bluuebunny/crossref_metadata_2025 huggingface dataset:
A Survey on the Overweight and Obesity Frequency Secondary to Unhealthy Dietary Intake among Housewives in Karachi
Authors: Sajjad Ambreen Asghar , Akhter Saeed , Arshad Syma
Published: March 2022

Background: Overweight and obesity is a major global problem and various medical conditions have been associated with overweight and obesity such as knees osteoarthritis, heart diseases including high blood pressure, diabetes and stroke. Obesity is also associated with unhealthy dietary intake and lack of physical activity. Objectives The objective of this survey was to find out the frequency of overweight and obesity among housewives related to inadequate and unhealthy dietary intake. Method and Materials. 62 housewives were participated in this cross-section design study and conducted in a private sector hospital, Karachi. Body Mass Index (BMI) was taken using weighing machine (Camry Company) and height measured using a standard measuring tape. A structural interview questionnaire Performa was devised to capture information’s about demographic profile and specific questions related to meals habit and unhealthy dietary intake. Results Large percentages of housewives were obese (51.61%) and unhealthy dietary intakes was observed among housewives with consumption of red meat, sweat dishes, snacks between meals, carbonated/soft drinks and junk foods on regular basis. Conclusion: The study findings revealed that obesity is a major problem among housewives with inadequate and unhealthy dietary intake appeared common in this study population. Keywords: Overweight, Obesity, Housewives, unhealthy diet and Physiotherapy
Evaluation of the oocyte quality versus ICSI outcomes in sub fertile Iraqi women with polycystic ovary syndrome
Authors: Abdulwahid Hameedah Hadi , Omran Zahraa Sabbar , Alhasanawy Saleem A. , Hussein Radhwan M.
Published: March 2022

Background: Polycystic ovarian syndrome (PCOS) is a common endocrine condition, occurs in about 5% to 10% of women and is thought to be caused by a hypothalamic disorder, In some women with PCOS especially obese one has hyper secretion of insulin with insulin resistance, the aim of study: To determine oocyte number and quality and ICSI outcome in infertile patient with PCOS. All patient fit with diagnostic criteria of PCOS where undergoes stimulation by antagonistic protocol and ICSI procedure is done under a control condition. The result of pickup (number and quality of oocyte) and result of ICSI (number of 2 pronclea), was compared with result of oocyte pick up and ICSI of tubal factor.  Result and Discussion: In this study characteristic clinical feature of PCOS like acne, hirsuitism, irregular cycle not found in tubal factor group. Also some hormones like LH, Testosterone and prolactin levels in PCOS higher than tubal factors group with normal ovaries As a result of ovarian stimulation and ICSI procedure shows There is good number of oocytes and good quality (M2), with higher fertilization rate in patient with PCOS undergoes ICSI than patient with normal ovaries.
The Art of Death in Ovid'sHeroides
Authors: Alekou Stella
Published: March 2022

Notwithstanding the focalization in Ovid's Heroides on love, one may also identify a consistent emphasis on death, as the letters grow to become a literary refuge for women who experience loss as well as physical and social isolation. Death plays a decisive role in the portrayal of the female writers as sympathetic victims. The fictionalization of death acts as a means of persuasion also for the poet, who situates his text against the background of Augustan politics. Writing about the art of death enables Ovid to implicitly defend the artists who had been defeated and violently silenced by power and renders his work an indispensable rhetorical tool for their literary survival.
Why Public Health Practitioners Should Care About Job Prospects for People with Criminal Records: Employment Challenges and Successful Prison and Jail Reentry
Authors: Saluja Sonali , Rosen Henry
Published: March 2022

Each year in the United States, over half a million individuals in prison and another nine million in jail will return to the community. Many of these men and women face extreme uncertainty when they are released: they may not know where their next meal will come from; they may not have a safe place to stay; they are often left without insurance or healthcare; their families may have left them; and very few know where to find work so they can begin to put food on the table and pay off court-ordered fines and fees. Among the myriad of needs a person has when they return from incarceration, individuals with criminal records and their probation or parole officers cite employment as the lynchpin to success.
Public Health and the Policing of Black Lives
Authors: Feldman Justin
Published: March 2022

The deaths of Michael Brown, Eric Garner, Freddie Gray, Rekia Boyd, and Walter Scott reflect a pattern of routinized state violence against black people in the United States. While police violence is not new, it has become newly visible over the past year as protesters in Ferguson, Baltimore, and hundreds of other cities have made the issue difficult for the public to ignore. As citizens of this society, each of us has a responsibility to work toward the structural changes necessary to end racially discriminatory policing practices that affect our communities. However, as public health professionals, our role in this movement is unique. Simply put, policing practices harm the public’s health and deepen racial health inequities. Since our existing public health infrastructure continuously collects data on injuries and deaths, public health agencies can play a critical role in preventing police violence by monitoring and systematically investigating its impact on communities. Additionally, while U.S. policymakers have decided that police departments should be one of the primary institutions tasked with addressing drug use, problem drinking, homelessness, sex work, and mental illness, these are all fundamentally public health issues requiring attention from public health researchers and professionals alike.
Improving Communities, Improving Health
Authors: Sanchez Jeffrey
Published: March 2022

