CEO Update | Monday 14 January 2019

JP Morgan saw key M&A activity, new approaches from key UK pharma, a buzz about cell and gene therapy and concerns about the ongoing impact of the US Government shutdown. I’ve written a short blog on my perspective here.  

On Brexit, the vote tomorrow is a key watershed, but for our sector we expect ongoing detail from the government on no-deal contingencies. We will focus our analytical and briefing capability on providing members with actionable information, in what is a very uncertain political context. On 3 January, the MHRA published a further guidance note on the regulation of medicines, medical devices and clinical trials in the event of a no deal Brexit, in addition to an update on negotiations and further guidance for pharmaceutical companies planning in advance of the final negotiated settlement, and technical information on what an implementation period would mean for the life sciences sector. Last week we circulated a briefing to members on these updates. Members can contact our Communications Executive, Joanne Duffy, to get a copy of the briefing.

We are pleased that MHRA has now agreed to provide free scientific advice to UK-based SMEs to support innovative biotech companies and help retain R&D activities in the UK following BIA activity.  We’re also glad to see that on orphan medicines, the MHRA proposed that the initial marketing authorisation application fee will be refunded at 100% for UK SMEs and 10% for all other manufacturers where a medicine receives orphan status. Be sure to register for January’s Brexit Webinar where Laura and I will discuss the latest. Look out in the following weeks for a new podcasted version of our Brexit webinars, making it easier for you to catch up on the go.

At the end of 2018 the Department of Health and Social Care ran a 1-week informal consultation on proposals for “Serious Shortage Protocols (SSPs)”, in the context of no-deal planning, but with proposals that would remain regardless of Brexit.  BIA’s response included concerns around trigger points and automatic substitution between biosimilars.  The Health Secretary has now written to state that many of our concerns have been addressed.  The final SI will be laid before Parliament on Tuesday.

We were delighted to see the announcement of Nicola Blackwood as new Under-Secretary of State for Health last week. Having served on the board of BIA member Eagle Genomics, and through her experience as Minister for Health, she has an excellent knowledge of the sector. We had an excellent relationship with Nicola when she was previously in government and we are looking forward to working with her in the future. Her new job role includes; making a success of Brexit; life sciences policy and industry engagement; industrial strategy and NHS innovation as well as medicines pricing and regulation; data; digital and technology, including cyber security and NHS land and estates; NHS litigation; migrant cost recovery and income generation.

Before Christmas we announced Action Medical Research for children as our new Charity of the Year. We’re really looking forward to working with them throughout 2019, and we’ll get things off to a great start at the Gala dinner. We will be joined on the night by Simon Harriss, whose daughter Lily has a rare disease called BPAN. This disease causes children to have delayed development and to miss key developmental milestones. Lily’s parents are strong advocates for medical research into this and other rare childhood diseases, and champion scientific research as the best way to combat these illnesses. We’re looking forward to hearing from Simon, and this week is the last chance to book a seat for the Gala dinner, and take part in our silent auction on the night, where there will be some great goodies up for grabs.

Also on 24 January we will have our Strategic Technologies in Life Sciences: The Future is Now event, which will look at our brilliant series of Explainer Videos on Genomics, Antimicrobial Resistance, Engineering Biology and Cell and Gene Therapies. We will also hear from an investor in each of these areas about why they are excited to be investing in innovative science. Hot desking space will be provided from 15:00 and there will be facilities to change for our Gala Dinner should you wish to join us.

We are looking forward to hosting our Committee Summit on 14 February which brings together our advisory committees and working groups to present on their key objectives from 2018, and to update us on their 2019 plans. We welcome all committee members and interested members of the BIA community to join us on the day, by signing up here. Members who have an interest in matters relating to IP can now sign up for a policy mailing list. Our Intellectual Property Advisory Committee is fully subscribed, but please get in touch with Martin Turner, Policy and Projects Manager at the BIA, if you’d like to keep abreast of the committee’s work. Those who sign up to the mailing list will receive: general updates about BIA/IPAC IP-related activities; IPAC agendas ahead of meetings; redacted minutes of meetings; requests for input to selected consultation submissions and evidence-gathering exercises. Blogs and other publicly-available information of interest will also be signposted. You can opt-out of receiving IP policy mailings at any time.  Our full privacy statement can be seen here: BIA Privacy Statement.

Also in February there will be a UK delegation of BIA members to BIO’s CEO and Investor Conference in New York for the first time.  We are offering BIA members discounted registration to the conference, providing them with the opportunity to meet potential investors and collaborators.  If you’d like to find out more please contact Michael McGivern.

I look forward to you joining us for the webinar Friday.

Best,

Steve