scholarly journals Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity

2021 ◽  
Author(s):  
Johnathon Liddicoat ◽  
Kathleen Liddell ◽  
Mateo Aboy ◽  
Jakob Wested
Keyword(s):  
Empirical Analysis ◽  
Marketing Authorisation ◽  
Drug Repositioning ◽  
Evidence Based ◽  
Eu Law ◽  
Limited Evidence ◽  
Drug Marketing ◽  
Market Protection ◽  
Before And After ◽  
The Eu

AbstractEU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as “repositioning”) by offering them an extra year of market protection if the new use is authorised. This extra year, known as the “+1”, was enacted on limited evidence, and no study has examined its effect since it began. Yet, several leading commentators suggest lengthening the +1. This study assesses the effectiveness of the +1 by analysing all the relevant instances of MAHs repositioning their drugs before and after the +1 came into effect. The results show that: (i) 42.2% of MAHs repositioned their drugs before the +1 came into effect, and (ii) once the +1 did come into effect, it did not increase the percentage of MAHs that repositioned their drugs. This study finds that the +1 failed to increase repositioning and then proceeds to consider reform options, including repealing the law. In doing so, this study takes the first steps towards an evidence-based policy for the topic.

Part I Introduction, 1 Introduction

2018 ◽  
Author(s):  
Wijckmans Frank ◽  
Tuytschaever Filip
Keyword(s):  
Competition Law ◽  
Historical Background ◽  
Private Enforcement ◽  
Eu Law ◽  
Public And Private ◽  
The Public ◽  
Eu Competition Law ◽  
Before And After ◽  
Public And Private Enforcement ◽  
The Eu

This chapter explains the term ‘vertical agreements’ and what it covers. It addresses a number of general issues that are relevant to the EU competition law treatment of vertical agreements in general. It describes the implementation and the (public and private) enforcement of Article 101 TFEU before and after the entry into force of Regulation 1/2003. The chapter provides the historical background of both Regulation 330/2010 and Regulation 461/2010. In particular, it devotes specific attention to the nature and legal and practical consequences of soft EU competition law (in the form of notices, guidelines, etc) as opposed to hard EU competition law (provisions of primary and secondary EU law).

scholarly journals Trust in the Law? Mutual Recognition as a Justification to Domestic Criminal Procedure

2020 ◽  
Vol 16 (1) ◽  
pp. 33-62
Author(s):  
Jacob Öberg
Keyword(s):  
Judicial Review ◽  
Mutual Recognition ◽  
Criminal Procedure ◽  
Evidence Based ◽  
Mutual Trust ◽  
Eu Law ◽  
National Courts ◽  
Division Of Powers ◽  
European Arrest Warrant ◽  
The Eu

EU law – Mutual recognition as a justification for EU competence – EU competence in domestic criminal procedure – Test and intensity of judicial review of EU criminal law legislation – Relationship between mutual trust and mutual recognition – Federalism and division of powers between the member states and the EU – Mutual recognition as a constraint to EU action – Presumption of Innocence Directive – Victims’ Rights Directive – Exercise of EU competence in domestic criminal procedure – Justifications for EU action in criminal procedure – Evidence-based legislation in the field of criminal procedure – Mutual trust as a legal and sociological concept – National courts’ compliance with EU law – European arrest warrant

A refusal to grant access to a grid within the provision of crude oil transfer services as an example of a prohibited abuse of a dominant position in the EU and Polish competition law

2018 ◽  
Vol 5 (2) ◽  
pp. 199 ◽  
Author(s):  
Wojciech Paweł SZYDŁO
Keyword(s):  
Crude Oil ◽  
Competition Law ◽  
Eu Law ◽  
The European Union ◽  
Dominant Position ◽  
Oil Companies ◽  
Effective Competition ◽  
Oil Pipelines ◽  
Transfer Services ◽  
The Eu

