Suchergebnisse

"The EC harmonized market entry regulation for pharmaceuticals from the early sixties on, but it achieved neither its goal of uniform national regulatory decisions nor that of automatic mutual recognition. Subsequent attempts to Europeanize the procedures themselves resulted in two alternatives in 1995: a centralized procedure for innovative pharmaceutical products implemented at the EU level, and a decentralized procedure which tries to assure mutual recognition. First, the paper analyzes the distinctive modes of Europeanization employed in these regulatory alternatives, examining both their impact on the effectiveness of European governing and the balance they strike between European interventionism, national participation and national autonomy. Second, it tries to assess whether Europeanization furthers the goals of pharmaceutical market entry policy as defined in European regulations - public health protection, creation of a single market and the reduction of regulatory costs to industry. There is little evidence that the public's health is less well protected when regulation is Europeanized. Only the centralized procedure contributes significantly to the goal of establishing a single market. Regulatory costs in terms of approval time did go down especially for pharmaceutical firms using the centralized procedure, mainly because of efficiency-enhancing legal provisions and institutionally induced regulatory competition between national authorities." (author's abstract)

Introduction: Public health practice must ensure efficient access to effective and safe pharmaceuticals, while protecting the population from health risks related to the inappropriate use of pharmaceuticals. Background: About half of all packs sold in German pharmacies are over-the counter (OTC) drugs; their use and regulation is thus a subject of high relevance to public health. At the same time, OTC drugs receive rather limited attention in the drug regulatory and pharmacological literature, and little empirical evidence is available about OTC drug consumption and risk perceptions. Scope: The present thesis is based on four individual research papers that cover perceptions of and behaviours regarding OTC drugs among German adults, reasons for unsuccessful applications for changes to drug trade statuses, pharmacological perspectives on prescription-only (Rx)-to-OTC switches and the prevalence and predictors of OTC drugs use. Methods: This research draws on mixed methods, including an online survey, qualitative content analysis of policy and legislative documents and epidemiological analysis of data from the first phase of the German Health Interview and Examination Survey for Adults. Results: Among the adult population living in Germany, a seven-day OTC drug use prevalence of 40.2% was found. Female gender, older age, self-reported reduced health status and multimorbidity were significant predictors of OTC drug use. There were seven Rx-to-OTC switches between 2006 and 2015, but not all of these decisions were fully in line with the recommendations of the EU guideline on changing drug trade statuses. Further, unsuccessful applications for Rx-to-OTC switches, OTC-to-Rx switches and other changes trade Status were not infrequent. At the expert level, the most important reasons for rejected applications were drug safety concerns and insufficient data. At the policy level, negative decisions were mainly made because of legal restrictions. It was also found that risk perception of OTC drugs greatly depends on the route of administration and whether the product is plant-based or not. Moreover, consumers do not always read all details in the package leaflet. Conclusions: This thesis constitutes the first measure of OTC drug use in a representative sample of the adult population living in Germany. With a seven-day prevalence of 40.2%, OTC drug use is significant. While applications for changes in drug trade status and their fate are transparent, the reasons for negative recommendations are far less traceable. The findings of this thesis have led to the identification of several opportunities to improve OTC drug regulation. Detailed justifications for negative decisions on applications to changing drug trade statuses should be provided. Data that are already available a for instance, from large epidemiological studies a could be used to inform decision-making on potential changes to drug trade statuses. Such studies should make a distinction between self-medication and OTC drug use; they should also collect information on the doses and durations of OTC drug use. In addition, past changes to trade statuses should be evaluated so that lessons learned can inform future decision-making. Elaboration of a set of criteria concerning the risks and benefits of OTC availability is also recommended to increase evidence-based OTC drug regulation.

Purpose
As China embarks upon a new era of high-quality development, it is increasingly important and imperative for China's economic development to live up to its real nature, which is to satisfy people's growing needs for a better life. The paper aims to discuss this issue.


Design/methodology/approach
The paper attempts to discuss the implication of HQD and its related theoretical issues from the basic theory of economics, and literature review. It is necessary to return to Marx's "dual character of commodity" to check the theoretical foundation of this issue, based on the duality methodology, namely, the duality of the value of use and the value of exchange.


