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- 2025-12-23 02:31:40
- Policy
- 500 billion won fund by the end of this year
- by Lee, Jeong-Hwan Jul 28, 2022 05:54am
- Public-private partnerships to develop blockbuster vaccines and treatments. The government will focus on supporting vaccines and treatments for infectious diseases under development by domestic bio-health companies. It plans to fully support vaccine candidate materials for diseases such as COVID-19 and core technologies for responding to infectious diseases, and strengthen licensing, location, and foundation support, tax deduction and financial support to revitalize private investment in biohealth. It will also expand public-private investments such as K-bio and vaccine funds, and will create a joint public-private fund worth 500 billion won within this year and pay a total of 2.2 trillion won in R&D expenses for new drug pipelines. The MOHW discussed the "BioHealth Industry Innovation Plan" at the 4th Emergency Economic People's Assembly presided over by President Yoon Seok-yeol on the morning of the 27th. The MOHW diagnosed that Korea's investment in vaccine and treatment development support is limited compared to other developed countries. Compared to AstraZeneca's development of COVID-19 vaccines and treatments with 2 trillion won, 1.9 trillion won for Novavax, and 550 billion won for Janssen, Korea spent only 257.5 billion won for vaccines and 155.2 billion won for treatments. The MOHW decided to continue to support the development of COVID-19 vaccines and treatments from 17 companies under clinical trials in six domestic companies. It helps Korea's No. 1 vaccine to enter the global market by passing the pre-qualification examination by the WHO and confirming the efficacy of additional vaccinations. After securing core technologies by researching and developing vaccine candidate materials for COVID-19 as well as candidates for infectious diseases such as MERS and Zika virus, it supports rapid development of vaccines in case of crisis. In order to revitalize private investment worth 13 trillion won by 2026, including Samsung Biologics, Lotte Biologics, SK Bioscience, and EuBiologics, it will also provide support at the level of ministries. It will closely support licensing, location, and foundation creation, and quickly strengthen tax deductions, financial and policy funding support for each major related institution, and expansion of support limits. In a recently announced tax reform plan to promote investment in vaccines, the deduction rate for investment in national strategic technology facilities of large companies was raised from 6% to 8%. In order to develop innovative new drugs and secure vaccine autonomy, it will create a private joint "K-Bio and Vaccine Fund" worth 500 billion won that invests in pharmaceutical and bio companies within this year, and expand it to 1 trillion won in the future. It has also decided to provide 2.2 trillion won in research and development expenses, including 1.5 trillion won in state funds, to new drug pipelines that have entered the second phase of clinical trials in discovering effective substances. Regulatory innovation will also be carried out. Innovative medical devices such as AI and digital will be improved so that they can be used as non-reimbursement or Medical Benefits after licensing. In the case of innovative medical devices, the evaluation period required for them to be put into the medical field after minimum administrative measures after licensing will be drastically reduced from 390 days to 80 days. It will fully redesign regulatory systems suitable for high-tech product characteristics such as digital and high-tech bio to closely support entry into the global market, and establish a biohealth-specific regulatory sandbox that reflects the specificity of innovative technologies and services. Lee Ki-il, the second vice minister of the MOHW, said, "We will present a roadmap for bio-health regulatory innovation and actively resolve difficulties through continuous communication with the industry."
