Tag Archives: medical innovation

Is the Medical Innovation Bill different from the current legal requirement that a decision to treat is one which would be supported by a responsible and rational body of medical opinion?

It is a practical application of the existing hypothetical test which asks doctors to imagine what colleagues’ views would be, but not to ask them unless and until the matter comes to trial.

Under the Medical Innovation Bill the doctor will actually ask colleagues for their opinion at the point of treatment.

Medical Innovation Bill is passed by Lords and sent to Commons at third reading

Maurice Saatchi’s Medical Innovation Bill was passed by the House of Lords and sent to the Commons following its third reading in the House of Lords on 23rd January 2015.


→READ: The full transcript of the debate in Hansard

→READ: The Bill as amended at third reading

There were two amendments tabled from Lord Winston and Lord Hunt both of which were supported and signed by Lord Saatchi.

We are thrilled that Lord Hunt’s amendment on the Medical Innovation Register was accepted.

This unprecedented register of innovation, which has been called for by many organisations and individuals, will make it a mandatory requirement for anybody using the Bill to register the treatment and the outcome, both positive and negative.

It moves treatments that without sharing and transparency could become just an anecdote into sharable evidence that can be used to treat other patients and inform clinical trials.

Oxford University have already offered to host the Medical Innovation Register and the Medical Innovation Bill team is consulting widely on how the register will be set-up, managed and funded. We will keep our website updated with all the latest developments.

The Bill has now moved to the House of Commons and is a step closer to helping patients receive novel and innovative treatments.

Thanks so much for your support so far.

During the third reading Lord Kakkar said:

“Clearly, providing transparency and the opportunity for sharing the outcomes of such innovations rapidly and broadly across clinical communities in this country and internationally is of so much importance.

It will allow colleagues to understand what has been achieved and not achieved; it will allow those with other ideas to build on knowledge gained from experience to date; and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection.”

Lord Kakkar is professor of surgery at University College London and a member of the General Medical Council.

During the third reading Lord Giddens said:

“Science is a collective enterprise. It depends on the accumulation of evidence. It is crucial that that be recognised formally somewhere in the Bill, with this embodied as part of the advancement of scientific progress more generally”


Telegraph:  We now have hope of finding new ways to treat incurable diseases

Telegraph: How Lord Saatchi won over the critics

Telegraph: The law can’t cure cancer but it can help people who might

Daily Mail: New ‘experimental drugs’ law moves a step closer

Case study

Lord Ribeiro, a British surgeon who served as President of the Royal College of Surgeons of England from 2005 to 2008. Shared a very interesting case from the 1990s which demonstrates both the need and benefits of having a innovation register.

“My Lords, many noble Lords will remember the disasters that occasioned the introduction of laparoscopic cholecystectomy in the 1990s.

Quite a few patients suffered as a result of the innovation of our surgeons playing with a new instrument, new tools and a new operation.

At the time, I was secretary of the Association of Surgeons of Great Britain and Ireland.

In recognising the problems, we introduced a voluntary register of all surgeons undertaking the procedure and got a very good response.

Admittedly, it was not compulsory and not every surgeon introduced their data to it, but the net effect was that when we analysed our data we were able to identify where many of the problems lay.

That led to further research and proper control trials in the procedure. We were able to turn to that from an innovation used by a succession of surgeons as and when they felt necessary, without any good evidence on how best to use it.

On that basis, and mindful of the benefits that we saw in the 1990s, I would very much support some form of register to ensure that, if an innovation is introduced, we have the information, can go back and refer to it again, learn from the mistakes and improve the outcome.”

The Medical Innovation Bill will support evidence-based medicine

Prof Walker - Medical Innovation Bill
Prof Walker – Medical Innovation Bill

One of the key tenets of the Medical Innovation Bill is that it will oblige doctors to record and share the results of incidental medical innovations in the Medical Innovation Register.

This applies to both positive and negative results.

→READ: About the Medical Innovation Bill Register

As such, the Bill will begin to build data around innovations in a way never before seen in this country.

We know that medical innovation already happens – though this bill will encourage more innovation by setting a clear process for doctors to follow that will ensure patient safety and offer the doctor legal clarity.

But currently, there is no register for innovation, no database, no record of success or failure.

