Law Commons^™

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S F Orubu, Muhammad H. Zaman, John Rex, Christine Ardal

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020 [1]. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs [2]. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to …

Loving It To Pieces: Eu Law In Us Legal Academia, Revisited, Daniela Caruso

Faculty Scholarship

The Editors of the Special Issue have kindly invited me to update earlier reflections on the state of EU law in US legal academia. For a variety of reasons, it is important to me not to mislead the reader with the false promise of some kind of summa. What follows is my own perception of a complicated landscape, which I shall sketch lightly here in the hop of prompting other scholars of EU Law to report on their own US experience.

Gdpr And The Importance Of Data To Ai Startups, James Bessen, Stephen Michael Impink, Lydia Reichensperger, Robert Seamans

Faculty Scholarship

What is the impact of the European Union’s General Data Protection Regime (“GDPR”) and data regulation on AI startups? How important is data to AI product development? We study these questions using unique survey data of commercial AI startups. AI startups rely on data for their product development. Given the scale and scope of their business models, these startups are particularly susceptible to policy changes impacting data collection, storage and use. We find that training data and frequent model refreshes are particularly important for AI startups that rely on neural nets and ensemble learning algorithms. We also find that firms …

Legal Scholarship And External Critique In Eu Law, Daniela Caruso, Fernanda Nicola

Faculty Scholarship

The propensity to engage in a sustained critique of EU law marbles several contributions in this Volume and certainly animates this chapter. This generally critical stance takes the present stage of legal Europeanization as a fact and aims to make full use of the possibilities for political and social justice it can currently support, but at the same time it decries its many structural and dynamic drawbacks. In doing so, this critical project borrows liberally from CLS without fear of misreading or misappropriation. Irreverence in this context is a feature, not a bug. The CLS toolkit is clearly useful to …

Fairness At A Time Of Perplexity: The Civil Law Principle Of Fairness In The Court Of Justice Of The European Union, Daniela Caruso

Faculty Scholarship

The general principle of fairness, recently articulated by the Court of Justice of the European Union in the context of consumer law, is bound to prompt ambivalent scholarly reactions. Fairness in private law could be dismissed as hopelessly indeterminate: yet another venue of judicial balancing, a technique already seen ad nauseam in Luxembourg, whereby lip service is paid to conflicting considerations, but no real solace can be found against regressive outcomes of law and policy choices. At the same time, the judicial articulation of a general principle of fairness in private law could be seen as a prompt for domestic …

Melki In Context: Algeria And European Legal Integration, Daniela Caruso, Joanna Geneve

Faculty Scholarship

This is a chapter prepared for the volume: Bill Davies and Fernanda Nicola Eds., EU Law Stories: Contextual and Critical Histories of European Jurisprudence, Cambridge University Press, May 2017. In line with the spirit of the book, this chapter tells the story of Melki – a landmark case in the jurisprudence of the CJEU, in a novel way and connects the individual journey of Mr. Melki to the broader context of north-south relations. Besides recounting the lawyerly strategy of Melki’s pro-bono counsel and the predicament of Algerian sans-papiers in France, the chapter aims to contribute to the literature on the …

Trade And History: The Case Of Eu-Algeria Relations, Daniela Caruso, Joanna Geneve

Faculty Scholarship

The recent centennial of Albert Camus’s birth has had little resonance in EU legal scholarship. Yet Camus’s work is a natural entry point into the EU’s trade relations with the global south, and Algeria’s case is a particularly salient one, given the oft-ignored fact that for five years the Algerian nation was a part of the European Economic Community. The onset of a free trade regime between the EU and the former colonies or territories of its member states is often touted as the culminating point in a line of constant progress, from dependency to autonomy and from asymmetry to …

Lost At Sea, Daniela Caruso

Faculty Scholarship

A reflection on the existential loss experienced by many young persons in the aftermath of the Euro-zone crisis (often referred to as ‘the lost generation’) must also acknowledge, for the record and for reasons of relative salience, those who have recently drowned in the waters of southern Europe in their quest for a better future. This essay proposes to reconsider, for a moment, the relation between the obstacles that third country nationals (TNCs) encounter at our external frontiers and the increasing permeability of internal EU borders. Normally, one thinks of the two as structurally opposed: within its boundaries, the EU …

Intermediary Trademark Liability: A Comparative Lens, Stacey Dogan

Shorter Faculty Works

Although we live in a global, interconnected world, legal scholarship – even scholarship about the Internet – often focuses on domestic law with little more than a nod to developments in other jurisdictions. That’s not necessarily a bad thing; after all, theoretically robust or historically thorough works can rarely achieve their goals while surveying the landscape across multiple countries with disparate traditions and laws. But as a student of U.S. law, I appreciate articles that explain how other legal systems are addressing issues that perplex or divide our scholars and courts. Given the tumult over intermediary liability in recent years, …

