Medical Innovation Bill [HL]

Baroness Masham of Ilton Excerpts

Friday 12th December 2014 Lords Chamber

Moved by

[Baroness Masham of Ilton]

4: Clause 1, page 1, line 15, at end insert “(based on explanation to the patient of the views and other matters considered, and steps taken, under this subsection)”

[Baroness Masham of Ilton]

My Lords, as medical innovation stands, any doctor providing an innovative treatment—for instance, departing from the existing range of accepted medical treatments for the patient’s condition—must consider a range of factors, including the views of at least one other appropriately qualified doctor about the proposed treatment, the risks and benefits associated with the proposed treatment, the risks and benefits associated with existing treatments, and the consequences of not providing these treatments. Amendment 4 will require doctors to explain these factors to the patient so that they are able to make a fully informed decision.

This is important because people have the right to a clear understanding of any innovative treatment, including how it is intended to work, and all the associated risks. Without robust safeguards there is a danger that people could undergo potentially risky treatments without a full appreciation of what they involve. Clause 1(3)(d) already requires doctors to take account of,

“any opinions or requests expressed by or in relation to the patient”,

a welcome and necessary provision. However, this relies on the patient or their carer proactively questioning or commenting on the proposed treatment. Given the complexity of innovative treatments and comparisons to existing treatments, it is unrealistic to expect that a patient or carer will be able to properly form opinion and requests without first receiving an explanation of the views, risks and benefits that have been considered by the doctor. The amendment will therefore strengthen Clause 1(3)(d) and ensure that this provision is able to fulfil its intended purpose.

Clause 1(3)(c) requires doctors to,

“obtain any consents required by law to the carrying out of the proposed treatment”.

Under existing legislation and case law, doctors must explain the risks associated with the treatment and ensure that the patients have the necessary support to help them understand relevant information. However, as the Bill stands, there is not any explicit legal requirement for doctors to provide patients with information on the specific new factors that they are required to take into account under Clause 1, such as the views of other doctors on the proposed innovative treatment.

The amendment will not require doctors to obtain any extra information over and above that already necessitated by Clause 1. It will simply mean that this information is shared with the person being offered the treatment.

In addition to facilitating informed choices, the amendment is also necessary to help ensure that patients have realistic expectations about the likelihood that an innovative treatment will improve their condition. Through receiving an explanation of the various assessments and views obtained by their doctor, patients will have a better understanding of how effective any treatment may be.

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[Baroness Masham of Ilton]

My Lords, I thank the noble Lord, Lord Saatchi, and I thank his team for its very helpful intervention. However, I must say that patients need very clear explanations of what is going to happen. I will take the amendment away again—we have one more stage—and continue the advice from many patient groups. Today on the “Today” programme it was said that in the other place there was considerable worry about patient safety. The Government, therefore, should emphasise this clearly if they want the Bill to go through. I beg leave to withdraw the amendment.

Amendment 4 withdrawn.

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[Baroness Masham of Ilton]

My Lords, I support the amendment, as do many organisations. They say that it is essential that provision is made for collecting and sharing data to ensure that information, both on beneficial and harmful effects of treatment, is captured for the benefit and subsequent use of patients. We should be much better at collecting data than we are at present. This is important for research, but also for safeguarding patients. I hope that the amendment will be accepted.

[Lord Mackay of Clashfern]

My Lords, one of the purposes of the amendment, as I understand it, is as the noble Baroness has said: to record the results of an innovative treatment for the benefit of succeeding generations. If innovative treatment has been successful in a particular case, the details of that case are required to make sure of the extent to which the results might be expected to follow in another case. I regard it as important that that should happen. I understand—no doubt this will be explained later—that there are possibilities of voluntary registration systems being set up. The Government may be able to help us on that, but I regard it as essential, if the Bill is to achieve its purpose, that the innovations, particularly if they are successful, are not kept secret. If they are unsuccessful it is also wise to warn people off later attempts.

