CEO Update: Monday 3 September

Thanks for the positive feedback on the Brexit announcements made by the UK government on the sector across the summer. As Westminster goes “back to school” I think we have a clearer idea of both what the UK government’s desired Brexit Deal (as set out by the Chequers’ plan and the MHRA’s early August announcement) looks like, and what No Deal would mean for our sector.  The technical notices published two weeks ago shed light on what a no-deal scenario would mean: a significant increase in duplication of bureaucratic red tape for developers of innovative medicines. We did see a number of specifics that the BIA has called for in these notices, including proposed unilateral recognition of existing EU processes, which is essential to minimise disruption.

 A number of technical notices not directly related to medicines were also relevant to the sector, around companies currently importing and exporting with the EU27 – namely the Customs and Trade Notice, VAT Notice and Tariff Notice. All of the notices can be read here and you can read our response to the notices here. We will of course continue to make our sector’s case with government, parliament and the public to ensure the implications of this once-in-a-generation debate are understood by key decision makers in the Brexit negotiations.

We also responded to the UK Government letter to the pharmaceutical industry on stockpiling medicines. I thank relevant members who are engaging with the Department of Health request for information on stockpiling additional supplies of medicines in preparation for a potential no-deal scenario. The Department are seeking formal responses by 10 September and are holding explanatory webinars this week. I have described this ask publicly as a massive challenge and encourage member feedback as the process develops.  

It's great to see the appointment of Joanna Dupont-Inglis as the new Secretary General of EuropaBio. Other changes there include Bernard Grimm’s appointment as healthcare director, and Agnes Borg as Industrial Biotech Director. Joanna boasts an excellent track record in the sector and her leadership will, I’m sure, be invaluable at EuropaBio.

It was disappointing last week to see Gilead’s CAR-T therapy rejected by NICE in the wake of its EU approval. Meindert Boysen, director of the centre for health technology evaluation at NICE, said: “CAR-T is an exciting innovation in very difficult to treat cancers, with a promise of cure for some patients.” They also mentioned that they still aim for patients in England to be among the first to access these new and innovative treatments in Europe. The NHS has been involved in ongoing work to ensure that CAR-T therapies get to patients, so we look forward to seeing developments on this soon. NICE are expected to published their guidance for Novartis’ CAR-T product, Kymriah in the Autumn.

In more positive news, was great to see Vertex and Genomics plc establish a collaboration last week, to use human genetics and data science to advance the discovery of precision medicines. The collaboration is set to last 3-5 years with the aim of discovering new targets for precision medicines, focusing on diseases which have significant unmet clinical need. Vertex has also made a £10.5 million equity investment in Genomics plc as part of its £25 million Series B funding.

With the summer holidays behind us September brings a great line up of events to get your autumn off to a good start! We have our regional networking lunch at Stevenage on 6 September, our last Women in Biotech evening of the year on 19 September focusing on advocating women in STEM, and a joint event discussing the importance of interdisciplinary collaboration and research at the Harwell Campus in Oxfordshire on 3 October. We then close the autumn season with our two flagship conferences; the UK Bioscience Forum on 18 October focusing on innovation and business strategies in the life sciences sector, and Bioprocess UK on 20 November showcasing the latest news and developments within the manufacturing and biologics arena.

Finally, the BIA are still seeking nominations from those interested in joining our board. Nominations must be received by close of business on this Friday, 07 September 2018. This year, there are five places up for election - four for 'Corporate' members and one for 'Other' members. The elections will take place during September and into October, and pending approval at the AGM in the Autumn, those elected will join the BIA's Board commencing 1 January 2019 and will serve a three-year term.  If you think any of your colleagues might be interested, please do let them know. You can find out more information about eligibility and how to apply on our website. If you would like to submit a nomination, please send no later than Friday 07 September 2018, to Nick Gardiner, Company Secretary [email protected]. If you have any questions, please contact Nick at the email address above.

Best, 

Steve