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- 2026-06-10 21:10:46
- Opinion
- [Reporter's View] Delays in medication switching for eczema
- by Eo, Yun-Ho Aug 13, 2024 05:48am
- When patients switch from their current medication to a different medication, the switched products are not covered by insurance reimbursement. This non-reimbursed status of medication switching has been a long-standing issue in South Korea. The field most impacted is atopic dermatitis. Treatment options had been limited for atopic dermatitis, but various new drugs became available over the past years. New medications, such as interleukin (IL)-inhibitors and JAK inhibitors, have relieved patient burdens, and fortunately, these drugs are listed for reimbursement. However, an issue related to medication switching recently surfaced. When a patient switches prescriptions to a different medication after initially using biologic mediation, such as interleukin (IL)-inhibitors, or oral medication, such as JAK inhibitors, reimbursement is no longer provided. As a result, patients cannot easily switch to a different drug when they experience adverse reactions during treatments or do not benefit from the drugs. Individuals respond differently to all drugs. This could be due to genetic differences or various factors such as age, gender, and race. Having many treatment options means that patients can choose from a pool and anticipate other possibilities when they do not respond to a particular drug. The current Korean policy may be limited to offering this type of 'expectancy.' Additionally, this policy leads to prescription bias. Conventional biologics are more expensive than chemically manufactured medicines. If two medications have equivalent therapeutic status but vary significantly in price, and medication switching is not covered, most patients may be biased towards biologics. In the first half of the year, the Korean Atopic Dermatitis Association stepped forward. The Association submitted an opinion report to the Ministry of Health and Welfare (MOHW) demanding medication switching in treating atopic dermatitis. Furthermore, the Association clarified that there are no differences in therapeutic status between biologic agents and oral medication through the guideline revision made in 9 years. The government initiated a review. Presumably because it has decided that demands and needs are precise. Previously, the government had hesitated to provide reimbursement approval for medication switching due to the "shortage of scientific evidence regarding medication switching." Of course, medication switching is not backed up by clinical studies. However, South Korea is the only country not approving medication switching. Indeed, a study cannot be conducted every time new drugs are introduced and cannot wait for real-world data or other literature review. Ultimately, the speed matters. We have records of wasting close to 10 years in approving reimbursement for medication switching of TNF-alpha inhibitors to treat rheumatoid arthritis. Medication switching of JAK inhibitors in other autoimmune diseases, including ankylosing spondylitis, is already allowed. If the government hesitates, it will take a long time. Furthermore, companies must put efforts into increasing volume of use and finance.
- Opinion
- [Column] On patent strategies post Amgen v. Sanofi dispute
- by Kim, Jin-Gu Aug 12, 2024 05:55am
- One of the most significant events that occurred in the bio-pharmaceutical sector in recent years was the ruling made on the Amgen vs. Sanofi patent dispute in the United States. In May last year, the U.S. Supreme Court issued its final ruling on the patent dispute between the two biotech giants. The case received special attention, as the dispute over the validity or invalidity of patents lasted for nearly a decade in the KRW 1 trillion drug market and the first in a long time the U.S. Supreme Court ruled on the 'enablement requirement' of a patent. In 2011, Amgen and Sanofi each patented an antibody for the treatment of hyperlipidemia that binds to the PCSK9 protein, and developed Repatha and Praluent, respectively. Three years later, in 2014, Amgen registered two additional patents for antibodies that bind to the PCSK9 protein and immediately filed a patent infringement lawsuit against Sanofi. In response, Sanofi sought to invalidate both of Amgen's patents, and the dispute came to a head. Amgen was able to file its patent infringement lawsuit in 2014 instead of 2011 for a reason. Amgen's 2011 patent limited antibodies to an amino acid sequence, whereas the 2014 patent claimed antibodies more broadly. Amgen’s patent consists of an antibody that ▲binds to a specific amino acid or epitope of PCSK9; and ▲ prevents PCSK9 from binding to the LDL receptor. Claiming an entire group of antibodies that exhibit this specific function is called a “genus type” claim, which can include millions of individual species antibodies. As a result, genus-type claims have a very broad scope. Despite making such a broad claim, Amgen’s patent specification only disclosed: i) 26 amino acid sequences for antibodies that would block or inhibit PCSK9, and ii) two alternative methods (the roadmap, conservative substitution) for arriving at the remainder of the genus. The court found that the 26 exemplified antibodies were not sufficient to readily produce the entire genus of antibodies and that Amgen's 2 methods constituted separate research projects. The experts ruled Amgen's patents invalid and that they did not meet the enablement requirement because it would require extensive experimentation and trial and error to reproduce the invention. The Supreme Court’s ruling does not overturn the existing view of the enablement requirement, but it does set a clear precedent for the strict application of the requirement, which will have a significant impact on the industry going forward. The Amgen case has several implications. First, it