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Medical Innovation Bill – adjournment debate

George Freeman during Bill Adjournment debate
George Freeman, MInister for Life Sciences, speaking during the adjournment debate

Yesterday December 10, 2014 Sarah Wollaston MP was granted leave to hold an adjournment debate on the Medical Innovation Bill.

The Bill team were also invited to meet Dr Wollaston earlier in the week to discuss the Bill. We thank her for that meeting and for requesting the debate.

During the debate Dr Wollaston raised several important points about the Bill, which could formally come to the Commons in early January.

The points revolve around patient safety and scientific rigour – issues which have been raised by senior doctors and lawyers in the House of Lords and which have been discussed with peers in committee and in bilateral meetings with Lord Saatchi, health ministers Earl Howe, George Freeman and Department of Health lawyers and officials.

On the back of these meetings, amendments have been laid which address the issues raised, and they will be further debated on Friday (December 12) in the Lords.

Edit: This debate has now taken place. Read here.

Chief Medical Officer Dame Sally Davies and NHS chief Sir Bruce Keogh, who has inputted into the Bill himself, remain satisfied that the Bill is robust, safe and will enhance, not hinder scientific research.

Summing up in favour of the Bill, Minister George Freeman said:

‘I want to close with some supportive quotes the Bill has received from a number of important people, lest the House should form the view that it is unanimously opposed, which is not the case.


Dame Sally Davies, the chief medical officer, has said:

“I am confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation.”


Sir Bruce Keogh, Medical Director of the NHS, said:

“Encouraging innovation in medicine and protecting patients are both of vital importance. That is why I am pleased that amendments have been devised to address concerns about patient safety.”


Sir Michael Rawlins, president of the Royal Society of Medicine, said that the Bill will allow responsible innovation and treatment:

“I believe the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science.”


A letter to The Telegraph from 40 leading medical professionals, including David Walker, professor of paediatric oncology at Nottingham university and Riccardo Audisio, the president of the Association of Cancer Surgery, said the Bill

“legally protects doctors who try out innovative new techniques or drugs on patients when all else has failed. This Bill will protect the patient and nurture the innovator. It will encourage safe medical advancement, while at the same time deterring the maverick, thereby recalibrating the culture of defensive medicine. Finally, it will work with evidence-based medicine and provide new data that will inspire and support new research.”

I hope very much that that is the case and that when the Bill leaves the House of Lords, the vast majority of qualified senior opinion in this field is able to agree with it. It is absolutely our intention to support the Bill’s noble intent to promote medical innovation, but equally our intention is to not undermine in any way the Government’s commitment to patient safety or the duty of care that all clinicians share and owe to their patients.’

→Read: The full text in Hansard 



BMJ: The “Saatchi bill” will allow responsible innovation in treatment says Sir Michael D Rawlins President, Royal Society of Medicine


By Michael D Rawlins President, Royal Society of Medicine

Published in the BMJ (British Medical Journal) 15th April 2014

You need to either be a member of the BMJ or to sign up for their 14 day trial.

Many doctors, myself included, will have occasionally tried to treat individual patients – where all else has failed – with novel interventions. This may be where there is no recognised form of effective treatment; or when existing one(s) have not produced the desired effect. The legal basis for doing so, at least for pharmaceuticals, has been the so-called “named patient” provisions of Section 9 of the Medicines Act 19682 which permits any doctor to be able “to sell, procure or supply a medicinal product to a patient under his or her care”.

Although my own experience has been disappointing there have been occasions, when intervening in such a manner, have subsequently led to significant advances. Indeed, such observations are arguably a form of n-of-1 trial.

