Information about Medicines for Patients in Europe: To Impede or to Empower?

Abstract

Information about medicines in Europe does not really fulfil its potential. For patients, it is often very hard to understand and to apply information in a specific situation. For the pharmaceutical industry, it is hard to develop (writing-designing-testing) due to strict regulations. And for the Regulatory authorities, the current situation is hard to control and check. One of the main causes is that legal-, economic-, and health-criteria are simultaneously applied to information about medicines. However, these three criteria are fundamentally different, and have proved to be unbridgeable in the last 20 years. In order to provide patients with usable information, it seems essential to develop a legal system that is not based on standardization of processes and results, but instead is based on required performances in context.