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- 2026-07-22 13:39:13
- Opinion
- [Reporter’sView] Finding the key in platform technology
- by An, Kyung-Jin Jul 03, 2020 06:18am
- The world is eyeing on companies developing platform technology for novel drug. In last few years, Korean bio technology companies like ABL Bio, LegoChem Biosciences and Alteogen have signed deals worth over a trillion won with global pharmaceutical companies on rights over platform technology that facilitates drug delivery. Each in last November and June this year, Alteogen signed two licensing agreements with global pharmaceutical companies on human hyaluronidase (ALT-B4) technology that enables intravenously injected biologics to also work as subcutaneous injection. The company earned 35 billion won from the two companies licensed in the platform technology. The number already exceeds the Korean company’s sales in last year totaling at 29.2 billion won. From last year and on, LegoChem Biosciences have inked three deals on antibody-drug conjugate (ADC) technology. The technology mediates efficient delivery of drug to cancer cells by improving the unstable linkers between protein and antibody. In March last year, LegoChem licensed out three ADC-applied novel anticancer therapies to Millennium Pharmaceuticals, a subsidiary of Takeda Pharmaceutical. And in April and May this year, the Korean company signed deals for the U.K.-based Iksuda Therapeutics to hold exclusive rights to use the ADC technology and ADC-based cancer therapy. A platform technology is defined as source technology to apply on development of new drugs. Such technology can enhance medication convenience or benefit by changing injection to oral administration or switching intravenous route to self-injectable subcutaneous injection. The biggest appeal of the platform technology in novel drug development is the potential of expansion. Generally, the probability of candidate medicine to receive sales approval at Phase I clinical trial stage is 10.4 percent, at Phase II is 16.2 percent and at Phase III is 50.0 percent. Even a company with multiple new drug pipelines cannot be completely free from the probability of failure. On the contrary, platform technology holds less risk in failure as it could be used on different candidate drug when it fails in other. For instance, Hanmi Pharmaceutical took a blow when Sanofi returned the rights over efpeglenatide, but if the neutropenia treatment Rolontis (eflapegrastim) gets approval from the U.S. Food and Drug Administration (FDA) within this year, the Lapscovery technology’s potential could be reevaluated. Like the licensing agreements LegoChem or Alteogen signed, an exclusive rights or a novel therapy based on the technology could be transferred. But also the licensing profit could be maximized by signing a non-exclusive deal on the technology. Good news to the Korean industry is that the world’s perception on Korean pharmaceutical and bio companies have significantly improved in last few years. The Korean industry’s successful outcomes are yet to be tangible, but there are many companies with platform technologies on par with other global companies. Hopefully, the heightened interest on the platform technology would induce investment on these promising companies.
- Opinion
- [Reporter’s view] Listed drug reevaluation, now what?
- by Lee, Hye-Kyung Jul 01, 2020 05:56am
- The Korean health authority issuing a statement on reducing choline alfoscerate coverage is just a beginning. On June 11, Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) announced the decision to raise the patient copayment rate on choline alfoscerate, which has been covered by the National Health Insurance so far, from 30 percent to 80 percent for the effect and benefit of treating neurometabolic disease, emotional and behavioral change, and senile pseudo-depression. Increasing the copayment rate means the authority is to narrow the coverage on the drug. The selective reimbursement on the drug would impose 80 percent of copayment rate. The original full coverage would be limited the indication treating severe dementia case among the patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome. HIRA revisited the cost-effectiveness of choline alfoscerate products by studying the clinical efficacy, alternative options, and administration cost of the drug based on textbooks, clinical guideline, Health Technology Assessment (HTA) and clinical research literature (SCI, SCIE). Reviewing the clinical evidence and other considerations like social demand focusing on financial impact, medical importance and patient’s economic strain, the reimbursement on the drug except for the dementia indication was switched to