Orkambi

Bill Wiggin Excerpts

Monday 4th February 2019 Commons Chamber

[Bill Wiggin (North Herefordshire) (Con)]

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.

[Bambos Charalambous (Enfield, Southgate) (Lab)]

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?

[Bill Wiggin]

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.

[Jim Shannon (Strangford) (DUP)]

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?

[Bill Wiggin]

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%.

[Rachael Maskell (York Central) (Lab/Co-op)]

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?

[Bill Wiggin]

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.

[Kerry McCarthy (Bristol East) (Lab)]

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.

[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 ---

[Bill Wiggin]

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.

[Anne Marie Morris (Newton Abbot) (Con)]

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.

[Bill Wiggin]

I have. This drug would cost £104,000 if bought from Vertex and about £5,000 if it were made generically, so there is a huge saving.

[Anneliese Dodds (Oxford East) (Lab/Co-op)]

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.

[Bill Wiggin]

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.

[Liz McInnes (Heywood and Middleton) (Lab)]

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?

[Bill Wiggin]

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.