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This article examines the role of informal primary caregivers and the similitaries they share with formal and informal caregivers. While both groups perform similar activities, the distinction lies in the fact that formal caregivers, such as nurses, have undergone training and certification for their roles. In contrast, family members often lack adequate training, as there is lack of targeted education on caring for others' health. Recently, public programs have been established to promote the development of basic caregiving skills; however, social and, more importantly, economic compensation for informal caregivers remains a responsibility of the government and legal sector. Legal regulation of primary caregivers is essential given the significant health costs associated with the responsibility of caring for another person. These costs may include the development of illnesses, increased strain, exposure to psycho-stressors, symptoms of overwork, and mental health issues. From a bioethical and human rights perspective, it is important to recognize that both caregivers and those they care for possess inherent value as human beings and deserve a quality life. [ABSTRACT FROM AUTHOR]

Background: To understand the impact of laws raising minimum legal sales age for tobacco products to age 21, researchers and policymakers need to recognize how recommended policy components vary across states. This paper identified and reviewed policy components across 43 jurisdictions that have enacted Tobacco 21 (T21) laws since 2015. Methods: Using NexisUni’s database of state laws and legislation, we evaluated T21 laws in effect as of January 2024 and assessed for the incorporation of six components recommended in proposed model legislation: 1) age verification; 2) tobacco retailer licensing; 3) provisions to suspend or revoke a license; 4) unannounced inspections; 5) retailer civil or criminal penalties; and 6) provisions that allow for more stringent local laws. Results: Only one state included all six components we reviewed, including limiting penalties to civil fines. All jurisdictions included a provision to change the legal sales age of purchase and 37 imposed requirements on retailers to verify identification. Thirty-eight jurisdictions had licensing programs, but only 31 included license suspension or revocation provisions for underage sales. Twenty-three jurisdictions preempt localities from imposing more stringent requirements. Twenty-five jurisdictions use a mix of civil and criminal or solely criminal penalties and 21 jurisdictions have penalties for underage purchasers. Conclusions: Our database of recommended T21 components with effective dates can be merged with other datasets to facilitate policy evaluation. We discuss ways to enhance research and data collection in this area, and recommend that states update MLSA laws to adopt all recommended policy components.

Abstract Background Health professionals and medical students have knowledge gaps about the law that governs end-of-life decision-making. There is a lack of dedicated training on end-of-life law and corresponding research on the impact of this type of training. Objective To examine the impact of online training modules on key concepts of end-of-life law on Australian health professionals’ legal knowledge and their self-reported confidence in applying the law in practice. Methods Online pre- and post-training surveys were completed by training participants. The optional surveys collected demographic data, directly assessed legal knowledge and measured self-reported confidence in applying the law in clinical practice, before and after training. Results Survey response rates were 66% (pre-training) and 12% (post-training). The final sample for analysis (n = 136 participants with matched pre- and post-training surveys), included nurses, doctors, allied health professionals, medical students and a small number of non-health professionals. Following completion of the online training modules, legal knowledge scores significantly increased overall and across each domain of end-of-life law. Participants were also more confident in applying the law in practice after training (median = 3.0, confident) than before training (median = 2.0, not confident). Conclusions This study found that completion of online training modules on end-of-life law increased Australian health professionals’ legal knowledge and self-reported confidence in applying the law in clinical practice. Participants demonstrated some remaining knowledge gaps after training, suggesting that the training, while effective, should be undertaken as part of ongoing education on end-of-life law. Future research should examine longer term outcomes and impacts of the training.

Health systems have committed their path to universal health coverage using health planning to accomplish their goals of efficiency, equity and sustainability. Chile, a high-income country with a public-private mix health system, has made significant progress through several successive health policies implemented in the last 20 years which have been consistent with this approach. However, in the last 5 years, the national congress has produced several disease-specific laws, which have been mainly promoted by the civil society. These laws indicate the actions the health authority must perform to tackle the needs of the affected population, which ultimately determine the priorities of the health system. We argue that this legal pattern has become an alternative path to priority-setting, as opposed to health planning. We claim this “legal path” is a mechanism used by civil society in a context where the health authority fails to implement a robust and legitimate prioritization process. Although these laws have brought benefits to patients suffering the corresponding conditions, we highlight this approach does not guarantee improvements in equity, efficiency and health system performance. Instead, we advocate for taking back the control of the priority-setting based on health planning, through a new institutionalization of health technology assessment and quality of care.

Background: Health professionals and medical students have knowledge gaps about the law that governs end-of-life decision-making. There is a lack of dedicated training on end-of-life law and corresponding research on the impact of this type of training. Objective: To examine the impact of online training modules on key concepts of end-of-life law on Australian health professionals' legal knowledge and their self-reported confidence in applying the law in practice. Methods: Online pre- and post-training surveys were completed by training participants. The optional surveys collected demographic data, directly assessed legal knowledge and measured self-reported confidence in applying the law in clinical practice, before and after training. Results: Survey response rates were 66% (pre-training) and 12% (post-training). The final sample for analysis (n = 136 participants with matched pre- and post-training surveys), included nurses, doctors, allied health professionals, medical students and a small number of non-health professionals. Following completion of the online training modules, legal knowledge scores significantly increased overall and across each domain of end-of-life law. Participants were also more confident in applying the law in practice after training (median = 3.0, confident) than before training (median = 2.0, not confident). Conclusions: This study found that completion of online training modules on end-of-life law increased Australian health professionals' legal knowledge and self-reported confidence in applying the law in clinical practice. Participants demonstrated some remaining knowledge gaps after training, suggesting that the training, while effective, should be undertaken as part of ongoing education on end-of-life law. Future research should examine longer term outcomes and impacts of the training. [ABSTRACT FROM AUTHOR]