selective reimbursement. Regarding the reevaluation result of the already-listed drug, a pharmaceutical company with a drug subject to reimbursement adjustment may appeal the decision for 30 days. Accordingly, the final decision on the coverage reduction would be enforced in coming August at earliest, after undergoing DREC re-deliberation and Ministry of Health and Welfare (MOHW) Health Insurance Policy Deliberation Committee (HIPDC) review. The government’s announcement has been expected since the National Health Insurance Master Plan was disclosed. MOHW has hinted of a listed drug reevaluation that generally takes account of clinical efficacy, financial impact and foreign country reimbursement status of the listed drug, as the ministry claimed reimbursement adequacy reevaluation mechanism reflecting the clinical efficacy was missing so far, unless the Ministry of Food and Drug Safety (MFDS) removes the coverage. For about a year, the public raised many issues regarding the first target of the reimbursement reevaluation. The reevaluation on choline alfoscerate was mentioned during the National Assembly Audit last fall, and eye drops were also mentioned as a target as well. However, it was narrowed down to the dementia treatment alone, as the eye drops have ongoing legal case. The pharmaceutical industry is reactively seeking for responsive plan after the announcement by HIRA DREC. Some say they would go as far as filing an administrative litigation to halt the execution, but it could be too late in the end. HIRA could have selected the second and the third listed drugs to reevaluate following choline alfoscerate. The next target would highly likely to be a drug prescribed as a supplement and not for unique effect or benefit. The pharmaceutical industry’s next action should be trying to predict the next target drug and concentrating on how to demonstrate clinical efficacy, cost-effectiveness and social demand better.
- Opinion
- [Reporter’s view] Unpredictable authorized generic policy
- by Lee, Tak-Sun Jul 01, 2020 05:54am
- The MFDS is planning to disclose the 'generic competitiveness strengthening plan' discussed through the public-private association in the near future. Some negotiated content has been reported. However, the main part of the generic policy seems to be known only when the final proposal is issued. The industry believes that the impact on the industry will also be enormous. These are tasks such as the introduction of INN (international nonproprietary names) in generic products. Currently, it is not possible to know whether the 'generic competitiveness strengthening plan' is a deregulation or a strengthening of regulations. The 'unification of authorized generics', which was first released to the media, was viewed as a deregulation in that the company does not need to undergo duplicate examinations. That is why the MFDS changed its policy after the co-biological equivalence limit policy failed at the Regulatory Reform Committee. However, the contents released afterwards are confused by strengthening regulations rather than deregulation. The challenge derived from the public-private councils, such as the development of quality indicators for livelihoods, disclosure of evaluation results, and enhancement of drug disclosure and information disclosure by pharmaceutical companies, is a policy of strengthening regulations to give generics a rank. As the policy direction of the MFDS is not shared, it is difficult for companies to pursue business. In particular, for companies seeking to expand the consignment manufacturing business, the method of limiting the co-biological equivalence test was frustrated, but the policy base was unpredictable, making it impossible to make an investment decision. This is explained by the fact that the contents of the discussion are shared only within the framework of the public-private council. The pharmaceutical industry points out that through the COVID-19 situation, the MFDS communicates in the course of policy making. In the case of the clinical reevaluation of recently announced Choline alfoscerate, it was difficult to know the exact contents until related companies were also announced. There seems to be no intention of policy communication. Press releases distributed to the media are everything The government's fate is to listen to as many opinions as possible and take criticism until the policy direction is decided. If policy promotion is inevitable, you can persuade them to fully understand. If this process is a reduced or deleted policy, the result will be bad. No matter how difficult it is to communicate with COVID-19, they have to disclose what they want to disclose and communicate with anyone who wants to communicate.
