EU Transparency Research Articles

Time to reimbursement of novel anticancer drugs in Europe: a case study of seven European countries

Time to reimbursement (TTR) of new anticancer medicines differs between countries and contributes to unequal access. We aimed to investigate TTR of new anticancer medicines and explore factors influencing the reimbursement process in seven high-income European countries. We carried out a retrospective case study of anticancer medicines with European Union Market Access (EU-MA) and a positive Committee for Medicinal Products for Human Use opinion from 2016 until 2021 with subsequent national reimbursement approval (NRA). The National Health Technology Assessment (HTA) and reimbursement websites of Germany, France, UK, the Netherlands, Belgium, Norway and Switzerland were used to identify TTR, defined as time from EU-MA to NRA. Additionally, we investigated medication-, country-, indication- and pharma-related factors potentially influencing TTR. Thirty-five medicines were identified for which TTR ranged from -81 days to 2320 days (median 407 days). At data cut-off, 16 (46%) were reimbursed in all seven countries. Overall, the shortest TTR was in Germany (median 3 days, all medicines reimbursed <5 days). The time limit for reimbursement of 180 days stated by the Council of European Communities after the EU-MA (EU Transparency Directive) was met for 100% of included medicines in Germany, 51% in France, 29% in the UK and the Netherlands, 14% in Switzerland, 6% in Norway and 3% in Belgium. The TTR was significantly different between countries (P < 0.001). In multivariate analysis, factors associated with shorter TTR were higher gross domestic product (GDP), absence of a pre-assessment procedure and submission by a big pharmaceutical company. TTR of anticancer medicines varies significantly between seven high-income European countries and leads to inequality in access. Among explored medication-, country-, indication- and pharma-related factors we found that a high GDP, the absence of a pre-assessment procedure and submission by big pharmaceutical companies were associated with shorter TTR.

Stakeholder consultations in the EU Commission: instruments of involvement or legitimacy?

ABSTRACT Governmental entities such as the EU Commission regularly consult societal stakeholders. In such consultations, a variety of different tools are used ranging from open online consultations over stakeholder conferences to discussions in closed policy fora. Recent research has demonstrated how the range and diversity of the consulted actors vary across these consultation formats. Yet, we know little about the value societal stakeholders attach to their participation in consultations. In this paper, we argue that some consultation formats facilitate an insider match between the motives of societal stakeholders and the Commission with clear potential for also affecting Commission initiatives. Other consultation instruments are more likely to facilitate an outsider match where stakeholders may draw public attention to their views and the Commission enhance the perceived legitimacy of its decisions. We find support for these expectations based on data from a survey administered to stakeholders registered in the EU transparency register.

Comparing the Effect of Intangible Assets and Macroeconomic Parameters on the Stock Prices in Firms Listed on the Stock Exchange of Iran, Saudi Arabia and Iraq

Comparing the Effect of Intangible Assets and Macroeconomic Parameters on the Stock Prices in Firms Listed on the Stock Exchange of Iran, Saudi Arabia and Iraq

The Reform of the EU Transparency Register

This paper looks at the latest reform of the EU Transparency Register (TR). I will approach the negotiations on the TR from the angle of the legislative process and will focus in particular on the life cycle of the TR proposal all the way from its preparatory phase within the Commission until the trilogue negotiations and the adoption of the TR package. I will be arguing that peer pressure between EU institutions had a significant impact on the negotiations. Furthermore, peer pressure inside EU institutions was also important. The final outcome of the TR will be analysed with regard to the effectiveness and added value of the TR interinstitutional agreement and the accompanying legal and political instruments. Solutions aimed at increasing transparency will be discussed in terms of their practical effect on EU institutions, the European Commission, the European Parliament and the Council of the European Union. The findings of this paper suggest that the achieved compromise provides added value to the TR regime of the EU. Moreover, the compromise has contributed to transforming the EU TR towards a hybrid transparency system consisting of elements of a different nature. Finally, I will conclude by discussing the future prospects of developing the EU TR regime. Keywords: EU law, transparency, transparency register, lobbying, interinstitutional agreements. &nbsp; This work is licensed under the Creative Commons Attribution − Non-Commercial − No Derivatives 4.0 International License. &nbsp; Suggested citation:&nbsp;K Fyhr, ‘The Reform of the EU Transparency Register’ (2021) 17 CYELP 177.

