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Access to Medical Treatments (Innovation) Bill

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16 October 2015
Innovations Bill Today the House of Commons debated the Access to Medical Treatments (Innovation) Bill. I have a number of concerns about the Bill and spoke against it. You can read my full speech below:

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Thank you Madam Deputy Speaker. 

Can I start by congratulating the Hon Gentleman on securing a place in the Private Members Ballot and thank him for meeting with me earlier this week. 

It seems to me that some of the time in this place, we need to be careful what we wish for. I know the process of steering a Private Member’s Bill through Parliament is not only time consuming but can also become very complicated. 

I suspect the Hon Gentleman may be feeling that at the moment and I should probably be honest at the outset and warn him that my contribution today may add to his headache. 

The very fact that we are discussing this Bill means we are having a vital debate about the critical issue of how we improve patients’ access to innovative and effective treatments.

In putting his case for the Bill’s second reading, the Hon Gentleman has demonstrated he has the right intentions. That is probably the best I can say. 

Many people in this House would have been in a position where someone we love was dying too soon.
In those situations, you want hope. 

Hope that there might be some kind of treatment or a drug that could offer a chance of survival, or of extending life that little bit longer.

If I thought this legislation would provide genuine, well founded hope in a safe and sound manner, I would support it but I am not convinced it does. 

The truth is that I am worried that it does the opposite. I am worried that unsafe treatments could be used on dying patients. I’m worried that the impact of this Bill would be to muddy the water for doctors who wish to innovate about the legal route to do so. I am worried it will reduce participation in clinical trials. And I am worried that it could remove legal redress for a patient with a genuine negligence claim. 

In the few weeks I have been in this job, I have approached this Bill with an open mind.

I have met with a range of different experts, patient groups, Royal Colleges, and charities.

I think it is fair to say, they are overwhelmingly opposed to this Bill. 

I’d like to put some of their concerns to both the Hon Gentleman who is proposing this Bill and the Minister who I understand is actively supporting it.

The first concern is that this Bill is attempting to remedy a problem which doesn't exist.

Let me briefly quote a few of the experts in this area:

The Academy of Medical Royal Colleges has said “the Bill rests on the false assumption that it is fear of litigation that is holding back innovation by doctors. There is simply no evidence that this is the case.”

The British Medical Association has said: “We are not aware of any evidence to suggest that the threat of litigation inhibits innovation or that confusion exists amongst doctors over the circumstances under which they can deviate from standard practice.”

The Royal College of Surgeons say “there is no evidence that doctors are deterred from innovating due to the threat of legal action.”

The Motor Neurone Disease Association has said: “The Bill would not remedy the problem it is aimed at, for such a problem does not exist.”
And Sir Robert Francis QC, who has done so much in recent years to make sure the NHS is focused rightly on patient safety, has said: “The law of negligence does not prevent responsible innovation and never has.”

I could quote many, many more but I think I have made my point.

Why does the Hon Gentleman and for that matter the Minister think all of these experts are wrong and they are right?

What evidence do they have that litigation or the fear of litigation is preventing new treatments or hampering doctors from innovating?

Madam Deputy Speaker, even if we accept there is an issue, the question then becomes whether this Bill provides a robust and safe mechanism to tackle it. I’m not sure it does but let me say to the Hon Gentleman and the Minister that I am willing to work with them both, and anyone else who is interested, to look at how we can, on a cross-party basis, work to address any potential barriers to innovation. 

Before I go on to set out why I do not believe this Bill is the right approach, I want to first deal with Clause 2 which provides the Secretary of State with the power to establish a non-statutory database of innovative medical treatments. 
My understanding is that the inclusion of this Clause arose as a result of concerns rightly raised in the other place by my Noble Friend Lord Hunt, when the previous incarnation of this Bill was debated. 

Lord Hunt secured an amendment to that Bill which would have required the Secretary of State to establish such a database.

The problem is this: that requirement doesn’t exist in this legislation. 

As written, this Bill gives the Secretary of State the power to establish a database, but places no such obligation on him to do so.

I also question whether this clause is needed at all. 

According to the House of Commons library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State the power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information.