- Opinion
- [Editor’s View] Adjustment on choline alfoscerate coverage
- by Nho, Byung Chul Jun 11, 2020 06:23am
- Korea’s National Institute of Dementia (NID) found that 43 percent of senior citizens aged 60 to 69 fear dementia the most as far as disease goes. The number of patients with dementia in Korea has rapidly surged to date, and it is projected to exceed one million by 2024 and two million by 2039. And the cost of state-led dementia management is projected to see 15-fold jump from 8.7 trillion won in 2010 to 134.6 trillion in 2050. Due to the surge in dementia patient population and raised awareness of the disease, many of middle-aged people started demanding prescription by healthcare providers to prevent developing dementia. Accordingly, the prescription volume of cognitive function improving choline alfoscerate, used on patients with mild cognitive impairment (MCI), soared exponentially and claimed reimbursement of 325.5 billion won in 2019, making it a major prescription drug market. Noticing the sharp increase in choline alfoscerate reimbursement claim, however, Ministry of Health and Welfare (MOHW) has started reevaluating the adequacy of National Health Insurance (NHI) reimbursement on the medicine, while Health Insurance Review and Assessment Service (HIRA) is to convene Drug Reimbursement Evaluation Committee (DREC) to discuss the issue. The pharmaceutical industry sources report the government bodies are leaning towards designating the use of choline alfoscerate in a person with MCI as selective reimbursement with higher copayment rate. The groups opposing on providing reimbursement on choline alfoscerate claim the substance’ clinical efficacy is insufficient and excessive prescription is damaging the NHI finance. Nevertheless, the clinical experts say otherwise. Currently, a treatment for dementia does not exist; pharmaceutical giants like Pfizer, MSD and Lilly have invested on the pipeline immensely, but they gave up on it in the end. Although many hopeful studies spoke of seemingly ending the fight against dementia, not one dementia drug has received the U.S. Food and Drug Administration’s (FDA) novel drug approval since 2003. Considering the situation, the best means of treatment is to protect the cognitive function as much as possible from the MCI stage, right before developing dementia, and to constantly observe the progress of dementia. Finding the sign of dementia at early stage and treating it can significantly reduce the pain and burden of the patient’s family, in which the social cost can be lessened as well. And healthcare provider’s frustration surfaces from here. The prescribers are running out of options in cognitive function related drugs as donepezil’s indication to treat vascular dementia is removed, acetyl-L-carnitine’s indications were narrowed and now choline alfoscerate reimbursement would be adjusted. These changes are contradicting the Korean government’s emphasized goal to expand state-led dementia management. When an alternative option is unavailable for the mild cognitive impairment—a crucial stage to treat dementia early, increasing the patients’ copayment rate may immediately bring down the cost. But patients would miss the window to comprehensively control dementia development due to frequent visit to hospital, which eventually would result in treating even more dementia patients. And applying differentiated copayment rate by disease type would technically cut down reimbursement more and distort the clinical scene by inputting different disease code. Choline alfoscerate may have been criticized to have insufficient clinical evidence, but it has the highest number of evidences among cognitive function enhancing drugs. And in Russia, where the drug is designated as prescription use, had positive findings in 50 patients with amnestic mild cognitive impairment. Regarding the study, the researcher states choline alfoscerate has outstanding tolerability and confirmed safety, and recommends using the drug in people with high-risk of developing Alzheimer’s disease, such as people with mild cognitive impairment, as a preventive measure. Moreover, brain disease treatments struggle to find participants for large-scale clinical trial, so evaluating the drug’s benefit tends to be extremely difficult. A high number of reimbursement claims well depicts high social demand and the reality with no other option. The health authority should be advised that adjusting reimbursement on the drug and impeding prescription due to high cost could have the patients and their families to resort to untested folk remedy with growing anxiety and ultimately spend more money in the process.
- Opinion
- [Reporter’s View] Not penalty but incentive to generics
- by Lee, Tak-Sun Jun 09, 2020 06:26am
- Under the grandeur name of ‘strengthening market competitiveness,’ Korean-made generics are to face various changes in policy in the future. Concerned of excessive number of generics weakening the market competitiveness, the Korean government has already attempted to restrict joint bioequivalence test and reduce pricing of generics with cosigned bioequivalence test result. But it was scrapped by the Regulatory Reform Committee. However, Ministry of Food and Drug Safety (MFDS) is unceasingly reviewing a number of plans to better manage generics with public-private consultative body. So far, they have mentioned of specially labeling package of drugs that conducted individual bioequivalence test, setting bioequivalence quality assessment indicators, and building a database on generic products by each substance. Regardless, only the time will tell, if all these actions would effectively improve generic products’ competitiveness. Unfortunately, most of the competitive enhancement plans are focused on ‘penalty.’ The policy to bring down the pricing of generics without individual bioequivalence test result is a good example. The public-private consultative body was on the same page about being more selective with generics. Naturally, the products at the end of the line would feel penalized. Nothing is more inspiring than a compliment. And we would have to see if the Korean-made generics, tattered by restricting regulation, would survive in the market with so-called ‘strengthened competitiveness.’ Rather, these restraints may even advertise generic as a lower-quality version of the original. Therefore, a means to grant incentives to well-developed good-quality generics should be discussed as well. For instance, the government should consider policies to provide benefit on patent-evading generic with preferential sales approval, generic with an overseas export deal and products contributing to save NHI finance through lowered price. Only when the government promotes the good side of generics, the market would be confident enough to trust those generics. Hopefully, the government would seek for policies granting incentives, besides the penalties, to improve generics’ market competitiveness.
