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Policy
Galvus SR developed by Alvogen, 100mg once daily
by
Lee, Tak-Sun
Dec 13, 2019 06:34am
Galvus by NovartisAlvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus SR tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The MFDS approved Alvogen Vildagliptin SR tablet’s clinical protocols on the 27th of last month. It proceeds to compare the pharmacokinetics and safety of the original drug, Galvus and to evaluate the pharmacokinetics after food intake. According to the latest detailed plan, clinical trials will be conducted from January to February next year for a total of 42 healthy adults. The control group is taking 50 mg of Galvus tablet twice a day, and the test group is taking 100 mg of Vildagliptin sustained-release tablet once a day. In the second test group, after taking a high-fat meal, take 100 mg of Vildagliptin sustained-release tablet and compare and analyze the pharmacokinetic characteristics. The original Galvus is 50mg. Alvogen Korea is trying to differentiate itself from domestic competitors by developing Galvus sustained-release tablets. The drug Alvogen develops is a sustained-release multi-layered tablet containing Vilagliptin, which is known to be taken once a day, unlike the original. The original Galvus is 50mg twice daily if needed. On the other hand, Alvogen's product is taken once a day, which seems to improve convenience. Vildaliptin is currently approved by Original Novartis and Generics Ahn-Gook Pharmaceutical. If Alvogen succeeds in commercializing Vildagliptin sustained-release tablets, it will be able to enter the market regardless of Ahn-Gook's right to exclusivity for generic product. This is because the main ingredient is the same, but This is not the case with exclusivity for generic product. However, as Galvus' material patents last until March 4, 2022, they will not be able to enter the market early unless they are neutralized. It is noteworthy which strategy Alvogen will enter the market.
Company
Lilly releases first non-reimbursed 'Emgality'
by
Eo, Yun-Ho
Dec 13, 2019 06:34am
Eli Lilly's migraine new drug 'Emgality' was released in Korea. Lilly Korea announced on the 12th that it will release non-reimbursed CGRP-targeted migraines prevention drug, Emgality (Galcanezumab). This drug is a humanized monoclonal antibody that binds to the Calcitonin gene-related peptide (CGRP) molecule which plays a key role in causing migraine symptoms in the brain and blocks binding to receptors. .This is the first drug in Korea .Last year, after being approved for migraine treatment, it recently acquired additional FDA approval for episodic cluster headache treatment .The permission was granted for the EVOLVE-1 and EVOLVE-2 studies in which 1,773 people with migraine headaches (average migraine days 4-14 days per month) participated for 6 months, and chronic migraine patients (average headache days 15 days, migraine days 8 months or more) .The study was based on a REGAIN study involving 1113 people over 3 months .Through two clinical trials for episodic migraine patients, placebo of Emgality-treated patients for migraine treatment compared to baseline (9.2 days for Emgality group, 9.1 days for placebo group) across six months of clinic compared to average monthly migraine incidence for 6 months .Therapeutic benefit was proved .In particular, in the EVOLVE-2 clinical study involving Koreans, the average number of migraine headaches for 6 months in the Emgality group (226 patients) was reduced by 2 days (4.3 days in the Emgality group, 2.3 days in the placebo group) compared to the placebo group (450 patients) .Amgelity-treated patients who had 50% reduction in the number of days of migraine headaches over 6 months were 59% (36% placebo), 75% reduction were 34% (18% in the placebo group), and 100% reduction were 12% (6% in the placebo group) .Min-kyung Chu, neurology professor of Severance hospital, said “Migraine is a pain beyond our imagination that impairs the quality of life of patients, Patients who experience migraines more than four to five days a month can expect to improve their quality of life through preventive care .Emgality's launch is encouraging, with high blood pressure and epilepsy drugs being recommended for preventive treatment .Until now, high blood pressure medications and epilepsy medications have been recommended for preventive treatment” .Meanwhile, commercialization of CGRP-based therapeutics has been ongoing since last year .In addition to Emgality in the United States, drugs such as Aimovig (Erenumab) and Teva's Ajovy (Fremanezumab), which have been jointly developed by Novartis and Amgen, have entered the market.
