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- Company
- What's the court ruling on the claim of CSO's money?
- by Jung, Hye-Jin Jan 02, 2020 06:05am
- Medical personnel who received rebates from the CSO in exchange for prescriptions of drugs pleaded not guilty in medical law, the court was found guilty. Doctors insisted that the money they received could not be rebated because the CSO was not a 'medical supplier' as defined by the Medical Law, but the court found that the amount provided by the pharmaceuticals and the CRO planning to offer the rebate was also guilty. The Seoul Western District Court sentenced the fines and penalties for medical doctors A and B last October. A and B, the head of the hospital of X hospital, accepted a proposal from a pharmaceutical company, CSO C, who was in charge of sales agency, saying that prescription of medicines will be given a certain amount of cash and meals. They were caught receiving cash of ￦4.5 million and ￦4.7 million respectively. Doctor A and B pleaded not guilty because ▲ the person who gave the money was not a drug provider, and ▲the individual did not use the money received. In particular, doctors A and B suggested that the amount received from the CRO cannot be rebate, and presented Article 23-2 of the Medical Act and Article 23-3 of the Medical Act. Defendants said that all medical laws prohibit medical workers and others accepting money, etc. from 'pharmaceutical suppliers' (according to Article 47, paragraph 2 of the pharmaceutical affairs law). One argued that money did not apply to this decree. It was argued that money received from a CSO sales person, not a drug supplier, does not fall under this law. The issue was whether the receipt of money from a CSO sales representative would not fall under the requirements of Article 23-2 of Article 2 of Medical Law and Article 23-3 (1) of Medical Law. Prosecutors in charge of the case were reportedly submitted to the Tribunal after investigating the meaning, background, role, problems, and actions of the government and related associations. The court did not accept all the claims of the doctors based on all the evidence. The judiciary said, “Even if the person who provided the money was not a drug supplier, it was processed in a violation of the pharmacist law, & CSOs are no problem in evaluating them as drug providers, CSOs can be evaluated as a drug provider if they can evaluate the degree of participation of CSO officials, the contents of collusion between drug companies and CSO officials, and the sharing of behaviors as joint norms”. Based on the data submitted to the court, between the pharmaceutical company's employees and the CSO officials, the company planned to receive money from the pharmaceutical company in the name of agency commission and pay most of it as a rebate to medical workers. This proved to be the case. The Tribunal decided that CSOs can be evaluated as drug providers and CSO can be seen as a co-criminal recognizing the fact that the CSO received commissioned money in the name of the agency commission, most of it was provided to the medical workers for rebates. The Tribunal also did not acknowledge that doctors claimed that the money they received from the CSO was used to run hospital wards, not individuals. The court judged, “Even if there is a part of the money received and belonged to other members, it does not exclude it from the economic benefits of Doctor A and B. It does not mean that the money belongs to the hospital, which is a medical institution”. The judiciary's judgment is that the hospital staff is an autonomous organization run by the hospital's affiliates and doctors, and is not an official organization of the hospital. In addition, it was hard to say that money was spent on the operation of the legislature due to the lack of substance and the lack of grouping, and there was no evidence that the money was distributed regularly to the members of the legislature. In addition, Doctor A and B, the head of the hospital, suggested that they realistically present drug prescription guidelines and influence residents’ prescriptions. The statement that the pharmaceutical offered them money also affected the ruling. The court pointed out that “after the defendants were paid directly, they used it as expenses for the members of the legislature, such as event expenses, and even if they knew it, it was only a consumption method after the violation of medical law”.
