The Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios or Cofepris) must begin to report the side effects caused by the application of medications in people, in response to a request made by the National Institute for Transparency, Access to Information and Personal Data Protection (Instituto Nacional de Transparencia, Acceso a la Información y Protección de Datos Personales or INAI). The measure was adopted after observing the impact of MabThera, manufactured by Roche (sanitary registration 248M98 SSA).
Another reason for this decision is to promote access to information by the citizenry, informing them of the scope of the oversight for the various drugs that are distributed and used in the country. It should be noted that Mexico has been conducting such oversight since 1989 through the National Center for Pharmacovigilance, opening its policies and mechanisms for public assessment to identify in a timely manner any health problems that the state should address.
The agents responsible for monitoring medications must fulfill their role in the most transparent way possible and include among their tasks a review of the effects caused by vaccines. It is important to emphasize this point given that the determination may also stem from a request for information presented by a private party in reference to a prescription manufactured by a laboratory.
Cofepris must qualify verified reactions as moderate, severe, or dangerous, while also evaluating the probability that the medication will cause side effects, according to four categories: certain, likely, possible, and others. Pursuant to this study, the state agency responded that MabThera had deviated from expected results in a total of 2,092 cases.