- Opinion
- [Reporter’s view] Pharmacists are tired of impurities
- by Kim JiEun Jun 04, 2020 06:13am
- Another task has recently been added to the pharmacy. From Valsartan, Ranitidine to Metformin. This is because pharmacies have to clean up with repeated impurities situation. The Metformin situation was stopped by the sale of some items, so there was not much confusion than the previous Valsartan or Ranitidine events. However, due to the past two cases, alternative medicines showed a shortage shortly after the announcement of discontinuation. In particular, some of the drugs that have been discontinued this time have fewer drugs to replace, and alternative drugs were sold out of major online drug stores less than an hour after the announcement of discontinuation. It had a hard time for pharmacists who couldn't order medicine quickly to get out of stock. Again, pharmacists who have come into contact with the media are in chaos. They had to clear the stock of drugs that had been discontinued since the morning, and they were busy going into and out of an online mall to order a replacement drug and inquiring about the drug at a wholesale dealer. The pharmacy dispensary was filled with new medicines that were ordered immediately after the announcement of the suspension. If the demand is unpredictable and they don't know when it will be out of stock, it is best to stock up on the new drugs. Even in the case of Valsartan and Ranitidine, pharmacies with many prescription preparations had to give up pharmacy space for drugs that had been ordered in advance for several months. This is not all. The pharmacy had to respond to patient inquiries that followed immediately after the announcement. Like any pharmacist who said, "We are not wrong, we must explain and persuade the pharmacy to be wrong every time." Even in this situation, pharmacists had to explain why the drug they were taking was discontinued and how to deal with it. It is not only a problem that will end with Valsartan, Ranitidine, and Metformin in an era when impurities have emerged as a new era of drug safety management. Although the original responsibility and management of impurity medicines ultimately belongs to the pharmaceutical industry and regulatory authorities, there is an unfair aspect in the current situation where pharmacies must stand at the center of the situation whenever it happens. Of course, it is a top priority to prevent the current situation from being repeated with clear standards and strict regulations. However, as impurities have emerged as a new paradigm for drug safety management, it seems that the government will not be able to ignore the introduction of the international common name and furthermore, the introduction of ingredient names. The fact that this year is the 20th anniversary of separation of prescribing and dispensing drugs will also be a part of empowering discussions on these systems.
