Public value judgments about the criteria for reimbursement of medicines in South Korea.

OBJECTIVES: This study quantified the public value (PV) of the criteria and sub-criteria in the current drug reimbursement systems in South Korea and examined sociodemographic factors that associated with PV. METHODS: The Analytic Hierarchy Process (AHP) was used to quantify the PVs of criteria and sub-criteria. We developed a questionnaire to generate pairwise comparison matrices among criteria and sub-criteria. From 27 March to 1 April 2023, we recruited 1,000 study participants using a quota sampling method stratified by age, sex, and region based on Korean census data. RESULTS: The PVs for the criteria were highest for clinical usefulness (28.5%), followed by cost-effectiveness (27.1%), budget impact (24.3%), and reimbursement in other countries (20.1%). The sociodemographic characteristics of the participants had a significant impact on the PVs of the criteria. Willingness to pay additional premiums for national health insurance was negatively associated with PV for clinical usefulness and cost-effectiveness and positively associated with PV for reimbursement in other countries. CONCLUSIONS: The public prioritized clinical usefulness and cost-effectiveness as the main criteria. However, the PVs of the criteria were divergent and associated with sociodemographic factors. Divergent public interests require an evidence-informed deliberative process for reimbursement decisions.

Which factor reduces pharmaceutical expenditure, number of entrants or price variance? Updated generic drug markets in South Korea.

BACKGROUND: Introducing more generics has been a successful strategy for lowering pharmaceutical prices and expenditure. However, the effect of the strategy depends on the pricing schemes for generics. We aimed to update the South Korean generic markets in terms of effective competition, and to examine the effects of number of manufacturers and price variance on pharmaceutical expenditure. METHODS: We constructed balanced panel data provided by the Health Insurance Review and Assessment Service covering 726 reimbursed substances from 2019 to 2023. We developed original indicators to analyze the generic markets: the maximum-minimum price variance (MMPV) and the maximum-weighted price variance (MWPV). Panel regression with fixed and time-fixed effects was used. RESULTS: Over the study period, the number of manufacturers increased from 17.81 in 2019 to 20.98 in 2020 and then decreased to 18.70 in 2023. The MMPV increased from 204.70 in 2019 to 230.07 in 2022 and then decreased slightly to 225.34 in 2023. The MWPV increased from 59.70 in 2019 to 72.58 in 2023. Two types of segmented markets were noteworthy: low use of low-cost generics with sufficient manufacturers and high use of low-cost generics with insufficient manufacturers. In the fixed and time-fixed effects panel analyses, the MWPV presented a negative association with the number of manufacturers and a positive association with the MMPV. CONCLUSIONS: A newly introduced tiered pricing scheme, designed to differentiate generic prices, was associated with a decrease in the number of manufacturers and an increase in price dispersion. The pricing schemes for generics should be designed with price variance in mind and limit the number of too many generics in South Korea.

Does the first generic exclusivity system provide an economic incentive for early generic entrance under the patent linkage system?

Introduction: A period of exclusivity for the first generics, as part of the patent linkage system, was established in South Korea to provide an economic incentive for early generic entry. This study describes the dynamics of generic penetration and assesses the first mover market share advantages under the patent linkage system. Methods: Pairs of originators and their corresponding generics granted the first generic exclusivity from 2015 to 2020 were identified. We categorized generics into first movers and latecomers, described the penetration curves of generics, and estimated the saturated market share of generics, first movers, and latecomers. Volume-based monthly prescriptions were used to describe the generics' penetration curves. A logistic growth model was adopted to estimate the saturated market shares of generics. Results: We identified 28 pairs of originators and generics, presented penetration curves, and estimated generics market shares. The saturated market share of generics was 30%, and the time to saturation was approximately 33 months. The shapes of penetration varied by nationality, route, and number of generics. The existence of latecomers was associated with the decreased penetration speed over time and decreased market share of generics. However, the first mover market share advantages or latecomers' disadvantages were consistently observed. Conclusion: The generic uptake in South Korea is delayed, limited, and context-dependent. However, first generics' market share advantage suggests that a period of exclusivity, as part of the patent linkage system, could provide an economic incentive for early generic entrance.

