Rare Cancers Bill

Nusrat Ghani Excerpts

Friday 11th July 2025 Commons Chamber

[Sir Christopher Chope (Christchurch) (Con)]

I beg to move amendment 1, page 1, line 5, leave out “and”.

[Madam Deputy Speaker (Ms Nusrat Ghani)]

With this it will be convenient to discuss the following:

Amendment 2, page 1, line 6, at end insert

“and

(c) set out a timetable for implementing any changes in the law recommended by the review.”

Amendment 3, page 1, line 7, leave out “in particular”.

Amendment 4, page 1, line 9, leave out “three” and insert “two”.

Amendment 5, page 2, line 3, leave out “in the opinion of the Secretary of State”.

Amendment 6, in clause 2, page 2, line 7, leave out from “are” to end of line 8 and insert “arrangements in place to”.

Amendment 7, page 2, line 12, after “appointed” insert

“within the period of 6 months beginning with the day on which this Act is passed”.

Amendment 8, in clause 3, page 2, line 33, leave out

“in the opinion of NHS England”.

Amendment 9, page 2, line 40, leave out subsection (4).

[Sir Christopher Chope]

This is certainly not a trivial Bill; it is a really important piece of legislation, which I congratulate the hon. Member for Edinburgh South West (Dr Arthur) on introducing and pioneering. It was not a Government handout; it was an idea that he thought needed to be the subject of legislation and he has pursued it. We had a fantastic Second Reading debate. There is tremendous interest in the Bill. May I therefore make it clear at the outset that my amendments are designed to try to strengthen the Bill rather than anything else?

I explained my position to the hon. Gentleman yesterday. He said, understandably, that to a large extent he was constrained, because he was trying to negotiate with the Government and with the Department of Health and Social Care, and unless he showed himself to be reasonably compliant, he would not have got the Bill to a state where it could be accepted by the Government.

I note the different positions on this, and I fully understand and respect the hon. Gentleman’s position. The hon. Member for Mitcham and Morden (Dame Siobhain McDonagh) basically said that if she had introduced such a Bill, she would have got so steamed up about it that she would have included a lot more strength and safeguards, and as a consequence it probably would not have got anywhere near being considered on Report. Those are two different approaches. I am, relatively speaking, neutral on the matter—I am a sympathetic supporter of the Bill—but I have a lot of background experience of how Governments always try to give themselves wriggle room, in effect to maintain control over everything, and in my view the Bill could be improved by being amended, with the will of the House, on Report.

We could talk about taking some of my amendments to the other place, but the trouble is that the Government machine may say that there will not be any more sitting Fridays in this House, so if the Bill were to be amended in the other place it might fall completely, because it would need to be brought back here. That is why it is important that the House should consider these amendments now rather than leave them to the other place.

Amendment 1, which is to be read with amendment 2, is a prime example of the point I made earlier. We have a commitment from the Government that:

“The Secretary of State must…carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer”—

great—

“and…prepare and publish a report setting out the conclusions of the review.”

But what is the timescale for that, and what will happen after those conclusions are produced? There is no obligation on the Government to do anything else. The review and its conclusions could be just left on one side. We in the House are in a position to tighten those provisions up and say, “This is not good enough. There should be a timetable for implementing the changes in the law recommended by the review.” That is the essence of the two amendments.

To look at another gap that could be exploited by the Government, the Bill says that the report must be

“published before the end of the period of three years beginning with the day on which the Act is passed”.

I have tabled amendment 4 to say that the period should be two years.

In respect of both those points, I have had a helpful email from Diana Jupp from Pancreatic Cancer UK, who writes on behalf of more than 30 charities representing patients affected by rare and less common cancers. She comments on my amendments. On amendment 2, she says,

“We are keen to push for this change with the Department once we reach implementation stage of the Bill.”

With the greatest of respect to Diana Jupp, we can do this now. Instead of leaving it to her and her colleagues to try to pressurise the Department later, we in this House have the power to change the legislation in the way that I have suggested, so that there would be a timetable set out for implementing the changes in the law recommended by the review.

In response to amendment 4, Diana Jupp says that

“this timeline has been agreed with the Department and in our opinion would tie into the timelines of other developing cancer policy implementation, including the cancer plan.”

Obviously, the most important part of her comment is that the timeline has been agreed with the Department, because if it had not been, the Department and the Minister would not have taken the Bill forward in this way and agreed to it.

