Regulatory Exclusivity Rights and Medicines

2021 ◽  
pp. 382-410
Keyword(s):  
Northern Ireland ◽  
Detailed Analysis ◽  
Marketing Authorization ◽  
Eu Law ◽  
Current Position ◽  
Market Exclusivity ◽  
Judicial Decisions ◽  
Legal Challenges ◽  
The Uk ◽  
The Eu

This chapter provides a detailed analysis of the rules that govern the award of regulatory exclusivity rights, which focuses on the EU law. It talks about the arrangements around Northern Ireland that will incentivize the UK and EU to stay in close alignment in heavily regulated product markets, such as pharmaceuticals. It also sets out an overview of the law surrounding the full and abridged generic marketing authorization applications from an exclusivity perspective. The chapter covers some of the seminal judicial decisions, which demonstrate the legal challenges and decisions that have shaped the current position. It provides a summary of the basics of data and market exclusivity in the EU.

scholarly journals Territorial Differentiation in EU Law: Can Scotland and Northern Ireland Remain in the EU and/or the Single Market?

2017 ◽  
Vol 19 ◽  
pp. 287-310 ◽  
Author(s):  
Nikos SKOUTARIS
Keyword(s):  
Northern Ireland ◽  
Single Market ◽  
Eu Law ◽  
Legal Basis ◽  
Eu Accession ◽  
Territorial Differentiation ◽  
Scottish Independence ◽  
The Uk ◽  
The Right ◽  
The Eu

AbstractIn the Brexit referendum of 23 June 2016, voters in England and Wales voted to leave the EU, while in Scotland and Northern Ireland they voted to remain. Following that, there has been a debate about how it would be possible to achieve the continuing presence in the single market of the UK constituent nations that do not want to be taken out against their will. This paper explores two pathways for Scotland and Northern Ireland to remain in the EU and/or the single market. The first entails the achievement of Scottish independence and the reunification of Ireland through democratic referendums. To this effect, the paper reviews the right of secession of those two constituent nations under UK constitutional law. It revisits the debate on the appropriate legal basis regulating Scotland’s future EU accession and discusses the Irish reunification from an EU law perspective. The second pathway explores how it would be possible for Scotland and Northern Ireland to remain in the EU and/or the single market even without seceding from the UK. In order to do that, the paper points to the remarkable flexibility of the EU legal order as evidenced in numerous cases of differentiated application of Union law. The paper shows that the EU possesses the necessary legal instruments to accommodate the divergent aspirations of the UK constituent nations.

scholarly journals Brexit and Territorial Preferences: Evidence from Scotland and Northern Ireland

2021 ◽  
Vol 51 (2) ◽  
pp. 186-211
Author(s):  
Lesley-Ann Daniels ◽  
Alexander Kuo
Keyword(s):  
Northern Ireland ◽  
Religious Background ◽  
Scottish Independence ◽  
The Uk ◽  
The Eu

Abstract Has the UK referendum to leave the EU (Brexit) affected territorial preferences within the UK? We draw on comparative theories of such preferences to address this question, as Brexit can be seen as a shock to a political unit. We test hypotheses in two key regions, Scotland and Northern Ireland, with original surveys fielded at a unique time (September 2019). We randomize making salient different Brexit scenarios and measure support for Scottish independence and unification with Ireland within each region. We find in Scotland the prospect of leaving the EU increases support for independence. This effect is pronounced among those who support the UK remaining in the EU. In Northern Ireland, religious background correlates highly with territorial views, and we find little evidence of Brexit or border-scenario effects. Our results contribute to the literature on decentralization processes and the EU, and provide evidence of when negative shocks affect such preferences.