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The patchwork of laws and regulations that affect abortion access in the United States has become increasingly complex since the 2022 Dobbs v. Jackson Women's Health Organization U.S. Supreme Court decision that gave states the right to enact and enforce policies facilitating or restricting abortion access. The authors examined state, local, and institutional policies in Virginia-which is one of the only remaining states in the South post- Dobbs with legal access to abortion care past 13 weeks gestational age-to better understand how the policy landscape is influencing provision of care in the state. The authors reviewed existing legislation, bills, and sources detailing the policy landscape in Virginia and interviewed a sample of clinicians and nonclinicians working at organizations providing or supporting abortion care. The study principally focused on state laws, local policies and actions, institutional policies, and reported implementation experiences affecting access to abortion care., (Copyright © 2024 RAND Corporation.)

Copyright of Prolegómenos Derechos y Valores is the property of Prolegomenos Derechos y Valores and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Revista Colombiana de Bioetica is the property of Universidad El Bosque and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The health policy of Primo de Rivera elaborated a regulatory legal body to protect the needy classes that attended to their needs; the increase in health activity led to the creation of a large number of care institutions as well as professional health professionals involved in its development. Objectives: the research aims to analyze the practical application of the municipal Health and Welfare Regulations of the city of 1928 and, on the other hand, its impact on the social life of the underprivileged class. Method: a historical research based on the literature review was carried out. Documentary sources: documentary catalogs of libraries and documentary archives, electronic databases, catalogs of magazines specializing in history and other online sources. Descriptors used: midwife, practitioner, doctor, pharmacist, census of the poor. Results: documents from studies based on primary sources were included in the analysis and the results are presented in 4 sections: The Municipal Regulation of 1928, Pharmacists and medicines for poor patients, Doctors and practitioners and Midwives, midwives and childbirth teachers. Conclusion: the Regulation is applied long before its publication and health care is constantly exercised by all the professionals that comprise it; the number of practitioners is equal to that of doctors in this period; the City Council is responsible for paying pharmaceuticals for poor patients to pharmacists and is distributed by quarters; With regard to doctors, and since 1924, sufficient places have been created for the demand of the poor, which will increase, as well as possible substitutes; the creation of the dental clinic for the poor in the Santo Hospital in 1930 is included; in 1928 and 1929 there are 4 matrons for the four districts of the city, following the legislation; In 1930 the municipal midwives received an annual salary increase from 720 to 900 pesetas from the town council. [ABSTRACT FROM AUTHOR]

Introduction and purpose: The fast oncological therapy was introduced in 2015 by a set of legal arts called an oncology package. Its main assumption was to reduce malignant neoplasms by improving the availability of diagnostics and complex treatment. The aim of the study is to analyse the level of knowledge and to learn opinions of patients of the Center of Oncology of the Lublin Region on the fast oncological therapy.Material and methods: Material used in the analysis is the results of survey conducted on a group of patients from different hospital departments. An original anonymous questionnaire with 25 open and closed questions was used. Out of 130 distributed questionnaires, 44 items were returned completed. The program used to perform the statistical analysis was Statistica PL 10.0 2011 StatSoft.Results: The survey indicates that 43.2% of respondents have ever heard about fast oncological therapy, 27.3% declare knowledge of the therapy's basic aims. In a detailed knowledge test 1 point was awarded for every right answer. A maximum of 11 points could be obtained, with the average score being 2.3 points. 22.7% of patients surveyed did not answer any question correctly. No relationship has been found between age, place of residence or duration of the disease and the level of knowledge about the fast oncological therapy. 36.4% of respondents admit that they have been treated in accordance with the fast oncological therapy, but most of those who did (75%), evaluate its effect positively.Conclusions: The patients' knowledge about the package is extremely low. Only a minority of respondents are aware of the package's existence. However, the patients judge the changes introduced by fast oncological therapy as positive.

The implementation and enforcement of state and local abortion policy can vary significantly between medical clinics and depend on the context and the individual decisionmakers involved. Research conducted prior to the U.S. Supreme Court decision in Dobbs v. Jackson Women's Health Organization showed that, when providers are unclear about potentially conflicting or changing local and state policies (formal and informal) or enforcement, many err on the side of caution and become more restrictive in their practices. However, it is unknown whether and to what extent state and local policies and practices adapted in the wake of Dobbs have influenced providers' practices. The authors conducted an initial study of laws and policies post-Dobbs in one state, North Carolina, to better understand the policy landscape and gather perspectives from staff in facilities or organizations that provide or support abortion care. This study served as a unique opportunity to explore laws and policies, as well as implementation experiences, given North Carolina's Senate Bill 20, which instituted a gestational limit of 12 weeks and 6 days, as well as other provisions, including a 72-hour in-person consent requirement. The findings highlight the reported impacts of Senate Bill 20 on facilities, providers, and patients, as well as other local and institutional policies on abortion care access. This work highlights the importance of understanding legislation and its underlying provisions to ensure a complete picture of implementation factors and potential impacts., (Copyright © 2024 RAND Corporation.)