Tackling Vat Fraud: Thirteen Ways Forward, Richard Thompson Ainsworth

Faculty Scholarship

In a May 31, 2006 Communication to the Council, the European Parliament, and the European Economic and Social Committee, the European Commission indicated a need to develop a coordinated strategy to improve the fight against fiscal fraud [COM (2006) 254 final]. Although the Communication considers fiscal fraud broadly (VAT, excise duties and direct taxes) the most pressing need seems to be for a VAT strategy that will effectively deal with carousel fraud.

This paper considers thirteen proposals that deal with missing trader intra-community fraud (MTIC):

(1) Common VAT (origin system) (2) Vanistendael’s foreign tax offices proposal (3) CVAT (Compensating VAT) …

Qu'ils Mangent Des Contrats: Rethinking Justice In Eu Contract Law, Daniela Caruso

Faculty Scholarship

The concern for justice in the context of EU contract law was central to a scholarly initiative that led, in 2004, to the publication of a Social Justice Manifesto. The Manifesto had the explicit goal of steering the Commission’s harmonization agenda away from purely neoliberal goals and towards a socially conscious law of private exchange. Contract law would be designed at the EU level so as to become (or remain, depending on the baseline of each member state) palatable to weaker parties. Today, in the many parts of Europe devastated by rising poverty, dire unemployment rates, and collapsing social safety …

Leveling The International Playing Field With The Marketplace Fairness Act, Richard Thompson Ainsworth, Boryana Madzharova

Faculty Scholarship

Quill v. North Dakota unbalanced the American retail market with its preference for out-of-state over in-state sellers. The preference under Quill is that sellers without physical presence in a state cannot be compelled to collect the sales tax. If the buyer does not voluntarily remit the complementary use tax, the purchase is effectively tax-free. As a result, Quill is seen as facilitating tax avoidance and driving business to sellers who have no in-state nexus, notably e-businesses. Revenue losses are estimated in excess of $10 billion per year.

The reach of the Quill decision is international. Preferred sellers can reside just …

The Baby And The Bath Water: The American Critique Of European Contract Law, Daniela Caruso

Faculty Scholarship

This paper aims to contribute to a larger research agenda concerning the possibility of meaningful transatlantic dialogue about private-law reform. Both the European Union and the United States regulate private autonomy extensively. In spite of contextual similarities, there are several barriers making dialogue among legal scholars difficult. In particular, the conversation about social justice, an important element of private law reform within the European Union, is now quite marginal in American contract law scholarship. In U.S. legal academia, social justice is a matter for moral philosophers, development economists, and constitutionalists. Against this background, this paper takes a close look at …

Stopping Mtic -- With A 3rd Invoicing Directive, Richard Thompson Ainsworth

Faculty Scholarship

A Third Invoicing Directive for the EU VAT seems to be a foregone conclusion. Corrections are needed in the Second Invoicing Directive. The hallmark of the next Directive will be its application of digital invoice technology. The Commission’s proposals will include adoption of tax-technology advances in invoice-control that are currently in use outside the EU. The next Invoicing Directive will require comprehensive e-invoicing, invoices that are digitally signed, and invoices that are fed into a system of relational databases that match transaction data across the Single Market. There will be real-time EU sales/purchases lists, and remote/real-time audit functionality.

This will …

The Transformation Of Europe In Us Legal Academia And Its Legacy In The Field Of Private Law, Daniela Caruso

Faculty Scholarship

The rise of EU law in US legal scholarship – from international lawyers' pet project to new fuel for comparative constitutional scholarship, and then on to self-contained subject matter with an independent raison d'être – is closely tied to the professional itinerary of Joseph Weiler. Under the auspices of Eric Stein and Peter Hay, EEC law developed as a discipline at the University of Michigan, and the collaboration between US legal academia and the European University Institute (EUI) grew in quality and intensity. The year 1984 saw the birth of a massive research project sponsored by the EUI and the …

Vat Triangulation With A Us Middleman Vstr, C-587/10, Richard Thompson Ainsworth

Faculty Scholarship

It is not every day that an American firm finds itself in the middle of an EU VAT controversy that significantly develops the law. However, the September 27, 2012 decision of the European Court of Justice (ECJ) does just that. The case is Vogtländische Straβen-,Tief- und Rohrleitungsbau GmbH Rodewisch (VSTR) v. Finanzamt Plauen.

