If a doctor has satisfied the reasonableness and responsibility requirements of the Bill, the Bolam and Bolitho tests will have been applied and satisfied at the point of treatment, so there will be no opportunity for lawyers to hire doctors to go into court and re-argue the issue in the hope of forcing a settlement from a risk-averse NHS budget-manager.
It is a practical application of the existing hypothetical test which asks doctors to imagine what colleagues’ views would be, but not to ask them unless and until the matter comes to trial.
Under the Medical Innovation Bill the doctor will actually ask colleagues for their opinion at the point of treatment.
No, this is not new – the Medical Innovation Bill is simply bringing forward the existing Bolam test and turning it from a hypothetical exercise into a real one.
Opponents of the Bill say it is unnecessary because the existing law is clear and they need “more than anecdotes to justify changing the law”.
The 19,521 “anecdotal” responses to the Department for Health public consultation supporting the Bill are apparently not enough evidence for some that the Bill is necessary to make the law clearer.
But evidence is to be found in the decisions of the courts, if one looks for it. Take the very recent case of McGovern v Sharkey. The Appendix to this Note contains extracts from the judgment in this case; the judge’s articulation of the special legal principles to be applied in cases of clinical negligence demonstrate that whatever the law on this area may be, it is neither clear, nor simple nor certain.
The case also illustrates how the present law assumes that every claim will involve the claimant and the defendant each hiring two or more doctors to oppose each other in the witness box. One reason why the law is so uncertain is that it depends on how impressive the two sets of witnesses are at trial.
Which is why at present claimants may be advised to sue whether they have a good case or not, because there is always a chance that they will have a “surprise win”; and key opponents of the Bill – notably Leigh Day & Co. – profit from running “no win no fee” cases relying on the uncertainty of the existing law.
The Bill will preserve the existing common law for cases where it is necessary and sufficient. But it will also add a new statutory procedure by which doctors and patients can achieve clarity and certainty at the point of treatment. By following the process set out in the Bill, doctors can be confident that a decision to depart from standard practice will be upheld as responsible by the courts, the regulatory bodies and others.
That will improve certainty for doctors and patients, who can concentrate on exploring sensible avenues towards innovative treatments for rare conditions, and bringing hope to patients where it is reasonable and responsible to do so.
EXTRACT FROM JUDGMENT IN MCGovern v Sharkey
 Disputes about questions of fact depend on the usual burden and standard of proof. However in relation to clinical or professional judgment the position is different. Bolam v Friern Hospital Management Committee  2 All ER 118 established that, in determining whether a defendant has fallen below the required standard of care, regard must be shown to responsible medical opinion, and to the fact that reasonable doctors may differ. A practitioner who acts in conformity with an accepted current practice is not negligent “merely because there is a body of opinion which would take a contrary view.” In Hunter v Hanley 1955 SLT 231 at 217 it was stated that
“In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his conclusion differs from that of other professional men … The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care … ”
That test in Hunter v Hanley, was approved in Maynard v West Midlands Regional Health Authority  1 All ER 635 and Lord Scarman also stated “It is not enough to show that there is a body of competent professional opinion which considers that theirs was a wrong decision, if there also exists a body of professional opinion, equally competent, which supports the decision as reasonable in the circumstances. … Differences of opinion and practice exist, and will always exist, in the medical as in other professions. There is seldom any one answer exclusive of all others to problems of professional judgment. A court may prefer one body of opinion to the other, but that is no basis for a conclusion of negligence.
… I have to say that a judge’s ‘preference’ for one body of distinguished professional opinion to another also professionally distinguished is not sufficient to establish negligence in a practitioner whose actions have received the seal of approval of those whose opinions, truthfully expressed, honestly held, were not preferred. If this was the real reason for the judge’s finding, he erred in law even though elsewhere in his judgment he stated the law correctly. For in the realm of diagnosis and treatment negligence is not established by preferring one respectable body of professional opinion to another. Failure to exercise the ordinary skill of a doctor (in the appropriate speciality, if he be a specialist) is necessary” (emphasis added).
