Four ways blue foods can help achieve food system ambitions across nations.

Blue foods, sourced in aquatic environments, are important for the economies, livelihoods, nutritional security and cultures of people in many nations. They are often nutrient rich1, generate lower emissions and impacts on land and water than many terrestrial meats2, and contribute to the health3, wellbeing and livelihoods of many rural communities4. The Blue Food Assessment recently evaluated nutritional, environmental, economic and justice dimensions of blue foods globally. Here we integrate these findings and translate them into four policy objectives to help realize the contributions that blue foods can make to national food systems around the world: ensuring supplies of critical nutrients, providing healthy alternatives to terrestrial meat, reducing dietary environmental footprints and safeguarding blue food contributions to nutrition, just economies and livelihoods under a changing climate. To account for how context-specific environmental, socio-economic and cultural aspects affect this contribution, we assess the relevance of each policy objective for individual countries, and examine associated co-benefits and trade-offs at national and international scales. We find that in many African and South American nations, facilitating consumption of culturally relevant blue food, especially among nutritionally vulnerable population segments, could address vitamin B12 and omega-3 deficiencies. Meanwhile, in many global North nations, cardiovascular disease rates and large greenhouse gas footprints from ruminant meat intake could be lowered through moderate consumption of seafood with low environmental impact. The analytical framework we provide also identifies countries with high future risk, for whom climate adaptation of blue food systems will be particularly important. Overall the framework helps decision makers to assess the blue food policy objectives most relevant to their geographies, and to compare and contrast the benefits and trade-offs associated with pursuing these objectives.

Availability of medical abortion medicines in eight countries: a descriptive analysis of key findings and opportunities.

BACKGROUND: In recent years a growing number of manufacturers and medical abortion products have entered country markets and health systems, with varying degrees of quality and accessibility. An interplay of factors including pharmaceutical regulations, abortion laws, government policies and service delivery guidelines and provider's knowledge and practices influence the availability of medical abortion medicines. We assessed the availability of medical abortion in eight countries to increase understanding among policymakers of the need to improve availability and affordability of quality-assured medical abortion products at regional and national levels. METHODS: Using a national assessment protocol and an availability framework, we assessed the availability of medical abortion medicines in Bangladesh, Liberia, Malawi, Nepal, Nigeria, Rwanda, Sierra Leone and South Africa between September 2019 and January 2020. RESULTS: Registration of abortion medicines-misoprostol or a combination of mifepristone and misoprostol-was established in all countries assessed, except Rwanda. Mifepristone and misoprostol regimen for medical abortion was identified on the national essential medicines list/standard treatment guidelines for South Africa as well as in specific abortion care service and delivery guidelines for Bangladesh, Nepal, Nigeria, and Rwanda. In Liberia, Malawi, and Sierra Leone-countries with highly restrictive abortion laws and no abortion service delivery guidelines or training curricula-no government-supported training on medical abortion for public sector providers had occurred. Instead, training on medical abortion was either limited in scope to select private sector providers and pharmacists or prohibited. Community awareness activities on medical abortion have been limited in scope across the countries assessed and where abortion is broadly legal, most women do not know that it is an option. CONCLUSION: Understanding the factors that influence the availability of medical abortion medicines is important to support policymakers improve availability of these medicines. The landscape assessments documented that medical abortion commodities can be uniquely impacted by the laws, policies, values, and degree of restrictions placed on service delivery programs. Results of the assessments can guide actions to improve access.

Unsafe abortion is a leading cause of death and disability among women of reproductive age. Medical management of abortion with mifepristone and misoprostol pills, or just misoprostol, is a safe and effective way to end a pregnancy. Owing to an increase in the number of medical abortion products that have entered country health systems, we examined access to these medicines from supply to demand in selected countries. The overarching goal of the national landscape assessments was to produce evidence to support advocacy efforts and policymaking for improved access to quality medical abortion products that is appropriate to the needs of the country. This paper aims to describe key findings across eight country settings on the availability of medical abortion medicines and identify key opportunities to improve access to them across countries.

