Ten Years in the European Union Selected Remarks Related To the Harmonisation of Slovak Competition Law with EU Competition Law

The aim of this paper is to provide an overview of the application of competition law in the Slovak Republic since it became a member of the European Union 10 years ago. Special emphasis is placed on selected problems and questions which arose in the application of European competition rules and the need for an adjustment of Slovak competition legislation to EU requirements. The paper presents the relevant amendments in the Slovak Competition Act and analyses in detail their background. Slovak competition law has undergone many changes in the past 10 years, not always without problems. The aim of this paper is to identify the most important of those difficulties and explain why they have occurred. The correct application of national and EU competition rules by Slovak courts has proven to be one of the biggest challenge here, ultimately even causing the European Commission to intervene as amicus curiae. The actions taken by the European Commission in relation to competition matters within the Slovak Republic, and its resulting recommendations, will also be considered. The paper will outline how Slovak competition law has been step-by-step increasing its harmonisation with EU competition law over the last 10 years. Indeed, it is now possible to claim that Slovak competition legislation is fully harmonised with the rules of the European Union. The paper will thus mainly focus on those elements of Slovak law which can give a clear picture of the state of convergence of both legal systems. Nevertheless, the end of the road has not yet been reached. Further harmonisation of selected current topics within Slovak competition law will need to be assessed also. It will also be necessary to analyse which direction should Slovak competition law take in the future with regard to current EU trends. These issues include the need to find a balance between the protection of business secrets and the right of procedural parties to due process, especially in connection with the protection of leniency documents.Cette contribution vise à fournir un aperçu de l'application de la loi sur la concurrence de la République slovaque au cours des 10 dernières années - depuis l'époque d’adhésion de la Slovaquie à l'UE. L’accent particulier est mis sur certains problèmes et questions qui se posent dans l'application des règles de concurrence de l'UE et sur la nécessité d'une adaptation du droit slovaque de la concurrence aux exigences de l'UE. Cet article présentera les changements pertinents dans la Loi slovaque sur la concurrence aussi qu’un analyse détaillé de l'arrière-plan de ces changements. Au cours des 10 dernières années, la loi slovaque de la concurrence a subi de nombreux changements – pas toujours sans problèmes. Le présent article tentera d'identifier les problèmes principaux et donner au lecteur une explication quant à la raison pour laquelle ils ont eu lieu. Dans ce sens-là, l'un des plus grands problèmes est la bonne application des règles nationales et communautaires de concurrence par les juridictions slovaques au moment de décider sur des affaires relatives à la concurrence. Cela a même abouti à la nécessité pour la Commission européenne d'intervenir comme un amicus curiae. Cet article vise également à fournir une analyse des actions de la Commission européenne en ce qui concerne les questions de concurrence en Slovaquie et les recommandations qui en découlent. Le présent article tente de présenter la manière dont le droit slovaque de la concurrence a suivi, étape par étape, un chemin vers l'harmonisation avec le droit communautaire de la concurrence au cours des 10 dernières années. Aujourd'hui, nous pouvons déjà affirmer que la réglementation juridique slovaque de droit de la concurrence est entièrement harmonisée avec la réglementation juridique de l'UE. Par conséquent, nous concentrerons notre attention sur les points dans la loi slovaque qui peuvent donner une image claire de la convergence de ces deux règlements juridiques. Néanmoins, nous ne sommes pas encore à la fin de la route. L'harmonisation supplémentaire de certains sujets actuels dans le droit slovaque de la concurrence devra être évaluée et il sera nécessaire d'analyser la direction vers l'avenir, en particulier ce qui sera le meilleur pour le droit de la concurrence slovaque en ce qui concerne les tendances actuelles dans le droit de la concurrence de l'UE. Parmi ces questions, il y a une nécessité d'un équilibre entre la protection des secrets d'affaires et le droit des participants à la procédure de concurrence pour un procès équitable, en particulier dans le cadre de la protection des documents de clémence

Genetic determinants of responsiveness to mesenchymal stem cell injections in non-ischemic dilated cardiomyopathy

Non-ischemic dilated cardiomyopathy (NIDCM) responds variably to intramyocardial injection of mesenchymal stem cells (MSCs). We hypothesized that NIDCM genotype may influence responsiveness to MSC therapy and performed genotyping on all patients in the POSEIDON-DCM trial. POSEIDON-DCM patients (n = 34) underwent genetic sequence analysis and deletion/duplication testing. The results were classified as positive for pathological variants (PV+; n = 8), negative for any variants (V−; n = 6), or as variants of uncertain significance (VUS; n = 20). All outcomes of therapy were analysed for each category of genetic results. The 3 groups were indistinguishable at baseline with regard to ejection fraction (EF), demographics, medication use, or functional parameters. V− patients had an increase in EF at 12 months: +13.6% (IQR = +7.8%; +20.5%; p = 0.002), compared with VUS (+6.5%; IQR = +0.9%, +11.1%; p = 0.005) and PV+(−5.9%; IQR = −12.7%, +1.0; p = 0.2; p = 0.01 between groups). Six-minute walk distance improved in V- patients, but not in VUS and PV+. V− patients improved MLHFQ, compared to the other 2 groups, which did not improve over time. EPCCFUs increased by 9.7 ± 1.9 in V− (p = 0.009) compared to VUS and PV+ patients. V− patients had one-year survival (100%) compared with VUS (85%) and PV+ (40%; p = 0.015 log-rank). Similarly, MACE rates were lower in V− (0%) than PV+ (61.9%) or VUS (42.2%; p = 0.021 log-rank). Our findings support the concept that the genetic profile of NIDCM patients plays a role in responsiveness to MSC therapy, with V− patients more likely to benefit and the converse for PV+. This observation emphasizes the need for further genetic studies, because of important implications for the management of NIDCM syndromes

Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty

Impaired endogenous stem cell repair capacity is hypothesized to be a biologic basis of frailty. Therapies that restore regenerative capacity may therefore be beneficial. This Phase 1 study evaluated the safety and potential efficacy of intravenous, allogeneic, human mesenchymal stem cell (allo-hMSC)-based therapy in patients with aging frailty. In this nonrandomized, dose-escalation study, patients received a single intravenous infusion of allo-hMSCs: 20-million (n = 5), 100-million (n = 5), or 200-million cells (n = 5). The primary endpoint was incidence of any treatment-emergent serious adverse events measured at 1 month postinfusion. The secondary endpoints were functional efficacy domains and inflammatory biomarkers, measured at 3 and 6 months, respectively. There were no treatment-emergent serious adverse events at 1-month postinfusion or significant donor-specific immune reactions during the first 6 months. There was one death at 258 days postinfusion in the 200-million group. In all treatment groups, 6-minute walk distance increased at 3 months (p = .02) and 6 months (p = .001) and TNF-α levels decreased at 6 months (p < .0001). Overall, the 100-million dose showed the best improvement in all parameters, with the exception of TNF-α, which showed an improvement in both the 100- and 200-million groups (p = .0001 and p = .0001, respectively). The 100-million cell-dose group also showed significant improvements in the physical component of the SF-36 quality of life assessment at all time points relative to baseline. Allo-hMSCs are safe and immunologically tolerated in aging frailty patients. Improvements in functional and immunologic status suggest that ongoing clinical development of cell-based therapy is warranted for frailty