CEO Update | Monday 12 August

It feels like the new Government has been making an announcement a day this August! My blog this week highlights the seven key announcements for our sector in the last week, so sorry it’s longer and denser than normal, especially if you are picking this up after a holiday.

 

First, on Thursday the Prime Minister Boris Johnson said that he wants to make the UK “even more open, even more welcoming to scientists from around the world” in a broadcast on Facebook from his desk in Downing Street. 

 

A Number 10 press release said: “Boris Johnson has instructed the Home Office and the Department for Business, Energy and Industrial Strategy to work with the scientific community to develop a new fast-track visa route for the brightest and best, with a view to launching it later this year”. It continued: “To ensure the UK is the most attractive country to live in and develop new ideas, options which could be discussed with leading institutions and universities include:

  • Abolishing the cap on numbers under the Tier 1 Exceptional Talent Visas
  • Expanding the pool of UK research institutes and universities able to endorse candidates
  • Creating criteria that confer automatic endorsement, subject to immigration checks
  • Ensuring dependents have full access to the labour market
  • Removing the need to hold an offer of employment before arriving
  • Accelerated path to settlement”

The BIA will engage with this emerging consultation process, to ensure that any scheme understands and works for scientists working in businesses in our life science ecosystem. The initial announcement doesn’t touch on Tier 2 visas or how this scheme interacts with or works alongside the relatively newly announced Innovator visas. The announcement also usefully reconfirmed that the new Government will also “provide additional funding for scientists and researchers who have sought EU funding before we leave. This includes schemes delivered by the European Research Council to ensure no-one is disadvantaged.”  If the UK leaves the EU without a deal, “the Government will ensure any Horizon 2020 applications stuck in the approval process when the UK leaves, will instead be automatically reviewed by UKRI - with successful applications provided with funding”. 
 

Second, the Chancellor Sajid Javid announced on Friday that the Government’s next Strategic Spending Review will be delayed until 2020. That means this autumn’s Spending Review will only look at  departmental revenue spending over one year. We will continue to lobby government on key funding commitments for our sector like R&D tax credits and the Biomedical Catalyst.

 

Third, on Thursday it was announced that the NHS in England will set up a national artificial intelligence (AI) laboratory, and that this will be alongside a £250m investment for AI within the health service. Through analysing huge swathes of data to spot trends, AI has the potential to transform the life sciences sector and improve the health outcomes of patients.  This is a really exciting area of discovery in our sector, and BIA member companies Cambridge Cancer Genomics, GTN, Deepmatter and Exiscentia are all operating in this innovative environment. The Accelerated Access Collaborative (AAC) will play a substantial role in delivering this programme of work, in partnership with NHSX. Details on the programme of work are still to be confirmed, but papers are being prepared for presentation to the AAC Board in October, where we will be joined by Matthew Gould, Chief Executive of NHSX, who will explain more about NHSX’s ambitions for the AI lab.

 

Fourth, on Monday the Government announced an NHS funding boost of £1.8billion, £850m of which will be spent on upgrading twenty hospitals across the country.

 

Fifth, the Government’s preparations for a no-deal Brexit continue. The Health Secretary, Matt Hancock is now so confident about NHS planning that he told ITV on Monday:  “I guarantee that we now have all plans in place to make sure that the NHS will be prepared whatever the Brexit scenario.” Explaining this he added: “There are 12,000 medicines that are generally prescribed, licensed to be prescribed in Britain, and in normal times there are always a handful which are in short supply and we have a unit within the department which constantly works on these to make sure there is always that unhindered flow, and the plans we have got are for that to continue exactly as normal through a no-deal Brexit if that is what is necessary.”

From a BIA perspective I find it very hard to imagine any scenario where things “continue exactly as normal through a no-deal Brexit” or that there is an “unhindered flow” across borders with significantly increased red tape, especially in the short straits between Dover and Calais, since  much of the rate of flow is beyond the control of the UK Government or companies. So it’s important to re-iterate that no-one should be under any illusions that ensuring UK medicines supply in a no-deal Brexit will be easy, but with patients at the end of the supply chains, I know that companies will continue to do all they can to be as prepared as possible for no-deal.
 

We have stressed before, and continue to stress to government, that having freight capacity for medicines and medical devices in place on 1 November is fundamentally important for the continued supply of medicines to NHS patients in the case of a no-deal Brexit. Government procurement contracts issued at the end of July are still simply looking at ‘options’ for ferries. If you want to see the detail of what the Department for Transport is procuring and the timeframe to which they are operating, the tender documents are publicly available here.

The BIA also continues to call on government to provide sector-specific ‘trader readiness’ support for companies, especially smaller companies.

Sixth, members should be aware of the Department of Health and Social Care (DHSC) survey launched on Friday, as part of their work on contingency planning for clinical trials. The DHSC is updating the information they have on how clinical trials sponsors are preparing for the possibility of the UK exiting the EU on 31 October with no deal. The information collected will help them to understand which clinical trials will be ongoing on 31 October and what level of contingency planning sponsors have put in place. The  questionnaire should be completed by Tuesday 27 August. The DHSC will be holding a webinar on Tuesday 20 August to address any queries sponsors have about completing the survey. Please contact clinicaltrialssurveyreturns@dhsc.gov.uk for more details.

 

Seventh, in September a further new Government Statutory Instrument on medicines and medical devices will come before Parliament  (Human Medicines and Medical Devices (Amendment etc.) (EU exit) Regulations 2019) . This amends the SI passed earlier in the year on medicines and device regulation.  The Government website states that it “makes a number of changes to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 to ensure that the UK legislation accurately reflects technical updates at EU level since April 2019 and also corrects drafting errors and omissions to reflect published policy in the event of a no deal Brexit”.
 

This updates on matters to do with PIPs, QPPV location and touches on orphan provision so, as ever, the precise detail matters to companies. This is another practical example of the new red tape burden which preparing for a no-deal Brexit imposes on the sector. I hope we can use our regulatory conference on Sept 17 to make this quantifiable, understandable and actionable. 

 

We have received information from the Office of Life Sciences that they will be holding a webinar on 21 August with HMRC, Border Delivery Group and the MHRA. The webinar will explore how businesses should prepare for  new border and customs arrangements in the immediate event of the UK leaving the EU without a deal. More information on how to join the webinar will be sent out directly to companies

 

Away from Brexit news there was an interesting intervention by the Health Secretary, Matt Hancock in relation to the  impasse between NHS England and Vertex over the cystic fibrosis drug, Orkambi.
 

The Health Secretary told the Daily Express, that he would seek to sit down with the leadership team at Vertex “as soon as possible”. This was followed by a Department of Health statement saying: “Mr Hancock previously felt he should not be the one to negotiate with Vertex, and it should be done independently through NHS England. But now no deal has been reached he is hoping to put his weight behind the ongoing talks and add his presence.” This is an interesting development which shows that this Health Secretary is prepared to take an interventionist approach in access negotiations. One to follow in the coming weeks.   

 

Genomics England has appointed Chris Wigley as their new CEO, with effect from 1 October. Chris was most recently the COO of QuantumBlack, a world leader in machine learning and artificial intelligence. He has also been a partner at McKinsey and worked as a diplomat for the Foreign Office. The BIA’s Genomics Advisory Committee built a strong relationship with his predecessor John Mattick and we look forward to engaging with Chris in his new role to ensure Genomics England fully succeeds with its aim to kick-start and build a UK genomics industry.

 

Best

 

Steve