Fears over the effectiveness of the European medical device regulatory system continue after the editor of The Lancet made an unprecedented attack on UK authorities, warning that the NHS reforms would increase the risk to patients.
In two editorial comment articles, the journal’s boss, Richard Horton, referred to the Medicines and Healthcare products Regulatory Agency’s ‘paralysis and inability to correct the failings of a severely-flawed system’. And he claimed the decision of the coalition government to open the NHS up to competition would only increase the dangers of unsafe devices getting onto the market.
His comments come after a year of growing concern over the current CE Marking process, the method by which medical devices are deemed safe for use across Europe. This culminated in the revelation just weeks ago that PIP breast implants, which were approved for use by French authorities in 2000, contain industrial-grade silicone not passed for medical use. This was followed, more recently, by fears that a metal-on-metal hip replacement implant has been found to cause erosion, releasing metal particles into the body. As a result of this second scare, the MHRA has issued a recall of the DePuy ASR device, telling surgeons to stop all implants and await the results of further investigations.
The MHRA’s mission is ‘to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe’. The MHRA is, by its own admission, unable to fulfil this mission
Horton said: “The MHRA has been well aware of the risks of serious device failures for some time, but it has barely begun to address these concerns. The operating principal at the MHRA seems to be: do nothing until something goes wrong. The MHRA’s mission is ‘to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe’. The MHRA is, by its own admission, unable to fulfil this mission.”
Currently, the MHRA is the UK’s ‘competent authority’ for device safety and reports directly to the Secretary of State. However, the actual assessment of the technologies is carried out by 70 ‘Notified Bodies’ across Europe, which are responsible for issuing the CE Mark certificates.
The CE marking provides a smoke-screen for faulty and dangerous devices that place patients and surgeons at risk
Horton said: “In other words, device regulation in the UK is outsourced to third-party organisations which may be operating to different standards. The MHRA periodically audits Notified Bodies, but does not itself, unlike for medicines, scrutinise safety and effectiveness data.”
Quoting from a presentation last year by Brian Toft, professor of patient safety at Coventry University, he added: “In the UK, devices reach patients ‘without the reassurance of adequate clinical trials to demonstrate their safety and efficacy’.”
And he warned that this would only get worse as the NHS becomes an open market under the government reforms.
It is of paramount importance that patients and consumers have the assurance of a high level of safety and quality of medical devices with clear and predictable safety requirements
He said: “The Health and Social Care Bill will open up the NHS to private sector providers. The events of the past month show why this policy is so misguided. This is the future of the NHS: a system of healthcare that cannot be held accountable by government, one that has no obligation to collect or supply accurate information about what it is doing, one that fiercely resists its duty of care to patients, and one that is more concerned with cost than it is with quality. The evidence is before us – it’s time to kill this Bill.”
Last summer similar fears over regulatory failings were raised by the UK Committee on the Safety of Devices. Minutes of a meeting in July 2011 state: “The CE marking provides a smoke-screen for faulty and dangerous devices that place patients and surgeons at risk. This is not just a UK problem, this is a worldwide global problem that needs to be dealt with.”
The committee went on to agree that ‘substantial progress’ had to be made in ‘tightening up the process’ of ensuring device safety.
But both the MHRA and industry leaders are hitting back, defending the regulatory process, which they say is among the most stringent in the world.
The EU system is ahead in terms of patient access as European patients benefit from the latest in safe technology nearly two years ahead of their US counterparts and up to five years ahead of Japanese patients
In response to the comment in The Lancet , an MHRA statement claimed the PIP scandal was not due to a fault in the system, but because the manufacturer was not sticking to the agreed terms of the original approval document. But the regulatory says it is supportive of system reform.
The statement says: “The EU directives which regulate medical devices are currently under review by the European Commission. Our detailed recommendations to the committee have included proposals to improve the oversight of Notified Bodies, the surveillance of post-market events, and the collaboration between national regulatory bodies.”
MedTech manufacturers are also concerned about how the criticism could affect confidence in the sector. A recent letter from Peter Ellingworth, chief executive of the Association of British Healthcare Industries (ABHI), and John Wilkinson, chief executive of Eucomed, the European industry body, said: “It is of paramount importance that patients and consumers have the assurance of a high level of safety and quality of medical devices with clear and predictable safety requirements.
We feel much criticism of the regulatory system and of industry behaviour is alarmist and fails to take account of both the strong positive track record of the medical technology industry and the regulatory controls applying to it, as well as recent developments and reforms which are in the process of being made both by the authorities and by industry
“Europe is approaching almost 20 years of proven effectiveness of the Medical Devices Directive in regulating the safe introduction of new medical technology. The EU system is ahead in terms of patient access as European patients benefit from the latest in safe technology nearly two years ahead of their US counterparts and up to five years ahead of Japanese patients. Recent research has shown that the regulatory process in Europe is more efficient than in the US while not compromising patient safety.
“It is important to note that industry has consistently supported the need for regulation of medical technology and has itself argued in favour of the reforms currently proposed by the commission and some member states. The reforms address the criticism with regards to the regulatory framework.”
It said the ABHI and Eucomed also operate their own codes of practice which members must abide by, adding: “In conclusion, we feel much criticism of the regulatory system and of industry behaviour is alarmist and fails to take account of both the strong positive track record of the medical technology industry and the regulatory controls applying to it, as well as recent developments and reforms which are in the process of being made both by the authorities and by industry.”