The Medical Innovation Bill: alarmingly at odds with ‘do no harm’

Published in today’s The Lancet Oncology is an Editorial entitled ‘Undermining the Hippocratic Oath: the Medical Innovation Bill’. It follows the letter published in the Times this month signed by over 100 prominent oncologists opposing the Bill, in which they confirm that the current law of negligence does not obstruct innovation in any way.   They warn that the Bill protects ‘irresponsible experimentation’ with the ‘potential expense of causing serious harm and suffering’  and express dismay at the Bill ‘being promoted as offering hope to patients and their families when it will not make any meaningful difference to progress in treating cancer.’   The signatories to the letter; all top clinicians and researchers, add their names to the already overwhelming and categorical opposition to Lord Saatchi’s project.

‘These oncologists join almost every prominent British medical association in condemning the Bill.’ – Lancet Oncol 2014

The expert condemnation includes that voiced in the responses to the Department of Health consultation. These were clear and overwhelmingly negative, clarifying that no organisation had any evidence that litigation deterred responsible innovation and that the Bill would be a significant threat to proper clinical research, best practice and, crucially, patient safety.

Opposition has continued from the organisations and experts that have issued briefings to the Lords at each stage so far. Such briefings include those from the BMA, Sir Robert Francis QC, medical defence organisations and key patient groups and research charities.

As the Bill reached Committee Stage in the Lords last month, again briefing documents were issued by doctors’ representatives and defence bodies as well as numerous expert medical research and charitable organisations including the Motor Neurone Disease Association, Parkinson’s UK, Leukaemia and Lymphoma Research and The British Heart Foundation. These briefings were unequivocal in re-stating that the Bill is dangerous and unnecessary.

Cancer Research UK are one of many organisations that have spoken out against the Bill. The charity responded to the original Department of Health consultation, confirming that they  ‘have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer’   and stating

the most important mechanism for encouraging responsible innovation in the UK is to continue to build a thriving clinical research environment. There are a number of other mechanisms already in place that should be evaluated which, if further strengthened, could lead to significant improvements in medical innovation..’

This month, CRUK’s executive director of policy and information, remarked: “There is…a risk of unintended consequences” “These concerns lead us to conclude that there is no pressing need for this legislation.”

Indeed, no relevant body of opinion can find any evidence or reasoned justification for the Bill. The voices in support are those who believe the PR campaign, mounted by an advertising magnate legendary for his effective techniques in politics ‘Labour isn’t Working’ and other domains, such as campaigns run for Silk Cut and his contracts with pharmaceutical giants. His full-time team of journalists, PR and media experts include Dominic Nutt and Liz Scarff, whose USP is her previous experience of ‘crowdsourcing’ support through human interest stories and social media.

Those in objection are loud, clear, unspun and irrefutable: it would be a terrible mistake for this to recklessly proceed any further. It fails to address any real obstacles to innovation that may exist and persists with a demonstrably false notion that the law of negligence is a problem, real or perceived. It still is not, despite the campaign’s best attempts at instilling that perception.   Further, they have tried hard to perpetuate a false and dangerous notion that using untested treatments that may have no evidence base or backing at all would be a safe and useful alternative to a trial.

‘To pretend that the alternative is the provision of untested evidence on one or two individuals’ potentially biased judgement is not only disingenuous, it is harmful.’ – Lancet Oncol 2014

To carry on, despite such broadly unanimous and well-reasoned opposition and such severe concerns about the lives of real people, would be to broadcast how very misguided a project this has become.  This is not an issue that should be rushed in an attempt to pass botched legislation before the general election. This is serious; affecting real people, real lives, real children, real wives. As noted by The Lancet, the Bill’s alarmingly non-specific drafting is designed to affect all forms of medical treatment; its scope for patient harm and suffering dwarfing the volume of objection listed here.

Lord Saatchi should wind it down, consult properly and listen to the doctors who devote their lives to treating patients in the very best way they can and improving care for all. So far he hasn’t listened.  We all want innovation, we all want the best possible treatments and outcomes. The Bill isn’t an answer to this.

Which organisations, experts and groups have expressed opposition to the Bill?

  • Academy of Medical Royal Colleges
  • Academy of Medical Sciences
  • Arthritis Research UK
  • Association of Medical Research Charities
  • AvMA
  • Association of Personal Injury Lawyers
  • Academy for Healthcare Sciences
  • The British Heart Foundation
  • The British Medical Association
  • British Pharmacological Society
  • Cancer Research UK
  • The General Medical Council
  • Genetic Alliance UK
  • Good Thinking Society
  • HealthWatch UK
  • Kingsley Napley LLP
  • Leigh Day & Co
  • Leukaemia and Lymphoma Research
  • The Medical Defence Union
  • The Medical Protection Society
  • Medical Research Council
  • Motor Neurone Disease Association
  • NHS Health Research Authority
  • NHS Litigation Authority
  • NICE
  • The Nightingale Collaboration
  • Parkinson’s UK
  • The Patients’Association
  • Price Slater Gawn Solicitors
  • Royal College of General Practitioners
  • Royal College of Physicians
  • Royal College of Psychiatrists
  • Royal College of Radiologists
  • Royal College of Surgeons
  • Royal College of Surgeons, Edinburgh
  • Sense About Science
  • Wellcome Trust

Individuals include

  • Sir Ian Kennedy QC
  • Sir Robert Francis QC, Chair of the Mid Staffordshire NHS Trust Public Inquiries
  • Jose Miola, Professor of Medical Law and Ethics; Professor Richard Ashcroft, Professor Jonathan Montgomery
  • Dr Margaret McCartney, Professor Michael Baum; Professor Susan Bewley; Nick Ross, President of Healthwatch
  • Nigel Poole QC, Amanda Yip QC
  • Dr Clive Peedell and more than 100 oncologists and researchers
  • Many doctors speaking individually
  • Additional signatories to the letter in the Times, March 2014
  • Lord Robert Winston
  • Lord Turnberg
  • Baroness Masham of Ilton

Many more.

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