- Opinion
- [Reporter’s view] We must prepare for the post impurity era
- by Kim, Jin-Gu May 27, 2020 06:04am
- The situation wasn't the worst. Unlike Ranitidine, not all Metformin sales have been stopped. It is expected that the confusion of patients and the potential damage of pharmaceutical companies will not be greater than in the case of the Valsartan·Ranitidine crisis. The MFDS decided to stop selling 31 of the 288 finished Metformin products in Korea on the 25th. The reason was the same as in the previous situation. N-nitrosodimethylamine (NDMA) was detected above the provisional management criteria. As a result, the case of impurities, starting from Valsartan and Ranitidine to Metformin, has been closed. At present, there are no other ingredients that raise concerns about impurities. However, it is not the end, it’s the beginning. Impurities have become a new disease and standard for drug safety management. The time has come for us to manage unexpected impurities in advance. It must be a contradictory situation. It is contradictory to anticipate and manage unexpected impurities in advance. However, this contradictory situation is the reality faced by the pharmaceutical bio industry. The paradigm of drug safety management has changed completely. The MFDS has been obliged to submit proof of safety for carcinogenic impurities, metal impurities, etc. when pharmaceutical companies apply for drug approval from September. It is only possible to preemptively check for harmful substances that can occur on its own and to prove safety. There are many problems that have not been solved. First, it is a standard for impurity management. Currently, NDMA·NDEA are all impurities that have been established as management standards. However, NDMA·NDEA are only some of the many impurities. The possibility of Nitrosamine-based impurities such as NMBA, DIPNA, and EIPNA cannot be excluded. If the range is extended to impurities other than Nitrosamines, theoretically, impurity problems close to infinity occur. These impurities should be cataloged, and separate control standards should be prepared for each impurity. The MFDS has announced that this work will be done in cooperation with regulatory authorities in each country. However, as COVID-19 suddenly became world-wide, it was postponed. The issue of responsibility derived from this is another problem. The regulatory authorities and the pharmaceutical industry may not be able to predict in advance, but the damage caused by the pharmaceutical industry should be more concerned. Discussions with the regulatory authorities and the pharmaceutical industry should begin to rationalize responsibility. At present, the Metformin situation is thought to be over. However, the new era of drug safety management has just begun. You can't have the same confusion every time. We look forward to setting new standards for the new era as soon as possible.
- Opinion
- [Reporter’s View]Raising the voice of rare disease patients
- by Eo, Yun-Ho May 20, 2020 06:11am
- Seems like rare diseases put patients in utmost pain, because of its ‘rarity.’ Rare disease treatments can hardly prove cost-effectiveness and predictability with limited patient size for the reimbursement listing approval. Regardless, the Korean government is aware of the struggle. The revised drug pricing system the Ministry of Health and Welfare (MOHW) unveiled is in process of legislative preannouncement until June 11. The key revision in the new drug pricing system is to expand eligibility in pharmacoeconomic evaluation (PE) exemption and RSA. The revision would stipulate the Korean government to sign risk sharing agreement (RSA) not only with first-in-class drugs, but also with follow-on drugs. And also the revision would expand subjects for PE exemption and coverage with phase III clinical evidence in development. Even the PE exemption, previously restricted to anticancer and rare disease treatments, would be applicable on National Essential Drugs, such as tuberculosis treatment, antibiotics and emergency antidotes. However, many of the public claim rare disease treatments would still face various obstacles before receiving RSA and PE exemption benefits. In Korea, rare disease is defined as a disease with patient size less than 20,000 with difficulties in diagnosis to survey accurate number of patients. The affected patients are desperate to get access to life-saving treatment as the diseases are difficult to diagnose and treat, but many of the diseases cannot even start a clinical study with barely sufficient number of patients. Pharmaceutical companies are hesitant to develop a novel drug for rare disease, as the limited number of patients means limited marketability, while the chances of successfully proving the cost-effectiveness of the drug through PE would be thin. Many countries around the world are introducing regulatory exceptions in legislation, special approval or reimbursement listing for better access to rare disease treatments. Korea has also provided regulatory exceptions like medically essential drug management, PE exemption system and RSA in reimbursement listing or drug pricing. Regardless, the limitations to treatment access still exist. In fact, data comparing listing rate by each drug type before and after implementing RSA and PE exemption systems for bettering the access to high-cost treatments showed a significant improvement in general drug (79.6 percent to 98.6 percent) and anticancer treatment (77.1 percent to 91.7 