highlights the need for new patent portfolio management. The U.S. Supreme Court's decision has a significant impact on the global patent industry in general. In the biotech sector, especially for antibodies, it will become more difficult to patent an entire genus of antibodies by function. The number of patent applications will naturally increase, and divisional patent application is expected to increase. Furthermore, the treatment of a double patent varies by country, requiring closer attention. A company that discovers a new target should attempt various different types of patent claims. In the bio field, discovering a new target is like finding a gold mine. Therefore, the company should protect the mine by pursuing the broadest claims possible. "Functional claims," like in Amgen’s case, have the advantage of capturing the best features of the target, but they are more likely to be rejected or invalidated. Therefore, rather than pursuing purely functional claims, claims should be drafted in a way that blends functional and structural elements. It's also a good idea to experiment with multi-step claim construction, such as going from broad to narrow. Deciding when to file is a key point in the bio patent application strategy. Historically, patent strategies had been focused on patent maps during the R&D phase, freedom to operate (FTO), or litigation strategies before the product launch, but companies should now pay more attention to the patent application strategy. In the bio sector, it takes a long time to generate experimental data, so it is especially important to decide when to file the patent, after securing how much data. More data can lead to a broader scope of rights but at the cost of a later patent application date. The patent application date should take into account whether the patent is for a platform technology or a follow-on technology, whether it is in the early research or clinical stage, how large the market is for the product, and how much data can be produced. It is recommended that universities, research institutes, and companies plan their patent application strategies according to their data production capacity. The stricter the patent system interprets the enablement requirement, the more favorable it is for global companies. For example, if a global company and a university discover a disease target "at the same time," the global company will have a better chance of obtaining a broad patent because it can produce a lot of data in a relatively short period of time. If a university, research institute, or startup makes an important early stage discovery, one way to reduce the risk is to find a collaborative research partner or license out the technology to increase data production capacity.
- Opinion
- [Reporter's View] Fostering Korea’s Pharma-Bio industry
- by Hwang, Byung-woo Aug 09, 2024 03:11am
- "Realistically speaking, it is not easy for the domestic pharmaceutical and bio industry to stand out in the global market. It's time we set a specific and clear direction and strategy." An industry expert with over 20 years of experience in pharmaceuticals in the U.S. who is currently serving as an advisor to government agencies in Korea responded so when asked about the status of Korea’s pharmaceutical and bio industry. While a few domestic companies are making a mark in the global market, the expert explained that Korea still has a long way to go in the big picture. The expert pointed to the difference in investments as a key example. When considering the trillions of won invested in R&D by global pharmaceutical companies every year, a natural gap in capabilities has to exist. Especially as R&D investments need to be made continuously rather than in the short term, the gap is bound to widen. The pharma and biotech industry has also been calling for the pooling of capabilities and resources at the national level to foster the industry. For example, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) submitted a statement to the 22nd National Assembly, calling for the government to fuifll its pledge made during general elections and increase R&D investment for new drug development. The government is also making efforts to foster the industry, including the launch of the Biohealth Innovation Committee under the Prime Minister's Office. However, much remains to be desired, as the K-Bio-Vaccine Fund is only half operational, and the Bio-Health Innovation Committee is operated under the Prime Minister’s Office instead of the President's Office. The industry pointed out the lack of synergy between policies caused by the various ministries involved in the development as one of the issues, leading to the rise of budget allocation issues, lack of direction, and fragmented communication. "The industry and policy direction needs to be aligned to support the expansion of Korea’s bio industry,” said Seung-kyou Lee, Vice President of the Korea Biotechnology Industry Organization, at Bioplus Interphex Korea 2024 in July. The time has come for the domestic industry to draw a bigger picture than the fragmented strategies devised by each ministry in finance, regulation, and global policy. The U.S. presidential election and the implementation of the IRA are opportunities that the domestic industry should not miss. Some advise against falling into the trap of thinking that the rise of a few companies is the rise of the entire domestic pharma and biotech industry. They caution against the pitfalls of focusing on where Korea ranks in the global market. In fact, when asked about the awareness of the Korean biotech industry, an overseas VC candidly replied, "Compared to China, Korea's is less known.” In order for the domestic pharmaceutical bio industry to become the next growth engine, the entire industry needs to step up, not just a few leading companies. It is time to think about policies and strategies that can move the industry in that direction.