Findings
Moving from HSG phase to HQD phase constitutes a major challenge and an arduous task that is extremely difficult both theoretically and practically. A series of new problems crop out as to the theoretical understanding and practical resolution. Fundamentally speaking, this new dynamic mechanism intrinsically requires a perfect integration of the instrumental rationality of market economy and the value-based rationality of economic development.


Originality/value
This new momentum requires a perfect match between the instrumental rationality of market economy and the value-based rationality of economic development.

Huge controversy has arisen since the Copyright (Amendment) Bill 2014 of Hong Kong, dubbed "Internet Article 23" by netizens, appeared in public view again, which was not adopted in the end. One of the concerns commonly raised by end users was whether uploading cover version (which refers to "online posting of earnest performance of copyright works" according to the Government's definition) would attract legal liability under the Bill. This article intends to first give an overview of the legal framework concerning cover version issue under Hong Kong copyright law. It then considers why such issue has provoked intense discussion in a political context. The article argues in conclusion that both the Government and public institutions can further their role in supporting creative and social innovation in music industry in the digital environment. ; Revised Version

The thesis consists of three essays in development and political economics. Political Connection, Government Patronage and Firm Performance: Evidence from Chinese Manufacturing Firms The paper tests whether politically connected firms receive preferential favor from the government, as measured by state capital investment from the central government and subsidies. My results suggest that firms connected with one more top leader from the State Council receive 9.4 percent more subsidies, firms connected with one more leader who holds positions on both the Central Committee and the State Council obtain 23 percent more state capital and then have a 2 percentage point higher product markup. When there is extra state capital due to political connections, other domestic capital is crowded out. The heterogeneous effects find that firms with more employees, but lower sales and less profit tend to receive more state capital if equally connected, while firms with higher sales tend to obtain more subsidies. This additional state capital and these subsidies do not seem to improve the firm's performance. The Determinants of Media Bias in China We measure and investigate the determinants of political control of newspapers in China. We find that more strictly politically controlled newspapers cover disasters and corruption more than their commercial competitors, most likely in order to monitor lower level officials. We also find that they cover leaders and the official news agency Xinhua to a larger extent. We find that in the cross section, the political control correlates negatively with GDP per capita and population size, but there is no time trend in the political control of Chinese newspapers in the 2000s. Finally, we analyze the effect of a reform to close down all county papers in 2003. The reduced competition significantly affected the degree of political control of the remaining papers. Chinese Microblogs and Drug Quality This paper examines the impact of the introduction of Sina Weibo, the most popular microblog in China, on the quality of drugs on the market. I find that the number of bad drugs is decreasing in Sina Weibo use: if the Sina Weibo use is doubled, the number of bad drugs found will be reduced by 21 percent. I show that the reduction of bad drugs is driven by two mechanisms: Sina Weibo induces more effort from the Drug Administration and it deters the production of bad drugs. The results suggest that microblogs can play an important role in monitoring both the public and the private sectors, especially in a context with media censorship.

This thesis provides a range of analyses to examine the current Chinese pension reform in both provincial and national contexts, with special emphasis on coverage increase and its long term financial implications. Quantitative assessment includes econometric analysis of survey data initiated and organized by the author and her colleagues. Special models are designed to reflect the transitional characteristics of the current Chinese pension system. The results confirm that the coverage increase delays the system-aging process, through labor migration and urbanization, by about 20 years. But a funding crisis is inevitable if no parametric reforms could be made in the current system and if the system is not well managed. Policy suggestions are made in line with the empirical analysis and model results. In addition, some structural pension reform options are discussed. Two Notional Defined Contribution (NDC) applications are presented and simulations indicate that an NDC system may be effective in smoothing the financial pressure for government while maintaining adequate levels of individual retirement benefit. In the final part of the thesis, a hypothetical safety net is assessed in the context of the current policy framework, and its cost is examined. The thesis introduces new data and first hand information about Chinese pension reform in a provincial context to reflect the features of the national system.