scholarly journals Implementation of the new EU IVD regulation – urgent initiatives are needed to avert impending crisis

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Christa Cobbaert ◽  
Ettore D. Capoluongo ◽  
Florent J. L. A. Vanstapel ◽  
Patrick M. M. Bossuyt ◽  
Harjit Pal Bhattoa ◽  
...  
Keyword(s):  
European Commission ◽  
Task Force ◽  
Healthcare Sector ◽  
The European Union ◽  
Medical Test ◽  
Link Type ◽  
Regulatory Affairs ◽  
European Regulatory ◽  
Medical Diagnostic ◽  
Prospective Risk

Abstract Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC (https://eur-lex.eur-opa.eu/legal-content/EN/TXT/?uri=CELEX%3A31998L0079&qid=1628781352814) to IVDR 2017/746 https://eur-lex.europa.eu/eli/reg/2017/746. Without amendments and contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infrastructural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its “droit d’exister”.

scholarly journals Remote monitoring of cardiac implanted electronic devices: legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report

EP Europace ◽  
2020 ◽  
Vol 22 (11) ◽  
pp. 1742-1758 ◽  
Author(s):  
Jens Cosedis Nielsen ◽  
Josef Kautzner ◽  
Ruben Casado-Arroyo ◽  
Haran Burri ◽  
Stefaan Callens ◽  
...  
Keyword(s):  
Remote Monitoring ◽  
Secure Communication ◽  
Task Force ◽  
Electronic Devices ◽  
Third Party ◽  
The European Union ◽  
Task Force Report ◽  
Regulatory Affairs ◽  
Joint Task ◽  
Joint Task Force

Abstract The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient’s device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.

Efficient use of subsidies in the financing of water and wastewater investments

2005 ◽  
Vol 5 (6) ◽  
pp. 197-207
Author(s):  
A.J. Almagro
Keyword(s):  
European Commission ◽  
Significant Risk ◽  
The European Union ◽  
Checks And Balances ◽  
Economic Agents ◽  
Economic Justification ◽  
Economic Rationale ◽  
Eu Directives ◽  
Water And Wastewater ◽  
Investment Subsidy

Compliance with the European Union (EU) standards in the provision of water supply and wastewater services, as set forth in the relevant EU Directives, may require a significant investment effort for some countries and more specifically the new Member States. In order to ease this effort, these countries have the possibility of receiving subsidies from the European Commission to finance their investments. Using as a reference the standard methodology applied by the European Commission to define its intervention rate in a project, this paper focuses on the economic rationale and risks behind the investment subsidies in the sector. The questions asked are (a) what is the economic justification of this kind of investment subsidy and who are the target beneficiaries; (b) what factors may cause these subsidies to reach other economic agents; and (c) what measures would prevent those unexpected transfers of taxpayer resources. The results of the analysis indicate that, although the underlying methodology is economically sound, there is a significant risk that part of the subsidies may end up benefiting economic agents other than those originally targeted. However, this risk can be easily mitigated with some basic checks and balances during the calculation of the intervention rate. The views expressed in this paper are strictly personal.

Austrian Veto against European Union Membership Negotiations with Turkey

2020 ◽  
Vol 8 (1) ◽  
pp. 103-122
Author(s):  
Ewa Kaczan-Winiarska
Keyword(s):  
European Union ◽  
European Commission ◽  
Security Policy ◽  
Negotiation Process ◽  
Point Of View ◽  
The European Union ◽  
Strategic Partner ◽  
Key Factor ◽  
European Standards ◽  
The Eu

The Austrian government is extremely sceptical about the accession negotiations which are conducted by the European Commission on behalf of the European Union with Turkey and calls for the negotiation process to end. Serious reservations of Vienna have been raised by the current political situation in Turkey under the rule of President Recep Tayyip Erdogan, as well as by the standards of democracy in Turkey, which differ greatly from European standards. Serious deficiencies in rule of law, freedom of speech and independence of the judiciary, confirmed in the latest European Commission report on Turkey, do not justify, from Vienna’s point of view, the continuation of talks with Ankara on EU membership. In fact, Austria’s scepticism about the European perspective for Turkey has a longer tradition. This was marked previously in 2005 when the accession negotiations began. Until now, Austria’s position has not had enough clout within the European arena. Pragmatic cooperation with Turkey as a strategic partner of the EU, both in the context of the migration crisis and security policy, proved to be a key factor. The question is whether Austria, which took over the EU presidency from 1.7.2018, will be able to more strongly accentuate its reservations about Turkey and even build an alliance of Member States strong enough to block Turkey’s accession process.

