Medical Innovation Bill [HL]

Baroness Garden of Frognal Excerpts

Friday 12th December 2014 Lords Chamber

[Lord Winston]

Before the noble Baroness sits down, I wanted, for clarity, to speak to two amendments at a time. I will speak to Amendment 13 in due course and say exactly what I meant. If the noble Baroness wishes me to speak to those amendments now I will do so.

[Baroness Garden of Frognal (LD)]

To clarify for the noble Lord, the amendments are grouped together, so he is required to speak to them in the group. He will, of course, have the right to come back at the end of the group and he may wish to include them at the end.

[Lord Winston]

I am very happy to speak to those amendments now. They are very simple. The question of the dental practitioner is simply that dental practitioners also are involved in maxillofacial surgery and other treatments that may require innovation. With regard to other practitioners who are not medically registered, we are going to require more and more nurses and other workers with university qualifications who will be conducting treatments, and it is therefore important that we clarify whether they will be able to innovate.

[Baroness Garden of Frognal]

I must point out to the noble Lord that it is not in order for him to speak twice to a group of amendments at Report stage.

--- Later in debate ---

[Baroness Farrington of Ribbleton (Lab)]

My Lords, I think that it would help the House if the government Whip could advise noble Lords on whether the appropriate time for Members of your Lordships’ House to speak to all the amendments in this group is now or later. At the moment, people are unaware of whether the net result of what my noble friend Lord Winston said was to degroup or whether we are in a position where Members must speak now to any of the amendments in the group.

[Baroness Garden of Frognal (LD)]

My Lords, I notice that the noble Baroness, Lady Wheeler, has spoken to the amendments which the noble Lord, Lord Winston, did not speak to. I will seek advice from the Clerk as to whether the noble Lord may wish to degroup the amendments to which he did not speak. I think that that would be up to the noble Lord. For the convenience of the House it might be clearer if he degrouped the amendments to which he did not speak. Does the noble Lord, Lord Winston, wish to do that?

[Lord Winston]

It is very kind of the Front Bench to offer that possibility. If I were to degroup an amendment, I would degroup the stem cell one and put it with Amendment 5, as it would fit better with patient safety. One of my difficulties is that the groupings are slightly odd in terms of the relevance of the different aspects of my amendments.

[Baroness Gardner of Parkes]

Perhaps I may raise a point. When you table an amendment, you are usually sent a draft list of the groupings. You are asked whether you are happy with that or whether you want your amendment to be grouped separately. I wonder why that has not happened in this case.

[Baroness Garden of Frognal]

My Lords, I thank my noble and learned friend for his suggestion. I think that the noble Lord, Lord Winston, suggested moving Amendment 13 into the group which begins with Amendment 5 but leaving Amendments 11 and 12 in this group. If we proceed on that basis, then, as my noble and learned friend said, when Amendments 11 and 12 are called, he will have the opportunity to speak.

[Baroness Jolly (LD)]

My Lords, this group of amendments relates to the scope of the Bill. As noble Lords are aware, the Bill relates to a decision by a doctor to depart from the existing range of accepted medical treatments for a condition. I make it clear that the Bill applies not to research but only to decisions relating to individual patient treatment. My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee that the conditions of the Bill might add to the requirements under which researchers operate. Amendment 8 in the name of my noble friend Lord Saatchi responds to these concerns, clarifying that the Bill does not apply to treatment carried out for the purpose of research. As such, Amendment 9 removes the existing provision on research, which is no longer necessary.

My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee and at the round-table event hosted by my noble friend on 11 November that cosmetic treatment may be subject to less scrutiny than other treatments. Peers were therefore reluctant that the Bill should apply to this area of practice. Amendment 10 ensures that the Bill does not apply to treatment which is carried out solely for cosmetic purposes. Beyond this, the Government do not consider it necessary to exclude certain treatments or conditions from the Bill.

Amendment 1 from the noble Lord, Lord Winston, seeks to clarify that a doctor would not have to rely on the Bill where time or place did not allow the required consultation. The Government do not view this as a necessary amendment as the Bill already makes it clear that there is no requirement to innovate. If a doctor chooses to innovate, it is for that innovating doctor to decide whether to rely on the protection of the Bill and therefore to take the steps set out under the Bill. Clause 2, as amended in Committee, ensures that the common law test of clinical negligence is not affected by the Bill.

My noble and learned friend Lord Mackay of Clashfern suggested that Amendment 1 would be a helpful clarification to the Bill. Amendment 14 in the name of my noble friend Lord Saatchi will clarify that the Bill does not limit the circumstances in which the common law may be relied upon, and it expressly gives emergency treatment as an example. Amendment 1 is not necessary and could create confusion for doctors in determining exactly when the Bill applies. The amendment might also suggest that it is only in these limited circumstances that the Bill would not apply, whereas it is intended that doctors can choose whether to rely on the Bill, and it provides an option for them to demonstrate that they have acted responsibly. Amendment 14 proposed by my noble friend Lord Saatchi clarifies the point, confirming that the Bill does not limit the circumstances in which the common law may be relied upon, giving emergency treatment as one such example.

I want to pick up a point raised by my noble friend Lord Colwyn concerning placing GPs in a position where they are asked to innovate but are not able to do so. The Bill requires a doctor, in making a decision to innovate, to consider any opinions or requests expressed by, or in relation to, the patient in order to ensure that the decision to do so is taken responsibly. The clause in question does not confer any additional rights on patients to demand innovative treatment. However, it is crucial that, when making a decision to innovate, a doctor considers the view of that patient. As such, I hope that noble Lords will throw their support behind Amendment 14 put forward by my noble friend Lord Saatchi.

