Google+ Medical Innovation Bill

Happening NOW

About

The Medical Innovation Bill will help doctors to innovate new treatments and cures safely and responsibly for cancer and other diseases.

READ: more


Latest draft Bill published: 2nd June 2014

Join us

23 Jul 14

'Written answer' by Daniel Poulter MP on Medical Innovation Bill

0 notes Reblog Comments

Daniel Poulter, The Parliamentary Under-Secretary of State for Health, has replied to a written answer from Jim Fitzpatrick MP (Poplar and Limehouse, Labour) on the Medical Innovation Bill.

Feedback on the Bill to date has already led to excellent suggestions - such as an open database of innovation, to be developed and hosted by Oxford University.

We look forward to the Government amendments.

Read the question and answer below and here in Hansard.

Jim Fitzpatrick (Poplar and Limehouse, Labour): To ask the Secretary of State for Health with reference to the written statement of 22 November 2014, Official Report, column 65WS, on the Medical Innovation (No. 2) Bill, when he plans to bring forward legislative proposals to remove barriers to medical innovation, along the lines set out in that statement.

Daniel Poulter (The Parliamentary Under-Secretary of State for Health; Central Suffolk and North Ipswich, Conservative)
My noble Friend Lord Saatchi has reintroduced the Medical Innovation Bill in the current parliamentary session as a private peer’s Bill, which had its second reading on 27 June. The Government is supportive of the principles of this Bill, but believes it is necessary to amend the Bill to ensure it does not:

put patients at risk;

deter good and responsible innovation;

place an undue bureaucratic burden on the national health service; or

expose doctors to a risk of additional liabilities.

The Bill will proceed through Parliament in the usual way.

Hansard source (Citation: HC Deb, 21 July 2014, c999W)

Daniel Poulter spoke to the BBC about the Medical Innovation Bill on January 16th 2013.

Follow Us

Follow Us

Follow Us

26 Jun 14

Sir Bruce Keogh, Medical Director of the NHS, proposes safeguard for the Medical Innovation Bill

0 notes Reblog Comments

image

Read in the Telegraph today

The Telegraph reported on 1st June 2014 that Sir Bruce Keogh, the medical director of the NHS, had been asked by the health secretary to decide how Medical Innovation Bill safeguards would work in practice.

The amendment, proposed by the Department of Health, comes after a meeting last month with the Bill team, Jeremy Hunt, Health Secretary, and officials and representatives from the professional bodies.

READ: http://medicalinnovationbill.co.uk/sir-bruce-keogh-medical-director-nhs-proposes-new-safeguards-for-medical-innovation-bill/

Follow Us

Follow Us

2 Jun 14

New draft of the Bill published

1 note Reblog Comments

A new Medical Innovation Bill has been drafted following the Department of Health’s public consultation into the Medical Innovation Bill which ended on 25 April 2014.

The consultation was designed to gather opinions as to whether the Bill was wanted and how it might best work. In other words, it was intended to obtain robust feedback in order to improve on the draft Bill.

Incorporating feedback

The overwhelming response from the more than 18,000 patients, doctors and institutions who responded was a clear vote in favour of the Bill.

The Bill team does not wish the Bill to be used as a guise for reckless experimentation and thus, the Bill states that it may only be used in the best interests of the individual patient.

Respondents also gave firm feedback that the Bill must be clearer on how it was to ensure that there was no room for the quack to use the Bill as cover for reckless experimentation.

So the new draft Bill is explicit and clear – a doctor who wishes to innovate cannot claim protection under the Bill without using a transparent and accountable process to consult a range of expert colleagues, including the doctor’s responsible officer and any relevant multi-disciplinary team, – only with broad consensus from colleagues will a doctor feel safe in relying on the protection provided by the Bill, which is the intention.

Sharing innovation data

Many also argued that for the Bill to work and to drive new treatments for hard to cure and currently fatal diseases data from innovative treatments must be collected and be capable of being shared among patients and doctors in an open, transparent and accessible manner.

