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Full-Text Articles in Legislation

The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan Nov 2018

The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan

Srividhya Ragavan

This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …


Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa Mar 2018

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …


Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa Mar 2018

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Ryan B. Stoa

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and …


Marijuana Appellations: The Case For Cannabicultural Designations Of Origin, Ryan Stoa Mar 2018

Marijuana Appellations: The Case For Cannabicultural Designations Of Origin, Ryan Stoa

Ryan B. Stoa

An appellation is a certified designation of origin that may also require that certain quality or stylistic standards be met. Appellations are most commonly associated with the wine industry, but they can be applied to any agricultural product for which the geographic origin carries importance. The MMRSA [California Medical Marijuana Regulation and Safety Act] … may have far-ranging effects on the marijuana industry in the United States. [A provision of the act permits the state Bureau of Medical Marijuana Regulation to ‘establish appellations of origin for marijuana grown in California.’] As the most populous state in the Union and the …


Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel Mar 2018

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …