The Lain American Lawyer: March 2018 Latam_March 2018 | Page 17

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registers of medicines, food,
pioneer a sector in the legal
beverages, medical devices, in vitro
market.” In addition, this field of
diagnostic reagents, cosmetics and
life sciences provides lawyers with
cleaning products. “The automation
the opportunity to work within
of the processes seeks to improve
multidisciplinary teams, “since
response times and make them
the support of technical experts is
more efficient,” she says.
crucial for the understanding and
In Mexico, Campos Vargas
application of regulations and the
predicts food safety issues playing
proper assessment of risks,” adds
Gillmore.
In addition, the fact
that the life sciences
New regulations for
industry includes many
biological and biosimilars
other disciplines like
consumer, regulatory, IP
will require increased
and finance, generates
compliance.
more work for law
Maritza Reátegui
firms, says Camargo.
Muñiz, Olaya, Meléndez,
“As regulatory and IP
legislation are different
Castro, Ono & Herrera
in each country, this
Abogados
offers the opportunity to
provide efficient services
an increasingly prominent role.
which saves companies costs and
“This is not only applicable to new
efforts.”
ingredients and substances used in
the food and beverage industry, but
Pursuing new horizons
also to the complete logistics for the
In terms of emerging life sciences
industry.”
trends in the coming year, Agosin
Meanwhile, Egaña expects
in Chile predicts that biotechnology
the life sciences sector in Chile to
is clearly going to be an area
remain concerned about Medicines
with more development and
Law Project II [a project which
challenges ahead. She says: “We
is set to substantively amend the
foresee important discussions in
Sanitary Code and introduce several
interchangeability, therapeutic
conflicting regulations for the
equivalence, data protection, clinical
pharmaceutical industry], and also
studies, patentability and access
believes compulsory licenses will
related to biological medicines.”
continue to be an issue. “This appears
However, according to Gillmore,
to be a common trend in several
while life sciences is one of the
countries in the region,” he adds.
sectors receiving most attention
Reátegui predicts the application
from investors and counsel – and
of new regulations for biological
should continue to be so – so should
and biosimilars will require
the area of pharmaceuticals as well
increased compliance as one of the
as the medical devices
minimum requirements to ensure
sector. “In addition, the
efficiency and safety for patients.
application, evaluation
The life sciences
“This means new issues arising,
and selection for
sector is viewed as an
such as interchangeability between
public funding of high
biological and biosimilar products,”
cost
treatments
and
industry which should
she says.
diagnostics – including
be subject to meticulous
However, although the need
orphan drugs for rare
scrutiny by the regulatory diseases – is expected to
for new cost-effective consumer
products will continue to present
continue as an industry
authorities
challenges, Camargo is hopeful that
trend,” he adds.
José Alberto Campos Vargas
the life sciences sector in Colombia
Pieschacon sees
Sánchez DeVanny Eseverri as a positive sign the
has started to interact with new
companies and more innovation.
implementation of
“Our country provides a great
online registration
environment for investment in
procedures before the Colombian
is a still a developing area and
innovation and entrepreneurship,”
sanitary authority INVIMA. The
lawyers focusing and specialising
she adds
new system will cover the sanitary
in this field gets the chance to
to their legal expertise, argues
Rolando Escobar, associate at
Dentons in Colombia. “We must
know and determine from the legal
and technical point of view, the
swiftest way of applying the rules
and technical regulations required
by each product. In doing so, we
can help these companies face
the relevant regulatory authority
and find the best option available
and necessary sanitary permits
to be able to imp ort and sell their
products,” he says. “It is also
crucial to have a clear and complete
vision of the regulatory entity that
we are addressing, in order to
have a greater confidence in the
process and obtain the obligatory
authorisations.”
Lawyers in the life sciences sector
must also provide wide-ranging
answers that cover not only classic
intellectual property issues, but also
regulatory matters, says Reátegui. It
is not useful for a company to have
all the protection of its intellectual
property, if it is not granted the
right permit from the regulatory
authority which allows it to place
that product on the market, she
adds.
Although the life sciences
practice requires lawyers to be
highly specialised to meet industry
demands, for Gillmore, it is not
just about understanding legal
and regulatory provisions but also
having experience in the technical
and business aspects of the
different related industries. “Such
specialisation is central to achieving
the expectations and demands of
clients,” he says. “In Chile, this
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March 2018 • THE LATIN AMERICAN LAWYER • 15