Orkambi

Debate between Lord Austin of Dudley and Steve Brine

Monday 4th February 2019 Commons Chamber

[Ian Austin (Dudley North) (Lab)]

rose—

[Steve Brine]

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

[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]

Will the Minister give way?

[Steve Brine]

Just because I cannot resist the hon. Gentleman, I will give way to him.

[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.

Oral Answers to Questions

Debate between Lord Austin of Dudley and Steve Brine

Tuesday 10th October 2017 Commons Chamber

[Ian Austin (Dudley North) (Lab)]

3. What his policy is on making Eylea available as a treatment for myopic choroidal neovascularisation.

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

The National Institute for Health and Care Excellence is developing guidance on the use of Eylea for the treatment of myopic CNV. NICE has published draft guidance for appeal that recommends use of the drug subject to a patient access scheme that makes it available to the NHS at a discounted price. NICE expects to publish final guidance this November.

[Ian Austin]

NICE needs to get a move on, because these drugs have been available to patients in Scotland and Wales, but patients in England will be going blind in the meantime.

Some people are told that their eyesight is too good to be treated, but by the time it has declined, they are told that nothing can be done to help. Will the Secretary of State meet my constituent, Elaine Shaw, who has been campaigning on the issue, the Macular Society and the Royal National Institute of Blind People so that we can discuss how to prevent people from facing an increased and unacceptable risk of preventable sight loss?

[Steve Brine]

Obviously I would be deeply concerned if patients were losing their sight due to treatment not happening in a timely way. Dudley clinical commissioning group tells me that it has already made funding available for Eylea following consideration of the NICE evidence summary issued in June 2016. This is the first drug that we have appraised through the new fast-track process for treatments that demonstrate clear cost-effectiveness. Patients will have routine access to Eylea from 1 December should the guidance remain unchanged. Of course, I would be happy to meet the hon. Gentleman and his constituent.

House of Lords Reform Bill

Debate between Lord Austin of Dudley and Steve Brine

Monday 9th July 2012 Commons Chamber

[Ian Austin]

Can the hon. Gentleman think of any job in Britain that is guaranteed for the next 15 years, because I cannot?

[Steve Brine]

No, I cannot, and I thank the hon. Gentleman for that intervention. Many of the constituents that he and I represent, in the public and private sectors, would give their eye teeth for a job with a 15-year guaranteed salary.

I wonder what the public would think if they actually saw the other place in action and were exposed to its debates in the same way they are to debates in this House, at Prime Minister’s questions for instance. I think that they would be genuinely shocked to find the level of debate that their lordships pursue and the much reduced partisan nature of their proceedings. Bagehot has been quoted a few times today, but clearly he has not been in the House of Lords lately.

The Bill, from my reading of it, would take all the worst element of this House, magnify them tenfold and place them at the other end of the building. The insane proposal to elect these senators to nine regions of the country by proportional representation would simply introduce a new breed of political animal to Parliament, one that owes everything to the party list that put them there. Of course they will act accordingly, and we would not blame them for doing so. Do right hon. and hon. Members really want to create a whole new raft of expensive, partisan and regionally roaming politicians?

I read in the weekend papers—there was a lot in them—the comments of one Liberal Democrat peer, who said that his party has had to swallow some bitter pills, such as student fees and the NHS Bill, strangely, as a result of coalition, and that it was time the Conservatives did the same.

That is one of the worst aspects of coalition, and I am a supporter of this coalition Government—and very much on the record as saying so. The horse-trading—the “you get, we get” mentality—that coalition fosters is a woeful way to carry on in any policy area, but when it comes to the constitution of our country it is just plain wrong and plain dangerous.

That is what is very wrong with this debate. The Bill is a reckless piece of proposed legislation that Baroness Boothroyd, who has far more experience of this House and the other than I do, described on the radio as “an abuse of Parliament.” I do not think that she would use that term lightly.

The Bill does not hang together intellectually. It is in part about coalition politics and, much more, about the internal politics of the Liberal Democrat party—and that is no reason to take a bulldozer to our constitution. In my bones I know that it is wrong, and the saddest thing of all is that it will probably set back sensible reform of the Lords for many years.

