Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific.

While some sort of regulatory convergence and harmonisation are often needed for achieving regulatory reliance, in reality, regulatory reliance as a strategy towards convergence and harmonisation has never been more significant in Asia-Pacific (APAC). A sustained, rapid and large-scale provision of medical devices, including articles and apparatus used in diagnosis, care, treatment or prevention of disease and softwares, etc, across national boundaries, is the key to winning the fight against future pandemics and improving people's well-being in such a populous and geographically diverse region. The COVID-19 pandemic highlighted the value of regulatory reliance to enable easier access to medical devices that have gone through regulatory approvals in countries with mature regulatory systems based on the Quality Management System and product assessment guidelines of the International Medical Device Regulators Forum. This analysis focuses on why regulatory reliance is needed, how much has been achieved, its impact on the development of the medical device industry and challenges to be addressed in the region. By drawing on the experience from the Singapore Health Sciences Authority-Thai Food and Drug Administration regulatory reliance pilot and Vietnam's inclusion of Korea Ministry of Food and Drug Safety and China National Medical Products Administration as reference markets for fast review/approval, it aims to explore next viable steps and future trend of the APAC regional regulatory harmonisation mechanism through regulatory reliance in the post-COVID-19 era.

Who is more likely to hesitate to accept COVID-19 vaccine: a cross-sectional survey in China.

BACKGROUND: The aim of our study was to identify factors associated with coronavirus disease 2019 (COVID-19)vaccine willingness in China to aid future public health actions to improve vaccination. RESEARCH DESIGN AND METHODS: This study was conducted in August 2020 using a mixed-method approach, including a cross-sectional self-administered anonymous questionnaire survey and in-depth interviews with community residents in China. RESULTS: Of the participants, 30.9% showedCOVID-19 vaccine hesitancy. Being female(OR = 1.297), having poor health(OR = 1.312), having non-health or medical-related occupations (OR = 1.129), no COVID-19 infection experience(OR = 1.523), living with vulnerable family members(OR = 1.294), less knowledge(OR = 1.371), less attention to COVID-19 information(OR = 1.430), less trust in official media(OR = 1.336), less perceived susceptibility to COVID-19(OR = 1.367), and less protective behavior(OR = 1.195) were more likely to hesitate. Qualitative research has shown that they doubt the importance and necessity, as well as the effectiveness and safety of the vaccination. The economic and service accessibility of the vaccination was an impediment to their vaccine acceptance. CONCLUSION: Nearly one-thirdof people showed hesitancy to accept COVID-19 vaccination in China. Our findings highlight that health communication and publicity should be performed for the targeted population, and immunization programs should be designed to remove underlying barriers to vaccine uptake.

Research capacity of global health institutions in China: a gap analysis focusing on their collaboration with other low-income and middle-income countries.

INTRODUCTION: This paper presented qualitative and quantitative data collected on the research capacity of global health institutions in China and aimed to provide a landscaping review of the development of global health as a new discipline in the largest emerging economy of the world. METHODS: Mixed methods were used and they included a bibliometric analysis, a standardised survey and indepth interviews with top officials of 11 selected global health research and educational institutions in mainland China. RESULTS: The bibliometric analysis revealed that each institution had its own focus areas, some with a balanced focus among chronic illness, infectious disease and health systems, while others only focused on one of these areas. Interviews of key staff from each institution showed common themes: recognition that the current research capacity in global health is relatively weak, optimism towards the future, as well as an emphasis on mutual beneficial networking with other countries. Specific obstacles raised and the solutions applied by each institution were listed and discussed. CONCLUSION: Global health institutions in China are going through a transition from learning and following established protocols to taking a more leading role in setting up China's own footprint in this area. Gaps still remain, both in comparison with international institutions, as well as between the leading Chinese institutions and those that have just started. More investment needs to be made, from both public and private domains, to improve the overall capacity as well as the mutual learning and communication within the academic community in China.

Pharmaceutical Industry's Engagement in the Global Equitable Distribution of COVID-19 Vaccines: Corporate Social Responsibility of EUL Vaccine Developers.

