Purpose and Principles of Regulation

The fundamental purpose of regulation is the protection of public health. 

To achieve their goal, the regulations rely on a number of core principles and concepts  

Product safety is an underlying principle for all products. Ideally, the product should do no harm. Thus, the regulations require that the developer or manufacturer must take appropriate steps to demonstrate and ensure the safety of the product under development. 

Obviously, for it to be worthwhile, the product must also do some good. Hence, the principle of efficacy or effectiveness has become another cornerstone in achieving the goal of regulation. To evaluate effectiveness you must also consider the purpose of the product as expressed in either an indications for use statement in the case of drugs, or intended use statement in the case of medical devices. As discussed in Section 1.6, and later in Sections 9.3 and 9.4, intended use statements are also vital in determining how some products are regulated in the first place, which in turn dictates the level of scrutiny to which they may be subjected. 

In recent years concerns have been raised in the popular press about possible side effects from the MMR vaccine, which is given to infants to guard against measles, mumps and rubella. Although this has led to a drop in the levels of vaccination, the advice from health professionals continues to be in favour of vaccination, because even if the claimed side effects were shown to be true, failure to vaccinate would still statistically pose the greater health risk due to the detrimental effects of the diseases themselves. 

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