Trade challenges at the World Trade Organization to national noncommunicable disease prevention policies: A thematic document analysis of trade and health policy space.

BACKGROUND: It has long been contested that trade rules and agreements are used to dispute regulations aimed at preventing noncommunicable diseases (NCDs). Yet most analyses of trade rules and agreements focus on trade disputes, potentially overlooking how a challenge to a regulation's consistency with trade rules may lead to 'policy or regulatory chill' effects whereby countries delay, alter, or repeal regulations in order to avoid the costs of a dispute. Systematic empirical analysis of this pathway to impact was previously prevented by a dearth of systematically coded data. METHODS AND FINDINGS: Here, we analyse a newly created dataset of trade challenges about food, beverage, and tobacco regulations among 122 World Trade Organization (WTO) members from January 1, 1995 to December 31, 2016. We thematically describe the scope and frequency of trade challenges, analyse economic asymmetries between countries raising and defending them, and summarise 4 cases of their possible influence. Between 1995 and 2016, 93 food, beverage, and tobacco regulations were challenged at the WTO. 'Unnecessary' trade costs were the focus of 16.4% of the challenges. Only one (1.1%) challenge remained unresolved and escalated to a trade dispute. Thirty-nine (41.9%) challenges focussed on labelling regulations, and 18 (19.4%) focussed on quality standards and restrictions on certain products like processed meats and cigarette flavourings. High-income countries raised 77.4% (n = 72) of all challenges raised against low- and lower-middle-income countries. We further identified 4 cases in Indonesia, Chile, Colombia, and Saudi Arabia in which challenges were associated with changes to food and beverage regulations. Data limitations precluded a comprehensive evaluation of policy impact and challenge validity. CONCLUSIONS: Policy makers appear to face significant pressure to design food, beverage, and tobacco regulations that other countries will deem consistent with trade rules. Trade-related influence on public health policy is likely to be understated by analyses limited to formal trade disputes.

Biodiversity governance: a Tower of Babel of scales and cultures.

The recently created Intergovernmental Platform on Biodiversity and Ecosystem Services (IPBES), originally focused on multilateral and global issues, is shifting its focus to address local issues and to include in its assessments local stakeholders and indigenous and traditional systems of knowledge. Acknowledging that full biodiversity governance is unavoidably rooted in participation of local actors and their problems and knowledge, we suggest that to deal successfully with the complexity and diversity of local issues, including indigenous knowledge systems, IPBES must recognize a key role of local institutions.

True Dopers or Negligent Athletes? An Analysis of Anti-Doping Rule Violations Reported to the World Anti-Doping Agency 2010-2012.

BACKGROUND: The sanction that an athlete receives when an anti-doping rule violation has been committed depends on the specific circumstances of the case. Anti-doping tribunals decide on the final sanction, following the rules of the World Anti-Doping Code. OBJECTIVES: To assess the athletes' degree of fault based on the length of sanctions imposed on them to feed policy-related discussions. METHODS: Analysing data from the results management database of the World Anti-Doping Agency for anonymous information of anti-doping rule violations in eight selected sports covering the years 2010-2012. RESULTS: Four out of ten athletes who committed an anti-doping rule violation received a suspension that was lower than the standard. This is an indication that tribunals in many instances are not convinced that the athletes concerned were completely at fault, that mitigating circumstances were applicable, or that full responsibility of the suspected violation should not be held against them. Anabolic agents, peptide hormones, and hormone modulators lead to higher sanctions, as do combinations of several anti-doping rule violations. CONCLUSIONS: This first analysis of information from the World Anti-Doping Agency's results management database indicates that a large proportion of the athletes who commit anti-doping rule violations may have done this unintentionally. Anti-doping professionals should strive to improve this situation in various ways.

Assessing access for prospective adoptive parents living with HIV: an environmental scan of Ontario's adoption agencies.

Work has been underway to increase the availability of parenting options for people living with and affected by HIV. One option, adoption, has not yet been explored in the literature. The study aimed to gain a better understanding of the potential of adoption for individuals/couples living with HIV in Ontario, and to assess potential structural barriers or facilitators that may impact their experience navigating the adoption system by conducting an environmental scan of adoption service providers in Ontario. A list of adoption service providers was compiled using the Ontario government's website. Information relevant to the study's measures was collected using service providers' websites. Service providers without websites, or with websites that did not address all of the research measures, were contacted via telephone to complete a structured interview. Online data extraction was possible for 2 and telephone surveys were completed with 75 adoption service providers (total n = 77). Most service providers reported that HIV status is not an exclusion criterion for prospective parents (64%). However, more than one-fifth of the participants acknowledged they were not sure if people with HIV were eligible to adopt. Domestic service providers were the only providers who did not report knowledge of restrictions due to HIV status. Private domestic adoption presented social barriers as birth parent(s) of a child can access health records of a prospective parent and base their selection of an adoptive parent based on health status. Adoption practitioners and licensees involved in international adoptions reported the most structural barriers for prospective parent(s) living with HIV, attributed to the regulations established by the host country of the child(ren) eligible for adoption. Although international adoptions may present insurmountable barriers for individuals living with HIV, public and private domestic adoption appears to be a viable option.

