Labour’s manifesto policies were designed to promote growth in the UK Life Sciences sector. This was welcomed by the Association of British Pharmaceutical Industry (ABPI) who applaud the “recognition of the revolution taking place in data and life sciences and the potential this has to transform our healthcare”. This insight considers the opportunities in that ‘revolution’, but also how risks should be analysed and managed.

The Labour government’s plan was reiterated within the House of Lords briefing note, made ahead of the King’s Speech, which confirmed that life sciences is one of the six areas in which they propose setting a ten year (rather than three year) funding budget to enable “meaningful partnerships with industry to keep the UK at the forefront of global innovation”. The Government intends to invest £10bn into research and development and create 100,000 new jobs in the life sciences sector by 2030 and have proposed working with universities to support spin-outs and ensure that other start-ups have sufficient access to finance. 

Part of the Life Sciences plan relates to the further promotion of clinical trials. The manifesto notes that the number of commercial trials decreased by 41% between 2017 and 2021 and the UK dropped from fourth to tenth in global rankings. As a result, Labour says that they will make it easier to conduct trials within the NHS, so that the clinical trials environment is:

• more competitive (e.g. reducing set up times)
• more efficient (e.g. reducing the number of contracts required)
• more accessible (e.g. some trials could be possible in community settings and GP practices).

Following the election Wes Streeting, Health Minister, has stated that Labour will invite private “entrepreneurs” and “innovators” into the NHS, and will make it easier to roll out innovative technology e.g. by removing the need to trial new technology to a single NHS Trust first and centralising procurement more than it currently is.

Will this make trials more risky?

Clinical trials have within them an inherent risk (the nature of trialling anything that is not yet sufficiently proven to obtain regulatory approval for wider use). The benefits of these steps proposed are obvious, and with 31 million people using the NHS app, this can be used to reach out to people who may be willing to participate in trials, and who may be more willing to participate if there are fewer onerous obligations to do so.

However, there are risks to this approach. Any loosening of regulatory requirements, expansion of the geographical areas within which trials are conducted, or widening of the scope as to where trials can take place (e.g. out of hospital settings) will increase the risk of those trials. This risk is multi-factorial – there may be increased risks of result inaccuracy, lack of compliance and injury. An example may be a failure to identify a serious adverse event in a timely fashion if the participant is engaged in a trial where they undertake an element of at home monitoring, or attend only a GP surgery rather than a more specialist hospital or clinical research organisation.

What do insurers and sponsors need to consider?

There is clearly an enormous opportunity for those within, or looking to break into, the life sciences sector. This includes insurers, and it is worth highlighting that for the most part, any additional risks are unlikely to outweigh the benefits of growth in the sector and increasing engagement with innovation and clinical trials.

However, as with any opportunity, there are also risks attached. Insurers will want to see that sponsors, as those most likely to be responsible for any trial liability, ensure that they take steps to mitigate these when trials are set up. Insurers will also need to:

• understand and be aware of the scope of any clinical trial, including
  • where this is being conducted (e.g. at one location, at multiple locations, in what jurisdictions)
  • by whom (clinical research organisation, hospital(s), GP practices)
  • the nature of the participants (are they at any particular risk given their backgrounds)
  • what the potential risks of injury are with the trial medicine/device
  • what steps the sponsor has put into place to minimise trial risks including adherence to any regulatory requirements.

Ultimately, the information that insurers are likely to require is not dissimilar to that which they will already seek. There may though be an added emphasis on areas where changes to be implemented by the Government reduce the control that the sponsor has over a trial on a day to day basis.

How Capsticks can help

Capsticks are routinely instructed to assist insurers and their insured in relation to claims that follow an injury suffered as a result of a clinical trial. We can assist with the management of these claims and can advise in relation to minimising risk of claims in a clinical trial process.

If you have any queries around what's discussed in this article, and the impact on your organisation, please speak to Ed Mellor, Majid Hassan, Sarah Bryant or Diandra Bennett.