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Telegraph: Lord Saatchi Bill: We must liberate doctors to innovate

Lord Saatchi urges the public to seize a ‘once in a lifetime’ opportunity to change how medicine is practised in British hospitals.

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I don’t remember feeling anger when my wife, the novelist Josephine Hart, died in 2011 of ovarian cancer. I certainly didn’t want to thump anyone. It was a calamity, but grief is not a disqualification for rational thought.

I knew that no one had done anything wrong, or behaved badly, that the doctors who had treated Josephine were neither incompetent nor inefficient, that they did what they were supposed to do with drugs and chemotherapy. They followed “standard procedure”, even if the treatment was degrading, medieval and ineffective, and they knew it would lead to her death.

What puzzled me was how there could be such a ready acceptance in the medical profession of “standard procedure” in the light of the hundreds of thousands who die of cancer. In the case of advanced gynaecological cancers, such as my wife’s, “standard procedure” is 40 years old, offers poor quality of life, and the mortality rate is 100 per cent, with the survival rate correspondingly zero.

They did it, I came to understand, because “standard procedure” is the only safe route they can take legally. The patient, their family, their partners and their lovers may all be desperate for something else to be tried, something new, something innovatory, but the law prevents any innovation, however reasonably chosen and carefully managed. Why? Because it defines innovation as deviation from “standard procedure”, and deviation makes it medical negligence.

In 2012, the NHS paid out £1.2 billion as a result of medical negligence claims, that figure had doubled in four years. And Treasury figures show that we have a pot of £24 billion set aside to cover future liabilities. That is a staggering sum, roughly half of the defence budget. The result is that, if you are a doctor in a hospital, you are all too conscious of the tide of litigation, and you become risk averse. And innovation averse.

There may not have been anything to stop Josephine dying, but the terrible thought that haunts me is that her death was a wasted death. Indeed, all 165,000 cancer deaths in this country every year are wasted deaths because science advances not one centimetre as a result of them. Nothing new is tried and so nothing can be learnt that might spare others. Scientific progress is being halted by the law and fear of negligence bills.

This culture has to change. Last year I introduced a Private Member’s Bill into the House of Lords that set out a legal framework “to encourage responsible innovation in medical treatment and to deter reckless departure from standard practice”.

It was drawn up with the help of the best legal and medical minds, and stipulated that, to innovate, doctors must have patient consent and the agreement of other senior medical experts and practitioners. They cannot go it alone, but they can go beyond standard procedure without fear of ending up in court.

Such Bills usually stand little chance of success, but two things were in my favour. The first was the overwhelming tide of support I received from doctors, lawyers and, most of all, from those who wives, husbands, sons, daughters, brothers and sisters have died wasted deaths from cancer.

“I truly hope with all my heart,” one correspondent told me, “that your Bill is a success and it changes for the better the treatment offered to cancer sufferers in the UK. It drastically needs to change. My husband was belatedly diagnosed with pancreatic cancer in February 2007. We were told (mistakenly) it was inoperable and that chemo was the only option, not as a cure, just to buy him more time, before finally a different surgeon at a different hospital agreed to operate to remove the tumour, saying he could’ve done so at time of diagnosis. The op was too late and the cancer had spread to his lungs. My husband died.”

Or another, who wrote that “when discussing the benefits/disbenefits of certain treatments with my GP, he pointed out that if he did not follow the “guidelines” and something went wrong, he could be open to a legal suit”.

And the second was that, last November, Jeremy Hunt, the Health Secretary, with the backing of the Prime Minister, announced his “wholehearted support” for my proposals, and promised government support to legislate to make them happen, after a public consultation.

But this had to be, he stipulated, “a full and open consultation, a consultation that gets the views of patients on the right balance between innovation and safeguards, a consultation that hears from clinicians on the problems they face in innovating and how to overcome them”. He has even agreed that responses to the consultation – which must be received by May – can be sent to the Department of Health via social media.

Mr Hunt has laid down the challenge. I’m appealing to Daily Telegraph readers to join with me, and the tens of thousands who have already given me their support, to make this the biggest government consultation response ever. We need to say loudly and clearly we want to try new treatments for cancer where the old ones are known to lead only to death. We want to escape being doomed to repeat an endless cycle of failure.

