Cystic Fibrosis Drugs: Orkambi

Stephen Hepburn Excerpts

Monday 10th June 2019 Westminster Hall

[Mr Stephen Hepburn (Jarrow) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Bailey. Like others, I pay tribute to the hon. Member for Sutton and Cheam (Paul Scully) for bringing about the debate and allowing us once again to give the Government a jog and tell them to get this sorted out once and for all. We are all aware of cystic fibrosis. It affects all of our constituencies. It is a life-limiting condition that affects more than 10,000 people in the UK. It is a condition with no cure as of yet, and half of those who have it will die before their 31st birthday.

We are also aware that there is a drug available. Orkambi, developed by Vertex, treats not only the symptoms associated with cystic fibrosis but the underlying causes. One of these patients is four-year-old Harriet Corr from Jarrow, whose parents Emma and Chris are here today. They desperately want a better quality of life for their daughter. They contacted me because they were frustrated and upset that Harriet could not get access to this life-changing drug as it is not available on the NHS in England. An even bigger blow to them is that if they lived an hour further north, in Scotland, Harriet could qualify for it next year. Why? The NHS in England and NICE do not deem the drug cost-effective and have spent more than two years negotiating a price, without success.

It is totally unacceptable that a country with the second highest number of sufferers, and one that leads the way in cystic fibrosis outcomes, now risks falling behind many other European countries and the USA and allowing people with the condition to become physically sicker than necessary all because an agreement on the economics of treatment cannot be reached. We all know that because of that we have had five parliamentary debates, and still there has been no action from the Government. These drugs need to be on the NHS now, because every day without them is another day of suffering for the people living with the condition.

If people want to focus on the economics, the evidence is clear. As Members have outlined, this treatment prevents the condition from escalating, thus preventing more expensive treatment further down the line. It would reduce the number of times patients used the NHS and hospitals throughout the year, which would obviously be a saving to the NHS and—more importantly—a better outcome for patients and their families.

Let us look at the human aspect of the debate. Families are well aware that access to the treatment is not a cure for the condition, but it certainly helps those affected live as normal and fulfilling a life as possible in the short time they are with us. The NICE appraisal methods fail to recognise that. How can a cost be placed on a child with cystic fibrosis and their ability to manage their condition, to go to school, to play with their friends, to go to university later on in life and get a job as well as easing the burden of care on their families and carers? Why should Harriet and her family not have a worthwhile quality of life and get to do the things many of us take for granted?

Time is running out for some patients, and we are calling on the Government to act now to resolve this matter urgently. I thank Members from across the House for pushing this case forward. I also pay tribute to the campaigners, who have fought hard, organised a petition and shouted so loudly that surely this Government, in the fifth or sixth richest country in the world, can no longer ignore them.

Oral Answers to Questions

Stephen Hepburn Excerpts

Tuesday 26th March 2019 Commons Chamber

[Caroline Dinenage]

We all miss my hon. Friend the Member for Winchester (Steve Brine), so I thank the hon. Lady for her comments.

Since prescription charges were introduced, Governments of all colours have decided that some patients should pay prescription charges to contribute to the cost of running the NHS, but almost 90% of prescription items are dispensed in the community free of charge, which I think the hon. Lady will agree is an enormous amount.

[Mr Stephen Hepburn (Jarrow) (Lab)]

6. What recent progress has been made in the discussions between NHS England and Vertex Pharmaceuticals on making Orkambi available on the NHS.

[The Secretary of State for Health and Social Care (Matt Hancock)]

On 11 March, I held a meeting with all the parties to discuss how best to ensure that people with cystic fibrosis and their families can benefit from the best drugs as soon as possible. Vertex, the National Institute for Health and Care Excellence and NHS England met on Thursday and have agreed to take those discussions forward.

[Mr Hepburn]

Does the Secretary of State support immediate interim access to Orkambi while the negotiations are going on, and has he asked NHS England, NICE and Vertex to consider this option?

Orkambi

Stephen Hepburn Excerpts

Monday 4th February 2019 Commons Chamber

[Bill Wiggin]

First, let me say how sorry I am to hear about the hon. Lady’s niece. We should take this very seriously. The figures that I have are even worse than the ones that she has laid out.

The price remains inaccessibly high, and this is entirely due to the powerful patent laws that allow pharmaceutical companies to monopolise drug production. Vertex expects to retain monopoly intellectual property protection on its cystic fibrosis drugs well into the 2030s. Analysts conservatively estimate that it will generate profits of $13 billion on Orkambi and another related drug, Kalydeco, alone. This could be used to fund further research and development—to reward its shareholders for its brilliant breakthrough and perhaps to encourage it to do more. But no, Vertex has spent $500 million on buying back its own shares. Well, that should certainly boost executive remuneration.

