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- 2025-12-20 03:55:04
- Opinion
- [Reporter’s view] Did they act honorably?
- by Kim, Jin-Gu Mar 06, 2020 06:05am
- Companies willing to develop COVID-19 treatment (or vaccines). Recently, press releases of this kind have increased in the reporter's mailbox. With the spread of the COVID-19 crisis, many pharmaceutical companies are jumping into the development of drugs or vaccines. But some do not seem pure intentions. It is obviously expected to float stocks. For example, Company A is developing a new drug that suppresses Cytokines, claiming it could be used to treat COVID-19. In addition, it added that it applied for an emergency clinical trial plan with the Ministry of Food and Drug Safety. Company B, which is developing a new antiviral drug, has announced that it has applied for approval for therapeutic use by the MFDS to administer a candidate substance that has not yet completed phase I clinical trials to COVID-19 confirmed patients. Company C that develops the TB vaccine is also working on developing a COVID-19 vaccine. The company will develop a universal COVID-19 vaccine that is not related to virus mutations with its immune booster technology. For other bioventures, the content of the press release is much the same. The three words are 'COVID-19', 'therapeutics' and 'development'. The rest is only convincing. Words such as 'IND' or 'NDA' are effectively not found anywhere else. It's hard to find out more about research and development. It does not explain how much work has been done on the treatment or vaccine and how effective the study has been. That's the reason for doubting the intention of some bioventures. There is no way to know if they have the capacity to develop COVID-19 medications or vaccines and how you are preparing for development. It's just a company's claim and a one-sided possibility. Most press releases are documented in a form close to 'copy & paste'. Posted on major Internet portals, the stock market reacts immediately. The media and the stock market have long established a symbiotic relationship. All three companies in the previous case have benefited significantly. Some stocks have hit the ceiling. I have a feeling of déjà vu. Let's go back to the 2015 MERS outbreak and as far back as the 2003 SARS outbreak. As it is, the corona virus was the cause. At that time, many companies announced that they would start developing drugs and vaccines. Of course, the stock price went up as a bonus. However, no one has ever succeeded in developing a cure or vaccine. I wonder how many companies that have declared their development have continued their research and development so far. Recently in China, a company called BrightGene Bio-Medical Technology lied about COVID-19 remedies and bought embarrassment. The company has said it has successfully mass-produced 'Remdesivir', which is expected to be a potential COVID-19 drug. Related stocks surged. It is said to have increased by nearly 60% over a month. The Shanghai SE came out. It was countered that it failed to obtain Remdesivir's manufacturing approval from Chinese pharmaceutical authorities. Not only did it lack qualifications, the Shanghai SE also made it clear that it was not capable of mass production. After all, BrightGene's share price plummeted 20% in one day. It is said that it has been steadily falling since then. Of course, I believe that not all pharmaceuticals that are involved in the development of COVID-19 medications have distributed the press release with a bad way as BrightGene. Certainly, there are companies that have been quietly working on COVID-19 treatments in difficult circumstances. Justice will assert itself. As time goes by and the COVID-19 outbreak is settled, Corporate conscience will be revealed. The headwinds at that time must be handled by the companies themselves. The media also needs to be self-reflection. Keep in mind that an uncritical paste article without fact check can be damaging to someone.
- Opinion
- [Reporter’s View] Irony in group-listing competing drugs
- by Eo, Yun-Ho Mar 03, 2020 06:10am
- Inducing competition between pharmaceutical companies could lessen the financial exhaustion, but National Health Insurance (NHI) reimbursement listing procedure would get delayed. Such is an irony we witness during high-cost new drug listing or reimbursement expansion procedures in Korea. The government could take an advantage of price competition between companies as drugs are expensive. Under the NHI system, savings could open up more opportunities. And more savings could affect coverage enhancement. But the issue is timing. It would be preferable to review reimbursement for all same-class drugs at once, but it is hardly feasible. Typically ranging from six months to over a year, the gap in timing of reimbursement listing application could be vastly dispersed. Regardless of the actual date of application submission and other delaying factors, the timing gap is crucial, because there are patients desperately waiting it. And the issue worsens usually with anticancer therapies. The government wishes to review drugs with significant financial impact all together, such as a CDK4/ 6 targeted therapy applying for reimbursement as a combination therapy with PD-1 or PD-L1 inhibiting immunotherapy Faslodex. It is obvious and somewhat understandable. A medication, a part of combination therapy, could fail to get listed for reimbursement and a pharmaceutical company could have been unenthusiastic about the government-proposed ‘trade-off (a policy to have the negotiating pharmaceutical company to lower pricing of off-patent drug and to compensate it with coverage on new drug).’ What has passed is past, and now is different. At least the tug of war between the government and companies should start properly. Whether it be Cancer Deliberation Committee or drug pricing negotiation, the government should be respectful and at least get ready to go. Pharmaceutical companies, who have applied first, are biting their nails as follow-on drugs competent to compete are emerging. COVID-19 is surely an urgent matter, but how could we let down cancer patients? Because there is no answer, a line should be drawn instead. We cannot wait for those sluggish drugs. Rather, the same-class group reimbursement listing review should rule out those latecomers.
