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- 2026-07-22 11:58:23
- Opinion
- [Reporter’s View] Verify the oral COVID-19 treatments
- by Lee, Tak-Sun Nov 10, 2021 05:55am
- Following COVID-19 vaccines, oral COVID-19 treatments are also expected to enter the market soon as the government plans to phase in 404,000 courses of COVID-19 oral antivirals from next February. If oral treatments for COVID-19 are introduced, Korea will have laid the groundwork for managing the COVID-19 virus like influenza. Also, clinical results for COVID-19 treatment candidates are being announced one after another. MSD's 'molnupiravir' was found to reduce the risk of hospitalization and death by 50% if taken within 5 days of symptom onset. Pfizer also released clinical results showing that ‘Paxlovid’ reduces the risk of hospitalization and death by 89% if taken within 3 days of symptom onset, and by 85% if taken within 5 days of symptom onset. The movement to introduce the drugs has also been speeding up abroad. On the 4th, the UK became the world’s first country to approve molnupiravir. The US FDA also plans to review the use of molnupiravir at the end of this month. The treatment is also set to be introduced in Korea from February through an advance purchase agreement. The faster the treatments are introduced the better, considering how late we were in introducing and commercializing vaccines compared to other countries at the end of last year. With legislation such as the Emergency Use Authorization established for the prompt introduction of such treatments, we will need to thoroughly prepare so that the oral antivirals developed abroad can promptly be imported for use in Korea. In addition to such prompt introduction, we would also need to pay close attention to and verify the oral treatments in advance so that the drugs may be safely used in Korean patients. This is a task for the Ministry of Food and Drug Safety. As the government announced that it will introduce COVId-19 treatments in February, the MFDS does not have much time for review. Therefore, MFDS would need to independently conduct its review and thoroughly verify the safety of the treatment in the limited time provided rather than rely on news of approvals from agencies abroad to reassure the public. In other words, now is the time for the government to take initiative. The government should proactively search for and persuade pharmaceutical companies to promptly introduce their COVID-19 treatments to Korea even if they have no plan to introduce the drugs to Korea yet. The reality is that Korea will have to depend on COVID-19 treatments developed overseas, just like the case was for the vaccines. Rather than focus on the commercialization of domestic COVID-19 treatments, the government should fully mobilize its administrative power to promptly introduce new COVID-19 treatments developed overseas.
- Opinion
- [Reporter’s View] New drugs for Alzheimer’s in development
- by Nov 05, 2021 05:24am
- "I felt like it was all a dream. But I wasn't sure if I was young dreaming that I’m older, or I was old dreaming that I was younger. I have Alzheimer's." This is what Hye-Ja Kim, acting as a dementia patient in the “The Light in Your Eyes” TV drama two years ago, said as she revealed her condition to her friends. The drama gained much acclaim with the twist that the story depicted the world from an Alzheimer’s patient's view rather than being a common ‘time leap (time travel)’ story. The most common cause of dementia among the 840,000 dementia patients over the age of 65 in Korea is Alzheimer’s. The exact pathogenesis or cause of Alzheimer’s remains unknown, but it is being presumed that the condition is caused by Beta-amyloid and tau deposition. One of the reasons why Alzheimer’s was feared was because no drug could fundamentally treat the disease, and only drugs used to improve cognitive function were available. Countless global pharmaceutical companies had attempted to develop treatments to no avail. With no treatment available, prevention was considered as the only option for Alzheimer’s. However, the field has entered a new turning point this year with Biogen introducing a new treatment for Alzheimer's. Biogen's 'aducanumab (product name: Aduhelm),' was approved by the US Food and Drug Administration, and Eli Lilly is also preparing for the approval and review of its ‘donanemab.' When approved, two new treatment options will suddenly be available in the 'impregnable' field of Alzheimer's disease. Of course, many issues remain to be addressed despite the introduction of these new drugs. Both Biogen and Lilly’s new drugs target beta-amyloid plaques and reduce beta-amyloid to improve Alzheimer’s symptoms such as cognitive function, etc. However, the issue is that it is unclear whether beta-amyloid is the determining cause of Alzheimer’s. Recent studies have shown that the tau protein may be the