Article Abstract

Access to the medicine market—we could do better!

Authors: Peter Kapitein

Abstract

Medicines are meant to make patients better or to keep them healthy, therefore they need to be able to gain access to them: ‘How do we bring the best medicines to the market as quickly as possible in order to get the best possible result, thereby giving value for the patient?’ To be effective: that is, for a doctor to be able to prescribe the treatment and for it to be reimbursed, it is necessary, irrespective of indication and related patient potential, that the treatment has been proved effective and has better results than a placebo or is not worse than an existing medicine (the so-called non-inferiority-principle (1). To get this ascertained and approved a potential medicine has to follow a one-size-fits-all route with generally the same procedures and criteria.