HL Committee Stage 24 October 2014

Summary of the Bill at 24 October 2014

We support responsible innovation but oppose the Medical Innovation Bill. It is unnecessary. It will not promote responsible innovation but will encourage irresponsible experimentation. It is liable to expose patients to disproportionate and avoidable harm.’

The Bill is unnecessary: innovative treatments happen daily, supported by the current law.The Bill acts to remove patient rights, not give new ones.

It permits treatment that would otherwise be regarded as negligent.

Its scope extends to any treatment for any condition and in any patient.

It will obstruct, inhibit and delay research.

It will not advance a cure for cancer or other disease, nor promote widened access to existing beneficial   therapies.

It will lead to increased legal uncertainty and bureaucracy for doctors.

It will increase the risk of legal action and result in protracted litigation.

It is a serious threat to patient safety.

It is opposed by all key medical, patient and defence organisations.

Premise for the Bill

Lord Saatchi has claimed 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. The belief is that in removing the threat of an action in negligence, the Bill will encourage ‘innovation’ and will empower patients to access untested, experimental treatments.

The Law

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.

A doctor is not negligent if he provides treatment to a patient which is supported by a responsible body of medical opinion, even if there are other bodies of medical opinion who would not support it. A doctor is only negligent if no responsible body of medical opinion would support their treatment or if the treatment has no logical or rational justification. If that negligent treatment harms or kills the patient then the patient or their family will be entitled to compensation.

The current law does not mandate adherence to a standard treatment. The Bolam test is flexible and allows for innovative treatment if a responsible body of medical opinion would support it, however small that body may be.

Primary effect of the Bill

Innovative therapy occurs daily in medicine. The great majority of doctors providing innovative treatment act in accordance with a responsible body of medical opinion and give treatment which has a rational basis. The Medical Innovation Bill will not affect them or their patients. In contrast, the Bill does seek to change the law in respect of the small minority of doctors who do not act in accordance with a responsible body of medical opinion or who provide treatment which has no rational basis. Lord Saatchi proposes that those doctors should have an immunity from being sued by patients who have been harmed by such treatment.

Under Clause 1(2) of the Bill a doctor providing treatment would no longer be negligent even if his treatment had no support from any responsible body of medical opinion, indeed even if no other doctor at all supported the treatment. The patients of those doctors will not be entitled to compensation however seriously they are harmed.

The Bill does require such doctors to consult with another doctor who has experience of the patient’s condition and to take into account that doctor’s views as well as matters such as the known risks of the treatment. But these are procedural requirements which do not safeguard a patient against being given experimental treatment which no other doctor supports or which has no rational basis. There is no requirement for agreement from another professional.

The latest version of the Bill is written to apply to the conduct of treatment itself, not only the decision to treat. The Bill does not apply to a narrowed class of patient, such as terminally ill patients, adults, cancer patients. It applies to every patient including non-terminal conditions, children and those treated in emergencies.

Support for the Bill

Supporters believe it will allow access to treatments that are currently unavailable. They believe it empowers them and will ensure doctors provide specific therapies to them or their family.

They believe that it champions autonomy and that patients should have the right to accept the risk of untested treatment.

They believe information gained from the process will benefit others.

Some supporters believe that the Bill applies only to terminally ill patients or cancer patients further to this representation in media coverage.

Criticism of the Bill

Strong criticism has come from leading medical, regulatory, research, patient and legal organisations. These include the BMA, whose membership exceeds 153,000, defence organisations representing doctors, the Royal College of Physicians, whose membership exceeds 29,000 doctors, patient groups and Sir Robert Francis QC, Chair of the Mid Staffordshire NHS Trust Inquiry.

Criticism includes:

– The proposed legislation is not needed.

– No organisation has evidence that a fear of litigation impedes innovation.

– Innovative treatment is expressly permitted under current law and professional guidance.

