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Lord Saatchi (Con)
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.
Baroness Masham of Ilton (CB)
My Lords, I feel that the noble Lord, Lord Saatchi, has the very best intentions behind his Bill and I congratulate him on his determination.
I have been in the position a few times when people I loved were dying too early. In such situations, if there is hope with a new medicine or procedure and if the patient wants to try it, as long as it does not cause suffering I am in favour of innovation. I was inspired by a remarkable person I met, Les Halpin, who had motor neurone disease. With only one drug for that deplorable condition, he was a leader in encouraging innovation and to speed up the development of new drugs to help combat conditions such as motor neurone disease.
With the growing realisation of infections becoming resistant to drugs, research and innovation are vital. There is no doubt that when people work together across the world, improvements are made. There have been important advancements with HIV and AIDS, but there is a need for a vaccine and more innovation. With so many people breaking their backs and necks and becoming paralysed, there is a need for innovation to find a way of joining and regenerating the spinal cord. I declare an interest in this.
Legislation sometimes does not do what it is intended to do. My queries are on behalf of patients. I have been in communication with Action Against Medical Accidents—AvMA—and there are some concerns. The Bill will remove a layer of protection and redress for vulnerable patients who are harmed when their doctors act in a way which no other doctor would support. It would encourage unsafe and unaccountable practice by doctors and lead to further tragedies and scandals such as that of Dr Ian Paterson. It would affect all forms of medical treatment, not only in exceptional circumstances such as when all evidence-based treatment options have been exhausted.
The Bill’s provision may have no positive impact on innovation. It will have no effect on funding, research programmes, clinical governance or professional and medical product regulation. Properly considered, the law already protects a doctor against an allegation of negligence if he innovates responsibly. The Medical Defence Union has publicly stated:
“The Secretary of State for Health in a written statement introducing the Medical Innovation (no. 2) Bill stated that doctors wishing to depart from established procedures and carry out an innovative treatment may be fearful of doing so because of the possibility of a clinical negligence claim. We have seen no evidence to suggest that this is the case … Our advice is that there should be no consequences providing there are appropriate safeguards in place, the patient fully understands what is proposed and why the clinician believes it is in their best interests, and they give their fully informed consent … We are happy to reassure doctors that medical innovation should not leave them open to an increased threat of litigation”.
The Bill provides a defence: doctors will not be negligent in relation to any treatment currently regarded at common law as negligent if they take the decision to treat responsibly. While the purpose of the Bill—to promote responsible medical innovation—is laudable, the intentional effect is to deprive patients who are harmed by doctors of a right to redress, even when the doctor has acted in a way that no other doctor would support. It is the rationale behind the Bill that doctors who would currently be regarded as negligent should no longer be held liable.
AvMA is concerned that patients should be afforded protection against irresponsible or negligent doctors. Regrettably, the Bill does not provide adequate protection and could actually encourage unsafe practices, leading to further tragedies and scandals such as that involving Dr Ian Paterson, among others. AvMA is also concerned that patients who agree to treatment that goes beyond the bounds of what is considered acceptable by all responsible bodies of medical opinion are precisely those who require particular protection. The desperate patient who will try anything to be cured or to secure a short extension of their life may be the most vulnerable to exploitation.
Media coverage and statements by supporters of the Bill give the impression that it is designed specifically to open doors to innovative treatments for people with life-threatening conditions for which all evidence-based treatment options have been exhausted. AvMA says that this is not the case. Is it correct that the Bill would apply equally to any form of medical treatment where the doctor convinces the patient that it would be in their best interests to receive it? This could include, for example, cosmetic treatment. I am very keen that there should be a positive effect on innovation, but the safety of patients must be the priority. There should be no loopholes in this legislation to ensure that patients are not put at risk without their knowledge and consent.
I would like to end by saying how important the work of charities is in helping with medical innovation, one of them being Parkinson’s UK. The charity strongly supports more innovation and its adoption into clinical practice so that new and better treatments can be developed to help people with Parkinson’s disease. Any change to the current legislative framework must be driven by clear evidence that the prospect of legislation is currently preventing innovation by doctors. Further clarity is needed on how the Medical Innovation Bill will give priority to informed consent and peer review in order to protect patient safety. Safeguards are needed against unintended consequences such as encouraging reckless innovation and exacerbating the postcode lottery of services.
I have two questions. What evidence is there to suggest that doctors have been discouraged from using innovative treatments for conditions such as Parkinson’s due to concerns about litigation? How many clinical negligence claims in recent years have been linked to innovative medicine? Is not one of the problems the fact that innovative medicine can be very expensive and there are problems around payment? There are many complex conditions, but there should always be honesty and transparency.
Lord Newby
My Lords, perhaps I may remind the House of what I said at the start of the debate; namely, that it is a firm convention that the House should rise at around three o’clock on sitting Fridays.
Lord Winston (Lab)
This is a Bill of colossal importance and to truncate speeches to six minutes, even though it is a Friday, seems to be highly undesirable. It needs to be discussed because there are many implications behind this piece of possible legislation.
Lord Newby
My Lords, I am not in any sense trying to curtail the debate. I am reminding noble Lords of the conventions of the House. My experience of listening to debates is that those in which the speeches last for six minutes can be among the best we have.
Lord Mackay of Clashfern (Con)
My Lords, I shall attempt to stick to the advisory limit. This is an extremely important Bill which, as has been said, has generated a lot of opposition and very many pages of debate. I am greatly obliged to Leigh Day solicitors for presenting me with a large file on the Bill. Of course, the flow of such material has continued up to the last minute. I want briefly to summarise the Bill as I see it because I believe that it provides the best possible protection in relation to medical innovation that could be devised. You just have to look at the Bill in this way.
Clause 1(4) states:
“(4) Nothing in this section—
(a) permits a doctor to administer treatment for the purposes of research or for any purpose other than the best interests of the patient”.
This is the centre of the Bill. If you innovate, you will depart from the existing practice. The law as I understand it in respect of medical and other professional people is that, in treating their clients or patients, they have to use the reasonable care that is expected of a person of that skill. That is the fundamental rule. Other ancillaries have been developed such as the Bolam principle, which says that if there is a body of medical opinion that is responsible and relevant, that is evidence that the doctor in question has in fact exercised reasonable care. The question is this: if there is no such body, how do you exercise reasonable care?
The Bill sets out a procedure by which that can be done. It analyses the process of coming to a decision that reasonable care has been taken in the circumstances of an innovation. It sets out that this must be done by a process which is accountable, transparent and allows for full consideration of all the relevant matters. I personally do not find it easy to suggest an improvement to that particular formula. The Bill sets out in some detail the process which must be followed in order to achieve that overall objective. The first requirement is,
“consultation with appropriately qualified colleagues, including any relevant multi-disciplinary team”.
That implies consultation. I have read some opinions which suggest that it could be ignored without any consequences whatever. You can ask someone’s opinion, and if it goes against what you want to do, you just ignore it and carry on. That is not my understanding of the term “consultation” as it is used in the law. Consultation means that you have regard to the opinion. In a case where a doctor is challenged, this will have to be set out. If, for example, Dr A says, “This is very dangerous”, the defendant doctor will have to give a good reason why he thinks that that statement is not correct. That is the first stage, and of course consultation would include looking at the relevant literature on the subject.
The second requirement is,
“notification in advance to the doctor’s responsible officer”,
which is in accordance with the statutory provisions covering medical responsibility. The third requirement is,
“consideration of any opinions or requests expressed by or on behalf of the patient”.
That would include the patient’s consent, which is absolutely essential for any treatment by a doctor. It must be full consent that is given after a full explanation of the risks involved in the treatment. The fourth requirement is,
“obtaining any consents required by law”,
which, as I say, includes the consent of the patient himself or herself. The last requirement is,
“consideration of all matters that appear to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment, including assessment and comparison of the actual or probable risks and consequences of different treatments”.
That is a very full assessment. As I say, I have received quite a body of literature but I have not seen any that actually formulates the way to achieve a result of reasonable care in the situation of an innovation. How do you do it if there is no body of opinion already in favour of it? How do you justify your decision as taking reasonable care? In my judgment, most of the literature that has come in from a great number of bodies, including all the professional bodies, is based on a failure to give full effect to the provisions of the Bill.
I declare an interest as an honorary fellow of three of the medical royal colleges. I am also a member of Cancer Research UK, and I join my noble friend in paying tribute to the work of the charities, particularly Cancer Research UK in its research function. I also had some experience of this area of the law when I was in private practice but, of course, as your Lordships will understand, that is rather a long time ago. I support the Bill heartily and I have seen very little in the way of suggested improvements to this line of thought.
Baroness Bakewell (Lab)
My Lords, I give my qualified support to the Bill, based on my experience of 10 series of a BBC programme called “Inside the Ethics Committee”. I have worked on programmes about medical ethics for many years and I remember when ethics committees were introduced into hospitals to resolve the issues facing doctors making difficult decisions.
From those programmes I have learnt certain things. One is that there is incredible responsibility in the medical profession when it comes to making difficult decisions. Great care is taken. Doctors are devoted to solving the problems presented by their patients. That is what they live for and they want to be successful at what they do. They often take great care and consider the nuanced arguments on both sides, seeking to balance benefit against risk. There is no such thing as absolutely safe innovation. It carries risk and it is the responsibility of doctors and their advisers to assess those risks.
I have also discovered that Dr Shipman casts a long shadow. I have run into situations in which medical men have wished to take certain steps but their healthcare supporters have been resistant to change for fear of litigation. Clearly, an issue exists throughout the caring professions about the nature, extent and possibility of litigation. We need more facts, which is what happens in ethics committees, and we need many viewpoints. The number of ethics committees has mushroomed because doctors take the law that exists very seriously and follow it, in my observation, with great scrupulousness.
The noble Lord, Lord Saatchi, mentioned the increase in litigation. There are many explanations for that. We live in quite a greedy society, litigious about many things. The opportunity to make some money out of something that happens in your life is regarded as quite commonplace and acceptable. But with more medical procedures and an increasing population, and new possibilities coming on stream all the time, I do not think that the rise in litigation is something to be feared. Litigation acts in the defence of patients. We want patients to be exposed to innovation that is safe. We want them to be protected against innovation that is risky. The need to protect patients against malpractice, carelessness, mistakes or neglect has to be paramount.
In his comments on the Bill, Sir Robert Francis cited what he saw as real obstacles to innovation. The House—and the medical profession—should note what they are: overzealous bureaucracy, scarce resources, ethical reservations and the length of decision-making processes. It seems appropriate to draw attention to those so that when we discuss the nature of innovation all those considerations get some support.