Policy
'WHO PQ' for 3 domestic vaccines, including Skycellflu
by
Lee, Jeong-Hwan
Dec 12, 2019 10:52pm
Three domestic vaccines have secured international procurement bidding rights, obtaining WHO Prequalification (PQ). SK Bioscience's Sky Cellflu Multi inj, Sky Cellflu inj, and Sky Varicella inj are the main characters. On the 11th, the Ministry of Food and Drug Safety (The Minister, Eui-Kyung Lee) said, "The domestic vaccines passed the WHO PQ, allowing participation in international procurement bidding". WHO PQ is a system for evaluating safety and efficacy for the supply of medicines, including vaccines, to developing countries through international procurement. MFDS has systematically supported WHO certification of domestic vaccines and biosimilar products by establishing a cooperative system with WHO as well as customized consultation services from companies and public-private experts. Specifically, ▲technical consultation on 1: 1 expert consultation team, ▲on-site technical advisory on certificated companies, ▲WHO PQ information sharing seminar, and ▲WHO PQ information book publication. Since 1996, 'Euvax B inj.' is a domestic product that has received WHO Prequalification. There are a total of 16 products by this year. The MFDS said, “We will actively support the activities of companies to enhance the export competitiveness of domestic biopharmaceuticals such as WHO Prequalification, in addition to running customized counseling services, we will continue to publish on-site technical consultations for WHO PQ survey experts and WHO PQ question and answer collections next year”.
Policy
Court controversy, the price of Synovian reduction postponed
by
Kim, Jung-Ju
Dec 12, 2019 06:31am
LG Chemicals dissatisfied with the drop in insurance prices, and the price of 3 ml of Synovian (BDDE cross-linked sodium hyaluronate gel), which is fighting a legal battle with the government, is being provisionally maintained. The trial is in progress, and the court has limited the time limit from the date of the sentence to 30 days. The 6th government of the Seoul Administrative Court decided to extend on the 10th of the trial against the company (2019KuHap88095) regarding the decision that the Ministry of Health and Welfare decided to lower the price of this drug in the 'List of Drug Benefits and reimbursed Limits' (Notice 2019-254). Earlier, the Ministry of Health and Welfare decided to lower the price of medicines through the November 28 notice. Afterwards, LG Chemicals filed a lawsuit for unfair drug price cuts, and the court suspended the Ministry of Welfare's action until the first interrogation date. As a result, the price, which was supposed to be lowered to ₩ 477,041, will remain at ₩67,200 as it was until the 30th day from the date of judgment. The Ministry of Health and Welfare explained that the case is currently underway and may change depending on the outcome of the trial in the future, and they will guide you further when it changes“. No.2 is effective as of July 1, 2020, due to the suspension date. As a suspension, ₩67,200 is applied instead of ₩47,041
Policy
5 years after the drug patent linkage system
by
Lee, Tak-Sun
Dec 12, 2019 06:30am
At the Four Points Hotel Seoul Guro, the 2019 Drug Forum was held under the direction of Jae-Hyun Lee, School of Pharmacy, Sungkyunkwan University (fourth from left)."There are many cases where overseas pharmaceutical companies have succeeded in using the US-licensed patent linkage system. But Korean pharmaceutical companies haven't even tried it. It's time to think about why they are not using the system". More than five years have passed since the introduction of Korean licensed patent linkage system based on the US Hatch Waxman Act with the Korea-US FTA in March 2015. The licensed patent linkage system protects the original drug patents listed in the MFDS and grants generic monopoly rights to companies that have neutralized the patents. Although there was a lot of concern that generic drugs would enter the market in the early stages of implementation, the impact on the market is less than expected. Director General, Myung-jin Chung Myung-jin Chung , head of the Korea Health Industry Development Institute, who conducted an impact assessment during the 2018 year at the Policy Forum held at the Four Points Hotel Seoul Guro, said, “Contrary to concerns over the introduction of the system, domestic pharmaceutical companies sales increased YoY due to the lack of many original companies’ ban on sales and the activation of exclusivity for generic product. The KHID's impact assessment showed that sales of generics increased up to ₩6.5 billion in 2018, and the market entry period was also shortened from 1.3 months to 4.6 months. However, there are a lot of comment that the