Market Access Mexico

Mar 28, 2012 - Mar 29, 2012, Mexico City, Mexico

Market Access Mexico

The Route to Market Access in Mexico

How can foreign companies achieve better market penetration in one of Latin America’s largest and most dynamic emerging markets? Ben Steele talks with Rafael Gual, director general of Mexico’s pharmaceutical trade association CANIFARMA, about the regulatory environment.



According to Rafael, the main criterion used by Mexico’s national regulatory agency COFEPRIS to assess new medications is cost-containment. This means that “pharma companies will need to be prepared with pharmacoeconomic studies showing how the drug stands out from those already on the market.”

CANIFARMA is working with the regulators in order to convince them that giving up their focus on short-term savings and better rewarding innovation will result in long-term savings further down the line. However, in the meantime, Rafael has some tips for how pharma companies can negotiate the regulatory environment in Mexico and achieve inclusion on government formularies.

The experience acquired by pharmaceutical companies while conducting clinical research in Mexico […] will be invaluable

“One way to speed up the approval process is to pursue licensing agreements with Mexican companies, this makes it a lot easier to deal with COFEPRIS. Another way for companies to improve their chances of regulatory approval and inclusion on formularies is by conducting clinical research in Mexico; this is probably the most effective strategy when it comes to achieving inclusion on formularies. The experience acquired by pharmaceutical companies while conducting clinical research in Mexico, including experience dealing with regulators and with the biggest public health insurance provider in Mexico, the Mexican Social Security Institute (IMSS), will be invaluable. Companies will get exposure for their new medications when conducting research, which could help these drugs to gain formulary access and therefore market share. The earlier and more comprehensively the IMSS is involved in the research process, the better this will be for companies looking to access IMSS formularies.”

Rafael sees the IMSS’s patient population as a potential goldmine for companies looking to conduct research in Latin America. “The potential of research conducted through the Mexican Institute of Social Security (IMSS) has been wasted over the last few years. Currently we are seeking to remove administrative barriers, mainly related to intellectual property, in order to harness the vast potential of the IMSS’s roughly 50 million patients and their health data. If these barriers are removed Mexico has the potential to become the leader in technological development and clinical research in Latin America.”

The knowledge gained from interacting with the Mexican healthcare system while conducting clinical research is particularly important considering the strict guidelines governing pharma’s relationships with physicians and patients in Mexico.

“In Mexico pharmaceutical companies’ interactions with physicians and patients are governed by a very strict code of ethics. Similar to the U.S, it is necessary to proceed with full transparency when dealing with physicians and patients, even in congresses or simple meetings – Mexican pharma is very concerned to avoid accusations of unfairly influencing physicians to include drugs on formularies. Regarding pharma’s interactions with patients, it is strictly prohibited for a company to provide payment to patients or patient advocates in return for any services.”

Gaining approval from COFEPRIS to market drugs in Mexico may be hard work, but having a product approved by the Mexican regulator can mean also gaining access to the markets of other Latin American countries. As Rafael explains, “last year COFEPRIS achieved recognition by the Pan-American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference. This means that once a company registers their drugs in Mexico, they will also have access to other Latin American markets. This is a great advantage for companies looking to invest in Mexico, as regulatory approval here could have wider effects on their success on the continent.”

Nevertheless, approval by COFEPRIS is not the only challenge for companies looking to gain market access in Mexico. Getting included on the country’s three major formularies is for Rafael an even more important part of achieving market penetration in Mexico, and the difficulties in this area need to be taken into account.

Applications for inclusion on Mexico’s formularies are often subject to delays of up to two years after registration has been completed

“The approval process for COFEPRIS is relatively quick, usually taking around six months. However, applications for inclusion on Mexico’s formularies are often subject to delays of up to two years after registration has been completed. The council that decides on the national formulary is made up of fifteen different organizations, which makes deciding on the inclusion of new products a complex process. This process usually requires a lot of pharmacoeconomic data, as the formularies are focused just as much as the regulator on cost-containment. Once a drug has been included on the national formulary, this is still not the end of the road, as it must then seek inclusion on the IMSS formulary and the formulary of the Institute for Social Security and Services for State Workers (ISSSTE).”

The silver lining for pharma companies is that, once a drug has gained inclusion on these three formularies, there remains little to be done to convince government physicians to prescribe it. “Once the product is included in the formulary, the physician is convinced already because the product has been sanctioned. There is not a lot of choice on the formulary so once your drug is on there you are ensured access.”

The final piece of the puzzle for gaining market access in Mexico is the wholesalers, who Rafael explains are a crucial link in the supply chain. The wholesalers are the part of the chain responsible for delivering a company’s products to health institutions. In many cases they are the companies’ only contact with physicians in institutions. Because they are the ones responsible for delivering the information provided by the pharma companies to government physicians, to some extent they take on the function of medical liaison between companies and physicians.

To get an idea of the importance of these distributors or wholesalers, it should be mentioned that 80 percent of drugs supplied to the government go through these channels, making them an important cog in the supply chain and one that pharma cannot afford to ignore. Without them, it would be much more difficult for pharma companies to reach the 1,000 or more points of distribution for their drugs.”


Rafael will be sharing more key insights with the pharmaceutical industry at this year's Market Access Mexico Summit from 8th - 9th October. For more information on his presentation or to find out who else will be speaking visit the official website.


Since you're here...
... and value our content, you should sign-up to our newsletter. Sign up here

Market Access Mexico

Mar 28, 2012 - Mar 29, 2012, Mexico City, Mexico

Market Access Mexico