The study shows the disputes around the right to health. It begins in 2008, year in which health was declared an autonomous fundamental right by the Constitutional Court. It ends in 2015, the moment in which the Statutory Health Law is enacted. The research was carried out through the documentary analysis of sources from the archives of Congress, the Constitutional Court, the press and academic texts. Likewise, semi-structured interviews with key actors in the conflict and categories of analysis related to the conception of the right to health were conducted and implemented. From this, advances in the jurisprudence of law were evidenced; the dichotomy of a State that guarantees health as a fundamental right and at the same time defender of the market; positions of the actors that transit between the defense of a cost-effective system and groups inclined to defend health as a fundamental right in charge of the State. [ABSTRACT FROM AUTHOR]

The subject of this article is to clarify the role and specificity of Medical law as a scientific discipline and a particular area of law. The aim is to investigate, through medico-legal settings, the broadening of the legal regulations in the field of performing medical activities with the goal of protecting human health; what is the role of health legislation, with references to the historical, developmental dimension, as well as to the character of the sources of Medical law. In doing so, the particular topic of consideration is the issue of conceptual delineation and relation to other related fields, especially Health law. In the beginning, Medical law was shaped by the merging of a large number of different branches of law: Human rights, Contract and Torts law, Property law, Family law, Public law and Criminal law. Medical law was not autonomously studied as an independent discipline, while today it is widely accepted in the field of Law studies. However, there is still some ignorance of this discipline, even among its supporters, as to what subjects it involves and how it differs from other areas of law. Academic staff is looking for more space for this discipline. The analysis of disputed medical cases, as well as the development of legal institutes and the practice of Medical law has become a subject of increased attention in Serbian law. The conclusion is that the field of Medical law has undergone an expeditious development, while at the same time contributing to the full recognition of rights for various categories of patients. In addition, the discipline of Medical law is gaining international prominence through the emergence of increasingly topical global health issues, and the collaboration of states and scientific communities on matters relating to international Medical law.

Copyright of Nuevo Foro Penal is the property of Universidad EAFIT and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract The study evaluated the drinking water quality from 45 public schools in the city of Curitiba, Brazil. Water samples were harvested from two different points at each school: the first one, drinking fountain used by students (n=45) and the second, kitchen faucet (n=45), comprising 90 samples. The samples were submitted to analysis according to current legislation, such as: dosage of free chlorine; colony counts of heterotrophic bacteria; presence of total coliform bacteria and Escherichia coli. In addition, an enterococci analysis was also included as a complementary microbiological indicator of fecal contamination. The isolated strains of enterococci were identified and submitted to an antibiotic susceptibility test. In relation to the legal parameters, 35.5% (n=16) of the 45 schools evaluated did not meet the quality water standards set by the Brazilian legislation. Although none of the 90 samples exhibited the presence Escherichia coli, 6.6% (n=6) of the analyzed samples presented enterococci contamination. Regarding the antibiotic susceptibility test, the isolated strains demonstrated a similar behavior, became resistant to six antibiotics and had intermediate sensitivity to one (Streptomycin) of the nine antibiotics tested. The drinking water destined for human consumption in the public schools may pose health risks for students since the fecal contamination by enterococci was confirmed, and it could be observed that the water may be a source of genes from bacteria resistant to antimicrobials. This study reinforces the importance of monitoring complementary microbiological indicators to assure water quality, seeing that fecal contamination was detected only when alternative parameters were inserted, emphasizing the relevance of including microbiological indicators beyond what the legislation requires to evaluate the drinking water more effectively and to safeguard public health.

Abstract Traditionally, the turning point in the fight against tuberculosis is perceived as Robert Koch’s description of the bacterium in 1882. In Norway, the legislation from 1900 has been interpreted as a breakthrough. However, how was tuberculosis understood by doctors in Kristiania in the latter half of the 19th century? As it appears in Norsk Magazin for Lægevidenskaben – the country's most important medical journal – the term was far from unambiguous and precise. During the period 1840-1900, three forms of understanding dominate: tuberculosis as hereditary, something which arose spontaneously from imbalance or as a disease mediated through infection. Throughout the period, tuberculosis was absent in the journal's infectious disease tables. Furthermore, the effective fight against the disease met resistance. Opposition expressed itself through liberal arguments: measures were terrorism and threats to personal freedom. The opposition to fighting tuberculosis was also based on scepticism towards bacteria as pathogens. There are grounds for claiming that “tuberculosis” did not exist in Kristiania – a parallel to Bruno Latour’s pointing out that Pharaoh Ramses could not have had tuberculosis, despite the fact that French doctors recently have detected the disease in his mummy. The Egyptians did not know tuberculosis 3,000 years ago.

This report examines the experiences of Small Island Developing States in the Caribbean— Barbados, Dominica, Jamaica, and in the Pacific— Fiji, Nauru, and Tonga with specific governmental regulatory measures to reduce the risk of obesity and associated diet-related chronic ­noncommunicable diseases (NCDs), as well as the obstacles and opportunities encountered. Guided by the diet-related indicators of the World Health Organization (WHO) Noncommunicable Diseases Progress Monitor 2017, the authors reviewed legislation, country reports, articles, and the databases of WHO and the World Trade Organization to identify relevant regulatory measures and to establish the extent of implementation in the selected countries. Obesity prevalence ranged from 25.9% in Dominica to 41.1% in Tonga. The principal diet-­related measures implemented by the selected countries were fiscal measures, such as sugar-­sweetened beverage taxes and import duties to encourage greater consumption of healthy foods. Governmental action was weakest in the area of restrictions on marketing of unhealthy foods. If they are to reduce their current high rates of obesity and associated NCDs, Caribbean and Pacific states need to intensify implementation of diet-related regulatory measures, particularly in the area of marketing of unhealthy foods and beverages to children. Key implementation challenges include financial and staffing constraints and the need for increased political will to counter industry opposition and to allocate adequate financial resources to keep advancing this agenda.

