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.

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.

Spreading the sharing economy: Institutional conditions for the international diffusion of Uber, 2010-2017.

This study examines the factors that facilitated the international diffusion of Uber, one of the fastest growing global companies in the sharing economy. We particularly focus on the legal and institutional conditions under which this ride-sharing platform could spread to customers online. Using a unique cross-national, longitudinal dataset, we employ event history models to investigate the effect of institutional environment on the diffusion of Uber. The results suggest that the establishment of the rule of law has a positive impact on the spread of Uber, even after controlling for economic and political characteristics. In addition, the overall quality of governmental regulations on markets is positively related to the diffusion of this ride-sharing platform. Our study contributes to the emerging literature on the sharing economy by identifying critical institutional factors that enable the transformation of business models worldwide.

Thousands of reptile species threatened by under-regulated global trade.

Wildlife trade is a key driver of the biodiversity crisis. Unregulated, or under-regulated wildlife trade can lead to unsustainable exploitation of wild populations. International efforts to regulate wildlife mostly miss 'lower-value' species, such as those imported as pets, resulting in limited knowledge of trade in groups like reptiles. Here we generate a dataset on web-based private commercial trade of reptiles to highlight the scope of the global reptile trade. We find that over 35% of reptile species are traded online. Three quarters of this trade is in species that are not covered by international trade regulation. These species include numerous endangered or range-restricted species, especially hotspots within Asia. Approximately 90% of traded reptile species and half of traded individuals are captured from the wild. Exploitation can occur immediately after scientific description, leaving new endemic species especially vulnerable. Pronounced gaps in regulation imply trade is having unknown impacts on numerous threatened species. Gaps in monitoring demand a reconsideration of international reptile trade regulations. We suggest reversing the status-quo, requiring proof of sustainability before trade is permitted.

Legal and ethical issues in cross-border gestational surrogacy.

This article aims to identify the main legal and ethical issues around international surrogacy. Owing to the legal diversity and ethical background of such a globalized practice, a review of the key existing literature on these two matters has been identified and analyzed. The article also identifies and analyzes the most significant legal solutions provided by supranational jurisdictions when dealing with cases of international surrogacy. The scope of the article includes the efforts to reach a minimum legal framework at the international level, with the aim not to standardize but to provide common legal solutions to those travelling abroad to have a child by means of surrogacy.

Parallel imports, price controls, and innovation.

The impact of parallel trade on innovation in R&D-intensive industries, such as pharmaceuticals, is a hotly debated question in antitrust and IP policy. The well-known argument that parallel trade dampens innovation by undermining firms' ability to price discriminate has been challenged by recent literature. The argument is that with endogenous price controls, parallel trade increases innovation by reducing governments' incentives to set particularly low price caps. In this paper, we show that this result crucially depends on the degree of homogeneity of the trading countries. The result only holds if consumers in poorer countries have a relatively similar demand for medication as consumers in richer countries. Instead, when countries are relatively heterogeneous, parallel trade dampens innovation and lowers welfare by exporting price cap regulation from poorer to richer countries. These findings are in line with recent case evidence. We also show that when patent length is endogenous, richer countries will tend to choose longer patent protection with parallel trade, whereas equilibrium price caps tend to be tighter in that case.

Born captive: A survey of the lion breeding, keeping and hunting industries in South Africa.

Commercial captive breeding and trade in body parts of threatened wild carnivores is an issue of significant concern to conservation scientists and policy-makers. Following a 2016 decision by Parties to the Convention on International Trade in Endangered Species of Wild Fauna and Flora, South Africa must establish an annual export quota for lion skeletons from captive sources, such that threats to wild lions are mitigated. As input to the quota-setting process, South Africa's Scientific Authority initiated interdisciplinary collaborative research on the captive lion industry and its potential links to wild lion conservation. A National Captive Lion Survey was conducted as one of the inputs to this research; the survey was launched in August 2017 and completed in May 2018. The structured semi-quantitative questionnaire elicited 117 usable responses, representing a substantial proportion of the industry. The survey results clearly illustrate the impact of a USA suspension on trophy imports from captive-bred South African lions, which affected 82% of respondents and economically destabilised the industry. Respondents are adapting in various ways, with many euthanizing lions and becoming increasingly reliant on income from skeleton export sales. With rising consumer demand for lion body parts, notably skulls, the export quota presents a further challenge to the industry, regulators and conservationists alike, with 52% of respondents indicating they would adapt by seeking 'alternative markets' for lion bones if the export quota allocation restricted their business. Recognizing that trade policy toward large carnivores represents a 'wicked problem', we anticipate that these results will inform future deliberations, which must nonetheless also be informed by challenging inclusive engagements with all relevant stakeholders.

Reciprocal vs nonreciprocal trade agreements: Which have been best to promote exports?

The Doha Development Agenda recognizes the central role that international trade can play in the promotion of economic development. In fact, the increase of exports from developing countries to developed nations' markets has been considered a key element for developing countries to realize the potential benefits of globalization. Over the last decades, developed countries have provided preferential access to their markets to developing countries through nonreciprocal trade agreements. Moreover, developing countries have also participated in reciprocal trade agreements. This paper re-examines comparatively the effect of both kinds of trade agreements on exports from developing countries but also from the developed world. In line with other studies, our results across specifications are unstable. However, the results of our preferred specification give additional support to the argument raised by critics of nonreciprocal preference regimes who consider that developing countries should abandon their reliance on one-way trade preferences in favor of reciprocal agreements.

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.

A review of international medical device regulations: Contact lenses and lens care solutions.

Medical devices are under strict regulatory oversight worldwide and such regulations prioritise patient safety and efficacy over anything else. Contact lenses fall under the medical device category - a result of direct contact with the eye. Equally regulated are the contact lens care product solutions, which include cleaning and maintenance solutions and lubricating and rewetting drops. In the USA, it is the FDA Centre for Devices and Radiological Health (CDRH) overseeing the regulations of medical devices, since 1976. In the European Union, it is the EU Commission responsible for regulating devices in Member States. The categorisation of contact lenses into medical devices is based on their inherent risk to the wearer. Contact lenses are subject to crucial regulatory oversight from concept to clinical evaluation, clinical investigations through to the finished lens product, and finally, strict conditions associated with their marketing approval including post-marketing surveillance. The physiochemical and manufacturing testing, such as biocompatibility testing alongside pre-clinical stability, sterility and microbiological testing are just some of the essential testing lenses must endure. Only through understanding the inherent risks and potential complications that can arise from contact lens wear, can one truly appreciate the need to adhere to strict regulations. The challenge however, lies in the need for more standardised regulations and flexible approaches, ensuring innovative device technologies reach patients in a timely manner without compromising public health and safety. This review highlights some key requirement, differences and similarities between the FDA and EU administrations in the approval of contact lenses.

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.