Implications of Health Care Reform (Medical Ethics Series, 2011)

A video of a panel discussion on how Obama's Health Care Reform would affect Texas Medical Center institutions and health care in general.Speakers include Tom Cole (moderator), Roberta Schwartz (Methodist Hospital), Pauline Rosenau (UT-Houston School of Public Health), and Laurence McCullough (Baylor College of Medicine).

Patent policy and public health in developing countries: lessons from Japan

The introduction of pharmaceutical product patents in India and other developing countries is expected to have a significant effect on public health and local pharmaceutical industries. This paper draws implications from the historical experience of Japan when it introduced product patents in 1976. In Japan, narrow patents and promotion of cross-licensing were effective tools to keep drug prices in check while ensuring the introduction of new drugs. While the global pharmaceutical market surrounding India today differs considerably from that of the 1970's, the Japanese experience offers a policy option that may profitably be considered by India today. The Indian patent system emphasizes the patentability requirement in contrast to the Japanese patent policy which relied on narrow patents and extensive licensing. R&D by local firms and the development of local products may be promoted more effectively under the Japanese model.

Separation of Control and Cash-Flow Rights of State Owned Listed Enterprises: Channels of Expropriation after the Discriminated Share Reform in China

Literature on agency problems arising between controlling and minority owners claim that separation of cash flow and control rights allows controllers to expropriate listed firms, and further that separation emerges when dual class shares or pyramiding corporate structures exist. Dual class share and pyramiding coexisted in listed companies of China until discriminated share reform was implemented in 2005. This paper presents a model of controller to expropriate behavior as well as empirical tests of expropriation via particular accounting items and pyramiding generated expropriation. Results show that expropriation is apparent for state controlled listed companies. While reforms have weakened the power to expropriate, separation remains and still generates expropriation. Size of expropriation is estimated to be 7 to 8 per cent of total asset at mean. If the "one share, one vote" principle were to be realized, asset inflation could be reduced by 13 percent.

Kenya after the 2007 "post-election violence" : constitutional reform and the National Accord and Reconciliation Act

Immediately after the announcement of the re-election of President Kibaki on the evening of 30 December 2007, Kenya was thrust into the worst civil unrest experienced by the country since independence – a development that became known as the "Post-Election Violence" (PEV). However, after a subsequent process of reconciliation, the PEV came to an end within a relatively short period. The present-day politics of Kenya are being conducted within the framework of a provisional Constitution that took shape through peaceful mediation. How did Kenya manage to put a lid on a period of turmoil that placed the country in unprecedented danger? This paper traces the sequence of events that led to mediation, explains the emergency measures that were needed to maintain law and order, and indicates the remaining problems that still need to be solved.

La tutela brevettuale : dalle modificazioni in sede di esame alle limitazioni del titolo concesso

La limitazione del brevetto in corso di causa è uno dei temi più caldi ed attuali del contenzioso brevettuale, a seguito dell’introduzione nel Codice della Proprietà Industriale, con la riforma dell’agosto 2010, del 3° comma dell’art. 79, a mente del quale “In un giudizio di nullità, il titolare ha facoltà di sottoporre al giudice, in ogni stato e grado del giudizio, una riformulazione delle rivendicazioni che rimanga entro i limiti del contenuto della domanda di brevetto quale inizialmente depositata e non estenda la protezione conferita dal brevetto concesso”. L’applicazione della disposizione in discorso genera una serie di interrogativi, ai quali giurisprudenza e dottrina cercano di rispondere, e determina, e sempre più determinerà, un cambiamento radicale dello svolgimento del contenzioso brevettuale, con la possibilità di un “riassetto” della privativa, anche per successivi tentativi, nella quale anche il C.T.U. è spesso (e non senza contestazioni, a questo riguardo) parte attiva, non essendo infrequente che questo offra indicazioni circa la sussistenza di un margine di validità del titolo . L’elaborato tenta, quindi, di approfondire le problematiche di natura sostanziale e procedurale che l’articolo 79, comma 3, C.P.I. solleva, ripercorrendo con l’occasione le possibili facoltà di intervento sul brevetto, sia allo stato di domanda, che a seguito di concessione, che l’ordinamento mette a disposizione dell’inventore per perfezionare la propria privativa.

Transmission and Transport of Energy in the Western U.S. and Canada: A Law and Policy Road Map

This collection of short essays arose from the inaugural meeting of the Idaho Symposium on Energy in the West, which was held in November, 2014. The topic for this first Symposium was Transmission and Transport of Energy in the Western U.S. and Canada: A Law and Policy Road Map. The essays in this collection provide a notable introduction to the major energy issues facing the West today. Topics include: building a resilient legal architecture for western energy production; natural gas flaring; transmission planning for wind energy; utilities and rooftop solar; special considerations for western states and the Clean Power Plan; the Clean Power Plan's implications for the western grid; siting renewable energy on public lands; and implications of utility reform in New York and Hawaii for the Northwest.

