Tag Archives: Department of Health

Amendments to be moved on report – 12th December 2014

Following the Committee Stage in the House of Lords on 24th October Lord Saatchi has tabled a set of amendments to be considered on Report on 12th December.

The amendments were prepared by the Department of Health  to respond to concerns raised by peers and others at and around the Committee Stage.

We are very grateful for all the input we have received.

The Bill is going through the usual Parliamentary process and amendments are part of that process.

→READ: The Bill has been amended many times. Why?

→READ: Download the amendments on the Parliament website.

The following explanatory notes have been prepared by parliamentary draftsman Daniel Greenberg.

MEDICAL INNOVATION BILL [HL] EXPLANATORY NOTES TO AMENDMENTS FOR REPORT TABLED BY LORD SAATCHI
ON WEDNESDAY 3
rd DECEMBER 2014

Introduction

  1. On 3rd December 2014 Lord Saatchi tabled a set of amendments to his Medical Innovation Bill to be considered on Report on 12th December.
  2. The amendments were prepared by the Department for Health to respond to concerns raised by peers and others at and around the Committee Stage.
  3. These Notes explain the manner in which the amendments meet the concerns expressed.

Transparency: patients’ notes; and recording outcome of consultation

  1. Some peers wanted details of decisions to innovate to be recorded in patients’ notes.
  2. Peers and others have also expressed a wish to see greater transparency about the nature of responses received by the doctor when undertaking the consultation with colleagues required by clause 1(3)(a) and (b).
  3. Amendment 1 requires the results of the consultation to be recorded in the patient’s notes, together with details of the doctor’s decision to innovate.
  4. There has also been pressure to turn the requirement to consult colleagues into a requirement to obtain colleagues’ written consent. These amendments do not give effect to that suggestion. Senior doctors consulted by Lord Saatchi expressed concern about giving formal written consent to another doctor’s proposed course of treatment, without knowing the full history and other circumstances, while they would be relaxed about expressing a view of the soundness of the doctor’s proposal as described to them. Lawyers consulted were also concerned about a possible new form of legal liability for consenting doctors. The requirement to record views in the patient’s notes should introduce the necessary formality, transparency and accountability, while avoiding both of these objections.

Preservation of existing law about clinical trials and other forms of research

  1. It has always been the intention of the Bill to make no change of the law relating to research (see clause 1(5)). But concerns were expressed that this needs to be made even clearer.
  2. Amendments 2 and 3 are designed to put the point beyond possible doubt.

Exclusion of cosmetic surgery

  1. At the Committee Stage and elsewhere suggestions have been made that the Bill should be confined expressly to the principal kinds of case at which it is aimed, namely relatively rare terminal cancers and other terminal conditions.
  2. Lord Saatchi has reconsidered attempting to define the intended scope of the Bill, but has found it impossible to do so in a way that answers more questions than it raises.
  3. Much of the concern has centred around the potential use of the Bill in relation to cosmetic surgery, and it was suggested that it could at least be made clear that it is not the purpose of the Bill to apply to that.

13. Amendment 4 accordingly excludes cosmetic surgery from the Bill. (Cosmetic surgery can of course in some cases be crucial to life or quality of life – as in the case of severe burns; doctors wishing to innovate in such cases will be able to rely on the existing common law Bolam test.)

Emergency treatment; and preservation of common law

14. Concern has been expressed whether in emergency situations doctors will realise that they are not expected to follow the procedures set out in the Bill.

15. Amendment 5 accordingly introduces a reference to emergencies, as an example of a situation in which the existing common law Bolam test would apply and a doctor might not engage the procedures in the Bill.

16. Amendment 6 recasts the principle that the Bill does not force doctors to rely on its procedures and that they can simply rely on the existing Bolam test in all cases. The new form is designed to meet concerns expressed as to whether the intention of existing clause 2(2)(a) was sufficiently clear.

17. Amendment 7 is a consequential amendment to reflect the numbering changes effected by Amendment 5.

Daniel Greenberg 3rd December 2014 

 

Why the Medical Innovation bill will be safer for patients

Surgery medical innovation from Flickr by Phalinn

Critics of the Medical Innovation Bill like to say that patients will be at risk from doctors trying out new treatments because they will somehow be protected from negligence claims.

This is wrong for two reasons. A patient will be safer under this bill than under current common law.

