CEO Update | Monday 28 October 2019

It was heartening to see Thursday’s announcement that NHS England and Vertex have been able to reach a deal, bringing life-saving treatments to patients with Cystic Fibrosis (CF) and a long running access negotiation to a close. This is one of many deals which the NHS and BIA member have reached in recent months enabling innovative treatments for a whole range of diseases to reach NHS patients.


I’ve noted five other deals between companies and NHS England this year. The NHS and Biogen have agreed a deal for Spinraza which is used to treat spinal muscular atrophy (SMA), while approval was granted to Roche’s Ocrevus which treats multiple sclerosis (MS). Treatments for Batten disease and rare eye disorders are also being adopted by the NHS.  These positive breakthroughs haven’t always made headlines, but innovative treatments are transforming care for many serious conditions and building Britain’s economy.


What’s most interesting for our sector in the Vertex NHS England deal is that it already anticipates the next CF treatment breakthrough and how to enable NHS patients to benefit, meaning there should be no need for another protracted negotiation as the next innovation comes through.


The EU27 have agreed today to accept the UK's request for a Brexit extension until 31 January 2020. Once the Government formally agrees to the decision, the Brexit clock will be reset. Until it is legally impossible for the UK to leave the EU on October 31 we will remain ready for a no-deal Brexit, although the chances of that happening this week, (and of the Prime Minister keeping to his word of taking the UK out of the EU by October 31 “no ifs no buts”) now look vanishing small. 


We will close out our Business Preparedness for no-deal Brexit on Oct 31 work with a final webinar tomorrow, at 16:00. We then expect to hear later in the week how government plans to evolve the no-deal planning guidance if a further period for negotiation is finalised and have meetings with Ministers in the diary to progress this.


The Budget that was planned for 6 November has now been postponed. We will see at Westminster this week whether talk of a General Election leads to a December polling day.  What this means for businesses is continuing uncertainty and the fact that we have yet again been marched up the hill to a Brexit deadline that then disappears at the final moment. I will continue to share members’ exasperation at this with Ministers and officials.  


Of course, only last week parliament voted for the second reading of Boris Johnson’s Withdrawal Bill and this may indicate the future direction of withdrawal negotiations. In my latest webinar I looked into the implications of Johnson’s deal for Northern Ireland and medicine regulation, especially in how it differs from the preceding Theresa May deal. As the MHRA is the medicines regulator for both Northern Ireland and Great Britain (the rest of the UK) under this new deal they will have to operate two sets of rules: EU rules in Northern Ireland, and GB rules in GB. So under the current proposed Withdrawal Agreement (to which the EU 27 signed up), it is hard to see that the UK would be a pure third country to the European Union in term of medicine regulation, so there now needs to be a detailed technical discussion on how this would operate. This is a new issue which we will pick up with colleagues in Brussels.


A new report about the AIM public market this week shows that in all sectors only 20 companies have had an IPO so far this year, compared to 65 last year and 519 in 2005, with the London growth exchange still the biggest growth market in Europe. It was interesting to see New York-based RTW Venture Fund raising $15m in an IPO on the specialist fund segment of AIM last week, short of their €350m target. To see a life sciences-focussed fund attracting thin investor interest is obviously disappointing. It’s why the BIA will continue to champion the needs of the sector and work with government and regulators to enable UK pension funds and others to invest in the growth opportunities in our sector. The UK public market ’market failure’ for life sciences shows the need for both appropriate investment vehicles and price discovery enablers (like analysts and liquidity), an analysis we’ve had for a while and continue to champion.


Looking forward, we have the 16th Annual bioProcessUK Conference 2019, this year taking place in Liverpool. The programme is packed with presentations, workshops, and tours, where you will hear about the latest news within the manufacturing and biologics arena. Do sign up here.


I opened my blog with good news, and I will finish my blog with good news. Government is backing the next generation of scientists to transform healthcare and tackle climate change. A combined government and industry investment of £370 million will deliver 2,700 new PhD places in biosciences and AI. This is great news, and just this month we hosted a blog discussing the skill gaps and shortages in this sector, this announcement is a great start to addressing this issue. More good news from BIA member GE Healthcare, which has have opened a lab for life sciences start-ups at Alderley Park. Alderley Park is the UK’s largest single-site life sciences campus and is home to many of our members.