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Last week, one of my constituents, whose daughter suffers from cystic fibrosis, came to see me. He explained that every year that access to Orkambi or other such similar drugs is delayed takes 10 years off the life of his daughter.
My constituent explained how the long hours in hospital and in treatment mean that cystic fibrosis defines his daughter’s life. However, clinical trials by Vertex seven years ago marked the start of a new hope. Vertex’s amazing progress suggested that he might not outlive his daughter, that she could have the fullest life now possible, and that he would not have to tell her that she was likely to die when barely into adulthood. The whole House will understand that never in his worst nightmares did he consider the fact that these drugs would succeed yet be unavailable to his daughter.
Is the hon. Gentleman aware that Orkambi, which is manufactured by Vertex, is licensed and available in Ireland and the Netherlands where there are only 1,000 cystic fibrosis sufferers, but not available in the UK where there are more than 10,000 sufferers? Does he agree that that is a terrible shame?
I suggest that the hon. Gentleman hears the rest of the speech before he expects to draw any conclusions.
Cystic fibrosis is a life-limiting genetic disorder. Patients with cystic fibrosis experience a build-up of thick mucus in their lungs. This can have a wide range of effects on their respiratory, digestive and reproductive systems. The disease is widespread in the UK. One person in 25 carries the faulty cystic fibrosis gene. Statistically, that is 26 Members of this House whose future generations could be affected by this cruel disease.
I congratulate the hon. Gentleman on bringing this debate to the House; there is such a good crowd in the Chamber tonight due to the importance of the issue. I also thank him for being an advocate of Orkambi not because I have had any dealings with the company, but because I have many constituents who are affected. One grandmother in particular has asked me to make a plea because the life not only of their grandchild, but the lives of the whole family, have been turned around by this drug. I want this drug to be available for families throughout Northern Ireland and the whole United Kingdom. Does he agree that this Crown licence is a way to get around the stalemate that is preventing CF sufferers throughout the United Kingdom of Great Britain and Northern Ireland from accessing this drug, which is proven to deliver tremendous improvement in quality of life?
I am sure that the hon. Gentleman’s constituents will be grateful to him for raising the issue in the House this evening.
Every week, five babies are born with the disease, according to Great Ormond Street Hospital, and every week two young people die as a result of cystic fibrosis. The disease accounts for 9,500 hospital admissions and over 100,000 hospital bed days a year. There are two main ways to treat cystic fibrosis: conventional treatments target the symptoms, and precision medicines such as Orkambi tackle the cause of the condition. For conventional treatment on the NHS, the average waiting time to be admitted to hospital is 45 days.
Orkambi presents a relatively safer, more effective and clinically meaningful alternative. In treating the root causes, it reduces lung damage and cystic fibrosis-related diabetes, and improves pancreatic function. The drug has been approved by the European Medical Association, and the Food and Drug Administration in the United States. It avoids the high risk associated with organ transplants.
Orkambi treats the F508del mutation, which around 50% of people with CF in the UK carry. Essentially, the drug permits more chloride ions to pass into and out of the cells. This helps to keep a balance of salt and water in affected organs. Ivacaftor is one of the active substances in Orkambi. It increases the activity of the defective cystic fibrosis transmembrane conductance regulator protein, thereby making the mucus less thick. Decline in lung function is the most common cause of death for people with cystic fibrosis and, although not a cure, Orkambi has been found to slow the decline in lung function by 42% and reduce hospitalisations by 61%.
Before coming to this place, I was a respiratory physio and worked with many people with cystic fibrosis. The cost of hospitalisation and treatment far outstrips the cost of this drug for many people with cystic fibrosis. Should not the National Institute for Health and Care Excellence change its criteria and look at the value of life, instead of only the day-to-day cost of this drug?
No, I do not agree. The purpose of this debate is to a show an alternative that allows NICE to spend taxpayers’ money on drugs for other conditions while still allowing cystic fibrosis sufferers to have access to this vital drug—and not just to Orkambi, but to the next generation of the same sort of drugs. Bear with me because we have not got to the good bit yet.
In July 2016, NICE recognised Orkambi as an important treatment, yet was unable to recommend the drug for use within the NHS on grounds of cost-effectiveness. The drug is estimated to cost around £104,000 per patient per year and must be taken for life. Orkambi is not provided by the NHS, except in rare cases on compassionate grounds. It remains patent to its manufacturer, Vertex Pharmaceuticals, under UK patent law. In July 2018, NHS England made what it said was its best and final offer to Vertex of £500 million over five years. This was described by the NHS as the “largest ever financial commitment” in its 70-year history. Tragically, Vertex rejected the offer.