- Policy
- Outpatient tx 14.7 times a year per person in Korea
- by Kim, Jung-Ju Jul 28, 2022 05:54am
- In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries. This is 2.5 times the average 5.9 times of member states. As a result of evaluating drug sales per capita with Purchasing Power Parity (PPP) reflecting the price level of each country, $ 760.9 PPP was 1.4 times higher than the OECD average of $547.2 PPP. The MOHW analyzed and announced the level and status of Korea and each country by major indicators of "OECD Health Statistics 2022" announced by the OECD on the 4th. Among them, we looked at health care use and health care resources. ◆ Outpatient treatment, average number of days of hospitalization, examination, and current medical expenses = In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries, 2.5 times higher than the average of member countries (5.9). Japan (12.4) has the second highest number of outpatient treatments per person after Korea, while Costa Rica (1.9), Mexico (2.1), Chile and Sweden (2.2), Colombia (2.6) and Greece (2.7) have less than three. In 2020, the average number of hospitalization days per inpatients in Korea was 19.1, the second longest among OECD countries after Japan (28.3 days). The OECD average is 8.3 days. The average number of hospitalization days per inpatients for acute treatment was 7.8 days, longer than the OECD average (6.6 days). Over the past 10 years, the average number of hospitalization days per inpatients in Korea has been on the rise, but the number of patients treated in acute phase has been on the decline. The total number of hospitalizations increased by 1.9% annually, and acute treatment decreased by 2.5% annually. In 2020, Korea's MRI usage was 71.7 cases per 1,000 people, which was lower than the OECD average, and CT was 250.0 cases per 1,000 people, which was higher than the OECD average. Over the past 10 years, CT and MRI usage in Korea has continued to increase. CT usage increased by 8.3% annually, and MRI usage increased by 14.6% annually. Current medical expenses, which mean the total annual expenditure of the entire people spent on services and goods in the health care sector, were 8.4% of GDP in 2020, lower than the OECD average (9.7%). The per capita current medical expenses were $3,582.3, an annual average increase of 6.9% over the past 10 years, higher than that of the OECD (3.3%). The proportion of medical expenses (direct household burden) borne by households gradually decreased to 34.0% in 2010, 33.7% in 2015, and 27.8% in 2020. ◆ Number of beds and medical equipment = In 2020, the number of hospital beds was 12.7 per 1,000 people, the largest among OECD countries, and about 2.9 times the OECD average (4.3). Among them, 7.2 beds per 1,000 people were treated in acute phase, more than twice the OECD average (3.5). In 2020, Korea's number of MRIs was 34.2 per 1 million people and CT was 40.6 per 1 million people, which was higher than the OECD average (29.1 units). "OECD Health Statistics is important to use as basic data for policies to provide the quality of health care services that people can feel directly by analyzing and evaluating the level of health care in Korea in the international community," said Yang Kyung-jin, a policy statistics officer.
- Policy
- The revised COVID-19 in vitro diagnostic device guidelines
- by Lee, Hye-Kyung Jul 27, 2022 05:50am
- Due to the prolonged COVID-19, the in vitro diagnostic devices of the MFDS and the Korea Food and Drug Safety Evaluation Institute were very busy. Since the outbreak of COVID-19, the export performance of in vitro diagnostic medical devices has increased by 1.5 times, and the degree felt by in vitro diagnostic departments is said to be 10 times. Currently, in vitro diagnostic devices are operated on a small scale with four researchers and five examiners. However, five examiners are reviewing the workload for approval of in vitro medical devices from 800 companies. Jung Ho-sang, head of the in vitro diagnostic device division, said in a briefing to the journalists on the 26th, "Before COVID-19, there were many complaints about imported products of in vitro diagnostic devices used in hospitals." "However, after COVID-19, the development and permission management of product lines that used a lot and had a lot of complaints have decreased, and the situation has become to focus on COVID-19," he explained. He said, "The number of applications for permission from companies that have no experience in developing COVID-19-related devices has increased, resulting in a surge in complaints." "It is not easy to replenish manpower, so there are many difficulties," he said. Fortunately, applications for permission for new products have not increased despite the current COVID-19 resurgence. Foreign companies are reportedly putting in complaints for permission for cancer diagnosis and blood diagnosis devices, which have been stopped while focusing on developing COVID-19-related devices. Manager Jeong said, "Foreign companies are focusing on COVID-19 and restarting devices such as cancer diagnosis and blood diagnosis, which have rarely been developed. There are still many applications for permission for COVID-19-related devices, but foreign companies have completed the development of COVID-19 diagnostic test kits and are receiving a lot of complaints about devices that have already been developed or have now begun." There was also an explanation of the recently revised guidelines for the approval review of COVID-19 in vitro diagnostic devices. The MFDS deleted design restrictions that detected two or more genes only for COVID-19 gene test reagents, and added data on major mutation virus detection performance evaluation designated by the WHO as a prerequisite. He explained, "It is not true that the revision of the guidelines eased the criteria for approval of test reagents." Regardless of the revision of the guidelines, the COVID-19 gene test reagent must meet the same licensing criteria as before regardless of the number of detected genes, he said. "The clinical performance criteria with a sensitivity of 95% or higher and a specificity of 97% or higher are applied without change." In Korea, 46 gene test reagents have already been approved to detect two or more genes, and he added, "In accordance with the Korea Centers for Disease Control and Prevention's diagnosis guidelines, more than two genes are tested, so it does not affect the COVID-19 diagnosis system at all." However, as products targeting multiple genes are advantageous in detecting mutations in response to the new mutation virus, it is expected that the development of products targeting multiple genes will continue under the current epidemic and the Korea Centers for Disease Control and Prevention's diagnostic guidelines. Regarding the deletion of design restrictions on genetic test reagents, he said, "We decided that there was no need to limit the design of genetic test reagents anymore because many genetic test reagents were performing well at home and abroad." He said, "This is to promote the development of new products and additional product types according to changes in the COVID-19 quarantine situation."