Medical Innovation Bill - Oxford University
We are working with Oxford University to produce an open access database of treatments and outcomes under the Bill.

So no one can replicate those successes and avoid the failures.

Recording such data would also allow doctors and researchers to follow up on promising new therapies.

Dr David Walker, professor of paediatric oncology at the University of Nottingham says:

“If evidence started to amass under the Medical Innovation Bill, that a treatment works then it would support the establishment of new trials.

“Historically medicine has a large number of situations where new treatments have been developed by repurposing drugs for a new indication.

“Currently this step is hard to make as people say that although the drug exists, is licensed, it cannot be used off license if there is no evidence as it would be  wasting money that could be spent on licensed drugs for licensed indications.

“This is particularly damaging for people with rare conditions where research is rare – this applies to cancers in particular.

“In childhood 60% of all drugs are off licenses many of our strongest treatments are a product of off license development or repurposing of drugs.”

The Medical Innovation Bill would could speed this process of re-purposing drugs up thereby enabling treatments to get to patients quicker.

Prof Walker added that this would create a system where the recording of pre-trial results of therapeutic innovation would become “a recognised and appreciated step in the drug selection process, particularly in rare conditions.”

“It could help to reduce the risks of failed trials”

→READ: About the Medical Innovation Bill Register

Dr David Walker is a Professor Paediatric Oncology
Children’s Brain Tumour Research Centre
Faculty of Medicine and Health Sciences
University of Nottingham

Telegraph: We now have hope of finding new ways to treat incurable diseases


Published in the Telegraph 24th January 2015

I left the Palace of Westminster yesterday with the word “content” ringing in my ears – the Medical Innovation Bill has passed the House of Lords.

A gentle utterance by fellow peers has ended a three‑year roller-coaster ride that has left me at times elated and at times in despair. But for the moment at least, I too am content. The day when patients with terminal diseases, and their doctors, will together be better able to try novel treatments, legally, safely and confidently, has all but arrived.

There is one more river to cross before we reach the Promised Land. The Bill will now be carried to the House of Commons by Michael Ellis MP, where it will again be debated. Time is the enemy now. Parliament is dissolved in a matter of weeks, ahead of the General Election. But I am confident, because the Lords have sent this Bill to the Commons in good order.

It has been roundly debated, challenged, amended, honed, tightened, clarified and improved by my colleagues on all sides of the House. Honest opposition to elements of it – no one has objected to the principle of the legislation – have now had their concerns met.

I’m particularly grateful to the Labour front bench and Lords Winston and Turnberg – both eminent doctors; Lord Pannick QC, a renowned legal mind; and Lord Hunt, who comes from a stellar medical background. They have debated the Bill and laid helpful amendments that have strengthened it. I also owe a debt to Baronesses Wheeler and Masham.

We have all worked together to lay a joint amendment making it a requirement that doctors who innovate under the Bill must record and share the results – good and bad – of their innovations on an open register. This is crucial if medical science is to be advanced. Doctors and scientists must know what works and what doesn’t. It is a leap forward for all doctors because today those innovations that do take place are not formally and universally recorded. It is also an amendment many medical and research bodies have called for, and I am delighted that today it is on the face of my Bill.

I must also thank the Telegraph and its readers who have followed this Bill and cheered for it. We would not be where we are today without you. Are we home? We are certainly close. I am confident we will find time in the Commons.

I say this because more than 18,000 patients contributed to the Department of Health’s consultation on the Bill last year. Another word for patients is voters. I believe that MPs will also recognise that their constituents want to see change. And they will see that the Bill has been tested no fewer than four times in the House of Lords, taken apart and reassembled line by line. Opposition has evolved into support. During the first committee stage there were 39 amendments made. Yesterday, there were just two – both of which I supported.

But what a journey it has been. The Bill was born in the mire of my personal grief, and inspired by some of Britain’s most brilliant doctors. In recent weeks I have seen supporters such as Charlie Kitley, Ismena Clout, Rachel Stevens – daughter of the Bishop of Leicester – all succumb to cancer. Their memory is dyed in the fabric of this Bill.

And opponents have fought the Bill. Most in good faith. Others less so – and it has been a struggle at times to hold back as my team and I have been accused of being liars, of being in bed with Big Pharma, of having some perverse agenda other than the acceleration of medical science. All I wish is that others may not have to experience what I and the families of those I have just mentioned are experiencing today.