- Company
- Round 2 of Eliquis pricing reduction litigation to begin
- by Kim, Jin-Gu Jan 01, 2020 10:35pm
- Bristol-Myers Squibb (BMS) has decided to make an appeal after losing the Eliquis (apixaban) pricing reduction litigation suit. The twice postponed Eliquis pricing reduction could be postponed, yet again. According to pharmaceutical industry sources, BMS has filed an appeal on Dec. 23 at Seoul High Court. Seemingly, the legal dispute between Ministry of Health and Welfare (MOHW) and BMS over Eliquis would continue. Seoul Administrative Court on Dec 19 rejected the litigation BMS filed against Minister of Health and Welfare to revoke the decision to adjust maximum reimbursed price, and ruled favorable to the defendant, MOHW. Accordingly, the maximum reimbursed price of Eliquis was supposed to be reduced by 30 percent, down to 830 won per tablet, from Jan. 1 next year. MOHW also announced it would postpone the new pricing of Eliquis until Dec. 31. However, the table has turned as BMS is appealing the court ruling. The drug pricing reduction could be postponed for three times. Legal experts say the suspension of drug pricing reduction is limited to each trial. Therefore, BMS may now request for another suspension of the execution as the company is to start another trial. However, it is still unclear if Seoul High Court would accept BMS’ request of suspension. Previously, the court accepted the request most of the times, but in some cases it had not. Regardless, the industry sources predict the ministry would take a reserved action as MOHW itself is unsure of the result of the second trial. In case the ministry loses the second trial after lowering the drug’s price on Jan. 1, the drug price would drop to 830 won and rise back up again to 1,185 won. The sources say the ministry would probably maintain the present pricing to minimize the confusion. A pharmaceutical industry insider analyzed ”The BMS’ appeal has double intentions. The company wants to revoke the ministry decision, while it delays the actual pricing reduction point as much as possible.” The current law states the original’s maximum reimbursed price is to be lowered by 30 percent from the point of same class generic is available, and it is to be brought down to 53.55 percent of the original price from the following year and on. As apixaban generic was launched in June, MOHW had initially planned to lower the price of Eliquis from 1,185 won to 830 won by 30 percent, starting from July 1. However, the reduction was postponed, when BMS requested for suspension of the execution on July 1, and the court accepted the request on July 19. The ministry stated the grace period would end on Dec. 31.
- Company
- The NPS, strengthen management intervention of companies
- by Chon, Seung-Hyun Dec 31, 2019 06:45am
- The nation's largest institutional investor, the National Pension Service declared that it will actively participate in management of investment companies. Starting next year, the possibility of exercising shareholder rights, such as dismissal of directors, will be raised against “bad companies” that violate laws such as embezzlement and resignation. Pharmaceutical bio companies with high stakes in the national pension will also be affected by their participation in national pension management. The National Pension Fund Management Committee held the ninth meeting in 2019 to deliberate and decide on the Guidelines for Active Shareholder Activities. This is a follow-up to the Principles for National Pension Depositary Responsibilities implemented in July last year. The stewardship code is an action guide for the institutional investors, such as pension funds, to faithfully fulfill the responsibilities of trustees, including shareholder activities, for the benefit of the citizens. The active shareholder activity guideline is based on the decision and implementation of the shareholder proposal by the Fund Management Committee within the scope of the Commercial Law and Capital Markets Act. If a pension-invested company undermines corporate value such as embezzlement or labor, and the company does not make efforts to improve it, the national pension may offer a shareholder proposal such as moving away from the company or changing its articles of incorporation. Active pension shareholders' activities are divided into key management issues and unexpected concerns. Key management issues include corporate dividend policy, adequacy of executive remuneration limits, embezzlement and directions, such as damage to corporate value, violation of shareholders' rights, and continuous exercise of voting rights. The National Pension Service will carry out four levels of trustee responsibility activities: private conversation target companies, private key management companies, public key management companies, and shareholder proposals. Unforeseen issues are those that may cause unforeseen damages to corporate values or shareholder rights in relation to the environment, society and governance. Large-scale industrial accidents or severe environmental damage are included. Unexpected concerns go through two stages: selection of companies to be closed talks and shareholder proposals. Neung-hoo Park, The Minister of Health and Welfare said, “The main purpose of the 'Active Shareholder Activities Guidelines' that the National Pension Plan is to create is not to intervene or interfere with corporate management, and it is to improve the profitability of the National Pension System by solving problems through dialogue