In November 1998 Atlantic International Trading Company (AIT), an American company established in New York, NY, purchased two stone-crushers from VSTR, a firm established in Germany. AIT quickly re-sold the stone-crushers to an end user established in Finland. The VSTR/AIT contract was “ex works,” that is AIT …

A Perfect Storm In The Eu Vat: Kittel, 'R' And Marc, Richard Thompson Ainsworth

Faculty Scholarship

EU VAT authorities are close to turning the tables on missing traders. For many years organized fraudsters have been stealing huge amounts of VAT on the domestic re-sale of exempt cross-border supplies. Losses have been enormous whether the transactions are in goods (notably cell phones and computer chips) or in tradable services (CO2 permits and VoIP). No market has been safe from the fraudsters.

Answers are developing, but these answers may look more like Armageddon than measured enforcement. Solutions are so draconian, and so all-encompassing that very few intra-community traders will feel safe from the gathering storm. The situation is …

Transfer Pricing: The Cup -- Case Studies: Australia, Us, Uk, Norway And Canada, Richard Thompson Ainsworth, Andrew Shact

Faculty Scholarship

All transfer pricing regimes give priority to the comparable uncontrolled price (CUP) method. Despite declarations that transfer pricing is a search for the “best method” or “most appropriate method,” all systems concede that the search is over when an exact comparable is found because a CUP is preferred over all methods. The best CUP is an exact CUP because it provides an arm’s length price that is not calculated. The price emerges directly from the comparison.

CUPs have traditionally been the most commonly applied method for both taxpayers and the government. They are the judicial gold standard. They hold sway …

Black Swans: Recapitulative Statements/Vies (Vat) & Use Tax Reciprocity (Rst), Richard Thompson Ainsworth

Faculty Scholarship

There is fundamentally no difference between a value added tax (VAT), and a retail sales tax (RST) when it comes to collecting the tax on cross-border sales. If (under a VAT) a seller is allowed to “zero-rate” cross-border sales, or if (under a RST) a seller is exempt from collecting the tax on cross-border sales, the critical enforcement question is exactly the same – how does the system assure that the buyer will self-assess (and pay) the tax?

The simple answer is that the tax administration audits. The more complicated answer notes that the effectiveness of the audit (by the …

The 'Justice Deficit' Debate In Eu Private Law: New Directions, Daniela Caruso

Faculty Scholarship

This essay outlines the ongoing debate on the justice deficit of EU private law – the ‘social justice’ debate – and then points at an underexplored avenue of inquiry that is essential for this debate to stay meaningful and constructive. Future research should aim to calibrate EU private law to the socio-economic asymmetries of the EU market, and to counterbalance the uneven weight of uniform rules, where they appear desirable, with proper compensatory mechanisms.

German Vat Compliance - Moving One Step Closer To Automated Third-Party Solutions, Richard Thompson Ainsworth

Faculty Scholarship

Recent developments in German VAT compliance, notably (a) the imposition of criminal penalties for failing to immediately amend a preliminary return that is known to be in error [Bundesgerichtshof decision of March 17, 2009, No. BGH 1 StR 342/08], when considered in tandem with (b) amendments to the voluntary disclosure rules, Gesetz zur Vebesserung der Bekämpfung von Geldwäsche und Steuerhinterziehung, it is clear that the German VAT compliance landscape has changed dramatically in the past year.

Taken as a whole, the German rules strongly encourage internal audits, self-reviews, and immediate self-disclosures of errors in previously filed returns and taxes paid. …

The Cambridge Companion To European Union Private Law, Daniela Caruso

Shorter Faculty Works

Well into its teens by now, the private law of the European Union has its own companion. The very appearance of a publication of this sort is indeed a coming-of-age moment for a discipline whose existence was hard to fathom until the 1980s. Member states’ judges and lawyers have come full circle, from resisting European Union private law as an intrusion into a quintessentially national sphere, to embracing it as a natural consequence of market integration. The question is no longer whether or not to approximate the private laws of the member states. The question is how to do it. …

E.U. Law In U.S. Legal Academia, Daniela Caruso

Faculty Scholarship

The history of EU law in the JD curriculum is a classical tale of rise and fail. An avant garde, boutique offering in the 1970s, and a fairly popular course in the 1990s, today EU law in US law schools is slowly losing prominence. This Article begins by tracking this parabolic trajectory and argues that the discipline both rose and fell for contingent reasons that are mostly unrelated to its pedagogical and analytical significance. The Article then provides a critical appraisal of what EU law is uniquely poised to offer both in the classroom and as a subject for legal …

The Morphing Of Mtic Fraud: Vat Fraud Infects Tradable Co2 Permits, Richard Thompson Ainsworth