When we talk about health care, we are often referring to hospitals or other acute facilities, imagining women and men in scrubs, long waits in emergency rooms, that distinctive smell of disinfectant. We “in the know” talk about checklists and ways to reduce inpatient costs; we discuss the absence or the glut of beds; and we count stats of length of stay, average daily census, and DRGs.
Auditors’ Liability in the European Union
Authors: Beckman Hans , Nass Eva C.A.
Published: March 2022

In September 2006 the European Commission published an independent study on the economic impact of current EU rules on auditors’ liability regimes and on insurance conditions in Member States. The authors discuss and evaluate this report, comparing several possible methods for limiting liability.
Protection of Minority Shareholders and Creditors in Italian Group Law
Authors: Kousedghi Samira
Published: March 2022

The author discusses developments in Italian group law and the pros and cons of recent legislation.
Abuse of the GmbH by Organized Corporate Gravediggers
Authors: Kleindiek Detlef
Published: March 2022

The voluntary liquidation of a company, primarily aimed at safeguarding its former shareholder(s) and director(s) against personal liability claims and actions of the public prosecutor, has become a business in its own right in Germany. The author analyzes the latest GmbH law reform proposals to adequately tackle this practice, in light of BGH case law.
Codetermination at Board Level in Germany
Authors: Waas Bernd
Published: March 2022

This contribution contains a discussion of the three arrangements for Employee Board Representation that exist in Germany: the Drittelbeteiligungsgesetz, the Mitbestimmungsgesetz and the Montan-Mitbestimmungsgesetz. The first act applies to companies that regularly employ more than 500 employees, the second to companies that employ more than 2,000 employees on a regular basis, whereas the third act holds special provisions for the coal, iron and steel industries.
The Ongoing Struggle of Multinational Groups of Companies under the EC Insolvency Regulation
Authors: Wessels Bob
Published: March 2022

In the application of the Insolvency Regulation, the centre of main interests (COMI) of a debtor determines which national court is competent in insolvency proceedings. The Regulation presumes that the COMI of a company is the place of its registered office. Such a presumption, however, could well be at odds in cases where a company is part of a multinational corporate group.
Shareholder Democracy à la Dworkin
Authors: Bartman Steef M.
Published: March 2022

Ronald Dworkin’s latest book, Is Democracy Possible Here?, inspired the author to transpose the American philosopher’s ideas expressed therein to the corporate governance debate and in particular to the position of shareholders in corporate disputes.
Cross-Border Division of SEs
Authors: Roelofs Erwin R.
Published: March 2022

An SE may be involved in cross-border reorganizations like mergers, divisions, and conversions. This article discusses both cross-border divisions whereby an SE is formed as well as divisions whereby an existing SE is involved.
Directors’ Duties in a Changing World: Lessons from the Cadbury Plc Takeover
Authors: Clarke Blanaid
Published: March 2022

The Cadbury takeover by Kraft Foods Inc. early this year has fuelled a fierce debate in the United Kingdom about the need to introduce a long-term sustainability test into takeover regulation, against the backdrop of restated Directors’ duties. This article considers the manner in which these duties were applied in the context of the said takeover and their consequences for stakeholders.
Orderly Sovereign Default in the EU: A Strong Case for European Regulation
Authors: Lamandini Marco
Published: March 2022

Although the risk of contagion from an Economic and Monetary Union (EMU) sovereign country default to the European private banking sector should not be overestimated, recent proposals calling for the setting up of a European Monetary Fund still are worthwhile considering. This should be done, however, through the enhanced cooperation procedure – a procedure that, so far, has never been followed.
Public Interest Norms in the European International Investment Policy: A Shattered Hope?
Authors: Levashova Yulia
Published: March 2022

Through the Lisbon Treaty, the EU acquired exclusive competence over foreign direct investment (FDI). Hence, the EU began to form the EU Investment Policy, which, among other issues, attempts to regulate on Bilateral Investment Treaties (BITs). This article addresses the role of public interest norms in the framework of BITs in the context of the emerging EU Investment Policy.
Venture Capital Funds: Regulation and Evolution
Authors: Nunes Diogo Pereira Dias
Published: March 2022

The proposed Regulation on European Venture Capital Funds aims not only to stimulate the rapid and smooth process of raising and structuring funds as an essential element to start and restart venture capital cycles, but also to develop a sustainable and robust venture capital industry. However, the rules on obtaining an EU-passport still make structuring venture capital funds quite an ordeal.
The Role of Transparency in Corporate Governance and Its Regulation in the EU
Authors: Sonmez Melih
Published: March 2022