- Opinion
- [Reporter's View] govt's foreign drug price comparisons
- by Kim, Jin-Gu Aug 08, 2024 09:24am
- The pharmaceutical industry's concerns grow over the government's plan to reevaluate foreign drug price comparisons. The government has established a policy to reduce domestic drug prices by comparing them to those in 'A8 countries (United States·Japan·Germany·France·Italy·Switzerland·Canada).' As the policy is set to be effective, the industry is busy estimating the scale of damage. Companies are estimated to experience a 5-20% reduction in annual sales. Therefore, the pharmaceutical industry voices concern that a sales reduction and an operational profit reduction will result in bigger damage. There are concerns that the scale of damage this time will be more substantial than the recent reintroduction of a stepped pricing system and reimbursement appropriateness reassessment. After considering the pharmaceutical industry's concern, the companies are not opposing to the reassessment soley due to the estimated damage. The industry has criticized that the criteria for comparing South Korean prices to those of foreign countries as unfair. For example, the industry considers referencing drug prices of Germany and Canada unfair. The government announced that when referencing drug prices in Germany and Canada, their public reimbursement prices, excluding outpatient payment, will be used. However, Korean drug prices include outpatient payments. In other words, the drug prices of countries for comparison will be lower, resulting in a greater degree of drug price reduction. For the past ten meetings since the end of last year, the pharmaceutical industry has strongly criticized the discrepancy in reassessing foreign drug price comparisons, including the issue mentioned earlier. However, sources said the government hesitated to take the pharmaceutical industry's opinion. Ten meetings between the government and the industry have concluded, and an agreement has yet to be reached. After the tenth meeting officially concluded, the Ministry of Health and Welfare (MOHW)'s Director of Pharmaceutical Benefits, who is in charge of the agenda, was replaced. In the second half of July, the MOHW held a regular personnel appointment and appointed a new Director of Pharmaceutical Benefits. Consequently, the person in charge of the final implementation of reassessing foreign drug price comparison has changed. The pharmaceutical industry has high hopes for these changes. They hope that the new Director will consider the industry's submitted opinions. At the last meeting, the industry had suggested several alternative measures. Opinions included improving how the government references drug prices in Germany and Canada, reducing drug price reductions amount by 50%, and putting a ceiling cap on the percentage of drug price reduction. It remains to be seen whether the new Director will consider these opinions. The prevalent opinion in the industry is that the government must completely reconsider the plan for reassessing foreign drug price comparisons. However, some are likely to follow the plan when unfairness is addressed. Now, the government is left to decide. The industry waits for appointment of the new Director.
