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Commissioner Andriukaitis: National health systems in need of fundamental reform









Call for Endorsement - HPP Joint Statement on Medical Education


The final Joint Statement developed under the EU Health Policy Platform's Thematic Network on Medical Education and Professional Development for Patient Safety, that was led by the European Society of Radiology (ESR) has been released on the Platform. The joint statement will be officially presented at the Health Policy Platform meeting in Brussels on 27 November, 2017. The Section of Radiology has given its support to the final version of the Statement.

A copy of the Statement is also visible in the Publications section of the website.

Please remember an ECAS account is required to access the Platform and visualise the relevant Thematic Network.


For further information, please contact the ESR:









Intercultural Training for Health Professionals


Intercultural training for health professionals is a project financed by the European Union which aims at increasing the intercultural competencies of healthcare professionals in Europe through non-formal training. In particular, one of the many objectives for the project is to promote the efficient provision of healthcare to migrants that either inhabit or pass through EU states. InterHealth will take into consideration the significance of different perspectives on health and illness for an efficient and cost effective healthcare system while also providing health professionals with the intercultural competences required in order to provide medical and healthcare services tailored to the needs of their patients. The InterHealth project is led by IASIS, an NGO based in Greece, and five other partners from Greece, Italy, France, Spain and Austria. The International Network for Health Workforce Education is assisting project partners in disseminating project findings to healthcare education actors and is also hosting the InterHealth Forum.


Further information can be found at:








EU-US agreement on mutual recognition of inspections of medicines producers



1st November 2017 marks the beginning of mutual recognition of inspections of manufacturing sites for human medicines between the US and eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom). The US Food and Drug Administration (FDA) has completed the capability assessments of drug manufacturing regulatory authorities in these eight EU Member States, while the remaining Member States will be assessed by the FDA on a rolling basis, to be completed by 15 July 2019. As part of the agreement, the European Commission also confirmed that FDA has the capability to carry out good manufacturing practice inspections at a level equivalent to the EU.


Mutual benefits will include:

  • The ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured.
  • Prioritising inspections of medicines manufacturing sites for higher risk cases.
  • Reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter if they have been manufactured in the EU or in the US.
  • Improving the ability to identify and address problems at manufacturing sites before they become a public health risk; and reducing the costs facing manufacturers.

Mutual recognition covers medicinal products for human use with the exception of vaccines, plasma derived medicinal products and investigational medicinal products (clinical trial material).


For more information:                                                                                      http://ec.europa.eu/newsroom/sante/newsletter-specific-archive-issue.cfm?newsletter_service_id=327&newsletter_issue_id=2632&page=2&fullDate=Fri%2003%20Feb%202017&lang=default






EU citizens, Health and the Digital Society


According to the last public consultations, EU citizens clearly care about the innovation and digitisation of health care services and have foreseen the potential of digital solutions in the prevention and management of chronic diseases and in keeping a healthy lifestyle. That is why the European Commission is - in the words of EU Commissioner Dr. Andriukaitis - "committed to overcoming the current barriers to the free movement of patients and data. If we want to safeguard the wellbeing of our citizens and support the modernisation of national health systems, we need to pool evidence and trigger research and investment in digital health, and help people manage their own health".

To achieve these aims, the Commission asked citizens and stakeholders for feedback on three main pillars:

  1. Citizens' secure access to their health data and the possibility to share it across borders through interoperable electronic health records;
  2. Connecting and sharing data and expertise to advance research, improve prevention, personalise health and care, and better anticipate epidemics;
  3. Using digital services to promote citizen empowerment and integrated person-centred care.

The public consultation drew nearly 1500 replies and showed a broad support for health related actions in the Digital Single Market. More than 90% of respondents agree that citizens should be able to manage their own data. More than 80% agree that sharing health data can be beneficial. Nearly 55% report not having access to digital health services. More than 80% agree that citizen feedback to healthcare providers and professionals is essential to improve services.


