Health Law and Policy Commons^™

Zika And The Regulatory Regime For Licensing Vaccines For Use During Pregnancy, Sam F. Halabi

Faculty Publications

Microcephaly and other severe fetal brain defects (congenital Zika syndrome) caused by the Zika virus have prompted an urgent effort to develop and license a safe and efficacious vaccine. Yet, that effort has run up against one of the most formidable barriers in vaccine research: pregnant women are almost always excluded from clinical trials for fear that the intervention may harm the fetus. This article analyzes the existing regulatory framework for vaccines intended for use during pregnancy in an effort to identify ways the process may be reconsidered in light of recent public health emergencies that had a disproportionate effect …

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Don’T Pull The Plug On Bioethics Mediation: The Use Of Mediation In Health Care Settings And End Of Life Situations, Amy Moorkamp

Journal of Dispute Resolution

A hefty decision, such as the life or death of a loved one, requires more than a few minutes of deliberation and a handful of outside consultations. Delicate, emotional, and potentially contentious medical decisions compel a structured, compassionate approach to produce quality and well-informed results. Due to the magnitude of the decision being made, as well as the abundance of other considerations, (emotional, religious, historic, financial, etc.) the case for a creative, problem-solving process of dispute resolution, such as mediation, is ripe.

This Comment will explore the use of mediation in bioethical disputes. In Part II, the Comment will give …