Commission Proposal Research Articles

How many drugs are repositioned each year in Europe?

AbstractFor two decades, commentators have argued for law and policy reform to incentivise organisations to develop new indications for (already) authorised drugs, an area of drug development known as ‘repositioning’. In short, they argue that hurdles in patent and pharmaceutical law hinder repositioning and, therefore, reform is required to increase its use. Yet, these arguments are made primarily on anecdotes; the empirical evidence is scant. One foundational question is how many drugs are repositioned each year in Europe. This study develops a method to examine the number authorised each year. The results show a marked increase in repositioning over the last 3 years, and that the number per year is comparable, though slightly fewer than, the number of new compounds, indicating modest to higher‐than‐expected activity. This study considers what the results mean for four suggested reform options, including the EU Commission's recent proposal. We conclude that the reforms may not achieve their goals or that further evidence is required before we can know whether they will be effective. Lastly, this paper explains how the method and data in this study could serve as a benchmark for evaluating the success of future reforms.

Intellectual property rights and plants made by new genomic techniques: Access to technology and gene-edited traits in plant breeding

Gene editing has the potential to make new crop varieties faster and more efficiently. New and more suitable crop varieties can increase sustainable agriculture, for instance, in the form of disease-resistant varieties that facilitate integrated pest management. The European Commission's proposal on the regulation of gene-edited and cisgenic plants produced with New Genomic Techniques (including CRISPR/Cas) has re-opened the discussion on Intellectual Property Rights on plants in Europe. We provide an overview of the possible impact of patent rights and Plant Variety Rights on the availability of technology and gene-edited alleles to breeders on an European level. We highlight potential problems with the two Intellectual Property Right systems and indicate potential avenues to solutions.

Power with Purpose? Further Reflections on Strengthening the Centre of Government

AbstractOn 10 March 2024 the Commission on the Centre of Government published its final report: Power with Purpose. The aim of the commission had been to explore why Number Ten, the Cabinet Office and HM Treasury do not always work as well as they should and to explore what could be done to improve the centre of government radically. Perennial concerns about the existence of a ‘hollow crown’ at the centre of British government were, the final report recommended, to be resolved through the implementation of a ‘radical’ reform agenda. This article interrogates the commission's proposals from a critical perspective and builds upon existing concerns as to the viability of further centralising power in Whitehall. It achieves this by reflecting on an understanding of why history, criticality, governance, evidence and relationships matter when seeking to cope with complexity or when designing genuinely ‘radical’ new governance capabilities. It is argued that a full appreciation of these factors is essential to any project to strengthen the core executive and offers a more balanced, relational and systemic approach to nurturing strategic capacity in government.

Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178).

EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation 'on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625'. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions.

The EU Commission During the Covid‐19 Crisis: Attempts at Self‐Empowerment, or Not?

AbstractWe argue that the European Commission, like national governments, is likely to have used the Covid‐19 crisis as an opportunity to bolster its own powers. We focus on the Commission's attempts to insert into legal proposals provisions to adopt delegated or implementing acts, as this is the only possible way to gain lasting rule‐making powers. We analyse all the Commission's legal proposals for an equal time span before and after the start of the Covid‐19 crisis and study whether the number of proposed delegation provisions has changed after the onset of the crisis. The analysis, to our surprise, does not show any clear evidence of a self‐empowerment strategy. In the conclusion, we discuss likely explanations for this non‐finding.

Qualitative Assessment of Two Recent EU Commission Proposals to Impose (More) VAT Obligations on Platforms

The VAT e-commerce package entered into application on 1 July 2021. It imposed new obligations on e-commerce platforms, including VAT liability and record-keeping obligations with respect to underlying transactions. In December 2022 and May 2023, the European Commission adopted a series of proposals that are meant to already adjust or significantly broaden the scope of these obligations. In addition, new obligations are proposed concerning platforms that facilitate short-term accommodation rental and passenger transport services. In this article, the authors seek to assess the expected impact of the proposed rules and to determine to what extent the compliance burden and associated risks would be increased as compared to the situation as it stands since 2021.

