Ensuring Medicines for Tomorrow’s World
Chapter 8: Specialized Policy Areas: Vaccines, Biologicals and Blood Products; Alternative and Traditional Medicines; Self-Medication; Counterfeit Medicines
VACCINES, BIOLOGICALS AND BLOOD PRODUCTS Vaccines and certain ‘biologicals’ (for example, immune sera and toxoids as well as blood products) merit somewhat separate consideration from drugs. Although in many respects the situation with regard to overall public policy, responsibility for quality and liability for possible injury is the same, a number of differences can arise. Those differences can reflect particular social and religious concepts, but also the nature of these products and the circumstances that dictate their use. VACCINATION AND THE CONCEPT OF PREVENTATIVE TREATMENT Since Edward Jenner in England and John Redman Coxe in America pioneered vaccination against smallpox at the beginning of the nineteenth century,1 the prevention of major epidemic diseases in this way has come to comprise a major component of public health policy. From the outset, however, it was realized that the process of mass vaccination had to be managed with the greatest care, especially since it involved exposing healthy individuals to a degree of risk. It is striking that in this field considerations of efficacy, safety and quality came to play a major role in policy a century before they became established with regard to medicines in general. Issues of legislation, information and access, too, were decided early, since it was clear that if mass prevention was to be successful the law must impose duties, public support must be recruited and free access unhindered by financial barriers must be assured. In the course of only a few decades, coordination of policy across the world...
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