CEO Update | 26 July 2021

The last week of Parliament before a summer recess often sees a raft of government announcements, as Ministers rush to get things into the public domain before heading off on holiday. Last week was a busy one with several key announcements affecting our sector, including updates on the National Security and Investment Act, the Innovative Medicines Fund, a new BEIS Innovation Strategy and a command paper on Northern Ireland. This was topped off for me by the misleading front page headline on Sunday suggesting “animal testing could end” due to a government review. 

Breakthroughs in Artificial Intelligence and protein folding

It was great to see a feature on the BBC News website of Deepmind’s Alphafold platform which has successfully predicted the structures of 350,000 proteins belonging to humans and other organisms. The article explores the potential of this discovery to boost the creation of new medicines and how Artificial Intelligence can bring wider benefit to global populations particularly in tackling climate change.  Well worth a read.

National Security and Investment Act 

The Government confirmed last week that the National Security and Investment Act will commence on 4 January 2022, applying to transactions that have taken place on or since 12 November 2020. Also published was the updated draft definition of Synthetic Biology which forms part of the regime, several pieces of guidance and a consultation on how the Business Secretary will use his call-in powers as part of the regime. The BIA will spend the next few weeks discussing this updated definition with members, relaying feedback to the Government and submitting evidence to its consultation. You can read more about our thoughts on the definition and guidance here.

NHS England announces Innovative Medicines Fund

Last week NHS England formally announced the Innovative Medicines Fund (IMF) that was first outlined in the 2019 Conservative Party manifesto. The announcement confirms that the IMF will be an extension of the current £340m Cancer Drugs Fund (CDF) and will cover treatments beyond oncology including for rare and genetic diseases. The planned additional £340m will mean that a total of £680m of ringfenced funding will be available to spend on fast-tracked drugs in isolation from the regular commissioning budget.  The fund, which will be publicly consulted on in the coming weeks, will work in a similar way to the CDF by supporting patients with any condition to access innovative and clinically promising treatments even where there remains significant uncertainty around their clinical and cost effectiveness.

New Government Innovation Strategy

Also launched just before Parliament’s summer recess was the Government’s new Innovation Strategy. This sets out how the Government intends to support innovation, and particularly innovative businesses, between now and 2035 to establish the UK as a global hub. Two further reports were also published on the R&D workforce and research culture. There’s much to absorb and welcome, from a new visa route for scale-ups to the identification of engineering biology, bioinformatics and genomics as technology families in which the UK is a world leader and which need active state backing to create new industries and economic growth.  It also signals a more active role for the Government in supporting innovation through a “missions” approach, learning from the Vaccines Taskforce, and starts an important conversation about the institutions in our ecosystem, including Innovate UK, with a review being led by Sir Paul Nurse. The BIA will be engaging with this and many other aspects of the Innovation Strategy, and I look forward to meeting the new CEO of Innovate UK, Indro Mukerjee, tomorrow, when I am sure we will discuss the strategy and Innovate UK’s next phase.    

Northern Ireland Protocol

Lord Frost and the Secretary of State for Northern Ireland published the Northern Ireland Protocol Command Paper on Wednesday which outlined the Government’s new approach. For our sector it proposed “the simplest way forward may be to remove all medicines from the scope of the Protocol entirely” and noted that “Medicines are at risk of discontinuation because the hurdles to clear to reach the small Northern Ireland market make supply unviable.” The proposal met with a strong negative response from the European Commission so we are no further forward and I expect to see further discontinuations of medicines in the weeks ahead.

It was frustrating that neither the Government, nor the European Commission, chose to share their detailed plans with those of us who have to operate any regulatory scheme before declaring each other’s proposals politically unviable. This remains a significant problem but it’s clear this remains political rather than a pragmatic discourse. Both the Government and the Commission are fully aware of the impact the inability to do a deal will have on the supply of medicines to patients in Northern Ireland and will be responsible to the public for the strategies they are pursuing.

Animal Testing

To finish the week The Sunday Telegraph had a headline yesterday stating “Animal testing could end as Priti Patel launches review”. The story comes from the Home Secretary briefing in response to misinformation circulating due to the continued Animal Rights protest at MBR Acres, a dog breeding facility near Huntingdon. There has been no formal government announcement of a new review of the law, nor is one expected. Understanding Animal Research have played a key role in explaining the facts behind the headlines. For example, the use of non-animal technologies is progressing all the time and it is illegal to use any animal in the UK where a viable alternative exists. 

No project of animal research or testing receives a licence from the Home Secretary without ethical and scientific scrutiny by the establishment applying to do the research and by the Animals in Science Regulation Unit of the Home Office and the governing legal requirements fall under constant review. The rapid development, testing and approval of the Oxford/AstraZeneca vaccine would not have been possible without judicious, well-regulated animal research, a fact about which falsehoods have unfortunately been poplularised by campaigners.

Conditions for research animals in the UK are among the best in the world and are constantly being reviewed and improved (and it is telling that campaigners have been forced to rely on old and discredited images to attempt to make their case). The UK facilities that breed dogs for research are tightly controlled by the Government and have stringent standards and dedicated staff who work extremely hard to ensure the welfare of animals in their care. As our sector knows well neuroscience, research into cancer, treatments for asthma and lung disease and many other areas of human and veterinary medicine depend upon the use of animals. Dogs bred for research in the UK are mainly used for legally required regulatory toxicology testing to ensure that potential new medicines are sufficiently safe to be given to humans in clinical trials.    

If non-animal methods improve to the extent that regulators are confident that humans will not be harmed by experimental new medicines, then it may be possible to phase out the use of dogs for this essential testing.  But currently, despite advances in new technologies, we all rely on the animals that support our science.