceutical Global Growth Policy Forum. Four years later, the plan changed once more. The Ministry of Food and Drug Safety has delayed the goal of achieving the goal by one more year, to 2023. At the same time, the self-sufficiency rate target was lowered from 80% to 75%. Then what about the current situation? According to the KPBMA, the domestic National Immunization Vaccine self-sufficiency rate is only 50% as of 2021. This means that only 14 out of 28 types can be produced domestically. This is because many of the vaccine stocks are dependent on foreign imports. There are only six vaccines that domestic pharmaceutical companies can manufacture and supply from raw solutions to finished products, including hepatitis B, influenza, chickenpox, and tetanus/diphtheria. The self-sufficiency rate is less than 30%. Vaccine self-sufficiency is a very old issue. However, progress toward resolving the problem has been slow. The order that the vaccine self-sufficiency rate should be increased is only repeated as an empty cry every year around the state audit. Over the past three years, while the corona crisis has been prolonged, we have realized how desperate it is to secure vaccine sovereignty. As SK Bioscience succeeded in developing its own COVID-19 vaccine, it also confirmed its development capabilities. All that remains now is the motivation to drive the development and production of the National Immunization Vaccine by private companies. The solution of affordable pricing for the National Immunization Vaccine has been around for a long time. However, the slogan of securing vaccine sovereignty burns for a very short time and then goes out. While more than 10 years have passed, the plan to achieve 80% self-sufficiency in essential vaccines remains only a lofty goal. The corona crisis is turning into an endemic. In other words, great momentum is passing by to achieve the ambitious goal of securing vaccine sovereignty. We must act now. It is difficult to achieve this goal with only the pure will and efforts of private companies. It is difficult to attract participation from private companies through indirect means such as supporting vaccine R&D or improving licensing and regulation. There is a quick and sure solution called 'reasonable compensation'. Unless this solution is introduced, it is clear that the lofty goal will be revised once again before the year is out.
- Policy
- Pharma industry makes a request to MOTIE and MOEF
- by Nho, Byung Chul Mar 23, 2023 04:45am
- Public opinion has been rising for the government to revoke the designation of botulinum toxin as a national core technology. The rise of this public opinion brings more meaning as the request was made by Korea Pharmaceutical and Bio-Pharma Manufacturers Association, which represents the industry. Breaking away from lesser movements that had been made by individual companies or internally within the Ministry of Trade, Industry, and Energy, KPBMA has taken entitative and requested the above for industry development and the future. According to industry sources, KPBMA sent an opinion statement last week requesting the MOTIE to revoke the national core technology designation it had set for the manufacturing technology of botulinum toxin strain and products. In addition, within this week, the association plans to deliver an improvement proposal to the Ministry of Economy and Finance’s Economic Regulatory Innovation TF that requests the revocation of the designation of the national core technology on toxins. KPBMA submitted the petition to MOEF to revoke the toxin national core technology destination request to MOEF because the ministry had organized an 'Economic Regulation Innovation TF' to foster and support the industry, which team listens to the voices of the field, and reflects them in actual policy and institutional improvement. The TF consists of 13 private members and 12 government members and is jointly led by the Deputy Prime Minister of Economy and Finance and a private expert. An industry official said, “Since a written opinion has already been submitted to MOEF, the agenda will be discussed at MOEF’s TF meeting. After setting the direction, official discussions will be made between the two ministries on the withdrawal of the national core technology designation to toxins.” The designation, maintenance, and cancellation of toxin as a national core technology is regarded a sensitive issue for which considerable debate has taken place even within MOEF. The MOTIE Minister can designate or drop the designation of a certain technology after deliberation with the Industrial Technology Protection Committee (which consists of less than 25 members including the chair) under Article 9 ① and ③ of relevant laws. However, the agenda is busy being discussed due to the strong difference in opinion among the 25 committee members, which is why the committee is having trouble setting the specific direction of modifications, and the technology is far from originality and lacks progressive superiority. The representative key core technology designations in Korea include the following technologies: ▲Semiconductor (DDI design technology for OLED to operate driving display panels); ▲Electricity and electronics (design, process, manufacturing, and evaluation technology of ultra-high-performance electrodes or solid electrolyte-based lithium secondary batteries); ▲Display (AMOLED panel design, process, manufacturing, and operating technology). The technologies above are widely accepted as advanced technologies, however, the prevailing opinion is that toxins do not require advanced technology as the toxin strains are more discovered and purchased than developed. As the safety of these toxins can be ensured with the existing management and supervision of the health authorities, the industry has been voicing that it is time for the government to actively prepare a blueprint (revocation of national core technology) on toxins to increase domestic demand and exports. In the absence of general knowledge and information, concerns about the threat of terrorism due to the chemical weaponization of toxins could be raised, but it is a consistent opinion in academia that it is virtually impossible to weaponize the toxins in general pharmaceutical/bio-pharmaceutical research institutes or the private sector. In this regard, another industry official said, "The national core technology designations are made to strengthen the competitiveness of domestic companies by preventing and protecting illegal leakage of industry technology and to contribute to national security and national economic development. However, such toxins are already being approved, manufactured, and sold in a consigned CDMO format among domestic biopharmaceutical companies after they sign joint sales contracts. Therefore, its value as a national core technology is lessening in value.” Meanwhile, KPBMA is taking active steps to revitalize the industry through cooperative governance, therefore, the specific direction on whether to maintain and revoke toxins as national core technology may be determined as early as this year.