What’s wrong, you may ask, with the way we explore new treatments for cancer now? Clinical trials, random clinical trials, take a long, long time to produce results. It can take 15 years and £1 billion to come up with just one drug. I believe passionately that we will get no closer to a cure for cancer until doctors can test new treatments, in a controlled way, not on laboratory animals but on real patients, with real illnesses in real hospitals.

I believe that we are on the brink of a great medical moment, a once-in-a-lifetime opportunity for a change of culture, away from being risk averse, and back to the spirit of medical innovation that once led Alexander Fleming to the discovery of penicillin or Sir Peter Mansfield to enable magnetic resonance imaging.

In this new culture, we will be able go to our doctors and say, “have you tried everything? I understand there is a treatment out there that might help. Can you try it on me? I have nothing to lose.” And the doctor, for the first time, will be able to say yes.

I can’t promise you that, by itself, this change will cure cancer, but it could encourage the person who is out there right now, who may still be a child, and who one day may free us from this blight on my life, and yours.

Curing leukaemia

IN THE 1940s, the survival rate for childhood blood cancers was pretty much zero. At the time, the scientific literature argued that anyone trying to cure childhood leukaemia was cruel, because the result was always the same: death.

Prolonging the agony with needless, unproven medical interventions was wrong, it was argued; the condemned child should be made as comfortable as possible and allowed to waste away.

A few determined doctors in the United States and Europe challenged this defeatist sentiment. They tried treating the disease with folate, a B vitamin, and discovered that it got worse.

As a result, they tried drugs which reduced folate levels instead. This worked and led to the introduction of the still-used drug methotrexate.

Andy Hall, Professor of Experimental Haematology at the University of Newcastle upon Tyne, says: “What those doctors did then couldn’t be done so quickly now.

“Those doctors were close to the patients dying on the ward and not prepared to accept the status quo. Survival rates for children with leukaemia today are around 90 per cent.”

‘Off-label’ drugs

DEVIATING from the standard medical procedure can offer hope to those with the most dire prognoses — which is why Prof Angus Dalgleish, Professor of Oncology at the University of London and the Principal of the Cancer Vaccine Institute, is a supporter of the Saatchi Bill. He feels doctors are too often afraid to try new ideas, by prescribing drugs “off label” — for diseases for which they have not been licensed. “I have recommended logical, non-standard treatments to cancer patients who have run out of standard options,” he says. “I have seen on many occasions patients who have benefited dramatically.”

One example was a 63-year-old man with metastatic prostate cancer for whom the usual treatments were not working. “We agreed that he try a drug licensed at a high dose for another condition. Even though his other doctors thought his case was terminal, he had a marked clinical response and survived for another three years, dying not from his disease but due to the indirect chronic effects of his previous therapies.”

How war promoted modern surgery

War is a crucible for medical innovation. Medics are faced with men and women who are dying, often in large numbers and are driven to try new techniques, sometimes developed in the heat of battle. They have little to lose and all to gain – saving otherwise doomed soldiers from death.

In the Falklands war of 1982, Surgeon-Captain Rick Jolly OBE – a man decorated both by the British and the Argentinians for saving lives on both sides – operated in a field hospital with an undetonated bomb lodged near his operating table. He discovered that casualties left out in the cold because it was impossible to collect them from the battlefield fared well, in many cases, leading to the development of theory of therapeutic hypothermia, whereby patients can benefit from deliberate cooling.

Penicillin was first used in earnest in the Second World War. Doctors were aware of its benefits, but not necessarily how to use it and in what doses. However, knowing that personnel would likely die without it, doctors administered it, learning as they went. Military doctors facing injury and suffering on a massive scale during the Second World War also pioneered advances in antibiotics, anaesthesia and blood transfusions – advances that would usher in the age of modern surgery.

The innovating breast cancer surgeon

GEOFFREY Keynes could arguably be considered the patron saint of innovation. In 1922, the surgeon, based at Barts Hospital in London, developed the lumpectomy for breast cancer, flying in the face of orthodoxy. Back then, the accepted practice for dealing with breast cancer, developed by the all-powerful American surgeon William Halsted was the radical mastectomy. The “Halsted Procedure” was a physically deforming operation involving removal of the breast tissue, skin, nipple, axillary lymph nodes and the underlying chest wall muscles.