drug patent linkage system lacks effectiveness. In the policy forum discussions, Sung-min Park, lawyer at HnL Law Office, pointed out that there were no cases of entry into the United States using the drug patent linkage system. “Even if a generic market monopoly is given through exclusivity for generic product, lower profits will be lowered if the market entry rate or market share of the latter is low during that period. In the US, the market share of late-release drugs is high in the monopoly period of 180 days, but in Korea, this is not the case, so we need to discuss how to increase the speed and market share” emphasized the lawyer. Hye-eun Shin, professor of law at Chungbuk National University, made a similar point. Professor Shin said, "There are no successful cases of entry into foreign countries by using the law, we should identify the cause and give direction". The professor added, "We need benchmarking on success cases such as Teva and Ranbak". Yoon-ho Kim, the chairman of the Korea Pharmaceutical Patent Research Society (Hanmi, Patent Team) said, “Maybe the goal was to minimize the impact when it was introduced in Korea. Now, I think that we will be a better system if we become more substantial and develop it as an opportunity for R & D development and globalize it”. In addition, the company is likely to raise the profits of items sold in exclusivity for generic product., and the MFDS, which is a related ministry, is concerned about entering the global market. Hyo-jeong Kim, Director of the Drug Management and Patent Licensing Division, said, "The way to increase the market entry rate and market share of exclusivity for generic product is deeply related to the reliability of generic drugs." "Currently, the MFDS is the most important part, and there is a part to improve awareness Kim said, "I believe that a patent case and product development technology have been accumulated through the introduction of the drug patent linkage system, so a real case study position is necessary for entering the US market." Some also suggested that the market entry period was shorter than the impact assessment results with the drug patent linkage system. Kyung-Joon Lee, head of Boryeong Pharmaceuticals, said, “If we take into consideration the fact that patents are incapacitated due to the challenges of pharmaceutical companies, we will have a much more positive number than the results of impact assessments.” “We are still unable to lag behind our competitors. There are many cases of requesting unconditional judgment without consideration, and I hope that the related laws will be revised in such a way that the positive aspects of the introduction of the drug patent linkage system can be highlighted through the impact assessment”. It was pointed out that if the patent invalidation is confirmed, exclusivity for generic product efforts will be lost. Therefore, even if it is determined to be invalid, it is necessary to improve the system so that it can be used as a right target. However, Hyo-jeong Kim explained, "There are some parts that are difficult to consider as a result of the review so far, but if you get exclusivity for generic product, you can be protected even if the patent is invalid In addition, it also defeats exclusivity for generic product challenge by intentionally deleting the patent list. Kim said, "There is a reasonable part, and we will revise and revise it". Kim said, “We will go through the process of collecting opinions by the end of this year, and we will start the legislative process for improvement plan, and we made some practical improvements and gathered opinions”.
Policy
10 new rare diseases applied with special case from 2020
by
Kim, Jung-Ju
Dec 11, 2019 10:20pm
Special case insurance benefit would be applied on ten new rare diseases including adult-onset Stills disease and Kienbock’s disease from next year. Korean Ministry of Health and Welfare (MOHW) issued a revised notice on Tuesday of ‘Standard on Special Case Insurance Benefit for Individual Copayment’ reflecting the changes. The special case benefit would be applied to patients, diagnosed with one of designated rare diseases, starting from the day of hospital visit or hospitalization the diagnosis is made. The newly designated ten rare diseases are; Cryoglobulinemia vasculitis; choroideremia; Long QT syndrome; hereditary hemorrhagic telangiectasia (HHT); adult-onset Still’s disease; Kienbock’s disease; adult-onset Kienbock’s disease; X-linked ichthyosis; steroid sulfatase deficiency and X-linked ichthyosis; and infant-onset Harlequin syndrome. The changes would come in effect from Jan. 1, 2020. The ministry is to accept public opinion on the notice until Dec. 20, and finalize the changes as it is, if no concerning issue arises.