The whole intention of the medical profession, its flagship slogan, is: “First, do no harm”. I reject the claim made by the Bill’s critics that it will weaken the defence of the patients. I see it as adding to the strength of existing legislation and I offer it my support.
Lord Cormack (Con)
My Lords, I have rarely experienced the House in a more sombre mood. The reason for that was briefly illustrated by the short intervention by the noble Lord, Lord Winston, from whom we will hear later. My noble friend Lord Saatchi spoke with a quiet, controlled passion. I admire his persistence and understand his concerns. It was also good that the debate became a debate with the speech of the noble Baroness, Lady Masham, because she put questions that not only deserve to be answered but must be answered.
I have to say that when my noble friend Lord Saatchi first introduced the Bill, I had certain strong misgivings. If those misgivings are to be encapsulated in a single word, it is the word to which he referred: quackery. We all know that there are those who, through the centuries, have peddled remedies that could benefit only themselves and not the people they sought to benefit. Even to this day, if there is any Member of your Lordships’ House who is not in receipt at least two or three times a week of some coloured leaflet promising the cure to all known and some unknown ills, I congratulate them. My wastepaper basket frequently overflows with such things.
My initial misgivings have to a large degree been answered by the knowledge that so eminent a legal luminary as my noble and learned friend Lord Mackay of Clashfern feels that the Bill is both desirable and necessary, and by the fact that noble Lords eminent in the medical profession have given it their support. My noble friend Lord Ribeiro will speak later in the debate, but I had the benefit of a conversation a week or so ago with the noble Lords, Lord Kakkar and Lord Patel, for both of whom I have a profound regard and respect, who told me that they felt the Bill was a small but good advance.
Of course, we must not fall into the danger of suggesting that we have not had tremendous innovation in medicine over the past few decades. It is exactly 44 years since I took my seat in another place. When I did so, not a single one of my constituents had an artificial knee or an artificial hip. My agent in the early 1980s, a young man in apparently vigorous health, collapsed and was one of the first recipients of a heart transplant. Medicine has advanced in a truly remarkable way. By the time I stepped down as the Member of Parliament for South Staffordshire, it was impossible to attend a gathering of those over 60 that was not also a “bionic” gathering: knees and hips all seemed to be artificial. I am glad to say that mine are not yet.
We have to look at it against that background but we also have to accept that there have been considerable advances in the treatment of cancers. There cannot be anyone in this House who has not been closely associated with that dread disease in one or other of its forms. I remember an aunt of mine in the late 1960s dying in considerable agony from cancer at a very young age. More recently, my wife’s father died of cancer, although, by then, the treatments were such that the pain was relieved. My noble friend Lord Saatchi—I do not wish to personalise this—has had a graphic and tragic personal experience which has motivated him in a way that we can all only admire. It is right that there should be no deterrent to proper innovation. The only question is: will this Bill create some of the problems which were forecast by the noble Baroness, or will it contain the safeguards that will prevent them?
I come down on the latter side, as did the noble Baroness, Lady Bakewell. What we are being offered today is a way forward that can do no harm to anyone and could conceivably be of real benefit to a number of people. If this Bill was to benefit only a handful of people, it would be worth while and it would be right to support it.
If ever a Bill cried out for pre-legislative scrutiny, it is this one. It is clearly not happening with the Bill at the moment. If the Bill goes on to the statute book along the lines advocated by my noble friend Lord Saatchi, that is well and good, but if he has to bring it back in a new Parliament, it would be right for the Government to take it over and for there to be pre-legislative scrutiny. I do not say that to deflate the ambitions of my noble friend, but I say to him that many parliamentary campaigns have lasted more than the three years that he has been involved with this one. He is a man who has the tenacity, the commitment and the determination to see this Bill through, and I truly hope that he will do so.
Baroness O'Neill of Bengarve (CB)
My Lords, I declare an interest in that I am on the board of the Medical Research Council and chair its ethics, regulation and public involvement committee. Nothing that I say is said in the name of the Medical Research Council, but I believe that it will be compatible with the views that it holds.
I have great sympathy with the purpose of the Bill and agree that we need to ensure that, where permitted, those providing innovative treatments under safeguards should be required to complete and to make available the relevant data for the benefit of others with like conditions. I was therefore very encouraged to hear about the initiative for the registration of innovations, which may make a difference. That benefit may be knowledge of cure or improvement, but, equally, it may be knowledge that protects against treatment that would either exacerbate or not benefit—benefits go two ways in this.
However, I want briefly to point to some wider issues that lie in the background of this discussion. The days of the blockbuster drug may be drawing to a close. We are seeing the emergence of many more narrowly targeted drugs that meet the needs of smaller numbers of patients. This is the promise, but also the problem, of stratified medicine. It raises problems for the classical model of the randomised controlled trial. Such trials are expensive and take a long time. Where a drug or innovation may benefit quite small patient populations, it may be difficult to recruit a cohort of trial participants with the relevant condition. Where a market is likely to remain small, it may not be feasible for any pharma company to take the financial risk. We therefore have strong reasons to think about possible ways of making legitimate clinical trials more feasible and more flexible, while protecting patients and always acting within their consent.
I want to point to one particular sort of research for which we need to make room, and that is participant-led research. In participant-led research, those who suffer from a condition agree to make their data available for analysis. That analysis may reveal that some form of treatment benefits or harms. It is marvellously cheap as a way of doing it. As an example, I would cite the ALS lithium study conducted by users of the online platform, PatientsLikeMe. It was initiated by two advanced-stage patients from Brazil and the US who were users of the platform and who died before the conclusion of the study. A group of 149 ALS patients on the platform took lithium in order to test the findings of a small earlier study into its effects on disease progression and symptom alleviation. The PatientsLikeMe ALS study was completed over a period of eight months—note how short that was—and was published in Nature Biotechnology. It found that lithium had no effect, which was subsequently confirmed by standard clinical trials, but the innovative approach to establishing a result was much faster.
Participant-led research faces some difficulties. It may not be eligible for ethical review, not because one cannot consider the ethics of the matter but because there is, believe it or not, no principal investigator—so how does one do the ethics review? It may not be eligible for publication in medical journals; for example, because it has not been subject to ethical review. I do not think that such research should be subjected to less rigorous ethical or scientific review than other research, but nor do I think that it should be obstructed because it does not conform to the precise assumptions of the classical randomised control trial. Is the Department of Health considering a wider review of the fitness-for-purpose of present ways of regulating clinical trials so that they might be extended to cover a greater range of innovative research and innovation proposals?
Lord Colwyn (Con)
My Lords, I should like to congratulate my noble friend Lord Saatchi on the many hours of research that he must have done to introduce this Bill.
I am not sure that the proposed legislation is necessary. Any need for additional support for doctors should be achieved through professional guidance, not rigid statute. I declare a one-time interest as chairman of the dental section of the Medical Protection Society, as a member of that council and as a long-term supporter of the integration of allopathic medicine with holistic and natural medicine. I am also president of the All- Party Group for Integrated Healthcare.
When my noble friend introduced his Bill on the 5 June, I assumed that it would be yet another complaint against those practitioners of complementary medicine who are not all registered and regulated. I am currently trying to persuade the Department of Health to introduce statutory regulation and registration for practitioners of herbal medicine, but very little progress is being made.
The Bill is designed to codify existing best practice in relation to decisions by medical practitioners to depart from standard practice and to administer innovative treatment, but I believe that existing legislation is sufficient and adequate and that the Bill is not necessary.
I have always encouraged innovation. I asked the Library whether it would look at some of the speeches that I made in the 1970s and 1980s which referred to innovation. It came up with a debate on heart disease on 25 July 1984, in which I said that,
“I am of the opinion that the deposition of cholesterol in our artery walls, and, for example, the abnormal cellular division that causes cancer, are all normal occurrences throughout life, and that it is the action of our immune system”—
I then listed some of the vital organs—
“which make the necessary day-to-day repairs. However, these repair systems are not perfect, and the rate of repair declines relative to the rate of damage”.—[Official Report, 25/7/84; col. 371.]
Recently, there have been references in the media that up to half of cancers could be fought using the body’s own immune system and that drugs to help patients heal themselves will be the next innovative breakthrough. Pharmaceutical companies are rushing to get therapies into the clinic as regulators agree to help fast-track approval after spectacular early trials. Doctors are beginning to understand that the treatment labelled “immunotherapy” is finally becoming a reality.
The issue of freedom of choice in medicine is paramount. There is no justification for assuming that practitioners of complementary medicine should be allowed to treat patients without undergoing the same high standards of training if they want the responsibility and authority to practise their medicine. I like an openness to other models of health and illness and a willingness to experiment. A number of holistically inclined doctors will try out botanical drugs, work in association with osteopaths, chiropractors and other fringe therapists, study such techniques as acupuncture and homeopathy, and consider the possibility that psychic healing is a reality worth documenting. I am pleased to meet doctors who concentrate on health and its maintenance rather than on disease and its treatment. To see them emphasise nutrition and discourage medication is a remarkable and welcome change.
Much of the publicity surrounding the Bill has focused on finding a cure for cancer but the amended Bill applies to any medical condition, thus providing an opportunity to provide unorthodox treatment for all sorts of common illnesses. Current law allows doctors acting responsibly to innovate. The Bill recognises the value of current law as it purports the current Bolam tests for standards of care as well as the current law on consent. The Bill seems to do the exact opposite. In a climate post Mid-Staffordshire, where hundreds of patients died from negligent care and with the cases against Mr Ian Paterson for undertaking many unnecessary operations, do we really want to diminish patients’ rights to redress? Thus, a doctor acting responsibly, with the support of a reasonable body of peers and the informed consent of their patient, would not be guilty of negligence under the current law. However, the Bill would allow that a doctor may no longer be negligent even when acting without the support of a reasonable body of doctors.
I have received Department of Health consultation responses from medical organisations, patients’ bodies and charities, all saying, that there is no evidence that doctors do not innovate because of the fear of litigation. I fear the amended Bill will increase litigation, as the lack of clarity, contradiction and uncertainty of terms, and the fact that there are no definitions of key words, will require interpretation by judges in court and create an avalanche of satellite litigation. Perversely the amended Bill may actually discourage innovation. The fact that key words—for example, “innovation”—are not defined will confuse doctors, who will be wary of any innovation because of concerns about what they are allowed to do. Exposing patients to innovative treatments is likely to involve a greater range of ethical and legal issues than standard treatments. Progress in cancer treatment comes about by carefully controlled studies and trials, where patients’ rights and ethics are protected.
The amended Bill does nothing to assist innovation. There is nothing about the regulation of doctors by the GMC and others, the lack of funding, the regulation of research, transparency or the sharing of information by pharmaceutical companies—all key to this issue. Surely there are better ways of promoting medical innovation than by precluding patients from seeking redress when harmed by doctors whose treatment is not supported by any responsible body of their profession. I support giving the Bill a Second Reading to allow careful scrutiny by a Committee of this House. I agree with my noble friend Lord Cormack that pre-legislative scrutiny would have been ideal.