First, a doctor wishing to rely on the bill must obtain the views of at least one other qualified doctor experienced in the patient’s condition.

This must be done in advance of treatment. Under current law, a doctor does not need to consult with colleagues; there is no legal requirement to take account of, or even obtain, the views of other doctors.

Therefore, the Medical innovation Bill is a step forward for patient safety.

It has been argued by some that the necessity to obtain the views – while not requiring their full agreement – is also a danger. This is not so.

A doctor wishing to innovate under the bill could not ignore advice because no judge would find in favour of a doctor who proceeded with an innovation against the advice of colleagues.

The Bill obliges the innovating doctor not only to seek the views of others before treating the patient, it also obliges the doctor to obtain all the standard consents necessary under current law.

Hence, a doctor must do what he or she does now AND build consensus for his or her innovation as well.

Therefore, those who like the current innovation process will welcome the Medical Innovation Bill for adding an extra level of patient protection.

Does the Bill apply to mental health?

The Medical Innovation Bill applies to all areas of medicine.

However as defined in the Bill a doctor cannot give any treatment without patient consent and the Bill does not change the law on what treatments may and may not be given to patients without consent.

So if a patient were detained under section 2 or 3 of the Mental Health Act, and thus being detained and treated without consent a doctor would not be able to give innovative treatment without consent.

The Bill does not change the law about what treatment can or should be given to persons suffering from mental illness (in particular, the issue of “appropriate” medical treatment under section 3(4) of the MHA 1983).

So the Bill could apply to determine whether a decision to exercise a discretion to depart from standard practice in the treatment of mental illness was negligent: but it does not determine whether the doctor has a discretion in the first place, in terms of the law applying to mental illness.

The Bill also expressly does not change the law as to the need for consents, as to which there are of course particular considerations in relation to mental illness.

The Bill expressly limits itself to treatment that in the opinion of the doctor, having consulted appropriately qualified colleagues, is in the best interests of the patient himself or herself: so there is no question of the Bill being relied upon to use patients suffering from mental illness as opportunities to experiment for the purpose of scientific research.

 The provision of treatment will have to be justified, exactly as in the case of non-innovative treatment, both in terms of the risk-benefit analysis for the patient and in terms of the laws addressing the provision of treatment to those suffering from mental illness.

The Times: Medical innovation that does no harm should be encouraged

 

By David Pannick QC

Published in The Times, 30th October 2014

Lord Saatchi’s Medical Innovation Bill completed its committee stage in the House of Lords last Friday. It has government support and so may become law before the end of this parliament next May. The bill could have a positive effect — though not as substantial as its supporters claim — and it contains (or will contain, with further amendments) sufficient protections to prevent it causing harm. It therefore deserves lukewarm support. The bill says that its purpose is “to encourage responsible innovation in medical treatment”. It provides that it is not negligent for a doctor to depart from the existing range of accepted medical treatments if the decision to do so is taken “responsibly”.

For the purposes of taking a responsible decision, the doctor must, in particular, obtain and take account of the views of one or more appropriately qualified doctors in relation to the proposed treatment, and consider the risks and benefits of that treatment, having regard to other available options.

This adds very little to the existing law. The common law test was stated by Mr Justice McNair in the Bolam case in 1957. A doctor is not guilty of negligence “if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”. In the Sidaway case in 1985, Lord Diplock emphasised that because the state of medical knowledge is not, and should not be, stagnant, the Bolam test does not require the doctor to follow the most orthodox approach: “there may be a number of different practices” that satisfy the test at any particular time.

The courts apply the Bolam criteria in a liberal manner in the interests of patients. Typical is the Judgment of Dame Elizabeth Butler-Sloss, as president of the family division, in the Simms case in 2002: she approved innovative treatment for two incapacitated patients suffering from brain disease. The treatment was “untried” with “no validation of the experimental work done in Japan”. But, she noted, there was responsible medical opinion in favour of trying the treatment. As she explained, the Bolam test should not be applied in such a way that “no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted”.

In practice, doctors do already innovate in the interests of their patients, as Lords Winston and Turnberg, with their decades of medical experience, explained during the committee stage debate.

Lord Saatchi believes that the fear of litigation is holding back innovation in the treatment of cancer and other diseases and so a new statute would have a positive effect. But there is little evidence to suggest that the law, rather than lack of funding or excessive bureaucracy, is currently a problem in this context.

