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Opinion
[Reporter's view] DC the absolute power behind hospital
by
Eo, Yun-Ho
Nov 11, 2019 11:08am
When each hospital’s Drug Committee (DC) is convened, pharmaceutical companies starts a fierce war to land a favorable drug deal. Just like any war in the world, the ‘DC war’ has a winner and a loser. Unfortunately, not always do the winners deserve a win or the losers deserve their defeat. To land a ‘drug code-in’ deal at some general hospitals, ‘inappropriate backdoor dealing’ is more important than outstanding evidences of a drug’s indication and efficacy. Such phenomenon is prevalent when an original’s patent is expired and new generic is released. A hospital’s DC mostly consists of doctors from each department and chief pharmacist. However, sometimes unheard-of drugs get their codes in and push out existing drugs, thanks to hospital foundation’s influence. To this date, a hospital with significantly influential DC brings in representative of a pharmaceutical company and demands for so-called ‘drug code maintenance fee’ on an original drug with expired patent. In fact, the hospital removed well-known original hypertension, hyperlipidemic and antithrombotic items for last two to three years. Their codes were removed, simply because the drug companies refused to pay the ‘maintenance fee’. The illegal rebate paid by drug companies is never handed straight to the foundation. Pharmaceutical industry insiders hint that the money is rerouted and laundered through separate corporations owned by the foundation or distribution companies with a close relationship, and finally gets to the foundation. DC lobbying exists between originals when there is a new generation or type of drug is launched. So for pharmaceutical companies to get a drug code-in deal, they need to coax foundation and doctors. Of course, the effort of Dual Penalty System and Fair Competition Agreement has brought some fairness to the business. Unless solid evidence of a drug is available, growing numbers of hospitals are not guaranteeing DC’s approval, regardless of a good connection between a healthcare provider and a pharmaceutical company. However, hospitals still associate DC with an absolute power. Even though it should be given that hospital’s drug coding depends on fair evaluation.
Policy
World's most expensive drug Zolgensma to challenge Spiranza
by
Lee, Hye-Kyung
Nov 11, 2019 06:11am
Launching of the most expensive drug in the world, Zolgensma (onasemnogene abeparvovec-xioi), with a price tag of 2.5 billion won per dosage, has gotten Korean health authority and pharmaceutical industry anxious. Although the drug had an allegation of data manipulation from animal testing two months after the U.S. Food and Drug Administration’s (FDA) approval, the industry experts see Zolgensma would enter Korean market soon as the allegation is unlikely to cancel its approval. In last May, the U.S. FDA approved Zolgensma, indicated for the treatment of pediatric patients less than two years of age with spinal muscular atrophy (SMA) with bi-allelic mutation in the survival motor neuron-1 (SMN1) gene. Also, its applications for Fast Track, Breakthrough Therapy, Priority Review and orphan drug were granted. But the treatment has not been introduced to Korean market, yet. The drug is a gene therapy designed to target the genetic root cause of the Type 1 SMA through one single session of therapy. Meaning, one injection of the therapy replaces the function of the missing or nonworking SMN 1 gene with a new, working copy of a human SMN gene and prolongs patient’s overall survival. Institute for Clinical and Economic Review (ICER), a U.S. based organization reviewing drug’s cost-effectiveness, set Zolgensma’s price at USD 90,000 (about 95 million won), but the drugmaker claimed it should be four million to five million dollars (about 5 billion won), because it is an one-time treatment. Currently, Zolgensma is sold in the U.S. for 2.1 million dollars (about 2.5 billion won), and the pharmaceutical company provides an option of five-year installment with an yearly payment of 425,000 dollars, with partial refunds if it does not perform as expected. Followings are major motor milestones of the final result of clinical study on 12 SMA Type 1 patients with the onset of clinical symptoms before six months of age (average age of 3.9 years, as of March 8, 2019); all patients at the 24-month study closeout, survived and are free of permanent ventilation; 11 patients were able to hold their head erect for three seconds and longer, and sit without support for five seconds and longer; ten patients were able to sit without support for ten