High levels of transparency and financial disclosure play a crucial role in both corporate governance and financial markets. Although the EU has made significant efforts on modernization of company law there are still a number of problematic issues that need to be considered in these areas.
Mandatory Corporate Social Responsibility: An Unwarranted Burden on Business
Authors: Choudhary Harish
Published: March 2022

The Companies Bill of 2012 in India is one of the key legislations introduced in the recent past introducing a mandatory provision of CSR spending by certain companies. The approach of mandatory CSR spending is highly controversial and raises questions like whether mandatory CSR satisfies Constitutional norms.
Can National Company Law Require a Branch of a Foreign Company to Have an Independent Name?
Authors: Werlauff Erik
Published: March 2022

With a basis in long-standing Danish company law but also drawing on European legal arguments valid for all EU and EEA countries, this contribution considers the question of whether a host country can legally require a foreign company to think up an independent name for its branch in the host country in addition to the demand that the branch name must repeat the company's name, its nationality, and include the designation 'branch'.
AASA: Locating the Central Administration of a Subsidiary Company Which Is Part of a Group of Companies under Article 60 of Brussels I Regulation
Authors: Okoli Chukwuma Samuel Adesina
Published: March 2022

There is no definition of the term 'central administration' under Article 60(1)(b) of the Brussels I Regulation; and Article 60 of Brussels I does not make specific provisions for locating the central administration of a subsidiary company within a corporate group. English Courts in Anglo American South Africa Limited after a re-evaluation of the correctness of previous decisions by English judges, sought to apply the concept of central administration in a 'European way' to a subsidiary company within a corporate group.
Regulating Banks in Europe
Authors: Söderström Rebecca
Published: March 2022

EU banking regulation has grown from a fundamental set of rules targeting the vast majority of banks, to a large amount of detailed rules with a focus to regulate the few very large banks in the Union. The EU passport for conducting banking business and other financial services was one of the first regulatory steps in this field. Today the rules are highly harmonized and also supervision is in focus not least since the Banking Union was set up.
What a US Buyer Should Expect in a Dutch M&A Transaction
Authors: Fluit Roel
Published: March 2022

Doing deals in Europe is quite different from doing them in the United States. Transactions are often structured differently, including with respect to purchase price determination mechanisms. While typical U.S. style agreements are getting more recognized in Europe, it is important for US buyers and their lawyers to understand the different approaches in transaction documents. In addition, Dutch M&A transactions have some peculiarities to be aware of such as the possible requirement for employee and labour union involvement (in the negotiations) and the necessity to involve a Dutch civil law notary for the transfer of registered shares.
Auditors’ Reporting to Those Charged with Governance
Authors: Seehausen Jesper
Published: March 2022

For audits of Public-Interest Entities (PIEs), the PIE Regulation introduced important new requirements regarding auditors’ reporting to those charged with governance – more specifically, auditors’ reporting to the audit committee in an additional report. However, for audits of both PIEs and non-PIEs, there are also requirements regarding auditors’ reporting to those charged with governance in the International Standards on Auditing (ISAs). This article starts by answering two important questions: (1) ‘Those charged with governance – who are they?’ and (2) ‘PIEs – which entities are they?’. Next, auditors’ reporting to those charged with governance in non-PIEs and PIEs, respectively, is discussed. The article closes with a discussion on signing of auditors’ reporting to those charged with governance.

Auditing Directive, Public-Interest Entities (PIEs), International Standards on Auditing (ISAs), European Model Companies Act (EMCA), Audit Committee
Company Purpose in the Context of Business Sustainability and Insolvency Proceedings
Authors: Linna Tuula
Published: March 2022

The organizational and operational company purposes of the debtor company terminate in liquidation proceedings. In addition, the nonfinancial sustainability elements vanish in a piecemeal selling. Through a selling as a going concern, the operational company purpose and sustainability elements may be transferred to a byer company. In restructuring proceedings, both the organizational and operational company purposes remain, but the shareholder primacy shifts to a creditor priority. When choosing between liquidation and restructuring proceedings, there are two tests: the viability test and the best-interests-of-creditors test. In these tests, all obligatory non-financial sustainability elements, such as environmental requirements laid down in the law, must be considered. Voluntary non-financial sustainability investments for implementing the company operational purpose are allowed also during the restructuring plan if they benefit the creditors.
Profiling Consumers Through Big Data Analytics: Strengths and Weaknesses of Article 22 GDPR
Authors: Niševic Maja
Published: March 2022

A new form of knowledge production that is flourishing in the Big Data age is profiling. In general, profiling means any form of discovering or constructing knowledge from large sets of data originating from a variety of sources. In a narrow sense, profiling is a way of making individual profiles, i.e. sets of characteristics, features, and attributes through which a person or group can be discerned from another person or group. Profiling is a relatively novel concept in European Union data protection law. It is defined in Article 4 (4) of the General Data Protection Regulation (GDPR). However, Article 22 of the GDPR determines the scope of protection in the case of profiling. This article focuses on an interpretation of Article 22. In addition, this article aims to give an overview of the wording, limitation and potential regulatory gaps, which exist in Article 22 of the GDPR.

