Migración en Venezuela, marco normativo e indicadores 2000- 2022 / Migration in Venezuela, regulatory framework and indicators 2000 - 2022

El objetivo fue describir el estado actual del marco normativo de migración, y la tendencia de indicadores de población y migración en Venezuela en el periodo 2000-2022.Métodos: Estudio descriptivo del marco normativo de migración y la tendencia de indicadores de población y migración en Venezuela. Indicadores: población total, tasa de dependencia demográfica (total, niñez, adulto mayor) y tasa de migración. Fuentes de datos: plataforma informativa salud y migración(marco normativo), Anuario estadístico de América Latina y el Caribe año 2000 al 2022 (indicadores de población).Resultados: El marco normativo de la migración en Venezuela está contenido en escasas leyes y Convenios Internacionales y regionales. La variación porcentual en la población venezolana fue descendente durante casi todo el periodo, donde se presentan incluso valores negativos para 2018-2021. La tasa anual decrecimiento poblacional, demostró un descenso constante y marcado desde el año 2000 hasta el año 2018, con altos valores negativos, luego asciende mostrando valores positivos a partir del año 2022, con un valor equivalente al año 2000. Conclusiones: El marco legal migratorio en Venezuela, es deficitario y no acorde a las necesidades de los migrantes. Los cambios ocurridos en la población venezolana de 2000 a 2022 fue debido a varios factores, siendo de gran impacto el fenómeno migratorio. La tasa de migración en Venezuela muestra tendencia negativa lo que indica que el país pierde población.

Objective Describe the current state of the regulatory framework for migration and the trend of populationand migration indicators in Venezuela for the period2000-2022. Methods: Descriptive study of the regulatory framework for migration and the trend of population andmigration indicators in Venezuela. Sample of national and international documents (regulatory framework). Indicators: total population, demographic dependency rate (total,childhood, elderly) and migration rate. Data sources: health andmigration information platform (regulatory framework) LatinAmerica and the Caribbean Statistical Yearbook 2000 to 2022(population indicators) Results: The regulatory framework formigration in Venezuela is contained in few international andregional laws and agreements. The percentage variation in the Venezuelan population was downward during almost the entireperiod, where even negative values are presented for 2018-2021.The annual rate of population growth showed a constant andmarked decrease from the year 2000 to the year 2018 with highnegative values, then it ascends showing positive values from theyear 2022 with a value equivalent to the year 2000. Conclusions:The migratory legal framework in Venezuela is deficient anddoes not meet the needs of migrants. The changes that haveoccurred in the Venezuelan population from 2000 to 2022 wasdue to several factors, the migratory phenomenon being of greatimpact. the migration rate in Venezuela shows a negative trend,which indicates that the country is losing population.

Regulatory and operational challenges in conducting Asian International Academic Trial for expanding the indications of cancer drugs.

There are many differences between Asian regions in terms of the regulatory requirements and operational procedures in conducting international academic clinical trials for the approval of new drugs. The National Cancer Center Hospital in Japan has launched an international investigator-initiated registration-directed trial (IIRDT) in Japan, Korea, Taiwan, and Singapore, aiming at obtaining pharmaceutical approval in participating regions. Differences in regulatory and operational procedures were identified while coordinating the trial. In Japan, regulatory authority reviews should be performed after approval by institutional review boards for IIRDT, whereas in other regions these can be done in parallel. There were disparities in Good Manufacturing Practice-related documents between regions. Several differences were found regarding investigational product (IP) management, specifically concerning labeling, import/export procedures, and customs clearance costs. On the other hand, safety reporting procedures were relatively well-harmonized in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH-E2A). Regions also differed in per-patient costs, due to varying regulations for academic registration-directed trials. In conclusion, the observed differences among Asian regions should be harmonized to facilitate international academic trials in Asia and thus resolve unmet patient needs worldwide. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? International clinical trials have become common because they make it possible to accrue patients faster and obtain new drug approval in wider areas. However, pharmaceutical regulatory differences hinder the efficient conduct of international clinical trials, especially in academia. WHAT QUESTION DID THIS STUDY ADDRESS? We conducted an academic international clinical trial on new drug applications in four Asian countries and clarified pharmaceutical regulatory differences and operational difficulties. WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? The study identified differences between countries in terms of regulatory affairs, institutional review board (IRB) review processes, investigational new drug (IND) dossiers, investigational product (IP) management procedures, and clinical trial costs, while safety reporting procedures were relatively harmonized. Japan utilizes investigator-initiated registration-directed trials, an advanced regulatory system for new drug application by academia, but the other countries do not. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? Harmonization of pharmaceutical regulations and trial initiation procedures, and regulatory reform of clinical trial costs are important to accelerate academic international clinical trials for new drug applications.

