Technology Assessment in the EU Institutions

2011 ◽  
Vol 6 (5) ◽  
pp. 522-527
Author(s):  
Michael D. Rogers ◽  
Keyword(s):  
Technology Assessment ◽  
New Technologies ◽  
Decision Makers ◽  
Regulatory Decision ◽  
Advisory Groups ◽  
Formal Requirement ◽  
Regulatory Impact ◽  
The Right ◽  
Regulatory Decisions ◽  
The Eu

Technology Assessment (TA) is the study and evaluation of new technologies with the objective of understanding the likely impacts (costs and benefits) of these technologies on society and the environment – with the explicit aim of improving regulatory decision making concerning these technologies. This is a prospective exercise helping to ensure that “better” regulatory decisions are made by decision makers. TA and “TA like” activities are embedded within the main EU institutions. The Commission carries out Regulatory Impact Assessments on every significant regulatory proposal. It also has at its disposal a range of advisory groups which includes the European Group on Ethics in Science and New Technologies and the Institute for Prospective Technological Studies. The European Parliament has its own TA unit – the Science and Technology Options Assessment unit. The institutions are committed to quality, transparency and effectiveness in their use of expert groups and all such assessments are published on the internet. Occasionally full citizens’ consultations are carried out but this is not a formal requirement. Recent changes in the regulatory development process have emphasised the concept of “smarter” regulations. This concept is concerned not just with prospective analyses in advance of new regulations but also with the retrospective evaluation of existing regulations asking the question“Did they meet the need that was the raison d’être for enacting the regulation under consideration.”The distinction highlighted by Churchill [2] that experts should advise but not decide is intended to ensure that regulators take account of aspects other than the expert view. Nevertheless, it is essential that expert groups have the right to introduce advice thatmight otherwise be overlooked by the regulators, as is the case in a number of expert groups in the EU institutions.

RESPONSIVENESS, LANGUAGE, AND ALIGNMENT: REFLECTIONS ON SOME CHALLENGES FOR HEALTH TECHNOLOGY ASSESSMENT

2015 ◽  
Vol 31 (4) ◽  
pp. 223-225 ◽  
Author(s):  
Andrew Dillon
Keyword(s):  
Health Technology Assessment ◽  
Health System ◽  
Health Systems ◽  
Technology Assessment ◽  
New Technologies ◽  
New Technology ◽  
Health Technology ◽  
Decision Makers ◽  
The Face ◽  
The Right

Health systems around the world cope with the challenge of difficult economic times, and the value of health technology assessment (HTA) is increasing. Making the right choices, with limited resources, in the face of increasingly complex technologies requires decisions informed by data and analyses that help us to manage the risks involved. Those who undertake and use HTA can play a greater role in helping decision makers meet these challenges; they need to think how to define innovation and respond to it, how to communicate their analyses, and, critically, how to align their work with the ambitions of their health systems. HTA can become a key health system enabler without compromising its objectivity or independence. It can say that it is too early to determine the value of a new technology when the data simply will not support a safe decision. However, it can also be bold and recommend the managed introduction of new technologies, even when the when the data is immature, provided that the health system understands the risks and there is a plausible case for believing that further research will support the value proposition. The goal for HTA is to be able confidently to do both.

scholarly journals Company Changing Status and Its Linking to Competitiveness

2015 ◽  
Vol 53 (1) ◽  
pp. 1-17
Author(s):  
Dragana Radenković-Jocić ◽  
Ivan Barun
Keyword(s):  
Mergers And Acquisitions ◽  
Legal Framework ◽  
Decision Makers ◽  
Economic Activities ◽  
Economic Interests ◽  
Eu Legislation ◽  
The Republic ◽  
The Right ◽  
A Company ◽  
The Eu

Abstract The authors present the issues and challenges related to the changes in status of a company and its impact on competitiveness. Status changes of companies, mostly mergers and acquisitions of companies, are one of the ways in which capital owners and management direct economic activities with the aim of maximizing profits. In order to make the right and justified decision, in terms of achieving the economic interests of the company, it is essential to know the laws and regulations in this area. This paper should provide answers on various questions which will be presented to decision makers in every company, considering status changes. Bearing in mind that the question of status changes often associated with an international element, the authors will pay special attention on the EU legislation and current legal framework in the Republic of Serbia.

scholarly journals Emerging technologies and their impact on regulatory science

2021 ◽  
pp. 153537022110522
Author(s):  
Elke Anklam ◽  
Martin Iain Bahl ◽  
Robert Ball ◽  
Richard D Beger ◽  
Jonathan Cohen ◽  
...  
Keyword(s):  
New Technologies ◽  
Emerging Technologies ◽  
Cost Effective ◽  
Assessment Tools ◽  
Regulatory Science ◽  
Science Field ◽  
Regulatory Decision ◽  
Technical Advances ◽  
Novel Approaches ◽  
Regulatory Decisions

There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools.

