Rare Cancers Bill

Christopher Chope 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.

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[Dr Scott Arthur (Edinburgh South West) (Lab)]

I rise to oppose the amendments, but I thank the hon. Member for Christchurch (Sir Christopher Chope) for tabling them, for engaging with the Bill and for our conversation yesterday, which I really appreciated. I understand the stated intent of the proposals, although I am not minded to support them.

Over the last 10 months, I have held dozens of meetings with families, survivors, sufferers, charities, clinicians and legal experts, all with the aim of delivering meaningful change in this field. Those meetings were not so that I could tell people about the Bill, but so that those people could shape the Bill. I fear that if we were to pass these amendments, they would upset the delicate balance of hopes and aspirations that underpins the Bill. It is not just about the Minister, as the hon. Member suggested; there is a whole coalition of people who have different opinions about the Bill, and I do not think any one person has a right to change it in that way, including me. That would be hugely disrespectful and a disappointment to that coalition, but I understand the hon. Member’s points.

The Minister will go through the amendments in turn, so I will focus on three key ones. The review of orphan drugs was one of the hardest-fought things in the negotiations with the Department and charities, but we found a point that we could all agree on. I appreciate that the hon. Member wants it to go further, and perhaps we could speculate about the outcome and better prepare for it, but it is much awaited by the charities and they are grateful for it. I do not want to speak on their behalf, but that is what I have heard from them. That covers amendments 1 and 2.

Amendment 5 is about the definition of a rare cancer, which is an aspect of the Bill that I have not spoken about in any great detail, so it is worth touching on here. The Bill sets the definition of a rare cancer in statute and aligns it with the definition of a rare disease, which is a useful simplification. In future, let us hope that some conditions fall out of that “rare” specification and need less emphasis, and let us also hope that people in the Department look at the treatments that are being developed inside and outside the UK. It is right that there should be a bit of flexibility at the edges of what the Department considers a rare cancer.

The timeline of the review is three years. Again, we spent a great deal of time talking about that. For some while, it was going to be much longer than three years, and all of us want it to be much shorter, but that was the compromise we reached—it was like “Goldilocks and the Three Bears”. We reached that compromise together, so I urge the hon. Member to respect our negotiations on that issue.

[Sir Christopher Chope]

I hear what the hon. Member is saying, but why does the impact assessment say that the costs are for staff for only one year? If the review will take three years, why are the staff funded for only one?

[Dr Arthur]

I thank the hon. Member for that question. Of course, the review will not start on day one after passing the Bill. It will take time to get up and running. The existing workload of those staff members will have to be reallocated, and I hope and expect there to be some initial engagement with the sector—both charities and pharmaceutical companies—so a bit of flexibility is required. To be honest, I would love more money to be spent on that review so that we can get more depth and it can have a greater impact. I am sure other hon. Members present would agree.

I hope the hon. Member for Christchurch understands my position and recognises the strength of cross-party and sector-wide support that has brought the Bill this far. I regret not inviting him to take part in the Bill Committee—we would have benefited from some of these comments at that stage—but some of the points that have been raised were discussed in Committee. It was a reasonably long discussion; it did not last for hours, but it was not as short as some. I remain committed to working constructively with colleagues as the Bill progresses beyond today—let us hope it gets beyond today—but I respectfully ask, in the strongest possible terms, that these amendments are not pressed. If they are, I hope Members will oppose them.

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[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.

[Sir Christopher Chope]

I am not quite sure whether my hon. Friend is responding to the amendments or making a Third Reading speech. I hope he will address the amendments I have tabled, including those that relate to clause 1, about which he has just spoken.

[Dr Evans]

If my hon. Friend bears with me, I will turn directly to his amendments. It is important to first set out the context, because we must understand the clauses if we are to debate the amendments to them.