seconds and longer; nine patients were able to sit without support for 30 seconds and longer; two patients were able to stand alone, walk with assistance and walk alone. The key results resemble that of Spinraza, listed on Drug Reimbursement List in Korea as of April 8, this year. In 2016, the US FDA granted approval on Spinraza, an antisense oligonucleotide (ASO), for treating SMA caused by mutations in chromosome 5q. At the point of approval, ICER evaluated price of first year Spinraza therapy to be 750,000 dollars (about 800 million won), and 350,000 dollars (about 400 million won) from second year and on. As of now, Spinraza is covered by National Health Insurance (NHI) in Korea with risk sharing agreement (RSA), and its price cap for a single vial (5ml) is at 92,359,131 won, and patient copayment is about 9.23 million won, a ten percent of the full price. Reimbursement is granted for patients with SMA caused by mutations in chromosome 5q satisfying all conditions of preliminary review. The conditions include, patients diagnosed with absence or mutation of SMN1 gene, having onset clinical symptoms of SMA from age of three or less, and not using permanent ventilation (more than 16 hours a day continuously for more than 21 days). Spinraza is an intrathecal injection, administering four loading doses of 12mg (5ml) into cerebrospinal fluid. The first three loading doses should be administered at 14-day intervals. The fourth loading dose should be administrated 30 days after the third dose. A maintenance dose should be administered once every four month thereafter. In July, Spinraza published an interim report of 60-month long-term Phase 2 NURTURE clinical trial. NURTURE is an ongoing Phase 2 study of 25 infants with the genetic mutation of SMN, who received their first dose of the drug in a pre-symptomatic stage and before six weeks old. 45.4 months into the trial, all 25 patients have survived without permanent ventilation and are able to sit without support. Apparently, 88 percent (22 patients) can walk without support, suggesting the drug could be effective for infants not showing SMA symptoms, yet. SMA is a rare recessive neuromuscular disorder caused by bi-allelic mutation in the SMN1 gene’s chromosome 5q. The disorder causes a deficiency of motor neuron protein called SMN, and about 95 percent of people with SMA have onset symptoms when SMN1 gene mutates. SMN1 gene mutation reduces production of SMN protein as downstream processing from DNA to RNA cannot develop enough SMN gene, and also it induces apoptosis of anterior horn cell causing degenerative change in motor neurons, which leads to a relatively fast progression and symmetrical muscle weakness resulting in early death. Reported estimated incidence rate of the condition is one in 6,000 to one in 10,000 live births and carrier frequency is about 1/40-1/50. Infants with symptoms are unable to independently move as they lose motor function due to muscle degeneration. Infants with SMA have the highest severity and frequency, which their symptoms are prevalent from birth or around six months after the birth. These patients with severe case rapidly lose motor neuron, in control of activities like breathing, swallowing, speaking and walking, and without a treatment their muscles weaken fast and die from respiratory failure, as even their respiratory root loses its function by the age of two. Currently Spinraza and Zolgensma are only two SMA treatments available. Spinraza is a SMN2-directed ASO, approved to treat 5q SMA with its results of ENDEAR study. Whereas Zolgensma is a gene therapy that replaces missing or mutated SMN 1 gene, and was approved to treat children less than two years of age having bi-allelic mutation in SMN1 with results demonstrated in STR1VE study. Zolgensma had a comparatively small-size clinical trial than Spinraza, which demonstrated its efficacy in Type 1 patient before the age of six months and Type 2 and 3 patients at the age of two to 12 with onset symptoms from six months after birth. On the other hand, Zolgensma can only be used for SMA patients before the age of two. As for their pricing, Spinraza is priced at around 100 million won per injection and needs continuous administration, but a single-administration therapy Zolgensma is priced at around 2.13 million dollars (about 2.52 billion won) per injection. Zolgensma currently holds the title of the most expensive drug in the world for the price of single dosage. However, Spinraza and Zolgensma still need more research and follow-up monitoring on the drugs’ efficacy and safety through long-term clinical trials. There are also needs for more reasonable pricing for better treatment access.
