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- 2026-05-01 13:10:24
- Opinion
- [Reporter’s View] Why Big Pharmas 'select and focus'
- by Mar 02, 2022 05:54am
- In the famous TV show ‘Backstreet,’ CEO Baek Jong-won’s main advice and solution for small eateries suffering from slow business was to ‘reduce menus.’ Paik tells the restaurant owners to concentrate on their main menus instead of trying everything. Due to his consistent act of reducing menus in every restaurant he consults, he was fondly dubbed ‘BBunos,’ a combination of his nickname ‘BBu the homemaker’ and the ‘Avengers’ villain ‘Thanos’ who eradicated half of all life in the universe. Global big pharmas are also busy ‘reducing their menus.’ The companies are letting go of their main sources of income, in particular, products in their Consumer Health care units that are mainly consumer goods. In this sense, Johnson & Johnson’s announcement of its plan to spin off its consumer division had received much attention. The spin-off will not only transfer the baby powder product that imprinted the J&J brand on the public, but also many familiar brands including Aveeno, Neutrogena, Listerine, etc. The company had also said that the planned separation was a “momentous event” and the “biggest change in direction in J&J's 135-year history.” GSK is also spinning off its consumer healthcare unit. The spin-off, newly named ‘Haleon’ does not contain the GSK name. GSK Consumer Healthcare had been in charge of OTC drugs and consumer goods including popular products such as Sensodyne, Otrivin, and Theraflu. GSK Consumer Healthcare, which had been formed as a joint venture with Novartis, increased its size by adding Pfizer’s Consumer Healthcare business in 2018. However, the company seems to have intended to separate from the business. The company announced its plans to sell the business last year and is known to be considering its acquisition offers. The same trend is evident in other big pharmas as well. Sanofi had transferred all of its OTC drugs to its newly established spin-off of its Healthcare ‘Opella Healthcare.’ Going further, MSD had even transferred its off-patent chronic disease business to its spin-off, Organon. The global pharmaceutical companies are making such decisions to 'select and focus' on their specialty drugs, especially those in the field of oncology, immunology, and rare diseases. Of course, J&J’s decision is being suspected as a sort of ‘sham’ to pass on its responsibility for compensation for its baby powder product, which caused controversy due to the detection of carcinogens. However, the global perception in the industry is that they may survive only by focusing on severe and rare diseases. Also, it has been evaluated the industry reached a limit in growing using OTC drugs and consumer goods. On the other hand, once commercialized, innovative new drugs for severe and rare diseases bring big profit to companies. This is because these drugs may be sold at a high price due to little or no competition and the use of next-generation technology. Such restructuring of businesses through reorganizations of their business units has recently begun in earnest. J&J promised to strengthen its pharmaceutical division at the JP Morgan Health Care Conference in January and aims to achieve sales of ₩70 trillion in its pharmaceutical division by 2025 with next-generation new drugs such as anticancer drugs and CAR-T therapies. GSK also plans to focus on developing innovative new drugs and vaccines. Sanofi also stopped investing in chronic diseases and is broadening its autoimmune diseases and vaccines portfolio. For this, the company bought several early-stage research biotechs rather than those that can generate immediate sales. Last year alone, the company carried out 6 M&As with biotechs. The domestic pharmaceutical industry should eye this trend and movement of global pharmaceutical companies. Although it is impossible to directly compare companies due to the different size and focus areas, domestic pharmaceutical companies are still mainly pursuing the business strategy of providing 'many generics' rather than a single ‘wise drug'. Cash cows are necessary to develop new drugs as this costs an astronomical amount of resources, but everyone knows that it cannot be a long-term survival strategy. It's time for Korean companies to devise their own differentiation strategy on what and which areas to ‘select and focus.'
- Opinion
- [Reporter's view]Will it be different this time?
