The current modifications to licensing procedures still leave a basically flawed system in
place. A more radical solution is proposed that involves dispensing with Phase 3 trials and making
medicines available at the end of Phase 2 to those who are fully informed of the potential risks and
benefits and wish to take part in this novel procedure. The advantages include a shorter development
time, lower development costs and allowing smaller companies to take medicines to the clinic. The
principal obstacle is that medicines are subject to strict liability rather than the tort of negligence – and
this will have to be amended in due course.
Keywords: Phase 3, strict liability.
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