CEO Update | Tuesday 26 February

UK politicians continue to discuss various Brexit scenarios – and put off making key decisions. We now expect any ‘meaningful vote’ in parliament to be delayed until or by 12 March but will watch closely the debate this week in the House of Commons that could force the government’s hand. We are in unprecedented political waters now with Parties splitting and government ministers defying government policy in newspapers, yet not being sacked.

 

At the same time, there is an incredible amount of information coming at the industry on how we will be asked to operate if there in no-deal scenario, so we’ve delayed Newscast to Tuesday this week to be able to include the latest information that was published late yesterday afternoon. 

 

Brexit | Key industry specific news: EU flexibility on batch testing and how to book UK gov ferry tickets

 

The UK Government’s no-deal planning has stepped up over the last month and we are now starting to see further public information on the Medicines Supply Contingency Planning Programme.

  • This Written Ministerial Statement was laid last night around 7pm and provides further information on the Programme
  • Following the statement the Medicines Supply Contingency Planning Programme team will hold a webinar on Thursday 28 February, 13.30 to 15.00  Please contact [email protected] for further information.

  • Last week the Government wrote to marketing authorisation holders.  The letter contains operational details about shipping routes between the EU and the UK and warehousing capacity for additional buffer stock. The information covers: biological substances (bloods, organs, tissues, cells), clinical trials materials, medical devices and clinical consumables, medicines, non-clinical goods and services and vaccines and asks companies to register with them and complete a survey.  The registration and survey will provide volume requirements for the transport contingency requirements, and be the way by which companies will be able to book ferry tickets for the government chartered ferry capacity in the event of no-deal. It is vital that BIA members submit their responses TODAY.  If you have not received the letter and think that you should have please contact [email protected]
  • Office for Life Sciences and MHRA are now providing no-deal updates and these are being added to the BIA Brexit website

NHS England has also published no-deal communications for patients and healthcare providers. The information can be found here:

The European Commission has finally provided some pragmatic guidance on medicines batch testing. In a letter from the Commission's Directorate General for Health and Food Safety (DG SANTE) to the EU27 Heads of Medicines Agencies and to the Executive Director of the European Medicines Agency (EMA) and makes clear that batch testing in the EU/EEA will be required, but it does allow some flexibility for where

  • A batch release site in the EU27 is identified by the marketing authorisation holder by the withdrawal date  
  • The batch release site is supervised by a qualified person established in the EU27 by the withdrawal date  
  • The establishment designated by the third party conducting the quality control testing may be verified by a competent authority of the EU27, including on the spot checks  
  • All necessary steps have been taken to prepare the transfer of the quality control testing site from the United Kingdom to the EU27.  
  • Find out more here

Monday’s Brexit Lead Network with MHRA and the Medicines Supply Contingency Planning Programme team provided further information for members on the Government’s no-deal work and provided members with a chance to take a collective view on the new information and how to prepare. The next Brexit Lead Network meeting takes place on 9 April and members can sign up here.  The next BIA Brexit webinar is on 22 March and you can register here.

 

If you regularly tune in to our Brexit webinars you might be interested to learn you can now catch up on-the-go with a podcasted version. The podcast is available on Soundcloud and will be available shortly on the Apple store. Of course you can still catch up on YouTube should you wish to view the slides.

 

Away from Brexit I’m looking forward to seeing many members this week at our event in Edinburgh on Thursday, ahead of the Scottish Life science dinner, which I’ll also be attending. It’s not too late to register, you can book here.

 

Also, be sure to join us next week on the eve of International Women’s Day, 7 March for our first Women in Biotech event of the year, at Bird & Bird in London. This year’s WiB agenda kicks off with a discussion on what it takes to build a good board. The number of women holding senior jobs in the boardrooms of Britain's biggest companies fell in 2018, and a Hampton-Alexander Review report in 2017 famously uncovered that the CEO of a FTSE 100 company is more likely to be called John than be a woman. We’re hoping that our WiB network will encourage productive conversations around how we can develop the pipeline of women reaching for executive and NED positions. On the night you’ll hear from Sarah Shackleton of Abingworth, Ursula Ney of NED Proteome Sciences and Denise Scots-Knight of Mereo Biopharma, followed by a Q&A with all speakers, refreshments and networking. You can find out more about the event here.

 

Applying maths to real-world problems might transport you back to your A-level days of revising and cramming – but rest assured we have a webinar that promises to make maths interesting. On 8 March, we will be joined by Dr Anthony Holmes (Director of Science and Technology at the NC3Rs) and Dr Manasi Nandi (Senior Lecturer in Integrative Pharmacology at King’s College London). The NC3Rs is the National Centre for the Replacement, Refinement and Reduction of Animals in Research. The BIA is a signatories of the Concordat on Openness in Animal Research and we recognise the vital role animals play in the work our member companies do. The 3Rs are a valuable guide for animal research and provide sensible aims for research involving the use of animals. Dr Nandi and Dr Holmes have developed a novel mathematical method to extract new information from routine physiological waveforms, including blood pressure and ECG, which allows the amount of data generated by each research animal to be maximised, reducing the overall number of animals required by a study. You can register for the webinar here.