scholarly journals Big Pharma and Investment Arbitration

2021 ◽  
Vol 4 (1) ◽  
pp. 88-114
Author(s):  
Sébastien Manciaux
Keyword(s):  
Marketing Authorization ◽  
Pharmaceutical Sector ◽  
Foreign Investors ◽  
Foreign Partner ◽  
Patent License ◽  
Investment Arbitration ◽  
State Authority ◽  
Health Products

Abstract Investment Arbitration in the pharmaceutical sector raises some specificities. Regarding jurisdiction of arbitral tribunals, it is questionable whether the registration of a patent abroad or a patent license granted to a foreign partner constitutes an investment. Similarly, as health products are not ordinary goods, arguments according to which marketing authorizations or monopolies granted constitute an investment are real issues. On the merits, the invalidation of a patent, the refusal or withdrawal of a marketing authorization or the decision of a state authority to end a monopoly can be analyzed as a violation of some of the commitments made by States in the treaties they conclude. The aim of this study is to address these questions thanks to the awards already rendered, making it a useful tool for countries -like Vietnam- that wish to develop their pharmaceutical sector by attracting foreign investors.

scholarly journals Handle with care: Umbrella clauses and MFN treatment in investment arbitration

2013 ◽  
pp. 978-994 ◽  
Author(s):  
Tarcisio Gazzini ◽  
Attila Tanzi
Keyword(s):  
Foreign Investors ◽  
Investment Arbitration ◽  
Legal Uncertainty

A large number of BITs concluded by France contain quite a peculiar clause (for instance Article 10 BIT with Argentina), which has been recently the object of questionable interpretations and applications in EDF International S.A. et al. v. Argentina and Mr. Franck Charles Arif v. Moldova. Both tribunals allowed the claimants to benefit, through the MNF clause, from umbrella clauses contained in BITs with third States. It is argued that neither tribunal has rigorously interpreted the relevant provisions in the basic treaty, nor ensured compliance with the ejusdem generis principle. The legal uncertainty that surrounds these provisions is detrimental for foreign investors and States alike. Concerned States should consider taking the measures necessary to clarify, jointly or individually, the content of these provisions and of the obligations stemming from them.

scholarly journals Investor Responsibility as Familiar Frontier

AJIL Unbound ◽  
2019 ◽  
Vol 113 ◽  
pp. 28-32
Author(s):  
Jackson Shaw Kern
Keyword(s):  
International Investment ◽  
Foreign Investors ◽  
Investment Arbitration ◽  
New Frontier ◽  
Modern Era

This essay suggests that amidst the various criticisms of investor-state arbitration, the most potent is the present inadequacy of this mechanism to establish a reciprocal responsibility of foreign investors. The founders of the modern era of international investment arbitration never intended to build a one-way street. In this sense, to seek a regime of investor responsibility may not be to reach toward a new frontier so much as to return to one that is familiar, though underexplored.

Transnational Public Policy as a Vehicle to Impose Human Rights Obligations in International Investment Arbitration

2020 ◽  
Vol 21 (6) ◽  
pp. 809-846
Author(s):  
Jean-Michel Marcoux
Keyword(s):  
Public Policy ◽  
Human Rights ◽  
International Investment ◽  
International Consensus ◽  
Foreign Investors ◽  
Material Sources ◽  
Investment Arbitration ◽  
Human Rights Norms ◽  
The Right

Abstract International investment arbitration has been criticized for its general reluctance to consider human rights concerns related to foreign investors’ activities. By contrast, arbitration tribunals have relied on transnational public policy to prevent a claimant whose investment is tainted with illegality from obtaining redress. This article explores how human rights norms could be conceptualized as part of transnational public policy to impose obligations on foreign investors. It proceeds in three steps. First, it addresses the role of transnational public policy in investment arbitration. Second, the article identifies the material sources considered by tribunals to delimit the content of the doctrine. Third, it focuses on three norms – the protection of fundamental human rights, a corporate responsibility to respect human rights and the right of Indigenous Peoples to be consulted – for which tribunals have found an international consensus and that could be conceptualized as norms of transnational public policy.

scholarly journals ISDS Regimes and Democratic Practice: Creating Conflict of Interests between Governments, Investors and Local Populations

2019 ◽  
Vol 25 (84) ◽  
pp. 36-52
Author(s):  
Martin Karas
Keyword(s):  
Decision Making ◽  
Dispute Settlement ◽  
Good Governance ◽  
Scholarly Work ◽  
Foreign Investors ◽  
Local Populations ◽  
Investment Arbitration ◽  
Democratic Practice ◽  
Recent Debate ◽  
The Relationship