Legal Maxims: Summaries and Extracts from Selected Case Law

2017 ◽  
Author(s):  
Sébastien Brisard ◽  
Guglielmo Cantillo ◽  
Ramona Grimberger ◽  
Victoria Hanley-Emilsson ◽  
Rebeka Hevesi ◽  
...  
Keyword(s):  
European Union ◽  
European Commission ◽  
Vice President ◽  
Case Law ◽  
The European Union ◽  
Grand Chamber

Council of the European Union v. European Commission, Case C-409/13, Grand Chamber, Judgment, 14 April 2015European Commission v. Vanbreda Risk & Benefits, Case C‑35/15 P(R), Order of the Vice-President of the Court, 23 April 2015Geoffrey Léger v. Ministre des Affaires sociales, de la Santé et des Droits des femmes, Établissement français du sang...

scholarly journals Sustainability in the European Union: Analyzing the Discourse of the European Green Deal

2021 ◽  
Vol 14 (2) ◽  
pp. 80
Author(s):  
Eva Eckert ◽  
Oleksandra Kovalevska
Keyword(s):  
European Union ◽  
European Commission ◽  
Critical Discourse Analysis ◽  
Political Institutions ◽  
Main Question ◽  
The European Union ◽  
International Media ◽  
Institutional Power ◽  
The One ◽  
The Eu

In the European Union, the concern for sustainability has been legitimized by its politically and ecologically motivated discourse disseminated through recent policies of the European Commission and the local as well as international media. In the article, we question the very meaning of sustainability and examine the European Green Deal, the major political document issued by the EC in 2019. The main question pursued in the study is whether expectations verbalized in the Green Deal’s plans, programs, strategies, and developments hold up to the scrutiny of critical discourse analysis. We compare the Green Deal’s treatment of sustainability to how sustainability is presented in environmental and social science scholarship and point out that research, on the one hand, and the politically motivated discourse, on the other, do not correlate and often actually contradict each other. We conclude that sustainability discourse and its keywords, lexicon, and phraseology have become a channel through which political institutions in the EU such as the European Commission sideline crucial environmental issues and endorse their own presence. The Green Deal discourse shapes political and institutional power of the Commission and the EU.

scholarly journals A Review of Bioplastics and Their Adoption in the Circular Economy

Polymers ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1229
Author(s):  
Alberto Di Bartolo ◽  
Giulia Infurna ◽  
Nadka Tzankova Dintcheva
Keyword(s):  
European Union ◽  
Life Cycle Assessment ◽  
Life Cycle ◽  
European Commission ◽  
Circular Economy ◽  
Environmental Risks ◽  
Plastic Waste ◽  
The European Union ◽  
Sustainable Society ◽  
Net Zero

The European Union is working towards the 2050 net-zero emissions goal and tackling the ever-growing environmental and sustainability crisis by implementing the European Green Deal. The shift towards a more sustainable society is intertwined with the production, use, and disposal of plastic in the European economy. Emissions generated by plastic production, plastic waste, littering and leakage in nature, insufficient recycling, are some of the issues addressed by the European Commission. Adoption of bioplastics–plastics that are biodegradable, bio-based, or both–is under assessment as one way to decouple society from the use of fossil resources, and to mitigate specific environmental risks related to plastic waste. In this work, we aim at reviewing the field of bioplastics, including standards and life cycle assessment studies, and discuss some of the challenges that can be currently identified with the adoption of these materials.

scholarly journals Differences between the European Union and United States of America in Drug Regulatory Affairs Affect Global Patient Safety Standards and Public Health Awareness: The Case of Deferasirox and Other Iron Chelating Drugs

Medicines ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 36
Author(s):  
George J. Kontoghiorghes
Keyword(s):  
Patient Safety ◽  
Generic Drugs ◽  
Benefit Assessment ◽  
Regulatory Control ◽  
Pharmaceutical Companies ◽  
The European Union ◽  
Regulatory Policies ◽  
Regulatory Affairs ◽  
Risk Benefit Assessment ◽  
The Eu

