The Saatchi Medical Innovation Bill Q&A Prepared August 31 st 2013 What is The Saatchi Bill? The Saatchi Bill is formally called The Medical Innovation Bill. It is designed to help doctors innovate, so that they can advance medical science and find new and better treatments and cures for diseases and conditions including cancers. What is happening on Wednesday? On Wednesday, September 11, 2013, the Bill is being introduced into the House of Commons by Michael Ellis MP. He will make a short speech in favour of the Bill. We hope this will raise awareness of the Bill and gain public and political support for it. Why are we here? Lord Saatchi wants to convince you that the Bill will help save lives, by supporting doctors who want to innovate and find new ways of treating disease. If you leave here today, convinced of his argument, we ask you to talk to your followers and let them know what is happening. In turn, we hope your audiences will let MPs know that they support the Bill. We want your help in building momentum. What will the effect of the Bill be, when it is passed? Doctors, patients and judges will have much greater clarity as to what is negligent and dangerous practice by clinicians and what is careful and sensible innovation. This will have two effects. 1/ It will allow good doctors who have the best interests of their patients at heart to deviate away from standard procedures and innovate, safely and with the protection of the law as long as what they plan to do follows a clear set of actions. 2/ It will clearly expose the doctor who acts alone and in a reckless way. Courts will be able to adjudicate on good and bad clinical behavior. 1
A doctor who follows the correct process will be protected, allowing and encouraging sensible, contained and measured innovation to take place, with patients consent. A doctor who does not go through the correct procedure and acts alone, as a maverick can be clearly and easily identified. Over time, the Bill will, we believe, encourage innovation and in turn support the development of better treatments and cures for all manner of diseases, conditions and cancers. It will foster a spirit of innovation, which will advance medical science and discovery in the interests of patients. At the same time it will act against the maverick and the snake oil salesman. The Bill will be a catalyst for change. What s in it for the patient? It will free your doctor to consider new treatments and ideas. But, and more importantly, it will allow the patient to demand innovative treatment. Armed with the legislation, a patient will be able to say to his or her doctor: Are you trying everything? Can you do anything differently? The doctor will no longer need to say he or she cannot risk trying anything new. How will it work, practically speaking? What is the so-called correct process? The process will be as follows. The patient s doctor will be obliged to discuss the patient s case with specialists and experts, normally within their own hospital or clinic, seeking consensus from them about the best course of action for the patient. This group of experts is often called the multi-disciplinary team or MDT. It may be decided that the standard procedure is not going to be effective and that offering the patient an innovative treatment that deviates away from standard procedures is a good thing to do. The option and it will only be an option must be explained carefully to the patient. This includes explaining the risks. In some cases this may mean explaining that the risks are unknown especially when the treatment on offer is new. 2
The MDT may not reach a unanimous view. If that happens, the doctor must let the patient know. The patient will always have the option to go through with standard procedures, or consent to the innovative treatment. Don t most hospitals already have multi-disciplinary teams? If so, what s the big deal? Yes, many hospitals already take difficult and challenging cases to an MDT for discussion. It is widely acknowledged as being best practice. The difference is that the Bill, if passed, will give doctors legal protection from being sued if, and only if they go through the MDT AND get consent from the patient. The good news is that the Bill doesn t impose a new process on hospitals and doctors. But won t the Bill will deny patients who have been harmed the right to sue and get compensation? No. A doctor who harms a patient through bad practice or negligent treatment or who makes a mistake can still be sued. Bad doctoring is still bad doctoring and a mistake that courses damage, remains a mistake. The difference will be in cases where an innovative treatment is agreed to and tried where the consequences cannot be known in advance. As long as the MDT and the patient recognize that and sign up to that, then the doctor cannot be sued. But the Bill does not protect the doctor from poor performance. Why do we need the bill? There is a lot of talk about breakthroughs in curing cancer and other diseases. But a brief look at the reality beneath the headlines tells a different story. It is true there have been big breakthroughs; diagnoses of childhood leukemia or breast cancer, for example, are no longer the nearcertain death sentences they used to be. 3