- Policy
- COVID-19 improved vaccines will be promoted
- by Kim, Jung-Ju Jul 27, 2022 05:49am
- The quarantine authorities said they have already begun work to quickly introduce an improved vaccine, an upgraded version of the COVID-19 vaccine. Currently, Pfizer and Moderna have signed a contract to introduce 60 million doses within the year, and if an improved vaccine is released in the meantime, the main point is to replace it with this. The details will be announced at the end of next month. According to the Korea Centers for Disease Control and Prevention on the 25th, the government is continuing to consult with pharmaceutical companies for quick introduction and safe and effective vaccination, and plans to announce the vaccination plan at the end of August. The U.S. and Japan have decided to actively use an improved vaccine that is more effective for omicron mutations in the fourth vaccination for the entire nation this fall. The amount of mRNA vaccine (Pfizer & Moderna) introduced within this year is about 60 million times. The Korea Centers for Disease Control and Prevention said, "Pharmaceutical companies have signed a contract to introduce the quantity as an improved vaccine if an improved vaccine is developed." The Korea Centers for Disease Control and Prevention explained, "This is enough for inoculation in the second half of the year." The government also held frequent monitoring and consultations with pharmaceutical companies on vaccine development trends to quickly introduce improved vaccines, and is always consulting experts. The Korea Centers for Disease Control and Prevention said, "The direction of the vaccination policy using the improved vaccine will be announced around the end of August after comprehensively reviewing the effectiveness and safety of the vaccine, development progress, introduction time and available quantity." The Korea Centers for Disease Control and Prevention said, "However, detailed inoculation strategies such as specific inoculation targets, timing, and method can be determined based on scientific grounds such as the type of mutation that is prevalent at the time of inoculation and the effect of improved vaccines on the mutation." The Korea Centers for Disease Control and Prevention added, "We are monitoring quarantine situations, new mutation trends, improved vaccine development trends, and overseas vaccination policies so that vaccinations through improved vaccines can be effectively carried out in a timely manner."
- Policy
- Paxlovid·Lagevio, the effect of inhibiting viral proliferat
- by Kim, Jung-Ju Jul 25, 2022 05:57am
- The National Institute of Influential Diseases (Director Jang Hee-chang) under the Korea National Institute of Health (Director Kwon Joon-wook) announced the results of the efficacy evaluation of treatments such as COVID-19 PO treatments, that is, Paxlovid and Lagevrio. Compared to the existing delta mutant virus, these drugs have maintained their effectiveness in suppressing virus proliferation, so they are not affected by omicron submutation. It was decided to prepare treatment guidelines through research on chronic aftereffects in the future. First, the National Institute of Influential Diseases evaluated the efficacy of three domestic COVID-19 antiviral drugs (Paxlovid, Lagevrio, Remdesivir) through cell-level analysis, and confirmed that Paxlovid and Lagevrio maintained their anti-virus proliferation inhibitory efficacy compared to the existing virus delta strain. Remdesivir, which is used as an injection, has been confirmed to still maintain antiviral efficacy for four types of omicron subdisplacement. The National Institute of Infectious Diseases announced that it will continue to monitor domestic and foreign treatment development trends and evaluate the efficacy of treatments in use in Korea in the event of a new mutation virus. The Korea National Institute of Health is promoting a large-scale systematic investigation and research project to prepare measures to manage chronic COVID-19 syndrome (aftermath) in Korea due to COVID-19. This project is a long-term observation and in-depth investigation study on large-scale aftereffects cohorts, including children and adolescents, and a study on identifying patterns, causative mechanisms, and preparation of treatment guidelines based on clinical cohorts. Currently, the announcement of research projects to select the main research institutes has been completed and related procedures such as selection evaluation are underway, and research will be launched by signing an agreement at the end of August. The Korea National Institute of Health said it will make efforts to quickly secure and provide information on systematic scientific evidence for treatment and management through this chronic COVID-19 syndrome cohort study.
