CEO Update: Monday 23 July

Two tracks are emerging following the publication of the UK government’s white paper on Brexit. Firstly, negotiations are underway with a formal offer on the table from the UK as to what it wants. Secondly, planning for “No Deal” is being talked about far more – and our sector is central in both debates.

Last week we saw UK political reaction to the white paper (no-one seemed happy), and a muted reaction from the EU negotiation team. We also saw the UK parliament test the strength of support for the government in a series of votes on the Trade and Customs Bills. One positive development for biotech was that the House of Commons voted in favour of amendment NC17 to the Trade Bill, tabled by Dr Philip Lee, who has recently resigned from the government and is a pro Remain rebel. The bill will make it a negotiating objective for the UK Government to seek to maintain its membership of the European Medicines Regulatory network. While it is up to the EU 27 as to whether this is agreed to, it is a positive step. You can read our response to the Trade Bill amendment here.

On preparations for “No Deal”, both  the UK government and the EU stated that businesses needed to up the preparation for this unwanted scenario, and the UK promised to publish documents on what those scenarios might look like over the summer. In a piece on BBC Newsnight this week, I spoke with Helen Thomas, BBC Newsnight’s Business Editor, about the impact of Brexit on our sector. I highlighted the negative effect the lack of certainty is having on the sector. Many of our members feel their hands are tied, with the European Regulator warning companies that they should prepare for an unwanted (and unlikely?) no-deal scenario now. We continue to press the UK government to set out the regulatory position for our sector in a no deal scenario – namely through unilateral recognition of EMA regulations in such an event, and I’d advise to watch this space closely in the coming month.  

Also worth a look is this new publication from BIA member IQVIA, which I was fortunate enough to join a panel on last week.   

Two of our members, AstraZeneca and Quay Pharmaceuticals were interviewed for the BBC Newsnight piece also, and representatives from each company highlighted the challenges facing them. Both expressed concerns about the double red tape that will be in store for pharmaceutical businesses if a deal is not reached on trade and regulation and spoke about their own contingency plans in relation to this. To keep up to date, you can catch our latest Brexit webinar from last Friday here.

It was also great to see plenty of coverage of new chief scientific advisor to the government, Dr Patrick Vallance’s comments this week. He hammered home the point that in order for a country to be successful in science, it must collaborate on an international basis. Over half of researchers in the UK are born overseas, and while scientists in the UK and EU agree that it is critical that international lines of communication remain open, Dr Vallance highlighted that we must not treat this as a foregone conclusion in terms of Brexit negotiations. In his words, it is essential that science is not parochial.

The Nuffield Council on Bioethics has published a new report, ‘Genome editing and human reproduction: social and ethical issues’ which concluded that the editing of DNA of a human embryo, sperm or egg to influence the characteristics of a future person could be deemed morally permissible. I thought Prof Fiona Watt, Executive Chair of the Medical Research Council gave the best reaction when she said :“The UK conducts word-leading research in genome editing, supported by our robust ethical and regulatory framework. This is already a rigorously-monitored area of research but it is vital that we continue to assess safety and feasibility before gene edits that can be passed across generations are permitted in people. We strongly support the report’s call for a public dialogue on this issue, as well as further research into the ethical and social impacts, to ensure this technology continues to be used only in an ethical and legally rigorous way.”

And in further interesting news this week, the Home Office published their annual report on the statistics of Scientific Procedures on Living Animals in Great Britain in 2017. 3.79 million procedures were carried out involving live animals, half of which were experimental procedures and half of which were creation or breeding of genetically altered specimens. This number represents a decrease of 4% from 2016, as researchers are continually finding ways to perform key research while minimising the need for use of live animals where possible. The BIA is a signatory of the Concordat on Openness on the Use of Animals in Research, which is supported by a range of organisations involved in clinical and pre-clinical research and development, all of whom commit to being open about the use of animals in research. This year, Understanding Animal Research encouraged research organisations and universities to tweet their own stats upon publication of the annual report, using #AnimalStats. It’s great to see organisations being open about their ongoing work using animals, helping the public to understand the work behind the medicines they rely on.

Finally, the BIA are delighted to invite nominations from individuals interested in joining our Board. 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. You can find out more information about eligibility and how to apply on our website. The deadline is Friday 07 September 2018.