We all know that it is essential that a solution is found as soon as possible to make the drug available, as every day counts in slowing the progress of the disease. In an email to me, Vertex states that it
“is committed to finding a sustainable solution for access to our medicines for Cystic Fibrosis patients, including Orkambi”.
That is not quite the impression I have received so far. I sincerely hope that that is indeed its highest priority.
The drugs that constitute Orkambi—Ivacaftor and Lumacaftor—can be synthetically developed at low cost, yet their price remains inaccessibly high.
As some of my colleagues will know, I have a 14-year-old niece with cystic fibrosis, as well as many constituents who have it. I obviously know people within the community, too. Is the hon. Gentleman aware that in 2017 Vertex earned £2.5 billion from the sale of Orkambi and the chief exec was paid more than $17 million? I think that the Department of Health and Social Care probably has to go some way towards meeting Vertex on this, but it seems to me that there is an awful lot of money sloshing around and both sides are in a position where they could compromise.
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.
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?
I tragically allowed the hon. Gentleman’s intervention one sentence too early. I was about to say that Crown use licensing would make the drug available to cystic fibrosis sufferers at a reduced price on the NHS, so I absolutely agree.
Those are just a few examples of how Crown use licensing can set the ball rolling on increasing public access to precision medicine. The UK Government have a powerful policy mechanism already behind them. They are now in a position to make a huge difference to many people’s lives. A bio-generic version of Orkambi manufactured at a lower price would save our NHS time, money and resources. The majority of medicines already in use by the NHS are generic versions of originator products.
I have a daughter whom I love unconditionally. Putting myself in the shoes of my constituent, I can only imagine the anguish that he faces, let alone the suffering of his daughter. We know that young children stand to gain the most from access to Orkambi, and I am sure that the Minister wants to give the taxpayer the opportunity to access this drug under the NHS and NICE.
Has my hon. Friend looked at the cost and time delay involved in producing the generic alternative that he describes? Has he factored into his argument the potential cost of litigation, which I assume Vertex would pursue? I wonder whether his proposal might actually be less cost-effective and speed-effective than trying to put a bomb under the two parties to reach agreement.
I have. This drug would cost £104,000 if bought from Vertex and about £5,000 if it was made generically, so there is a huge saving.
I am grateful to the hon. Gentleman for giving way. He is making an excellent case. Those of us who have been active on this issue—it is wonderful to see so many of them in the Chamber—have faced the argument from the company that it wants to have a licence for a whole class of these medicines, so that it can plan that future investment. He seems to suggest that that is not necessarily a valid argument. I wonder if he could respond to that argument, which has been used against those of us who have suggested that there should be a fairer way of proceeding.
I am not quite sure I follow. I would have been much more sympathetic to Vertex if it had not been doing share buybacks. If a company expects to make $13 billion of profit, it will have factored into its calculations a reasonable profit margin. I believe that Vertex has an unreasonable profit margin. I support the private sector, and I like the idea of that R&D going on to benefit the shareholders, but I also recognise that we have a responsibility. As people who want to see patients cured, we want to see this deal done ideally by Vertex and NICE. This is a £500 million gamble for Vertex, because it will not get the money if it does not do the deal.
I am grateful to the hon. Gentleman for giving way. He mentioned the R&D that is going on. That R&D does not exist in a vacuum; it is done on patients, with input from doctors. Does he agree that the company, no matter how much profit it might want to make, has a moral obligation to cystic fibrosis patients?
I absolutely agree, which is why I am suggesting that the Crown use licence ought to be used and taken seriously. I imagine that people working for Vertex are listening closely to this debate. They will have heard the hon. Lady’s point, and I think they need to move on from this attention to profit margin.
As a Conservative, I understand the importance of managing the expectations of private companies. We in Parliament have a responsibility to people with cystic fibrosis to stand up to the greed. That is what we are doing now, and it is lovely to see so many Members here. I urge the Government to consider enacting a Crown use licence, to break the deadlock on this patented drug and reduce the price of Orkambi and the suite of medicines that go with it, which are so desperately needed not only by our constituents, but by their children.
It is a pleasure to see you in the Chair for the Adjournment debate, Mr Speaker. My hon. Friend Bill Wiggin and all Members who have contributed to the debate, some of whom I recognise from previous debates, have spoken on behalf of constituents from the heart as usual, regardless of political persuasion, with one voice. That is good to hear. I had a school here this morning, and the students asked me what the biggest misconception about this place is. I said that we get on far more than we do not, even at the moment. If they tune in this evening, they might see that happen. Adjournment debates are always a good example of that, in my experience—and as Public Health Minister, I have significant experience of the Adjournment debate, as does my poor Parliamentary Private Secretary.