Privacy and security remain the main concerns, as the most important tasks for the EU are the development of standards for data quality and reliability, standardised electronic health records and health-related cybersecurity standards. This precious input will help finalise the policy communication setting out the scope for further measures in digital health and care, in the coming months.


You can read the press release below:






Re-Health2 - Personal Health Record as a tool for integration of refugees


After an initial piloting phase of the Personal Health Record (PHR) and in line with the EU Migration Agenda, the goal of Re-Health2 project is to consolidate the use of electronic tools as an instrument for the correct integration of refugees in EU health systems. Therefore, the project aims at contributing to the integration of newly-arrived migrants and refugees, including those to be relocated, in the EU Member States' health systems through the utilization of the PHR/e-PHR - a universal electronic tool for health assessments - ensuring the continuity of care and facilitating data transmission and collection to better understand migrants' and refugees' health needs.

The ongoing implementation of the e-PHR will include:

• Needs assessments
• Recruitment of health mediators selected among the migrant/refugee population
• Training of staff on the utilization of the electronic platform in implementing sites
• Provision of essential supplies and other equipment;
• Consolidation of the use of the e-PHR in coordination with health stakeholders;
• Dissemination of the tool.









VulnerABLE pilot project


VulnerABLE - a pilot initative which investigates effective strategies for improving the health of people living in isolated and vulnerable situations in the European Union - will present its results at a conference on in Brussels on 7th November, 2017. This event will bring together national, regional and local authorities from Members States; health providers; NGOs and civil society organisations working in the field of health inequalities and vulnerable persons; the European Commission and other EU institutions. VulnerABLE looks into the health needs of specific vulnerable and isolated populations such as children and families from disadvantaged backgrounds; those living in rural/isolated areas; those with physical, mental and learning disabilities or poor mental health; the long-term unemployed; the inactive; the 'in-work poor'; older people; victims of domestic violence and intimate partner violence; people with unstable housing situations (the homeless); and prisoners.


Link: http://www.the-vulnerable.eu






EU Joint Action against Cancer



Cancer is a major public health concern in terms of disease burden and economic cost. Prevention and early detection are fundamental keys. While responsibility for the delivery of health services lies with the Member States, the European Union contributes to tackling cancer with awareness-raising, guidance and investment in research and fostering cooperation.

In addition, the European Commission takes direct action in the following areas:


- support for Member States

- prevention

- screening

- quality assurance

- research

- cancer information

- coordination


In 2009, the Commission adopted the Communication on Action against Cancer: European Partnership and established the European Partnership for Action against Cancer (EPAAC).


Building on the EPAAC, the Comprehensive Cancer Control joint action 2014 - 2017 (CANCON) aims to help reduce the cancer burden in the EU. It delivered a European Guide on Quality Improvement in Cancer Control. An expert group on cancer control has been established by the Commission in 2014, gathering representatives from EU, EEA and EFTA countries, but also patients´ and professional associations and IARC.


Developed in cooperation with WHO, the European Code against Cancer is a set of 12 recommendations as to how people can reduce their cancer risk: it has been constantly updated since 1987.


The EU funded cancer research schemes throughout the 7th Framework Programme for Research (2007 - 2013) and provided further support under Horizon 2020 (2014 - 2020), including research programmes into cancer progression to improve treatment and development of new therapies.


The Joint Action on Cancer Control's policy recommendations aim to improve the patient's reintegration to employment and social life. The main messages of this work are: Cancer survivors' follow-up, late effect management and tertiary prevention needs to be anticipated, personalized and implemented into care pathways, with active participation of survivors and relatives. Improvement of early detection of patients' needs and their access to rehabilitation, psychosocial and palliative care services is required. An integrated and multi-professional care approach with a coordination of community care providers and services are needed to implement a survivorship care plan that enhances patient's self-management and quality of life. For children, adolescents and young adult survivors, late health and psychosocial effects of cancer and its treatments need to be anticipated and addressed. More research in the area of survivorship is needed to provide data on late effects, as well as the impact and cost-effectiveness of supportive care, rehabilitation, palliative and psychosocial care interventions.