Abstract The recent debate over the Investor-State Dispute Settlement (ISDS) regimes of international arbitration has resulted in concerted efforts aimed mainly at protecting the rights of states to regulate, improving transparency of proceedings and eliminating inconsistency in decision making of the tribunals. While the existing scholarly work frequently addresses issues of the relationship between the existing investment regimes and good governance in general, increased attention is rarely paid to the effects that investment arbitration has on democratic practice. The article applies an “action-based” approach to democracy, in order to analyse the role that the ISDS regimes play in exacerbating conflicts between the local populations, foreign investors and governments. The analysis leads to a conclusion that the ISDS regimes create incentives for the governments and foreign investors to disregard sound democratic practice. The article represents an attempt to move the discussion about the ISDS regimes away from the question of legitimacy of the regimes to the question of the impacts that the regimes have in practice.

scholarly journals Counterclaims and the Rule of Law in Investment Arbitration

AJIL Unbound ◽  
2019 ◽  
Vol 113 ◽  
pp. 33-37 ◽  
Author(s):  
Tomoko Ishikawa
Keyword(s):  
Rule Of Law ◽  
International Investment ◽  
Access To Justice ◽  
Foreign Investors ◽  
The Rule Of Law ◽  
International Investment Law ◽  
Rule By Law ◽  
Investment Arbitration ◽  
The Law ◽  
Broad Interpretation

While the rule of law was originally developed with reference to domestic constitutional orders, it is also widely embraced by international lawyers. This essay argues that the admission of counterclaims in certain circumstances helps investment arbitration advance the rule of law on several counts. The rule of law is defined here to include not only formal elements such as rule-by-law and formal legality, but also “thicker” elements attached to certain substantive values, including fundamental human rights. The UN's work on the rule of law clearly adopts a broad interpretation of this concept. This essay examines the potential for counterclaims to bridge the gap between the lack of effective mechanisms to hold foreign investors accountable for their conduct and the extensive protection of foreign investors in international investment law. By doing so, counterclaims in investment arbitration may promote the thicker elements of the rule of law such as accountability to the law, access to justice, and fairness in the application of the law.

“Missing Links” in Investment Arbitration: Quantification of Damages to Foreign Shareholders

2013 ◽  
pp. 434-479
Author(s):  
Jimmy Skjold Hansen
Keyword(s):  
Law And Economics ◽  
International Investment ◽  
Foreign Investors ◽  
Legal Principles ◽  
Investment Arbitration ◽  
Corporate Entity ◽  
Share Value

This article focuses on the tensions between law and economics which inevitably occur in connection with the quantification of damages in international investment disputes between foreign shareholders (foreign investors) and host states. In this context, four contemporary approaches to quantification are addressed. These concern 1) full loss of the investment or invested amounts, 2) lost share value, 3) lost dividends, or 4) discretionary compensation. It is analyzed to what extent these approaches comply with the fundamental, legal principles which are in play in most investment disputes today, that is a) identification of the protected investment, b) recognition of the corporate entity, c) “full reparation” of injury, d) causation and certainty of losses, and e) avoidance of double recovery. It is demonstrated that each approach may pose challenges in respect of one or more of these legal principles.

INCONSISTENCIES IN ICSID AWARDS ON DISPUTES RELATED TO MFN AND UMBRELLA CLAUSE

2021 ◽  
Vol 6 (2) ◽  
pp. 247-264
Author(s):  
Herliana Herliana
Keyword(s):  
Developing Countries ◽  
Foreign Direct Investment ◽  
Direct Investment ◽  
Case Study Method ◽  
Host Countries ◽  
Foreign Investors ◽  
Investment Arbitration

Investment arbitration has been acclaimed as an important part of Foreign Direct Investment (FDI) movement around the globe because it provides a neutral and trustable forum for settling investment dispute. However, many argue that investment arbitration often becomes advocates of foreign investors and neglect the developing country’s interests as the host of investment. This paper aims at studying the investment arbitration awards rendered by International Center for Settlement of Investment Dispute (ICSID) tribunals launched against developing countries. The question is whether and to what extent those awards have equally observed the interests of foreign investors and host states of investments. To answer the questions, this paper employs case study method and use publicly available ICSID cases. This research shows that some ICSID tribunals have inconsistent reasoning which led to contradictory decisions. Apparently, as some cases indicate ICSID tribunals gave more weight to the need to protect foreign investors rather than host countries’ development interests. As a consequence, inconsistency and ambiguity have led to uncertainty and unpredictability of the forum. This is not only disadvantaged the parties due to inability to foresee the likely outcome of the disputes but also endanger the ICSID tribunals’ credibility as neutral and reliable forum.

