ABSTRACT

In this chapter the author argues in favour of more private initiative and responsibility in the market for drugs. Specifically, they argue that patents for drugs should largely be abolished; drug regulation by a government body such as the FDA should be abolished. One reason why drug development is so expensive is that the FDA requires extensive testing that goes through four phases, culminating in long randomised clinical trials for a New Drug Application (NDA) to have a chance of success. Thus, if FDA approves of a drug, thereby accepting the hypothesis that it is safe and effective, it risks that future evidence may demonstrate that it wasn't safe and effective for everybody. While it is true that much is wrong with the way in which much biomedical, in particular pharmaceutical, research is practiced, the right response does not seem to be less competition, which we would have if BMR was socialised, but rather more competition.