Access to Medical Treatments (Innovation) Bill (Money)

Philippa Whitford Excerpts

Tuesday 3rd November 2015 Commons Chamber

[George Freeman]

My hon. Friend makes a good point. That is the premise on which the Bill introduced by Lord Saatchi in the other place earlier in the year in the previous Parliament was predicated. My hon. Friend is right that it is a controversial proposition that fear of litigation for medical negligence is putting clinicians off innovating. The evidence that the Government received through the consultation was that some clinicians do feel that that is a problem, but very few saw it as the principal problem or the principal obstacle. A number of clinicians made the point that several factors have acted in recent decades to slow down the rate of innovative prescribing and other procedures in surgery and elsewhere, not least increasing central control of procurement from NHS England, which puts in place very tight procurement guidelines, as well as a general sense of an increasingly litigious society, which is just one of a number of factors cited in an extensive range of barriers to innovation.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Does the Minister not recognise the concern of the Association of Medical Research Charities and many within the profession about what the Bill opens up? The position when I started 30-odd years ago was that doctors could do what they liked. We have spent decades protecting people, slimming down the ethics paperwork to run trials, and I do not see that the Bill is necessary. I think it is dangerous. The problem is that people think it is about access to new drugs. It is not. Any drug that is licensed we can prescribe. This says that doctors can try what they like. That is quite scary.

[George Freeman]

The hon. Lady makes a series of interesting points. Her criticisms would perhaps apply more to the Bill introduced by Lord Saatchi in the other House. Let me confirm that this Bill has nothing at all to do with clinical research. It is to do with clarifying the freedoms that she is right to say that clinicians enjoy today. Clinicians are free to prescribe any treatment for their patients that they feel is appropriate on the basis of the clinical evidence.

The specific problem that the Government recognise, whether or not this Bill is the appropriate mechanism to deal with it, is that in order for clinicians to feel confident in making an innovative prescription or adopting an innovative procedure, the biggest barrier is the lack of information on what innovative procedures are out there already and being used by other clinicians. It was with that in mind that the registry was originally proposed in the Bill introduced by Lord Saatchi. It was originally intended as a registry of innovative practices that clinicians adopted under the procedures in the Bill, which merely clarify the existing protections already afforded by medical negligence law. It was felt that that registry would be a helpful innovation in itself.

The Government’s view is that, as we build an infrastructure for the provision of information to clinicians to support off-label use of medicines and access to the latest information on innovative treatments, that registry could provide a much more interesting function of providing to clinicians, at the click of a mouse, an up-to-date registry of innovative medicines that are available and off-label and other treatments that other clinicians are already using. I want to stress that this Bill, which has a very different structure from the original Bill introduced by Lord Saatchi, has nothing to do with research at all. It is purely to do with supporting innovative prescribing by clinicians by providing them with information on innovations that they might consider.

[Dr Whitford]

Does not this undermine our existing structures of clinical research? Those protect the patient through ethics and research being reviewed, whereas this allows a couple of doctors to say, “We’re going to give you liquorice for your cancer”, and that can get put on to a database. Many in the profession are anxious about this.

[George Freeman]

I want to make two things absolutely clear. First, this Bill, in law, would have no impact at all on clinical research. We in the Department have been very clear about that. If it in any way changed the basis on which clinical research is regulated, it would be a very serious matter, because we lead the world in terms of our ethical and regulatory controls on research, and it is vital that we do not affect that.

Secondly, it would be a matter of very serious concern if this Bill were to undermine patient or public trust and confidence in our NHS, our research medicine and our clinical trials infrastructure. I flagged up on Second Reading the fact that I do have some concerns. Some of those relate to the way in which this debate is conducted, although I am not making any comment about the hon. Lady’s intervention. It is very important that we explain to people what this Bill does and does not do. If we mislead them, it is not surprising that we will get a lot of unnecessary fear. It is very important that we clarify that this has nothing to do with clinical research.

--- Later in debate ---

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

There are many ways for a surgeon to share their experience if they have carried out an operation in the heat of the moment to save someone’s life. The BMJ publishes things on a weekly basis and can share interesting cases. The danger of the Bill is that the database is being used as a fig leaf to make it sound like access to innovative treatments. The hon. Member for Daventry (Chris Heaton-Harris) said that a doctor would have to prove that something was safe, but the first person prescribing liquorice for cancer has no method of proving that it is safe. That is the basis of research.

Phase 1 trials involve a small group of patients who fully consent to undergo treatment and know what they are taking on, based on pre-clinical research. Phase 2 is larger, and phase 3 involves multiple hospitals. We have that process to avoid a couple of doctors in a canteen saying, “That’s not a bad idea. I’ll back you if you back me”, and patients being given something dangerous. The Bill would not, of itself, undermine research in some way, but if patients and the public feel that they are guinea pigs for any old treatment that someone wants to have a bash at, that will undermine research.

It has taken decades to get to our current level of safety, checks and balances. That has been streamlined, and single ethical permissions are carried out once for the whole country, and then recognised in all health boards and areas. That has made things a lot easier, but it is crucial that patients who sign up to a treatment know that there has been a degree of rigour before they are given that drug.

If someone is bleeding to death in the middle of the night, of course a surgeon can innovate because every operation is slightly different, but we are talking about access to medical treatment that will predominantly involve drugs that have not had sufficient pre-clinical work. That is of concern to research charities and the royal colleges—I am a member of the Royal College of Surgeons—because of patient safety. The absolute concern is not even the secondary impact on research; it is the impact on patient safety and people finding that they are being given something totally unproven.

[Andy Slaughter (Hammersmith) (Lab)]

The hon. Lady is making a good point, and I agree with everything she says. As a lawyer rather than a doctor, I think the problem with the Bill is that—unintentionally, I am sure—it also undermines carefully constructed jurisprudence on clinical negligence, and it is dangerous for that reason.

[Dr Whitford]

Of course the Bill is well intentioned, and its title will attract support from people who think that it means getting access to drugs to which we do not currently have access. It is not that any doctor can prescribe anything—we cannot. We can prescribe drugs that are licensed and recognised, and have a basic safety profile. In Westminster Hall we often debate access to expensive, innovative, brand-new treatments, but that is not about our right as a doctor to prescribe them; it is about who will pay for them because some of those drugs are expensive. As the Minister has said, that would still be an issue. In what sense would a commissioning group have evidence to allow a doctor to prescribe a drug that has absolutely no basis, but that would have to be funded?

The Bill is basically a bit of a mess. What problem is it trying to answer? People think it means that they will get earlier access to new drugs, but drugs should be taken forward on the correct path to protect patients and doctors. Doctors need to know that what we are doing is right, and not some random thing that has been on a database after somebody tried something once and it seemed to work. We know that there are placebo and random effects.

[Maria Caulfield (Lewes) (Con)]

I support everything the hon. Lady has just said. I was a research nurse in cancer care for more than 10 years. We observed good clinical practice standards, and the standards of the Medicines and Healthcare Products Regulatory Agency and the FDA, because mistakes happened. Those safeguards are in place for a reason. The No. 1 reason is to protect the patient.

[Dr Whitford]

I did my MD thesis in the late ’80s on the use of monoclonals in breast cancer, which was then totally blue-sky thinking. What became Herceptin was found at that time. I remember speaking at a conference in America where people presented their research. At that time, they thought they had to put a toxin on the back of an antibody to make it work. They were using ricin, which was used in the Bulgarian umbrella murder, and—surprise, surprise—almost all their patients died. They got around that in America by going to Mexico and to prisons. It is not the case that everything a doctor thinks might work will be good for patients. We have developed a safe system over decades and we give it away at our peril.