Table 4.
Transparency | The priority-setting process and the way in which decision makers are chosen are established in the bylaws of the National Drugs Catalogue.71 Justifications for specific decisions cannot be consulted, but it is possible to consult the guidelines that decision makers used to evaluate the evidence.72 |
Relevance | Health providers, health authorities, and a representative of the National System for Integral Family Development (which is part of the Ministry of Social Development) participate with voice and vote in the commission in charge of the National Drugs Catalogue.73 Other health authorities and three representatives of the pharmaceutical industry participate only with voice; additionally, specific committees made up of members of the General Health Council, as well as an expert committee selected by the commission, analyze the proposals.74 The public has 10 days to review and make comments on the projects.75 Cost- and clinical effectiveness studies are considered in the priority-setting process.76 Equity must be considered as part of the cost-effectiveness analysis.77 Autonomy is not present in any of the legal instruments, but solidarity is considered to some extent: orphan diseases and drugs are analyzed with criteria that are difficult to comply with, such as the requirement that orphan drugs have an adequate financial impact study.78 |
Review and revision | The catalogue is updated three times a year.79 |
Oversight and supervision | Authorities responsible for the priority-setting process can be sanctioned under the public servants’ liability law; other decision makers must abide by the General Health Council Code of Ethics.80 |