- Policy
- Legislation requiring submission of botulinum strains
- by Lee, Jeong-Hwan Mar 23, 2023 04:45am
- A bill that makes it mandatory to submit genetic information of bioterrorism infectious diseases such as botulinum toxin to domestic quarantine authorities and cancels the possession permit if not submitted did not pass the Health and Welfare Committee of the National Assembly held on the 22nd. If the bill is passed, it may lead to excessive regulation of trade secrets and property values of pharmaceutical companies with botulinum toxin strains, and retroactive application of the submission obligation to pharmaceutical companies prior to the enforcement of the law may be intrusive or cause trust protection problems. This is the result of reflecting the opinion of the expert member's office of the Welfare Committee that a policy judgment on legislation is necessary. The members of the subcommittee on the bill sympathized with the expert's point out that corporate trade secrets and property values could be excessively regulated while acknowledging the necessity of the bill. The bill has emerged as a controversial bill in the pharmaceutical industry as it contains a retrospective application clause that imposes the obligation to submit genetic information such as strains and base sequences to licensees and pharmaceutical companies that have obtained domestic marketing permission and have botulinum toxin before implementation after passing the National Assembly. Pharmaceutical companies with botulinum toxin have mixed opinions about the passage of the bill, but the opposing pharmaceutical companies are in the position that the legislation, such as the source of the strain and the submission of the base sequence, is ineffective given that the botulinum toxin strain is a natural substance. It is pointed out that Medytox and Daewoong Pharmaceutical are in a dispute over whether to steal botulinum strains in Korea, so if the bill is passed, disputes between pharmaceutical companies may escalate. The amendment to the Infectious Disease Prevention and Management Act, proposed by Choi Jong-yoon, a member of the Democratic Party, requires those who possess a total of eight types of bioterrorism infectious disease pathogens, including botulinum bacillus, to submit the pathogens to the Director of the Korea Centers for Disease Control and Prevention within 30 days from the date of possession. It also contains a provision allowing the director of the Korea Centers for Disease Control and Prevention to cancel the permit to possess the pathogen of an infectious disease of bioterrorism, even though it must be submitted within 60 days from the date of request for resubmission. The Director of the Korea Centers for Disease Control and Prevention checked whether the submitted bioterror infectious disease pathogens and the bioterror infectious disease pathogens approved for possession matched and made it possible to build a database. The purpose is to strengthen the safety management system for bioterror infectious disease pathogens. While acknowledging the necessity of the bill, the expert pointed out that it is necessary to judge whether there is room for excessive regulation on companies and research activities if the state management of pathogens, which are corporate trade secrets and property values, is strengthened. In particular, it was considered that it was necessary to review whether there is room for less invasive means to be applied and whether there is a possibility of specifying a legitimate reason for the content that allows the cancellation of the possession permit rather than an administrative fine as a sanction in the case of non-submission of pathogens of biological infectious diseases. Regarding the clause imposing the obligation to submit bioterror infectious disease pathogens of previous holders, the expert committee's office believed that there should be a policy judgment on whether the database establishment would pose an additional burden or protection of trust in the related industry. “The bioterrorism database, in which the state analyzes and builds genetic information for the submitted pathogens, is planned to be used for the purpose of preparing for and responding to bioterrorism, which requires strict security management", the director stated. As the legislative subcommittees decided to continue the review, the bill requiring the submission of botulinum strains was a chance for future legislative review.
