title: Conceptual clarifications regarding Chilean Act 20850 on public funding of high-cost diseases.
abstract: In 2015, Chile enacted the 20850 law, providing public funds for rare and costly diseases that demanded high diagnostic and therapeutic expenditures. The law modifies the Chilean Sanitary Code regulation of research with human beings, aiming at the protection of subjects by securing post-investigational medical benefits and insurance coverage for damage imputable to the research they participated in. Due to ambiguous phrasing, a polemic rose for fear that these protective measures applied to all clinical research, although a careful reading of the law in its context clearly suggests that it refers to phase I therapeutic trials. This paper stresses the distinction between compassionate use and genuine phase I/II therapeutic trials aimed at both pharmacodynamics and an intended therapeutic effect for severe and progressive diseases that are therapeutically orphaned, emphasizing the ethical and medical duty of providing post-trial beneficial medication.
authors.affiliation: Escuela de Salud Pública, Universidad de Chile, Santiago, Chile. Address: José Miguel de la Barra 521, Departamento 4-B, Santiago, Chile. Email: mkottow@gmail.com.
authors.forename: Miguel Hugo
authors.initials: MH
authors.lastname: Kottow Lang
mesh_terms: D002677:Chile; D017321:Clinical Trials, Phase I as Topic / Q000191:economics*; D017322:Clinical Trials, Phase II as Topic / Q000191:economics*; D057176:Compassionate Use Trials / Q000191:economics*; D005378:Financial Support; D005380:Financing, Government / Q000331:legislation & jurisprudence*; D017048:Health Care Costs / Q000331:legislation & jurisprudence; D006801:Humans; D019458:Insurance Coverage / Q000191:economics; D035583:Rare Diseases / Q000191:economics / Q000628:therapy
keywords: clinical trials; compassionate use; rare diseases