Tightened social distancing measures and increased violence during the COVID-19 pandemic in South Korea.

Introduction: In 2020, the South Korean government introduced social distancing measures, varied by region, to address the pandemic. We captured variations in social distancing measures among regions in South Korea and investigated the association between the stringency of measures and the increased incidence of violence. Methods: Incidence reports from calls to violence hotlines, including school and domestic violence and sexual harassment, from 2016 to 2021 were retrieved. The regional per capita incidence rates for each violence hotlines were calculated. Difference-in-difference design with fixed effects was used to elucidate different trends in the incidence rate of violence between regions with stringent social distancing measures and regions with looser measures. Results: Social distancing measures led to a decreased incidence rate of school violence and an increased incidence rate of domestic violence and sexual harassment. Different trends in the incidence of violence were noted between regions with strict social distancing measures and regions with more lenient measures. Tightened measures caused surges in domestic violence and sexual harassment. Conclusion: Social distancing measures have been an inevitable mitigation strategy against virus transmission throughout the pandemic. However, women residing in tightened social distancing measures, in particular urban areas, need more support against domestic violence.

Impact of the COVID-19 Pandemic on the Public Perceptions of the Roles and Functions of Community Pharmacies in South Korea: Updated Cross-Sectional Self-Reported Web-Based Survey.

BACKGROUND: Community pharmacists confronted dual burdens in response to the COVID-19 pandemic by expanding the scope of pharmaceutical practices. OBJECTIVE: This study aimed to assess the perceived roles and functions of community pharmacies during the pandemic and to explore their updated roles after the pandemic began. METHODS: We conducted a self-reported web-based survey in October 2022. Based on Korean census data, we recruited the study participants (n=1000) through quota sampling stratified by age, sex, and region, yielding a 7.45% (1000/13,423) response rate. The questionnaires were composed of 3 sections: demographics, the roles and functions of community pharmacies during the pandemic, and the updated roles of community pharmacies during disasters. Each question in the second and third sections was rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), and each item's mean scores and SDs were reported. The study participants were categorized into 2 groups: individuals who had a family pharmacy and those who did not. A chi-square test and ordered logistic regression analyses were conducted. RESULTS: Out of 1000 respondents, 418 (41.8%) had a history of COVID-19, and 639 (63.9%) had a family pharmacy. Assigning specific roles and functions to community pharmacies during the pandemic contributed to positive assessments. Respondents gave higher scores to community pharmacies that had responded appropriately (a mean Likert score of 3.66, SD .077 out of 5) and provided continuous pharmaceutical services (mean 3.67, SD 0.87) during the pandemic. The pandemic served as an opportunity to positively recognize the role of community pharmacies (mean 3.59, SD 0.83). In the ordered logistic model, having a family pharmacy was consistently associated with positive perceptions. Respondents perceived that community pharmacies collaborated with general practitioners and health authorities. However, community pharmacies need to function appropriately in terms of knowledge. The mean score of the 4 domains of community pharmacy functions was the highest for collaboration (mean 3.66, SD 0.83), followed by communication (mean 3.57, SD 0.87), responsiveness (mean 3.54, SD 0.87), and knowledge (mean 3.41, SD 0.91). CONCLUSIONS: The pandemic resulted in interprofessional collaboration between community pharmacists and general practitioners. Family pharmacies could be a valuable asset to the comprehensive case management of patients. However, community pharmacists should have the expertise to build solid interprofessional collaborations and fulfill their expanded and updated roles.

Patenting and patent challenges in South Korea after introducing a patent linkage system.