percent), but the improvement in rare disease treatment (71.1 percent to 71.4 percent) was rather unnoticeable. As a solution to the much needed access to rare disease treatment, some argue the PE exemption eligibility should be expanded for the rare disease treatment. They say the reimbursement review system should be flexible to exempt PE or adjust the number of PE sample patients similar to the special case reimbursement standard, when a drug has no other alternative option or has been approved with placebo-controlled study results. For instance, the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy Designation (BTD) or European Medicines Agency’s (EMA) Priority Medicine (PRIME) designation could be referred as a review standard. The PE exemption system aims to provide patients the access to rare disease and anticancer treatments unable to produce PE data, while protecting the initial purpose of positive listing system. So to serve its purpose, the Korean health authority should contemplate on the flexibility of the healthcare reimbursement listing procedure. Same goes for RSA. Compared to numerous anticancer treatments that received coverage through RSA, many of rare disease treatments have failed in passing the barrier to RSA due to lack of PE data. As far as quality-adjusted life-year (QALY) goes, the majority of rare diseases results in severe physical damage in patient’s body, lowers quality of life, and shortens life expectancy. And because of extremely small number of users, rare disease treatments are inevitably high-priced and show poor cost-effectiveness. The rare disease treatments can hardly prove cost-effectiveness, when applied with incremental cost-effectiveness ratio (ICER) thresholds on par with other general drugs. The regulation stipulates the health authorities to flexibly set ICER thresholds on rare disease treatments, but the drugs are challenged with PE barriers higher than that of anticancer treatments due to their practices so far. This is why many urge more adaptable ICER thresholds should be given to rare disease treatments for their PE. When the Rare Disease Management Act came in effect in 2015, the Korean government designated May 23 as the Rare Disease Day to raise awareness and understanding of patients fighting against rare diseases. Rare diseases have a handful of treatments for a handful of patients, which is why the voice to demand their healthcare benefit is so easily lost. Hopefully in the near future, the government and pharmaceutical companies would pay a closer attention to those patients, as much as they do for cancer patients.
- Opinion
- [Reporter’s View] COVID-19 and vaccine self-sufficiency
- by An, Kyung-Jin May 18, 2020 06:15am
- The U.S. and Europe have sparked a conflict over COVID-19 vaccine still in development. The tension arose when a multinational pharmaceutical company Sanofi announced its intention to prioritize the distribution of the vaccine to the U.S., in case the company successfully completes the development. During an interview with Bloomberg, Sanofi’s British CEO Paul Hudson who newly took over the office in last September said, “The U.S. government has the right to the largest pre-order because it’s invested in taking the risk,” so “the Americans will likely get Sanofi’s COVID-19 vaccine before the rest of the world.” Along with its competitor GlaxoSmithKline (GSK), the French-based multinational company has initiated COVID-19 vaccine co-development project. And apparently, the U.S. Biomedical Advanced Research and Development Authority (BARDA) has provided USD 30 million (approximately 36.8 billion won) for the project Immediately after the news was released, the whole of Europe was shaken. Particularly, the reaction from France, where Sanofi’s headquarters and manufacturing plants are housed, was rough. The French government was infuriated by the pharmaceutical company’s public comment as the country and the EU have been often giving direct and indirect support for the company’s R&D programs. French Prime Minister Édouard Philippe reproached by twitting “A #COVID19 vaccine should be a global public good. And the equal access to the vaccine is not negotiable.” The European Commission official also published a statement insisting that “The vaccine against COVID-19 should be a global public good and its access needs to be equitable and universal.” The pharmaceutical industry experts are claiming the international cooperation has worsened as the EU intervened the U.S. and China’s race for the COVID-19 vaccine. Some are concerned that a war on exclusive pre-ordering of the vaccine in development may break out. Eventually, CEO Hudson took back his words, as his ‘America-first’ comment has inflicted a firestorm. When the vaccine is fully developed, he said all countries around the world would have an equal access to the vaccine. But the CEO also urged “the European countries should also assertively take risks on the vaccine development like the U.S.” He pointed out how the U.S. is taking a risk even before scientifically confirming the success of the vaccine development, whereas the European countries have not. The CEO also argued the risk should be shared among European countries and the U.S. Sanofi CEO’s comment also rings in a grave tone in Korea as well, where the country has not yet fully resolved the vaccine self-sufficiency issue. When Green Cross established the Hwasun vaccine plant in 2009, South Korea has become the 12th country in the world to locally