Sunday Dinners and Hot Baths in a ‘Wild Wild North’? The Nordic Discussions on Lobbying Regulation and Implications for the EU Transparency Agenda

The Nordic countries are known as frontrunners of transparency, and the European Union’s transparency regime owes many of its ideals, if not the reality, to Northern influences. Nonetheless, although perceived as a transparency-enhancing measure, none of the Nordic countries has adopted lobbying regulation. Assessing the Nordic parliamentary and governmental debates from the 1980s onwards, this article offers an analysis of a complex relationship between legislative transparency and lobbying regulation in the five countries. The Nordic countries have different ideas of whose transparency lobbying regulation is meant to increase. In Sweden, Denmark and Norway, lobbying regulation is seen as a policy measure to enhance transparency about lawmakers’ activities, while the Icelandic and Finnish debates consider lobbying regulation as a way to increase information about the role lobbyists play in law-making. Although all the Nordic countries exhibit varying degrees of an elitist small country mentality where lobbying regulation would interfere with ‘informal governance’ by way of Sunday dinners and hot baths, the difference in transparency emphases is crucial. It helps to understand the divergent Nordic policy paths and to contextualize both EU and Member State discussions on lobbying regulations and transparency. EU Courts, Right to trial within a reasonable time, Excessive duration of court proceedings, Effective remedies, Damages liability of the EU, Economic harm, Non-material harm, Conditions for liability, Requirements for establishing harm and causation, Significance for EU damages liability law

EU Transparency as ‘Documents’: Still Fit for Purpose?

In this thematic issue, the question whether EU decision making might be characterised by an excess of transparency stands central. This contribution addresses an issue that precedes such questions of quantity: that of transparency’s qualities, i.e., its specific shape. From an early point in time, transparency in the EU has been equated with the narrow and legalistic notion of ‘access to documents.’ Although since then, transparency has become associated with a wider range of practices, the Union has not managed to shake off the concept’s association with bureaucracy, opacity, and complexity. This remains the case, in spite of the fact that administrations and decision-makers across the world increasingly utilise the possibilities of technological innovation to communicate more directly with their electorates. In this changing communicative context, this commentary considers whether EU transparency as access to documents is still fit for purpose. It does so by exploring access policy from the vantage point of legal developments, administrative practices, political dynamics, and technological innovations. The commentary concludes that while improvements are needed, the access to documents concept endures. However, access to documents needs to be complemented by constructive (rather than predatory) public justification and contestation, to remain viable.

Quality Models for Open, Flexible, and Online Learning

This article is based on research conducted for the European Commission Education &amp; Training 2020 working group on digital and online learning (ET2020 WG-DOL) specifically regarding policy challenges, such as the following: 1) Targeted policy guidance on innovative and open learning environments under outcome; 2) Proposal for a quality assurance model for open and innovative learning environments, its impact on specific assessment frameworks and its implication for EU recognition and transparency instruments. The article aims to define quality in open, flexible, and online learning, particularly in open education, open educational resources (OER), and massive open online courses (MOOC). Hence, quality domains, characteristics, and criteria are outlined and discussed, as well as how they contribute to quality and personal learning so that learners can orchestrate and take responsibility for their own learning pathways. An additional goal is to identify the major stakeholders directly involved in open online education and to describe their visions, communalities, and conflicts regarding quality in open, flexible, and online learning. The article also focuses on quality in periods of crisis, such as during the pandemic in 2020. Finally, the article discusses the rationale and need for a model of quality in open, flexible, and online learning based on three major criteria for quality: excellence, impact, and implementation from the learner’s perspective.

Clinical Trial Data Transparency and GDPR Compliance: Implications for Data Sharing and Open Innovation

Recent EU initiatives and legislations have considerably increased public access to clinical trials data (CTD). These developments are generally much welcomed for the enhancement of science, trust, and open innovation. However, they also raise many questions and concerns, not least at the interface between CTD transparency and other areas of evolving EU law on the protection of trade secrets, intellectual property rights and privacy. This paper focuses on privacy issues and on the interrelation between developments in transparency and the EU’s new General Data Protection Regulation 2016/679 (GDPR). More specifically, this paper examines: (1) the genesis of EU transparency regulations, including the incidents, developments and policy concerns that have shaped them; (2) the features and implications of the GDPR which are relevant in the context of clinical trials; and (3) the risk for tensions between the GDPR and the policy goals of CTD transparency, including their implications for data sharing and open innovation. Ultimately, we stress that these and other related factors must be carefully considered and addressed to reap the full benefits of CTD transparency.