Big Data Analytics, algorithms, AI, GDPR, profiling, consent, contract
Deciphering Encryption Rights in India: The Road Ahead
Authors: Kaushik Devansh
Published: March 2022

Encryption enhances privacy and cybersecurity and contributes to the growth of the digital economy. India is the second largest online market in the world and yet still lacks a comprehensive data protection law and a conductive regulatory approach towards encryption. Recent developments, particularly the 2021 Intermediary Guidelines, indicate the state adopting an approach aiming to restrict use of encryption, providing wide leeway for surveillance and introduce traceability.

The ‘Right to Privacy’ was first formulated in India in 2017, in the landmark Puttaswamy judgment by the Supreme Court. This imposes constitutional limitations on the scope of state intrusion into individual privacy.

This article critically examines three decades of the regulatory approach in India towards encryption and the expectations post the Puttaswamy judgment, the 2021 Intermediary Guidelines and the upcoming Data Protection Law. It examines whether a right to encryption can be said to exist in India and analyses various facets of the global encryption debate in the Indian context.

Nigeria, NDPR, GDPR, Data Protection, Data Processing
Unpicking the Textiles Trade – The Impact of Liberalization on the Global Textiles Sector
Authors: Curran Louise
Published: March 2022

The global textiles trade has been subject to major restructuring in recent years due to the phase out of quota restrictions under the Agreement on Textiles and Clothing (ATC). The impact of this liberalization on the EU and US markets has been considered elsewhere (Curran, 2008a). However it is only recently that figures have become available to enable a global picture of the impacts of the quota phase out (and subsequent re–imposition of export restraints on China) to be drawn.

This article looks at these global figures and compares them, both to the forecasts made by various researchers prior to liberalization and to the impacts on the EU/US markets analysed previously. It finds that impacts were extensive, both directly in terms of clothing and textiles imports in the liberalized markets and indirectly within the supply chain of the textile sector. Overall,forecasts were correct on several key impacts – such as the increased exports of certain key suppliers, the negative impacts on the exports of certain other suppliers (although forecasts were generally overly pessimistic) and the positive indirect impacts in terms of increased textile demand from increased clothing production. However certain anomalies are identified, reflecting the difficulty in modelling the impact of restrictions on the sector.

The overwhelming winners from the globalization of the clothing and textiles markets were China and India. The article looks in somewhat more detail at these two suppliers to disaggregate the factors contributing to their overall positive trade performance. In the aggregate, India increased their exports in value terms to a greater extent than China (although from a lower base).However, this positive performance needs to be seen in the context of the remaining restrictions on Chinese exports to India’s two key clothing markets – EU and the United States – and the fall in Indian exports in both textiles and clothing in the years immediately prior to liberalization.

In undertaking this exercise, it was necessary to compare the global trade figures which are extracted from the UN’s COMTRADE database, with the EU’s own figures on trade from COMEXT, the Eurostat database, on which previous work was based (Curran, 2008a). It is evident that there are major differences in the figures, in particular in relation to declared exports from Hong Kong and China. Clearly, there are unresolved issues in terms of the declaration of the origin of trade between China and Hong Kong in this sector. Unpicking exactly what is happening in the sector is complicated by these differences in what should be ‘mirror’trade.
A Dissection of the different Solutions Resulting from the Anti–dumping Investigations of the European Community
Authors: Chao Liu
Published: March 2022

The European Community’s Anti–dumping Regulation clearly stipulates the following possible solutions that could result from an anti–dumping investigation – termination of the investigation without the adoption of anti–dumping measures; imposition and collection of anti–dumping duties; and/or acceptance of undertakings. However in practice, over the years, the European Commission (‘Commission’) has complicated these three possible solutions to quite an extent. In different cases, the Commission can prudently and skillfully select a specific solution on the basis of the clearly stipulated anti–dumping law provisions, while balancing various conflicting interests. As a matter of fact, concerns of economic interests, though untraceable in the legal provisions, are yet hidden in each possible solution. Moreover, each solution entails a positive or negative legal and economic impact of a different degree.