Confidence in using the “named patient” provisions of the Medicines Act has though become eroded. A number of legal authorities have pointed out that departing from what is regarded as “established practice” or “the standard of care” leaves a doctor open to an action for negligence. The definition of “the standard of care” traditionally follows the Bolam principle2 as amended by the Bolitho decision3 but was forcefully criticised by Lady Butler-Schloss4 in her capacity as President of the Family Division of the High Court:

“The Bolam test ought not to be allowed to inhibit medical

progress. And it is clear that if one waited for the Bolam

test to be complied with to its fullest extent, no innovative

work such as the use of penicillin or performing heart

transplant surgery would ever be attempted”.

The Medical Innovation Bill attempts to rectify this situation. It proposes legislation stating that it would not be negligent for a doctor to depart from the existing range of accepted medical treatments, for a condition, in carefully defined circumstances. These circumstances – allowing for responsible innovation – are laid out in later Sections of the Bill. They include a plausible basis for the use proposed treatment, and an assessment of the risks that could be reasonably expected to be associated with it. The Bill also proposes that, before embarking on such a treatment, the doctor should have discussed it with the patient, the multi-disciplinary team responsible for the patient’s care, and with the Institutions Responsible Officer. The Bill emphasises that its provisions are solely concerned with the patient’s best interests.

The Bill as originally introduced into the House of Lords in May 2013, as a Private Members Bill by Lord (Maurice) Saatchi, and has become known colloquially as “The Saatchi Bill”. The Department of Health is currently consulting on a draft version of it5. I was originally sceptical about the need for the Saatchi Bill but I have been persuaded otherwise. First, it is clear from the comments of Lady Butler-Schloss4, as well as other legal authorities Lord Saatchi has consulted, that there are serious legal impediments in civil law to using therapeutic interventions that do not represent the current standard of care. Second, although Lord Saatchi’s original Bill was confined to patients with malignant disease this restriction has, rightly in my view, been removed in the current draft. There are, after all, many other miserable conditions for which we have no, or very limited, remedies. Third, I did not believe that his suggestion for approval by a multi-disciplinary team, alone, provided sufficient safeguards: the inclusion, now, of agreement by a doctor’s Responsible Officer provides me with re-assurance.

Despite my strong support for the Medical Innovation Bill there are important consequences for the professions when (as I hope) it becomes law:

1) Just because a particular intervention appears to have been effective in an individual patient it cannot be assumed that the results are generalisable. Further research in the form of one or more randomised controlled trials, or case series, will be necessary to establish its effectiveness. To take a recent example, a case report6 describing the apparently successful treatment of generalised juvenile pustular psoriasis with etanercept, requires confirmation before it can be regarded as the current standard of care.

2) There may be occasions when Responsible Officers wish to seek other advice before approving the proposed use of an intervention in accordance with the provisions of the Medical Innovation Bill. This will often need to be provided very rapidly especially when a patient has a life-threatening illness. The Academy of Medical Sciences, or some of the specialist associations such as the British Pharmacological Society, could have an important role here in offering a speedy advice service.

3) If the intentions behind the Medical Innovation Bill are to be fulfilled, NHS hospital Trusts, and their Responsible Officers, will need to look on proposals sympathetically. Anecdotal evidence suggests that too many Trusts are fearful of departing from the prevailing standard of care because of the possibility of litigation. The Bill should provide them with adequate reassurance.

4) It is essential that the results of using the Bill’s provisions, in individual patients, are placed in the public domain whether or not they have been successful. This would allow others not only to learn from such experiences but – especially for interventions that appear to have been successful – to undertake formal research.

I believe that the use of the provisions in the draft Medical Innovation Bill offer benefits to patients – especially those with rarer diseases – as well as to the furtherance of medical science. Subject to the responses to consultation it is the government’s intention to have it on the statute book at the earliest opportunity5.