Policy
On a mission to eradicate KOEDC’s deep-rooted ill practice
by
Lee, Jeong-Hwan
Nov 10, 2019 10:00pm
Sources confirmed Korea Orphan and Essential Drug Center (KOEDC) submitted the National Assembly (NA) a plan to resolve its issue of redirecting profit made from drug expense gap, as it was pointed out at the latest NA Annual Audit. The center is committed to eradicate its deep-rooted practice of making profit from drug price difference and reusing it as the center’s budget. However, some point out the center would eventually need significantly increased budget approved by the center’s affiliated government body, Ministry of Food and Drug Safety (MFDS) and Ministry of Economy and Finance (MOEF). On Nov. 6, NA Health and Welfare Committee lawmaker, In Jae-Keun’s office explained “KOEDC submitted a proposal to cease their ill practice of redirecting unfairly made profit”. By the end of the year, KOEDC plans to compile ‘Evidences for Drug Pricing Readjustment Application’, needed to remove profit from drug price differences. Until February next year, KOEDC is to initiate a negotiation with Health Insurance Review and Assessment Service (HIRA) on modifying drug pricing, and in March, it would execute a lump-sum reevaluation on drug price gap. The center claims it would be done with redirecting drug pricing gap profit to budget use after HIRA completes drug reimbursement listing procedure by December next year. Newly appointed KOEDC Chairperson Yun Young Mi is reportedly determined to eradicate unethical practice within the center and normalize its internal management. As a matter of fact, KOEDC has been under a criticism for last five year on re-utilizing 6.5 billion won, made from differences in orphan drug’s actual transaction price and National Health Insurance Service (NHIS) billing price, as the center’s budget. The center official explained the practice actually has been a solution to MFDS’ insufficient budget support rate of average 37 percent. Although the center has consistently confessed of abnormal use of drug price differences and urged MFDS to boost its budget support, KOEDC did not get any answer. So in the end, it is up to MFDS to allocate budget support for the center to ultimately resolve the budget redirecting practices, according to the plan submitted to the NA. Apparently, the center used drug price differences of about one billion won every year as their organizational operation expense. But after HIRA’s adjustment on the drug pricing, the center would lose budget of one billion won. However, it is not going to be an easy ride. KOEDC has already asked for next year’s budget of 14.03 billion won, but the government only passed about 17 percent of the requested amount, 2.39 billion won. The NA is already reviewing the government’s next year budget plan, but the Health and Welfare Committee’s ‘Budget and Accounting Evaluation Subcommittee’ and ‘Budget Deliberation Special Committee’ have not yet made a decision on whether or not to increase KOEDC’s budget. Even after the committees decide to increase the overall budget, the key to the problem is then passed to MFDS and MOEF’s decision to provide the center’s requested budget. KOEDC official said, “A number of lawmakers at the NA Health and Welfare Committee audit session demanded the government to work on the center’s drug price gap profit redirecting issue, insufficient budget and low government support funding rate. For the center to operate properly, the addressed issues have to be resolved completely, and it ultimately comes down to the matter of budget allocation. The center would do its best waiting for the NA make a decision.” “For now, Health and Welfare Committee is to request Budget Deliberation Special Committee to consider increasing budget for KOEDC basic operation expense, personnel expense, and regional center operation expense. As the center’s issue of redirecting profit from drug price difference has been addressed, the lawmakers have asked MFDS to submit a solution to KOEDC’s problems,” an official from Lawmaker In Jae-Keun’s office commented.
