scholarly journals Balanced Investment Treaties and the BRICS

AJIL Unbound ◽  
2018 ◽  
Vol 112 ◽  
pp. 217-222 ◽  
Author(s):  
Congyan Cai
Keyword(s):  
South Africa ◽  
The United States ◽  
The European Union ◽  
Brics Countries ◽  
Investment Treaty ◽  
Wide Range ◽  
Cast Doubt ◽  
Investment Treaties ◽  
Emerging Powers ◽  
Bretton Woods Institutions

Brazil, Russia, India, China, and South Africa (the BRICS) have emerged as a new hub of power in international relations. They have begun to speak out jointly on a wide range of issues and to explore cooperating collectively. For instance, they strongly urge the Bretton Woods institutions to address their legitimacy deficits by transferring substantial voting power to emerging powers, and suggest that failure to do so will “run the risk of seeing [those institutions] fade into obsolescence.” The investment treaty regime may be another field in which they can exert influence, but the investment treaty policies of BRICS countries are diverging now more than ever. In particular, India and South Africa have taken significant measures, such as terminating investment treaties, that cast doubt on whether the BRICS can play a collective role in reforming such treaties. In this essay, I make two arguments. First, the recent investment treaty policies of some BRICS (India, South Africa, and to some extent Brazil) have shifted from one imbalanced approach that is too protective of foreign investors to another that is too protective of host states and is likely to be rejected by major powers such as the European Union, the United States, and China. Second, the BRICS together have the ability to craft approaches to investment treaties that encourage greater balance in the regime overall, including by remedying some of the defects inherent in the traditional investment treaties.

scholarly journals Investment Treaties: The Reform Matrix

AJIL Unbound ◽  
2018 ◽  
Vol 112 ◽  
pp. 191-196
Author(s):  
Anthea Roberts
Keyword(s):  
United States ◽  
South Africa ◽  
European Union ◽  
The United States ◽  
The European Union ◽  
Investment Treaty ◽  
Investment Treaties ◽  
Treaty Reform

This essay proposes a matrix for understanding the dynamics of investment treaty reform. It tracks incremental, systemic, and paradigmatic reform options as applied across procedure, substance, and form. Although stylized and thus unable to capture all the nuances of individual positions, the reform matrix creates a framework for understanding some of the main debates about investment treaty reforms and offers a template for locating and comparing the approaches of key international actors, including the United States, the European Union, and Japan, together with Brazil, Russia, India, China, and South Africa (the BRICS).

Regulatory Freedom and Control in the New ASEAN Regional Investment Treaties

2015 ◽  
Vol 16 (5-6) ◽  
pp. 1018-1057 ◽  
Author(s):  
Diane A. Desierto
Keyword(s):  
The United States ◽  
The European Union ◽  
Asean Member ◽  
Investment Treaty ◽  
Regional Investment ◽  
Treaty Compliance ◽  
Treaty Interpretation ◽  
Investment Treaties ◽  
Institutional Controls ◽  
And Control

The expanding universe of regional investment agreements of the Association of Southeast Asian Nations (ASEAN) illustrates the difficulties of accepting host States’ expansive regulatory freedoms, while neglecting to design durable institutional controls for regionally-coordinated investment treaty compliance and regionally-harmonized investment treaty interpretation. Since its transformation from a loose economic cooperation into a rules-based organization discharging binding executive-legislative functions under its 2008 Charter, ASEAN has already entered into regional investment treaties applicable within the ten ASEAN Member States (2009), as well as with China (2010), India (2014), Australia and New Zealand (2009), Korea (2009), and Japan (2008). Negotiations are pending with the United States, the European Union, and Canada. Institutional deficits in the monitoring and implementation of ASEAN regional investment treaties could be addressed by strengthening the mandate and capacity of the ASEAN Investment Area (AIA) Council. An intergovernmental centralized appellate mechanism could help facilitate harmonized interpretation of these regional treaties.

International Report: Sludge management and related legislation

2002 ◽  
Vol 46 (4-5) ◽  
pp. 367-371 ◽  
Author(s):  
R. Leschber
Keyword(s):  
South Africa ◽  
European Union ◽  
United States Of America ◽  
Management Practices ◽  
The United States ◽  
Future Trends ◽  
The European Union ◽  
Sludge Management ◽  
International Report ◽  
America South

This report comprises the present sludge management practices with special view to agricultural utilization in the European Union and some accessing countries in eastern Europe in comparison with countries from Asia, the United States of America, South Africa and Australia. Information is given on the respective legislation and on future trends.