main cause of Alzheimer’s, which raises mixed opinions on what needs to be targeted to treat Alzheimer’s. Also, the two new drugs will need to be further verified. The FDA had granted breakthrough therapy designation to both drugs and accelerated approval for aducanumab in consideration of the lack of treatment for Alzheimer's. Donanemab is also expected to go through the same accelerated approval process soon. Drugs that are approved with the accelerated approval system can receive faster approval than through traditional review processes but needs to demonstrate their clinical benefit through a confirmatory trial. Otherwise, their approval is revoked. In particular, Biogen’s aducanumab needs to justify its approval through further clinical trials as its two Phase III trials showed mixed results. On the positive side, the introduction of these new drugs has changed public perception. Alzheimer’s is no longer considered unconquerable. Pharmaceutical companies in Korea and abroad are eagerly racing to be the first to develop more and better drugs for Alzheimer's. Just earlier last year, the COVID-19 outbreak brought fear to the whole world. However, with the introduction of COVID-19 vaccines and the introduction of COVID-19 treatments soon to be expected, COVID-19 has now entered the realm of being 'manageable.' This is why countries are now gaining the courage to attempt to live ‘With COVID-19’ even if more than 2,000 patients are confirmed every day. Awaiting the second new Alzheimer’s drug to come, I have faith that Alzheimer's will soon become manageable, as with COVID-19 and the many other crises that we managed to overcome.
- Opinion
- [Desk's view] It should also prepare for "With Corona"
- by Chon, Seung-Hyun Oct 25, 2021 05:50am
- The government has announced that it will shift the COVID-19 quarantine system to a "step-by-step daily recovery" (with COVID-19) centered on the management of the number of critically ill patients or deaths. As the proportion of COVID-19 vaccination completion exceeds 70%, a relaxed quarantine system such as lifting restrictions on operating hours for multi-use facilities such as restaurants and cafes is expected to be implemented. The pharmaceutical industry is also gradually moving to prepare for "With Corona." Along with the COVID-19 pandemic, the number of people working at home seems to be reduced and the number of people working at the company is increasing. Some companies terminate the flexible working system implemented to avoid overlapping working hours of executives and employees as much as possible. In fact, the pharmaceutical industry has changed a lot in the COVID-19 situation that has been going on for more than a year and a half. The drug prescription market has changed significantly. Markets such as antibiotics and Jinhae girders have shrunk significantly as the number of flu and cold patients has plummeted due to strengthened personal hygiene management to prevent COVID-19. As the COVID-19 vaccination expanded, the pain reliever "Tylenol" jumped to the top in general drug sales. The market landscape has also changed as companies that have benefited from COVID-19 have emerged one after another. SK Bioscience's performance jumped sharply due to the consignment production of the COVID-19 vaccine. Samsung Biologics' performance has soared due to consignment production of COVID-19 antibody treatments, and it is also preparing to produce a Moder or COVID-19 vaccine. Diagnostic kit companies have exceeded 1 trillion won in sales. Pharmaceutical companies' R&D capabilities were also focused on conquering COVID-19. Many pharmaceutical bio companies have rushed to develop COVID-19 vaccines and treatments. Celltrion, which was focusing on biosimilars, developed its own COVID-19 treatment "Regkirona." On the other hand, in general, domestic companies' R&D performance has been lower in technology exports than before COVID-19. The spread of COVID-19 has reduced direct exchanges with global companies and focused on non-face-to-face promotion, so they have not been able to actively win technology exports. Even if the government gradually eases the quarantine system, it will not return to its daily life before COVID-19 in a short period of time, but pharmaceutical companies should gradually prepare for "With COVID-19." If R&D capabilities are actively appealed at large domestic and international academic conferences in the future, it is expected that technology exports, which have been stagnant, will also become active. The development of COVID-19 treatments and vaccines also requires strategies. It is necessary to reflect on whether the R&D efforts to conquer COVID-19 were simply a trick to boost stock prices. Many people in the pharmaceutical industry were also hurt by COVID-19. However, we hope that the COVID-19 crisis will serve as an opportunity for our pharmaceutical industry to become more mature.