The EU as an “enforcement patchwork”: the impact of national enforcement for compliance with EU water law in Spain and Britain

2013 ◽  
Vol 34 (2) ◽  
pp. 331-353 ◽  
Author(s):  
Mónica García Quesada
Keyword(s):  
Waste Water Treatment ◽  
National Level ◽  
State Level ◽  
Detailed Examination ◽  
Deterrent Effect ◽  
Eu Law ◽  
Wide Range ◽  
The Uk ◽  
The Impact ◽  
The Eu

AbstractFailures of compliance with European Union (EU) directives have revealed the EU as a political system capable of enacting laws in a wide range of different policy areas, but facing difficulties to ensure their actual implementation. Although the EU relies on national enforcement agencies to ensure compliance with the EU legislation, there is scarce analysis of the differential deterrent effect of national enforcement in EU law compliance. This article examines the enforcement of an EU water directive, the Urban Waste Water Treatment Directive, in Spain and the UK. It focuses on the existing national sanctions for disciplining actors in charge of complying with EU requirements, and on the actual use of punitive sanctions. The analysis shows that a more comprehensive and active disciplinary regime at the national level contributes to explain a higher degree of compliance with EU law. The article calls for a detailed examination of the national administrative and criminal sanction system for a more comprehensive understanding of the incentives and disincentives to comply with EU law at the national state level.

Micula v Romania between International Investment Law and European Law – The UK Supreme Court Judgement – the Final or the NEXT PIece of the Puzzle?

De Jure ◽  
2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Steliyana Zlateva ◽  
◽  
◽  
Keyword(s):  
Supreme Court ◽  
International Investment ◽  
European Law ◽  
Eu Law ◽  
International Investment Law ◽  
Investment Treaty ◽  
Investment Law ◽  
Uk Supreme Court ◽  
The Uk ◽  
The Eu

The Judgement of the United Kingdom’s Supreme Court in the long Micula v. Romania investment treaty dispute confirmed that the arbitral awards of the International Centre for Settlement of Investment Disputes (ICSID), rendered by tribunals established under intra-EU BITs, could be enforced in the UK. The Micula case concerns the interplay between the obligations under the ICSID Convention and EU law. In particular, it addresses the question of whether the award obtained by the Micula brothers against Romania constitutes state aid prohibited by EU law, as well as the enforcement obligations under the ICSID Convention in view of the EU duty of sincere cooperation.

The UK's Withdrawal from the EU

2021 ◽  
Author(s):  
Michael Dougan
Keyword(s):  
European Union ◽  
Northern Ireland ◽  
Critical Analysis ◽  
Legal Perspective ◽  
The Future ◽  
Article 50 ◽  
The Uk ◽  
The Eu

Following a national referendum on 23 June 2016, the UK announced its intention to end its decades-long membership of the EU. That decision initiated a process of complex negotiations, governed by Article 50 of the Treaty on European Union, with a view to making the arrangements required for an ‘orderly Brexit’. This book explores the UK’s departure from the EU from a legal perspective. As well as analysing the various constitutional principles relevant to ‘EU withdrawal law’, and detailing the main issues and problems arising during the Brexit process itself, the book provides a critical analysis of the final EU–UK Withdrawal Agreement—including dedicated chapters on the future protection of citizens’ rights, the border between Ireland and Northern Ireland, and the prospects for future EU–UK relations in fields such as trade and security.

9. European Union law and institutions

2021 ◽  
pp. 124-141
Author(s):  
Colin Faragher
Keyword(s):  
European Union ◽  
Fundamental Rights ◽  
Eu Law ◽  
The European Union ◽  
European Union Law ◽  
Cooperation Agreement ◽  
The Status ◽  
Fundamental Rights And Freedoms ◽  
The Uk ◽  
The Eu

Each Concentrate revision guide is packed with essential information, key cases, revision tips, exam Q&As, and more. Concentrates show you what to expect in a law exam, what examiners are looking for, and how to achieve extra marks. This chapter discusses the Treaty framework and sources of EU law as well as the institutions of the EU. It covers the legal background to the UK’s departure from the EU, the legal process through which the UK left the EU, the key provisions of the EU–UK Trade and Cooperation Agreement (2020), and the European Union (Future Relationship) Act 2020. This chapter also discusses the effect of the UK’s departure from the EU on the status of the sources of EU law and the effect of leaving the EU on the Charter of Fundamental Rights and Freedoms as well as failure to transpose a Directive into national law and the effect of leaving the EU on the Francovich principle.