Exploration of Policy Makers' Views on the Implementation of the Framework Convention on Tobacco Control in the Gambia: A Qualitative Study.

BACKGROUND: The World Health Organization's Framework Convention on Tobacco Control (FCTC) is the first international health treaty and has now been ratified by 181 countries. However, there are concerns that in many countries, particularly in sub-Saharan African countries, FCTC legislations and implementation are weak. In this study, we report a qualitative study undertaken to assess policy makers' awareness of the FCTC and national tobacco control policies, and assessed the achievements and challenges to the implementation of the FCTC in the Gambia. METHODS: The study involved semi-structured one-to-one interviews with 28 members of the National Tobacco Control Committee in the Gambia, which is responsible for formulating tobacco control policies and making recommendations for tobacco control. We used the Framework method and NVivo11 software for data analysis. RESULTS: Our findings demonstrate that the Gambia has made modest progress in tobacco control before and since ratification of the FCTC, particularly in the areas of policy formulation, bans on tobacco advertising and promotion, smoke-free laws, and tobacco taxation. Although several pieces of tobacco control legislation exist, enforcement and implementation remain a major challenge. We found that policy makers' awareness of polices covered in the FCTC was limited. CONCLUSION: Our findings highlight several challenges to the FCTC implementation and the need to step up efforts that will help to accomplish the obligations of the FCTC. To achieve the obligations of the FCTC, the Gambia should develop specific public awareness interventions, establish cessation services, mobilize adequate resources for tobacco control and strengthen tobacco surveillance and research.

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate.

Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of research-absent in the GDPR-which can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational self-determination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy.

Therapeutic food claims: a global perspective.

PURPOSE OF REVIEW: Medical foods in the United States, and foods for special medical purposes in other countries, are food formulations used to manage specific chronic diseases or conditions under medical or physician supervision. The process of reviewing and approving food claims for health benefits varies widely from country to country. RECENT FINDINGS: CODEX Alimentarius, a 187-country and one-member (European Union) organization, has standardized not only nutrition labeling and food safety worldwide but has also recently taken on a prominent role in analyzing therapeutic and health claims for food in member countries by providing a framework to study these issues. Two recent activities at CODEX - analyzing foods for special dietary uses and foods for special medical purposes therapeutic food claims - have focused on both how these food categories are formulated for patients with specific conditions and diseases. SUMMARY: Food and specially formulated foods can play a role in preventing or mitigating disease and other health-related conditions. This article will examine the means by which regulatory authorities across the globe address health claims for foods and food-derived products to alter human physiology and disease outcome.

El Convenio Marco para el Control del Tabaco de la Organización Mundial de la Salud / The Framework Convention on Tobacco Control of the World Health Organization

Resumen El Convenio Marco para el Control del Tabaco (CMCT) es el primer tratado internacional, negociado bajo el amparo de la OMS como respuesta coordinada a la pandemia del tabaco y fue aprobado en la 56a Asamblea Mundial de la Salud, en mayo de 2003, por unanimidad. Fue suscrito por Chile el 25 de septiembre de 2003 en la sede las Naciones Unidas en Nueva York y ratificado el 13 de junio de 2005 para entrar en vigencia con carácter de ley, el 11 de septiembre de 2005. A partir de esa fecha el marco regulatorio del tabaco en Chile está dado por: • El CMCT; • El Decreto Ley 828 (27/12/1978), que regula temas relacionado con producción y comercialización del tabaco. • La Ley 19.419 (del 6/09/1995), que regula publicidad, promoción, patrocinio y ambientes libres de humo, entre otros. Si bien en nuestro país la legislación para el control del tabaco evidencia una gran producción legislativa, se puede observar que ésta se ha focalizado en algunos temas específicos, quedan pendientes importantes materias establecidas en el CMTC, en las que es necesario avanzar: • Medidas de reducción de la demanda relativas a la dependencia y al abandono del tabaco; • Comisión Coordinadora Control del Tabaco: • Control del Comercio Ilícito.