I have, on occasion, let my feelings show. It has been particularly irksome to be criticised by legal firms who profit by suing doctors. In particular, I think of Leigh Day – under investigation themselves for destroying evidence crucial to the defence of British soldiers in Iraq wrongly accused of deliberately abusing detainees.

What is my motivation? Do I have an axe to grind? What is my interest? I will be clear. I am doing this because I believe it is the right thing for patients, for medical science, for finding new ways to treat incurable diseases. And in memory of my wife and all those who have died of cancer.

Published in the Telegraph 24th January 2015


Telegraph: The law can’t cure cancer. But it can help the people who might


Published in the Telegraph 22nd January 2015

Written by Lord Saatchi.

Cancer and its treatment is the number one cause of the untimely death of British citizens. There were around 165,000 cancer deaths this year – the same as last year and the same as next year.

Apparently, cancer is so complex that it is beyond the judgment and understanding of the human mind to comprehend all its variables.

This point was confirmed in a recent study by scientists at America’s distinguished Johns Hopkins University which concluded that many cancers are “just bad luck”.

The law cannot cure cancer. Parliament’s power, though awesome, is not sufficient. Only science can do that.

But the law does have the power to change the culture. Consider its impact on race, drink-driving, smoking in public places. No amount of exhortation or guidance from on high could have achieved what the law has done. No one would consider smoking in a restaurant today.

The Medical Innovation Bill, which tomorrow returns to the House of Lords for its third reading, does not offer some miracle treatment for a sofar incurable disease. But it will, I believe, encourage the men and women who will who find those cures.

This is why I hope the House of Lords will decide to pass the Medical Innovation Bill – a Bill that has been strongly supported by The Telegraph from the start – and send it to the House of Commons for approval.

This follows 18-months of line-by-line scrutiny by some of Britain’s greatest judges, doctors and scientists, with safeguards designed by Sir Bruce Keogh, Medical Director of the NHS and with the approval of the Government and many thousands of doctors and patients.

Here is the situation for many people today. When a patient with cancer or a child with a degenerative disease – such as Duchene muscular dystrophy – is handed a terminal diagnosis, when the doctor says there is nothing to be done other than offer standard treatments which are known not to work, two things happen.

First, the patient dies. Second, medical science is halted in its tracks by the repetition of the same, failed experiment. Doing the same thing, offering the same treatment, knowing it won’t work is madness.

Today, the law protects the doctor who carries out only standard procedures. It says that that doctor cannot be sued if – as it always will – the treatment fails.

My Bill won’t change that. A doctor can continue safely and legally prescribing the standard therapies if they wish. There will be no obligation to innovate. What the Bill will do is offer the same protection to a doctor who offers an innovative treatment to the dying patient – in advance of the treatment taking place, as long as they can get the support of at least one other relevantly qualified doctor.

It will encourage them to think beyond the standard treatment. It will allow them to see what else might – only might, for there are no guarantees – make a difference to the dying patient.

It will change the culture of defensive medicine to one where the balance of risk is gently recalibrated making it permissible to consider trying something new, something less well documented than the well-worn path to death.

And lest there be any doubt about what is responsible for the culture of defensive medicine, look at the facts. Last year we, the taxpayer, paid out £1.2bn to meet negligence claims against the NHS, a figure that has doubled in five years. According to the Treasury, we the people have a further liability for a staggering £26bn, up £2bn since last year.

Many who have had concerns about the Bill have pointed out that if it is to make a difference to medical science, then the results of innovations need to be documented and be shared so that other doctors and scientists can make use of the results – avoid the failures and try to repeat the successes by setting up full medical trials.

Yesterday, the Genetic Alliance UK wrote to Lords saying it was vital that “registries are created to enable the collection and exploitation of real-world patient data, and promote the sharing of research findings and best practice.” The Government agrees that the collection and sharing of new data derived from innovation will both advance scientific knowledge and provide the accountability and transparence required for patient safety

The Bill encapsulates what is seen as by the top hospitals as best practice – that is discussing innovative treatments with expert colleagues in advance of that treatment. Doing this means that doctors can formulate the best options – and calculate the risks to the patient. The Bill says if doctors do this and write it all down and get the patient’s consent, they will be legally protected.