- Opinion
- [Reporter’s View] More legislation needed for CSO reporting
- by Lee, Jeong-Hwan Aug 01, 2024 05:48am
- The enforcement of the Pharmaceutical Affairs Act, which requires Contract Sales Organizations (CSOs) to report to local governments and educate their employees on the prohibition of rebates, is now 2 months away. The pharmaceutical and CSO industries are hoping the implementation of the reporting system will serve as a milestone to increase the transparency of illegal drug rebate practices and put behind their past where CSOs were used as black money payment channels to promote the physicians’ prescription of certain drugs. In law with the law's implementation, the Ministry of Health and Welfare (MOHW) announced the proposed amendments to the Enforcement Rules of the Pharmaceutical Affairs Act on March 18 and began collecting industry opinions. Once the reporting system is implemented, CSOs are expected to ensure justice in sales practices within the pharmaceutical and biotechnology industry and be incorporated into the system, thus being manageable by the government. Of course, the Ministry of Health and Welfare, the pharmaceutical industry, and the CSO industry will need to work together to improve the problems or shortcomings that may arise upon the implementation of the system, but the CSOs, whose existence has been virtually unrecognized until now, will be able to take shape and advance the pharmaceutical industry’s sales practices. However, there is still legislation that needs to be enacted in line with the CSO reporting system -the Medical Service Act. The act needs to prohibit doctors from accepting rebates, including financial kickbacks and entertainment provided by CSOs. Such amendment to the Medical Service Act passed the Health and Welfare Committee review and was pending at the Legislation and Judiciary Committee’s 2nd Bill Review Subcommittee stage at the 21st National Assembly, but was eventually abandoned due to the closure of the 21st NA. The CSO reporting system and training obligations will strengthen the government and local governments' control over CSOs' illegal rebate practices, but there are concerns that its effect may be halved unless it is followed by an amendment to the Medical Service Act, which will prohibit doctors from accepting rebates. Article 23(5) of the Medical Service Act, which prohibits doctors from gaining improper financial benefits, needs to be amended. The "drug suppliers" need to be changed to "drug suppliers and contract sales organizations (CSOs)" to provide a clear legal basis to punish doctors for accepting rebates from CSOs. Some have even suggested that amending the Medical Service Act would be more effective in eradicating rebates than the CSO reporting system. Therefore, the Ministry of Health and Welfare and the 22nd National Assembly should work together to promptly amend the Medical Service Act. The authorities need to minimize the period of the CSO reporting system being operated as a half-baked system because the legal basis for prohibiting doctors from receiving rebates for CSO payments has not been established. The MOHW should reiterate the need to quickly introduce, examine, and pass the proposed amendments to the Medical Service Act, and the ruling and opposition parties in the Health and Welfare Committee should also join forces to expedite the passage of such legislation to achieve the goal of eliminating rebates. With the CSO reporting system set to go into effect on October 19th, the National Assembly needs to seriously consider passing amendments to the Medical Service Act to enhance the effectiveness of the system and fill in the gaps in the legislation in time.
- Opinion
- [Reporter's View] Insight into reimb of high-priced drugs
- by Eo, Yun-Ho Jul 30, 2024 05:52am
- How should we consider the reimbursement coverage of 'preventive' drugs that are not used to treat disease or improve symptoms? This is not a new concept. Individuals have taken medicines for 'management' rather than treatment for chronic diseases. Medicines such as coagulants are primarily preventive care. However, it has become an issue as more high-priced drugs are on the market, expanding reimbursement coverage to anticancer drugs. Various new anticancer drugs are being studied to secure and add indication for use as pre- and post-operative adjuvant therapy. Numerous next-generation new drugs, including cancer immunotherapy, targeted cancer therapy, and antibody-drug conjugate (ADC), now have expanded indications for adjuvant therapies. In other words, there are plenty of indications. However, an issue arises with adjuvant therapy. The challenge is the price. As most people know, cancer can relapse even if initially diagnosed as fully recovered. Depending on different cancer types, the recurrence rate can be up to 80%. Prescribing anticancer drugs as adjuvant therapy and allowing those to be reimbursed burdens the Ministry of Health and Welfare (MOHW). It is uncommon for adjuvant therapy to be reimbursed in South Korea. Furthermore, academics also pay attention to the benefits of adjuvant therapy. Guidelines by notable international academic organizations have started to include adjuvant therapy and assign the highest grade. The Korean market must stop looking the other way. Relevant parties must carefully assess the necessity of adjuvant therapy and consider its benefits rather than viewing it as an unwarranted 'burden.' Administering adjuvant therapy to relapsed patients can be less cost-effective. The number of pharmaceuticals acquiring indications for adjuvant therapy and maintenance therapy is increasing. Rather than considering only the loss and benefits, pharmaceutical characteristics and patients' circumstances must be considered. Efforts from all relevant parties are required to reach an agreement that considers the National Health Insurance system and the pharmaceutical industry's stances.