Policy
Eliquis faces 42 generics after patent invalidated
by
Lee, Tak-Sun
Nov 10, 2019 10:00pm
The list of generics launched in the New Oral Anticoagulant (NOAC) Eliquis (apixaban) market is getting longer by the day. Especially after generic manufacturing companies won the case invalidating Eliquis’ patent in last March, number of regulator-approved generics has skyrocketed. Ministry of Food and Drug Safety (MFDS) confirmed that the total number of MFDS-approved apixaban medicine products as of Nov. 6, including the original Eliquis by BMS, is 84 supplied by 42 companies. 19 companies supplying 38 items have been approved by the ministry after the patent was invalidated at a court decision. Daewoong Bio and GC Pharma are a few of latest additions. At the moment, 38 items by 19 companies are listed with reimbursement and competing in the same market. After winning the patent invalidation case, Chong Kun Dang, Alvogen Korea, Huons and Yuhan immediately applied for reimbursement listing and entered the market from last June. Other freeloading pharmaceutical companies did not participate in the patent litigation, but decided to launch their generics expecting the patent to be invalidated. More generics are projected to be released in the future based on the number of approved products. Currently, an appeal against the patent invalidation decision has been filed but is pending at the Supreme Court. But as generic companies won both first and second trials, the Supreme Court would likely to rule in favor of the generics. On Oct. 18, the Supreme Court dismissed a trial on a medicine patent invalidation case, finalizing the previous judiciary decision to invalidate the patent. In other words, the generics sales would not have any legal barrier against sales, when the Supreme Court decides to invalidate the medicine patent. As for apixaban market, even the preferential sales approval period on the patent challenger, banning sales of other equivalent generic, has passed already. Three items, including Yuhan Apixaban, were granted with preferential sales period from May 12, 2018, to Apr. 2, 2019, but their actual sales were suspended as BMS’ sales ban application was accepted. Sales ban injunction was lifted only after the Patent Court invalidated apixaban patent. Now the key is on how well generic companies would expand the trending NOAC market. Among all NOAC medicine, only Eliquis has generic competitors. As NOACs are mostly used in general hospitals, Korean generic companies are focusing on the clinic market instead. But it seems like it would take some time for NOAC generic market to fully flourish. Since its sales started from June, Chong Kun Dang’s Liquisia made disappointing sales of 178.35 million won (Source by UBIST) until September. Meanwhile, the original Eliquis reaffirmed its market leadership by making accumulated prescription sales of 31.3 billion won by September, hiking up 32.1 percent from the year before.
Policy
“Less on chronic drug, but more on innovative drug”
by
Lee, Jeong-Hwan
Nov 10, 2019 09:59pm
Principal Boo Ji-hong Claims have been made that the government drug expenditure model should be fundamentally reformed, instead of adopting new drug-centered drug pricing policy, to simultaneously better Korean patient's access to new and breakthrough treatments, and to secure financial health of National Health Insurance (NHI). The criticism is that the government should face the reality of excessive use of digestive medicine, antacid, and antibiotics and other chronic drug, and rather limit the frequent use of those mild condition and chronic disease drug to redirect the saved expense on enhancing access to new drug and healthcare coverage. On Nov. 7, a principal of IQVIA Korea, Boo Ji-hong spoke at a policy seminar regarding the social value of new drug and NHI financial management. Principal Boo gave a presentation on sustainability of NHI and advancement of pharmaceutical expenditure model. The principal explained Korean government’s pharmaceutical coverage enhancement plan for unmet needs of severe and rare disease treatment is established based on moderately controlled drug expenditure. Boo also reproached, although the government’s NHI coverage enhancement initiative has improved access to innovative drug and rare disease treatments than before, coverage on specialty drug, such as anticancer and AIDS-like infectious condition treatment, is still fairly low. Specifically, Principal Boo sees that need for innovative drug access is clearly unmet, when comparing Korea and developed countries’ pharmaceutical expenditure models and the ratio of new drug expenditure. He also explained comparatively low medical expenditure in Korea has affected the country’s perception that local drug expenditure is higher than that of other developed countries. As a result, Principal Boo argued, the government can catch two birds, new drug access enhancement and NHI financial health, when it drastically reforms and advances pharmaceutical expenditure structure. He advised the government’s unconditional reduction of drug pricing would basically threaten patient’s access to treatment. Instead, it should lessen excessive use of chronic and mild condition