Regulatory policies on drugs have a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, leading sometimes to irregularities and illegal activities. Misinformation on the orphan drug deferasirox has reached the stage of criminal investigations and fines exceeding USD 100 million. Additional lawsuits of USD 3.5 billion for damages and civil fines were also filed by the FBI of the USA involving deferasirox and mycophenolic acid, which were later settled with an additional fine of USD 390 million. Furthermore, a USD 345 million fine was also settled for bribes and other illegal overseas operations including an EU country. However, no similar fines for illegal practises or regulatory control violations have been issued in the EU. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison to deferiprone and deferoxamine appear to reduce the effective treatment prospects and to increase the toxicity risks for thalassaemia and other iron loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patented versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly market driven with no clear safeguards or guidelines for risk/benefit assessment indications or for individualised effective and safe optimum therapies. There is a need for the establishment of an international organisation, which can monitor and assess the risk/benefit assessment and marketing of drugs in the EU and globally for the benefit of patients. The pivotal role of the regulatory drug authorities and the prescribing physicians for identifying individualised optimum therapies is essential for improving the survival and safety of millions of patients worldwide.

scholarly journals Joint bodies in the European Union's international agreements: Delegating powers to the European Commission in EU external relations

2021 ◽  
pp. 146511652110273
Author(s):  
Markus Gastinger ◽  
Andreas Dür
Keyword(s):  
European Union ◽  
European Commission ◽  
Empirical Support ◽  
International Agreements ◽  
Principal Agent ◽  
The European Union ◽  
Original Dataset ◽  
Voting Rule ◽  
External Relations ◽  
Set Up

In many international agreements, the European Union sets up joint bodies such as ‘association councils’ or ‘joint committees’. These institutions bring together European Union and third-country officials for agreement implementation. To date, we know surprisingly little about how much discretion the European Commission enjoys in them. Drawing on a principal–agent framework, we hypothesise that the complexity of agreements, the voting rule, conflict within the Council, and agency losses can explain Commission discretion in these institutions. Drawing on an original dataset covering nearly 300 such joint bodies set up by the European Union since 1992, we find robust empirical support for all expectations except for the agency loss thesis. Our findings suggest that the European Commission is the primary actor in the implementation of many of the European Union's international agreements, allowing it to influence EU external relations beyond what is currently acknowledged in the literature.

scholarly journals The common energy market of the European Union – utopia or reality?

2017 ◽  
Vol 11 (1) ◽  
pp. 93-102 ◽  
Author(s):  
Ana-Maria Iulia Şanta
Keyword(s):  
European Union ◽  
Renewable Energy ◽  
European Commission ◽  
Social Impact ◽  
Clean Energy ◽  
Energy Market ◽  
The European Union ◽  
Legal Provisions ◽  
Energy Union ◽  
The Common

Abstract The European Commission has the initiative to foster the sector of renewable energy and to build an Energy Union, with a common energy market at the level of the European Union, but is this only an utopic vision or is this possible to achieve? The topic of clean energy is very new and of great interest for the European Union, which is shown by the fact that the European Commission recently adopted on the 30th November 2016 the package “Clean Energy for All Europeans”, which contains proposals for the modernization of the energy market at the level of the European Union. But which are the challenges such a project is confronted with? According to the literature, such challenges are related to the process of liberalization of electricity markets. Conflicts between national interest and international actors of the energy market might occur. Due to the oligopolistic structure of the energy market, there are several barriers to the market entry. In order to answer to the research questions, case studies regarding the liberalization of the energy market will be analyzed in a comparative manner, offering an international overview. Furthermore, the legal provisions on which the common energy policy of the European Union relies, will be analyzed, as well as their economic and social impact. The package “Clean Energy for All Europeans” comprises a proposal of the revised Renewable energy Directive, energy efficiency measures and issues related to the Energy Union Governance. It contains as well proposals for the electricity market design, which will be analyzed and the present paper outlines the contribution of this proposal in building a common energy market of the European Union. What role does competition play in implementing the common energy market of the European Union? Which role do competition authorities have in this context? These are interesting aspects to be analyzed in the present paper.

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