Freedom of Scientific Research and Embryo Protection Under Italian and European Court of Human Rights' Jurisprudence. Brief European Legislation Overview.

The paper addresses the issues of admissibility of human embryo research and the legal protection to be recognized, in light of the growing importance that scientific research has been gaining in the clinical and biomedical fields of embryonic stem cells for therapeutic purposes. As for human embryo experimentation, particularly on cryopreserved supernumerary embryos, European legislation varies, since the European Court has granted member States a wide margin of appreciation. Some countries, including Italy, have strict legislation protecting embryos from the fertilisation stage, whereas others have taken permissive approaches, allowing experimentation until 14 days after fertilisation. Science, however, has shown that the 14-day limit can be moved. The author finds it necessary to achieve broad international consensus and shared regulations. Lawmakers, however, need to balance respect for the principle of life, represented by the embryo, against scientific needs, in order to devise sound regulations safeguarding both apparently conflicting fundamental values.

Clarification of access regulations to genetic resources that are subject to the sovereign rights of sovereign states and the deposit of nomenclatural types under the International Code of Nomenclature of Prokaryotes.

One of the goals of the International Code of Nomenclature of Prokaryotes is not only to make nomenclature transparent and predictable, but to also make sure that the biological material on which it is based is available to either verify previous work or to allow further work to be undertaken. The key elements in ensuring the latter two aspects are nomenclatural types (type strains) at the rank of species and subspecies. With increasing regulations controlling access to genetic resources, the limitations put on access are not always evident at the time novel species or subspecies are proposed and corresponding nomenclatural types (type strains) designated. In a number of cases, limitations put on access have been discovered after the fact.

Is International Surrogacy the Lark's Glimmer?: When Covid-19 Reveals the Legal Insecurity of Surrogacy Use.

If globalisation has led to a greater mobility of people specific issues have emerged with the current coronavirus pandemic. Consequently, extreme measures have been taken worldwide to flatten the curb of the virus. From lockdowns to several levels of isolation these measures have worked undoubtedly for some situations. Nonetheless, these same measures have sown chaos in other situations. One good example is surrogacy especially when this practice is undergone overseas, revealing the legal insecurity of the use of surrogacy whether for the intended parents, the surrogate born child or the surrogate mother for whom the risks have heightened.

Legal capacities required for prevention and control of noncommunicable diseases.

Law lies at the centre of successful national strategies for prevention and control of noncommunicable diseases. By law we mean international agreements, national and subnational legislation, regulations and other executive instruments, and decisions of courts and tribunals. However, the vital role of law in global health development is often poorly understood, and eclipsed by other disciplines such as medicine, public health and economics. This paper identifies key areas of intersection between law and noncommunicable diseases, beginning with the role of law as a tool for implementing policies for prevention and control of leading risk factors. We identify actions that the World Health Organization and its partners could take to mobilize the legal workforce, strengthen legal capacity and support effective use of law at the national level. Legal and regulatory actions must move to the centre of national noncommunicable disease action plans. This requires high-level leadership from global and national leaders, enacting evidence-based legislation and building legal capacities.

Le droit est au cœur des stratégies nationales efficaces de lutte contre les maladies non transmissibles. Par droit, nous entendons les accords internationaux, les législations nationales et infranationales, les réglementations et autres instruments exécutifs, et les décisions des cours et des tribunaux. Cependant, le rôle vital du droit dans le développement de la santé à l'échelle mondiale est souvent mal compris, et éclipsé par d'autres disciplines telles que la médecine, la santé publique et l'économie. Cet article définit des domaines d'intersection clés entre le droit et les maladies non transmissibles, en commençant par le rôle du droit en tant qu'outil pour mettre en œuvre des politiques visant à prévenir et maîtriser les principaux facteurs de risque. Nous mettons en évidence des mesures que l'Organisation mondiale de la Santé et ses partenaires pourraient prendre pour mobiliser les professionnels du droit, renforcer les capacités juridiques et soutenir une utilisation efficace du droit au niveau national. Des mesures juridiques et réglementaires doivent être placées au centre des plans d'action nationaux pour la lutte contre les maladies non transmissibles. Cela nécessite un leadership de haut niveau de la part des dirigeants internationaux et nationaux, à travers l'adoption de lois fondées sur des données scientifiques et un renforcement des capacités juridiques.