 In Bolitho (Administratrix of the Estate of Patrick Nigel Bolitho (deceased)) v City and Hackney Health Authority  4 All ER 771 it was established that a doctor could be liable for negligence in respect of diagnosis and treatment despite a body of professional opinion sanctioning his conduct where it had not been demonstrated to the judge’s satisfaction that the body of opinion relied on was reasonable or responsible. In the vast majority of cases the fact that distinguished experts in the field were of a particular opinion would demonstrate the reasonableness of that opinion. However, in a rare case, if it could be demonstrated that the professional opinion was not capable of withstanding logical analysis, the judge would be entitled to hold that the body of opinion was not reasonable or responsible. Accordingly the final arbiter as to whether there has been professional negligence is the court and not the medical profession. It is for the court to decide whether the requisite logical basis for a defendant’s expert medical opinion is absent. The legal question is as to what features particularly characterise an expert medical opinion as one that is “illogical”, “irresponsible”, and “indefensible”. It is clear that merely being a minority view of accepted medical practice does not, of itself, render that view “illogical” or “irrational” in the Bolitho sense. However it is suggested that a court would be more ready to find that the body of opinion was not capable of withstanding logical analysis if there was a dubious expert whose professional views existed at the fringe of medical consciousness, see Khoo v. Gunapathy d/o Muniandy  2 S.L.R. 414, at . Another example would be “a residual adherence to out-of-date ideas” which “on examination do not really stand up to analysis” see Hucks v. Cole  4 Med. L.R. 393.
 It is however important to consider some limitations to the Bolitho test. A practice is illogical if there was a “clear precaution” which ought to have been, but was not taken. In this case the precaution that is suggested is that there ought to have been a diagnostic vitrectomy after one month given the risks of an unidentified tear of the retina and what is suggested was the lack of response to steroid treatment. However if there are risks attached to the precaution, in this case the risks associated with operating on an inflamed eye and the risk that the operation will not resolve the underlying problem, and one body of medical opinion considers that the risks ought to have been taken and the other does not then there is no “clear precaution” but rather a balancing of risks. In such circumstances both sets of expert opinion withstand logical analysis. For the plaintiff the expert opinion being that the risk of an adverse outcome, in that a tear was present in the retina, should have been prevented by taking the precaution of performing the vitrectomy. For the other body of expert opinion on behalf of the defendant, the precaution of performing a vitrectomy would have posed an unacceptable risk of operating upon an inflamed eye where given the diagnosis of ERD the operation would not have achieved a satisfactory outcome. This is merely a different weighing of risk rather than a determination that the defendant’s expert opinion is illogical. The precaution that is being suggested is not a “clear precaution” but rather a precaution which involves a balancing of risks and that is a matter of clinical judgment with a logical basis.
 Another feature of applying the Bolitho test is that it introduces a lack of symmetry as between the plaintiff and the defendant’s expert evidence. The defendant’s expert has only to persuade the court that his views are capable of withstanding logical analysis, but he does not have to satisfy the court that the views of the plaintiff’s expert are not capable of withstanding logical analysis. However, the plaintiff’s expert has to do both.
 If the case is one that involves clinical judgment to which the Bolam test applies, and if the medical practitioner does produce evidence that his practice was supported by a responsible body of medical opinion, then, in the words of Sedley L.J. in Adams v. Rhymney Valley DC  Lloyd’s Rep. P.N. 777, at , “the judge or jury have to accept the opinion of a body of responsible practitioners, unless it is unreasonable [in the Bolitho sense]” (emphasis added).
Accordingly in an action involving clinical judgment there is a two-step procedure to determine the question of alleged medical negligence:
(a) whether the medical practitioner acted in accordance with a practice accepted as proper for an ordinarily competent medical practitioner by a responsible body of medical opinion; and
(b) if “yes”, whether the practice survives Bolitho judicial scrutiny as being “responsible” or “logical”.
 Questions of fact and the question as to whether there was negligence are not to be conflated. Questions such as whether in the event there was a right retinal tear or hole in December 2006 or whether there was inflammation in the right eye in 2007 or whether there was scleral thickening in the right eye are questions of fact to be determined on the balance of probabilities with the onus of proof being on the plaintiff. The question of clinical and professional judgment as to whether a responsible body of medical opinion would form the view, in say January 2007, that there was a right retinal tear or hole or that there was inflammation in the right eye or that there was scleral thickening in the right eye are all subject to the Bolam test as qualified in Bolitho. In some cases the determination of a question of fact may lead inexorably to a finding that the medical practitioner did not act in conformity with an accepted current practice. In others it may have no such impact. So for instance in this case if there was a factual finding, on the balance of probabilities, that on 26 December 2006 the first defendant was informed that the plaintiff had suffered a sudden and profound loss of vision in his right eye and that the plaintiff’s right eye was not assessed or if the plaintiff was not advised to have his right eye assessed that day then inexorably that would lead to a finding that the first defendant had not acted in conformity with an accepted practice. Inexorably because no logical accepted current practice would do or advise anything other than immediate action. However if the factual finding was that the first defendant was informed that the plaintiff had some extremely modest effect on his vision in conjunction with a history that drops had not been taken then (though there was a dispute about this) it might be that to delay an examination until 4 January 2007 and to recommend that the plaintiff use his drops was in conformity with a logical accepted current practice.