This is why I hope today my Bill, soundly tested, forensically analysed line by line by my colleagues in the Lords who number among them some of Britain’s top legal and medical brains – and amended by them – will pass to the Commons.

And it is why Regius Professor of Medicine at Oxford University Prof Sir John Bell says: “There will be no cure for cancer until real doctors with real patients in real hospitals can attempt an innovation.”

Telegraph: Lord Saatchi, ‘Cuts to cancer drug funding will cause ‘great anxiety’ for thousands’


Published in the Telegraph By Ben Riley-Smith, Political 
12 Jan 2015

Thousands of Britons with cancer will be plunged into “great anxiety” because of cuts to crucial drug treatments announced on Monday, Lord (Maurice) Saatchi has warned.

The Conservative peer and advertising mogul told The Telegraph his life has been “immersed” with cancer recently with loved ones battling the same disease that took his wife as he criticised the scaling back of NHS funding.

It comes as charities and industry experts warned that NHS England’s expected decision to stop funding a series of cancer drugs was “short-sighted” and would endanger lives.

A review by the Cancer Drugs Fund, introduced in 2011 after the Conservatives pledged cancer patients would no longer be denied drugs on grounds of cost, is published today.

As many as half of the 25 drugs under review – which are used in 42 treatments – could have funding pulled according to industry sources.

The move comes amid spiralling costs, with the initial £200 million budget set aside by the Coalition already having increased to £280 given demand.

However the expected ‘delisting’ of potentially life-changing drugs has triggered uproar from cancer charities who fear the impact of pulling the funding on future patients.

Lord Saatchi, whose Medical Innovation Bill is being debated in Parliament and would increase the ability of doctors to try out new medicines on willing patients, said the funding cuts were of “great concern”.

“There is a sense of possibility with the Cancer Drugs Fund. Withdrawing funding is going to cause people who would potentially benefit from the treatments great anxiety,” Lord Saatchi told this newspaper.

However he noted that the fund could never alone answer why there has not been more innovation in cancer treatments and called for “big, cultural, systematic change”.

“I am immersed with cancer as friends and loved ones around me suffer from the same disease which also took my wife [the novelist Josephine Hart],” said Lord Saatchi.

“What I faced – as thousands do across the country – is the problem that doctors are only able to use those tools that are in front of them.

“I don’t want cancer patients to be told drugs can only stem their dying – that is a guarantee of failure. I want us to give people the opportunity to try to survive.”

It is understood pharmaceutical companies were given until the end of Friday by NHS England to justify why cancer drugs they produce should still receive funding.

At least eight life-extending treatments will be denied funding, with drugs that offer a last chance to patients with breast, prostate and bowel disease among those affected.

Prof Karol Sikora, chief medical officer at Cancer Partners UK and one of the country’s leading cancer experts, told The Telegraph the situation was “very sad”.

“Why cant the NHS negotiate better with the pharma industry so that our patients can have equivalence with the rest of Europe? Sure these are all expensive but lives have been prolonged significantly,” he said.

“To know that there is a drug out there that might give you a chance and to be turned down is not what our patients need.”

In a letter to this newspaper, Jonathan Emms, president of the Association of the British Pharmaceutical Industry, warned against the NHS cutting funding for medicines.

“The NHS already spends less than £1 in every £10 on medicine. Further cuts would be short-sighted and compromise patient care,” he said.

“Innovation in medicines is moving faster than the health system can deliver to patients. The NHS needs to catch up.”

Danni Manzi, head of policy at Breast Cancer Care, said: “This re-evaluation shows yet again that the Cancer Drugs Fund is not fit for purpose. We hope that none of the breast cancer drugs are removed due to cost.

“Having secondary, incurable breast cancer is devastating – and these patients should be entitled to improved quality of life and extra time with their loved-ones.”

“Until this is resolved cancer patients could miss out on vital treatment. We must urgently find a long-term, sustainable system that works.”

Solicitors Journal: Saatchi Bill will stifle explosion of NHS litigation



Published in the Solicitors Journal 6th January 2015

There has been much heat generated by the debate over the Medical Innovation Bill. Only recently, some described it as a ‘PR war’.

