It’s rather hard to know where to begin with the latest from the Saatchi PR onslaught – bulldozing ahead with version #3 deliberately without a public consultation – this Bill is like a runaway train about to wreak havoc on those least expecting it further down the track- The recent consultation on the subject received overwhelmingly negative responses from an exceptionally long list of expert bodies – from charities, from patient groups, health groups, Royal Colleges, lawyers, doctors and including the GMC, BMA, RCP, MDU, MPS, Nightingale Collaboration, Wellcome Trust, NHS Health Research Authority, HealthWatch – the feedback from those who could refer to experience, facts and knowledge rather than swallowing spin from the Telegraph was a loud, unequivocal NO.
For if this were a good idea – I would be jumping for joy! Less chance of being sued, you say? Oh of course I’ll take that thanks. But after the very first glance what becomes abundantly clear to anyone who takes the time to think it over, including doctors, rather than listen to Saatchi’s lines that your entire livelihood, career will be destroyed is that this is as far removed from a good idea as it can possibly get. What then becomes apparent is that this Bill should never have had the time of day, let alone the media backing that it has, and nor would it have in different circumstances with, I suspect, less powerful financial and political lobbying in the background.
If nothing is done the Bill clearly will be passed if it reaches the Commons, as Hunt has already guaranteed. It suits the government to try to triplewhip the House as there is surely no better retort to criticism over privatisation and destruction of the NHS (over 70% of its contracts since April 2013 are private) when it comes to the 2015 elections, than ‘ah, but we cured cancer!’ ‘we did what the people wanted!’
This Bill is NOT what the people want – they have been systematically, unrelentingly deceived – they want what is promised to them, not the reality of what it would deliver. If my child had cancer of course I would want to do everything in my power to give her every chance of survival – pull out all the stops. This bill is terrifying for that very reason alone – it removes real informed consent, plays on desperation , a need for some hope – and will result in painful, terrible deaths and removal of quality of life for many and overall respect for life’s worth in terminal conditions. Who next?
Nor will it add to the evidence base, further research or science. Furthermore it removes what little access to justice or redress there may be available left for those harmed by negligent treatment.
What about for doctors? Well it won’t actually protect them either – quite the opposite. To introduce a consumer demand will hugely increase litigation around such concepts as right to the treatment, negligence in not treating, failures to warn, res ipsa cases. It will dramatically increase litigation around the meaning and scope of the Bill. It will potentially force the hands of many doctors. It may create situations where patients are more inclined to sue, for not providing a treatment – or may create new confusion that makes innovation much less likely.
It will completely destroy the remit of the RO as stands, with dangerous and unrealistic implications. It will demand decisions beyond the scope are decided by MDTs who may lack specialised knowledge, or have an abundance of competence but not approve the treatment for uncertainty as to the new legislation. MDTs have no time as it is already to get through what needs to be done. It will create a situation where doctors are acting in direct contravention of GMC guidance and will NOT provide a defence to the GMC fitness to practise panels. The current law is protective of doctors responsibly innovating, and is supportive of such innovations. This codifies and seals an uncertain fate for the good innovator, and enables ‘the perfect storm’ to occur for both doctor and patient.
It is likely to reduce public trust in doctors – for it creates the real chance not for the good doctor to innovate, but for the bad doctor to exploit and defend himself. This Bill has ridden on the back of the image of the doctor as a self interested financially driven individual who deliberately causes harm to their patients – repeated over and over by Lord Saatchi. This is not only offensive, it is highly inaccurate, inappropriate and already damaging for patients and doctors. Furthermore the arguments that it does nothing to protect patients against ‘quacks’ are true – and this will have a knock on effect not only on patient safety and exploitation but also on trust in the good doctor. It will create the situation of desperate patients shopping around for someone willing to give something (harmful) a try. It will protect the reckless and shackle the true innovators–vastly impeding progress. It will leave the door open for financially linked motives with pharmaceutical companies. In an era of transparency, one-off attempts at innovation with obscured motives will achieve the very opposite, while substantially risking patient safety. It will be a wrecking ball to the integrity of the medical profession, and I do not want to work under such a misguided, confining and duplicitous statute, and nor would I wish to be a patient degraded in terms of human worth on the basis of my disease and put at real risk of harm in such a way.
Nigel Poole QC illustrates very well in this blog post what the Bill v3 will enable.
The present law encourages and protects doctors to innovate responsibly, while maintaining a standard and safeguard for patients and respect for the patient’s worth as an individual. ‘The protection of patients is ensured by a requirement that treatment should be capable of reasoned justification, as explained in Bolitho. A requirement that proposed treatment should be supported by some responsible professional opinion provides a degree of assurance that the risks and benefits have been appropriately balanced. This does not require a treatment to have been adopted already by others, merely that there is a level of professional support for it which has a logical basis.’ – Robert Francis QC
It is a great shame that Lord Saatchi has not bothered to take into account the many expert responses received to the DoH consultation – for they provide much information, well considered insight and advice on what would help patients both now and in the future, and what would actually help doctors to innovate. The same potential barriers are raised many times: funding, research approval, bureaucracy and so on. Solutions are proposed: Innovation Oversight Panels, an open-access database, better data usage, using the Systematic Anti-Cancer Therapy (SACT) data set model for databases, clarifying EU Clinical Trials Directives and UK Medicines for Humans Use (Clinical Trials) Regulations and existing ways to improve innovation that could be enhanced – the MHRA Early Access Scheme, the EMA’s Adaptive Licensing, the Cancer Drugs Fund. Extensive access to CECs, improved commissioning, funding availability and streamlining to reduce delays. Better access to trials, recording and access to information worldwide and reduced bureaucracy would all help. This will add bureaucracy, reduce access to trials and keep some information at a local level. It is thoroughly inappropriate. There is real potential for Lord Saatchi to make a positive difference here – but it is certainly not with the Medical Innovation Bill v.3.
Here are, in table format, a number of responses from some key organisations and their findings/recommendations: Consultation responses & recommendations