Medical Innovation Bill – key points

The latest expert news and views on the Medical Innovation Bill have been posted here at stopthesaatchibill.co.uk 

The Medical Innovation Bill is a private members bill introduced by Lord Maurice Saatchi. It has followed a tortuous route through parliament so far. Unusually, a No.2 bill procedure was used to introduce it into the Lords and the Commons simultaneously in 2012. This is rarely used and typically reserved for legislation that must be passed very quickly. Following much criticism, it was withdrawn from the Commons and a second draft was produced of the Medical Innovation (No.2) Bill to progress through the Lords.

Despite the unequivocal opposition voiced by leading organisations to the Department of Health consultation on the Bill, which closed in April 2014,  it has not been withdrawn. There has been no arrangement to consult upon what barriers to innovation actually are. Instead, the bill was ‘redrafted’ rapidly before publication of the (very negative) consultation responses.   Its second reading in the House of Lords occurred on 27 June  2014, following which it was redrafted again,  and again.  The Medical Innovation (No.2) Bill (fourth draft) – (HL Bill 4) went to Committee Stage in the House of Lords on 24 October 2014. Thirty nine amendments were tabled. A revised version has been produced with amendments, due to be discussed further and intended for Report Stage.

Lord Saatchi’s assertion is that the current law of negligence inhibits innovative practice and hinders progress in research and patient care. He defines negligence as deviation from standard procedure, and innovation as deviation.  He believes that by removing any threat of an action in negligence the Bill will encourage innovation and will empower patients to demand access to experimental treatments.

Expert organisations, individuals and representatives have strongly opposed the Bill in force, and maintain their opposition to its current draft. Those opposing include leading medical charities and research organisations, the BMA, the RCP, MDU, MPS, and Sir Robert Francis QC, legal expert and Chair of Mid Staffordshire NHS Trust Public Inquiries.

Key Points

  • The current law of negligence does not inhibit medical innovation.

The law of medical negligence is settled and well understood by judges, lawyers and doctors. The test of whether a doctor has been negligent was set down in the case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 and adapted in the case of Bolitho v City and Hackney HA [1998] AC 232.

The law is very flexible and allows for innovative treatment if a responsible body of medical opinion would support it, however small that body may be. A doctor is only negligent if no responsible body of medical opinion would support their treatment or if the support for the treatment has no logical or rational justification.

The current law therefore does not mandate adherence to a standard treatment. Innovative therapy, including off-label prescribing of medication, is used daily by responsible doctors, and this is expressly supported by considerable weight of case law, alongside professional and ethical guidance, such as that from the GMC.   The law does not impede innovation, and no organisation has any evidence that a false perception of the law manifesting a fear of litigation, impedes innovation. If anything does, the law is not it.

  • The Bill would remove the most fundamental patient protections.

The Bill would act to change the law to offer absolute protection for conduct falling so far below an acceptable level that it would be negligent.   Lord Saatchi proposes that doctors should have an immunity from being sued by patients who have been harmed by such treatment, establishing that such a doctor would not be negligent even if no other doctor at all would have supported the treatment or the reasoning behind it. Those patients harmed by what would now be regarded as treatment so unacceptable, illogical, irresponsible or unjustifiable that it is negligent would have no access to any form of redress, no matter how serious their injury or suffering.   The latest versions of the Bill have been written in terms that apparently apply to the conduct of treatment itself, not only the decision to treat, and to apply to all medical treatment for all conditions.

The Bill does not empower a patient. It does nothing to help access to treatment: barriers to which are entirely unrelated to the law of negligence. In doing nothing to increase or enable access to a treatment (albeit one that may harm) it operates in theoretical terms only, and focuses on something that will only remove rights and remove safeguards from patients.

  • The Bill would not help or benefit doctors.

The Bill would not be helpful for doctors. Doctors’ representatives, including the RCP, other Royal Colleges, the BMA, Medical Protection Society and Medical Defence Union, have voiced strong opposition.

