(2000; 28 pages) [French]
4.4 Mandatory or voluntary reporting?
In many countries the reporting of adverse drug reactions is voluntary, but in an increasing number of countries some legal reporting obligations on healthcare professionals have been established (although a penalty is not usually associated with failure to report). Little information is available regarding the advantages and disadvantages of such obligations. In addition, in many countries it is mandatory for pharmaceutical companies to report suspected adverse drug reactions to the health authorities.