ACCESS TO MEDICAL TREATMENTS (INNOVATION) BILL

Philippa Whitford Excerpts

Wednesday 16th December 2015 Public Bill Committees

[George Freeman]

I do not. I am politely winding my way round to saying that. However, the reasons are important. It is not that I object to amendments at all—I hope the Bill will be heavily amended in Committee to reach that nirvana of all the parties—but, because the clause is important and helps to clarify the Bill’s intention, I suggest that the amendments should not be pressed. However, we might work on a package of amendments on Report that tackle giving clinicians access to information about innovative medicines and the important points made by the hon. Gentleman.

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

My concern about the Bill is that it seems to create a parallel system for something that we already have. We already have clear structures around litigation, defence and informed consent, which the Bill seems to bypass. If a doctor finds one other doctor who agrees with them, they can do what they like to somebody—they can go out and clip their privet hedge and give it to them: they are at the end of life and desperate, so they will try anything. That is really concerning.

The database would create a second information system that is not just about people reporting something. Someone might go to it in desperation, read about privet hedges and try that. That creates a separate system from the research system that has been developed over many years.

When I was a young doctor—sadly that was quite a long time ago—there was a paternalistic approach, in which the patient did exactly what the doctor told them. The thing is, when people are at the end of life or suffering from something for which we do not have an easy treatment, they are incredibly vulnerable, so we have a duty to protect them.

Part of the problem with the Bill is that it would create separate systems. Why should a doctor go through the entire system of pre-clinical research phases 1, 2 and 3, getting permission and getting things passed when, whatever their idea is, they can talk some wee lady into it and give it to them without any cover? That is quite frightening and would undermine our trials process.

There are things that could be improved. I agree with the Minister that some institutions have become rigid and defensive, thinking, “We don’t want you using that for anything else.” Out of the Bill we could get, as the Minister said, a database that talks about research that is going on that we could collaborate in, and what the findings and trial results are. Busy, front-line clinicians are often unaware of trials. In Scotland, we have the Scottish Breast Cancer Trials Group so that we flag up trials to people. There could be merit in that, but the idea that putting on a database something that I do to a patient, just randomly, somehow gives it credence is actually quite frightening.

We have Bolam. We have a system and a definition of negligence and litigation. Creating these two parallels undermines the patient. How can they give informed consent if we are talking about something that has no work-up, no safety profile and no phase 1 trials? How do we ensure that we are not encouraging people to do that across the country? There are things that could be done with the Bill but, as it stands, I have grave concerns, as many other doctors do.

[The Chair]

Before I call the Bill’s promoter, I have allowed quite a lot of latitude but it is important in Committee to focus specifically on the amendments that we are deliberating, which the hon. Lady did without referring to them. That is the way forward and that is our system.

--- Later in debate ---

[George Freeman]

I thank and pay tribute to the hon. Member for Torfaen for his persistence and patience in working with all parties on this matter. Similar to the Bill we are discussing, his Bill touched on an ambition shared by colleagues across the House to promote greater off-label use of medicines. I have encouraged him and my hon. Friend the Member for Daventry has welcomed his commitment to try to work through this Bill to see whether we might be able to tackle some of the same objectives, which is an ambition I strongly support.

In this Bill, my hon. Friend the Member for Daventry has repositioned a much stronger focus on the database being a registry not for capturing innovations that medics might or might not think are reasonable to record, but for the provision of information to clinicians on licensed, unlicensed and off-label uses for innovative medicines that are currently being developed. That represents a powerful opportunity for us to strike a blow for getting clinicians access to drugs that are in development, in trials or in an early access to medicine scheme and to off-label drugs currently in use of which clinicians might be unaware.

I dream of the day when a clinician can talk to a patient, click on their electronic medical records to see their history, click on available treatments for patients of that profile and see, at the click of a mouse, what clinicians around the country are doing, including the numbers. That could then be used to help intelligent prescribing, using their best clinical judgment and their knowledge of the patient. There is an interesting opportunity for us to do something here.

Let me turn to the amendments. Amendment 7 seeks to make it explicit in the Bill that “treatments” includes access to off-patent drugs. I actually support that ambition. Lawyers at the Department of Health will tell me that it is otiose—a legal term meaning that it is not strictly necessary—but, as a pure democrat, I think that it would be helpful if we could find a way to make it clear that that is specifically what we want to achieve. I can list the reasons why a lawyer might say it is not a good use of legislation because it is already covered by the existing definition, which it is. I think it would be helpful to send a message that we explicitly want the database to promote off-label use. As the Minister responsible, I would happily take instruction in whatever mechanism from the House to go away and come back with a proposal on it.

Amendment 8 seeks to provide for the establishment of an arm’s length body to assist those seeking regulatory approval for off-patent drugs in a new indication. As the hon. Member for Torfaen is aware, we have talked about that at length. Although I understand the thinking behind it, I do not accept it. For those colleagues who have not been following this debate closely, the thinking is broadly that because an off-label indication does not have an applicant company with a patent and a commercial interest, there is nobody to promote its case, and to put together the data package, lobby for it and advocate for it through the system, and to ask NICE to look at it. Word has got round that, because of that absence of a commercial interest, those uses are not being properly looked into, and that if it had a licence clinicians would use those off-label indications.

I understand it, but I think that the logic is profoundly flawed for two or three reasons. First, the evidence is that even where off-label indications are well evidenced and even recommended by NICE, in which case there is clearly no barrier, uptake is patchy and in some places slow. That is not because of the absence of recommendations and data. In the example of the use of Tamoxifen as a preventative treatment for cancer, in fact, patients and clinicians decide not to use it, in many cases because of the side effects or because women prefer to have surgery. It is not due to the lack of a licence; it is because it is an off-label use and has different impacts on different patients, and patients always want to reserve the right. It is the same with the use of bisphosphonates. There are off-label treatments that are well evidenced and well supported and recommended by NICE. It is not about the absence of a licence.

Most profoundly, I worry that if we expected all off-label uses to have a licence we would inadvertently create a situation in which those off-label uses that did not have a licence would suddenly become questionable. I totally understand that is not the intention of the hon. Member for Torfaen. We might actually undermine our objective and end up in a situation in which we have to license every single off-label use in order to keep it legitimate, which would be the complete opposite of what my hon. Friend the Member for Daventry wants to achieve. I will come later to why the Secretary of State and I do not want to become the licensors of medicines.

[Dr Whitford]

I accept the Minister’s point about Tamoxifen. There are certainly other reasons why patients do not take it. As we move into an era of more and more non-medical prescribers—nurses and professions allied to medicine—those people are going to be a lot less comfortable prescribing unlicensed drugs that are not in the “British National Formulary”. Those people are made to sign a liability form and they are simply not going to do that. We are moving patients out into the community. The idea that they will come to a specialist every eight weeks for a prescription is not practical.