- Opinion
- [Reporter’s View] Fake news deadlier than novel virus
- by An, Kyung-Jin Mar 02, 2020 06:21am
- “Don’t talk to anyone! Don’t touch anything!” These were the catchphrases printed on marketing poster of a movie Contagion, released in September 2011. Starring beloved Hollywood stars like Gwyneth Paltrow and Kate Winslet, the movie focused on an unknown infectious disease creating a global crisis. A woman, who came back from a business trip to Hong Kong, abruptly experiences seizure and dies. Soon after, people who had been in contact with the woman show similar symptoms and die, unfolding dramatic conflicts and chaos. Presumable by the poster’s catchphrase, the infectious disease portrayed in the movie spreads through people by touch. People get infected by handing a credit card back and forth, holding a bus handle, and taking away an empty plate from a restaurant table. In the film, all researchers of World Health Organization (WHO) and the U.S. Centers for Disease Control (CDC) come together to identify the pathogen. The feature film ends with somewhat cliché ending with intelligent scientists on a mission track down the patient zero and research antiviral agent that successfully develops into a vaccine. Nevertheless, the movie has been a hot issue again within social media channels due to the recent outbreak of COVID-19. The plot of the movie resembles a number of actual happenings during the COVID-19 outbreak. The investigated disease source found from animals like bat or pig, people losing mind from the news of severe symptoms reported all over the globe, and of course, the government taking an extreme action to shut down a whole city to stop the fast-spreading disease—the movie almost spoiled the recent outbreak. Despite unknown infectious disease itself, what drives people into extreme fear is fake information and conspiracy. The film realistically illustrates people surrounded by apprehension and insecurity as a freelance journalist publishes blog postings of untested folk remedy and claims of conspiracy among the public agencies. Maybe, the makers of the film wanted to tell the audience the lost trust and relationship between people could endanger the people more than the disease. The nine-year-old movie is getting highlighted again as the portrayed scenes overlap with the actual events taking place in Korea at the moment. Seemingly easing out at first, COVID-19 outbreak has been spreading rapidly since the 31st confirmed case. Centering Daegu and surrounding North Gyeongbuk Province, the number of confirmed cases has soared exponentially. Now the region is filled with fear and desolation. Discriminating terms like ‘Daegu Corona’ or ‘Wuhan of Korea’ are gushing out every day and fake news on confirmed patient’s travel route is spreading through Youtube, KakaoTalk, and online communities in a speed of light. Apparently, there has been a reported case of phishing regarding a confirmed patient. And the public outraged over an attention-seeking Youtuber that screamed “I’m from Wuhan. Get away from me” on a subway, who pretended to be an infected patient. The highly advanced information technology and dependency on social media seem to have worsened the spread of fake news than five years ago with MERS. WHO has recently warned, “Infodemic has reached a severe level,” and started seeking for countermeasure with global IT giants like Facebook, Google and Amazon. ‘Infodemic,’ or short for ‘information pandemic,’ means a chaos caused by inaccurate information and harmful rumor spreading swiftly through mass media and the Internet. Korean government also has declared, an individual disseminating inaccurate information would be charged with strict sanctions. Rumors are more contagious than the novel coronavirus. Sending out fake information without a hint of guilt could paralyze an entire local business, cause delay in disinfection process or even forever scar an innocent individual. To step away from such infodemic, everyone in the community should help out. Amid chaos, people need to close their ears on fake news and know better to block off inaccurate information spreading. Of course, the news media should also remind themselves that their mission is to deliver accurate information, and not focusing on shocking breaking news.
