Dataset Information

Stakeholder analysis with regard to a recent European restriction proposal on microplastics.

ABSTRACT: Stakeholder involvement is pivotal EU governance. In this paper, we complete a stakeholder analysis of the European Chemicals Agency's recent Annex XV restriction proposal process on intentionally added microplastics. The aim of this study is to map the interests, influence and importance of active stakeholders in order to understand the arguments being put forward by different stakeholders and provide recommendations to policy-makers on how to ensure a balanced consideration of all stakeholder perspectives. Stakeholders were identified through niche media analysis and by scrutinising comments from the public consultation on the restriction proposal. Their importance and influence were mapped using three approaches: "scale from low to high", "psychometric scale" and "qualitative ranking". We identified 205 different stakeholders out of which 77 were industry and trade associations, 25 were large companies and only four were small and medium-sized enterprises. National authorities and researchers did not comment on the restriction proposal, whilst large companies were very active providing comments. Industry trade associations and sports-related non-governmental organizations articulated anxiety about the costs associated with the implementation of the restriction proposal. Among environmental non-governmental organizations, there was consensus that plastics should be handled like other substances under EU's chemical regulation. Primary stakeholders identified exhibited high importance, but varying degrees of influence, while the opposite applied to the major European institutions. Based on our analysis, we recommend that: The European Chemicals Agency implement measures to include "silent" stakeholders and invite guest experts to participate in their committees on Risk Assessment and Socio-Economic Analysis; Researchers should be more active in the public consultation; and that special emphasis should be put on helping small and medium-sized enterprises. With regards to stakeholder consultation, we find that media analysis is a good supplement to stakeholder analysis and that a more objective top-down measure of stakeholder importance and influence is needed.

SUBMITTER: Clausen LPW

PROVIDER: S-EPMC7307934 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Stakeholder analysis with regard to a recent European restriction proposal on microplastics.

Clausen Lauge Peter Westergaard LPW Hansen Oliver Foss Hessner OFH Oturai Nikoline Bang NB Syberg Kristian K Hansen Steffen Foss SF

PloS one 20200622 6

Stakeholder involvement is pivotal EU governance. In this paper, we complete a stakeholder analysis of the European Chemicals Agency's recent Annex XV restriction proposal process on intentionally added microplastics. The aim of this study is to map the interests, influence and importance of active stakeholders in order to understand the arguments being put forward by different stakeholders and provide recommendations to policy-makers on how to ensure a balanced consideration of all stakeholder ...[more]

PMID: 32569303

Similar Datasets

Project description:Introduction: Radiology plays a crucial role in the emergency care setting by delivering early and precise diagnoses under pressure of time, right at the beginning of patient treatment. Although there is a need for postgraduate education in emergency radiology, most of the national bodies responsible do not offer it in a uniform fashion and a general proof of qualification is missing in Europe. Therefore, the European Society of Radiology (ESR) has founded the (Sub-)Society of Emergency Radiology (ESER), prompting them to develop a European curriculum. This trend, which is currently also encouraged in many other non-radiological specialties which demand the highest professional qualifications, often lacks expertise in medical education. Goals: The goal of this article is the general description of the curricular planning process for a European postgraduate subspecialisation programme, using the example of Emergency Radiology (European Diploma in Emergency Radiology, EDER), including the utilisation of TOOLS and recommendations derived from comparable projects. Project description: The project was divided into partial steps: the timeline displayed in a GANTT chart, and tasks and responsibilities assigned in a RASCI matrix. The curriculum was iteratively developed using the KERN approach and steps were prioritised using the PARETO principle. Furthermore, the following TOOLS were used: limitations and needs assessment, SWOT analysis, formulating learning objectives and categorising them after MILLER and SCLO, and using BLOOM's taxonomy for cognitive learning objectives and operationalising them according to MAGER. Psychomotoric and affective learning objectives were assigned to CANMEDS roles, grouped by topic using CLUSTERING, and then mapped by MATRIX analysis to appropriate learning and evaluation methods. Striving for continuous improvement, the curriculum was finally embedded in curricular quality management. Results: The standardisation of the EDER access, considering the different national conditions, the minimisation of European learners' attendance phases, restricting expenses by best possible use of existing structures, respecting the requirements and retaining the support of the European umbrella society ESR, finishing the project by a specific deadline and the demands of continuous improvement were particular challenges. A curriculum with the eligibility of five years' speciality training in general radiology has evolved on schedule. The subspeciality training lasts at least one year and is divided into webinars, workshops during congresses (e.g. the annual ESR and ESER congresses) and one year practical training at the individual learner's corresponding local hospitals, which adhere to a catalogue of requirements, comparable to national educational policies. The curriculum is completed by passing a written and oral exam (diploma) and re-accreditation every five years. Conclusions: Despite complex requirements, the TOOLS utilised allowed an almost seamless, resource-minimised, professional, location-independent distributed development of a European subspeciality curriculum within one year. The definitive implementation is still due. If any deviations from the draft presented should become necessary in the future, the embedment in the curricular quality management will lead to a redirection in the right way and, furthermore, secure a continuous improvement in the best way possible.

