ABSTRACT
An issue of major importance for all concerned is whether the new Europeanised system of medicines regulation will improve public health by promoting the development of safer drugs on to the market or compromise it by permitting patients to be exposed to hazardous drug products, which might have been rejected or withdrawn under the former national systems of regulation. Assessments of drug safety are often difficult for regulatory agencies, who have to weigh up a complex array of risks and benefits for patients in a context of incomplete information and scientific uncertainty. Moreover, as we have argued in previous chapters, medicines regulation is not a purely scientific process. Rather, scientific uncertainties are compounded – and sometimes even produced – by commercial, professional and institutional interests. Thus, the challenge for a supranational European regulatory system to harmonise the protection of public health adequately is formidable.