Public Consultation: Transformation Health and Care in the Digital Single Market


Please find below the link to access the public consultation and have your say on digital innovation and other measures to improve European people´s health:








EC Expert Panel on effective ways of investing in health



The European Commission´s Expert Panel on effective ways of investing in health - an interdisciplinary and independent group - is currently providing non-binding on an Opinion on «tool and methodologies for assessing the performance of primary care» as part of its continued work on innovation in care. This Opinion will also contribute to the work of the Expert Group on Health Systems Performance Assessment (HSPA), which has among its main goals for the current year the identification of tools and methodologies to support policy makers in assessing the performance of primary healthcare systems.

In particular, the Panel is targeting the following goals:


- Dimensions and domains to be taken into consideration in assessing the performance of primary care (effectiveness, access, etc.) and tailored domains that are specific to primary care.

- Specific indicators to be collected and analysed to give a better understanding of the performance of primary care. The Expert Panel should distinguish whether the indicators are already available and used regularly, or if they are still in their piloting phase.

- Advice for an EU agenda on performance assessment of primary care: goals, opportunities, activities, and possible deliverables.


For more information and to know the dates of the next hearing of the Panel:









European Observatory on Health Systems and Policies


The European Observatory on Health Systems and Policies supports and promotes evidence-based health policy-making through comprehensive and rigorous analysis of the dynamics of health care systems in Europe. The Observatory is a partnership that includes the Governments of Austria, Belgium, Finland, Ireland,  Norway, Slovenia, Sweden, Switzeland and the United Kingdom; the Veneto Region of Italy; the French National Union of Health Insurance Funds (UNCAM); the World Health Organization; the European Commission; the World Bank; the London School of Economics and Political Science (LSE; and the London School of Hygiene & Tropical Medicine (LSHTM). The partnership is hosted by the WHO Regional Office for Europe.


For further information:









New developments in EU Health Information System



The current EU Health Information system may suffer from major problems, including:


- Dispersed, incomplete and difficult to access material

- Differences in quality and comparability

- Lack of sustainability



For these reasons, a Joint Action to approach the problem of Health Information has been elaborated and presented during the last meeting of the Expert Group on Health Information and Joint Meeting of the Expert Groups on Health Information and Health System Performance Assessment (Luxembourg, 8-9 June 2017).


The project will see 30 different partner countries (including two non-EU countries: Bosnia Herzegovina and Serbia) joining forces over a 3-year programme financed with a budget of € 4 mio.Each country or group of countries will take care of a different Working Package (WP), like WP8 - Health information support platform, which includes the creation of a sustainable web platform tho share expertise and best practices across the Member States.


Furthermore, a specific tool named SHARED will be dedicated to monitoring, benchmarking and analysing population ageing and socioeconomic interactions in European welfare states.


Finally, the meeting has been the occasion to illustrate the periodical report of the Health Division of OECD on the state of affairs of Health Care Quality, in particular the most update statistics on cancer prevention and patient safety.


For additional information, please visit DG SANTE website:







EU - US joint strategy on Medicine Safety


In August 2017, the European Commission, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment related to medicine safety. This agreement is a milestone in the implementation of the Mutual Recognition Agreement concluded between the EU and the US on March 2, 2017 and will allow the EU and US regulators to share non-public and commercially confidential information, including full reports on medicine inspections, potentially improving patient safety on both sides of the Atlantic.


Although the EU and the US have had confidentiality arrangements in place since 2003, the current step allows the sharing of more types of non-public information, so that regulators can make better use of their inspection resources to focus on manufacturing sites of higher risk. This enhanced cooperation with US regulatory authorities will also improve the EU's ability to identify and address problems at factories before they become a public health risk.


For more information:








EC initiative on Breast Cancer


The ECIBC - European Commission Initiative on Breast Cancer - is developing recommendations for breast cancer screening and diagnosis. Over the course of the next two years, approximately 90 evidenced-based recommendations regarding screening and diagnosis will be developed and published on this site as they become available. Supplemental recommendations will be developed and updated as new evidence and priorities emerge. Future recommendations will cover other aspects of breast cancer.

