Problems in the regulatory policy of the drug market

OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber.METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012.RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies.CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body.

The importance to update the guidelines for the use of genetic testing in noncancer patients in Brazil

The Brazilian National Regulatory Agency for Private Health Insurance and Plans has recently published a technical note defining the criteria for the coverage of genetic testing to diagnose hereditary cancer. In this study we show the case of a patient with a breast lesion and an extensive history of cancer referred to a private service of genetic counseling. The patient met both criteria for hereditary breast and colorectal cancer syndrome screening. Her private insurance denied coverage for genetic testing because she lacks current or previous cancer diagnosis. After she appealed by lawsuit, the court was favorable and the test was performed using next-generation sequencing. A deletion of MLH1 exon 8 was found. We highlight the importance to offer genetic testing using multigene analysis for noncancer patients.

Validação de metodologia analítica para o doseamento simultâneo de mebendazol e tiabendazol por cromatografia líquida de alta eficiência

The aim of this work was to develop and validate an analytical methodology for simultaneous determination of mebendazole and thiabendazole, two benzimidazoles used as anthelmintics. The method was based on high performance liquid chromatography, using a C18 column, a mobile phase composed of KH2PO4 0.05 mol L-1 and methanol 40:60 (v/v) and UV detection at 312 nm. The results showed that the method presented linearity from 60.0 to 140.0 µg mL-1 for mebendazole and from 99.6 to 232.4 g µL-1 for thiabendazole and it was considered selective, accurate, precise and robust according to the specific resolution from ANVISA, the Brazilian regulatory agency.

Desenvolvimento e validação de metodologia analítica por CLAE-IR para determinação de artemisinina em Artemisia annua L

The aim of this work was to develop and validate an analytical methodology for determination of artemisinin used as antimalaric. The method was based on high performace liquid chromatography, using a CN column with mobile phase composed of methanol : H2O 50:50 (V/V). The results showed that the method presented linearity from 50 to 1500 µg/mL. It was considered selective, accurate, precise according to the specific resolution from ANVISA, the Brazilian regulatory agency.

Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção

A cleaning validation method was developed and validated, based on swabbing sampling and simultaneous chromatographic determination of sulfamethoxazole (SMX) and trimethoprim (TMP) residues. The method presented limits of detection of 0.06 mg mL-1 for SMX and 0.09 mg mL-1 for TMP. It was considered selective, precise, accurate and robust according to the guidelines from ANVISA, the Brazilian regulatory agency, and International Conference on Harmonization. Mean swab recovery factors of 98.5% for SMX and 97.7% for TMP were obtained for spiked stainless steel plates. The method was successfully applied to the assay of actual swab samples collected from eleven points on an equipment surface.

Public hearings as a tool to improve participation in regulatory policies: case study of the National Agency of Electric Energy

The participation of citizens in public policies is an opportunity not only to educate them, but also to increase their empowerment. However, the best way for deploying participatory policies, defining their scope and approach, still remains an open and continuous debate. Using as a case study the Brazilian National Agency of Electric Energy (Aneel), with its public hearings about tariff review, this paper aims at analyzing the democratic aspects of these hearings and challenges the hypothesis of many scholars about the social participation bias in this kind of procedure. This study points out a majority participation of experts, contrasting with the political content of discussions. And, this way, it contributes to a critical analysis of the public hearings as a participatory tool, indicating their strengths and their aspects which deserve a special attention.

VISUAL ART AND REGULATORY FIT MESSAGES ON CONSUMER EVALUATIONS

ABSTRACT In this study, we demonstrate that the art infusion effect, in which the presence of visual art causes a positive impact on consumers' perceptions of products and advertising messages, might have a moderation effect on regulatory fit and non-fit messages. We investigate the impact of visual art on advertisement evaluations in regulatory (non-) fit conditions. Regulatory focus theory suggests that consumers rely on their motivational focus (prevention vs. promotion) for their evaluations and decisions. Usually, consumers prefer products that fit with their personal motivational focus. In the present study, the results of three experiments indicate that using visual art with a promotion or prevention fit message is recommended, while non-art images increase message persuasiveness when non-fit messages are presented. Therefore, not all information compatible with the consumer's motivational focus are best evaluated. When non-art images are presented, non-fit messages might be more persuasive.

