CEO Update - 22 April 2025

Soon after I finished my blog last week, the US Federal Administration announced how it proposes to treat the life science sector from a tariffs perspective, as I predicted in my blog two weeks ago.

In essence, the Secretary of Commerce has initiated an investigation to determine the effects on US national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items.

Steve Bates OBE
CEO, BIA

The sector-specific approach is set out through a national security lens and treats our sector in a similar way to semiconductors. The comments can be submitted within 21 days via regulations.gov.

I have been coordinating with US colleagues at BIO, European colleagues through Europabio and global colleagues via the ICBA on the best way to respond. The UK government are also engaged and are keen to get members' views.

I’ll explain our latest thinking and share insight on our webinar on Thursday lunchtime, which I know many of you have already signed up for.

As a starting point, the US Secretary of Commerce’s investigation to determine the effects on US national security of imports of pharmaceuticals provides an opportunity to show that the UK is an active and valuable US ally in developing new therapies. From the discovery and mass production of penicillin to today’s best-selling medicines, UK-US cooperation on drug development and manufacture has made US citizens healthier and better off. However, I am deeply aware of how concerning chaotic policy announcements from Washington DC are for members and the impact it has already had on the sector.

The UK government is directing companies to this webpage and will provide updates there as things progress. UK political debate on the appropriate response is also underway.   

Alongside the general macro concerns, members are already raising with me specifically around:

• The AMR pipeline, which gets hundreds of millions of dollars for clinical development through BARDA and NIAID, which are being cut, is facing a grave threat.
• The tightening of data regulations through new US Department of Justice rules, which place strict limits on collaborations involving researchers or companies from countries deemed to be of political concern, will stifle collaboration, make data sets hard to use and put up costs.
• The erosion of experienced leadership and cost-cutting at the FDA, as seen in the resignation of Peter Marks, is impacting the timeline of the development of transformative therapies, as BIO’s statement warns.

Although there is little we can directly influence with regard to US administration policy, it's really helpful to understand the impact on members so we can make sure UK policymakers are aware of the impact. Please do share your concerns with me directly by email or at the webinar.

The UK: keeping calm and carrying on in life science

The US developments are in marked contrast to the UK. At the regulatory level, the MHRA continues to deliver. The latest performance data shows strong clearance rates across licensing routes, with continued improvement in responsiveness, especially within the new ILAP and international recognition frameworks. At a time when regulatory science is under strain in the US, the UK’s system is working.

Furthermore, public sector investment in our scientific ecosystem remains on track. The UKRI budget allocations announced last week confirmed continued support for our research base. The Prime Minister’s personal commitment to the sector, as seen in £520 million going into advanced manufacturing and health resilience, and the Scancell announcement (see last week's blog) is further evidence of a government that not only understands life sciences but sees it as central to the UK’s future.

In addition, this week Moderna has announced that its manufacturing facility in Harwell, Oxfordshire, the Moderna Innovation and Technology Centre (MITC), has been granted a Manufacturer’s/Importer’s Authorisation (MIA) by the Medicines and Healthcare products Regulatory Agency (MHRA).With the manufacturer’s licence now in place, the company can move forward with commercial mRNA vaccine manufacture, which will be subject to the standard regulatory review processes with the MHRA.

Why the CBD needs to rethink its approach

BIA has responded to the Convention on Biological Diversity (CBD)’s consultation on thresholds for determining small, medium and large entities and the expectations on them to contribute to a new global fund intended to share the benefits of Digital Sequence Information (DSI) with less developed countries.

As I wrote back in November, we are pleased the CBD listened to BIA and our industry’s call that the Cali Fund must be voluntary to be workable, but we are still concerned that the detail of it – including the thresholds - are not fit for purpose for UK companies.

The current criteria could misclassify many small and medium-sized UK biotech firms as large entities, imposing disproportionate expectations on them. Without clarity on thresholds and fair, proportionate contribution rates, especially for SMEs, the system risks undermining the very innovation that contributes to biodiversity and global health. Our sector already plays a crucial role through non-monetary benefit sharing and cutting-edge biosolutions—contributions that must be recognised. We urge the CBD to refine its framework to reflect real-world commercial realities and support long-term collaboration that delivers for people.

Sign up to our webinar in June to find out more. 

Building the future through innovation

Last week the BIA responded to a House of Commons inquiry on the National Wealth Fund (NWF) – a new government-backed vehicle to funnel public investment into UK infrastructure and leverage private investment.

We called for the NWF to align with the government’s pro-innovation Industrial Strategy and include a focus on high-growth, innovative sectors like engineering biology and medical life sciences. These sectors are already recognised by government for their growth potential but infrastructure remains a key challenge that the NWF can help address – both engineering biology and medical life sciences face unique gaps that require additional investment, and both are dependent on broader, more traditional infrastructure such as transport and construction. The NWF must therefore consider the needs of priority sectors in its investment decisions. We also need the NWF to work in concert with established institutions like the British Business Bank and Innovate UK, drawing on their expertise and avoiding duplication of efforts.

UK Biobank data - an Easter media moment

If you were on holiday last week, you may well have missed this story about the UK Biobank and how scientific researchers around the world use its data. The UK Biobank responded here to reassure concerned participants.

The news follows the UK Government’s pre Easter data announcement, where the government and the Wellcome Trust said they will invest up to £600 million to create a new health data research service. This will transform access to NHS data by providing a secure single access point to national-scale data sets, slashing red tape for researchers. Emma Lawrence’s blog sets out how we got to this point and what comes next.