- by Kim, Jin-Gu Feb 23, 2022 05:49am
- Earlier this month, the government announced "Comprehensive Measures for Stable Supply of National Essential Drugs." In the wake of the COVID-19 crisis, the importance of stockpiling and supplying essential medicines has increased, and the government has stepped up. National essential drugs refer to drugs that are essential for health care, but are difficult to supply stably only with market functions. It will be designated by the MOHW and the MFDS through consultation. Currently, 511 items are designated as national essential medicines. The government announced a comprehensive measure of the same name in 2016. At that time, instead of COVID-19, MERS served as a catalyst for establishing countermeasures. Even then, the government said that a stable supply of national essential medicines is important to cope with the public health crisis. After the announcement of comprehensive measures in 2016, did the stockpiling and supply of national essential drugs improve? The prevailing assessment is that this is not the case. Rather, the suspension of supply of essential national drugs is expanding every year. After the establishment of comprehensive measures, the "Lipiodol incident" occurred in 2018. The reason for repeated supply interruptions is simple. This is because pharmaceutical companies no longer supply them. Currently, the government is compensating pharmaceutical companies that produce and import national essential drugs at the "cost" level. However, the pharmaceutical industry argues that this alone is not enough. Who will step up for the public interest in a structure in which the more they produce, the more damage they incur. The government seems to be fully aware of this reality. In fact, the measures announced in 2016 included contents such as "support for the supply of essential medicines for stockpiling" and "establishment of support measures when the supply is suspended." However, adequate support has not been provided, and the national essential medicine system has been lax and has reached this day. Similar information is included in the measures announced this time. The government said it will support production costs for drugs that have been suspended due to poor profitability. In addition, the government said it would purchase all of its production in the case of rare disease treatments that have less domestic demand than the minimum production. The pharmaceutical industry's response is not positive. It has not yet been decided how much production costs will be supported, but the pharmaceutical industry believes that the scope of support is limited to "production costs," which will be far from appealing to companies. Appropriate compensation is an essential solution for a stable supply of national essential drugs. If a company is judged to make any physiological profits, it will jump into the production of national essential medicines even if the government stops them. You cannot forever appeal to the pharmaceutical industry only for the "public interest." We hope that the details of this measure will include reasonable and appropriate compensation.
- Opinion
- [Reporter’s View] Why set deadlines in pricing negotiations
- by Eo, Yun-Ho Feb 17, 2022 05:53am
- A deadline is a pre-determined set amount of period. If this period is extended frequently, what meaning would setting a ‘deadline’ have? This question arises with the uprise of deadline extensions being made in the drug pricing negotiations between the National Health Insurance Service and pharmaceutical companies for reimbursement listing or reimbursed indication extensions. Simply put, too many ‘exceptions’ are being made. When the drug pricing negotiation period for the 3rd generation lung cancer treatment ‘Tagrisso (Osimertinib)’ was extended five years ago, the media had described the extension as ‘exceptional’ or ‘unprecedented.’ However, so many drugs, especially anticancer drugs, have recently failed to reach negotiations or completed negotiations after the deadline. Even now, more than 3 drugs are in negations past their deadlines. This is why pharmaceutical officials awaiting negotiations sometimes make jokes that “We wouldn’t be able to complete negotiations at once, but maybe during the extended period.” With the introduction of the effective but high-priced drugs, the increased extensions, and exceptions may be implying that the ’60 day’ negotiation period is now not sufficient time for the government pharmaceutical companies to reach an agreement. However still, a deadline is a deadline. Moreover, the reduction of the negotiation period is being used as an incentive and a benefit. In other words, the period was set to accelerate listing and limit the final period of negotiations and allow predictability of listings. However, no either party is fully accountable. The common period extensions, the introduction of more expensive and difficult-to-negotiate drugs, and the lack of determination to produce results within the deadline have led to a repetition of such ‘exceptions.’ Also, the companies’ dragging out negotiations due to delay in communication with its headquarters, and the administrative department’s complacency in postponing the immediate breakdown of negotiations fearing the rush of complaints from patients, undermines the purpose of the system. If discussions became difficult, strengthen the conditions for initiating negotiations. The required documentation should be reviewed and discussed with the NHIS in advance at the HIRA review stage, and the parties should be pressed to complete the negotiations within the set period. Do it “for the patients,’ that both parties have frequently referred to. Frequent exceptions are no longer exceptions.
