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- 2026-04-30 19:05:36
- Opinion
- [Reporter's view] Reform of the innovative system
- by Lee, Jeong-Hwan Sep 19, 2022 05:56am
- Will the "innovative pharmaceutical company certification system," which has been operating unchanged for 10 years since its introduction in 2012, be able to pave the way for reform through the disclosure of the reorganization plan? The Ministry of Health and Welfare announced plans to announce the reform of the innovative pharmaceutical company certification system at the end of the year. It is a relatively large reorganization plan, including subdivision of certification types and customized support measures, and attention is being paid to whether it can be a turning point to remove the stigma of the certification system that is low in effectiveness. Strengthening support for innovative pharmaceutical companies has been an agenda that has been needed for years. The pharmaceutical industry demanded that actual drug treatment or tax support for innovative pharmaceutical companies should be greater to encourage innovative pharmaceutical companies to develop new drugs and encourage non-selected companies to select new drugs, but the government has not been able to provide enough budget or come up with innovative drug measures due to trade friction. The Ministry of Health and Welfare continued to make efforts to improve the certification system for innovative pharmaceutical companies to resolve such criticism, and the reorganization plan, which will be unveiled at the end of the year, will be the first result to determine whether it will improve. First of all, the reorganization plan is expected to discriminate against the actual support method as the certification screening criteria for each size and type of pharmaceutical companies are different. As the customized support plan for innovative pharmaceutical companies has been discussed several times, such contents are expected to be included in the reorganization plan to be unveiled at the end of the year. More important than improving the framework and extension of the certification system is the government's reinforcement of support for innovative pharmaceutical companies, which is the purpose of operating the certification system. If designated as an innovative pharmaceutical company, the government should provide benefits such as preferential drug prices, tax support, and R&D support, but the pharmaceutical industry has long complained that it is difficult to expect sufficient benefits. Innovative pharmaceutical companies are given symbolic titles, but they do not have significant benefits that directly benefit from the development of new drugs. Among the companies selected by innovative pharmaceutical companies, there is also a pessimistic response that they will not be hit much even if the certification is canceled because they do not enjoy any practical benefits. The National Assembly also urges the government to strengthen support for innovative pharmaceutical companies every year. It is pointed out that the overall fostering of the domestic pharmaceutical industry can be achieved only when both the quantity and quality of support measures for innovative pharmaceutical companies are improved. The Ministry of Health and Welfare, which is set to unveil the certification system, also agreed with the criticism that the budget and policy support in line with the reorganization plan should follow, so we hope that the reform will be repeated starting with the reorganization plan.
- Opinion
- [Reporter’s View] Evrysdi awaits reimb review for over 1 yr
- by Eo, Yun-Ho Sep 16, 2022 05:53am
- One year has passed since the company applied for insurance reimbursement but to no avail. No progress has been made on the matter, not even the frequent news of the agenda being rejected by the Drug Reimbursement Evaluation Committee has been heard on the matter. Although the reimbursement application for the spinal muscular atrophy (SMA) treatment ‘Evrysdi (risdiplam)’ had been submitted in July last year after its approval in November 2020, the agenda has not been listed for deliberation on any of the lists disclosed by the Health Insurance Review and Assessment Service. There is a deadline for each stage of HIRA’s reimbursement assessment. The current overall reimbursement review period is 150 days, and the government had announced a systemic reform to reduce the period to 120 days. However, this period is often not kept. This is why the industry was not so enthusiastic about the reform plan. In the case of Evrysdi, its review period had already exceeded 150 days earlier this year, as the company had once failed to pass the Drug Reimbursement Standard Subcommittee and reapplied for reimbursement after supplementing data. On this, the Solidarity Against Disability Discrimination issued a statement last month when Zolgensma started being reimbursed, asking HIRA to abolish the reimbursement discontinuation standards set for another SMA treatment, ‘Spinraza (nusinersen),’ and the prompt reimbursement discussion to be made for Evrysdi. SADD had pointed out that SMA patients are being left unattended in the blind spot because HIRA is postponing discussions on Evrysdi just to discuss it in line with the adjustment made for Spinraza’s reimbursement criteria. So Evrysdi, which has applied for and is awaiting review, is still waiting in line after a year without even a single discussion made for its reimbursement and remains a ‘pie in the sky' for the patients. The importance of providing a clear explanation of an administrative decision is essential in the process of handling administrative affairs. This becomes all the more important when an exception arises in the application of a system, which raises more questions than an introduction or abolition of a system. However, the government has never provided an explanation on drugs that were extended their drug pricing negotiation period after passing the set deadlines. And more and more drugs receiving reviews for reimbursement listing or standard extensions or are being left without news. In the current “high-priced drug era,” plenty of very effective but expensive drugs are being introduced to the market. Therefore, it can be difficult for the government and the pharmaceutical company to reach an agreement within the set ’60-day’ period. In particular, the area of SMA treatments had been an ongoing issue due to their high price. However still, the emphasis needs to be laid on the word, deadline. Deadline is a promise. Also, the NHIS has described the negotiation deadline as a sort of "benefit" when announcing its plan to shorten the deadline for new drugs. In other words, the period is set for the final negotiation period to speed up listing and allow others to estimate the time to listing or rejection. Also, the people need to know why the negotiation fell through so that they could criticize the faulty party and find a compromise.