Abstract Background Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are emergent. Health apps are regulated in order to minimise their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment. We aimed to produce a comprehensive guide to assist app developers in producing health apps that are legally compliant and in keeping with high professional standards of user protection. Methods We conducted a case study analysis of the Australian and related international policy environment for mental health apps to identify relevant sectors, policy actors, and policy solutions. Results We identified 29 policies produced by governments and non-government organisations that provide oversight of health apps. In consultation with stakeholders, we developed an interactive tool targeted at app developers, summarising key features of the policy environment and highlighting legislative, industry and professional standards around seven relevant domains: privacy, security, content, promotion and advertising, consumer finances, medical device efficacy and safety, and professional ethics. We annotated this developer guidance tool with information about: the relevance of each domain; existing legislative and non-legislative guidance; critiques of existing policy; recommendations for developers; and suggestions for other key stakeholders. Conclusions We anticipate that mental health apps developed in accordance with this tool will be more likely to conform to regulatory requirements, protect consumer privacy, protect consumer finances, and deliver health benefit; and less likely to attract regulatory penalties, offend consumers and communities, mislead consumers, or deliver health harms. We encourage government, industry and consumer organisations to use and publicise the tool.

Typhoid fever is a disease that maintains a social character throughout the 20th century, related to wars and economic inequalities. It was the subject of a legislative response from the State, which from the end of the 19th century until 1930, systematized science against typhoid fevers and their vaccination in the form of large campaigns whose result was the progressive decrease in incidence, morbidity and mortality until its eradication practice. The research that concerns us refers to a sociohistorical and legislative study of the disease until the late 20s of the 20th in Spain. [ABSTRACT FROM AUTHOR]

The frequency of legislation changes and their utility is a subject of interest and always under debate with pro and contra arguments. In the current study, the perception of students regarding medical legislation changes was analyzed. In general, no statistically signifi- cant differences were found between the sub-groups of students, thus underlining a unitary perception. The general perception is that changes in legislation are made too often. Moreover, only a small part of the analyzed group agrees on the utility of these changes. Finally, it seems that income is the main driver for students as future employees in the medical system. Also, significant differences between males and females' perceptions are emphasized, and legislation changes should take into account the primary drivers. Other issues, such as corruption, stability, and performances should be the key points in legislation changes. These results should be a challenge for all stakeholders, in particular for policymakers. [ABSTRACT FROM AUTHOR]

Access to health is one of the basic pillars of the Spanish welfare state. Since the late 1970s, legislative changes introduced have modified both access conditions and the degree of state coverage of pharmaceutical products. Since the late 1970s, legislative changes have been introduced that have modified both the conditions of access and the degree of state coverage of pharmaceutical products. The pharmaceutical co-payment system established in Spain has undergone recent substantial changes in both drug coverage and the economic contribution to access them. This research aims to know the implications of these reforms in the population and determine the most affected profiles. The approach to the object of study has been made following a methodological pluralism. Main legislative changes and data sources related to the access to pharmaceutical products were analyzed. Results confirm the lack of progressivity of the legal reforms concerning the health co-payment. Furthermore, they show an increase in the difficulties of access to prescribed medicines for the most vulnerable people, in this case, women and those households with lower income. [ABSTRACT FROM AUTHOR]

Background In many parts of the world, ongoing deficiencies in health systems compromise the delivery of health interventions. The World Health Organization (WHO) identified four functions that health systems need to perform to achieve their goals: Efforts to strengthen health systems focus on the way these functions are carried out. While a number of studies on health systems functions have been conducted, the stewardship function has received limited attention. In this article, we evaluate the extent to which the Botswana Ministry of Health (MoH) undertook its stewardship role. Methods We used the WHO Health Systems Performance Assessment Frame (HSPAF) to guide analysis of the stewardship function of the Botswana’s MoH focusing on formulation of national health policies, exerting influence through health regulation, and coalition building. Data were abstracted from published and unpublished documents. We interviewed 54 key informants comprising staff of the MoH (N = 40) and stakeholder organizations (N = 14). Data from documents was analyzed through content analysis. Interviews were transcribed and analyzed through thematic analysis. Results A lack of capacity for health policy development was identified. Significant policy gaps existed in some areas. Challenges were reported in policy implementation. While the MoH made efforts in developing various statutes that regulated different aspects of the health system, some gaps existed in the regulatory framework. Poor enforcement of legislation was a challenge. Although the MoH had a high number of stakeholders, the mechanisms for stakeholder engagement in the planning processes were weak. Conclusion Problems in the exercise of the stewardship function posed challenges in ensuring accountability and limited the health system’s ability to benefit from its stakeholders. Ongoing efforts to establish a District Health System under control of the MoH, attempts to improve service delivery at a national level and political will to strengthen public-private engagement mechanisms are some of the prospects that can improve the MoH’s stewardship function.