The Annual Reports Becoming Digital - An Initial Field Analysis of the NYSE Listed IFRS-Filers

It was a very long way from the initial development of the XBRL (eXtensible Business Reporting Language) standard in 1998 to the initial release of digital structured business reports based on International Financial Reporting Standards (IFRS). The US Securities and Exchange Commission's recognition of the IFRS taxonomy in March 2017 with the origin of a law issued in 2014 also introducing the Interactive Rule for all non-US companies, for the first time, the IFRS taxonomy of approximately 10,000 non-domestic (non-domestic) company was applied. To the surprise of many market participants, the SEC's initial phased implementation, which included a two-year implementation, was replaced by a complete one-time implementation, including detailed tagging. The European Securities and Markets Authority (ESMA) has begun to implement provisions contained in the new EU Transparency Directive of 2013. The aim is to develop a European electronic standard for financial reporting. With effect from 1 January 2020 all stock-listed companies have to prepare their Annual Financial Reports in the European Single Electronic Format (ESEF). The aim is to build on the IFRS taxonomy. This article gives a first overview of the results of the analysis of these electronic annual reports of the NYSE listed IFRS-filers. This will also provide relevant insights for the preparation for ESEF.

Compulsory Disclosure of Private Information: Theoretical and Experimental Results for the Acquiring-a-Company Game

Based on the “acquiring-a-company”game of Samuelson and Bazerman (1985), we theoretically and experimentally analyze the acquisition of a firm. Thereby we compare cases of symmetrically and asymmetrically informed buyers and sellers. This setting allows us to predict and test the effects of information disclosure as prescribed by two recently implemented directives of the European Union, the Transparency and the Takeover-Bid Directive. Our theoretical and experimental results suggest a welfare-enhancing effect of compulsory information disclosure. Hence, the EU Transparency and the EU Takeover-Bid Directive should both be welfare enhancing.

FORMATION OF UKRAINE TRANSPARENCY BANKING

The article analyzes requirements of the National Bank of Ukraine for transparency of banks, banking groups and non-banking financial market participants. Transparency development process in the Ukrainian banking sector considered in a dynamic and in context of the EU's transparency requirements. Authors came to conclusion that the National Bank of Ukraine have to extended last achievements at banks transparency issues on activities of banking groups and to non-banking financial institutions. This conclusion based on rudiments of effective supervision of banking groups on a consolidated basis, as well as the adoption by the Verkhovna Rada of Ukraine of the Law on "Split". This law extends the National Bank's responsibility in the supervision of non-banking financial institutions (insurance, leasing, financial companies, credit unions, pawnshops and credit bureaus) since July 2020. Therefore, the National Bank should introduce new regulatory requirements to increase the transparency of banking groups and non-bank financial intermediaries. These reforms will establish uniform approaches and standards for disclosure of information on the activities of financial institutions, as well as provide the harmonization of national legislation with EU requirements. Expanding the list of public reporting information and establishing proper reporting intervals will ensure the stable functioning of the financial market and will increase the confidence in the financial system by the users of financial services. These measures will also help management of the financial organization to make informed decisions in defining their development strategy. Besides, they will provide further development of the competitive environment in the financial services industry. Keywords: transparency of banking system, transparency requirements, bank, banking group.

Komparativna analiza pravnog okvira kratkoročnog finansijskog izveštavanja u jugoistočnoj Evropi

Interim financial reporting is the process of preparation, compilation and disclosure of financial statements for periods shorter than one year. The most commonly discussed are semi-annual and quarterly reporting. In many countries, interim financial reporting is compulsory for companies whose securities are traded on a regulated market and is regulated by both national capital market legislation and international regulations - this refers primarily to IAS 34 and the EU Transparency Directive. This paper analyzes the legal framework for interim financial reporting in ten Southeast European countries. Despite the ongoing process of harmonizing accounting regulations and the fact that all observed countries have adopted IAS/IFRS, the analysis has shown that differences in interim reporting persist and are significant. They are particularly prominent in non-EU countries and in segments where international regulation has left flexibility to national regulations. The results of this research may be of value to investors, regulators and future researchers looking at the quality of interim financial reporting.