Some aspects of implementing Regulatory Impact Analysis in Brazil

In an increasingly complex society, regulatory polices emerge as an important tool in public management. Nevertheless, regulation per se is no longer enough, and the agenda for a regulatory reform is increasing. Following this context, Brazil has implemented Regulatory Impact Analysis (RIA) in its regulatory agencies. Thus, Brazilian specificities have to be considered and, in this regard, a systematic approach provides a significant contribution. This article aims to address some critical reflections about which policy-makers should ask themselves before joining the implementation of a RIA system in the Brazilian context. Through a long-term perspective, the implementation of RIA must be seen as part of a permanent change in the administrative culture, understanding that RIA should be used as a further resource in the decision-making process, rather than a final solution.

The human immunodeficiency virus preventive vaccine research at the French National Agency for acquired immunodeficiency syndrome research

The human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic is of unprecedented gravity and is spreading rapidly, notably in the most disadvantaged regions of the world. The search for a preventive vaccine is thus an absolute priority. For over 10 years the French National Agency for AIDS research (ANRS) has been committed to an original program combining basic science and clinical research. The HIV preventive vaccine research program run by the ANRS covers upstream research for the definition of immunogens, animal models, and clinical research to evaluate candidate vaccines. Most researchers in 2004 believe that it should be possible to obtain partial vaccine protection through the induction of a strong and multiepitopic cellular response. Since 1992, the ANRS has set up 15 phases I and II clinical trials in order to evaluate the safety and the capacity of the candidate vaccines for inducing cellular immune responses. The tested candidate vaccines were increasingly complex recombinant canarypox viruses (Alvac) containing sequences coding for certain viral proteins, utilized alone or combined with other immunogens (whole or truncated envelope proteins). ANRS has also been developing an original strategy based on the utilization of lipopeptides. These comprise synthetic fragments of viral proteins associated with lipids that facilitate the induction of a cellular immune response. These approaches promptly allowed the assessment of a prime-boost strategy combining a viral vector and lipopeptides.

Innate immunity and regulatory T-cells in human Chagas disease: what must be understood?

There is a general consensus that during chronic Trypanosoma cruzi infection, the host immune system induces complex processes to ensure the control of parasite growth while preserving the potential to mount and maintain a life-long controlled humoral and cellular immune response against the invading pathogen. This review summarises evidence in an attempt to elucidate "what must be understood" to further clarify the role of innate immunity in the development/maintenance of clinical Chagas disease and the impact of etiological treatment on host immunity, highlighting the contributions of the innate immunity and regulatory T (Treg) cells. Recently, increasing focus on innate immunity suggest that chronic T. cruzi infection may cause morbidity when innate effector functions, or the down-regulation of adaptive regulatory mechanisms are lacking. In this context, stable asymptomatic host-parasite interactions seem to be influenced by the effector/regulatory balance with the participation of macrophages, natural killer (NK) and CD8+ T cells in parallel with the establishment of regulatory mechanisms mediated by NKT and Treg cells. Moreover, a balanced innate immune activation state, apart from Treg cells, may play a role in controlling the adverse events triggered by the massive antigen release induced by trypanosomicidal agents during Chagas disease etiological treatment.

Molecular characterization of regulatory polymorphisms in the promoter region of the STAT6 gene in a Gabonese population

Parasites remain competent invaders of host immunity. Their invasion strategies have proven to impact immunorelevant genes leading to diversity among gene families. We focussed on signal transducer and activator of transcription (STAT6) factor that plays a fundamental role in signal transduction and activation of transcription. Recent studies have highlighted the role of STAT6 variants in control of infection levels. We identified and investigated regulatory single nucleotide polymorphisms (SNPs) in the promoter regions of the STAT6 gene in a group of Gabonese individuals exposed to a variety of parasitic infections. Three promoter variants were identified in 40 individual subjects. We further validated these promoter variants for their allelic gene expression using transient transfection assays. One promoter variant, rs3024944 (G/C), revealed an altered expression of the marker gene. The identification of function-altering SNPs in the promoter may facilitate studying parasite susceptibility in association studies.

Regulatory elements involved in the post-transcriptional control of stage-specific gene expression in Trypanosoma cruzi: a review

Trypanosoma cruzi, a protozoan parasite that causes Chagas disease, exhibits unique mechanisms for gene expression such as constitutive polycistronic transcription of protein-coding genes, RNA editing and trans-splicing. In the absence of mechanism controlling transcription initiation, organized subsets of T. cruzi genes must be post-transcriptionally co-regulated in response to extracellular signals. The mechanisms that regulate stage-specific gene expression in this parasite have become much clearer through sequencing its whole genome as well as performing various proteomic and microarray analyses, which have demonstrated that at least half of the T. cruzi genes are differentially regulated during its life cycle. In this review, we attempt to highlight the recent advances in characterising cis and trans-acting elements in the T. cruzi genome that are involved in its post-transcriptional regulatory machinery.