- Opinion
- [Reporter’s view] Regional infection of COVID-19 has spread
- by Lee, Hye-Kyung Feb 25, 2020 06:10am
- On the 18th, the HIRA turned upside down when news of the first positive COVID-19 patient occurred in Daegu. It was reported that a family of the HIRA’s Daegu branch staff members worked in Daegu Saeronan Hospital, where patient #31 suspected of being a ‘super spreader’ of the spread of community infection in COVID-19, was working. The HIRA, which runs the COVID-19 Countermeasures Team, immediately grasped the facts. Fortunately, the employee's family was not classified as a contact person with patient#31. However, starting with patient#31, as of 9:00AM on the 23rd, The number of COVID-19 confirmed patients increased to 556, with 4 deaths. In particular, at the Shincheonji Church of Jesus, which had been visited by patient#31, in a situation where mass infected patients occur, it is known that Gangwon-do members who visited Daegu Church from January 29 to February 16 included Wonju citizens The atmosphere in Wonju, Gangwon-do, where the HIRA and the NHIS are located, has became strange. From the morning of the 20th, concerns about spreading of COVID-19 in Wonju and false information ran rampant. I also received false information text mixed with several regards to COVID-19. Among them, the staff of Wonju headquarters of the HIRA is waiting for the test result as suspected COVID-19'. As a result, employee A, who visited Daegu to attend the wedding ceremony of the HIRA’s employee on the 15th, was diagnosed and screened at the clinic for self-isolation. The employee had a fever from two weeks before his visit to Daegu, but after his wedding visit (but not the Queen Vell Hotel visited by patient#31), his symptoms worsened. He received two medical examinations at a medical clinic in Wonju innovative city and was examined at a screening clinic by doctor’s recommendation. The COVID-19 countermeasures team of the auditor evaluation was aware of the fact on the 20th, and took not only the employee but also all the employees who had close contact with the employee from February 15th to 20th home. In the process, the COVID-19 suspicious symptoms were made public, and in the process of spreading this information, various false information appeared. The government raised its alert level for COVID-19 to the highest level as the number of confirmed patients with COVID-19 has increased rapidly. The severity level is the highest level of wealth and is triggered when foreign infectious diseases introduced in Korea spread to the community or spread nationwide. False information and indiscriminate fears are one of the things to watch out for in a national disaster. It is also important for the government to come up with strong countermeasures against unproven information or fake news, but citizens must also take care not to engage in or mislead in disseminating false information. COVID-19 has no vaccine or cure at ths time. If you develop fever or respiratory symptoms (cough, sore throat, etc.), you should contact the KCDC call center (1339) or the Public Health Center. If you want to see a doctor for suspected symptoms, you should first visit your local screening clinic (check the KCDC or the MOHW). For now, don't forget that personal hygiene, masking, and compliance with infection prevention rules are the best ways to stop the spread of COVID-19 nationwide.
- Opinion
- [Column] Regulations hindering healthcare IT development
- by Jung, Hye-Jin Feb 24, 2020 06:27am
- Dr. Ji Young Ho People say ‘data is petroleum of the future.’ ‘Big Data’ is the key resource and product of data economics and digital economics, but also is a key factor deciding the state competitiveness. With the recently passed Three Data Bills, anonymous information system has been adopted and obfuscated data incorporation between companies or public institutes via security specialist agency have been stipulated. While the anticipation on increasing number of high value-added businesses created from data value chain model (generate, collect, analyze, apply), the table would turn for the government’s D-N-A (Data, Network and AI)-focused sectors and emerging industries like, system semiconductor, biohealth, and future car. ◆"Three Big Data Economics Bills legislated, importance of healthcare big data emphasized" The Three Big Data Economics Bills mean three bills stipulating data utilization by revising ‘Personal Information Protection Act,’ ‘Act on Promotion of Information and Communications Network Utilization and Information Protection, etc. (Information and Communication Network Act),’ and ‘Credit Information Use and Protection Act (Credit Information Act).’ The three laws have different government ministries and agencies in charge, so the bills were introduced to remove overlapping regulation and expand scope of information utilization for private and corporate use to accommodate the Fourth Industrial Revolution era. Korea has Mandatory Electronic Record Archiving System that requires all medical record, including patient’s personal information, medical history, hospitalizations record, to be databased digitally. Therefore, vast amount of health insurance database, medical check-up database and hospital medical information are already available. However, the vast amount of medical data were not allowed to be utilized, and even surveying and analyzing personal medical data for research purpose was heavily regulated by Personal Information Protection Act. As a result, using personal medical information for healthcare management was impossible. Ministry of Health and Welfare’s (MOHW) healthcare big data platform has been established in September 2019. And the ministry plans to use the platform to obfuscate medical data like disease prevalence, prescription, insurance reimbursement claim, and patient data collected from respective healthcare institutes by removing names and making them unidentifiable. ◆ The rise of My Data to change pharmaceutical industry paradigm People use credit cards to pay for snacks and a cup of coffee at a convenient store. As soon as the card slides down the machine, their purchasing data is transferred to the credit card company and used to analyze consumers’ purchasing tendency. And the company giving back the personal data collected to individuals is called ‘My Data.’ According to industry source, when the Credit Information Act revision is finalized, the industry would be able to actively use the My Data system. My Data could be used for healthcare sector. Upon patient’s request, hospitals would use patient’s diagnosis record for medical practice without requesting for consent from the archiving institute. For instance, the system could minimize the inconvenience of a patient hauling medical document from a healthcare institute to another. For such purpose, My Data online portal website would be opened and managed by healthcare related public institute. These days, AI and big data have been the biggest topics in pharmaceutical and bio industries. The industry expects the technologies to reduce development period of a breakthrough investigational drug by four to five years, and also to significantly lower the development cost. This is why the affected companies are welcoming the Three Data Bills stipulating use of medical big data in Korea. In fact, the pharmaceutical and bio markets are eyeing on Korean and global venture and start-ups with technology to dramatically shorten the period from candidate medicine exploration to pre-clinical trial phase. And some predicts these technologies could make a breakthrough for struggling small and medium enterprises. "Healthcare regulations should be alleviated with the Three Data Bills " Pharmaceutical and bio industries are carefully anticipating that the legislated Three Data Bills would mark a turning point for the healthcare AI technology development by accessing to the vast amount of medical big data in Korea. Besides increasing AI-based development of new drug, interest on venture and start-up companies developing AI platform would also surge as well. After overcoming Three Data Bills, other regulations should be reformed and broken down. The most urgent regulation is restriction on telemedicine. Naver has initiated telemedicine business in Japan with a Japanese partner company. The government should stop watching Korean companies spreading their wings of new business in other countries as they have been crippled in Korea. And rather, the government should stand up against opposing medical industry and privileged groups. High-quality emerging industry could be found and developed into an exporting industry, when converging the world class medical technology and IT technology. It is difficult to comprehend why Korean telemedicine should be shut off when other surrounding Asian countries have already opened their minds to the idea. Pharmaceutical sector would also experience a series of changes. Using AI technology for literature review, and analysis on genetic or patent information could speed up the candidate medicine exploring phase. There is already a new market providing personalized service based on personal health record and lifestyle information. A company could generate profit from the market as well by utilizing anonymous information, collected database and additional big data together. Regardless of the Three Data Bills, the medical data-using industry cannot guarantee an accelerated growth. Actually, a bigger problem is in the Medical Service Act banning individuals from using their personal health records on demand. The law should be amended to have healthcare institutes to digitally share information on patient and healthcare institutes. As the economic recession worsens, emerging industry and future growth engine should be tended. Regulations strapping down emerging industry should be reformed assertively. Reinforce support and give investment opportunities to ventures and start-ups to present them with hopes in emerging industries.
