12. Breach of statutory duty

This chapter discusses liability for breach of statutory duty. There may be cases where a statute renders a certain activity a crime, and the law imposes an additional civil liability towards a person harmed by the act. While some statutes state this directly, most statutes make no mention of potential civil liability, but nevertheless liability may be imposed if the court believes that Parliament impliedly intended there to be a remedy. Not only are there difficulties about when a civil duty will be spelt out of a criminal or regulatory statute, but there are also problems about the role and function of the tort of statutory duty.

A Brief History of Biomedical Products Regulation

The history of biomedical product regulation is a history of hard-won progress. Often, only after tragedy, has regulatory statute caught up to drugs with horrid side effects or medical devices that offer no benefit but may do harm. Harmful or questionable products slip through cracks in regulatory statutes and are brought to market quickly and prolifically, while regulators play catch up and must demonstrate harms before being enabled to police or regulate them. A notable present-day example is e-cigarettes, a multi-billion-dollar industry with clearly questionable marketing practices, which arrived and grew quickly without any form of premarket regulatory obligation. Similarly, digital health tools are proliferating, and most are yet to be subject to premarket regulation. This chapter provides a brief history of biomedical-products regulation with a focus on benefit-risk determination and its impacts on regulatory policy.

12. Breach of statutory duty

This chapter discusses liability for breach of statutory duty. There may be cases where a statute renders a certain activity a crime, and the law imposes an additional civil liability towards a person harmed by the act. While some statutes state this directly, most statutes make no mention of potential civil liability, but nevertheless liability may be imposed if the court believes that Parliament impliedly intended there to be a remedy. Not only are there difficulties about when a civil duty will be spelt out of a criminal or regulatory statute, but there are also problems about the role and function of the tort of statutory duty.

12. Breach of statutory duty

This chapter discusses liability for breach of statutory duty. There may be cases where a statute renders a certain activity a crime, and the law imposes an additional civil liability towards a person harmed by the act. While some statutes state this directly, most statutes make no mention of potential civil liability, but nevertheless liability may be imposed if the court believes that Parliament impliedly intended there to be a remedy. Not only are there difficulties about when a civil duty will be spelt out of a criminal or regulatory statute, but there are also problems about the role and function of the tort of statutory duty.

Derivatives: Theoretical Approach Accounting for Market Realities

The article analyses how different factors, including market environment and intra-firm factors, have influenced the rapid development of derivatives market during the last 20 years. The author studies the fundamental concept of the derivative instruments regulation (SFAS 133) and proposes some amendments to the regulatory statute. He also builds a conceptual model of the derivative instrument and suggests a system for derivative instruments classification. The analysis of modern derivative instruments' potentially harmful characteristics is also carried out.