On the timeline, I draw the House’s attention to the evidence base set out in the impact assessment. It says that the whole process will take one year. The Department reckons that it will cost £130,000 and sets out how many full-time equivalent civil servants will be involved in it. If it will only take one year, why are we saying that it needs to have three years? That is an example of why we need to tighten up the Bill, because if this is a review that needs to and will be carried out, why do we not get on with it? To suggest that it will take longer than a year is to go against the Department’s own evidence set out in the impact assessment.

The impact assessment says on page 6, under the heading “Mandating a Government review of the orphan drug regulations”:

“This will place a duty on the Government to publish a review which will be a comparison of orphan drug Regulations (specifically Part 5 of the Human Medicines Regulations 2012) and international regulatory approaches to supporting the research and development of orphan medicinal products that are for the diagnosis, prevention or treatment of cancers. Since the review is concerned with orphan drug regulations it is by default covering rare cancers. The findings should be published within 3 years.” On page 7, paragraph 19 on financial costs says,

“It is difficult to estimate the resourcing costs required for the orphan drug review, since the exact scope remains to be agreed. However, we estimate the cost to the Department of Health and Social Care to produce and publish a report on orphan drug Regulations to incur costs of approximately £0.14m in relation to staff resource. This reflects the cost of 0.3 x SCS staff, 1 x FTE Grade 6 or Grade 7 staff, 0.3 x Grade 7 staff and 0.5 x SEO staff for one year.”

That is what the Government say: only one year will be necessary.

In that case, why is my generous amendment, which would restrict the period from three years to two years, unacceptable to the Government? There is a history of dragging of feet at the Department of Health and Social Care, I am afraid; we certainly heard about that on Second Reading. I give the House that specific example of why, on the Government’s own evidence, they should accept the change from three years to two.

Amendment 3 would leave out “in particular” from line 7, which reads:

“In carrying out the review the Secretary of State must, in particular, consider regulatory approaches in other countries.”

The amendment is intended to probe rather than anything else. Why do the words “in particular” need to be incorporated? Surely it would be simpler to say that the Secretary of State “must consider regulatory approaches in other countries”—full stop, period. But that is not how it is at the moment.

Amendment 5 would leave out the reference to the Secretary of State. This is to do with the definition of a rare cancer. Currently, clause 2 would add this wording to the National Health Service Act 2006:

“The research that the Secretary must facilitate or otherwise promote under subsection (1)(a) includes research into cancers that in the opinion of the Secretary of State are rare cancers.”

Why cannot it not just say “that are rare cancers”? Indeed, clause 2 would also add this wording to the 2006 Act:

“In this section ‘rare cancer’ means a cancer that affects not more than 1 in 2000 people in the United Kingdom.”

That is an issue of fact. The Secretary of State should not be able to basically have a veto over the interpretation of what is or is not a rare cancer.

This is just another example of the control freakery within the Department. I am sorry that so far the Minister does not seem to have stood up to officials who have persuaded him, no doubt, that we need the expression

“in the opinion of the Secretary of State”.

Again, the argument is quite straightforward and the people from Pancreatic Cancer UK are on my side, but they are obviously very keen for the Bill to get on to the statute book. We all have to recognise that it is within the Government’s power to prevent it from making any further progress. That is why it will be quite difficult, I suppose, to persuade the Minister to accept amendment 5.

Amendment 6 would leave out from “are” to the end of the line and insert “arrangements in place to” in this statement in clause 2:

“In discharging the duty under subsection (1)(a) in relation to those cancers, the Secretary of State must, in particular, ensure that there are such arrangements in place as the Secretary of State considers appropriate to”.

Why can we not just say “arrangements in place to enable potential participants in clinical trials”, and so on? Why do we need to give the Secretary of State discretion —a veto, essentially—over whether he considers those arrangements to be appropriate? It seems to me completely redundant, unnecessary and, indeed, oppressive. It is counter to the expressed wishes of this House on Second Reading, when there was impatience over the delay, because of the need to get on with this, and suspicion over the failure of the Department of Health and Social Care—under not just this Government but previous Governments, which I would be the first to accept—to actually deal with the crisis involving people who are subject to rare cancers. That is amendment 6. I am trying to beetle through these amendments quite quickly, Madam Deputy Speaker, so that other people can participate in this important debate.

--- Later in debate ---

[Gregory Stafford (Farnham and Bordon) (Con)]

To your delight, I am sure, Madam Deputy Speaker, and to the delight of the whole House—especially that of the Government Whips—I am not going to speak for very long on Report, although I am not promising not to speak for some time on Third Reading. I wish to briefly speak to amendments 5 and 8 tabled by my hon. Friend the Member for Christchurch (Sir Christopher Chope). Before that, though, I congratulate the hon. Member for Edinburgh South West (Dr Arthur) on the Bill. I am generally supportive of it and think it is entirely necessary.

Turning to the amendments, my hon. Friend the Member for Christchurch is right. It does concern me that the words

“the opinion of the Secretary of State”

are included proposed new subsection (2) of section 1E of the National Health Service Act 2006. As my hon. Friend has pointed out, proposed new subsection (4) of section 1E and proposed new subsection (5A) of section 261 of the Health and Social Care Act 2012 set out the definition of a rare cancer, and if the Bill passes, that definition will become law. I therefore think there is a contradiction within this piece of legislation: it contains an absolute definition of a rare cancer, but adds some ambiguity by referring to the “opinion” of the Secretary of State. I ask the Minister to explain how both those things can be true. If the Secretary of State decides that there is some other definition of a rare cancer, how can that possibly be in line with the definition that is written into the law?

As the hon. Member for Edinburgh South West has said, the definition that has been included in the Bill—that a rare cancer is

“a cancer that affects not more than 1 in 2000 people in the United Kingdom”—

aligns it with the UK rare diseases framework, which was published by Lord Bethell in the other place in 2021. It seems to me that that is an effective and suitable definition, so again, I ask the Minister whether he expects there to be some other definition. If he does not expect that, why is it necessary to include the words

“the opinion of the Secretary of State”?

The Bill is not even consistent. Proposed new subsection (2) of section 1E of the National Health Service Act 2006 refers to the opinion of the Secretary of State, but proposed new subsection (5A) of section 261 of the Health and Social Care Act 2012 talks about

“the opinion of NHS England”.

As my hon. Friend the Member for Christchurch has pointed out, NHS England is fortunately going to be abolished very soon. When that happens, will we have to pass either primary legislation or secondary legislation to delete those words from the Bill? Would it not be better if we deleted the words “the opinion of NHS England” now? Why will the Minister not consider removing them? If there is some reason why he thinks the Secretary of State might have to change the definition, why are those two clauses of the Bill not consistent?

I hope hon. Members will see that what the hon. Member for Christchurch and I are trying to achieve—certainly through amendments 5 and 8—is to establish a clear definition of a rare cancer. We are aiming to ensure that there is no ambiguity in that definition, and if there is to be ambiguity, we want to at least ensure that the body or authority that is going to make any changes is consistent in the legislation.

[Madam Deputy Speaker (Ms Nusrat Ghani)]

I call the shadow Minister.

[Dr Luke Evans (Hinckley and Bosworth) (Con)]

I rise to speak on behalf of His Majesty’s official Opposition in support of the Rare Cancers Bill, and to welcome its thoughtful and necessary intervention on behalf of a group of patients who have been under-researched, under-represented, and under-acknowledged for too long. I commend the hon. Member for Edinburgh South West (Dr Arthur) on bringing this Bill forward, and on his ongoing dedication to the issue.

The case for the Bill is clear: rare cancers—defined, in line with the UK rare diseases framework, as conditions affecting fewer than one in 2,000 people—are individually uncommon but collectively account for more than 20% of all cancer diagnoses. However, as we know, patients with rare cancers routinely face delayed diagnosis, limited treatment options and far fewer opportunities to participate in clinical research.

The Bill does not claim to be a silver bullet, but it does mark a significant step forward in how we think about and legislate for research, regulation and data access in rare cancer care. It is focused, proportionate and strategically aligned with the existing NHS and National Institute for Health and Care Research frameworks.

Clause 1 places a duty on the Secretary of State to carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer. It also rightly requires that the review includes comparisons with regulatory approaches in other countries. This is vital. The explanatory notes rightly observe that research into rare cancers is often commercially unattractive because of small patient populations and high developmental costs. If our regulatory environment creates further barriers to entry, patients suffer—not because the science does not exist but because the system does not support it.

The UK’s current approach to orphan designation lacks the pre-authorisation incentives found in systems such as the European Medicines Agency and the US Food and Drug Administration. The review required under the Bill is the opportunity to ask whether we are doing enough to attract the research and development that rare cancer patients deserve.

--- Later in debate ---

[The Minister for Care (Stephen Kinnock)]

I am grateful to my hon. Friend the Member for Edinburgh South West (Dr Arthur) for bringing this Bill before the House, and I congratulate him on getting it to Report. Amendment 1 allows amendment 2 to be inserted into the Bill. Amendment 2 would require the Secretary of State, having carried out the review described in clause 1, to set out a timetable for implementing changes to the law recommended by the review. However, it would not be appropriate to presume the outcome of the review of orphan drug regulations that is outlined in clause 1. Amendment 2 presupposes that the review will recommend changing the law, and that there are changes the Secretary of State would be willing to support, following a legal consultation. That is not considered appropriate at this stage.