So this bill is itself not much of an innovation. Its main effect, as Earl Howe, the health minister, explained last Friday, would be to “bring forward the Bolam test to before treatment is carried out”, while preserving the common law rule for doctors who do not follow the procedures in the bill.

It is possible, though unlikely, that these new provisions will make a difference by encouraging otherwise timid doctors to innovate. It is a legitimate OBJECT of legislation to promote innovation, which is desperately needed in combating cancer. Parliament does not subscribe to the views of Sam Goldwyn, the film producer (as expressed in a pre-Twitter age): “messages should be delivered by Western Union”.

The crucial question, then, is whether the bill will offend against the basic principle of medical ethics recognised by Florence Nightingale as “the first requirement in a hospital”: it “should do the sick no harm”. The bill only applies to “responsible” innovation, which the law confines to reasonable treatment backed by a body of medical opinion. This excludes quacks. But there are important questions still to be decided at report stage.

At present, the bill applies to all medical treatment. But should the law be encouraging innovation in, for example, cosmetic surgery? A way forward would be to empower the secretary of state to prescribe excluded areas of treatment. A further defect is that the bill currently contains no requirement that those carrying out innovative treatment must record it on the patient’s notes or in a public register.

If we are to learn from the success, and more often regrettable failures, of medical trials, information needs to be recorded and shared. A third concern is that a bill which is said to be necessary to provide legal certainty for doctors in the interests of patients contains no provision safeguarding doctors who decline to innovate. The bill needs to state that a doctor is not obliged to innovate if he or she considers that to be contrary to the best interests of the patient.

The author is a practising barrister at Blackstone Chambers in the Temple, a Fellow of All Souls College, Oxford, and a crossbench peer in the House of Lords.

House of Lords – Committee stage round-up

On Friday 24th October 2014 the House of Lords committee stage for the Medical Innovation Bill took place.

The Bill has now passed through to the report stage.

Lord Saatchi has agreed to a round table discussion prior to the reporting stage.

Watch the full debate here

→READ: The bill as amended in the committee stage on 24th October 2014

→ READ : All the documents relating to the Bill and the committee stage debate

→READ: The debate in Hansard.

The committee stage included debating amendments produced by NHS medical director Sir Bruce Keogh on behalf of the Government that were laid down in Lord Saatchi’s name.

The amendments offered by Sir Bruce have met considerable favour among stakeholders – some of whom were previously concerned about the old version of the Bill.

For example the General Medical Council chair, Professor Sir Peter Rubin, said:  “Medicine is a risky business. There are many people alive today because of the willingness of doctors to innovate, deal with uncertainty and take reasonable risks which are understood, shared with, and consented to, by the patient in accordance with good medical practice. While we welcome the amendments to the Bill in Lord Saatchi’s name, we look forward to seeing the final version.”

→Read: Report in Telegraph featuring General Medical Council latest view.

And Cancer Research UK also made a positive statement about the new Bill.  Sarah Woolnough, the charity’s Director of Policy and Information, said: “We will monitor the Bill’s progress closely and hope we will see a greater focus on innovation thanks to this Bill.”

→Read: Cancer Research UK latest blog post on the Medical Innovation Bill containing the extract above (published 7th October 2014).

Media on the debate:

  READ: Telegraph: 20/10/14 – Saatchi’s Model Bill  

 

   
The above article is written by Dominic Nutt – who is part of the Saatchi Bill team.

Guardian: ‘Saatchi’ law for use of untested medicines on dying patients ‘wins Hunt’s backing’

Guardian - Medical Innovation Bill
Guardian – Medical Innovation Bill

→READ: the full feature in the Guardian

A new law allowing dying patients to be treated with untested medicines has reportedly moved a step closer after the government gave its backing to the plan.

The health secretary, Jeremy Hunt, is throwing his department’s weight behind a backbench bill which will be debated in parliament this week, according to the Daily Telegraph.

Conservative peer Lord Saatchi’s medical innovation bill aims to give legal protection to doctors who try out different procedures or treatments when they have exhausted other options.

The legislation will have its detailed committee stage debate on Friday, and the Department of Health (DH) said Saatchi had tabled amendments adding extra safeguards to the bill.