Codes of conduct and practical recommendations as tools for self-regulation and soft regulation in EU public affairs

During the 2000s–2010s, EU Commission and Parliament and European interest groups advanced a specific model of regulation. It combines, on one side, lobbyists self-regulation—the codes of conduct for EU lobbying professionals' associations, such as SEAP and EPACA—with institutional nonbinding or “soft” regulation on the other side—the EU Transparency Register framework for registered interest groups, its code of conduct, the related system of checks, alerts, and complaints about interest groups misconduct put forward by the EU Joint Transparency Register Secretariat, the list of Dos and Don'ts by the EU Ombudsman. This paper examines the peculiar lobbying self-regulation and soft regulation tools and practices, as implemented within the EU model: SEAP and EPACA codes of conduct, EU Transparency Register, EU Interest Groups Code of Conduct, Commissioners and MPs codes of conduct, the procedures of the EU Joint Transparency Register Secretariat, and the Ombudsman list of Dos and Don'ts, underlining their growing impact on interest groups registration to the EU Transparency Register. This EU innovative regulatory model-based on a peculiar mix of self-regulation and institutional, incentive-based, soft regulation-stands as a concrete alternative to the traditional North American top-down binding regulatory pattern. The EU model is based on a participatory, cooperative, and pragmatic dialogue between European policy makers and interest groups. Clarifying the concept, the nature, and the functions of this model, while underlining its peculiarity is the purpose of this paper.

Assessing the Effects of European Union Funding of Civil Society Organizations: Money for Nothing?

AbstractThis study investigates whether the European Union's funding of civil society organizations (CSOs) can foster equal access to existing channels of participation. This is analyzed by using data from 7,889 CSOs that are registered in the EU Transparency Register. Two criteria should be met for funding to combat inequalities among CSOs: the funding must support underrepresented interests, and it must increase their participation in the policy process. The results of a logistic regression analysis show that the Commission's funding scheme does support underrepresented interests but makes participation more unequal by also supporting already overrepresented groups. Furthermore, the analysis shows that the probability of a CSO having access to formal channels of participation significantly increases if it has received funding. The conclusion is that funding could be used more efficiently if the Commission were to consistently support underrepresented interests.

Suspension of the Exercise of Voting Rights: A Step Towards Deterrent and Consistent Sanctioning of EU Transparency Requirements?

With the adoption of Directive 2013/50/EU, the Member States have been required to introduce the sanction of suspending the exercise of the voting rights of shareholders who fail to notify their major shareholdings in accordance with the national rules that implement the Transparency Directive (Directive 2004/109/EC). Directive 2013/50/EU does not regulate in detail how such suspension should be implemented, nor its consequences, so it is hardly surprising that its implementation varies widely. This article shows where the major differences lie. Directive 2013/50/EU is intended to set a minimum standard, but it is concluded that the wide differences in its implementation may mean that the minimum standard set by the Directive with regard to the suspension of voting rights may be said to very low. This does not necessary mean that the harmonisation is a failure, as it is the total mix of sanctions required by the Directive that should set the minimum level. However, as the Commission considers the suspension of the exercise of voting rights to be a particularly important sanction, it may be presumed that it expected this sanction to be implemented with more teeth than appears to be the case.

Suspension of the Exercise of Voting Rights A Step towards Deterrent and Consistent Sanctioning of EU Transparency Requirements?

With the adoption of Directive 2013/50/EU, the Member States have been required to introduce the sanction of suspending the exercise of the voting rights of shareholders who fail to notify their major shareholdings in accordance with the national rules that implement the Transparency Directive (Directive 2004/109/EC). Directive 2013/50/EU does not regulate in detail how such suspension should be implemented, nor its consequences, so it is hardly surprising that its implementation varies widely. This article shows where the major differences lie. Directive 2013/50/EU is intended to set a minimum standard, but it is concluded that the wide differences in its implementation may mean that the minimum standard set by the Directive with regard to the suspension of voting rights may be said to very low. This does not necessary mean that the harmonisation is a failure, as it is the total mix of sanctions required by the Directive that should set the minimum level. However, as the Commission considers the suspension of the exercise of voting rights to be a particularly important sanction, it may be presumed that it expected this sanction to be implemented with more teeth than appears to be the case.

Transparency in EU law-making

EU Treaties, Regulation 1049/2001 and the CJEU’s case law require the highest standard of transparency for EU law-making. Yet, some pivotal stages of the legislative process remain completely opaque until the relevant decisions are adopted. This paper focuses on three different stages of this process, namely the adoption of the Commission’s impact assessment, of the European Parliament’s report by MEPs in the relevant committee within shadow meetings and the adoption of the final text of legislation within trilogue meetings. It concludes that opposing efficiency to transparency is a misguided approach.