The future of the Eurozone and the role of the German Constitutional Court. Research Papers in Law, 05/2012

[Introduction.] Necessary reforms towards a deepened and increased European shaped economic, financial and budgetary policy, paraphrased with the term “fiscal union”, could possibly reach constitutional limits. In its EFSF judgment1, the German Constitutional Court, following the Lisbon judgment in which certain government tasks were determined as being part of the “constitutional identity”2, connected the budget right of the parliament via the principle of democracy to the eternity clause of Art. 79 para 3 Basic Law. A transfer of essential parts of the budget right of the German Bundestag, which would be in conflict with the German constitution, is said to exist when the determination of the nature and amount of the tax affecting the citizens is largely regulated on the supranational level and thereby deprived of the Bundestag’s right to disposition. A reform of the Economic and Monetary Union that touches the core of the budget right can, according to the German Federal Court, with regard to Art. 79 (3) of the Basic Law only be realized by way of Art. 146 of the Basic Law, thus with a new constitution given by the people that replaces the Basic Law.3

The Convention on the Future of Europe: Extended Working Group or Constitutional Assembly? Research Papers in Law, 4/2005

From the Introduction. “We are a Convention. We are not an Intergovernmental Conference because we have not been given a mandate by Governments to negotiate on their behalf the solutions which we propose. We are not a Parliament because we are not elected by citizens to draft legislative texts. […] We are a Convention. What does this mean? A Convention is a group of men and women meeting for the sole purpose of preparing a joint proposal. […] It is a task modest in form but immense in content, for if it succeeds in accordance with our mandate, it will light up the future of Europe”.1 In his speech inaugurating the Convention process on 26 February 2002 in Brussels, Convention President VALÉRY GISCARD D’ESTAING raises three issues: first, he refers to the Convention’s nature and method; second, he talks of the Convention’s aim and output; and, third, he evokes the Convention’s historic and symbolic significance. All three aspects have been amply discussed in the past two years by politicians and academics analysing whether the Convention’s purpose and instruments differ fundamentally from those of previous reform rounds; whether the input into and output of the Convention process qualitatively improves European Treaty revision; and whether the Convention as an institution lived up to its symbolic and normative load, reflected in comparisons with “Philadelphia” or references to a “constitutional moment”.2

Why the Open Method of Coordination (OMC) is bad for you: a letter to the EU. Research Papers in Law, 5/2006

From the Introduction. The aim of the present “letter” is to provoke, rather than to prove. It is intended to further stimulate the – already well engaged – scientific dialogue on the open method of coordination (OMC).1 This explains why some of the arguments put forward are not entirely new, while others are overstretched. This contribution, belated as it is entering into the debate, has the benefit of some hindsight. This hindsight is based on three factors (in chronological order): a) the fact that the author has participated himself as a member of a national delegation in one of the OMC-induced benchmarking exercises (only to see the final evaluation report getting lost in the Labyrinth of the national bureaucracy, despite the fact that it contained an overall favorable assessment), as well as in a OECD led exercise of coordination, concerning regulatory reform; b) the extremely rich and knowledgeable academic input, offering a very promising theoretical background for the OMC; and c) some recent empirical research as to the efficiency of the OMC, the accounts of which are, to say the least, ambiguous. This recent empirical research grounds the basic assumption of the present paper: that the OMC has only restricted, if not negligible, direct effects in the short term, while it may have some indirect effects in the medium-long term (2). On the basis of this assumption a series of arguments against the current “spread” of the OMC will be put forward (3). Some proposals on how to neutralize some of the shortfalls of the OMC will follow (4).

The Italian Merck Case. Research Papers in Law, 1/2007

From the Introduction. Regulation 1768/921 created supplementary protection certificates (hereinafter, ‘SPCs’) for medicinal products (hereinafter, “pharmaceuticals”) protected by patents. SPCs afford the same exclusive rights as those conferred by patents once these expire and may be granted for a maximum of five years.2 Italy enacted similar legislation in 1991, the most salient difference between both texts being that, pursuant to Law No. 349/91,3 holders of Italian patents for pharmaceuticals could be granted supplementary protection for a maximum period of 18 years after the expiration of the patent. Following the enactment of Regulation 1768/92, SPCs granted by the Italian authorities were brought in line with the period provided for in that text. However, pharmaceuticals for which supplementary protection was sought in the lapse between the adoption of Law No. 349/91 and Regulation 1768/92 (around 400 products) continued to enjoy the protection provided for in the former text.4 Several steps were taken by the Italian authorities to progressively reduce the length of protection granted to these products.

The AstraZeneca Case. Research Papers in Law, 4/2007

Introduction. On June 2005, after a five year investigation, the Commission imposed a 60 millions euros fine on AstraZeneca (hereinafter AZ) for having abused its dominant position in several Member States in the market for proton-pump inhibitors (PPI)2. It was alleged that AZ misused the patent system and procedures for marketing pharmaceuticals to block or delay the entry of generic competitors and parallel traders to its ulcer drug Losec3. This decision is a seminal one. The political and legal importance of the CFI judgment that will review the case (and the ECJ appeal that is likely to follow) cannot be understated. On the one hand the incentive to innovate and to undertake R&D is at stake, on the other, the uncertain boundaries between competition and intellectual property law should once again be explored. In contrast to the US, where many cases concerning the abuse of regulatory and governmental procedures have already been dealt with competition authorities and courts, it is the first time in Europe that such conduct is subject to scrutiny through an anti-trust lens. Moreover, following the appeal brought by AZ against the Commission decision, the CFI will be confronted for the first time with an abuse of a dominant position in the pharmaceutical sector, which explains why this judgment is eagerly anticipated4.