The BRICS Countries and the European Union

2020 ◽  
Author(s):  
Bas Hooijmaaijers ◽  
Stephan Keukeleire
Keyword(s):  
South Africa ◽  
Strategic Partnership ◽  
Western World ◽  
The European Union ◽  
Strategic Partnerships ◽  
Informal Networks ◽  
Brics Countries ◽  
Policy Fields ◽  
Political Economic ◽  
The Eu

Brazil, Russia, India, China, and South Africa (BRICS) have, since the beginning of the 21st century, gained greater influence in global political and economic affairs and, since 2006, also steadily developed and increased their political dialogue and cooperation. South Africa joining the BRICS political grouping in 2011 was matched by a strengthening of the BRICS dialogue. This was reflected in the broadening range of issues covered, the increasing level of specificity of the BRICS joint declarations and cooperation, and the institutionalization of BRICS cooperation in various policy fields, including the creation of the New Development Bank (NDB). Notwithstanding the increased interaction between the BRICS states on the various political, economic, and diplomatic levels, the countries differ considerably in their political, economic, military, and demographic weight and interests and in their regional and global aspirations. China particularly stands out among the BRICS due to its political and economic weight. There are sufficient reasons to question the significance and impact of the BRICS format. Still, the BRICS countries have found each other in their commitment to counter the “unjust” Western-dominated multilateral world in which they are generally underrepresented. The EU did not develop a “BRICS policy” as such, which is understandable given the major differences between the BRICS countries and the ambiguous nature of the BRICS format. To deal with the various emerging powers and complement its predominantly regional partnerships, the EU instead institutionalized and deepened the political and economic bilateral relations with each of the BRICS countries, including through the objective of establishing a bilateral “strategic partnership” with each of these countries. However, the analysis of the EU’s relationship with the BRICS countries indicates that the label “strategic partnerships” mainly served as a rhetorical façade which belied that the EU failed to turn these relationships into real strategic partnerships and to behave strategically toward the BRICS countries. Another challenge for the EU appears when analyzing the BRICS within the broader context of various emerging power constellations and multilateral frameworks, including variations of the BRICS format (such as BRICS Plus, BASIC, and IBSA), multilateral frameworks with one or more BRICS countries at their center (such as the SCO, EAEU, and BRI), and regional forums launched by China. Taken together, they point to an increasingly dense set of partially overlapping formal and informal networks on all political, diplomatic, and administrative levels, covering an ever-wider scope of policy areas and providing opportunities for debate, consultation, and coordination. Whereas most of these forums are in and of themselves not very influential, taken together they have an impact on the EU and its traditional view on multilateralism in several ways. Seen from this perspective, the BRICS and other multilateral forums pose major challenges for both European diplomats and European scholars. They will have to make considerable efforts to understand and engage with these various forums, which are manifestations of an increasingly influential and powerful non-Western world wherein the role of Europe is much more limited.

scholarly journals Federico Ortino

2018 ◽  
Vol 112 ◽  
pp. 67-68
Author(s):  
Federico Ortino
Keyword(s):  
European Union ◽  
Market Access ◽  
Trade Agreement ◽  
The United States ◽  
Third Party ◽  
The European Union ◽  
National Treatment ◽  
Investment Protection ◽  
Investment Treaties ◽  
The Eu

Even when it comes to investment, despite appearances to the contrary, it does not seem to me that there is a shift to the non-discrimination principle. First, there is no doubt that absolute standards such as fair and equitable treatment or the provision on expropriation have by far overshadowed the relative standards, in particular national treatment. Second, while the MFN standard has, on the other hand, been a key provision in investment treaty arbitration, particularly as an instrument to expand the scope of the ISDS system (based on more favorable provisions found in third-party treaties), there are clear signs in recent investment treaties of the willingness to curtail the use of the MFN provision as a way to extend the procedural and substantive protections of investors. This seems to be the current position, for example, of both the United States and the European Union (EU). Third, when it comes to the apparent disappearance of the absolute standards of treatment in some of the treaties being negotiated by the European Union (such as with Japan), this is more simply due to a question of the nature of the EU external competence in commercial matters. In its recent opinion on the EU-Singapore FTA, the Court of Justice of the EU has determined that the EU does not have exclusive competence to conclude agreements covering non-FDI and ISDS. The EU has thus responded to such opinion by splitting investment protection (with ISDS) from the rest of the trade agreement, thus keeping investment liberalization (including market access and national treatment) in the latter. In this way, while the trade agreement will fall under the exclusive competence of the EU, the former will still require ratification by each member state. While it is not clear whether the backlash vis-à-vis investment protection and ISDS in some quarters within some of the member states will eventually lead to the end of EU investment treaties, a decision in this sense has not yet been taken by EU institutions.

scholarly journals A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme

2019 ◽  
Vol 22 ◽  
pp. 28-36 ◽  
Author(s):  
Alfredo Garcia Arieta ◽  
Craig Simon ◽  
Gustavo Mendes Lima Santos ◽  
Iván Omar Calderón Lojero ◽  
Zulema Rodríguez Martínez ◽  
...  
Keyword(s):  
South Africa ◽  
New Zealand ◽  
Immediate Release ◽  
The United States ◽  
Essential Medicines ◽  
Oral Dosage ◽  
Quantitative Composition ◽  
Limiting Factor ◽  
The European Union ◽  
Regulatory Requirements

