CEO Update | Monday 04 January

Happy New Year! 2021 got off to a promising start with the rollout of more innovative COVID-19 vaccines, sector recognition in the New Year Honours and we are now getting to grips with what the UK-EU deal will mean for our sector.

Vaccine news

Today marks a major milestone in the fight against COVID-19 with the first doses of the Oxford University-AstraZeneca vaccine being administered in the UK. It’s thanks to the foresight, collaboration and immense hard work of our sector that the doses to support a mass vaccination programme will be available in the coming weeks.

The BIA’s manufacturing community has been at the heart of efforts to understand and meet the challenges of the manufacturing, and scale up of a successful COVID-19 vaccine. You can find out how BIA member companies have supported both the Oxford University Jenner Institute’s ChAdOX and Imperial’s RNA vaccines here.

New Year Honours 2021 

It was great to see members of our community recognised in the New Year Honours 2021. Congratulations to Sally Ann Forsyth, CEO of Stevenage Bioscience Catalyst who has been awarded an OBE, and congratulations to Stephen Bagshaw of Fujifilm Diosynth Biotechnologies and Keith Thompson of Cell and Gene Therapy Catapult for being awarded CBEs. 

Brexit update

Today is the first working day of the new relationship between the EU and the UK, after the trade deal agreed on Christmas Eve and ratified by the UK Parliament last week. We are currently studying the detail and implications of the deal for our sector. You can view our initial analysis of the deal here. For any immediate issues with supplying medicines to the UK, please look at Steve Oldfield’s letter from 17 November.

It is clear that the new trading arrangements will have a significant impact on our sector and I am especially keen to ensure that a pragmatic, long-term approach to supplying Northern Ireland is agreed promptly. Whilst Brexit is done, it is clear that the exact trading relationship between the United Kingdom and the European Union will continue to be a live debate for as long as both exist. New working groups have been created as a part of this deal, the agendas and composition of which will be of keen interest to our sector.

The deal includes some positives for our sector. The continuation of tariff-free trade is a good thing for all businesses, although that is tempered by the new requirement for customs checks. The agreement also includes mutual recognition of Good Manufacturing Practice (GMP) inspections and documents. Manufacturing sites will not have to register with, and be checked by, additional regulatory authorities. However, the deal does not cover the mutual recognition of batch testing and release of medicines between the UK and EU/EEA, while the UK has said it will continue to recognise batch testing conducted in the EEA until 1 January 2023, the EU has not reciprocated. There will also be no regulatory information sharing between the EMA and MHRA other than for medicines placed on the Northern Ireland market. Throughout negotiations, we and our European partners were lobbying hard for mutual recognition of batch testing. It is possible to sign a mutual recognition agreement outside a free trade deal and pushing for this will be one of our priorities in 2021. This may be facilitated by some of the new working groups that have been created as a part of this deal.  If you have any immediate positive or negative experiences of the new relationship between the EU and UK, then please let us know, particularly if they relate to batch testing and medicines supply to Europe. We can help to put you in touch with government officials to resolve any issues and your case studies and examples will help us to continue lobbying for mutual recognition in the future.

We will be hosting a webinar this Thursday which will focus on the new trading relationship between the EU and the UK, register here.

J.P. Morgan Conference

For the first time in many years I, like many of you, will not be travelling to San Francisco for J.P. Morgan week, the traditional biotech kick-off to the year. Instead, I will be carrying the UK message to the world virtually via panels at the Wuxi Global Forum and Biotech Showcase. I look forward to showcasing more of your news in the weeks ahead.

Best,

Steve Bates

Chief Executive Officer

BIA

Steve Bates has been the CEO of the UK Bioindustry Association since 2012. He currently chairs the International Council of Biotech Associations and has been a Board member of Europabio since 2015. Steve is the visible face of the vibrant UK life sciences industry to government and media. He sits on the UK’s Life Sciences Council and Life Sciences Industrial Strategy Implementation Board. Steve has championed with government effective industrial incentives like the Biomedical Cataylst which have crowded-in private sector investment into UK SMES. He has forged links for the sector across the USA, Europe and in China. In his time at the BIA Steve has developed new member groups focused on cell and gene therapy, genomics and engineered biology. A strong advocate of partnership working, Steve champions sector collaboration with research charities and academia. Proud to lead an organisation with a diverse Board with over 40% female representation, Steve is committed to next generation talent and developing the skills needed for the sector to flourish. Before the BIA, Steve worked for Genzyme and as an advisor to the UK Government of Tony Blair. He was made OBE for services to innovation in 2017.