But in many in fact most cancers, too little progress has been made in recent decades. For many cancers, there are no treatments available other than surgery no drugs, no chemotherapy, nothing. For others, such as the ovarian cancers, there has been no therapeutic development for decades, and what treatments are available are, as Maurice Saatchi describes them, medieval, degrading and ineffective. We need more progress. We need doctors who are creative and innovative who are ready to try new ideas and make things happen to innovate. But there is a problem. Defensive medicine is increasingly putting a brake on medical advances. The law is stacked against the doctor who, in the interests of the patient, tries something new. Such a doctor faces a greater chance of being sued and losing his or her livelihood and reputation. At the same time, the law fails to protect patients adequately against the maverick doctor who recklessly experiments on his or her patients. The Medical Innovation Bill will clarify the laws that govern medical negligence cases. It will protect the good doctor who innovates sensibly in the interests of patients, and, at the same time isolate the negligent, reckless doctor. Why can't doctors innovate at the moment? They can. But it is a high-risk enterprise, which many doctors seek to avoid. There is a culture in the NHS that drives clinicians to stick to what are known as 'standard procedures'. These are the proscribed norms of practice for any given illness. Sticking to these gives the clinician protection in law in the event of a negligence claim - irrespective of whether the standard procedures are effective or not. So, a doctor who follows the standard procedures for, say, late stage ovarian cancer will be protected by the law, even if, as is likely, his or her patient dies. A doctor who, knowing his patient has little chance of survival, tries something new, even with the patient s permission, has a far greater chance of losing a legal battle if the patient or their family decides to sue. 4
So, why try something new? Why innovate when it is safer to stick to the well worn path, even when that path leads to the death of the patient? If Doctors were able to innovate in the past and the law hasn't changed, what has and why do we now need the Bill? We have become more litigious. In the past four years the amount of money paid out by the NHS for medical negligence claims has doubled, reaching 1.2 billion in the last financial year. And by the NHS own calculation on cases stacked against it pending court decisions, the NHS faces a bill of 19b these are cases the NHS thinks it will lose in the coming years. In these circumstances, doctors and hospital managers are less likely to step outside the standard procedures and try to find better ways to treat patients. The law doesn t protect them. This builds a deep culture of defensive medicine, such that innovation is not even considered as an option in many cases. Doctors become so used to standard procedures, they may not even think to push beyond failed standard procedures. Of course, innovation happens. But the culture of innovation is dying. This law will encourage it and protect those who innovate sensibly. Why do you keep referring to rare cancers? The Bill is for all doctors and all patients, irrespective of the condition or disease they present with. However, rarer conditions are a particular issue for doctors, and one with which the Bill is most likely to help. Standard procedures are based on what is called Big Data and evidence-based medicine that is, they are designed around what is known to work. At least that is the theory. And it is fine when it comes to common conditions, such as diabetes and broken legs, where there are many patients and where theories have been well tested and proved. But standard procedures based on rarer conditions, where the data and evidence is patchy is a problem. If there isn t an evidence base for a disease, it makes innovation difficult because there are not the 5