- Policy
- Donepezil patch is cheaper than 99 existing formulations
- by Lee, Tak-Sun Jul 22, 2022 05:53am
- Donepezil, a dementia treatment that has attracted attention for its convenience of administration, has been listed at a lower price than existing drugs, indicating that it has price competitiveness. 87.5mg patch, which replaces the existing 5mg tablet, costs 8,310 won per week, which is about 6,000 won cheaper than the highest price of the tablet. It's lower than the latest production. The Health Insurance Policy Review Committee of the Ministry of Health and Welfare held a meeting on the 20th and deliberated and voted on the upper limit of ICure Donhesive Patch and Celltrion Pharmaceutical Donerion. The two drugs were jointly developed by the two companies. Icure leads the commercialization clinical trial and is licensed jointly with Celltrion Pharmaceutical. The production is handled by the ICure. It is the first product to make Donepezil, which dominates the Alzheimer's dementia symptom treatment market by 80%, in the form of a patch. In particular, unlike oral drugs that must be taken every day, it is expected that the compliance of dementia patients who forget to take medicine will be greatly improved as they only need to be attached twice a week. The Korean Dementia Association believes that the drug is clinically useful because it has improved safety and convenience of taking medicine compared to oral drugs. Looking at the upper limit registered this time, it was found that it has such convenience and economy. The upper limit of 87.5mg, which is attached twice a week, was set at 4,155 won and 175mg at 6,076 won. This is less than 90% of the weighted average of generics. 87.5 mg replaces the existing 5 mg tablet taken once a day. The weekly price of 5mg tablets is distributed in various ways, with 125 products ranging from the lowest price of 3,500 won to the highest price of 14,420 won. The original Aricept 5mg has an upper limit of 1,902 won per day, and the price per week is 13,314 won. The 87.5mg patch is about 5,000 won cheaper. Initially, ICure and Celltrion Pharmaceutical also predicted that they would sell it cheaper than the original, but it came out cheaper than expected. It is much cheaper than powder type, which was first listed last month. Hyundai Pharmaceutical's Hypezil. The price of 5mg powder is 11,900 won, which is 3,590 won more expensive than 87.5mg patch. From a company's point of view, if the sales volume is the same, the price must be high to make more profits. However, since Donepezil is already a market where more than 100 pharmaceutical companies compete due to the expiration of patents and the recognition of original drugs is high, some analysts say that it will be difficult to settle in the market if the price is high as generics. Celltrion Pharmaceutical is on the verge of withdrawing its benefit as Godex, which has recently reached 70 billion won in sales, concluded that it is not suitable for the evaluation. Celltrion Pharmaceutical is also selling products that are acquired by its parent company Biosimilar and Takeda. But there is a lack of blockbuster brands other than Godex. Attention is being paid to whether Donerion Patch, which will be released this time, can be a representative item of Celltrion Pharmaceutical that connects Godex.
- Policy
- Drug e-labeling and abolition of PMS reexaminations...