Introdução: Este estudo trata da efetividade das ações de Vigilância Sanitária (VISA) municipal em relação ao cumprimento da Resolução da Diretoria Colegiada (RDC) nº 302/2005 no contexto de laboratórios clínicos (LC) jurisdicionados à Superintendência Regional de Saúde de Patos de Minas, Minas Gerais (SRS/PM/MG). Objetivos: Buscou-se verificar se a VISA, ao liberar o alvará sanitário, tem cumprido as exigências de onze itens da referida RDC. Método: Os dados foram obtidos de 181 relatórios anuais de inspeção sanitária realizados de 2006 a 2013. A análise se deu por meio de frequências simples e por cruzamento de dados. Resultados: As ações de VISA mostraram-se incipientes nos anos de 2006 e 2007. A partir do ano de 2008, constatou-se um aumento significativo dessas ações, que foram menos efetivas em relação ao cumprimento de itens que estão sobremaneira ligados à acurácia dos exames laboratoriais e à segurança dos funcionários e dos pacientes. Conclusão: Essa falta de efetividade das ações de VISA pode ser considerada grave e revela problemas vivenciados pela equipe de VISA que devem ser investigados a fim de que essa situação seja solucionada oferecendo, assim, mais qualidade na prestação de serviços dos LC à população. ======================================= Introduction: This study focused on the effectiveness of municipal Sanitary Surveillance actions carried out in the context of clinical laboratories under the jurisdiction of the Regional Health Superintendence of Patos de Minas, state of Minas Gerais, Brazil. Objective: To verify if the Sanitary Surveillance followed eleven regulations set forth by Resolution No. 302/2015 of the Collegiate Board of Directors of the Brazilian Health Surveillance Agency when issuing sanitary permits to such laboratories. Methods: Data were collected from 181 annual health inspection reports from 2006 to 2013. Simple frequency and cross-checking analyses were carried out to treat data. Results: Sanitary Surveillance actions were still incipient in years 2006 and 2007. From 2008 on, however, there has been a significant increase in such actions, although they have shown to be less effective when it comes to compliance with items that are closely related to accuracy of laboratory tests and to the safety of patients and staff. Conclusion: the lack of effectiveness concerning Sanitary Surveillance actions is serious and brings out problems experienced by its team. Such problems ought to be investigated and resolved in order to improve the quality of the services provided by clinical laboratories.

O objetivo deste trabalho foi avaliar se as bulas de medicamentos fitoterápicos industrializados estão de acordo com a legislação nacional vigente. Foram analisadas 41 bulas dos medicamentos fitoterápicos compostos por alcachofra, castanha da Índia, ginkgo e sene, adquiridas nos sites das empresas titulares dos registros. A análise foi feita quanto à presença de itens segundo a RDC nº 47 de 2009 e ao conteúdo de indicação de uso, posologia e reações adversas comparada às bulas padrão e à literatura científica. A análise quantitativa provou que as bulas têm cumprido o que é exigido pela legislação vigente. No entanto, quanto à análise qualitativa, todos os fitoterápicos analisados neste trabalho possuíam pelo menos uma bula com erro relacionado à posologia, indicações de uso e reações adversas. Houve uma melhora gradativa das bulas dos medicamentos fitoterápicos, porém mesmo com as bulas padrão ainda existem erros, que podem induzir o paciente ao uso incorreto do medicamento. -----------------------------------------------------------------------------------------------The objective of this study was to assess whether the package inserts of industrialized phytomedicines are in line with current Brazilian legislation or not. Forty-one package inserts of phytomedicines containing artichoke, horse chestnut, ginkgo and senna were accessed in the respective proprietary websites and then analyzed. The analysis aimed to verify the presence of items required by the normative RDC 47/2009 and the usage indication, dosage and side effects compared to standard package inserts and to the scientific literature. Quantitative analysis proved that the package inserts are in accordance with the current legislation. However, in qualitative analysis, all phytomedicines analyzed in this study had at least one error related to dosage, posology or adverse reactions. A gradual improvement of the package inserts of phytomedicines has been noticed but, even with the availability of standard package inserts, some mistakes persist, which can induce the patient to incorrect use.

Objective. The objective of this study is to prepare a "Concept Map on Health and Intellectual Property in Central America and the Dominican Republic" in order to help identify the main access barriers to health, especially medicines, and to guide state authorities toward actions to improve the efficiency and effectiveness of policies. Methods. The report "Concept Map on Public Health and Intellectual Property, Regional Perspective: Central America and the Dominican Republic" was analyzed. Then the knowledge generation and management methodology was applied and a search strategy was identified to recover the information for preparation of the concept maps. Results. The legal framework and institutional structure, as well as policies, programs, plans, and strategies for health and intellectual property, were identified. A set of barriers that hinder access to medicines was also identified, as well as solutions to overcome them. Conclusions. In Central America and the Dominican Republic, health strategies, policies, programs, and plans are in place, but unfortunately their scope and degree of dissemination is uneven. This, together with social and economic factors, explains why health inequity persists between and within countries. The identified barriers to access to medicines included the expansion and strengthening of the rights of pharmaceutical patent-holders, problems with implementing the flexibilities of the Agreement on Trade-related Aspects of Intellectual Property Rights, pricing policies, and strict regulatory standards. [ABSTRACT FROM AUTHOR]