Keynes, the brother of economist John Maynard, began using removal of the tumour and radiation therapy to treat breast cancer. More than 70 per cent of his patients survived five years, a rate that was similar to that in patients who underwent the Halsted operation, yet without the massive, debilitating surgery.

For his pains, Keynes was ridiculed — yet lumpectomy was gradually accepted as a standard treatment, with the Halsted operation rarely performed today.

The future?

How might the Saatchi Bill work in practice: a hypothetical case study.

Doctor Glenda Smith is treating a patient, Alison Jones, for a rare and life-threatening condition. She asks Dr Smith about a new kind of non-surgical treatment she has read about. Dr Smith discovers the new treatment has not been tested for Alison’s condition, although it has been used for other illnesses.

Under the present legal conditions, Dr Smith will feel safest to say that in the absence of published research, she cannot advise anything departing from the standard surgical procedure. If she innovates and Alison dies earlier than would be expected statistically with standard treatment, she will be vulnerable to disciplinary or legal proceedings.

Under the Bill, if Dr Smith was impressed by the arguments in favour of the new treatment, she could follow the process outlined in the Bill, which includes talking to other experts and to Alison and her relatives about the innovative treatment, and obtaining a consensus as to its use.

If the case came to court, Dr Smith could be confident she had followed the Bill’s processes and any court decision would be made in that light. There would be no opposing ranks of “experts” commissioned by the two opposing legal sides, after the event.

→Watch Lord Saatchi explain his Bill visit telegraph.co.uk/video

→Read: Telegraph stories and updates on the Bill:telegraph.co.uk/health/saatchi-bill/

 

 

Why innovation would help patients with womb cancer

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Photograph ©_honus_ on flickr 

By Kaz Molloy

As a womb cancer survivor I endured surgery, chemotherapy and then radiotherapy – often referred to as the slash, poison and burn approach to dealing with cancer.

Over the past few decades there have been many advances in detecting cancers early but the standard approaches to treatment remain mostly unchanged. In some cases the treatment regime has been the same for decades, leaving patients at the mercy of sometimes ineffective and often barbaric treatments.

Routine chemotherapy for womb cancer is a very recent innovation in the NHS as studies have shown that 1 in 10 women will be helped by chemo – so it is definitely worth trying.  But maybe an individual assay of each patient’s tumour might be able to detect which tumours will be susceptible to chemotherapy and which tumours won’t. This would spare 9 out of 10 patients (and their families) a seriously distressing treatment programme.

We are now in the 21st century and yet innovation in the treatment of most cancers has not progressed because of the failure of the NHS medical establishment to try anything new. Many doctors are afraid to try new procedures because of the risk of being sued if something goes wrong.

The Saatchi Bill seeks to bring about a change in the law to protect doctors and allow them to push forward with innovation in new treatments, which is something that we all want.

As far as womb cancer is concerned, although it is often classed as a rarer cancer, it is still a cancer with a relatively good survival rate, if detected early. It is predominantly a cancer of post menopausal women, although in recent years there have been more and more younger women being diagnosed. However, when they present at their GP with all the typical womb cancer symptoms, they are often told they are too young to have womb cancer so the chance of early detection is missed.

We at Womb Cancer Support UK would like GP’s to take our symptoms more seriously. Most of us had problems with heavy bleeding, fibroids, polyps etc. for many years prior to diagnosis. Some of us have had polycystic ovary syndrome or have Lynch Syndrome in our families.

Womb cancer, like cervical cancer, commonly goes through a well-known pre-cancerous stage known as EIN :  Endometrial Intraepithelial Neoplasia  (Abnormal thickening of the womb lining). Statistically a woman with EIN is according to one researcher 45 times more likely than a woman without EIN to develop womb cancer.

Of course until there are definite biomarkers for EIN and womb cancer, it seems sensible to give at risk women a far better chance of earlier diagnosis of womb cancer. Surely it would make sense that if a woman is presenting at her GP with severe heavy bleeding, that she be monitored to see if she has EIN and if it increases or decreases.

The issue of younger women being diagnosed with womb cancer also brings up the fertility issue. At present many young women are being denied the chance of motherhood because of the pressure to have an immediate hysterectomy and/or cancer treatment. We would like to see all women of child bearing age being given details of all options available to them. In the case of early stage cancer it is sometimes possible for a woman to go ahead with a pregnancy before any treatment commences.