BACKGROUND: South Korea introduced the patent linkage system in 2015 as part of the implementation of free trade agreements with the United States. This study assessed trends in brand-name drug patenting and generic patent challenges in South Korea after the introduction of the system. METHODS: From 2012-19, we constructed a novel dataset that combines information about listed patents with their corresponding brand-name drugs and patent challenges against these brand-name drugs. We analyzed brand-name drug patenting and generic patent challenges and elucidated factors in timely patent challenges using event history analysis. RESULTS: During the study period, 659 brand-name drugs listed their patents in the K-Orange Book and patent challenges against 95 brand-name drugs were initiated. The number of listed patents and their nominal patent term varied by the characteristics of the brand-name drugs. Patent challenges of generic drugs were marginal in South Korea even though the surge of patent challenges of generics were noticed right after the introduction of the patent linkage system. CONCLUSIONS: Patenting and patent challenges are critical factors when introducing generic drugs into the market under the patent linkage system. However, the impact of the patent linkage system on patenting and patent challenges could be varied by the specific form of the patent linkage system and the contexts of pharmaceutical markets.

Who initiates price competition when generic entrants are introduced into the South Korean pharmaceutical market?

Background: Price competition has the potential to reduce health expenditures without hindering pharmaceutical innovation. However, empirical evidence on price competition after generic drugs are introduced is scarce. This study investigates product- and substance-level determinants of price competition following the entry of generics into the South Korean market. Methods: We selected substances that were approved by the Ministry of Food and Drug Safety from 2000 to 2019, linked their corresponding pharmaceutical products, measured the degree of price competition under various scenarios, and utilized multilevel analysis to investigate the determinants of price competition. Results: A total of 986 substances and 12,109 corresponding pharmaceutical products were identified. Only 11% of products were affected by price competition in the 10% scenario. However, the number increased to 43% when we measured price competition at the substance level. Major domestic manufacturers mainly initiated price competition at the product level, while foreign manufacturers were reluctant to initiate price competition. At the substance level, the maximum reimbursement price was a significant determinant of price competition. Conclusion: Price competition at the product level is rare in South Korea. In contrast, the market is quite price competitive at the substance level. Policy options could be introduced to encourage "discounted generic" substitution in an effort to maximize the effects of price competition at the substance level. Major domestic manufacturers are essential in the introduction of discounted generics into the South Korean health system.

Understanding patient and physician responses to various cost-sharing programs for prescription drugs in South Korea: A multilevel analysis.

Introduction: Patient and/or physician responses are a pivotal issue in designing rational cost-sharing programs under health insurance systems. Objectives: This study aims to understand patient and/or physician responses to cost-sharing programs designed for prescription drugs in South Korea. Methods: As a framework, we took advantage of a tiered cost-sharing program, including from copayment to coinsurance (threshold 1) and reduced coinsurance (threshold 2). Given the hierarchical structure of prescriptions nested within patients, we utilized a multilevel analysis to assess effects of various cost-sharing programs on patient and/or physician responses using National Health Insurance claims data from 2018. Results: We found that a tiered cost-sharing program was effective in changing the behaviors of patients and/or physicians. Threshold 1 was found to be more effective than threshold 2 in changing their behaviors. At the prescription level, sensitivity to cost-sharing programs was associated with prescribed days of treatment and locations of prescription. In a similar vein, sensitivity to cost-sharing programs was associated with gender and age group of patients. Conclusion: A simplified cost-sharing program with extended intervals should be considered to rationalize cost-sharing programs. Specifically, a cost-sharing program designed for long-term prescriptions for chronic diseases together with an emphasis on cost transparency is required to better guide price-conscious decisions by patients and/or physicians.

Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea.