Prompt implementation of the right to deduct input tax in light of EU regulations

2020 ◽  
Vol 3 (283) ◽  
pp. 9-15
Author(s):  
Beata Rogalska
Keyword(s):  
Value Added ◽  
Value Added Tax ◽  
Eu Regulation ◽  
Settlement Period ◽  
Economic Event ◽  
Formal Requirement ◽  
The Moment ◽  
The Right ◽  
The Eu ◽  
Made In

In a situation where the taxpayer [resp. person taxable] holds an invoice prior to submittal of the return/statement for the settlement period in which the tax obligation occurred on the part of the contracting party, the term laid down in Article 178 (a) of Directive 112 has been met. Whilst the holding of an invoice is the only formal requirement, the notion of ‘holding’ ought to be interpreted in a manner compliant with its colloquial understanding. In turn, ‘holding’ is not equal in meaning to ‘receiving’/‘receipt’. In the event that an economic event has occurred and the taxpayer is capable of giving evidence for it, as he holds the invoice at the moment the tax settlement is made in the return/ statement, there are no grounds that would be legitimate under the EU laws for arguing that the taxpayer must shift his vested right to have the input tax deducted to the subsequent month, being the months in which he receives the invoice. The rule of prompt implementation of the right to deduct input tax should be taken into account. If the national regulations provide for shifting the above-specified moment through formulating any additional conditions are contrary to Directive 112. It is therefore apparent that Article 86, clause 10 (b), item 1 of the Polish Value-Added-Tax Act of 11th March 2004 is not in agreement with Article 178 (s) of Directive 112 as the former sets forth a condition that is not provided in the said EU regulation–namely, the right to have the output tax reduced by the input tax only as part of the settlement for the month in which the taxpayer receives the invoice.

scholarly journals Breaking up is hard to do: why disinvestment in medical technology is harder than investment

2012 ◽  
Vol 36 (2) ◽  
pp. 148 ◽  
Author(s):  
Marion Haas ◽  
Jane Hall ◽  
Rosalie Viney ◽  
Gisselle Gallego
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Policy Makers ◽  
Healthcare Interventions ◽  
Practice Variations ◽  
The Right

Healthcare technology is a two-edged sword - it offers new and better treatment to a wider range of people and, at the same time, is a major driver of increasing costs in health systems. Many countries have developed sophisticated systems of health technology assessment (HTA) to inform decisions about new investments in new healthcare interventions. In this paper, we question whether HTA is also the appropriate framework for guiding or informing disinvestment decisions. In exploring the issues related to disinvestment, we first discuss the various HTA frameworks which have been suggested as a means of encouraging or facilitating disinvestment. We then describe available means of identifying candidates for disinvestment (comparative effectiveness research, clinical practice variations, clinical practice guidelines) and for implementing the disinvestment process (program budgeting and marginal analysis (PBMA) and related techniques). In considering the possible reasons for the lack of progress in active disinvestment, we suggest that HTA is not the right framework as disinvestment involves a different decision making context. The key to disinvestment is not just what to stop doing but how to make it happen - that is, decision makers need to be aware of funding disincentives. What is known about this topic? Disinvestment is an increasingly popular topic amongst academics and policy makers. Most discussions focus on the need to increase disinvestment as a corollary of investment, the lack of overt disinvestment decisions and the use of a framework based on health technology assessment (HTA) to implement disinvestment. What does this paper add? This paper focusses on the difficulties associated with deciding which technologies to disinvest in, and the problems in using an HTA framework to make such decisions, when disinvestment involves a different decision making context from that of investment. What are the implications for practitioners? The key to disinvestment is not just what to stop doing but how to implement such decisions. Making it happen means being aware of funding disincentives.

scholarly journals Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice

2017 ◽  
Vol 243 (3) ◽  
pp. 256-261 ◽  
Author(s):  
William B. Mattes ◽  
Federico Goodsaid
Keyword(s):  
Product Development ◽  
Diagnostic Tests ◽  
New Technologies ◽  
Biomarker Discovery ◽  
Medical Product ◽  
The Road ◽  
Regulatory Decision ◽  
The Us ◽  
Recent Developments ◽  
Regulatory Decisions

While the term ‘biomarker’ is relatively new, the concept is millennia old. However, with the introduction of new technologies to discover potential biomarkers comes the need to assess their utility and veracity for any given use. This is particularly true for the use of biomarkers to support regulatory decisions in medical product development. Hence the US Food and Drug Administration has developed processes for the qualification of biomarkers and other medical product development tools, processes that are underscored by recent legislation (i.e. the 21st Century Cures Act). In addition to these qualification processes, diagnostic tests that measure a biomarker may follow a process for regulatory decision through the processes that evaluate companion diagnostics. This mini-review provides an overview of these processes and their role in pharmaceutical development and clinical use. Impact statement This work summarizes very recent developments in the US FDA’s biomarker qualification program. Furthermore, it contrasts biomarker qualification with companion diagnostic evaluation. As such, it will be highly informative for researches considering taking a biomarker discovery farther along the road to validation.

