Drepturile pacientului: calificarea juridică a reacției adverse și a efectului indezirabil al medicamentului [Articol]

Abstract

The health protection legislation of the Republic of Moldova contains a series of regulations regarding the adverse reaction produced by a medicine and the undesirable effects in the case of the use of certain medicines. At the same time, however, even if there are regulations in the matter, including those that were taken over by our legislator for the purpose of harmonizing the national legislation with the regulations in the matter of the European Union, there is a series of ambiguities, which may generate certain negative consequences for patients in their capacity as beneficiaries of health services. Thus, the legislator is ambiguous in what concerns the answer to the question, whether the manufacturer of medicines is or is not obliged to mention directly, in the medicine’s leaflet, the fact that in the case of the use of the medicine no adverse effects of it have been reported.