Before medicinal products may be marketed, extensive research is
carried out. This clinical research programme follows strict rules,
and is designed to demonstrate a positive benifit/risk ratio for a
When new medicinal products are authorised by authorisation
agencies, the benefit/risk ratio is positive at the moment market
authorisation is given. This means therapeutic efficacy has been
demonstrated, and the risks – in the form of
adverse events – are considered acceptable at that time.
Once a medicinal product has been
approved, knowledge about the product must be expanded further.
The clinical research programme is conducted under specific, ideal
- Patients are selected specially for the study
- The duration of the study and the number of participants is
- Participants receive frequent check-ups
- Patients usually do not have other problems
At the end of the research programme, the most common adverse
events are known. Following approval, a medicinal product enters
the market under far less ideal circumstances. Rare adverse events
often only become apparent at this stage.
Signalling and analysing these as yet unknown adverse events
marketing a medicinal product is known as pharmacovigilance.
This is one of the MEB's tasks.
The goal is to maintain or create the best possible benefit/risk
ratio for medicinal products in daily practice.
The MEB is aware that there are differences between the very
precise, organised research conducted with medicinal products prior
to marketing and the daily practice of prescription and use. Daily
practice is what it is ultimately all about.
The MEB wants to contribute to a responsible, authoritative
system of medicines assessment and pharmacovigilance.
Together with parties in the field, the industry and
scientists, the MEB wishes to find new ways to get medicinal
products to patients and health care professionals in a responsible
Mapping and communicating potential risks
The goal of pharmacovigilance is to maintain or create an
optimal benefit/risk ratio. This is done by identifying adverse
events quickly, and determining whether measures need to be taken.
Furthermore, the MEB may need to quickly discuss potentially severe
new risks associated with a medicinal product as well as the
possibilities for limiting or preventing adverse events with health
care professionals and patients.
The MEB has set both methodology development and practical
implementation for pharmacovigilance as priorities. This aligns
with the broader policy agenda to promote patient safety set by the
government and various other parties. Patient and consumer
organisations are closely involved in these developments.