- Opinion
- [Reporter's view] PVA market should be actively reflected
- by Lee, Tak-Sun Sep 13, 2022 05:51am
- The pharmaceutical industry is in accordance with PVA didn't like being drug price cut. Excessive government intervention in the law according to the principle of supply and demand markets. Other goods has increased the use of demand than supply shortages, needs to be raised prices. But people pay health insurance run to fund health insurance system for the integrity of the principles that are not in arms. The COVID cold medicines such as drug case is a typical example of the increased trend in use. In an emergency due to infectious disease, without reflecting the system would drugs is lowered to in the pharmaceutical industry is concerned. But, but not the government through the correction amount of disadvantage companies contained in the target group cut drug price just worried. Sudden reflex to stop sales profit is a drug containing impurities need medication to take a closer look at the situation. The drugs increased by the use of existing drugs often cheaper than the sales suspension is true, but rather believed to have to reduce the drug price. Whenever these situations unfold, the pharmaceutical industry suggests the Ministry of Health and Welfare or the NHIS to exclude PVA. Each time, the government fully collects opinions from the pharmaceutical industry, but does not reflect all of the industry's claims by citing the purpose or principles of PVA. Some vendors in the end product price to appeal the cut is an injustice to happen happens. The NHIS is currently conducting research services for PVA improvement plans. That are currently fixed up to 10% will raise new standards will increase direct deposits. Most of them are intended to seek expansion and operation of the system for fiscal reduction. But the system of acceptability of the participants to build a broader view of the principles and detailed criteria with the situation and the environment should be reflected in the same time is also necessary. As such, detailed proposals such as national emergency situations caused by infectious diseases and increased use of drugs with reduced finances compared to alternative drugs should not be made to prevent unfair cases. If the system is operated as it is now, consumers will discuss the effectiveness of drug reduction, and on the contrary, suppliers will only highlight unreasonable aspects. We hope that PVA will come up with a more elaborately designed improvement plan.
