The new National Drugs Formulary: challenges and perspectives

Abstract

The health authority has decided to update the National Drugs Formulary, to turn it into a therapeutically and socially efficient instrument within the health reform, particularly for the “Universal Access to Health Care with Explicit Guarantees”. To this effect, the authority has put forward objectives and lines of action in its national drugs policy, enacted in 2003 and 2004. The materialization of these aims will not be easy since essential medicines with generic denomination must necessarily be bioequivalent and the studies performed to satisfy this requirement have been continually delayed. Add to this situation, the effect that the enforcement of the new law for pharmaceutical patents may have on the price of innovative drugs. Although the National Formulary (F.N.) was very useful in the past, it was definitely overcome by the proliferation of pharmaceutical specialities, one of the situations that the NF tried to correct. A “therapeutic jungle” has developed in the pharmaceutical area under the open market economy. The new National Formulary should include many molecules which have appeared after 1994 and should exclude others that are ineffective. The health authority will have to face several pending problems; among others, accredited bio-equivalence; full compliance with GMP regulations; and the eventual parallel imports, and non voluntary licences that would have to be enforced