Access to Medical Treatments (Innovation) Bill

Lord Patel Excerpts

Friday 26th February 2016 Lords Chamber

[Lord Patel (CB)]

My Lords, I am delighted to support this Bill and hope that it will have a swift passage through this House and become legislation. I congratulate the noble Lord, Lord Saatchi, on presenting it in great detail and in his usual style, and—given the difficulties his predecessor Bill had—on his tenacity in listening to people in and outside this House and getting to the position whereby the Bill is now acceptable to all the professionals I have spoken to.

Perhaps I may briefly go off the Bill and come on to some comments that have been made. Before I do that, I will declare my interests. I am, as everybody knows, a doctor by background. I am the chancellor of the University of Dundee, which is one of the key UK universities for life sciences. I chaired until recently the UK cancer research centre in Dundee. I now chair, as a board member, another research group in Dundee that is looking at the scientific evidence as to why cancer outcomes can be worse among people from a poorer background, where they are disastrously worse. I was also responsible in this House for chairing a report on genomic medicine. That led, thankfully, to the developments in genomic medicine in the United Kingdom and the research centre which the Government support through the research councils.

It is true that as we learn more and more about genomics and genetics, we will need to have a huge database from which we can learn. What the noble Lord, Lord Ryder, said is correct: there will be patients who would be appropriate for stratifications of medicines that we know now and which are found to be effective because they are used more generically. If we learn from genomic medicine that stratification makes them more suitable for that treatment, because of their genetic make-up, such drugs will be very beneficial.

It is also true that innovations occur in the United States at a faster rate—the noble Lord, Lord Ryder, referred to this—because the processes of the different trial phases there are much more efficient. Some say they are too quick; I do not subscribe to that view. Let me give one example. The noble Lord referred to this concept briefly. Some of the breast cancer treatments do not work in all women. We know that the drug that is given will work but that it cannot be given in the quantities required because most drugs, as we know, are poison. You can use it in a dosage that will treat the disease but if you exceed that dose, you are likely to do more harm than good. But if you can limit that treatment to only the cancer cells, those drugs will be effective. We now have innovations whereby this can be done by identifying the molecular make-up of the cancer and then loading the drug with that molecular marker, so that it will attack only the cancer cells and leave the normal cells alone.

We need a different way of innovating. My own university also has a drug discovery unit. We have contributed to the development of several drugs, two of which would be regarded as blockbuster drugs, through understanding the science of disease processes—the biology of disease. Such understanding is crucial before you develop a treatment.

However, we need to move away from that to other ways of developing drugs. We try to do this by using 70,000 compounds that were previously identified by pharmaceutical companies but not used because they were not found to be effective in treatment. We are seeing if any could be used for the treatment of so-called tropical diseases that are not infectious, which a huge number of people are affected by. We do this in collaboration with other countries by supplying them with these compounds. I agree that we need to look at different ways of innovating drugs and treatments, particularly as the science develops. There will be other ways of dealing with diseases, such as gene-editing, which was how Layla, a young girl in Great Ormond St, was treated. That may also require the development of other drugs to make sure that side-effects are suppressed.

The point I am trying to make is that the Bill may well act as a catalyst. The noble Lord, Lord Saatchi, should be pleased that people are thinking more widely and outside the box. We have an opportunity to develop good databases, as the noble Lord indicated, and to use them for innovative development of treatments. I hope this will happen. I hope that the Government will bring in wider legislation on the issues that the noble Lord, Lord Ryder, referred to, such as better ways of conducting clinical trials. We need transparency and openness. I do not think the medical profession is averse to that, and it is what the public need. We have to be honest: not all the treatments we try will work, but if we try harder, we will find treatments that work which we have been ignoring.

I have to admit to something here, which I hope the GMC does not hear me say—although it might, and if it does, I do not care. I have used off-licensed drugs on several occasions, with the full consent of the patients I was treating, when no other treatment was working. Lots of my colleagues do this. If any doctor stands up and says they never do it, I would not suggest that they might not be telling the truth, but I would be surprised if they were innovators in the true sense.