- Opinion
- [Reporter’s View] Novartis's restructuring path similar
- by Eo, Yun-Ho Aug 31, 2022 05:40am
- Mergers, split-off, purchases, and sales... Global biopharmaceutical companies are busy making transformations to their respective businesses. Among the various transformations being made, the spin-offs and sales of the multinational pharmaceutical companies’ divisions have received particular attention over the past few years. Although such transformations are made under the premise of adopting a "selection and concentration" strategy, the spin-offs and sales draw out various positive and negative responses from society. One thing to note is that this phenomenon is being serially observed in various Novartis, one of the leading Big Pharmas, is currently integrating and spinning off its business at the same time. The company had integrated its Oncology and Pharmaceuticals business units that had been virtually operated like separate entities and announced its decision to separate its generics and biosimilars division, Sandoz. Although Novartis's spin-off of Sandoz was not unexpected, the integration of its other business units may have seemed less usual at first. However, the goal of the company - in conducting the spinoff and merger – has always remained the same. Like the other companies, Novartis is making corporate transformations to “separate innovation with legacy” in its business. Although being in the same company, Novartis’s Pharmaceuticals and Oncology Business Units had been on quite different paths. Its Pharmaceutical Unit focused on sales of relatively low-cost drugs for chronic diseases such as diabetes and respiratory diseases, whereas the Oncology Unit focused on premium-priced oncology drugs like Gleevec. However, at some point, the Pharmaceutical Unit started deviating from its usual path. Including ‘Zolgensma,’ high-priced premium drugs have now become flagship products in non-cancer areas as well. This is why the company decided to integrate the units into one combined unit - Innovative Medicines. Did the company’s separation from Sandoz also affect the company’s internal integration? Of course. With the integration, Novartis is also preparing to create a business unit dedicated to off-patent drugs. Corporate spin-offs cause separation in corporate size and profit structure. In other words, the company is seeking rebirth by dividing its business by concept, into an investment-oriented unit and a legacy unit. Such spin-offs do not impose a financial burden on companies because no claims for stock purchases are made in the process. Since it becomes a legally independent company after the split, the separate company may immediately be listed on the stock market upon spin-off. Most multinational companies conduct split-offs prior to such measures, which then would serve as a stepping stone for improving financial soundness and support sales of companies. For example, Pfizer established three business units (BUs), including its Upjohn Business Unit (BU) that was dedicated to its legacy brands, before initiating the separation of Viatris. Afterward, news of its merger with Mylan had been reported in line with the spin-off. In this sense, Novartis’s separation of Sandoz and integration of its business units are consistent with the steps that had been taken by other multinational companies in the past.
- Opinion
- [Reporter's view] Reflecting opinions on cold medicine
- by Lee, Hye-Kyung Aug 31, 2022 05:39am
- The Ministry of Food and Drug Safety has been monitoring the supply and demand of cold medicines since March. The targets for monitoring are NSAIDs and Expectorants such as complex cold medicines, Acetaminophen, Ibuprofen, Dexibuprofen, Loxoprofen, and Erdosteine. When pharmaceutical companies computer-report the production (import), sales, and inventory of products to the Drug Safety Country's Weekly Production and Import Status Report system, they have identified cold drugs in circulation and encouraged them to produce insufficient or unproduced items. However, there was a big difference between the results of monitoring the supply and demand status and the distribution of cold medicines felt at the front-line pharmacy site. The Ministry of Food and Drug Safety said that if there are items that are producing and distributing even a little, they are not "out of stock." It is an opinion that pharmacies cannot have inventory of cold medicines with certain ingredients. In the end, officials from the Ministry of Food and Drug Safety said they wanted to resolve the supply and demand of cold medicines only with monitoring results, and the Ministry of Food and Drug Safety established a quick response system for cold medicines using a small-packed drug supply guide system. The Korean Pharmaceutical Association selects 10 items of cold medicines requested by pharmacies and reports them to the Ministry of Food and Drug Safety every week, and when the Ministry of Food and Drug Safety groups the items requested and provides them to the Pharmaceutical Association, the pharmaceutical company enters the system. Although the cold medicine supply and demand monitoring and rapid response system are operating at the same time, the front-line pharmacies still complain that supply and demand are disrupted even if they check inventory in the system and ask wholesalers to supply supplies. The Ministry of Food and Drug Safety is also asking for cooperation from individual pharmaceutical companies and wholesalers in connection with pharmaceutical and distribution associations and distributed prescriptions for cold medicine ingredients that are smooth in supply and demand, but they have no significant effect. The operation of such a system has not caused the cold medicine to be sold out, which occurred during the re-proliferation of COVID-19 earlier this year. It is necessary to solve practical problems about the fact that the supply of cold medicines for specific ingredient preparation is not smooth, and pharmacists who have to prepare prescribed Rx are burdened with difficulties. Just as the public mask system was introduced during the mask crisis, the government plans to establish a public supply management system to actively prevent cold medicine from being sold out in the future. It is commendable that the Ministry of Food and Drug Safety has been continuously checking the distribution status by monitoring the supply and demand status since March in the wake of the cold medicine sold out earlier this year. However, if they respond only with statistics entered into the system, they will have no choice but to file complaints at the front-line sites. In the future, we look forward to actively preparing countermeasures to prevent the second cold medicine from being sold out by steadily reflecting the opinions of the site.
