Steve Brine
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Orkambi
Steve Brine Excerpts(5 years, 2 months ago)
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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 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.
Ian Austin
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.
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.
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.
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.