procure flu vaccine. The locally made vaccine is viewed as the top contributor in overcoming the 2010 flu pandemic. Although it has been a decade since then, Korea’s self-sufficiency rate in vaccine has not improved much. Out of 19 National Immunization Program (NIP) vaccine types, only six types—hepatitis B virus, hemorrhagic fever with renal syndrome (HFRS), varicella, influenza, tetanus, diphtheria, and pertussis (Td), Haemophilus influenzae type b (Hib)—are locally produced without importing the vaccine strain. Other three vaccine types are locally produced with imported strain, and the rest of the nine types are imported as finished products. In case of a pandemic or biologic terrorism, Korea has to unavoidably rely on other countries for vaccine. When the country cannot even self-procure vaccines long demanded, it is skeptical if Korea would be able to promptly produce vaccine during a novel infectious disease outbreak. According to the World Health Organization’s (WHO) update, total eight cases of clinical studies in COVID-19 vaccine have started their global trial phase. Four of them are funded by Chinese government and corporations. Partnered with a biotechnology company Moderna, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), associated under the National Institute of Health (NIH), has started a clinical trial for a vaccine against COVID-19 from last month. The U.S. government body aims to report the immunological reaction in around coming July or August. In Korea, a number of pharmaceutical companies like SK Bioscience, GC Pharma and Genexine are seeking for a vaccine against COVID-19, but the progress is far behind compared to the U.S. or China. The country was able to put the limelight on its promising global level biotechnology as the world highly evaluated Korea’s ability to test the disease. To maintain the outstanding disease control capacity, the Korean government would need to invest and support the vaccine and treatment development, bottomlessly. Korea should let the latest pandemic be the reminder of the necessity of ‘vaccine self-sufficiency.’
- Opinion
- [Reporter's view] ‘Generic exclusivity' must be improved
- by Lee, Tak-Sun May 15, 2020 06:04am
- As the proposed regulation of the co-biological equivalence test was stopped by the Regulatory Reform Committee, The consigned generics business has revived. On the other hand, companies producing single generics that have claimed to regulate co-biological equivalence testing are concerned. They point out that there are many competitors in the market due to the activation of consigned generics, so there is no advantage of single-developed generics. Since the pharmaceutical industry was divided in half with respect to this regulation, it seems that everyone cannot be satisfied unless a new system is introduced. To this end, the generic exclusivity needs to be improved so that everyone can be satisfied. The generic exclusivity, which was introduced as the Korea-US FTA in 2013, has been collecting opinions from all over the recent improvement plan, but has not progressed. However, it is unlikely that any improvement measures that have been significantly changed . The biggest problem with the current generic exclusivity is that marketing exclusivity has no great benefit. The 9-month monopoly period is also a short period for generics to settle down, and there are many items that receive the generic exclusivity, so it is more than just satisfied with entering the market rather than being a monopoly. Some predicted that if the regulation is enforced, many companies will lose their generic exclusivity. However, with the withdrawal of co-regulation, the consignment system for entering the market is unlikely to be different. Through this regulation, it is predicted that the generic exclusivity will be acquired by a number of contractors with pharmaceutical companies that have successfully developed generics. As competition increases, marketing exclusivity becomes meaningless. In this regard, a plan should be devised so that generic exclusivity can be given only to companies that have overcome patents and developed generic drugs. In order to do that, even if the consignment company does not make a consignment production to the majority, it must create a structure that can benefit from the generic exclusivity to copyright. For example, it is necessary to find a way to extend the period of the right to copyright much more than 9 months a year, or to give preferential prices to the generics. If the ₩10 billion is secured during the period of generic exclusivity, there will be no other company to give profits to others. However, it is difficult for the generic to get ₩1 billion for 9 months. It is necessary to inform the medical institutions the generic exclusivity is the only generics that confronts the original through export preferential support, various tax benefits, and brand support. The MFDS has recently formed a public-private council aimed at strengthening international competitiveness of domestic generics to seek ways to support them. However, it is more difficult for generics that are not treated in the domestic market to have competitiveness overseas. Rather, it is better to grow it in the domestic market so that pharmaceutical companies can make global new drugs with that money. It is difficult to create a competitive generic with a system that cannot take advantage of generics as it is now. It seems that a more innovative support plan is needed.