(1) Objectives: Inequality in the global distribution of COVID-19 vaccines has brought about great challenges in terms of resolving the pandemic. Although vaccine manufacturers are undoubtedly some of the most influential players, studies on their role in global vaccine distribution have been scarce. This study examined whether the pharmaceutical industry is acting according to the principles of corporate social responsibility (CSR) during the pandemic. (2) Methods: Three categories were used to analyze the CSR of vaccine developers. The first was research and development: effectiveness, funding, and profits were measured. The second was transparency and accountability: the transparency of clinical trials and vaccine contracts was analyzed. The final was vaccine delivery: the status of the provision of vaccines to COVAX and lower-income countries, intellectual property management, manufacturing agreements, and equitable pricing were measured. (3) Results: Vaccine developers have acquired large profits. The vaccine delivery category faces the most challenges. Participation of pharmaceutical companies through COVAX was significantly low, and most vaccine supply agreements were secretive, bilateral deals. It was not clear if companies were maintaining equitable pricing. The evaluation indicated that the companies' CSR practices have differed during the pandemic. (4) Conclusions: Our study contributes to the methodology of assessing the CSR of vaccine developers. This would help understand the current COVID-19 vaccine distribution inequality and propose that pharmaceutical companies re-examine their roles and social responsibilities.

Leveraging the Public Health Emergency Operation Center (PHEOC) for pandemic response: opportunities and challenges.

Public Health Emergency Operation Center (PHEOC) was conceptualized and established for coordinating information and resources towards goal-oriented response in large scale public health emergency. Yet, the activities undertaken by PHEOCs and their intended goals have not been fully optimized in current scenario. This paper revisited the collective efforts invested in PHEOC conceptualization and development, identified the opportunities and challenges in compliance with standards and framework, demonstrated the accountability of PHEOC network, thereby promoted best practice guidance for global public health emergency preparedness and response. This review will help navigate emergency response complexities leveraging PHEOC partnerships and advance the ability to detect and respond to public health emergencies in low resource settings. The review shows that the information on how to adapt best practice guidance to local circumstances could incentivize the full implementation of prevention, early detection and response to outbreaks. Identifying and correcting deficiencies in effectiveness evaluation will provide the basis for continuous PHEOC improvement. With the gradually reopening economies and public services in some countries, there is an urgent need to emphasize and validate the collective efforts undertaken by PHEOCs for tackling the COVID-19 pandemic.

State fragility and the coronavirus disease 2019 (COVID-19) pandemic: an ecologic analysis of data from 146 countries.

BACKGROUND: Global spread and impact of the coronavirus disease 2019 (COVID-19) pandemic are determined to a large extent, by resistance to the pandemic and public response of all countries in the world; while a country's resistance and response are in turn determined by its political and socio economic conditions. To inform future disease prevention and control, we analyzed global data to exam the relationship between state vulnerabilities and COVID-19 incidences and deaths. METHODS: Vulnerability was measured using the Fragile States Index (FSI). FSI is created by the Fund for Peace to assess levels of fragility for individual countries. Total FSI score and scores for 12 specific indicators were used as the predictor variables. Outcome variables were national cumulative COVID-19 cases and deaths up to September 16, 2020, derived from the World Health Organization. Cumulative incidence rates were computed using 2019 National population derived from the World Bank, and case fatality rates were computed as the ratio of deaths/COVID-19 cases. Countries with incomplete data were excluded, yielding a final sample of 146 countries. Multivariate regression was used to examine the association between the predictor and the outcome measures. RESULTS: There were dramatic cross-country variations in both FSI and COVID-19 epidemiological measurements. FSI total scores were negatively associated with both COVID-19 cumulative incidence rates (ß = -0.0135, P < 0.001) and case fatality rates (ß = -0.0147, P < 0.05). Of the 12 FSI indicators, three negatively associated with COVID-19 incidences were E1(Economic Decline and Poverty), E3 (Human Flight and Brain Drain), and S2 (Refugees and Internally Displaced Persons); two positively associated were P1 (State Legitimacy) and X1 (External Intervention). With regard to association with case fatality rates, C1 (Security Apparatus) was positive, and P3 (Human Rights and Rule of Law) and X1 was negative. CONCLUSION: With FSI measures by the Fund of Peace, overall, more fragile countries are less likely to be affected by the COVID-19 pandemic, and even if affected, death rates were lower. However, poor in state legitimacy and lack of external intervention are risk for COVID-19 infection and lack of security apparatus is risky for COVID-19 death. Implications of the study findings are discussed and additional studies are needed to examine the mechanisms underpinning these relationships.