Transnational Public Policy as an International Practice in Investment Arbitration

2019 ◽  
Vol 10 (3) ◽  
pp. 496-515
Author(s):  
Jean-Michel Marcoux
Keyword(s):  
Public Policy ◽  
International Relations ◽  
International Relations Theory ◽  
International Investment ◽  
Legal Basis ◽  
Foreign Investors ◽  
International Investment Law ◽  
Investment Arbitration ◽  
Investment Law

Abstract International investment arbitration tribunals have used the doctrine of transnational public policy to prevent claimants whose investments are tainted with illegality from obtaining redress. Whereas tribunals generally have the authority to apply transnational public policy when deciding a claim, they have often assumed rather than demonstrated the obligation for foreign investors to comply with the doctrine. This article proposes an interdisciplinary account that draws upon ‘international practices’ in International Relations theory to understand the normative pull toward this obligation. It does so by shedding light on tribunals’ general lack of consideration for a proper legal basis to impose an obligation on foreign investors to comply with transnational public policy. It then suggests that the normativity of the doctrine primarily rests on a practice that is reproduced and reinforced by tribunals themselves. Understanding transnational public policy as an international practice ultimately illustrates the role of tribunals to reform international investment law.

OP56 Are Therapeutic Positioning Reports Driving Pharmaceutical Reimbursement Outcomes In Spain?

2019 ◽  
Vol 35 (S1) ◽  
pp. 13-14
Author(s):  
Raquel Fernandez Dacosta ◽  
Andrea Berardi ◽  
Richard Macaulay
Keyword(s):  
Alternative Treatment ◽  
Statistical Tests ◽  
Treatment Options ◽  
Marketing Authorization ◽  
Market Approval ◽  
Health Products ◽  
Chi Squared ◽  
Autonomous Regions ◽  
The Impact

IntroductionFollowing marketing authorization in Spain, new medicines are assessed by the Inter-Ministerial Pricing Commission for Pharmaceuticals (CIPM), which provides reimbursement recommendations with a maximum ex-factory price. However, there are 17 autonomous regions, which can make distinct reimbursement decisions. To drive consistency, the Spanish Agency for Medicines and Health Products has issued national Therapeutic Positioning Reports (TPRs) for new medicines since 2012. Since November 2017, CIPM recommendations have been published monthly, giving the opportunity to analyze the impact of TPRs on the speed and outcome of CIPM decisions, which this research evaluates.MethodsPublicly-available CIPM and TRP decisions were identified from www.msssi.gob.es and www.aemps.gob.es, respectively. Marketing authorization dates were identified from www.ema.europa.eu or www.aemps.gob.es (10 March 2007-11 February 2018). Pearson's chi-squared and Mann-Whitney U statistical tests were performed using R.ResultsOne hundred and ninety-three drug-indication pairings with an associated TPR were identified. The majority (62% [120/193]) were recommended as alternative treatment options with only 19 percent (36/193) deemed to be superior and 19 percent (37/193) not recommended. One hundred and eight CIPM recommendations were identified across seven monthly reports, issued a mean of 12.2 months after market approval, 59 percent (64/108) were positive and 41 percent (44/108) were negative recommendations. There were 34 drug-indication pairings with both CIPM and TPR recommendations available. Of these, 24 percent, 56 percent and 21 percent had TPR outcomes of ‘superior’, ‘alternative’ and ‘not recommended’, respectively and 71 percent and 29 percent had positive and negative CIPM outcomes. Drug-indication pairings with ‘negative’ TPRs were significantly more likely to have negative CIPMs than those with either ‘alternative’ or ‘superior’ TPRs (71% vs. 19%, respectively, χ2 = 5.16, p = 0.02) and were more likely to experience significantly longer delays to CIPM recommendation (23.9 vs. 13.5 months, respectively, U = 50, p = 0.03).ConclusionsDrug-indication pairings with ‘positive’ and ‘alterative’ TPR outcomes are associated with significantly better and faster CIPM recommendations than those with ‘not recommended’ TPR outcomes

scholarly journals La légalité de l’investissement devant l’arbitre international : à la recherche d’un point d’équilibre

2017 ◽  
Vol 14 (2) ◽  
Author(s):  
Hervé Ascensio
Keyword(s):  
International Law ◽  
Legal Basis ◽  
Foreign Investors ◽  
Balanced Approach ◽  
Investment Arbitration ◽  
The Moment ◽  
Over Time

The idea that the protection offered to foreign investors under international law is conditioned upon the respect of legality has emerged in the practice of investment arbitration, on the basis of some treaty provisions and on the basis of general principles of international law. The effect of such legality condition is however intricate, because an argument on illegality is raised sometimes as a jurisdictional objection, sometimes as an admissibility issue, and sometimes on the merits. This article argues that arbitral decisions have become more consistent over time, and that different legal characterizations are understandable, taking into account the different legal basis for a legality condition, the timing of proceedings, and the multifaceted aspects of legality. A balanced approach of the legality condition would be to ground it in international as well as national law, and to focus on the moment of the making of the investment; conversely, an expansive approach would create conceptual and practical difficulties.

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