ABSTRACT
To date, extensive research has been conducted on vaccination against COVID-19 during pregnancy to verify the safety and efficacy of the vaccines, despite the fact that pregnant women were excluded from the initial clinical trials. The ever-increasing number of scientific publications has confirmed the absence of biological mechanisms associating mRNA vaccines with adverse effects in pregnancy and breastfeeding, although few studies have been carried out on their effect on fertility. While the Italian legal system provides for maternity protection measures and indemnity for vaccination damages pursuant to law no. 210/1992, it is not exempt from controversy. This contribution describes the state of play on COVID-19 vaccination in pregnant and lactating women, including: current recommendations for pregnant and lactating women; ethical issues related to vaccination hesitancy among pregnant women; the legislative paradox whereby sanctions may be imposed on women in certain professional categories who refuse vaccination because they are pregnant; and the possible legal consequences in the event of harm to the unborn child due to vaccination. All of this is considered in accordance with the principles of medical ethics, taking into account the national legislation.
ABSTRACT
Objetive: This article objective is to analyze the consequences of the legal regime of producer non-liability clauses for rare adverse events from vaccines. I also analyze why the World Health Organization (WHO) sees this legal regime as the most recommended and modern one to properly address vaccine injury indemnity claims. Methodology: The article presents a bibliographical review of the scientific and technical literature on legal regimes for compensation for adverse effects of vaccines, followed by an overview of the historical experience of some illustrative countries with different regimes. Finally, I employ theoretical considerations from economic analysis of law to assess the adequacy of the legal instruments involved in view of the potential consequences and the efficiency of this in relation to the alternative accountability regime. Results: The legal regime of non-liability of pharmaceutical laboratories for rare adverse effects resulting from the application of vaccines, when accompanied by their own regime for the evaluation of claims for damages by specialized technicians and an adequate mechanism of financing for damages, promotes greater allocative efficiency and likely improved Kaldor-Hicks efficiency than the individual litigation system against laboratories. By not adopting the most efficient system, Brazil is exposed to the aggravated risks associated with it and, in the context of the Covid-19 pandemic, it went through and may continue to face difficulties negotiating vaccine purchases due to judicial risk. Contributions: Brazil, along with other developing countries, has relatively inefficient accountability legislation for rare adverse effects of vaccines. The context of the Covid-19 pandemic would be conducive to the revision of this legislation to reduce transaction costs in the entry of vaccines and to reduce legal risks. The emergence of new pandemics is inevitable in the future, so the legislative update would also bring long-term benefits. © 2022, Centro Universitario Curitiba - UNICURITIBA. All rights reserved.
ABSTRACT
Several types of SARS-Cov-2 vaccine have been quickly developed and officially approved for emergency use in accordance with the Pharmaceutical Act. Mass vaccination in workplaces in Japan was subsequently promoted, targeting health care workers and senior citizens. We overviewed the pathophysiology of COVID-19 and reviewed reports containing fatal outcomes, compensation programs, and remedial measures for health damage after vaccinations, in relation to their relevant legislations. The Immunization Act was amended prior to the mass vaccination to authorize the indemnity agreement between the government and pharmaceutical companies to compensate for losses based on health damages after vaccination. Pursuant to the Civil Code and the State Redress Act, employers reserve the right to obtain reimbursement when they are liable to pay compensation for damages inflicted on a third party. There are no provisions to exclude healthcare workers and occupational health staff who participated in practical procedures from lawsuits and liability. We propose legislative reformation and careful contracts with responsible organizations concerned with emergency vaccinations in order to confront forthcoming new or re-emerging infections beyond this pandemic.