Lord Turnberg (Lab)
My Lords, it is absolutely essential that we strive as hard as we can to find new cures and make them available as rapidly as possible. The principle behind this Bill is entirely in accord with that deeply felt need. I admire and respect the noble Lord, Lord Saatchi, for bringing the Bill forward in his persuasive and passionate speech. His motives are impeccable and he provided us with a valuable opportunity to debate this difficult issue.
Why has such strong opposition to the Bill been expressed by some significant bodies and respected individuals who cannot be easily dismissed? What does the General Medical Council have against it? We cannot really discard its fear of a rise in the number of cases of reckless and damaging practice. What do the Academy of Medical Sciences, the Wellcome Trust and Cancer Research UK have against it? CRUK says that the Bill is unnecessary because it can find no evidence that the doctors it supports are put off by a fear of litigation. What do the Patients Association and the charity Action against Medical Accidents have a problem with? Again, it is uncertainty about opening up patients to potentially damaging practices. Why is Sir Robert Francis still anxious about the Bill before us? A very respected medical litigation lawyer, he remains worried about the wording and safeguards in the Bill, and suggests that in any case it is unnecessary. These are significant anxieties from responsible people. At the very least they give us reason to be cautious about how we view the current Bill.
I hope your Lordships will forgive me if I spend a moment discussing the barriers to innovative practice. I fear that there are many. First, delays are imposed by an overly bureaucratic regulatory environment. The myriad regulatory bodies pose a major hurdle and there is much to do there. Then there are the funding issues. We still need much more money for research. There is the issue of affordability by hospital trusts and CCGs. Too often they find it difficult to provide the resources for very expensive treatments, even with the Cancer Drugs Fund, and because of that doctors are prevented from prescribing what they think their patients need.
Of course, we also have the natural conservatism of some doctors who seem unwilling to try anything new. However, the reasons for that seem more to do with a reluctance to try something of which they have had little experience rather than a fear of litigation. There is certainly need for guidance on good innovative practice, as described in the Association of Medical Research Charities publication, Our Vision for Research in the NHS. I declare my employment by the AMRC as a scientific adviser.
There are many targets at which we should aim if we are to improve access to novel treatments. Of course, the Bill is not designed to influence any of those. It is designed specifically to try to remove a fear of litigation by doctors wishing to use novel treatments. However that does not appear to be a problem in the major centres. For example, in the case of cancer treatments the Royal Marsden Hospital in London constantly tries novel treatments well before they have been approved or licensed. Oncologists working there say they do not need any help to innovate and are doing it all the time. They do the basic research, often with the involvement of the pharmaceutical industry, to produce new drugs and test them on their patients well before they have been approved and licensed.
Indeed, the whole personalised medicines agenda is one in which drugs are designed for very specific individual patients based on their own or their cancer’s genetic make-up. Clearly, the usual process of prolonged regulatory approval is inappropriate for these types of treatment. It is the case, too, that the majority of cancer patients are now in one type of clinical trial or another, where the possibility of litigation is not a barrier. Indeed, Mr Greenberg, Parliamentary Counsel, told me that the Bill is not intended for those situations.
Who is it intended for? Who might be put off trying something new on their patients for fear of litigation? Perhaps it might be an isolated doctor, outside one of the main specialist centres; a physician in private practice, general practice or a small district general hospital; or perhaps a surgeon wanting to try out a new procedure not tested elsewhere. These are the doctors we should certainly encourage to take up all the latest developments that have been shown to be effective at least somewhere or—preferably—refer patients desperate to try the latest possible treatment to a major centre that is trying them out in proper trials.
One can imagine the situation in which a new drug was being tried in America, Japan or Israel but not yet here and a doctor wanted to try it on his or her patient. Doctors can prescribe such drugs now on what is called a “named patient basis”, with all the safeguards of patient consent and a rational basis for the treatment to back them up. Certainly, better guidance on what doctors can and should do would be enormously helpful—the opportunity for debate that the Bill is giving us is invaluable in that regard—but the idea that someone working in isolation will come up with an entirely new treatment de novo seems inherently unlikely. Where will it have come from? What underlying research will have been done? What toxicity studies and tests will have been done to make it a reasonable option? Such innovation is far too risky.
Forgive me for going on for so long, but I wanted to explain why I have some difficulty with the Bill as it stands. Those working at the cutting edge of research and application of new treatments say that they do not need it; they have no fear of litigation. Those not working in the major specialised centres need better guidance, not a weakening of the law that might open opportunities for them to be more reckless than they are now.
I have read with interest and, I have to say, some confusion the legal opinions expressed by lawyers on both sides on the wording of the Bill. They have certainly made me realise why I am not a lawyer. I have also listened carefully to the wise words of the noble and learned Lord, Lord Mackay, but I also recognise that one has to be very cautious about accepting a Bill where there is room for disagreement among lawyers. Although the noble Lord, Lord Saatchi, for whom I have particular regard, has given us an extremely valuable opportunity to open up the whole subject of innovative practice—we certainly need that—and it may be possible to amend the Bill to make it more acceptable, we will have to look at that very carefully in this House. Meanwhile, I am sorry to say that I remain to be convinced that the Bill is the answer to the problem it seeks to solve.
Baroness Gardner of Parkes (Con)
My Lords, I rise to support the Bill because I am convinced that it offers hope, and I think that that is one of the most important things in life. Many years ago, when I was on the Greater London Council, our Chief Whip, a very nice woman, was in the Royal Marsden and in a terminal condition. She said to me, “It has been marvellous to have my colleagues come in, except for that one”—he happened to be a doctor—“who came in and said, ‘Oh well, that’s it, Billie, you’re finished and on your way’”. She said, “That was the one thing I did not want to hear. I wanted hope and the feeling that there was some hope”.
I had not remembered that until I met Les Halpin, of whom I am sure many noble Lords have heard. In 2011 he was diagnosed with motor neurone disease. The Daily Mail, which I do not often quote, described him as a maths genius confined to bed—this was towards the end—with a new aim: becoming a guinea pig for the experimental drugs which could save his life. That is the very important thing. My godson in Australia died not long ago from motor neurone disease, and it is a horrible condition. Les would certainly have been in a position to give informed consent. Various letters of opposition that we have received say that informed consent will be impossible to get. He was quite clear. When I first met him, he was quite fit, and he explained in great detail that he wanted to have these new drugs tried and was prepared to be self-funding at that stage because he thought it might benefit others.
It is quite by coincidence that I have held this view for some time; it is not just because I happened to be sitting next to my noble friend Lord Saatchi on the day that we had the First Reading of the Bill. At the time, I had a Question along the same lines. I met Les when he was quite fit, and then just a year, or a little more, later he was totally tied to bed and unable to do anything. The one thing that he had been deprived of was the hope that something might have helped him. It is more important than that; it is both hope and research, a double value. If it helps the person who has the innovative treatment, that is good in itself—but if, on the other hand, it helps people who follow and is just one element in a chain of tests for something, that will be hugely valuable to others. It is surprising how many people who are very ill would like to be able to help those who follow.
Les set up a charity called Empower: Access to Medicine. I understand that an application has been made to the Charities Commission for registration, but that process takes a fair time. So although he did not get acceptance for the type of treatment he wanted during his lifetime, his work is continuing, and today’s Bill is important and, I believe, very much in the interests of patients. I have received many briefing papers from many groups, most of which seemed pretty self-interested or self-protective. The point has been made how valuable it is for practitioners to have a means of protection, but I was reassured completely by listening to my noble and learned friend Lord Mackay of Clashfern that the protections are there in the Bill and that reasonable treatment is what we are talking about. The noble Baroness, Lady Bakewell, made other points. I rarely disagree with my noble friend Lady Masham, but on this occasion I do disagree with her. I understand her views, but I think that the Bill is more important and I do not think that she will find that there is a lack of the necessary protection there. I strongly support the Bill.
Lord Winston
My Lords, when I first read the Bill I was deeply impressed and thought how important it was. I congratulate the noble Lord, Lord Saatchi on introducing it. It is a hugely welcome discussion; I am very pleased that we are having it today, albeit in a truncated fashion. When we come to Committee, we will need to tease out a number of issues that the Bill raises. As I think more and more about the Bill, I have increasing misgivings, which I must explain to the noble Lord, Lord Saatchi, whom I deeply respect; I think he has acted with huge dignity and great compassion throughout his speeches on this issue, including on this occasion.
I am not against innovation in any way. In fact, innovation—if I may dare to be so pompous—has really been my entire life. For 40 years in surgery, I have innovated. I produced the finest microsurgical needles, which were not made by manufacturers—we made them on the bench ourselves because we needed them. I designed my own instruments, which subsequently became a general standard throughout the world and were finally designed by a German company. They were not standard in Britain. I swung a microscope over the abdomen of a patient for the first time anywhere in the world—something which most people thought was actually risky because it might introduce infection. It transformed pelvic surgery. I have to say that when laparoscopy came along, I think I was probably the first person to operate down a laparoscope, well before any general surgeon did so. Indeed, it was only with subsequent experience that we realised that laparoscopic surgery—fortunately, not in my hands as a gynaecologist but in the hands of general surgeons—actually caused a number of very serious accidents and even a few deaths. Of course, it took experience to find out that that innovation actually had all sorts of complications which might not have been recognised by any committee assessing the situation to start with.
Also, in the field of in vitro fertilisation, we have clearly been innovative in this country. We introduced hormone treatments, which could not be assessed by a randomised controlled trial initially—one of the points that Onora, the noble Baroness, Lady O’Neill, made was that there are many ways of assessing research. Programmed dosing of drugs in IVF, which transformed that treatment and made it possible to perform retrievals without laparoscopy at all, without a surgical procedure, were started in my unit and are now used world wide. There is also the example of ultrasound replacement of the embryo.
One trial that we did that was not truly randomised was to give patients alcohol at the time of the embryo transfer, because we thought that alcohol might calm the uterus down and therefore stop it contracting. Of course, that was not something you could really submit to an ethics committee, but it is the sort of thing that a woman might take during treatment. We found that white Loire wine had no proven benefit, but a good red from Pauillac was really quite effective.
Subsequently, genetic diagnosis, which was important in how legislation was formed in this House, could not easily be assessed, except by an ethics committee. There was a whole range of innovative procedures there that did not need this Bill. Neither did sperm microinjection nor endometrial abrasion. We now find, for example, that if you make a deliberate injury in the lining of the uterus before in vitro fertilisation, you can improve the success rate. That is completely counterintuitive and might be quite difficult to get through a committee without very difficult scrutiny. We also introduced what is called sham transfer, which prevented a lot of patients having unnecessary embryo transfers.