Recognising the importance of collecting evidence and data from innovative treatments, the Bill team is committed to working with Oxford University who have agreed to develop a method of data collection and sharing which arise from the Bill.

Specially, following feedback from the consultation, we are committed to including an obligation on doctors that they must register innovative interventions in order to be protected by the Bill.

This obligation will be included as part of the statutory process during the Public Bill Committee Stage in the House of Commons.

Read the new Bill

Follow Us

30 Apr 14

A balance between evidence-based medicine and responsible innovation

0 notes Reblog Comments

By Charlie Chan

The Medical Innovation Bill is in the process of re-drafting. The consultation is likely to take into account the many comments from patients and doctors. Many of the concerns raised in the consultation have centred on the issue of possible “quackery”.

The Bill’s critics have suggested that this new piece of legislation might encourage non-scientific “experimental” treatment, which might be viewed as bordering on charlatan behaviour. However, the Bill does have important safeguards to ensure protection for the patient, and scientific advancement.

Concerns by some that this Bill will lead to reduced scientific integrity and a lower emphasis on clinical trials, can be allayed. In fact, the Bill will only protect doctors, who are planning to treat patients, who have exhausted standard treatments and existing suitable clinical trials.

For some patients with common life-threatening diseases (e.g. breast cancer, bowel cancer, heart disease), there may be several standard treatments and a multitude of trials. However, for patients with rare diseases, there is often no treatment at all and few if any randomised trials.

If one considers the sum total of patients with “rare cancers”, their sum total exceeds the number of new cases of the top four cancers every year in the UK. Yet for this significant proportion of rare cancer sufferers, there are few treatments and a dearth of clinical trials.

For patients, both young and old, with rare diseases, the current scientific model of large randomised clinical trials means that they are predominantly excluded from scientific research and the development of new treatments. It is surely not the right thing to do to ignore this large number of patients, for whom the current status quo is failing.

An important concept being considered for this Bill is a Central Data Repository, which would record all patients having novel treatments. Ideally, this should be open access to both doctors and patients, so that people are able to learn rapidly about the efficacy, if any, of novel treatments for these difficult clinical problems.

Rather than inhibiting the development of clinical trials, this data repository can then provide a valuable resource for generating novel hypotheses for new studies. These clinical trials can then underpin any promising benefits shown by patients having innovative treatments.

Thus, the current status quo of clinical practice, based predominately on the randomised clinical trial might even be improved, and a sensible balance struck between evidence-based medicine and responsible innovation.

As Sir Austin Bradford Hill, one of the godfathers of modern clinical trials, said in 1966:  “Any belief that the controlled trial is the only way would mean not only the pendulum had swung too far but that it had come right off its hook.” Perhaps now this Bill might restore the pendulum into its rightful position.

Charlie Chan, Consultant General Surgeon

Charlie Chan is consultant surgeon, specialising in the treatment of people with breast cancer and malignant melanoma. He has been a national committee member at the Association of Breast Surgeons, and the British Association of Surgical Oncology. He has also been the senior author for UK surgical guidelines for the management of breast disease. He is on the Trial Management Group for 3 large UK breast cancer trials.

*Edit 2nd June 2014 - the Government consultation has now closed. The Bill team has drafted a new Bill that meets the robust feedback: Read the new Bill

Follow Us

29 Apr 14

Published in The Times today our letter to the Editor

1 note Reblog Comments

Published in The Times today our letter to the Editor in response to the letter published Monday 28th April regarding the Medical Innovation Bill.

image

Sir,

The evidence for the need for the Medical Innovation Bill is compelling. Around 18,000 doctors and patients replied to the Department of Health consultation supporting the Bill, many confirming that they have experienced the deterrent effect that an increasingly risk-averse culture is having on responsible medical innovation.

The objections in Mr Poole’s letter (Apr 24) relate to details of the Bill that were not in Lord Saatchi’s original text and will not be in the text that he intends to introduce early in the new session. The Bill team will soon publish a new draft which meets concerns expressed by legal and medical professionals.

Doctors must be given the freedom to innovate responsibly, with the confidence that the law will protect them if their decision is made with the support of a responsible body of medical opinion.