– The Bill poses a serious threat to patient safety and threatens the welfare of vulnerable groups of people.

– It is based on a false premise, which fails to address access or other barriers to innovation that may exist.

– The erosion of professional responsibility, the illusion of choice and the likelihood of harm would damage a patient doctor relationship and overall trust in the profession.

– Codifying best practice is flawed and inappropriate in this area.

– Doctors’ refusal to treat with what they regard as a potentially harmful therapy may result in new legal actions while inability to fund or access therapy may result in more legal action involving an individual doctor.

– The consequence will be increased legal action, liabilities and satellite litigation surrounding any Act.

– It may involve breaches of professional and ethical guidance and principles, and increase the likelihood of regulator sanction for individual doctors.

– The Bill expressly removes liability for treatment that would otherwise be regarded as negligent.

– It removes access to any redress for patients who are seriously injured by negligent decisions or conduct, leaving them without remedy.

– In the event of a legal action proceeding, it conceals and confuses liability for harm caused and may serve to increase scrutiny on individual doctors and bureaucratic process, while potential product liability concerns are protected and unchallenged.

– It makes it easier for a quack doctor to prey on vulnerable people, without any potential for legal or peer scrutiny after the event.

– It fundamentally confuses research and treatment activities and processes, and may remove REC approval oversight and insurance requirement for what would otherwise be research on this basis.

– Makes no provision for data protection and storage of information.

– It will add more bureaucracy and confusion to clinical practice, in time taken, managerial and legal barriers to innovation.

– Daily, responsible, innovation that happens now will be obstructed.

– It obstructs and inhibits progress in clinical research, and would delay appropriate research findings, perhaps by many years, with significant resultant harm.

– It fails to provide for medical and technological advances such as precision medicine techniques, and does not promote personalised medicine.

– It is an archaic model, long outdated, and patients deserve better.

– It fails to distinguish medical and surgical treatment which present very different challenges.

– It fails to address infrastructure, resources and funding.

– It arrives at a time when Academic Health Science Network ‘Innovation Funds’ not provided, reduced and removed by government for academic institutions, funding to cancer services has been reduced by £790m and other significant cuts have occurred across relevant sectors.

– The Bill would put doctors under pressure from pharmaceutical companies and the most understandably desperate patients to try out potentially dangerous treatments.

– The Bill applies to any form of medical treatment and any category of patient.

– It will benefit pharmaceutical companies, lawyers and ‘charlatans’ but confers no benefit to patients or doctors.

Criticism of the Bill Campaign

– Lord Saatchi has consistently misstated the law when speaking in public and in the Lords.

– There was a failure to conduct any consultation regarding the premise for the bill, that doctors do not innovate because they fear being sued. 4

– No evidence has been provided that doctors do not innovate because of a fear of litigation.

– There has been no effort to construct any appropriate or legitimate consultation in respect of what may obstruct innovation and therefore what could be addressed and supported.

– Media manipulation, misleading anecdotes, emotive human interest stories and spin have been used to great effect by the Saatchi team.

– Vulnerable and desperate groups of people have been manipulated by the campaign.

– Key speakers for the campaign, such as cancer representatives, bereaved parents and parents of sick children, have been targeted and misled to gain public backing and deflect criticism. Their genuine and laudable desire to improve treatment has been used to drive forward support for a change in the law that will not represent their needs or achieve their aims.

 

5 key points

  1. The current law does not impede innovation.

Lord Saatchi has used the message that the current law requires doctors to follow standard procedure to gain public and media support. His accompanying remarks about doctors’ livelihoods being at stake, or destroyed, and a rising litigation culture have attempted to gain medical support. This is not at all an accurate definition or representation of the current law. Doctors can and do ‘innovate’ daily; experimental therapies are frequently recommended and drugs frequently used off-label.

Case law supports the use of innovative treatment, and cases include those where a treatment has never been used in humans for that purpose before, and those where a minority of only 2 doctors in a speciality would have agreed with the conduct in question.

