This study examines how the Securities and Exchange Commission balances competing regulatory objectives in its decisions to approve requests to withhold proprietary information from firms' financial reports. The confidential treatment process requires the SEC to balance the public interest in protecting proprietary information with the public interest in promoting disclosures to investors. I draw upon the economic and political science literatures on regulatory decision-making to test the strength of these interests on three aspects of the SEC's decisions to grant confidential treatment: the duration of time required to approve the request, the duration of time the SEC agrees to protect proprietary information from disclosure, and whether the firm is successful in securing confidential treatment for all redacted information. I find that the public interest in promoting disclosure and protecting proprietary information influence different aspects of the SEC's decisions to grant regulatory exemptions for confidential treatment. Firms requiring greater monitoring by the SEC receive greater scrutiny and have lower odds of successful redaction. High proprietary costs are associated with significantly longer protection periods but proprietary costs generally are not associated with duration to approval or the success of the application. Finally, I find that the SEC applies greater scrutiny to firms exhibiting objective and salient measures of low financial reporting quality although these firms have higher odds of success. These findings are consistent with the SEC reviewing CTRs to reduce the risk of legislative oversight. This study contributes to the literature on disclosure regulation by providing evidence as to how securities regulators balance competing interests when reviewing requests for disclosure exemptions. These findings also contribute to the role of political influence on disclosure policy, as the SEC's exemption decisions are consistent with avoiding the threat of legislative oversight. Second, these findings contribute to the literature on the SEC's regulatory decisions by demonstrating that the SEC staff appears to allocate resources and apply scrutiny to applications for disclosure exemptions using aspects of registered firms' financial reporting quality. Third, these findings contribute to the literature on redaction as a disclosure choice by providing evidence suggesting that firms with low financial reporting quality are more likely to redact, and I provide evidence on the success of this disclosure choice. Overall, these findings suggest that the public interest in promoting disclosure, as well as the threat of legislative oversight, influence the SECs decisions when granting regulatory exemptions to protect proprietary information.

Magister Pharmaceuticae - MPharm / Medicines registration decision-making and regulatory best practice involve transparent and consistent rule making and processes with publicly available published assessment decisions and reports (Kaine, 2020). Publication of information relating to evaluation of medicines in the form of Public Assessment Reports (PARs) is one way of ensuring transparency in medicines registration decision making. It is however not clear whether National Medicines Regulatory Authorities (NMRAs) in the Southern African Development Community (SADC) region are in a position to generate or even publish such PARs / summary basis for registration of medicines. Objectives: The study investigated transparency in medicines registration decision-making processes for NMRAs within the SADC region. Specifically, the availability or non-availability of PARs / Summary basis for registration of medicinal products. To establish if all SADC NMRAs have legislative frameworks for regulating medicines and to investigate the sources of funding for SADC NMRAs. Methods: A cross-sectional exploratory descriptive study design with qualitative techniques by questionnaire as a data collection tool was used. Questionnaires were sent via email to senior members / key informants of 11 regulatory authorities belonging to SADC. Trend analysis was conducted based on the emerging themes from questionnaire response. Results The study revealed that currently five (5) NMRAs are operating as semi-autonomous agencies namely: BOMRA, MCAZ, PMRA, SAHPRA and TMDA .While NMRC, DNME of Angola, ACOREP of DRC and DNF of Mozambique are functioning within their respective Ministries of Health Departments. Furthermore, all NMRAs have a legislation framework governing the regulation of medicines in their respective jurisdictions. However, DNME of Angola’s legal framework is not yet officially formalised and as such, they follow a Presidential decree enacted in 2010. Four (4) of nine (9) NMRAs (44 %) reported to have more than 20 internal assessors / evaluators. This indicates a significant milestone for SADC NMRAs in terms of capacity building within the region. The study findings indicated that the SADC NMRAs are receiving funding from multiple sources ranging from a minimum of one to maximum of four funding sources. There were only two NMRAs, MCAZ and PMRA, that were not receiving funding from their governments. The study results further indicates that only TMDA is able to generate and publish PARs amongst SADC NMRAs. Conclusions: The findings in this study suggest that the majority of NMRAs within SADC are not yet matured as compared to countries in the developed world such as the US, Europe, Canada and Australia. It can also be concluded that for SADC NMRAs to be efficient and responsive, they will require massive financial resources. For example, the budget for a matured NMRA such as the US Food and Drug Administration (US FDA) for the 2019 financial year was estimated at US$ 5.7 billion. Literature further indicates that publication of the summary basis of approval or PARs is a norm for mature NMRAs and acts as a tool for regulatory authorities to build and establish confidence in their review processes and provides assurance regarding safety of medicines. The study results indicate that TMDA is publishing PARs or summary of grounds on which approvals are granted. This demonstrates a significant level of transparency in the TMDA medicines registration processes and therefore other SADC NMRAs can benchmark with TMDA to implement this key parameter.