with companies to increase corporate value and shareholder value”. However, the business community criticizes the national pension as a management intervention. This is because, depending on the will of the National Pension, there is more room to interfere with management such as the removal of directors and the change of articles of incorporation. The Federation of Korean Industries criticized on the day, “If the national pension increases involvement in corporate management and interference with corporate governance, the business activities of companies that have to concentrate on entering new industries and creating jobs will be reduced, and the vitality of our economy will be lost”. As of the end of 2018, national pension investment pharmaceutical bio companies and their shareholdings (Source: The National Pension Service)Pharmaceutical bio companies with high stakes in the National Pension will also be affected by management intervention. As of the end of last year, there are eight pharmaceutical bio companies with more than 10% of the national pension, including Dong-A Socio Holdings, Dong-A ST, Kolmar Korea, Chong Kun Dang, SK Chemicals, Suheung, Yuhan, and Hanmi Pharmaceutical. A total of 22 pharmaceutical bio companies have more than 5% of the national pension. Dong-A Socio Holdings and Dong-A ST, who have the largest stake in the national pension, have faced opposition from the national pension. In 2013, when Dong-A Pharm attempted to split the company into a holding company system, the National Pension Service, which owns a 9.5% stake, then voted against it. The split of the old Dong-A Pharmaceutical is divided into the holding company 'Dong-A Socio Holdings', 'Dong-A ST' in charge of specialty medicines, and 'Dong-A Pharmaceutical', including the general medicine business division, including Bacchus. Dong-A Pharm is a wholly owned subsidiary of the holding company. At the time, the National Pension Service rejected the agenda item, saying, “Because the Bacchus division, which earns 50% of its operating profit from Dong-A Pharm's cash cows, becomes a privately held company, there is a risk of losing shareholder value, despite opposition from the three major shareholders pensions, Dong-A Pharm managed to split 73.38% of the shares in the extraordinary shareholders' meeting”. However, it is also observed that major pharmaceutical bio companies, such as large pharmaceutical companies, have stable control through the change of holding company structure, so that the active shareholder activity of the National Pension will not be a threat. In March, the National Pension Service voted against some agenda at the regular shareholders' meetings of seven pharmaceutical bio companies, including Dong-A ST, Dong-A Socio Holdings, Hanmi Pharmaceutical, Samsung BioLogics, Celltrion, and Seoheung, but all passed by the original plan.
- Policy
- Keytruda-Lenvima already got 9 trials approved in Korea
- by Lee, Tak-Sun Dec 31, 2019 05:51am
- MSD Korea and Eisai Korea are conducting a series of clinical studies in Korea to confirm cancer-treating efficacy of combination therapy of immunotherapy Keytruda (pembrolizumab) and targeted therapy Lenvima (lenvatinib). In Korea alone, nine clinical protocols on the combination therapy have been approved. The pharmaceutical industry is keeping close eyes on how the immunotherapy market leading PD-1 inhibitor Keytruda and new targeted therapy for liver cancer after a decade-long wait would create synergy effect together. On Dec. 30, Korea’s Ministry of Food and Drug Safety (MFDS) granted approval on Phase 3 clinical trial protocol for Keytruda-Lenvima combination therapy treating patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). The trial would be conducted in 12 university hospitals in Korea comparing efficacy of Keytruda monotherapy. Two companies have reported already nine protocols of Keytruda-Levima combination therapy have been approved in Korea alone. Since Phase 3 trial for combination therapy treating patients with advanced hepatocellular carcinoma (HCC) was cleared, the pharmaceutical companies have conducted clinical trials for treating patient with advanced melanoma, solid tumor with previous treatment record, metastatic HNSCC non-small cell lung cancer (NSCLC), and for treatment-naïve metastatic NSCLC patients with tumor proportion score higher than one percent. Moreover, the Korean government body granted approval on the combination therapy’s trials confirming safety and efficacy on previously treated participants with metastatic NSCLC and progressive disease after platinum doublet chemotherapy and immunotherapy; participants with advanced or recurrent endometrial cancer; and cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) or participants ineligible for any platinum-containing chemotherapy regardless of combined positive score with advanced unresectable or metastatic urothelial carcinoma. Eight out of nine trials are Phase 3, and two are targeting patients with a specific solid tumor. Co-commercializing the two treatments under a strategic collaboration, MSD and Eisai have also started their co-sales and marketing of the two treatments from January this year. The companies have been running transnational trials of the combination therapy since March 2018. The fruitful results from the trials are expected to expand Lenvima’s indication on other types of cancer, besides already-cleared indication for first-line treatment of liver and thyroid cancer, and raise cancer treatment success rate.
