- Describe the structure and process of law and regulation and the basics of the system of health governance. Explain what law and regulation is, how they are developed and implemented.
- Explain and give examples of principles of good law-making, general principles of public (administrative) law, and fundamental rights; evaluate policy proposals for compatibility with these principles and evaluate health innovations for compatibility with the law.
- Explain and apply stakeholder analysis to health policy issues, and formulate an effective political strategy for achieving a public policy goal
Public health is up for a challenge. Basic public health measures of the past century such as improvements in hygiene and vaccinations have contributed dramatically to the improved life expectancy and quality of life of the past generations. The big health issues of our day, however, have increased in sophistication and require a different approach. Problems such as obesity, toxicity, antibacterial resistance, and environmental degradation have huge implications for health outcomes; yet, they are caused or influenced by factors that are often far removed from the places traditionally associated with health such as hospitals, doctor’s offices, and pharmacies. It is increasingly recognized that addressing the major health issues of the 21st century will require innovative approaches and collaboration across a number of actors. These actors may be governments and legislators, public agencies, private bodies such as industry and standard-setting organizations, and communities. Due to the cross-border and interconnected nature of problems (think of diseases such as Ebola), action is required at various levels – at the local, but also at the national, supranational and international levels. Solving these problems requires that experts have a deep understanding not only of health and illness, but also that they be competent in matters related to policy-making and planning, legislative processes and legal principles, implementation and enforcement of regulation.|
This course provides students with the knowledge and tools necessary to be an active participant in the shaping of future public health policies. It starts by giving an overview of the health system in a comparative perspective. How is our health system organized? Who are the main actors? What are the major assumptions underlying the system design? In the first lectures, we tell the story of how a relatively private, un-regulated service became a major focus of public policy and government activity, and also the more recent story of health market liberalization. Next, we look at the essential legal and regulatory infrastructure behind the system. We start by looking at the field of ‘health law’. What are the basic public and private law norms that govern the relationship between healthcare providers and patients, between hospitals, insurers and the government? Next, we move to a more general discussion of law and regulation. Specifically, we look at questions such as: what is the role that patients can play in a system of responsive regulation? In what way can government intervention – in areas other than health regulation – improve health outcomes? And finally, what role can the government play in shaping health innovations?
After the introduction to the broad legal challenges, students dive deeper into the nitty-gritty of the politics of policy-making and regulating. Legal commitments to health outcomes should in theory lead to better health outcomes. Yet, regulation is often ineffective and fails. In six interactive, practice-oriented classes, students learn tools such as stakeholder analysis that help them analyze and improve the effectiveness of regulation.
At the end of the course, the students apply their knowledge about policy, law and regulation to a concrete case of health innovation. Students prepare a poster and a short paper analyzing the legal and regulatory challenges for health innovations with the help of the tools learned in the course. The posters will be presented at a final colloquium at the end of January.
|P Drahos (ed.), Regulatory Theory: Foundations and Applications (Australian National University Press 2017) freely available online at https://press.anu.edu.au/publications/regulatory-theory|
|J Hage and B Akkerman (eds.), Introduction to Law (Springer 2014) (ebook downloadable via the UT library)|
|Baldwin, Cave & Lodge (2012) Understanding Regulation, Oxford University Press. (excerpts on Canvas)|