MEP pushes for new drug safety law

A NORTH East MEP has been pushing the case for new legislation to test for drug safety.

Stephen Hughes, along with his Labour colleagues and some members of other parties in the European Parliament, has voted that new warnings should be made where appropriate as well as advocating a joined-up approach to the issue.

The politicians brought this matter forward following a scandal in France last year with a diabetes drug called Mediator.

Mr Hughes said: “With the thalidomide scandal back in the news after so many years, we have to say ‘never again’ when patients suffer because their prescribed drugs have not been properly tested and monitored.

“The same drugs are sold across Europe, so it makes sense for regulators to collect information on a Europe-wide basis from as many patients as possible so that problems can be picked up more quickly.”

Under the new proposals, in cases where regulators have asked companies to carry out a safety study on a particular medicine, it 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.

Mr Hughes and his colleagues have been negotiating for the support of EU governments to fast-track the legislation to get it onto the statute books so the changes can be implemented quickly across the EU.