Pharmacovigilance, cosmetovigilance, materiovigilance, nutrivigilance… the different types of health vigilance are growing rapidly. An increasingly meticulous monitoring now applies to all health-related products.
Europe: a driving force for change. Recurrent public health scares have made people in Europe aware of health risks. The European parliament has rationalized the decision-making process within the EU on issues related to the safety of health products, by guaranteeing the application of safety measures.
Strengthening and coordinating pharmacovigilance. The new system helps to identify safety problems quickly and facilitates effective communication between the parties concerned. It promotes cooperation in assessing risks linked to the use of health products and facilitates decision-making. The pooling of all product-related information has been improved.
The declaration of adverse effects has been standardized, and the focus is now on new products and products known to be of high risk. Pharmacovigilance has been extended to embrace all adverse reactions, irrespective of context (misuse, errors, abuse, overdose, etc.). Patient participation in reporting adverse reactions is now actively encouraged.
European decisions concern all Member States and emphasis has been put on transparency and communication.
An expert’s job. This recent development is the continuation of a long-standing process, which has led manufacturers to consider health vigilance as a professional activity in itself. They must work with these specialists, sometimes handing over all their pharmacovigilance activities to them. Over past decades, new companies have emerged, whose sole activity is monitoring the constant changes in legislation.
Vigipharm has fulfilled this role for nearly 20 years..
Caroline Navarre, CEO