It is – or ought to be – no such thing, and I appeal for calm consideration on all sides.

For two years, Lord Saatchi, parliamentary counsel Daniel Greenberg and I have been talking to doctors, lawyers and patients about how best to encourage medical innovation in order to facilitate better, faster and safe discovery of more effective treatments for currently incurable diseases.

Indeed, we have held meetings with leading medical negligence lawyers and have adapted the Bill accordingly, and it has changed in light of the feedback and challenges given.

This feedback has been gratefully received, by the concerned parties mentioned, as well as former senior judges, politicians and former opponents.

Few would agree that the medical status quo is working well for patients with rare diseases for whom randomised clinical trials (RCTs) are not an option – often because there are few trials open to them, because the cohort numbers are insufficent to populate them.

→READ: Why there will never be enough trials by Professor Walker

But let me be clear. This is not in anyway a derogation of the importance of RCTs. Evidence-based medicine is the gold standard. And it is why we are still committed to logging on a central, open database all innovations under the Bill – so that incidental evidence can be built up and taken forward to full RCTs.

It is, however, a statement of what to many is obvious; RCTs are not the answer for every disease type and every patient. One size does not fit all.

An example – and there are many – how many trials are open in the UK to patients with aneuroendocrine tumour? The answer is one.

Putting aside the fact that the trial is not about researching a potential cure, but comparing two current treatments, neither of which will save lives, there is an exclusion list that rules out many patients.

I am one of them. Two years ago I was diagnosed with a nueroedocrine tumour. I had surgery. If it comes back, I will be excluded from this trial because I am an insulin-dependent diabetic.

In short, there is no trial available. This is the case for so many currently incurable diseases.

Under the Bill, a doctor can be given the necessary confidence, in appropriate cases, to investigate and, if appropriate, offer, an innovative treatment to such a patient outside an RCT.

However, the Medical Innovation Bill is only one of a raft of initiatives that either are – or should – be in play. No one – including Lord Saatchi – claims this Bill is the silver bullet.

As an aside, Lord Saatchi did once pose the question: ‘How can an Act of Parliament cure cancer?’ He answered his own rhetorical question thus: It can’t – but it will enable the men and women who will. It is a question that has unintentionally riled those who have allowed themselves to get angry about the Bill. I say again, this Bill is no cure-all, but is an important step forward.

Bolam test

What does the Bill do? In short it brings forward the Bolam test to a pre-treatment setting. Doctors wishing to avail themselves of protection under the Bill must build a responsible body of medical opinion prior to treatment, rather than hoping they can construct one after the event, if they are sued for negligence or threatened with disciplinary proceedings.

This is designed to give doctors and patients certainty and clarity at the point of treatment, and therefore the necessary confidence to proceed and innovate.

First, this does not mean a doctor must follow this procedure. Some doctors, especially high ranking ones in centres of excellence, may be confident to innovate now.

Others tell us they are not. This Bill is for them. Doctors will have a choice – to rely on Bolam or the Bill.

To defeat a claim of clinical negligence under Bolam, a healthcare professional is required to adduce evidence from respected peers within their speciality who agree with the standard of practice which is the subject of the action..

Under Bolam, a defendant doctor will not be deemed to have been at fault, providing his or her course of action is one that is professionally backed by appropriately experienced colleagues, even if certain other members of the medical profession may take an opposing view. The Bill requires the same, but in advance and with greater clarity.

There has been much made of the requirement in the Bill to ‘obtain the views of’ other doctors, rather than requiring their ‘agreement’ to proceed.

We considered introducing a requirement for agreement, and were persuaded against it by senior doctors. They were worried that being asked formally to approve a colleague’s proposed course of treatment would act as a deterrent, and doctors would feel reluctant to do so without having a complete history. However, they would be happy to feed in their own views, as they already do in many contexts.

As with the Bolam test now, a responsible body of medical opinion supports the treatment – unanimity is not required – so that no one consultee has a veto on a patient’s treatment,

Instead of consultation taking place after the event if the doctor is sued, under the Bill it will take place prior to treatment: views have to be obtained, and there is an express requirement to give effect to them in a reasonable way. The profession, and ultimately the courts, will give guidance on what that means in practice.