I feel a little like the noble Earl, Lord Howe, who is sitting on the Front Bench. I do not think that he was in his place during Prayers this morning, when we heard from the right reverend Prelate the Bishop of Birmingham:
“I will lift up mine eyes unto the hills, from whence cometh my help”.
I suspect that he feels that quite often when he is besieged by doctors protesting against legislation or improvements in governance. However, this issue really is causing increasing concern among many practitioners, as the noble Lord, Lord Turnberg, said. It is not quite as simple as was originally thought and we need to be very well aware of that, because it has the possibility of untold consequences. I want to explain what I think those are in just one minute or so.
We can see very well that in the practice of in vitro fertilisation now being carried on, all the governance in the world, including a regulatory framework, does not prevent innovative treatments which risk damaging patients. Let me give just two examples. One of them is embryo biopsy, which is substantially to try to understand which embryo might be better for transfer. What we actually know now, after various meta-analyses of a number of randomised trials, is that this procedure not only decreases the chance of a pregnancy by about 50% but is ineffective in understanding whether an embryo is truly suitable for transfer. Moreover, animal experiments now being done are showing that some mice show changes in their central nervous system, which lead to cognitive impairment when they are adults. Some of them are showing demyelination of nerve fibres in the brain. This potential innovation is one example of in vitro fertilisation—but not the only one—that might cause untold circumstances without all sorts of issues which innovation might risk. Not the least of those is blastocyst transfer, which we know causes changes in gene expression in humans in some cases.
Innovation undoubtedly has risks and we really have to understand that. If this Bill goes through to Committee, as I hope it will, we will clearly need to look at it very carefully to make sure that a number of amendments are made to it. I notice that the noble Baroness, Lady Bakewell, is now not in her place. Sadly, and in spite of what the noble Baroness said, litigation might increase as a result of the Bill as patients might decide to litigate because a doctor has not tried innovation in an unusual circumstance. Whether we like it or not, the problem really is that litigation under any circumstances is extraordinarily damaging to all parties concerned, even when a patient wins the case. It should be avoided not least because of that psychological damage, leaving aside the cost to the national purse.
The massive correspondence which I have received is very concerning. I conclude with the words of Michael Baum, one of the leading innovative surgeons in cancer in this country, whose contribution to breast cancer is second to none. He has said to me that in his view, “Their Lordships are walking over a precipice if they pass this Bill”. We have to listen to that very carefully. Of course I really want to demonstrate my absolute sympathy for what the noble Lord, Lord Saatchi, has said. I congratulate him on bringing forward the Bill but we need to consider it very carefully on the Floor of the House in due course.
Lord Ribeiro (Con)
My Lords, I am pleased to follow the noble Lord, Lord Winston, who is an acknowledged innovator outwith the accepted norm. I welcome the introduction of this Bill, which has generated much interest and debate following the recent NHS consultation—based, I might add, on an earlier iteration of the Bill. The Bill we are discussing today is simple and easy to implement, if confined to hospital practice involving surgery and interventional procedures. The terms “treatments” in Clause 1(3)(e) and “treatment” in Clause 1(4)(b) open this up to all treatments provided, whether in the regulated area of the NHS and private hospitals or the unregulated area of the cosmetic industry, where unqualified practitioners may undertake Botox treatments for cosmetic purposes.
During the early stages of the Bill I met my noble friend Lord Saatchi with colleagues from the Pelican Cancer Foundation, a cancer charity, to explain some of the barriers to innovation that we had experienced. These have been mirrored by Sir Robert Francis and were identified earlier by the noble Baroness, Lady Bakewell: bureaucracy, scarcity of resources and ethical reservations. We stressed the importance of keeping patients at the centre of the decision-making process and providing them with as much information as possible on, for example, the number of patients who had previously received the procedure or treatment; the percentage cure rate of the treatment; the likely impact of side effects and an obligation to explain the impact of those side effects to the patients. These are all encapsulated in Clause 1(3)(c) and (e). The Medical Defence Union and others feel that Clause 1(3)(e) is unnecessary, given the current use of Clause 1(3)(d), which deals with informed consent.
Informed consent is even more important when dealing with new and untried techniques. The practice of medicine is regulated through numerous guidelines, guidance, protocols and pathways which must be followed to ensure the safe delivery of care. Many of these did not exist when I began my surgical career and I was free to innovate in the best interests of my patients, usually after joint consultation and agreement. This is not the case for surgeons today. The advent of laparoscopic cholecystectomy, or keyhole removal of the gall bladder, is a case in point. In 1989, a French gynaecologist removed the gall bladder of a patient while carrying out a routine gynaecological operation. As we heard earlier, gynaecologists have been rummaging around in the stomach with their little telescopes for an awfully long time. This ushered in a new era of surgery, which challenged the gold standard of open surgery for gallstones that had held for 100 years.
However, the freedom to undertake such operations without any oversight came at a price to some of the patients involved, who developed unnecessary complications. At the time, I set up a national register to collect data on laparoscopic cholecystectomy, from which we published reports of complications to warn colleagues of the hazards of these new procedures. It is an innovation which would be impossible to introduce today and many of us would be considered mavericks for carrying it out.
The Royal College of Surgeons and the Government established a minimal access training unit to teach the new procedure and, in 1996, introduced a safety and efficacy register for new interventional procedures, called SERNIP. The register accumulated a list of new procedures and allocated each to a category, signifying its perceived degree of safety and efficacy, but it had no legal power and so its effects were limited. It was taken up by NICE in 2002 and remains within its remit. If the Bill is adopted, it would be essential to have a national register with legal powers to log and follow up with patients. I am delighted to hear that Oxford University has agreed to undertake this.
One way to ensure the Bill’s stated aim—that it,
“allows the test of whether innovation is negligent to be applied at the time when the doctor is deciding to innovate”,—
is to provide access to expert independent advice, particularly when the multidisciplinary team or the body of one’s peers fails to sanction the procedure being proposed. The invited review mechanism deployed by the Royal College of Surgeons to assess failing surgical departments in the NHS at the request of a trust board could act as a blueprint for such independent advice, providing two experts from relevant specialties to review the case for innovation, one from the Royal College and the other from the specialty association or society. This is no different from requesting a second opinion—something we all find valuable and which reassures patients that a body of opinion agrees with your proposals for treatment. The situation becomes more complicated, however, when the practitioner does not have a responsible officer, an MDT, a clinical director, a medical director or a chief executive to consult and, as in the case of the NHS, to approve the introduction of a new technique or procedure.
The overarching umbrella of protection—some may say “bureaucracy”—is not available to non-NHS practitioners, some of whom are not medically qualified but undertake cosmetic procedures in the private sector. Some, for financial gain, may work out of their own clinics or hospitals. How can we ensure that the treatment they provide is covered by the Bill? Will they also be free to innovate? The answer is yes, because they do already. Some end up creating problems and facing negligence charges, but they would not enjoy the protection that the Bill provides. This is something that we must look at carefully. When we talk about cancer, it is very easy to talk about innovation and freeing people from the shackles that bureaucracy provides because we all want the best for our patients, particularly when we are dealing with cancer. However, the use of the term “treatment” opens up the Bill to a wide area that will need to be covered. That is the only area that I have reservations about; otherwise, I am in support.
Baroness Emerton (CB)
My Lords, I add my thanks to the noble Lord, Lord Saatchi, for putting forward this important Bill. I add my appreciation to all those who have provided helpful and thought-provoking briefs. I also thank Peers who have widened the debate and discussion today. I declare an interest, being a retired nurse, a former lay member of the General Medical Council and a member of its professional conduct committee, and chairman of the Nursing and Midwifery Council.
I am very much in favour of innovation. I have had years of experience now within the health service and witnessed the many innovations that have come about. My first great impression was the introduction of the surgery and treatment for tuberculosis. However, innovation needs to be controlled.
I want to make two points, although I also thank the noble and learned Lord, Lord Mackay of Clashfern, for eruditely taking us through the safeguards this morning. First, I want to pick up on the point about the inclusion of the “multi-disciplinary team”. It must be recognised within the health service that, while doctors prescribe, diagnose and treat, other healthcare professions are often also involved. My concern is: what is the vicarious liability for the professions in terms of the organisations that they work for if we have no absolute research backing for the treatments that are taking place? This opens up an area that needs more discussion, and I ask the Minister whether there are any thoughts on the vicarious liability of the other healthcare professionals. Secondly, regarding the safeguards, I think that they have to be looked at in terms of the way in which the criteria are set and how the research is carried out.
As far as the patients are concerned, I take the point made by the noble Baroness, Lady Gardner of Parkes, about hope. Of course we all wish to see patients’ hopes met, and we must remember that we—doctors, nurses and healthcare professionals—are a compassionate and caring profession. However, we live at the moment in what has been described as a culture of fear. We need to think very carefully, if the Bill is to proceed, how that culture is to be overcome for the benefit of patients and of the professions by involving them across the multiprofessional teams in innovation. If the Bill proceeds to the next stage, and I hope that the opportunity is open to it to do so, I hope that these things can be addressed.
Lord Howard of Rising (Con)
My Lords, I congratulate my noble friend Lord Saatchi on introducing this important Bill. The Bill is about innovation, but one of its benefits would be to enable dying patients to obtain potentially life-saving treatment even if that treatment had not been fully investigated. I have been lobbied by those against the Bill with arguments varying from lengthy legal discourses to comments such as, “The medical treatment may not have the support of a responsible body of medical opinion”. My reaction to much of this has been much the same as that of the noble Baroness, Lady Gardner.
Of course it is desirable and important to have thorough investigation of innovative medical treatment, but if someone is dying they are not interested in whether a possible life-saving treatment has the support of responsible medical opinion. The patient is interested in survival; after all, the alternative is terminal. Many impressive and technical arguments have been put forward today, but where the simple point is “Experiment or die”, there is really only one option.
It is possible, as has been claimed, to innovate under the law as it exists today but, as has been pointed out, we live in a litigious society. Ambulance-chasing lawyers are lurking around every corner, searching for new opportunities. The law as it stands does not do enough for a doctor who wishes to administer an innovative treatment that may give the last chance of a cure to a dying patient; indeed, there is a bias towards no action. The Bill will help to remove doubt about a doctor’s ability to act in what he and his patient believe to be the patient’s best interest. It would be far better for a doctor’s energy and concerns to be focused on the patient’s health rather than worrying about their own position if he or she were to take innovative steps to save a patient’s life. There should not be a bias against the ability to give a potentially life-saving treatment to save a dying patient.
