EU medicines head urges tougher implant rules

The new head of Europe's drugs watchdog said on Friday there was an acute need to tighten regulations on medical devices, adding to pressure for radical change in the wake of a global scandal over French-made breast implants. "I see an urgent need to regulate devices at the same level of science and attention as with drugs," Guido Rasi, executive director of the European Medicines Agency (EMA), told Reuters.
Medical devices are regulated in the European Union not by the EMA, but under the "CE mark" scheme, which is also used for household appliances such as electric toasters, a notably relaxed regime that has been criticised by doctors. In contrast to prescription medicines, devices need only a simple quality certification before being sold to the public.
In his first published interview since taking office in November, Rasi added the bar for medicines was set to rise as new treatments were increasingly tested against active comparator drugs rather than placebos, or dummy products. Growing concerns about breast implants made by now-defunct French company Poly Implant Prothese (PIP) have focused attention on devices regulation, and could accelerate changes to rules governing the medical technology sector.
"This might speed up some decisions," Rasi said. 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. Unlike the US Food and Drug Administration (FDA), the London-based EMA only has a mandate to regulate drugs, not devices.
But 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. Whether the EMA should eventually have a full remit for devices as well as drugs is up to politicians. "We are civil servants; we will do what we are told to do," Rasi said.
French Health Minister Xavier Bertrand also highlighted Europe's regulatory shortcomings on Thursday, arguing devices should go through the same rigorous review as medicines, with approval given either by national regulators or the EMA. 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.
Major makers of medical devices - which range from stents and artificial heart valves to replacement hips and knees, as well as breast implants - include Johnson & Johnson, Medtronic, Boston Scientific, Abbott Laboratories, Allergan and Smith & Nephew. A challenge for the EMA in future will be to work closely with national health technology assessment (HTA) agencies to ensure patients get access to new medicines at a time of cutbacks in government spending, Rasi said.
This would include providing scientific advice on clinical trial design to drugmakers that need to satisfy the EMA their medicines are safe and effective and prove to agencies such as Britain's National Institute for Health and Clinical Excellence (NICE) that they offer value for money. The result, Rasi predicted, would be an increasing shift towards clinical trials that compare new drugs with existing treatments before approval.