Then, there is research. I have done research that I am not very happy about and that I wish I had not done, but at the time I did it with a clear conscience. In retrospect, I now know that it probably did not work as well as expected and was probably not all that good for the patient—I hope it did not do any harm—but if I had not tried it, I would never have known. It is important that we stop arguing at length and trying to regulate and control in the minutest detail innovations in medicine that we can drive forward. We do this more easily with innovations in surgical and other procedures. We are much freer about that and clearly understand that, as doctors, you work with people in other countries to introduce the same procedures and use a common database to learn.

[Lord Hunt of Kings Heath (Lab)]

Would many current surgical procedures have been authorised if they had had to go through the kind of clinical trial process that medicines do?

[Lord Patel]

We would not have had stents put in hearts, bypasses, ablations—

[Lord Blencathra (Con)]

Marie Curie.

[Lord Patel]

Yes, we would not have had Marie Curie’s radiation treatment. One of my children is an oncologist, so I know what they do. The noble Lord is quite right: fortunately, such procedures do not have to go through this stringent process. Some argue that they should, but that would be a backward step.

The only minor concern the professional organisations have had is to clarify the definition of medical innovations. It is true that practitioners must clearly understand that they cannot bypass current regulations on patient safety; I have no doubt that the Minister will confirm that. The other matter, which has been mentioned and on which the noble Lord, Lord Saatchi, convinced me in his introduction, is that the database has to be transparent and shared and there must be clear stewardship of it. I hope the Minister will confirm that.

I strongly support the Bill and wish it a speedy passage.

Mental Health Taskforce

Lord Patel Excerpts

Tuesday 23rd February 2016 Lords Chamber

[Lord Prior of Brampton]

My noble friend is absolutely right. I am glad he finished by referring to quality in outcomes rather than just activity. That is the critical thing about getting the tariff right, that it is based not just on activity but on quality in outcomes.

[Lord Patel (CB)]

In responding to the task force report, is it the Government’s intention to produce a mental health strategy that will encompass all the issues, including the funding?

[Lord Prior of Brampton]

Together, the task force report, the report produced by the noble Lord, Lord Crisp, and the earlier report on children and young people really do comprise a strategy for mental health for the next five years.

Alcohol Strategy (EUC Report)

Lord Patel Excerpts

Wednesday 10th February 2016 Grand Committee

[Lord Patel (CB)]

My Lords, I will be brief, because much of what could be said has already been said. I was going to say that the only thing left that has not been covered is how occasional or moderate alcohol drinking is quite satisfying, but my noble friend Lady Murphy even covered that—she did not leave it for me. I agree that we should thank the EU committee and my noble friend Lady Prashar for presenting this report. It is a well-produced report that makes all the points and highlights the lack of a co-ordinated alcohol strategy in the EU and the United Kingdom. We have a piecemeal approach, and it would be nice to develop a co-ordinated strategy.

Let me deal briefly with one or two of the committee’s recommendations and the Government’s response. First, I agree with my noble friend Lady Murphy about pricing. Why is pricing not based on strength of alcohol? That would mean that those who enjoy alcohol could drink lower-strength alcohol, which would be more popular. It is higher-strength alcohol that is largely responsible for the behaviour we see from those who drink too much. So I would support that and I would be interested to hear the Minister’s response.

I know that bottles are labelled saying that alcohol can be harmful during pregnancy, but that does not go far enough. In my clinical practice I have always advocated giving up drinking during pregnancy, or even before if you intend to become pregnant. The labelling should be much stronger.

I was interested in Recommendation 11, on marketing. The Government’s response seems rather a fudge. It states:

“This work will lead to a new draft of the Directive by June 2016. The revised Directive will need to be transposed into UK law”.

It would be nice to know the Government’s view on marketing, rather than their saying they will wait until the EU produces something. The Government must surely have a view on marketing.

Recommendation 12 says that,

“the Government should press the Commission to propose amendments to the Food Labelling Regulation”.

My noble friend Lady Murphy referred to the calorific content of some drinks and how that may affect nutrition. The Government seemed to be quite strong on this, saying that we should have labelling related to nutritional and calorific values, but in their response they seem to have weakened. I may have misread their response, but it would be nice to know which strategy is correct.

I will finish there as most of the other points have already been made in great detail by other speakers.