A Decade-Long Crusade against Transfer Pricing Rulings Turns into a Proposal for a Transfer Pricing Directive: A European Attempt to Introduce a Harmonized EU Arm’s Length Standard?

The recent European Commission proposal for a transfer pricing directive comes after years of attempts to claim the existence of illegal State aids allegedly granted by Member States to multinational enterprises (MNEs) that were deemed to have been provided through advance pricing agreements. However, the Court of Justice of the European Union has consistently denied the Commission’s assumptions and clarified that no autonomous arm’s length principle, different from that of the OECD, was identifiable under EU law. In this article, the author analyses the major transfer pricing cases scrutinized by the European Commission and their connection to the Commission’s attempt to introduce a European arm’s length standard by reverting to the directive procedure after having failed to prove the existence of such a standard over a ten-year-long judicial battle.

Greece’s current water and wastewater regulations and the risks they pose to environmental hygiene and public health, as recommended by the European Union Commission

To address emerging environmental issues, the European Union (EU) regularly updates its directives and regulations in the areas of wastewater treatment, water reuse, and water quality. The plan specifies standards for safe water reuse as well as quality requirements for treated wastewater. Legislation and regulations in Greece pertaining to wastewater management and water reuse assess how well-functioning current methods are at maintaining water quality, cutting pollution, and protecting public health. Analyze any unique challenges or successes in putting current laws into effect and keeping them in place. Determine areas of agreement and disagreement between EU plan and Greek legislation. EU proposal’s possible effects on Greece’s infrastructure, adoption of new technologies, and financial implications. This study is a perspective qualitative analysis. Selection of legislation, outline the criteria used for selecting the relevant legislation from EU and Greece. Data sources from obtained the legislation texts. Official government documents, legal databases, and reputable sources. Data variables extracted from the legislation, focusing on aspects related to environmental hygiene and public health risks. Comparative framework used to compare EU commission proposal with existing legislation in Greece. Evaluate the environmental hazards and problems associated with present wastewater management practices in Greece in terms of their potential influence on water quality, ecosystems, public health, and promote environmental hygiene.

Carbon Farming and the Commission Proposal for a Regulation on a Certification Framework for Carbon Removals: a Legal Perspective

Abstract Carbon farming is a term associated with land-based practices, agricultural practices that aim at reducing emissions and sequestering carbon. These are, for example, agroforestry practices and practices that result in the maintenance and enhancement of soil organic carbon through the exploitation of the carbon cycle and the sequestration potential of soils. Given the evident links with climate change mitigation, the subject matter of carbon and carbon removals has seen important developments in the European Union (EU) in the past few years. This has culminated in the adoption of a Commission Communication on sustainable carbon cycles and a Commission Proposal for a Regulation on a certification framework for carbon removals. This contribution is meant to address the content and the potentially problematic aspects of the Commission Proposal from a legal perspective.

The effect of trilogues on the European Commission's success in legislative negotiations: A reappraisal

Informal negotiations have become the norm in the European Union legislative process. Yet, researchers are divided over the effects of this change on the European Commission's ability to defend the content of its proposals from modifications by the co-legislators. This article addresses this puzzle by using a fine-grained measure of whether informal negotiations took place which includes trivial agreements, namely legislation adopted in first reading because the co-legislators agree on the content, as a specific category. The results suggest that informal negotiations do not lead to more changes to the Commission's proposals than the formal process. This calls for a better consideration of trivial agreements in studies of the European Union legislative process.

Consent Management System on Patient-Generated Health Data.

We consent to many things in life, but sometimes we do not know what we consent to. When discussing data protection in Europe, consent has been associated with permission under the GDPR, and health data are highly sensitive. Patients cannot make an informed decision without being provided with the information they need upfront: no informed decision, no informed consent. This paper presents a consent management system for patient-generated health data stored with HL7 FHIR specification, tested on Type 1 diabetes synthetic data. This architecture, based on using FHIR as an unequivocal data exchange format, can lead to individuals (patients) taking control of their data, enabling potential data exchange and reuse of health data across countries and organisations, in line with the European Commission proposal of a European Health Data Space.

Solidarity : new paradigm for health data spaces?

