Tag Archives: saatchi Bill

Telegraph: Experimental drugs for patients could be available from March after Government backs Saatchi Bill

Front page of the Telegraph today.
By Christopher Pope, Senior Political Correspondent

Experimental drugs for patients could be available from March after Government backs Saatchi Bill
Experimental drugs for patients could be available from March after Government backs Saatchi Bill

Jeremy Hunt throws his health department’s weight behind the Medical Innovation Bill which will make it easier for doctors to try out new treatments on patients without the fear of being sued

Dying patients could be given access to untested medicines from early next year after the Government and doctors gave their backing to a bill proposed by Lord Saatchi.

Jeremy Hunt, the Health Secretary, has now thrown his department’s weight behind the Medical Innovation Bill which will make it easier for doctors to try out new treatments on patients without the fear of being sued.

The Bill – which has sharply divided the medical profession – has also received tentative backing from the General Medical Council, which earlier this year come out firmly against any change in the law, and a leading cancer charity.

The legislation was proposed by Lord Saatchi, the advertising magnate, who started to campaign on the issue after his wife Josephine Hart died from ovarian cancer.

Lord Saatchi told The Telegraph that the principle of allowing new drugs to be tested on desperately ill people was already being applied in the case of Ebola victims in Africa.

He said: “In dealing with the deadly Ebola outbreak, the World Health Organisation has decided that departure from standard evidence-based treatment is fully justified and essential.

“It has set ethical guidelines for the use of new therapies and interventions – they are identical to the provisions of the Medical Innovation Bill.”

Supporters said the plans – which could be law by March if MPs and peers agree – will allow victims of rare cancers to volunteer to be treated with untried drugs.

Cutting out the need for years of clinical trials will bring down the cost of the medicine and may make pharmaceutical firms more likely to fund experimental drugs that only help a small number of people with rare diseases.

The Bill will be debated in the House of Lords this Friday and is due to be considered by MPs in the House of Commons In December. Its supporters said that the Bill now had a 75 per cent chance of becoming law.

Mr Hunt is hoping that the extra safeguard for patients will be enough to see off claims that the Bill is a “quacks’ charter”.

The Government has decided to support the Bill after new safeguards were agreed with Sir Bruce Keogh, NHS England’s medical director.

The amended Bill now requires the agreement of at least one other speciallist before trying out untested medical treatments on patients.

Currently doctors routinely ask colleagues in their hospital for their opinion on how to treat patients in what is called the “Bolam test”. The amended Medical Innovation Bill will require them to seek consent from other specialists in the field to pass this test.

This will stop “dominant personalities” in a hospital – perhaps a senior consultant – getting their own way and acting against the interests of the patient.

A Department of Health spokesman said: “Innovation is at the heart of modernising the NHS and is essential for improving treatments and finding new cures and work on the Medical Innovation Bill is ongoing.

“We are pleased that Lord Saatchi has tabled amendments to the Bill to help ensure patient and staff safety.” A source added: “The Government is currently minded to support the bill as amended by Lord Saatchi.”

The amendments have persuaded the General Medical Council – which opposed any changes in April – to give its tentative support for the change in the law.

Professor Sir Peter Rubin, the council’s chairman , said: “Medicine is a risky business. There are many people alive today because of the willingness of doctors to innovate, deal with uncertainty and take reasonable risks which are understood, shared with, and consented to, by the patient in accordance with good medical practice.

“While we welcome the amendments to the Bill in Lord Saatchi’s name, we look forward to seeing the final version.”

Cancer Research UK, which has also expressed concerns about the originally-drafted Bill, also now supports the change in the law.

→Read: Cancer Research UK latest statement

Sarah Woolnough, the charity’s Director of Policy and Information, said it was important that Parliament discussed medical innovation.

“We know that more could be done to promote innovation in cancer treatment, especially for patients with life-threatening conditions where there are few treatment options, and the Medical Innovation Bill aims to support clinicians to act innovatively where they have exhausted other options.

“The latest set of amendments laid on the Medical Innovation Bill are an improvement, requiring a doctor to seek advice from an appropriately qualified colleague before departing from standard treatment.

“We must ensure the Bill contains appropriate safeguards to protect patients. We will monitor the Bill’s progress closely and hope we will see a greater focus on innovation thanks to this Bill.”

Despite the changes, other doctors still remain concerned. Michael Baum, Professor Emeritus of Surgery at University College London, said last night: “Never once have we encountered interference or obstruction due to fear of litigation.

“There are of course many other obstacles to progress but changing the law with this bill is not going to accelerate innovation in cancer therapy, but might, as a result of unintended consequences, endanger our patients by uncontrolled experimentation.”

Read on the Telegraph website.

BBC Radio 4 Today: Sir Mike Rawlins, President of Royal Society of Medicine talks about the new Medical Innovation Bill

Medical Innovation Bill - Saatchi Bill - Sir Mike Rawlins talk to BBC 4 Today
Medical Innovation Bill – Saatchi Bill – Sir Mike Rawlins talk to BBC 4 Today

Sir Michael Rawlins, President of the Royal Society of Medicine and former Chairman of NICE has this morning spoken with BBC Radio 4 Today program about the new version of the Medical Innovation Bill (Saatchi Bill).