Aim: The paper discusses cases in which a refusal by an energy enterprise to connect other enterprises to the network is treated as a prohibited abuse of the enterprise's dominant position and, equally, will represent behavior prohibited by art. 12 of the Treaty on the Functioning of the European Union and by art. 9 par. 2 item 2 of the Competition and Consumer Protection Law as well as legal consequences of such refusal. It is important to pinpoint such cases since the EU sectoral regulation does not provide for obligating any undertakings which manage and operate oil pipelines to enter into contracts with other undertakings such as contracts on connecting into their network or contracts on providing crude oil transfer services. Conditions for accessing oil pipelines and selling their transfer capacities are determined by the owners of the networks: private oil companies in the countries across which the pipelines are routed. These conditions are not governed by the EU law.  Furthermore, the very obligation of connecting other entities to own network by energy undertakings operating in the oil transfer sector in Poland will only arise from generally applicable provisions of the Polish competition law.  Design / Research methods: The purpose of the paper has been reached by conducting a doctrinal analysis of relevant provisions of Polish and EU law and an analysis of guidelines issued by the EU governing bodies. Furthermore, the research included the functional analysis method which analyses how law works in practice. Conclusions / findings: The deliberations show that a refusal to access the network will be a manifestation of a prohibited abuse of a dominant position and will be a prohibited action always when the dominant's action is harmful in terms of the allocation effectiveness. It will be particularly harmful when delivery of goods or services objectively required for effective competition on a lower level market, a discriminatory refusal which leads to elimination of an effective competition on the consequent market, a refusal leading to unfair treatment of consumers and an unjustified refusal. Originality / value of the article: The paper discusses the prerequisites which trigger the obligation to connect entities to own network by energy undertakings operating in the oil transfer sector. The obligation has a material impact on the operations of the oil transmitting undertakings, in particular on those who dominate the market. The regulatory bodies in the competition sector may classify a refusal of access to own network by other enterprises as a prohibited abuse of the dominant position, exposing such undertakings to financial consequences.Implications of the research: The research results presented in the paper may be used in decisions issued by the President of the OCCP and in judgement of Polish civil courts and EU courts. This may cause a significant change in the approach to classifying prohibited practices to prohibited behavior which represent abuse of the dominant position. The deliberations may also prompt the Polish and EU legislator to continue works on the legislation.

EU Non-Refoulement: (The Irrelevance of) Territoriality and Pre-Border Controls

2017 ◽  
Author(s):  
Violeta Moreno-Lax
Keyword(s):  
International Human Rights Law ◽  
Eu Law ◽  
Human Rights Law ◽  
Refugee Law ◽  
Functional Understanding ◽  
Scope Of Application ◽  
International Refugee Law ◽  
Border Controls ◽  
The Eu

This chapter identifies the content and scope of application of the EU prohibition of refoulement. Following the ‘cumulative standards’ approach, the analysis incorporates developments in international human rights law (IHRL) and international refugee law (IRL). Taking account of the prominent role of the ECHR and the Refugee Convention (CSR51) as sources of Article 19 CFR, these are the two main instruments taken in consideration. The scope of application of Articles 33 CSR51 and 3 ECHR will be identified in turns. Autonomous requirements of EU law will be determined by reference to the asylum acquis as interpreted by the CJEU. The main focus will be on the establishment of the territorial reach of EU non-refoulement. The idea that it may be territorially confined will be rejected. Drawing on the ‘Fransson paradigm’, a ‘functional’ understanding of the ‘implementation of EU law’ standard under Article 51 CFR will be put forward, as the decisive factor to determine applicability of Charter provisions. The implications of non-refoulement for the different measures of extraterritorial control considered in Part I will be delineated at the end.

A Union of Peoples

2020 ◽  
Author(s):  
Pavlos Eleftheriadis
Keyword(s):  
European Union ◽  
International Law ◽  
Political Theory ◽  
Domestic Institutions ◽  
Eu Law ◽  
The European Union ◽  
Rival Theory ◽  
Law Of Nations ◽  
Domestic Law ◽  
The Eu

This book offers a legal and political theory of the European Union. Many political and legal philosophers compare the EU to a federal union. They believe that its basic laws should be subject to the standards of constitutional law. They thus find it lacking or incomplete. This book offers a rival theory. If one looks more closely at the treaties and the precedents of the European courts, one sees that the substance of EU law is international, not constitutional. Just like international law, it applies primarily to the relations between states. It binds domestic institutions directly only when the local constitutions allow it. The member states have democratically chosen to adapt their constitutional arrangements in order to share legislative and executive powers with their partners. The legal architecture of the European Union is thus best understood under a theory of dualism and not pluralism. According to this internationalist view, EU law is part of the law of nations and its distinction from domestic law is a matter of substance, not form. This arrangement is supported by a cosmopolitan theory of international justice, which we may call progressive internationalism. The EU is a union of democratic peoples, that freely organize their interdependence on the basis of principles of equality and reciprocity. Its central principles are not the principles of a constitution, but cosmopolitan principles of accountability, liberty, and fairness,

Review by Constitutional Courts of the Obligation of National Courts of Last Instance to Refer a Preliminary Question to the Court of Justice of the EU

2015 ◽  
Vol 16 (6) ◽  
pp. 1663-1700 ◽  
Author(s):  
Clelia Lacchi
Keyword(s):  
European Union ◽  
Eu Law ◽  
The European Union ◽  
Constitutional Courts ◽  
Member States ◽  
Constitutional Review ◽  
National Courts ◽  
Court Of Justice ◽  
Judicial Remedy ◽  
The Eu