- Opinion
- [Reporter's view] Disclosure of the results of the Committee
- by Eo, Yun-Ho Oct 25, 2021 05:49am
- The results of the Cancer Drugs Benefit Appraisal Committee were released from the 13th. The HIRA has accepted complaints continuously filed in the pharmaceutical industry. Some point out that they are not satisfied yet, but it can be said that it is encouraging in itself because the HIRA expressed its intention to deliver the exact reason for the success at the request of the company. In the pharmaceutical industry, discussions on expanding insurance benefits for new drugs have been focused on the Cancer Drugs Benefit Appraisal Committee along with the COVID-19 incident.The Cancer Drugs Benefit Appraisal Committee, which was discussing the clinical usefulness of drugs, began examining the financial burden last year. Since then, as more and more drugs are pending in the pharmaceutical industry due to the Cancer Drugs Benefit Appraisal Committee, even companies have submitted economic evaluation data to the subcommittee. Of course, there may have been many pharmaceutical companies that were greedy last year, and there may have been many drugs that were not clinically useful. So the industry's argument was focused on transparency. This was not a necessary procedure only for the pharmaceutical industry. This is because knowing which drugs have been judged to be unsuitable for what reason, greedy pharmaceutical companies can be criticized and make efforts to find a compromise. Of course, the disclosure of the details of the discussion is 'not yet', but the transparency of the committee has risen to the first level. Beyond the pharmaceutical industry, the healthcare industry is facing a new era. Patients, or their families, now search for surgical papers and search for new drug information in the clinical trial database clinic at clinicaltrial.gov. If domestic licensed drugs do not receive insurance benefits, complaints will pour out to the relevant ministries, the HIRA and the MOHW. The anger of patients and their families looking at "the medicine that exists but cannot be taken" is indescribable. The urgency that cannot be estimated unless it is a party, the level of knowledge of the people who have risen, and the administrative power resulting from the development of the Internet are amazing. Transparency in the process of listing or expanding insurance benefits for new drugs will gradually increase in the future. Both the government and pharmaceutical companies should now fear social views that include desperation. The disclosure of the results of the Cancer Drugs Benefit Appraisal Committee is welcome for now.
- Opinion
- [Reporter's view] A manual has been established
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- The recovery of hypertension treatments containing excess impurity Sartans is significant in that it has established a new manual for drug recovery. All items were banned and recovered, making it difficult for manufacturing, sellers, and medical institutions to do additional work due to collection. However, since only excess Sartan items have been recovered this time, the loss of pharmaceutical companies is expected to be minimized, and the inconvenience caused by the recovery of medical institutions such as pharmacies is expected to be reduced. All of these measures were not perfect. In particular, the MFDS explained that the risk of impurity-containing drugs is low, but that patients with health concerns can be exchanged for normal products. In order for consumers to exchange them for normal products, pharmacies must exchange medicines to open pt's medicine packet. The question was who should pay the additional fees and additional work costs incurred by this. The government wants pharmaceutical companies to pay health insurance premiums, saying it is difficult to pay. Pharmacies are also not willing to volunteer for free. In this situation, the MFDS mediated to discuss settlement issues between pharmaceutical companies and pharmacists. The consultation was satisfactory. Two pharmaceutical companies have agreed to pay 110% of the existing formulation, which has become a guideline for other pharmaceutical companies. As the recovery has been delayed for more than a week, there is no separate suspension of sales, so the response is too late. Another problem is that it is not easy for consumers to put it into practice. Since this recovery only applies to the product number in question, consumers need to know the product name and manufacturing number to request an exchange. However, most patients often do not know the name. It is not easy for many elderly people to know this through the internet. Most patients do not know about this recovery. Therefore, it is necessary to establish a system so that minimal information can be delivered, even if it is difficult to actively communicate the recall to consumers, as in the case of automobile recall. With this voluntary recovery, the government should create a manual and take measures to enable consumers to actually recover so that they do not suffer damage.
