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- 2026-04-17 15:11:30
- InterView
- “Key to healthcare innovation is pharmaceutical industry"
- by Kim, Jung-Ju Jan 02, 2020 06:08am
- Korea’s Ministry of Health and Welfare (MOHW) has stated two core goals of the current administration are ‘creating an inclusive welfare state’ and ‘supporting innovative growth of emerging industry.’ The key is definitely the pharmaceutical industry. During a question and answer session with correspondents, Park Min-soo, a director of Health Insurance Policy Bureau under Office for Planning and Coordination at MOHW, said this year the ministry is committed to support all-around new drug development covering from basic science research to commercialization, and to strengthen industry competitiveness. Director Park, in charge of the ministry’s budget plan each year, allocated 12.9 trillion won on healthcare sector this year. The plan reflects the record-high National Health Insurance state funding of 1.86 trillion won, whereas 2.7 trillion won was allocated besides for healthcare. Director Park stressed the importance of pharmaceutical industry among the industries government is backing up. He elaborated, “Other than the goal of creating inclusive welfare state, the government is devoted to support innovative growth of emerging industry.” “The government is trying to find the hidden gem of the healthcare industry and create an environment to polish it. Among the emerging industries of IT, bio, pharmaceuticals, agriculture, and food the government is currently pushing on for innovation, the pharmaceutical industry is the most valuable key,” he continued. One of ongoing inter-ministerial programs supporting the key industry is the big data platform project. Director Park explained, “Big data utilization is expected to embody vast amount of data, but it needs the government to build a foundation to optimize utilization of the information, because it has a limitation of private information protection.” So apparently the director allocated budget to connect the dots between dispersed information. Government support for R&D is another highly expected project. He emphasized the investment value for R&D is high as Korea’s R&D investment rate against GDP is at worlds highest. “From basic science research to commercialization, we need to bridge the gaps to ultimately make a living out of the industry. To strengthen the industry competitiveness, the ministry would support new drug development in every step of the way and also train specialists to reinforce the industry strength,” Director Park said. He added, “Laying the groundwork for the R&D system would encourage more research activities and contribute on advancing technology further. The result may not be tangible immediately, but the government is committed to continue support it.” Moreover, Director Park explained about MOHW’s plan to open a tentatively named ‘Office for Health Policy’ that reinforces government’s preventive healthcare programs to reduce medical expense and solve the issue of increasing dependants in the aging society. Additionally, he emphasized the importance of preventive healthcare programs to get under way from this year. “The point of the policy in the end is to make people live their lives without dealing with serious health condition. Mobile Healthcare program providing high-risk chronic disease management would open 30 more centers this year, while the mental health sector would secure human resources and open Emergency Intervention Team with 39 percent increase in budget,” he said.
- Product
- Samsung completes Phase III of Lucentis Biosimilar
- by Lee, Seok-Jun Jan 02, 2020 06:08am
- Samsung Bioepis’ Lucentis Biosimilar (SB11)' phase III completed. Lucentis' global sales last year were about ￦4.2 trillion. Samsung Bioepis recently announced its last patient visit for the SB11 phase III trial was done. Phase III examined compared non-inferiority with the original Lucentis in a total of 705 patients with Wet Age-related Macular Degeneration from Mar 2018. Lucentis is a treatment for eye diseases such as macular degeneration and diabetic macular edema, jointly developed by Roche’s subsidiary Genentech and Novartis, multinational pharmaceuticals. Samsung Bioepis plans to announce the results of phase III next year and proceed with the marketing authorization application process in Europe and the United States. SB11 is Samsung Bioepis' first eye disease treatment project. Meanwhile, Samsung Bioepis recently signed marketing partnerships about two types of eye disease treatment pipelines (SB11: Lucentis Biosimilar, SB15: Ilia Biosimilar) with Biogen, including the US and Europe. SB15 is a case that recognized market value from partners even though it is a candidate for clinical preparation.
