Litigation for Health Technology Accessibility: A Tool for Inequality? Reflections Based on Case Study Analysis

INTRODUCTION The objective of this work is to analyze the characteristics of litigation for access to health’s goods and services in the Social Health Insurance (SHI) of Buenos Aires, Argentina. METHOD Descriptive study with analytical stage, performed in SHI, analyzing litigation done by beneficiaries along 15-years period to obtain goods or service from health managers. Variables explored were: Reason for litigation, delay time in case resolution, final result of judicial sentence, judges, lawyers and intervening professionals, income level of beneficiaries who started the litigation. RESULT 825 cases were analyzed during the study period according the method described. Demands increased 29.2 ±% per year. Medicines were the goods that most requested legal protection resources (32.5%). 51.9% of these litigations were due to medicines that have less than 24 months of registration by the National Regulatory Agency. The average delay for the final resolution of the procedure was 3.7 months. Judge's sentence was favorable to the beneficiaries in 97.4%. Although there are 27 judicial departments and many courts in each one; cases were concentrated in 47.4% only 2 very few courts. Litigation cases promoted by 112 out of the 15000 doctors that provides services to the SHI. In 73.7% of the cases, beneficiaries that litigated had a salary that exceed 4 times the minimum wage, and only 3.2% of them had low income. CONCLUSION We show how legal appeals might be working as an inverse strategy to the one desired, transferring collective resources belonging to the entire population, towards an specific demand from the most economically wealthy sector of society. As long as access to health care litigation maintains its current individualistic pattern, it will hardly be able to develop its full potential to guarantee effective respect for the collective right to access to goods that beneficiary the whole community.

Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study

Background The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic. Methodology The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented. Discussion It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level. Conclusion Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.

Historical Perspectives on Ethical and Regulatory Aspects of Human Participants Research: Implications for Oncology Clinical Trials in Africa

Clinical trials research involving human participants has led to numerous medical advances. Historically, however, clinical trials research was the source of major concerns for the safety and welfare of the human participants taking part in these studies. The ethical principles of autonomy, beneficence, and justice came about in response to medical atrocities, and regulations were ultimately put in place to protect the rights and welfare of human participants and to maintain the public trust in the research enterprise. Today, clinical trials are one of the most heavily regulated practices in the world, and yet still not all people are provided the same oversights and protections, with improprieties disproportionately affecting poor-resource nations and vulnerable populations. As Africa approaches the post–communicable disease era, cancer is set to take the lead as the most burdensome disease, making the need for oncology clinical trials in Africa greater than ever before. Africa represents a heterogeneous market with 55 countries, most with their own National Regulatory Agency (NRA) and each with varying levels of regulatory maturity. This diversity creates a highly complex regulatory environment and causes challenges when bringing drugs to market. There is a large need for harmonization and increased collaboration between the African nations’ NRAs. In addition, many African countries need to be better equipped to handle research ethics committees and/or learn how to rely on neighboring countries with more established ethics committees. Well-run clinical trials offer solutions to national health care problems, and all people deserve equal access to their benefits.

Private health insurance coverage-related lawsuits

ABSTRACT Objectives: to analyze lawsuits brought by beneficiaries of health insurance operators. Methods: this was a cross-sectional descriptive study carried out in a large-capacity private health insurance operator using data collected by the company from 2012 to 2015. Results: ninety-six lawsuits were brought by 86 beneficiaries regarding medical procedures (38.5%), treatments (26.1%), examinations (14.6%), medications (9.4%), home care (6.2%), and other types of hospitalization (5.2%). The procedures with the highest number of lawsuits were percutaneous rhizotomy; chemotherapy; treatment-related positron-emission tomography scans; and for medications relative to antineoplastic and Hepatitis C treatment. Conclusions: the lawsuits were filed because of the operators’ refusal to comply with items not established in contracts or not regulated and authorized by the Brazilian National Regulatory Agency for Private Health Insurance and Plans, refusals considered unfounded.

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.

Petrobras Transporte S.A.: Transpetro’s Ultrasonic Flow Meter Recalibration Program

In recent years, the use of ultrasonic flow meters has gained worldwide acceptance for natural gas custody transfer applications. TRANSPETRO has also increased significantly the use of this technology because of the important role it plays in reducing lost and unaccounted for (LUAF) gas. A plan of this equipment is essential to guarantee the proper operation and the specified accuracy of the meter runs as well as mandatory in order to comply with a national regulatory agency (ANP) ordinance, which requires ultrasonic meters to be recalibrated every 30 months. This interval can be extended if the agency approves a study submitted by the operator, presenting a reasonable historical metrological performance the meters. In 2009, the Measurement Technical Committee of the Pipeline Research Council International (PRCI) published a report recommending ultrasonic meters to be recalibrated based on time-in-service, but on periodic assessment of the diagnostic parameters provided by the equipment. The report states that if these diagnostic logs indicate performance change, the meter should be cleaned and the performance re-checked; the recalibration should be considered only if the performance change remains after the cleaning. Carrying out this procedure guarantees, according to the report, the calibration is within the uncertainty of the calibration facility for a period of at least six years. Although the several PRCI reports recommend some diagnostic parameters to be followed, their names, categories and limits vary from manufacturer to manufacturer. A narrow relationship with each manufacturer must be established in order to define the finest practices. The periodic basis of the diagnostic logs collection is also an important concern. The state-of-art on following the diagnostic parameters is to have them integrated to the SCADA system, random problems can be neglected if manual collection is performed from time to time. The objective of this paper is to present TRANSPETRO’s ultrasonic flow meters recalibration program based on PRCI reports and manufacturers’ recommendations, as well as show the company’s strategy for the diagnostic parameters collection.