treatments, and reuse it as resource to cover severe disease treatment and orphan drugs. Moreover, the principal stated NHI expenditure would be raised only by 0.6 percent at highest with financial impact of healthcare coverage expansion on new drug, including coverage on non-reimbursed drug, and approving and listing not-yet launched drug in Korea and investigational drug. “Volume of digestive medicine, antacid and antibiotics frequently used in Korea doubles the volume in other advanced countries, which is why the government should consider limiting the volume. Also, efficiency of insurance income allocation could be improved by studying overseas cases of innovative payment system, drug usage volume control, and public-private collaborated management of chronic disease patient”, said Principal Boo. He also stressed, “To enhance NHI coverage on patient-centered breakthrough innovative drug, expenditure structure should get further upgraded and incentive should be granted for the recognized value of an innovation. The effect of price-centered new drug expenditure management policy would be mediocre. But so the government should consider moderately controlling drug usage volume and amending expenditure structure”.
Company
Generic to pay for original’s lowered pricing loss?
by
Kim, Jin-Gu
Nov 08, 2019 08:55am
To this date, a boundary of patent infringement damage against generic was up to ‘sales profit of generic’. But now a lawsuit claims the damages should include ‘loss made from original’s price reduction’ due to generics’ launch. Related court case is currently waiting for the Supreme Court’s final decision. Lilly Korea and two Korean companies, Hanmi Pharmaceutical (“Hanmi”) and Myung In Pharm (“Myung In”), are tangled in a decade-long fierce dispute over patent covering Xyprexa (olazapine). Initially, Xyprexa’s patent was supposed to expire on Apr. 24 of 2011, but Hanmi and Myung In challenged the patent. Both ‘Intellectual Property Trial and Appeal Board’ and Patent Court ruled in favor of the Korean companies stating that the original’s patented invention lacks creativity. Based on the ruling, Hanmi and Myung In launched their generics in early 2011, a few months earlier than the challenged patent’s expiration date. At the same time, Xyprexa’s price was lowered by the government. Patent case gets a twist, litigation for damages immediately followed But, things got complicated as the Supreme Court overruled the previous decision stating the patent is still valid. The patentee, Eli Lilly, filed litigation for damages against the two Korean companies’ patent infringement. As a result, Hanmi and Myung In paid Lilly all sales profit made from the generic as damages. Typically, a patent infringement case concludes there. But Lilly did not stop and filed another case claiming the two companies should also pay for Lilly’s loss caused by the original’s price reduction. Lilly insisted Hanmi and Myung In’s early generic release had the original’s price to drop and hence, the loss from the price reduction should be compensated. Contrasting second trial, Supreme Court to make final decision in December at earliest The court gave a nod to some of Lilly’s claim at the first trial against each of the two Korean companies. But the second trial was ruled quite the opposite. The Seoul High Court dismissed Lilly’s claim on the case against Hanmi. Infringement of patent was recognized, but the court rejected damage claim on loss by drug price reduction. On the other hand, the Patent Court agreed with Lilly’s case against Myung In. The decision ordered Myung In to pay damages even for Lilly Korea’s loss generated by the original’s price drop. The court stated “The generic’s drug price listing application has directly affected government’s decision. And it brought Xyprexa’s price down to 80% of the original price”. The two contrasting decisions have been sent to the Supreme Court. Experts predict the court would make a decision by the end of the year. “The Supreme Court is reviewing legal principle and the issue comprehensively. The court decision would be out before next year,” a legal expert commented. More burden on early generic release if Lilly wins Actually, the damage amount alone for the two Korean companies was not that much. For instance, Myung In was ordered to pay damage of KRW 98.07 million from the first and second trials. The total sales were low to begin with, as the launch was only a few months ahead of the patent expiration. However, pharmaceutical industry’s patent experts view the decision on the litigation would significantly affect the industry. The court ruling in favor of Lilly would heavily influence early release of generics in the future. If patent infringement damages are to consist of generic sales profit and loss by the original’s price reduction, the damage amount could sum up astronomically and detrimentally depending on the generics’ release date. The Supreme Court’s final decision is soon to be made. As a matter of fact, Korean judiciary has never made a precedent ordering a generic manufacturer to pay for the original’s loss by price reduction. Now the public waits to see whether or not an exceptional decision would be made.
