title: [The pharmaceutical industry and the sustainability of healthcare systems in developed countries and in Latin America].
abstract: The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.
authors.affiliation: Área de Análisis del Uso de los Medicamentos, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Ministerio de Ciencia e Innovación, Madrid, España. ainesta@isciii.es
authors.forename: Antonio
authors.initials: A
authors.lastname: Iñesta
authors.forename: Luis Angel
authors.initials: LA
authors.lastname: Oteo
mesh_terms: D035843:Biomedical Research; D003695:Delivery of Health Care; D019049:Developed Countries; D004345:Drug Industry; D004363:Drug Utilization; D007843:Latin America; D012941:Social Responsibility