Project description:Background:The integration of digital treatments into national mental health services is on the agenda in the European Union. The E-COMPARED consortium conducted a survey aimed at exploring stakeholders' knowledge, acceptance and expectations of digital treatments for depression, and at identifying factors that might influence their opinions when considering the implementation of these approaches. Method:An online survey was conducted in eight European countries: France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland and The United Kingdom. Organisations representing government bodies, care providers, service-users, funding/insurance bodies, technical developers and researchers were invited to participate in the survey. The participating countries and organisations reflect the diversity in health care infrastructures and e-health implementation across Europe. Results:A total of 764 organisations were invited to the survey during the period March-June 2014, with 175 of these organisations participating in our survey. The participating stakeholders reported moderate knowledge of digital treatments and considered cost-effectiveness to be the primary incentive for integration into care services. Low feasibility of delivery within existing care services was considered to be a primary barrier. Digital treatments were regarded more suitable for milder forms of depression. Stakeholders showed greater acceptability towards blended treatment (the integration of face-to-face and internet sessions within the same treatment protocol) compared to standalone internet treatments. Organisations in countries with developed e-health solutions reported greater knowledge and acceptability of digital treatments. Conclusion:Mental health stakeholders in Europe are aware of the potential benefits of digital interventions. However, there are variations between countries and stakeholders in terms of level of knowledge about such interventions and their feasibility within routine care services. The high acceptance of blended treatments is an interesting finding that indicates a gradual integration of technology into clinical practice may fit the attitudes and needs of stakeholders. The potential of the blended treatment approach, in terms of enhancing acceptance of digital treatment while retaining the benefit of cost-effectiveness in delivery, should be further explored. Funding:The E-COMPARED project has received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 603098.

Project description:Background: Involving patients' representatives in the research and development of medicinal products (medicines R&D) leads to better medical treatment. In 2014, the European Patients' Academy on Therapeutic Innovation (EUPATI) was started with the goal of increasing the capacity and capabilities of patient representatives in this field. To make this academy more accessible and applicable for the Netherlands, a Dutch version was launched in September 2019. To explore the options for a durable infrastructure for organizing the Dutch EUPATI course, a multi-stakeholder qualitative study was done. The views of various stakeholders from pharmaceutical industry, governmental organizations, patient organizations, and the academic world were examined about the benefits and challenges of this course for patient involvement in medicines R&D. Methods: From April to June 2019, 10 semi-structured interviews were completed, each with two representatives of all stakeholders involved. In addition, individual Dutch graduates of the European EUPATI (EUPATI fellows) were consulted via an e-mail questionnaire. Using a directed content analysis based on the Business Canvas Model, the transcribed interviews were coded, analyzed, and final attributes consolidated. Results: The semi-structured interviews and completed questionnaires explored how the stakeholders are aiming to assist patient involvement in medicines R&D through the Dutch EUPATI course. The building blocks of the Business Canvas Model were described with concrete attributes for making the business case. Stakeholders stated that the Dutch EUPATI course was an incentive for patient involvement in medicines development, for patient-oriented research and outcomes, for the availability of patient representatives (expert ones in particular), and for the content and representation quality of patient representatives. The key values for collaborating in the network as mentioned by the stakeholders were neutrality, patients' interests, equality, independence, shared objectives, long-term commitment, transparency, understanding, trust, and respect. Conclusions: Patient involvement in medicines R&D is evolving and the demand for qualified patient representatives is growing. Dutch stakeholders confirmed the added value of the patients' academy and expressed their willingness to contribute. Important values and conditions for long term collaboration were formulated.

Project description:BackgroundDespite the benefits offered by biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as switching.ObjectiveThis study aims to provide recommendations on how to improve biosimilar understanding and adoption among stakeholders based on insights of healthcare professionals (physicians, hospital pharmacists, nurses), patient(s) (representatives) and regulators across Europe.MethodThe study consists of a structured literature review gathering original research data on stakeholder knowledge about biosimilars, followed by semi-structured interviews across five stakeholder groups including physicians, hospital pharmacists, nurses, patient(s) (representatives) and regulators across Europe.ResultsAlthough improvement in knowledge was observed over time, generally low to moderate levels of awareness, knowledge and trust towards biosimilars among healthcare professionals and patients are identified in literature (N studies = 106). Based on the provided insights from interviews with European experts (N = 44), a number of challenges regarding biosimilar stakeholder understanding are identified, including a lack of practical information about biosimilars and their use, a lack of understanding about biosimilar concepts and a lack of knowledge about biologicals in general. Misinformation by originator industry is also believed to have impacted stakeholder trust. In terms of possible solutions and actions to improve stakeholder understanding, broad support exists to (1) organize initiatives focussed on explaining the rationale behind biosimilar concepts and the approval pathway, (2) invest in education about biologicals in general, (3) develop clear and one-voice regulatory guidance about biosimilar interchangeability and switching across Europe, (4) disseminate real-world clinical biosimilar (switch) data, (5) share biosimilar experiences by key opinion leaders and among peers, (6) provide practical biosimilar product information, (7) provide guidance about biosimilar use, (8) actively counterbalance misinformation and organize information initiatives by neutral entities, (9) organize multi-stakeholder informational and educational efforts, aligning information between involved stakeholder groups and (10) design initiatives in a way that ensures active information uptake. Furthermore, interviewees argue that governments should be proactive in these regards.ConclusionsThis study argues in favour of a structural, multi-stakeholder framework at both European and national level to improve stakeholder biosimilar understanding and acceptance. It proposes a number of actionable recommendations that can inform policy making and guide stakeholders, which can contribute to realizing healthcare system benefits offered by biosimilar competition.

Dataset Information

Stakeholder analysis with regard to a recent European restriction proposal on microplastics.

Publications

Stakeholder analysis with regard to a recent European restriction proposal on microplastics.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets