The Mexican Federal Commission for the Protection against Sanitary Risk has issued marketing authorisation for 36 new innovative medicines, including Sanofi Pasteur (France)'s dengue vaccine Dengvaxia, for the treatment of the main causes of death in the country.
Implications | This is the eighth package of innovative medicines approved in the last three years, with a total of 213 innovative drugs in 13 different therapeutic areas that represent the diseases that are the main causes of death in Mexico. |
Outlook | For the innovative pharmaceutical industry, the increase in the number of innovative medicines approved for marketing authorisation is positive. However, the challenges in securing reimbursement of these high-cost medicines in the public market could harm the positive outlook. |
The Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has issued marketing approvals for 36 new innovative medicines, including the tetravalent dengue vaccine Dengvaxia produced by Sanofi Pasteur, the vaccines division of the French pharmaceutical company Sanofi.
During a ceremony held last week, COFEPRIS commissioner Julio Sánchez y Tépoz and the Mexican ministry of health (MoH) gave approval to the pharmaceutical companies to register the medicines. However, COFEPRIS has not yet released an official publication listing the new innovative treatments. COFEPRIS's announcement can be accessed here, in Spanish.
COFEPRIS explained during the ceremony that this was the eighth package of innovative medicines approved in the past three years, totalling 213 innovative drugs in 13 different therapeutic areas that represented the diseases that were the main causes of death in Mexico (see Mexico: 3 December 2015: Mexico's COFEPRIS issues marketing authorisation for 27 innovative medicines).
Outlook and implications
COFEPRIS has made moves towards increasing the number of innovative medicines in the Mexican market, which has been dominated by low-cost medicines.
Nevertheless, some parts of the industry have stated that recent approvals by COFEPRIS would only have positive impacts in the private sector, as the main payors in the public sector, such as the Mexican Institute of Social Security (IMSS), tended to prefer the reimbursement of generics and medicines with low prices, rather than innovative drugs, such as those recently approved by COFEPRIS (see Mexico: 18 August 2014: Mexico's COFEPRIS moves forward in strengthening regulations for access to medicines). Indeed, last year, the National Chamber of the Pharmaceutical Industry (CANIFARMA) criticised the low penetration of innovative medicines in the Mexican public sector (see Mexico: 22 April 2015: CANIFARMA criticises low penetration of innovative medicines in Mexico's public sector).
In fact, at the beginning of this month, COFEPRIS announced the 14th package of generics, comprising 45 newly registered generic medicines, which was likely to reduce drug prices by between 30% and 75% (see Mexico: 5 May 2016: Mexico's COFEPRIS announces registration of 45 generic medicines).
For the innovative pharmaceutical industry, the increase in the number of innovative medicines that have been granted marketing authorisation is a positive development. However, the challenges in securing reimbursement of these high-cost medicines in the public market could harm the positive outlook.