- Opinion
- Clear standards needed for direct purchase of drugs overseas
- by Kim JiEun Sep 08, 2021 06:06am
- The world’s leading online e-commerce platform Amazon joined forces with one of the top e-commerce companies in Korea to set foot into the Korean market. The entry of this global direct purchasing giant into Korea had raised industry concerns that it would increase the illegal direct purchase of pharmaceuticals overseas and void the government’s efforts to eradicate the expanding market for such items. Aware of such concerns, 11street had prepared a separate guide on ‘precautions for direct purchase of drugs and health functional foods overseas’ to its Amazon store website and blocked the transaction of pharmaceuticals and health functional foods that contain ingredients that are not permitted in Korea. While answering that they feel partially reassured by such measures, pharmacists stressed that a more fundamental standard and measures are necessary to regulate online transactions of pharmaceuticals at a time when the direct purchase of goods overseas is being established as a culture in the midst of the rise of the e-commerce. The Pharmaceutical Affairs Act in Korea completely prohibits the sale of pharmaceuticals online. However, the Customs Act recognizes overseas transactions of pharmaceuticals as legal to a limited extent, leading to a conflict between the two Acts. In addition, the standards for overseas transactions stipulated in the Customs Act are obscure. The law stipulates that up to 3 months' worth or 6 bottles of OTCs that do not contain specific products or ingredients may be brought into the country for self-use, which leaves much room for interpretation. Some pharmaceuticals contain 100 tablets or even 1,000 tablets per bottle. The ‘Pharmacists’ Community for Future Pharmacy’ pointed out that the customs regulations mentioned above are unclear and meaningless, as a consumer may abuse the regulation and purchase up to 6,000 tablets at most to bring into the country. The illegal direct purchase of pharmaceuticals overseas had been carried out openly in many e-commerce open markets in Korea. Leading e-commerce platforms in Korea have allowed transactions of pharmaceuticals through direct purchase from overseas, including many unauthorized drugs as well as prescription drugs that should not be traded between individuals. Times have changed. E-commerce has taken over the offline retail market, and the market for direct purchases from overseas is also growing at a rapid pace. With the growth, the direct purchase of illegal pharmaceuticals has also increased explosively. This is why the government can no longer hold back revising the related laws while weighing the different perspectives held by the ministries.
- Opinion
- [Reporter’s View]Reimbursement of antidiabetic combos
- by Eo, Yun-Ho Aug 27, 2021 05:59am
- After 3 long years, discussions on extending reimbursement of SGLT-2 inhibitor combos are expected to begin. In September, the Health Insurance Review and Assessment Service will hold an expert meeting to discuss approving reimbursement for combination use of the two classes of oral antidiabetics: DPP-4 inhibitors and SGLT-2inhibitors. ‘Recognizing the expected efficacy of two drugs with the same MOA.’ Acknowledging this class effect has been a long-discussed dilemma in the industry. The opinion has been divided among the HCPs, and the interest of individual pharmaceutical companies also differ. The conclusion was to take on the agenda ‘case by case.’ It is not necessarily a question that requires a fixed answer. The decision made by the prescribing doctor based on his or her experience and medical knowledge is, of course, most important. However, for the SGLT-2 inhibitor issue, the problem lay in the consistency of the decisions. For some classes, the class effect was recognized regardless of the drug’s indications and applied the same reimbursement standards, while reimbursement for other classes was approved for different scopes by each product. In 2013, the Korean Diabetes Association had played a leading role in extending reimbursement to cover the combined use of DPP-4 inhibitors and Thiazolidinedione (TZD) class drugs, insisting on the justification and necessity of its reimbursement. Clinical experience and expert judgment were emphasized rather than the fiscal