Description
This paper will investigate regulatory bottlenecks in global health. International regulations typically evolve over four stages: (1) need identification and acceptance (2) drafting (3) adoption and (4) implementation. Effective regulation can be stymied at any of these stages. The United Nations Educational, Scientific and Cultural Organization (UNESCO), for example, has been at the forefront of bioethics regulation in the last two decades. Yet recent attempts to establish international instruments have failed to get beyond the idea stage, even when the need for regulation has been clearly identified. In 2015 UNESCO’s International Bioethics Committee recommended a ban on human reproductive cloning, but the organisation has not acted on this. In September 2017 the same committee, in its draft report on big data and health, recommended that UNESCO negotiate a convention on the protection of privacy, but this has also not been taken forward. Even when regulations are drafted and adopted, these processes can take several years and interest-based bargaining can lead to weak or ambiguous content. Implementation is often patchy, hampered by lack of capacity and/or will at both international and national levels. This paper will present a theoretical framework for the ‘regulatory bottleneck’ concept, drawn from the regime theory and global governance literature within International Relations, as well as theories of norm diffusion, law, organisational management and public policy. The framework with be the springboard for case study research on regulatory bottlenecks in global health, including UNESCO’s failure to develop a convention on health data privacy.