Clause 2 makes crucial changes to the Secretary of State’s duty under the National Health Service Act 2006 by stating explicitly that it must include research into cancers that, in the opinion of the Secretary of State, are rare. Although this matters, the research agenda is often driven by numbers and funding scales. By mandating that rare cancers be part of the agenda, the Bill begins to shift the culture towards inclusion, equity and long-term thinking.

I particularly welcome the creation of the national specialty lead for rare cancers, modelling the NIHR’s existing structure of research delivery leaders. This individual will be tasked with promoting and facilitating research, advising on trial design and convening collaboration. The success of this role will depend on it not just being symbolically supported but having a clear remit, adequate funding and a strategic alignment with the wider NIHR research delivery network.

Clause 3 amends section 261 of the Health and Social Care Act 2012 to allow NHS England to disclose information from cancer registries for the purpose of identifying and contacting potential clinical trial participants. This is a significant and necessary step. The Bill distinguishes between a disease registry, like the National Disease Registration Service, and a contact registry, such as Be Part of Research. Making sure that these systems can speak to each other will be of significant benefit when it comes to matching patients with opportunities. Importantly, the clause reaffirms that any such data sharing must remain compliant with the Data Protection Act 2018. As proposed new subsection 6A to the 2012 Act makes clear,

“A power conferred by this section to process information does not authorise the processing of information which would contravene the data protection legislation”.

This is a safeguard that we must preserve, not weaken, if we are to maintain public trust in the system.

At this point I turn to the amendments tabled by my hon. Friend the Member for Christchurch (Sir Christopher Chope). He approaches private Members’ Bills in the way that a jeweller examines diamonds—with a magnifying glass, a steady hand and absolutely no tolerance for flaws. We may grumble as the clock ticks on, but deep down we all sleep better knowing that he is reading the footnotes. This Bill is no different; he has approached it with rigour, and I thank him for his commitment to precision and improving clarity and accountability. As he pointed out, the Bill is not trivial. Therefore, it is not only right, but indeed the duty of this House, to scrutinise closely legislation and amendments laid before us.

To that end, several of the amendments aim to tighten the Bill’s drafting or introduce firmer deadlines. For example, amendment 4 would reduce the timeframe for the review under clause 1 from three years to two. Amendment 2 would require the Secretary of State to

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

I understand the concern that reviews can drift, but the three-year period reflects the complexity of the subject: a UK-wide review of the Human Medicines Regulations 2012, including benchmarking against other jurisdictions and engaging multiple agencies. Compressing the timeline might jeopardise the depth or quality of the analysis. Likewise, a statutory timetable for implementation could constrain the Government prematurely, before the review’s conclusions are even known.

[Sir Christopher Chope]

I am very grateful to my hon. Friend for his unprompted comments. He will know that the funding is sufficient to staff the review only for one year. If there is only funding for one year, why does it take three?

[Dr Luke Evans]

My hon. Friend knows, far better than I, not to look at legislation in isolation. The Government will at some point bring forward the cancer plan, which will have a direct crossover with the Bill, so it is right to give the Government the freedom and space to implement the legislation. If we rush it, we could get it wrong, which would be even more detrimental for those who suffer with rare cancers.

Other amendments address definitions and discretion. For example, amendment 5 would remove

“in the opinion of the Secretary of State”

from the definition of rare cancer, and amendment 8 would remove similar wording in relation to NHS England’s discretion. At first glance, the amendments may seem like matters of tidy drafting, but retaining discretion is important, especially as regards rare cancers. Prevalence data can be uncertain or lagging, and flexibility allows for expert judgments about edge cases in which rigid definitions may unintentionally exclude patients from trials or research that could benefit them.

On top of that, there are concerns even about simple definitions. We are still exploring the difference between, for example, pre-cancerous and cancerous cells. If someone goes for a smear, that is what they are told. This is a new area. Who knows what will come up in the future? Simply defining rare cancers on the basis of lagging prevalence data is a risk, and it is therefore right that the Government and the Secretary at State have discretion to direct in one way or another.

