Medical Innovation Bill [HL] Debate

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Department: HM Treasury

Medical Innovation Bill [HL]

Lord Saatchi Excerpts
Friday 27th June 2014

(9 years, 10 months ago)

Lords Chamber
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Moved by
Lord Saatchi Portrait Lord Saatchi
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That the Bill be read a second time.

Lord Saatchi Portrait Lord Saatchi (Con)
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My Lords, what a privilege it is to address your Lordships’ House with so many distinguished Peers and noble and learned Lords in their places today. I thank the usual channels for arranging the time for the debate, and my noble friend the Minister. The Medical Innovation Bill can be regarded as one of the many initiatives being taken in his innovation agenda to advance medical science, along with early access to medicines, the cancer fund, the genomics project et cetera.

I congratulate the Minister’s department for a model consultation on the Bill. A full-scale public consultation of this kind is an enormous undertaking and it has carried it out brilliantly. I understand that the public service ethos not only exists but is alive and well in our top civil servants, and is nurtured by them in the true spirit of Northcote-Trevelyan. In particular I thank the director of legal services in the Treasury Solicitor’s Department, Isabel Letwin; the head of legislation, Ian Dodge; his deputy, Peter Howitt; Jenny Harper; and Jenny Munday.

Advice has been received from over 20,000 doctors, patients, charities, the Royal Colleges and many other medical and legal organisations. I thank them all. I should say that the noble Lords, Lord Patel and Lord Kakkar, who cannot be here today, have asked me to express their strong support for the Bill.

It is hard to overpraise the distinguished former parliamentary counsel, Daniel Greenberg—the draftsman of the Bill—and Dominic Nutt and Liz Scarff, who have managed parliamentary and media liaison. My warmest thanks are due to Debbie Binner, whose daughter Chloe died of cancer aged 18; Alex Smith, whose son Harrison suffers from cruel Duchenne disease; Mavis Nye, a lung cancer victim; and the hundreds of other families whose stories have all been part of the Bill from the outset.

The Medical Innovation Bill has been on a long, winding and sometimes bumpy road, as it should. My noble friend Lord Strathclyde, who was the Leader of our House, says it should be hard to change the law. There are many hurdles, even for Governments. So it should be and so it is. Whatever happens to the Bill now, I have made lifelong friends in the medical and legal worlds, from whom I have learnt so much and to whom I am so grateful.

I will start by laying out the parliamentary status of the Bill. It was originally introduced in your Lordships’ House at the end of 2012. In October 2013 Michael Ellis, the Member of Parliament for Northampton North, introduced the Bill in another place. In November 2013 the Secretary of State for Health expressed the Government’s intention to bring forward early legislation, subject to the public consultation, which closed in April this year. On 1 May the Secretary of State asked Sir Bruce Keogh, the medical director of the NHS, to advise on the safeguards in the Bill. I am sure that the Minister will bring us up to date. I am greatly encouraged by what I have heard about Sir Bruce’s work.

The government Chief Whip advises that, if no amendments are tabled in your Lordships’ House, the Bill will go to another place before the Summer Recess. Amendments can then be laid there in Public Bill Committee. Then, all being well, the Bill will go to Her Majesty for Royal Assent in February 2015 and become an Act of Parliament before the next general election.

I turn to the Bill. In our House a précis is a form of good manners. The best summary I can give you of what this Bill is about comes from Professor Norman Williams, the President of the Royal College of Surgeons, who sums it up in six words:

“Protect the patient: nurture the innovator”.

That is exactly what the Bill does. I will explain.

“The sentence of this Court is that you be taken from hence to the place of execution and that each of you there will be hanged by the neck until you be dead. And may Almighty God have mercy on your souls”.

So wrote Charles Dickens, 150 years ago. It sounds medieval—barbaric even—does it not? Yet much the same can be heard in every cancer ward in every NHS hospital every hour of every day, with only one difference. In Dickens, the condemned were sentenced to death by a court of law. I am not aware that the cancer dead or the victims of any other terrible disease are guilty of any crime. Death by hanging, by firing squad, by electric chair—no human being has ever devised a more brutal execution than death by cancer. Perhaps only the Benches of the right reverend Prelates can advise us on the vexing theological question of why bad things happen to good people.

Either way, those condemned by cancer suffer a worse fate than the worst mass murderer. While they await execution, they are tortured. For them, hair loss is the good news. Less good news is that their treatment regime—the drugs and the cycles of their administration, and the surgical procedures—are often 40 years old. They create the same symptoms as the disease: nausea, diarrhoea, vomiting and fatigue. A beautiful woman’s legs turn into elephant’s legs; her arms begin to make a heroin addict’s arms look attractive; and her bosoms turn into raisins. That is before the bad news: the discovery that standard cancer treatment does such damage to the immune system that the cancer patient is quite likely to die from fatal infections such as MRSA, E. coli and so on—like Mrs Goodrum, aged 46 and a mother of five, who died a few weeks ago of septicaemia during her chemotherapy.