At the intersection of health promotion and health data sharing, a normative paradigm is emerging: solidarity. This principle became evident with the European Commission's proposal for the European Health Data Space in 2022, approved by the European Parliament in 2024, and Switzerland's DigiSanté project. This article examines health data spaces beyond traditional legal considerations, exploring the implications of increased reliance on solidarity. Highlighting public and private actors, it analyzes the use of health data for research, health surveillance, and profit. The article emphasizes the need for robust frameworks to balance data use for the common good and mitigate the risks of repression and exploitation.

Position Statement of the Max Planck Institute for Innovation and Competition of 6 February 2024 on the Commission's Proposal for a Regulation on Standard Essential Patents

Position Statement of the Max Planck Institute for Innovation and Competition of 6 February 2024 on the Commission's Proposal for a Regulation on Standard Essential Patents

Liability for Corruption in Poland in Light of the Commission Proposal for a New Directive on Corruption : The Devil is in the Details

Liability for Corruption in Poland in Light of the Commission Proposal for a New Directive on Corruption : The Devil is in the Details

Combating Corruption in EU Legislation : An Analysis of Some Aspects of the Commission Proposal for the EU Anti-corruption Directive

Combating Corruption in EU Legislation : An Analysis of Some Aspects of the Commission Proposal for the EU Anti-corruption Directive

Gelişen Teknolojilerin Çok Uluslu Şirketler Üzerindeki Etkileri: Hukuki Zorluklar ve Fırsatlar

This paper examines the application of new technologies in addressing the conventional legal challenges encountered by multinational companies due to the principles of company law. These challenges often give rise to concerns regarding liability in the presence of human rights violations and environmental violations caused by multinational enterprises (MNEs).
 Governments worldwide are responding by crafting domestic and international regulations aimed at addressing MNEs' transgressions, particularly in the domains of environmental protection and human rights. The European Commission's proposal for a Corporate Sustainability Due Diligence Directive (CSDDD) is a notable example. It mandates comprehensive due diligence measures that transcend geographical boundaries, encompassing every facet of a company's value chain. Nevertheless, while significant, the directive grapples with criticisms surrounding liability resolution.
 This article takes an innovative approach, seeking solutions within technology. It commences by introducing MNEs elucidating their operation domains and contributions to the global economy. Subsequently, it investigates environmental and human rights transgressions committed by MNEs, unraveling the enduring responsibilities and liabilities inherent to their operations. In doing so, it explores an alternative path forward, one that harnesses technology's transformative potential to address the complex challenges MNEs and countries face in an evolving global landscape.

The pre-pack regulation in the EU Commission proposal for a second insolvency directive

This article draws an analysis of the pre-pack as set forth in the recent EU Commission proposal for a second insolvency directive. We explain the context in which this proposal is born, as well as its main features regarding the pre-pack. Also, this proposal for a directive unveils a certain normative foundation for pre-packs that this article aims to describe. In view of the increasing market interest in pre-packs, this proposal for a Directive is likely to supply a normative context to the professional community.

A Closer Look at the European Commission Proposal for Harmonized Rules for Transfer Pricing

In this article, the authors provide the background and objection of the EU TP Directive, and analyse the proposal and its position in respect of other international tax developments. They conclude that the TP Directive is expected to increase tax certainty for taxpayers across the European Union, as the CJEU would become the court of highest instance for the application of the arm’s length principle. Unfortunately it will take substantial time to reach the increased certainty.

A Closer Look at the European Commission Proposal for Harmonized Rules for Transfer Pricing

In this article, the authors provide the background and objection of the EU TP Directive, and analyse the proposal and its position in respect of other international tax developments. They conclude that the TP Directive is expected to increase tax certainty for taxpayers across the European Union, as the CJEU would become the court of highest instance for the application of the arm’s length principle. Unfortunately it will take substantial time to reach the increased certainty.

Mind the (CRISPR) gaps: The European Commission's proposal for the use of NGTs in the EU.

The proposal by the European Commission to regulate New Genome Technique (NGT) plants is a leap forward, but it does not revise the current legislation on GMOs and includes many inconsistencies that may hinder the adoption of specific NGTs.