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[Baroness Jolly]

As I have said, the Government are very sympathetic to the idea of a registry. On Monday, I have a meeting with the noble Earl, Lord Howe, when I shall pass the views of the House to him. Third Reading will be in the new year.

[Baroness Masham of Ilton]

My Lords, surely patients have a right to know what works and what does not work and surely the noble Lord, Lord Saatchi, wants his Bill to be positive rather than negative.

[Baroness Jolly]

I have said that the Government are very supportive of a registry. Of course, patients would want to know what does and does not work, as would all doctors. I have said that I will take this issue back and discuss it with the noble Earl, Lord Howe.

Assisted Dying Bill [HL]

Baroness Masham of Ilton Excerpts

Friday 7th November 2014 Lords Chamber

[Baroness Masham of Ilton (CB)]

I shall tell the noble Lord, Lord Jopling, about the death penalty in America where the lethal drugs had a disastrous effect, with prisoners dying very slowly.

[Lord Harries of Pentregarth]

My Lords, I have my name down in support of the amendment tabled by the noble Lord, Lord Carlile. He has explained the rationale behind it with his usual clarity and I am not going to repeat his arguments. I support very strongly what the noble Baroness, Lady Finlay, said about the importance of taking the whole process—the independent assessment and the administration of the drug—out of the hands of doctors and making it from beginning to end in every detail a court-controlled process.

I shall address briefly one question which may be on the minds of many noble Lords. Indeed, it has been said before that this may be to set the bar too high. It is true that under this amendment the tests are very stringent and rigorous, but surely on an issue of life and death such as this, they need to be as stringent and rigorous as possible. Provided that a decision can be made quickly—we have heard many reassurances that the courts can make decisions like this quickly—surely the test cannot be too stringent or too rigorous. What many of the opponents of the Bill are worried about is not that they are failing in compassion for people who find their life unbearable, but about the overall effect of the erosion of the value of human life in our society by decisions on this kind of issue. If the tests are rigorous and stringent and are made from beginning to end by a court process, people will be able to see that these are truly exceptional cases and there will be less effect in terms of eroding more generally the value of human life and in the way we nurse the sick and treat other people who feel their life is a burden.

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[Baroness Masham of Ilton]

My Lords, I support Amendment 71 in the name of my noble friend Lady Hollins. As in the case of those with terminal illness, we know that identifying depression is particularly challenging in some other groups, such as those with physical disabilities, intellectual disabilities or autism spectrum disorders.

Depression is more common in those with physical disabilities arising, for example, following a stroke, spinal cord injury or as a consequence of multiple sclerosis. Research shows that that is particularly so when factors including chronic pain, reduced mobility and poor social support are present. Identifying and treating depression and attending to contributory factors can improve both mental and physical health, but depression is difficult to detect in those with physical disabilities. That is because symptoms of the underlying disability can overlap with symptoms of depression—for example, fatigue, lack of interest in previously enjoyed activities, difficulties in sleeping and emotional lability. Depression can be missed by doctors who are not experienced in assessing mental disorders in the context of physical disabilities. Specialist assessment is often required.

Similarly, people with autism spectrum disorders may have characteristics such as social withdrawal, impaired communication and sleep and appetite disturbance which can mask symptoms of depression. Depression often manifests differently in those with intellectual disabilities compared to the general population.

Furthermore, detecting mental disorders in people with autism or intellectual disabilities, as well as assessing their mental capacity to make specific decisions, requires an understanding of their communication needs and how they may differ from the general population. For example, some people with intellectual disabilities may find it easier to communicate using pictures rather than words; others may demonstrate acquiescence, or a tendency to repeat the last words spoken to them. A doctor who has not had experience of or training in assessing mental disorders and mental capacity in people with autism or intellectual disability may be unable to identify the presence of disorders such as depression and may struggle to optimise the person’s decision-making capacity. Again, specialist assessment is vital.

