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- Policy
- “MOHW neglected 10000 practices by 56 suspended doctors”
- by Kim, Jung-Ju Nov 04, 2019 03:11pm
- Sources report tens of doctors, Korean medicine doctors and dentists with suspended licenses have practiced over 11,000 medical services and claimed over 800 million won of insurance reimbursement. The Board of Audit and Inspection of Korea (BAI) notified the details the health authority and ordered to take a corrective action on its negligence on obligated monitoring of suspended healthcare providers. On Oct. 31, BAI officially disclosed a Ministry of Health and Welfare (MOHW) management audit report on containing the details. The audit was conducted on the ministry’s inappropriate internal and external practices. The audit report on the ministry’s management negligence over healthcare providers with license suspended from illegal practice found 56 doctors, dentists and Korean medicine doctors have practiced 11,102 cases of medical service. Moreover, the doctors received 808,358,420 won of National Health Insurance (NHI) reimbursement claimed from HIRA, during their suspended license period. Field inspection on two doctors and a Korean medicine doctor randomly selected by MOHW from the 56 suspended doctors, confirmed their medical practices. The Korean medicine doctor, for example, practiced total 1,469 cases of medical service from last Jan. 1 to Mar. 6, such as acupuncture on outpatient with spinal pain. The doctor claimed and received 38,510,110 won of NHI reimbursement. BAI estimates two other doctors have practiced medical service on outpatient and inpatient during their suspension period and received back 176,649,200 won and 3,816,360 won, respectively, for NHI reimbursement. And BAI pointed out MOHW was completely unaware of the situation and did not revoke their licenses. Regarding the issue, MOHW accepted BAI’s audit result and suggested it would establish a system to inspect medical service practiced by suspended healthcare providers by cooperating with related government agencies, and also impose appropriate penalty to 56 doctors, who have been paid with NHI reimbursement, after a thorough inspection on any medical service practiced during their suspension period. BAI ordered Minister of Health and Welfare to take appropriate action on the 56 healthcare providers, such as field inspection, and establish a system to monitor and inspect healthcare providers’ practice during their license suspension period.
- Policy
- First year of Rare Disease Support Scheme
- by Eo, Yun-Ho Nov 04, 2019 08:13am
- The biggest issue of the policy is ‘lack of interest’. ‘Rare disease’ is not a specific categorization, but rather it is designated based on frequency of diagnosis. Korea defines ‘rare disease’ as a disease diagnosed to less than 20,000 people. With small patient size and lack of drug, these diseases are in dire need of new drug. But the voices of small handful of patients are easily lost in the air. At the moment in Korea, 951 diseases are designated as subject for Rare Disease Medical Aid Program, in which 927 of them are eligible for special case benefit. The total of 927 consists of 827 rare diseases as defined by the National Health Insurance special case copayment benefit system, and about 100 more added, as of August 2017, by a rare disease survey reflecting opinions of patients and their families, patient advocacy group, and medical experts. Previously, the government did not have a government-managed rare disease list without sufficient legal basis to back it up. So the size of rare disease patients was estimated according to the special case benefit subject list. Rare and chronic diseases were confused and defined as one keeping rare disease related policy making and researches limited. But growing voices criticized government for neglecting rare disease, and finally the Rare Disease Management Act was enacted in 2016. Since then, the first Rare Disease Management Plan was established, and in September 2018, the Rare Disease Patient Support Scheme was first implemented as more demanded for state-level rare disease patient support like disease management, treatment and prevention. ◆Rare disease patients supported by government:The objective of the Rare Disease Patient Support Scheme was to lessen patient’s financial burden of medical expense. The health authority applied special case benefit on the new rare diseases and expanded eligible disease for low-income patient medical aid. Including the newly designated 100 rare disease, now about 1,800 patients receive special case benefit, annually. Special case benefit system for rare disease patient started from applying 20 percent of copayment rate on artificial kidney dialysis or continuous ambulatory peritoneal dialysis for chronic kidney failure patients, and the benefit continued to expand on