Opinion
[Eyes of a Reporter] Are you a ‘good company?’
by
An, Kyung-Jin
Nov 08, 2019 08:45am
Every year around this time, one book hikes up the best seller ranking at book stores. The book, ‘Trend Korea Series’ by Professor Kim Nando of Seoul National University, summarizes next year’s trend in Korea with a list of keywords. ‘Trend Korea 2020’ had a top ten consumer trend keyword list including ‘fair play’. The book explains how the notion of ‘good company’ has gotten popular among consumers over the years, therefore, ‘fair competitiveness’ would become a more vital factor affecting consumer’s choice. At a recent special lecture session, Professor Kim claimed “Growing up in a society where individuality is prevalent, Millennials wants to change their society with a small effort. Even when buying a product, they put value not only in the product itself, but also in the brand’s good influence towards the society”. With his theory, he further explained the lately popular boycott movement against problematic brand is not just a simple aggression, but an expression of desire to be fair and correct. During the lecture, I suddenly thought of a question. Which pharmaceutical company is actually a ‘good company?’ In Korean society, pharmaceutical companies have a relatively positive public image. The society appreciates how the companies provide needed drugs to patients and contribute in saving lives. How wonderful is it that their income made from drug sales is reinvested toward new drug R&D, and also on corporate social responsibility (CSR) activities. However, some companies have disappointed Koreans and crippled their trust in the industry in recent years. Last year March, a French pharmaceutical company announced it would suspend supplying a contrast agent used for liver cancer treatment due to low pricing in Korea. As a response, the Korean society got infuriated. A British multinational healthcare company has been the infamous company for a while as the one responsible for making humidifier disinfectant with severe health hazard. After developing an anticancer treatment significantly extending patient’s overall survival period, a large-scale pharmaceutical company experienced painful clash and dispute with patient groups as the company insisted on drug pricing at around few million won per month. Global companies are not alone on this topic. Prosecutors are still investigating a Korean bio company accused of manipulating ingredient report on its osteoarthritis gene therapy. An allegation of another Korean company, despite its title of ‘good company’ earned from the society, providing illegal rebate to healthcare provider for prescribing their products turned out to be true and the their executives were sentenced with jail term. Also there are many companies regularly making negative postings at vulnerable time for investors fearing it would affect stock price. In this capitalistic society, reproaching pharmaceutical companies for their profit-making decisions could be too harsh. Supplying needed drug or CSR activities can only be possible, when a company is sustainable. But, shouldn’t the executives of pharmaceutical companies feel more responsible about the society’s higher expectation of business ethics on health related companies? We can only hope that those pharmaceutical companies would repent their wrong choices and stand tall again as a ‘good company’, keeping their initial objective of ‘contributing to public health’ in mind.