Lord Davies of Stamford (Lab)
My Lords, in my days in the City, there were a number, and I hope that they are no longer there at all, of fund managers and their client trustees who invested the funds of rather unsophisticated beneficiaries—I am thinking particularly of beneficiaries of small family trusts set up by some bequest or, very often, the funds of small charities, of which there are an amazing number in this country—entirely in the gilt market. Anyone who knows the first thing about finance knows that throughout the second half of the 20th century, if you invested in gilts over the long term then that was a sure-fire way of ensuring that the value of the fund would be eroded over time; indeed, after a decade or so, the erosion would be substantial. Why did they do it? Were they stupid? No. They did it because if they had invested that money in equities, there would have been a risk that they would get the timing wrong. If they had got the timing wrong when they went into equities, they could have been sued for having taken that decision. They therefore stayed in gilts because there was always a protection there; you could say that it was the practice of the market to invest, say, widows’ and orphans’ funds in the gilt market.
So I have been familiar for quite a long time with the context in which the law of tort and the system of civil justice and civil damages that we have in this country, which is designed to protect individuals, particularly vulnerable and unsophisticated ones, and indeed does so, can sometimes turn against the interests of precisely those whom it is trying to protect. It seems to me that in the area of medical negligence and malpractice the law has had exactly that perverse effect on innovation described by the noble Lord, Lord Saatchi, this morning. Therefore, in principle I am very much in favour of this essential and permissive legislation.
I shall deal briefly with the three main objections that have been made this morning. The first was made by my noble friend Lord Turnberg, whom I always listen to with great attention and respect on these matters, as I did today. Essentially, his point was that the changes, if they are required, can be achieved by guidance rather than by changes in the law. I think that in principle that is always wrong. If there is something inadequate about the law, if the law is unclear or perverse, or if there is a mismatch between the apparent meaning of statute as ordinarily interpreted and the practice of jurisprudence over the decades after it has been passed, that can be remedied only by a change in the law, and it is the responsibility of Parliament to see whether such perversities or anomalies are emerging and to deal with them. No guidance by any professional organisation is a substitute for that.
The second line of objection that we have heard this morning is that in many cases many doctors and medical units around the country feel that the present regime does not in any way inhibit the degree of innovation they think appropriate in their field. I do not think that is a logical objection to this Bill because such people can carry on. Indeed, their way of proceeding is not in any way threatened by the provisions in the Bill. That matter should be set aside.
The third objection was very powerfully made by the noble Lord, Lord Winston. Essentially, it amounted to saying that innovation can be very risky and in the case of medical innovation can lead to people’s deaths. We have to be adult and accept that, in the whole of human existence, there is always a positive relationship between risk and reward. If you take no risk, there is no reward, there is no return. If there are no risks, there will be no innovation. There must be innovation, and there must therefore be risks. If I found myself with a terminal condition, I should be very inclined indeed to say to my doctors that I would like them to take some risk because I am about to die anyway under the normal prognosis based on the standard treatments and if there is a chance of trying something else, if it does not work, at least my last act in this world would have been to have made a small contribution to the progress of medical science, which would be some consolation.
However, I would do that only if I felt the protections were adequate. This is where I want to make a suggestion for looking again at one aspect of the Bill. It is about patients’ rights. Clause 1(3)(c) requires that the process include:
“consideration of any opinions or requests expressed by or on behalf of the patient”.
The word “consideration” seems extremely weak. We have heard a very authoritative account this morning from the noble and learned Lord, Lord Mackay, who seems to be satisfied with the protections. I take his views very seriously on this, as on every occasion. I can well imagine that, taken together with paragraph (d) of that clause,
“obtaining any consents required by law”,
the consideration of any opinions expressed by the patient plus the statutory need to obtain the patient’s consent, which, of course, can be obtained only where there has been disclosure, may be considered to be an adequate protection in law. However, I can see no disadvantage and can see great advantage, if only presentationally, in reassuring patients—who, as in the example I just gave, might include me one day—that they have the clear, absolute authority to decide what will happen to them and the right to have absolute, exhaustive disclosure of the potential risks and rewards and the potential advantages and difficulties of any therapy or treatment that is being proposed. That word “consideration” could be changed so that it is absolutely clear that the patient is sovereign. There must be a legal obligation exhaustively to explain completely and in detail the reason for the proposed new treatment, its possible merits and risks and that the decision of the patient is final and sovereign. If that could be expressed by an amendment that might take place in another place—I certainly do not propose to hold up the Bill by proposing an amendment on my own—it might be very reassuring to many people who still have doubts on the merits of this extremely valuable Bill.
Lord Blencathra (Con)
My Lords, I declare a deep and personal interest which I have had for the past 16 years since I was first diagnosed with MS. I congratulate my noble friend Lord Saatchi on the way he has introduced his Bill, on the content of the Bill and on the way he has conducted himself over the past three years. It is a lesson to us all. I thank my noble and learned friend Lord Mackay of Clashfern, who has reassured us that there are adequate safeguards in the Bill and that we should not have concerns about any additional risk of doctors being sued for inappropriate or overinnovative behaviour.
The objection to the Bill from the medical profession is, in the main, that innovation happens already and the Bill is not necessary. I do not see that as in any way taking away the need for the Bill. If the Bill is not causing any slowdown in innovation, it is reasonably safe to let it through.
The objection from many in the legal profession seems to be that it will limit the chances of people being able to sue their doctors for negligence. If that is the case, that is a jolly good thing because I worry that in this country we are heading towards the American model where doctors seem to be afraid to prescribe an aspirin in case they get sued.
With all due respect to noble—and noble and learned—Lords on either side and to the medical profession, we have not heard much from the patient’s perspective this morning, and if your Lordships will forgive me, I will selfishly and arrogantly speak from the patient’s perspective.
I am lucky. I have slow-progressive MS. Those who get motor neurone disease or Parkinson’s disease are in a much worse position. Every time I see my consultant, I do not take my lawyer in tow behind me, waiting to sue him if he has given me wrong advice. Our discussion is always: what are the Americans up to? What is the breakthrough? Is it time for beta interferon? Should I change from injections of copaxone to something else? It is always about searching for that hope that there is something that will fix it one day.
I believe that we are getting close to a fix on multiple sclerosis. Certainly for relapsing and remitting, we are getting close. I think that if you were to do a study, if hypothetically the Department of Health were to say, “We have got a new drug. Could we have volunteers to try it?”, overnight you would find 10,000 people with multiple sclerosis saying, “Yes, we’ll give it a go in proper trials”. Worldwide, you might find 1 million willing to give it a go.
A breakthrough was announced in the United States in October last year by the Scripps Research Institute. It discovered that a drug called benztropine, which is currently on the market, has been on the market for many years and has been approved to deal with the side-effects of Parkinson’s, completely restored the myelin sheath in mice and rats. The institute is going on eventually to conduct some clinical trials. This drug is approved for use in this country, again for Parkinson’s patients. I think it has been approved for many years, and we know the side effects. But American GPs have greater rights to prescribe off-label than British GPs.
I believe the General Medical Council was consulted a couple of years ago about giving British doctors the right to prescribe off-label. That was strongly opposed by the pharmaceutical industry—I think we can all understand why—and the GMC dropped the proposal. American doctors can prescribe any licensed drug off-label if they feel it is in their patient’s best interest. British GPs do not have that right. So although there may be many people in this country being prescribed benztropine legally because they have Parkinson’s, the tens of thousands of us with multiple sclerosis, for whom it has been discovered the drug may work, cannot legally or properly get it. I hope that this Bill will be able to change that scenario. Ideally, the GMC should look again at its guidelines. Ideally, it should allow British doctors the same right to prescribe off-label if they think it is in their patient’s interest.
I was greatly heartened by the speech of the noble Baroness, Lady O’Neill, on participant-led research. I discovered a few years ago that the National Hospital for Neurology and Neurosurgery in London was about to conduct some clinical trials on the use of botulinum toxin. I persuaded, forced and blagged my way on to that study; I was patient number 51. We conducted the study and I signed every waiver under the sun. I was not interested in suing if something went wrong, but I wanted the hope that it would change and improve things. It did. That drug was life-changing in dealing with some of the side-effects of multiple sclerosis, and NICE has now approved it.
I assure your Lordships that in any study you undertake, in any research you do, you will find that there are tens of thousands of us, particularly those suffering the worst diseases such as motor neurone disease and Parkinson’s, who will volunteer to participate in clinical trials. We do not want to wait five years while another pile of mice and rats are experimented on. This rat is willing to become a guinea pig at very short notice.
I cannot see any medical harm from my noble friend’s Bill. I can see that there may be a loss of income for some in the legal profession, but my concern is to get medical treatment when I go to see my consultant or doctor—not to give a lawyer an excuse to sue my doctor if he gets it wrong. The medical profession is being held back, slightly, because of the fear of litigation. If my noble friend’s Bill allows more of us to participate in a rapidly organised clinical trial, or even to test out drugs that have been approved for one use and may be beneficial for another, we should be allowed to do so.
I have never sat in this Chamber or the other place and demanded rights for this or that, but those of us with some of these illnesses can make a contribution as we head to our eventual end game. It is not just trying any quackery or weird invention in desperation. There will be properly conducted trials along the lines of my noble friend’s Bill, with all the safeguards which the noble and learned Lord, Lord Mackay of Clashfern, suggested. I therefore support my noble friend’s Bill.
Lord Giddens (Lab)
My Lords, I join other noble Lords in congratulating the noble Lord, Lord Saatchi, on his extraordinary determination in conceiving of the Bill and in bringing it this far. Many here will remember his opening comments in the short debate some while ago. The noble Lord, Lord Willis, who followed the noble Lord, Lord Saatchi, commented that in all his years in the House of Lords,
“I do not think I have ever heard a more moving, considerate or emotive speech than that of my noble friend Lord Saatchi”.—[Official Report, 16/1/13; col. 761.]
We have heard another emotive and powerful speech from the noble Lord this morning.
A good deal of public discussion and consultation has ensued since then. Emotion and compassion may remain the driving forces behind the Bill, but it must clearly be shaped by reason, since we are talking about promoting the cause of medical science. It is fair to say, as we have heard today, that core aspects of the Bill remain controversial and fiercely debated.
At the minimum, the noble Lord, Lord Saatchi, has stirred up a significant debate, which has involved many people, including patients, and has had the outcome of unsettling the medical establishment to some extent. I have been sitting here and the noble Lord, Lord Winston, has been fidgeting away through some of the observations that have been made; he himself gave an extremely interesting speech. However, whatever else happens, the noble Lord, Lord Saatchi, has already achieved a great deal by stirring up the issues and bringing them to widespread attention.
