scholarly journals A Healthy Sense of Trust

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-10
Author(s):  
Denis Horgan
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Big Data ◽  
Data Protection ◽  
Fast Moving ◽  
Ethical Issues ◽  
Personalised Medicine ◽  
Drug Pricing ◽  
The Right ◽  
The Eu

In the fast-moving arena of modern healthcare with its cutting-edge science it is already, and will become more, vital that stakeholders collaborate openly and effectively. Transparency, especially on drug pricing, is of paramount importance. There is also a need to ensure that regulations and legislation covering, for example the new, smaller clinical trials required to make personalised medicine work effectively, and the huge practical and ethical issues surrounding Big Data and data protection, are common, understood and enforced across the EU. With more integration, collaboration, dialogue and increased trust among each and every one in the field, stakeholders can help mould the right frameworks, in the right place, at the right time. Once achieved, this will allow us all to work more quickly and more effectively towards creating a healthier - and thus wealthier - European Union.

The Right To Be Forgotten

2016 ◽  
Author(s):  
Edward L. Carter
Keyword(s):  
European Union ◽  
Data Protection ◽  
Search Engines ◽  
Freedom Of Expression ◽  
The European Union ◽  
Legal Concept ◽  
Court Of Justice ◽  
Right To Be Forgotten ◽  
The Right ◽  
The Eu

The right to be forgotten is an emerging legal concept allowing individuals control over their online identities by demanding that Internet search engines remove certain results. The right has been supported by the European Court of Justice, some judges in Argentina, and data-protection regulators in several European countries, among others. The right is primarily grounded in notions of privacy and data protection but also relates to intellectual property, reputation, and right of publicity. Scholars and courts cite, as an intellectual if not legal root for the right to be forgotten, the legal principle that convicted criminals whose sentences are completed should not continually be publicly linked with their crimes. Critics contend that the right to be forgotten stands in conflict with freedom of expression and can lead to revisionist history. Scholars and others in the southern cone of South America, in particular, have decried the right to be forgotten because it could allow perpetrators of mass human rights abuses to cover up or obscure their atrocities. On the other hand, those in favor of the right to be forgotten say that digital technology preserves memory unnaturally and can impede forgiveness and individual progress. The right to be forgotten debate is far from resolved and poses difficult questions about access to, and control of, large amounts of digital information across national borders. Given the global nature of the Internet and the ubiquity of certain powerful search engines, the questions at issue are universal, but solutions thus far have been piecemeal. Although a 2014 decision by the Court of Justice of the European Union (EU) garnered much attention, the right to be forgotten has been largely shaped by a 1995 European Union Directive on Data Protection. In 2016, the EU adopted a new General Data Protection Regulation that will take effect in 2018 and could have a major impact because it contains an explicit right to be forgotten (also called right to erasure). The new regulation does not focus on the theoretical or philosophical justification for a right to be forgotten, and it appears likely the debate over the right in the EU and beyond will not be resolved even when the new rule takes effect.

scholarly journals Leviathan, or the Rudder of Public Health

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-8
Author(s):  
Denis Horgan ◽  
Walter Ricciardi
Keyword(s):  
Public Health ◽  
Big Data ◽  
New Technologies ◽  
Personalised Medicine ◽  
Member States ◽  
Reform Agenda ◽  
The World ◽  
The Face ◽  
The Eu ◽  
Do So

In the world of modern health, despite the fact that we've been blessed with amazing advances of late - the advent of personalised medicine is just one example - “change” for most citizens seems slow. There are clear discrepancies in availability of the best care for all, the divisions in access from country to country, wealthy to poor, are large. There are even discrepancies between regions of the larger countries, where access often varies alarmingly. Too many Member States (with their competence for healthcare) appear to be clinging stubbornly to the concept of “one-size-fits-all” in healthcare and often stifle advances possible through personalised medicine. Meanwhile, the legislative arena encompassing health has grown big and unwieldy in many respects. And bigger is not always better. The health advances spoken of above, an increased knowledge on the part of patients, the emergence of Big Data and more, are quickly changing the face of healthcare in Europe. But healthcare thinking across the EU isn't changing fast enough. The new technologies will certainly speak for themselves, but only if allowed to do so. Acknowledging that, this article highlights a positive reform agenda, while explaining that new avenues need to be explored.

