Search Results (9)

Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA. Methods: The methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024. Results: In the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of ‘transparency’ and ‘competency’ are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities. Conclusions: The key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States. Full article

Because of the international significance of Dobšiná Ice Cave (Slovakia), it is important to have proper data about the state, movement, or decrease of the ice in which various information about past environments can be preserved. Thus, the goal of the study is to find out which of the 3D scanners used here is the most suitable for long-term monitoring of ice changes. A comparison of the 3D point clouds acquired from laser scanners Leica C10 and Leica RTC360 and the mobile scanners GeoSLAM Zeb Horizon and the iPhone 14 Pro to reference clouds from photogrammetry or tacheometry is provided, and also the process of data acquisition and registration is described. To catch the differences in point clouds according to different types of ice, cross-sections of the vertical and layered ice wall, horizontal ice surface, and artificial ice tunnel are analysed. Some remarkable but also unwanted properties of 3D scanners have been concluded, and the best compromise for 3D scanning of this ice cave has been chosen. According to the diversity of ice types and different layers occurring in Dobšiná Ice Cave, results could be partially helpful in choosing a suitable measurement technology for ice in other caves worldwide. Full article

Additive Manufacturing (AM) of parts used in nuclear power plants can solve many issues like those related to obsolescence. Of the gap limiting the use of AM parts in nuclear is the need of reliable non-destructive inspection capable to meet the qualification requirements. Recently, efforts in this direction have been made worldwide within several research projects, like the EU Horizon 2020 NUCOBAM. In the framework of NUCOBAM, this article presents the activity related to the inspection of 316-L AM nuclear parts produced by L-PBF and inspected via advanced ultrasonic (UT) methods, like MultiPoint Focusing (MPF) and Total Focusing Method (TFM). Multiple UT array probes are used, linear, matrix and annular. Emphasis is dedicated to the inspection of classified valve bodies produced with known internal seeding flaws. The analysis of the results shows the effect of AM induced anisotropy on the propagation of the ultrasonic wave characteristics, the sound velocity increased with 3% when the sound beam deviated 15° against the perpendicular axis. The TFM method contributed significantly regarding defect detection, Signal to Noise Ratios (SNR) increased with at least 9 dB compared to the Multi-Point Focusing method. Smaller errors were noticed when examination frequency was increased and TFM was applied. The combination of an annular array with TFM and mechanical scanning demonstrated to be the best approach. Full article

National pricing and reimbursement agencies face growing challenges with complex health technologies, prompting European policy advancements. Beneluxa is a cross-country collaboration involving Belgium, the Netherlands, Luxemburg, Austria, and Ireland that aims to address sustainable access to medicines. In view of the soon-to-be-implemented EU HTA Regulation, insights and experiences from stakeholders with Beneluxa cross-country collaboration could provide possible transferable learnings. Therefore, this research aims to (i) identify the opportunities and challenges faced by Beneluxa, (ii) gather insights from stakeholders, namely (possible) applicants and policymakers, within and beyond Beneluxa on the initiative and broader cross-country collaboration principles, and (iii) transfer these insights into learnings and recommendations in anticipation of the full implementation of the new HTA Regulation. Fifteen semi-structured interviews were conducted with industry and European HTA/policy stakeholders. The principal challenges discussed by stakeholders encompass hesitancy from the industry toward Beneluxa assessments, which were attributed to procedural and timeline uncertainties, legislative framework ambiguity, and challenges in terms of industry’s internal organization. Another challenge highlighted is the resource-intensive nature of the procedure due to diverse approaches among member states. In addition, industry stakeholders mentioned limited communication and procedural complexity. Despite challenges, both stakeholder groups recognized important opportunities for cross-country collaboration. Transferable insights for future cross-country collaboration include transparent communication, clear legislative embedding, internal industry restructuring to facilitate joint HTAs, and member state support for conducting collaborative assessments. The study underscores diverging views among stakeholders on cross-country collaboration’s potential to support HTA and the market access of complex health technologies. While acknowledging benefits, there still are challenges, including industry hesitancy, emphasizing the need for transparent communication and clear guidance in the evolving EU HTA landscape. Full article

The release of novel genetically modified (GM) virus applications into the environment for agricultural, veterinary, and nature-conservation purposes poses a number of significant challenges for risk assessors and regulatory authorities. Continuous efforts to scan the horizon for emerging applications are needed to gain an overview of new GM virus applications. In addition, appropriate approaches for risk assessment and management have to be developed. These approaches need to address pertinent challenges, in particular with regard to the environmental release of GM virus applications with a high probability for transmission and spreading, including transboundary movements and a high potential to result in adverse environmental effects. However, the current preparedness at the EU and international level to assess such GM virus application is limited. This study addresses some of the challenges associated with the current situation, firstly, by conducting a horizon scan to identify emerging GM virus applications with relevance for the environment. Secondly, outstanding issues regarding the environmental risk assessment (ERA) of GM virus applications are identified based on an evaluation of case study examples. Specifically, the limited scientific information available for the ERA of some applications and the lack of detailed and appropriate guidance for ERA are discussed. Furthermore, considerations are provided for future work that is needed to establish adequate risk assessment and management approaches. Full article

