CEO Update | Monday 11 February

Today is ‘International Day of Women and Girls in Science’, a day where we celebrate the fantastic work of women right across our sector.  At the BIA we champion women’s role in science through our regular Women in Biotech Networking events, with the next one happening in March, while at our Gala Dinner this year I was delighted that Melanie Lee from Life Arc was awarded the BIA lifetime achievement award. There is some great material being shared online so do stay up to date on twitter using the hashtag #womeninscience and help inspire the next generation.


On Brexit the EMA and the European Commission have published updates on the questions and answers related to centrally authorised medicines in the event the UK leaves the EU on 29 March without a withdrawal agreement. The added Q&As address supervisory authorities for manufacturing sites; GMP certificates issued by UK authorities; FMD safety features; parallel distribution notices; reporting requirements into EudraVigilance concerning data from UK; and the impact on on-going referral procedures involving the UK. The Q&As and Brexit-related guidance can be found on the EMA website. For more on this please contact BIA Head of Regulatory Affairs Christiane Abouzeid.

This week we see what the Prime Minister has to offer MPs after her discussions with the EU, the leader of the opposition and her own party. Guessing what comes next in Brexit at Westminster remains a challenge but the BIA will monitor all the developments this week, all in time to explain it in a succinct and informative manner at our Brexit webinar this Friday. If you haven’t registered or would like more information please follow this link to find out more. 


A couple of titbits on the details of Brexit Statutory Instruments for aficionados. First the website has published the government’s own impact assessment of No Deal    The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019. It makes interesting reading and shows the Government expect medicines to come to market in the UK later and the costs of doing business for our sector to rise, there will be further duplicative 'red tape'(my shorthand term not theirs) and the costs be passed on to the healthcare system.  Despite this they are asking parliament to pass it under an expediated process. The Impact assessment also cites the work we commissioned from OHE and published with the ABPI in December 2017. It’s well worth a re-read especially as it provides some analysis of the likely cost impacts of the different types of Brexit for our sector (something the Government’s own impact assessment fails to do).


The Government last week committed to further consultation with the BIA on the UK’s future Intellectual Property rights regime in the event of a ‘no deal’ Brexit following concerns raised in the House of Lords. The Patents (Amendment) (EU Exit) Regulations 2018, along with other intellectual property related regulations, returned to the House of Lords on 6 February – after previously being 'negatived' by the House of Lords Grand Committee.  From the dispatch box the Rt Hon Lord Henley, Parliamentary Under-Secretary of State at the Department for Business, Energy and Industrial Strategy, provided reassurance that if they come into law, the 'no deal' Statutory Instruments (SIs) are a temporary solution, and that the Government is considering options for a future regime and will crucially for us, consult with business.  Following debate the SI was agreed by the House of Lords. 


Applications close this week for PULSE our three day leadership and entrepreneurship training programme developed by the BIA with the Francis Crick Institute. The programme is for aspiring entrepreneurs and new CEOs looking for advanced practical advice, support and feedback from leading entrepreneurs, renowned professionals and CEOs. The programme comprises a mix of sessions, talks, interactive exercises, interspersed with networking opportunities to equip you with necessary information and inspiration to become leading CEOs and entrepreneurs. It will give you a chance to practise relevant skills and share ideas in a safe space, with expert feedback and advice. It will also give you the invaluable opportunity to build links and networks across the sector, from industry experts to your CEO peers, and form an ongoing relationship with the Crick and BIA. This is one of my favourite events of the year, and I know how invaluable it has been to attendees in the past, so do sign up or  encourage people who could benefit to apply. I look forward to seeing you there. 


On Tuesday, we organised an event through our All-Party Parliamentary Group (APPG) for Life Sciences together with the APPG on Medical Research. The event focused on how cross-government coordination on this year’s Spending Review can help ensure that the UK remains a world leader in medical research. The panel was chaired by Chris Green MP and we heard interesting speeches by Labour Shadow Treasury Minister Anneliese Dodds, Barbara Domayne-Hayman as the Entrepreneur in Residence at the Crick and Jane Taylor as a patient advocate at Versus Arthritis, followed by a lively Q&A session. Thank you to the speakers and all the attendees – we hope you enjoyed the event.