The Framework Convention on Tobacco Control (FCTC) is the first international treaty, negotiated under the umbrella of WHO as a coordinated response to the tobacco pandemic, and was unanimously approved by the 56th World Health Assembly in May 2003. It was signed by Chile on september 25, 2003 at United Nations headquarters in New York and it was ratified on june 13, 2005 becoming a law, on september 11, 2005. Since that date the regulatory framework of tobacco in Chile is given by: • The WHO Framework Convention on Tobacco Control (FCTC); • Decree Law 828 (27/12/1978), which regulates issues related to the production and commercialization of tobacco; • Law 19.419 (of 09/09/1995), which regulates advertising, promotion, sponsorship and smoke-free environments, among others. Although our country shows a big legislative production, it can be observed that this one has focused on some specific subjects, important matters are still pending established in the CMTC, in which it is necessary to advance: • Demand reduction measures related to tobacco dependence and cessation; • Tobacco Control Coordinating Committee: • Control of Illicit Trade.

[Principles of the EU Clinical Trials Regulation No 536/2014 : What will change?] / Grundzüge der EU-Verordnung 536/2014 : Was wird sich ändern?

The new Regulation (EU) No. 536/2014 for clinical trials of medicinal products for human use will replace the still valid European Directive 2001/20/EC in the future. The new regulation aims to further harmonise authorisation and reporting procedures for clinical trials and introduces of a joint European assessment for multinational clinical trials in the EU. Despite the joint assessment administered by a reporting member state, each member state continues to authorise clinical trial applications nationally. In the future, applications and any communication will be submitted paperlessly via a new electronic EU portal, which is still being developed. The regulation provides detailed information on the implementation of multinational clinical trials. In particular, the complex processing procedures and shorter time limits are to be stressed in comparison to the previously valid regulations. This is a major challenge for all stakeholders, but on the other hand it should contribute to the future role of the EU in the development of innovative medicines.

The global health law trilogy: towards a safer, healthier, and fairer world.

Global health advocates often turn to medicine and science for solutions to enduring health risks, but law is also a powerful tool. No state acting alone can ward off health threats that span borders, requiring international solutions. A trilogy of global health law-the Framework Convention on Tobacco Control, International Health Regulations (2005), and Pandemic Influenza Preparedness Framework-strives for a safer, healthier, and fairer world. Yet, these international agreements are not well understood, and contain gaps in scope and enforceability. Moreover, major health concerns remain largely unregulated at the international level, such as non-communicable diseases, mental health, and injuries. Here, we offer reforms for this global health law trilogy.

Trade liberalization and social determinants of health: A state of the literature review.

The health impacts of trade liberalization are often described in relation to access to medicines, changing dietary patterns, tobacco use and alcohol consumption. The impacts of trade liberalization on the social determinants of health (SDH), are by contrast, less well known. Missing is an account of how liberalizing processes identified across different research areas relate to each other and how the association between trade liberalization and health is conceptualized within each of them, especially with reference to SDH. This paper presents a systematic review which provides a more complete picture of the pathways between trade liberalization and health, with special attention to SDH pathways. This picture captures the interrelationships between different areas of investigation, along with current limitations of our understanding and recommendations for future research.

Trade law and alcohol regulation: what role for a global Alcohol Marketing Code?