hemophilia, Gaucher’s disease, leukemia and cancer patients. But some undiagnosed rare disease patients had been excluded from the special case benefit due to unidentifiable diagnosis and disease code with limited patient size. And from last January, the roster for special case benefit and rare disease medical aid program subject diseases were unified. The revised regulation also stipulated special case benefit for undiagnosed rare disease patients without a disease code. Medical aid subject disease roster expanded significantly from 652 to 927 cases, granting financial support to about 2,600 more patients. Compared to last year, the Rare Disease Medical Aid Program bumped up this year’s budget and allocated about 32 billion won. The Rare Disease Patient Support Scheme includes Rare Disease Diagnosis Support Program to prevent patients from missing adequate treatment timing with difficulty in diagnosis. The diagnosis support program covers patients with Genetic Testing Support subject disease and undiagnosed condition. Also from this year, Rare Disease Regional Care Center Network has been expanded to ten centers, consisting of one Central Support Center and other Regional Support Centers. To sum it up, the Rare Disease Support Scheme mainly focuses on ▲establishing rare disease list and registration system, ▲increasing medical aid to reduce financial burden, and ▲expanding rare disease diagnosis support and Regional Support Centers. ◆Only 5% of diseases have treatment and NHI coverage rate is still low: Despite the government’s effort, some rare disease patients are still struggling to get access to treatment. Only about five percent of rare diseases have treatment developed. Diagnosis and treatment developments are far slower than other general medical conditions, because of small limited number of patients and prospective profit estimated low. And even if better treatments are developed, many of them are unapproved or non-reimbursed, leaving patients hopeless. Without guaranteed National Health Insurance (NHI) coverage on treatment, patients and their families would suffer not only from physical pain, but also with financial strain. More than 80 percent of rare diseases are inherited and patient’s family member show similar conditions. This vicious cycle leads medical expense in one single household to surge exponentially. However, the current Rare Disease Management Act does not specifically stipulate expansion of NHI coverage on rare disease treatments. Related industry claims Korea lacks a legal basis to back policy and regulation to boost pharmaceutical accessibility for rare disease patients catering unique qualities of the disease. Korea may have established a meaningful legislation of Rare Disease Management Act, but in fact, the law does not help many of struggling patients to get better access to drug to this date. Even at the National Assembly Annual Audit session, lawmakers urged the government to enhance NHI coverage on rare disease. Lawmaker Yoon Jong-pil of Liberty Korea Party spoke at Ministry of Health and Welfare audit session and pointed out, “Considering exceptionally limited number of patients and difficulty in developing effective treatment, rare disease treatment should be reviewed with more flexible criteria or they would not be accessible to patients in need”. .Drug pricing department of a multinational pharmaceutical company claimed, “An independent set of reimbursement review criteria should be designed for rare disease treatment as it is impossible to evaluate with common economic sense .And this is why special clause or supplementary article as a part of Rare Disease Management Act should stipulate expansion of coverage on rare disease treatment” .
- Policy
- Industry burdened but accepting of mandatory DSUR
- by Byun Kyung A Oct 31, 2019 09:59am
- Pharmaceutical industry initially complained of administrative strain when the government issued a notice on enforcing mandatory drug safety update report (DSUR)’, as advised by the National Assembly. But the industry also agrees with Korean government’s intention to enforce the pre-marketing regulation, which now has become a global trend. The pharmaceutical industry sees why the government would rather tighten the pre-marketing regulation than to cause actual corporate loss and public confusion over post-marketing recall and reimbursement and approval revocation. According to the lawmakers and pharmaceutical industry on October 27, Ministry of Food and Drug Safety (MFDS) plans to enforce mandatory submission of DSUR to strengthen clinical trial safety control. Currently, the Pharmaceutical Affairs Act does not stipulate mandatory DSUR submission. Along with post-marketing periodic safety update report (PSUR), DSUR has been an issue as a whistleblower from MFDS reported how “the ministry neglects its most basic job and does not even