Faculty Scholarship

Missing trader intra-community (MTIC) fraud has been slowly morphing from cell phones and computer chips to other commodities. In the last few months however MTIC made a dramatic appearance in tradable CO2 permits. It closed exchanges and prompted France and the Netherlands to unilaterally change their tax treatment of CO2 trades. The UK has followed the French treatment in large measure. On Monday June 8, 2009 rumors of MTIC fraud in carbon emission permits closed the main European exchange for spot trading of European Union carbon emissions permits and Kyoto offsets. When BlueNext began trading permits again on Wednesday, June …

Use And Enjoyment Of Intangible Services: The German, Austrian, Danish And Estonian Vat Derogations, Richard Thompson Ainsworth

Faculty Scholarship

When the Czech Republic elected (effective January 1, 2009) to derogate from the standard rules for determining the place of supply for intangible services, pursuant to Article 58 of the Recast VAT Directive (RVD), it was following the lead of ten other Member States. This paper considers four of those other jurisdictions - Germany, Austria, Estonia, and Denmark - and compares their derogations with that of the Czech Republic.

In each instance a use and enjoyment standard determines the place of supply for certain intangible services. The affected transactions are (potentially) wide ranging. In each instance non-EU countries are on …

Use And Enjoyment Of Intangible Services: The Czech Republic's Vat Derogation, Richard Thompson Ainsworth

Faculty Scholarship

On January 1, 2009 a minor change in the Czech Republic VAT became effective. A use and enjoyment standard was added to modify the sourcing of certain service transactions. Traditional proxy-based rules, derived from Articles 43 and 56(1) of the Recast VAT Directive (RVD), are set aside by this modification when the customer receiving the services has a permanent establishment (PE) in the Czech Republic. The modification is authorized by RVD 58.

This change is a limited adoption of RVD 58(b), and functions like a full force of attraction principle in direct taxation. If caught by these rules, transactions that …

Quebec's Module D'Enregistrement Des Ventes (Mev): Fighting The Zapper, Phantomware And Tax Fraud With Technology, Richard Thompson Ainsworth

Faculty Scholarship

On January 28, 2008 the Quebec Minister of Revenue, Jean-Marc Fournier, announced that by late 2009 the MRQ will begin testing a device, the module d'enregistrement des ventes (MEV) that is projected to substantially reduce tax fraud in the restaurant sector. By 2010 or 2011 MEVs will be mandatory in all Quebec restaurants, where they will assure accuracy and retention of business records within electronic cash registers (ECRs).

This paper moves beyond a discussion of the variety of sales suppression programs in use - zappers and phantom-ware. The concern here is on enforcement efforts, particularly the MEV. The intent is …

Mtic (Carousel) Fraud: Twelve Ways Forward; Two Ways 'Preferred' - Has The Technology-Based Administrative Solution Been Rejected?, Richard Thompson Ainsworth

Faculty Scholarship

In a May 31, 2006 Communication to the Council, the European Parliament, and the European Economic and Social Committee, the European Commission indicated a need to develop a co-ordinated strategy to improve the fight against fiscal fraud [COM(2006) 254 final]. Although the Communication considers fiscal fraud broadly (VAT, excise duties and direct taxes) the most pressing need seems to be for a VAT strategy that will effectively deal with MTIC (Missing Trader Intra-Community) or carousel fraud. To this end the Commission hosted a conference: Fiscal Fraud - Tackling VAT Fraud: Possible Ways Forward. The March 29, 2007 conference was constructed …

Uk Car-Flipping: The Vat Fraud Market-Place And Certified Solutions, Richard Thompson Ainsworth

Faculty Scholarship

Missing Trader Intra-Community (MTIC) fraud and its offspring carousel fraud and contra trading fraud are siphoning huge amounts of VAT revenue from the UK Treasury. This fraud is not a function of the goods involved. It is a function of the market-place. Recently another type of market-place dependent VAT fraud has taken hold in the UK - car-flipping.

In some instances the market-place where these frauds festers is a pre-existing or natural market-place, one that grows out of legitimate commercial practices. Fraudsters enter this market-place (so the argument goes) and take advantage of legitimate businesses who unwittingly get caught up …

Genealogies Of Soft Law, Anna Di Robilant

Faculty Scholarship

The relatively recent blossoming of multiple soft law tools and the calls for a soft harmonization of European private law have invited reflection on the genealogy of soft law. Genealogical arguments have come to play a critical role in the heated European soft law v. hard law debate. While some find the ancestors of soft law in the medieval legal regime and particularly the lex mercatoria, others link soft law to a prolific strand of 19th and early 20th century theories of social law and legal pluralism. At times explicitly invoked, more often im plicitly alluded to, the neo-medieval genealogy …