- Opinion
- [Reporter's view]Predictability should be increased
- by Lee, Tak-Sun Feb 14, 2022 05:54am
- Starting with Choline Alfoscerate, a brain function improving agent, the benefit reassessment, which has been in full swing since last year, has risen again this year. On the 11th, HIRA's Drug Reimbursement Evaluation Committee confirmed the items subject to salary revaluation in 2022 and 2023. Detailed items will be released through the Health Insurance Policy Committee. However, despite the HIRA notice, the target item was released to the media a few hours later. Six drugs, including Godex, were included in 2022 and eight drugs, including Hyaluronic acid eye drops, in 2023. Since media reports, the HIRA has not made any opinions on this. Perhaps this is because the items subject to re-evaluation match. Rather, they seem to be more curious about how the target item was delivered to the media. The exposure of items is due to the constant intelligence activities of the pharmaceutical industry to know the subject of re-evaluation in advance. No matter how much the HIRA cracks down on subcommittees or groups of experts in the committee that deliberate on revaluation targets, it is interpreted that it has not overcome the pharmaceutical industry's desire to predict revaluation projects in advance. This is because the benefit revaluation project is piled up in the veil. When The HIRA announced its five-year revaluation plan last year, it said it would use ▲ 0.1% of claims, or more than 20 billion won ▲ less than one of A8 countries, ▲ policy and social demands, insufficient intellectual drugs ▲ other committees. On top of that, there is an opinion that the registration date may have been considered. However, it is difficult to predict target items based on these criteria. Rather, looking at the selected drugs, most of them have undergone clinical re-evaluation by the MFDS or controversy over their socially usefulness. In fact, it is difficult to predict the order of re-evaluation. From a pharmaceutical company's point of view, if they knew the order of re-evaluation of benefits a few years ago, they would decide whether to maintain the business of the item and develop a new business to replace it. However, if it is announced so suddenly, companies cannot afford to prepare. Therefore, it may be a natural choice for companies to continue lawsuits such as suspension of execution. In order to increase predictability, the HIRA plans to disclose items subject to re-evaluation not only this year but also next year. Accordingly, the items subject to next year's re-evaluation have gained time to prepare for now. However, there is a limit to enhancing the predictability of the business by disclosing only the target items for next year. For now, it is not known whether the project will continue in the long run or end up with five years. If it is carried out regularly, how about applying a renewal system like the MFDS to determine whether or not to reevaluate benefits according to the order of registration date? In addition, if it was a five-year temporary project, the predictability of pharmaceutical companies would have increased if it had been divided by disease in the first place. The revaluation in this way is much more unilateral. Rather, the predictability of the business should be increased, giving the company more time to prove the clinical usefulness of the drug. Although it is a burden on health insurance finances, it is still important that drugs necessary for patients are not expelled due to lack of data evidence. It is questionable whether this will be properly filtered out by a short-term re-evaluation.
- Opinion
- [Desk] 550,000 soldiers and COVID-19 vaccine
- by Nho, Byung Chul Feb 10, 2022 05:54am
- In mid-August last year, the Ministry of National Defense completed the first and second vaccinations against 550,000 soldiers. The types are identified as Moderna and Pfizer vaccines, including the Janssen vaccine. It deserves to be evaluated as a "successful vaccine operation" achieved quickly in a quasi-war situation facing North Korea. Currently, all COVID-19 prevention vaccines in circulation have an ERA of more than 70% based on the WHO. Therefore, the completion of vaccinations for all troops is essential for maintaining and improving combat power. What is particularly interesting is the joint civilian-military vaccination program. This refers to an operation jointly conducted by private consigned medical institutions and military hospitals from December 13 last year to January 14 this year. The intention of the operation, which was temporarily carried out, is to guarantee the right to self-determination and achieve a rapid vaccination rate for Armed Forces soldiers. Compared to the military's traditional closed organizational culture for security maintenance and military establishment, this operation is an unusual policy. Military hospitals mobilized at the time of the first and second inoculations are counted as 91 clinics, including Army, Navy, and Air Force medical units. The military hospital consists of 17 nursing institutions, including the Korean Armed Forces Capital Hospital. Affiliated institutions include the Armed Forces Medical School, the Armed Forces Medical Research Institute, and the General Medical Situation Center. At the time of the third inoculation, the number of privately entrusted medical institutions cannot be revealed as private. However, 10% of all soldiers, that is, about 55,000 out of 550,000 Armed Forces soldiers, were vaccinated at outpatient clinics, not military hospitals. The Ministry of National Defense collected soldiers who wanted to be vaccinated in private hospitals and received medical treatment by bus. The same per capita vaccination cost as the private sector of 19,000 won was applied. In other words, about 1 billion won in defense budget has been spent on private medical institutions. It is estimated that there are about 3,000 military doctors and nursing officers in Korea. They are considered experts who have completed their professional qualifications after graduating from medical school or have completed elite medical education at the Armed Forces Nursing School. Some point out that when inoculated at a military hospital, medical personnel could save taxpayers' money for aesthetic purposes. However, there is something that should not be overlooked here. It is commendable that their own military organization is interested in the needs of the people and the human rights of military soldiers, and is making a gesture of communication. It is also commendable that soldiers stopped by an outpatient pharmacy located near the hospital to purchase antipyretic analgesics such as acetaminophen and ibuprofen, and revitalized the surrounding commercial districts, although small. Parents with sons who joined the military are very worried about side effects after vaccination. In this situation, it can be seen as a reform through change that soldiers were allowed to decide to vaccinate. At a time when policies such as the volunteer military system and salary increase are being discussed, the time has come to discuss the reorganization of the public-private joint medical system related to the improvement of military medical rights.