Regulatory decisions for new drugs approval present high uncertainty, low reversibility, the avoidance of observable errors, and high political stakes. However, research on the behavior of regulatory agencies is scarce, particularly in the context of more open decision-making processes. We aimed to evaluate the perceptions of regulatory decision-making for new drugs approval from the viewpoints of the manufacturers in South Korea. In 2019, employees in domestic (n = 5) and foreign (n = 7) manufacturers with expertise in regulatory affairs were invited to participate in a questionnaire survey and semi-structured group interview. We asked about the relevance of various criteria in regulatory decision-making, the participation of various stakeholders, and the degree of consent for new drug approval with uncertainty. The domestic and foreign manufacturers perceived that a regulatory decision made by the MFDS was solely based on technical merit within a closed decision-making system. They responded that safety, efficacy, and benefit-to-harm ratio were the most relevant criteria and the most prioritized criteria in regulatory decision-making. They also perceived that the MFDS was the sole relevant member in a regulatory decision. However, the foreign manufacturers disagreed that the regulatory agency and the advisory committee were independent of conflicts of interest, which might imply that regulatory decisions were occasionally determined by the agency given the political benefits and/or costs within a more open system. The role of an advisory committee in terms of deliberation and participatory democracy were requested to make politically legitimate regulatory decisions from the viewpoints of the manufacturers. However, their perceptions toward public involvement in regulatory decision-making is still at the early stage.

The impact of COVID-19 on the number of active small primary care businesses by severity of the pandemic: evidence from South Korea.

BACKGROUND: Health systems have become financially fragile owing to the economic recession caused by the COVID-19 pandemic. However, small primary care businesses have received less policy attention than public health and secondary care. We aimed to estimate the impact of COVID-19 on the number of active small primary care businesses in South Korea. METHODS: We selected clinics, dental clinics, oriental clinics, and pharmacies as primary care businesses. Our estimation took advantage of regional variations in COVID-19 cases in South Korea. We determined the number of active primary care businesses from 2019 1Q to 2021 1Q on a quarterly basis, and conducted interrupted time series analysis to estimate the effects of COVID-19 on this sector. RESULTS: This study found no significant increase or decrease in the number of clinics, dental clinics, and oriental clinics immediately after the pandemic began or in the time trends after the pandemic. However, there was a significant increase in the number of pharmacies immediately after the pandemic. The most affected area presented different trends in the number of pharmacies, dental clinics, and oriental clinics. CONCLUSIONS: Impact of the pandemic on the number of active small primary care business were low in South Korea. However, the impact varied according to the type of primary care setting and severity of the pandemic. The additional public health role of primary care could be associated with the sustenance of primary care businesses.

Perceived impact of the patent linkage system on pharmaceutical market from the viewpoint of the domestic manufacturers in South Korea.

BACKGROUND: The United States requires a patent linkage system in other countries as part of free trade agreements. However, introducing a patent linkage system could be a significant barrier to the timely approval of generic drugs. This study aimed to evaluate the perceived impact of the patent linkage system in South Korea held by domestic manufacturers and analyze variations in evaluating the system according to the characteristics of domestic manufacturers. METHODS: In 2020, we conducted a questionnaire survey of 39 domestic manufacturers. The survey consisted of perceptions of the system, factors affecting patent challenges, and the perceived impact of the system. A 5-point Likert scale was used to rate each item. Domestic manufacturers were categorized into three groups based on their experience of listing a patent and acquiring first generic exclusivity. RESULTS: More than half of the manufacturers surveyed had experience of listing a patent. The patent linkage system could protect the involved patents. However, manufacturers perceived that they could successfully challenge the validity of the involved patents and then obtained market approval for generic drugs. Manufacturers responded that market size, expectations for succeeding in litigation, and expectations for manufacturing the drug were the most relevant factors when they initiated patent challenges. Manufacturers reported that the system, in particular the first generic exclusivity, enhanced the research and development capability of generic manufacturers, increased their domestic sales, and improved access to generic drugs. CONCLUSIONS: The perceived impact of the patent linkage system was limited to the domestic market and generic drugs. In narrowing the impact to the effects on the domestic industry, the system had positive impacts of the system on generic manufacturers. The first generic drug exclusivity lies at the center of this positive perception. However, manufacturers perceived that the current system did not provide enough incentives for domestic manufacturers to be granted first generic drug exclusivity through patent challenges.