Of course, what we at Womb Cancer Support UK would really like to see is more research done into the causes of womb cancer which will then hopefully lead to a simple screening test.

Some of the recent media reports about women getting womb cancer because they drank too many sugary drinks; drank too much/not enough coffee; don’t get enough exercise; are too fat; etc. are not helping to raise awareness. They are simply trying to blame the patient for getting cancer.  I know of women who have never drunk sugary drinks, who ran marathons and are/were far from being obese yet they still got womb cancer.

The blame game has to stop. Instead we need proper research to find out the causes of womb cancer.  GPs need to focus not on stereotypes, which can be misleading, but on symptoms, which are very clear.  To be fair to GPs, they need rapid access to diagnostic tests.  It’s not rocket science that when symptomatic patients have direct access to specialists they are diagnosed with cancer at a much earlier stage.

And just as one-size-fits-all cancer treatment isn’t suitable for every individual patient, neither is the NHS standard test for womb cancer: one-size-fits-all quick, cheap and nasty outpatient hysteroscopy/biopsy with no pain-relief.  This test may be well tolerated by some fortunately tough patients but may prove a nightmare and a deterrent for other patients.

Womb Cancer Support UK (WCSUK) started out in April 2011 as an online support group for women who had or had had a womb cancer diagnosis. It soon became apparent that there was very little awareness of womb cancer so we try to raise awareness of the signs and symptoms as well as offering support and advice to women who have been diagnosed.

About the author:

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Kaz Molloy, founder of Womb Cancer Support UK, was diagnosed with womb cancer at the end of 2009. After treatment which involved surgery, chemotherapy and radiotherapy she became aware of a lack of dedicated support for women with womb cancer so set up an online support group in April 2011.

They now raise awareness of womb cancer as well as continuing to offer support and advice.

Kaz is married and lives on Isle of Bute, off the west coast of Scotland.

http://wombcancersupportuk.weebly.com/

Daily Mail: ‘It could lead to a cure': Jeremy Hunt praises Saatchi’s bid to overhaul ‘medieval’ cancer care

Lord Saatchi and Josephine Hart

→READ: article in the Daily Mail

By Stephen Adams for The Mail on Sunday

Advertising guru Maurice Saatchi, whose wife died of ovarian cancer, has won Government backing for his private member’s Bill calling for more innovation in treatment of the disease.

When novelist Josephine Hart died two years ago, the Tory peer described her treatment  as ‘medieval’.

Lord Saatchi has since fought to enable doctors to use procedures other than surgery, radiotherapy and chemotherapy.

He argued they are too often hamstrung by legal rules which mean they can be sued if they ‘deviate’ from standard treatments, even if they know it will do little good.

 The peer, founder of advertising giants Saatchi  & Saatchi, sponsored the Medical Innovations Bill to reduce the threat of litigation and ‘encourage responsible innovation’.

And on Friday, Health Secretary Jeremy Hunt praised the Bill, saying it ‘could lead to major breakthroughs, such as a cure for cancer’

Mr Hunt announced a ‘full and open consultation’ in the New Year to understand ‘the problems [doctors] face in innovating’ and strike ‘the right balance between innovation and safeguards’.

Last night, Lord Saatchi said: ‘I think the  Prime Minister and the Secretary of State want Britain to regain its place as the world leader  in medical innovation.’

He stressed patient safety was at the heart of his proposals. ‘We do not want reckless experimentation that puts patients at risk, and we don’t want patients to be treated like mice,’ he said.

Obtaining informed consent to take part in experimental treatments would remain essential, the peer stressed,  and doctors would retain full legal responsibility for  their decisions.

→READ: article in the Daily Mail

Your support won the Government consultation for the Saatchi Bill

The strength of public support for the Medical Innovation Bill (Saatchi Bill) has persuaded the Government to offer legislation along the lines of the Medical Innovation Bill, following a public consultation to start in January 2014 and report no later than May.

The ministerial statement and press release expressly referred to the professional and public support that Michael Ellis MP and Lord Saatchi had received (read them here). Your support won the consultation.

As a result of all this, Michael Ellis did not propose the Second Reading of his Bill today, and the Bill in its present form will not be proceeded with this Session.