- Opinion
- [Reporter’s View] Mutual understanding is required
- by Kim, Jin-Gu Feb 04, 2022 05:57am
- The National Health Insurance Service made a pre-announcement for the amendment of the detailed guidelines of the ‘Price-Volume Agreement.’ The Price-Volume Agreement, or PVA, is a system that discounts a drug’s price by up to 10% through negotiation between the pharmaceutical company and NHIS for products whose use volume had rapidly increased. The system was implemented to save NHI finances. The current system has been in place since 2014 after the system was implemented in 2007, therefore the move for its improvement seems timely. However, the NHIS and the pharmaceutical industry have mixed opinions on how to amend the system. This clash is most prominent in the matter of deciding whether to expand or reduce the scope of eligibility of the system. The NHIS believes more pharmaceuticals should be applied the system through an amendment. In other words, the authorities plan to reduce the scope of pharmaceuticals that are exempt from PVA negotiations, therefore applying the system to a broader range of pharmaceuticals. In detail, the authorities had planned to narrow the exclusion criteria to ‘below 90% of the arithmetic mean price’ from the ‘below the arithmetic mean price of same ingredient drugs,’ Under the new criteria, products subject to PVA negotiations would increase to 69 from the 59 reviewed in the previous year. On the other hand, the industry claims that the scope of exclusion should be increased to reduce even just one more pharmaceutical subject to price cuts. Currently, products that file an annual claims amount of less than ₩1.5 billion every year are excluded from PVA negotiations. The industry claims that this limit should be raised to ₩5 billion or even ₩10 billion, The NHIS had partially accepted the industry claims and can accept increasing the ceiling to ₩2 billion from the current ₩1.5 billion. Disregarding the complex calculations in place, the clashing values of the industry and NHIS are clear. The NHIS prioritizes ‘sustainability in NHI finances,’ whereas the industry prioritizes ‘concern over reverse discrimination of homegrown new drugs.’ Neither side can be 100% right, and no side should be forcing its claim on the other. This is why the NHIS’s past actions leave some room for disappointment. The NHIS had continuously emphasized that “the industry needs to understand and sympathize” with the NHIS’s position. Although the words “understand” and “sympathy” were used, in context it is more coercion than persuasion. Under the inviolability rationale of protecting the sustainably of our national health insurance, the sacrifice of the pharmaceutical industry was dismissed as a ‘trivial’ matter. The NHIS had planned to enforce the guidelines effective as of January 1st this year. However, the authorities held back from implementing the amendment due to strong opposition from the pharmaceutical industry and said it will prepare a better The industry believes that the amendments will be disclosed soon. However, one clear thing is that neither side can unilaterally continue to force understanding and sympathy on the other’s part. It is this reporter’s hope that an improvement on which both sides can truly understand and agree on could be reached soon.