Regulatory biocompatibility requirements for biomaterials used in regenerative medicine.

The biological safety of biomaterials used for implantable medical devices is usually determined by a series of standard tests that assess the effects that extractable substances have on cells in vitro and in simple short term animal studies. To use these tests to determine the suitability of materials for tissue engineering templates is inappropriate. This short essay discusses the issues that are involved.

Health law and policy in the European Union.

From its origins as six western European countries coming together to reduce trade barriers, the European Union (EU) has expanded, both geographically and in the scope of its actions, to become an important supranational body whose policies affect almost all aspects of the lives of its citizens. This influence extends to health and health services. The EU's formal responsibilities in health and health services are limited in scope, but, it has substantial indirect influence on them. In this paper, we describe the institutions of the EU, its legislative process, and the nature of European law as it affects free movement of the goods, people, and services that affect health or are necessary to deliver health care. We show how the influence of the EU goes far beyond the activities that are most visible to health professionals, such as research funding and public health programmes, and involves an extensive body of legislation that affects almost every aspect of health and health care.

Ratification vote on taxonomic proposals to the International Committee on Taxonomy of Viruses (2014).

Changes to virus taxonomy approved by a vote of all ICTV members in February-March 2014 are reported.

Population biobanking and international collaboration.

Population-based biobanks promise to be important resources for genetic research. However, the study of normal genomic variation across populations requires the collection of data and biological samples from individuals on a large scale. While international collaboration has become both a scientific and an ethical imperative, international sharing of data and samples poses many challenges. Significant variation persists among the legal and ethical norms governing population biobanks in different jurisdictions. Many of these norms do not clearly provide for international access. To illustrate these problems, we collected and compared applicable legislative instruments, as well as ethical guidelines issued by national, regional, and international bodies. In addition, harmonization is faced with important limitations and may not be sufficient to ensure effective international sharing. Population biobanks are therefore looking for new ways to promote sharing and improve interoperability. The formation of biobank networks and the development of common governance tools are two approaches that are setting the groundwork for international collaboration in genetic research.

Rapid development of tissue bank achieved by International Atomic Energy Agency (IAEA) Tissue Banking Programme in China.

Before 1986, the development of tissue banking in China has been slow and relatively uncoordinated. Under the support of International Atomic Energy Agency (IAEA), Tissue Banking in China experienced rapid development. In this period, China Institute for Radiation Protection tissue bank mastered systematic and modern tissue banking technique by IAEA training course and gradually developed the first regional tissue bank (Shanxi Provincial Tissue Bank, SPTB) to provide tissue allograft. Benefit from training course, SPTB promoted the development of tissue transplantation by ways of training, brochure, advertisement and meeting. Tissue allograft transplantation acquired recognition from clinic and supervision and administration from government. Quality system gradually is developing and perfecting. Tissue allograft transplantation and tissue bank are developing rapidly and healthy.

[Anti-doping policy development process in the sports world (1968~1999): focusing on IOC activities and passive response from Korea].

This study investigated the anti-doping policy promoted by the IOC historical sociologically focusing on the period from 1968 to 1999. Public opinion surrounding doping control has emerged as a large amount of drug possession by athletes who had participated in the 1952 Olympics was caught, as well as following the accident where an athlete had died during the competition as a result of doping. From 1960, as many doping cases in sports games were exposed, several international organizations proclaimed fight against doping in order to seek a preventive measure. In 1961, the IOC newly established a medical commission within the organization. It was decided to implement doping control and female sex testing at the same time for all athletes who participated in the 1967 Olympics, and they were implemented from 1968 winter and summer Olympic Games. In 1971, the provisions for the tests were prescribed as mandatory on the IOC charter. From 1989, the OCT system was introduced as a measure to overcome limitations of the detection during competition period. As political problems and limitations emerged, WADA (World Anti-Doping Agency) was established in 1999 to professionally manage and push for doping control. Female sex testing policy contributed to preventing males from participating in female competition by deceiving their gender to some extent. However, it was abolished due to strong public condemnation such as women's rights issues, social stigma and pain, and gender discrimination debate. In 1984, a doping control center was established in Korea, which enabled drug use or doping in the sports world to emerge to the surface in our society. Korea Sports Council and KOC articles of association that supervise doping related matters of Korean athletes were revised in 1990. The action of inserting doping related issue in the articles of association was taken 20 years after the start of IOC doping policy. Beginning with two international competitions in the 1980s, Korean athletes experienced doping test directly, yet education about doping was limited. However, some national team level athletes tested positive on the doping test and underwent disciplinary action. In addition, athletic federation or leaders acquiesced athletes doping made secretly; this indicated that South Korea was also not free from doping. It was found that Korea world of sports showed very passive countermeasures and development process.

