Orkambi

Ivan Lewis Excerpts

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.