Amendment 3 is unnecessarily restrictive, introducing wording that confines the review unnecessarily. We want to ensure that a thorough review is conducted, and my hon. Friend the Minister for Secondary Care will be working with her officials to ensure that that happens. For amendment 4, the three-year timeframe to prepare and publish the review and the necessary resourcing requirements have been discussed with officials in my Department and at the Medicines and Healthcare products Regulatory Agency. I remind Members that the text in the Bill reflects the statutory deadline, but we will endeavour to publish a report ahead of the three-year timeframe, which has been put forward to be consistent with the MHRA’s overall workplan.

On amendment 5, there are different definitions of a rare cancer, and we worked with my hon. Friend the Member for Edinburgh South West to agree the definition in the Bill as a cancer that affects not more than one in 2,000 people in the UK. However, a level of discretion for the Secretary of State is required over what falls within that definition, since the facts underlying and the data on diagnoses are constantly changing. The amendment would make it difficult to implement the clause in practical and operational terms.

Amendment 6 would remove the ability of the Secretary of State to exercise discretion as to how their duty would be discharged. This is not considered appropriate, since it makes the operation of clause 2 less workable in practice, and would lack the Government’s assessment of what in all the circumstances would be the most appropriate manner of implementation. Amendment 7 would introduce a specific timeframe—just six months—to allow the appointment of the specialty lead. Although I agree that we will need to appoint the specialty lead promptly, introducing a statutory timeframe is not considered workable for practical reasons. There could be unforeseen delays; for example, recruitment processes might delay the appointment beyond six months.

On amendment 8, as mentioned previously there are different definitions for a rare cancer. That is because the data on cancer diagnoses is constantly changing, and decisions on whether the criteria for a rare cancer are met will inevitably involve an element of judgment. The amendment would make it difficult to implement the clause in practical and operational terms.

I turn finally to amendment 9. It is essential that information relating to people’s health and care is shared appropriately, lawfully, and in line with their reasonable expectations. Amendment 9 would remove the provision confirming that any sharing of information pursuant to the powers created by the Bill, and under NHS England’s existing powers, must be in accordance with data protection legislation. That includes compliance with key principles such as lawfulness and fairness. That layer of assurance is essential for the protection of patients, and clause 3 is a standard provision that makes that explicit.

For those reasons, I ask the hon. Member for Christchurch (Sir Christopher Chope) to withdraw all nine of his amendments.

[Madam Deputy Speaker (Ms Nusrat Ghani)]

Sir Christopher, is it your pleasure that amendment 1 be withdrawn?

[Sir Christopher Chope]

Is it possible to respond, Madam Deputy Speaker?

[Madam Deputy Speaker]

Very briefly. I was asking whether amendment 1 would be pushed to a vote or withdrawn, so if you could alert me to that it would be very useful.

[Sir Christopher Chope]

I will respond briefly to the debate. In so doing, I thank my hon. Friends the Members for Hinckley and Bosworth (Dr Evans) and for Farnham and Bordon (Gregory Stafford) for their contributions.

I listened for what the Minister would say in response to my point about NHS England, but I did not hear the expression “NHS England” come from between his lips, and I wonder whether that was an oversight or whether it was left out of his brief deliberately by officials from NHS England. Amendment 8 specifically deals with NHS England, and my hon. Friend the Member for Hinckley and Bosworth referred to it. Does the Minister’s reluctance to intervene at this stage show that he is in denial about the policy in relation to NHS England? I presume that he is in such denial.

We have had a classic example from the Minister of why the civil service is ruling okay, because it can come forward with a valid objection to every possible suggested alternative and amendment. I do not think that this attitude will be very helpful to the people we are trying to help through the Bill—namely, those who are suffering from rare cancers and who want us to make progress in this area. I will not press any of these amendments to a vote, but I hope that when the Bill gets to the other place there will be more persistent probing, particularly on the issues around NHS England and the definitions.

To give credit where it is due, I was pleased with what the Minister said about the specialty lead. As discussed, we do not need legislation for this anyway. He said he wants to have that dealt with promptly but is fearful of accepting an amendment that requires it to be done within six months because of the possibility of unforeseen delays. I take it from that that he is going to get on with that aspect, and let us hope that that goes faster rather than slower. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Third Reading