Doctors simply ignoring the views of experienced colleagues who were clearly opposed to the treatment could not expect protection under the Bill. And the same goes for doctors who simply surround themselves with ‘yes men’ to approve their proposed treatments.

Culture change

But the Bill is more than a prosaic piece of putative legislation. The Bill also works on another level.

It will allow more doctors to consider innovating as a matter of course, rather than defaulting to procedures that are known not to work. In this respect, the Bill acts as an agent of culture change. It has also stirred welcome debate on how we can drive innovation in healthcare.

Some opponents say the Bill targets the wrong issue. To them I say two things: first, it is an answer to some of these issues. There is a culture of defensive medicine growing in the UK, fuelled in part by the explosion of medical negligence suits against the NHS. This Bill will help to moderate that, safely and sensibly.

Second, it is now for people of goodwill to use the space created in the media by this debate to offer solutions to the problems faced by patients, for whom evidence-based medicine is chimera, and who will die waiting in the queue for the never-to-happen clinical trial.

Dominic Nutt works with Lord Saatchi and Daniel Greenberg on the Medical Innovation Bill

Published in the Solicitors Journal 6th January 2015

Guest blog: Saatchi Bill and Medical Anecdotes

By scientist Pan Pantziarka, a scientist in the UK employed by the Anticancer Fund of Belgium. Pan works on drug research as part of the Repurposing Drugs in Oncology project

Re-blogged with permission from  anticancer.org.uk


Opponents of the Medical Innovation Bill (aka as the Saatchi Bill), such as Sarah Wollaston MP, have been very vocal in attacking the Bill by making a number of false claims about what the Bill will do.

One such argument is that the Bill will undermine medical progress by doing away with clinical trials, and that instead we will just have to rely on individual anecdotes that arise from doctors using innovative off-label treatments on patients. In fact Sarah Wollaston even referred to the Bill as the ‘Medical Anecdotes Bill’ in her recent speech in the House of Commons.

There are a number of points that to raise in response to this false assertion.

First, there is no intention to replace clinical trials. The Bill is about treating patients with no place left to turn – these are people who have exhausted standard therapies and for whom there are few options left to explore. If a clinical trial is open and the patient is eligible then that is the place to go if it is in the patient’s best interest. There may be cases where it is the right thing to do, just as there are cases when it will not benefit the patient who is offered the additional choice of an non-standard treatment (for example an off-label drug with evidence of clinical activity in the patient’s illness). This will be decided on a case by case basis, what it will not do is force doctors to ignore clinical trials or undermine the trials process.

We also have to keep in mind that for many rarer cancers, genetic conditions and chronic illnesses there are few clinical trials available. Just as important, even when there are clinical trials open, many patients may not be eligible because of prior treatments, confounding conditions, age or physical status restrictions and so on. What are patients supposed to do when they cannot gain access to clinical trials?

Many of the opponents of the Bill act as if there are no unmet patient needs, as if every patient has access to trials and that there is no need to consider alternatives.

Secondly, rather than leaving us with a collection of anecdotes, the Bill offers the prospect of making a huge step forward in medicine through the creation of a central database to record patient data.

This database will be hosted at Oxford University, and work is progressing with the Department of Health to work out the details. A central database which will record each patient’s details, the treatment they receive and their outcomes is actually a hugely advance in medicine.

With all of the patient data recorded we do not have a collection of anecdotes but a database that we can mine and explore and use to design clinical trials based on the signals we can glean from real patient data. It also means that non-standard treatments that work can be identified more quickly, and just as importantly those that do not work can also be identified and discouraged.

This isn’t a replacement for the clinical trial, it’s an advance on the system we now have.

The central database is really the essential piece that makes the Bill so compelling. It offers doctors looking for innovative treatments a chance to explore and learn from the experience of their colleagues.

Many of the opponents of the Bill suggest that it is not needed – they claim that doctors are already free to innovate and explore non-standard therapies. But what is not in place now is a standard process for this to occur, nor a method by which doctors can learn from each other and help to evolve the breakthroughs we so badly need.

And, finally, a central database means that patient safety will be increased. As all data has to be recorded, those unscrupulous individuals prescribing crank treatments will have to reveal their data, they will no longer be able to keep their results away from scrutiny as they now can.