However, I would grateful if the Government would answer the question, which has been rightly posed, of who or what will fill the role when NHS England is abolished. It is not clear exactly what that will look like. I have asked the Minister this question several times, in relation to the Mental Health Bill and other areas, and it is a question that this House should rightly ask. Who will be responsible for what, when and why?

That said, amendment 7, which would ensure that the proposed national specialty lead is appointed within six months of Royal Assent, deserves serious consideration. Patients have waited long enough. If the Government are confident that the post can be established promptly and resourced effectively, I would welcome that ambition being stated at the Dispatch Box today.

Finally, I must express my concern about amendment 9, which proposes to remove the data protection safeguard in clause 3(4). Although the provision may be declaratory, in that it reaffirms existing legal obligations, it none the less offers clarity and reassurance. In an area as sensitive as health data, such clarity matters, and the subsection’s removal could cause unnecessary concern, even if the underlying law remains unchanged.

In conclusion, this Bill is not about grandstanding. It is modest in financial cost, careful in its drafting and realistic in its scope, but its impact could be significant. For patients living with rare cancers, and clinicians and researchers striving to support them, the Bill offers real hope—hope for faster access to innovation, hope for more inclusive research and hope for a regulatory system that works for the many, not just the minority. Every patient matters, whether they are one in two or one in 2,000. As we stated on Second Reading and in Committee, we support the Bill, and I thank the House for giving me the chance to explain why.

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[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

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[Sir Christopher Chope]

It is a pleasure to follow the hon. Member for Brent West (Barry Gardiner). I echo his tribute to the hon. Member for Mitcham and Morden (Dame Siobhain McDonagh), who continues to be a pioneer in this campaign and is what I would describe as a no-nonsense lady. She has been in this place since 1997, and she has made and continues to make an enormous contribution.

This Bill will hopefully be an exemplar for Members who are successful in the private Members’ Bills ballot. So often, those who are successful in the ballot are told, “Here’s a handout Bill—we need to fill a little niche here in a bit of legislation.” The hon. Member for Edinburgh South West (Dr Arthur) has used his good fortune in having success in the ballot to bring forward something that he wanted to do and that meant a lot to him, but he did not do it selfishly; he did it after listening to a whole lot of other people and realising that this is a subject on which there is deep-seated consensus, unrest and concern among parliamentarians. Full marks to him for doing this.

I was only once successful in the private Members’ Bills ballot, and it was just after the rules were changed, so even though I came third out of the hat, I was No. 17, because it was done in reverse order so that it looked better on television. I think the previous Deputy Chairman of Ways and Means was responsible for that change. I have never had the good fortune of having a Bill that has been able to make progress; it is something I still look forward to and yearn for.

This is a really important subject. When we look at the Second Reading debate, in which I was briefly able to participate by way of an intervention, we can see the strength of feeling.

I go back to the Minister’s response to my amendments on Report. I hope he will be a bit more helpful on Third Reading about the role of NHS England and what will happen. I have paid tribute to him for agreeing that priority should be given to getting on with setting up these research bodies and looking into these issues. It is asking too much for the Government to agree to put those things on the face of the Bill, but I think it is clear from the pressure that is already on the Minister that his Department—however much it may have dragged its feet in the past—is now intent on rectifying that.

Most important of all, we will get the Government’s cancer plan. Let us hope that it will not be on the slow burner—we are promised it before the end of the year, and I hope it will be nearer this end of the year than next year. That could be very important, and as my hon. Friend the Member for Hinckley and Bosworth (Dr Evans) said, it links in with a lot of what we have discussed today.

Cancer needs to be taken more seriously in this country. We need to invest more. We need to get back to the top of the international league table, where we should be, as a leading nation with a very strong economy. I see in today’s news that the economy is shrinking, but that should not be a reason not to campaign to get these cancers shrunk.

[Madam Deputy Speaker (Judith Cummins)]

I call the shadow Minister.