abstract / Law / Doctoral / Doctor of Philosophy

Background: Drugs have become an essential necessity in public health, people and the government has become willingly to spend more money on the country’s healthcare system to restore health, save lives, preventing disease and epidemics. Drugs should be properly regulated throughout development, production, importation and subsequent distribution to ensure it is prescribed with safe, effective and of good quality standards. The structure of drug regulations today has evolved over time. During the process, the scope of legislative and regulatory power expanded in result of a series of disastrous events related to pharmaceutical products, the adoption of more restrictive legislative were put in place for stronger safeguard to the public. In comparison to Singapore, Taiwan, US and EU where the drug regulatory system is highly structured, flexible and innovative, Hong Kong (HK) has a relatively simple and stubborn drug regulatory system and drug approval is greatly dependent on the approval status of the advance countries. According to the current registration system in HK, a new drug usually takes about 18-24 months to obtain an approval, and this figure is far behind the standard of Singapore in which medicine could be registered in 60 days. It is vital to have speedy approval process with high standards in safety, efficacy and quality on all approved drugs. If drugs are approved in a rush manner, it will lead to serious adverse drug reactions (ADR), or even deaths in consumption of unsafe, and ineffective drugs. On the other hand, slow approval will make patients suffer and increase the mortality rate to due inaccessibility of appropriate medicines to sustain life and combat diseases. With reference to the initiatives and innovative regulatory frameworks in the abovementioned countries, the modification of the local drug regulatory system is strongly recommended. Aim: 1. To examine the regulatory frameworks between Singapore, Taiwan, US and EU which affect the evaluation timeline required for new drugs approval. 2. As the first study to examine the drug regulations in HK, the regulatory barriers for new drugs submission will be explored and whether the regulatory initiatives from the abovementioned countries may result in an improvement in the overall drug regulation system HK. Method: This dissertation is a literature review and it will employ concentration in the drug regulation systems in Singapore, Taiwan, US and EU with varying levels of pharmaceutical regulation capacities. Search engines including Google, MedLine, PubMed (database up to 2012) with key words search of “Department of Health (DoH), Food and Drug Administration (FDA), European Union (EU), Taiwan FDA, Health Sciences Authority, evaluation routes, drug registration requirement, review timeline, Centre for Drug Evaluation, Pharmaceutical Evaluation Reports, risk management systems, pharmacovigilance, drug legislation”. Results: With an in-depth evaluation of the HK’s guideline and supporting document required for new drug submission, it is highly recommended that unnecessary documents at new drug submission (NDA) should be elimination to facilitate the new drugs approval process. The regulatory frameworks between all studied countries vary significantly in which implementation of initiatives (e.g. multiple evaluation routes, in-house evaluation system) from individual country affects the standards of new drugs approval and the evaluation timeline required to grant approvals. Conclusion: The regulatory frameworks in HK shall be revised with reference to numerous initiatives developed in the regulatory systems in Singapore, Taiwan, Us and EU. The possible key regulatory barriers which leads to the delays in new drugs approvals in HK includes duplication of certificates, limited number of Pharmacy and Poison Board meetings, the requirement of endorsement of new drugs approvals at the legislative council , absence of in-house evaluation system which allows full assessment of submission dossier, deficiency of clinical trials with the inclusion of local population, absence of electronic submission, multiple evaluation routes and rigorous post-marketing pharmacovigilance monitoring system. If the Department of Health (DoH) in Hong Kong could scrutinize the current regulatory frameworks with referenced to these countries, it will improve the overall drug regulatory system and reduce drug lag due to unnecessary barriers. / published_or_final_version / Public Health / Master / Master of Public Health

No description available.

Launch activities are increasingly performed by private entities and launch participants deal with a complex legal environment. The Space Treaties provide a framework placing liability for non-governmental activities on the launching State and the duty to authorize and supervise them on the appropriate State. Launch participants are subject to specific regulation in certain States or are under institutional State control in others. They also have to comply with general domestic law of liability. Limited insurance availability led to the development of contractual risk allocation techniques, the inter-participants waivers of liability and claims, inspired by NASA practice. / This thesis offers a contribution with the synthesis of information, so far scattered, on today's legal environment, providing an overview of the norms at play in this field to allow the grasp of their relative weight and interactions in the assessment of liability risk attached to launch activities. / This synthesis reveals a legal framework presently lacking the predictability necessary for an efficient liability risk management: (1) inter-participants waivers of liability suffer the weaknesses of all limitation of liability clauses; they also lack uniformity and implementation rigor; (2) the Space Treaties contain ambiguous terms preventing predictable determination of the State liable for damage and the State obliged to authorize and supervise launch activities, and do not reflect the de facto primary liability of launch operators. / This thesis offers a contribution to the advancement of legal work on these problems by suggesting new approaches emphasizing the need for: (1) harmonization of inter-participants waivers of liability to improve their consistency and validity and ensure identical flow-down by all participants; (2) improvements of the Outer Space Treaty, Liability Convention and Registration Convention for their implementation to non-governmental launch activities. / Although the launch community is small and the need for lawmaking is not as compelling as in fields such as aviation. Nevertheless, tailored adjustments to the present legal framework are required and proposed in this thesis through model clauses and an international instrument, both of which are submitted for further thinking and contribution by those sharing the opinion that creative lawmaking is now necessary to prepare for tomorrow's endeavors.

