Manifesto for patient safety in biological treatments
The position of the Latin American Center for Research in Biological (CLAPBio), the Rio de Janeiro State University (UERJ) and associations ABRALE, AMAVI Amavi, ANAPAR, APMPS, Casa Hunter, EncontrAR, GADA, GARCE, GRUPAR - RP , GRUPARJ - Petrópolis, Grupo Otimismo e Psoríasie Brasil, has criticized the extrapolation of indications approved by ANVISA to be at odds with the description in the DRC 55/2010, and the absence of scientific evidence to support, in terms of efficacy and safety.
The main objective of this manifesto is to protect the patient with the guarantee to access of quality, effective and safe medicines.
ClapBio encourage regulators and health policy makers to promote technical discussions on the issue, calling for academies and medical societies, with the participation of patient associations.
The Latin American Center for Biological Research at the University of Rio de Janeiro, is willing to support decision makers in health to be the technical body responsible for representing, in these discussions, civil society organizations that signs the document.