- Opinion
- [Reporter’s View] Ahead Kymriah’s NHIS negotiations
- by Eo, Yun-Ho Jan 28, 2022 05:57am
- Only the National Health Insurance Service left to go, the ultra-high-priced novel CAR-T therapy ‘Kymriah (tisagenlecleucel)’ passed all the steps necessary for insurance benefit. In other words, the fate of Kymriah’s reimbursement now lies The fate of Kymriah’s reimbursement, a drug that costs around ₩500 million for a single shot, now lay at the hand of the NHIS negotiations. However, the prevailing view is that the road to reimbursement would not run so smoothly. The drug is indicated for: ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse The reimbursement standards set for Kymriah that is taking the PE exemption pathway differ by indication. Only the expenditure cap was applied to the B-ALL indication, but for DLBLC, the performance-based type of restriction was added to the expenditure cap. This means that the company would have to share a certain proportion of the cost used by DLBLC patients according to treatment performance. The problem is that unlike the mass-produced general drugs, a single batch of Kymriah is produced with the cells extracted for each patient, which brings the manufacturing cost to be astronomically high. In such cases, when the number of patients exceeds the expenditure cap set by the government, the exceeding cost directly becomes the burden for the company. Of course, Novartis Korea’s ‘efforts’ are essential to bring the ‘drug pricing negotiations’ through and reach an agreement, whether the efforts will definitively bring positive results remains unknown. Other drugs that are mass-produced and generally have a low manufacturing cost are not greatly affected in their profit structure when exceeding the expenditure cap set for the drugs. However, as Kymriah has a high manufacturing cost, just a few patients exceeding the expenditure cap can bring a significant burden. Also, reimbursement in the DLBLC indication has the added limitation of being performance-based. From the NHIS’s perspective, the authorities will be determined to protect the sustainability of its NHI finances by setting the right first step with Kymriah in preparation of the high-priced cell and gene therapies that are expected to pour in in the near future. With negotiations soon to engage, the wish is that those sitting at the negotiation table overcome the compulsion of deriving a certain result and consider the specificity of the manufacturing process as well as the limited number of patients subject to its care, and that the pharmaceutical company’s sincere ‘patient-focused’ mind shine through.
- Opinion
- [Desk] The task of reimbursement for ultra-high-priced drugs
- by Kim, Jung-Ju Jan 18, 2022 06:05am
- The evaluation of the adequacy of the super-high-priced Kymriah's benefit is approaching insurance coverage. This is because the agenda to expand the health insurance standards for Kymriah, a treatment for acute lymphocytic leukemia and lymphoma CAR-T, and Keytruda, a non-small cell lung cancer immuno-cancer drug, passed side by side at the HIRA meeting on the 13th. Until now, the biggest obstacle when it was decisively blocked by cost-effectiveness in the process of reimbursement for high-priced drugs was the discussion process of the Pharmacist Evaluation Committee or the Cancer Disease Review Committee. Whenever the reimbursement priority and adequacy were discussed, the effect and necessity were recognized, but the cost was too high, so Kymriah's registration was delayed for 11 months, and Keytruda was also in progress for 4 years and 4 months. Patients' struggles to ensure these drugs were also tearful. Patients and their families who need immediate medication as life-related drugs have protested in front of the company to urge rational fiscal sharing, issued press conferences and statements, and filed petitions against the government, so the committee's passage will be impressive. Drug price negotiation procedures are still needed, and considering the period required for deliberation and resolution by the Health Insurance Policy Deliberation Committee, two to three more months must be waited. As such, it is a drug that is essential to patients, but it is an innovative drug that the general public cannot afford, and as technology continues to develop, similar cases like this are expected to continue to appear in the future. In fact, the government is aware of this and has prepared various mechanisms such as positive list system to strengthen the coverage of not only drugs but also medical technology, but it cannot cover all innovations with limited finances. Patients argue that a rapid health insurance registration system should be introduced for new drugs directly related to life to protect their lives at the national level, but the difficulty of accepting them from the government's point of view may be due to predictability and financial problems. As mentioned earlier, ultra-high-priced drugs such as Kymriah and Keytruda will be released every time, and the speed will increase as technology develops. Currently, in the face of such a problem, the authorities demand a rational fiscal sharing plan between the company and the government (insurer) from the developing company. There are already many cases empirically that such an agreement is not premised in the drug price negotiation process, which is another major obstacle. The government sought to strengthen the coverage and accessibility of ultra-high-priced drugs, but has repeatedly expressed its intention to use the existing negotiation mechanism under the positive list system. It is necessary to effectively establish a reasonable and predictable finance, that is, a voting structure and procedures to share mutual risks, and a mechanism to prevent delays in discussions without damaging the screening registration system, the central axis of drug registration. Academia should actively and actively conduct related research to present evidence and solutions to patients, the government, and companies, and the government and the National Assembly should consider them in practice to find solutions that our society can accept.
- Opinion
- [Reporter’s View] Can companies get EUAs as they promised?