review submitted drug safety materials”. Criticism on MFDS neglecting drug review expertise grew intensely as drug quality and safety issues, such as ranitidine impurity incident and Invossa-K approval revocation, surfaced all at once. Accordingly, the lawmakers tackled the ministry on DSUR and PSUR management at the recent National Assembly Annual Audit. MFDS accepted the criticism and vowed to reinforce related regulation. MFDS official stated, “The ministry reviewed a total of 2,823 PSUR materials in last five years, and drug safety information reported from around the world were evaluated and reflected during the reexamination period”, and “mandatory DSUR would be enforced from 2020 based on the five-year National Health Insurance Comprehensive Plan announced last August”. Starting with new drug, MFDS is to phase in mandatory DSUR submission from next year considering pharmaceutical industry’s human resource, cost and other preparation procedure. Pharmaceutical industry showed mixed feelings of burden and need of the tightened regulation. Many also saw DSUR as unavoidable task the industry should take in as it is a pre-marketing regulation in clinical trial phase. “It is difficult to happily accept the new regulation as a company. DSUR submission, despite the phase-in introduction, would inevitably burden the industry with development cost and time,” but “we do agree the regulation is needed. Already many pharmaceutically advanced countries have enforced mandatory DSUR and it is now a global trend Korea cannot avoid,” a pharmaceutical administrative personnel from Korean pharmaceutical company commented. The Korean company associate also added, “Time would not be much of an issue, as it would be applied to new drug first, and give plenty of preparation time. The regulation aims to reinforce drug safety measures before commercialization, and not to be an excessive over-regulation. MFDS officials would probably convene a regulatory seminar for companies”. A multinational pharmaceutical company insider predicted DSUR would be less of a problem, as it regulates pre-marketing phase and not post-marketing. The multinational company associate said, “The authority has been trying to swiftly solve recent drug safety and approval revocation issues with strict regulation, retrospectively. Meanwhile, DSUR is a pre-marketing regulation that minimizes post-marketing measures but raises the bar for drug safety management. The actual strain on the industry would be relatively insignificant”.
- Policy
- Weighted pricing benefit abused as permanent price booster
- by Byun Kyung A Oct 31, 2019 09:58am
- The government evaluated the current weighted drug pricing system has been digressed as a permanent pricing benefit. Apparently, 96 percent of items have maintained the benefitted pricing for more than three years, and the authority sees that such practice has distanced itself from the initial objective to secure stable supply. Ministry of Health and Welfare (MOHW) submitted a statement answering the National Assembly Health and Welfare Committee Audit addressing the issue. Previously, Liberty Korea Party Lawmaker Kim Soon-Rye questioned the ministry about revising drug pricing system and strengthening competitiveness of Korean companies. In summer, MOHW presented revised 'Decision-making and Modification Standard for Drug Item' and unveiled weighted pricing system revision plan as a part of generic pricing system revision. The system was revised to set one year period of weighted pricing for synthetics and biopharmaceuticals, but provides maximum two years in case number of companies supplying the equivalent generics is less than three. The revision also established generic drug pricing standard and pricing for multi and single-use eye drops. On the revised weighted pricing system, MOHW explained “The initial objective of the system was to stabilize drug supply (weighted pricing for generics with less than three suppliers) and to induce soft landing for a generic entering the market where the original is lowering its price, from 100 percent to 70, and then to 50 percent.” “The revision was planned to keep the regulation faithful to its original objective maintaining stable drug distribution”, the ministry added. And the government emphasized its justification of drug pricing system revision as “244 out of 254 items, or 95 percent of the benefited items have been maintaining its increased price for more than three years, abusing the system as a permanent price boosting tool”. The ministry also ensured it would thoroughly review individual cases that need special support to stabilize drug supply. The statement added MOHW’s commitment to contribute strengthening Korean pharmaceutical company’s global competitiveness by executing the Biohealth Industry Innovation Strategy and Pharmaceutical Industry Fostering and Support Master Plan.