Submitted by Maria Mello Franco (maria.mf@gmail.com) on 2017-03-23T05:46:04Z No. of bitstreams: 1 Dissertação Final biblioteca21.03 pdf.pdf: 4177623 bytes, checksum: 789f03e4f3c212eac381d004cbe7b88b (MD5) / Approved for entry into archive by Leiliane Silva (leiliane.silva@fgv.br) on 2017-03-23T15:37:01Z (GMT) No. of bitstreams: 1 Dissertação Final biblioteca21.03 pdf.pdf: 4177623 bytes, checksum: 789f03e4f3c212eac381d004cbe7b88b (MD5) / Made available in DSpace on 2017-04-03T19:18:42Z (GMT). No. of bitstreams: 1 Dissertação Final biblioteca21.03 pdf.pdf: 4177623 bytes, checksum: 789f03e4f3c212eac381d004cbe7b88b (MD5) Previous issue date: 2017-02-21 / The present study intends to evaluate citizen participation in the decision making process of some Brazilian institutions assigned for regulating certain economic sectors in the country. Some regulatory agencies activities are analysed, highlighting the issues concerning independence and control of these organs. We focus on some international bodies guidelines regarding regulation via regulatory agencies, as well as some national bodies studies on the subject. In addition, the relevant legislation and the debates elaborated by the academia are demonstrated. Specifically, the study aims to evaluate public hearings empirically in the regulatory decision-making process of two federal regulatory agencies - the National Water Agency (ANA) and the National Electric Energy Agency (ANEEL). It seeks to identify (i) Who are the participants in the public hearings held by the agencies; (Ii) At what point in the regulatory decision-making process are the mechanisms for public deliberation inserted, and (iii) what is the justification for it - Who, When and Why? The results of the empirical analysis collected call attention to the necessary care to be employed in the practice of public hearings. It is evident that the malfunctioning of these instruments may affect the fulfilment of the purpose for which they were instituted. It is reiterated that the way in which social participation is practiced through public hearings in regulatory agencies is decisive for considerations about the legitimacy of regulatory decision making in these bodies. / O presente estudo pretende avaliar o funcionamento de mecanismos de participação popular em algumas instituições brasileiras responsáveis pela regulação de determinados setores econômicos no país. As atividades regulatórias de algumas agências reguladoras federais são avaliadas, evidenciando-se a temática relativa à tensão existente entre independência e controle destes órgãos. Destacam-se orientações de órgãos internacionais defensores da difusão da regulação através do modelo de agências reguladoras, bem como inclui-se estudos de alguns órgãos nacionais sobre a temática. Adicionalmente, demonstram-se a legislação pertinente e os debates elaborados pela literatura especializada. Especificamente, o estudo objetiva avaliar empiricamente as audiências públicas no processo decisório regulatório de duas agências reguladoras federais ‒ a Agência Nacional de Águas (ANA) e a Agência Nacional de Energia Elétrica (ANEEL). Busca-se identificar (i) Quem são os participantes das audiências públicas realizadas pelas agências; (ii) Em que momento no processo decisório regulatório os mecanismos de deliberação pública são inseridos e, (iii) Qual a justificativa para tanto ‒ Quem, Quando e Por quê? Os resultados da análise empírica empregada chamam a atenção para o cuidado necessário a ser empregado na prática das audiências públicas. Isso porque evidencia-se que o mau funcionamento desses instrumentos pode afetar o cumprimento da finalidade para a qual foram instituídos. Reitera-se que a forma pela qual a participação social é praticada via audiências públicas nas agências reguladoras é determinante para considerações sobre a legitimidade da tomada de decisão regulatória nestes órgãos.

L'évaluation des bénéfices et des risques des médicaments joue un rôle central dans la protection de la santé publique. Cependant, et de l’avis général, il apparaît que cette évaluation nécessite d’être revisitée. En 2010, aucun examen n’avait encore été effectué pour déterminer si les méthodes disponibles pouvaient être appliquées à l’évaluation de la balance bénéfice-risque des médicaments dans le cadre réglementaire, et si oui à quel point elles seraient applicable. L’objectif de cette thèse a donc été d’identifier la ou les méthodes pouvant être théoriquement utilisées pour ce type d’évaluation, puis de les confronter à des cas concrets afin d’en déterminer leur applicabilité. Les résultats de l’évaluation des méthodes ont montrés que les méthodes les plus appropriées sont la méthode d’aide à la décision multicritère (MCDA) ainsi que ses variantes. Les résultats de l'application pratique de la méthode MCDA ont indiqué que cette méthode peut être utilisé dans les scénarios communs d'enregistrement en Europe. Cependant il convient de noter que cette méthode ne fournit ni une recette « prête à l'emploi » pour exécuter cette évaluation ni une réponse directe. / The benefit-risk evaluation of new medicines plays a central role in safeguarding public health. Nevertheless, it seems that the benefit-risk evaluation calls for further improvement. In 2010, no review had been performed of how available benefit-risk assessment methods could be applied for a regulatory benefit-risk assessment and how feasible that would be when facing real-life cases. The objective of this thesis has thus been to identify method(s) that could be theoretically used for such an assessment, and then to confront it/them to real-life cases, in order to determine their applicability. The results of the methods evaluation showed that the most suitable methods for a regulatory benefit-risk assessment of medicinal products are the MCDA method and the MCDA based methods. The results of the practical application of the MCDA indicated that the method could be used for medicinal products registered through a common registration scenario in Europe. However it should be noted that this method provides neither a “ready-made” recipe to perform an assessment nor a direct answer.