- by Lee, Tak-Sun Jan 12, 2022 06:04am
- The Emergency Use Authorization (EUA) system was first introduced to Korea in March last year. AstraZeneca’s COVID-19 vaccine manufactured in Italy, Moderna’s COVID-19 vaccine manufactured by Samsung Biologics, Pfizer’s oral COVID-19 treatment Paxlovid, and the COVID-19 injection Remdesivir for use in patients under 15 were approved using Korea's EUA system. All of the drugs above were introduced to Korea through EUA before receiving marketing authorization through an official process. Among these, AstraZeneca’s vaccine that was manufactured overseas and Samsung Biologics’ Moderna vaccine are now officially approved in Korea. As such, the EUA system had gained attention as the new way to introduce COVID-19 drugs before applying for marketing authorization. Using this as momentum, companies have even set out goals to introduce their drugs to Korea using the EUA system. Rather than applying for marketing authorization that requires a long time for review, the companies made the plan to quickly introduce their drugs using the EUA track after completing domestic clinical trials. However, some have criticized that the companies are setting impractical goals and making hollow promises to raise their stock price. The idea that the companies that completed clinical trials may voluntarily apply for EUA is in itself a false logic. The EUA is granted only after a request from a head of a relevant agency such as the KDCA, and when the MFDS deems the drug is necessary for responding to a public health crisis. Therefore, the pharmaceutical company cannot first ask authorities to grant EUA to its drugs. The only way this is possible is when the MFDS issues a public notice on the scope of medical products in need. Of course, there is a possibility that the companies may actively appeal the need for their drugs to the MFDS to receive EUA. However, this is also quite impractical. The government is in charge of introducing and purchasing COVID-19 drugs. Therefore, it would be very unlikely for the MFDS to grant EUA to drugs that are not included in the purchasing agreement. Therefore, the only realistic way for a drug to receive EUA is if the drug was already approved in other countries and has made a purchasing agreement with our government. The 4 products that were previously granted EUA had also been first approved overseas and signed advance agreements with the Korean government. Therefore, the claim of pharmaceutical companies that it will promptly introduce its drug through EUA can be considered an overstatement, deceiving investors who invested in the companies after reading promotional materials that contain such contents. Pharmaceutical companies must provide accurate information about their respective companies to fulfill their ethical responsibilities. They should state the feasibility and risks involved in addition to their goals. If not so, their intent pursuit to raise their stock price in this COVID-19 crisis will adversely result in the loss of what should matter the most - the consumer’s trust.
- Opinion
- [Reporter’s View]Year of regulations, principle vs practice
- by Kim, Jin-Gu Jan 05, 2022 05:57am
- As in every other year, regulations imposed on the pharmaceutical and biopharmaceutical industry are again expected to be further reinforced this year. In particular, GMP-related regulations will be strengthened even further. Starting this month, the government may impose punitive fines on the arbitrary manufacture of pharmaceuticals by companies. In addition, the government and the National Assembly are pushing to amend the law so that an assigned GMP investigator could conduct on-site investigations on drug manufacturing plants. Also, a bill to revise the law to allow business suspension dispositions up to one year and license revocations in case of GMP violations is pending at the National Assembly. Some may complain that such excessive regulations hinder the development of the pharmaceutical and biopharmaceutical industry. However, the regulations did not appear out of nowhere. There were always events that triggered the tightening of regulations. The GMP regulations were reinforced due to the series of arbitrary manufacturing events that occurred last year. The arbitrary manufacturing of pharmaceuticals that were once considered rare incidents conducted by one or two companies was identified in several companies last year. The industry thus lost the public’s trust. In depth, the ruling may indeed have felt unfair for some pharmaceutical companies. However, their protests failed to gain public sympathy as their argument, in essence, is an excuse that they did not follow the 'principle' in the name of customs and practice. And this is not an issue that just arose last year. The license of Kolon’s ‘Invossa’ was canceled in 2018, Medytox’s botulinum toxin in 2019 because they were found to have manufactured their product differently from their approved specifications. This would not have happened if the companies stuck to the basic principles. This new year, the industry should look back on itself. Companies should look back and examine whether they have chosen practice rather than principle in other areas of their business as well. If so, they must remedy their ways immediately as these small incidents are what intensify to become serious issues. The MFDS should also review its ways to become an institution that is faithful to principles. This does not mean that the ministry should adhere to principles on every issue that arises. Punishing pharmaceutical companies based on pure principle is not a fundamental solution. If deviations of front-line pharmaceutical companies have become a practice, the ministry should more deeply look into the background on why it became so. As the regulatory authority, the MFDS’s role is to establish principles in the direction that can protect the public’s health and further develop the industry. In other words, if the regulations are causing the issue, it is the MFDS’ role to establish “new principles.”