- Opinion
- [Reporter’s view] MFDS’ eyebrow-raising review dependency
- by Lee, Tak-Sun Feb 24, 2020 06:24am
- Obviously not true, but a series of recent incidents have gotten the public skeptical about Korea’s Ministry of Food and Drug Safety’s (MFDS) independent pharmaceutical review capacity. Many of recent safety issues have surfaced from overseas, and none of them were first found in Korea. Merely in a day, the ministry decided to copy the U.S. Food and Drug Administration’s (FDA) official action to ban sales of an appetite suppressant, Belviq (lorcaserin), due to its cancerous risk. While FDA has reported Belviq’s risk of causing cancer last month and issued a recommendation to pullback the item from market on Feb. 13, MFDS not only did not have a chance to review clinical data that raised the issue but also was unable to acquire it. And apparently, European Medicines Agency (EMA) had known about the cancerous risk before and refused to approve the item. So the public naturally started questioning MFDS’ ability to review pharmaceuticals properly by itself. In another instance, Korean-made cell and gene therapy ‘Invossa’ made a ruckus last year, leaving MFDS’s review ability seem even more questionable. Besides the developer Kolon Life Science’s ethics issues, one could wonder if MFDS could have filtered it out during the approval review procedure from the first place. When reviewing thousands of pages of pharmaceutical data, lack of review reviewing capacity or company’s deceptive data could be considered their inevitable limitation. But maybe it is time to rethink if it isn’t merely an excuse. How could MFDS be clueless until some problem arises? If it was not for the U.S. regulator pinpointing the clinical procedure, Invossa could have been used on patients without knowing that the key active pharmaceutical ingredient was switched. MFDS has retroactively banned sales of anti-hypertension substance valsartan and stomach ulcer treatment ranitidine, when a report of cancerous impurity found was issued from overseas. As the ministry took a strict action on the matter, the public’s criticism on the ministry’s timing of recognizing the issue was relatively mild. But we are left with no answers as to why the Koreans are late in the game to realize such problems. Former MFDS Clinical Trial Review Committee member Kang Yoon-hee, who received disciplinary action with an issue reported by a whistle-blower and had her contract terminated, claimed MFDS lacks ability to review independently. She argued MFDS basically imitates decisions by other overseas health regulators. Specifically for first-in-class drugs, the ministry has never proactively approved any without FDA or EMA’s decision. She reproached MFDS is not ‘reviewing,’ but is ‘learning’ from other’s decisions. Kang’s criticism may have neglected the reality, but her comment should not be overlooked. It is time for MFDS to assess itself on what is the cause of such dependency on foreign institutes, on lack of qualified human resources, and on problems in reporting procedure or review system.
- Opinion
- [FOCUS] Distrust caused by pharmaceutical and bio companies
- by Chon, Seung-Hyun Feb 20, 2020 06:34am
- Financial authorities again cut the disclosure of pharmaceutical and bio companies. The Korea Exchange prepared the 'Inclusive Disclosure Guidelines for Pharmaceuticals and Bio-Industry' and recommended that specific disclosure cases be followed and followed in accordance with industry characteristics. The intention is to encourage investors to provide detailed information on important management matters in order to make reasonable investment decisions. In detail, listed companies should disclose the facts and results of their application for a clinical trial plan. Even if a previously approved clinical trial plan has changed, it needs to be disclosed. Even when the trial is suspended or terminated, companies should be informed in detail. The facts and results of companies applying for an authorization for a new drug under development are also included in the important information. The release of a drug with a certain sales volume is also subject to disclosure. This is not the first time financial authorities have proposed disclosure standards for pharmaceutical and bio companies. In 2018, the Financial Supervisory Service inspected the business reports of pharmaceutical and bio companies, and as a result, the disclosure of important information and risks was insufficient. At the time, the Financial Supervisory Service recommended the detailed disclosure of major management contracts and R&D activities. Since then, pharmaceutical and bio companies have begun to disclose the progress of technology transfer projects, R&D personnel, and government subsidies in a unified form. The reason why financial authorities continue to question the disclosure of pharmaceutical and bio companies is investor protection. The company's activities are not being delivered to investors. In fact, suspicions have long been raised that pharmaceutical and bio companies only provide limited information on stock prices. Hundreds of clinical trials are initiated each year with the approval of the Food and Drug Administration. It was hard to find cases of voluntary disclosure of clinical trial discontinuation or failure. Considering the fact that the success rate of new drug development is less than 10%, doubts were raised that pharmaceutical companies conceal unfavorable information on stock prices. Although overseas, many pharmaceutical and bio companies preemptively disclosed unfavorable cases such as clinical discontinuance or abandonment of license application, the atmosphere was quite different in Korea. There was a lot of talk about the issue of ambiguous clinical trial results on bio companies. In many cases, they reported failures in key clinical trials, and then added conditions to confuse investors in a 'virtual success' manner. In introducing the results of clinical trials, there were many cases where unfamiliar words such as 'usefulness' and 'uselessness' were disclosed. The ambiguity was repeated, "The first goal failed, but the second goal was achieved". The article about a meeting with a regulatory officer who is not involved in the success of the trial or marketing authorization can be mistaken as if it were a great success. Even with the results of the same clinical trial, the stocks were fluctuating as the interpretations were mixed. After recording the lower limit, a few days later, it went back to the upper limit, and the jagged steps continued. At this point, I would like to ask what are the goals of drug development. It is the ultimate goal of new drug development to develop and supply innovative medicines to patients. Even with the approval of foreign regulators, we cannot guarantee how much sales will actually occur. Even if they haven't entered the license application step, it's hard to argue success with just one or two indicators. The financial authorities are also introducing the disclosure standard, the success of new drug development is determined by the regulatory agency's marketing authorization based on the results of clinical trials. Financial authorities pointed out that it is not advisable to announce the results of an intermediate trial as a clinical trial success. Unfortunately, Korea has never produced a success story on the global stage yet. In the future, it is likely that there will be more failure cases than probability. Indeed, the fact that financial authorities are providing pharmaceutical and bio companies with detailed disclosure standards and best practices for new drug development is a sign of great distrust. Some companies may complain that the government is trying to intervene in too little detail. However, the distrust of domestic pharmaceutical and bio companies has caused themselves. Developing new drugs with funds from investors is a duty to provide investors with clear information. If it was intended to mislead investors, it should not have been invested in the first place.