Listen to his interview.

The Telegraph: Lord Woolf, former Lord Chief Justice, outlines from the legal perspective why the Saatchi Bill is necessary

Published in the Telegraph today Lord Woolf, former Master of the Rolls and Lord Chief Justice, writes from the legal perspective why the Saatchi Bill is necessary and why it has his support.

Lord Woolf on the Medical Innovation Bill
Lord Woolf on the Medical Innovation Bill

By Lord Woolf:

Read in the Telegraph

Maurice Saatchi is passionate about the legislation he is promoting to encourage responsible innovation in medical treatment. He has a very personal reason for his campaign. His wife, the novelist Josephine Hart, died of ovarian cancer in 2011 and he believes, in his own words, “that her death was a wasted death, indeed that all 165,000 cancer deaths in this country every year are wasted deaths because science advances not one centimeter as a result of them”. His bill aims to change that situation.

My own reasons for giving my support to his plans – currently the subject of a Department of Health consultation that ends tomorrow – arise from my work as a lawyer. I have not, thankfully, had to face a similar domestic tragedy to his, but what I do know about, from sitting as a judge, are the cases where doctors are sued for negligence because they have innovated in the treatment they offer, rather than following generally-accepted medical standards.

In my experience, professional people are, on the whole, very conservative, and it is cases such as the ones I mention that make doctors frightened to try something different, something not yet fully tested, even when their patients give their consent, and when, as was the case with Josephine Hart and many others, they face certain death if standard procedure is all that is on offer.

Doctors don’t by nature want to step out of line, risk their professional reputation, or being labelled a quack by colleagues. That is, most of the time, a good thing. There should not be a culture in our hospitals of risk-taking with patients’ lives. But what is covered in these plans is a very specific set of exceptional circumstances, where there are potential benefits to allowing doctors to put their heads above the parapet.

It is important to understand here that we are talking about a new law that will make a limited, but significant contribution in a small number of difficult cases. Maurice Saatchi, with the support of Health Secretary, Jeremy Hunt, and of the government, is seeking to introduce legislation that will only apply to: (1) patients who are not responding to conventional treatments; (2) patients who give their consent to such innovation; (3) new treatments that are still at a experimental stage; (4) new treatments that hold out a real prospect of being able to help, both the patient and others in similar circumstances who come after them.

It shouldn’t require too much imagination to envisage those that these proposals might help. If you are a patient suffering with a terrible cancer, where conventional treatment has proved ineffective, your doctor may be aware of something else that could be of benefit, but which has not yet gone through the currently very long process of being fully tried and tested. It can take 15 years and £1 billion to approve just one drug. By the time that has been done, the patient will be dead.

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

Crucial to the whole proposal is the principle of true consent. Patients may be in exceptional circumstances, facing death under standard procedures, but that doesn’t mean they are incapable of saying yes or no. Many will, indeed, refuse to be treated as guinea pigs, but some will decide to consent, because they believe it offers them hope of extending their lives, and perhaps saving the lives of others in years to come.

Surely, the patient, as the person most affected, must be allowed the chance to make up their own mind in such circumstances. There must, of course, be safeguards, and to achieve true consent the proposed legislation will require very careful drafting, and close scrutiny by the revising chamber of Parliament, the House of Lords, where I sit alongside a number of very distinguished lawyers and medics. Indeed, it has been the decision of some of those senior medical figures in the Lords to give their support to Maurice Saatchi’s plans that has persuaded me to line up behind him in arguing for this change to the law.

It would be a mistake to think, as some are perhaps tempted to do, that what is being proposed here is part of another current debate – over giving the terminally ill the choice to determine how and when they will die. Maurice Saatchi’s proposal is about is extending and saving life, not cutting it short. That should make it more readily acceptable.

I therefore urge Daily Telegraph readers to make their voices heard in the current consultation round by following the link below.

Lord Woolf was Lord Chief Justice of England and Wales from 2000 to 2005

Read in the Telegraph


‘Protect the patient: nurture the innovator’ writes Norman Williams, President, Royal College of Surgeons

‘Protect the patient: nurture the innovator’ writes Norman Williams, President of the Royal College of Surgeons (RCS) in the March 2014 RCS bulletin.

→READ: the full article in the bulletin

The bulletin text is reproduced below:


A few weeks ago I spent the weekend in Innsbruck, participating with several European colleagues in a surgical workshop that concentrated on a new minimally invasive technique of sphincter preservation in rectal cancer. This innovation has the potential not only to reduce the incidence of permanent stomas significantly but to do so with the minimum of trauma.

It occurred to me and my fellow participants that it might also, if developed appropriately, be possible to carry out the whole procedure via one orifice – no prizes for guessing which one! I also thought that if robotics develop at the estimated pace then the technique could be performed with even more precision, thus reducing the margin of error inherent in such an operation.