- Opinion
- [Reporter’s View] Unresolved insulin cold chain issue
- by Aug 24, 2022 05:56am
- With no clear alternative found for insulin distribution in Korea, on how to set the regulations for cold chain transport of insulin remains unresolved and beleaguered. Unlike other biological agents that are mainly prescribed in hospitals, insulin is often dispensed at outside pharmacies. And the lives of patients with Type 1 diabetes, who cannot produce insulin in their own bodies, may be threatened if this insulin is not readily available. However, on the pharmaceutical distribution companies’ part, insulin is a ‘white elephant.’ Although it is not a favored item on the companies' part due to its low distribution fee, it is an essential item when considering the companies' business relationship with patients and customers. For this reason, distributors refer to insulin as "a drug that is being distributed as a service item with little or no distribution margin." In other words, although the companies are currently distributing insulin, there is no reason or benefit for the company to distribute it at a loss. When the transport regulations for vaccines were revised earlier last year, and then extended application to all biological products, the government did not consider the difficulty and complexity the revised regulations would bring to insulin distribution. The fact that insulin would be included as biologics may not have even crossed their minds during the revision process. There Ministry of Food and Drug Safety had newly enacted guidelines thereafter to reflect the voices of the industry after receiving countless complaints from the distribution companies but to no avail. Although the newly enacted guidelines showed some progress, such as allowing insulin to be contained in various transport containers and not taking issue with temperature fluctuations during delivery to pharmacies as long as the company can verify the validity of the cold chain process. However, even these changes were not worth the excessively increased workload and cost required to maintain the thorough cold chain requested by the government. In fact, as of July 17th, when the revised regulation was implemented, instability in insulin supply and demand arose at distribution sites. Also, with orders piling up due to fears of stock shortages, this instability in supply and demand continued to deepen. The reduced number of insulin deliveries and extended terms between deliveries to pharmacies further heightened the anxiety of the patients. And due to railing opposition from diabetes patient groups, the MFDS granted an additional 6-month guidance period specifically for insulin distributions. However, anxiety continues to sweep through the industry with the sentiment that this problem cannot be resolved without further consideration of the fundamentals of the revision itself. Officials from distribution companies jointly voiced that “the guidance period is virtually meaningless.” With no distribution, an increased amount of insulin stock would be useless. Also, with the government holding a close eye over the issue, insulin may be better distributed in the short term during the guidance period, but it is clear that the same problem would return as soon as the eye moves away. In other words, there is no other viable option without the additional review of the revised regulations. However, how the revisions should be re-revised remains a further issue, and concerns deepen due to lack of reasonable grounds required for additional revisions of regulations. It is not easy to make further revisions because the regulations were not made after collecting sufficient data and identifying realistic situations in the first place. The government is continuing discussions with the industry, patient organizations, and relevant organizations, and the proposal for holding a public hearing is only now being discussed. It is odd that a public hearing, which should have been conducted before the revision was finalized, is only being discussed now, 8 months after the enforcement of the regulation. It is understandable how frustrated the patients would feel about the unresolvable insulin distribution issue.
