Kyung-Bok Son

Ewha Womans University · Graduate School of Industrial Pharmaceutical Sciences

Background: The competition for and market dynamics of generic medicines can be understood by analysing manufacturers’ behaviour. In this study, we analysed the various types of generic atorvastatin and rosuvastatin that were introduced onto the South Korean market from 2002 to 2018 and their corresponding manufacturers. Methods: Based on publicly...

Background: Recently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country's income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to ut...

Background: Regulatory approval and reimbursement decisions are necessary if new drugs are to become accessible in a timely manner. However, the process of regulatory approval and the establishment of reimbursement decisions varies across countries. This study aims to analyze the duration between regulatory approval and reimbursement decision for n...

Background: The inclusion of patent linkage mechanisms in bilateral and plurilateral trade and investment agreements has emerged as a key element in the United States’ TRIPS-Plus intellectual property (IP) negotiating agenda. However, the provisions establishing patent linkage mechanisms in several agreements appear to reflect a degree of ambiguity...

To examine patterns and trends in attempts, distinguished from issuance, to issue compulsory licensing of pharmaceuticals and to assess related implications in the era of high-cost medicines. Documents from various civil society organisations were primarily used to search attempts, as well as published literature. The identified attempts were analy...

Objectives: In 2013, South Korea introduced risk-sharing agreements (RSAs) as a new reimbursement mechanism to enhance access to new medicines and to manage pharmaceutical expenditures. This study evaluates RSAs in South Korea from the viewpoints of key stakeholders. Methods: In 2022, a survey and semi-structured interviews were conducted. Study...

Introduction: The sales patterns of original drugs after patent expiration in Korea differ from those in other countries. This study investigates how they differ. Methods: Using data from the Ministry of Food and Drug Safety, original drugs whose patents expired in 2012–2018 were divided into two groups depending on the generic drug approval. The d...

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...

Background: Community pharmacists confronted dual burdens by expanding the scope of pharmaceutical practices in response to the COVID-19 pandemic. Objective: This study aims to assess community pharmacies' perceived roles and functions during the pandemic and to explore their updated roles after the pandemic began. Methods: We conducted a self...

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 sel...

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 combi...

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 c...

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 manufac...

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 wer...

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 th...

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 t...

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...

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 ar...

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 f...

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...

Background: Since the influx of international immigrants to South Korea (Korea) in the 1980s, the number of immigrants married to native Koreans has increased substantially over the last 30 years. This study aims to provide recent evidence on the self-rated health of immigrant women married to native men and raising children. We evaluated the self...

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 li...

This study used the Korean National Health Insurance (NHI) claims database from 2011 to 2017 to estimate the incidence and the incidence-based cost of cervical cancer and carcinoma in situ of cervix uteri (CIS) in Korea. The primary outcome was the direct medical cost per patient not diagnosed with cervical cancer (C53) or CIS (D06) 2 years prior t...

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...

Background: Human papillomavirus (HPV) is associated with a significant public health burden, yet few studies have been conducted in Asia, especially on noncervical cancers. We estimated the incidence and cost of oropharyngeal and noncervical anogenital (anal, vulvar, vaginal, penile) cancer in Korea. Methods: We conducted a retrospective cohort...

Background: The speed of adoption of new drugs and frequencies of substitutions leads to changes in health care expenditures as well as patient outcomes. In this study, we aim to understand the speed of adoption of new drugs and their prescription volume in health care institutions and evaluate the impact of policy options to manage pharmaceutical...

Introduction Sodium hyaluronate eye drops are frequently prescribed for dry eye disease in South Korea. Objectives This study analyzed the trends in the utilization of sodium hyaluronate eye drops and evaluate the impact of the introduction of high-priced disposable forms in the South Korean market. Methods The yearly claims data for sodium hyalu...

Tablet subdivision by physicians or patients frequently occurs in various clinical settings for multiple reasons, including dose adjustment, alleviation of swallowing difficulties, or cost savings. However, not all tablets are suitable for subdivision, and it might cause side effects. It is informative to know which medicines are regularly subdivid...

Introduction Understanding marketing strategies and price competition among manufacturers is essential to manage health care expenditures, particularly those related to blockbuster drugs. Objectives To assess marketing and pricing strategies of blockbuster drugs in South Korea. Methods Baseline information on manufacturers who were granted market...

The KORUS FTA includes various clauses on marketing approval of new medicines and their reimbursement decisions. We aim to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate the effect of the KORUS FTA on the timely availability of new medicines in the Korean market. We selected new drug applicatio...

Introduction This study aims to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate various factors affecting timely availability of new medicines in Korean market. Methods We construct two models for the analysis; logistic and Cox model. First, we provide the logistic regression to analyze the ava...

Background Although the majority of clinical guidelines indicate the use of NOAC (nonvitamin K antagonist oral anticoagulant) over vitamin K antagonist in nonvalvular atrial fibrillation patients, there is no information on real-world prescription factors that lead to a specific type of oral anticoagulant selection. Objective To evaluate the prescr...

Objective This study analysed utilisation of statins for new statin users and assessed market dynamics of statins in South Korea. Design This study is a retrospective cohort study. Setting The yearly claims data for statins were retrieved from the National Health Insurance Service-National Sample Cohort. Main outcome measure We are interested in...

Community pharmacies in many countries have expanded from their traditional roles and responsibilities of dispensing medicines to also providing additional health services. Our aim was to understand perceptions of the current roles and functions of community pharmacies held by the public and their attitudes towards pharmacy utilisation for selected...

This study evaluated the effect of the patent linkage system, fully introduced by the Korea-U.S. Free Trade Agreement in 2015, on patent challenges and the effective market exclusivity of new medicines in Korea. We used pharmaceutical approval data and pharmaceutical litigation data to detect new medicines and their counterparts, to collect patent...

Compulsory licensing (CL), provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights, enables countries, including high-income countries, to ensure the protection of public health in the context of stringent intellectual property regimes. This study investigated associations between the time to attempted CL and a series of...

Objectives: Recent international trade agreements require member countries a prolonged statutory exclusivity for biologics, and domestic legislation guarantees various forms of exclusivity for specific drugs, indications, or studies. This study notes prolonged exclusivity provisions for biologics in the United States and international trade agreeme...

When pharmaceuticals are not fully available mainly due to the high cost of medicines, a government can issue compulsory licensing (CL). It is well documented that Brazil and Thailand have notably attempted CL. A realist review was undertaken to understand the identical social interventions in comparative settings, and to draw practical implication...

The purpose of this study is to analyse the trends in international agreements including Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Korea-United States Free Trade Agreements, and Trans-Pacific Partnership Agreements on intellectual property and pharmaceutical affairs with the updated framework. The study also assess...