A further clarification is provided by my noble friend’s Amendment 15. In Committee, the noble and learned Lord, Lord Woolf, argued that the Bill does not offer an alternative defence to that under common law; rather, it is supplementary. The Government agree with that interpretation and also that the Bill’s current wording is not sufficiently clear on this point. Amendment 15 clarifies that a decision to innovate in accordance with the Bill does not prevent a doctor also relying on the existing common law defence under Bolam, and it would be a valuable addition to the Bill.

Amendments 11 and 12 seek to extend the application of the Bill to dentists as well as doctors. The Bill applies only to doctors, as it responds to concerns that doctors have raised concerning the fear of litigation. The Bill is aimed at reassuring doctors who feel unable to innovate due to concerns about litigation. The Department of Health’s consultation on the Medical Innovation Bill revealed that some doctors find the threat of litigation to be a block to innovation, although this view was not universally held. The consultation did not reveal the same demand for the Bill from dentists. If the Bill passes, we will consider its impact and will continue to listen to the concerns of all healthcare professionals.

Amendment 12 also seeks to limit the application of the Bill to practitioners or health workers who are registered by the GMC or to dentists who are registered by the General Dental Council. The Government consider this amendment to be unnecessary as the Bill’s scope is already limited to doctors, who are defined under the Bill as registered medical practitioners. All registered medical practitioners are registered with the GMC.

Amendment 6 in the name of the noble Lord, Lord Winston, seeks to define the meaning of innovation under the Bill. Over the course of the debates on this Bill, a number of suggestions have been brought forward on how to approach this issue. Drafting a positive definition of innovation is a difficult task. This is revealed by the addition in this amendment of paragraph (e) relating to the application of a monitoring device or biosensor, which has been absent from prior definitions. It is crucial that the definition of innovation under the Bill is future-proof and clear for both doctors and patients.

The Bill defines innovation as a situation where a doctor decides to depart from the existing range of accepted medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether they are following accepted treatments. Here I pick up three points, one being from the noble Lord, Lord Colwyn. I was asked about upholding the advice given by NICE and whether the Bill would allow doctors to go against NICE guidelines. The Bill does not impact on the existing legal obligation for NHS commissioners to provide funding for drugs that have been recommended in NICE technology appraisals. However, it will remain for doctors to decide on the most clinically appropriate treatment for their patients, whether or not they are innovating under the Bill.

--- Later in debate ---

[Lord Winston]

In another place on Tuesday evening, there was an Adjournment debate moved by the honourable Member for Totnes, who is a qualified medical practitioner. In her outstanding speech, she raised serious concerns about the issue of patient safety. In particular, she cited her concern that patients, particularly those with cancer, may be at serious risk from quack practitioners who are offering a quick-fix solution for money rather than a course of authentic treatment, and possibly entering a clinical trial. The effect of this on cancer treatment could be disastrous. First, not only might we end up endangering patients by their entering a treatment that is not valid or appropriate. Secondly, research may be inhibited because we cannot fill the clinical trials needed to prove that cancer drugs are effective.

We are now in the age of genomic medicine. Genomic medicine means, more and more, that each cancer is different. Essentially, we are understanding that there are more and more mutations. As each of us in this Chamber gets older, we develop more and more mutations, so we are more liable to get different cancers in different cells. Of course, there are the common ones, but it is worth bearing in mind that more than 50% of cancers are actually quite rare. It is important to understand that each individual rare cancer makes a massive difference to life expectancy and health in Britain. Indeed, about one-third of us in this Chamber will suffer with a cancer and, on the figure I just quoted, roughly half of those will be rare cancers.

We are beginning to understand that each of these cancers can be targeted with a specific genomic medicine which may apply only to that cancer. A classic example was the case of vemurafenib, which was used for a rather unusual form of skin cancer and resulted in metastases massively drying up—but it would not work for other cancers, because the mutations were different.

It is imperative, as Cancer Research UK clearly says, that we get patients who are able to go into trials. Apart from the fact that it would be disastrous for the safety of the patients who are being treated irrationally by illogical treatments, there is also a question of patient safety generically for our entire British population. That is the purpose of the amendment.

I have focused on one area in my Amendment 13, which is the use of cells and tissues that are biologically derived. The reason I included that is because stem cells will clearly be an important use in future. Already, we are seeing practitioners setting up quack medicine which is not proven, where they are injecting cells into patients without proper validation. That is clearly dangerous. It is being used for dementia, some forms of motor neurone disorders and other neurological disorders, such as disseminated sclerosis. A number of cancer patients have also had these horrendous treatments. That is likely to burgeon, so it must be taken very seriously by the House.

We have to be absolutely clear that whatever we do, we do not endanger patient safety. There are some interesting examples in the history of medicine. The noble Lord, Lord Walton, who comes from Newcastle, told me yesterday that he is hugely against the Bill. He is very concerned that it will damage patient safety, but for health reasons—as your Lordships know, he is now 92—he felt unable to come down from Newcastle today. He reminded me of a case which I knew of way back in the 1950s. In Oxford, where he came from at that time, there was a Dr Honor Smith. Dr Smith thought that the injection of tuberculin into the spinal cord of patients with neurological disorders—in particular, with disseminated sclerosis—might alleviate their condition. In fact, it did not.

[Baroness Garden of Frognal]

My Lords, I apologise for intervening, but is the noble Lord now speaking to Amendment 13 as well? Is he speaking to Amendment 13 in this group?

[Lord Winston]

I am speaking to both.

[Baroness Garden of Frognal]

No, no. We are in the second group. The noble Lord is moving Amendment 2 in the second group, but he seems to be speaking also to Amendment 13 in this group. Is that correct? If it is, then other noble Lords will want to respond to Amendment 13 as well. Perhaps the noble Lord could clarify which amendments he intends to speak to in this group.