pharmacovigilance

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 medicinal product.

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 circumstances:

• Patients are selected specially for the study
• The duration of the study and the number of participants is limited
• 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 after 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 fashion.

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.