- Policy
- Maviret, liver & kidney transplant patients benefit extended
- by Kim, Jung-Ju Dec 31, 2019 05:51am
- Liver and kidney transplant patients will be expanded and added to the administration of adult chronic hepatitis C treatment drug, Maviret (Glecaprevir + Pibrentasvir), and the reimbursed period of administration will be divided. reimbursed indication of Jext inj (Epinephrine bitartrate)150μg is changed to anaphylaxis, and covered up to two pens a day. The MOHW recently revised some of the details of the 'applicable criteria and methods of reimbursement benefits'. The effective date is January 1 of next year. Looking at the major revisions, Reimbursement of liver or kidney transplant patients for Maviret have been extended and the dosing period has changed due to a change in permit. It is noted here that the permit changes to 8 weeks when patients with cirrhosis have genotypes 1 to 6 who have no previous treatment experience. The administration target is changed to anaphylaxis in 150 μg of Jext. This is possible when prescribing discharge after anaphylaxis treatment or when prescribing to patients with a history of anaphylaxis. In addition, the reimbursement will be extended to allow up to two pens at a time. The diagnostic criteria of Repatha inj(Evolocumab) for homozygous familial hypercholesterolemia has been changed to be the same as the registration standard for the exception. Benefits will also be extended to additional indications: hypercholesterolemia and mixed dyslipidemia and atherosclerotic cardiovascular disease. In the case of steroid injections, such as Jeil Dexamethasone inj, the allowance was exceeded and the benefit could be granted for the purpose of preventing fetal complications in pregnant women at risk of preterm birth. In addition, patients with Guillain-Barré syndrome with human immunoglobulin G injections, such as IV-Globulin SN inj 50ml, were changed to ‘unable to walk without aids or other people’ without the MRC score, and reimbursement is approved for the second dose to refractory Kawasaki disease and atypical Kawasaki disease.
- Policy
- IMD pricing reduction dispute to continue on
- by Lee, Jeong-Hwan Dec 30, 2019 09:48pm
- Pharmaceutical industry and lawmakers are reprehending the government for not laying down any specific plan, despite their demand for the government to abolish or revise the pricing reduction policy on new incrementally modified drugs (IMDs). The criticism is on the lack of any follow-up action from the government, although Minister of Health and Welfare Park Neung-hoo at the National Assembly annual audit session agreed with the lawmaker’s concern about reducing incrementally modified drug pricing and stated he would revisit the matter. According to the industry sources and a few of lawmakers of the National Assembly Health and Welfare Committee on Dec 29, Ministry of Health and Welfare (MOHW) has not disclosed a detailed policy revision plan as demanded. The industry and the lawmakers claim IMD is a uniquely competitive cash cow and stepping stone for the emerging Korean bio and pharmaceutical industry that would leverage Korea to become a new global pharmaceutical powerhouse. Ultimately, abolishing pricing benefit for IMD would impair pharmaceutical industry’s advancement and their commitment to develop new drug. Such point was clearly made when the Health and Welfare Committee-affiliated Democratic Party lawmakers, Nam In-soon and Oh Jae-sae, questioned Minister Park directly at the National Assembly audit session. The issue fired up the