1. What consideration has the Welsh Government made of NHS England’s decision to approve the use of Orkambi and Symkevi? 359

Thank you for the question. The use of Orkambi a Symkevi in NHS England is approved only through a commercial access agreement. My officials have met with, and await a formal offer from, Vertex. Given the confidential nature of our discussions, there is, of course, a limit to the comment that I can make. 

Thank you for that, Minister. As you are aware, I have constituents who are now travelling across the border to Liverpool and Manchester for treatment. They will be in the same building as England patients who can access this medicine. Minister, can you assure me that negotiations in the conversations you are having with Vertex are ongoing and are positive so that my constituents and the people of Wales can access these medicines as soon as possible? And, finally, Minister, have you also given any consideration to introducing an interim patient access scheme, as was the case in NHS Scotland, while the agreement was being reached on access to these two very important medicines?

The Member will be aware of the letter published by Simon Stevens, the chief executive of NHS England on this matter, sent to the House of Commons's Health and Social Care Select Committee. That set out that Northern Ireland and Wales have stood alongside England in the negotiation of the agreement that has been reached. My expectation is that those terms will be honoured. I made public comment yesterday that I would sign up today to exactly the same pro-rata terms for Wales, and I wish to be able to do so. That is my commitment. There should not be a delay for any family in Wales. I look forward to a properly constructive and honest response from Vertex that allows that to take place. 

Minister, I know that you share with me concerns that, every day that passes, we have patients in Wales who aren't able to access these extremely important drugs. Now, on 25 October, you said that you and your officials were meeting with representatives from Vertex the following week to discuss details of these terms and how they might be applied. I do understand you've got company confidentiality issues here, but are you able to give us any form of update on that? 

May I also ask what lessons have been learned from the length of time that it's taken to make progress on this issue, and how could things be done differently in future to ensure that we're not left behind the curve when it comes to reaching agreements on making life-saving drugs available for Welsh patients?

And finally, in terms of learning lessons, I understand that in early 2018, the company had been in discussions with NHS Wales on a portfolio proposal for all their current and future cystic fibrosis medicines. However, and I'm directly quoting, these discussions were halted in March/April, due to what we understood at the time to be a staffing issue at NHS Wales all-Wales medicines procurement. Minister, can you shed any light on that and provide assurances that such hold-ups will not happen again?

On your final point, that simply isn't true. It's simply not true. Vertex understand very well the well-established appraisal mechanisms we have right across the United Kingdom for new medicines: the National Institute for Health and Care Excellence appraisal system that we sign up to, the particular appraisal systems also available in Scotland, and here in Wales through the All Wales Medicines Strategy Group. What they have done, in reaching an agreement with England, which is in the text of Simon Stevens's letter, is they've agreed to provide real-time patient data on a basis where they've agreed a price for access to be made available for every patient for whom the treatment and the condition are indicated, and they will then submit their whole portfolio, with that real-time data, to NICE for appraisal. Now that makes sense, and that was not the proposal that was ever provided here in Wales.

I am clear that we are not responsible in Wales for holding up access to these medicines. The issue is that Vertex need to do what they've committed to do, which is in Simon Stevens's letter. And that is the start and the end of the matter. No family in Wales should be put into a less advantageous position than a family across our border because of an inability to meet the terms of the deal that has been agreed. I look forward to a positive and constructive response from the pharmaceutical company.

Thank you. The second topical question this afternoon is from Angela Burns.