Access to Medical Treatments (Innovation) Bill

Lord Hunt of Kings Heath 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—

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, I thank the noble Lord for bringing the Bill to your Lordships’ House and I commend him for his perseverance and stamina as he sought to take it and the previous Bill through. I, too, pay tribute to the honourable Chris Heaton-Harris for taking the Bill through the House of Commons.

When the noble Lord opened his speech he referred to the adoption of new medicines, and I am very sympathetic to the point he raised. The fact is that we have a shocking record in the UK on the adoption of new medicines. We use fewer branded medicines per person than comparable countries; we tend to use older rather than the latest medicines; fewer patients in the UK receive new, innovative medicines than those in comparable countries; and we have a problem in that NICE-recommended medicines—even those that have been through the NICE process and have been shown to be clinically effective and cost effective—face further reviews and restrictions at local level, even though there is a legal requirement on clinical commissioning groups to make sure that NICE technology appraisals are put into action. For me, that adds to the concerns of the noble Lords, Lord Patel and Lord Ryder, about the position of the UK when it comes to investment in R&D by the pharmaceutical sector. We know that we have a very strong science base and at the moment we have a strong pharma R&D base, but those are at risk, partly for the regulatory reasons that noble Lords have already referred to. I do not think that that is so much the case in this country but I take the point made by the noble Lord, Lord Ryder, about European regulation.

The other big problem we have is that the NHS is hopeless at adopting new medicines. We have the Hugh Taylor Accelerated Access Review, which has been sponsored by Mr George Freeman, to whom I pay tribute for the work he is doing in this area. The review has produced an interim report and the final report will come out in the summer. It is concerned with access to innovative drugs, devices and diagnostics, which it aims to speed up. But however good the recommendations are and will be, unless the NHS and NHS England completely change their perspective and recognise that we have to adopt these fantastic new innovations that are coming to the UK or are developed here, in the end we will not be seen as a country in which it is worth investing. My experience—it may also be the noble Lord’s experience—is that the big problem is that there is a culture within the NHS that regards drugs as a cost rather than a benefit to patients. There is a need to take a very different approach, even in relation to new equipment and clinical staffing. There is a huge cultural barrier that we have to face up to.

Noble Lords, including the noble Baroness, Lady Masham, mentioned that we have received briefings from a number of medical bodies—the ABPI, the BMA and many of the royal colleges—which are still expressing concern, even though the Bill has changed considerably since the noble Lord took it through in the last Session. We know that they still have some concerns about the database and about what they regard as the perverse incentives. Is the Minister confident that his department can help to assuage those concerns? If we are to see this Bill progress—and we all want to see the benefit that the noble Lord wishes to bring to healthcare in the UK—it is important that there be some way of reassuring those bodies that what is intended here will not put at risk some of the things they have put forward.

I also hope that the noble Lord will respond to my noble friend Lord Murphy on the very important point about off-patent drugs. I am not convinced that the authorities in the UK have ever understood the importance of making progress in this area. In the end, only Ministers can kick people to make progress. I agree with him—let us hope that this database is at least a start in giving prescribers confidence to prescribe off-patent drugs.

Finally, I come to the recommendations in the Delegated Powers Committee’s report published on 25 February. I do not know whether the noble Lord has seen it but it makes reference to this Bill and I am slightly concerned about it. The committee is concerned about Clause 2, which,

“enables the Secretary of State, by negative procedure regulations, to confer functions on the Health and Social Care Information Centre … in connection with the database”.

In particular, the regulations may include requiring or authorising the centre to disclose information to specified persons. The Delegated Powers Committee has no problem with the use of subordinate legislation to do that, nor with the use of the negative procedure, but it says that,

“clause 2 appears to envisage no provision, either in the Bill itself or in the regulations, for the enforcement of conditions imposed by virtue of subsection (4)(b), and we draw this matter to the attention of the House so that it may seek an explanation, either from the Member promoting the Bill or from the Minister”.

I do not expect the Minister to be able to respond today. However, if the committee has identified a drafting issue, the question of how it is going to be dealt with is a concern.

I end with the point that the noble Lord, Lord Blencathra, made about timing. Presumably, he is basing his assumption on the Commons rising in May, but he seemed to be saying that 11 March would be the last time in this Session that the Commons would deal with it.

[Lord Blencathra]

My assumption is not based on when the Queen’s Speech would be or when the Commons rises. In the Commons, the days for Private Members’ Bills are announced at the start of the Session, and Friday 11 March has been announced as the last day. Even if the Commons ran into June or July, there would not be an extension beyond 2.30 pm on Friday 11 March.

[Lord Hunt of Kings Heath]

But on that basis, even if there were no Committee or Report stage, it would still be too late. Will the Minister join me in asking the usual channels whether we can find some time before 11 March to take this Bill through, even if the Government may need to table a technical amendment? Obviously, a recommendation from the Delegated Powers Committee cannot be ignored. We on this side of the House would certainly support the Minister in doing that.