Orkambi

Debate between Ivan Lewis and Steve Brine

Monday 4th February 2019 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Steve Brine)]

It is a pleasure to see you in the Chair for the Adjournment debate, Mr Speaker. My hon. Friend the Member for North Herefordshire (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.

[Mr Ivan Lewis (Bury South) (Ind)]

rose—

[Ian Austin (Dudley North) (Lab)]

rose—

[Steve Brine]

I will give way once—and that is it—to the hon. Gentleman who rose first.

[Mr Lewis]

I thank the Minister for giving way, and I congratulate the hon. Member for North Herefordshire (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?

[Steve Brine]

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 the hon. Member for Bury South (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 the Member for Newton Abbot (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.

Access to Orkambi

Debate between Ivan Lewis and Steve Brine

Tuesday 17th July 2018 Commons Chamber

[Steve Brine]

I said I would not give way, and I will not do so.

I thought the hon. Member for Bury South made a good point when he said if NICE did not exist, we would have to invent it. I agree. Indeed, NICE has been able to recommend a number of drugs for patients with rare diseases through its technology appraisal process, including pirfenidone for pulmonary fibrosis and mifamurtide—why they cannot produce easier names, I will never know—for a rare form of bone cancer, to name but two.

I know that it is distressing, to put it mildly, for patients and their families, as well as campaigners, when NICE is not able to recommend a treatment. Unfortunately, there will continue to be occasions when NICE is not able to a recommend one for routine use on the NHS. As we know, NICE has not so far been able to recommend the use of Orkambi for treating CF, because the benefits were not sufficient to justify its considerable cost. At list price, the cost per quality-adjusted life year of Orkambi is many times higher than the upper end of the threshold used by NICE in deciding whether to recommend a treatment. NICE does not stick rigidly to a cost per QALY threshold, and it applies plenty of flexibility in deciding whether to recommend treatments where the decision is a borderline one. However, it must be stressed that the cost per QALY is not an arbitrary measure, but a tool to assess what the impact would be on other NHS patients if the NHS were to spend money on a particular treatment.

I want to talk about the discussions with Vertex. As Members know, NHS England has been in intensive discussions with Vertex to encourage it to lower the cost of Orkambi to a level that would allow NHS England to fund its use without adversely impacting other patients. I and the Under-Secretary of State Health, Lord O’Shaughnessy, who sits in the other place—he leads on this area for us—have been keeping an extremely close eye on these discussion, as I promised the House in the Westminster Hall debate I would do. As Members will remember, we wrote to Vertex in April, urging it to commit to pricing that is responsible and proportionate. I have the personal assurance from NHS England that it is committed to seeking a way forward in these negotiations, and I think it has shown flexibility.

Sadly—I am not ratcheting up the rhetoric or name-calling, as this is just fact—Vertex has been unwilling to price responsibly thus far, which has, as we have heard today, meant that patients have missed out on two years of treatment. Vertex claims that it has made the NHS

“the best offer in the world”—

but it has yet to substantiate that claim. I would challenge Vertex to waive confidentiality—which it can do: I cannot—so that we can all see, in the interests of transparency, the kind of prices it is trying to charge the NHS and, as a result, our constituents.

As mentioned this evening by the hon. Member for Bury South, NHS England wrote to Vertex yesterday to set out a proposed five-year deal with an option to extend, which provides the potential for Vertex to secure revenues from the NHS in the region of £500 million over the next five years. NHS England has made the content of this proposal public, to give patients and taxpayers the opportunity to make a judgment about the fairness of this offer. The proposed deal, if accepted, would guarantee immediate and expanded access, as clinically appropriate, to the two licensed medicines, Orkambi and Kalydeco—as was said earlier, Orkambi is not the only show in town. It would also provide immediate access for Symdeco from the date it is licensed for use in the UK, which is expected in coming weeks.

If Vertex is not willing to accept the deal, it must return to discussions with NICE and go through that process. Let me be clear that I truly hope it does not come to that, but until Vertex adjusts its prices, NICE will not be able to recommend the drug’s use. I repeat that we have put a figure on the table. The ball is in Vertex’s court. It has made a preliminary response today, saying that it is good to see that NHS England is negotiating. NHS England has been negotiating throughout. It is not Ministers who are negotiating on this.

[Mr Ivan Lewis]

rose—

[Steve Brine]

I will break my rule and give way to the hon. Gentleman who secured the debate.

[Mr Lewis]

That is kind of the Minister and I thank him for his serious response to the debate.

We said the last time we met that we did not want Ministers to keep an eye on the issue: we wanted Ministers to be actively engaged in it. The Minister gave us an assurance that his colleague would be actively engaged, not keeping an eye on it. Today, we repeat that we do not want NHS England and the drug company left in a room alone to work this out, otherwise we will be back here in six months’ time. We expect the Secretary of State to be in the room with the chief executive of NHS England and the drug company to bang heads together and come up with a satisfactory conclusion. Will the Minister respond directly to that point and give us an assurance that there will be political involvement and engagement in the negotiations, because we have waited for too long?