- Opinion
- [Reporter's View] Pharmas rethink bio venture investments
- by Lee, Seok-Jun Jul 30, 2024 05:51am
- Multiple pharmaceutical companies have made significant investments in promising bio ventures, spending a substantial amount to acquire shares. Some have become the largest shareholder, and those holding over 5% of the share are involved in the management. Through the investment, companies anticipate sharing R&D results in the future. However, such expectations pose challenges. First, ventures require regular funding. Venture pipelines are mostly in early clinical stages. They must secure costs for the later phase of clinical trials. However, it is uncommon for ventures to generate sales regularly. As they advance to later phases of clinical trials, they may quickly need funds. Listed ventures depend on exterior funds, such as recapitalization and convertible bonds (CB). This process works by issuing new stock to raise funds. Pharmaceutical companies investing in ventures want to secure liquidity through clinical trials. However, the percentage of shares owned by pharmaceutical companies decreases with new stocks. Some companies have complained that unnotified funding disrupts their business plans. Pharmaceutical company A owner complained, "We have invested in Venture A by acquiring over 5%. However, our stock share reduced to 3% after Venture A received multiple funding. Frequent funding of Venture A caused a market liquidation signal, leading to decreased stock prices. Unnotified funding has resulted in a setback for our business plan. We are reconsidering whether to hold the share." Moreover, pharmaceutical companies are also concerned about the gap between the venture's plan for clinical trials before going public and the present. In this case, a decrease in stock prices could result in a reduction in stock share value. In the fifth year of listing, most pipelines of TiumBio did not reach the originally planned clinical stage or achieve technology transfers. Their accumulated net loss is over KRW 100 billion. Before being listed on the KOSDAQ at the end of 2019, TiumBio expected to turn a net profit from 2022, anticipating generating a net profit of KRW 54.1 billion by 2023. However, the company has been in deficit. The company also expected to raise operating revenue of KRW 81.5 billion in 2023 but realized operating revenue amounted to KRW 4.9 billion instead. During this time, TiumBio's market capitalism plunged by one-fourth over three years and a half. Consequently, pharmaceutical companies are withdrawing their venture investment shares because of frequent funding and differences in their investment plan compared to the venture's listing. Companies like D and W have retrieved their principal, leaving only the rest of the shares, and another company sold the entire second-quarter stock. Of course, pharmaceutical companies invest in ventures at high-risk and high return because they have invested in the potential R&D of those ventures. However, ventures must also take some responsibility. Ventures must not defend that frequent funding is prerequisite for clinical trials. They must notify all investment partners before raising funds. Additionally, ventures must explain the differences between expected gain and realized loss. They should not argue that delays in earning profits are anticipated outcomes of clinical studies. Many venture companies receive frequent funding, and their outcomes are different from their initial plan before going public. Pharmaceutical companies that have invested in these venture companies are reconsidering their investments. If this trend continues, it may disrupt the virtuous circle of investment between pharmaceutical companies and venture technology.