In addition, on the ECIBC website, you can access information for the 35 countries participating to the initiative. Each Country profile shows breast cancer data, organisation of care, and engagement in ECIBC. The information will be regularly updated and translated into the official languages of their respective countries. Factsheets are saved in the Agora Library, under the Expert Group - Cancer control folder.


Finally, the ECIBC Concept Document has been updated and is now published. The document describes ECIBC's background, general goal, specific objectives and expected benefits and includes information on on-going activities

You can find the list of recommendations just below:








Focus on the EU Proportionality Directive in the regulation of professions


In 2016, regulated professions accounted for about 22% of the European labour force, representing around 50 million citizens. As part of the value chain and their role as input to production processes as well as their output, services provided by professionals, such as engineers, architects, accountants, lawyers, are crucial to the functioning of the European economy more broadly and across sectors. Excessive regulatory barriers to professional entry have negative consequences for job creation, productivity, mobility and the consumer who is forced to pay higher prices by a less competitive market.


Professional activities are regulated by Member States at national, regional or sometimes at local level. Securing the modernisation of the regulated professions and in particular the review of reserves of activities and the cumulative impact of measures requires that proper proportionality analysis be carried out at national level.


The first European Commission´s proposal for a Proportionality Directive in the regulation of professions was presented on January 2017, and since then the co-legislators have moved at very different speeds: while the Council completed its negotiations in the adoption of a general ap-proach in May 2017, the European Parliament is still in the early stages of adopting its position and a decision is expected for the autumn.


The right to work in the sense of the freedom to pursue one's chosen profession or to conduct a business is enshrined in the Charter of Fundamental Rights of the EU. The key benefits of the EU Single Market include the freedom of establishment and the freedom to provide services.


The proposal will introduce a general obligation for member states to carry out an ex-ante proportionality assessment before adopting new or modifying existing legislation restricting access to or the pursuit of regulated professions. It must be also considered that economic considerations can only partially affect the health professions, as patient safety and access to healthcare are equally important.




The first deliberations of the European Parliament have proposed more extensive changes to the draft Directive, including an exemption for health professions as included in the draft Report of the Commit-tee for Internal Market and Consumer Protection (IMCO) and in the draft Opinion of the Committee for Envi-ronment, Health and Food Safety (ENVI).

Several health organisations have raised their voice concerned by the potential impact of the Directive on their practices: as an example, CPME, alongside other health stakeholders, in particular the Council of European Dentists (CED) and the Pharmaceutical Group of the European Union (PGEU), have highlighted the fundamental difference of conceptual approach to regulation demonstrated by the draft Directive in comparison to the rationale for regulating doctors and other health professions.


Link: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2016:0822:FIN




New priorities of the EU health strategy:

Payment models for high-cost medicines, access to healthcare and the performance of primary care


An ad-hoc Expert Panel on effective ways of investing in health is preparing three opinions on the incoming priorities of the EU health strategy: payment models for high-cost medicines, access to healthcare and the performance of primary care. These opinions will later feed into the further policy work of the European Commission.


- Innovative payment models for high-cost innovative medicines.

In the EU, efforts to invest on development and timely authorisation of innovative medicines are confronted with challenges, such as the sustainability of health systems, patient access and affordability. The Commission is committed to ensure accessibility of patients to innovative medicinal products and explore possible synergies between various bodies in the EU zone. The opinion is expected to be finalised by November 2017.

- Access to healthcare in the EU

In April 2017 the European Commission recommended a principle on access to good quality preventive and curative health care.

The Panel has been requested to:

  • suggest quantitative benchmarks/targets on access to healthcare based on the unmet needs for medical examination indicator.
  • propose a qualitative benchmark, based on principles and policy levers and which can be operationalised, to improve access to healthcare in the EU Member States.
  • discuss the possible utilization of EU funds and/or other mechanisms to support the improvement of access to healthcare according to the benchmarks proposed.

This opinion is expected to be finalised in September 2017.