- Policy
- For reimbursed drug, efficacy and cost-efficiency come first
- by Byun Kyung A Oct 31, 2019 09:34am
- On the last day of the 20th National Assembly Annual Audit for the Health Insurance Review and Assessment Service (HIRA), half the questions were dedicated to pharmaceutical affairs. The lawmakers of the NA Health and Welfare Committee questioned HIRA about NHI reimbursement reevaluation on dementia treatment choline alfoscerate, reimbursement expansion on NOAC Xarelto, and reimbursement expansion on the anticancer treatment reflecting its frequent non-reimbursed off-label use as ophthalmic solution. Some lawmakers claimed the General Principle of Healthcare Reimbursement on liquid solutions, like syrup and suspensions, should be revised and expand utilization cap eligible for reimbursement. As always, however, HIRA had a strictly basic answer for the said topics and stated, “The issues addressed would be sufficiently reviewed when clinical efficacy and cost-efficiency are proven”. Below is Daily Pharm’s summary of HIRA’s written answer submitted to the NA on Oct. 28. ◆Reimbursement reevaluation on choline alfoscerate: The current system does not stipulate a reevaluation for NHI reimbursement based on clinical efficacy, except for special cases of Ministry of Food and Drug Safety (MFDS) revoking an approval. The government's National Health Insurance Comprehensive Plan is to establish a pharmaceutical reevaluation system considering clinical efficacy of listed drug, financial impact and healthcare coverage listing status in foreign countries. HIRA, then, plans to have Drug Post-evaluation Subcommittee under Drug Reimbursement Evaluation Committee (DREC) to conduct NHI reimbursement feasibility reevaluation with the new system. Particularly, HIRA official stressed uncertainty of choline alfoscerate “has been questioned constantly” and that the agency would “establish reevaluation system promptly for it”. The dementia treatment is usually sold as a health functional food in other countries. ◆Expanded reimbursement benefit on Xarelto: Medical industry urges the health authority to grant NHI benefit on new oral anticoagulant (NOAC) Xarelto (rivaroxaban) to high-risk patients with coronary artery disease (CAD), specifically for cases of atrial fibrillation (AF) before and after catheter ablation and electrical cardiodiversion, nonvalvular AF with hypertrophic cardiomyopathy, and nonvalvular AF with CHA₂DS₂-VASc score 1. At the moment, Brilinta (ticagrelor) and Xarelto are listed for reimbursement as antiplatelets, and the benefit for Xarelto only covers high-risk patients with nonvalvular AF. HIRA answered, “As medical academic society has requested expanding reimbursement benefit on Xarelto, the agency plans to promptly review additional clinical evidences, such as revised guideline in foreign countries”, and the treatment’s “reimbursement would be expanded depending on clinically proven efficacy”. ◆Revising General Principle for syrup and suspensions: The current General Principle on Healthcare Reimbursement Criteria and Method stipulates granting NHI reimbursement benefit on pharmaceutical syrup and suspensions, also available in types of table or capsule with equivalent ingredient, in following cases; prescribed to patients younger than 13; patients with old age, dementia or other dysfunctional esophagus unable to swallow; prescribed with antacid, sucralfate, and sodium alginate under approved indication. The National Assembly pointed out the General Principle regarding pharmaceutical liquid solution should be amended and provide healthcare benefit for all Koreans to consume drug more conveniently. But HIRA official explained, “Liquid solution tends to be more expensive than tablet or capsule drugs”, therefore, “the General Principle, on Oct. 1, 2011, stipulated providing benefit to subject drugs meeting cost-efficiency standard under certain medical state and patient condition”. Since 2011, some syrup and suspension with proven cost-efficiency have received reimbursement as an exception to the General Principle. HIRA official added, “The agency would accordingly review the need to amend general reimbursement criteria based on cost-efficiency standard”. ◆Listing Avastin for reimbursement: This year’s National Assembly Audit addressed promptly providing reimbursement for non-reimbursed off-label treatment approved to be used. The issue refers to the use of anticancer treatment Avastin in ophthalmology as a non-reimbursed off-label treatment for macular generation. After consulting with Ministry of Food and Drug Safety (MFDS), HIRA allowed request for use of non-reimbursed treatment at clinics without an institutional review board (IRB) by revising ‘Standard and Procedure of Requesting Usage Approval of Non-reimbursed Off-label Drug’ this month. HIRA stated it would consider providing healthcare reimbursement benefit in the future, when the legitimately used off-label drugs meet clinical efficacy and cost-efficiency standards. ◆Expanding RSA for follow-on drugs: As the RSA subject regulation for severe disease has been revised in last July, HIRA plans to positively review feasibility of expanding RSA subject for follow-on drugs after collecting public opinions. ◆Preventing illegal drug distribution: HIRA has decided to upgrade monitoring system to better manage all drug distribution information and to utilize