numbers of patients available to develop new treatments. It means the standard procedures get repeated, continually fail. And it means, also that less research is carried out because no one wants to spend a billion pounds researching drugs into rare diseases for which the market is small, and scientists often don t wish to study an area for which there is less funding. Big diseases tend to carry the day. This relegates the rarer conditions into a scientific and medical backwater with doctors left able only to repeat their failures. This is why we need to free doctors to innovate, safely, with and for patients. Who is this Bill for? This Bill is for doctors it will protect those who want to find new and better ways of caring for their patients and finding better ways to treat patients. It is for the courts current law is ambiguous and leads to uncertainty. The current law does not define clearly what good, or bad, practice is in regards to innovation. It causes doubt among judges and doctors. This Bill brings clarity. And most of all it is for us patients. Most of us have been touched by ill health, by cancer and rare or hard to treat diseases. And those of us who haven t been, almost certainly will be, one day. None of us know what is round the corner. It will allow us to go to our doctor and say: Have you tried everything? Is there anything new out there? Something that is not standard procedure? I would like you to try it you can, you know, because of the Saatchi Bill. What is innovation? Innovation is anything that is not standard procedure, anything new, anything designed to improve results, find better treatments and cures for patients compared with standard procedures. Innovation does not have to be anything spectacular. It might be a slightly different surgical technique, or using a different combination of drugs, or a different dose and it might be doing nothing. The history of innovation often revolves around the individual clinician 6
who has an idea, who is inspired to try something new, who has seen a pattern that others have missed and who bucks the trend. There are many examples. The doctor, at Barts, who refused to do what surgeons across the UK and US were doing with breast cancer - the Halsted method - whereby women with breast cancer faced a double mastectomy, and the removal of all tissue from the shoulder, to the chest wall, to ribs - anything and everything that could be removed without killing the women. Geoffrey Keynes, alone, removed only the tumour and undertook radiotherapy, in combination. He was ridiculed and humiliated on a world stage. Halsted followers called it a 'lumpectomy' as a term of derision. Of course, today, the lumpectomy is standard procedure. That was innovation. If Keynes did that today, and a patient died down the line, he would probably face being sued. Penicillin is another example. It came straight out of the lab and was used to save the lives of soldiers fighting the Desert Campaign WWII. Doctor s didn t have rules or standard procedures or a clear evidence base to work from. They just had a new treatment and a lot of men dying from infections. That was innovation. Of course, NHS hospitals are far-removed from any warzone. But, on the other hand, it is not so different it s just that people are dying from cancers and other diseases one-by-one, up and down the country, in wards, in operating theatres and hospices, unnoticed. Another classic example is HIV combination therapy. In the 1980s men were dying and the drugs that were available were failing them. They demanded better treatment and for doctors to throw every drug at them. There was no trial; at death's door they had nothing to lose. Combination therapy was born. Isn t it the case that we are winning the war on cancer already? No, we re not. It is true that there have been huge advances in some cancer treatments, including breast and blood cancers. But the majority of cancer deaths are from so-called rare cancers. Such cancers, individually, account for a relatively small number of deaths. But together, they account for the majority of cancer-related fatalities. Indeed, one in six of us will die from a so-called rare cancer. There have been few advances in most of them. And for many there simply are no treatments, other than the surgeon's knife. In many cases, going through standard procedures, when the standard procedures are ineffective is a painful demonstration of Einstein s theory 7
of insanity doing the same thing over and over and expecting different results. Is the Saatchi Bill dangerous? No quite the opposite. Not only will it encourage better treatments and advance medical science, with the consent of patients, it will isolate the maverick, the eccentric and the snake oil salesman who act alone. What is the process the Bill has to go through? The Medical Innovation Bill, a Private Member s Bill conceived and sponsored by Lord (Maurice) Saatchi needs to be passed, like any other, through Parliament. This means it needs to be passed by a majority of MPs and Lords in both Houses of Parliament. The constitutional process can be seen here. http://www.parliament.uk/about/how/laws/passage-bill/ But the practical reality is that if MPs and Lords are to pass it, it will need to be approved by the Prime Minister, David Cameron, and the Secretary for Health, Jeremy Hunt. This is so because, as a Private Member s Bill, it is competing for very limited