La ley es la clave del éxito de las estrategias nacionales para la prevención y el control de las enfermedades no contagiosas. Por ley entendemos los acuerdos internacionales, la legislación nacional y subnacional, los reglamentos y otros instrumentos ejecutivos, así como las decisiones de los tribunales y las cortes de justicia. Sin embargo, el papel vital de la ley en el desarrollo de la salud mundial a menudo no se comprende bien y se ve eclipsado por otras disciplinas como la medicina, la salud pública y la economía. Este documento identifica las áreas clave de intersección entre la ley y las enfermedades no contagiosas, empezando por el papel de la ley como herramienta para implementar políticas de prevención y control de los principales factores de riesgo. Se determinan las medidas que la Organización Mundial de la Salud y sus asociados podrían adoptar para movilizar al personal legal, fortalecer la capacidad jurídica y apoyar el uso eficaz de la legislación a nivel nacional. Las acciones legales y reglamentarias deben pasar a ser el centro de los planes de acción nacionales para las enfermedades no contagiosas. Esto requiere un liderazgo de alto nivel por parte de los líderes mundiales y nacionales, para promulgar una legislación basada en pruebas y crear capacidades jurídicas.

Normalizing Tobacco? The Politics of Trade, Investment, and Tobacco Control.

Policy Points Tobacco industry denormalization is a key strategy for tobacco control that has been formalized in the WHO Framework Convention on Tobacco Control. International trade and investment laws are a potential threat to tobacco industry denormalization because they do not automatically incorporate denormalization and, in theory, treat tobacco firms like other commercial interests. Countries that seek to defend tobacco control policies against international trade and investment challenges need to have good governance in two senses: good governance as understood by tribunals and good-enough governance to manage the processes and requirements that enable policies to survive international challenges. CONTEXT: Tobacco industry denormalization (TID), portraying tobacco product manufacturers as a deadly industry, is a major strategy for public health advocates. Using this strategy, activists around the world have successfully pushed for governments to enact tobacco control regulations, including the unprecedented international Framework Convention on Tobacco Control (FCTC). TID has been a distinctive legal and political strategy that has affected the place of tobacco in law and has both inspired and constrained those who would imitate the strategy in other areas of regulation, such as diet or alcohol. It is therefore a case study in the creation of a distinctive legal approach and of threats to that approach from the changing role of world trade and investment law, which creates a new set of venues that tobacco industry advocates can use to redefine tobacco as a normal good and to seek out "fair and equitable treatment" for their industry. METHODS: I review legal and policy documents pertaining to two major challenges to tobacco control policies in Australia and Uruguay aimed at controlling industry branding. FINDINGS: International trade and investment law challenges TID and raises fundamental questions about the role of the state in protecting public health. Recent trade disputes involving Uruguay and Australia illustrate this dynamic. Despite losing high-court challenges against packaging regulations in both countries, tobacco firms were still able to challenge states in a different way, through international trade and investment agreements. This article identifies the industry's strategies and the responses of those seeking to avoid renormalizing tobacco as a part of world trade. In particular, states must demonstrate that their tobacco control policies satisfy standards set by tribunals, which include standards of good governance, and they must prepare their policies in a way that reduces legal risk and requires good governance. CONCLUSIONS: Although TID has strengthened the hand of tobacco control advocates, TID strategies alone are not sufficient to defend public regulations against extraterritorial legal challenges in an arena that resists the basic TID technique of singling out a particular industry. Public health advocates might also note the FCTC's aid in helping governments defend themselves against these challenges and consider similar international instruments for other areas.