- Assessing the performance of primary care

Strong primary care can contribute to consolidating the overall health system's performance by providing affordable and accessible care, guiding patients through the health system to find the most appropriate care, focusing on individual needs and offering tailored, patient-centred care. The Expert Panel will provide its views on:

  • dimensions and domains for assessing the performance of primary care, (effectiveness, access, etc.) and tailored domains that are specific to primary care;
  • specific existing or new indicators for a better understanding of the performance
  • how the analysed indicators are fitted for policy making and whether they allow the identification of specific levers and policy actions to respond to the highlighted issues;
  • advice for an EU agenda on performance assessment of primary care: goals, opportunities, activities, and possible deliverables.

The opinion of the Panel is expected to be finalised in September 2017, and will feed into the Expert Group report on primary care, which will be published in the first quarter of 2018.


Find more on the Expert Panel:






European Commission started public consultation on Health and Care in the Digital Single Market


On July 20, 2017 the European Commission has aunched a public consultation on how Europe should promote digital innovation in health and care, for the benefits of citizens, patients and health systems of the Member States.

The input of this consultation will feed into a new policy document to be adopted by the end of 2017, as recently announced by Commissioners Mr. Vytenis Andriukaitis, Ms. Mariya Gabriel and Mr. Carlos Moedas, who stated:


'We are dedicated to improving European citizens' quality of living by improving Europe's health, care and research systems by using digital technologies to their full potential. This consultation will help us identify ways to offer citizens, medical professionals and researchers better access to health data, prevention, rapid response to pandemic threats, personalised treatments and care. We are considering new digital initiatives to deliver on the free movement of patients and data, to support the modernisation of national health systems, and to bring together scattered evidence and innovative knowledge from across Europe. At the heart of our policies, citizens and their wellbeing are our first priority.'

The consultation will collect information on three main pillars:

  1. Citizens' secure access to their health data, including their privacy rights, interoperability and the possibility to share it across borders and health systems in Europe.
  2. Connecting and sharing data and expertise to advance research, personalise health and care, and better anticipate epidemics.
  3. Citizen empowerment and integrated person-centred care through digital care.

Citizens, patient organisations, health and care professionals, public authorities, researchers, industries, investors, insurers and users of digital health tools are all invited to share their views via EU Survey until 12 October 2017


Link to EU Survey:






ESR Call for a European Action Plan for Medical Imaging



The ESR - European Society of Radiology calls on EU policy makers to:
• support the establishment of European quality and safety indicators for imaging
• support an audit of imaging equipment, doses, image quality and procedures of the medical imaging chain in Europe and to develop plans to modernise equipment
• support efforts to improve communication with patients
• improve inter-institutional cooperation for more coherent action in the area of health
• support the EuroSafe Imaging campaign to raise awareness of the importance of radiation protection


This is necessary to improve access to better and safer healthcare for citizens, promote good health, prevent diseases and protect Europe's citizens from cross-border health threats, in accordance with the provisions of the Health for Growth 2014‑2020 plan, as well as the EU's Horizon 2020 research programme.


The ESR Call for a European Action Plan for Medical Imaging is endorsed by many National Radiology societies and subspecialty societies of Radiology (e.g. CIRSE, ESGAR, ESNR and EUSOBI). In addition, it has received support from notable health organisations as the European Patients´ Forum (EPF) and the Stroke Alliance for Europe (SAFE).


You can find the text of the Call in the attachment below.





4th ENSREG Conference on Nuclear Safety



ENSREG - the European Nuclear Safety Regulator Group - held its fourth conference on nuclear safety on 28-29 June 2017 hosted by the European Commission in Brussels.

The conference addressed potential challenges for nuclear safety regulation, key recent developments in EU policy (directives on nuclear safety, on spent fuel and waste management and on basic safety standards) and emerging topics in the field of nuclear safety, such as long-term operation of nuclear installations and irregularities and supply chain control.

ENSREG) is an independent, expert advisory group created in 2007 following a decision of the European Commission. It is composed of senior officials from the national nuclear safety, radioactive waste safety or radiation protection regulatory authorities and senior civil servants with competence in these fields from all 28 Member States in the European Union and representatives of the European Commission. The role of ENSREG is to help to establish conditions for continuous improvement and common understanding in nuclear safety and radioactive waste management.


