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This thesis consists of three essays that contribute to the understanding of the economic implications of Extended Producer Responsibility (EPR) for certain durable (e.g. electronics) and consumable (e.g. pharmaceuticals) products from an operational perspective. In the first essay, we investigate the effect of EPR-based policy on a durable good producer’s secondary market strategy. Our analysis uncovers possible strategic approach of durable good producers to EPR obligations, which may result in unintended outcomes. We provide insights into how to set EPR obligations to avoid these adverse outcomes. In the second essay, we examine the operational details of market-based EPR implementation on the ground. We analyze whether the advocated premises of the marked-based approach hold by focusing on the Minnesota Electronics Recycling Act. Based on evaluation reports and stakeholder interviews, we find that the Minnesota Act achieves the premises of the market-based approach, but this occurs at the expense of several unintended outcomes, following unforeseen market dynamics and associated stakeholder interactions. In the third essay, we explore how the EPR-based policies can be effectively operationalized for managing pharmaceutical overage by analyzing the interactions between major stakeholders and moderating factors for these interactions. We demonstrate that the preferred policy depends on the healthcare and externality characteristics of the medicine together with collection-related requirements. Additionally, we investigate the perspectives of pharmaceutical stakeholders on the policy choice and identify the influential factors in this context.

Thesis (M.B.A.)--Boston University

Scientific and technological (S&T) advances underpin opportunities for innovation in the pharmaceutical industry. Government-funded research institutions and firms perform biomedical research to generate S&T advances and enable pharmaceutical innovation. Previous research found that the number of new drugs approved by the US Food and Drug Administration (FDA) has stagnated. The observed stagnation has been interpreted as a decline in the return on research investments. The apparent decline in productivity may be due to the increasing technological difficulty of using S&T advances to develop new drugs and the organizational complexity of incorporating S&T advances generated by government-funded research institutions and firms to develop a new drug. I apply theories of organizational learning to examine how the use of S&T advances to develop new drugs affects the productivity of drug development activities, measured as the time taken to complete early stage pre-clinical research and late stage clinical development activities. I have constructed a novel data set that maps the production and utilization of S&T advances in three phases of market-oriented drug development. By measuring productivity at the project level, I am able to model productivity as the time taken to complete a R&D project as a function of three factors: (1) the technological characteristics of the drug; (2) the use of components generated by other entities; and (3) the research capabilities of the innovating firm. These models enable me to identify technological and organizational factors that affect the efficiency with which S&T advances are transformed into new drugs. Analyses indicate that different technological and organizational factors affect the productivity of pre-clinical research and clinical development. While the time taken to complete a pre-clinical research project is largely determined by the complexity and innovativeness of the drug, the time taken to complete clinical development is a function of the firm's R&D previous experience. The time taken to complete the entire drug development project is determined by the complexity of pre-clinical research and the firm's R&D capabilities. The results are discussed in detail along with policy implications. / text

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Benzodiazepines are the most commonly prescribed group of psychotherapeutic pharmaceuticals on a global scale and have been on the market since the 1960s. Benzodiazepines remain in the aqueous effluent from sewage treatment plants and have been found in natural aquatic environments. The aim of this study was to investigate if there is benzodiazepines in natural sediment from Lake Ekoln situated downstream River Fyris in Uppsala, where previous studies have detected high concentrations in the water. The study tested following hypotheses: (1) benzodiazepines are accumulating in sediments; and (2) breakdown of benzodiazepines is slow in sediment resulting in them being preserved in sediments that are several years/decades old. An extraction method for sediment was developed followed by liquid chromatography-tandem mass spectrometry for analysis of oxazepam, alprazolam, clonazepam, flunitrazepam, diazepam and prazepam. All investigated benzodiazepines occurred in the sediment of Lake Ekoln; hence, in line with hypothesis 1, benzodiazepines are accumulating in natural sediments. Further, all benzodiazepines were found in the upper 10 cm of the sediment and oxazepam, clonazepam and diazepam was found at depth below 20 cm, corresponding to an age of more than 20 years indicating that benzodiazepines resists degradation processes in sediment and are persistent for decades as predicted by hypothesis 2. To my knowledge this is the first study demonstrating that benzodiazepines are accumulated and preserved in natural sediments.

This diploma thesis focuses on interactions of chosen pharmaceuticals with soil and study their mobility. First part is devoted to the characteristics of the most common pharmaceuticals that appear in the environment, specifically antibacterial chemoterapeutics and analgetics. Subsequently, the occurrence of the pharmaceuticals in environment, their sources and effects are described. Further, the work focuses on soil components and soil organic matter. In conclusion of the theoretical part is the description of used analytical method for processing of the results and also the current state of the problematics. In the practical part of the thesis the experiments were made and analyzed and further served for better understanding of adsorption and interactions of chosen pharmaceuticals with soil and humin acids as the main reactive part of the soil.

Research continues to show that pharmaceutical environmental contamination has caused adverse environmental effects, with one of the most studied effects being feminization of fish exposed to pharmaceutical endocrine disruptors. Additionally, there are also public health risks associated with pharmaceuticals because in-home reserves of medications provide opportunities for accidental poisoning and intentional medication abuse. Pharmaceutical take back programs have been seen as a remedy to these concerns; however a thorough review of peer-reviewed literature and publicly available information on these programs indicates limited research has been conducted to validate these programs as a purported solution. Furthermore, there are significant data gaps on key factors relating to take back program participants. The purpose of this dissertation was therefore to address these gaps in knowledge and ultimately determine if take back programs could actually improve public and environmental health. This was accomplished by conducting social and scientific research on a take back program called Denton Drug Disposal Day (D4). Socioeconomic, demographic, and geographic characteristics of D4 participants were investigated using surveys and geographic analysis. Impacts on public health were determined by comparing medications collected at D4 events with medications reported to the North Texas Poison Center as causing adverse drug exposures in Denton County. Impacts to environmental health were determined by monitoring hydrocodone concentrations in wastewater effluent released from Denton’s wastewater treatment plant before and after D4 events. Data collected and analyzed from the D4 events and the wastewater monitoring suggests D4 events were successful in contributing to improvements in public and environmental health; however there was insufficient evidence to prove that D4 events were exclusively responsible for these improvements. An additional interesting finding was that willingness to travel to participate in D4 events was limited to a five to six mile threshold. This geographic information, combined with other findings related to socioeconomic, demographic, and risk perception characteristics of D4 participants, has the potential to help improve the effectiveness of future take back events. This would allow these programs to better meet their common goals of improving both public and environmental health, which this study has shown is achievable to some degree.

Law of Pharmaceutical Patents in International Trade Agreements Klíčová slova: TRIPS, Patents, Pharmaceuticals Abstract Trade related aspects of intellectual property rights - especially pharmaceutical patents - were one of the most controversial topics in Trans-Pacific Partnership and Transatlantic Trade and Investment Partnership negotiations. Whereas just thirty years ago international intellectual property law was mostly tied to the multilateral playground of the Agreement on Trade-Related Aspects of Intellectual Property rights (TRIPS), nowadays we can see increasing bilateralism and regionalism in this area. The agreements that build on the protection guaranteed by the TRIPS agreement are known as TRIPS-plus agreements. One of the root causes that led developed countries to promote intellectual property rights shifting from multilateralism to regionalism was the increased negotiation power tied to a smaller playground. This thesis argues that there is a shift in intellectual property rights regulations from multilateral to bilateral and regional trade agreements. This shifting serves the purpose of promoting increasingly extensive intellectual property rights protection. In its theoretical chapter the thesis describes the powers that formed the foundation of the World Trade Organisation. It...