I urge the Government to step back, even at this late hour, and the Prime Minister and the Deputy Prime Minister to look each other in the eye over the Cabinet table this evening and simply to ask themselves whether these proposals will leave our Parliament a better place if they go through. I suspect that in their hearts both know the answer to that question, and I ask them to ask it.

I have never before voted against the coalition Government on a Government Bill, but with a very heavy heart, as others have said, I will do so tomorrow night.

Cycling

Debate between Lord Austin of Dudley and Steve Brine

Thursday 23rd February 2012 Westminster Hall

[Ian Austin]

The right hon. Gentleman is absolutely right to mention that. He and his constituents should be commended for the campaign they have run.

When Cath Ward was killed, the driver was convicted of careless driving and received a short driving ban. He will be back behind the wheel very soon. Cath’s friend Ruth Eyles wrote to me:

“What shocks me is that the driver who killed Rob Jefferies will be able to drive again in 18 months.”

She said:

“If that young man had had a legal firearm and had accidentally shot and killed someone through carelessness, would he be given a new licence 18 months later?”

We need the sentencing guidelines to be revised, in the same way the way guidelines for assault were revised, to reflect the harm the victim suffers. Will the Minister press the Ministry of Justice to change the guidance, to ensure the punishment fits the crime and, more importantly, to deter drivers from engaging in the stupid and dangerous driving that puts cyclists and other road users at risk?

My central point is that, as the CTC report “Safety In Numbers” points out, the more people who cycle, the safer cycling will be. Since 2000, bike use in Britain has quadrupled. The number of those cycling in London has soared by 150%, and the number of deaths is down by 60%. Between 1985 and 2005, the number of those cycling rose by 45% in the Netherlands, and fatalities fell by 58%.

This summer, as the hon. Member for Cambridge said, gives us a huge opportunity to transform cycling in Britain. Britain’s brilliant cyclists look set for huge success here in the Olympics, and also in some of world’s other biggest races. As a result many more people—particularly youngsters—will get on their bikes. With the “Summer of cycling”, which I hope the Minister will today commit to fund, we aim to double the number of people cycling this year. Let us get all the political parties and cycling organisations, and the media, following the lead of The Times and working together to transform the number of people cycling, and their safety.

As hon. Members can imagine, there are many things on which I disagree with Prime Minister, but it was fantastic when, as the Leader of the Opposition, one of the ways he chose to try to show that he was a different sort of Conservative was getting on his bike. It was great as well that he backed the Times campaign yesterday, but the truth is that he has the power—more than any of us—to act and get the Government focused on improving safety for cyclists.

[Steve Brine (Winchester) (Con)]

I thank the hon. Gentleman, with whom I enjoy working on the all-party group. I want to back him up on his points about the Prime Minister having the power, and about Departments working together. In Winchester we have works above junction 9 of the M3, which are needed and wanted, and have been campaigned for by Members of Parliament, but they threaten to put a stop to national cycle route 23. With a little more thought and planning we can avoid such situations. Such not-joined-up thinking is literally getting in the way of cycling.

[Ian Austin]

That reinforces the point I made earlier about ensuring that cycling is at the heart of all major transport schemes, at their inception and in their execution and development.

Finally, the campaign and today’s debate, with the number of MPs present and the outside interest, show that the issue will not go away. The Times is committed to campaigning on the issues for as long as it takes. I want to say that people—whether they are Sir Chris Hoy or Victoria Pendleton, a club cyclist like me or a commuter; whether they ride once a year on holiday or are parents who want to get their kids on a bike—should e-mail or write to their MP, or go to their surgery, and persuade them to back this campaign. I want every MP who has attended the debate to join the all-party cycling group, raise the issues in the Chamber, work with us and back our campaigns to boost cycling and improve safety for cyclists. That would be the biggest tribute we could pay to Rob Jefferies, Eilidh Jake Cairns, Cath Ward and of course to Mary Bowers and all of those injured or killed while cycling.