On the Path to an European Single Electronic Format ESMA Consultation for the IFRS Taxonomy of Structured Electronic Reporting

Manuscript Type: TheoreticalMain Focus: At European level signs become more obvious that structured electronic reporting using XBRL (eXtensible Business Reporting Language) will be part of a future European single electronic standards for financial reporting (ESEF). This ESEF is planned to be build on the IFRS Taxonomy. The European Securities and Markets Authority (ESMA) has begun to implement rules that were included in the new EU Transparency Directive, 2013. Background of the consultation of ESMA, the amended provisions of the Transparency Directive, according to which with effect from 1 January 2020, all annual financial reports to be created in a common electronic reporting format (European Single Electronic Format (ESEF)). To this end, ESMA should submit to the European Commission not later than 31 December 2016 draft regulatory technical standards to define the electronic loading reporting format, taking into account existing and future technology options. The regulations aimed at facilitating submissions for issuers, and the filed Information for investors and regulators to improve access to and thus also to enable better analysis and peer comparisons. This article analyzes the 110 commentaries to ESMA release paper.Results: The evaluation of the commentaries has shown that the majority of commentators the ESMA proposals support the implementation of the ESEF. A small number reject the proposals completely or is against certain aspects to ESEF. Critics of the proposed ESEF can be summarized in three categories. The first group rejects completely all proposals. Striking on this commentaries is that the text of the comments is semantically completely identical. All of these comments came from one geographical area. From this it can be concluded that the content of the comments has been agreed in advance by the companies, which can be traced back to a pooling of common interests. Although the consultation process represent a transparent proven process to public participation, so this result shows that this kind of consultation process not protected from a political-driven participation of interests. The second group consist essentially of stakeholders: regulators, IT companies, standard-setters and auditors who in general support the proposals. However, a majority of the second Grupen rejects company-specific elements which are also called common practice elements. A third group rejects the majority of proposals, but no identical semantic comments are detectable. Usually, the public consultation process has the task to disclose divergent opinions and interests and to initiate a competition. This that more than half of the commentary contains the exact same comment text, this goal is not reached. This raises the question whether ESMA should assess these commentaries in their final assessment as one comment.

PHP52 - Access To Innovative Medicines In The Czech Republic: Length Of Price And Reimbursement (P&R) Procedures

Since January 2008, the Czech Republic (CZ) regulation on P&R processes in drugs follows both specific assessment and formal proceeding rules including timelines based on EU Transparency Directive. But only much later (2012/2013), specific methodologies for mandatory budget impact and cost-effectiveness analyses were issued by Czech P&R decision body (State Institute for Drug Control; SUKL) formalizing the SUKL’s position as a national HTA agency for appraisal of medicines. The aim of the present study was to describe how the current status quo affects the actual length of the procedures concerning innovations. Lists of administrative proceedings and individual proceeding files, were both accessed via public SUKL web page. First, all proceedings initiated between January 2013 and February 2016 were identified (N = 4,153). Consequently, only P&R proceedings on innovative medicines were selected: the inclusion criteria were strictly limited to first-in-class drugs at their 1st submission. The selected proceedings (N = 65) were then analysed and followed up to May 10th 2016. At the time of data collection closure, 40 procedures had at least appraisal report issued, out of which 28 had also decision issued. The average time until the first appraisal report was 9.2 (± 3.9) months. The average procedure length, i.e. until decision publication, was 12.9 (± 4.8) months. No correspondence or relation was observed between the procedure length and drug-related properties of the dossier, such as budget impact size or medicine therapeutic area. Combination of the very formal administrative character and rigorous scientific evaluation, together with parallel complex negotiations between the proceeding’s stakeholders, apparently leads to delays in P&R decisions, i.e. patients’ access. The key question for the regulators possibly remains how to increase SUKL’s throughput, i.e. reduce delays, without stepping down on the recently acquired high-quality scientific assessment and rigour.

The Multiplex Network of EU Lobby Organizations.

The practice of lobbying in the interest of economic or social groups plays an important role in the policy making process of most economies. While no data is available at this stage to examine the success of lobbies in exerting influence on specific policy issues, we perform a first systematic multi-layer network analysis of a large lobby registry. Here we focus on the domains of finance and climate and we combine information on affiliation and client relations from the EU transparency register with information about shareholding and interlocking directorates of firms. We find that the network centrality of lobby organizations has no simple relation with their lobbying budget. Moreover, different layers of the multiplex network provide complementary information to characterize organizations’ potential influence. At the aggregate level, it appears that while the domains of finance and climate are separated on the layer of affiliation relations, they become intertwined when economic relations are considered. Because groups of interest differ not only in their budget and network centrality but also in terms of their internal cohesiveness, drawing a map of both connections across and within groups is a precondition to better understand the dynamics of influence on policy making and the forces at play.