The managed entry of new drugs into a national health service

This case study originated from the need and willingness to implement managed change to the policy and practice for the introduction of new drugs into the national health service in Malta. A logic model was used to represent a descriptive evaluation(1999), to prioritise and document changes achieved from planned interventions and to present the final outcome evaluation(2003). This action research presents the subjective opinion of the author at that time. The methodology and findings can be generalised and applied. Hopefully those embarking on a challenge to bring about change in their organisation are encouraged to act. The study was finalised just before Malta''s accession to the European Union (EU)(May 2004)and considered the possible impact of accession. With hindsight, the prediction that adoption of EU legislation would introduce a strong pharmaceutical framework which drives required changes and increases transparency in decision making proved to be correct. The issues with availability, affordability and equity of new drugs, which were a problem for Malta in 1999, remain, not only for Malta but also for other countries.