 “The law currently works and is fair and clear. I am afraid that I require more than a few anecdotes to justify changing the law.” – Suzanne White, Partner, Leigh Day & Co; http://www.clinicalnegligencelaw.co.uk/2014/07/20/innovate-innovate-saatchi-bill/ – accessed 4.1.15.
  NIQB 117 – http://www.bailii.org/nie/cases/NIHC/QB/2014/117.html
 “Do you take cases on a “no win, no fee” basis? Does that mean I won’t have to pay anything at all? Yes we do.” – http://www.leighday.co.uk/Illness-and-injury/Clinical-negligence/FAQs/Costs – Accessed 4.1.15.
Maurice Saatchi’s Medical Innovation Bill was passed by the House of Lords and sent to the Commons following its third reading in the House of Lords on 23rd January 2015.
WATCH THE DEBATE
There were two amendments tabled from Lord Winston and Lord Hunt both of which were supported and signed by Lord Saatchi.
We are thrilled that Lord Hunt’s amendment on the Medical Innovation Register was accepted.
This unprecedented register of innovation, which has been called for by many organisations and individuals, will make it a mandatory requirement for anybody using the Bill to register the treatment and the outcome, both positive and negative.
It moves treatments that without sharing and transparency could become just an anecdote into sharable evidence that can be used to treat other patients and inform clinical trials.
Oxford University have already offered to host the Medical Innovation Register and the Medical Innovation Bill team is consulting widely on how the register will be set-up, managed and funded. We will keep our website updated with all the latest developments.
The Bill has now moved to the House of Commons and is a step closer to helping patients receive novel and innovative treatments.
Thanks so much for your support so far.
During the third reading Lord Kakkar said:
“Clearly, providing transparency and the opportunity for sharing the outcomes of such innovations rapidly and broadly across clinical communities in this country and internationally is of so much importance.
It will allow colleagues to understand what has been achieved and not achieved; it will allow those with other ideas to build on knowledge gained from experience to date; and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection.”
Lord Kakkar is professor of surgery at University College London and a member of the General Medical Council.
During the third reading Lord Giddens said:
“Science is a collective enterprise. It depends on the accumulation of evidence. It is crucial that that be recognised formally somewhere in the Bill, with this embodied as part of the advancement of scientific progress more generally”
Telegraph: How Lord Saatchi won over the critics
Daily Mail: New ‘experimental drugs’ law moves a step closer
Lord Ribeiro, a British surgeon who served as President of the Royal College of Surgeons of England from 2005 to 2008. Shared a very interesting case from the 1990s which demonstrates both the need and benefits of having a innovation register.
“My Lords, many noble Lords will remember the disasters that occasioned the introduction of laparoscopic cholecystectomy in the 1990s.
Quite a few patients suffered as a result of the innovation of our surgeons playing with a new instrument, new tools and a new operation.
At the time, I was secretary of the Association of Surgeons of Great Britain and Ireland.
In recognising the problems, we introduced a voluntary register of all surgeons undertaking the procedure and got a very good response.
Admittedly, it was not compulsory and not every surgeon introduced their data to it, but the net effect was that when we analysed our data we were able to identify where many of the problems lay.
That led to further research and proper control trials in the procedure. We were able to turn to that from an innovation used by a succession of surgeons as and when they felt necessary, without any good evidence on how best to use it.
On that basis, and mindful of the benefits that we saw in the 1990s, I would very much support some form of register to ensure that, if an innovation is introduced, we have the information, can go back and refer to it again, learn from the mistakes and improve the outcome.”
Published in the Telegraph 24th January 2015
I left the Palace of Westminster yesterday with the word “content” ringing in my ears – the Medical Innovation Bill has passed the House of Lords.