Through this article I attempt to make a legal and economic analysis, on the basis of the anti–dumping law of the European Community (EC) and its actual practice, of all the possible solutions that can result from an anti–dumping investigation. The aim of this study is to serve as a source of guidance and reference for understanding and dealing with the anti–dumping proceedings conducted by the Commission.
Creative or Artificial, That’s the Question!
Authors: Rovetta Davide , Rovetta Davide
Published: March 2022

This article will show how the interface between trade and customs law can play a pivotal role for the everyday life of economic operators. This is done starting by an individual case and extending the research to the protection of Union financial interests and the general principle of abuse of rights in Community law.
The Revised Kyoto Convention versus the Old One: A Capable Tool for Trade Facilitation?
Authors: Weerth Carsten
Published: March 2022

The World Customs Organization (WCO, Organization Mondiale des Dounaes, OMD) is an intergovernmental organization of 176 Member States that was founded as European Customs Cooperation Council in 1952. The first Kyoto Convention on simplification of customs procedures is one of its most important legal instruments. This article questions whether the Revised Kyoto Convention (RKC) is a success story, which countries are signatory countries, and whether the Developing countries are also participating in this area of trade facilitation.
International Trade, Public Health, and Intellectual Property Maximalism: The Case of European Border Enforcement and Trade in Generic Pharmaceuticals
Authors: Kumar Shashank P.
Published: March 2022

Even as the world witnesses another pandemic, industrialized nations and their industries continue their efforts to ‘rachet-up’ levels of intellectual property (IP) protection. Such a maximalist agenda drives another paradigm shift in the international IP regime today. While maximalists employ several methods to promote their agenda, this work seeks to study the case of European border enforcement law (Council Regulation (EC) No. 1383/2003 of 22 Jul. 2003, Concerning Customs Action Against Goods Suspected of Infringing Certain Intellectual Property Rights and the Measures to be Taken Against Goods Found to Have Infringed Such Rights [hereinafter ‘EC Regulation 1383’]) and its effects on international trade in generic drugs. Triggered by several incidents involving ‘seizure’ of in transit generic drugs by European customs, the issue continues to be ‘hotly debated’ on at the international level and is of immense contemporary relevance to larger issue of global justice. After a discussion on the evolution of European border enforcement law and its interpretation by European courts to determine its scope, this work seeks to study the effect of EC Regulation 1383 on international trade in generic pharmaceuticals by studying several instances of ‘seizure’ of generic pharmaceuticals in transit between developing nations and the international debate it has generated at the World Trade Organization (WTO). The discussion highlights the maximalist (and ‘TRIPS-Plus- Plus’) nature of the European law and raises important issues concerning the interpretation of Agreement on Trade-Related Aspect of IP Rights (TRIPS), public health, World Trade Organization, Ministerial Declaration of 14 Nov. 2001 (hereinafter ‘Doha Declaration’), and the possibility of a future WTO dispute. The discussion concludes with some comments on broader issues of global justice and the WTO that are raised by the European law and its enforcement affecting access to medicines in developing countries.
The Panel Report on Tariff Treatment of Certain Information Technology Products: Classification Is the Key to Effective Implementation
Authors: Grayston John
Published: March 2022

The Report of the Panel in Tariff Treatment of Certain Information Technology Products confirms the wide scope of concession granted under the ITA in relation to set-top boxes with a communication function. The EU now needs to bring its provisions on classification in line with these commitments. The Report leaves open the question of when an ITA set-top box will be so altered by the development of hitherto ancillary functions that it no longer falls within the scope of the concession. This article sets out some views on the correct classification of set-top boxes with a communication function (STBCs) and with an HDD and explains why the contested CNEN should have been considered as incompatible with EU classification rules.
Mexican Developments in the Review of Foreign Trade Transactions
Authors: Mendoza Luis , Martinez Carlos , Ceballos Francisco
Published: March 2022

This article discusses the development of the framework and procedures followed by the Mexican authorities in the verification of origin of products under free trade agreements (FTAs) signed by Mexico but mostly under the North American Free Trade Agreement (NAFTA), which is the FTA that given the value of the commercial exchange between the United States and Mexico is most commonly tested by Mexican courts. Furthermore, this article tries to view in some perspective the action of the Mexican authorities and the reaction of the Mexican Federal Tax Court to a very critical legal issue: the reception of international trade law in the Mexican formal legal system. The conclusion is that the verification is still unconcluded process.
What Is a Public Body for the Purpose of Determining a Subsidy after the Appellate Body Ruling in US  AD/CVD?
Authors: Brink Tegan
Published: March 2022

The Appellate Body Report in US - AD/VCD set a new standard for defining a 'public body' whose financial contribution may constitute a subsidy under Article 1.1 of the SCM Agreement. It reversed the Panel's interpretation that a public body is 'any entity controlled by the government' and found instead that a 'public body' is an 'entity that possesses, exercises or is vested with governmental authority'. While the new standard introduces some uncertainty into the revelant test, it is not clear that it has substantively narrowed the conduct subject to the disciplines of the SCM Agreement over all. Investigating authorities may need to expand the scope of their inquiries. The entrustment and direction of private bodies under Article 1.1(a)(1)(iv) also remains an avenue through which the financial contributions of governments can be assessed.
The U.S. Biologics Price Competition and Innovation Act of 2009 Triggers Public Debates, Regulatory/Policy Risks, and International Trade Concerns
Authors: Kogan Lawrence A.
Published: March 2022

