MEB Annual report 2010

What safety requirements should medicines satisfy? What risks are acceptable when using new medicines? How far-reaching should measures be to avoid that medicine efficacy no longer outweighs the risks? How do we manage the differences between the meticulous, structured premarketing medicine trials and prescribers’ and users’ daily practice? And how do we ensure this is done transparently, independently and with integrity?

These questions are core to the Medicines Evaluation Board’s (MEB) work. The central issue in evaluating and monitoring the efficacy, risks and quality of human and veterinary medicinal products is: what risks are acceptable in relation to the benefits? If the compound is for a severe disease such as cancer, is the benefit/risk ratio different from a disorder such as headache? The severity of the disease also plays a role.

The evaluation process continues once marketing authorisation for a medicine has been granted. New developments may impact the benefits and risks of a medication as time passes. The MEB is involved in the entire medicine life cycle.

This annual report addresses the evaluation criteria and provides background information on how the benefit/risk ratio is assessed and safeguarded during the entire medicine life cycle. We will use case studies to illustrate the dynamics and challenges facing the MEB in 2010 as it accomplished its responsibilities and mission. The report format separates facts and statistics from the other text, enabling readers to study the report in part or in full, depending on their prior knowledge and interest. This format is driven by our intention to report our activities in an accessible, transparent and patient-oriented manner.