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.

The Asset Quality Review and Capital Needs: Why re-capitalise banks with public money? CEPS Policy Brief No. 311, 19 December 2013

It is generally assumed that any capital needs discovered by the Asset Quality Review the ECB is scheduled to finish by the end of 2014 should be filled by public funding (= fiscal backstop). This assumption is wrong, however. Banks that do not have enough capital should be asked to obtain it from the market; or be restructured using the procedures and rules recently agreed. The Directorate-General for Competition at the European Commission should be particularly vigilant to ensure that no further state aid flows to an already oversized European banking system. The case for a public backstop was strong when the entire euro area banking system was under stress, but this is no longer the case. Banks with a viable business model can find capital; those without should be closed because any public-sector re-capitalisation would likely mean throwing good money after bad.

The Review of the Europe 2020 Strategy: From austerity to prosperity? CEPS Policy Brief No. 322, 28 October 2014

The future of Europe 2020 lies in its ability to become the protagonist of a new season in EU policy, in which countries can apply for more flexibility only if they can prove both structural reform and good governance, argues the author. By establishing a ‘new deal’ among member states, an improved Europe 2020 strategy can help Europe to complete its transition from austerity to prosperity. This Policy Brief makes the case for approaching the mid-term review of Europe 2020 on three different levels: i) the revision and update of the content of the Europe 2020 strategy, including its objectives, targets and major flagship initiatives; ii) the reform of the governance of the strategy; and iii) the repositioning of the strategy at the core of EU policy. The content of the strategy should be revised to include initiatives on infrastructure, the internal market and administrative capacity at all levels of government. The author sets out a number of policy recommendations for the European Commission and the member states to help realise these objectives.

Towards a New (European Research) Deal: The Case for Enhanced Fiscal Policy Coordination on Research and Innovation. Bruges European Economic Policy (BEEP) Briefing 20/2008

The paper reviews the evolution of research and innovation in the EU and assesses how current policies and programmes have influenced the development of Europe's research landscape. Based on existing literature, evaluation reports and practice, the paper critically examines the effectiveness of current European research funding instruments in a context of open innovation and in the presence of global spillovers. It therefore develops a subsidiarity test to assess whether current rationales still prove sufficient to justify policy intervention in this area. The paper sheds light on how to improve the effectiveness of EU action by enriching it by the use of coordinated fiscal policy for research funding. This will constitute an incentive to genuine bottom-up research, development and innovation (R&D&I) and a stimulus to local investments in innovation. The paper also assesses the potentials of a reinforced open method of coordination as well as a review of state aid law in the field of research funding in the EU.

Is Withdrawal from the European Union a Manageable Option? A Review of Economic and Legal Complexities. Bruges European Economic Policy (BEEP) Briefing 28/2013

Withdrawal from the EU is no more a taboo subject. However, the process by which it can happen is unclear and potentially complex. The purpose of this paper is to show that a withdrawing Member State will not only rid itself from the constraints and obligations of EU rules, but it will also have to re-invent many policies and institutions to fill the gap left by the non-application of EU rules. The paper examines closely the case of the UK and Scotland and concludes that outright exit is not the best option for a withdrawing Member State. The best, but possibly the least feasible, option is an intermediate arrangement falling between full membership and complete separation from the EU. The exact position between the two extremes can only be determined by the exit negotiations and will be influenced by the political climate that will prevail at that time. While the final destination of an acceding country is well known [full adoption of the obligations of EU membership], the exiting country will be embarking on a trip with unknown destination and full of surprises.