A gentle utterance by fellow peers has ended a three‑year roller-coaster ride that has left me at times elated and at times in despair. But for the moment at least, I too am content. The day when patients with terminal diseases, and their doctors, will together be better able to try novel treatments, legally, safely and confidently, has all but arrived.
There is one more river to cross before we reach the Promised Land. The Bill will now be carried to the House of Commons by Michael Ellis MP, where it will again be debated. Time is the enemy now. Parliament is dissolved in a matter of weeks, ahead of the General Election. But I am confident, because the Lords have sent this Bill to the Commons in good order.
It has been roundly debated, challenged, amended, honed, tightened, clarified and improved by my colleagues on all sides of the House. Honest opposition to elements of it – no one has objected to the principle of the legislation – have now had their concerns met.
I’m particularly grateful to the Labour front bench and Lords Winston and Turnberg – both eminent doctors; Lord Pannick QC, a renowned legal mind; and Lord Hunt, who comes from a stellar medical background. They have debated the Bill and laid helpful amendments that have strengthened it. I also owe a debt to Baronesses Wheeler and Masham.
We have all worked together to lay a joint amendment making it a requirement that doctors who innovate under the Bill must record and share the results – good and bad – of their innovations on an open register. This is crucial if medical science is to be advanced. Doctors and scientists must know what works and what doesn’t. It is a leap forward for all doctors because today those innovations that do take place are not formally and universally recorded. It is also an amendment many medical and research bodies have called for, and I am delighted that today it is on the face of my Bill.
I must also thank the Telegraph and its readers who have followed this Bill and cheered for it. We would not be where we are today without you. Are we home? We are certainly close. I am confident we will find time in the Commons.
I say this because more than 18,000 patients contributed to the Department of Health’s consultation on the Bill last year. Another word for patients is voters. I believe that MPs will also recognise that their constituents want to see change. And they will see that the Bill has been tested no fewer than four times in the House of Lords, taken apart and reassembled line by line. Opposition has evolved into support. During the first committee stage there were 39 amendments made. Yesterday, there were just two – both of which I supported.
But what a journey it has been. The Bill was born in the mire of my personal grief, and inspired by some of Britain’s most brilliant doctors. In recent weeks I have seen supporters such as Charlie Kitley, Ismena Clout, Rachel Stevens – daughter of the Bishop of Leicester – all succumb to cancer. Their memory is dyed in the fabric of this Bill.
And opponents have fought the Bill. Most in good faith. Others less so – and it has been a struggle at times to hold back as my team and I have been accused of being liars, of being in bed with Big Pharma, of having some perverse agenda other than the acceleration of medical science. All I wish is that others may not have to experience what I and the families of those I have just mentioned are experiencing today.
I have, on occasion, let my feelings show. It has been particularly irksome to be criticised by legal firms who profit by suing doctors. In particular, I think of Leigh Day – under investigation themselves for destroying evidence crucial to the defence of British soldiers in Iraq wrongly accused of deliberately abusing detainees.
What is my motivation? Do I have an axe to grind? What is my interest? I will be clear. I am doing this because I believe it is the right thing for patients, for medical science, for finding new ways to treat incurable diseases. And in memory of my wife and all those who have died of cancer.
Published in the Telegraph 24th January 2015
Written by Lord Saatchi.
Cancer and its treatment is the number one cause of the untimely death of British citizens. There were around 165,000 cancer deaths this year – the same as last year and the same as next year.
Apparently, cancer is so complex that it is beyond the judgment and understanding of the human mind to comprehend all its variables.
This point was confirmed in a recent study by scientists at America’s distinguished Johns Hopkins University which concluded that many cancers are “just bad luck”.
The law cannot cure cancer. Parliament’s power, though awesome, is not sufficient. Only science can do that.
But the law does have the power to change the culture. Consider its impact on race, drink-driving, smoking in public places. No amount of exhortation or guidance from on high could have achieved what the law has done. No one would consider smoking in a restaurant today.
The Medical Innovation Bill, which tomorrow returns to the House of Lords for its third reading, does not offer some miracle treatment for a sofar incurable disease. But it will, I believe, encourage the men and women who will who find those cures.
This is why I hope the House of Lords will decide to pass the Medical Innovation Bill – a Bill that has been strongly supported by The Telegraph from the start – and send it to the House of Commons for approval.
This follows 18-months of line-by-line scrutiny by some of Britain’s greatest judges, doctors and scientists, with safeguards designed by Sir Bruce Keogh, Medical Director of the NHS and with the approval of the Government and many thousands of doctors and patients.
