LS&HC Horizons 2023 - Flipbook - Page 13
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Clinical Trials
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Clinical trials in Mexico
Clinical trial sponsors face increased scrutiny
and more stringent requirement to ensure that
their trials enroll diverse patient populations
that are representative of the end users who
will have access to the final product. A “one
size fits all” approach is no longer acceptable in
balancing the risks and rewards in developing
new health inputs and industry stakeholders
have begun to recognize that meaningfully
diverse representation in clinical trials can
ultimately improve patient outcomes.
Concurrently, we are seeing an increasing trend
that sponsors view Mexico as an attractive
market for carrying out various pharmaceutical
research activities, not least because its
established health institutions, capable doctors,
biotechnology investment, geography, and
diverse population make Mexico an attractive
place for development. Clinical trials in Mexico
are no exception.
Sponsors need to follow standard rules for the
transplants and handling of human blood and
tissues, which allows some flexibility when
implementing a protocol. One important
consideration is whether a product is
considered a “biologic” or a “transplant”. This
classification must be addressed with the
relevant authorities in the context of clinical
trials to ensure that regulations for, e.g.,
informed consents and data privacy notices can
be completed to properly conduct the clinical
trial. Successful implementation, however, can
be attractive for the sponsor, the institution
and investigators, as well as the government
and the public.
For example, in the context of cell, tissue, and
gene therapies (CTGT), Mexico provides a wide
field for carrying out clinical trials, whether
as a part of the overall therapy or the final
regenerative medicine product. Unlike many
other jurisdictions, Mexico has no particular
framework for stem cells and gene therapies.
Ernesto Algaba Reyes
Partner, Mexico City
Cecilia Stahlhut Espinosa
Counsel, Mexico City
