MEPs back higher medical safety standards following PIP scandal
22.10.13 @ 18:53
BRUSSELS - Medical devices ranging from pacemakers to breast implants will be subject to stricter controls under rules agreed by MEPs on Tuesday (22 October).
Deputies voted by a large majority to support two new laws covering more than 10,000 medical devices currently sold in Europe. But more ambitious plans to beef up the EU's medicines agency were shelved in a last-minute change of heart by conservative members.
Under the reforms, patients would be registered and given an ‘implant card’ with detailed information on the medical device with which they were about to get fitted. Rules on granting safety-approval to devices would be delegated to in-house 'experts', with particular attention on 'high risk' devices such as heart valves.
Meanwhile, the draft directive would also allow regulators to carry out unannounced inspections of factories making medical products.
Deputies are also keen to ensure that 'over the counter' HIV tests should only be bought in pharmacies with a prescription. The General rule should be 'prescription-only' but member states would be able to have special exemptions.
Speaking after the vote, Peter Liese, a German centre-right MEP, and one of two deputies responsible for preparing parliament's report, said that MEPs had secured "a great result for patients" which industry could "live with."
But Liese's enthusiasm was not shared by centre-left deputy Dagmar Roth-Behrendt, who complained that her centre-right EPP colleagues had reneged on an agreement that would have required the European Medicines Agency to authorise 'high risk' devices before they were allowed to go on sale.
Instead, deputies voted to allow EMA to set up special expert groups of doctors and specialists to scrutinise new technologies and devices, but the recommendations would not be legally binding.
Roth-Behrendt said that she "would have expected a better result and described the EPP's stance as "totally ridiculous and unjustifiable", adding that her proposal had been supported by doctors and patient groups.
Lawmakers had demanded reforms to the EU's six year old directive on medical devices in the wake of the breast implant scandal involving the now defunct French-firm Poly Implant Prothese (PIP) in 2011.
PIP had been caught using industrial grade silicone to replace the gel in implants, affecting thousands of women, many of which are still to be compensated.
For their part, consumer groups offered qualified support for the result.
“Today’s vote finally enhances both consumers’ information and involvement in the monitoring of such devices," said Monique Goyens, of pan-European consumer group (BEUC), who added that the proposed regime would make it easier for patients to report faulty devices.
However she added that "consumers will continue to be used as guinea pigs."
MEPs now face a race against time to secure agreement on the legislation with governments.
Although the commission tabled the proposal over a year ago, ministers are yet to agree their position on the file.