As an emerging innovative sector addressing unmet mental health needs, psychedelic drug developers are poised to greatly benefit from the diverse initiatives offered within this package.
As a key industry driving growth in the UK, Life Sciences has become a focal point for the government's efforts to foster innovation through effective regulation. The recently unveiled life sciences investment package aims to do just that, introducing fresh commitments and funding initiatives that specifically target the acceleration of clinical trials and the advancement of mental health research.
The multi-faceted ‘Life Sci for Growth' package builds upon the progress made since 2021, which has seen significant reforms such as the introduction of the Innovative Licensing and Access Pathway (ILAP) and the fast-track review for clinical trials. In a competitive global landscape where nations are striving to attract life sciences companies, this comprehensive package incorporates ten policies, supported by £650 million, to ensure that the UK remains the most enticing destination.
Among the noteworthy components of this package, two are particularly significant for the psychedelic sector: £121 million to improve commercial clinical trials; and £42.7 million investment into mental health research.
How the Government will spend £121 million on clinical trials
Figures show that the number of industry clinical trials initiated in the UK per year fell by 41% between 2017 and 2021. With the time between a clinical trial applying for regulatory approval and that trial delivering its first dose to a participant getting longer, the UK has fallen behind international competitors.
To address the challenges faced in conducting commercial clinical trials, the Government recently commissioned an independent review, which sought recommendations from various stakeholders across the sector. In response to the review's findings, the government has made five headline commitments, all of which are supported by the £121 million funding allocation.
These commitments are primarily intended to expedite the delivery of new medicines to patients by enhancing the regulatory landscape for Life Sciences companies and transforming the UK's approach to commercial clinical trials, pointing to ways forward to reverse the decline in the number of clinical trials. These commitments will address the two main challenges that the psychedelic companies have been tackling, leading to significant benefits for the sector.
Clinical trial approval timelines
The recent changes have enabled both UK-based and international drug developers to obtain full approval within two months from the time of regulatory submission. Nevertheless, not all trials were eligible for this expedited process, and in certain cases, the Medicines and Healthcare products Regulatory Agency (MHRA) was unable to meet its statutory deadline.
Having listened to industry feedback, the Government has committed to rebuilding capacity and substantially reducing the time taken for approval of commercial clinical trials, with the goal of reaching a 60-day turnaround time for all approvals. To address the backlog of delayed applications, the MHRA has established a task and finish group in collaboration with industry trade associations, demonstrating their dedication to resolving the issue promptly.
International recognition framework
This news comes as an addition to the £10 million awarded to the Medicines and Healthcare products Regulatory Agency (MHRA) to speed up the approval process for cutting-edge treatments.
This funding will also support the establishment of an international recognition framework, allowing the MHRA to provide patients with fast-track access to best-in-class medical products that have been approved in other countries.
The first regulatory partners that the MHRA intends to build new recognition routes with include the FDA. This is huge news for the psychedelic sector as it means the UK will benefit from the approval of psychedelic drugs in other countries and could see the approval of MDMA-assisted therapy as early as 2024.
Patient participation in clinical trials
Finding an adequate number of suitable patients poses a common issue in conducting psychedelic clinical trials. The good news is that the Government’s third headline commitment covers health data and notes how it can be used to give patients the opportunity to participate in clinical trials of innovative treatments.
This approach follows the success of the UK in enabling the participation of over 2 million people in COVID-19 trials using the power of health data and the collaboration that arose between the National Health System (NHS), the government and the life sciences sector. This led the UK to become the first country in the world to approve and administer a COVID-19 vaccine and the first to identify an effective treatment, dexamethasone.
Based on these learnings, the Government put together a workgroup to streamline the process of approaching patients about research. This group will also identify whether legislation is needed to establish clinical research as part of direct care, making it easier to provide innovative treatments to patients. The changes that will be implemented as part of this work should make it easier to recruit patients for psychedelic trials in the future.
Exploring the £42 million investment into mental health
A £42 million investment has been allocated for the delivery of Mental Health Mission also as part of the ‘Life Sci for Growth' package. This new mission, following a £30 million boost into mental health research in 2021, will specifically focus on testing innovative treatments and technologies for patients with unmet needs, making it particularly relevant to psychedelic drug developers.
Commenting on the Mission and pointing to the relevance of psychedelics, Prof Peter Jones, Trustee of Mental Health Research UK, said:
“Recently we have seen some novel treatments showing significant promise, such as [NMDA] antagonists and psilocybin for depression, and the use of virtual reality headsets for PTSD and psychosis. The focus on a new ‘Mental Health Mission’ and significant injection of funding for mental health research will raise all our efforts to improve the lives of people living with mental ill-health in the future.”
While the funding and the recognition of psychedelics is great news, in the grand scheme of bringing a new drug to market, which costs around £1 billion on average, these figures are a drop in the ocean. We have seen UK companies such as Beckley raising £84 million alone from private investors. Indeed, the psychedelic sector is still mostly privately funded – over $730 (around £580 million) was invested in psychedelics in 2021 globally.
The value of the UK’s Mental Health Mission will come from bringing together the public sector, patients and industry to capitalize on the size and scope of the NHS and the National Institute for Health and Care Research (NIHR) and on the depth of their data sources. Alongside the investment in research, the Mission aims to increase the use of technology in treatment. Altogether, these initiatives should help improve the cost-effectiveness of psychedelic clinical trials.
Psychedelic drug developers emerge as the beneficiaries of this package
The ‘Life Sci for Growth' package demonstrates the Government’s recognition of the UK’s shortcomings and their commitment to change in order to position the UK as the most attractive hub for testing new products, particularly to treat mental illness. The Government understands that making the UK an attractive destination for commercial clinical trials requires regulatory reform, speedier study approvals, and improved access to data and patients.
As Prof Andrew Morris, Director of Health Data Research UK says, “The one missing thing in [these] announcements that would transform life science research in the UK is a positive conclusion to the talks for the UK to access the EU’s Horizon research programme. Research today is built on team science with collaborations across the globe.”
Alongside the international recognition framework, an established research infrastructure and a large recruitment pool for patients and talent, the ‘Life Sci for Growth' package puts the UK on the front-foot in the global race to develop the next generation of medicines. As an emerging innovative sector addressing unmet mental health needs, psychedelic drug developers are poised to greatly benefit from the diverse initiatives offered within this package.
Clerkenwell Health is now working on designing and delivering several trials around testing the use of psychedelics such as psilocybin to treat depression-related illnesses, and are actively recruiting triallists for potential upcoming trials.