impact, and the government accepted the reimbursement extension based on the disease characteristics and drug use experience. What has changed since then? In 2018, the academic community had mixed opinions regarding SGLT-2 inhibitors, which put discussions on reimbursing the combined use of the drug on hold. Many drugs were at stake, as this not only affected SGLT-2 inhibitors like ‘Jardiance(empagliflozin),’ ‘Forxiga(empagliflozin),’ ‘Suglat (ipragliflozin), ‘Steglatro (ertugliflozin),’ but also the many DPP-4 inhibitors including ‘Januvia (sitagliptin), ‘Galvus (vildagliptin),’ ‘Tradjenta (linagliptin),’ ‘Gemiglo(gemigliptin),’ etc. However, the changes that followed were encouraging. In April last year, the academic society saw consensus and submitted the opinion that expanding reimbursement is necessary. In August last year, the Ministry of Health and Welfare announced that it will simplify the indication listing method of antidiabetic drugs from by substance to ▲monotherapy or ▲combination therapy. Now the baton is in the hands of the insurance authorities. Time has already passed, and dissatisfaction still does exist around primary medical institutions. As it is a prescription drug, it is also true that the issue should be considered carefully, and a cautious approach is needed. However, if the class effect is to be finally acknowledged, this could be the perfect opportunity for the stakeholders to reach a consensus on ‘the time or amount of prescription required to accumulate sufficient prescription experience.’
- Opinion
- [Reporter's view] Controversy over α-GPC
- by Lee, Hye-Kyung Aug 25, 2021 05:57am
- Negotiations on the return of benefits of the 'Choline alfoscerate' legislation, which was the subject of the revaluation project of the listed drugs, have been concluded. However, the controversy over the return rate has not ended. The NHIS negotiated with 58 pharmaceutical companies that owned 123 Choline alfoscerate on August 10. It announced that it has agreed with 44 pharmaceutical companies on a 20% return rate. Chong Kun Dang, which had been conducting PVA in the third quarter of this year, also finished negotiations. There are about 10 pharmaceutical companies that have not agreed. Negotiations on the repatriation of Choline alfoscerate lasted about eight months from December 14 to August 10. In the process, the timing of recovery was changed from "the day of submission of a clinical trial to the MFDS" to "the day when the MFDS approved the clinical trial," and the amount of recovery also fell from "full 100%" to "20%." The controversy erupted when three pharmaceutical companies that had already signed a 100% return rate in PVA negotiations before the benefit revaluation Choline alfoscerate filed complaints with the Anti-Corruption and Civil Rights Commission for equity reasons. Negotiation about Choline alfoscerate is the first conditional recovery negotiation in conjunction with the MFDS' clinical reassessment. However, all the NHIS negotiations in accordance with the safety and validity verification and quality control requirements have a redemption clause related to revaluation. This is a revised guideline after the 2019 Lipiodol crisis. In the second quarter of last year's PVA negotiations, Arlico, Hana and Kyongbo agreed that if the authorization for revaluation is dropped, the pharmaceutical company should return the full claim from the date of clinical testing to the NHIS. Anti‑Corruption and Civil Rights Commission has conveyed to health authorities that the NHIS and the three pharmaceutical companies should maintain a contract following a clinical trial revaluation, but set a 100% return rate equal to 20%. Anti‑Corruption and Civil Rights Commission's recommendations are not compulsory. However, it is unlikely to raise the rate again, as the rate of return of Choline alfoscerate, which is undergoing simultaneous re-evaluation and clinical re-evaluation, has been agreed to 20% with an eight-month negotiation process. The NHIS should set out what guidelines to maintain in future drug price negotiations in accordance with AAnti‑Corruption and Civil Rights Commission's recommendations. Through revaluation, it is necessary to clarify whether there is a possibility of maintaining the existing "health insurance claim in full" or changing it to 20% agreed with pharmaceutical companies.