the collected information properly through the serialization system. HIRA currently requires a serial number to be labeled on minimal drug distribution unit container for the health authority to track individual unit in all phase of distribution, from manufacturing to import, distribution, and consumption. In last May, HIRA cooperated with Seoul city community police to investigate illegal distribution of a weight-loss medicine Saxenda injection. ◆Drug pricing standard for the revised Generic Pricing Policy: The latest revision in the Generic Drug Pricing Policy stipulates drug pricing differentiated with compensation for cost, time and investment spent on generic development, and revised weighted pricing system. Nonetheless, the pricing standard for incrementally modified new drug is same as before. As the new weighted pricing policy could bring down prices of some incrementally modified drugs (IMD), HIRA plans to adequately amend the standard with Ministry of Health and Welfare. HIRA official said, “IMDs are mostly developed by Korean pharmaceutical companies, so drug pricing benefit without limitation on IMD could cause international trade discrepancy as unfairly favorable benefit for Korean companies only”, but “the agency would continue to talk to other related ministries and industry about other means to promote development of IMD with better clinical efficacy”. ◆Revising PE analysis review process: In Australia and Canada, a company is responsible for submitting pharmaco-economic analysis and a public agency is responsible for reviewing the submitted material. But in Korea, pharmaceutical companies have difficulties editing submitted PE analysis report. Lawmakers claimed Korea should adopt ‘Application Registration System’ to prevent such inconvenience. HIRA official answered, “it would be reviewed in detail, surveying overseas cases and current conditions in Korea”.
- Policy
- Jext, only distributed to KOEDC for profits
- by Lee, Jeong-Hwan
- The company that exclusively deals with one of urgent drugs, Jext used for allergic reaction Shock (Anaphylaxis) was criticized for distributing drugs only through KOEDC( Korea orphan & Essential Drug Centers ) for profit. Even though Jext was listed insurance registration last July and it is possible for the company to make direct distribution, The price between general reimbursement and KOEDC reimbursement has big difference. So, Jext distributed only to KOEDC. According to the patients and KOEDC on the 11th, Jext has been distributed and sold patients only through KOEDC since domestic reimbursement listed. It is in patients and KOEDC view that KOEDC reimbursement is much higher than general reimbursement, and it makes economic burden to patients. The company says it is not for profit at all. The headquarters regulates the distribution of general reimbursement items, so the company is inevitably unable to distribute the supply. In fact, KOEDC reimbursement price of Jext is ₩134,933 more than double the general reimbursement price is ₩56,670. The company distributes Jext only through KOEDC until insurance registration listed. But it is still on sale only through KOEDC, even though Jext got general reimbursement listed and can be distributed at clinics or retail pharmacies. The reimbursement price of KOEDC is calculated based on the import cost, whereas the general reimbursement price is meticulously formulated through registraion procedure of Health Insurance Review & Assessment Services. It is the majority opinion of reimbursement specialists that it is much more profitable to sell at KOEDC than to distribute Jext at the general imbursement. Furthermore, the distribution of Jext through KOEDC significantly reduces additional marketing and management tasks such as account management costs required for direct distribution. That's one of the reasons why the direct distribution is delayed. However, if the distributor don't handle the medicine reimbursement listed directly for 6 months, the regulatory action is removed. It even raises doubts that the company deliberately distributes Jext only to KOEDC. Regardless of the company's intentions, as a result, patients need to get Jext ony by paying more expensive money through KOEDC because thiere is no distribution volume, even though there is a way to purchase Jext at significantly lower reimbursement. KOEDC official said, the prodcut is not in shortage of distribution, but the the company distributes medicines only to KOEDC and dose not supply them directly. It's reluctant. In the end, patients have to go and buy through KOEDC with higher price for almost 6 months even after reimbursement listed, there has never been a company using this trick so far. The deliberate coordination disregards the purpose of establishing KOEDC and the policy of expanding access to ER medicines for patients. In response to such criticism, the company said that it is not a distribution control for profitability, and will start direct distribution as soon as possible. The company official said, It was true that Jext was distributed only to KOEDC after July when reimbursement listed, but it was not intended. It was a supply disruption at the headquarters in preparation for improved Korean insert, etc. The official added, "The company will import Jext products within this month and supply them directly from next January after our own quality inspection".