I am aware that provisions exist under the Patents Act 1977 for the Government to take independent action against Vertex. Crown use licensing is a powerful legal tool that can be used to safeguard public health. It can ensure the availability of fairly priced medicines in a competitive pharmaceutical market. Section 55(1) of the Act states that the Government can be granted non-authorised use of patents

“for the services of the Crown”.

That can be granted at all stages of manufacture, use, importation, sale and retention of a product. This is a legal opportunity to break the lethal deadlock that eats away at the youngest sufferers who stand to gain the most from this medicine. Crown use licensing has been used by the UK Government before, to great effect. They can suspend a patent and thereby force down the high price of particular pharmaceutical or medical equipment. For example, in 1991 the Government authorised the supply of machines known as lithotriptors for treating kidney stones. More recently, breast cancer patients have lobbied the Scottish Government to implement a Crown use licence on the drug Pertuzumab. Crown use licensing could similarly be used to overturn the patent monopoly on Orkambi by Vertex.

[Mr Stephen Hepburn (Jarrow) (Lab)]

I applaud the hon. Gentleman for his initiative and guarantee him my 100% support. Does he not agree that this drug should be supplied on the NHS? We are all born equal in this country, but unfortunately if you are a millionaire you can pay for it but if you are working class like my constituents you cannot get it. I have constituents—Emma and Chris Corr and their young daughter Harriet—who are considering leaving England so as to be able to get the care that they need. Does he agree that this country is unfair?

--- Later in debate ---

[Steve Brine]

In response to the hon. Gentleman and to one of the other interventions about compromise and meeting in the middle—there is lots of talk about compromise at the moment—I suggest that the £500 million offer is a pretty good first step from the Government. I suggest that that is a pretty good attempt to meet in the middle. That is our constituents’ money.

[Mr Hepburn]

Will the Minister give way?

[Steve Brine]

I will not.

The hon. Member for Dudley North (Ian Austin) talked about breaking the impasse and breaking the deadlock. I said in response to the point from my hon. Friend about Crown use that I have not closed the door on it tonight. I am not trying to put obstacles in the way. I have been asked a question at the Dispatch Box about the practical realities of making this policy move, and I am setting out for the House’s benefit—on the record for everybody listening and for Members—the practicalities.

My hon. Friend talked about use of similar mechanisms by other countries. It is always interesting to understand what other countries are doing and what they are considering and implementing in their health services—there is much that we can learn from each other. However, I cannot comment on the circumstances that would prompt another country to take these steps; other countries have different health systems, and they do not have NICE. We have said—the hon. Member for Dudley North touched on this in his intervention—that we are looking to review the NICE processes, but we should also remember that NICE is respected around the world. If we did not have NICE, we would probably have to invent NICE—that is the truth for Ministers in this Government, as it would have been for Ministers in the previous Government.

I understand the sense of frustration in this Chamber.

[Mr Hepburn]

Will the Minister give way?

[Steve Brine]

I said I would not.

I think the House gets a minuscule sense of my frustration about the situation. I want this sorted. I have constituents who contact me about this too. I am sure the key question we are all thinking about is, where does this leave us now? I suppose that is the point of the intervention that the hon. Member for Dudley North made. I just want to be clear that we are still taking a very close interest in this matter.

The reason I responded so robustly to the earlier intervention about Ministers getting their hands dirty is that I do not think that is particularly helpful. Ministers are not the customer here; NHS England is the customer, Vertex is the seller and NICE is involved. Ultimately, we have made a very, very generous offer to this company, and I think that it should look again, and look long and hard, at its moral obligations as much as anything else, as somebody mentioned in their intervention.

Of course I recognise the impact that these protracted discussions are having on the daughter of my hon. Friend’s constituent. I heard the lady on the “Today” programme this morning on Radio 4, and it breaks our hearts to hear these stories. Of course we want this sorted. For many of the patients who suffer from this debilitating disease, including constituents of my own, it is extremely disappointing that Vertex rejected the final offer made by NHS England, as well as rejecting the opportunity for NICE to appraise its new medicines.

I have talked about the £500 million over five years; it is the largest ever commitment of this kind in the 70-year history of the NHS—it is not insignificant. It is a huge sum of money and of course NHS England must also fund other drugs for other distressing diseases. My hon. Friend made reference to that. I do not often get asked to come and answer Adjournment debates about spending less on precision drugs for other conditions. There are many, many other drugs that demand our funds. Vertex must re-engage with the NICE appraisal process. We understand the frustration of the CF community. However, it has been made crystal clear to Vertex that its drugs need to be priced responsibly and that any reassessment of Orkambi’s effectiveness must be carried out by NICE’s established process.