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 ('BPCIA') to create an abbreviated approval pathway for generic 'biological products' that are demonstrated to be highly similar (i.e., biosimilar) to or interchangeable with an FDA-licensed reference biological product. The BPCIA is intended to reap cost savings for patients by creating a means for the production, use and sale of follow-on biologic therapeutics in the United States. The BPCIA's intellectual property provisions are modeled in part, after the Drug Price Competition and Patent Term Restoration Act of 1984 (i.e., the 'Hatch-Waxman' Act) pursuant to which generic versions of branded drugs, namely, chemically synthesized small-molecule products, have been approved by permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. Like the Hatch-Waxman Act, the BPCIA provides for the establishment of a form of proprietary rights that are distinct from patent rights, sometimes termed 'data exclusivity' or 'data protection', that consist of a period of time during which the USFDA affords an approved drug protection from competing applications for marketing approval and restricts generic competitors' ability to reference the data generated by the manufacturers of brand-name drugs. Important technical differences, nevertheless, exist between traditional pharmaceuticals and biologic drugs that significantly drive up research and development, regulatory market authorization and product marketing costs. To recoup these greater expenditures, the BPCIA has provided correspondingly longer periods of marketing/data exclusivities to original biologic drugs - generally twelve years instead of five years under Hatch-Waxman - to protect clinical testing data and other proprietary and confidential (trade secret) information generated by an original brand-name drug developer to obtain a biologic license. The BPCIA's longer twelve-year exclusivity period, however, has continued to generate considerable post-enactment debate among healthcare activists, academicians, brand name and generic pharmaceutical manufacturers, and U.S. congressional representatives, which compromises U.S. bilateral and regional trade relations, and potentially impairs the competitiveness of the U.S. biopharmaceutical industry and the economic value of such companies' IP assets. Until recently, public opposition to the BPCIA's twelve-year exclusivity period and patent provisions had frustrated Obama administration efforts to both secure congressional ratification of the previously signed and modified bilateral Korea-U.S. Free Trade Agreement and to successfully advance a favorable U.S. negotiating position that guarantees strong patent and marketing/data exclusivity protections at recent Trans-Pacific Partnership Agreement negotiating sessions.
Disciplining the Use of TDI against China through WTO Dispute Settlement
Authors: Vermulst Edwin , Vermulst Edwin
Published: March 2022

After having spent the better part of its first ten years as a WTO member either answering cases as a respondent or registered as a third party, China has recently begun to assert itself as a complainant, particularly with regard to the various trade defence instruments (TDIs) used against it. The year 2011 alone saw the circulation by the Appellate Body (AB) of three such reports - one pertaining to anti-dumping duties (ADDs), another safeguards, and another both concurrently imposed ADDs and countervailing duties (CVDs) - which all dealt at least in part with issues germane to TDI practice against China specifically or non-market economies (NMEs) generally. The article reviews some of the more pertinent issues of first impression ruled upon by the AB in those cases, concluding that China has registered some substantial victories that should be expected to limit the use of TDI against it but also that the AB has, in some respects, allowed for substantial leeway for investigating authorities to modify their current practices in such a way that, without further litigation, the impact of those victories could be reduced.
Multilateral Disciplines on Rules of Origin: How Far Are We from Squaring the Circle?
Authors: Lacey Simon
Published: March 2022

A significant quantity of global merchandise trade takes place under one of two sets of preferential rules of origin (ROO), either those of the European Union, the so-called Pan-European Cumulation System (PECS), or those generally preferred by the United States, as manifested in free trade agreements (FTAs) such as NAFTA and the many subsequent FTAs the US has concluded with various trading partners since then.

Many years of work conducted by the World Customs Organization and the World Trade Organization have finally culminated in a draft text on non-preferential ROO, with the only thing standing in the way of its adoption being a relatively limited subset of narrowly defined political economy interests in some of the largest trading nations.

Some observers have argued that the so-called spaghetti bowl of preferential trade agreements can be 'multilateralized', and that one way to achieve this would be to harmonize preferential ROO at the multilateral level, that is, at the WTO.

This paper looks at how easy or difficult it would be to achieve such harmonization, both in purely technical terms as well as a political economy matter. It concludes that the current system of ROO is quickly being overtaken by the realities of increasingly unbundled and globally dispersed production processes and that these rules are even more likely to need a complete rethink as global manufacturing in so many industries undergoes what is probably the most profound economic shakeup in over a hundred years.
WTO Customs Valuation Agreement: Customs Value of Goods Imported as Gifts
Authors: Schloemann Hannes , Pitschas Christian
Published: March 2022

This paper addresses the issue of how to determine the customs value of goods that are imported as genuine gifts, that is, goods that are neither the subject of an export sale nor sold in the country of importation. The goods used as an example for purposes of the analysis are publications and electronic media (e.g., CD, DVD and Video) of denomination-specific religious content, imported and then passed on free of charge to believers and/or the general public based on religious, non-commercial motives. This paper argues that the customs value of such goods has to be determined based on Article 7 of the Customs Valuation Agreement, which sets forth the fall-back method, since none of the other customs valuation methods under the Customs Valuation Agreement is applicable to the aforementioned goods due to their non-commercial nature. The customs valuation of the goods in question based on the fall-back method involves a modified application of the computed value method, excluding an amount for profit given that these goods are not the subject of commercial sales transactions.