I lend my general support to the Bill, although I accept that there are some difficult problems to be resolved. I have a different view, as someone who has worked on innovation issues for some years, from most noble Lords who have spoken so far. I am a social scientist. If you look across the whole field of science and technology, we are living through a period of the greatest and most accelerated innovation in human history. There has never been a period with so many breakthroughs and transformations in so many areas of the sciences and other aspects of our lives. In terms of its speed, scope and global nature, this is a time of technological and scientific innovation simply beyond parallel.
In some areas which overlap heavily with medicine, innovation is exponential rather than simply linear. This is the backdrop to the concerns of the Bill, which I take to be—in some parts, anyway—about the widening gap between the accelerating pace of innovation and the time-consuming nature of established testing procedures. There is often good reason for caution in bringing new treatments to the patient. Yet with the onrush of advances it must make sense to pioneer much faster ways of deploying them, especially when the level of need is acute. We have heard from two noble Lords next to me that the medical profession is exploring various ways of doing this and it is necessary to do so. However, the proposals in the Bill are certainly worth pursuing to see whether they do add something different.
The point of the proposals as I understand them is not only—perhaps not even primarily—that some people close to death might be saved or have their suffering alleviated. It is, following what the noble Baroness, Lady O’Neill, has said, that their involvement could bring benefits to perhaps very large numbers of people in the future if this is seen as part of an ongoing learning process. Like everyone, I think that plenty of questions remain which need to be explored if and when the Bill proceeds. I will briefly mention three.
If the Bill’s objective is to be a kind of mutual learning process, which is how I see it—I was encouraged by what the noble Lord who referred to himself as a rat said in his contribution—we have to decide what would be the nature of the evidence base that is accumulated and who would police it. Open-source access will help but is clearly not enough in itself. I was reassured to hear that there is an Oxford initiative, referred to by the noble Lord, Lord Saatchi, which might be a beginning. This would need to be done in a systematic, co-ordinated way or it simply would not belong within the province of science.
Secondly, as the critics ask, are there adequate safeguards to prevent an imbalanced dialogue between patient, doctor and relatives? We know that it would not be the patient’s decision alone; relatives would almost certainly be called in along with the doctor. This issue has to be explored. Since patients are in a highly vulnerable position it is not always clear that there is an egalitarian dialogue between doctor and patient. I do not say that it cannot be achieved, but this has to be further explored.
Thirdly, as has been mentioned by noble Lords and is important for us social scientists, well motivated policies often have unintended consequences. These have to be thought about in advance. For example, a well publicised case in which a treatment backfires through this process might produce greater rather than less conservatism if it achieves a great deal of public attention. My question for the Minister is whether people are thinking about the possible unintended consequences. Have they been thoroughly scrutinised and thought through?
I hope that the Minister will comment on these points. However, I reiterate that the Bill should be taken forward, and repeat my congratulations to the noble Lord, Lord Saatchi, on his quite extraordinary, amazing persistence, involvement and capacity, and on the speaking qualities that he has demonstrated in pushing this on.
Lord Goodlad (Con)
My Lords, I join other noble Lords in congratulating my noble friend Lord Saatchi on his achievement in securing Second Reading for his Bill and on his advocacy today, and I wish the Bill a successful passage. I also applaud the Government’s role, in which I believe the Minister played a significant part.
The potential implications of the Bill’s enactment are impossible to predict with exactitude, but they could be of great importance. Personally, I hope that enactment of the Bill will lead to an improvement in the understanding and treatment of mental illness; we have heard from noble Lords who are expert in other fields. I was fortunate that my home for the first 14 years of my life was a mental illness hospital—The Lawn, Lincoln—at which my late father was for many years the medical superintendent. I see the Bill as potentially advancing the purposes of his working life.
The extent of mental illness is huge. The Medical Research Council Review of Mental Health Research in 2010 said:
“Poor mental health is common and disabling, affecting 16.7 million people in the UK at any one time and accounting for 15 per cent of all the disability due to disease. It is estimated to cost at least £77 billion annually in England alone and severe forms of mental illness are associated with social exclusion and deprivation”.
The potential for the Bill to improve knowledge and treatment of severe mental illness, anxiety and depression, and neurodevelopmental learning and intellectual disabilities is very significant.
The responses to the Government’s consultation earlier this year have not yet been published, but a response was submitted on behalf of the Faculty of Academic Psychiatry and the Special Committee of Psychopharmacology, both of the Royal College of Psychiatrists, by Professor Anne Lingford-Hughes, vice-chair of the Faculty of Academic Psychiatry. In that response she said that,
“in the last few years management of risk has increased such that doctors may not be able to be as innovative as they wish. NICE demands a certain level of evidence, which may be lacking … A likely unintended consequence of NICE is that some provider organisations appear to regard them as a protocol, with the result that if NICE does not recommend a treatment or approach, a doctor will find it hard if not impossible to deliver it. We suggest that fear of litigation is at the heart of this caution”.
Referring to the draft Bill, which was the subject of the consultation, Professor Lingford-Hughes continues:
“The definition of ‘doctor’ requires consideration since currently ‘doctor’ means ANY registered doctor, specialist or not, and therefore the way is open for any doctor who might be wholly unqualified to determine whether the conditions of subsection (3) apply”.
Today is not the occasion to consider all further concerns of the Royal College of Psychiatrists, which we shall address during the Committee and Report stages. However, I hope that in considering the Bill the Minister will confirm that the Government will give full attention to the opportunity created by the tenacity of my noble friend Lord Saatchi to the interests of the mentally ill, as well as of countless others.
Lord Brennan (Lab)
My Lords, everybody in the House admires the determination of the noble Lord, Lord Saatchi, in advancing the Bill. I am sure that noble Lords all agree that we should improve and enhance responsible medical innovation. However, the question to answer is not that, but whether the Bill performs a significant part of that objective. I speak as a practising barrister who has done medical negligence over the years on both sides, and as a trustee of the International Centre for Circulatory Health at St Mary’s Hospital, which regularly finances cutting-edge research into circulatory health.
Let us test the Bill against the objectives. First, is it necessary? Secondly, are there dangers? And thirdly, how does it fit in to an overall framework for improving medical innovation in this country?
First, is the Bill necessary? This point has nothing to do with litigation. It is highly unusual, and I cannot at present think of another example of a statute that gives legal immunity to a profession in certain circumstances. The Bolam test, as it is called after the case that decided it—which was explained by the noble and learned Lord, Lord Mackay—applies to all professions, not just to medicine. Therefore to give such an immunity by statute is highly unusual. The first and obvious question is: is it necessary? Is the present law lacking? I beg to differ from the noble and learned Lord, Lord Mackay, whom I respect as a most distinguished lawyer, for the following reasons.
The Bolam test—whether the practice accords with a responsible body of opinion—was developed in another case, called Bolitho, in which I appeared in one of the sides of the argument in the House of Lords, which said that that test had to be refined. If there are different bodies of responsible opinion, the test is not a numerical one—whether there are in existence such opinions—but looks at the logical basis to them. Can they be justified in risk-benefit analysis as being in the best interest of the patient and in accordance with a reasonable standard of care? That is an efficient test because it is not numerical; you can hypothesise on a specialised sector of medicine where there might be only two practitioners, or even just one, in a very specialised kind of operation, for example. The test would not fail because of numbers but would be applied on the basis of risk benefit and the logic of serious sustainable practice.
I therefore venture to suggest that the majority of lawyers and judges in this country at the moment would say that the present test was adequate and that it has not hindered the advance of a variety of medicine but has supported it. The noble and learned Baroness, Lady Butler-Sloss, in her then role as President of the Family Division, decided a case where the operation to be carried out on a patient who did not have capacity was pretty well unique. She determined that case on the Bolam test—was it logical and in the best interests of the patient? This has nothing to do with litigation but is to do with principled conduct of professional practice in this country. I am not aware of any evidence of a substantial kind that litigation is affecting doctors’ ability and desire to introduce innovative treatment.
The next question is: are there dangers? The Bill does not distinguish between private and public medicine. Its text almost presupposes public medicine as the paradigm. It refers to any condition, as the noble Lord, Lord Colwyn, pointed out, at any stage of that condition. The risk is obvious. Some practitioners, small groups in a private practice, or the private sector of a medical practice will know that they are going to be legally immune, or will feel confident that they are, and will take advantage of this. It is self-evident. We know, historically, how vulnerable patients will do anything; even with pretty average clinicians, when they have no great confidence in them, some people will do anything in medical terms. That is a danger, and this Bill does not embrace sufficient protections to meet that danger.
Noble Lords should remember the MMR scandal, where the proposed treatment of the rebels led by the medical man who produced the paper, was, “Let’s have a treatment that involves no treatment—don’t give the MMR jab”. We cannot assume that, in this modern world, everybody will act responsibly. There is a risk of medical quackery, and the Bill is not presently sufficient to meet it.
Finally, what about the bigger picture? It is dangerous to conflate the words “doctor”, “patient” and “treatment” as the basis for a test of medical innovation, because it does not take into account the supply chain of medical innovation—the inventors, universities, medical scientists and the big medical companies in pharmacology, or whatever, all of which are inventing. That passes on into clinical trials—and, as the noble Baroness, Lady O’Neill, pointed out, they need serious attention—and into the medical marketplace, where doctors learn about it and apply the treatment. They are the end point in a long process. This Bill does not take that process into account but concentrates particularly on the doctors’ decision. I suggest to the House that that is inappropriate. If we want to do something about medical innovation—I refer to the contribution of the noble Lord, Lord Turnberg—we must look at bureaucracy and regulation and other impediments. With the challenge of cancer and diabetes, with which my trust is concerned, there is much more to be done. We should not allow this Bill to detract from the fact that those major illnesses require a major campaign or programme—call it what you will—by society in general and the state in particular. I am deeply concerned about this Bill, but it could be the vehicle for a much greater attempt to improve medical innovation.
Lord Woolf (CB)
My Lords, like those who have gone before me, I congratulate the noble Lord, Lord Saatchi, on his Bill and endorse the view of the law as it is at present, so clearly enunciated by the noble and learned Lord, Lord Mackay. What is important to appreciate—and, possibly, this may not have come through clearly in some of the speeches delivered today, although all of them were carefully considered and moderate in their tone—is the fact that the Bolam test, good as it is in the courts for determining questions of negligence, is not designed to deal with the question of innovation, although it has been tempered so that it does not prevent innovation, as it might otherwise.
Some time ago now, I had the task, given to me by the noble and learned Lord, Lord Mackay, of looking at civil justice and proposing reforms to it. The area in which there was the greatest need for reform was with regard to medical negligence and how such cases were conducted. There was a remarkable situation whereby doctors and patients were unable to speak to each other and had no confidence in what would be the consequence of doing so. The doctors on the one hand said, “We are threatened by these actions, which can ruin our lives and our careers”, and the patients on the other hand said, “All I wished was for somebody to say sorry for what happened, and no doctor came and said that to me”. The reason for that was that the doctors were worried that, if they did say sorry, it would be interpreted as an admission of negligence, whereas no sensible court would ever take that view.
