Orkambi

Lord Austin of Dudley Excerpts

Monday 4th February 2019 Commons Chamber

[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.

[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.