lawmakers and the industry when MOHW issued a notice on the generic pricing regulation revision, which would apply the same early pricing reduction regulation as generic on the IMD to reduce the pricing after maximum three years a same class generic is launched. Although the generic pricing reduction may be inevitable, the industry insists pricing benefit on IMD should be maintained as it is associated as a drug with innovativeness-recognized data. A Health and Welfare Committee lawmaker’s office official pointed out, “The National Assembly audit has raised the same issues on the IMD pricing reduction policy numerous times, and the minister has said he would look into the matter. But the ministry has now followed up with any plan for months now.” “The Special Act on Fostering and Support of Pharmaceutical Industry that passed the National Assembly plenary session clearly provides pricing benefit on IMD. Basically, the government is removing regulations the lawmakers have regulated. Recklessly lowering drug pricing would eventually harm the quality of drug product directly affecting the people’s health. We suspect the recent valsartan contamination issue broke out, partially because the companies were pushed to use competitively low-priced active ingredients due to the past drug pricing reduction,” the official elaborated. A director of drug development department at a medium-sized pharmaceutical company urged, “Fundamentally, we understand the government’s intent and logic behind the pricing reduction. They are trying to reform the Korean pharmaceutical industry’s present business model centering generic. Although we agree with the intent, their actions are too fast and too unrefined. Their message would come across fine regulating only against generics while maintaining the benefit for IMDs.” “The Korean pharmaceutical industry has already well-noted the government’s intent to redirect the industry’s effort on new drug development with the revised generic pricing reduction regulation. It would make a better sense for pharmaceutical industry and government to cooperate and together leap as an emerging pharmaceutical powerhouse than to strictly regulate IMD pricing,” said the director. However, MOHW begs to differ and argues drug pricing regulation is essential for Korea to become a new global pharmaceutical powerhouse. At a recently convened drug pricing-related policy seminar, the ministry reiterated its aim to significantly raise the proportion of new drug expenditure within the National Health Insurance (NHI)-covered drug expenditure breakdown. In other words, the ministry means to significantly cut down the NHI expenditure on expensive generic and IMDs. At a seminar convened last month by Korean Research-based Pharmaceutical Industry Association (KRPIA) about the social value of new drug and management of NHI, MOHW expressed its commitment to shift the NHI expenditure management towards new drug and explained, therefore, regulating the pricing of generic and IMD is unavoidable. A MOHW official at the seminar stated, “Other pharmaceutical powerhouses do not spend as much as Korea does on generics. Off-patent drugs should exit the market and inexpensive generic should fill up the market instead. While we needed to reconstruct the pharmaceutical expenditure structure itself, we happen to have reformed the generic pricing regulation first as a transitional step.” As a result, the pharmaceutical industry and lawmakers, and government would continue to clash about the IMD pricing benefit and regulation.