The GMC expressly supports innovative treatment, as do other sources of ethical and professional guidance.

Doctors are not unclear about the law, and in the event that they were, the correct response would be supportive education and training to encourage better understanding, not increasing legislation, confusion and bureaucracy. No evidence has been produced to substantiate the anecdote that doctors’ fear of litigation, caused by the current law, inhibits the use of innovative treatment options with patients. No expert body responding to the consultation or subsequently has agreed with this assertion, instead all have strongly disputed this.

There is not an increase in ‘defensive medicine’ as a result of the law in this country and there is no real evidence of a litigation crisis. It is extremely hard to win a clinical negligence case. The increase in new negligence actions notified to the NHSLA is due to:

– An increase in negligent treatment, often similar incidents repeating and not being addressed; lack of funding, resource cuts and staffing levels contribute.

– An increase in non-expert firms taking highly specialised clinical negligence claims, following earlier government changes to legal case funding.

– The LASPO changes to CFA funding arrangements ‘no win no fee’ and costs recoverability, and the near-total removal of legal aid which already serve to decrease access to redress; many new claims were notified or issued to precede the change in funding arrangements.

– Importantly there is no evidence of claims in clinical negligence occurring following innovative treatment.

The law in this area has evolved carefully and robustly considers cases on an individual basis, progressing with the rapid advancement of medical science and supporting doctors in treatment decisions. A change in this careful and nuanced field of law is extremely inappropriate and would serve to confuse and deter innovative practice and increase rather than decrease involvement in legal action and satellite litigation.

 

  1. The Bill acts to remove patient rights, not give new ones.

The Bill does not empower a patient to demand a treatment. It does not enable them to ask for a specified therapy and expect to receive it; it does nothing to address this most important issue of access to treatment. Many drugs have known efficacy yet are not commissioned or funded for patients. This Bill does not provide funding or access to these drugs. 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’.

For the patient it provides no funding for treatment, no increased access to trial networks or other strategy for accessing potentially beneficial therapy, which would be permitted under the current law. Instead it removes safeguards for patients, removes a requirement for any peer to have agreed with a treatment decision and removes the ability of a Court to examine whether a decision was logically explicable or justifiable. It prevents legal action for treatment that would otherwise be so unacceptable as to be negligent. This leaves patients or relatives of those who have been seriously harmed, have suffered or died as a result of a decision or treatment that would today be negligent, without any legal remedy, and very vulnerable to exploitation or simply to misplaced hope.

 

  1. The Bill as it stands applies to all medical treatment, all conditions and all patients.

As the Bill stands it applies to any category of patient, not solely those who are terminally ill with cancer; and to any form of medical treatment. It does not limit the scope to cancer patients, to terminal illness or to those who have exhausted other treatment options. It is not limited to treatments with a known chance of success. It is not limited to adults, and would apply in paediatric cases, emergencies and other situations where both consent may be impossible and where the addition of a bureaucratic process may delay or prevent medical treatment that can be given according to the current law, and operate to the patient’s detriment.

This remains the case if Lord Saatchi’s amendments are accepted. Although additional amendments may serve to limit the operational remit of the Bill they fail to remedy the position for relevant persons who could be treated under the proposed Act. In narrowing a class of patients to limit the scope and potential harm caused by the Bill, it increases risk and carries significant implications to those within the relevant categories. In narrowing experimentation to a class of patients, an ethical shift occurs that fails to consider extremely important issues of quality of life, wellbeing, patient trust and the subtlety and complexity of illness experience and decision making. Furthermore, any amendments to the Bill do not address the fundamental aspects that this legislation is not well targeted and is unnecessary when both current law and professional guidance support innovative treatment.