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

BACKGROUND: There is no evidence-based guidance to facilitate design decisions for confirmatory trials or systematic reviews investigating treatment efficacy for adults with tinnitus. This systematic review therefore seeks to ascertain the current status of trial designs by identifying and evaluating the reporting of outcome domains and instruments in the treatment of adults with tinnitus. METHODS: Records were identified by searching PubMed, EMBASE CINAHL, EBSCO, and CENTRAL clinical trial registries (ClinicalTrials.gov, ISRCTN, ICTRP) and the Cochrane Database of Systematic Reviews. Eligible records were those published from 1 July 2006 to 12 March 2015. Included studies were those reporting adults aged 18 years or older who reported tinnitus as a primary complaint, and who were enrolled into a randomised controlled trial, a before and after study, a non-randomised controlled trial, a case-controlled study or a cohort study, and written in English. Studies with fewer than 20 participants were excluded. RESULTS: Two hundred and twenty-eight studies were included. Thirty-five different primary outcome domains were identified spanning seven categories (tinnitus percept, impact of tinnitus, co-occurring complaints, quality of life, body structures and function, treatment-related outcomes and unclear or not specified). Over half the studies (55 %) did not clearly define the complaint of interest. Tinnitus loudness was the domain most often reported (14 %), followed by tinnitus distress (7 %). Seventy-eight different primary outcome instruments were identified. Instruments assessing multiple attributes of the impact of tinnitus were most common (34 %). Overall, 24 different patient-reported tools were used, predominantly the Tinnitus Handicap Inventory (15 %). Loudness was measured in diverse ways including a numerical rating scale (8 %), loudness matching (4 %), minimum masking level (1 %) and loudness discomfort level (1 %). Ten percent of studies did not clearly report the instrument used. CONCLUSIONS: Our findings indicate poor appreciation of the basic principles of good trial design, particularly the importance of specifying what aspect of therapeutic benefit is the main outcome. No single outcome was reported in all studies and there was a broad diversity of outcome instruments. PROSPERO REGISTRATION: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525 . Registered on 12 March 2015 revised on 15 March 2016.

Drivers for and against municipal wastewater recycling: a review

The reclamation, treatment and reuse of municipal wastewater can provide important environmental benefits. In this paper, 25 studies on this topic were reviewed and it was found that there are many (\textgreater150) different drivers acting for and against wastewater recycling. To deal with the challenge of comparing studies which entailed different research designs, a framework was developed which allowed the literature to be organized into comparable study contexts. Studies were categorized according to the level of analysis (wastewater recycling scheme, city, water utility, state, country, global) and outcome investigated (development/investment in new schemes, program implementation, percentage of wastewater recycled, percentage of water demand covered by recycled water, multiple outcomes). Findings across comparable case studies were then grouped according to the type (for or against recycling) and category of driver (social, natural, technical, economic, policy or business). The utility of the framework is demonstrated by summarizing the findings from four Australian studies at the city level. The framework offers a unique approach for disentangling the broad range of potential drivers for and against water recycling and to focus on those that seem relevant in specific study contexts. It may offer a valuable starting point for building hypotheses in future work.

Bivalirudin for Alternative Anticoagulation in Extracorporeal Membrane Oxygenation: A Systematic Review.

BACKGROUND Extracorporeal membrane oxygenation (ECMO) offers therapeutic options in refractory respiratory and/or cardiac failure. Systemic anticoagulation with heparin is routinely administered. However, in patients with heparin-induced thrombocytopenia or heparin resistance, the direct thrombin inhibitor bivalirudin is a valid option and has been increasingly used for ECMO anticoagulation. We aimed at evaluating its safety and its optimal dosing for ECMO. METHODS Systematic web-based literature search of PubMed and EMBASE performed via National Health Service Library Evidence and manually, updated until January 30, 2016. RESULTS The search revealed 8 publications relevant to the topic (5 case reports). In total, 58 patients (24 pediatrics) were reported (18 received heparin as control groups). Bivalirudin was used with or without loading dose, followed by infusion at different ranges (lowest 0.1-0.2 mg/kg/h without loading dose; highest 0.5 mg/kg/h after loading dose). The strategies for monitoring anticoagulation and optimal targets were dissimilar (activated partial thromboplastin time 45-60 seconds to 42-88 seconds; activated clotting time 180-200 seconds to 200-220 seconds; thromboelastography in 1 study). CONCLUSION Bivalirudin loading dose was not always used; infusion range and anticoagulation targets were different. In this systematic review, we discuss the reasons for this variability. Larger studies are needed to establish the optimal approach with the use of bivalirudin for ECMO.

IVHS Institutional and Legal Issues Program. Review of the Travlink and Genesis operational tests. Final report.

Federal Highway Administration, Washington, D.C.

ITS Institutional and Legal Issues Program. Review of the SmarTraveler operational test. Final report.

Federal Highway Administration, Washington, D.C.

IVHS Institutional and Legal Issues Program. Review of the FAST-TRAC operational test. Final report.

Federal Highway Administration, Washington, D.C.

New Florencia : a case study for the 1970 censuses of population and housing.

" ... Through the financial assistance of the AID" (U.S. Agency for International Development) ISP (International Statistical Programs) of the Bureau of the Census.

Drilled and grouted micropiles : state-of-practice review /

Cover title.

Motor vehicle safety - a review of the NTSB report on rear seat lap belt effectiveness.

Mode of access: Internet.

Case report.

Description based on: 1991; title from cover.