Company
China okays Samsung’s Herceptin biosimilar Phase 3 trial
by
Lee, Seok-Jun
Dec 11, 2019 10:20pm
The Chinese health authority has green lit Samsung Bioepis’ first clinical trial in China. On Dec. 10, Samsung Bioepis announced China’s National Medical Products Administration (NMPA) has approved the company’s Phase 3 investigational new drug protocol on SB3, a biosimilar version of Hercpetin with trastuzumab. The first patient of Samsung Bioepis’ first clinical trial is scheduled to get treated in the first quarter of next year. The Phase 3 trial is planned treat 208 Chinese patients with breast cancer. Samsung Bioepis to initiate its first clinical trial in China (indicated in red) In February, Samsung Bioepis has signed a partnership contract with Chinese private equity firm C-Bridge Capital for clinical trial, government approval and commercialization in China. The recently approve clinical trial would be conducted along with C-Bridge Captial’s biopharmaceutical company, ‘AffaMed Therapeutics.’ Established in 2014, C-Bridge Capital is China’s topline healthcare-dedicated private equity firm. The company’s portfolio covers general healthcare service sectors including biopharmaceutical, medical device and diagnostics, and its current assets under management is approximately two trillion won. Besides SB3, Samsung Bioepis is to collaborate with C-Bridge Capital on conducting clinical trials, processing approval applications and launching SB11 (ranibizumab biosimilar, referencing Lucentis), SB12 (eculizumab biosmilar, referencing Soliris) and SB15 (aflibercept biosimilar, referencing Eylea) in Chinese market. Before inking the partnership with C-Bridge Captial, Samsung Bioepis has also inked another partnership with China-based biopharmaceutical company ‘3S Bio’ in last January to market SB8 (bevacizumab biosimilar, referencing Avastin) and some other pipelines.
Company
Hanmi’s diabetes pipeline still standing in the storm
by
Chon, Seung-Hyun
Dec 11, 2019 06:47am
Hanmi Pharmaceutical’s efpeglenatide with the title of the biggest license-out deal to date is going through harsh times before reaching the finish line. The company’s unbent commitment for the pipeline kept it alive, despite amending the license out agreement twice and the partner company shifting R&D pipeline focus. Although it seems to have international clinical trials on their way unaffected, the company is now concerned of change in global commercialization partner. Headquarters of Hanmi Pharmaceutical On Dec. 10, Hanmi Pharmaceutical’s stock price closed at 298,000 won with 6.88 percent drop from the day before. Hanmi Science also took a 4.57-percent fall. Experts see that news of Hanmi Pharmaceutical’s partner company, Sanofi looking for a partner to launch efpeglenatide may have intimidated the investors. ◆Efpeglenatide surviving albeit Sanofi’s R&D pipeline shake-up In fact, efpeglenatide’s development timeline has not been changed. Sanofi broke a news of acquiring a U.S.-based oncology R&D company Synthorx for USD 2.5 billion (approximately three trillion won) on Dec. 9, and elaborated its plan to shift the focus of R&D pipeline and management style. Sanofi official stated it would prioritize investment on oncology, rare disease, blood disorder and neurology, while it would cease researches on diabetes and cardiovascular disease. However, the multinational company’s news also included its plan to complete ongoing Phase 3 clinical trials of efpeglenatide, but not to pursue a efpeglenatide launch. At face value, Sanofi means to not commercialize efpeglenatide, but it also means the pipeline survived another major pivot in Sanofi’s R&D pipeline. The candidate drug is the only diabetes treatment pipeline among five investigational drugs the multinational company plans to submit the U.S. Food and Drug Administration (FDA) New Drug Application (NDA) for in two years time. A Sanofi executive stressed “It was the best decision for the successfully launch of efpeglenatide while maximizing the productivity of our research engine. It was irrelevant to efficacy and safety of the substance, and it would make no changes on license-in agreement with Hanmi Pharmaceutical”. Technically, efpeglenatide proved its potential to Sanofi’s new CEO, Paul Hudson appointed last August, despite his firm commitment to reprioritize R&D pipeline. In the year, Sanofi suddenly stopped research in a trigonal GLP-1/GIPR/GCGR