Is it not the case that the Secretary of State already has the power to establish a non-statutory database of innovative treatments without legislation?

I’d be grateful if the Minister could confirm that.
The Bill also gives no detail whatsoever on how this database might work.

And isn’t this crucial – the database will only be effective if it is compulsory, regulated and is quality controlled.

For a database to work it requires participants to be just as likely to register failure as successes.

So will there be a requirement to remove an innovation that is not effective from the database?

Will the database be quality assessed or peer reviewed?

Will it be used for marketing to patients? 

The Bill makes no reference to these crucial points.

Madam Deputy Speaker, I am also concerned about the impact of this Bill on research, and in particular participation in clinical trials.

As the Life Sciences Minister will know, we are a world-leader when it comes to clinical research – and we must be careful not to do anything that might put that status at risk.
Last December the Minister said he hoped that the forerunner to this Bill would develop into a form which “the vast majority of medical opinion and respectable bodies in the medical field feel able to support”. 

So let me now list some of the medical research charities opposed to this Bill.

Alzheimer’s Research UK, The British Heart Foundation, Cancer Research UK, the Motor Neurone Disease Association, Parkinson’s UK, the Wellcome Trust.

Is the Minister really comfortable supporting a Bill which these experts say could have “significant unintended consequences for medical research”?

It seems entirely possible that a doctor might choose to prescribe an innovative treatment, or indeed a patient decide to take an innovative treatment, rather than enter a clinical trial. 

If a patient is faced with the choice of guaranteed access to a treatment, or participation in a trial in which there is a 50:50 chance they will not be part of the group receiving the “innovative” treatment, why would you choice to be part of the trial?

I’d be grateful for the Minister’s comments on this. Does he not accept that the arrangements for clinical trials – including as they do, monitoring and ongoing data collection – provide a better mechanism for evaluating new treatments and advancing medical progress than the situation which could become more pervasive as a result of this bill? 

Madam Deputy Speaker, if the concerns I have set out aren’t enough, let me now turn to my main concern about this Bill, which if passed, could undermine a patient’s ability to hold doctors to account when things go wrong. 

The Hon Gentleman has claimed this is not Lord Saatchi’s Bill, but the wording of his clause 3 is very similar to Clause 1 of the previous Bill. 

Subclause (2)(a) of the Bill we have before us today, requires a doctor to obtain the views of one or more doctors, (which in practice could mean one doctor), “with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion.”

Can the Hon Gentleman confirm that this relies on someone’s interpretation of a responsible body as opposed to seeking a view from a responsible body directly?

Does this Bill not boil down to one doctor who wishes to deviate from accepted medical treatments, asking another Doctor whether he or she thinks there is a reasonable body of medical opinion which would support such a treatment? As long as that second doctor perceives such an opinion to exist about support for the proposed treatment, then this provides cover for the patient’s doctor to proceed? 

I can’t say I am convinced by this. 

Interestingly, the explanatory notes to the Bill confirm “There is no requirement to follow the steps in the Bill. Doctors can instead rely on the existing common law, which allows a doctor to show that a responsible body of medical opinion supports his or her actions (the Bolam test), thus demonstrating that the individual was not negligent.” 

Is it not the case that the alternative approach offered will simply cause confusion and uncertainty and undermine mechanisms already in place to safeguard patients?

Could this not lead to doctors being absolved from any liability for an experimental treatment if they followed the Bill’s standards making it much harder for patients to redress malpractice?

Sir Robert Francis QC has said this would – and I quote - “deprive patients of remedies when mistreated by those who have no acceptable justification for what they have done.”

In conclusion, we are faced with deep and broad concerns as expressed by patient groups, medical research charities and royal colleges. I don’t think we can ignore those voices.

Voices such as Action against Medical Accidents who say the Bill is a threat to patient safety. Such as the Association of Medical Research Charities who say this Bill “may adversely impact on patients and medical research.”

And voices such as the Royal College of Paediatrics and Child Health - the President of which simply says the Bill is dangerous to the safety of infants and children.

Mr Speaker, I think it would be irresponsible to support this Bill today. That’s why I will be voting to oppose it, and I encourage other Hon Members to join me.


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