- by Lee, Hye-Kyung Jul 22, 2022 05:53am
- The Ministry of Food and Drug Safety announced that it will refrain from making a unilateral announcement of regulations, and Suk-Yeol Yoon’s government announced that it would reform regulations by listening to the opinions of the industry. As part of such efforts, the MFDS had conducted 7 internal discussions since Yoon’s inauguration to set tasks for regulatory innovation and conducted a national public debate at the Korea Chamber of Commerce and Industry from 10:00 a.m. today (21st). (From the left) Seok Yeon Kang, Director-General of the Pharmaceutical Safety Bureau; Sang Bong Kim, Director-General of the Biopharmaceuticals and Herbal Medicine Bureau; Nam Hee Lee, Director-General of the Medical Device Safety Bureu; Hun Woo Hong, Deputy Director General for Narcotics Safety Planning Through the public debate, the MFDS was able to prepare key tasks to review for regulatory innovation, including ▲the introduction of a classification system for temporary items such as digital healthcare devices, ▲support for rapid development of biopharmaceuticals developed using innovative technology (microbiome, exosome, etc.) ▲expanding designation of innovative medical devices ▲promote allowance of the manufacture and import of cannabis containing pharmaceuticals ▲preparing a classification and safety management system that aligns with the characteristics of combination products ▲exemption from receiving MFDS approval for clinical trial protocols for medical devices with a low understanding ▲allowing the performance of clinical trials on diagnostic software at sites other than clinical trial institutions, etc. Also, the MFDS plans to review 20 tasks including: ▲expanding subjects for prior review to rapidly commercialize medical devices, ▲phased introduction of e-labels for pharmaceuticals ▲ private-led conversion of natural/organic cosmetic certification system ▲allowing holding concurrent positions as a manufacturing manager for low-strength vitamin preparations (quasi-drugs) ▲Expanding the use of overseas investigational drugs for therapeutic purposes ▲Improving post-marketing surveillance systems for biopharmaceuticals ▲transferring the sample collection procedure required for national lot release approval to the private sector ▲Introduction of a differential management system when changing labels of a drug ▲Improving indications for quality testing of biologics ▲Simplifying application for performance testing of in-vitro diagnostic devices ▲Abolishing reporting obligations on use of cosmetic ingredients ▲Abolishing reexamination of of post-marketing safety management system and , integrating it into the risk management plan ▲ abolishing the transfer approval system to return medical narcotics. More specifically, in the case of changing the labels of a drug, the company had to change the insert paper in its printed form within the grace period (1-3 months), however, through the phased introduction of the e-label, the ministry plans to provide safety information in real-time with the e-label when labeling changes occur. Also, to allow for the use of real-world data (RWD) in the post-marketing pharmacovigilance of vaccines for infectious pandemic diseases, the MFDS will improve the post-marketing pharmacovigilance system for biopharmaceuticals, as in the US and Europe. Also, among the post-marketing safety management system that has been dualized into the reexamination and risk management plan system, the MFDS will work to abolish the reexamination system and integrate it into the risk management plan system. In the case of the abolition of the transfer approval system, as people had complained of the work delay on site due to the transfer approval procedures of the medical institution, pharmacy, etc. after the transferee receives approval from the competent licensing authority and returns the pharmaceutical to the original owner. Therefore, the system will be improved so that narcotics and psychotropic drugs may be returned to the original owner without approval from the competent licensing authority. At the event, Yoo Kyung Oh, Minister of Food and Drug Safety, said “the subject of regulations is important for the industry to emerge into the global market while ensuring safety. Regulatory innovation should not be a unilateral process where the government decides to lift certain regulatory items and announces it.” Yoo Kyung Oh, Minister of Food and Drug Safety announced that the ministry will l refrain from making a unilateral announcement of regulations at the ‘Public Debate on Regulatory Innovation for the Medical-Pharmaceutical Industry” Minister Oh added, “The MFDS is a regulatory institution that protects public safety. I have contemplated much on wetting the right regulatory target for the past 50 days since my appointment. Regulations play an important role in protecting safety but they may act as a barrier to the industry, so we held 7 internal discussion sessions on regulatory innovation.” Minister Oh said, “The regulatory barriers in the pharmaceutical sector are high and we still have a long way to go. The MFDS wishes to support the pharmaceutical industry’s prompt entry into the global market. Yoon’s administration also aims to innovate the administrative process for food and drugs to meet the international standards, therefore we will humbly listen to the voices of the people rather than unilaterally act on it.” On the 21st, the MFDS held a Public Debate on Regulatory Innovation for the Medical-Pharmaceutical Industry” at the at the Korea Chamber of Commerce and Industry. The MFDS plans to publicly announce its tasks for regulatory innovation that can be felt by the public and industry, including the regulatory innovation review tasks that were disclosed this time. Also, the MFDS announced it will continue to maintain a regulatory innovation system to aid public convenience and industry development, by operating public-private consultative bodies in each field and operating a regulatory innovation promotion team under the MFDS.