Purpose: To carry out a reflection on the oral health policies of oral health in the Argentine Republic. Methods: Oral health policies, their pertinence and relevance in the context of the national health system, current legislation, and epidemiological background in Argentina are analyzed. Special mention is made to the characteristics of dentistry in a federal country and its particular social, geographical, economic and institutional conditions. Conclusion: Recommendations and lines of action are proposed with the premise of constituting oral health as a State policy. It is concluded that it is a priority to achieve joint participation of all political, social, economic, academic and health service providers to optimize oral health care for all its inhabitants, with an emphasis on the most vulnerable. [ABSTRACT FROM AUTHOR]

Organ transplantation represents one of the most successful chapters in the history of world health. This therapeutic practice is no longer associated, as once, with the risk of the procedure, but with the opportunity to offer a new life to the recipient. The transplant depends on the acceptance of the donation of organs that, by involving aspects related to life and death, implies ethical dilemmas that stimulate the formulation of norms in this regard. This study aimed to reflect on the evolution of Brazilian legislation that regulates the National Transplant System in regard to the donation-transplant process, focusing on the bioethical aspects associated with the subject. It was identified that the understanding of health legislation encourages action based on fundamental rights and human dignity by the health professional. From this perspective, it is essential that health professionals possess, in addition to technical knowledge, legal knowledge and understanding of existing norms and their evolution, in order to guarantee the fundamental rights of people. [ABSTRACT FROM AUTHOR]

A biotecnologia aplicada à saúde necessita de células humanas para controle de qua-lidade de produtos e para análise toxicológica das moléculas que entram em contato com o corpo humano. Métodos alternativos validados promovem redução e substituição do uso de animais nos ensaios toxicológicos, mas a legislação brasileira referente ao uso de material biológico humano não prevê disponibilização de células com qualidade controlada e certificada.A análise crítica da legislação brasileira sobre vias de acesso legal a materiais bio-lógicos humanos para obtenção, caracterização e disponibilização de células humanas, abrangendo o período da Constituição Federal de 1988 até o mês de maio de 2014, evidencia que a sociedade Brasileira carece de regulamentação para coleta e uso de material biológico humano incluindo o fornecimento de células para fins terapêuticos ou para utilização na aplicação dos métodos alternativos.Propomos como modelo para disponibilização de materiais biológicos humanos como células, tecidos, órgãos ou partes do corpo humano para fins de pesquisa, ensaios toxi-cológicos e uso terapêutico o mesmo modelo de oferta do excedente de sangue e seus derivados. ------------------------------------------------------------------------------ Biotechnology applied to health requires human cells for quality controls of products and for toxicological assessment of molecules that enter in contact with human body. Validated alternative methods allowed reduction and/or replacement of animal use in toxicology, but the Brazilian legislation on the use of biological materials of human ori-gin does not provide human cells with controlled and certified quality.The critical analysis conducted in the Brazilian’ legislation on legal ways of access to human biological materials for obtaining, characterization and availability of hu-man cells, from the period of the Federal Constitution in 1988 until May 2014, showed that Brazilian society lacks rules for collection and use of human biological materials, including supply of cells, either for therapeutic use or for in vitro assays including the alternative methods for toxicology.We propose a model for providing human biological materials such as cells, tissues, organs or body parts for research, toxicological or therapeutic use similar to the model of the surplus production of blood and its derivatives.

O rótulo é o primeiro elemento informativo do medicamento a ser visualizado pelo usuário no momento da compra. A padronização dos rótulos é fundamental para a promoção do uso racional de medicamentos. A Agência Nacional de Vigilância Sanitária (ANVISA) é a responsável pela regulação de medicamentos no Brasil. Um total de 100 rótulos de medicamentos fitoterápicos industrializados foi analisado para verificar sua adequação às normas sanitárias, em especial à RDC no 71/09. A presença dos itens gerais exigidos pela norma foi conferida com o auxílio de uma planilha de verificação da rotulagem. O levantamento mostrou resultados positivos, visto que a maioria dos itens estava em conformidade com a RDC citada. Os itens mais ausentes nos rótulos foram o nome comercial escrito em Braille e a frase “Medicamento fitoterápico”. Como o prazo legal para adequação à norma foi suspenso, encontram-se no mercado medicamentos fitoterápicos cujos rótulos ainda estão inadequados. Grande parte dos medicamentos analisados apresentava registro sanitário válido, o que garante à população acesso a produtos com segurança, qualidade e eficácia. ---------------------------------------------------------------------------- The labeling is the first information of drug visualized by the user at time of purchase. The standardization of labeling is important to promote rational use of medicines. The National Health Surveillance Agency (ANVISA) is responsible for drug regulation in Brazil. A total of 100 labels of manufactured herbal medicines was analyzed to verify its suitabi-lity to the sanitary legislation, especially, RDC no. 71/09. The presence of general items required by the norm was analyzed with the help of a labeling verification worksheet. The survey showed positive results since most items were in accordance with the Brazilian legislation. The most absent items on labels were the drug trade name in Braille and the phrase “Herbal Medicine.” As the legal deadline for compliance with the rule was suspended, there are in the market herbal medicines whose labels are still inadequate. Among the herbal medicines analyzed, most had valid sanitary registration, which gua-rantees the public access to products with safety, quality and efficacy.