- Policy
- "Phase III trial exemptions for combi"
- by Lee, Tak-Sun
- The Drug Evaluation Department of the MFDS National Institute of Food and Drug Safety Evaluation held a session at its Osong headquarters on November 25, inviting press reporters to explain the medical product field tasks as part of 'The Top 50 Food and Drug Safety Tasks.' (Juhye Kang, Director General of the Drug Evaluation Department, gives remarks)The pharmaceutical industry is giving favorable review of the pharmaceutical regulatory reform that the Ministry of Food and Drug Safety (MFDS) has selected as its 50 major tasks.The task of stipulating exemptions from Phase III trials for disease-comorbidity combination drugs is attracting attention, with the MFDS expected to lead the world, as it has with biosimilars. There is also the view that clarifying document submission requirements for Over-the-Counter (OTC) drugs may enable greater imagination in new product development.Notably, an analysis suggests that this task is particularly significant, as it was developed by the pharmaceutical industry and the CHannel On RegUlatory Submission & Review (CHORUS).The Drug Evaluation Department of the MFDS National Institute of Food and Drug Safety Evaluation held a session at its Osong headquarters on November 25, inviting press reporters to explain the medical product field tasks as part of 'The Top 50 Food and Drug Safety Tasks.'Pharmaceutical officials who contributed to the task formulation were also present at this session. Juhye Kang, Director General of the Drug Evaluation Department, said, "We discovered tasks needed in the field while exchanging many opinions with the pharmaceutical industry on what is rational," and added, "Task discovery began from discussing 'Can we develop more diverse OTC products?' and 'Can we rationalize data submission for combination drugs, similar to biosimilars?'."First, the Ministry plans to revise the combination drug clinical trial guidelines within the year so that approval for hypertension·hyperlipidemia combination drugs is possible with only a Phase I clinical trial.Kim So-hee, Head of the Circulatory and Neurologic Drugs Department, stated, "In the situation where the development of hypertension-hyperlipidemia combination drugs exceeds 10 years, the MFDS analyzed Phase III data from 28 products involving approximately 5,000 subjects," and added, "As a result, the two components did not affect the therapeutic efficacy, and there were no safety concerns to worry about."Based on this result, the data scope is being rationalized so that approval for a hypertension-hyperlipidemia combination drug can be obtained with only Phase I clinical trials, rather than Phase III.Regarding this, Gil Chan-ho, Senior Managing Director of Sama Pharm, said, "The statement about exempting Phase III clinical trials for combination drugs for co-morbidities is not specified even in overseas guidelines," and added, "However, after reviewing it from various angles, we judged that it is scientifically and regulatorily valid."Gil continued, "When we began discussions in the Combination Drug Consultative Body, we thought the foundation for South Korea becoming a biosimilar powerhouse was the MFDS's global leadership in regulation," and applaued, saying, "Among combination drugs for co-morbidities, drugs where Phase III clinical trials are unnecessary can enter overseas markets faster through the relevant regulation, and we also believe this regulation is a major movement that overseas regulatory bodies can adopt."If Phase III clinical trials are exempted for hypertension-hyperlipidemia combination drugs, data protection benefits will not be granted. The explanation is that the pharmaceutical industry judged that, nonetheless, saving Phase III costs leads to a virtuous cycle of better product development.An industry official also added that combination drugs for co-morbidities were not designated initially as subjects for incrementally modified drugs, so this part was also considered."Broadening imagination for OTC product development with formulation changes"The part clarifying OTC drug data submission was prepared to revitalize the development of OTC products through formulation changes by providing the necessary data in the guidelines.For example, it specifies that comparative dissolution data may be omitted when changing a similar component, same-route-of-administration ointments to a gel.Regarding this, Sung-woo Jung, Team Leader at Genuone Sciences, applauded, saying, "This amendment provides the pharmaceutical industry with new ground that can bring change," and added, "The expansion of Standard Manufacturing Criteria is actually limited (for OTC product development), but (with this amendment) we can unleash the wave of new imagination."For example, it was difficult to prove equivalence during formulation changes because matching PH and concentration was challenging.However, the analysis is that the area of new product development will widen significantly if the guidelines exempt data for proving equivalence.The assessment is that the pharmaceutical industry analyzed the Japanese system and suggested these parts when the consultative body started in April. With the MFDS's acceptance, a technically infeasible area has been opened.The MFDS plans to expand patients' options for medicines by supporting product development through the implementation of these drug regulatory reforms, including revising the Regulations on marketing authorization·reporting·review of pharmaceuticals by the end of next year.
