Frontiers In Market Access

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers’ needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product

With the entry into force of the Treaty of Lisbon in 2009, the EU became a global actor in the field of foreign direct investment. Since then, the field of EU investment policy has been gradually shaped by numerous political changes, judgments and opinions delivered by the Court of Justice of the EU, as well as lively scholarly debate. Today, a clear division between the “internal” and “external” dimensions of EU investment policy has emerged, which constitutes the general topic of this book. Within these dimensions, additional – and sometimes contradictory – facets of the EU’s multi-layered approach to investment protection can be identified. On the one hand, EU investment policy is shifting toward a decentral approach when it comes to substantive standards of investment protection. On the other hand, the EU is following a multilateral approach with regard to procedural innovations in investor-State dispute settlement. In this EYIEL Special Issue, leading experts in the field discuss the latest developments with regard to the above-mentioned dimensions and facets, which reflect new trends and challenges for EU investment policy. Among others, the book discusses the EU’s participation in the reform process for the international investment regime, the emergence of central planning and decentral implementation of EU investment policy, the feasibility of an intra-EU investment court, the protection and enforcement of investment standards under EU law, and the suitability of mediation as an alternative to intra-EU investment arbitration.

This collection of essays honors the life and work of one of the most prominent and fervent heterodox economists, Frederic S. Lee, who has been at the heart of the heterodox economics movements for the past three decades. Authors in this book demonstrate that heterodox economic has transcended the criticism of mainstream economics and, more importantly, that constructive developments are in the making by way of cross-communications among various heterodox economics traditions. Frederic S. Lee’s contributions to heterodox economics are centered on three themes: the making of a history and identity of heterodox economics, heterodox microeconomics, and the heterodox analysis of social provisioning. Part I addresses the importance of history, theory, research methods, and institutions in the making of the identity of heterodox economics as an alternative to mainstream economics. Part II delves into heterodox microeconomic theories—in particular, investment, pricing, competition, markets, and market governance—as foundations of heterodox macroeconomic analyses. Part III expands the analysis of the capitalist social provisioning process with an emphasis on its subsystems and their relationships over historical time. Part IV encapsulates the life and work of Frederic S. Lee. Throughout his intellectual life Frederic S. Lee has shown to many that the development of heterodox economics is rendered possible by unselfish and ceaseless efforts to build both theory and institutions. Essays in this book attest that establishing an alternative critical theory to the status quo is not only possible but also serviceable to the majority of the population.

While the internal market has been at the heart of the European project from the very beginning, it has rarely been the subject of sustained and comprehensive scholarly examination in its entirety. In the face of profound legal, political and policy pressures, this timely Research Handbook reflects on the cutting-edge issues, horizontal themes and the big questions which illuminate the shape of the internal market. It places the law and policy of the internal market within the context of the financial crisis and the existential questions this has raised for future European integration.

Economic Theory, academic policy analysis and public policy design are becoming more interdependent. Hence, the demands for close interactions between the policy community and the research community have been rising significantly. This book assesses how recent economic thinking has advanced under these influences. Furthermore, it evaluates the important contribution economics can add to the design and evaluation of public policy, now more than ever before. The study is of interest to policy makers, policy analysts, researchers and students of economics at all levels. The authors, which include many of Germany's most eminent economists, draw on their wide experience in research and consultancy to present a coherent view of where European economic theory stands today and how it can play a role in the management of the economy of the new millennium.

Market access is the process by which a pharmaceutical company gets its product available on the market after having obtained a marketing authorization from a regulatory agency and by which the product becomes available for all patients for whom it is indicated as per its marketing authorization. It covers a group of activities intended to provide access to the appropriate medicine for the appropriate group of patients at the appropriate price (in most countries). Market Access may also be seen as activities that support the management of potential barriers, such as non-optimal price and reimbursement levels, the restriction of the scope of prescribing for the drug or complicated prescription writing or funding procedures. Since there are cultural differences among countries, any Market Access strategy needs to be culturally sensitive. Pharmaceutical Market Access in emerging markets has been extensively discussed in our previous book, published in 2016. The present book focuses on developed markets with the goal of helping students, academics, industry personnel, government workers, and decision makers understand the environment in developed markets.