Breast implant scandal: Health chief says Europe in need of tighter laws

THE new head of Europe’s drugs watchdog said yesterday there was an acute need to tighten regulations on medical devices, adding to pressure for radical change in the wake of the global scandal over the French-made breast implants.

“I see an urgent need to regulate devices at the same level of science and attention as with drugs,” said Guido Rasi, executive director the European Medicines Agency (EMA).

Medical devices are regulated in the European Union under the same “CE mark” scheme used for household appliances, such as electric toasters, a notably relaxed regime that has been criticised by doctors.

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In contrast to prescription medicines, devices need only a simple quality certification before being sold to the public.

Growing concerns about implants made by the now-defunct French company Poly Implant Prothese (PIP) have focused attention on regulation and could accelerate changes to rules governing the medical technology sector.

“This might speed up some decisions,” said Mr Rasi, who took over as head of the London-based EMA in Novembed.

New proposals from the European Commission on regulating devices, including measures for more pre-market testing and post-marketing surveillance, are set to go before EU ministers this year.

Mr Rasi said medicines and devices were increasingly converging, as some products – such as coronary stents – are used to deliver drugs, so the EMA would in future need to look closely at the “borderline” area between the two fields.

Mr Rasi cautioned, however, that overhauling the regulatory system could be a slow process.

“There is resistance from sectors of the industry and resistance from some national authorities, so I don’t expect anything fast, but we need something for public health protection,” he said.