- Policy
- 'Platform wholesaler ban law' forum faces backlash over bias
- by Lee, Jeong-Hwan
- Rep. Hankyu Kim of the Democratic Party of Korea (center) hosted an emergency forum titled 'Asking the Venture Industry's Opinions on the Pharmaceutical Affairs Act Amendment' on December 16.Rep. Hankyu Kim of the Democratic Party of Korea received criticism from the healthcare and medical communities for openly opposing a bill that would prohibit platforms from also serving as pharmaceutical wholesalers. Rep. Kim opposed this bill, which passed the Health and Welfare Committee and theLegislation and Judiciary Committee with agreements reached by both parties, during an emergency National Assembly forum that he hosted.During the forum, Rep. Kim reportedly voiced strong opposition to the statement from a division head from the Ministry of Health and Welfare (MOHW), the primary department responsible for the proposed amendment to the Pharmaceutical Affairs Act. Some in the medical community expressed concern that the "host lawmaker appeared to be targeting the official by demanding an immediate change in stance or a revision to the legislative proposal". Objections have been raised that the forum was operated with a coercive manner, essentially ordering the ministry to draft an amendment in favor of platform industries and startups for a bill that is already awaiting a final plenary session vote.During the emergency forum on December 16, Rep. Kim stated, "Today’s seminar was co-hosted by 10 members of 'Unicorn Farm', but if the MOHW does not listen to the opinions [of startups and VCs], I will gather 20 members next time for a seminar. If that is still insufficient, I will gather 30 members for discussion."On December 17, representatives from the medical community and bipartisan officials from the National Assembly’s Health and Welfare Committee evaluated Rep. Kim's remarks as biased. They noted that holding a division head responsible for follow-up measures regarding a bipartisan agreement that has already cleared the Welfare and Judiciary committees is likely to draw criticisms of partiality.Medical industry insiders and committee officials argued that the operational direction of the forum, titled "Asking the Venture Industry's Opinion on the Doctor Now Prevention Act," could be perceived as an attempt to intimidate the MOHW administration, which is working to protect public health and the drug distribution ecosystem.Jun-Hyuk Kang, Director of the Pharmaceutical Policy Division at the MOHW, stated during the event, "The Pharmaceutical Affairs Act amendment is different from the 'Tada Ban Law.' The expression 'Doctor Now Prevention Act' is also incorrect, and it is not a law that hinders innovation." He explained, "If a platform operates a wholesaler, it cannot be free from the incentive to drive the prescription and dispensing of its own distributed medications. This law is designed to prevent such conflicts of interest."Kang's statement implied that the delay in passing the bill, which has stalled despite clearing committees, must be resolved to prevent telemedicine platforms from abusing the system for private profit.Immediately after Kang's statement, Rep. Kim continued with remarks that appeared to demand an immediate revision of the bill.Rep. Kim said, "Just because the MOHW says I shouldn't call it a 'Tada Ban Law' doesn't mean I can't. Because many people see it that way, I call it the second 'Tada Ban Law,' and I believe 'Doctor Now Prevention Act' is an accurate term." He added, "The MOHW seems to question why companies enter the