[Steve Brine]

When I say “keeping an eye”, I do not mean it like keeping an eye on the football scores on a Saturday afternoon. It is just my turn of phrase. Ministers are keeping very close tabs on this and making sure that NHS England is in no doubt that we want it to come to a conclusion with Vertex. But it takes two to tango, as we are seeing in another negotiation right now. We need Vertex to tango. The ball is in its court, and it is time to return it.

I stand by what I said at the last debate: it is vital that we go through the right process here. There is a process. I do not think for one minute that the Opposition are suggesting that if they were in government, Ministers would be making these decisions like Roman emperors, as that would be totally wrong. It is an important principle that the NHS must ensure that healthcare services get the best value for patients, and that is the approach NHS England is rightly taking.

NHS England has proven that it can strike innovative deals, working with the life sciences sector to make treatments available for patients, while securing fair value for taxpayers—our constituents. That includes hundreds of patients with multiple sclerosis who now benefit from a treatment called cladribine and the use of pertuzumab for breast cancer. It is important for me to be clear with hon. Members that Ministers should not make a decision on behalf of NHS England, which has the clinical expertise and the powers to purchase medicines.

I put it on record again that I urge Vertex to accept the proposal presented by NHS England, or it will only make those living with cystic fibrosis suffer. Yes, of course there are discussions among the new ministerial team. I spoke to the new Secretary of State just this evening in the Lobby. He is taking an incredibly close interest in this issue, less than a week into the job, and I pay tribute to him for that. I ask Vertex to recognise NHS England’s flexible approach. It would represent the largest ever financial commitment of its type in the 70-year history of the NHS. I certainly hope that they can reach a deal. Many, including in my own Winchester constituency, are counting on them.

Question put and agreed to.

 Orkambi and Cystic Fibrosis

Debate between Ivan Lewis and Steve Brine

Monday 19th March 2018 Westminster Hall

[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

It is a pleasure to serve under your chairmanship, and that of Mr Evans, Sir Roger. May I be the final speaker to thank my hon. Friend the Member for Sutton and Cheam (Paul Scully), who has done his job as a member of the Petitions Committee in introducing the debate on the petition today. As the hon. Member for Washington and Sunderland West (Mrs Hodgson) said, the number of Back-Bench MPs who have spoken is 22. My Parliamentary Private Secretary reckons that we have had 60 Members through the Chamber in the past three hours. Of course that is only just over 9% of MPs, but, as we all know, having been to many Westminster Hall debates between us, that is a lot of MPs in one debate. That did not even include the hon. Member for Strangford (Jim Shannon)—I am worried for him. As we know, so many MPs attending the debate suggests a great deal of interest in the subject, and the way everyone spoke was excellent. Perhaps I may mention that the speech of the hon. Member for Motherwell and Wishaw (Marion Fellows) cannot have been an easy one to make, and she delivered it with grace.

With more than 115,000 signatures—my goodness—the petition shows what huge public support there is for tackling this terrible disease. The passionate way in which hon. Members across the board have spoken on behalf of their constituents is testament to that support. I want to make a special mention of the “Bury brothers”, who represent the 202 people in the Bury constituencies who signed the petition: the hon. Members for Bury North (James Frith) and for Bury South (Mr Lewis) both spoke well and in a sensible and balanced way. I can only assume that the hon. Member for Bury South, from what he said, must be a former Health Minister. Am I right?

[Mr Lewis]

indicated assent.

[Steve Brine]

I thank 163 of my own constituents who signed the petition and who have been in touch with me, and one who has been to my constituency surgery. I may be the Health Minister responding to the debate, but I am also a constituency MP and a parent of two young children.

I pay tribute to the Cystic Fibrosis Trust, which does a tremendous job on behalf of all our constituents. I know we are not meant to address the Gallery. I will not do so, but if I did I would thank those who have made the trip in the snow and ice, probably not all from SW1, to come to Westminster today. It is a credit to them that they have made time to do that.

I recognise the progress that Vertex has made to date in its mission—I believe it is a mission—to discover ultimately a cure for cystic fibrosis, and recognise the treatments that it brings to the market. I know Vertex understands the importance of the UK market, and NHS England as a customer, to its future and to that mission.

This petition is calling on the British Government—that would be me—

“to call for a resolution to ongoing negotiations between Vertex Pharmaceuticals, NHS England and NICE as a matter of the utmost urgency. It is essential that a fair and sustainable agreement is found.”

I am here today to do exactly that. It is not a difficult call to agree to. The negotiations must remain constructive and be undertaken with the utmost urgency, for all the reasons we have heard—I will not repeat them all—or, as my hon. Friend the Member for Mid Dorset and North Poole (Michael Tomlinson) said, people living with cystic fibrosis will suffer.

It seems to me that the main ask I have heard from pretty much every hon. Member speaking today is, “Get involved.” I am not the Minister directly responsible. That falls to Lord O’Shaughnessy, the Parliamentary Under-Secretary who sits in the other place, but I can say on his behalf and on mine that we are involved, and you can bet your life that we will continue to be involved. I do not think I can be clearer.