- Opinion
- [Reporter's View] Keeping up with the Chinese bio industry
- by Son, Hyung-Min Jul 24, 2024 05:51am
- The research and development (R&D) capabilities of Chinese pharmaceutical companies are going from strength to strength year after year. Last year, the immuno-oncology drug Loqtorzi, developed by Junshi Biosciences, was approved in the United States. It became the first Chinese immuno-oncology drug to be approved by the U.S. Food and Drug Administration (FDA). While Chinese anti-PD-L1/PD-1-targeted immuno-oncology drugs have been approved within China, this is the first time they have crossed the FDA approval threshold. This year, BeiGene’s immuno-oncology drug Tevimbra was approved by the FDA. Another Chinese drugmaker, Innovent, is also seeking FDA approval for its own immuno-oncology drug sintilimab in partnership with Eli Lilly. The domestic pharma and biotech industry has also launched a number of immuno-oncology drugs, but most of them are still in the pre-Phase II stage. This is in contrast to Chinese companies, which have completed Phase III trials and are closer to global commercialization. China is leading the way in global commercialization not only of immuno-oncology drugs but also of next-generation therapies such as targeted anti-cancer drugs, gene therapies, and nucleic acid therapeutics. On the other hand, Korea has not been able to make a significant impression in the global market outside of biosimilars. In fact, the number of global new drug approvals by Korean pharmaceutical companies is incomparable, far less than that of Chinese pharmaceutical companies. The number of global new drug approvals by Chinese pharmaceutical companies in countries other than the US has also been steadily increasing, receiving approvals for 44 new drugs in 2020, 40 in 2022, and 14 last year. In the United States, 11 Chinese-made drugs have been approved in the past 3 years. In the case of Korean pharmaceutical companies, only 8 new drugs have been approved so far. In terms of clinical trials, China's share grew by 6.1% from 2019 to 2023, while Korea's share grew by only 0.3% during the same period. Government support has played a major role in raising the Chinese pharmaceutical industry's R&D capabilities. The Chinese government has deisgnated the pharma-bio industry as its economic growth engine and has shortened the approval time for drugs by innovating the CFDA’s review system. Examples include priority review drugs, expanding the number of Centers for Drug Evaluation (CDEs), and accepting overseas clinical data. As a result, China's clinical and new drug review time has been reduced by about one-third compared to before 2015. The expansion of China’s insurance reimbursement that increased the number of drugs on the reimbursement list has also worked in favor of Chinese pharmaceutical companies. The Chinese government continues to expand insurance reimbursement coverage of new drugs, and the revenues are being channeled into R&D investments. Korea, on the other hand, has been less successful in supporting R&D. The Yoon Suk-Yeol's government pledged to support bio R&D from the beginning of his administration, pledging to ‘establish a pharma-bio control tower’ to integrate, foster, and support the pharma-bio industry. However, to date, cooperation between the government and the industry has not been active, as the control tower, the Biohealth Innovation Committee, has not been fully operationalized, and regulations restricting the pharmaceutical industry, such as the drug price reduction system and reimbursement adequacy reevaluations, continue to increase. In order to create new global drugs, Korea needs to establish specific regulations and support systems for innovative drug development. It is illogical to expect good drugs to be made while investing less. Only more investment can lay the foundation for the development and launch of new global medicines. The government has budgeted KRW 2.9 trillion for fundamental R&D next year, which is the largest amount ever allocated. It is this reporter’s hope that this will spur the biotech industry to invest in challenging research areas and develop innovative new drugs.
- Opinion
- [Reporter’s View] ‘Cool time’ too short for price cuts
- by Kim, Jin-Gu Jul 19, 2024 05:47am
- There is a gaming term called 'cool time.’ It refers to the cooling down time a character in a game needs to wait before reusing a certain skill. Looking at the government's recent drug price reduction measures, its ‘cool time’ seems to be too short. The price cuts have been imposed on generic drugs continuously since around the 2020 drug price reform. In July 2020, the government revived the 'tiered drug price system'. If a generic drug meets the requirements of conducting a self-bioequivalence test and registering a domestic active pharmaceutical ingredient, the price of the generic drugs listed on the 21st and later were cut by 15%. The government retroactively applied the new system to previously listed generics. Twenty thousand listed generics were subject to price reevaluations, and the prices of more than 7,000 generics were lowered simultaneously last year. Earlier this year, a second round of reevaluations was conducted on listed generics, resulting in additional price cuts of more than 1,000 items. In July this year, the price cuts on actual transaction price that is conducted every 2 years were conducted. The prices of more than 4,000 drugs that were supplied and billed at lower prices than the upper