Regulation suspending the effects of Collegiate Board Resolution – RDC No. 234, of June 21, 2018, which provides for the outsourcing of production stages, quality control analysis, transportation and storage of medicines and biological products, and other measures, may be dismissed by the judiciary later this year.
By Press| Cassab Law – Advogados
October 16, 2019
For clear violation of the principles of free enterprise, free competition and free exercise of economic activity, the National Health Surveillance Agency – ANVISA may see the effects of the Resolution of the Collegiate Board – RDC No. 268, of 25 February 2019 that had as its purpose (irregularly) amending, despite better judgment, the Resolution of the Collegiate Board – RDC No. 234, of June 21, 2018, creating true market reserve for domestic manufacturers.
The irregularities spotted by the lawyers Pedro Cassab (Esq), Amanda Cassab (Esq) and Patrícia Ribeiro, (Esq, LL.M.) partners of the firm Cassab Law – Advogados and, respectively, specialists in Regulatory, Economic, Intellectual Property and Corporate Law, may serve as a guide for the immediate removal of the effects of Resolution (RDC) No. 268 of February 25, 2019, to re-establish the provisions of Resolution (RDC) No. 234 of June 21, 2018, which deals with the outsourcing of production stages, quality control analysis, transportation and storage of medicines and biological products, and other measures.
In a study conducted over the last six (6) months, lawyers had the opportunity to follow the legal and practical effects suffered by the regulated sector as a result of the acts performed by the Agency, therefore concluding that the suspension of quality control outsourcing as provided by the Resolution of the Collegiate Board – RDC No. 268, of February 25, 2019, affects not only free competition but blocks the development of new business; This impacts on the competitiveness of the sector and, as a consequence, reflects negative effects on the end consumer who no longer has access to new, sometimes cheaper, medicines.
Still regarding the case, the lawyers concluded that the measure, adopted by the National Health Surveillance Agency – ANVISA, suggests a possible legal breach, which remains a matter of study by them, who intend to judicialize the matter in order to protect their client’s right to market access under the aegis of the Resolution of the Collegiate Board – RDC No. 234, of June 21, 2018. Finally, the measure also violates the guidelines brought by the Declaration of Rights of Economic Freedom – Law No. 13.874 / 2019.
The ruling, if favorable, will remove the effects of the Resolution of the Collegiate Board – RDC No. 268, of February 25, 2019, restoring the effects of the Resolution of the Collegiate Board – RDC No. 234, of June 21, 2018 which, as already mentioned, provides for the outsourcing of production stages, quality control analysis, transportation and storage of medicines and biological products, and other measures, but will not generate collective effects warns the Pedro Cassab (Esq) who will sponsor the case . Each company that feels injured should seek to ensure its operation directly by judicializing the matter with a lawyer it trusts.
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