Lei nº 13.269 de 13/04/2016. AUTORIZA O USO DA FOSFOETANOLAMINA SINTÉTICA POR PACIENTES DIAGNOSTICADOS COM NEOPLASIA MALIGNA.
LEI Nº 13.269, DE 13 DE ABRIL DE 2016
Autoriza o uso da fosfoetanolamina sintética por pacientes diagnosticados com neoplasia maligna.
A PRESIDENTA DA REPÚBLICA
Faço saber que o Congresso Nacional decreta e eu sanciono a seguinte Lei:
Esta Lei autoriza o uso da substância fosfoetanolamina sintética por pacientes diagnosticados com neoplasia maligna.
Poderão fazer uso da fosfoetanolamina sintética, por livre escolha, pacientes diagnosticados com neoplasia maligna, desde que observados os seguintes condicionantes:
I - laudo médico que comprove o diagnóstico;
II - assinatura de termo de consentimento e responsabilidade pelo paciente ou seu representante legal.
Parágrafo único. A opção pelo uso voluntário da fosfoetanolamina sintética não exclui o direito de acesso a outras modalidades terapêuticas.
Fica definido como de relevância pública o uso da fosfoetanolamina sintética nos termos desta Lei.
Ficam permitidos a produção, manufatura, importação, distribuição, prescrição, dispensação, posse ou uso da fosfoetanolamina sintética, direcionados aos usos de que trata esta Lei, independentemente de registro sanitário, em caráter excepcional, enquanto estiverem em curso estudos clínicos acerca dessa substância.
Parágrafo único. A produção, manufatura, importação, distribuição, prescrição e dispensação da fosfoetanolamina sintética somente são permitidas para agentes regularmente autorizados e licenciados pela autoridade sanitária competente.
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