Public support has got us this far and now, as we work with the Government, a new stage of the campaign to encourage more medical innovation begins.

This direct chance for patients and their families to affect policy will stand or fall by the quality of what we say.

Now is the time to begin to consider personal experience of treatment, to think what might be made better for friends, family and loved ones through innovation.

The team are excited that we have come this far, this fast. Thank you for making it happen.

There is a long road still to travel, but we are on our way.

Photograph: ©Phalinn Flickr

Government agree to full consultation on Saatchi Bill

Read full statement from the Department of Health: http://t.co/Tvcbvf7cpf

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

WRITTEN MINISTERIAL STATEMENT
DEPARTMENT OF HEALTH
Medical Innovation (No 2) Bill
Friday 22 November 2013

The Secretary of State for Health (Jeremy Hunt): Medical innovation has been vital to the dramatic rise in life expectancy of the last century. This country has a proud heritage of medical innovation from Alexander Fleming and the discovery of penicillin to Sir Peter Mansfield’s enabling of magnetic resonance imaging.

The government should do whatever is needed to remove barriers that prevent innovation which can save and improve lives. We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment.

The Medical Innovation (No 2) Bill, sponsored by my honourable friend the Member for Northampton North (Michael Ellis), and the comparable Bill introduced by my noble friend Lord Saatchi in the other place, correctly identify the threat of litigation as one such barrier. Their hope is that legislation to clarify when medical innovation is responsible will reduce the risks of clinical negligence claims. Their argument is that with this threat diminished, doctors will be confident to innovate appropriately and responsibly. This
innovation could lead to major breakthroughs, such as a cure for cancer.

Their cause is a noble one, which has my wholehearted support. Lord Saatchi, in particular, is a great example of a parliamentarian motivated by conscience.

It is precisely because this issue is so important, because it affects us all, that we need a full and open consultation. A consultation that gets the views of patients on the right balance between innovation and safeguards. A consultation that hears from clinicians on the problems they face in innovating and how to overcome them. We are grateful to the hon Member and the noble Lord for their own work to understand and address these issues.

So the government commits today to carrying out a full consultation, working with Lord Saatchi and the hon Member for Northampton North. This will draw on the wide engagement and discussions that they have already carried out with the public, patients and the legal and medical professions. Such a consultation will enable an open debate on medical innovation, as well as highlighting its vital importance. The government expects to launch this consultation in January 2014 and to respond by May 2014.

My second commitment is that the government will seek to legislate at the earliest opportunity, subject to the results of the consultation.

We all owe a debt to the hon Member and Lord Saatchi for the great effort they have already expended on this issue. The government will work closely with them to bring this to a
satisfactory conclusion.

Read full statement from the Department of Health: http://t.co/Tvcbvf7cpf

 

 

The importance of innovation

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By Chris Lewis 

This piece has probably been one of the most challenging that I have ever written, because the subject can be so broad. Most of my writing is in the ‘cancer field,’ but I am going to write about some more general issues, and attempt to tie it all together by the end.

My first task is to define the word in simple terms, and this is the best description I have found. 

‘Innovation means doing something new, different, smarter or better, that will make a positive difference.’

As a self-employed business consultant in my life before cancer, I was always looking for solutions to problems. What could improve things, for both the business and the customer? Not all problems are solved by spending more money. It is often possible to make small changes to the way you do things, which can produce beneficial results. In many instances, it is very difficult for the people close to the business to either see or accept that change is required. That is where a fresh pair of eyes can really help.

Since cancer entered my life, it, and the treatment associated with it, have battered me for 6 years, meaning that I have been unable to continue my work. However, old habits die hard, and despite lengthy spells in hospital, I have been looking at ways to improve things in the current service.

The main thing that became obvious to me is that there is very little support, for people affected by cancer, outside the hospital environment. I was shocked to discover that! Before I got sick, I always assumed that the system would provide support for me where necessary. It is important to add, that I am not one for even asking for any help, but it would be nice to know if something was there for the people who may need it.

The fallout from a cancer diagnosis and treatment can be more damaging than the cancer itself, both physically and emotionally. Causing people to lose their job, partner, house etc and ultimately creating a downward spiral for that person. As more and more people are affected by cancer, this problem is increasing. Due to the fact that every case is unique, our previous approach of ‘one size fits all,’ is no longer appropriate.