The acceptance of foreign comparator products is the most limiting factor for the development and regulatory assessment of generic medicines marketed globally. Bioequivalence studies have to be repeated with the local comparator products of each jurisdiction because it is unknown if the comparators of the different countries are the same product, with the consequent duplication of efforts by regulators and industry alike. The regulatory requirements on the acceptability of foreign comparator products of oral dosage forms differ between countries participating in the Bioequivalence Working Group for Generics of the International Pharmaceutical Regulators Programme. Brazil, Colombia, the European Union member States, Japan, Mexico, South Korea and the United States only accept bioequivalence studies with their local comparator. In contrast, Australia, Canada, New Zealand, Singapore, South Africa, Switzerland and Taiwan accept studies with foreign comparators under certain conditions. Canada limits its use to highly soluble drugs with a wide therapeutic range in immediate release products. Australia requires a comparison of the quantitative composition. In contrast, there are fewer restrictions on the acceptance of foreign comparators in New Zealand, Singapore, South Africa, Switzerland and Taiwan. For the WHO Prequalification of Medicines and for developing generics of the essential medicines the WHO lists comparators from different countries. In conclusion, there is currently no consensus amongst regulators on the acceptability of foreign comparator products.

scholarly journals Pushing Back on Stricter Copyright ISP Liability Rules

2021 ◽  
pp. 299
Author(s):  
Pamela Samuelson
Keyword(s):  
United States ◽  
Service Providers ◽  
The United States ◽  
Fundamental Rights ◽  
Safe Harbor ◽  
The European Union ◽  
Internet Service ◽  
Liability Rules ◽  
Stakeholder Interests ◽  
Wide Range

For more than two decades, internet service providers (ISPs) in the United States, the European Union (EU), and many other countries have been shielded from copyright liability under “safe harbor” rules. These rules apply to ISPs who did not know about or participate in user-uploaded infringements and who take infringing content down after receiving notice from rights holders. Major copyright industry groups were never satisfied with these safe harbors, and their dissatisfaction has become more strident over time as online infringements have grown to scale. Responding to copyright industry complaints, the EU in 2019 adopted its Directive on Copyright and Related Rights in the Digital Single Market. In particular, the Directive’s Article 17 places much stricter obligations on for-profit ISPs that host large amounts of user contents. Article 17 is internally contradictory, deeply ambiguous, and harmful to small and medium-sized companies as well as to user freedoms of expression. Moreover, Article 17 may well violate the European Charter of Fundamental Rights. In the United States, Congress commenced a series of hearings in 2020 on the safe harbor rules now codified as 17 U.S.C. § 512 of the Digital Millennium Copyright Act (DMCA). In May 2020, the U.S. Copyright Office issued its long-awaited study on Section 512, which recommended several significant changes to existing safe harbor rules. The Study’s almost exclusively pro–copyright industry stances on reform of virtually every aspect of the rules notably shortchanges other stakeholder interests. Congress should take a balanced approach in considering any changes to the DMCA safe harbor rules. Any meaningful reform of ISP liability rules should consider the interests of a wide range of stakeholders. This includes U.S.-based Internet platforms, smaller and medium-sized ISPs, startups, and the hundreds of millions of Internet users who create and enjoy user-generated content (UGC) uploaded to these platforms, as well as the interests of major copyright industries and individual creators who have been dissatisfied with the DMCA safe harbor rules.

scholarly journals Live biotherapeutic products: the importance of a defined regulatory framework

2020 ◽  
Vol 52 (9) ◽  
pp. 1397-1406 ◽  
Author(s):  
Magali Cordaillat-Simmons ◽  
Alice Rouanet ◽  
Bruno Pot
Keyword(s):  
Health Benefit ◽  
The United States ◽  
Regulatory Framework ◽  
European Medicines Agency ◽  
The European Union ◽  
Technical Requirements ◽  
Regulatory Constraints ◽  
Wide Range ◽  
The Impact ◽  
Intended Use

Abstract Probiotics have been defined as “Live microorganisms that when administered in adequate amounts confer a health benefit on the host”. This definition covers a wide range of applications, target populations and (combinations of) microorganisms. Improved knowledge on the importance of the microbiota in terms of health and disease has further diversified the potential scope of a probiotic intervention, whether intended to reach the market as a food, a food supplement or a drug, depending on the intended use. However, the increased interest in the clinical application of probiotics may require specific attention given their administration in a diseased population. In addition to safety, the impact of the type of product, in terms of quality, production method and, e.g., the acceptance of side effects, is now part of the current regulatory constraints for developers. In the European Union, foods are regulated by the European Food Safety Authority and drugs by the European Medicines Agency; in the United States, the Food and Drug Administration (FDA) deals with both categories. More recently, the FDA has defined a new “live biotherapeutic products” (LBP) category, clarifying pharmaceutical expectations. Since 2019, the quality requirements for this category of drug products have also been clarified by the European Pharmacopoeia (Ph. Eur.). Similar to all products intended to prevent or treat diseases, LBPs will have to be registered as medicinal products to reach the market in the US and in Europe. In this area, regulatory authorities and the pharmaceutical industry will routinely use guidelines of the “International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use” (ICH). Although ICH guidelines are not legally binding, they provide very important recommendations, recognized by almost all drug authorities in the world. In this review, we discuss some aspects of this regulatory framework, especially focusing on products with an intended use in a diseased or vulnerable target population.

Sign in / Sign up

Export Citation Format

Share Document