This paper is structured as follows: section A briefly explains the link between customs valuation and market access commitments undertaken by WTO Members. Section B provides an overview of the two key principles underlying the Customs Valuation Agreement, namely transaction value and the sequential order of application of customs valuation methods. Sections C and D assess whether the customs value of the goods at issue can be established on the basis of the customs valuation methods set out in Articles 1-6 of the Customs Valuation Agreement. As this assessment leads to the conclusion that none of these methods is applicable in the present case, section D deals with the application of the fall-back method.
Customs Sanctions of the EU-27: A Detailed Analysis and a Preview on the Modernized Customs Code of the EU and the European Union Customs Code
Authors: Weerth Carsten
Published: March 2022

The customs sanctions of the EU-27 are not harmonized - the sanctioning of customs offences is still the task of the twenty-seven Member States and their national legislation. The US has attacked the purely national customs sanctions of the EU as break of the WTO rules in the WTO Dispute Settlement Case WT/DS315 'Selected Customs Matters' but they lost the case. Now an in depth research shows that twenty-six Member States have sufficient national customs sanctions. It also gives an overview about new ideas of the modernized EU Customs Codes on common customs sanctions.
The EUs Anti-Brosmann Amendment: Back to the Future  Part II
Authors: Graafsma Folkert , Graafsma Folkert
Published: March 2022

Market economy treatment (MET) for exporters from non-market economy countries in anti-dumping cases is an opportunity to avoid the artificial use of substitute data from a reference country, an opportunity reinforced by the so-called Brosmann judgment of the European Court of Justice (ECJ). Concerned about its administrative burden, the European Commission enacted the Anti-Brosmann Amendment to narrow and limit MET. This article considers the history and operation of the Anti-Brosmann Amendment, including its retroactivity and legality generally.
Improving the Compliance of Vietnamese Exports with Importing WTO Member SPS/TBT Measures: Learning Experiences from Malaysia and Thailand
Authors: Vu Ngan K. , Ho Ngoc T.
Published: March 2022

Although Vietnam has been an official member of the WTO since 2007, non-tariff measures such as Technical Barriers to Trade (TBT) and Sanitary and Phytosanitary (SPS) measures in WTO agreements are unfamiliar to many corporate and governmental entities. Given that the plastics and agricultural industries are fast-emerging markets of particular importance to Vietnam's economy, they were chosen as the focus of our study. It was determined that education on international agreements, looking to other countries' experience for transferable "best practices," and identifying common trends and pressures would be avenues towards improving domestic policy to facilitate compliance with importing country TBT and SPS regulations. Two other Southeast Asian countries, Malaysia and Thailand, were selected for our policy education study. The study results suggest that the achievements of Malaysia and Thailand are attributable to well-engineered government policy, as well as corporate compliance with TBT and SPS measures in both countries.
Trade Agreements and Legal Services: An Anatomy of the GATS and Preferential Trade Arrangements
Authors: Muller Gilles
Published: March 2022

There is little doubt that the past two decades have seen an extraordinary advance in the globalization of the world's economies. In this context, the legal services play a crucial role in facilitating business and form a vital part of the infrastructure that underpins world commerce. As a result, this service sector has experienced continuous growth over the last ten years. However, the regulation of legal services in most jurisdictions did not follow the same evolution, which results in restrictions on cross-border legal practice. Yet economic growth and globalization of economies increasingly require the adaptation of the regulation of legal services. In most instances they take place in the context of trade agreements. Until recently to the exception of the EU and the NAFTA, the liberalization of trade in services took place within the General Agreement on Trade in Services (GATS). However, the last decade has seen a proliferation of Preferential Trade Agreement (PTAs), which contain liberalization of trade services, including legal services. Such evolution leads to the coexistence of the GATS and the PTAs. The objective of this article is to analyse the interaction of these agreements in the context of the liberalization of trade in legal services using four principles of trade liberalization: the transparency; the nondiscrimination; the avoidance of unnecessary restrictions; the recognition.
Five Ways to Get in Trouble Buying from the United States
Authors: Norton Corey L.
Published: March 2022

For many companies around the world, the United States is obviously an attractive supplier of various products and technologies. Those sales, however, are usually subject to US export controls that actually restrict the customer's own plans to resell or otherwise use what it purchased, even after an item is outside the United States. Consequently, US exporters are not the only ones that have to keep US export control compliance in mind. The customer outside the United States can also commit violations of US law even though its business activities might occur solely outside US territory.

