The scrutiny and pressure on the pharmaceutical sector to deliver safe medicines has never been so great as
it is now. This pressure comes from all directions: both enhanced compliance with more regulation and yet a
demand for value for money from both governments and patients. This is against a backdrop of accusations
of misconduct about financial inducement to change prescribing practices and encourage off label use.
It is now urgent for the pharmaceutical sector to consider and explore how closer and active collaboration
between stakeholders in marketed products may produce the best evidence so that we can deliver society’s
Expectations about safety and effectiveness.
Ideally, decisions about benefit-risk should be informed by patients’ outcomes in the real world.