For more information:





EC Expert Group on Safe and Timely Access to Medicine for Patients (STAMP)


The European Commission Expert Group on Safe and Timely Access to Medicine for Patients (STAMP) was established in 2015 as a sub-group of the Pharmaceutical Committee to provide advice and expertise to Commission services on how to improve implementation of EU Pharmaceutical legislation and speed up access to innovative and affordable medicines.

Access to medicines in the EU currently depends on many different factors from research and development, to regulatory approval and effective market uptake which is linked to health technology assessment (HTA) as well as pricing and reimbursement decisions.

Regarding the future strategy, the work of the STAMP needs to be seen in the wider context of ongoing activities in the area of pharmaceuticals. The STAMP group has currently initiated discussion on the following issues:

• Repurposing of established or off-patent medicines or active substances
• Off-label use of medicines
• Early access tools, including compassionate use schemes


The STAMP has the potential to be instrumental in the next one to two years to consolidate ongoing work, discuss outcomes of ongoing and completed studies, cooperate with other bodies notably HTA bodies and the HMA and hence provide orientation to the Commission in defining policy options for dealing with the challenges of the pharmaceutical system.




Maltese EU Presidency ends with excellent results in the health sector


As the Maltese presidency is coming to an end (June 2017), the island´s Health Minister - Dr. Chris Fearne - talked about the results of these six months.

"Malta's choice of priorities was designed to reflect issues considered to be relevant to the national agenda as well as being a priority and concern for the vast majority of European Union member states. We sought to ensure that there was a focus on public health issues as well as on health system concerns. I am delighted that after months of hard work, last Friday we adopted two sets of Council Conclusions namely; Council conclusions to contribute towards halting the rise in Childhood Overweight and Obesity and Council conclusions on Encouraging member states-driven Voluntary Cooperation between Health Systems", Mr. Fearne said.

Finally, "I consider the closure of our presidency not as the end of a process, but merely the beginning. Having been reconfirmed as Minister for Health in Malta, I am deeply committed to following up on the objectives set out in our Council Conclusions to ensure that these do not remain commitments on paper but serve to bring about positive changes to the health and well-being of European citizens", concluded the Minister.


To read the full interview, please visit:






The importance of medical training for patient safety



The European Society of Radiology has published the first draft of the Joint Statement on the Thematic Network on Medical Training and Professional Development for patient safety, which has been released on the Health Policy Platform. The final statement should be a collaborative document: therefore, the ESR would like to receive further inputs, in addition to the ones provided by UEMS, ECCO, CPME, EPF and HOPE.

The European Society of Radiology has contributed to the creation of a Thematic Network on the EU Health Policy Platform which will focus on the importance of an effective medical education not only for healthcare professionals, but for patients too.


With regards to the importance of an effective medical education - not only for healthcare professionals, but for patients too - the ESR has long advocated that direct access to doctors, and providing information to patients, carers and relatives in an easily understandable way is an important aspect of delivering high-quality healthcare.


In addition, the European Society of Radiology's Patient Advisory Group (ESR-PAG) was established in 2013 to enhance the communication strategies with patient groups and organisations. The goal of the ESR-PAG is to bring together patients, the public, and imaging professionals in order to positively influence advances in the field of medical imaging to the benefit of patients in Europe. The last ECR 2017 in Vienna featured two well-attended sessions organised by the ESR-PAG which enjoyed high interest by the congress delegates and featured lively discussions between panellists and the audience.


Read more about ESR-PAG at:



More information available on the EU Health Policy Platform available here:




and on the ESR website:






European Commission expresses on the need for primates in biomedical research, production and testing of products and devices


Today - June 6, 2017 - the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) publish the final Opinion on 'the need for non-human primates (NHP) in biomedical research, production and testing of products and devices'.