Decentralisation of EC Competition Law Enforcement and General Principles of Community Law. Research Papers in Law, 4/2004

From the Introduction. By virtue of Council Regulation No. 1/2003, as of 1st May 2004 the full application of EC competition law will be entrusted to national competition authorities (hereinafter NCAs) and national courts. The bold reform of EC competition law enforcement adheres to the system of executive federalism1 which characterises the EC legal system. The repartition of competences within the Community allocates implementation of Community law mainly at Member States level. Pursuant to Article 10 EC, they are responsible for the implementation of the measures which have been adopted at Community level for the achievement of the objectives specified in the EC Treaty. Consequently, the attainment of the Community objectives depends very much upon the cooperation of national authorities, which act in accordance with their own national procedural rules.2 The various national procedural rules present themselves as conduits through which Community law is implemented and enforced. While as a rule Community law is not designed to alter national procedural rules, the Community legal order cannot afford to leave national procedural rules untouched when they are liable to hamper the effective application of Community law....For reason of space, this contribution intends only to highlight some aspects of Regulation No. 1/2003 with regard to which general principles of Community law are able to condition national procedural rules.

La disoccupazione giovanile in tempo di crisi: un monito all’Europa (continentale) per rifondare il diritto del lavoro? = Youth Unemployment in Recessionary Times: a Caveat to (Continental) Europe to Reconstruct its Labour Law. WP C.S.D.L.E. "Massimo D'Antona" .INT - 91/2012

The current debate taking place in continental Europe on the need to reform labour law to reduce the duality between labour market insiders and outsiders, thus giving new employment opportunities to young people seems to be, at its best, a consequence of the crisis, or at its worst, an excuse. The considerable emphasis placed on the power of legislation to reduce youth unemployment prevents real labour market problems from being clearly identified, thus reducing the scope to adopt more effective measures. Action is certainly required to help young people during the current crisis, yet interventions should not be exclusively directed towards increased flexibility and deregulation. This paper questions the “thaumaturgic power” wrongly attributed to legislative interventions and put forward a more holistic approach to solve the problem of youth employment, by focusing on the education systems, school-to-work transition and industrial relations. As a comparative analysis demonstrates, in order to effectively tackle the issue of youth employment, it is not enough to reform labour law. High quality education systems, apprenticeship schemes, efficient placement and employment services, cooperative industrial relations and flexible wage determination mechanisms are the key to success when it comes to youth employment, not only in times of recession.

Shifting EU Institutional Reform into High Gear. Report of the CEPS High-Level Group. CEPS Task Force Reports

To contribute to the important debate on EU institutional reform in the run-up to the European Parliament elections and the start of a new Commission, CEPS formed a High-Level Group on EU Institutional Reform under the leadership of Danuta Hübner MEP and member of the CEPS Board of Directors. The report of this distinguished group of MEPs, former and current EU institutional members and leading scholars on EU law and institutional affairs focuses on reforms that could be taken within the framework of the current treaties to build a more responsive and accountable Union. The report analyses the main inter- and intra-institutional weaknesses in terms of efficiency, democracy and differentiation and puts forward a number of recommendations addressing issues such as the reorganisation of the College of Commissioners, the promotion of strategic legislative planning, the enhancement of the role of the EP and the rotating Presidency of the Council, the improvement of the democratic accountability of the European Council and the adequate engagement of the national parliaments.

Judicial Selection, Lay Participation, and Judicial Culture in the Czech Republic: A Study in a Central European (Non)Transformation. College of Europe Research Paper in Law 03/2014

Introduction. The idea that “merit” should be the guiding principle of judicial selections is a universal principle, unlikely to be contested in whatever legal system. What differs considerably across legal cultures, however, is the way in which “merit” is defined. For deeper cultural and historical reasons, the current definition of “merit” in the process of judicial selections in the Czech Republic, at least in the way it is implemented in the institutional settings, is an odd mongrel. The old technocratic Austrian judicial heritage has in some aspects merged with, in others was altered or destroyed, by the Communist past. After 1989, some aspects of the judicial organisation were amended, with the most problematic elements removed. Furthermore, several old as well as new provisions relating to the judiciary were struck down by the Constitutional Court. However, apart from these rather haphazard interventions, there has been neither a sustained discussion as to how a new judicial architecture and system of judicial appointments ought to look like nor much of broader, conceptual reform in this regard. Thus, some twenty five years after the Velvet Revolution of 1989, the guiding principles for judicial selection and appointments are still a debate to be had.