Objetivo: explorar la atención de las urgencias médicas de los pacientes con inconsistencias en la afiliación al Sistema General de Seguridad Social en Salud (sgsss), en diferentes IPS de Medellín en el año 2012. Metodología: Se realizó una investigación cualitativa aplicando la Teoría Fundamentada; se realizaron 20 entrevistas semiestructuradas al personal de salud que laboraba en los servicios de urgencias y a pacientes con inconsistencias en la afiliación al sgsss. Resultados: existe incumplimiento de la normatividad que regula la prestación de los servicios de urgencias, convirtiendo los procesos administrativos en barreras para el acceso y la atención de las urgencias médicas, lo que deriva en atenciones carentes de integralidad. Conclusión: es necesario que los organismos de vigilancia del sgsss garanticen el cumplimiento de la normatividad vigente; además se requiere de un cambio en la legislación que supere los vacíos normativos, y una transformación en la forma de vinculación de los ciudadanos al sistema de salud que garantice el acceso universal y la atención integral de manera independiente de la estabilidad de las relaciones laborales Objective: to explore the healthcare provided for medical emergencies to patients with inconsistencies in their affiliation with the General System of Social Health Security (gsshs) in various Health Providing Institutions (hpi) of Medellin in 2012. Methodology: we conducted a qualitative study using Grounded Theory. Twenty semi-structured interviews were applied to healthcare professionals working at emergency departments and to patients with inconsistencies in their gsshs affiliation. Results: there is non-compliance with the regulations governing the provision of emergency services, which turns the administrative processes into barriers preventing access to the system and for providing healthcare in medical emergencies; this ultimately results in a lack of comprehensive healthcare. Conclussion: It is therefore necessary that the gsshs monitoring organizations ensure compliance with the current regulations. Likewise, a change in the legislation is required to bridge the legal gaps as well as a transformation in the way in which the citizens affiliate with the health system. Such transformation should also guarantee universal access and comprehensive care and must be independent from the stability of work relationship

Perhaps originating from the Hispaniola Island, an epidemic of syphilis arose in 1495 in the Old Continent, and ravaged it for 20-25 consecutive years. Given the proliferation of vernacular and medical names assigned to Morbus Gallicus, this review addresses the discriminatory and racist role of these synonyms, and the implementation of public health legislation and quarantine to contain its spread. Also the controversy about its geographical origin and its possible presence in Europe before the discovery of America are discussed, as well as the disputes and mistakes concerning the nature, etiology and taxonomy of the newly discovered pathogen -Treponema pallidum-.

Objective. Compare World Health Organization (WHO) guidelines for contraception in a human rights framework with the existing regulatory frameworks of Bolivia, Colombia, and Uruguay and evaluate which aspects of those regulations need to be developed. Methods. A systematic analysis was based on the WHO analytical framework "Ensuring human rights in the provision of contraceptive information and services: Guidance and recommendations" to determine whether the legislation of Bolivia, Colombia, and Uruguay contain general references to the population, specific references to adolescents, or do not refer to the topic. To this end, 36 documents related to contraception were analyzed: 9 from Bolivia, 15 from Colombia, and 12 from Uruguay. Results. It was confirmed that each country's legislation complies with several WHO recommendations. The three countries have strengths in nondiscrimination and in opportunity for informed decision-making, and have weaknesses in accessibility, quality, and accountability. Acceptability is a strength in Colombia and Bolivia, and confidentiality is a strength in Bolivia and Uruguay. Colombia has weaknesses in availability, confidentiality, and participation. Conclusions. Comparison of national legislation with WHO guidance helps to see the strengths and weaknesses of national regulatory frameworks and to see opportunities to improve regulations. [ABSTRACT FROM AUTHOR]

Background: Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are emergent. Health apps are regulated in order to minimise their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment. We aimed to produce a comprehensive guide to assist app developers in producing health apps that are legally compliant and in keeping with high professional standards of user protection.Methods: We conducted a case study analysis of the Australian and related international policy environment for mental health apps to identify relevant sectors, policy actors, and policy solutions.Results: We identified 29 policies produced by governments and non-government organisations that provide oversight of health apps. In consultation with stakeholders, we developed an interactive tool targeted at app developers, summarising key features of the policy environment and highlighting legislative, industry and professional standards around seven relevant domains: privacy, security, content, promotion and advertising, consumer finances, medical device efficacy and safety, and professional ethics. We annotated this developer guidance tool with information about: the relevance of each domain; existing legislative and non-legislative guidance; critiques of existing policy; recommendations for developers; and suggestions for other key stakeholders.Conclusions: We anticipate that mental health apps developed in accordance with this tool will be more likely to conform to regulatory requirements, protect consumer privacy, protect consumer finances, and deliver health benefit; and less likely to attract regulatory penalties, offend consumers and communities, mislead consumers, or deliver health harms. We encourage government, industry and consumer organisations to use and publicise the tool. [ABSTRACT FROM AUTHOR]

