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SPECIAL SPONSORED SECTION
between patent loss and generic arrival on
the market was two years… today COFE-
PRIS is making a great effort to reduce the
time needed to issue a generic
registration. In some cases the
time to market has reduced to a
couple of months. This is very
important for the authorities because
it represents a lot of savings.”
International Recognition
The third step for COFEPRIS
is to build international recognition.
In 2005, the organization
launched a project with
PAHO to harmonize regulators in Latin
America. Since then, other countries in
the region have been much faster on the
uptake in recognizing the importance of
being audited and approved by the international
health authority. Brazil and Colombia
were the first to be given recognition,
followed by a string of other
Dr. Dagoberto
Cortés, General
Director, Hormona
Laboratorios
countries, and only in June 2011 did
COFEPRIS reinitiate the process with
PAHO. At the moment they are already
on their final audit: a positive
sign for a country, where recognition
has been long overdue.
An approval from PAHO
would indicate the strength and
rigidity of Mexico’s sanitary
regulations, and the bar that
has been raised in terms of the
quality of drugs produced in
Mexico.
As Mikel Arriola puts it, to
receive PAHO certification
means that “we will have closed
the circle in terms of modernization of the
agency and implementing the best practices
required. More importantly, COFEPRIS
will be able to guarantee predictability, efficiency,
safety and now recognition by an
external authority which is the fourth pillar
in our work agenda. It will be the added
value of President Calderon’s presidency
– to build a strong, comprehensive and
recognized sanitary institution.” he says.
COFEPRIS has come a long way since
it opened in 2003. It is still a very young
organization that has to deal with constantly
increasing responsibilities, but
PAHO recognition will be the first step in
sending a plain and categorical message
to other regulatory agencies about Mexico.
COFEPRIS would not only fulfill its
role as a sanitary regulator, but also as an
economic regulator.
SHIFTING LANDSCAPES
SHIFT STRATEGIES
The patent cliff is not a ground-breaking
story. It is affecting Mexico as well as other
pharmaceutical markets across the globe.
Sources say that in Mexico, the market will
lose 600 million USD in exclusivity by 2015.
Marked socio-economic differences are also
playing an important role in pushing the
uptake of generics, and these issues are
starting to affect multinational corporations
(MNCs). MNCs are being forced to
open up and diversify, quite simply to have
their fingers in as many pies where they can
compete successfully. Alternatively they are
applying a more focused sales strategy to
concentrate on niche markets.
Alvarez Tostado of AstraZeneca believes
that MNCs need to adjust their activities
to become competitive in both the private
and public sector.
“Mexico provides a uniquely generous
market structure where you have the institutional
sector, the private out-of-pocket
segment of the market, and then you have
the new up-and-coming popular insurance
systems that will cater to those who have
very little access to medical care, if they
have access at all. So in that regard, I think
the industry has to realign itself to make
sure that it is able to provide adequate services
to the institutional sector; provide
broadened access to the out-of-pocket consumer,
and obviously realign to be competitive
in the Seguro Popular concept.”
Mexico is no exception to the global
trend of companies moving towards branded
generics either, a successfully growing
sector in a very much brand-driven Mexi-
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