- Opinion
- [Reporter’s View] Next year wishes for the industry
- by An, Kyung-Jin Dec 30, 2019 09:47pm
- “Last year, not one of Korean-made new drug was approved by the U.S. Food and Drug Administration (FDA). Ever since hemophilia treatment Aftyla was passed in 2016, Korean drugs have not been able to get a green light from the U.S. health regulator for two consecutive years. However, the industry is expected to bring a series of good news this year about Korean drugs entering the U.S. market.” In the beginning for the year, Daily Pharm had opened an article with the lead. And as predicted, Korean pharmaceutical and bio companies had a year filled with good news. Starting from Yuhan closing a license-out deal with Gilead Sciences on candidate medicine for non-alcoholic steatohepatitis (NASH), SK Biopharmaceuticals, OliX Pharmaceuticals, LegoChem Biosciences, Bridge Biotherapeutics, JW Pharmaceutical and Alteogen also scored license-out deals. Total nine license-out deals from January to November this year were closed by Korean pharmaceutical and biotechnology companies for 290 billion won. Also, other good news reported new pipelines developed with Korean-made technology have been approved in global markets. The U.S. FDA gave a nod respectively on treatment for excessive daytime sleepiness associated with narcolepsy, Sunosi (solriamfetol), and for partial-onset seizure, Xcopri (cenobamate) that SK Biopharmaceuticals licensed out to Jazz Pharmaceuticals. Led by botulinum toxin medicine Nabota developed by Daewoong Pharmaceutical, Samsung Bioepis and Celltrion’s biosimilars also had a notable achievement of grabbing foreign regulators’ approval this year. Although they were not first-in-class breakthrough drugs, Nabota and the biosimilars have been making profits from global markets in competition against other blockbuster drugs. Celltrion Healthcare has generated total of 800 billion won up to the third quarter with three biosimilars, Resima, Truxima and Herzuma. The volume surged by 60 percent from the same time last year. Samsung Bioepis selling three biosimilars—Benepali, Flixabi and Imraldi—in European market is expected to turn around for the first time in the year with accumulated net profit of 97.2 billion won up to the third quarter. Unfortunately, the industry had to endure a number of setbacks as well. Following the sales ban on Kolon Life Science’ Invossa, emerging biotechnology companies like Sillajen, Helixmith, and HLB Life Science released regretful news of failed clinical trials and left the public doubtful of the pharmaceutical and bio industry. Hanmi Pharmaceutical with the most aggressive R&D investment strategy in Korea had to give up on two R&D milestones from its license-out deal, whereas botulinum toxin companies like Medytox and Hugel stagnated with litigation over the source of strain and regulation on Chinese resellers. In contrast, the sluggish bio stocks growth having to turn around recently gave a hint of hope for next year. Investors are expecting the J.P. Morgan Healthcare Conference 2020 in January to be a catalyst to drive up the bio stocks. The J.P. Morgan Healthcare Conference is the one of the world’s most renowned conferences for the bio sector. It has been reported major pharmaceutical and biosimilar companies from Korea, such as Hanmi Pharmaceutical, Yuhan, Daewoong Pharmaceutical, JW Pharmaceutical, Dong-A ST, Celltrion and Samsung Biologics, as well as other bio companies like Medytox, Hugel and ABL Bio are planning to participate in the event. Moreover, the industry predicts SK Biopharmaceuticals going public in the first half of next year would also boost investors’ confidence. Hopefully, Korean pharmaceutical and bio industry would achieve even more R&D milestones in year 2020.
- Policy
- Impurity checks are left to the industry
- by Lee, Tak-Sun Dec 30, 2019 09:47pm
- As announced after the 2018 Valsartan incident, the MFDS focused on regulating generic entry this year. In the sense that all restrictions can be made, irrational systems were introduced as soon as possible to prevent the entry of generics. Generic regulatory measures, including restrictions on cooperative and entrusted activities, the introduction of three batches of commissioned generic trial production, and mandatory licensed generic DMF, have already been implemented or heralded. Among them, the joint and consignment limit is an administrative notice announced in April, and the domestic pharmaceutical industry is under pressure and is keen to implement it. Generic entry restrictions up to maximum aimed at consigned production items The restriction on the joint