Yesterday I wrote about how the breast implants scandal has disrupted Department of Health communications, but there are of course far more serious issues at stake, notably the concerns of some 40,000 affected women.
This blog is not about why this scandal has occurred, although it is clear that the regulatory system has failed. Nor is it about what the appropriate course of action should be for the 40,000 women affected, although it is clear to me that the psychological impact could be as significant as the potential physical implications, and should not be dismissed.
Instead, I want to look at the impact the PIP scandal could have on the wider health policy debate. This is not an issue which has come from nowhere. As Sir Bruce Keogh’s interim report on the issue notes, the MHRA has been noting concerns about PIP implants since 2008, with a medical device alert about the quality of silicone used in the implants being issued in 2010. This ultimately led to the French Ministry for Health announcing just before Christmas that it was advising women, as a precautionary measure, to consider removal.
So what are the wider implications? Firstly, we can add the regulation of the cosmetic surgery industry, as well as consideration of any changes that need to be made to medical devices regulation to the growing list of thorny regulatory issues the Department of Health will need to resolve, alongside the recommendations from the Mid Staffs inquiry and the imperative to improve the quality of social care provision. The Health Select Committee is already poised to investigate, but, as previous attempts to improve regulation have shown, this won’t be simple. It is probably the last thing the Department of Health wants as it continues to grapple with the practical and political challenges created by the reform transition.
Secondly, issues like this become tests of competence for politicians, even though they are rarely in control of events. Handling situations out of their control is a key task for any Secretary of State. Too often it involves making judgement calls in the absence of comprehensive evidence. However unfairly, it can define a politician’s time in office. The decision to offer women who were treated by the NHS free replacements is the right one. The attempt to pressure the private sector to do the same, whilst making clear that the NHS will be the provider of last resort (as it always is with private care) is also sensible, even if it does expose the limitations of the Secretary of State’s power over privately funded healthcare. The extent to which the NHS is forced to step in to support privately-treated patients may, however unfairly, determine how Lansley’s handling of the crisis is perceived.
Thirdly, it is a reminder that simply taking a rational approach is often not enough to reassure scared patients. The MHRA’s initial advice may have been correct, but it was hardly reassuring in the context of differing action across the Channel. Were these implants more likely to rupture or cause toxicity in France than in the UK? Health scares – of varying degrees of seriousness – are everywhere and yet the way in which we respond to and manage them remains relatively primitive. If ever there is an argument for high quality data collection and clinical audit (in both the NHS and the private sector), then this is it. The absence of data on implants is frankly embarrassing. In this case, it is the private sector that has been exposed, but it could have been the NHS in too many areas of care. The professions, commissioners, providers and regulators need to work together to do better.
Perhaps a bigger challenge for Lansley could come if the scandal is used in critique of ongoing reforms – and many campaigners against reform have already tried to do this – citing the scandal as an example of what is in store for the NHS. For example, in an otherwise excellent article, Richard Horton argued – almost as a throwaway comment – that: ”the events of the past month show why [opening up the NHS to private providers] is so misguided.” In my view this is an erroneous link. Whatever your beliefs about the role of the private sector, I fail to see how this is the case. Private sector organisations providing NHS-funded care are commissioned by the NHS to do so, and the NHS can impose whatever contractual requirements it wishes on them (including relating to what might happen if something goes wrong). This is very different from the case of women who paid private providers to perform procedures involving PIP implants. It is an issue about consumer protection, not NHS reform.
That the NHS can mobilise its resources to address the issue is indeed a great strength. How any removals will be paid for appears to have been left to local discretion (Sir David Nicholson’s letter simply said: “I know that commissioners and providers will work together locally to ensure that the model of care set out above is operationalised and resourced appropriately”). We need to make sure that, whatever the ownership structure of the provider, this flexibility is maintained. This will be as much about culture and financial stability as it will be ownership (there are already plenty of NHS providers – such as foundation trusts – who would be unwilling to do work for free).
The PIP scandal will have significant implications for wider health policy – and it should do. But we shouldn’t use it as a parable for wider issues. Those that oppose or support NHS reform have plenty of arguments already. This shouldn’t be one of them.