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In an era of highly advertised blockbuster medicines, newly approved pharmaceuticals can pose a hazard to the public if not properly monitored following their approval. Drugs are only given to a limited number of healthy individuals during clinical trials, leaving significant questions as to the risks for the population at large. There are limited opportunities for assessment following the product’s introduction onto the market and adverse effects may not be detected. This paper argues that hurdles in tracking long-term safety and effectiveness can be partially remedied through the aggregation and analysis of information collected through pharmaceutical data mining. Pharmaceutical data mining is a process whereby private organizations compile extensive information on patients’ prescription histories, including: the drug prescribed, recommended dosage, and the patient’s subsequent history with the medication. The Canadian government should collect this information and analyze its meaning to better ensure the long-term safety and effectiveness of drugs.

In an era of highly advertised blockbuster medicines, newly approved pharmaceuticals can pose a hazard to the public if not properly monitored following their approval. Drugs are only given to a limited number of healthy individuals during clinical trials, leaving significant questions as to the risks for the population at large. There are limited opportunities for assessment following the product’s introduction onto the market and adverse effects may not be detected. This paper argues that hurdles in tracking long-term safety and effectiveness can be partially remedied through the aggregation and analysis of information collected through pharmaceutical data mining. Pharmaceutical data mining is a process whereby private organizations compile extensive information on patients’ prescription histories, including: the drug prescribed, recommended dosage, and the patient’s subsequent history with the medication. The Canadian government should collect this information and analyze its meaning to better ensure the long-term safety and effectiveness of drugs.

Brazil is renowned worldwide for its remarkable reforms in pharmaceutical regulation, which have enhanced access to essential medicines while lowering drug costs. As part of these reforms, the Generic Drug Act was introduced in 1999. This policy mandates that pharmaceutical products that are no longer protected by a patent must be interchangeable with an innovator (reference) drug. This thesis examines how and why Brazil promoted this large-scale regulatory policy. The literature on pharmaceutical policy often invokes international guidelines that inspire countries to reformulate their regulatory regimes or argues that regulations emerge in order to serve the interests of powerful interest groups. In contrast, this thesis examines how changes in the regulatory environment affect actors’ policy preferences. It argues that as actors adapt and respond to new regulatory environments, they also push the policy path further along the way. This historical qualitative case study relies on in-depth interviews and documentary research to trace the policy process of generic drug regulation in Brazil. It finds that Brazil’s generic drug reform can be attributed to a convergence of the evolution of pharmaceutical regulation, unexpected events (AIDS epidemic and scandal of fake medicines) and political activity of the Minister of Health. In turn, this study demonstrates that the new regulatory development altered the preferences of local pharmaceutical firms, who now support and uphold a policy they once opposed because of the high costs associated with adapting their industrial plants and processes. The regulation of generic drugs has also culminated in other unintended consequences. Public pharmaceutical factories were still unable to fully adjust to the new regulatory environment and patient groups slowly became aware of these limitations. Paradoxically, the generic drug regulation introduced in the name of patients and opposed by local pharmaceutical firms, is today opposed by important patient advocacy groups but solidified by the strong support of local and multinational pharmaceutical firms. These findings suggest although pharmaceutical firms strongly support the generic drug regulation today; they did not control the policy process that created it. Although Brazil’s norms resemble international guidelines, they were developed locally. Brazil’s case demonstrates that evolution of domestic political institutions were the most important determinant of the timing and direction of the regulatory policy. Thus, this thesis concludes that the state still matters for pharmaceutical regulation and that pharmaceutical regulation is only partially influenced by non-state actors.

En Afrique de l’ouest, le processus d’harmonisation des réglementations pharmaceutiques se caractérise par des initiatives souvent séparées et propres, d’une part à la Communauté Economiques Des Etats de l’Afrique de l’Ouest (CEDEAO), et d’autre part à l’Union Economique et Monétaire Ouest Africaine (UEMOA). Cette étude dont l’objectif était de contribuer à l’optimisation de la réglementation pharmaceutique montre que la CEDEAO a essentiellement élaboré des lignes directrices, tandis que l’UEMOA, mettant à profit la force et la portée juridique des normes à sa disposition et opposables aux Etats membres a pu obtenir des résultats tangibles. L’optimisation de la réglementation pharmaceutique passe par la prise en compte des autres fonctions réglementaires insuffisamment régulées et par une coopération active entre les deux organisations, renforcée par l’intervention de l’Union Africaine, qui permet de construire une démarche incluant la création d’une agence ouest africaine du médicament et la mise en œuvre d’une source innovante de financement, dans le but ultime de favoriser l’accessibilité des populations à des médicaments de qualité. / In West Africa, pharmaceutical regulations harmonization process is characterized by initiatives on one hand separate and specific to Economic Community Of West African States (ECOWAS) and on the other to West African Economic and Monetary Union (WAEMU). The present study which aims at contributing to pharmaceutical regulation optimization reveals that ECOWAS has essentialy elaborated guidelines while WAEMU by taking advantage of the strength and scope of legal standards available and opposable to member states succeeded to get tangible results. Pharmaceutical regulation optimization involves taking into account other reglementary functions not sufficiently regulated and in an active cooperation between both organisations reinforced by African Union intervention. This permits to build an approach including the creation of a west african agency for medecine and the implementation of inovatives sources of funding, whith the ultimate goal to promote access of populations to good quality medecines.