 

  1. It would not advance a cure for cancer or other disease.

The Bill is restricted solely to changing the law of clinical negligence, removing the ability of patients to have access to legal redress. This very narrow approach and the failure to undertake prior consultation does not address existing barriers to innovation. It does nothing to support doctors in responsibly innovating or effectively conducting clinical research; while promoting an unrealistic expectation from patients.

Areas of focus that may assist include:

-Funding provision for all related activities

-Increased funding for research

-Increased access to trials

-Rigorous design, speeding up and promoting individual patient access to trial networks

-Investment in infrastructure locally and globally in equipment, capabilities and trial networks

-Removing bureaucratic barriers

-Regulation of drug marketing and media misrepresentation 6

-Disclosure of business relationships

-Publication of all results in trials

-Information sharing and availability

-Supporting clinicians practically

-Supporting education and awareness of existing legal position if required

-Supporting shared decision making

-Encouraging innovation culture and research skills

-Widening and improving ethical support mechanisms

-Widening of existing schemes

The Bill has been promoted as allowing a cure for cancer to be found It promotes public demand for inclusion in clinical research and access to therapies, however it expressly excludes research. The use of the Bill would therefore not yield valuable data, and patients who support the Bill are unlikely to be aware of this. 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 again unnecessary. It will promote a form of experimentation with protection from a claim in negligence. It may pressure, encourage or mislead doctors so that they breach existing and continuing regulations, while still failing to yield relevant data or progress scientific knowledge.

In times long past, astute observation of health effects was the only scientific method available, but one that led to false inferences and many tragedies in recent medical history, and which frequently delayed the acquisition of evidence. 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. Rapid adoption of a treatment with decreased critical evaluation is both inappropriate and reckless. A pro-innovation bias in the media, in research and with accompanying social demand risks causing harm, plays to profit motives and does not progress individual patient care or wider medical knowledge.

Innovative, novel treatments are permitted expressly by law and professional guidance. Therapy should be supported where it is carefully targeted and critically evaluated, and infrastructure and funding should allow for rapid dissemination of advancements and wide access to properly conducted clinical trials.

New technological advancements have permitted a personalised and precision based approach through genomic applications, including pharmacogenomics, particularly in cancer care. This approach requires a significant investment in the UK. The Bill promotes a very imprecise and outdated model that would yield no results at all for any scientific community, would not be reliable or reproducible and any data capture as part of the Bill if added at a later stage would fail to allay these concerns or wider issues of increased bureaucratic process and protection of patient data.

Many examples exist where the introduction of an experimental treatment has delayed the acquisition of evidence and reduced trial participation. This delays and impedes scientific progress, and has led to many cases of harm in the interim. A study of the FDA in the US revealed more than 10% of drugs licensed are later withdrawn or subject to black box warnings, and adverse drug reactions are a leading cause of death.

Patients deserve increased access to clinical trials, accurate data and rapid advancement and adoption of the most effective treatment, without an unacceptable risk of harm, suffering or hastened death. They deserve to make informed decisions based on reliable, meaningful information. They deserve this without reckless experimentation at best, and dishonest exploitation at worst, which is what the Bill serves to protect.

 

  1. Opposition from key medical bodies, experts, patient groups, charities, research and defence organisations.

The Department of Health consultation responses from all expert organisations revealed that none had evidence that the law prevented innovation. All felt that the Bill was unnecessary, would remove vital patient protections, impede doctors and obstruct responsible research. New drafting or proposed amendments do not address fundamental concerns about the Bill and key organisations maintain their opposition.