The position of Vertex is unreasonable. It is unacceptable to us, to patients and to our constituents. I know that other countries also worry for their patients because of Vertex’s unfair pricing of this drug, so let me put on record once again that Vertex should and must take up the very generous offer that NHS England has made. That offer will improve the lives of eligible cystic fibrosis patients and their families. For all the reasons I have set out, it is far and away the quickest and simplest way to resolve this matter.

Question put and agreed to.

Oral Answers to Questions

Stephen Hepburn Excerpts

Tuesday 23rd October 2018 Commons Chamber

[Matt Hancock]

Yes, my hon. Friend is absolutely right. In fact, the number of EU nationals working in the NHS has now risen by more than 4,000 since the referendum, and we welcome them all.

[Mr Stephen Hepburn (Jarrow) (Lab)]

13. What recent progress has been made in negotiations between NHS England and Vertex Pharmaceuticals on making Orkambi available on the NHS for people diagnosed with cystic fibrosis.

[The Lord Commissioner of Her Majesty's Treasury (Nigel Adams)]

It was disappointing that in July and August, Vertex, the manufacturer of Orkambi, rejected the final offer made by NHS England, as well as rejecting the opportunity for the National Institute for Health and Care Excellence—NICE—to appraise its new medicines, as is required for all companies seeking routine NHS funding for their products. Vertex must re-engage with NICE and NHS England, and I am encouraged that it attended a meeting with NICE on 4 October to discuss next steps.

[Mr Hepburn]

As the Minister knows, Orkambi is available for cystic fibrosis sufferers in Ireland, Greece, Denmark and a host of other countries around the world, so when will it be available for cystic fibrosis sufferers in this country?

[Nigel Adams]

I know that the hon. Gentleman takes a keen interest in this subject and that he campaigns assiduously on behalf of his constituents in this regard. He is right to suggest that Ministers are keeping a very close eye on these negotiations, and we urge Vertex to consider NHS England’s fair and final offer. However, it is absolutely right that we have a system—introduced by the Labour party—in which experts, not politicians, determine the fair price for a drug, based on robust evidence.

 Orkambi and Cystic Fibrosis

Stephen Hepburn Excerpts

Monday 19th March 2018 Westminster Hall

[Mr Stephen Hepburn (Jarrow) (Lab)]

It is a pleasure to see you in the Chair, Mr Evans.

I thank hon. Members on both sides of the House who are here to push this great case forward. I pay tribute to my hon. Friend the Member for Dudley North (Ian Austin), who organised a very constructive roundtable meeting where we learned a hell of a lot. I also pay tribute to all the campaigners, some of whom are represented today. They fought hard, got the petition organised and had such a loud voice that Parliament has not been able to ignore them.

We are all here because we want Orkambi to be made free on the NHS. It is a drug that works, improves lives and gives hope, so there is no reason why it should not be available. We agree that NICE’s 2016 decision to class Orkambi as not cost-effective for the NHS was wrong. Frankly, the Minister is in a position to get round the table with the drug companies, NICE and the NHS to resolve this and break the deadlock.

[Margaret Greenwood (Wirral West) (Lab)]

My hon. Friend is making a really good speech. A constituent—a proud and loving grandad—came to my surgery with two sets of photographs of his granddaughter, who is nearly six. One photograph was of a lively little girl, full of energy, and the other was of all the medication that she has to take every single day. The imagery could not have been starker. Does my hon. Friend agree that when someone is nearly six, a year is a very long time to wait for change, and the Minister should get a move on?

[Mr Hepburn]

I agree entirely and am pleased my hon. Friend has repeated my earlier plea to the Minister.

It has been said that Orkambi is recognised in a lot of countries—I do not want to go through the list, because there are many. We are getting left behind. Imagine what it is like to be a sufferer and to be told, “There is something out there that will improve your life and your family’s life, but, sorry, it is just not cost-effective.” Imagine how that makes them feel.

I have two constituents down here today: Emma and Chris Corr. They have a three-year-old daughter who has undergone more hospitalisations, more medical treatments and more operations than the vast majority of people will go through in the whole of their lives. All Emma and Chris want is to give their daughter a future and ensure that she is not limited in her life chances. I will be brief, but my plea is to think of the likes of Harriett: let her go to school and get a full-time education, without impediment; let her get qualifications; let her get a job; and let her live a long life. The alternative is unthinkable, whereby Harriett will have a deteriorating lifespan, leading to an early death, which I am sure we would all agree is unacceptable for anyone.

The final decision is with the Minister. I hope he recognises the unity of purpose in the House and acts immediately.