2021 LS&HC Horizons - Flipbook - Page 11
Life Sciences and Health Care Horizons 2021
11
Off-label use during the pandemic
Prescribing a medicinal product for therapeutic
indications or at a dosage not indicated in its
marketing authorization (MA) is a recurring issue
for all actors: public authorities, prescribers, MA
holders, and distributors. These parties may face
liability for off-label use, unless such use occurs
as part of so-called “early access” programs that
enable pharmaceutical companies to supply
unauthorized products to patients in accordance
with strict regulatory requirements.
Pharmaceutical companies must monitor their
medicinal products’ prescriptions and, depending
on their jurisdiction, may have a duty to report
to the competent authorities any use outside the
terms of the MA. In practice, the efficient control
by pharmaceutical companies of their products’
prescription in the scope of the MA’s indications is
only possible when pharmacovigilance reports are
made, or through company sales representatives.
All health actors (e.g., prescribers, pharmacists,
etc.) must act with transparency and in perfect
collaboration with pharmaceutical companies.
At the start of the pandemic, some countries
authorized the emergency and off-label use of
the prescription drug hydroxychloroquine for
treatment of COVID-19. The debate over the drug
was not merely scientific, but turned political.
Scientific uncertainty and disagreement within
the medical community as to the efficacy of the
drug led to misunderstanding — and even, at
times, defiance — from people who felt their
government was preventing the larger public
from having access to what some believed to
be an effective medicine.
Courts have therefore in 2020 had the occasion
to remind that off-label use was only allowed on
condition that prescribers considered it essential
to use such drug to improve their patients’
clinical condition, and that such assessment
was to be made in light of the scientific accepted
data. Through new debate and jurisprudence,
the contention over hydroxychloroquine and
COVID-19 treatments has brought new attention
to the risks associated with off-label use, and
spotlighted the issue as a compliance concern for
companies in the life sciences and health
care space.
Matthew Felwick
Partner, London
matthew.felwick@hoganlovells.com
Charles-Henri Caron
Counsel, Paris
charles-henri.caron@hoganlovells.com
