Chapter 19 - The International Law and Regulation of Medical Genetics and Genomics

Abstract

This chapter aims to investigate the global phenomena that allow for the common practice of “cherry picking” of international instruments by national governments; international, regional, or national professional organizations; public and private bodies offering health services or conducting research. This chapter seeks to provide systematic analysis of the recent processes of fragmentation, proliferation, and juridification of international biomedical law. These phenomena, along with constitutionalization, globalization, pluralization, and privatization, have dominated legal debates in the twenty-first century. Interestingly, international biomedical law remains at the periphery of these discussions. Particular attention will be given to rules governing the genetic and genomic technologies in medical research and practice, including genetic testing, biobanking, data sharing, or reproductive medicine. This chapter first summarizes the recent regulatory developments in the area of biomedicine and identifies the most pressing problems that have emerged at the international level. It is argued that the problems stem from two seemingly opposite, yet closely interwoven processes, that is, the institutional and normative proliferation coupled with scarcity of international legally binding (“hard law”) norms and reflexive (second-level) rules guiding normative conflicts as well as absence of an adjudicative body—in other words, a lack of a constitutional framework containing the basic principles governing international biomedical law. Second, it proposes an explanation of these problems rooted in sociological theories of functional differentiation. This approach enables an analysis that goes beyond normative claims about fragmentation and institutional or normative proliferation and it helps to observe these processes as an integral part of the rising autonomy of the global health system. It also provides analytical tools for coherent conceptualization of the prima facie chaotic expansion of legal, ethical, and professional norms created by public, private, and semiprivate actors.