Those opposing the Bill include:

Sir Robert Francis QC, Chair of the Mid Staffordshire NHS Trust Public Inquiries

Sir Ian Kennedy QC

The BMA (British Medical Association)

The RCP (Royal College of Physicians)

The RCGP (Royal College of General Practitioners)

The RCR (Royal College of Radiologists)

The RCPsych (Royal College of Psychiatrists)

RCP Edinburgh

The Academy of Medical Royal Colleges

The Association of Medical Research Charities

The Wellcome Trust, Medical Research Council, Academy of Medical Sciences

NICE

MDU (Medical Defence Union)

MPS (Medical Protection Society)

The NHS Litigation Authority

The Health Research Authority

Academy for Healthcare Sciences

The British Pharmacological Society

Sense About Science

The Good Thinking Society

The Nightingale Collaboration

AvMA (Action against Medical Accidents)

MND Association

The Patients Association

Healthwatch

APIL

Leigh Day & Co

Kingsley Napley LLP

Notable academics, consultants and experts, including: Professor Michael Baum, Professor José Miola, Professor Richard Ashcroft, Professor Susan Bewley, Nigel Poole QC, Professor David Colquhoun, Dr Margaret McCartney.

 

Experts say:

 ‘The BMA strongly believes that this Bill should not become law and.. does not believe that primary legislation which focuses on redefining clinical negligence is the best mechanism to promote or encourage responsible innovation’ …‘is unnecessary, risks removing important protections for patients and could encourage reckless practice, with attendant risks for patient safety.’ BMA

 

 ‘Legislation is both unnecessary and undesirable.’ ‘Legislation which aims to clarify and encourage good practice in terms of when medical innovation is responsible could have the opposite effect as well as unintentionally weaken the principles which we regard as fundamental to safe, effective patient care.’ GMC

 

 ‘The proposal of this Bill proceeds from a fundamental misunderstanding of the effect of the current law’ ‘no evidence has been produced which shows that innovative treatment has been significantly deterred by a fear of litigation related to the Bolam test.’ ‘It explicitly frees the doctor to offer treatment which has no support from responsible medical opinion’

‘the vulnerability of those who desperately seek new treatments should not be forgotten: those in the greatest medical need deserve protection from injury caused by unjustifiable practice, exploitation, the raising of false hopes, and outright deception.’ ‘Therefore to legalise the taking of a step which may result not only in disappointment but in some cases actual injury, while at the same time removing the right to compensation, is to do a disservice to patients’ Sir Robert Francis QC

 ‘This Bill is, like its two or three predecessors, based on the fundamental misapprehension that the law of negligence inhibits genuine and responsible innovative treatment.

Not only that, but for all its good intentions, it is actually dangerous for patients because it proposes “safeguards” which are illusory and which may give free rein to mavericks peddling dangerous remedies to vulnerable and desperate people.’

‘the law of negligence does not prevent responsible innovation and never has’

‘The Bill would apparently free a doctor from any constraint to act in a logical, responsible or reasonable manner, so long as he/she follows a process the outcome of which he/she is free to reject’

‘This Bill introduces a level of complexity and process driven rigidity to an area calling out for responsible flexibility to meet new circumstances as they arise, as well as an increased risk of provoking litigation over the meaning of the legislation’ Sir Robert Francis QC

 ‘In summary the new version of this Bill suffers from the same deficiencies as its predecessors:

  1. It purports to address a problem of law which in reality does not exist.
  2. It proposes requirements which are bureaucratic and ineffective.
  3. It does not succeed in limiting its scope to treatment that would be generally accepted as innovative.
  4. It frees a doctor from any duty to be reasonable or rational in a decision to offer a treatment so long as he goes through the motions of a process. It is therefore a threat to patient safety in relation to a particularly vulnerable group. In reality the claimed safeguards are no safeguards at all.’ Sir Robert Francis QC

 

‘We have not seen any evidence that suggests litigation or the possibility of litigation is deterring clinicians from innovative practice’ ‘Bill will not actually deter innovation which is irresponsible and may indeed have the opposite effect’ AoMRC

 

 We ‘have no evidence that doctors are deterred from innovation by fear of litigation.’ ‘we are very concerned that there could be serious unintended consequences of the proposed legislation.’ ‘If the doctor considers that the proposed treatment would not …satisfy the Bolam test if challenged in court, then the overwhelming likelihood is that the treatment will not be of value and there is a significant risk that it may be harmful.’