- Policy
- Billions of won in losses if applied retroactively
- by Lee, Tak-Sun Jul 22, 2022 05:53am
- The pharmaceutical industry is complaining about the retroactive application of detailed operation guidelines revised in April at this year's PVA. Although it has already officially proposed excluding retroactive application to the NHIS twice, the NHIS' position is firm. Analysts say that such an issue will be a hurdle to settle the negotiations at a time when the NHIS entered negotiations with the aim of adjusting drug prices in September. In particular, there are pharmaceutical companies that are expected to suffer billions of won in losses from retroactive use, which is expected to take legal action in the worst case scenario. According to the industry on the 20th, the industry officially proposed excluding the retroactive application of detailed operation guidelines in May and June, but the NHIS does not accept it and is negotiating. In the detailed operation guidelines revised in April, the key is to limit PVA exclusion to cases where the main component code is less than 90% of the arithmetic average. Previously, cases where the arithmetic mean was less than that were excluded. As a result, although the arithmetic average price is less than 90%, there are items that have been newly negotiated. For example, in the case of Choline alfoscerate which was mentioned in the revision of the guidelines, Gliatamin soft cap, the No. 1 item in sales, is subject to negotiation in accordance with the revised guidelines. The price of the Gliatamin soft cap is 504 won, and the arithmetic average of the main component code is less than 512 won, but the arithmetic average exceeds the 90% (460 won) standard and is included in the target. As of last year's UBIST, Gliatamin's outpatient prescription amount was 110.1 billion won. PVA is supposed to adjust the upper limit from less than 10%, and if the upper limit of Gliatamine falls by only 5%, the company will lose more than 5 billion won. As such losses are formidable, the pharmaceutical industry as a whole is raising its opinion that the revised guidelines should not be applied retroactively in the negotiations. Usually, compared to the previous year's and the previous year's claims, it is an item subject to negotiation if it increases by more than 60% from the previous year's claims, or if it increases by more than 10% and more than 5 billion won. The industry points out that it is impossible to proceed with negotiations based on the previous year's claims as the guidelines have been revised this year. However, the NHIS explained that there is no issue of equity as it has continuously mentioned the guidelines, strengthened the scope of exclusion from negotiations, and applied relaxed standards. The NHIS plans to negotiate with the aim of adjusting the upper limit in September. An official from the NHIS said, "The opinion has been submitted twice, but we plan to proceed with the negotiations as planned." An official from the pharmaceutical industry said, "We mentioned the revised guidelines since last year, but the pharmaceutical industry continued to maintain its opposition until the revision." "If it is applied as a small amount, we plan to watch the results of the negotiations and respond as the damage is great," he said. It is known that both sides are currently reviewing legal principles. If negotiations break down, renegotiation is possible, but if differences are not narrowed in renegotiation, the drug will be excluded from the benefit. In this case, it is highly likely that the pharmaceutical company will solve the problem through lawsuits.
- Policy
- Negotiations for Pfizer Lorviqua have not been completed
- by Lee, Tak-Sun Jul 22, 2022 05:52am
- Pfizer It was found that Lorviqua' a third-generation non-small cell lung cancer treatment that inhibits ALK (anaplastic lymphoma kinase), failed just before being listed. The HIRA announced the establishment of a standard next month, but the NHIS negotiations were not completed, leading to the deletion again. According to the industry on the 19th, Lorviqua passed the HIRA Pharmaceutical Benefit Evaluation Committee in April and has since been negotiating drug prices with the NHIS. As the committee judged that there is an appropriate benefit for the treatment of adult patients with ALK-positive progressive non-small cell lung cancer, the industry believes that it would not be unreasonable to pass if the pharmaceutical company and the NHIS derive an appropriate drug price. As a result, some predicted that the benefit would be registered as early as the 1st of next month. However, the negotiations have not yet been completed, so it is expected that it will not be registered until September at the earliest. This fact is known as the announcement of the establishment of an anticancer drug benefit standard by the HIRA. Initially, the HIRA conducted an opinion inquiry on the revision of the announcement according to drugs prescribed and administered to cancer patients on the 18th, signaling the establishment of a new benefit for Lorviqua in August, but it was immediately deleted. This was because drug price negotiations with the NHIS have not yet been completed. Lorviqua is a third-generation drug that can be used if ALK-positive non-small cell carcinoma patients use first-generation Xalkori, second-generation Zykadia, and Alecensa, but it is not effective. In other words, it is a new alternative for patients who have used second-generation drugs but become resistant. Patients are also expected to be registered quickly. However, it will be possible only after one more month.