and entrusted bioequivalence test was cited as the most representative generic entry regulation when criticism was raised that there were many Valsartan preparations in which carcinogen NDMA was detected. Earlier this year, the MFDS held a meeting with CEOs to limit the number of items allowed for co-communication to 1 + 3 from 2020, and informed them that they will not allow it in 2022, three years later. In April, the government announced an amendment to the relevant regulations and is going to start at any moment. However, it is unreasonable regulation that the co-commission is not allowed. In 2010, the regulatory reform committee under the Prime Minister's Office was also braked. As the review of the proposed rule is delayed, it is noteworthy whether the 1+3 regulation, which was announced in the first half of next year, will be implemented on time. Currently, generic drugs of the same ingredient produced in the same plant through a consignment contract are replaced by a review of the existing Bioequivalence test by existing consignees. This has been criticized for the exponential increase in the number of generically approved generic ingredients. In November, it announced the introduction of another regulation. The contractor is obligated to produce three batches of licensed drugs that were exempted. The system, which disappeared in 2014, has also been revived in the name of preventing generic upheaval. Once this system is introduced, the consignor, who is entrusted with the production of the consignment company, must test and produce three batches as part of the GMP review, even at the time of generic approval. The domestic pharmaceutical industry is complaining of the burden of livestock costs due to the limitation of co-prosperity and the additional cost of trial production due to the revitalization of three batches. There are also new regulations that have already been announced as part of the ban on generics. In March, an amendment that mandates the submission of safety proof data on the genotoxicity or carcinogenic impurities and metal impurities of medicines will be announced in next September. In October, an amendment was announced to include licensed generics in stages for drug substance registration. ▲ Commercial drugs by December 31, 2021 ▲ High-cost drugs by December 31, 2022 ▲ Other drugs and drugs that require testing without a living body should register DMF by June 30, 2023. Since June 12, the pharmacological law revision has extended the restriction period for healthy people to participate in clinical trials to six months, making it difficult to conduct bioequivalence trials in the field. Ranitidine, Nizatidine Impurities Continue to Burst, direct assessment of all synthetic raw materials Even during the mobilization of generic regulations, the fear of impurities in pharmaceuticals did not go away. Following the hypertension Valsartan formulation, the carcinogen NDMA was continuously detected in the gastric ulcer therapeutic Ranitidine and Nizatidine formulations. Pharmaceutical industry officials attending the drug impurity response briefing held at Samjung Hotel on the 6th attended and showed interest.The MFDS banned sales and recovery of all Ranitidine products in September, and banned and recalled some Nizatidine products in November. In addition, as NDMA is detected in the anti-diabetic Metformin preparation in Singapore, some items are being recovered and impurity fears are still in shape. The MFDS instructed pharmaceutical companies to submit their own results of impurity evaluations to all synthetic materials by next May and test results on drugs concerned with impurities by May 2021 for self-examination of persistent impurity issues. Advanced Law Passes Parliament, laying grounds for fast track such as serious diseases Unlike generic regulation, new types of drugs have provided the basis for supporting rapid licensing. This is accelerated in August when the Act on Advanced Renewable Medical and Advanced Biologics Safety and Support passed the National Assembly. As a result, drugs that need to come to market early, such as serious illnesses, rare diseases, and pandemic infections, will be included in the expedited treatment for early approval. The organization and system are being set up by establishing the Convergence Innovative Product Support Group in the Korea Food and Drug Administration for the next August. However, the threshold for safety testing for advanced drugs has been strengthened due to the effects of ' Invossa', which was released in April due to the fact that the main component cells were changed and the license was revoked.