Dredging in the Spratly Islands: Gaining Land but Losing Reefs.

Coral reefs on remote islands and atolls are less exposed to direct human stressors but are becoming increasingly vulnerable because of their development for geopolitical and military purposes. Here we document dredging and filling activities by countries in the South China Sea, where building new islands and channels on atolls is leading to considerable losses of, and perhaps irreversible damages to, unique coral reef ecosystems. Preventing similar damage across other reefs in the region necessitates the urgent development of cooperative management of disputed territories in the South China Sea. We suggest using the Antarctic Treaty as a positive precedent for such international cooperation.

The Role of Nurses in Advancing the Objectives of the Global Compacts for Migration and on Refugees.

Nurses and other health care professionals are in a unique position to shift the paradigm around migration debates. As caregivers and advocates for patients and other providers, nurses are crucial to the health and well-being of individuals, families, and communities. This is especially true for migrants, including increasingly vulnerable refugee populations around the world. As negotiations surrounding the Global Compact for Migration and Global Compact on Refugees come to a close, nurses' roles are becoming more apparent. Nurses are facilitators of migration and can help ensure that the benefits of migration are maximized and the challenges are mitigated. Often, nurses are migrants themselves. Leveraging nurses' knowledge, experience, talents, and compassion is crucial for attaining the objectives of both the Global Compact for Migration and the Global Compact on Refugees. Nurses are large contributors to the United Nations' 2030 Agenda for Sustainable Development and its 17 Sustainable Development Goals. The global nursing workforce has enormous potential to advance the achievement of these goals and objectives. In a world that appears to be increasingly xenophobic and hostile to migrants, nurses stand out as professionals who can change the narrative while providing compassionate care for the most vulnerable.

Heated tobacco product regulation under US law and the FCTC.

Tobacco companies are marketing new 'heated tobacco products' (HTPs) composed of battery-powered holders, chargers and tobacco plugs or sticks. The non-tobacco HTP components have escaped effective regulation under many countries' tobacco control laws because they are packaged and sold separately from the tobacco-containing components. In the USA, HTPs cannot be marketed unless the Food and Drug Administration determines that allowing their sale would be 'appropriate for the protection of the public health'. Philip Morris International (PMI) is seeking permission to market its IQOS HTP in the USA with 'modified risk tobacco product' (MRTP) claims that it reduces exposure to harmful substances and is less harmful than other tobacco products. However, PMI has not submitted adequate scientific evidence required by US law to demonstrate that the product is significantly less harmful to users than other tobacco products, that its labelling would not mislead consumers, or that its marketing-with or without MRTP claims-would benefit the health of the population as a whole. Parties to the WHO Framework Convention on Tobacco Control (FCTC) must take measures to reduce tobacco use and nicotine addiction, and prevent false or misleading tobacco product labelling, advertising and promotions; the introduction of new HTPs must be assessed according to these goals. All components of HTPs should be regulated at least as stringently as existing tobacco products, including restrictions on labelling, advertising, promotion and sponsorship, sales to minors, price and taxation policies and smokefree measures. There is nothing in US law or the FCTC that prevents authorities from prohibiting HTPs.

Future directions for notifiable diseases: tuberculosis-related laws in the Philippines.

