The Medical Innovation Bill: helping patients and innovation, or a prescription for negligence?

Proposed legislation put forward by Lord Saatchi aims to enable doctors to use untested treatments for patients with life-threatening conditions. pharmaphorum spoke to Dominic Nutt, director of Communications – The Saatchi Cancer Initiative, about the Medical Innovation Bill, which has generated considerable controversy.

The UK Parliament is currently reviewing draft legislation called the Medical Innovation Bill, which aims to ‘encourage responsible innovation’ by removing what its supporters say is a fear of litigation among doctors.

The Bill states that it wants to allow doctors to ‘depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly’.

The legislation has been proposed by Lord Saatchi, best known for his advertising empire, who started a campaign on the issue two years ago after his wife Josephine Hart died from ovarian cancer.

Supporters of the ‘Saatchi Bill’ say it will help speed up the discovery and development of new treatments being developed for life-threatening conditions, by freeing doctors to try new approaches.

But opponents says the Bill is fundamentally flawed, and that it will undermine the current legal framework which protects patients from negligence, and which they claim already allows medical innovation.

After being initially reluctant to support the proposals, Health Secretary Jeremy Hunt declared the Government’s support for the legislation last month. The Government has decided to support the Bill after Sir Bruce Keogh, NHS England’s medical director, helped draft new safeguards, which have now been added to the legislation.

The legislation now looks likely to be made law in 2015, but is still facing stiff opposition from some groups. This includes a group of medical research charities, including the Wellcome Trust which says it risks ‘subverting the frameworks currently in place to preserve patient safety’, and fear it may deter patients and their physicians from participating in clinical trials because it could allow ‘ad hoc’ availability of investigational medicines.

Pharmaphorum put some of the issues to Dominic Nutt, director of Communications at The Saatchi Cancer Initiative.

What is the Medical Innovation Bill trying to achieve?

The Medical Innovation Bill is designed to encourage doctors treating patients whose outcomes under standard medical protocols are likely to be poor, to feel able to try new and innovative treatments – should such treatments be available.

The Bill requires doctors to undertake a clear risk assessment – balancing the likely outcomes for a patient receiving standard procedures with the risks of trying a different treatment for which there is less evidence.

For example, the Bill will be relevant in the case where a patient is likely to die, and where standard procedures are unlikely to extend life significantly but at the same time reduce the quality of life, and where, in such a case an experimental treatment may be available.

We know that many doctors feel able to innovate now. We also know that many fear it. So this Bill will support doctors who fear moving away from standard procedures which, though ineffective, are legally safe. If they follow the procedures within the Bill – that is taking account of the views of other relevantly qualified doctors and gaining the consent of their patient – then they can move forward with confidence and with legal certainty.

Those that feel able to innovate now, or for doctors who need to act fast – such as in a trauma case – can rely on the common law as it currently stands. Common law is protected, explicitly, within the Bill.

Common law, under what is known as the Bolam test, allows a doctor a defence against negligence if they can prove that other doctors would have undertaken the same innovative procedure.

The Bill does one simple thing: it brings the Bolam test forward to the pre-clinical phase by obliging a doctor to build a consensus of support from other practitioners in advance of treatment. In this way, doctors who choose to use the provisions of the Bill (and there is no obligation to do so) can proceed with confidence knowing they have a defence in advance against negligence claims.

Furthermore, a doctor cannot be sued for not innovating – the Bill does not allow for this. It places no burden on the doctor to do anything other than the standard procedure. This remains a matter of choice for the doctor and the patient.

“The Bill is designed to give clarity and confidence to all doctors to innovate and to help effect a culture change in medical practice”

In the final analysis, the Bill is designed to give clarity and confidence to all doctors to innovate and to help effect a culture change in medical practice whereby doctors naturally ask themselves whether more can be done for a patient whose prognosis is poor. By so doing, it is hoped that the Bill will add VALUE to the work of researchers, including within the pharmaceutical industry – researchers who are already pushing the boundaries of medical science. The Bill, of itself, is but a small part of a system of research and delivery that needs reform.

Despite numerous changes to the Bill, critics still say that it is taking aim at the wrong target – the fear of litigation. Michael Baum, Professor Emeritus of Surgery at University College London, told The Telegraph: “Never once have we encountered interference or obstruction due to fear of litigation.”

He added: “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.”

What is your response to Professor Baum’s remarks?