- Opinion
- [Reporter's view] Legalization of Non-face-to-face Care
- by Lee, Jeong-Hwan Aug 18, 2022 05:48am
- Non-face-to-face treatment has become a social topic beyond the health and medical community. Non-face-to-face treatment, which has been temporarily allowed since February 2020, has been on the rise for three years, and the public and domestic medical systems, which are users, have naturally become accustomed to non-face-to-face treatment. Non-face-to-face treatment, which has become a hot topic, is now beyond temporary permission and the need for legislation is emerging. This is because the current medical law and pharmaceutical law principles are shaking due to excessive expediency and some illegal acts of non-face-to-face treatment platform companies derived from temporary permission. The Ministry of Health and Welfare recently reiterated its willingness to institutionalize non-face-to-face treatment to the National Assembly's Health and Welfare Committee and submitted a position to strongly control illegal attempts by delivery pharmacies or non-face-to-face treatment platform companies. The Ministry of Health and Welfare plans to start legislating within the year based on the non-face-to-face treatment bill pending in the National Assembly, and believes that the current face-to-face treatment alone cannot solve the problem of access to medical services such as islands and wallpaper. One more thing is needed to strengthen the legislation of non-face-to-face care. It is an interest in non-face-to-face treatment of the power of the ruling people. Currently, two cases (Choi Hye-young, Kang Byeongwon) have been proposed in the main opposition Democratic Party of Korea alone, including the legislation of non-face-to-face treatment. Shin Hyun-young, the main opposition Democratic Party, also announced plans to propose additional non-face-to-face treatment bills. In the power of the people, the non-face-to-face treatment bill has not yet been proposed. The Ministry of Health and Welfare and the Democratic Party are waiting for the ruling party's representative to propose a bill to strengthen the legislation of non-face-to-face care, but no lawmaker is reportedly interested in the bill yet. Non-face-to-face treatment should start discussions on legislation to strengthen the management of platform companies and the current medical law and pharmacology law principles at the same time as the need to stipulate the system itself as a law. At a time when the number of users of non-face-to-face treatment and non-face-to-face treatment services is exploding, there may be many side effects that need not be experienced if related regulations are established too late. Starting with the representative presentation of the non-face-to-face treatment bill, the ruling party should make efforts to improve legislative completeness by widely accepting the needs of the Ministry of Health and Welfare, the medical community, the Pharmaceutical Association, and the platform companies. It is a way to improve the stability of the health care industry and to prevent the principles of medical law and pharmacology law from being disturbed. It is expected that the ruling party will make an agile move to prevent platform companies from making mistakes in shaking the domestic health care system by neglecting non-face-to-face treatment with some expedient and illegal methods.
- Opinion
- [Reporter’s View] Industry sullen over revised PE exemption
- by Eo, Yun-Ho Aug 17, 2022 05:52am
- The pharmaceutical industry is sullen despite the government's announcement of a measure to expand drug coverage, as the so-called measures for expanded coverage are closer to reductions from the industry’s point of view. The main issue lies in the improvement of the pharmacoeconomic evaluation (PE) exemption system that was included in the “Measure to improve patient access and reinforce reimbursement management for high-priced severe disease treatments” that was recently presented by the government. The goal of the improvement is to expand coverage for the pediatric patients. The government added a clause allowing PE exemption for "drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee." The added clause excluded the “life-threatening disease” condition required for PE exemptions in pediatric patients. In other words, if drugs used for pediatric patients satisfy the remaining conditions, the PE exemption may be applied even if the condition is not life-threatening. On the surface, it seems like an encouraging improvement. Many multinational pharmaceutical companies and the Korean Research-based Pharmaceutical Industry Association have been requesting the ‘life-threatening’ condition be removed from the eligibility criteria for PE exemptions. In this sense, this exclusion, although limited to pediatric patients, is a valuable step forward. However, a major premise for PE exemptions had also been revised. The government had added the phrase “a small number of eligible patients ” in the revision. This condition had previously been an “OR clause" included in Article 2c of eligibility for PE exemption regulations, along with other clauses such as ‘if a single-arm study was conducted,’ etc. In other words, if the amendment is applied in the current state, all drugs that wish to take the PE exemption track would have to have a small number of patients (as defined as 200 in the current criteria) and receive recognition from the committee for its difficulty in producing evidence to satisfy Article 2c of the regulation. Multinational pharmaceutical companies have been criticizing that this has narrowed the pathway for PE exemptions rather than expanding it. In fact, the KRPIA had issued a statement immediately after the government announced the revision, criticizing that the amended measure “overlooks the fact that it can demotivate companies from developing innovative new drugs and impede access to severe rare disease treatments.” Although such industry complaints are common following government policy announcements, considering the fact that the new government promised prompt listing of anticancer and rare disease drugs upon inauguration, and the non-reimbursed blind spots still exist for drugs that apply for special exemptions, the government needs to consider whether this revision is achieving its original purpose.