scholarly journals Research Choices: Time for Europe to Decide

2017 ◽  
Vol 2 (Suppl. 1) ◽  
pp. 1-9
Author(s):  
Denis Horgan ◽  
Torsten Harfelach ◽  
Gennaro Ciliberto
Keyword(s):  
Personalised Medicine ◽  
Public Understanding ◽  
Regulatory Role ◽  
Regulatory Environment ◽  
Skill Sets ◽  
Research And Innovation ◽  
The Right ◽  
Research Choices ◽  
The Eu

Taking real advantage of Europe's excellence in research to improve citizens' lives presents challenges that Europe's policymakers have not yet fully met. The EU has shown some clarity of assessment in recognising the needs, and some laudable determination to improve the situation, and it has intermittently taken some real steps to deliver on its ambitions to turn its research into valuable innovations. But Europe still faces harsh choices about whether it is actually going to do what it has so often discussed. The EU has to make some firm decisions about what research deserves support - and where. It must turn words into deeds to promote effective links between research and innovation. That requires a sharper focus on developing and retaining the right skill sets in Europe, on funding innovation, on creating an encouraging regulatory environment, and on building greater public understanding and engagement. Here, among other issues, the authors discuss where resources should be deployed, how to maximise the potential of personalised medicine, the time it takes for search to be turned into products ready for market, education, and the EU's regulatory role.

scholarly journals The European Union and the Search for an International Data Protection Framework

2014 ◽  
Vol 2 (2) ◽  
pp. 55 ◽  
Author(s):  
Christopher Kuner
Keyword(s):  
European Union ◽  
Data Protection ◽  
Legal Framework ◽  
Fundamental Rights ◽  
The European Union ◽  
International Data ◽  
Data Protection Law ◽  
Eu Fundamental Rights ◽  
Global Data ◽  
The Eu

The European Union (EU) has supported the growing calls for the creation of an international legal framework to safeguard data protection rights. At the same time, it has worked to spread its data protection law to other regions, and recent judgments of the Court of Justice of the European Union (CJEU) have reaffirmed the autonomous nature of EU law and the primacy of EU fundamental rights law. The tension between initiatives to create a global data protection framework and the assertion of EU data protection law raises questions about how the EU can best promote data protection on a global level, and about the EU’s responsibilities to third countries that have adopted its system of data protection.

scholarly journals Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union

2021 ◽  
Vol 12 ◽  
Author(s):  
Carolina Iglesias-Lopez ◽  
Antònia Agustí ◽  
Antonio Vallano ◽  
Merce Obach
Keyword(s):  
European Union ◽  
Clinical Trials ◽  
Added Value ◽  
Life Cycle Approach ◽  
The European Union ◽  
Open Label ◽  
Advanced Therapy ◽  
Advanced Therapies ◽  
Number Of Patients ◽  
The Eu

Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved ATMPs in the EU. A systematic review of the characteristics of pivotal CT of ATMPs approved in the EU until January 31st, 2021 was carried out. A total of 17 ATMPs were approved and 23 CT were conducted to support the MA (median, 1, range, 1–3). Of those studies, 8 (34.78%) were non-controlled and 7 (30.43%) used historical controls. Only 7 (30.4%) were placebo or active-controlled studies. Among all CT, 21 (91.3%) were open-label and 13 (56.52%) had a single-arm design. To evaluate the primary endpoint, 18 (78.26%) studies used an intermediate and single variable. The median (IQR) number of patients enrolled in the studies was 75 (22–118). To date, ATMPs’ approval in the EU is mainly supported by uncontrolled, single-arm pivotal CT. Although there is a trend toward an adaptive or a life cycle approach, a switch to more robust clinical trial designs is expected to better define the benefit and the therapeutic added value of ATMPs.

scholarly journals Renewable energy resources in the EU (Policy scenario)

2013 ◽  
pp. 143-146
Author(s):  
Orsolya Nagy
Keyword(s):  
Climate Change ◽  
European Union ◽  
Renewable Energy ◽  
Energy Use ◽  
Biomass Energy ◽  
Energy Resources ◽  
The European Union ◽  
Renewable Energy Resources ◽  
The Right ◽  
The Eu