1. Medicines Act (1968). www.legislation.gov.uk/ukpga/1968/67 (accessed 12.04.14)

2. McNair J. Bolam v Friern Hospital Management Committee (1957) 1 WLR 582. www.e-lawresources.co.uk/Bolam-v—Friern-Hospital-Management-Committee.php (accessed 12.04.14)

3. House of Lords. Bolitho v City and Hackney Health Authority (1998) AC 232. www.bailii.org/uk/cases/UKHL/1997/46.html (accessed 12.04.14)

4. Butler-Schloss LJ. Simms v Simms (2002) FAM.83 para 48. www.bailii.org/ew/cases/EWHC/Fam/2002/2734.html (accessed 12.04.14)

5. Department of Health. Legislation to encourage medical innovation. www.gov.uk/government/uploads/system/uploads/attachment_data/file/285272/9959-TSO-2901828-Legislation_to_Encourage_Medical_Innovation.pdf (accessed 12.04.14)

6. Fialová J1, Vojáčková N, Vaňousová D, Hercogová J. Juvenile generalized pustular psoriasis treated with etanercept. 2014;2:105-8. doi:10.1111/dth.12065.

Sign the petition for the Medical Innovation Bill: http://chn.ge/1pqY6lS


This Bill is very important, as the scientific world has changed


By Charlie Chan, Consultant General Surgeon, Nuffield Health

In spite of medical advances over the last 50 years, many people across the world still die prematurely from cancer, heart disease, lung disease, and terrible degenerative diseases like muscular dystrophy and motor neurone disease.

For many of these people, the options for treatment and run out quickly, with no prospect of improvement in quality of life or life expectancy. For some, but not all, exploring new treatment in a responsible manner is something that the individuals may wish to do, if only to benefit future generations.

This Bill is very important, as the scientific world has changed. The last generation has seen an enormous change in our fundamental understanding of diseases and their processes.

Sign the petition for the Medical Innovation Bill: http://chn.ge/1pqY6lS

This has been underpinned by the massive changes in laboratory research, genetics, 3-D printing, and regenerative medicine. This knowledge could not have been foreseen over 50 years ago, when the Bolam case was first heard.

This new knowledge has been underpinned by the vast improvement in computer technology, which has benefited all parts of society. When treating patients and diseases, doctors and scientists are waging a conflict on 2 fronts.

The frontline remains the one of the individual patient, with the doctor at the bedside or in the operating theatre. Behind-the-scenes, there is a continuing intelligence campaign underpinned by scientific research in the laboratory.

100 years ago, communication between the front and Intelligence Corps might well have been done by carrier pigeon. Now, information exchange occurs rapidly in real-time between GCHQ and troops in Afghanistan. In medicine however, this communication or translation of new scientific knowledge to the bedside remains slow.

We are fast approaching and era when scientific research may outstrip our ability to deliver this to the patients. Hence, we need to address a new way to deliver innovative treatments.

That is not to say that the standard clinical trial model is dead. There is still much merit in the randomised trial as a paradigm. It is vitally important that the development of new standard treatments for large numbers of people is underpinned by solid statistical analysis and estimation of perceived benefits.

However, a new process for innovative treatments may provide many new hypotheses for new trials, which can then cement new techniques and drugs.

There are some colleagues who rightly have concerns that a change in the law may constitute a charlatan’s charter. However, the Bill contains safeguards to ensure that there is no quackery. All standard and trial treatments need to be exhausted, there needs to be logic behind the proposed treatment, and this treatment needs to be agreed within the peer group, prior to discussion with the patient.

The agreement within the peer group will need to be done in a timely manner. There is a significant challenge for the profession to establish a framework for such peer group discussions, which may occur on the local level or through a National Specialty Association.

However, it is well recognised that this must be something that can be done quickly for patients treated in a district general hospital by local consultants, as well as those managed in large teaching hospitals.

Some of my colleagues would strongly support some form of central data collection.

A central data repository to be analysed on a regular basis, in order to establish whether any putative innovative treatments have any merit for further investigation in large clinical trials.

This might be located in an academic university department, so that this might be independent of central government control.

The future is extremely exciting. Basic scientific research has enhanced greatly our fundamental understanding of many diseases, such as cancer.