Penalties in this area are extremely steep and can be USD 250,000 or more per violation or even involve criminal charges. Given the possible penalties and that these laws are not particularly intuitive for anyone, nonetheless non-US companies, substantial enforcement cases can arise from violations of US export controls that follow US products around the world.

This commentary highlights five of the more common reasons why non-US companies find themselves tangled in a US export control violation and how to avoid a mess in the first place.
Friday the 13th or, How to Classify Parts and Accessories in the European Union
Authors: Kanters Leon
Published: March 2022

The Harmonized System was adopted in the European Union ('EU') via Council Regulation (EEC) No 2658/87 of 23 July 1987, Appendix 1 and known as Combined Nomenclature. ('CN'). Classifying goods in the CN is often anything but straightforward. Despite general rules for interpretation, the classification of goods is frequently disputed. A substantial number of the judgments rendered by the Court of Justice of the European Union ('CJEU') relate to disputes about CN classification. The classification of parts and accessories has taken an unexpected turn on the basis of recent CJEU case law. As a result, many businesses have had to make changes in their databases for the import and export of goods.
New Countries Applying the Harmonized System Nomenclature: Update 2014
Authors: Weerth Carsten
Published: March 2022

More countries and economic regions are applying the Harmonized Commodity Description and Coding System (Harmonized System Convention). Here is an overview for 2014 of the new countries which are using the worldwide uniform language of trade now and will apply the tariff scheme from 2015.
Strengthening the Fight against Customs Fraud in the EU: New European Parliament and Council Regulation Amending Regulation 515/1997
Authors: Xenakis Yannis
Published: March 2022

In the context of the fight against customs fraud the EU recently adopted an amendment to Regulation 515/97, its basic instrument for mutual assistance. This article provides an analysis and assessment of the amended Regulation, as well as background information and clarifications on the main issues addressed: the Container Status Messages and customs declarations enabling a better detection of fraud; admissibility of mutual assistance evidence in judicial procedures; better protection of information supplied by the Member States; streamlined data protection supervision; and institutional adaptation to the Lisbon Treaty.
Cross-Border Intellectual Property Rights in Digital Data: The Legal Framework in Europe and the United States in the Light of ClearCorrect v. US International Trade Commission
Authors: Simões Bruno G.
Published: March 2022

The article will address the authority of the European Union (hereinafter, EU) to detain goods at its borders that infringe, or are suspected of infringing, intellectual property rights (hereinafter, IPRs), in part through a comparison of similar regulations in the United States (hereinafter, US), and especially with respect to the detainment of digital goods. On 10 November 2015, the US Court of Appeals for the Federal Circuit released its Opinion in ClearCorrect Operating, LLC v. United States International Trade Commission, a case that, in part, examines the definition of ‘article’ under section 337 of the US Tariff Act of 1930. In the EU, Regulation (EU) No. 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No. 1383/2003 entered into effect in 2014. This regulation expanded the scope of competent authorities in EU Member States to detain suspected infringing goods at the EU’s borders, including new powers to detain and destroy ‘small consignments’ of such goods absent a formal decision confirming an infringement of an intellectual property design right. EU courts have yet to address the issue of whether digital data transmitted electronically applies to such legislation. The article will provide a review of the recent Opinion of the US Court of Appeals for the Federal Circuit, as well as an analysis of the relevant EU framework.
TPP and Investor-State Dispute Settlement: An Intertwined Spectrum of Options for Investors?
Authors: Mathison Eduardo , Pendás Mariana
Published: March 2022

Once ratified, Chapter 9 of the TPP (the Investment Chapter) will provide important protections to investors through the Investor-State Dispute Settlement (ISDS) system. While the Investment Chapter has triggered certain criticism, TPP members have relied for years on the ISDS system as an effective mechanism to solve disputes under pre-existing international investment agreements (IIAs). The new ISDS provisions are not revolutionary but reflect an effort by TPP members to regulate and include public concerns in the Investment Chapter.

There is, however, a remarkable absence in the TPP: there is no provision addressing the “coexistence” between TPP and preexisting IIAs. This absence—which very likely will result in investor-State treaty shopping— will offer alternatives to investors to bring arbitration claims under preexisting investment treaties.
FTA Origin Preference Claims: The Shift to Self-Certification
Authors: Torigoe Kazuyoshi
Published: March 2022

Certificates of origin issued by a competent authority have been used to prove that goods originate under many Free Trade Agreements (FTAs). This system, however, has limitations as trade volume grows under FTAs, so countries have been shifting toward self-certification origin systems. Self-certification systems are less costly and less time-consuming, but system depends on following the rules. This article discusses the examination of certification documents under these systems from viewpoints of authenticity, identity, and originating status. Being aware of the difference between these systems, measures are considered to achieve a smooth transition from the conventional certification system to one of self-certification.