BACKGROUND AND AIMS: Following calls for restrictions and bans on alcohol advertising, and in light of the tobacco industry's challenge to Australia's tobacco plain packaging measure, a tobacco control measure finding support in the World Health Organization (WHO) Framework Convention on Tobacco Control, this paper considers what role, if any, an international alcohol marketing code might have in preventing or reducing the risk of challenges to domestic alcohol marketing restrictions under trade rules. METHODS: Narrative review of international trade and health instruments and international trade court judgements regarding alcohol products and marketing restrictions. FINDINGS: The experience of European trade courts in the litigation of similar measures suggests that World Trade Organization rules have sufficient flexibility to support the implementation of alcohol marketing restrictions. However, the experience also highlights the possibility that public health measures have disproportionate and unjustifiable trade effects and that the ability of a public health measure to withstand a challenge under trade rules will turn on its particular design and implementation. CONCLUSION: Measures implemented pursuant to international public health instruments are not immune to trade law challenges. Close collaboration between health policymakers, trade officials and lawyers, from as early as the research stage in the development of a measure to ensure a robust evidence base, will ensure the best chance of regulatory survival for an international marketing code.

International codes and agreements to restrict the promotion of harmful products can hold lessons for the control of alcohol marketing.

Background and aims The 2011 UN Summit on Non-Communicable Disease failed to call for global action on alcohol marketing despite calls in the World Health Organization (WHO) Global Action Plan on Non-Communicable Diseases 2013-20 to restrict or ban alcohol advertising. In this paper we ask what it might take to match the global approach to tobacco enshrined in the Framework Convention on Tobacco Control (FCTC), and suggest that public health advocates can learn from the development of the FCTC and the Code of Marketing on infant formula milks and the recent recommendations on restricting food marketing to children. Methods Narrative review of qualitative accounts of the processes that created and monitor existing codes and treaties to restrict the marketing of consumer products, specifically breast milk substitutes, unhealthy foods and tobacco. Findings The development of treaties and codes for market restrictions include: (i) evidence of a public health crisis; (ii) the cost of inaction; (iii) civil society advocacy; (iv) the building of capacity; (v) the management of conflicting interests in policy development; and (vi) the need to consider monitoring and accountability to ensure compliance. Conclusion International public health treaties and codes provide an umbrella under which national governments can strengthen their own legislation, assisted by technical support from international agencies and non-governmental organizations. Three examples of international agreements, those for breast milk substitutes, unhealthy foods and tobacco, can provide lessons for the public health community to make progress on alcohol controls. Lessons include stronger alliances of advocates and health professionals and better tools and capacity to monitor and report current marketing practices and trends.

The Legal Strength of International Health Instruments - What It Brings to Global Health Governance?

Public health instruments have been under constant development and renewal for decades. International legal instruments, with their binding character and strength, have a special place in this development. The start of the 21st century saw, in particular, the birth of the first World Health Organization (WHO)-era health treaties - the WHO Framework Convention on Tobacco Control (WHO FCTC) and its first Protocol. The authors analyze the potential impact of these instruments on global health governance and public health, beyond the traditional view of their impact on tobacco control. Overall, the very fact that globally binding treaties in modern-era health were feasible has accelerated the debate and expectations for an expanded role of international legal regimes in public health. The impact of treaties has also been notable in global health architecture as the novel instruments required novel institutions to govern their implementation. The legal power of the WHO FCTC has enabled rapid adoption of further instruments to promote its implementation, thus, enhancing the international instrumentarium for health, and it has also prompted stronger role for national legislation on health. Notably, the Convention has elevated several traditionally challenging public health features to the level of international legal obligations. It has also revealed how the legal power of the international health instrument can be utilized in safeguarding the interests of health in the face of competing agendas and legal disputes at both the domestic and international levels. Lastly, the legal power of health instruments is associated with their potential impact not only on health but also beyond; the recently adopted Protocol to Eliminate Illicit Trade in Tobacco Products may best exemplify this matter. The first treaty experiences of the 21st century may provide important lessons for the role of legal instruments in addressing the unfolding challenges in global health.

To what extent does a tobacco carve-out protect public health in the Trans-Pacific Partnership Agreement?

In November 2015, negotiations of the Trans-Pacific Partnership Agreement came to a close with the release of the final text. It included an optional carve-out (exclusion) for tobacco control measures from the TPP's investor-state dispute settlement mechanism. Despite the apparent 'win' for the field of tobacco control, the limited scope of the carve-out provides only partial protection for public health regulatory measures.