Self-regulation enforcement

P Lepore. Presentation at PRIM R s Animal Care Committee and Enforced Self-Regulation Making It Work at Your Institution conference, in Boston, March 19-20, 1992. 

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

Can industries be trusted to self-regulate the amount of pollution they produce Is government really necessary to enforce these regulations Shouldn t the opinion of the consumer and the economic advantages of sustainable practices be sufficient to motivate industries to protect the environment ... 

The Code of Conduct for Pharmaceutical Advertising (CPA) lays down rules similar to those included in the Medicines Advertising Decree. Most pharmaceutical companies have agreed to comply with this code via the industry association Nefarma. Nefarma and other industry associations have established a self-regulating body (the Code geneemiddelenreclame or CGR). The Minister of Health, Welfare and Sport has stipulated that the rules on advertising should be enforced by the CGR as well as by the Public Health Inspectorate. 

As the PEA does not allow iimovation and the enforcement of the law is a major problem, a new food law is underway. It will ensure safety and quality for consumers, bring about greater transparency, self-regulation, harmonisation of standards and mles, and give a boost to the country s agriculture processing industry [95]. 

Where the regulators were concerned, this helped them to introduce and develop ideas of government-enforced self-regulation or internal control, also supported by evolving trends nationally and internationally. These concepts were not new, and had been applied, for instance, in Norway s nuclear power sector as early as the 1950S.5... 

A supervisory regime based on government-enforced self-regulation embraces all tbe activities conducted by the PSA to take steps to ensure that the responsible parties in the petroleum industry perform prudent and safe operations in compliance with the regulations. ... 

Follow-Up in a Government-Enforced Self-Regulation Regime... 

---