The Political Economy of ‘Innovative’ Drug Regulation in the Neo-Liberal Era

Abstract

As explained in Chapter 1, the basic legislation governing pharmaceutical regulation in Europe and the US was established by the 1970s. That legislation did not require, as a condition of marketing approval, that new drug products should provide therapeutic advance for patients over drugs already on the market, and nor has it been revised to do so. Nonetheless, other farreaching institutional, administrative, policy, and legislative reforms concerned with expediting the development, regulatory review, and marketing approval of new drugs have been introduced since 1980. Most of those reforms have been aimed at speeding up patient access to new drugs, product development times, and regulatory review times. European and American governments have justified the reforms on the grounds that they benefit patients and public health by increasing and accelerating new drug innovations that patients need, though, as we show in this chapter, such arguments and rationalizations have rested on a particularly limited conceptualization of patient ‘need’, namely the need for quicker access to new drugs.