Parliamentary time with official government legislation and a host of other Private Member s Bills. So, the government must support the Bill and make time for it and encourage their MPs to vote for it ideally along with members of the opposition parties in order to secure a majority. There is another way; the Government may decide that it too likes the Bill and wants to add it to one of its own health Bills and make it official government legislation. If this happens, it will be a good thing. Equally, the Government may oppose the Bill, which will make it nigh on impossible for it to proceed. We need public support to ensure it progresses. Without it, the Bill is doomed. How long will it take? That s impossible to say. It could go through both houses very quickly and be on the statute books by, perhaps, next summer. But this is unlikely. We are prepared for a long campaign, which may take two or more years. But the more public support we get, the more likely it is the government will support the Bill. 8
How much will the Bill add to the health budget? Nothing. The Bill is cost-neutral. It encourages innovation. That s it. It is wise to be cautious, but it may even save money. The cost of litigation against the NHS is rising drastically. It has doubled within the past four years and the NHS believes it will be forced to pay out around 19b on cases in the pipeline at the moment. If anything, the Bill may reduce this cost though if it does, it is impossible to say by how much. Who has written the Bill? The idea of the Bill was conceived by Lord (Maurice) Saatchi. The Bill was written by Daniel Greenburg, a specialist lawyer, called a legal draughtsman, who is an expert in constitutional process and in writing legislation. Why has Lord Saatchi created the Medical Innovation Bill? Lord Saatchi s wife, Josephine Hart, died two years ago this summer of a form of ovarian cancer. Moved by grief, taxed by the treatment his wife had to endure and shocked by the lack of progress made in treating and curing gynecological cancers, Lord Saatchi sought to act. He felt that more progress needed to be made and could be made in finding new treatments for cancers and other diseases and conditions. His research discerned that one brake on progress was the fear doctors have of trying new techniques where old techniques have failed. This fear is a result of law suits which can be brought against doctors who deviate from standard procedure. All innovation is, by definition, deviation. The law protects those who tread the well-worn path and can punish those who don t. Lord Saatchi is a Tory. Is this Bill party political? No. This Bill is not party political. We are reaching out to politicians and the media across the political spectrum. There is no enemy, no baddy, no political agenda other than to help doctors find new and better treatments and cures for diseases. Who supports the Bill? We have been working hard, though quietly, to gain support from legal and medical experts and leaders. Today, we can confidently say 9
we have support from many leading doctors and scientists across the country. We have also tested the Bill on some of the UK s most senior legal experts, and they have stated that they understand the need for legal clarity in cases where doctors seek to innovate and that this Bill provides that clarity. They conclude that the Bill will support sensible innovation, while protecting patients. We have also canvassed support from politicians from both sides of the House. On Wednesday September 11 th 2013, Michael Ellis MP will bring the Bill to the House of Commons in the form of a Ten Minute Rule Bill. This could be the first step in gathering Parliamentary support for the Bill. With your help, we will gain political momentum. For more information on Private Member s and Ten Minute Rule Bills see: http://www.parliament.uk/about/how/laws/bills/privatemembers/ Where can I download the Bill? The Bill can be downloaded from the House of Lords Website, here: http://www.publications.parliament.uk/pa/bills/lbill/2012-2013/0061/lbill_2012-20130061_en_1.htm Where can I read more about Lord Saatchi and the Bill? Are there any press cuttings? Yes, there are loads of press cuttings. Here are a few examples but an internet search will throw up many more. http://www.theguardian.com/commentisfree/2013/jun/05/treatingcancer-lord-saatchi-legislative-shrine http://www.telegraph.co.uk/health/9733286/the-fear-of-being-sued-isruining-modern-medicine.html http://www.telegraph.co.uk/health/10024231/i-was-a-desperate-lovertrying-to-save-his-love.html 10
Do you have any other material I can use to write my blog post, tweet about the bill or make a video? Yes. We have uploaded numerous resources, including photographs, to this drop box folder: https://www.dropbox.com/sh/qlquy9fneprk5ly/frqgjz7o4i Social Media Channels Twitter: @SaatchiBill Hashtag: #SaatchiBill ENDS 11