- Policy
- “Pharma companies cannot conduct online product briefings"
- by Kim, Jung-Ju Jul 21, 2022 06:04am
- “Online product briefing sessions by pharmaceutical companies are clearly illegal, but we cannot directly warn the pharmaceutical industry by pressing charges or requesting investigations at the moment." With the prohibition temporarily lifted on the pharmaceutical and medical device companies’ support of online academic conferences, the government made it clear that the online product briefing sessions should be straightened out in a relatively mild manner, such as by status surveys or advance notices. Director Tae Gil Ha and Deputy Director Jung Hyun Yeo of the Division of Pharmaceutical Policy at MOHW responded so during the QA session on the present state of affairs that was held with the MOHW correspondent council. The following is a QA on the present state of affairs discussed at the session. (From the left) Deputy Director Jung Hyun Yeo, Director Tae Gil Ha of the Division of Pharmaceutical Policy at MOHW ▶The government has temporarily extended the allowance of advertisements and sponsorships on online and ‘hybrid (on+offline)’ academic conferences due to the COVID-19 situation. Do you have any plans to institutionalize this in the future? “The regulation on online academic conferences, if amended, falls under the Fair Competition Code of the Korea Fair Trade Commission. Therefore, to systemize this, changes should be made to the Fair Competition Code. We discussed this while meeting with the FTC to temporarily extend the allowance of online academic conferences. The FTC’s position is that the current form of online academic conferences is not fit for temporary extensions and would need to be institutionalized in the future. Lifting the temporary period limitation can be done by revising the Fair Competition Code. Of course, this discussion would be made next year (after the temporary extension ends), but the direction that they will take is to institutionalize online academic conferences through code revision. ▶The training education by individual medical institutions that were allowed for the past one year is now impermissible. Why has this changed? “This is an exception made from the previously allowed acts against the Fair Competition Code. It is MOHW’s role to compromise the opinions between the industry and the medical community. As the online training was exceptionally allowed due to the nation’s social distancing measures, the MOHW worked to coordinate and combine the opinions and derive a compromised option. The “no expense support for long-term care institution-level academic conferences” was not decided by MOHW. The decision reflects the opinion of member companies of industry associations such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the Korea Medical Devices Industry Association, and the Korea Research-based Pharma Industry Association. They say that online events are less effective in terms of advertisement than face-to-face events. There are grounds for allowing events at the long-term care institution level regardless of size. This means that the member companies regarded this burdensome with little advertisement effect. Some may ask whether we disallowed it against evidence, but in the relationship aspect, its allowance would have tilted the scale to one side. This was why we decided to reflect industry opinions.” ▶What plans do you have in place for regulating “digital marketing," the online product briefing sessions? “Under the current law, holding an online product briefing session in itself is allowed, but the company may not provide economic benefits to medical professionals attending the event. Some in the pharmaceutical industry believe this should be deregulated somewhat. However, others in the industry have pointed out that if this is allowed, it may become means to provide detour rebates online. We have listened to the industry’s opinion on this recently, but the discussion is still ongoing as a consensus has not been made yet. In conclusion, it is illegal to hold an online product briefing session and provide economic benefits to attending medical personnel under the current law. We are currently discussing the need to improve the system." ▶Then as the discussions are still ongoing, don’t you think you should inform the companies that are currently providing such benefits of the possibility of punishment to clarify the signal? “We need to first understand the current situation rather than press charges or requesting investigations. We need to see which companies are providing benefits. It means that we should meet with the companies and listen to their story rather than press charges right away.” ▶The pharmaceutical industry would want the government to clarify and organize the situation in advance before cracking down on the industry as it had done in the past for offline rebates. "We will not be requesting prosecutions immediately. It is realistically impossible for MOHW to find all companies and file charges. We should first provide guidance or advance notice.”