Our population is so much more diverse now than it was even 20 years ago, and I am not convinced that our support reflects that. Different communities deal with these issues, in contrasting ways. Also we are only recently starting to get to grips with the different needs of young children compared to older people. How long has it taken for us to get to single sex wards?

Things have changed dramatically in recent years, and the way we live our lives is now totally different, with technology playing a massive part in that. However, when I look closer into the cancer world there are still many things that haven’t changed. One example of this is ‘support groups.’ I would like to start by saying there are some very good ones around. But mostly, they are run by volunteers, for people who are unwell. Not everyone can make a fixed monthly time, of course, and for some people, the last thing they really want to do is talk in front of others about their very personal issues. The attendance becomes sporadic, and after sometime they fold, mostly due to lack of support in running the group, or attendance drops due to lack of interest.

It is so important to start looking differently, at the way we deal with our healthcare, not just cancer. Ill health is not something that only happens to other people. Unfortunately it will happen to us all! We are now living in a 24/7 society, but, we don’t have a health service that reflects that! Our GPs rarely work after 7pm and at the weekends. Million pound machines lay idle, and waiting lists grow, as we struggle to accept weekend working. By the above definition, this would be innovation. (Working smarter)

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My business guru is Steve Jobs (Apple.) A recent example of innovation is the ipad. Jobs believed in it, when no one else could see where it would fit into the market, but his instincts were right, as by the middle of 2011, the iPad was proving to be a more revolutionary product than even the iPhone and the iPod. The iPod and iTunes changed the way people bought and listened to music. The iPhone changed what people could expect from their mobile phones. But the iPad was turning five industries upside down. It was changing the way consumers bought and read books, newspapers, and magazines — as well as the way they watched movies and television.

He was close to the market, and saw what the next trend might be and created it! He wasn’t afraid of criticism and was always looking to try new things. Today, we have technology to help us, but that is only really half the story. The biggest battle that I encounter in healthcare is that so many organisations are ‘closed’ to the idea of change. An air of suspicion is aroused. Red tape is thrown up to aid defences, and inevitably innovation is slowed. Ironically the welfare of the patient is cited as the reason that things can’t change! Excuse me, but things may improve if we looking at doing things differently!

People tell me that healthcare is not a business, but actually it is, just as charities are too! From my experience they can all be run ‘leaner and meaner.’ Innovation is something to embrace, not to fear! But until we learn that, we will always be holding back progress.

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Chris Lewis is an international cancer blogger, speaker, patient and mad Crystal Palace fan. Read Chris’ popular blog here: www.chris-cancercommunity.blogspot.co.uk and follow him on Twitter: @christheeagle1

Update: 18th October – A chance for Parliamentary progress

The next important Parliamentary event for the Bill will take place on Friday 18th October.   

The Bill is on the House of Commons’ Order Paper for 18th October as one of the Bills waiting for Second Reading.

Friday 18th is a private Member’s Friday, which means that there is a long list of private Members’ Bills for Second Reading on that day, and they will be debated in order from 09:30 until 14:30.

Our Bill is much too low on the list to have a chance of sharing in the available debating time.

But at 14:30 when debating time runs out, every Bill on the list will be “called over”: that means that the Member in Charge of the Bill, in our case Michael Ellis MP, will get a chance to move the Question that the Bill should be given its Second Reading.

If nobody in the Chamber at the time shouts out “Object”, the Bill will be treated as having passed its Second Reading stage and will proceed automatically to its next stage, Committee.

So we need to persuade everyone who is likely to be in the Commons Chamber at 14:30 on Friday 18th October (including the Government’s “Whip” – or business manager) to stay quiet at that critical moment; if we succeed, the Bill will pass its Second Reading stage and will be sent “upstairs” for its Committee Stage, where its details will be scrutinised line by line in a public forum.

Friday 18th is not going to be a chance for a public debate on the Bill, but it is an absolutely critical opportunity for the Bill to make process towards public debate and Parliamentary progress in the Commons.

A number of MPs who have been lobbied so far have replied that the Bill is too low on the Order Paper for 18th October to be debated that day.

It is important to reply that we know that, and that our objective for 18th is not to have the Bill debated, but to have it passed “on the nod”, without debate, through Second Reading and into Committee.