Abstract

The Penumbra of Thalidomide

It is some fifty years since the thalidomide disaster when several thousand children around the world were born with severe limb defects after their mothers had been given thalidomide as sedative and remedy for morning sickness. Drugs at that time were not required to have been tested for potential effects on the fetus.

One consequence of this tragedy was a great enhancement of the processes for licensing new medicines in an attempt to assuage public anxiety that there could ever be another similar disaster; and that there was any risk at all involved in taking a licensed medicine. Where, nevertheless, significant side effects were found it became the practice to sue for damages.

In this lecture a case will be argued that these consequences have given rise to possibly an even greater disaster damaging a much larger number of people and threatening ruin to health services everywhere.

The huge increase in both the time taken and the cost involved in bringing a new medicine to market is increasing the price of many new medicines to unsupportable levels. It has also lead to the situation where only companies with deep pockets are able to take medicines to market; and even they will do so only for diseases common enough that they can envisage making a profit. The licensing of new medicines therefore requires urgent and wide-ranging reform which will need changes to both national and European legislation.

The increasingly wide spread litigation culture for “statistical” harmful effects that involve neither negligence nor other malfeasance also needs to be addressed. The damages incurred lead to a further increase in the price of medicines.

Reforms to reduce the cost of medicines would save the NHS far more than the structural changes now before Parliament. But it will no easier to bring them about.