Ballast water regulations and the move toward concentration-based numeric discharge limits.

Ballast water from shipping is a principal source for the introduction of nonindigenous species. As a result, numerous government bodies have adopted various ballast water management practices and discharge standards to slow or eliminate the future introduction and dispersal of these nonindigenous species. For researchers studying ballast water issues, understanding the regulatory framework is helpful to define the scope of research needed by policy makers to develop effective regulations. However, for most scientists, this information is difficult to obtain because it is outside the standard scientific literature and often difficult to interpret. This paper provides a brief review of the regulatory framework directed toward scientists studying ballast water and aquatic invasive species issues. We describe different approaches to ballast water management in international, U.S. federal and state, and domestic ballast water regulation. Specifically, we discuss standards established by the International Maritime Organization (IMO), the U.S. Coast Guard and U.S. Environmental Protection Agency, and individual states in the United States including California, New York, and Minnesota. Additionally, outside the United States, countries such as Australia, Canada, and New Zealand have well-established domestic ballast water regulatory regimes. Different approaches to regulation have recently resulted in variations between numeric concentration-based ballast water discharge limits, particularly in the United States, as well as reliance on use of ballast water exchange pending development and adoption of rigorous science-based discharge standards. To date, numeric concentration-based discharge limits have not generally been based upon a thorough application of risk-assessment methodologies. Regulators, making decisions based on the available information and methodologies before them, have consequently established varying standards, or not established standards at all. The review and refinement of ballast water discharge standards by regulatory agencies will benefit from activity by the scientific community to improve and develop more precise risk-assessment methodologies.

International Conference on Harmonisation; proposed change to rodent carcinogenicity testing of pharmaceuticals; request for comments. Notice; request for comments.

The Food and Drug Administration (FDA or the Agency) is considering a proposed change to the International Conference on Harmonisation (ICH) Sl guidance on rodent carcinogenicity testing. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2-year rodent carcinogenicity studies add value to that assessment. The basis of this proposed change is the retrospective analyses of several datasets that reflect three decades of experience with such studies. The datasets suggest that knowledge of certain pharmacologic and toxicologic data can sometimes provide sufficient information to anticipate the outcome of 2-year rodent studies and their potential value in predicting the risk of human carcinogenicity of a given pharmaceutical. FDA is requesting public comment regarding a proposed change in approach to carcinogenicity assessment, on the prospective evaluation period intended to test this new approach, and on the proposed weight-of-evidence factors for carcinogenicity assessment.

[On the improvement of the legal support of the food safety in the conditions of trade and economic integration of states-members of the Customs union and the Russian Federation's accession to the WTO].

In the article priority activities of The Federal Service for the Oversight of Consumer Protection and Welfare on improvement of standard legal support of safety of foodstuff and control of compliance of foodstuff to legislation requirements are reported. The main documents directed on harmonization of the international requirements with national ones and requirements of the Customs union on safety of foodstuff are submitted. Work within a framework of Russian Federation's accession to the WTO is described. And data on control of quality and safety of foodstuff are provided also.

[International adoption: children's health risk evolution]. / Adoption internationale: évolution des risques de santé chez les enfants.

The socioeconomic and sanitary conditions in many countries make it necessary to weigh as precisely as possible the uncertainties which might affect the health of internationally adopted children, which is one of the key drivers to adoption decision. Indeed, health troubles are more and more frequent among children proposed by countries, at a time when there are fewer children to be adopted. Hence the institutions and the actors in the field of international adoption are compelled to frequently update their professional practices, so as to cope both with the declining offer for adoptable children and with the increasing pressure from the birth countries of children to make host countries adopt children with high age or with special needs. It also requires from the administrations the will to provide better initial information and to implement the demand for an agreement. Meanwhile, in spite of those growing constraints, adopting families have been more and more risk adverse during the latest decades, this being a common trend in our developed countries.

How does the World Trade Organization know? The mobilization and staging of scientific expertise in the GMO trade dispute.