This understanding of the basic diseases means that some new biological drugs may have multiple applications across different cancer types. It makes logical sense to exploit this basic science knowledge, particularly to benefit those patients with rare diseases, for whom a standard clinical trial may be impractical or financially non-viable.

Advances in regenerative medicine, particularly in the USA, now mean that organs can be printed in a matter of hours or weeks.

This will herald a completely different way in which we might manage people with cardiac, kidney, or liver disease.

We must grasp this opportunity to change things for future generations, otherwise these scientific advances may be for naught.

About the author:

Charlie Chan is a Consultant General Surgeon with a special interest in breast disease, skin cancer, and soft tissue tumours. He also has a varied practice in general surgery. He has extensive research interests, and is currently involved on the Trial Management Group for 4 large UK breast cancer trials.

On average, he performs 30 to 40 major breast reconstructions a year, as well as numerous cosmetic breast procedures. Amongst his breast cancer patients, he is normally able to conserve the breast in 70-75% of his patients. AIong with his colleagues in Cheltenham, James Bristol and Fiona Court, he is one of only a few surgeons in the UK who are trained in the new Breform™ cosmetic breast operation. He has contributed to numerous articles in the national press (Sunday Telegraph, Daily Telegraph, Daily Mail) as well as the local press and BBC Radio Gloucestershire.

He has written breast cancer guidelines for the Association of Breast Surgeons, organised national cancer surgery meetings for the British Association Of Surgical Oncology, and reviews oncology education across Europe for the Accreditation Council of Oncology in Europe.

Sign the petition for the Medical Innovation Bill: http://chn.ge/1pqY6lS

Launching the Early Access for Innovative Medicines scheme

By George Freeman, MP for Mid Northfolk

First published in the Spectator


Imagine this: you take a routine trip to the doctors. Except it doesn’t turn out to be routine at all. Instead, the doctor tells you that you only have months to live. Worse still, there is no certified cure. There is a potential drug that could save your life, but it’s stuck in a regulatory tangle, waiting for approval which takes years. It might come on the market in a decade. But by then, of course, it will be too late for you.

33 days to change medical history: sign our petition to enable medical innovation: http://chn.ge/1pqY6lS

Ludicrous, surely? Yet that has been the dilemma facing too many over recent years, unable to get access to the drugs that could save their lives. Decades more of enjoyment, time with the grandchildren, a whole chunk of life wiped out when a cure could be sitting there unused.

As was announced on Friday 15th 2014, this is going to change thanks to the Early Access to Innovative Medicines scheme I have helped design. It has the potential to revolutionise drug development and completes the vision set out in the UK Life Sciences Strategy launched by the Prime Minister in 2011 and the NHS Innovation Health and Wealth reforms. The core vision was that the UK would be a crucible of medical innovations that could help all of us live better for longer. It is the same philosophy that lies behind the Saatchi Bill, putting medical innovation front and centre of healthcare and helping find new cures that work for patients.

 Medicine is currently undergoing a seismic shift, from a 20th century model (something done to us by Government) to a 21st century model (something we increasingly take a responsibility for ourselves). Revolutions in genomics and data are driving a new generation of targeted and personalised medicines, and reshaping the landscape of drug design. The old traditional ‘blockbuster’ Big Pharma model of the post-war years is ceding to the world of ‘translational’ or ‘experimental’ medicine in which drugs are designed with, and around, patients, their data and tissues, in clinical research facilities and hospitals.

 This is part of a wider revolution of patient empowerment. Instead of sitting passively waiting for new medicines, today’s patients are increasingly impatient and want access to innovative treatments now. Patient charities and advocacy groups are becoming powerful players in the new landscape: funding research, lobbying for access and forming new companies. The Early Access Scheme fast-tracks the best new life-saving medicines to patients earlier while maintaining robust safety standards. It can only happen if the new drug is targeted at an area of unmet clinical need, there is powerful data and evidence to show the drug is safe and the patient taking the drug has provided informed consent.

