This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry’s approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.

Traditional knowledge protection methods are becoming increasingly out-dated in the face of modern challenges. Focussing on the protection of traditional knowledge and related genetic resources, this book is the first of its kind to amalgamate a novel theoretical framework with the practical applications of the combined theories of Rawls and Coase. The Protection of Traditional Knowledge on Genetic Resources analyzes various means of protection for traditional knowledge that cohere with Rawls? and Coase?s specific objectives regarding fairness and efficiency. It utilizes flexibilities provided by binding international conventions in the field in order to propose alternative methods to protect different forms of traditional knowledge. Frantzeska Papadopoulou reaches the conclusion that property, liability and reward systems are forms of protection that fulfill the fairness and efficiency criteria whilst remaining compliant with the general international legal framework. This book is ideal for international property law and development academics and policy makers, especially those working on international property rights (IPRs), as it proposes a novel methodological framework for the evaluation of IPRs.

In the aftermath of the MeToo movement, during an ongoing pandemic, and in the midst of repeated demands for a 50/50 split between men and women in above-the-line positions, this book analyzes and interrogates the politics of gender focusing on the Swedish film industry, often considered to be the most "gender equal" film industry worldwide. While this gender equality (with a considerable proportion of women behind the camera) is much due to policies carried out of the state funded Swedish Film Institute, women filmmakers in Sweden still struggle with the same problems as do women in other national film industries. These problems entail having smaller production and distribution budgets than men and working in an environment involving recurring scandals of gender discrimination and sexual harassment. This open access book looks behind the statistics and explores the often complex cultural, legal, and political conditions under which women have entered a male-dominated industry and discusses women's strategies and efforts to promote change while providing evidence on how women's presence has challenged the industry by provoking critical reactions and introducing new ways to portray women on screen. Using a wide range of different sources (e.g. archival material, laws, contracts, films, biographical materials, and interviews), the book tells the history of the rise of gender equality efforts undertaken by the Swedish Film Institute and investigates women's possibilities to manage the rights to their work. It offers compelling portraits of pioneering women who have worked in or in relation to the industry and looks at the experiences of women currently working in the film industry. The ebook editions of this book are available open access under a CC BY-NC-ND 4.0 licence on bloomsburycollections.com. Open access was funded by OErebro universitet.

This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.