I stress these matters because, at present, doctors do what I would regard as vital work, taking their courage in their hands and doing what they think is in the best interests of their patient, even though it involves innovation, while having no way of telling beforehand whether they can successfully comply with the Bolam test. The other thing that the law does not do at present is to require doctors to do what is necessary if they are going to innovate in a responsible way—that is, to be open about what they are doing, to make it clear that what they are doing is innovating and to take carefully thought-out steps to see that the cleansing effect of openness that we have heard about applies to what they do. One very important effect of this Bill is to set out a course that must be taken by a doctor if he is going to innovate. Those steps have been gone through in turn by the noble and learned Lord, Lord Mackay; they speak for themselves, and I do not propose to say any more about them than this.
In a Bill of this sort, you can try to find a balance between the dangers involved in innovation and the protections necessary in the interests of the patients, albeit that the patient may not be appreciative of that fact, and may be desperate for something to be done, while no responsible doctor should do what an irresponsible doctor would do. There is always going to be a danger, but there can be a balance. That is a word that really has to be applied with regard to consideration of the Bill. I suggest to the House that it draws a proper balance and takes into account the need to encourage innovation and remove barriers to innovation, while at the same time taking into account the risks by doing so.
The final thing that I would say about this Bill is that it is nonsense to suggest that the culture of litigation that now exists does not have a dampening effect on doctors. The doctors with whom I spoke when I conducted my inquiry made that clear, and doctors whom I have met in the course of my social life have equally made that clear. It is something that hangs over them. At the moment, the problem with the Bolam test is that it may provide them with protection when they get to court, but that is little comfort to doctors who have litigation going from stage to stage through the process to the courts, and whose lives are cast into the shadows by what is happening to them. It will be a great benefit that comes from this Bill, if that is removed by the open and transparent steps that it recommends.
Lord Winston
I apologise for intervening, as I understand that this is a time-limited debate, but this seems to me a very important issue. Every surgical operation in a sense is innovatory because anatomy varies from patient to patient, and many emergencies are highly innovatory when a patient is bleeding. Is the noble and learned Lord convinced that litigation may not be a problem in those circumstances where a surgeon decides not to innovate to try to save a patient’s life when they are bleeding? That seems a very difficult issue under law.
Lord Woolf
Of course, I fully accept that there is a problem in that situation and that not all doctors will be as brave as the noble Lord, given the innovations he told us about in his speech. Other doctors will take the less courageous course and, if faced with an emergency, will take what they feel is essentially the safe route, even though it may not be the best one.
Lord Henley (Con)
My Lords, I start with a brief message to my noble friend Lord Newby, who is no longer in his place, that I will be short and keep within the six minutes. However, I do so purely to remind the noble Lord, Lord Winston, that this debate is not time limited; we can take as much time as we wish as it is a Second Reading debate. We should speak for as long as we wish on Bills of this sort, although the Government can offer guidance as and when they wish. It is largely on the question of the timetable that I wish to speak this afternoon.
I support the Bill for the reasons given by my noble friend Lord Saatchi in his very good précis of it. It is designed to protect the patient and nurture the innovator. I will say no more about the Bill’s merits as they have all been dealt with by other noble Lords, whether speaking as lawyers, medical practitioners or others.
As a former participant in the usual channels, I want to talk about the timetable and to remind the House that this debate is not time limited; indeed, perhaps I should have intervened earlier to point that out. I also want to talk about the truncated nature of this debate and how we can push the Bill on to make sure that it gets to the Commons and has a reasonable chance, despite the difficulties of dealing with Private Members’ Bills, of completing its passage before we rise some time next April.
I find it rather peculiar that a Bill that has attracted 23 speakers should have been put down for debate today, followed by another equally important Bill in the name of the noble Baroness, Lady Deech, which is in turn followed by a third Second Reading on a Bill which seems to have no merit in it whatever as its provisions will all be dealt with by the Deregulation Bill. I simply do not know why the Bill in the name of the noble Lord, Lord Lester, has been put down at all, but there it is. As I say, its provisions are entirely covered by the Deregulation Bill, but for some reason the usual channels decided that it was necessary to debate it when I am told there is a total of 27 Private Members’ Bills queuing up waiting for Second Reading—but, there we are, that is what they have done. Given that we have so few Friday Sittings, it seems very odd to put down for debate today two very important Second Reading debates and one that has no merit in it whatever as the latter will waste time by using up some of those six minutes that my noble friend Lord Newby suggested we should each speak for. I make that plea to the Government. I do not expect a response from my noble friend Lord Howe as he does not have to speak for the usual channels. Having said that, I would be grateful to my noble friend if he could offer reassurance from the Government in his response.
The Government stated in a Written Statement in November last year that they were broadly in favour of the Bill. The Written Statement said:
“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”.
It went on to say:
“Their cause is a noble one, which has my wholehearted support”.—[Official Report, WS 74, 25/11/13; col. 74.]
Bearing in mind the difficulty of the few days that are allotted to all Private Members’ Bills, I make a plea to my noble friend to ensure that the Government do what they can to provide time for this Bill to make sure that it receives the appropriate discussion and investigation that noble Lords, such as the noble Lord, Lord Winston, have asked for, and that it can proceed to the Commons so that another place can deal with it before we rise some time next April, or whenever it is.
That is all I want to say. I do not suppose that my noble friend will feel able to respond to that point in detail at this stage. However, if he could respond at some point, I would be most grateful.
Baroness Wheeler (Lab)
My Lords, I, too, pay tribute to the noble Lord, Lord Saatchi, for his courage and determination in bringing the Bill forward. This House has an excellent record in making sure that the importance of NHS innovation and research is kept to the fore of our debates, and in its scrutiny of health and social care legislation, including, most recently, ensuring that both the Health Research Authority and Health Education England have the key duty to promote innovation and research at the heart of their statutory responsibilities and duties.
As all speakers today have said, there is strong support for the principles and intent of what the noble Lord is trying to achieve and widespread respect for the dignified and very powerful and moving contribution and arguments he put forward. There is also full recognition that the Bill raises key issues over how innovation and research can best be pursued which need to be addressed.
Labour has always strongly supported efforts to bring innovative treatments to patients faster and underlined 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. As we know, the consultation on the Bill was conducted on the previous draft of the Bill. Many of the respondents to the consultation rightly underline their desire to see new and innovative medical treatments in the NHS and support the efforts of the noble Lord, Lord Saatchi, to achieve this. We all want to achieve this aim, and the question before us today is how and whether the changes proposed will help achieve this.
Having been a Member of the House for four years now, and like other noble Lords, I cannot recall another occasion when I have received such a huge amount of solid background briefings, legal documents and advice. I have certainly never before experienced such a powerful and overwhelming “home-straits” push from the sponsor of a Private Member’s Bill. The final 60-page briefing of the noble Lord, Lord Saatchi, sets out his belief that the two major concerns of opponents to the Bill are, first, that there is insufficient evidence that the Bill is needed; and, secondly, that the Bill may encourage quackery. The noble Lord, Lord Saatchi, believes that the fear of litigation or disciplinary proceedings stops doctors adopting innovative treatments and reinforces the culture of fear and defensive medicine in a risk-averse NHS.
In July 2013, in response to an Oral Question from the noble Lord, Lord Saatchi, on the costs of medical litigation, the Minister has previously commented that he has seen,
“no evidence that a particularly large or indeed significant element of that bill relates to medical innovation”.—[Official Report, 15/7/13; col. 524.]
Will the Minister update the House on the latest Department of Health information concerning medical litigation costs and any further research that has been conducted by the department on how the increasing litigation bill impacts on medical innovation?
The noble Lord, Lord Saatchi, also argues that the Bill would provide legal clarity and confidence for doctors when they wish to innovate and that without a change in the law many doctors feel compelled to stick to the well worn path of standardised treatments. He has endeavoured to set out under the Bill essential safeguards and an accountable and transparent system for doctors to follow when deciding whether and how to innovate. Our understanding from press reports was that Sir Bruce Keogh, the NHS medical director, had been asked by the Secretary of State, Jeremy Hunt, to set out the process and framework of how the new legislation could work in practice. That, of course, is vital to consideration of the Bill. We now understand that he has been working on amendments to the Bill itself, and I look forward to hearing further from the Minister on this.
Jeremy Hunt’s Written Statement in the Commons on 22 November last year committed the Government to seeking to,
“legislate at the earliest opportunity, subject to the results of the consultation”—[Official Report, Commons, 22/11/13; col. 66WS]—
on the Bill. I look forward to hearing from the Minister what support the Government are giving to the Bill before us, given the changes to the Bill after the consultation. Will the Government be publishing a formal response to the consultation? Do they undertake to make time for the Bill in this Session of Parliament, as the noble Lord, Lord Saatchi, wants to see?
Finally, in his Statement Jeremy Hunt also supported the contention in the Bill of the threat of litigation against doctors but recognised that as just “one … barrier” to medical innovation. The noble Lord, Lord Saatchi, has made it clear that he, too, sees his Bill in that context; and it is important that, whatever the shape of any final legislation, the House acknowledges that too. Medical innovation and the adoption of new treatments require the whole NHS making research and innovation its business—as was so powerfully set out in the Association of Medical Research Charities’ excellent 2013 report, Our Vision for Research in the NHS, which was the subject of a debate in the House initiated by my noble friend Lord Turnberg and referred to by him earlier.
In response to that debate, the Minister’s follow-up letter of July 2013 to my noble friend contends that,
“the current system allows for medics to initiate novel treatments as long as they are in the best interests of patients and with the patient consent”.
That view is supported by the majority of the bodies representing the medical profession and other health organisations which responded to the consultation. During the AMRC debate, the Minister also reported to the House, in very helpful detail, the actions being taken by the various NHS bodies to address the current obstacles to innovation. Sir Robert Francis, a strong opponent of the Bill in its current form, sums up these obstacles in his very concise and to-the-point way as,
“overzealous bureaucracy, scarcity of resources, ethical reservations and decision-making processes”.
What have the Government done to address these obstacles, so fully identified in debates in this House, and the frustrations expressed that the existing processes and pathways are not being fully used? How have they promoted early access schemes to introduce new drugs and treatments? Take-up by health authorities has been painfully slow, so what are the latest figures? What is the latest position on take-up figures on other key measures designed to speed up getting research and innovation transcribed into practice, such as named patient schemes and adaptive licensing schemes? Are the Government satisfied that the Health Research Authority’s new process for speeding up approval for clinical trials is achieving this? How is the variation across NHS trusts in the take-up of NICE-approved technology appraisals and of the actions outlined in the UK life sciences strategy being addressed?
