2021 LS&HC Horizons - Flipbook - Page 21
Life Sciences and Health Care Horizons 2021
21
Cannabis and psychedelics: The transformative medicine frontier is here
Cannabis, cannabis derivatives, and a range
of psychedelics like psilocybin, ibogaine, and
lysergic acid diethylamide (LSD) are no longer
relegated solely to the column of recreational
drugs. There is a growing recognition of the
therapeutic potential of these pharmacologically
active substances and the need for disciplined
science to harness their potential as treatments
in indications ranging from neurological and
mental health conditions to pain and addiction
treatment.
The investigation, development, approval and
marketing of these substances, which we call
“Transformative Medicines,” present unusual
regulatory challenges that require a thoughtful
approach, engagement with regulators, and
support from sound regulatory science.
Development and approval of Transformative
Medicines raise a myriad of complex topics,
including:
• Challenges of development of a naturally
sourced product: While some regulators
have sought to provide guidance on the
development of botanical products, the
reality is that few botanically derived
products have been brought to market.
• Patent protections and exclusivity:
Naturally derived compositions may require
innovative IP strategies, and the issue of
whether synthetic versions of naturalsource constituents may be considered
“interchangeable” raises unchartered
regulatory questions.
• Safety: Psychedelics are likely to require
additional efforts to ensure safe and
appropriate use.
• Scheduling: In markets such as the U.S.,
products typically must be rescheduled
under both the federal and certain statecontrolled substances acts.
• Decriminalization and legalization: Like
cannabis in the U.S., where the states
have changed the regulatory scheme to
provide access beyond that expected for a
pharmaceutical, legislation at the local level
can add to the complexity of developing
and successfully marketing an approved
pharmaceutical.
By applying sophisticated drug development
tools, and working closely with regulators,
sponsors of highly active psychedelic and
cannabis substances have begun to chart a path
for mainstreaming the regulation and approval of
these substances into Transformative Medicines.
David Fox
Partner, Washington, D.C.
david.fox@hoganlovells.com
Lynn Mehler
Partner, Washington, D.C.
lynn.mehler@hoganlovells.com
Jane Summerfield
Partner, London
jane.summerfield@hoganlovells.com
They are fresh thinking and provide a
balance between policy and business
decisions.
Client, Healthcare, Chambers USA, 2020