The use of renewable energies has a long past, even though its share of the total energy use is rather low in European terms. However, the tendencies are definitely favourable which is further strengthened by the dedication of the European Union to sustainable development and combat against climate change. The European Union is on the right track in achieving its goal which is to be able to cover 20% its energy need from renewable energy resources by 2020. The increased use of wind, solar, water, tidal, geothermal and biomass energy will reduce the energy import dependence of the European Union and it will stimulate innovation.

scholarly journals Ethical Issues and Barriers for Multi-National Paediatric Clinical Trials: The Challenging Experience of the DEEP Project

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4820-4820
Author(s):  
Viviana Giannuzzi ◽  
Mariagrazia Felisi ◽  
Hugo Devlieger ◽  
Aurelio Maggio ◽  
George Papanikolaou ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ethical Issues ◽  
Descriptive Analysis ◽  
National Level ◽  
Comparative Trial ◽  
Phase Iii ◽  
Eu Countries ◽  
Paediatric Trial ◽  
Significant Difference ◽  
The Eu

Introduction: The procedures and requirements for the clinical trial application (CTA) to Ethics Committees (ECs) and/or Competent Authorities (CAs) are not fully harmonised, and this is even more evident when non-EU countries are involved. This lack of harmonisation makes more difficult the approach in the case of 'small populations', such as children and patients affected by rare diseases. A phase III efficacy-safety comparative trial (DEEP-2) involving paediatric patients affected by transfusion dependent haemoglobinopathies from seven European and non-European countries (Albania, Cyprus, Greece, Italy, United Kingdom, Egypt, Tunisia) was carried out in the context of a FP7 project (HEALTH-F4-2010-G.A. n. 261483) and included in an agreed Paediatric Investigation Plan. Aims: The aims of this paper are to describe in a complex multi-national/multi-ethnic framework the different provisions and procedures to authorise a paediatric trial in EU/non-EU countries and to evaluate the possible impact of the following key indicators on the timing of ECs approval and CAs authorisation: complexity of the national/local provisions and procedures to authorise a paediatric trial, including the number of ECs and CAs to be addressed; number and type of additional local/national documentation; number of queries from CAs and ECs; geographic setting (EU and non-EU). Methods: The following information was collected from official websites and through a survey addressed to Principal Investigators: The regulatory and legal frameworks in force at the time of the submission of DEEP-2 in each involved country;The procedures required at local/national level (i.e. number of ECs and CAs to be addressed, parallel or subsequent submission to the CA and the EC, preparation of the CTA form and documents required from CAs and ECs);The timing of ECs approval and CAs authorisation, including number and types of queries, were collected from DEEP-2 Trial Master File. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model (GLM) analysis were used to describe results and to analyse significance of the considered indicators. Results: In the EU countries, relevant legislative acts apply and include GCP and specific procedures for paediatric trials, in non-EU countries GCP guidelines apply but have not been implemented in the national laws regulating clinical trials. Moreover, within the 4 EU Member States a different approach was in place, even if under the same rules (i.e. Directive 2001/20/EC as implemented in the national law) with distinctive documents required for the CTA in almost all the EU countries compared with the EC provisions. The CTAs were performed in the period June 2012 - September 2015 in 23 trial sites. The EC approvals and CA authorisations were issued between January 2013 - September 2015. In the EU countries, the authorisation process was completed within 7,3 to 33,8 months (median = 15 months), while in non-EU countries, the authorisation process was completed by 7 months (median = 4 months) (figure 1). In particular, the comparison of the CA time authorisation shows a significant difference between EU and non-EU clusters (p = 0.001); however, if the statistical model is adjusted for the number of EC requests as covariate, the difference is not significant. Thus, it seems that the main factor influencing the time for EC approval is the number of requests for changes/clarifications (mainly on informed consent/assent, study protocol, insurance) (figure 2). Conclusion: Delays in completion of the authorisation phase in many countries seems to be a relevant issue and the timeframes for the authorisation in EU countries are not compliant with the European requirements (60 days for single opinion release and 30 days for its acceptance, as stated in Directive 2001/20/EC). The main reasons for delay is the complexity of the procedures and the requests from the ECs/CAs. In non-EU countries, procedures are different and faster with less requests from ECs and CAs. The upcoming application of a stronger set of rules, CT-Regulation (EU) 536/2014, is expected to harmonise practices in Europe and possibly outside Europe. The final aim of this change should be to assure a good balance between a timely approval and a high-level of children protection. Disclosures Reggiardo: CVBF: Consultancy. Tricta:ApoPharma: Employment.

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