Équilibre et transition du droit à la santé dans un contexte d'innovation : une étude comparative entre la France et le Québec

Abstract

Preserving and restoring people's health has gradually emerged as a major issue in contemporary society, leading to the emergence of a right to health at both international and national level. At the same time, the development of healthcare knowledge, techniques and technologies has enabled medical innovation to achieve goals previously considered out of reach, raising many hopes in the fields of care and prevention. This development has been accompanied by the emergence of innovation law, whose aim is to create incentives to innovate, while seeking to mitigate the risks and optimize the benefits inherent in innovation. How has the right to health, enshrined as a fundamental human right at international level, been integrated into French and Quebec domestic law? In France, it is embodied in the right to health protection, while in Quebec, it manifests itself as the right of access to health services. Both systems recognize access to healthcare as the lowest common denominator of the right to health. But is this recognition always sufficient to guarantee equitable access to healthcare for all in the long term? Does it also guarantee access to innovative treatments and medicines? In addition, the emergence of medical innovation law, represented, among other things, by changes in intellectual property rights, seeks to promote the development of new technologies and medical treatments. But at what cost? In France and Quebec, these developments have created a framework in which innovation is encouraged by legal and economic incentives, but they have also given rise to conflicts between the protection of innovators and the patients' needs. Can these divergent interests be reconciled without compromising one or the other? How does the development of innovation law jeopardize access to healthcare? To answer these questions, this thesis takes a comparative legal history approach and applies it to the right to healthcare. In the first part, it identifies the current state of balance of the right to health, as well as the tensions that keep it that way, and assesses the extent to which the development of innovation law may upset this balance. In the second part, this thesis looks at the development of medical innovation law and the challenges of reconciling it with the right to health. How do developments in health-related intellectual property rights influence the regulation of medical innovations? What regulatory efforts are being undertaken to manage the tensions between innovation and equitable access to care? The analysis presented focuses on the regulation of medical innovations in France, Europe, Quebec and Canada, with particular emphasis on the law governing clinical trials, the development of advanced therapy drugs and the consideration of ethical and bioethical aspects. In conclusion, this thesis offers ideas and recommendations for better reconciling the right to health and the innovation law. What legal and political reforms could harmonize these two essential objectives? How can we guarantee equitable access to healthcare and healthcare technologies, while continuing to encourage medical innovation? These questions, crucial to the future of our healthcare systems, are addressed in this thesis. Preserving and restoring people's health has gradually emerged as a major issue in contemporary society, leading to the emergence of a right to health at both international and national level. At the same time, the development of healthcare knowledge, techniques and technologies has enabled medical innovation to achieve goals previously considered out of reach, raising many hopes in the fields of care and prevention. This development has been accompanied by the emergence of innovation law, whose aim is to create incentives to innovate, while seeking to mitigate the risks and optimize the benefits inherent in innovation. How has the right to health, enshrined as a fundamental human right at international level, been integrated into French and Quebec domestic law? In France, it is embodied in the right to health protection, while in Quebec, it manifests itself as the right of access to health services. Both systems recognize access to healthcare as the lowest common denominator of the right to health. But is this recognition always sufficient to guarantee equitable access to healthcare for all in the long term? Does it also guarantee access to innovative treatments and medicines? In addition, the emergence of medical innovation law, represented, among other things, by changes in intellectual property rights, seeks to promote the development of new technologies and medical treatments. But at what cost? In France and Quebec, these developments have created a framework in which innovation is encouraged by legal and economic incentives, but they have also given rise to conflicts between the protection of innovators and the patients' needs. Can these divergent interests be reconciled without compromising one or the other? How does the development of innovation law jeopardize access to healthcare? To answer these questions, this thesis takes a comparative legal history approach and applies it to the right to healthcare. In the first part, it identifies the current state of balance of the right to health, as well as the tensions that keep it that way, and assesses the extent to which the development of innovation law may upset this balance. In the second part, this thesis looks at the development of medical innovation law and the challenges of reconciling it with the right to health. How do developments in health-related intellectual property rights influence the regulation of medical innovations? What regulatory efforts are being undertaken to manage the tensions between innovation and equitable access to care? The analysis presented focuses on the regulation of medical innovations in France, Europe, Quebec and Canada, with particular emphasis on the law governing clinical trials, the development of advanced therapy drugs and the consideration of ethical and bioethical aspects. In conclusion, this thesis offers ideas and recommendations for better reconciling the right to health and the innovation law. What legal and political reforms could harmonize these two essential objectives? How can we guarantee equitable access to healthcare and healthcare technologies, while continuing to encourage medical innovation? These questions, crucial to the future of our healthcare systems, are addressed in this thesis.