Importance of a usual source of care in choosing low-priced generic drugs: a cross-sectional study.

BACKGROUND: The potential to lower pharmaceutical spending exists if physicians prescribe low-priced generics. This study aimed to empirically investigate the determinants of choosing low-priced generic drugs in South Korea. METHODS: The 2018 HIRA-NPS dataset was used for this study. Among 1.45 million individuals, we identified the patients who were prescribed atorvastatin 10 mg for more than 60 days in 2018 as the study subjects, separated the subjects into high- and low-priced groups based on their average unit price, and applied a series of logistic regression models to elucidate the factors affecting low-priced drug choice. RESULTS: Out of 60,984 subjects, only 10,228 (17%) were categorized into the low-priced group. The majority of the subjects (31%) were prescribed drugs at the maximum reimbursement price. Age of the subject, the frequency of visits to the institution, the existence of a usual source of care, and the institution type that a subject mainly visited for prescriptions were associated with being prescribed low-priced generics. CONCLUSION: The association of being prescribed low-priced generics with the primary care institution and the usual source of care could be interpreted as evidence for the role of primary care in the continuity of patient-centred care. Creating health systems under which professionals act as perfect agents of a patient and/or an insurer is required.

Generic drugs with a discounted price compared to their corresponding brand-name drugs could be prescribed for patients. Therefore, spending on pharmaceuticals could be saved if physicians prescribed low-priced generics and/or patients switched from high-priced drugs to low-priced drugs. Policymakers have introduced several ways to encourage choosing low-priced generic drugs. This study focussed on the factors associated with choosing low-priced generic drugs in South Korea. Contrary to our expectations, only a few patients (17% of the total patients) choose low-priced generics, indicating potential to save pharmaceutical expenditure. Geriatric patients, patients who mainly visited primary healthcare institutions, and patients who had a usual source of care were more likely to choose low-priced generics. This study also suggested various ways to encourage choosing low-priced generic drugs in health systems.

Understanding long-listed pharmaceutical products without competition in South Korea: policy implications in managing generic entrants and pharmaceutical expenditures.

BACKGROUND: The nature of competition within the pharmaceutical sector has received a great deal of attention from policymakers and researchers. This is the first study to comprehensively analyze long listed single-source products within the South Korean market. METHODS: Long listed single-source products are defined as pharmaceutical drugs that are available in the market for at least 8 years, without competition. We analyzed the determinants that lead to long listed single-source products in the market, and then evaluated their impact on health systems by examining the subsequent price responses of manufacturers. RESULTS: Based on the number of drugs and their market values, pharmaceuticals categorized as long listed single-source products constitute a substantial portion of the market. Characteristics of the market are closely associated with generic entrants. In particular, the market size of a substance is associated with generic entrants, while the price of a brand-name drug is related to being long listed single-source products. CONCLUSIONS: Our analysis supports the creation of a regulatory and/or reimbursement system in order to support robust and effective competition within the marketplace. The first step toward rationalizing the system is to provide widespread information on drugs with limited competition or no competition.

How can we improve patients' access to new drugs under uncertainties? : South Korea's experience with risk sharing arrangements.