This thesis appears to be the first academic recognition of the public trust doctrine at Canadian common law. Surprisingly, despite the explosion of the doctrine in the United States, there has been little consideration of the doctrine by Canadian courts and only one Canadian article on the subject. To date, Canadian interest in the doctrine has been primarily statutory. In essence, the public trust doctrine means that despite its ownership of natural resources, the government holds certain resources, such as navigable waters, on trust or in a fiduciary capacity for the public. The origins of the doctrine are somewhat vague, but can be traced back to Roman law and the English public rights of navigation and fishing. A review of these public rights reveals that at both law and economics, certain resources are "special" and inherently public in nature. A long and dusty trail through Canadian law reports reveals that Canadian courts have recognized a public trust with respect to navigation and fishing as well as highways. Although the public trust concerning navigation and fishing has lain dormant since the late nineteenth century, the distinctive features of the public rights of navigation and fishing which led both American and Canadian courts to declare a public trust, have been mirrored in Canadian law. Coupled with the initial Canadian recognition of the public trust, the foundations therefore exist for a modern common law revival of the public trust doctrine in Canada. The likely consequences of recognition of the public trust at Canadian common law are : (1) the recognition of a substantive right, and therefore legal standing, in members of the public to vindicate public trust interests; (2) the imposition of an affirmative fiduciary obligation on government with respect to trust resources; (3) the imposition of an administrative process on government with respect to supervision and disposition of public trust resources; (4) restrictions on alienation of trust resources, in particular the restriction that legislation is required to modify or extinguish public trust resources and, (5) in an environmental context, recognition of the importance of the natural environment and the special and inter-related nature of trust resources.

There has been considerable interest in finding and explaining the basic elements that can drive product quality up. In the literature this is largely done by modelling the effects of investing in learning and process improvement, and of cost reduction. In the first essay, demand is modelled as a function of price and quality. With this demand function, the firm should produce output of higher quality, the increase in quality being dependent on consumers’ sensitivity to quality and to price, and the effect of technological improvement on product price and quality are very different from those when the demand is a function of price alone. Some twenty states in the U.S. have passed recycling laws which mandate consumption of old newspaper by the newsprint industry. To study the effect of regulation, a model is used in which two firms compete under the regulatory constraint—one firm producing the recycled product, the other the virgin product. Assuming the regulatory constraint is binding, and the demand for the recycled product is derived solely from the legislation, interesting results such as the two firms share equal profits, and consumers pay higher average price in competitive equilibrium than the cartel price, are obtained in the second essay. The two firm model is generalized to include n firms which compete under the same kind of regulatory constraint in the third essay. Results similar to the two firm case are obtained. When the recycled product and the virgin product are partially substitutable, regulation that mandates consumption of the recycled product results in infinitely many equilibria. A dominating equilibrium exists if the demand parameters satisfy a certain condition, otherwise it is not clear how to select an equilibrium. On the other hand, a suitable tax on the virgin product, or its producer, serves to induce compliance with the recycling policy and equilibrium selection. The equilibrium prices and profits of the two firms under the schemes of production tax, excessive consumption tax and progressive profit tax are examined and compared in the fourth essay. It is interesting to find that the tax rate for excessive consumption is comparatively low and, in equilibrium, this tax scheme collects no tax payment.

