Reducing barriers to entry
Step two on the COFEPRIS agenda was to eliminate barriers to entry in the market. This was partly done by suppressing the
manufacturing plant requirement enabling foreign companies to distribute and sell their products in the market hence adding
to pricing competition. COFEPRIS also built a consensus around biotechnology regulation. Thirdly they issued 109 new generic
drug registrations in the last twelve months. The registrations granted covered almost 60% of diseases related to mortality
in Mexico. According to COFEPRIS it saved around 100 million USD in just six months, and the agency will save a further 1
billion USD in private and public money over the next four years.
Dr. Dagoberto Cortés, general director of Hormona Laboratories, points out that in the government's continued push to open
access and reduce barriers for cheaper generic products, they have also significantly reduced time to market.
"A couple of years ago, the average time between patent loss and generic arrival on the market was two years... today COFEPRIS
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
Dr. Dagoberto Cortés, General Director, Hormona Laboratorios
|
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 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.
|
PharmExec Blog
Follow Us
RSS
Bookstore