They must not be forced to wait until their decision is tested in expensive and traumatic litigation or disciplinary proceedings. Nobody wants that, except perhaps a small group of lawyers who make their living from the existing litigation-focused system.

The Bill will be an opportunity for all those who are concerned that the legal system is not properly serving patients with rare diseases, whose hope rests entirely on innovation.

Patients want to know that every responsible avenue is being explored in order to help them, and that doing nothing is no longer the easy and safe answer.

Good doctors must be given the protection and encouragement of the law to innovate; and bad doctors must be deterred from innovating without support of their colleagues.

The Bill achieves both aims, and is to be welcomed by lawyers, doctors and patients.


Daniel Greenberg
Parliamentary Counsel to the Medical Innovation Bill team

*Edit 2nd June 2014 - the Government consultation has now closed. The Bill team has drafted a new Bill that meets the robust feedback: Read the new Bill

Follow Us

26 Apr 14

The Saatchi Bill Consultation is over – what happens now?

0 notes Reblog Comments

The Department of Health’s consultation into the Medical Innovation Bill has closed and we now know that the evidence demonstrating a need for the Bill is compelling.

So far, more than 18,000 people ¬– including patients, doctors, researchers, scientists and charities – have responded to the consultation supporting the Bill, many confirming that they have experienced the deterrent effect that an increasingly risk-averse culture is having on responsible medical innovation.

The Saatchi Bill team is grateful for all the comments and input we have received throughout the consultation period. Thank you for your help and support.

All the concerns expressed about the Bill have been heard and a new draft Bill is already in play – it remains true to the core principles of nurturing the innovator and protecting the patient, but is clearer on the process that doctors must go through if they are to innovate safely.

The Bill team will publish a guide showing how the new draft Bill meets concerns expressed by legal and medical professionals. (For those lawyers reading this, it will make it clear that Bolam-Bolitho still stands and that the Bill will not support reckless experimentation).

At the same time, the new Bill will hold fast to our guiding principles. Doctors must be given the freedom to innovate responsibly, with the confidence that the law will protect them if their decision is made with the support of a responsible body of medical opinion and consultation.

They must not be forced to wait until their decision is tested in expensive and traumatic litigation or disciplinary proceedings. Nobody wants that, except perhaps a small group of lawyers who make their living from the existing litigation-focused system.

The Bill will be an opportunity for all those who are concerned that the legal system is not properly serving patients with rare diseases, whose hope rests entirely on innovation.

Patients want to know that every responsible avenue is being explored in order to help them, and that doing nothing is no longer the easy and safe answer.

And patients will still be protected from negligent treatment. A doctor who harms a patient through bad practice or negligent treatment or who makes a mistake can still be sued. Bad doctoring is still bad doctoring and a mistake that causes damage, remains a mistake.

Good doctors must be given the protection and encouragement of the law to innovate safely and responsibly.

And bad doctors must be deterred from innovating without support of their colleagues.

The Bill achieves both aims.

So, what happens next?

Jeremy Hunt promised to pass the Bill into law if the public wanted it. You have spoken and you have said, clearly and in numbers, that you support the Bill.

Civil servants in the Department of Health will analyse the results and then make a recommendation to Jeremy Hunt whether to support the Bill or not.

We are confident that he will.

It will then be up to the Government to find time to bring the Bill before Parliament for debate and to be passed in to law. This should happen before the next election. 

The new Bill and the guide will be published shortly.

*Edit 2nd June 2014 - the Government consultation has now closed. The Bill team has drafted a new Bill that meets the robust feedback: Read the new Bill

Follow Us

24 Apr 14

Lord Woolf, former Lord Chief Justice, outlines from the legal perspective why the Saatchi Bill is necassary

1 note Reblog Comments

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.

image

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

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

Want more info?

READ: Get the facts

READ: Jeremy Hunt’s support for the Bill

READ: Coverage in the Telegraph

*Edit 2nd June 2014 - the Government consultation has now closed. The Bill team has drafted a new Bill that meets the robust feedback: Read the new Bill

Follow Us