Those vulnerable patient groups are not adequately protected by the Bill as it stands. That is even more reason to introduce a process to make specialist assessment of mental disorder and end-of-life decision-making capacity mandatory. Disability is very complicated, and everyone is an individual.

[Baroness Grey-Thompson]

My Lords, I speak in favour of the amendment tabled by my noble friend Lady Hollins. I felt, coming into the Bill, that I needed a much deeper understanding of mental capacity because my only personal experience of dealing with psychiatrists and psychologists goes back to when I was 11 years old. I have to thank my noble friend Lady Warnock for that because of her incredible work on special educational needs. At the time, I was not allowed to go to a mainstream school and my only gateway into it was going through mental capacity tests.

I have read so much on this but one article that I found stood out to me. It was written, I accept from a very particular point of view, with reference to Herbert Hendin MD, who is CEO and medical director of Suicide Prevention Initiatives. He is also professor of psychiatry at New York Medical College. He stated in congressional testimony in 1996 that,

“a request for assisted suicide is … usually made with as much ambivalence as are most suicide attempts. If the doctor does not recognise that ambivalence as well as the anxiety and depression that underlie the patient’s request for death, the patient may become trapped by that request and die in a state of unrecognized terror”.

The article also said:

“Most cases of depression … can be successfully treated …Yet primary care physicians are … not experts in diagnosing depression. Where assisted suicide is legalized, the depression remains undiagnosed, and the only treatment consists of a lethal prescription”.

We have heard a lot about the difficulties of diagnosis. My noble friend Lady Hollins mentioned the 6% of doctors who are confident that they can diagnose depression. If we look at the figures from Oregon, which the Bill is based on, back in 1998 31% of patients underwent psychiatric evaluation. In 2003-04 it was 5%, and in 2007 no patients underwent psychiatric evaluation. There is the case of Michael Freeland, who for 43 years had diagnosed mental health issues and suicidal tendencies—this was all recorded. He was able to obtain the drugs.

Several studies have shown that incidences of psychiatric illness, particularly depression, are linked to 30% of people with a terminal illness. We have to make sure that these safeguards are included. In my mind, we must make sure that anyone who wants to go down this route has to be evaluated in a clear manner by people who understand mental capacity.

Medical Innovation Bill [HL]

Baroness Masham of Ilton Excerpts

Friday 27th June 2014 Lords Chamber

[Baroness Masham of Ilton (CB)]

My Lords, I feel that the noble Lord, Lord Saatchi, has the very best intentions behind his Bill and I congratulate him on his determination.

I have been in the position a few times when people I loved were dying too early. In such situations, if there is hope with a new medicine or procedure and if the patient wants to try it, as long as it does not cause suffering I am in favour of innovation. I was inspired by a remarkable person I met, Les Halpin, who had motor neurone disease. With only one drug for that deplorable condition, he was a leader in encouraging innovation and to speed up the development of new drugs to help combat conditions such as motor neurone disease.

With the growing realisation of infections becoming resistant to drugs, research and innovation are vital. There is no doubt that when people work together across the world, improvements are made. There have been important advancements with HIV and AIDS, but there is a need for a vaccine and more innovation. With so many people breaking their backs and necks and becoming paralysed, there is a need for innovation to find a way of joining and regenerating the spinal cord. I declare an interest in this.

Legislation sometimes does not do what it is intended to do. My queries are on behalf of patients. I have been in communication with Action Against Medical Accidents—AvMA—and there are some concerns. The Bill will remove a layer of protection and redress for vulnerable patients who are harmed when their doctors act in a way which no other doctor would support. It would encourage unsafe and unaccountable practice by doctors and lead to further tragedies and scandals such as that of Dr Ian Paterson. It would affect all forms of medical treatment, not only in exceptional circumstances such as when all evidence-based treatment options have been exhausted.