Company
Carcinogen impact halves Zantac global sales
by
An, Kyung-Jin
Nov 07, 2019 08:55am
Suspected sales damage due to impurity found ranitidine came true for global pharmaceutical company Sanofi-Aventis’ Zantac. On Oct. 31, Sanofi reported global net sales of the company’s third-quarter 2019 rose by 1.1 percent over a year to EUR 9.5 billion (about 12.4 trillion won). Mainly driven by new atopic dermatitis treatment Dupixent, Sanofy Genzyme’s sales were up by 19.5 percent than last year same quarter, but Consumer Healthcare (CHC) sales contrasted drastically as it only grew about 0.4 percent. The company reported CHC global sales in the third quarter marked 1,136 million euro (about 147 billion won). Zantac is an original ranitidine medicine developed by GSK and is sold by Sanofi in the U.S. Canada and some other countries. Sanofi used to make Zantac sales of about 130 million euro sales annually. In each quarter the OTC drug used to make over 30 million euro, but this third quarter it only made about 14 million euro (about 18.1 billion won) with 58 percent drop from a year ago. The figure reflects Sanofi’s decision to voluntarily recall the products in the U.S. and Canada from last month. Sanofi Consumer Healthcare and Zantac’s global sales trend (Unit: € 1 million) Source: Sanofi On October 18, Sanofi officially made a statement about voluntary recall on Zantac OTC in the U.S. and Canada. The decision was made 37 days after the U.S. Food and Drug Administration (FDA) disclosed possibility of ranitidine medicine contaminated with N-nitrosodimethylamine (NDMA) carcinogen. Reportedly, Sanofi’s decision was mainly affected by ‘inconsistencies’ in preliminary test results of the API used in the U.S. and Canada products. However, the recall is limited to the two countries only as the API supplier varies in different regions. At the moment, recall on ranitidine medicine prescribed to Zollinger-Ellison syndrome patients in Columbia, Honduras, Guatemala, Ecuador and other Latin American countries is ongoing. Sanofi Chief Executive Officer, Paul Hudson, joining the conference call commented “As FDA raised concern over the safety of ranitidine medicine, Sanofi has decided to conduct precautionary voluntary recall on Zantac in the U.S. and Canada. Despite the negative issue in last quarter, CHC has maintained relatively stable sales”.
Policy
Law firms shakes hands with 8 government officials this year
by
Lee, Hye-Kyung
Nov 07, 2019 08:55am
Large-scale law firms in Korea are adding more and more former government officials affiliated with National Health Insurance (NHI) to their roster. A former Executive Director of Planning at Health Insurance Review and Assessment Service (HIRA), Hwang Eui-dong, 61, was recently welcomed by law firm ‘LK Partners’ as an advisor. Lately, LK Partners formed a pharmaceutical affairs team to handle diverse law suit related to pharmaceutical rebate case and medical, pharmaceutical and medical device industries. Attorney Kim Hyeong Seok, formerly a director of Food and Drug Inspection Division at Supreme Prosecutors’ Office, was added to the pharmaceutical affairs team at LK Partners, where Hwang was also agreed to join as an advisor. The team also shook hands with Attorney Jung Dawoon, a former director of Administrative Law Division at HIRA. Advisor Hwang majored in law at Sungkyungkwan University, and joined National Medical Insurance Corporation, now National Health Insurance Service (NHIS), in 1986. He served as chief of ICT Division, director of Daegu District Office, director of Automobile Insurance Review Center, director of Medical Information Analysis Division and retired after serving as executive director of planning. After his retirement at HRIA, Advisor Hwang was appointed as a chief of Policy Development Division at Korea Institute for Healthcare Accreditation (KOIHA), but decided to join LK Partners recently. Law firms’ demand and interest on medical, medical device and pharmaceutical and bio industries have been constantly expressed. And it finally exploded as major law firms ‘Kim & Chang’ and ‘Lee & Ko’ started revving up the NHI-associated government official recruitment market from last year. Just in this year alone, eight former government officials have been scouted by law firms, including former chief at HIRA Kang Kyung-soo; former vice-minister of Health and Welfare Choi Won-young; former Regional Office Director at National Health Insurance Service Cho Yoo-hyun; former executive director at HIRA Hwang