agonist, SAR441255. And the French company also has paid back upfront fee to exit a 300-million-dollar partnership deal over SGLT1/2 dual inhibitor Zynquista (sotagliflozin) signed in 2015. ‘New Drug Application Submission Timeline 2019-2023’ unveiled during 3Q performance presentation by Sanofi ◆Amending license-out agreement twice, two LAPSCOVERY medicines returned Starting with the license-out agreement, efpeglenatide has gone through a series of ups and downs. Efpeglenatide, a GLP-1 injection for type 2 diabetes, is a bio drug candidate that extended once-daily administration interval to once-weekly and even once-monthly. It incorporated Hanmi Pharmaceutical’s key platform technology, ‘LAPSCOVERY’. LAPSCOVERY, or Long Acting Protein/ Peptide Discovery platform technology prolongs the duration of biologics’ short half-life to reduce administration frequency and dose, which would ultimately reduce adverse reaction and improve efficacy. Chemically conjugated biologics and protein ‘LAPS-carrier’ amplifies duration of the substance’ effect in human body and maintains the effect for maximum one month even with a small amount. In November 2015, Hanmi Pharmaceutical signed a license-out agreement with Sanofi on efpeglenatide, which still to this date is the biggest deal in the history of Korean pharmaceutical industry. The 2015 deal transferred technology of a EUR 3.9 billion-worth Quantum Project (efpeglenatide, long-acting insulin, and efpeglenatide with long-acting insulin) to Sanofi. The upfront fee alone was 400 million euro. But after closing the deal, a number of unexpected changes were made. In December of 2016, Hanmi Pharmaceutical amended the agreement to drop one of the drug candidates from the ongoing technology transfer project. Out of three drug candidates, Sanofi decided to return license over the long-acting insulin. Agreement terms on the long-acting insulin combination was also changed so that Sanofi would acquire it after Hanmi Pharmaceutical develops it for a certain period of time. As a result, Hanmi Pharmaceutical paid back 196 million euro out of Sanofi’s 400-million-euro upfront payment. The milestone payments were also affected and the overall deal was shrunk by over one billion euro, down to 2.82 billion euro. Regardless of the reduction, the upfront fee and overall scale of the efpeglenatide deal is still historic record high within the Korean pharmaceutical industry. Hanmi Pharmaceutical-Sanofi agreement revised in June (Source: Financial Supervisory Service) In June, however, Hanmi Pharmaceutical and Sanofi agreed to amend the agreement once again. Hanmi Pharmaceutical lowered the maximum co-research expense from 150 million euro to 100 million euro with about 50 million euro (approximately 65 billion won) cut. The first amendment actually included a clause for Hanmi Pharmaceutical to contribute 25 percent of efpeglenatide R&D expense, which was supposed to be covered entirely by Sanofi. And Hanmi Pharmaceutical set the research expense cap at 150 million euro. In just about two years, Hanmi Pharmaceutical was able to revise the clause added in 2016 to be more favorable to them. When amending the agreement for the second time, Hanmi Pharmaceutical also postponed its payment period of clinical trial expense. Initially, Hanmi Pharmaceutical was supposed to pay when Sanofi quarterly billed for efpeglenatide’s clinical expense. The additional expense of 40 million euro out of 68.5 million euro would be billed on an earlier date between September 2022 and submission date of Biologics License Application (BLA) to FDA. The bill is to be cleared by Hanmi Pharmaceutical within 15 days. The rest of 28.5 million euro would be paid on earlier date, either in September 2023 or the FDA approval date. Basically, Hanmi Pharmaceutical is to pay Sanofi whenever efpeglenatide development achieves a milestone. When Sanofi initiated large scale clinical trials on efpeglenatide, the expense soared more than expected. But then Sanofi seems to have accepted Hanmi Pharmaceutical’s request to lower its contribution in clinical expense. Meanwhile, risk factors in LAPSCOVERY technology have been raised. Janssen signed a technology transfer deal on JNJ-64565111, a candidate diabetic obesity drug, but it had to suspend clinical trial due to production delay. In July, Janssen returned its license on JNJ-64565111 and the license-out agreement covering two candidate drugs based on LAPDISCOVERY technology fell through. Spectrum Pharmaceutical’s in-licensed Rolontis, a neutropenia treatment, is the first LAPSCOVERY-applied medicine to get so close to commercialization. A U.S.