Novo sistema de aplicação de drogas em cirurgias oftalmológicas

The topical corneal application of antimitotic mitomycin-C (MMC) during refractive surgery is still characterized by a lack of standardization and considerable empirism. For this reason the creation of a system capable of reliable drug delivery represents a beneficial innovation for patients submitted to these procedures. Objective: Elaborate a new MMC delivery system during the transoperatory period of photorefractive keratectomy (PRK) followed by patent application. Methods: The project consists of an in vitro experimental study to create an MMC (0.02%) release system. The drug was impregnated in sterile Whatman® 41 paper filter discs with a diameter of 8 mm. After drying, the discs were applied to antibiogram plates seeded with Staphylococcus epidermidis (American Type Culture Collection ATCC 12228), followed by the addition of a drop of sterile water. At the end of 1 minute, the discs were removed and the plates incubated for 48 hours at 35oC. Mean drop volume in the collyrium flasks was measured using analytical balance weighing. The inhibition halo (mm) was correlated with the MMC impregnated into the disc. After completion of the invention design a patent application was lodged at the National Institute of Industrial Property. Results: The correspondence between MMC-produced inhibition halos indicated that a dose of 16μg was ideal for impregnating into the discs. The mean drop volume obtained from the collyrium flasks was 37.7 μL. A minute after the application of one drop of balanced saline solution, the system released an adequate concentration for PRK surgery. Conclusion: A new MMC delivery system was created for transoperatory application in photorefractive keratectomy (PRK). Publication of the patent application (number PI 0704739-8) gives the authors exclusive intellectual property rights. The study was sponsored by Ophthalmos Indústria e Comércio de Produtos Farmacêuticos S.A. (São Paulo-SP, Brazil) and received the indispensable scientific contribution of researchers from the fields of Pharmacy, Medicine, Biology, Statistics and Law, characterizing the work as multidisciplinary, in accordance with norms established by the Postgraduate Health Sciences Program of the Federal University of Rio Grande do Norte (UFRN)

Os limites constitucionais ao exercício de direito de patente e seus reflexos na indústria do petróleo, gás natural e biocombustíveis

This dissertation deals with the constitutional limits on the exercise of patent rights and its effects on the oil, natural gas and biofuels. Held with the support of ANP / PETROBRAS, It seeks to show how the law will limit the exercise of industrial property, based on a reinterpretation of private law by the constitutional development perspective . Today it is a fact that Petrobras, a Brazilian joint venture, has the latest technology in various sectors of the oil industry, and is one of the highest investments in developing new technologies. The overall objective of this thesis is to establish the relationship between the public interest of the Petroleum Industry, Natural Gas and Biofuels and constitutional limits to the free exercise of patent rights, then confirm or refute our hypothesis that Article 71 on Industrial Property Law is contrary to the existing objectives in Article 3 of the Constitution of the Federative Republic of Brazil. The research aims to examine the relevant aspects of the legal nature attributed to IPGN constitutionally confronting the constitutional limits on the free exercise of patent rights, with the purpose to outline the state of the performance limits in the regulation of the economy, in particular the application of feasibility limitations on the right of property in favor of national interest on the strategic energy industry. The aim is to confront the fundamental rights to property and economic development, against the public interest, limiting these first. As to the objectives, the research will be theoretical and descriptive and harvest of industrial property, respect the possible impact of regulatory standards and limiting the right of ownership in the oil industry. To establish how the state will mitigate the intellectual property right, we discuss, at first, a definition of public interest from the general theory of state and sovereign character in order to establish a new concept of national interest and popular interest, which will in turn the definition of our concept of public interest. In the second phase, will be addressed the issue of industrial property rights and how to will be free exercise thereof, in the constitutional sphere, infra, and demonstrating the use of industrial property rights with examples of market and IPGN . After situating the industrial property rights in the constitution and national legislation, establish their relationship with the national and regional development, will be addressed in this chapter in particular the patent law, as most usual form of intellectual property protection in IPGN. Used a study highlighting the number of patents in the area of the analyzed industry, demonstrating with hard data the importance of a sector for industrial development. The relationship between the social function of intellectual property and the constitutional objective of development was characterized to demonstrate the strategic nature of oil to Brazil in the national and international scene, and put into question the hypothesis of the research which provides that even with large investments the lack of legal certainty in the sector turns out not to have a considerable volume of investment as it could.

A propaganda de medicamentos voltados à clínica obstétrica e/ou ginecológica e sua influência sobre a prescrição

INTRODUCTION: Drug advertisement stimulates self-medication and irrational use of medicines, especially when it starts to interfere in the prescription. Monitoring advertisements, as well as the observation of its influence on health professionals, prescriptions become necessary because of this public health problem. OBJECTIVE: The aim of this work was to analyze drug advertisements directed to gynecologists and/or obstetricians doctors relating them to the current legislation as well as its influence on prescription. METHODOLOGY: The sample was composed of drug advertisements divulged to the gynecologists and / or obstetricians doctors and was analyzed according to RDC96/2008. To evaluate the influence of advertisement on prescription, a questionnaire was administered to gynecologists / obstetricians doctors and prescriptions of a public maternity were also evaluated. RESULTS AND CONCLUSION: Concerning the advertisements analyzed, 48% complied fully with current legislation and 52% of the advertisements analyzed were in accordance to the RDC No. 96/2008 in most of the items evaluated. The doctors interviewed are used to receive the visits of propagandists, even in the public service, receiving gifts offered by the industry and believe that medicine advertisement tries to influence prescribing. Many of them use the material provided by the propagandist as a source for their prescription, although they present a critical view about them information. The use of trade name / mark on the prescription is a common practice among the doctors interviewed, even in the public service, suggesting there is an influence of medicine advertisement on the prescription

A intervenção do poder judiciário no acesso a medicamentos no Rio Grande do Norte: uma análise sob a ótica das políticas nacionais de medicamento e de assistência farmacêutica

The present study aimed to evaluate the inclusion of the principles of the National Medicines Policy - PNM and the Pharmaceutical assistance - PNAF in the prosecution of lawsuits involving medicines. To fulfill this necessity , data collection was performed on the website by the Tribunal Rio Grande do Norte - TJ RN ( Rio Grande do Norte Court) , in 2012 . It was obtained 115 judgments, which were analyzed in order to generate Monitoring Indicators from lawsuits and conduct content analysis proposed by Bardin (2006). The results showed that : a) 100 % of the decisions were favorable to the author , b) 76 % of decisions were requests by the trade name of the drug , c) only one drug (eculizumabe) had not granted by ANVISA , d) 36 % of drugs were present in the list of standard medicines in SUS , 16 % of primary care block and 20 % of specialized component , e) 76 % of the decisions presented the request of at least 01 non-standard medicine. With regard to decentralization of PNM and PNAF we observed a commitment to this principle at judicial decisions, to see that municipalities and states are often forced to buy medicines of responsibility from another federal entity or other tertiary units as CACONs and UNACONS. The content analysis revealed that the argument from the judges used when you utter their decisions was that the right to health is recognized by Brazilian law as a fundamental right and should be guaranteed by the State for all its citizens. So, health is more than budgetary constraints of federal entities, which are severally liable for lawsuits , regardless the medication requested belongs or not to a particular block of a pharmaceutical assistance funding. Given these data, it is observed that there are gaps in the judgment when it comes to the insertion of the words and principles of PNM and PNAF, creating then the need for greater dialogue between the executive and judicial, so that they may consider relevant the effectiveness and application of such principles to minimize the negative consequences of the phenomenon of health judicialisation. Keywords: Judicialisation, Medicines, Public Policy, Pharmaceutical Care