Here is the situation for many people today. When a patient with cancer or a child with a degenerative disease – such as Duchene muscular dystrophy – is handed a terminal diagnosis, when the doctor says there is nothing to be done other than offer standard treatments which are known not to work, two things happen.
First, the patient dies. Second, medical science is halted in its tracks by the repetition of the same, failed experiment. Doing the same thing, offering the same treatment, knowing it won’t work is madness.
Today, the law protects the doctor who carries out only standard procedures. It says that that doctor cannot be sued if – as it always will – the treatment fails.
My Bill won’t change that. A doctor can continue safely and legally prescribing the standard therapies if they wish. There will be no obligation to innovate. What the Bill will do is offer the same protection to a doctor who offers an innovative treatment to the dying patient – in advance of the treatment taking place, as long as they can get the support of at least one other relevantly qualified doctor.
It will encourage them to think beyond the standard treatment. It will allow them to see what else might – only might, for there are no guarantees – make a difference to the dying patient.
It will change the culture of defensive medicine to one where the balance of risk is gently recalibrated making it permissible to consider trying something new, something less well documented than the well-worn path to death.
And lest there be any doubt about what is responsible for the culture of defensive medicine, look at the facts. Last year we, the taxpayer, paid out £1.2bn to meet negligence claims against the NHS, a figure that has doubled in five years. According to the Treasury, we the people have a further liability for a staggering £26bn, up £2bn since last year.
Many who have had concerns about the Bill have pointed out that if it is to make a difference to medical science, then the results of innovations need to be documented and be shared so that other doctors and scientists can make use of the results – avoid the failures and try to repeat the successes by setting up full medical trials.
Yesterday, the Genetic Alliance UK wrote to Lords saying it was vital that “registries are created to enable the collection and exploitation of real-world patient data, and promote the sharing of research findings and best practice.” The Government agrees that the collection and sharing of new data derived from innovation will both advance scientific knowledge and provide the accountability and transparence required for patient safety
The Bill encapsulates what is seen as by the top hospitals as best practice – that is discussing innovative treatments with expert colleagues in advance of that treatment. Doing this means that doctors can formulate the best options – and calculate the risks to the patient. The Bill says if doctors do this and write it all down and get the patient’s consent, they will be legally protected.
This is why I hope today my Bill, soundly tested, forensically analysed line by line by my colleagues in the Lords who number among them some of Britain’s top legal and medical brains – and amended by them – will pass to the Commons.
And it is why Regius Professor of Medicine at Oxford University Prof Sir John Bell says: “There will be no cure for cancer until real doctors with real patients in real hospitals can attempt an innovation.”
Thousands of Britons with cancer will be plunged into “great anxiety” because of cuts to crucial drug treatments announced on Monday, Lord (Maurice) Saatchi has warned.
The Conservative peer and advertising mogul told The Telegraph his life has been “immersed” with cancer recently with loved ones battling the same disease that took his wife as he criticised the scaling back of NHS funding.
It comes as charities and industry experts warned that NHS England’s expected decision to stop funding a series of cancer drugs was “short-sighted” and would endanger lives.
A review by the Cancer Drugs Fund, introduced in 2011 after the Conservatives pledged cancer patients would no longer be denied drugs on grounds of cost, is published today.
As many as half of the 25 drugs under review – which are used in 42 treatments – could have funding pulled according to industry sources.
The move comes amid spiralling costs, with the initial £200 million budget set aside by the Coalition already having increased to £280 given demand.
However the expected ‘delisting’ of potentially life-changing drugs has triggered uproar from cancer charities who fear the impact of pulling the funding on future patients.
Lord Saatchi, whose Medical Innovation Bill is being debated in Parliament and would increase the ability of doctors to try out new medicines on willing patients, said the funding cuts were of “great concern”.
“There is a sense of possibility with the Cancer Drugs Fund. Withdrawing funding is going to cause people who would potentially benefit from the treatments great anxiety,” Lord Saatchi told this newspaper.
However he noted that the fund could never alone answer why there has not been more innovation in cancer treatments and called for “big, cultural, systematic change”.
“I am immersed with cancer as friends and loved ones around me suffer from the same disease which also took my wife [the novelist Josephine Hart],” said Lord Saatchi.
“What I faced – as thousands do across the country – is the problem that doctors are only able to use those tools that are in front of them.