The Bill’s provision may have no positive impact on innovation. It will have no effect on funding, research programmes, clinical governance or professional and medical product regulation. Properly considered, the law already protects a doctor against an allegation of negligence if he innovates responsibly. The Medical Defence Union has publicly stated:

“The Secretary of State for Health in a written statement introducing the Medical Innovation (no. 2) Bill stated that doctors wishing to depart from established procedures and carry out an innovative treatment may be fearful of doing so because of the possibility of a clinical negligence claim. We have seen no evidence to suggest that this is the case … Our advice is that there should be no consequences providing there are appropriate safeguards in place, the patient fully understands what is proposed and why the clinician believes it is in their best interests, and they give their fully informed consent … We are happy to reassure doctors that medical innovation should not leave them open to an increased threat of litigation”.

The Bill provides a defence: doctors will not be negligent in relation to any treatment currently regarded at common law as negligent if they take the decision to treat responsibly. While the purpose of the Bill—to promote responsible medical innovation—is laudable, the intentional effect is to deprive patients who are harmed by doctors of a right to redress, even when the doctor has acted in a way that no other doctor would support. It is the rationale behind the Bill that doctors who would currently be regarded as negligent should no longer be held liable.

AvMA is concerned that patients should be afforded protection against irresponsible or negligent doctors. Regrettably, the Bill does not provide adequate protection and could actually encourage unsafe practices, leading to further tragedies and scandals such as that involving Dr Ian Paterson, among others. AvMA is also concerned that patients who agree to treatment that goes beyond the bounds of what is considered acceptable by all responsible bodies of medical opinion are precisely those who require particular protection. The desperate patient who will try anything to be cured or to secure a short extension of their life may be the most vulnerable to exploitation.

Media coverage and statements by supporters of the Bill give the impression that it is designed specifically to open doors to innovative treatments for people with life-threatening conditions for which all evidence-based treatment options have been exhausted. AvMA says that this is not the case. Is it correct that the Bill would apply equally to any form of medical treatment where the doctor convinces the patient that it would be in their best interests to receive it? This could include, for example, cosmetic treatment. I am very keen that there should be a positive effect on innovation, but the safety of patients must be the priority. There should be no loopholes in this legislation to ensure that patients are not put at risk without their knowledge and consent.

I would like to end by saying how important the work of charities is in helping with medical innovation, one of them being Parkinson’s UK. The charity strongly supports more innovation and its adoption into clinical practice so that new and better treatments can be developed to help people with Parkinson’s disease. Any change to the current legislative framework must be driven by clear evidence that the prospect of legislation is currently preventing innovation by doctors. Further clarity is needed on how the Medical Innovation Bill will give priority to informed consent and peer review in order to protect patient safety. Safeguards are needed against unintended consequences such as encouraging reckless innovation and exacerbating the postcode lottery of services.

I have two questions. What evidence is there to suggest that doctors have been discouraged from using innovative treatments for conditions such as Parkinson’s due to concerns about litigation? How many clinical negligence claims in recent years have been linked to innovative medicine? Is not one of the problems the fact that innovative medicine can be very expensive and there are problems around payment? There are many complex conditions, but there should always be honesty and transparency.

[Lord Newby]

My Lords, perhaps I may remind the House of what I said at the start of the debate; namely, that it is a firm convention that the House should rise at around three o’clock on sitting Fridays.

Welfare Benefits Up-rating Bill

Baroness Masham of Ilton Excerpts

Tuesday 19th March 2013 Lords Chamber

[Baroness Masham of Ilton]

My Lords, I have my name to Amendment 12. I support what my noble friend Lady Morgan of Drefelin said.

The Bill could see vulnerable cancer patients and other seriously ill patients losing out on almost £500 per year if inflation rises. That is a great deal of money for people who are not working and who are ill. I hope that the Minister will give some hope that those vulnerable people will not suffer and that he will support this helpful amendment.

[Lord Forsyth of Drumlean]

My Lords—