Better Regulation for Better Health Access

Improved processes and a speedier regulatory system are allowing Mexico better and more affordable access to medicines and treatments thanks to COFEPRIS, Juan Gallaga, Commissioner for Sanitary Authorization, said at the start of the Mexico Health Summit 2016.

In his opening remarks, Gallaga introduced the role of COFEPRIS in Mexico, explaining that it is present in many sectors of the economy, especially pharmaceuticals. Gallaga emphasized the importance of the pharma business for the Mexican economy. “Certainty in business is important for investment in Mexico,” he said. Products approved by COFEPRIS represent 9.8 percent of GDP while those regulated by the agency are 10.4 percent of exterior commerce.

Gallaga provided an overview of the most vital regulations created and updated by COFEPRIS since its inception in 2001. He explained the areas of pharma the regulatory commission is involved in and the role it has given to authorized third parties, of which there are 19 in Mexico and which have greatly helped in clearing the backlog of pending registrations. “We are going to see in which other ways we can use these to the benefit of the industry and the authorities,” he said.

Although health spending between 2008 and 2012 rose 64 percent, there has been an almost equal reduction in prices. This has been possible thanks to generics and the evolution of their regulation. “The savings have meant we can tend to more patients, especially through social security,” he said, adding that generics have managed to drop prices on average 61 percent. The greatest reductions have been achieved in important areas such as cardiovascular (90 percent), cancer (82 percent) and diabetes (91 percent). “One of the main costs incurred by health systems is in the purchase of medicine.”

Gallaga said this has helped other Central and South American countries who follow COFEPRIS’ register. The institution has agreements with seven countries including Colombia, Ecuador, El Salvador, Chile, Panama, Belize and Costa Rica.

COFEPRIS has also introduced regulations for biotechnological drugs, a sector gaining importance in the pharma industry. The Commissioner said that 35 percent of new drugs registered are biotechnologicals. Regulation in this area began in 2009 and is still evolving. Only last December, NOM 257 was published concerning the regulation of biotechnological medication.

Gallaga reiterated the government is focusing on a policy of innovation and has agreements of equivalence with the US, Canada, Australia, Switzerland and the EU. These mean that devices approved in the US, Canada and Japan will take only 30 days to gain approval in Mexico. The Agreement for the Promotion of Innovation allows new molecules to be approved within 60 days.

Some medical devices and other products have also been deregulated, Gallaga said. COFEPRIS has removed items from its list in two stages, disposing of 1,669 devices in the first phase and 2,242 in the second. “Previously, even toothpaste needed to be registered,” Gallaga said.

COFEPRIS was approved as a regulatory body by WHO in 2014, which entailed a greater production of vaccines in Mexico, mostly those for influenza, diphtheria and tetanus.

The pharma market in Mexico has come a long way, Gallaga concluded, stressing the importance of transparency in the governing health institutions. “There is a link between efficiency and transparency in healthcare,” he said.