EU
DOSSIER
The EU Dossier brings together key information and updates on European policies, legislation, consultations, and initiatives relevant to eye health and vision research.
Explore the latest developments and their relevance to the ophthalmology and research community.
eHealth
The European Commission has made progress in the implementation of the eHealth Action Plan, a roadmap improve health services by linking up devices and technologies, and investing in research towards the personalised medicine of the future. The following have been formed:
– a voluntary Network of national authorities responsible for eHealth has been set up aiming to achieve continuity of care and to ensure access to safe and quality healthcare.
eHDSI
the eHealth Digital Service Infrastructure (eHDSI), an electronic cross-border health services infrastructure ensuring continuity of care for European citizens while travelling abroad in the EU. This gives EU countries the possibility to exchange health data in a secure, efficient and interoperable way
ePrescription and eDispensation
which allows EU citizens to obtain their medication in a pharmacy located in another EU country, thanks to the online transfer of their electronic prescription from their country of residence where they are affiliated, to their country of travel
Patient Summaries
Patient Summaries which provide information on important health related aspects such as allergies, current medication, previous illness, surgeries, etc. It is part of a larger collection of health data called an electronic Health Record. The digital Patient Summary is meant to provide doctors with essential information in their own language concerning the patient, when the patient comes from another EU country and there may be a linguistic barrier
Additional information:
European Health Data Space (EHDS)
The European Health Data Space is a new regulation making it easier to exchange and access health data at EU level
European Open Science Cloud
The European Open Science Cloud (EOSC) is a network of organisations and infrastructures from various countries and communities that supports the open creation and dissemination of knowledge and scientific data. The EOSC is part of the European Commission’s strategy to open up European research and innovation systems.
Position of the EU EYE on EOSC
The EU EYE applauds the move towards Open Science and the implementation of European Open Science Cloud (EOSC) and anticipates huge implications for medical research. We pledge to assist the EOSC efforts by initiating work in data sharing among the ophthalmology community as complementary to its ongoing work as a partner of the European Innovation Partnership on Active Healthy Ageing. We raise however our concerns regarding the management of health data in a cloud environment calling for recognition of the contribution of existing localised efforts to the progress of the EOSC project and the strengthening of the representation of the medical community within the Open Science Policy Platform to address in a systemic manner the diversity in open data needs in medicine.
WHO World Report on Vision
Position of the EU EYE on EOSC
EU EYE calls for fairer assessment of cost-effectiveness and a balance in metrics regarding the disease impact on the quality of life. Read more on the EU EYE’s position regarding the WHO Report
European Disability Rights Strategy
The European disability rights strategy for 2021-2030 is due to be updated, since the list of initiatives published in 2021 only goes up to 2025. During its December plenary session, Parliament is expected to hold a debate on the new initiatives the European Commission should commit to for the 2025-2030 period.
Disability is a rights issue and not a matter of discretion. The UN Convention on the Rights of People with Disabilities, obliges its parties to produce an Implementation Strategy. The European Union adopted the European Disability Strategy 2010-2020 in 2010, to fulfill its obligation to UN and to complement national efforts with a European-wide framework. The main aim of the Strategy is to empower persons with disabilities so that they can fully enjoy their rights and to participate in society and the economy on an equal basis with others.
The Strategy has identified eight main areas for action at EU level:
Accessibility
Participation
Equality
Employment
Education & Training
Social Protection
Health
External Action
A number of actions have already been carried out in terms of improving access to buildings, equal opportunities in work environment, etc.
Access the European Disability Strategy in your language
European Professional Card and the Alert Mechanism
The Directive 2013/55/EU amending Directive 2005/36/EC on the recognition of professional qualifications and Regulation (EU) No 1024/2012 on administrative cooperation through the Internal Market Information System (IMI) was implemented in January 2016. The new directive aims to facilitate and enhance the mobility of professionals across the EU and to address local staff shortages. It introduces the European Professional Card (EPC), an electronic certificate one can use to have his/her professional qualifications recognised in another EU country. The EPC is currently available for five professions (general care nurses, physiotherapists, pharmacists, real estate agents and mountain guides). It might be extended to other professions in the future.
The EPC does not replace the ‘traditional’ recognition procedures under the Professional Qualifications Directive.
An alert mechanism integrated within the IMI ensures that EU patients and consumers are adequately protected. The Competent Authorities of EU countries are required to warn each other about professionals who:
- have been prohibited or restricted from practicing the profession in one country
- have used falsified diplomas for their application for the recognition of their qualification.
Medical Devices, In Vitro Diagnostics and Eudamed
The EU has released new guidance governing medical devices – the first time in 20 years. The most important changes include:
- Increased scope of medical device definition
- More stringent linguistic requirements for medical devices sold in the EU market
- New classification rules (including Rule 11 that specifically addresses software)
- Increased scope of general safety and performance requirements, technical documentation, and clinical data and evaluation requirements
- Introduction of traceability and identification system and database
- Increased post-market product surveillance
The medical devices regulation (MDR) and in vitro diagnostic medical devices regulation (IVDR) replace the three Directives (90/385/EEC, 93/42/EEC and 98/79/EC) for medical devices. The MDR came into application on 26 May 2021 but provides for a transitional period for certain devices. The IVDR came into application on 26 May 2022 but also provides for a transitional period for certain devices. These regulations include provisions concerning the responsibilities of the EMA, National Competent Authorities (NCA) for medicinal products and medical devices and notified bodies as regards combinations of medicinal products with medical devices.
All legacy devices must be MDR compliant by the end of December 2028.
Patient safety and Medical Training
The capacity of health systems to deliver health services and meet the changing demands of care depends on the availability of a workforce with the right skills and flexibility. EU-wide activities in health workforce planning and forecasting support EU countries in building national capacities. Our members support high levels of specialist training as part of our commitment to patient safety and quality care. We invest consistently in continuous professional development so that the ophthalmology services of our respective national health systems are better equipped to respond to the major challenges that the EU is facing with the prevalence of eye diseases in an ageing population.
The ongoing commitment of our members to education, excellence and innovation is demonstrated by:
Evaluating knowledge and expertise through certification programmes in each subspecialty
providing funding for training, identify training sites and facilitating access to fellowship and residents’ programmes
creating innovative tools and resources including online educational portals that transfer new knowledge into clinical practice
launching international journals to promote the study and learning of the science and practice of all matters related to the health and management of the eye as an organ and as part of the patient as a whole
2024 EU4Health Work Programme
EU4Health is the fourth and largest of the EU health programmes since their launch in 2003. The EU4Health programme is an investment with an initial €5.3 billion budget for the 2021-27 period, reduced to €4.4 billion following the revision of the 2021-2027 MFF.It is implemented by HaDEA which also manages calls for proposals and tenders from 2021 to 2027. The programme and its calls represent an ambitious response to the COVID-19 pandemic, but go beyond crisis response to address the resilience of European healthcare systems and contribute to a healthier Europe.
- Assessing applications for EU funding (including prizes and tenders)
- Monitoring of EU funded projects and contracts
- Giving advice on specific issues
European Degrees
The European Commission has adopted a package of ambitious proposals for Europe’s higher education sector, with the aim of working towards a European degree. The package contains a blueprint for this new and universally recognised qualification, as a result of deeper and wider transnational cooperation between higher education institutions – a key component of the European Education Area.