The current law is very deferential to medical opinion and expertise. It allows consideration on an individual case basis, allowing for developments, rapid scientific progress new ideas and individual features, supporting the exercise of clinical autonomy. If clinical autonomy faces a challenge, it is not justifiably a legal one.  The law does allow for the oversight of peer support to maintain a good standard, prevent serious bias, guard against exploitative or simply terrible practice and thus maintain public trust in the profession, with a consequential benefit to each clinical encounter. This is rarely used, however this ability serves to protect and uphold the deferential position that the law follows, respecting medical opinion and progress.

The illusions promoted by the introduction of such legislation would not help doctors. The perceived, illusory, shift of power further to the patient is set in a landscape of media hype, misinformation, increased expectation and demand, and with no resources, funding or infrastructure in place the likeliest outcome is patient dissatisfaction or harm. The increased pressure from patients and pharmaceutical companies would leave a doctor, in an office with bureaucracy propping up the ceiling, hands tied by purse strings and tape, in an untenably fraught position.

The Bill does nothing to support doctors in responsibly innovating, obtaining funding, access or time to effectively conduct appropriate activities; it merely promotes an unrealistic expectation from patients while adding to a bureaucratic nightmare for the doctor. There would be a significant increase in legal action, and doctors would be drawn into it. In treating a patient, the doctor may breach a number of professional regulations, while facing increased scrutiny for adverse events by virtue of decreased liability across the board, even for pharmaceutical products.

More doctors would face legal scrutiny and a potential litigation process, alongside an increased likelihood of regulator investigation or sanction for individuals. It would be a legal disaster with attempts in res ipsa, or a failure to treat,  loss of a chance, judicial reviews and considerable other legal challenge, including criminal liability. The scope for satellite litigation around the bill’s operation is significant and has the potential to continue for years, increasing confusion, adding barriers, damaging doctor-patient interaction and obstructing best practice.

  • The Bill would not advance scientific progress.

Many examples from recent history have shown that permitting access to a ‘treatment’ that may have no beneficial effect at all delays the acquisition of evidence required to determine its effects. It is an archaic and inappropriate model to promote in today’s era. Scientific progress is rarely linear and newer treatments are not always better, and rapid use with decreased critical evaluation is both inappropriate and reckless. Genome sequencing, and fields such as pharmacogenomics and concurrent rapid advances allow for precision in rationalising a treatment strategy for an individual.

Responsible decisions and compassionate access to treatments or potential treatments are supported by the current law, and if this is the Bill’s aim, it is unnecessary. It serves to obstruct the trials process and diminish available evidence, putting people at serious risk of harm, without progressing their care or advancing medical knowledge. No data generated would be of benefit to anyone, and the concept fails to address real areas that may assist in advancing progress, such as removing rather than adding bureaucracy; providing funding and support. Research and trials access and networks could be widened, not shut down. This would increase access to accurate data and meaningful, reliable information and encourage rapid advancement and adoption of effective treatment strategies without unacceptable risks of harm, suffering or hastened death.  It would promote a form of very high risk, reckless experimentation on patients, or dishonest exploitation at its worst, without the need for any evidence of benefit or any logical rationale with protection from a claim in negligence.

  • All key expert organisations oppose the Bill.

There is no evidence of claims in clinical negligence occurring following innovative treatment, and no evidence in support of the assertion that doctors do not innovate for fear of litigation. Instead there is a wealth of opposition; from doctors’ representatives, legal and defence bodies, patient organisations and medical research groups and charities, alongside notable experts including Lord Winston and Sir Robert Francis QC.

Key concerns are that it is founded on a clear misunderstanding of the law, it is a severe threat to patient safety, it is put forward by non-experts who fail to understand the clinical position and complexities and fail to recognise serious risk to patient groups, it applies to all patients, conditions and treatments and it fails to address anything that may in fact support doctors and enable access to more treatment or innovation appropriately.  It further fails to consider extremely important issues of quality of life, wellbeing, patient trust and the subtlety and complexity of illness experience and decision making.   Instead it expressly permits the use of drugs or therapeutic techniques where there is no known efficacy and no evidence base at all. It would also permit treatment where it is not logically or rationally justifiable. This would benefit pharmaceutical companies financially through the use of unused drugs and patent extensions, but may cause significant harm to the patients being ‘treated’.

Furthermore, any amendments to the Bill do not address the fundamental aspects that this legislation is  unacceptably dangerous, poorly targeted and is unnecessary when both current law and professional guidance support innovative treatment.

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