The Constitutional Courts of a number of Member States exert a constitutional review on the obligation of national courts of last instance to make a reference for a preliminary ruling to the Court of Justice of the European Union (CJEU).Pursuant to Article 267(3) TFEU, national courts of last instance, namely courts or tribunals against whose decisions there is no judicial remedy under national law, are required to refer to the CJEU for a preliminary question related to the interpretation of the Treaties or the validity and interpretation of acts of European Union (EU) institutions. The CJEU specified the exceptions to this obligation inCILFIT. Indeed, national courts of last instance have a crucial role according to the devolution to national judges of the task of ensuring, in collaboration with the CJEU, the full application of EU law in all Member States and the judicial protection of individuals’ rights under EU law. With preliminary references as the keystone of the EU judicial system, the cooperation of national judges with the CJEU forms part of the EU constitutional structure in accordance with Article 19(1) TEU.

scholarly journals PARE0007 PATIENT AND PUBLIC INVOLVEMENT IN CLINICAL TRIAL DESIGN

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1289.1-1290
Author(s):  
S. De Souza ◽  
R. Williams ◽  
E. Johansson ◽  
C. Zabalan ◽  
T. Esterine ◽  
...  
Keyword(s):  
At Risk ◽  
Lived Experience ◽  
Public Involvement ◽  
Clinical Trial Design ◽  
Patient And Public Involvement ◽  
Face To Face ◽  
Before And After ◽  
Extensive Consultation ◽  
New Perspective ◽  
The Eu

Background:Patient and public involvement (PPI) is gaining increasing recognition as important in ensuring research is relevant and acceptable to participants. Rheuma Tolerance for Cure (RTCure) is a 5 year international collaboration between academia and industry; focusing on earlier detection and prevention of rheumatoid arthritis (RA) through the use of immune-tolerising treatments.Objectives:To bring lived experience and insight into scientific discussions; and to evolve collaboration between lay representatives and academia/industry.Methods:9 Patient Research Partners (PRPs) from 5 European countries were recruited via the EULAR PARE Network and institutions within the RTCure Consortium (8 PRPs with RA and 1 ‘at risk’). They were asked to enter into a legal agreement with the Consortium. PRPs participated in teleconferences (TCs) and were invited to attend face-to-face (F2F) meetings at least annually. Requests for input/feedback were sent from researchers to PRPs via the project’s Patient Engagement Expert [SK].Results:PRP involvement has given researchers and industry partners a new perspective on patient priorities, and focused thought on the ethics of recruitment for and participation in clinical trials of people ‘at risk’ of developing RA. PRPs have helped define the target populations, given their thoughts on what types of treatments are acceptable to people ‘at risk’ and have aided the development of a survey (sent to EULAR PARE members) regarding the use of animal models in biomedical research. Positive informal feedback has been received from researchers and industry regarding the contribution of PRPs to the ongoing project (formal evaluation of PPI in RTCure will be carried out in 2020 and at the project end in 2022).Challenges:Legal agreements- Many PRPs refused to sign the Consortium’s complex PRP Agreement; feeling it unnecessary, incomprehensible and inequitable. After extensive consultation with various parties (including EULAR and the Innovative Medicines Initiative) no similar contract was found. Views for its requirement even varied between legal experts. After 2 years of intense discussion, a simple non-disclosure agreement was agreed upon. Ideally any contract, if required, should be approved prior to project onset.Meeting logistics- Other improvements identified were to locate the meeting venue and accommodation on the same site to minimise travel, and to make it easier for PRPs to take breaks when required. This also facilitates informal discussions and patient inclusivity. We now have agreed a policy to fund PRPs extra nights before and after meetings, and to bring a carer if needed.Enabling understanding– Future annual meetings will start with a F2F meeting between PRPs and Work Package Leads. Researchers will be encouraged to start presentations with a summary slide in lay language. Additionally, an RTCure Glossary is in development.Enabling participation– SK will provide monthly project updates and PRP TCs will be held in the evening (as some PRPs remain employed). PRPs will be invited to all project TCs and F2F meetings. Recruitment is underway to increase the number of ‘at risk’ PRPs as their viewpoint is vital to this study.Conclusion:Currently PPI in RTCure is an ongoing mutual learning process. Universal guidance regarding what types of contracts are needed for PPI would be useful. Communication, trust and fruitful discussions have evolved through F2F meetings (both formal and informal) between PRPs, academia and industry. It is important that all parties can be open with each other in order to make PPI more meaningful.Acknowledgments:This work has received support from the EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking RTCure grant number 777357.Disclosure of Interests:Savia de Souza: None declared, Ruth Williams: None declared, Eva Johansson: None declared, Codruta Zabalan: None declared, Tom Esterine: None declared, Margôt Bakkers: None declared, Wolfgang Roth: None declared, Neil Mc Carthy: None declared, Meryll Blake: None declared, Susanne Karlfeldt: None declared, Martina Johannesson: None declared, Karim Raza Grant/research support from: KR has received research funding from AbbVie and Pfizer, Consultant of: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai, Speakers bureau: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai

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