“I don’t want cancer patients to be told drugs can only stem their dying – that is a guarantee of failure. I want us to give people the opportunity to try to survive.”
It is understood pharmaceutical companies were given until the end of Friday by NHS England to justify why cancer drugs they produce should still receive funding.
At least eight life-extending treatments will be denied funding, with drugs that offer a last chance to patients with breast, prostate and bowel disease among those affected.
Prof Karol Sikora, chief medical officer at Cancer Partners UK and one of the country’s leading cancer experts, told The Telegraph the situation was “very sad”.
“Why cant the NHS negotiate better with the pharma industry so that our patients can have equivalence with the rest of Europe? Sure these are all expensive but lives have been prolonged significantly,” he said.
“To know that there is a drug out there that might give you a chance and to be turned down is not what our patients need.”
In a letter to this newspaper, Jonathan Emms, president of the Association of the British Pharmaceutical Industry, warned against the NHS cutting funding for medicines.
“The NHS already spends less than £1 in every £10 on medicine. Further cuts would be short-sighted and compromise patient care,” he said.
“Innovation in medicines is moving faster than the health system can deliver to patients. The NHS needs to catch up.”
Danni Manzi, head of policy at Breast Cancer Care, said: “This re-evaluation shows yet again that the Cancer Drugs Fund is not fit for purpose. We hope that none of the breast cancer drugs are removed due to cost.
“Having secondary, incurable breast cancer is devastating – and these patients should be entitled to improved quality of life and extra time with their loved-ones.”
“Until this is resolved cancer patients could miss out on vital treatment. We must urgently find a long-term, sustainable system that works.”
On Friday 12th December 2014 the House of Lords report stage for the Medical Innovation Bill took place.
The Bill has now moved through to a third reading stage.
Watch the full debate here
→READ: The debate in Hansard
A few highlighted extracts :
Lord Saatchi (Con): Before I start, I will take a moment to echo what the noble and learned Lord, Lord Woolf, said. He described the discussions about the Bill at all its stages as being your Lordships’ House at its best. I so agree.
I said in the debate in the Moses Room last week in the name of the noble Lord, Lord Kakkar, that the experience of watching your Lordships’ House debate and discuss the Bill is, as far as I am concerned, a tremendous privilege to be able to hear the greatest legal and medical minds in the country at work.
I thank the noble Lord, Lord Turnberg, for saying that there had been a constructive process of listening to Peers’ views as expressed in Committee. I am also grateful for the view expressed by the noble Baroness, Lady Wheeler, that the Bill team and the Department of Health have behaved constructively since Committee.
I have really been only a witness to the toing and froing between Peers whose views were expressed in Committee and the Department of Health through our own Bill team.
It will not come as any surprise to your Lordships that this has been a really admirable process of the officials and the legislation department in the Department of Health listening carefully and trying to respond, and I certainly have appreciated that hugely. I know your Lordships will agree.
I also thank my noble friend the Minister for her clarification of the Government’s position on many of these amendments.
Baroness Wheeler (Lab): My Lords, as this is the first contribution from the Front Bench to the discussion of today’s amendments, perhaps I may again place on the record our support for the key principles and intent of the Bill.
As we stress, Labour has always strongly supported efforts to bring innovative treatments to patients faster, and we underline the need for a major effort by government to address the barriers and bureaucracy that prevent progress being made and ensure that innovations are rapidly transcribed into practice.
The noble Lord, Lord Kakkar, recently held a short debate in the Moses Room on the impact of innovation and research strategies on health improvement. It provided an excellent overview of the key issues, the progress being made, and the problems still to be addressed.
We are keen to ensure that the Bill of the noble Lord, Lord Saatchi, is seen in the context of this wider, bigger picture.
I know that the noble Lord accepts that his Bill will be one measure in the broader landscape of what needs to be done.
Along with my noble friend Lord Turnberg, I am also grateful to the noble Lord for the efforts he has made to address the issues and concerns raised by noble Lords across the House.
In Committee we underlined our broad support for the changes—the “Sir Bruce Keogh amendments”, as they are now known—which have been made to ensure patient safety and safeguarding.
We also found the round-table discussions for Peers that were organised by the noble Lord following our suggestions in Committee very valuable and useful.