Article 50 TEU: The Quest for an Orderly Withdrawal and the Possibility of Alternative Denouements

2021 ◽  
pp. 21-47
Author(s):  
Michael Dougan
Keyword(s):  
European Union ◽  
Member State ◽  
Eu Law ◽  
Legal Systems ◽  
Article 50 ◽  
The Uk ◽  
The Eu

This chapter sets out the basic constitutional framework, under EU law, governing the withdrawal of a Member State. Article 50 of the Treaty on European Union recognizes the sovereign right of any State to leave the EU and sets out a process for agreeing the terms of an orderly departure. But Brexit also required the EU and the UK to undertake extensive internal preparations, to ensure their own legal systems were ready for the UK’s departure. Moreover, Article 50 itself is drafted in only brief and sketchy terms, leaving many important decisions about Brexit to be worked out in practice. And EU law allows for other final outcomes to the withdrawal process—including a ‘no deal Brexit’; or the UK’s right to ‘revoke and remain’ under the Wightman ruling.

The Irish Border

2020 ◽  
pp. 148-168
Author(s):  
Colin Harvey
Keyword(s):  
Northern Ireland ◽  
Peace Process ◽  
Violent Conflict ◽  
Controversial Issue ◽  
Long Term Consequences ◽  
The Uk ◽  
The Eu

This chapter focuses on Northern Ireland, a jurisdiction within the UK acutely affected by the nature of the Brexit debate and the process. It is a contested region that is divided along ethno-national lines and still emerging from a violent conflict. Removing Northern Ireland from the EU against its wishes will have long-term consequences that remain difficult to predict. One result is a more intense discussion of the region’s place within the UK, with Irish reunification acknowledged to be a way to return to the EU. The chapter then analyses the Protocol on Ireland/Northern Ireland attached to the Withdrawal Agreement which regulates the single most controversial issue in the Brexit process: namely, the Irish border question. It looks at the difficulties connected to the fragile peace process in Northern Ireland and explains the creative solution that was ultimately agreed in the withdrawal treaty to prevent the return of a hard border in the island of Ireland through regulatory alignment, while also indicating the challenges that the Protocol creates.

3. The relationship between European Union and United Kingdom competition law

2019 ◽  
pp. 57-75
Author(s):  
Sandra Marco Colino
Keyword(s):  
European Union ◽  
Competition Law ◽  
Eu Law ◽  
The European Union ◽  
National Competition ◽  
Current Interaction ◽  
Article 50 ◽  
The Uk ◽  
The Relationship ◽  
The Eu

This chapter focuses on the current interaction between European Union and UK law. EU law is currently a source of UK law. However, the relationship between the two regimes is expected to change in the future as a consequence of the UK’s decision to withdraw from the EU. The European Union (Withdrawal) Act 2018 stipulates that the European Communities Act 1972 will be ‘repealed on exit day’, which would be 29 March 2019 provided that the two-year period since Article 50 TEU was triggered is not extended. Once the European Communities Act 1972 has been repealed, EU law will cease to be a source of UK law. No major immediate changes to the national competition legislation are to be expected, but future reforms could distance the UK system from the EU rules.

9. The European Union and Brexit

Public Law ◽  
2020 ◽  
pp. 355-396
Author(s):  
Mark Elliott ◽  
Robert Thomas
Keyword(s):  
European Union ◽  
Legal System ◽  
Lessons Learned ◽  
Eu Law ◽  
The European Union ◽  
Eu Membership ◽  
Parliamentary Sovereignty ◽  
The Uk ◽  
The Eu

This chapter focuses on the constitutional implications of the UK’s membership of the European Union and the constitutional implications of its exit from the EU (or ‘Brexit’). The chapter examines how EU law was accommodated within the UK legal system during the period of the UK’s membership of the EU, and in particular considers the consequences of the primacy of EU law for the doctrine of parliamentary sovereignty. The chapter also considers the extent to which lessons learned about the UK constitution as a result of EU membership will remain relevant now that the UK has left the EU.

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