“There must be no more “thalidomides,” Labour’s Leader in the European Parliament has said, as new laws to ensure better drug safety were due to be passed by the European Parliament in Strasbourg today.
Glenis Willmott said: “With the thalidomide scandal back in the news after so many years, and a major scandal in France recently with a diabetes drug called Mediator, it’s a timely opportunity to say ‘never again’ to a situation where prescribed drugs have not been properly tested and monitored.”
“The new EU rules on what is called “pharmacovigilance,” which we’re voting on today, are about monitoring new medicines for their side effects.”
“With the same drugs being sold across Europe, we need to ensure that health regulators can collect information across member states, so that any problems can be picked up and dealt with as quickly as possible.”
Under the new proposals, in cases where regulators have asked companies to carry out a safety study on a particular medicine, that medicine will now have to carry a black “warning” symbol on the packaging and on the patient information leaflet until the study has been carried out.
In addition, serious concerns about drug safety will trigger an automatic investigation by European regulators, instead of being left to the discretion of individual national regulators.