- Opinion
- [Reporter's view] Unstable supply of imported vaccines
- by Lee, Tak-Sun Aug 13, 2021 05:58am
- Moderna's unstable supply and demand disrupted the vaccination. Moderna's vaccine was originally scheduled to come in 8.5 million doz in August, but Moderna informed that it would supply less than half of the vaccine due to laboratory problems related to production. As a result, not only Moderna but also the first and second vaccinations of the same mRNA vaccine, Pfizer vaccine, will temporarily increase inoculation interval from four weeks to six weeks. The quarantine authorities, which are preparing for the final vaccination in their 40s or younger due to the sudden supply disruption notice by Moderna, are also in trouble. However, since Pfizer vaccine is being supplied properly, it is expected that there will be no change in the primary vaccination plan for 70% of the nation until September. However, it is not known when the second vaccination will proceed normally because the supply and demand of modalities or vaccines will be resolved.. AstraZeneca vaccine is produced at SK Bioscience' Andong plant by several million doz at a time. It is much more stable in terms of supply and demand than Pfizer and Moderna vaccine, which are imported by airplanes below 1 million doz per week. The quarantine authorities used the amount of AZ vaccine contracted because the number of people aged 60 to 75 exceeded 10 million. However, since all of them are imported vaccines except for AZ, we should have prepared for possible supply accidents. It is the quarantine authorities that have not used the AZ vaccine well. In February, when AZ vaccine was first approved, the MFDS allowed the elderly to be vaccinated despite a lack of clinical data, but quarantine authorities failed to ensure administration of the age of 65. Since then, data has been accumulated abroad such as the UK, allowing vaccinations for older people aged 65 or older, but the government has decided to vaccinate the elderly aged 75 or older. In April, people under the age of 30 were excluded from the inoculation list due to rare thrombosis, and in July, people under the age of 50 were not allowed to be inoculated. As a result, those under the age of 50 who took the first AZ vaccine before July will be cross-inoculated with Pfizer vaccine during the second round. Such inoculation policies are largely responsible for the unstable public opinion and quarantine authorities created by the media. Of course, there are some reflections that reflect cases from other countries such as advanced countries, but it is questionable whether the conclusion was made based on public opinion rather than science. Although AZ vaccine played a role in preventing infectious diseases among the elderly, the quarantine authorities should reflect on the fact that it is recognized as the next-order mRNA vaccine due to negative public opinion. Also, for those aged 50 and 75 and older who can use AZ vaccine, it was changed to Moderna and Pfizer respectively, which prevented the use of AZ vaccine produced in Korea. If AZ had been used for these age groups according to the inoculation criteria, it would have dealt with both modalities and supply and demand instability. Quarantine authorities should think about the utilization of AZ vaccine. Although there are no vaccines developed in Korea yet, it is fortunate that there are vaccines produced in Korea. If the supply of imported vaccines such as Moderna is uncertain, it should take advantage of the fact that AZ domestic vaccine is being secured.
- Opinion
- [FOCUS] Why retrieve the insurance paid for CA?