In my visit with my honourable friend Michael Ellis to the NHS hospice in Northampton, the wonderful volunteers explained to me that 80% of the patients in their hospices are cancer patients. Average life expectancy is six weeks. If they leave the hospice, it is two weeks. It would take quite a few of the biggest JCBs of my noble friend Lord Bamford to dig the mass grave for the 165,000 British cancer dead this year—the same as last year and the same as next year. With current UK mortality rates, this looks like reliable repeat business for gravediggers—and for grave-robbers, too. For them, it is quite easy. After Hamlet and Laertes leave Ophelia’s grave, they jump into it with a claim against her doctor for failure to diagnose her suicidal tendencies, and another against the river authority for failure to put out adequate warning notices to swimmers.

The law cannot cure cancer—Parliament’s power, though awesome, is not sufficient. Only science can do that. However, the law does have the power to change the culture. Let us consider its impact on attitudes to race, drink-driving, homosexuality and smoking in public places. No amount of exhortation or guidance from on high could have achieved what the law has done. This law change will not cure cancer but it will encourage the man or woman who will.

All cancer deaths are wasted lives. Scientific knowledge does not advance by one centimetre as a result of all these deaths, because the current law requires that the deceased receive only a standard procedure—the endless repetition of a failed experiment. In this way, the current law is a barrier to progress in curing cancer. It defines medical negligence as deviation from standard procedure. In other words, any deviation from standard procedure by a doctor could currently result in a verdict of guilt for medical negligence. However, as innovation is deviation, non-deviation is non-innovation. Sticking to the status quo—I am looking anxiously at the noble Lord, Lord Giddens—does not meet Professor Popper’s The Logic of Scientific Discovery: refutation by application. If there is no application, there is no refutation and no science. This is at least one reason why there is no cure for cancer.

As a result of this change in the law, medical practitioners will be encouraged rather than discouraged to seek improvement to the standard procedure. This Bill achieves that in a safe and responsible way. I shall not make any attempt to describe the legal status of the Bill—certainly not in front of a former Lord Chancellor and a former Lord Chief Justice. I shall simply say that the Bill achieves its aim—safe and responsible innovation—in a simple way. It moves the Bolam “responsible persons” test from after the event to before the event. The result is that doctors are not obliged to speculate in advance about what might happen in a subsequent trial, and they can move forward with confidence, safe in the support of a responsible body of medical persons—in other words, the Bolam test brought forward. This crucial time change removes any uncertainty and ambivalence about what is or is not lawful medical innovation.

If I may, I shall take a few minutes to try to deal with one question. It sounds quite logical, yet noble Lords will all be aware that some have objected to the Bill, and I think that I should try to address some of the objections from serious people. The Bill has touched a nerve. For some, it has been painful. Some doctors have asked, “Is this Bill saying that we are not innovating?”. Some medical negligence lawyers have asked, “Is this Bill saying that we are responsible for the fact that there is no cure for cancer?”. No, my Lords, this Bill is not a criticism of anyone—by anybody. Nobody is doing anything wrong. Everyone is doing their best, by their own best lights, to serve the community. However, the fact remains that there is no cure for cancer.

Your Lordships may have heard it said that the Bill is unnecessary because, as I said, innovation is taking place now. Of course it is, and I take my hat off to those who are working flat out to achieve the innovations that have taken place, but to be in favour of innovation is not to say that there is no innovation; it is just saying that we need more of it. On that, we can all agree.

Your Lordships may have heard it said that the Bill is unnecessary because there is no fear of litigation. The Medical Defence Union has protested strongly that no doctor has ever asked it for advice about litigation risk. Yet the MDU is an insurance company for doctors. It receives millions of pounds of insurance premiums from doctors to insure them against—yes—medical negligence claims. But at the same time it says that doctors have no fear of such claims. That does not make much sense, does it? Perhaps the MDU runs the risk of appearing too clever by half.

In the real world, the culture of medical litigation grows and grows, and I cannot spare your Lordships the statistics. Last year, we, the taxpayer, paid out £1.2 billion to meet negligence claims against the NHS. That figure has doubled in five years. According to the Treasury, we the people have a further liability for a staggering £24 billion—another sum that has doubled in five years. Are we to assume that doctors have never heard of all this litigation? Fortunately, the Government are not so deaf. The NHS Litigation Authority has been formed to deal with this tidal wave of litigation. It has, according to its report,

“an extensive risk management programme ... Most healthcare organisations are regularly assessed against the NHSLA Risk Management Standards”.