- Opinion
- [Column] Pharmacist's role during COVID-19 outbreak
- by Jung, Heung-Jun Feb 17, 2020 06:26am
- “Do you have hand sanitizer?” “Do you have masks?” These were the most frequently asked questions at my pharmacy starting from Lunar New Year holiday season when the first case of COVID-19 in Korea was confirmed. It is disheartening to see people looking for hand sanitizer in every pharmacy as if not owning one would kill them. Obviously, a public place required have one is unavoidable. But thinking that hand sanitizer would give immunity to virus is a problem. I tried to tell people to carry personal liquid soap and wash their hands at public restrooms as Korea has clean and convenient facilities. But it frustrates me to see people trusting information from the Internet. Nevertheless, I am glad the government and the people are reacting much better after experiencing a number of major respiratory virus outbreaks. During the 2009 flu pandemic, the health authority took almost two weeks to disseminate responsive guideline. The country was confused and restless for a long while, because disease preventive guideline was not presented promptly. I owned a small pharmacy back then as well. I remember informing customers, based on the fact the novel flu’s pathogen is an influenza virus, soap and alcohol could kill the virus and simple single-use mask would also be effective to prevent droplet infection even if it is not difficult to acquire N95 mask. And obviously, my expertise as a pharmacist has helped me to make a judgment. Lately, health issues affecting the society have been occurring more frequently. Besides respiratory virus outbreaks, events with harmful and toxic substances have also been reported. Humidifier disinfectant incident was a case that toxic substance stirred the public. Presumably, the consumers were shocked even more as disinfectant, supposedly protecting human body, was actually damaging the people. Pharmacist should not only talk about drugs. All pharmacists study toxicology at university. As Paracelsus said, “All things are poison,” all chemical substance found in daily life could be toxic or bad for human body. So it is pharmacist’s social responsibility to warn and advise about toxic substance or health risk the public is unaware of. We do need to reflect back on ourselves to see if the pharmacist organization has been playing a key role when a social health issue breaks out. We also need to ask ourselves if we are playing the role of a watchdog forewarning an upcoming risk. The pharmacist organization could not raise a voice to warn about the humidifier disinfectant. Regardless of being an expert of substance acting on human body, the organization could not even explain the problem or present a counteraction plan when the problem arose. If the pharmacists have been constantly warning about various toxic substances, the public would have listened to the pharmacists opposing against the government opening the pharmaceutical market to convenient store. This was a quite regretful incident. It is unfortunate that today’s pharmacy visitors are looking for hand sanitizer and not listening to my advice. But before I blame such state, we need to ponder over what should do as an expert rebuilding trust and authority. Korean Pharmaceutical Association (KPA), representing Korean pharmacists, should always explore health risks and constantly speak up on various safety issues. And also they should be able to promptly provide trustworthy information whenever public health incidents surface. Credibility of a person continuing to speak up for good cause would naturally solidify. I can assure such effort would change the attitude of pharmacy-visiting consumers.
