The penumbra of thalidomide, the litigation culture and the licensing of pharmaceuticals

Abstract

Fifty years ago several thousand children were born with severe limb defects after their mothers had been given thalidomide in pregnancy. This tragedy caused procedures for licensing new medicines to become much stricter. Where, nevertheless, significant side effects were found it became common to sue for damages. These consequences have caused possibly an even greater disaster damaging many more people and threatening ruin to health services everywhere. The huge increase in both time and cost in bringing medicines to market is increasing their price to unsupportable levels; and only wealthy companies are now able to do so. This requires reform as does litigation for 'statistical' harmful effects.

Figure 1

The Drowned Prince. Reproduced with permission from the artist.

Figure 2

Drug development process. By courtesy of Sir Kent Woods at MRHA.

Figure 3

Cost per molecule (including cost of failure). The Boston Consulting Group 2011.

Figure 4

NMEs per $B R&D spent (inflation adjusted). Reproduced and modified with permission from Bernstein Research paper which forms the basis of reference 10.

Figure 5

Advertising class actions—a public harm.

Figure 6

Litigation funding guarantees significant returns.