Health: Zika Virus

Lord Patel Excerpts

Thursday 4th February 2016 Lords Chamber

[Lord Prior of Brampton]

My Lords, there has been one case where Zika may have been sexually transmitted—I use the words “may have been” advisedly because it is not proven. Indeed, the link between Zika and microcephaly is not yet scientifically proven. There seems to be a strong probability that that is the case, but we should bear in mind that Zika was first identified back in 1947 in Africa and since then there has been no such connection with microcephaly, although in Brazil there appears to be a very strong connection now. There has been one case in Texas, where there may have been sexual transmission and the advice for men who are sleeping with women who may become pregnant is to wear a condom.

[Lord Patel (CB)]

My Lords, while absolutely agreeing that we should carry on supporting the science of genetically modified mosquitoes, it may be that mosquitoes that are already genetically modified for dengue can do the same job for Zika, but we do not know that. Much more important is the recent report and questions about the assessment of the spread of the Zika virus. The Minister has just referred to sexual transmission, but that applies to any bodily fluids, not just sexual transmission. The other worrying thing is that the common mosquitoes have now been found possibly to be infected by Zika. That is a much more worrying prospect, because they are much more widespread.

[Lord Prior of Brampton]

I understand that the common mosquito which we find in southern Europe could potentially carry Zika, which I think was reported in the Times today. There is as yet no evidence that it does carry Zika, but it is something that we need to watch very carefully.

Sugar Tax

Lord Patel Excerpts

Wednesday 3rd February 2016 Lords Chamber

[Lord Patel (CB)]

My Lords, I am sure the Minister is aware of a meta-analysis study carried out of nine studies which compared the pricing of sugar-sweetened beverages against the reduction of consumption of such drinks. It showed considerable price elasticity. Therefore, it is difficult to determine in an economy like ours the level of taxation that is required to achieve the right reduction. What plans do the Government have to find such evidence?

[Lord Prior of Brampton]

My Lords, it is interesting that in the plans put forward for consultation by Simon Stevens of NHS England they are looking at a levy of 20% on sweetened beverages. In Mexico, they brought in a sugar tax of 10%, which according to a study by the Lancet resulted in a reduction in consumption of some 12%. But it is very difficult to isolate the particular impact of tax when many other measures are being used at the same time.

NHS: Trust Finances

Lord Patel Excerpts

Monday 1st February 2016 Lords Chamber

[Lord Prior of Brampton]

My Lords, it is true indeed that Jim Mackey mentioned those figures. He is hoping that he can get that deficit down to £1.8 billion by the end of the year as a result of some of the capital to revenue and other accounting adjustments to which the noble Lord referred. We are also hoping that the reduction in agency spend will start to have a big impact in the final quarter of the year. We will get the third quarter results in two weeks’ time, when we will have a better idea as to where we will end up at the end of the year.

[Lord Patel (CB)]

Correct me if I am wrong, but the noble Lord mentioned in his Statement imposing a tariff on agency staff, cutting down on consultancy fees and the potential savings that the report of the noble Lord, Lord Carter, might produce—although most people doubt that it will. Where does he think that the finances of the NHS will be on 1 April 2017? What is his prediction?

[Lord Prior of Brampton]

The cap on agency staffing rates and on agency staff has really started to apply only in the past six weeks. So far, it looks as if we are making significant progress there. As I said in answer to the Question, the NHS is receiving £3.8 billion of extra funding in the forthcoming year. We believe that that will enable it to restore its finances to a proper balance by April 2017.

Pregnancy: Neural Tube Defects

Lord Patel Excerpts

Monday 21st December 2015 Lords Chamber

[Lord Prior of Brampton]

My Lords, I do not think that what the noble Lord has said is entirely correct. My honourable friend Jane Ellison received a letter from the SACN, the committee on nutrition, on 20 October that indicated that many more women were below the foliate level than had previously been thought. That evidence is quite new and came in at the end of October. That is what she is now considering.

[Lord Patel (CB)]

My Lords, the Minister has said that he is against mass medication. Do we really think that this is mass medication? We are talking about adding to flour micro amounts of nutrition that is lacking, to give a choice to people: if they intend to get pregnant, they eat bread made from that flour and not unfortified flour.

[Lord Prior of Brampton]

Just to correct the noble Lord. I did not say that I was against mass medication; I said that it was one of the things that should be considered. It is also worth saying that, even if there was mass medication, it probably would affect between 15% and 30% of women who have babies with neural tube defects and not all women.