Now, I know many of you will be thinking that the President is in ‘cloud cuckoo- land’ but I would like you to reflect on the considerable progress we have made in surgery over the past 50 years. When I was a medical student there was no such thing as organ transplantation, cardiac surgery was in its infancy, joint replacement had just been introduced (but only for hips), and laparoscopic and microsurgery were both at a very rudimentary stage.

The pace of innovation has been truly remarkable and yet we in the UK could be criticised for dragging our heels when it comes to the dissemination of some developments.

Four years ago, when I was Chairman of the RCS Research Board, we published a report entitled From theory to theatre, in which we explored the barriers to translational research that threatened to stifle surgical innovation and identified a series of actions to deliver high-quality surgical research now and in the future.

I am pleased to say the College rose to the challenge and, in addition to raising funds and influencing research councils and charities, has managed to develop an infrastructure that should markedly change for the better the way in which we carry out clinical surgical research. All in the research and development departments should be congratulated on their achievements.

I should also compliment the many surgical trainees who have contributed their time and efforts to developing trainee research collaboratives. There are more than 20 of these across the country, each carrying out some large clinical trials and audits as they try to answer important questions. All these efforts are to be applauded and celebrated but the challenges do not stop there.

The fruits of research are of little value if they are poorly implemented. Discovery only matters if it reaches all those patients who might benefit. The diffusion of surgical innovation has at times been painfully slow. The reasons are many, ranging from lack of evidence to training and capacity issues. We hope we are beginning to address some of these barriers with the actions mentioned above but others will require different solutions.

If we are to tackle the slow diffusion of innovation then we must learn from experience and not keep making the same mistakes.

That is why we commissioned a piece of work to investigate how we might improve. The report of this investigation, entitled From innovation to adoption: Successfully spreading surgical innovation, will be published soon. It sets out for the first time what makes adoption of surgical innovation different and why we need a new approach.

It is based on a review of five mainstream surgical procedures, across a number of specialties, in which patterns of uptake are analysed and the factors that helped and hindered surgical adoption in England are explored. As a result, a pathway of surgical innovation has been developed, which is made up of six critical factors:

1. Early identification of the promise of an innovation

2. Leadership to champion and advocate its adoption

3. Establishing the infrastructure to enable its use

4. Defining what should be implemented and how its impact will be measured

5. Developing levers and incentives to encourage appropriate adoption

6. Providing information to support clinical adoption and patient choice

These are vital factors if we are to achieve a more streamlined adoption mechanism but in addition I must stress that there is a responsible and ethical approach.

This applies particularly at the earliest stages but of course must be applied throughout the whole process. There is no room for ‘cowboys’ or the ‘have-a-go’ merchant.

My memory goes back to the early 1990s when a news conference was held at the College about the death of a patient that occurred at the hands of a surgeon performing an early laparoscopic procedure without appropriate governance arrangements in place.

The patient’s husband was a QC and the subsequent fallout was disastrous for the profession and set back laparoscopic abdominal surgery in the UK for a decade. Although governance has improved, a clear path showing how to support the innovator, while at the same time protecting the patient, is still lacking.

We need a transparent and supportive mechanism to assist the innovator in honing a truly new concept without the constant fear of litigation (or worse). Yet at the same time safeguards need to be in place so that patients are fully informed and protected from the unscrupulous practitioner.

This will not be easy but it is an issue that can no longer be avoided, otherwise it is only a matter of time before one of us is incarcerated for trying to advance his or her specialty.

I understand that several consecutive patients died when Professor Sir Roy Calne carried out the first liver transplants; I wonder what would happen to him nowadays were there to be a similar outcome. Complications are inevitable with new procedures and only by facing up to them and understanding them can they be overcome.

This requires courage on behalf of the innovator (and, indeed, the patient) and support from colleagues. Research ethics committees have their place but they are invariably composed of non-surgeons who do not have an appreciation of the problems. I would like to see our profession taking on this responsibility.

One way to do this might be for each specialty association to set up an Innovation Oversight Panel composed of individuals with experience of the trials and tribulations involved in surgical innovation. Such a panel could receive proposals for innovative procedures to assess whether or not they were feasible, appropriate and designed to improve the status quo.

The panel could then give approval for a small pilot study but request regular reports, so that when complications occurred they could help the innovator to resolve the particular issue. The process would be iterative and hopefully the new procedure would evolve so the trial could be widened to involve other groups. Ideally this would take place within the infrastructure discussed above to ensure more rapid dissemination.

Such a structure would enable the realisation of this piece’s title and is in keeping with the new Medical Innovation Bill promoted by Lord Saatchi, which is designed to improve responsible innovation in medicine and remove the fear of litigation.

I would exhort the officers of the specialist societies to think seriously about setting up an appropriate mechanism. It does not need to be the model I have outlined; they may well feel they could do better and I would be the first to applaud them.

However, unless a mechanism of some form is set up I fear that the progress of surgical innovation may be impeded by the imposition of stringent external regulation. I also fear that patients will be damaged unnecessarily and surgeons will be impugned or, at worst, indicted. Unless potential developments like the one I learnt about in Innsbruck can be developed speedily yet ethically, then disseminated appropriately, we are all the losers.