A proteção jurídica dos dados clínicos de testes em medicamentos para humanos

Abstract

The legal discussion can be the protection or not of clinical data and undisclosed information "Data Package", obtained through clinical research, from the development of a new drug. It is important to carrying out a preliminary investigation to find out if the new drug to be marketed, has beneficial or adverse effects that may affect humans, thus ensuring the efficacy and safety of its use. The file containing the clinical data is submitted to the National Agency for Sanitary Vigilance the use of a specific assignment and depending on the assessment of compliance with juridical - administrative and technical-scientific relation to efficacy, safety and quality of the product as Law 6360/76 and Decree 79.094/77 determines the sanitary registration. The claim made by the pharmaceutical research companies is that it would be forbidden to ANVISA grant records to generic and similar drugs with the same active , based on clinical research conducted while force the exclusivity period , on the basis of Article 5 , XXIX of the Federal Constitution , articles 39.1 , 39.2 , 39.3 of the Agreement on aspects of Intellectual Property Rights - TRIPS Agreement , Article 195 , XIV Law 9.279/96 ( Industrial Property Law ) , Article 421 , 884 , 885 and 886 CC , Article 37 , caput, of the Federal Constitution and Article 2 of Law 9.784/99 and analogical application of Law 10.603/2002. ANVISA to allow manufacturers of generic drugs and the like using the package of clinical data , supplied by the holder of the reference drug, would be promoting unfair competition and parasite by allowing generic versions and the like, join in the market under cost production and trade substantially smaller than those committed by drug reference. This argument has the fulcrum in the standard of Article 39.3 of the TRIPS Agreement entered among the members of the World Trade Organization - WTO in 1994 , in which Brazil is a signatory, and pledged to take steps to keep confidential and protected unfair commercial use clinical data related to clinical research, necessary for approving the marketing of pharmaceutical products. Dissemination, exploitation or use of clinical data, without the consent of the holder, which demanded considerable material and human resources and since this information has been submitted to governmental entities as a condition of approving the marketing of a medicinal product shall be protected. The WTO members and subscribers of the international agreement should ensure that competitors do not have access to the information received by the state entity, which do not exploit them or may wrongly assess both direct and indirect benefits for the benefit of the technical-scientific knowledge, investment and efforts made by the owner of that clinical research. Within this scenario, it is necessary that the State produces a regulatory framework capable of providing legal certainty, which allows pharmaceutical companies to provide high investment, allowing it to perform clinical research and introduction of new medicines.