Making the investment case for national regulatory authorities

Well-functioning national regulatory authorities (NRAs) ensure access to safe, effective, quality-assured, and affordable medical products. However, the benefits of their work are often unseen and difficult to attribute, thereby making NRAs undervalued and under-resourced, particularly in low- and middle-income countries. This paper offers three key arguments NRAs and other stakeholders can use to advocate for greater investment in regulatory systems strengthening—medical products regulation effectively safeguards public health; effective regulation improves health system’s efficiency by increasing access to affordable medical products, contributing to universal health coverage; and robust regulation strengthens local pharmaceutical manufacturing and bolsters pharmaceutical trade. NRAs’ critical role in health systems is indisputable, yet they need to better promote their value to receive the requisite resources to function effectively.

Impact of Cross-border Mergers and Acquisitions on the Development of Chinese Pharmaceutical Exports and Imports

The article is devoted to the research into the impact of cross-border mergers and acquisitions, conducted by international pharmaceutical companies in China, on Chinese participation in international pharmaceutical trade. Relevance of the study resides in the importance of mergers and acquisitions as instruments that are widely used in a foreign markets penetration process and that lead to the enhancement of intercorporate trade, thus significantly influencing country’s foreign trade. International pharmaceutical companies expanded their operations in Chinese market during the last two decades as a result of the market liberalization. Mergers and acquisitions, conducted by international players, have directly or indirectly led to higher growth rates of Chinese foreign trade in pharmaceutical products, to geographic diversification of pharmaceutical exports and to an increase in deliveries from developed countries. China more than doubled its share in global exports of pharmaceutical products and almost quadrupled its share as an importer of pharmaceuticals. The specific features of Chinese pharmaceutical trade are high growth rates in imports and imports’ significant excess over exports. Substantial proportion of Chinese imports is constituent by pharmaceutical components, that are needed to ensure production of high quality pharmaceuticals in China. Mergers and acquisitions play important role in this process and cause changes in geographical structure of imports. Seven biggest suppling countries, which hold more than two thirds of imports to China, represent the countries of origin of companies that are actively involved into mergers and acquisitions in Chinese pharmaceutical market. The research results can be used by public regulatory authorities for the elaboration of industrial development policies through stimulating or deterring foreign direct investments. Research can be of use to pharmaceutical companies in formulating competition strategies for domestic and foreign markets.

Analysis of Issues and Future Trends Impacting Drug Safety in South Korea

New drug safety issues are emerging that are beyond the existing medication safety management system. To pre-empt these problems, forecasting future drug safety trends and issues is a necessity. The objective of this study was to identify issues and future trends impacting drug safety using foresight methodologies. The study started by identifying global megatrends, trends in safety management of medicines, and key issues in drug safety. A total of 25 global megatrends were selected by extracting and clustering keywords from 26 reports concerning the future. Using the text-mining method, 10 trends in drug safety were identified from 3593 news articles. This study derived 60 issues which can arise from the trends, and finally, the 20 key issues with the highest urgency and impact scores were selected. Some examples of issues with high scores were as follows: illegal distribution of medicines, lack of technology for managing and utilizing big data, change in the pharmaceutical trade environment, lack of education and safety management for specific populations, lack of artificial intelligence-based technology for the safety management of medicines, and the prevalence of drug advertisements through social network services. The key issues could be used to establish plans for medication safety management.

The Consequences of Coercion in Badakhshan

This chapter examines what led to the 1958 ban of opium in Badakhshan. After 1945, Afghanistan began a concerted effort to be ratified by the international drug control regime as a legal producer of opium for the global pharmaceutical trade. Although there was some support for Afghanistan, Mohammad Daud Khan abruptly announced a ban and eradication of all opium in Badakhshan province in 1958. This chapter examines the internal and external forces that shaped the implementation of the ban, and the consequences of the ban. Internally, Daud chose to eradicate crops in Badakhsan, not in three other opium producing provinces, mainly because it was inhabited by Tajiks, an ethnic minority which could not threaten the stability of the Afghan government. Daud also recognized that the international community was well aware opium’s importance to the Badakhshan economy, and would increase economic development aid and assistance to the Afghan government.