Again, we are broadly supportive of the new amendments he has brought forward today, which are the result of the discussions, on emergency care, on the recording of key information in the notes of the patient receiving the treatment, on excluding cosmetic surgery from the scope of the Bill, and on ensuring the preservation of the existing law about clinical trials and other forms of research.
Lord Woolf (CB): The progress of the Bill has been a remarkable example of this House at its very best.
The Bill has been very carefully scrutinised by people who have immense knowledge of the areas covered in the Bill.
That does not mean that anything said by a particular Member of the House with undoubted expertise in this area is necessarily right in this matter.
As is the case with many Bills, sometimes more than one profession can be involved.
I suggest that this is an example where two professions, which in the past have been guilty at times of excessive conservatism, are involved and have been loud in some of the things that they have had to say.
The other profession of which I am thinking is my own; lawyers are not always celebrated for their innovative approach.
They have improved from the situation of not so long ago. They are more ready to accept change—indeed, they have been forced to accept it—than they willingly would have done in the early days when I was practising.
I have been criticised in letters I have received in a way in which I perhaps am not accustomed for my involvement in the Bill sponsored by the noble Lord, Lord Saatchi.
Those who have asked me to identify cases by name and reference so that they can analyse the cases and show how they do not help any particular argument might be relieved to hear me say that if they want to know where I come from, I wrote a little book called The Pursuit of Justice.
I focused on the medical profession at that time because I found that its conservatism was interfering with the pursuit of justice.
As far as victims were concerned, one of the most difficult areas of litigation in this country was clinical negligence cases.
Both sides in those cases were put into great difficulty because of that conservatism. On one side were the patients who often wanted the doctors to say sorry. On the other side were the doctors who felt that they could not say sorry because if they did they would be admitting liability for negligence. So the two never met—and that, I am afraid, can happen.
I listened very carefully to the graphic examples given by the noble Lord, Lord Winston, of where he thought that the Bill could be a problem.
In his first example, he said that there was a difference of opinion between his anaesthetist, who did not think that an unusual and innovative form of intervention was appropriate, and the noble Lord, who thought that it was appropriate in the circumstances.
Happily, he took the initiative and acted in an innovative way. But if one pauses and thinks about what would have been the position under the Bill as it is at present, would it have made the situation more difficult or would it have alleviated the situation?
I suggest it is quite clear that it would have done neither.
Yesterday December 10, 2014 Sarah Wollaston MP was granted leave to hold an adjournment debate on the Medical Innovation Bill.
The Bill team were also invited to meet Dr Wollaston earlier in the week to discuss the Bill. We thank her for that meeting and for requesting the debate.
During the debate Dr Wollaston raised several important points about the Bill, which could formally come to the Commons in early January.
The points revolve around patient safety and scientific rigour – issues which have been raised by senior doctors and lawyers in the House of Lords and which have been discussed with peers in committee and in bilateral meetings with Lord Saatchi, health ministers Earl Howe, George Freeman and Department of Health lawyers and officials.
On the back of these meetings, amendments have been laid which address the issues raised, and they will be further debated on Friday (December 12) in the Lords.
Edit: This debate has now taken place. Read here.
Chief Medical Officer Dame Sally Davies and NHS chief Sir Bruce Keogh, who has inputted into the Bill himself, remain satisfied that the Bill is robust, safe and will enhance, not hinder scientific research.
Summing up in favour of the Bill, Minister George Freeman said:
‘I want to close with some supportive quotes the Bill has received from a number of important people, lest the House should form the view that it is unanimously opposed, which is not the case.
Dame Sally Davies, the chief medical officer, has said:
“I am confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”
Sir Bruce Keogh, Medical Director of the NHS, said:
“Encouraging innovation in medicine and protecting patients are both of vital importance. That is why I am pleased that amendments have been devised to address concerns about patient safety.”
Sir Michael Rawlins, president of the Royal Society of Medicine, said that the Bill will allow responsible innovation and treatment:
“I believe the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”
A letter to The Telegraph from 40 leading medical professionals, including David Walker, professor of paediatric oncology at Nottingham university and Riccardo Audisio, the president of the Association of Cancer Surgery, said the Bill
“legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed. This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine. Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”
I hope very much that that is the case and that when the Bill leaves the House of Lords, the vast majority of qualified senior opinion in this field is able to agree with it. It is absolutely our intention to support the Bill’s noble intent to promote medical innovation, but equally our intention is to not undermine in any way the Government’s commitment to patient safety or the duty of care that all clinicians share and owe to their patients.’
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