In a war – and this is a war against disease – there are many targets.

Professor Baum makes a reasonable point within his own terms. He is a surgeon who feels able to innovate. Surgeons work within the moment and often have to make snap decisions. Clinicians are in a different boat. So, while we have support from many surgeons, the Bill is less likely to apply to surgery and to Professor Baum. And Prof Baum is right to say litigation is not the only obstacle to innovation. But that there are many obstacles does not stand against the thesis that litigation is one of those barriers. We have received degrees of support from Oxford University, from the GMC [General Medical Council], Marie Curie, Cancer52, Cancer Research UK and scores of doctors. See this letter in The Telegraph, for example.

The point is not to trade blows with opponents as to who supports us and who opposes us. The simple conclusion to be drawn is that the disagreement among the medical profession as to the merits of the Bill stands only to confirm that there is doubt and confusion around litigation.

This Bill will clear up that confusion simply and safely.

Why is reducing the risk of litigation the focus of the Bill? Did the Saatchi team consult widely within healthcare circles before drafting the Bill?

Absolutely yes. This Bill has been consulted on for two years. We have interviewed, met, discussed with and listened to, thousands of patients, doctors, researchers, charities, regulators and interested parties.

Furthermore, the Department of Health also ran a consultation on a version of the Bill.

Lord Saatchi has no axe to grind in this matter. He received the clear message from leading doctors and from junior doctors that this is an issue for many practitioners and they urged him to draft this Bill.

Why will this Bill promote innovation? Cancer Research UK (CRUK) has backed the bill – but says it wants to see greater focus on innovation within the draft, suggesting that this aspect is currently weak.

No. CRUK does not say this. In fact CRUK has said: ‘We… hope we will see a greater focus on innovation THANKS to this Bill’, which is quite the opposite assertion. See:

http://www.cancerresearchuk.org/about-us/cancer-news/news-report/2014-10-07-medical-innovation-bill-to-be-discussed-in-house-of-lords

The Bill will promote innovation by giving doctors a process to follow that will give them confidence to innovate, should they feel they need it – which many do. In so doing, it will help effect a culture change in medical practice whereby the notion of innovating becomes increasingly front and centre to a doctor’s thinking.

What kind of reaction have you had from the pharmaceutical industry? The Bill looks like it could undermine clinical trials, which are the mainstay of pharma industry research, and required by medicines regulators such as the MHRA and health technology assessment bodies such as NICE.

“We have had very little contact with the pharma industry and no discernable reaction from it. The Bill will not touch clinical trials in any shape or form, other than positively”

We have had very little contact with the pharma industry and no discernable reaction from it. The Bill will not touch clinical trials in any shape or form, other than positively.

The Bill explicitly states that: ‘Nothing [in this section] permits a doctor to carry out treatment for the purposes of research or for any purpose other than the patient’s best interests.’

The only conceivable impact the Bill will have will be to generate data around new and potential treatments which may in turn inspire new research and clinical trials. It is likely, therefore, to support trials. This will particularly be so if, as we intend, we are able to include a requirement within guidance or on the face of the Bill itself, obliging or encouraging clinicians to capture and share the data from individual innovative interventions.

It is worth noting that the former chair of NICE, Prof Michael Rawlins, supports the Bill.

Parliament is continuing to review the Bill after the Government gave its backing in October. There have been a lot of revisions to the Bill – what are you prepared to compromise on, and what would you insist stay in the legislation?

The Bill has been through a genuine and open consultation process and changes have been made as a result.

This continues as it proceeds through Parliament.

Lord Saatchi has committed to host a roundtable with those who have questions, ideas and issues they wish to raise. After that, the Bill will be reviewed again at Report Stage in the House of Lords.

Areas of likely compromise and change will probably be around the element of data collection – something we want in the Bill – but beyond that Lord Saatchi remains open to all suggestions, as evidenced by the changes already made. In conclusion, it is fully worth lobbying the Bill team.

There are many stakeholders and some are pushing for amendments, which cannot all be met – because they ask for contradictory changes. But the past two years have taught us that we can and will find a way to make this Bill work well for everyone who has an interest in it.

About the interviewee:

Dominic Nutt is director of Communications – The Saatchi Cancer Initiative.

Have your say: Do you think the Bill should pass into law?

Read more on the background to the Bill:

UK experimental drugs bill ‘could hit clinical trial recruitment’

www.MedicalInnovationBill.co.uk