limit were reduced. In addition, since 2020, the annualized reimbursement reevaluation has been repeatedly eliminating reimbursements, reducing the scope of reimbursement, and forcing voluntary drug price reductions. Drug prices have also been repeatedly reduced due to price-volume agreement negotiations. Since the end of last year, the government has been discussing comparative reevaluation of overseas drug prices (external reference pricing reevaluations). The plan is to reduce the price of generic drugs in Korea by comparing their price with A8 countries, which are Korea’s drug price referencing countries. The repeated drug price cuts have caused much confusion in the pharmaceutical industry. Pharmaceutical companies are bearing losses due to price cuts, and pharmacies are experiencing confusion due to the monthly changes in drug prices. Some pharmaceutical companies challenge the drug price cut measure through lawsuits. The confusion on the front lines is amplified when courts issue and lift injunctions. This is not to say that price reductions have not happened before, but the pharmaceutical industry has had plenty of time to adapt at the time. Historically, major generic pricing policies have typically been in place for 6-7 years upon implementation. The tiered pricing system, introduced in 2007, operated until 2012. After the 2012 generic price cuts, the system of equal pricing for identical ingredients was implemented until 2020. However, since the revival of the tiered drug price system in 2020, various price reduction measures have been operated simultaneously. And another huge wave of reevaluations is set to hit the field, with the imminent implementation of the external reference pricing system. Games have a ‘cool time’ because the overuse of a specific skill can put off the balance of the entire game. The same goes for the drug price reduction measures. Too many repetitive drug reductions will unbalance the entire pharma-bio industry. The current ‘cool time’ is too short.
- Opinion
- [Reporter’s view] public-private consultative body
- by Lee, Jeong-Hwan Jul 17, 2024 05:50am
- During the swine flu pandemic, South Korea had a challenging time due to the Tamiflu shortage. Then, during the COVID-19 pandemic, the government spent national finances to import vaccines from the U.S., Europe, and even Russia due to the absence of local mRNA vaccines. During the COVID-19 pandemic, countries worldwide focused on locally distributing medicines and active pharmaceutical ingredients (API), and strengthened the trade hurdle, maintaining a closed economy. Therefore, South Korea acknowledged the importance of the pharmaceutical and biotech industry as a national security industry. The World Health Organization (WHO) announced the end of the COVID-19 pandemic in May of last year. However, the pharmaceutical sector is still affected by its aftermath. There are shortages of basic essential drugs, such as antipyretic analgesic agents containing acetaminophen. Fortunately, the government department responsible for the sector actively meets with a public-private consultative body for drug shortages to resolve the issue. The Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) regularly host meetings with officials from the Health Insurance Review and Assessment Service (HIRA), Korea Pharmaceutical Association, the Korean Medical Association, and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) to review current drug shortages list and possible causes and discuss solutions. Consequently, out-of-stock medicine issues have been resolved with updated policies, such as maintaining production cost and conditional drug price increase, to encourage the volume of production by the pharmaceutical companies that are manufacturing out-of-stock medicines, and administrative measures to simplify the distribution stage. For these effective administrative measures to continue producing positive results, we need to institutionalize them through legislation. In other words, this must be submitted for an item to the National Assembly to specify running a public-private consultative body for drug shortages in the Pharmaceutical Affairs Act. The "public-private consultative body for drug shortages" bill was passed by consensus in the relevant standing committee, the Health and Welfare Committee, in the 21st National Assembly and submitted to the Legislation & Judiciary Committee. However, it was not enacted due to the expiration of the legislative term, resulting in legislative failure. Fortunately, the same bill was reintroduced in the early stages of the 22nd National Assembly and will be considered for review. Drug shortages, which occur frequently and suddenly, disrupt pharmacies and pose a threat to public health. The National Assembly must prioritize and address this pressing national issue with total effort for the well-being of the citizens. Establishing a management committee involving both public and private sectors is crucial to supervising drug shortage distribution and implementing a drug shortage management system. Additionally, legislative measures should ensure the authority to issue emergency production and import orders for drugs in short supply. Establishing this will be essential for effectively addressing drug shortages without delays in an upcoming pandemic. We hope the new National Assembly is aware that the previous legislative term ended without passing this bill, and we hope they will promptly resolve issues through swift legislation.
