Labour leads on new EU rules to enforce drug safety

Arlene McCarthy

Labour's Euro MPs are at the forefront of new legislation to test for drug safety which is being voted on in the European Parliament in Strasbourg today.

Local Labour Euro MP, Arlene McCarthy said: "The thalidomide scandal has been back in the news again recently and it has re-affirmed our resolve to ensure that never again should patients suffer because their prescribed drugs have not been properly tested and monitored."

"We know that good medicine needs drugs but it is important that the right level of vigilance is in place to monitor new medicines for their side effects. 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.”

Euro MPs are looking again at drug safety laws following a scandal in France last year with a diabetes drug called Mediator. This drug was not licensed in the UK but was widely available in a number of other European countries.

Commenting on Mediator Arlene McCarthy said, "Potential safety problems were raised with regulators in the early noughties and a drug safety study requested from the manufacturer Servier in 2000. But the study wasn't carried out in time frame requested and the drug remained on the market until it was finally withdrawn in 2009. An estimated 500-2000 deaths have been linked to the drug and a court case is pending in France."

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.

Labour Euro MPs have the support of other political parties in the European Parliament and EU governments to fast track today's legislation to get this it on to the statute books so the changes can be implemented quickly across the EU.