-based Spectrum Pharmaceutical filed for FDA approval on Rolontis at the end of last year, but it dropped the BLA in March as the authority ordered for more supplementary data. The application was submitted again in October. ◆ Five out of two efpeglenatide clinical trials completed selecting participants Currently, the efpeglenatide development is going smoothly. Two years after signing the deal, Sanofi officially unveiled a detailed plan on efpeglenatide at the end of year 2017. By the end of 2017, Sanofi initiated the first Phase 3 clinical trial to compare efpeglenatide and placebo, and in April last year, the company initiated a large-scale Phase 3 trial to test efficacy and safety in treating cardiovascular diseases. Another Phase 3 trial was initiated since September last year to compare efpeglenatide and competing product Trulicity (dulaglutide) as a combination therapy with Metformin. In October last year, a protocol on combination therapy with efpeglenatide and basal insulin was registered, and in December same year, the fifth Phase 3 trial was initiated to confirm the drug treating Type 2 diabetic patients who cannot control glucose level either after Metformin single therapy or Metformin and sulfonylureas combination therapy. The overall target number of sample is 6,340. As of now, two out of five Phase 3 trials on efpeglenatide have gathered sufficient number of participants. Most recently, placebo-comparing Phase 3 trial AMPLITUDE-M has gathered targeted number of patients. The investigational drug’s key trial, AMPLITUDE-O testing effect of efpeglenatide on cardiovascular outcomes has registered more than planned number of participants of 4,076 patients in June. A Hanmi Pharmaceutical official stated, “Sanofi has promised to concentrate on completing numerous Phase 3 trials currently ongoing to develop efpeglenatide successfully”. Two Phase 3 efpeglenatide trials have registered enough number of patients (Source: ClinicalTrials.gov)
Opinion
[Reporter's view] Illegal Rebate CSO
by
Lee, Jeong-Hwan
Dec 11, 2019 06:40am
I suddenly thought that the trifoliate orange is innocent when I was covering the law revision extending medical and pharmacological expenditure reports to pharmaceutical CSOs. Pharmaceutical industry ethics management (CP) experts refer to CSOs based on drug expertise as tangerines, the CSO which was altered as an illegal rebate, as trifoliate orange Unlike tangerines that boil sweet and sour flesh, the trifoliate orange has a thick peel and a lot of seeds, so it has little flesh and a strong sour taste, making it suitable for comparing illegal CSOs. However, the pharmacological benefits of November’s trifoliate orange in season were excellent compared to the illegal CSO. Donguibogam (Principles and Practice of Eastern Medicine) says that the trifoliate orange is also effective for respiratory diseases and congestion such as relieving severe itching and detoxification of liver, relieving bloating and coughing. Even citric acid removes fat, which promotes nutrient metabolism in the body and helps with diet. Illegal CSOs, on the other hand, are all evil and no good to the health and pharmaceutical industry as well as to the health of normal CSO industries. The Korean version of Sunshine Act, launched from this year, is poised to expand the scope of application to pharmaceutical CSOs following pharmaceutical companies. It will be realized through the revision of the Pharmaceutical Affairs Law and the Medical Device Act, which contains the regulation on drug rebate, but it requires the efforts of the pharmaceutical industry and some altered CSOs. Korea's pharmaceutical industry, the future growth engine, is no longer able to stay in the generic drug structure. Generics that are already on the market and have expired major patents and poured out many of the same ingredients cannot lead the industry in the rapidly changing Fourth Industrial Revolution. It's been a long time since generics have lost their power as a cash cow, supporting the pharmaceutical industry and serving as a source of new drug research and development (R & D). There are numerous precedents that the generic fraudulent competition, which is hard to find market innovation, eventually leads to an