- Policy
- NHIS "providing reliable and reasonably priced generics"
- by Lee, Hye-Kyung Dec 30, 2019 06:19am
- Korea’s National Health Insurance Service (NHIS) has reported it would take over the generic management from next year. The Price-volume Agreement (PVA) system currently limited to new drug only would be also applied on generic pricing negotiation. The government agency plans to form a task force team to support Ministry of Health and Welfare (MOHW) making a related revision on the official notification. NHIS is focusing on the additional conditions required by side agreements for the generic pricing negotiation. The government body’s plan is to set a legal basis for imposing price reduction on rebate-providing drug as stated by the side agreement. President Kim Yong Ik of NHIS spoke at the end-of-the-year press conference for government correspondents convened recently, and stated “NHIS would endeavor managing generics next year,” and accordingly “we have acquired insights on generic supply structure through the recently completed research on prospective improvement on pharmaceutical supply and purchasing system.” The research is also known as the ‘All-around Pharmaceutical Product Research,’ initially led by then Professor Lee Eui-kyung of Sungkyunkwan University School of Pharmacy since November last year. The research was later passed on to her student Professor Lee Sangwon, as the former principal investigator was appointed as a new Minister of Food and Drug Safety, and it presented the final result of the research recently. The one-year-long study comprehensively delved into pharmaceutical development, manufacturing, supplying, distribution and consumption with key research topics, such as the present pharmaceutical industry status and regulatory policy in Korea; analysis on generic supply structure and efficient pharmaceutical expense management; new drug supply analysis and recommendation on improving efficiency in pharmaceutical distribution industry; recommendation on advancing pharmaceutical distribution transaction system; prospective vision and tasks of pharmaceutical supply structure. In particular, the research task of analyzing generic supply structure and improving efficiency in pharmaceutical expense management studied the present regulations and related improvements, and also analyzed generic manufacturing structure of Korean pharmaceutical companies. President Kim said, “80 percent of listed drugs at the moment are generics, and most of the health conditions are treated with generics. As we mentioned many times before, we, as an insurer, need inexpensive but good generics.” So far, the president has been emphasizing on amending the industry’s distribution structure for the ‘principle’ of providing the best drug with the lowest price. “We need reliable generics with reasonable price. But when it was announced NHIS would be managing the generics, the public thought we would recklessly lower the pricing. However, we see that consistent investment is needed to purchase even better quality of generics with even lower price,” said President Kim. In short, a ‘two-sided strategy’ is needed to purchase better priced but reliable generic with a consistent investment. President Kim stated, “We would make various plans for next year to figure out how to provide better quality but better priced generics.” Regarding the side negotiation for the generic pricing negotiation, Health Benefit Strategy Office Park Jong Heon mentioned, “A task force team would be formed early next year to support the process of amending the official notification. The amended negotiation procedure would not be in effect immediately from next year. The goal is to have the notification revised within next year.”
- Company
- Pharmaceuticals produced an average of 58 drugs 2018
- by Chon, Seung-Hyun Dec 30, 2019 06:19am
- Last year, Korean pharmaceutical companies produced 58 finished drugs on average. The amount produced per item was only ₩900 million. Among the three in 3 pharmaceutical companies, the proportion of small-scale pharmaceuticals are high, with the annual output of less than ₩1 billion. According to the '2019 Statistical Yearbook of Food and Drugs,' published by the Ministry of Food and Drug Safety on the 27th, the finished drug production totaled ₩18.5 trillion last year. It was 5.7% higher than 2017's ₩17.6 trillion. In 2010, it increased by 30.3% from ₩14,2 trillion in 2010. Last year, there were 19,239 products produced. In 2017, 52 fewer than 19,291, but 3,266 up from 15,973 in 2010. In 2018, the production performance of each drug product is calculated to be ₩ 963.86 million. Although it is gradually expanding from ₩891.17 million in 2010, it is still small scaled. Finished drug production in 2018 (left) and output per item (right) (Unit: ₩ million, Source: the Ministry of Food and Drug Safety) Last year, there were 329 drug manufacturers. Although 28 fewer than the previous year, 59 more than 270 in 2010. In 2018, an average of ₩56.4 billion of drug production was recorded per pharmaceutical company, and 58 items were produced on average. In general, domestic pharmaceutical companies handle various products and do not escape from department store management, which generates small sales per item. Drug producers (left) and number of items (right) in 2018 (Unit: numbers , Source: the Ministry of Food and Drug Safety) In fact, there were a lot of small companies that did not have a good record of finished drug production. Out of 329 drug product producers in 2018, the company recorded 32.5% of the total production of less than ₩1 billion. One out of three is a small company with less than ₩1 billion in drug production. 166 companies with less than ₩10 billion in production recorded more than half of the total. A total of 48 companies with over ₩100 billion in finished drug production were reported. More than ₩500 billion were in six places. Number of firms by size of finished drug production in 2018 (unit: Numbers , source: the Ministry of Food and Drug Safety)