- Opinion
- [Reporter’s View] MFDS opens up, discloses contact info
- by Lee, Hye-Kyung Aug 16, 2022 05:46am
- The Ministry of Food and Drug Safety is changing. The ministry's efforts to transform into an ‘Open MFDS’ as emphasized by Minister Yu-Kyoung Oh since her day of appointment on May 27th, is showing results. After holding 7 ‘ultimate debate’ sessions in June this year, the MFDS also held 16 roundtable meetings and discussion sessions with the industry, associations, and academia, as well as 2 separate public debates for the medical and food sector to prepare '100 tasks for regulatory innovation.' Based on the feedback accrued, the MFDS announced the final 100 tasks for regulatory innovation on the 11th. The Korea Chamber of Commerce and Industry and the Korea National Council Consumer Organization attended the announcement, signifying the deep public-private communication that had been made in its process. A bigger change is that the contact information for each department in the organizational chart on the MFDS’s webpage that had been hidden since February 22nd last year was disclosed again. At the time, the MFDS deleted the contact information of the officials in charge, deciding that regular business was difficult due to the flood of inquiries and complaints made by the general public regarding COVID-19 vaccines and treatments. Complaints followed this deletion of contact information, but the MFDS only repeated its response that it has prepared a main representative number system for inquiries to resolve the difficulty of making contacts arising from the absence of officials in charge and to increase focus on the ministry's review work. Therefore, the inconvenience caused by the lack of communication was entirely borne by the complainant. The introduction of the ‘core time system’ to allow officials to focus on their regular work, had further caused hardships in reaching MFDS officials. However, the contact information for each department in the organizational chart on the MFDS’s webpage has been disclosed since the 8th. Although the core time system will still be in place, the MFDS decided to reduce its period from the previous 7 hours (10:00 a.m.-5:00 p.m.) to 4 hours (11:00 a.m.-3:00 p.m.). On the day of her appointment, Minister Oh said, “The MFDS needs to become a science and technology expert, crisis management expert, and public communications expert. Communications between ministries, departments, and various stakeholders, as well as internal inter-field and inter-function communication, must be encouraged for growth. I will create an open MFDS in which employees can actively communicate, and one that encourages public-private communication and cooperation." Minister Oh had constantly emphasized communication during her official appearances. She said she will listen to various opinions in the process of preparing and implementing the 100 tasks for regulatory innovation. In 100 days after her appointment, Oh’s determination for communication is coming to fruition in various ways. The reporter hopes that the MFDS’s efforts for ‘open communication’ continue.
- Opinion
- [Reporter’s View] Seek industry opinion before implemention
- by Lee, Tak-Sun Aug 12, 2022 05:58am
- Although the government announced measures to reinforce patient access to high-priced severe disease treatments on the 20th of last month, the pharmaceutical industry’s response to the new measures has been lukewarm at best. Moreover, the industry is ferociously criticizing how the government presented the measure without collecting industry opinion. The main point of implementing the new measure was to reduce the reimbursement period while reinforcing post-marketing management, however, the industry is claiming that the measure will have little effect in reducing the reimbursement period while focusing too much on drug price reduction, ultimately further impeding patient access. The government plans to reduce the reimbursement review period of treatments for life-threatening conditions by 60 days through the concurrent operation of reimbursement evaluation and pricing negotiations, among other measures. On this, the Korean Research-based Pharmaceutical Industry criticized, “Reducing 60 days from a review period that already takes up to 3 to 4 times the actual statutory period (210 days) will be insignificant from the patient’s perspective in feeling any improved access. The industry added, that preparing a pharmacoeconomic evaluation exemption regulation for treatments with a small number of patients and improving the maximum discount rate of the Price-Volume Agreement system from the current 10% will only lower motivation for new drug development or reimbursement. The problem is that the government did not seek the pharmaceutical industry’s opinion before announcing the measure. KRPIA also expressed concern regarding this matter, saying that “It is a shame that the government, which had been emphasizing private-public cooperation, disclosed a major policy that may affect the whole field without conferring it with the biopharmaceutical industry.” Since early last year, the government and pharmaceutical associations have been meeting every month through a private-public consultative body established to improve the drug pricing system. However, the measure for improving access to high-priced drugs that had been announced was found to have never been discussed at the meetings. It is difficult to properly implement or promote a policy that is unilaterally announced without collecting the opinions of its users and suppliers. The ‘Lowering the elementary school entry age to 5 years’ policy that was recently withdrawn due to opposition from the education community, was also aborted due to this non-collection of opinions from the education community. Why the Ministry of Health and Welfare, which lacks a head, made such a hasty decision to announce an important policy without collecting opinions from the industry remains in question. If the government respects the pharmaceutical industry as its future driver of growth, it should not exclude the industry in the process of making such serious policies.
