Court denies request from compounding pharmacy to use medicinal Cannabis phytopharmaceuticals
According to the judge, the Judiciary and Legislature should not intervene in technical issues
Charles Vilela
On Wednesday (12), the court denied a request from a pharmacy that intended to develop formulas with derivatives or phytopharmaceuticals based on cannabis sativa. The company wanted authorization to dispense products treated in RDC 327/2019, a regulation from Anvisa (National Health Surveillance Agency) that deals with industrialized or compounded medications. It also requested a license to handle products with plant-based actives or phytopharmaceuticals from cannabis sativa.
The denial in the 2nd instance was issued by the 5th Panel of the Federal Regional Court of the 1st Region (TRF1), which upheld the decision of the 1st instance that denied the request. The pharmacy sought a declaration of the illegality of articles 15 and 53 of the regulation. However, the rules prohibit the manipulation of formulas containing derivatives or phytopharmaceuticals based on Cannabis and establish that Cannabis products must be dispensed exclusively by pharmacies without manipulation or drugstores upon presentation of a prescription by a legally qualified medical professional.
According to the judge, the Judiciary and Legislature should not intervene in technical issues
The rapporteur, federal judge Daniele Maranhão, stated that, in the face of such a technical issue, the Judiciary is not allowed to intervene. “Neither is the Legislature capable of creating regulations on highly technical issues, giving rise to legal authorization for certain matters to be addressed by regulatory acts,” she said. “The intervention of the Judiciary in these approaches, whose control should be limited to the examination of the legality or abuse of administrative acts.”
Furthermore, according to the judge, the Judiciary does not have the necessary expertise to pronounce on the adequacy or not of the prohibition object of challenge, “notably due to Anvisa's action within the scope of its regulatory, constitutional, and legally authorized power.”
As it involves an input that can result in public health damage, regulation falls under Anvisa's jurisdiction
According to the judge, this regulation is even more necessary when it concerns an input that can result in public health damage and whose use must be adequately controlled, as is the case with the active ingredient of cannabis sativa. The plant is subject to special control under the terms of Ordinance/SVS no. 344, of May 12, 1998, given that narcotic substances can be extracted from it. “Therefore, the purpose of the regulatory agent, in establishing the restriction on the use of cannabis, aims to provide safety and efficacy, since the product's level of complexity results in its incompatibility with its use by a compounding pharmacy, and also aims to prevent deviations or improper use of the substance in order to safeguard public health.”
When analyzing the interlocutory appeal, Daniele Maranhão highlighted that the possibility of granting urgent relief is supported by art. 300 of the Civil Procedure Code and presupposes the configuration of the likelihood of the right and the danger of harm, requirements that are not evidenced by the provisions of Anvisa Resolution no. 327/2019.
According to the judge, the issuance of the Anvisa Resolution was carried out in the legitimate exercise of the regulatory power conferred on the regulatory agency, based on the provisions of Law no. 9,782/99 – art. 2, sections I, II, and III; art. 7, sections III and IV, and art. 8, § 1 and Law no. 9,782/99, art. 15, sections III and IV.