The World Trade Organization (WTO) dispute settlement procedure is a key arena for establishing global legal norms for what counts as relevant knowledge. As a high-profile case, the WTO trade dispute on GMOs mobilized scientific expertise in somewhat novel ways. Early on, the Panel put the dispute under the Sanitary and Phytosanitary (SPS) Agreement through a new legal ontology; it classified transgenes as potential pests and limited all environmental issues to the 'plant and animal health' category. The selection of scientific experts sought a multi-party consensus through a fast adversarial process, reflecting a specific legal epistemology. For the SPS framing, focusing on the defendant's regulatory procedures, the Panel staged scientific expertise in specific ways that set up how experts were questioned, the answers they would give, their specific role in the legal arena, and the way their statements would complement the Panel's findings. In these ways, the dispute settlement procedure co-produced legal and scientific expertise within the Panel's SPS framework. Moreover, the Panel operated a procedural turn in WTO jurisprudence by representing its findings as a purely legal-administrative judgement on whether the EC's regulatory procedures violated the SPS Agreement, while keeping implicit its own judgements on substantive risk issues. As this case illustrates, the WTO settlement procedure mobilizes scientific expertise for sophisticated, multiple aims: it recruits a source of credibility from the scientific arena, thus reinforcing the standard narrative of 'science-based trade discipline', while also constructing new scientific expertise for the main task--namely, challenging trade restrictions for being unduly cautious.

[Nuclear energy and environment: review of the IAEA environmental projects].

The review of the environmental projects of the International Atomic Energy Agency is presented. Basic IAEA documents intended to protect humans and the Environment are considered and their main features are discussed. Some challenging issues in the area of protection of the Environment and man, including the impact of nuclear facilities on the environment, radioactive waste management, and remediation of the areas affected by radiological accidents, nuclear testing and sites of nuclear facilities are also discussed. The need to maintain the existing knowledge in radioecology and protection of the environment is emphasised.

World Trade Organization activity for health services.

Since the establishment of a multilateral trading system and the increasing mobility of professionals and consumers of health services, it seems strongly necessary that the World Trade Organization (WTO) undertakes negotiations within the General Agreement on Trade in Services (GATS), and that WTO's members attempt to reach commitments for health-related trade in services. How important is the GATS for health policy and how does the GATS refer to health services? What are the current negotiations and member's commitments?

[About the regulation of ionizing radiation using for food treatment in the international legislation].

The international and European legislation in the field of ionizing irradiation (gamma rays, electrons or X-rays) using for food treatment for improving food safety, for disinfestation of plants or plant products and improving of technological characteristics of food are discussed in this article. Obtained data can be used for foundation of Russian legislation and normative documents in the field of radiation methods using in the food industry.

A false start in the race against doping in sport: concerns with cycling's biological passport.

Professional cycling has suffered from a number of doping scandals. The sport's governing bodies have responded by implementing an aggressive new antidoping program known as the biological passport. Cycling's biological passport marks a departure from traditional antidoping efforts, which have focused on directly detecting prohibited substances in a cyclist's system. Instead, the biological passport tracks biological variables in a cyclist's blood and urine over time, monitoring for fluctuations that are thought to indirectly reveal the effects of doping. Although this method of indirect detection is promising, it also raises serious legal and scientific concerns. Since its introduction, the cycling community has debated the reliability of indirect biological-passport evidence and the clarity, consistency, and transparency of its use in proving doping violations. Such uncertainty undermines the legitimacy of finding cyclists guilty of doping based on this indirect evidence alone. Antidoping authorities should address these important concerns before continuing to pursue doping sanctions against cyclists solely on the basis of their biological passports.

Is international agricultural research a global public good? The case of rice biofortification.

The status of international agricultural research as a global public good (GPG) has been widely accepted since the Green Revolution of the 1960s and 1970s. While the term was not used at the time of its creation, the Consultative Group on International Agricultural Research (CGIAR) system that evolved at that time has been described as a 'prime example of the promise, performance and perils of an international approach to providing GPGs'. Contemporary literature on international agricultural research as a GPG tends to support this view and focuses on how to operationalize the concept. This paper adopts a different starting point and questions this conceptualization of the CGIAR and its outputs. It questions the appropriateness of such a 'neutral' concept to a system born of the imperatives of Cold War geopolitics, and shaped by a history of attempts to secure its relevance in a changing world. This paper draws on a multi-sited, ethnographic study of a research effort highlighted by the CGIAR as an exemplar of GPG-oriented research. Behind the ubiquitous language of GPGs, 'partnership' and 'consensus', however, new forms of exclusion and restriction are emerging within everyday practice, reproducing North-South inequalities and undermining the ability of these programmes to respond to the needs of projected beneficiaries.