Market access barriers for multinationals, but Argentina still offers attractive pharma opportunities

Several barriers impede market access but the regulatory landscape in Argentina is changing and attractive opportunities exist for multinational pharmaceutical companies, according to a new report from health care advisory firm Decision Resources.

After first adopting new guidelines for biological products, biosimilars, “enfermedades poco frecuentes” (rare diseases) and blood products of biological origin, Argentina then established the first 50 “tecnologias sanitarias emergentes” (emerging health technologies) for catastrophic diseases. The intent is to use health technology assessment in cost-effectiveness analyses and decision making but the operational processes needed to meet these goals are not yet transparent or well-developed.

The Argentina: Market Access Tracker service finds that, in 2013, the Argentine government added more than 200 additional drugs to the National Drug Traceability System, which track all drugs listed in the Register of Medical Specialties, and will require that agents of the National Health Insurance must certify the authenticity and traceability of drugs submitted for reimbursement. In addition, new reimbursement requirements from the “Sistema Unico de Reintegro” (Uniform Reimbursement System) have been established for catastrophic diseases, which are those diseases of low incidence and high economic impact that require long term treatment.