Eui-dong; former director at HIRA Jung Dawoon; and former director at Ministry of Health and Welfare Ryu Yang-Ji. Large-scale law firms are appointing government officials for titles like advisor, senior consultant and consultants, which previously were taken by industry and drug pricing experts. Other law firms are also quick to follow and open healthcare or medical and pharmaceutical specific teams. At first, Kim & Chang welcomed Lee Byung-il, a former chief of Pharmaceutical Management Department at HIRA, as an advisor in May, 2018, and continued on to scout Ko Su Kyoung, formerly associated with HIRA, NHIS and multinational pharmaceutical company, as an expert consultant. Kim & Chang’s rivaling law firm, Lee & Ko organized Healthcare team consisting of former Minister of Health and Welfare Rim Chemin, former vice-minister of Health and Welfare Sohn Gunn Yik, and former director general at Ministry of Food and Drug Safety Han Young Sup. Their last addition was Kang Kyung Su, a former chief at HIRA, in last February. The firm is also strengthening their healthcare expertise with senior consultant Byun Youngshik, a former senior director at AstraZeneca Korea, and Advisor Kim Sungju, a former executive director at Novartis Korea. Law firms like ‘HMP Law’, ‘Yulchon’ and LK Partners have been busy this year lining up pharmaceutical expert teams with health sector experts. In last March, HMP Law organized Healthcare team for the first time since the firm was founded. The team invited former vice-minister of Health and Welfare Choi Won-young as an advisor and former chief of Legal Affairs Support Team at HIRA Byen Chang-suk as a chief of the team. Moreover, Park Young Hwa, formerly a medical case judge at Incheon Regional District Court, joined HMP Law as a Managing Partner, whereas Cho Woo-hyun, a former director of NHIS Seoul and Incheon District Office, and Lee Chung-gu, a former director of Administration Department at Hallym University Hospital, joined the firm as advisors. Yulchon has had a full-fledged Healthcare and Pharmaceuticals team with Choi Hee Joo, a former chief at MOHW, Kim Sung Jin, a former director at MFDS, and Choi Cheol Su, and a former chief at HIRA. But its roster recently made an addition, a former director at MOHW now a senior advisor Ryu Yang Ji, to boost the firm’s strength. These law firms assertively seeking out for healthcare related government officials could mean that the need for legal consulting and lawsuit is growing fast in related industries, specifically regarding pharmaceutical and medical device insurance reimbursement listing and application, various administrative penalty, medical dispute and government policy.
Company
Scouting fresh face for CEO at merged BMS and Celgene
by
Eo, Yun-Ho
Nov 07, 2019 08:54am
Merged Korean branch of Korea Bristol-Myers Squibb (BMS) and Celgene has now high probability of bringing in a new chief executive officer from outside of the company. According to pharmaceutical industry, BMS and Celgene headquarters have agreed on scouting a CEO openly for the merged Korean office scheduled to open before next year. Reportedly, many of current and former pharmaceutical company CEOs in Korea have applied for the job, including the current 47-year-old Celgene Korea CEO Ham Taejin. The company associates views that the headquarters’ decision to make it a public recruitment could mean they are contemplating on hiring personnel currently unassociated with the company. Including the headquarter office, BMS and Celgene are in process of appointing CEOs for major regional offshoots. And merged regional corporations with new CEO are undergoing overall reorganizations. The Korean branch has appointed a new head for Regulatory Affair department, and other departments including Market Access, Government Affair and Public Relation are also expect some changes. More than anything, the company insiders confirmed the two companies have reached a fair agreement to reorganize the corporation regardless of who is acquiring whom. In last January, BMS announced acquisition of Celgene with a value of about USD 74 billion (about 86.4 trillion won). BMS was said to acquire Celgene in cash and stock equity, and pending merger is still ongoing after closing the agreement. Sources confirm, BMS and Celgene have mutually agreed to hire a new CEO for the merged corporation. Besides the CEO scouting, the two companies are working on reorganization of the merged company.
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