The issue of whether the current law needs to be changed involves complex legal arguments which have been ably set out by the noble Lord, Lord Saatchi, both today and in his briefing documents, and expertly supported by the noble and learned Lords, Lord Mackay and Lord Woolf, and other speakers. These have been equally expertly refuted by noble Lords with deep concerns about the Bill, as well as by the many organisations that have expressed reservations and opposition. They argue strongly that no change in the law is necessary, that a different change is needed and that any additional support required by doctors should be achieved through guidance on good practice, not through legislation.
I look forward to hearing the Government’s view on the proposed changes to the law. The Opposition will be seeking their own legal advice as the Bill progresses. On that issue, I emphasise that Labour’s strong wish and hope is that the Bill should proceed to full Committee scrutiny. The issues raised are crucial, and my understanding is that the noble Lord, Lord Saatchi, is keen to ensure that, rather than any rushed process, there will be a full debate and scrutiny after today.
The noble Lord, Lord Saatchi, is to be commended on his concern to ensure that the importance of patient consent to treatment is firmly embedded in the Bill and that his proposed change in the law would not affect this. As the Bill progresses we will want to see further measures that ensure that decisions on innovative and new treatments are made with sufficient regard to efficacy and patient safety. In this debate we have heard of concerns expressed by the some of the key patient safety organisations about the Bill.
Noble Lords will know that Action against Medical Research has contended that, although having good intentions, the Bill could have the gravest “unintended consequences” by removing a layer of protection and redress for vulnerable patients who are harmed when their doctors act in a way that no other doctor would support. AvMR says that it would also encourage unsafe and unaccountable practice by doctors and lead to further scandals and tragedies. Sir Robert Francis’s concern is that the Bill removes protection from patients and a right to redress without any adequate safeguards. The noble Lord, Lord Saatchi, addressed many of these concerns in his opening speech, and I look forward to hearing the Minister’s response to the AvMR, Sir Robert Francis’s concerns on patient safety and warnings from the medical organisations about safeguarding patients. How do the Government propose to address these concerns?
There is strong concern over how the doctor’s “responsible officer”, referred to in the Bill, is to be identified. What is the Government’s response to this? What is the Government’s view on how this proposed new law will facilitate and help achieve the major culture change that is needed in the NHS among staff at all levels to ensure that research and innovation is everybody’s business? The survey accompanying the AMRC vision report set out the extent and scale of change among staff and patients that needs to happen to achieve the Government’s goal of,
“every clinician a researcher and every willing patient a research participant”.
In summary, we support the principle of the Bill; we support the desired effect that the noble Lord, Lord Saatchi, wishes to achieve; and we want to have the Bill seen and considered in the context of the urgent need to make real progress on tackling the obstacles and barriers that stop the existing laws and processes which support the introduction of new and innovative treatments being fully used and effective. I look forward to hearing from the Minister how he proposes to proceed.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, I begin, as other speakers have, by congratulating my noble friend Lord Saatchi on bringing forward this Bill and on the inspiring way in which he introduced it. I am sure that he will agree that we have been treated to a debate of remarkable quality. It is of course primarily for my noble friend to respond to the speeches we have heard. It falls to me simply to add a few observations from the Government’s point of view.
It is difficult to approach the theme of the Bill without being mindful of the past and what our forebears have handed down to us. This country has a proud history of medical discovery and innovation. In the 19th century, John Snow’s reasoned approach to a cholera outbreak in Soho gave birth to the discipline of epidemiology. Just across London, at St Mary’s Hospital, the 20th century saw the discovery of penicillin by Alexander Fleming—an advance in medical practice that has saved many millions of lives. Today, in the 21st century, the NHS remains at the pioneering edge of health and care.
Exactly a week ago, in this House, I launched the Assisted Living Innovation Platform, putting the NHS at the forefront of using leading-edge technology in healthcare. At the Health Service Journal innovation summit this week, Innovation Connect and Innovation Exchange were launched—websites that make it easier to connect NHS organisations with both industry and NHS innovators. Also, the establishment of 15 academic health science networks continues to support the uptake and diffusion of innovation.
The UK is also proud to host modern and cutting-edge facilities such as the Manchester Citylabs campus. Partnerships between NHS, industry and academia are pushing the boundaries of medical research, generating growth in the economy and helping NHS patients receive world-class care. Notable examples include the Anglia Ruskin MedTech Campus and the Northern Health Science Alliance.
Innovation is of course especially important in tackling the scourge of cancer, the disease that has been the particular focus of my noble friend Lord Saatchi and his Bill. The Government invest in a wide range of research into the causes of cancer, its prevention, screening, diagnosis and therapy, as well as the organisation and delivery of services. Investment in cancer research by the National Institute for Health Research increased from £101 million in 2010-11 to £133 million in 2012-13. Through the NIHR Clinical Research Network, the proportion of patients entering cancer clinical trials and studies is more than double that in any other country for which data exist, including the United States. Annual recruitment in England to cancer studies is nearly 100,000. In August 2011, the Government announced an £800 million investment over five years in a series of NIHR biomedical research centres and units. This includes £61.5 million funding for the Royal Marsden Institute of Cancer Research’s Biomedical Research Centre. The NIHR funds 14 experimental cancer medicine centres across England, with joint funding from Cancer Research UK. Those centres bring together laboratory and clinical patient-based research to speed up the development of new cancer therapies and to individualise patient treatment. In 2012-13, the centres attracted more than £16 million of new funding from commercial partnerships.
The Government invested £23 million, aimed at increasing the capacity of radiotherapy centres in England to deliver intensity modulated radiotherapy—IMRT—so that it can be offered from April 2013 to all patients who might benefit. IMRT is a targeted type of radiotherapy, particularly useful for cancers in the head and neck. I assure my noble friend and the House that our priority is to ensure that all patients, including those with rare and life-threatening or limiting conditions, have access to new and effective treatments on terms that represent value to the NHS and the taxpayer.
However, it is important to bear in mind that patients with rare conditions deserve the same quality, safety and efficacy in medicines as those who have more common conditions. Indeed, I can say in particular to the noble Baroness, Lady Wheeler, that it was partly with this in mind that we announced the early access to medicines scheme on 14 March 2014. Our hope is that the scheme, which launched on 7 April this year and will operate within the current medicines regulatory structure, could give patients with these conditions access much sooner to medicines that may help to treat their conditions. In particular, a promising innovative medicine or PIM designation will provide a positive early signal to industry of the regulator’s views, which will be particularly valuable to SMEs, as well as providing valuable real-world data to companies for use in subsequent health technology appraisal processes.
By giving patients early access to the next generation of medicines before they are licensed, this scheme could help seriously ill patients in areas of unmet clinical need. We continue to support the existing incentives offered at EU level to encourage the development of medicines for small numbers of patients, or “orphan” medicines as they are known, and the development of the Commission’s plans for adaptive licensing, including its launch of the EMA adaptive licensing pilot on 19 March.
Clearly, the development of new and better treatments in cancer care is a noble aim. That is the goal of the Bill, although, as noble Lords have pointed out, its provisions extend to all care, not just cancer care. This House has considered previous versions before: in the previous Session of Parliament the Government decided that this important issue merited a full and open consultation. That consultation ran from February to April this year and the Government received a large number of responses, ranging from detailed submissions by professional bodies, to the personal views of patients and clinicians. We aim to publish a summary of the consultation responses before the House rises for the summer. The Government worked closely with my noble friend Lord Saatchi on the consultation and it was as a result of the consultation that he made revisions to his Bill. If I may say so to him, it is to his credit that he listened to concerns that the Bill could give rogue doctors licence to practise unsafe medicine, and so acted to increase safeguards in the Bill.
I shall deal briefly with one or two questions raised by noble Lords during the debate. My noble friend Lord Blencathra asked why doctors in the US have much greater freedom to prescribe a drug for an off-label indication than doctors in this country. He cited a GMC guideline that he said made it exceedingly difficult for off-label prescribing to take place. I hope my noble friend will forgive me for not knowing the intricacies of the US system, but I do know that General Medical Council guidance on prescribing is clear that clinicians may prescribe a medicine outside its licensed indication where they judge it is necessary to do so to meet the specific needs of a patient.
The noble Baroness, Lady O’Neill of Bengarve, asked whether the Department of Health was considering a wider review of evidence about clinical trials to encourage patient involvement. Since 2006, the National Institute for Health Research has funded and supported the organisation INVOLVE to advance and promote public involvement in research, including involvement in trials and research studies, from design to publication of results. I also understand that the National Institute for Health Research is conducting a review of public involvement in research called Breaking Boundaries. I would encourage the noble Baroness to involve herself in that work.
The noble Baroness, Lady Emerton, asked about the possibility of vicarious liability for other professionals in a multidisciplinary team. If we look at the way litigation happens, it is hospitals that are sued. We do not expect other MDT professionals to be liable as individuals. In any event, as the Bill is currently drafted, their involvement could be expected to be too remote to found any claim of negligence.
Noble Lords have highlighted the need to strike a proper balance between innovation and safeguards. That balance is a delicate one. Clearly, patient safety is vital and we would all agree that rogue doctors seeking to take advantage of patients with evidence-free treatments must be stopped. Yet a necessary focus on patient safety must not stifle responsible innovation. Doctors should have the confidence to innovate, particularly where existing approaches have been exhausted and where there is no plausible alternative. It is therefore important that the Bill does not create new bureaucratic burdens that could actually decrease innovation, acting against its expressed purpose.
The Bill, as presented, gives a role to multidisciplinary teams in overseeing innovation. This is a solution that Sir Bruce Keogh, national medical director for NHS England, and I do not consider appropriate. Multidisciplinary team meetings involve busy clinical discussions that would struggle to focus on the evidence base for innovative treatments. They are not statutory bodies and their membership varies from specialism to specialism. They may be prone to being under the sway of a dominant consultant. Research and evidence suggest that, while MDTs as a whole are a good thing, their quality can be variable.
For those reasons, Sir Bruce Keogh, through his work with the medical community, has concluded that a focus on MDTs in the Bill is inappropriate. Instead, the Government believe that oversight should come from other doctors with experience and expertise in dealing with the condition in question, in line with the existing Bolam test for clinical negligence. For that reason, the Government believe that amendments are needed to the Bill so that it can as closely as possible reflect the desire to, as my noble friend put it, “bring forward” the Bolam test.
I hope and believe that we can work constructively with my noble friend Lord Saatchi to ensure that the final version of his Bill strikes the correct and necessary balance between safeguarding patients and encouraging innovation as it progresses.
Lord Saatchi
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.