Pharmaceuticals have benefitted countless lives. New therapies are being developed every day—many prove effective, but many do not. In order to ensure only safe and effective drugs enter the market, the United States' Food and Drug Administration (FDA) approves each treatment based on data garnered from clinical trials. Clinical trials take time, however, and investigational new drugs (INDs) can demonstrate signs of efficacy long before approval. These cases introduce a fundamental question: should the government limit patient access to a drug that has yet to be proven safe and effective? Or do patients have the right to freedom from governmental intervention in their medical decision-making? In this paper, the history of IND regulation will be explored, followed by an examination of the freedom to access from constitutional, ethical, and infrastructural perspectives. Changes to the current system will then be proposed.

1 Thesis Summary Private Enforcement of EU Competition Law Zuzana Šimeková 1. Starting points and goals of the thesis The main goal of my thesis is the application of the ever-evolving contemporary issues of private enforcement of the EU competition law, its developments in the legislative area and the decision- making practice of the European Commission and the Court of Justice of the European Union (the ECJ) to the pharmaceutical sector area. As regards the functioning of competition rules, the pharmaceutical sector found itself in the cross-hairs of the European Commission fairly recently. Its efforts resulted in the Pharmaceutical Sector Inquiry Final Report of 8 July 2009 (the Final Report). The primary subject-matter of my thesis is the assessment of the competition relationship dynamic between the originator and generic pharmaceutical companies, especially the degree by which the conduct by the originator pharmaceutical companies can delay market entry by the generic pharmaceutical companies and thereby negatively affect the consumers by (among other things) limiting availability of cheaper drugs. Despite the expectations of legal practitioners and academia, the European Commission did not rule in the Final Report whether the discovered conducts constitute violations of the EU competition law. The...

In 2005, the House of Commons (HoC) Health Committee produced a report on The Influence of the Pharmaceutical Industry – the first of its kind since 1914. The inquiry concluded that there were ‘over-riding concerns about the volume, extent and intensity of the industry’s influence, not only on clinical medicine and research but also on patients, regulators, the media, civil servants and politicians’, and stressed the need ‘to examine critically the industry’s impact on health to guard against excessive and damaging dependencies’ (HoC 2005, p. 97). It also noted that it is important to comprehensively analyse pharmaceutical regulation in order to ascertain whether there are systemic problems: In some circumstances, one particular item of influence may be of relatively little importance. Only when it is viewed as part of a larger package of influences is the true effect of the company’s activity recognised and the potential for distortion seen. The possibility that certain components of any such campaign are covert and their source undeclared is particularly worrying. (HoC 2005, p. 97) This study addresses this recommendation and was primarily conducted to examine whether recognised concerns are merely ad hoc or as a result of systemic flaws in the current system of pharmaceutical regulation. The work addresses a gap in the academic literature by drawing on the fragmented criticisms of the pharmaceutical industry in order to produce a model to illustrate how various stakeholders collaborate with drug companies to promote licensed products, and to explore the nature of the relationships between these elite stakeholders. The thesis begins with a literature review which determines who is involved in pharmaceutical regulation; how the regulatory system works; and explores the key role of communication in this process (Chapters 1 to 3). The recurrent theme is the neglect or exclusion of the patient/consumer, which leads to the development a model of intra-elite communication in drug regulation called Pharmaffiliation (Chapter 3). The thesis then looks for evidence to support or refute this model, using multiple methods (Chapter 4). Four case studies (with specific selection criteria) are chosen to test the model’s constructs and indicators (Chapters 5 to 8). The research uncovers systemic problems in the current system of pharmaceutical regulation which can ultimately harm the patient/consumer, and the implications of these findings are discussed (Chapter 9). Solutions on a micro-level include consumer involvement in decision making processes, which can be enhanced through public education and awareness campaigns and the instigation of public inquiries whenever drugs are withdrawn from the market (HoC 2005, p. 105). On a macro-level, however, this will involve critically exploring neoliberal capitalism and the empowerment of the citizenry (Street 2001).