News Article

The Rise of Generics and Market Access Trends

Wed, 09/09/2015 - 13:18

The final panel was welcomed by Rafael Maciel, President of AMEGI, acting as moderator for a debate on the topic of Generics and Market Access Trends. Maciel informed us about the importance of generic drugs in the Mexican market. “The largest part of the world’s illnesses can be cured with medicine, 80% of which are generic drugs.” The generics market represented US$194 billion in 2014. The savings for the general population is clear, saving EU$100 billion last year in Europe. He asked what the future of generics will be, and predicted that they will continue to grow and dominate the market for many years to go. Mexico currently exports U$2 billion worth of generics per year, considerably lower than many European countries that export over US$30 billion in the same timeframe. Maciel predicts that pharmacies that are not parts of chains will continue to drop in number in coming years. 

The first input was offered by Cecilia Bravo, Vice President of ANAFAM, who told us that efficiency is an important milestone, something that must be improved to generate a better generics market. In terms of the government, she explained that uniform rules at a national level have helped increase trust in the industry, and therefore increase demand for generics.

Juvenal Becerra Orozco, President of UNEFARM, expanded on this topic by explaining that it is a problem of culture, but that the monetary savings were clear, encouraging the population to recognize the homogeneity of these alternatives. He admitted that there is still plenty of ground to gain to convince every patient that generics respect the original formula, but that pharmacies have helped considerably to encourage market penetration of generics.

“Why have generics grown at such speed?” asked Maciel, and Cristina Viruega Aranda, Director General of TAPVS, answered that there is a need for therapeutic options as an effective treatment. “Bioequivalence studies are attended by a limited amount of third party authorization centers.” She explained that this still requires more investment but that fortunately 357 new drug registrations were processed this year, 91% of which were processed successfully. Becerra Orozco reiterated how pleasing it was to see such a huge backlog of registries being released and processed to date. “We want to be extremely precise and unambiguous in order to generate trust, to create solidarity and confidence in products processed by TAPVS,” added Viruega Aranda.

The moderator drew the discussion toward the importance of Mexico’s regulatory environment being comparable with international regulations. He touches on the Trans Pacific Partnership (TPP) and the issues surrounding data protection and the difficulties of launching a new product. Bravo states that “it is inacceptable for an authority to takes such a long time to allow the generation of generics, should patents be extended the population would suffer from an administrative piece of red tape.” The TPP needs to take into account different socioeconomic purchasing power in Mexico before making any decisions that would limit access. A potential move is to increase protection rights from 5 to 8 years, which would be dangerous for the distribution of existing chemical molecular formulas. Bravo mentioned that in the area of biotechnologies, she believes that Mexico has been very slow in catching up on the distribution of this new type of treatment. Bravo emphasized the importance of the whole population having access to this new type of generic product in Mexico. Maciel concluded by commenting that drug policing is the responsibility of all authorities and companies in the industry