Southern Health NHS Foundation Trust

Lord Patel Excerpts

Thursday 10th December 2015 Lords Chamber

[Lord Prior of Brampton]

Avoidable deaths are estimated at some 10,000 a year. “Unavoidable deaths” is the phrase that I think I used, which are estimated at some 10,000 a year. That is not out of line with what is found in other countries, such as America and Germany. However, it should not be accepted, which is why the Secretary of State has asked Bruce Keogh to produce these new statistics for every trust, starting from next spring.

[Lord Patel (CB)]

The Minister might want to look at those figures again, and correct them with a letter if necessary, regarding avoidable and unavoidable deaths. Turning to my question, on a daily basis now we get at least two items of bad news relating to the NHS, mental health, public health or other issues in social care. Is it not time to look at the whole organisation of the NHS, including funding and so on, through an independent commission? Why would the Government not do that? The Opposition might not support it but it would take politicians out of it and we might end up with a better service.

[Lord Prior of Brampton]

The noble Lord makes an interesting point. We have a much more transparent system than we used to. Surely it is better that we know about what is going wrong within the NHS rather than that we cover it up as it was in the past.

Alcohol

Lord Patel Excerpts

Wednesday 9th December 2015 Lords Chamber

[Lord Prior of Brampton]

I am happy to be told that by my noble friend and I can only agree with him.

[Lord Patel (CB)]

My Lords, as it is Christmas, does the Minister think that the Parliamentary Estate should be alcohol-free, as it is smoke-free?

[Lord Prior of Brampton]

My Lords, I think that we would be setting an excellent example if we did that.

National Health Service (Licensing and Pricing) (Amendment) Regulations 2015

Lord Patel Excerpts

Tuesday 1st December 2015 Lords Chamber

[Lord Patel (CB)]

My Lords, perhaps I might start by suggesting to the Minister that this is another example of why the NHS might be unsustainable and that we probably need an independent commission to look at the whole of the NHS. I realise that neither he nor the Opposition Front Bench are likely to agree with me on that, but I make the point that this is yet another nail in the coffin, so to speak, which will get us to that end some day.

I find myself in agreement with some of the things that the noble Lord, Lord Hunt, has just said. We have an example here of where raising the tariff to 66% actually means ruling out the ability of the providers to engage in any kind of discussions relating to the tariff because the target is too high. If that is the case and the providers are therefore not able to engage with NHS England and Monitor, which sets the tariffs, what other mechanisms do they have? They cannot see the proposed tariffs until the consultation occurs, which is rather too late for them even to road test whether the tariffs are likely to be workable—particularly if they involve, for instance, any implications on pensions or proposals that the Government may have brought about pay deals, or any other issues that may impact on the cost. So how is the provider likely to get any input at an early stage and engage with the tariff-setting mechanism? There will be no such input, I suggest, through these proposals, which will make it impossible. They will therefore have to live with the tariff.

I realise that the big providers might be able to do that, because they might save some money from other aspects, but let us take the specialist providers. We can particularly imagine this in paediatrics and with some cancers, where providers work on small margins and the costs may escalate. Because of a few patients having highly complex issues, costs can overrun. That is why the top-up fees of some £300 million were introduced, 70% of which go to paediatric specialist services. Now the proposal is to remove those or reduce them considerably. In paediatrics, the top-up might go down from £217 million to £95 million. So these specialist providers have a choice: either to provide poor-quality service, which impacts on the patients, or to opt out. Who will then suffer? It will be not the commissioners, NHS England or Monitor but the patients—because they will not have a service or will have a poor-quality service.

I agree with the noble Lord, Lord Hunt, that there needs to be some kind of mechanism where there is early involvement of the providers, which can engage in the tariff-setting mechanism. They would not necessarily dictate it; they might disagree with it but suggest some proposals. One of the ways, as he suggests, would be a stakeholder forum involving all the parties at an early stage. The Department of Health can then have some accountability from all the people in the stakeholder forum, including the providers. I am attracted to that suggestion, and I hope the Minister will respond to it.

The Minister responding in the other place sounded sympathetic—or at least suggested that he understood the issues. I hope that we can go further today and that the Minister will say that it sounds attractive and that he might look at it.