Everyone has been speaking without political bias and with one voice, and that voice wants patients to benefit from effective treatments for cystic fibrosis. So do I, and the Government wholeheartedly share that view. We have urged Vertex to accept the fair offer that NHS England has made to the company, which would guarantee immediate access for NHS patients to all Vertex’s cystic fibrosis treatments. I hope that the pleas we have heard from my hon. Friend and other Members once again this evening will go some way to persuade Vertex—I agree that it will be listening intently—to consider NHS England’s fair and best offer.
I thank the Minister for giving way, and I congratulate Bill Wiggin on securing this Adjournment debate. We have been debating this in this place for months, and the fact is that our constituents and patients still do not have access to Orkambi. May I say to the Minister that it is time that Ministers themselves took over these negotiations and responsibility for sitting face to face with and eyeballing the company so that our constituents get the justice they deserve? These negotiations between NHS England and the drug company have got us nowhere, despite the efforts of right hon. and hon. Members in this House. Will Ministers now directly get their hands dirty, roll up their sleeves, participate in these negotiations and bring this matter to a conclusion on behalf of our constituents?
Okay, the hon. Gentleman has got his press release with his intervention. Perhaps I should go back on what I said at the start. All he has done is to take away time, on what is a very complex issue, from my trying to set out a response to my hon. Friend’s Adjournment debate.
My hon. Friend has called on the Government to consider making use of the legal provision in UK patent law of Crown use licensing to break, as he rightly puts it, the current “deadlock”. As Mr Lewis said, in a reasonable part of his intervention, it is a deadlock and it has been going on for some time. I commend my hon. Friend’s efforts in raising this. Indeed, it is right that we consider every possibility. Every effort must be made to ensure that effective medicines are made widely available to cystic fibrosis patients. There is no doubt and no debate about that.
I can assure my hon. Friend that we, too, have considered this option. Indeed, I have received initial advice on Crown use licensing. While the use of these mechanisms is not our preference, we are looking at all options. Crown use licensing is complicated, and it would not represent a quick solution to ensuring patient access to Orkambi. My hon. Friend Anne Marie Morris mentioned that in her intervention and, sadly, she is right.
The UK is one of a limited number of countries that actively protects the role of intellectual property in medicines development in international forums. We believe, however, that there is a balance to be struck between providing incentives to create and commercialise new medicines and ensuring that they remain affordable to the taxpayer—our constituents.
The 2019 voluntary scheme for branded medicines pricing and access, alongside the statutory scheme for branded medicines, are two mechanisms that are in place for ensuring branded medicines are affordable to the NHS. The 2019 scheme provides for flexible commercial arrangements between companies and NHS England—in other words, the customer in this scenario.
In theory, Crown use licensing could be utilised with respect to Orkambi. However, in the past Crown use has only really been intended or designed to deal with emergencies, where a particular patented product is not available in the UK at all. Crown use has not historically been intended to circumvent commercial agreements or to create a mechanism for the production of medicines at a lower price.
The relevant legislation on Crown use states that compensation would need to be provided to the original patent holder—in this case, Vertex, and that would stick in the throat of many of us—which would need to take into account any loss of profit from not being awarded a contract to supply the patented medicine. Unless an agreement could be reached with Vertex, it would be for a court to decide on an amount in this instance. This would of course need to be paid from the public purse. If a Crown use licence were issued, then there would be a subsequent, critical question about how the medicine would be produced and authorised as the usual licensing requirements would apply, with approval required by the Medicines and Healthcare Products Regulatory Agency.
Vertex has protections in the form of both data and marketing exclusivity for Orkambi, and it will continue to have these for a number of years. As such, unless another manufacturer conducted its own clinical trials, there are no realistic alternatives at this time to produce it and the NHS does not hold such a capacity. Using this route, it could take several—many—years before the drug was available on the market, and it would, in all likelihood, be very expensive for another manufacturer. The total length of time and cost of manufacturing and licensing—plus the compensation to the patent holder and a potential appeals process through the courts, which seems inevitable everywhere we turn these days—could be potentially significant.
We also do not know what impact Crown use would have on the other medicines that Vertex supplies to the NHS or the pipeline of products that it is developing. We should remember—and my hon. Friend reminded us of this in his opening speech—that around 50% of people with CF would benefit from Orkambi; in other words, 50% would not.
Crown use could have the effect of putting patients at a disadvantage, jeopardising access to future medicines and potentially setting a precedent of issuing further licences at very high cost.
I am grateful to the Minister for giving way. He is setting out all the arguments against Crown use licensing. I agree with the point that he has made in the past—that Vertex needs to show flexibility on this—but I think we all think that the Government also need to show flexibility and to think carefully about whether the NICE guidelines work when evaluating these new, precision medicines. What we would all like to hear from him tonight is what he proposes to do, and what the Government are going to do, to break this deadlock and bring these negotiations to a conclusion.
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.
I will not.
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.
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.