About the author:

Pan Pantziarka is a scientist in the UK employed by the Anticancer Fund of Belgium. He works on drug research as part of the Repurposing Drugs in Oncology project. He is also the co-founder and chairman of the George Pantziarka TP53 Trust, the only charity in the UK dedicated to supporting families with an inherited cancer predisposition condition called Li Fraumeni Syndrome. He lost his first wife to ovarian cancer when she was 29, and his son George died in 2011 at the age of 17 from osetosarcoma.

Further reading:

→READ: Oxford University offer to host the database

→READ:Prof Walker writes – there will never be enough clinical trials



Amendments to be moved on report – 12th December 2014

Following the Committee Stage in the House of Lords on 24th October Lord Saatchi has tabled a set of amendments to be considered on Report on 12th December.

The amendments were prepared by the Department of Health  to respond to concerns raised by peers and others at and around the Committee Stage.

We are very grateful for all the input we have received.

The Bill is going through the usual Parliamentary process and amendments are part of that process.

→READ: The Bill has been amended many times. Why?

→READ: Download the amendments on the Parliament website.

The following explanatory notes have been prepared by parliamentary draftsman Daniel Greenberg.

rd DECEMBER 2014


  1. On 3rd December 2014 Lord Saatchi tabled a set of amendments to his Medical Innovation Bill to be considered on Report on 12th December.
  2. The amendments were prepared by the Department for Health to respond to concerns raised by peers and others at and around the Committee Stage.
  3. These Notes explain the manner in which the amendments meet the concerns expressed.

Transparency: patients’ notes; and recording outcome of consultation

  1. Some peers wanted details of decisions to innovate to be recorded in patients’ notes.
  2. Peers and others have also expressed a wish to see greater transparency about the nature of responses received by the doctor when undertaking the consultation with colleagues required by clause 1(3)(a) and (b).
  3. Amendment 1 requires the results of the consultation to be recorded in the patient’s notes, together with details of the doctor’s decision to innovate.
  4. There has also been pressure to turn the requirement to consult colleagues into a requirement to obtain colleagues’ written consent. These amendments do not give effect to that suggestion. Senior doctors consulted by Lord Saatchi expressed concern about giving formal written consent to another doctor’s proposed course of treatment, without knowing the full history and other circumstances, while they would be relaxed about expressing a view of the soundness of the doctor’s proposal as described to them. Lawyers consulted were also concerned about a possible new form of legal liability for consenting doctors. The requirement to record views in the patient’s notes should introduce the necessary formality, transparency and accountability, while avoiding both of these objections.

Preservation of existing law about clinical trials and other forms of research

  1. It has always been the intention of the Bill to make no change of the law relating to research (see clause 1(5)). But concerns were expressed that this needs to be made even clearer.
  2. Amendments 2 and 3 are designed to put the point beyond possible doubt.

Exclusion of cosmetic surgery

  1. At the Committee Stage and elsewhere suggestions have been made that the Bill should be confined expressly to the principal kinds of case at which it is aimed, namely relatively rare terminal cancers and other terminal conditions.
  2. Lord Saatchi has reconsidered attempting to define the intended scope of the Bill, but has found it impossible to do so in a way that answers more questions than it raises.
  3. Much of the concern has centred around the potential use of the Bill in relation to cosmetic surgery, and it was suggested that it could at least be made clear that it is not the purpose of the Bill to apply to that.

13. Amendment 4 accordingly excludes cosmetic surgery from the Bill. (Cosmetic surgery can of course in some cases be crucial to life or quality of life – as in the case of severe burns; doctors wishing to innovate in such cases will be able to rely on the existing common law Bolam test.)

Emergency treatment; and preservation of common law

14. Concern has been expressed whether in emergency situations doctors will realise that they are not expected to follow the procedures set out in the Bill.

15. Amendment 5 accordingly introduces a reference to emergencies, as an example of a situation in which the existing common law Bolam test would apply and a doctor might not engage the procedures in the Bill.

16. Amendment 6 recasts the principle that the Bill does not force doctors to rely on its procedures and that they can simply rely on the existing Bolam test in all cases. The new form is designed to meet concerns expressed as to whether the intention of existing clause 2(2)(a) was sufficiently clear.

17. Amendment 7 is a consequential amendment to reflect the numbering changes effected by Amendment 5.

Daniel Greenberg 3rd December 2014