Pay-for-Delay Agreements in the Pharmaceutical Sector: Towards a Coherent EU Approach?`

2014 ◽  
Vol 5 (1) ◽  
pp. 79-86 ◽  
Author(s):  
Stefano Barazza
Keyword(s):  
Competition Law ◽  
Generic Manufacturer ◽  
Clear Indication ◽  
Pharmaceutical Sector ◽  
Legislative Proposals ◽  
Eu And Us ◽  
Monitoring Activity ◽  
The Eu

This Report examines the competition law issues that arise, in the EU pharmaceutical sector, from pay-for-delay agreements concluded between an originator company and a generic manufacturer. The Commission's approach to these agreements is reviewed evaluating the findings of the on-going monitoring activity of patent settlements, the outcome of recent investigations, and the legislative proposals specifically aimed at dealing with the phenomenon. Finally, a comparison of the EU and US approaches provides a clear indication of the challenges that still lie ahead.

Exclusionary Abuses

2021 ◽  
pp. 79-112
Author(s):  
Renato Nazzini
Keyword(s):  
Competition Policy ◽  
Competition Law ◽  
Private Enforcement ◽  
Pharmaceutical Sector ◽  
Public And Private ◽  
The Third ◽  
Public And Private Enforcement ◽  
The Uk ◽  
Abuse Of Dominance ◽  
The Eu

Chapter 4 deals with exclusionary abuses under the Competition Act 1998, covering both public and private enforcement cases. The analysis concerns the approach to dominance as well as tests for abuse, focusing on retroactive rebates and bundled discounts, exclusion in multi-market settings, exclusivity, most favoured nation and equivalent clauses, discrimination, and exclusionary abuses in the pharmaceutical sector. This chapter argues that, in its second decade, modern UK competition law continued a trend that was already clear in the first decade: the prohibition of abuse of dominance is applied in a more economically robust and commercially reasonable way than it is by the EU institutions - the Commission and the EU courts - and in certain other Member States. The chapter notes that the third decade of the Competition Act 1998 will see the UK develop its competition policy free from the constraints of EU law and may allow for some divergence in the approach to exclusionary abuses in the future.

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.

scholarly journals Energy Policies at Crossroads − Will Europe's 2030 targets and framework be in line with the Paris Climate Agreement?

2019 ◽  
Vol 4 ◽  
pp. 4
Author(s):  
Rainer Hinrichs-Rahlwes
Keyword(s):  
Energy Efficiency ◽  
Clean Energy ◽  
European Parliament ◽  
New Governance ◽  
Energy Policies ◽  
Governance System ◽  
Regulatory Frameworks ◽  
Legislative Proposals ◽  
Paris Climate Agreement ◽  
The Eu

In November 2016, the European Commission presented the Clean-Energy-for-all-Europeans Package. It consists of eight legislative proposals which should define targets and policy and regulatory frameworks for the EU's climate and energy policies up to 2030 and beyond. Recasts of the existing Renewable Energies Directive and the Energy Efficiency Directive, as well as proposals for a new energy market design, which should be fit for renewables, are among the key elements of the package, which aims at replacing the existing 2020-framework. The package includes 2030-targets for Greenhouse Gas Reduction (at least 40%), Energy Efficiency (at least 27/30%), and the share of Renewables in Gross Final Energy Consumption (at least 27%). In contrast to the 2020-framework, the EU-wide renewables-target would no longer be underpinned by binding national targets but should be reached in a joint effort with a new governance system. Since the proposal was submitted to the European Parliament and the European Council for the legislative procedures which must end in an agreement before the next elections for the European Parliament in 2019, controversial debates are taking place. The intention is to finalise the legal procedures before the end of 2018. Parliament and Council had planned to decide about their respective opinions about the various pieces by February 2018. Afterwards, probably not finished before the end of 2018, compromise negations will take place, before the whole package will eventually be accepted by both bodies. Among the most controversially discussed topics is the ambition level of the proposals and whether or not it is in line with the commitments signed by the EU and all its Member States in the context of the Paris Agreement. Industry stakeholders not only from the renewable energy sector and environmental NGOs have proposed significantly higher targets in order to stay “well below 2 °C” of global warming before the end of the century. They also suggested continuing binding national targets or − as a compromise − enacting a very strict governance system. I shall present and evaluate the state of play of the 2030-framework decision process. And I shall end with some policy recommendation still to be considered in the ongoing debate.

scholarly journals A Transatlantic Secular Divide? The Representation of Religion in EU and US Foreign Policy

2019 ◽  
Vol 15 (4) ◽  
pp. 451-469 ◽  
Author(s):  
Anne Jenichen
Keyword(s):  
United States ◽  
Foreign Policy ◽  
The United States ◽  
Us Foreign Policy ◽  
Foreign Affairs ◽  
Policy Documents ◽  
Foreign Policies ◽  
Eu And Us ◽  
And Behavior ◽  
The Eu

AbstractIt is a common—often stereotypical—presumption that Europe is secular and America religious. Differences in international religious freedom and religious engagement policies on both sides of the Atlantic seem to confirm this “cliché.” This article argues that to understand why it has been easier for American supporters to institutionalize these policies than for advocates in the EU, it is important to consider the discursive structures of EU and US foreign policies, which enable and constrain political language and behavior. Based on the analysis of foreign policy documents, produced by the EU and the United States in their relationship with six religiously diverse African and Asian states, the article compares how both international actors represent religion in their foreign affairs. The analysis reveals similarities in the relatively low importance that they attribute to religion and major differences in how they represent the contribution of religion to creating and solving problems in other states. In sum, the foreign policies of both international actors are based on a secular discursive structure, but that of the United States is much more accommodative toward religion, including Islam, than that of the EU.

“Think small first in the EU”? A Reality Check

2014 ◽  
Vol 5 (1) ◽  
pp. 93-96
Author(s):  
Typhaine Beaupérin
Keyword(s):  
European Commission ◽  
Costs And Benefits ◽  
Reality Check ◽  
Legislative Proposals ◽  
The Eu

Despite recent efforts by the European Commission to improve the application of the SME test by its services, EUROCHAMBRES 2013 SME Test Benchmark reveals that the Commission is still, in the majority of the dossiers analysed, failing to ‘think small first’ and take into account the costs and benefits to smaller businesses in the preparation of legislative proposals.

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