The Role of Authorized Third Parties in the 4TBy Miriam Bello | Wed, 10/14/2020 - 18:05
The government’s goal to centralize processes and eradicate intermediaries in an effort to reduce corruption has left holes in already established processes and in the roles of third parties supporting formerly decentralized bodies like COFEPRIS.
Authorized third parties support COFEPRIS in sanitary vigilance and control through various analytical tests, samples or verification acts, as well as through bioequivalence and bioavailability studies. Since the beginning of Andrés Manuel López Obrador’s administration, COFEPRIS has gone through numerous changes, starting from the designation of Commissioner Novelo Baeza. He has been very vocal about ending corruption acts inside COFERIS and how the commission is aligned with the government’s goals of transparency and austerity. During Baeza’s pronunciation as the new Commissioner, he shared his commitment to “wiping out corruption from COFEPIRIS’ areas of pharmacovigilance, authorized third parties and innovative medicines.” From his perspective, authorized third parties, were born due to the alleged inability of COFEPRIS to serve all users. “COFEPRIS will redirect its primary function of protecting the population against health risks, since for a long time it functioned as a facilitating agency of industry and economic interests.”
Two days ago, Novelo Baeza told the Senate that COFEPRIS was evaluating authorized third parties. “Several have not passed and others were no longer interested in renewing the certification. There are about 180 left (from 222 that existed in 2019), but their work has reduced by half because, each time, there are more companies preferring to do the procedure without intermediaries.” Baeza highlighted that from the beginning of his administration, practices that put health of the population at risk were canceled, “such as the use of authorized third parties to get a preliminary opinion on applications.”
“There is no more corruption, no preferential lanes. The order of arrival of the procedures is respected. There is a level floor for everyone.”
Director General of TAPVS Cristina Viruega shared during an interview with MBN that there has been a pause in communications between COFEPRIS and authorized third parties since the beginning of the current administration. However, the latter bodies are recently seeing interest from the commission in resuming talks. “COFEPRIS and authorized third parties have the same goal so there is no reason to close the door to collaboration.”
Alfonso Arroyo, Director of Sonne & Mond, explained to MBN that the creation of authorized third parties led COFEPRIS to clarify several internal requirements, which provided better guidance for those outside the organization and kept approvals from being discretionary. “During this administration, many processes performed by authorized third parties were internalized again, giving way to discretionary approval processes once again,” he said. Arroyo observed that the current government administration has given itself very ambitious goals that require significant funding. “We believe that government offices will be more motivated to monitor the market to identify and fine those who break the regulatory rules.”
Where does this leaves third parties? According to what Josue Garza, Director of Business Development and Operations at Insumos para la Salud, shared with MBN, “COFERIS established a ‘first in, first out’ model that rendered third parties almost irrelevant because there was no prioritization for submissions under that route.”