Level playing field: Chile aims for bioequivalence in 2014
Chile is aiming to achieve complete bioequivalence of generics by the end of 2014. Chile’s Public Health Institute is leading the bioequivalence testing, aimed at regulating differences between generic and bioequivalent drugs. The recently appointed director of the Public Health Institute, Ricardo Fabrega, echoes the need for drastic change and stresses that: “laboratories that produce generics will have to understand that they must comply with bioequivalence studies; otherwise we will take them out of the market.”
The request for bioequivalence could be a game changer. Local companies producing similares should be forced out of the market, or to drastically change their practices. According to Carlos Cicogna, managing director of MSD Chile, it could also drive investments from MNCs in the country: currently, MNCs are responsible for more than half of the bioequivalent generics on the market. “The environment is getting more attractive for innovators such as MSD: with the new regulations we will see an equal playing field; fair conditions are being implemented. And as a result there is an increasing interest from the industry to increase investment in the country,” he says.
Cicogna, who has been in Chile since 2009, has already witnessed drastic change in the market: “There have been two major developments in the past five years: the implementation of the new drug law and the shift in landscape: the top players on the Chilean pharmaceutical market used to be local players, but today the key players are multinationals.”
Another proposal currently being discussed in parliament is the complete overhaul of ANAMED, the national regulatory agency for medicines in order to bring it in line with other regulatory bodies around the world. Elmer Torres Cortes, General Manager of ASILFA (the association representing generics companies in Chile) explains, ANAMED is currently part of Chile’s Public Health Institute, but should be separated in order for it to stand as an independent regulator of medicines. The current plan being discussed for ANAMED is for it to reach level four of the Pan American Health Organization (PAHO) assessment table, at which point it can be designated a reference authority for medicines. “ANAMED should be autonomous, independent and capable of monitoring the local and international industry. We believe this is fundamental for the pharmaceutical industry in Chile,” Cortes adds.