BACKGROUND: New drugs including cancer drugs and orphan drugs are becoming increasingly more expensive. Risk sharing arrangements (RSAs) could manage the risk based on both financial impact and the health outcome of new drugs if reimbursed. To improve patients' access to new drugs under uncertainties, many developed countries have adopted RSAs. In this study, we aimed to understand the effects of RSAs in South Korea on patients' access. METHODS: We reviewed current status of RSA drugs in South Korea. The number of appraisals and time gap between market approval and reimbursement per RSA drug were considered to quantify improvement of patients' access as they showed how rapidly decisions on reimbursement of RSA drugs were derived. Then, we applied a comparative analysis to determine whether the RSA drugs in South Korea were reimbursed in the UK, Italy, and Australia. Most data for this study were obtained from websites of the governmental department/agencies responsible for appraisal of drug reimbursement in each country. And literatures related to RSAs were investigated as well. RESULTS: The eligibility for Korean RSAs had two key components - drugs for cancer and rare diseases and not having other alternative treatments. As of the first half of 2019, there were 39 RSA drugs reimbursed in South Korea, the majority of which were financial-based schemes. Refund and expenditure cap were the representative types (89.7%). After introduction of RSAs, the time gap and number of appraisals were decreased. Based on the indications of RSA drugs, the level of drug coverage in South Korea was found lower than Italy, similar to the UK, and higher than Australia. CONCLUSIONS: RSAs in South Korea significantly enhanced patients' access to new drugs and led to the alleviation of patients' out-of-pocket expenses. The drug coverage of South Korea had a level comparable to that of other countries. This study provides implications for countries that have a dual mission of containing pharmaceutical expenditure and improving access to new drugs.

Patent challenges and factors associated with successful patent challengers under the patent linkage system: recent evidence from South Korea after the Korea United States free trade agreement.

OBJECTIVES: The patent linkage system upgraded patent challenges to an important factor in granting timely market approval for generic drugs. We aim to understand patent challenges and identify the factors that are associated with successful patent challengers under the patent linkage system in South Korea. METHODS: We constructed a novel dataset that combined information on manufacturers with detailed data about their patent challenges after introduction of the patent linkage system. Based on the number of successful patent challenges, manufacturers were categorized into non-challengers, passive challengers, and aggressive challengers. Then, two types of logistic models were applied to identify the factors associated with successful and aggressive challengers. FINDINGS: Only 39 active ingredients were challenged by 77 manufacturers from March 2015 to December 2019. Of 171 manufacturers, 94 (55 %) were non-challengers, 58 (34 %) were passive challengers who had succeeded in fewer than 4 patent challenges, and 19 (11 %) were aggressive challengers who had succeeded in 4 or more patent challenges. Higher sales, more employees, and a greater number of reimbursed drugs were associated with being a patent challenger, while a greater number of reimbursed drugs was associated with being an aggressive challenger. CONCLUSION: Some manufacturers utilize patent challenges to strengthen their product portfolios in the market. However, under the patent linkage system, the frequency of patent challenges is limited in South Korea compared to the United States. In particular, patent challenges against drugs in injection form and biologics are very rare.

Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study.

Introduction: Generic entry is a well-known driver of competition and cost containment. Objectives: We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea. Methods: A list of originator drugs approved by the authority from 2000 to 2013 and their corresponding generics were paired. An event history model was applied for a statistical estimation for the duration until generic entry and to identify abbreviating or prolonging factors on the duration. Results: A total of 2,061 pairs of originator and generics were identified. The market exclusivity for the originator drugs, including NDAs and non-NDAs, has not notably changed. However, competition among non-NDAs was less common than we expected. We found delayed time to entry of generics in the long run, particularly for non-NDAs in injection forms and biologics, and this finding is partially associated with market attractiveness. Conclusion: The authority should address the delayed availability of certain types of generic drugs. The government could provide information on off-patent pharmaceuticals with no generic competition, designate their corresponding submissions as prioritized in the review process, and provide additional market exclusivity when entering the market via a long period of exclusivity.

Disease severity classification and COVID-19 outcomes, Republic of Korea.

