CEO Update|Monday 14 September
The BIA-MHRA Regulatory Innovation Conference will take place this Thursday. Our virtual conference will enable you to listen to MHRA and industry expert speakers, join discussion groups and connect with the wider regulatory community at this pivotal time for medicines regulation in the UK and around the world. Take a look at the programme and register here. I recently spoke to Pink Sheet ahead of the conference about the future of the UK’s life sciences sector, in a post-Brexit, post-coronavirus world in terms of regulatory flexibilities and faster clinical trial approvals. This will be a key theme we will explore on Thursday.
COVID-19 news
Last week, the Prime Minister announced ‘Operation Moonshot’, a plan to get society back up and running by accelerating COVID-19 testing efforts. The project has the ambitious aim to expand the national testing programme to 10 million tests a day by early next year. BIA member companies are set to play a significant role on innovation in testing capacity. A comprehensive list of tests currently under review can be found here. Since the start of the pandemic, our sector has been at the forefront of COVID-19 testing and we, along with other partners, have worked hard on a platform to share novel solutions for increasing testing - the Testing Methods Sourcing Platform. At the same time there is an urgent need for laboratory staff who can help run the high-volume labs for testing, and the Prime Minister has written to our sector seeking our help to increase the testing workforce. You can find the letter here which provides contact details of who to get in touch with if you, or anyone you work with, can help this vital national effort.
The highly anticipated COVID-19 contact-tracing app will be launched across England and Wales on 24 September and will complement the NHS Test and Trace Service. The app will let people scan QR codes to register visits to hospitality venues and will utilise Apple and Google's method of detecting other smartphones.
On COVID-19 vaccine development, nine drug-makers who are developing vaccines have signed a pledge not to file for regulatory approval or authorization of their experimental vaccines until they have been shown to work safely through late-stage clinical testing. It was good to hear over the weekend that the AstraZeneca trial has now resumed. The Centre for Process Innovation’s Non-Executive Director, Steve Bagshaw, well known to many of you, was featured on BBC Inside Science explaining the role of UK manufacturing of COVID-19 vaccines, well worth a listen here.
Brexit news
Last week was a big one for Brexit developments with the publication of the UK Internal Market Bill. I welcomed the commitment in the Bill to preserve the UK internal market, to provide certainty for businesses to work and trade freely across the whole of the UK. However, the Bill fails to provide the detail or clarity on medicines regulation and supply in Northern Ireland which we have been seeking for many, many months. By trying to put into law clauses that explicitly undermine the previously negotiated and legally binding Withdrawal Agreement, this Bill, as presented reduces the chance of securing a deal and increases uncertainty around Britain’s future trading relationship with the European Union. It is also seen as a threat to the Northern Ireland peace process in the eyes of other important trading partners. Expect much more on this in the news this week. The Internal Market Bill and its impact will be covered in our next BIA Brexit Briefing Webinar on 24 September.
Trade News
Last week we saw the UK securing its first major post-Brexit free trade deal with Japan. Although the full text is not yet publicly available, the Association of the British Pharmaceutical Industry (ABPI) has welcomed the continuation of the Mutual Recognition Agreement (MRA). Our sector was not mentioned in the government press release that accompanied the news. The Government’s Life Sciences Trade Advisory Group (TAG) had its first meeting last week, which I attended. The gov.uk website is not up to date on the group’s membership.
ScaleUp survey 2020
The ScaleUp Institute is looking for the UK’s scaling companies’ voices as they carry out the ScaleUp Survey. The survey’s influence and importance has grown rapidly, providing crucial data and insights which are informing how both the public and private sectors better support and break down barriers that face scaling businesses. The heart of the survey remains the barriers to growth as our businesses look forward - as well as seeking to draw out the impact COVID-19 has and will have. The deadline for completion of the Scaleup Survey is 5th October 2020, take part here.
20th BIA Parliament Day
I’d like to reflect on a very successful BIA Parliament Day which took place virtually last week. Parliament Day facilitates important interactions between BIA members and policymakers across Westminster and Whitehall.
Screenshot of discussion between BIA members and Baroness Blackwood on how Genomics England can work with SMEs to grow the ecosystem further to benefit NHS patients.
In total 40 members participated, representing the broad spectrum of the sector. We had 26 meetings with Ministers, Shadow Ministers, MPs and officials across the day. Meetings included the Universities Minister, Michelle Donelan MP; the Shadow International Trade Secretary, Rt Hon Emily Thornberry MP; the Chair of the Commons Science and Technology Committee, Rt Hon Greg Clark MP and the Chief Executive of NICE, Prof Gillian Leng CBE.
We were also pleased to hear from the former Justice Secretary and Lord Chancellor, the Rt Hon David Gauke, in our lunchtime webinar. The link to the webinar is here.
The meetings this year provided an important opportunity for our members to speak directly to decision makers, often providing a perspective and knowledge to which Parliamentarians have limited access.
BIA Board elections
Finally, a reminder that the nomination for BIA Board Directors has been extended until the close of business on Thursday 17 September and anyone interested in becoming a BIA Board Director should contact Nick Gardiner as soon as possible for more information on how to submit your nomination.