The major purpose of this study is to analyze and assess the validity of those charges which have alleged: (1) that political parties impede voters' efforts to make rational choices between issue alternatives and between candidates by failing to take clear cut positions on the issues which confront them; and (2) that the parties frustrate the efforts of the voters to appraise legislative performance because that performance bears little resemblance to the program which the parties presented to the electorate. A second purpose of the study is historical: to investigate, and present an account of political and legislative developments in the nineteen fifties and early nineteen sixties regarding four relatively broad issues. Each of these issues--foreign aid, civil rights, labor-management relations, and farm policy-received major national attention during the decades of the fifties and sixties and each continues to be significant as the nation enters the decade of the seventies.The study began by tracing the main elements in the historic background of the above issues. This background served as the springboard from which the investigations into the role of the political parties in formulating and implementing public policies were launched. The positions which the Democratic and Republican Parties developed on the issues were examined and contrasted for 1952 and 1960. In addition, the elaboration of these positions by the respective Presidential candidates was examined. The four issues were then studied as they were formulated into legislative proposals, and party legislative performance with respect to them was described and analyzed for the 83rd and 87th Congresses. These two Congresses were selected because in each one the party which had been out of power was reassuming control of both houses of Congress as well as the Presidency.The investigation of the four issues and the analysis of party performance with respect to them yielded only qualified answers to the two questions which guided the investigation. These two questions were: (1) Did the parties take clear-cut positions on the issues?; and (2) Did the party which controlled the Government follow through on the positions it had taken? With respect to party positions the study revealed that on two of the issues the parties did offer diametrically opposed alternatives. These two issues were labor-management relations and farm policy. Moreover, distinguishable alternatives were offered on the other two issues, foreign aid and civil rights.In the implementation of party programs the study revealed that on two of the issues, labor-management relations and civil rights, the Republicans in the 83rd and the Democrats in the 87th Congress honored their pledges more in the breach than in the observance. On the other hand, both parties did implement programs in foreign aid and in farm policy which corresponded with the programs they had sented during the respective campaigns.The data indicate then, that there were distinguishable differences between the positions taken by the parties on those issues which the study covered. In addition, the process by which these positions were reached as well as the legislative debates on the proposals stemming from them, should have enhanced, rather than inhibited the citizen's understanding of the important issues. Finally, the legislative debates and the voting records of the party members provided a basis for evaluating party performance. The results of this study strongly suggest that the interested citizen who takes the time to do so can use the machinery of the American party system to make intelligent choices at election time, and to evaluate the performance of the individuals and the party for whom he has voted.3

The number of students enrolled in United States public schools speaking a language other than English in their homes doubled over the last decade. In Indiana more than 60% of all public school districts reported having at least one English Learner student enrolled. It is projected that Indiana EL enrollment will increase 21% by the year 2021 (National Center for Education, 2009). These statistics make EL students, those students whose native language is not English, the fastest growing demographic in the Indiana public school system. As such, there is a need to know, and adhere to, the numerous laws that govern EL education in America. No Child Left Behind (NCLB) allows for state-specific guidelines concerning EL education, but it monitors the states’ progress of the EL student federally. Schools that do not have EL students who show adequate progress are subject to a loss of funding or closure for failing to serve all of their enrolled student population. This has caused many Indiana schools to review their EL practices and procedures when considering instructional strategies. This study examined the history of EL education and what Indiana schools at the elementary level are doing enough to prepare EL students. / Department of Educational Leadership

This thesis is as an attempt to overview the forms of trade secret protection presently in place in the United States, Canada, the European Union and Romania. These jurisdictions were selected because they present a diversity of legal background and a variety of forms of trade secret protection. / The introductory chapter deals with the historical and economic backgrounds of the trade secret protection. An overview of trade secret protection at international scale is also provided. The thesis compares the forms of trade secret protection available in each jurisdiction. Based on the survey, the thesis comes to an answer of the question of "What is the most appropriate form of trade secrets protection?". / The final chapter provides a number of conclusions and recommendations.

The use of medical devices and drugs is constantly increasing in the United States. New techniques are developed, pharmaceutical companies manufactured thousands drugs and medical devices each year, these products are put on the market immediately; therefore, the consequences can be terrible. / In the US, thousands even millions of people suffer from personal injuries because they use a defective medical product; this is referred as a mass tort. The class action procedure is often used in order to repair these personal injuries. Plaintiffs always ask for the use of this procedure, but the federal American courts always refuse the certification of the class because the conditions of Rule 23(b)(3) are not fulfilled. This is what is called "the new trend of American courts". / The non application of the class action procedure leads to terrible results; victims of a defective medical product cannot receive compensation for the injury they are suffering from. These victims choose the class action procedure because of its advantages, if the class action is not certified they won't sue individually. If the real problem was the non respect of Rule 23(b)(3)'s conditions, a modification or a reform of the Rule would have been done. Unfortunately the laxity of the federal judges tends to influence the American Congress who ignores the need for a reform of this rule. This makes us wonder what the real justifications motivating this refusal of certification are.