 With the right safeguards in place, it soon becomes clear that the benefits of this new scheme are profound. Not only will this help save lives by providing patients with life-saving drugs quicker, it can help the UK be at the forefront of this new world of twenty-first century healthcare. We have the chance to cement a competitive advantage (over the USA and Europe especially) as the global location of choice for designing, testing and proving the new generation of personalised medicines. Under this Early Access scheme, UK patients will be able to trial the most innovative medicines before any others. With the NHS seal of approval, we can then help sell these drugs to the Qataris, Saudis and emerging-world rich all over the planet, investing the revenues back into the NHS to the benefit of us all.

Nothing in healthcare is without controversy. But with innovative medicines, as with the recent controversy over patient data, the arguments on both sides boil down to one single point: who wants to be better for longer? One thing’s for sure – I do. I think you do too. If any of us got that diagnosis, we’d want to know we had access to the latest drugs. Last week’s announcement – and the pioneering campaign of the Saatchi Bill – helps make sure we do.

33 days to change medical history: sign our petition to enable medical innovation: http://chn.ge/1pqY6lS


How Medical Innovation Saved My Life


By @DominicNutt diabetic and cancer patient

Two years ago I was diagnosed with a rare, incurable cancer. Had it not been for my surgeon, who pushed the boundaries of accepted treatment, the chances are that I would now be living on death row. But unless a new Bill is made law, other doctors may be too scared to do the same.

In December 2011, I developed a nagging pain in the lower right side of my stomach and was admitted to hospital for an emergency appendectomy. However, tests showed there was nothing wrong with my appendix. But my consultant, told me that “by luck” they had found on it a rare, 12mm neuroendocrine tumour (known as a Net).

It had not been responsible for the pain, the cause of which to this day remains a mystery.

I had my appendix removed, which is standard treatment for Nets – otherwise, the tumour would have spread and killed me, because Nets do not respond to chemotherapy or radiotherapy.

The next bit was tricky. Nets are so rare that there is little knowledge as to how they behave. All doctors do is make estimates based on limited case studies.

My consultant, a colorectal surgeon, said that standard procedure for a Net of 10mm or smaller is to remove it, but not to take any other action, since the best guess is that the chance of spread is low.

Anything over 20mm, however, and doctors will remove nearby lymph nodes, the first organs that cancers normally spread to before invading the rest of the body.

Anything between those sizes, like my tumour, leaves doctors scratching their heads. They would be entitled to take no action. Also, surgery to remove my lymph nodes would mean slicing out a large part of my colon, with all the inherent risks. I am an insulin-dependent diabetic, so the hazards of surgery were even greater for me.

Fortunately, my consultant reviewed my case with other experts and they recommended surgery.

When the results came back, they found a cancerous cell in one of the 17 lymph nodes they had removed. The cancer had spread, despite very low odds.

This is a tale of a doctor who was prepared to take a risk – one that has probably saved my life. But had there been complications, and had he not found a cancerous cell, I, or my widow, could have sued.

Last year, spending on negligence claims by the NHS Litigation Authority, which provides indemnity cover for such claims, was, for the first time, more than £1  billion.

And legal cases against the NHS pending in the litigation pipeline could amount to a bill of £24 billion – around half the UK defence budget.

Frightened of litigation, many doctors do not push the boundaries of medical knowledge, and opt instead for “safe” standard procedures.

I tell this tale in support of Maurice Saatchi, who has drafted the Medical Innovation Bill which, if passed, will allow doctors, with the patient’s consent and in cases where the evidence on standard procedures is unclear, to innovate.

It would enable them to review such cases with other experts – as my consultant did – and come to a collective decision. Following this process would give them a legal defence if things were to go wrong.

The Secretary of State for Health, @Jeremy_Hunt, supports the Bill and has opened it out to a public consultation.  He has told Parliament that if the public responds positively to the consultation, then the Bill will become law.

It’s now in our hands.

Dominic Nutt is part of the Saatchi Bill team.