Recovering minority olive tree varieties helps preserve genetic diversity and contributes to sustainable agriculture practices. The International Olive Council has recognized the importance of conserving olive tree genetic resources and the European Union’s Horizon Europe program has identified the preservation of crop diversity as a priority for sustainable food systems. In the work presented herein, old olive groves in the province of Huesca (NE Spain), managed according to the traditional model, were surveyed, sampled, and analyzed using molecular characterization techniques (based on EST-SNPs markers). Twenty-nine new varieties were identified and deposited in IFAPA’s World Germplasm Bank of Olive Varieties. In the first step towards their valorization, eight single-varietal oils from Alto Aragon varieties were produced and characterized, and their organoleptic properties were evaluated, paving the way for the production of differentiated quality oils. Furthermore, ancient olive trees were selected and 3D scanned to promote their protection as singular or monumental trees and for oleo-tourism purposes. The reported findings highlight the rich olive-growing heritage of this northernmost frontier of olive tree cultivation in Spain. Full article

There is need to better understand the trends and future challenges influencing the marine and coastal environments and identify the opportunities to develop innovative sustainability-oriented solutions to address these. Alongside mainstream decision support tools used in environmental management and conservation sciences, foresight techniques provide comprehensive and well-rounded information and knowledge about likely developments in the long-term future. This study uses a horizon scanning exercise to explore emerging signals and trends of future developments and innovation for the sustainable development of the blue economy looking towards 2030. It derives a series of global developments, challenges and opportunities relating to the blue economy from a review of high-level international reports and studies. Through a workshop conducted with 29 scientists and researchers based in maritime universities in six countries in Europe, the study identifies and prioritizes emerging signals and trends considered of high impact for a sustainability transition. The outputs include a synthesis of 11 global developments in the blue economy and 7 cross-cutting trends and trend projections. These may be valuable to marine scientists as a source of inspiration for a future research agenda or can be used as evidence for decision- and policymakers to deal with future uncertainties about the growth of the blue economy. Full article

Some invasive alien species (IAS) may constitute an important threat to global biodiversity due to major ecological impacts. In 2014, the European Union (EU) introduced a regulation (EU) No 1143/201 on the prevention and management of the introduction and spread of IAS. EU member states are required to carry out an analysis of the introduction and spread of potential IAS in their territories. In the case of aquatic alien species, shipping is considered as the main pathway for their introduction. In this study, a horizon-scanning tool was applied for identifying potential aquatic IAS introduced by shipping into the EU Baltic Sea Region (BSR) countries. This tool has mostly been applied on a country level, but it is more reasonable to study the invasive potentiality at a regional scale, especially for aquatic species that generally disperse over long distances. Individual Baltic countries may also benefit from the results of this study. The result of the horizon-scanning method that we applied produced a list of 27 potential aquatic invaders for the EU BSR countries introduced by international marine and inland shipping. In order, Asia (34% of the species), North America (27% of the species), and Indo-Pacific (23% of the species) were the most frequently listed geographical origins of concern. Marine habitat was the most frequent of the potential IAS, accounting for 41% of the species. Fish (26% of the species), Mollusks (18% of the species), and Crustacea (15% of the species) were the most frequent taxonomic groups. The list of potential IAS was prioritized from highest to lowest probability of invasion (establishment, spread, and impact). Eight species reached the highest probability of invasion. One of the potential IAS, Mytilus galloprovincialis, is native to the Mediterranean Region. These results provide valuable information that policy makers can use to develop more efficient prevention strategies for IAS introduced by shipping into the Baltic Sea. Full article

The demand for minute-scale forecasts of wind power is continuously increasing with the growing penetration of renewable energy into the power grid, as grid operators need to ensure grid stability in the presence of variable power generation. For this reason, IEA Wind Tasks 32 and 36 together organized a workshop on “Very Short-Term Forecasting of Wind Power” in 2018 to discuss different approaches for the implementation of minute-scale forecasts into the power industry. IEA Wind is an international platform for the research community and industry. Task 32 tries to identify and mitigate barriers to the use of lidars in wind energy applications, while IEA Wind Task 36 focuses on improving the value of wind energy forecasts to the wind energy industry. The workshop identified three applications that need minute-scale forecasts: (1) wind turbine and wind farm control, (2) power grid balancing, (3) energy trading and ancillary services. The forecasting horizons for these applications range from around 1 s for turbine control to 60 min for energy market and grid control applications. The methods that can be applied to generate minute-scale forecasts rely on upstream data from remote sensing devices such as scanning lidars or radars, or are based on point measurements from met masts, turbines or profiling remote sensing devices. Upstream data needs to be propagated with advection models and point measurements can either be used in statistical time series models or assimilated into physical models. All methods have advantages but also shortcomings. The workshop’s main conclusions were that there is a need for further investigations into the minute-scale forecasting methods for different use cases, and a cross-disciplinary exchange of different method experts should be established. Additionally, more efforts should be directed towards enhancing quality and reliability of the input measurement data. Full article