New rules to end the secrecy over the safety of devices such as hip replacements and breast implants are being drawn up after a series of scandals.
By Laura Donnelly, Health Correspondent
7:50AM BST 09 Sep 2012
The changes will mean that for the first time the public will be able to access details of the clinical research behind the products, and their safety record since coming on to the market.
The rules are being drawn up by the European Commission in the wake of the PIP breast implant fiasco and the scandal of metal-on-metal hips, which were found to poison the body and suffer failure rates of up to 50 per cent.
Under the current system, the clinical evidence to support devices, and the records of adverse incidents linked with them are kept behind closed doors.
Manufacturers must share some information with a “nominated body” of their choice, which authorises their products for use, yet it cannot be seen by the public, nor by independent scientists because of draconian European Union regulations.
British regulators run a voluntary system so surgeons can report concerns about medical devices, yet the EU confidentiality rules mean their data is not published, with patients and doctors told nothing – unless the situation deteriorates so badly that a safety alert is issued.
Last December it emerged that more than 40,000 British women received substandard breast implants, made by Poly Implants Protheses (PIP), with some made from industrial silicone, instead of the medical substance which had been authorised.
In January, The Sunday Telegraph disclosed that thousands of Britons had been given metal-on-metal hip implants which were found to poison the body, with some devices having failure rates of up to 50 per cent.
Weeks later, regulators the Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning that 49,000 people with the implants should undergo checks throughout their lifetime and undergo further operations to replace the devices if problems were found.
The new proposals from the European Commission, due to be published within weeks, are expected to recommend that three directives on medical devices, passed during the 1990s, are rewritten.
Under the plans, a duty of confidentiality which is currently placed on all organisations which handle clinical data would be erased, in a bid to make the system more transparent.
The current rules were intended to protect the commercial interests of manufacturing companies, but safety campaigners and regulators believe they have gone too far in putting the interests of business ahead of patient safety.
Professor Sir Kent Woods, chief executive of the MHRA, which has called for the change, said: “The evidence should be out there – so that scientists can look at it, so that patients can look at it and so the public can look at it.”
He said it had now become “widely accepted” in the pharmaceutical industry that companies had to make the data from their clinical trials public after drugs were licensed, and that reports of adverse reactions to drugs were documented and published.
Medical devices and implants should follow the same direction, he said.
Because of the single European market, devices used in this country can be manufactured elsewhere, then authorised by a “notified body” in any of the 27 EU member states.
That meant that in the case of the PIP implants, a company in Germany was responsible for the quality of devices produced in France and imported for use in 300,000 women around the world, including Britain.
British regulators the MHRA accredit the six notified bodies which operate in this country and can audit them to check their processes – but have little control over the quality of checks done abroad.
The MHRA has urged the European Commission to change the system, so that accreditation is done by representatives from several countries, in order to ensure that all countries are working to the same standards.
Prof Woods said he felt confident about the expertise of the organisations it inspects but said: “I can’t be confident that notified bodies in every one of the 27 countries are working the same way”.
He said the rules of a single market in Europe meant it was not possible for British regulators to check all the devices used in this country.
The MHRA is also calling for more rigorous standards to ensure that the clinical evidence to support the application for a licence is more consistently and robustly scrutinised.
The commission is considering how information should be better shared across EU member states, which Prof Woods said could have helped regulators to detect the PIP scandal sooner.
“If we had been able to easily share adverse incident data across Europe I think we would have picked up an increased signal about rupture rates – though not that the filler was fraudulent,” he said.
The Commission is also considering whether an “implant card” should be given to all patients who receive an implant, with details of the date, name of device, batch, lot and serial number.
The MHRA said it became clear when problems arose over breast implants and metal-on-metal hip replacements that most patients given implants were not aware what type of device they had.
Sir Bruce Keogh, the Department of Health medical director, is leading a review of cosmetic surgery which is considering whether details of all operations should be held on a central register, to help detect problems with particular types of implants.