- Opinion
- [FOUCS] Fundamental issues with listed drug reevaluation
- by Kim, Jung-Ju Feb 13, 2020 06:27am
- The government is currently fine-tuning the detailed draft of Pharmaceutical Reevaluation Standard and Method. Although the initial drafting schedule disclosed at last year’s meeting with pharmaceutical industry and public hearing has been delayed, the government’s commitment on the task is still strong regardless of the urgent issues like the infectious disease outbreak. Ministry of Health and Welfare (MOHW) and Health Insurance Review and Assessment Service (HIRA) have briefed the draft of reevaluation guideline at the Drug Reimbursement Evacuation Committee’s (DREC) February meeting and mentioned of some changes and selecting subjects for pilot program. Apparently, the previous framework of already-listed drug reevaluation would be applied and the initially planned foundation would be kept, but JADAD scoring and other issue the pharmaceutical industry has strongly opposed would be dealt more flexibly. The pilot program would highly likely to begin with choline alfoscerate, as expected. The pharmaceutical companies have been skeptical of the pharmaceutical reevaluation system. They claim the current post-reimbursement management systems like price-volume agreement system and preliminary drug price reduction system would inevitably overlap with the reevaluation. And also they argue the government would face difficulties in surveying actual transaction price when referencing external drug pricing. Also there are polarizing views on gap between definition of Ministry of Food and Drug Safety’s (MFDS) ‘efficacy’ and MOHW’s ‘effect’ in the evaluation. For drugs like rare disease treatment with difficulties in conducting randomized clinical trial (RCT), the companies question if the regulators would be able to properly evaluate the drugs with universal validity and predictability. The industry is already concerned of reevaluating the drugs again with government-confirmed clinical efficacy and cost-effectiveness under unified standards. Expecting there is an ultimate goal of pricing reduction, the industry views the government would take different forms of reevaluation depending on various situation fitting to their goal. Choline alfoscerate, the government has set its mind on for the pilot program, is a good example. Because of its unique quality, it is difficult to conduct a RCT so applying unified standard has its limits. What it comes down to is which methodology the regulators would take. Regardless of MFDS maintaining the approval, adjusted reimbursement standard could restrict reimbursement on certain indications, and in worst case scenario the drug could be removed from the listing. Such nature of the drug well-illustrates how complicated the issue is. The industry claims it is an over-regulation that choline alfoscerate, five years since its release, now has to prove ‘effectiveness’ to MOHW and HIRA, even after it has recently revalidated its efficacy due to license renewal regulated by MFDS. For the authority it may seem like one whole regulation, the evaluated subject feels the burden of undergoing evaluation by each ministry. With the access to drug fast improving, the global trend of health regulators leaning heavily on post-management is clearly unavoidable. However, the authority should not neglect the concerns raised by the pharmaceutical industry, in other words the evaluated subjects. Like any other regulation, meticulously perfect regulation is extremely hard to come by to begin with. But a regulation with such significant influence on the survival of business and industry’s ecosystem should construct principles fastidious but lenient enough to tolerate exception. This would be the reason why the industry is paying close attention on the regulation still in development.
- Opinion
- [Reporter’s view]2019n-CoV & safety ignorance of companies
- by Kim, Jin-Gu Feb 12, 2020 06:27am
- Rumor has it that the new coronavirus confirmers 17 and 19 are employees of pharmaceutical companies. The fact is not known. However, it is speculated that they were attending a plastic surgery conference held in Singapore recently, and the KCDC confirmed that they are not doctors. More important than rumor is the possibility that pharmaceutical salespersons can become super propagators, and this is the ripple effect.. Many pharmaceutical companies have already started working at home or are encouraging salespeople to refrain from visiting hospitals. It is a measure to protect the company's sales staff and to prevent the spread of the virus. Most of these steps have been taken by global pharmaceutical companies. Among domestic firms, only Samil was found to be working from home. Most of the other domestic companies are taking measures that say, "Be careful", and they are told to wear mask and hand sanitizer when visiting hospital. Rather, some domestic executives are saying that the crisis is an opportunity. This situation would have prompted other pharmaceutical salespersons to visit their main rivals’ hospitals. It is a sophistication. It is also very dangerous gambling. If there is a confirmer among pharmaceutical salespeople, it is obvious that the issue will not end at one of those employees. In general, it is known that there are as many as 5~15 visiting places a day by one salesperson. Considering the medical staff, patients, and caregivers of the hospitals and pharmacies he visited, it is estimated that 1,000 people will be direct or indirect contacts. Some of them will become new infected people and spread the virus to their family and colleagues at home and at work. In terms of corporate profits, huge losses are inevitable. When the confirmed person comes out, the clinic closes, and the sales from this disappear. The company should also be accused of promoting virus outbreaks. Working from home or refraining from hospital visits is not the only obvious solution to the new coronavirus outbreak. However, in the situation where the whole society is trying to prevent the spread of the virus, unnecessary retrogradation should disappear. This time, it is wrong to say that crisis is an opportunity.
