EU Licensing and Regulations – Is Patient safety being put at risk?
Kerry Fifield comments upon the Telegraph/ British Medical Journal expose on the European system for regulating and licensing medical implants and medical devices.
The Telegraph reported yesterday today following undercover investigations of the European medical implant licensing and regulatory framework. The report reveals that the European system for licensing and regulating medical implants does not adequately protect patients and allows for unscrupulous practices amongst the private companies contracted to act as regulators within Europe (known as Notified Bodies). There are over 70 such companies in Europe and a manufacturer can apply to any one of them for approval. Once approved and licensed, the product can be sold all over Europe, including the UK. The Notified Bodies are not required to carry out their own tests on medical implants and nor is there even a requirement for evidence of specific and rigorous testing of the implant by the manufacturer itself.
According to the Telegraph, the licensing and regulation of implants in Europe is conducted on the same system as that of domestic products and toys rather than the more rigorous system of licensing drugs. It is suggested that competition between the private companies acting as Notified Bodies allows for the interests of the (paying) manufacturers to be prioritised well above the interests of patient safety.
Under cover reporters for the Telegraph (working in conjunction with the British Medical Journal) created a bogus hip implant device and submitted specifications of the device to a number of European Notified Bodies. The device was modelled upon a metal on metal device which has been withdrawn world wide due to well publicised complications and failure rates (the DePuy ASR XL acetabular system). Despite this, provisional approval for licence was provided by one company based in Slovakia.
The loopholes and weaknesses revealed by this investigation are surprising. It is difficult to understand how such a system exists for medical implants and devices. The question needs to be asked of what the UK regulatory body – the Medicines and Healthcare Products Regulatory Agency (the MHRA) – are doing to ensure the protection of NHS patients in the UK from potentially dangerous medical implants and devices licensed for use in Europe.
If you have concerns about your medical implant or if you think that you may have a claim for injury arising from a faulty medical implant, contact us on 0800 3168892 and ask to speak to someone in our medical negligence team.