After 180 days from the publication in the Official Gazette, the Law 13.123 entered into force on November 17th, 2015, and, according with the legal deadlines, the government had these same 180 days for the regulation of the law by the publication of a decree. However, past this deadline, the regulatory decree was not published and the Provisional Measure 2186-16 / 01, the previous legislation, was revoked. So, we stayed for almost 6 months in a scenario in which there was a law in force without regulation, resulting in a legal vacuum. Finally, on May 12, 2016 the Decree 8.772 was published.
Fiocruz participated with the Ministry of Health to draw up proposals for the enactment of the decree draft which was submitted to the Civil House, along with other proposals made by ministries and by Embrapa. Some of this proposals were accepted in the final draft of the decree, among them the important inclusion of an article (Art. 118) that ensures that the user requesting any intellectual property right and exploited economically finished product or reproductive material, or reported results, final or partial, in scientific or media held between the entry into force of the law and the availability of the electronic system of registration by the Ministry of Environment (MMA), be exempt from any punishment. In these cases, the user will have a period of one year for registration or notification from the date of availability of the National System for the Management of Genetic Resources and Associated Traditional Knowledge, the SisGen at CGen. However, in the final drafting of the decree, the shipping abroad was not included in the device and therefore it can be subject to administrative sanction.
Still on the decree, we guaranteed together with the Ministry of Health, its inclusion as a member of the Plenary Council of the Genetic Heritage Management (CGen), which was out of the original draft of the decree made available for public consultation.
In case of doubt, researchers and other users of Brazilian biodiversity from Fiocruz should contact the Technological Innovation Center - NIT of their unit.
Text by the researcher Manuela da Silva.