Brave New Borders: The EU’s Use of New Technologies for the Management of Migration and Asylum

2017 ◽  
Author(s):  
Jorrit J. Rijpma
Keyword(s):  
21St Century ◽  
Data Protection ◽  
New Technologies ◽  
Fundamental Rights ◽  
Member States ◽  
Asylum Policy ◽  
Use Of Technology ◽  
Grand Design ◽  
The Right ◽  
The Eu

This chapter shows how in the 21st century new technologies and new bureaucracies have become part and parcel of the EU’s migration and asylum policy, and how these two are intimately linked. Together they have allowed the EU and its Member States to tighten their grip over the movement of people. The use of technology has transformed the nature of the European border and has reinforced the agencies in charge of its management. This has largely been done without a clearly defined vision or grand design. Rather, it was technology itself that enabled this development and has greatly helped to shape it. While technology has often been portrayed as value-neutral, it may now pose challenges to some of the EU’s fundamental rights, most notably the right to data protection.

scholarly journals Adult Education in the EU and the Main Challenges in Response to the Covid-19 Pandemic

2021 ◽  
Vol 11 (1) ◽  
pp. 75-95
Author(s):  
Simona Polonyová
Keyword(s):  
Adult Education ◽  
Older Workers ◽  
New Technologies ◽  
Adult Population ◽  
Vulnerable Groups ◽  
Current View ◽  
Structural Support ◽  
Adequate Funding ◽  
The Right ◽  
The Eu

The importance of adult education in today’s world is constantly growing. The need for adult education in the EU intensifies with demographic and climate changes, automation, new technologies as well as digital transformation. Adult education provides an opportunity for individuals to adapt to changes in the labour market and society, especially for the low-skilled and older workers. Although people understand the importance of adult education, progress in achieving participation rates in adult education towards the EU target is insufficient. The current situation associated with COVID-19 has further highlighted the importance of non-formal adult education, especially for the most vulnerable groups of people to whom it has created or deepened barriers to education. It emphasized, even more, the problem of limited digital skills and equipment, reinforced the need for the importance of the right skills from a work and social perspective and the need to build resilience. It has set out new challenges aimed at strengthening the adult education strategy at the EU level, at promoting civic, financial, environmental and health literacy, as well as structural support to countries where such support is absent, and at ensuring stable and adequate funding with specific support for vulnerable groups of the adult population. The study aims to present a current view on adult education in EU conditions and to point out the main challenges that adult education has to face in the context of lifelong learning regarding the ongoing Covid-19 pandemic.

International Investment Agreements, 2015–2016

2017 ◽  
Author(s):  
Coleman Jesse ◽  
Johnson Lise ◽  
Sachs Lisa ◽  
Gupta Kanika
Keyword(s):  
Dispute Settlement ◽  
Codes Of Conduct ◽  
International Investment ◽  
Decision Makers ◽  
Investment Treaty ◽  
International Investment Agreements ◽  
The Right ◽  
Investment Agreements ◽  
The Eu

This chapter considers developments in 2015 and 2016 that illustrate trends and features in recent treaty drafting. It first discusses the expanded awareness of, and interest in, the investment regime that has emerged in recent years, followed by the role of ratification in the context of investment treaty drafting and policy. It then discusses four drafting trends: (1) constraining investor access to dispute settlement and limiting arbitral discretion; (2) better protecting the right to regulate; (3) establishing investor obligations; and (4) introducing codes of conduct for decision makers in investment disputes. Finally, the chapter provides a brief overview of new provisions regarding the conduct and qualifications of arbitrators, including a glimpse at the EU proposal for a multilateral court.

scholarly journals HOW TO AVOID GIVING THE RIGHT ANSWERS TO THE WRONG QUESTIONS: THE NEED FOR INTEGRATED ASSESSMENTS OF COMPLEX HEALTH TECHNOLOGIES

2017 ◽  
Vol 33 (5) ◽  
pp. 541-543 ◽  
Author(s):  
Ansgar Gerhardus ◽  
Wija Oortwijn ◽  
Gert Jan van der Wilt
Keyword(s):  
Health Technology Assessment ◽  
European Commission ◽  
Technology Assessment ◽  
Ethical Issues ◽  
Health Technology ◽  
Decision Makers ◽  
Patient Centered ◽  
Health Technologies ◽  
The Right ◽  
Integrated Assessments

Health technologies are becoming increasingly complex and contemporary health technology assessment (HTA) is only partly equipped to address this complexity. The project “Integrated assessments of complex health technologies” (INTEGRATE-HTA), funded by the European Commission, was initiated with the overall objective to develop concepts and methods to enable patient-centered, integrated assessments of the effectiveness, and the economic, social, cultural, and ethical issues of complex technologies that take context and implementation issues into account. The project resulted in a series of guidances that should support the work of HTA scientists and decision makers alike.

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