The peer, who began campaigning on the issue after his wife Josephine Hart died from ovarian cancer, told the Telegraph: “In dealing with the deadly Ebola outbreak, the World Health Organisation has decided that departure from standard evidence-based treatment is fully justified and essential.

“It has set ethical guidelines for the use of new therapies and interventions – they are identical to the provisions of the medical innovation bill.”

When the bill had its second reading in June, Saatchi told peers: “All cancer deaths are wasted lives. Scientific knowledge has not advance by one centimetre as a result of all these deaths, because the current law requires the deceased receive only the standard procedure – the endless repetition of a failed experiment.

“The current law is a barrier to progress in curing cancer.”

It is understood that the DH is minded to support the bill, which would have to complete its passage through the Lords and then go through all its Commons stages before becoming law.

A DH spokeswoman said: “Innovation is at the heart of modernising the NHS and is essential for improving treatments and finding new cures and work on the medical innovation bill is ongoing. We are pleased that Lord Saatchi has tabled amendments to the bill to help ensure patient and staff safety.”

→READ: the full feature in the Guardian

Telegraph: If it works for Ebola, it can work for cancer

Read the article in the Telegraph
Read the article in the Telegraph

In the Telegraph today Lord Saatchi writes: ‘If it works for Ebola, it can work for cancer’

How do the conditions imposed by the WHO on ZMapp compare with the conditions set in the Medical Innovation Bill?

Read the article in the Telegraph 

It is hard, when confronted with pictures and reports detailing the Ebola outbreak in Africa, not to shake one’s head in pity. What medical facilities there are, we hear, are overwhelmed by the scale of it. So it is extraordinary to learn that Liberians dying of Ebola have better access to groundbreaking, potentially life-saving new treatments than do people dying of cancer here in Britain.

The Ebola treatment in question is ZMapp, an experimental serum which has not been tested on humans in medical trials, but was none the less given to two American doctors – Kent Brantly and Nancy Writebol – who were infected while working in Liberia. Both have now made a full recovery. Three infected African medics who have received ZMapp in Liberia are also reportedly doing well. Now a British doctor, infected with Ebola while working in Sierra Leone, is to be returned to this country for treatment at the Royal Free Hospital in north London.

The reason that such patients are able to receive ZMapp is because an ethics panel at the World Health Organisation has decided that, given the magnitude of the Ebola outbreak, a departure from standard evidence-based treatments is justified. Potential treatments that have shown promising results in the laboratory but have not been evaluated for safety and efficacy in humans are, in certain conditions, now acceptable on both ethical and evidential grounds, the WHO says.

Few doubt that the gravity of this outbreak of Ebola, which has killed about 1,500 so far, requires a response by all means necessary. Yet in Britain today the toll of another disease – cancer – is 100 times higher, and access to such experimental treatments is not available, even for those desperate patients beyond the help of current medicine.

Some 150,000 British citizens will die from cancer this year, making it the number one cause of untimely death. And while the disease may have a different name, our response should be the same as with Ebola – doctors should be encouraged to try new treatments, and be protected when they do so. Importantly, the Medical Innovation Bill, now before Parliament, will allow doctors and their patients in Britain to try treatments that have not been tested or fully trialled.

Inevitably, there are objections that the Bill’s restrictions and conditions placed on doctors are too lax – that they can play fast and loose with vulnerable, dying patients. So it’s worth looking at the conditions imposed by the WHO on ZMapp to see how they compare with the conditions set in the Medical Innovation Bill.

First: lethality. On Ebola, the WHO panel agreed that the threat posed by Ebola, with its “high case-fatality rate” was sufficient to warrant the use of experimental therapies. The Medical Innovation Bill is explicitly designed to achieve the very same result. This is why the Health Secretary, Jeremy Hunt, said about the Bill that “the Government should do whatever is needed to remove barriers that prevent innovation which can save and improve lives. We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment.” The Secretary of State wisely asked Sir Bruce Keogh, the medical director of the NHS, to devise the legislative safeguards to be included in the Bill.

Secondly, ethics: the WHO rightly sets a high ethical standard for use of ZMapp, including “transparency about all aspects of care, informed consent, freedom of choice, confidentiality, respect for the person, preservation of dignity and involvement of the community”. The Bill echoes this ethical standard, requiring informed consent of the patient, or the patient’s representative, and full transparency. Indeed, the Bill goes further than the WHO guidelines, stating that in order to depart from the existing range of accepted medical treatments, a doctor must also obtain the views of at least one other relevantly qualified doctor, carry out a full risk assessment, and obtain any other consents required by law.