- Policy
- Lipiodol’s gap recurrence prevention law is pushed forward
- by Lee, Jeong-Hwan Jan 02, 2020 06:06am
- A bill, which the government is obliged to conduct regular surveys on the state of supply of essential medicines, to build a stable supply environment will be promoted. The legislative goal is to prevent the gap of essential medicines to prepare for major national disasters such as terrorism and radioactive pollution. Representative Myung-yeon Kim of the National Assembly's Health and Welfare Committee (Danwon gu, Ansan, Liberty Korea Party) presented the proposed amendment to the pharmaceutical affairs law on the 30th. Under the current law, national essential medicines are necessary for health and medical services such as disease control and radiological disaster prevention, but they are difficult to supply in a stable manner due to lack of marketability. Related departments, such as the MFDS, are designating and managing 351 items. But Representative Kim criticized that the vast majority of emergency medicines for terrorism and radiological warfare were less than a tenth of statutory reserves. In particular, in 2018, the sale of special contrast agent 'Lipiodol', which is used to treat liver cancer, was stopped. In January of this year, anxiety arose due to unstable supply of essential drugs, such as the anti-cancer and glaucoma drug ' Mitomycin', which is in danger of being stopped. In order to solve the problem, Representative Kim said he proposed an amendment to the Pharmaceutical Affairs Law that strengthens the responsibility for the Agency to function as a national essential drug control center and specially manages the supply situation such as complete enumeration of the expiration date. Representative Kim said, “The current stockpile and stockpiling location of essential medicines are not well understood, and it is expected that this amendment will proactively respond to national emergency situations”.
- Policy
- Report find MFDS cleared 112 IMDs in past decade
- by Lee, Tak-Sun Jan 02, 2020 06:05am
- Apparently, more than half of incrementally modified drugs (IMDs) approved in the past decade were combination drug. And majority of them were approved for treating chronic disease. On Dec. 30, Korea’s Ministry of Food and Safety (Minister Lee Eui-kyung) published ‘IMD Approval Report’ reviewing current status and past cases of approved IMDs. The report was compiled to inform the IMD-developing companies of approval criteria, approval failed cases and a list of all approved IMDs in the past decade, since the IMD approval was implemented from 2008, to enhance the predictability of the approval system. The report found the total of 112 IMDs has been cleared from 2009 to last November. Breaking down the approval list, 62 items (55.4 percent) ‘improved effectiveness,’ 39 items (34.8 percent) ‘improved usability,’ seven items (6.3 percent) was ‘recognized with innovativeness of pharmaceutical technology,’ and four items (3.5 percent) ‘improved safety.’ 62 items, recognized with improved effectiveness, were all combination drugs (two or more active ingredients are combined as one item). Among which, 52 items were dual agent combination drug and ten items were triple agent combination drug. 39 items, recognized with improved usability, were approved with decreased dose or more convenient administration method providing better drug adherence. Approved IMDs from 2009 to Nov. 2019 Breaking down the list again by class, 47 items (40.4 percent) were for cardiovascular and circulatory system drugs (antihypertensive, anti-arteriosclerotic drug), while 16 items (14.3 percent) were anti-diabetic drugs. It was apparent the majority of IMDs were developed for chronic disease (hypertension, hyperlipidemia, diabetes and etc.). The key finding was that Korea entering the era of aging society is resulting in increased chronic disease, and accordingly, pharmaceutical companies have developed more drugs with simplified multiple drug dose or administration method for better drug adherence. Analyzing the drug development types, 70 items (62.5 percent) improved safety (reduced adverse reaction) or effective (increased treatment effect) and 29 items (25.9 percent) improved dose and administration by lessening frequency of administration (twice-daily to once-daily, or three times-daily to twice-daily). MFDS official explained, “We expect the report would provide practical information to Korean pharmaceutical companies currently developing or preparing drugs in different types. The ministry would continue to provide more useful information to the industry for developing new drugs.”
- 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.
