After nine years and many doubts over the lack of regulation of the Law 12/2005, of January 26 regarding information of personal genetics and health information, the Decree-Law 131/2014, of August 29, was approved, regulating Law 12/2005 in what concerns the protection and confidentiality of genetic information, the databases of human genetics with the purpose of providing healthcare services and health research, the conditions of supply and realization of genetic tests and the conditions under which the consultations on human genetics are assured.
According to Decree-Law 131/2004, the supply and realization of genetic tests that are health-related, by medical genetics laboratories, whose licensing is now also regulated by the same Decree-Law, should be limited to tests that possess analytical and clinical validity and for which there is indication of clinical utility.
Now it is strictly forbidden to sell directly to the public genetic tests that are health-related, as well as promoting and advertising them. The rationale, which had been previously advocated by several entities, in particular by the National Commission of Ethics for Life Sciences, is based on the complexity of information contained in the genetic tests and the consequent difficulty in its interpretation by the users. It was concluded that an adequate medical care both in the prescription, disclosure and interpretation of the tests results was essential.
It is worth mentioning the role of the National Commission for Data Protection (“CNPD”) with regard to the processing of genetic information, either within the creation of genetic databases in which the autorization of the CNPD is required for its formation, and in relation to the destruction, transfer and communication of genetic information.