PROBLEM: The surge in coronavirus disease 2019 (COVID-19) cases overwhelmed the health system in the Republic of Korea. APPROACH: To help health-care workers prioritize treatment for patients with more severe disease and to decrease the burden on health systems caused by COVID-19, the government established a system to classify disease severity. Health-care staff in city- and provincial-level patient management teams classified the patients into the different categories according to the patients' pulse, systolic blood pressure, respiratory rate, body temperature and level of consciousness. Patients categorized as having moderate, severe and very severe disease were promptly assigned to beds or negative-pressure isolation rooms for hospital treatment, while patients with mild symptoms were monitored in 16 designated facilities across the country. LOCAL SETTING: The case fatality rate was higher in the city of Daegu and the Gyeongsangbuk-do province (1.6%; 124/7756) than the rest of the country (0.5%; 7/1485). RELEVANT CHANGES: From 25 February to 26 March 2020, the ratio of negative-pressure isolation rooms per COVID-19 patient was below 0.15 in the city of Daegu and the Gyeongsangbuk-do province. In the rest of the country, this ratio decreased from 5.56 to 0.63 during the same period. Before the classification system was in place, eight (15.7%) out of the 51 deaths occurred at home or during transfer from home to health-care institutions. LESSONS LEARNT: Categorizing patients according to their disease severity should be a prioritized measure to ease the burden on health systems and reduce the case fatality rate.

Understanding the trends in international agreements on pricing and reimbursement for newly marketed medicines and their implications for access to medicines: a computational text analysis.

BACKGROUND: Health systems are struggling with unprecedented drug spending and governments have devised various policy options to manage high-priced medicines. Meanwhile, some pricing and reimbursement processes are currently moving under the jurisdiction of international agreements. This study aims to understand trends in international agreements from the perspectives of pricing and reimbursement policies for newly marketed medicines. METHODS: We proposed the framework to interpret the international agreements as code and applied computational text analysis to understand international agreements as data. In particular, we selected the AUSFTA, KORUS, and TPP to assess the progress and evolution in international agreements and investigate the existing relevant content on the pricing and reimbursement of newly marketed medicines. RESULTS: Similar to the provisions for intellectual property, the scope of international agreements regarding pricing and reimbursement decisions are broadened and strengthened. Over time, the domain of transparency, re-naming procedural fairness, has changed significantly more than the remaining domains. Pharmaceutical companies will have more opportunities to advocate for their positions, to protect their interests in decision processes, to investigate the decisions on listings and setting the amounts of reimbursement, and to challenge these decisions. CONCLUSIONS: Recently signed international agreements favor companies over governments with underscoring procedural fairness and timely access. However, access to affordable medicines is the goal towards which international agreements should aim. In a similar vein, substantial fairness and the accountability of companies should be discussed when negotiating agreements or adopting international agreements through domestic legislation.

Is greater generic competition also linked to lower drug prices in South Korea?

BACKGROUND: Although the association between the price of generic drugs and market competitiveness has been explored in various high-income countries, this association has not been empirically evaluated in South Korea. We aim to determine the association between the prices of generic drugs and market competitiveness in South Korea. METHODS: A list of originator drugs approved by the national authority from 2000 to 2019 and their corresponding generic drugs were grouped along with the baseline information. The market was categorized into four groups based on the number of manufacturers: duopoly (2 manufacturers); low- (3-25 manufacturers); medium- (26-75 manufacturers); and high-competition (more than 76 manufacturers) markets. Price variance, calculated as the difference between the maximum price and minimum price divided by the maximum price, was obtained. A multivariate regression model was applied to regress price variance on the characteristics of market competitiveness, controlling for the characteristics of the originator drugs and their price level in the market. RESULTS: A total of 986 originator drugs were identified and then divided into duopoly (31%), low- (56%), medium- (9%), and high-competition (4%) markets; the median of the price variance for these markets was 0.013, 0.077, 0.200, and 0.228, respectively. In a multivariate regression model, price variance was associated with the characteristics of the originator drug, including the Anatomical Therapeutic Chemical classification, the route of administration, and the approval year. Controlling for the characteristics of the originator drugs, market competitiveness was positively associated with price variance. CONCLUSIONS: The positive association between price variance and market competitiveness is still consistent in South Korea, where rare price competition among a large number of generic manufacturers has been reported. However, no significant price variance was observed between medium- and high-competition markets. These findings support policies for managing a large number of generic manufacturers in South Korea.