Following the dissolution of Parliament last week, we have officially entered the pre-election period. The impact of this period on Parliamentary activity, and the ramifications for MPs, is well understood, but there are wider implications that impact the machinery of Government and how Governmental bodies operate.
For companies within the health and life sciences landscape, this is particularly pertinent as organisations impacted by the pre-election period, such as the Department of Health and Social Care, NHS England, and NICE play a key role in the medicines access process and wider health policy to support this.
We have taken the time to analyse the pre-election period impact, as well as what may happen to ongoing policy developments to support Life Sciences companies during this period and beyond.
Department of Health and Social Care
In line with official Civil Service guidance, the activity of the Department of Health and Social Care (DHSC) will be reduced during the election, putting into question ongoing policy activity.
Perhaps the most awaited piece of policy activity is the Major Conditions Strategy that was touted to be published this summer, with work well underway to develop it. As it was not published before Parliament, it will now be a matter for the next Government as to whether they wish to progress with this policy initiative.
NHS England
NHS England (NHSE) have published their guidance for the pre-election guidance for NHS organisations, which places NHSE under strict requirements not to make any announcements on policy, strategy, procurement, or business development during this period.
NHSE are not permitted to launch consultations during the pre-election period unless they are considered essential. Ongoing consultations should continue but should not be promoted and existing consultations can be extended if deemed appropriate.
This puts into question the timing of the consultation on the updated Commercial Framework for New Medicines that was originally due to be published in June.
As for medicines access and approval, NHSE will continue to operate as normal, but the pre-election period may impact public facing activity following agreements.
Regulators
The Medicines and Healthcare product Regulatory Agency (MHRA) will conduct activity in line with civil service guidelines for the pre-election period, so do not expect any policy activity over this period.
Communications referring to items such as licensing announcements, marketing authorisations, and manufacturing licensing will continue as normal through their customer service team.
The National Institute for Health and Care Excellence (NICE) adhere to the same guidelines which means during the pre-election period they will avoid posting news on updates to NICE methods, changes to NICE policy, or consultation results during this time.
However, the pre-election period does not prevent NICE from operating as usual in terms of publishing guidance or HTA recommendations. This work will continue to the same timeframe and cannot be influenced during the pre-election period by NHS England or Government.
This means that during this time, NICE will continue to progress key policy areas such as highly specialised technology criteria and the severity modifier internally, but wider consultation and public engagement with industry on these issues may not occur until after the election.
In Scotland, Government business will continue as normal as the Scottish Parliament is still in session. That said, Scottish Government civil servants, including those working with Government agencies such as the Scottish Medicines Consortium (SMC), are to conduct themselves in line with the Civil Service Code and exercise caution when conducting public activity that could have a bearing on the UK General Election.
For the SMC, this means business will continue as normal but activity with reserved or cross-border implications, such as activity with NICE, may be postponed until after the election.
If you would like further information on the impact of the pre-election period and to discuss opportunities to engage with relevant stakeholders during this time, please do get in touch – [Health@wacomms.co.uk].
WA have also prepared a guide on how best to hit the ground running, assessing the first 100 days post-election. This can be accessed here: https://wacomms.co.uk/hitting-the-ground-running-the-first-100-days/.