‘We do not believe this legislation is needed. We do not feel that doctors are constrained as regards innovation and we believe that the current structures provide the appropriate checks and balances. This could have perverse effects as there might be fewer checks and balances to ensure that innovation is appropriate, safe and potentially effective.’ RCR

 

 ‘ The existing legal framework allows for innovation in the NHS’ NHS Health Research Authority

 

 ‘..we know of cases where drugs are used by NHS clinicians off-licence when doctors consider that their prescription will be beneficial for individual patients.’ ‘Our broad view is that existing case law caters appropriately for cases of innovative treatment’ NHSLA

 

 ‘The RCP does not have significant evidence (anecdotal or through case examples) from our members and fellows, nor we understand do two medical protection organisations, that litigation or potential litigation is a substantial or primary deterrent to clinicians’ use of innovative treatment’ ‘departure from standard practice is not prevented in law’ ‘clinician involvement in and patient referral into larger NHS clinical trials.. could be put at risk’       ‘proper consent from patients is crucial. Beyond this, it is also necessary to protect vulnerable patients who may have received a devastating diagnosis or have exhausted standard treatment options’ RCP

 

‘We have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer.’

‘We have been unable to find evidence that cases have been brought, or led to compensation, based on a competent doctor attempting to use an innovative treatment with the consent of a patient.’ CRUK

 ‘We believe that some of the biggest barriers to innovation are at the structural and organisational level, rather than at the level of the individual.’ Wellcome Trust/MRC/AMS

 

 ‘The MDU does not have any experience or evidence to suggest that doctors are deterred from innovating by the fear of litigation. We have no experience or evidence to suggest there is or that our members believe there is a lack of clarity or certainty about the circumstances in which they can innovate without fear of litigation’

‘The law currently considers innovation is responsible if it is in the patient’s best interests and can be supported by a responsible body of medical opinion and the patient has been fully informed and given consent. We do not think anything else needs to happen to encourage responsible innovation.’

‘If the standard applied to determining whether the doctor acted responsibly in making the decision would be the Bolam standard, this suggests that the current test that applies provides all the protection a doctor needs when considering innovation and that there is no need for a new law.’ MDU

 

 ‘Despite many years of experience in the clinical negligence claims environment we have no evidence that the fear of litigation is holding back innovation in medicine.’ ‘There is a risk that patients will misunderstand and overestimate what this Bill would do’ ‘We believe that it increases risk… The consultation admits that ‘it has not been possible to identify the likelihood and scale of these risks’. ‘It is important that thorough analysis is undertaken before there is any change in law.’ MPS

 

 ‘We have no evidence to suggest that that the possibility of litigation, or a lack of clarity and certainty about the circumstances in which a doctor may innovate without fear of litigation, has ever deterred a doctor from deploying an innovative treatment in respect of MND.’ ‘These clauses ..appear to give a signal to doctors that ‘anything goes’ when faced with a terminal and profoundly disabling illness’ ‘a charter for irresponsible treatment and experimentation, and the exploitation of potentially vulnerable patients faced with a devastating diagnosis and feeling – rationally or not – that they have nothing to lose’

‘the quality of life that a person ..can achieve with appropriate care and support should not be gambled with lightly’

‘We believe that the current legal position offers an appropriate balance between latitude for doctors and safeguards for patients’ ‘Bill offers no prospect of benefit but poses a genuine risk of causing harm, and we advise the Government not to proceed with it.’ MND Association

 

 ‘We agree with the many doctors and doctors’ organisations who say that as well as being based on a false premise, the Bill would actually make it harder to provide innovative treatment by creating a confusing, bureaucratic set of rules set in law’ ‘Medical Innovation is too important to be dealt with by a hastily prepared and ill evidenced Bill which only seeks to help innovation by depriving the injured patient of the legal remedy to which they have up to now had a right.’ AvMA