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.