For The Psychedelics as Medicine Report: Fourth Edition, PSYCH spoke with Dr Laura Squire, Chief Healthcare Quality and Access Officer at Medicines and Healthcare products Regulatory Agency (MHRA).
The agency regulates medicines in the UK and has supported psychedelic research through the provision of Innovative Licensing and Access Pathway (ILAP) Innovation Passports.
The MHRA has granted these passports to therapies harnessing MDMA, psilocybin and DMT. For a deeper dive into the regulatory process, PSYCH asked Dr Squire for an overview of the executive agency and its role in supporting innovation.
‘The MHRA is the body that regulates medicines and medical devices in the UK,’ stated Dr Squire. ‘We play a leading role in protecting and improving public health and support innovation through scientific research and development.
‘This is an age of change, and we see ourselves as a collaborative and enabling regulator that looks for opportunities to support innovative new products and ways of working. We aim to combine a high level of scientific support and expertise with agility, to enable robust decisions to be reached in the shortest possible time.
‘To help the life sciences industry to develop effective and innovative healthcare products, we engage proactively from the earliest stages of development. For example, we advise on the design of clinical trials to support innovation while ensuring scientific rigour and participant safety as well as encouraging meaningful patient involvement.
‘We advise on the evidence of safety and impact that developers will need to demonstrate for each product, to help products reach patients as quickly as possible while maintaining high standards of safety and quality.
‘We have seen the benefits of early engagement with the MHRA and would encourage health innovators to come to us as early as possible for regulatory advice. Our Innovation Office is open to queries about innovative medicines, medical devices and manufacturing processes. It provides free and confidential expert regulatory information, advice and guidance to organisations of all backgrounds and sizes based nationally or internationally.’
Against the backdrop of a deepening mental health crisis, there have been considerable developments in psychiatric healthcare both in the UK and abroad. Dr Squire outlined the role of the Innovation Passport.
‘The ILAP combines the MHRA’s globally recognised high standards of quality and safety with improved flexibility to reduce the time it takes innovative treatments to be available to NHS patients. The “Innovation Passport”, a new medicine designation, acts as the gateway to entry into this pathway and is awarded to innovative products submitted to the ILAP.
‘The ILAP covers the entire development programme with a clear ambition to speed up the time to patient access. Companies are encouraged to engage early before they have clinical data in order that all the benefits of enhanced interactions with the MHRA and the partners can take place.
‘The ILAP covers the whole life cycle of products, supporting clinical trial recruitment, adaptive inspections, and the collection of real-world data. Most important of all, it involves patients in all aspects of decision-making.
‘The entrance criteria for the ILAP are broad and inclusive to support a wide range of products and new indications, including Advanced Therapy Medicinal Products, medicines for rare diseases, and repurposed medicines.
‘A successful Innovation Passport designation then triggers the MHRA and partners to create the Target Development Profile document. This living document will set out a unique product-specific roadmap towards patient access in the UK healthcare system.’
MDMA-assisted therapy and psilocybin therapy are expected to be regulated in 2024 and 2025. MDMA-assisted therapy and psilocybin therapy are expected to be regulated in 2024 and 2025. Assuming similar timelines for other treatments with Innovation Passports, there could be three psychedelic compounds used to treat mental health disorders – MDMA, psilocybin and DMT.
‘There is significant work undertaken to support mental health and wellbeing through advances in neuroscience and drug discovery,’ expressed Dr Squire, ‘As patients still have significant unmet therapeutic needs in this area.
‘The MHRA supports innovation through the ILAP, as well as broad regulatory and scientific advice, to facilitate the development of new treatments for a wider variety of psychiatric and behavioural conditions, with a particular focus on treatments tailored to the specific needs of individual patients.
‘This should lead to increased availability of safe and effective treatment options to improve cognition, function and social outcomes of people with neuropsychiatric disorders.’