platform wholesale business, but what business a company chooses to conduct should be a matter of corporate freedom."Rep. Kim continued, "It is unreasonable for the MOHW to judge whether something constitutes innovation. While the ministry wants to separate the dispensing and prescription of drugs from wholesaling, the correct legislative approach would be to regulate specific conduct, such as penalizing a wholesaler or platform that negatively influences a pharmacist’s prescription or forces generic substitution, rather than banning the wholesale business itself." He argued, "It is strange to insist on this amendment just to block a wholesaler that distributes 90 types of drugs, as Doctor Now does."Rep. Kim further challenged the official, saying, "I could offer a rebuttal to every single point the MOHW makes. I am questioning the procedural legitimacy. I believe the ministry should state its willingness to seek alternatives to the venture industry's opinions. What is most disappointing is that, based on the division head's words today, the MOHW seems to have no intention of changing its position or engaging in further discussion. Is it the official position of the department that no further discussion is possible?"As these remarks became public, the healthcare community questioned whether the emergency forum was intended solely to pressure the MOHW.A pharmaceutical industry official noted, "I heard that Rep. Kim openly pressured the ministry for a revision. Why demand a modification from the MOHW for a bill that secured bipartisan agreement and is awaiting a plenary vote? Remarks about gathering 20 or 30 lawmakers if the ministry doesn't comply sound like a threat."The official added, "The delay in the Pharmaceutical Affairs Act amendment is a matter that could shake the domestic healthcare system and the public health safety net," and added, "Dismissing doctors and pharmacists as focused on protecting their own turf, while framing platforms and startups as the 'weak' party to block the bill, is an act that ignores people’s right to health and life."The official said, "Despite numerous explanations for the legislation and reports of illegal platform activities during the pilot project, Rep. Kim’s insistence on protecting specific corporate interests through a distorted frame is difficult to understand," and concluded, "This attempt to modify the bill will only increase the burden on the Democratic Party, the government, and the President."
- Policy
- 식약처 "신약·바이오시밀러 허가기간 240일로 단축"(K)
- by Lee, Tak-Sun
- [데일리팜=이탁순 기자] 식품의약품안전처가 허가심사 기간을 내년 하반기부터 240일로 단축하겠다고 밝혔다.현재 평균 허가심사 기간은 신약이 420일, 바이오시밀러 406일, 신의료기기가 398일이다. 이를 240일로 대폭 줄이겠다는 것으로, 세계 최단 수준이다.오유경 식약처장은 16일 대통령 업무보고에서 "심층 예비검토와 항목별 병렬심사, 전담 심사팀, 허가 단계별 대면상담 등 허가심사를 혁신하겠다"고 설명했다.또한 의약품 허가·심사 효율화를 위해 AI 활용 제출자료 요약·번역, 검토서 초안 작성 등이 가능한 'AI 허가·심사지원 시스템' 구축할 계획이다. 내년부터는 전문번역과 동등 의약품을 검토하고, 2027년부터는 개량신약을 검토하고, 2028년부터는 신약 등에 AI를 투입하겠다는 목표다.허가심사 인력 207명도 내년 투입된다. 여기에 경력단계별 역량관리와 최신기술 전문교육으로 심사자 전문성을 강화한다는 방침이다.식약처는 또한 규제 합리화 방안으로 바이오시밀러 허가자료 중 3상 임상결과 제출 요건을 내년 하반기부터 완화할 계획이다.알약, 캡슐 형태 일반식품 중 의약품과 건강기능식품으로 오인될 우려가 큰 제품은 생산을 제한하기로 했다.예를 들어 멜라토닌, 글루타치온 등이 함유되고, 섭취방법이 의약품과 유사한 제품은 생산을 제한한다는 것이다.또한 일반 식품에 위고비 등 처방의약품 명칭·성분명 등과 유사한 표시·광고는 금지하고, 정제·캡슐 식품은 소비자 오인 방지 표시를 추가할 계획이다.희귀·난치 질환자 치료제 안정공급 기반도 확대한다. 희귀·난치 질환자 치료에 필요한 의료제품의 정부 직접 공급을 지속 확대하고, 관련 법적 근거를 마련하기로 했다.특히, 약가 부여 전에 대형 글로벌 제약사가 고가 희귀의약품을 환자에게 무상 제공해 치료권을 보장하는 인도적 치원 제도화도 내년 추진할 계획이다.필수 의료제품 공급 확대를 위해서 정부-단체-제약사 간 '공공 생산·유통 네트워크'를 본격 운영해 필수의약품 위탁생산 기간 단축 및 생산 규모 확대를 추진해, 2030년까지 긴급도입 필수의약품 총 40개의 25%까지 공공 위탁생산으로 단계적으로 전환할 계획이다.