illegal rebate war. Even in the case of generic competition, there is no argument against the need for a direction based on drug expertise through legitimate CSOs. The legislature and the Ministry of Health and Welfare soon agreed that they would embark on a complementary legislation that would include CSOs as drug companies in drug suppliers. This means a direct signal to the pharmaceutical industry and the CSO industry to initiate self-cleaning as a means of amending the law. The Welfare Ministry also believes that the revision of the law cannot be the magic bullet to eradicate all drug rebates. In the end, the rebate eradication can only be achieved if the pharmaceutical industry and the CSO themselves show their professionalism in the legal pharmaceutical competition market established by the government and the National Assembly, and then dig out the old and corrupt business. In addition to the yellow and coveted fruits, the trifoliate orange trees have been planted as a substitute for fences since ancient times, because of the stems of roses and oaks that are scary and thorny. Taking into account the medicinal efficacy and physical function of the trifoliate orange, which has been likened as an illegal CSO, we are dreaming of a future where the domestic CSO industry will grow into a strong and robust industry dedicated to pharmaceutical sales for medical and pharmacist experts.
Company
MSD’s new labor union in talks for unpaid wage compensation
by
Kim, Jin-Gu
Dec 11, 2019 06:39am
MSD Korea employees have gathered again under a new umbrella. Majority of the members previously affiliated under Korea Democratic Pharmaceutical Union MSD Chapter left and established a new labor union of their own. ‘MSD Korea Laborers’ Union’ is the new name for the independent corporate labor union. On Dec. 5, the union convened its first general meeting and kicked off with a union representative election. MSD Korea’s labor union was formed for the first time as the 17th chapter of the Korea Democratic Pharmaceutical Union last year. Since then the union engaged in a single union talks with the corporate management over compensation of unpaid wages and other agenda. However, discrepancies loomed between the executive body and members during the process. Some members started complaining that the executive body is not properly speaking up for the compensation for weekend wage. As a result, the members started working on forming a new labor union from September last year. Except for the chairperson from the MSD Korea Chapter, most of the executive body left the union and formed a new one. 80 percent of the members also joined the new one. Currently, the new union has about 280 members. With the scale, the new union gained support of the majority and earned the representative bargaining rights. The new union is now in talks with the employer about compensation for weekend wage and reasonable salary raise negotiation. Since October 31, total five talks have been held. The labor union is specifically demanding for an immediate payment of five-year overdue weekend work wage, and affirmed seven percent raise in salary. According to the labor union, MSD Korea has not properly paid employees for the weekend work by calculating it as normal daily expenses. The union estimates the overall unpaid weekend wage is about five billion won. The management is holding on to the four percent salary raise. They have agreed on compensating for the overdue weekend wage, but they want to further discuss about the details of the payment later. As it is a matter of ‘unpaid wage’, the union is asking for a letter to affirm payment of the unpaid wage without further discussion. Apparently, both of parties have agreed to make decisions and resolve the said issues within this year. Shim Sang-nam, elected as a chairperson to lead the first general meeting explained the reason of forming a new labor union saying “The recently addressed issues needed a union with more democratic and ethical qualities. Also multiple problems reported constantly called for a new union urgently and solely for MSD employees”. “MSD Korea Laborers’ Union aims to resolve salary raise negotiation and unpaid payment issues in short term, but it would thrive to create the best working environment with MSD-appropriate levels of salary, benefits and guaranteed retirement age”, the chairperson added.
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