BACKGROUND: With the increasing burden of tuberculosis (TB) in the Philippines, and the risk of multidrug resistance to TB, there is a need to strengthen the surveillance system. In many countries, cases of TB are reported to health authorities, and reporting is an effective way to manage TB. Although TB is a universal and representative reportable disease, the Philippines does not designate it as a notifiable disease. MAIN TEXT: This study aimed to review and compare current communicable disease-related laws and regulations in the Philippines with relevant international laws and regulations in other countries, to highlight where current TB notification regulations require change, or to determine whether they reflect global trends. Furthermore, we aimed to have TB included along with other communicable diseases on the list of legally required notifiable diseases in the Philippines. We reviewed current TB-related laws, acts of parliament, executive orders, presidential decrees, administrative orders, and memorandums. We undertook a literature review of relevant World Health Organization documentation, with 17 countries selected for comparison. Data on reported TB cases in the Philippines were obtained from health authorities, and health legislation data from foreign countries was collected from a public law database or from the government websites of each country. Most of the selected countries have a legislative basis for regulating notifiable diseases. In many countries, including Australia, Canada, China, Kiribati, Nauru, Niue, New Zealand, the Republic of Korea, Singapore, the United Kingdom, and Vanuatu, laws on communicable disease notification include TB notification. Our results suggest that notification of communicable diseases should be enforced through domestic health legislation. CONCLUSION: To align the Philippines with standard practice in the selected countries, TB could be included on the list of notifiable diseases in one of two ways. First, the current regulation "Revised List of Notifiable Diseases, Syndromes, Health-related Events and Conditions of 2008" could be revised to include TB. Second, new TB regulations could be introduced and implemented. Any revisions or new regulations should specify methods to identify and manage TB, and safeguard individual rights.

Economic Impacts of the Generic Drug User Fee Act Fee Structure.

BACKGROUND: A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find. OBJECTIVE: To look at the economic impact of the GDUFA fee structure. METHODS: We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs. RESULTS: The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees. CONCLUSIONS: We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry.

Global approaches to regulating electronic cigarettes.

OBJECTIVES: Classify and describe the policy approaches used by countries to regulate e-cigarettes. METHODS: National policies regulating e-cigarettes were identified by (1) conducting web searches on Ministry of Health websites, and (2) broad web searches. The mechanisms used to regulate e-cigarettes were classified as new/amended laws, or existing laws. The policy domains identified include restrictions or prohibitions on product: sale, manufacturing, importation, distribution, use, product design including e-liquid ingredients, advertising/promotion/sponsorship, trademarks, and regulation requiring: taxation, health warning labels and child-safety standards. The classification of the policy was reviewed by a country expert. RESULTS: The search identified 68 countries that regulate e-cigarettes: 22 countries regulate e-cigarettes using existing regulations; 25 countries enacted new policies to regulate e-cigarettes; 7 countries made amendments to existing legislation; 14 countries use a combination of new/amended and existing regulation. Common policies include a minimum-age-of-purchase, indoor-use (vape-free public places) bans and marketing restrictions. Few countries are applying a tax to e-cigarettes. CONCLUSIONS: A range of regulatory approaches are being applied to e-cigarettes globally; many countries regulate e-cigarettes using legislation not written for e-cigarettes.

IJEPA: Gray Area for Health Policy and International Nurse Migration.

Indonesia is recognized as a nurse exporting country, with policies that encourage nursing professionals to emigrate abroad. This includes the country's adoption of international principles attempting to protect Indonesian nurses that emigrate as well as the country's own participation in a bilateral trade and investment agreement, known as the Indonesia-Japan Economic Partnership Agreement that facilitates Indonesian nurse migration to Japan. Despite the potential trade and employment benefits from sending nurses abroad under the Indonesia-Japan Economic Partnership Agreement, Indonesia itself is suffering from a crisis in nursing capacity and ensuring adequate healthcare access for its own populations. This represents a distinct challenge for Indonesia in appropriately balancing domestic health workforce needs, employment, and training opportunities for Indonesian nurses, and the need to acknowledge the rights of nurses to freely migrate abroad. Hence, this article reviews the complex operational and ethical issues associated with Indonesian health worker migration under the Indonesia-Japan Economic Partnership Agreement. It also introduces a policy proposal to improve performance of the Indonesia-Japan Economic Partnership Agreement and better align it with international principles focused on equitable health worker migration.