THE HEALTH LEGISLATION OF THE ROMANIAN OLD KINGDOM CONSISTED OF THE MAIN HEALTH LAWS OF 1874 AND 1910, AS WELL AS OF OTHER HEALTH LAWS, GENERAL HEALTH REGULATIONS AND LOCAL HEALTH REGULATIONS. WITHIN THE FRAMEWORK OF THE HEALTH LEGISLATION, THE HEALTH LAWS REPRESENTED ONLY A SMALL PART OF THE LEGISLATION. THEREFORE, THE HEALTH LEGISLATION WAS COMPLETED BY THE HEALTH REGULATIONS WHICH ARE MORE NUMEROUS AND AS IMPORTANT AS THE LAWS. THE GENERAL HEALTH REGULATIONS WERE ISSUED BY THE LOCAL AUTHORITIES, - SUCH AS THE HOSPITALS' ADMINISTRATIONS, THE URBAN COUNTY AND COMMUNAL COUNCILS - AND THEY WERE APPLICABLE TO A WELL - DEFINED ADMINISTRATIVE UNIT, AFTER THEY HAD BEEN SANCTIONED BY THE EXECUTIVE POWER. [ABSTRACT FROM AUTHOR]

En 2002, Brasil se convirtió en el primer país de la región en implementar etiquetas de advertencias sanitarias con pictogramas en los paquetes de cigarrillos. Desde la adopción del CMCT de la OMS en 2005, otros nueve países adoptaron advertencias con pictogramas y seis más aprobaron legislación cuya implementación está pendiente. El contenido del mensaje y el estilo del pictograma varían entre los países. Diecisiete países prohibieron descriptores de marca y nueve requieren una advertencia cualitativa con información de constituyentes y emisiones. Un importante progreso se ha alcanzado en la región desde 2005. Sin embargo, los países ratificantes del CMCT aún no han implementado todas las recomendaciones de las Directrices del Artículo 11.In 2002, Brazil became the first country in the region to implement pictorial health warning labels on cigarette packages. Since the adoption of the FCTC/WHO in 2005, nine more countries adopted pictorial labels and six passed legislation that is pending of implementation. The message content and the picture style vary across countries. Seventeen countries have banned brand descriptors and nine require a qualitative label with information on constituents and emissions. Since 2005, important progress has been achieved in the region. However, countries that have ratified the FCTC have not yet implemented all the recommendations of Article 11 Guidelines.

O artigo analisa as atuações dos Poderes Legislativo e Executivo no Brasil quanto à formulação de propostas políticas para a saúde, no âmbito legislativo, a partir do ano de 1990. Para tanto, identifica-se a produção legislativa em saúde aprovada pelo Congresso Nacional no período de 1990 a 2006. Os documentos foram analisados por tipo, autoria, tempo de tramitação e temática, considerando o contexto político-institucional. O estudo mostra que o Poder Executivo aprovou 89,8% das matérias em saúde, editou matérias orçamentárias, modificando o orçamento aprovado, e garantiu um tempo de tramitação para matérias de sua autoria seis vezes mais acelerado do que nas matérias de autoria do Legislativo. Conclui-se que o processo político encontra-se desbalanceado, com um Executivo que concentra poder e que assume o papel principal de filtro das demandas políticas propostas para a saúde, refletindo uma forma ainda pouco madura das instituições no processo democrático.This article analyzes the submission of health policy bills by the Legislative and Executive Branches in the Brazilian National Congress, since 1990. The study analyzes the health legislation passed by the National Congress from 1990 to 2006. The bills were analyzed by type, authorship, review time, and thematic content, considering the political and institutional context. The Executive Branch passed 89.8% of its health bills, submitted budget issues and modified the approved budget, and ensured review and passage of its own bills six times faster than bills submitted by the Legislative itself. In conclusion, the policy process is imbalanced, with power concentrated in the Executive, with the latter assuming the main role of filtering health policy demands, thus reflecting a persistently immature approach for institutions in the democratic process.

No Brasil, a bula é usada como fonte de informação sobre medicamentos. O estudo desenvolveu uma análise de sua evolução histórica, procurando observar a influência do desenvolvimento científico, da globalização da informação e das diferentes políticas de saúde. Procedeu-se uma revisão retrospectiva da legislação sanitária brasileira até 1920, ano da instituição do Departamento Nacional de Saúde Pública. A análise documental sobre a evolução da regulamentação sanitária no Brasil se iniciou pela Coleção Farmácia Brasileira - Portarias Sanitárias. Na segunda etapa as normas foram pesquisadas nos portais: VISALEGIS - Legislação em Vigilância Sanitária, Portal de Legislação do Sistema de Informações do Congresso Nacional e Sistema de Legislação da Saúde - Saúde Legis. A bula tornou-se um importante veículo informativo no Brasil, passou por profundas transformações regulamentares na segunda metade do século XX. Entre 1946 e 2006 o número de itens obrigatórios aumentou e sua descrição aprofundou. Entretanto, a padronização da informação para os medicamentos com o mesmo princípio ativo não se efetivou, não obstante sua importância e apesar das diferentes iniciativas observadas nas normas legais.In Brazil, package inserts provide key information on pharmaceuticals. The current study analyzes the evolution of package inserts and the impact on this process by scientific research and development, globalization of information, and various health policies. The study began with a retrospective review of Brazilian health legislation until 1920, the year when the National Public Health Department was created. The analysis of documents on the evolution of health regulation in Brazil began with the Brazilian Pharmaceutical Collection - Health Rulings. The second stage of the study involved a search of standards and norms in VISALEGIS: Health Surveillance Legislation, Portal for Legislation from the National Congressional Information System and the Health Legislation System. Package inserts became an important vehicle for information in the country and underwent important regulatory changes in the latter half of the 20th century. From 1946 to 2006, the number of mandatory items increased, with more in-depth description. However, the standardization of information for medicines with the same active ingredient failed to materialize, despite its importance and the various legal initiatives in this direction.