- by Chon, Seung-Hyun Aug 09, 2021 06:04am
- The tug-of-war between the health authorities and pharmaceutical companies over the negotiation on the restitution of insurance claims paid for the brain function enhancer choline alfoscerate (cholinergic agents) has been now ongoing for 8 months. In December of last year, the Ministry of Health and Welfare (MOHW) ordered the National Health Insurance Service (NHIS) to negotiate with choline alfoscerate companies by February 10th of this year to agree on 'returning the full amount of insurance that was claimed for the drug, from the date the clinical trial protocol was submitted to the Ministry of Food and Drug Safety to the date the indication is removed if the clinical trial fails' to retrieve the claims paid for the drug. 8 months had passed since the order was issued, and 6 months had passed from the first deadline that was set for negotiations. However, the only change made to the terms of the negotiation was that the period of insurance retrieval had been pushed back from the 'date the clinical trial protocol was submitted to the 'date the protocol was approved,' and the breakdown of negotiations and deadline extensions have repeated continuously. Some companies have agreed to the 20% retrieval rate proposed by the NHIS. In other words, these companies will be paying back to the NHIS 20% of the amount that was prescribed from the date the clinical trial protocol was approved by MFDS to the date the indication is deleted if their clinical reevaluations for their choline alfoscerate products fail. However, many other pharmaceutical companies, including those that are earning much from choline alfoscerate products, have not been able to reach an agreement with the NHIS even in the several additional negotiation periods that were provided. Even the 20% rate was considered to be too great a risk for these companies. The clinical reevaluations will be completed in 6.5 years at the latest. If companies agree on the 20% rate, and the trial fails after 6.5 years, each company may have to pay out more than 100 billion won each. Due to this burden, many companies are trying to reach an agreement by proposing a lower recollection rate. Some companies are also considering discounting their drug prices in advance while requesting a recollection rate that is lower than 20%. Their opinion is that it may be more efficient to share the risk early on rather than paying out a large sum at once if the clinical trial fails. However, the biggest reason why the negotiations are being indefinitely extended is that there is no justification for the negotiation itself. There had never been a case where the companies had to agree to a restitution rate of the prescribed amount, presuming that the clinical trial would fail even before the trial has begun. There also has been no social consensus made on whether it is reasonable to demand restitution for the failure of a clinical trial that was conducted for reevaluation purposes, for a product that had already been approved and was distributed according to due processes. Clinical reevaluations are conducted to reexamine the safety and efficacy of drugs that are on the market. Selling the drugs that are under clinical reevaluations during the trial period is not illegal because the approval granted by the MFDS stays valid. The MFDS approved the renewal of the product license for choline alfoscerate drugs in 2018. In other words, the authorities in charge of approving drugs acknowledged the safety and efficacy of choline alfoscerate drugs just 3 years ago. Therefore, the legal dispute over whether the attempt to retrieve the claimed insurance benefits is reasonable if the clinical reevaluations fail is deemed inevitable. The health authorities had never once asked the companies to pay back the prescribed amount of a drug that failed reevaluations. The health authorities are also now at a dead-end in this never-ending tug-of-war. With some companies already reaching an agreement with the authorities, the authorities have no choice but to impose sanctions on the pharmaceutical companies that refuses to negotiate and take measures such as removing the company's drugs from the reimbursement list. However, pharmaceutical companies will naturally take legal action if their drug is removed from the reimbursement list. The negotiations on choline alfoscerate products have deepened the confusion across the pharmaceutical industry. One question that lingers is: did the health authorities not expect such fierce resistance when they began negotiations? Did they really not expect the pharmaceutical companies to take legal actions in every direction, filing suits to nullify the negotiation, suspend execution, as well as file constitutional and administrative appeals? Even the period of retrieval that had been modified recently was changed inevitably due to unexpected variables. Choline alfoscerate is approved under 3 indications: to treat ▲ secondary symptoms and degeneration due to cerebrovascular defect or degenerative organic brain syndrome ▲ emotional and behavioral changes ▲ senile pseudo-depression. Of these, only ‘secondary symptoms and degeneration due to cerebrovascular defect or degenerative organic brain syndrome’ is subject to reevaluation, and the remaining two indications will be removed regardless of the clinical trials' success or failure. If the time of retrieval is set to 'the date the clinical trial protocol was approved', pharmaceutical companies will have to pay back insurance for the two indications that had been removed before the clinical reevaluations had begun. This indicates that the retrieval period has not been through from the start. If pharmaceutical companies have to pay back several years' worth of prescriptions due to the failure of their clinical trials, patients could also demand repayment for the drugs that they have taken during those years. The government may also be criticized for allowing the sale of such a problematic drug. A clear explanation seems to be necessary as to why the government is causing more harm than good by pushing ahead with the negotiations for recollection of insurance benefits.