And, of course, while the WHO offers guidelines, the Medical Innovation Bill is backed by the full force of the law.

Finally, WHO guidance requires that all data generated by the use of ZMapp should be collected and shared. If scientific progress is to be made through such experimental use of untested treatments, results must be available to the scientific community. The Bill will secure this. The University of Oxford has offered to create a database to register innovative medical interventions under the Bill and to collect and share the data from them, so that they may inform and inspire clinical trials. As Sir John Bell, Regis Professor of Medicine at Oxford, said: “There will be no cure for cancer until real doctors with real patients in real hospitals are allowed to innovate.”

So those of us who have cheered the use of an untested drug to help apparently hopeless cases in Liberia should cheer the Medical Innovation Bill. It will help medical science progress, aid researchers in their hunt for cures for fatal diseases – and offer hope to the 300,000 Britons who will be diagnosed with cancer this year.

Read the article in the Telegraph 

Telegraph: Sir Bruce Keogh, medical director NHS, proposes new safeguards for Medical Innovation Bill

In the Telegraph today : Doctors will have to obtain agreement from specialists in other hospitals before trying untested medical treatments on patients, under new amendments to the Medical Innovation Bill.

Department of Health - Medical Innovation Bill
Department of Health – Medical Innovation Bill

The amendment, proposed by the Department of Health, comes after a meeting last month with the Medical Innovation Bill team, Jeremy Hunt, Health Secretary, and officials and representatives from the professional bodies.

 

The Telegraph reported on 1st June 2014 that Sir Bruce Keogh, the medical director of the NHS, had been asked by the health secretary to decide how safeguards would work in practice.

Sir Bruce Keogh Medical Innovation Bill safeguard
Sir Bruce Keogh Medical Innovation Bill safeguards

READ: in the Telegraph today

By Christopher Hope and Laura Donnelly

A new Bill to allow dying patients to try untested medicines could be eased through Parliament by new safeguards proposed by ministers requiring doctors to seek an independent opinion.

Lord Saatchi, the advertising magnate, has been campaigning for changes in the law following the death of his wife Josephine Hart from ovarian cancer.

The Medical Innovation Bill would allow doctors to try out innovative new techniques or experimental drugs on patients, without the fear of prosecution, when all else has failed and patients are nearing the end of their life.

A public consultation showed overwhelming backing for the idea, but some medics have raised concerns that the bill could promote “reckless practice” and quackery.

The new amendment, proposed by the Department of Health, means doctors would have to secure the agreement of specialists in other hospitals before trying out untested medical treatments.

The change is being proposed ahead of the Bill’s second reading in the House of Lords on Friday.

Jeremy Hunt, the Health Secretary, is hoping that the extra safeguard for patients will be enough to see off claims from opponents that the Bill is a “quacks’ charter”.

Currently doctors only have to satisfy themselves that the treatment they decide to give patients would pass the “Bolam test – based on a 1957 medical negligence ruling – that an average doctor might have taken the same view.

To do so, doctors often seek the opinion of peers in their own hospital.

The amendment to the Medical Innovation Bill would require them to go outside the hospital to seek specific consent from other specialists in the field to pass this test.

Whitehall sources said that this was to stop “dominant personalities” in a hospital – perhaps a senior consultant – getting their own way.

Mr Hunt committed to bringing in safeguards at a meeting of officials and representatives from the professional bodies last month.

The compromise has been put together by Professor Sir Bruce Keogh, the NHS’s medical director, over the past six weeks.

The source said: “The feeling is that because membership of those teams varies you can have one very strong minded and bossy consultant who says ‘look I am the expert in this area and I think it is a good idea’.

“The Government feeling is that oversight should come from other doctors with experience and expertise in dealing with that condition.”

Lord Saatchi said he was pleased with the amendments. He said: “I greatly welcome the Secretary of State’s invitation to Sir Bruce Keogh to consider the oversight mechanism in the Bill. We will gratefully take forward the safeguards he recommends.”

A Department of Health spokesman said: “NHS England’s Medical Director Professor Sir Bruce Keogh recognises the critical importance of the innovation agenda, and is working with the medical profession to further consider ways of guaranteeing patient safety if the Bill is enacted.”