Are we to believe that no hospital trust has ever heard of these legal risk management assessments? Of course not, particularly as only this week the Secretary of State has asked Sir Robert Francis to review what Sir Robert calls the “culture of fear” in the NHS. That, of course, is why Professor Sir Michael Rawlins, president of the Royal Society of Medicine, says, flat out, that,

“departing from what is regarded as ‘established practice’ or ‘the standard of care’ leaves a doctor open to legal action for negligence”.

The noble and learned Lord the former Lord Chief Justice, who I am pleased to see in his place and who will speak later, agrees. He said:

“At the moment, the doctor’s hands are tied—by concerns about professional reputation and potential negligence claims. That needs to change”.

Some have still objected that if more innovation is needed, the right place for it to be is in clinical trials. Sir Austin Bradford Hill, the forefather of the RCT—the randomised control trial—writes:

“Any belief that the control trial is the only way”—

to study therapeutic efficacy—

“would mean not only the pendulum had swung too far but that it had come right off its hook”.

This is why the Regius Professor of Medicine at Oxford, Professor Sir John Bell, said:

“There will be no cure for cancer until real doctors with real patients in real hospitals can attempt an innovation”.

The Secretary of State for Health said:

“We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment”.

The Prime Minister said that his vision of the NHS is:

“Every clinician a researcher, every willing patient a research patient”.

Can we safely put aside the objection that this Bill is unnecessary? The objection, however, that we must consider most seriously is that in its attempt to open the door to more innovation the Bill opens the door to quacks, crooks, cowboys and charlatans. No one wants that and so I greatly welcome the Secretary of State’s invitation to Sir Bruce Keogh to consider the oversight mechanism in the Bill. I am greatly encouraged by his thoughts. My noble friend will say more about that later, I am sure.

As well as that, there has been another important new result from the consultation which I should like to announce to your Lordships. Oxford University has come forward to say that it will maintain a public register of innovations that take place under the Bill. This Oxford initiative achieves two aims simultaneously: to advance scientific progress through the dissemination of knowledge to the global medical community; and full public disclosure and transparency to deter recklessness. Sunlight is the best disinfectant.

The Bill has exposed a fault line in the medical legal profession. Some say the law does not block innovation; others say it does. Some say there is no fear of litigation; others say there is. Some say they can innovate now; others say they cannot. We have here proof of one thing beyond doubt. After all the words, blogs, letters, interviews, tweets and articles that have been written about the Medical Innovation Bill, there is one definite, irrefutable conclusion. As the noble Lord, Lord Kakkar, says:

“There is an ambiguity in the way that the current law may be interpreted”—

and, therefore, uncertainty about what constitutes a safe path to lawful innovation. A lack of clarity demands a clarification.

Cancer is the number one cause of the untimely death of British citizens. Who among us can accept the counsel of patience and delay? Scientists want this Bill, the Prime Minister wants this Bill, the Secretary of State wants this Bill—and, last but not least, patients in their thousands want this Bill. Unless the phrase “putting patients first” is a mere platitude, let us listen to them. They ask a simple, despairing question: “Can anything more be done? Is there anything else we can do?”. They have tried every form of prayer to beat cancer. The Almighty cannot do this job for us. He wants us to do it for ourselves. With your Lordships’ help, that is what we will do. I beg to move.

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Lord Saatchi Portrait Lord Saatchi
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My Lords, I thank all noble Lords who have spoken today. As my noble friend the Minister said, it has been a remarkable privilege to address, and to hear, your Lordships. There may have been moments when it did not sound like it but I think that your Lordships’ House is unanimous in that we want to encourage more innovation but we want it to happen safely.

In that context, I now give an undertaking before the whole House regarding what the Secretary of State has put in motion to deal with the safeguards in the Bill to achieve the dual aim of more innovation, safely. The Secretary of State asked the medical director of the NHS, Sir Bruce Keogh, to examine that, and he has done so with great care and diligence. I believe that the result of his work will be, as my noble friend summarised briefly, that the Government will themselves propose amendments to the Bill in the Public Bill Committee in the House of Commons. I hope that that may be an appropriate point for other amendments to be tabled, following the Government’s example in the Public Bill Committee in the House of Commons.

I give the House this undertaking. I and Michael Ellis, the MP for Northampton North, who will propose the Bill in the House of Commons, undertake here and now to adopt the government amendments that my noble friend and the Department of Health will put forward and to take them forward in our name in the House of Commons.

I thank all noble Lords very much indeed. It is indeed a privilege to have addressed your Lordships and I now ask the House to give the Bill a Second Reading.

Bill read a second time and committed to a Committee of the Whole House.