The Commission has requested SCHEER to review and update its previous opinion, as foreseen by Directive on the protection of animals used for scientific purposes (2010/63/EU).  The 2017 Opinion addresses several issues, such as areas of research where primates continue to be used today, opportunities for reducing and refining their use and scientific viewpoints on when NHP use will no longer be necessary.  It also considers potential implications an EU-wide ban of NHP use would have on biomedical research.

The new opinion also highlights the many scientific approaches that could significantly contribute to the replacement, reduction and refinement for the use of NHPs, using alternative methods, training, improvement of techniques and protocols, sharing of knowledge, removal of barriers and research needs.


You can read the opinions of the Commission at the following link:






Health challenges during the European Semester


The European Semester provides a framework for the coordination of economic and social policies across the European Union. It allows EU member countries to set their priorities, discuss their economic/budget plans and monitor progress at specific times throughout the year.


"Health systems are complex organisations whose good functioning is crucial for the good health of EU citizens." explained Mr. Arūnas Vinčiūnas, Head of Cabinet of the Commissioner for Health and Food Safety. Against the backdrop of a changing environment, Member States need to ensure that health systems are able to adapt effectively to people's needs and identify and apply innovative solutions to tackle the significant challenges ahead, with the ultimate goal of improving the health of the population they serve.


Health and long term healthcare are among the key topics of the European Semester (Spring package) as presented by the Commission on May 22, 2017.

To view the health priorities for each different country, please visit the dedicated website below:






New Thematic Network on Medical Training and Professional Development for Patient Safety


On the EU Health Policy Platform (registration required to access) a new thematic network has been created by the European Society of Radiology (ESR) to focus on:


- how to promote evidence-based medicine through education;

- how education and mutual recognition of qualifications can enhance mobility of health professionals;

- the harmonisation of educational programmes and medical school curricula in the EU.


This thematic network seeks to explore the connection between education and professional development with enhanced patient safety. From the ESR's perspective, among many other aspects, three are particularly relevant in the context of the Platform:


With the amount and quality of technological capabilities, scientific studies and available data increasing exponentially, it has become increasingly difficult for healthcare professionals to keep abreast of the latest developments, and to treat their patients according to the latest medical evidence. Creating a truly European healthcare labour force through university education and continuing medical education (CME-CPD) is therefore particularly important, yet many legal and political barriers remain for healthcare professionals that move to different countries.


Link to the EU Health Policy Platform:







European Solidarity Corps for inclusion and equity in Health Care


Recently announced by the EC President Jean-Claude Juncker, the creation of the European Solidarity Corps aims to offer volunteering and work placement opportunities to young people around Europe.

The European Solidarity Corps is the new European Union initiative which will provide opportunities for young people to volunteer or work in projects in their own country or abroad that benefit communities and people around the entire continent, including those related to health, (e.g. prevention, solidarity campaigns. health promotion, healthy lifestyle and inclusion of disadvantaged groups in health screenings). It could be also useful to engage the young patients themselves and let them have their first job experience.

On 12 April 2017, an ad-hoc Stakeholder Forum brought together national and European representatives of civil society organisations and public authorities to discuss the key issues related to the project, as over 27,000 young people have signed up so far.


The official website of the project is:






Facts and figures on digital health in the EU


On 12th May 2017, the European Commission has published the mid-term review of the Digital Single Market (DSM) Strategy.

Adopted in 2015, the DSM aims to make the EU's single market freedoms "go digital" and boost growth and jobs in the EU.

  • The percentage of hospitals exchanging patient information electronically with other health care organisations within the same country ranges from 33% to 39%. Exchange with health and care providers in another EU country is only 4%.
  • 52% of citizens wish to have electronic access to their health records, but only 9% of hospitals in Europe allow citizens to access online their own patient records, even partially.
  • Faster diagnosis and more personalised treatment of rare and complex diseases can be achieved if scientific expertise and data are pooled across borders, significantly reducing the 5.6 years on average that it takes currently to diagnose a rare disease in Europe. An estimated 30-40 million Europeans are affected by rare and complex diseases.
  • Faster diagnosis of infectious diseases and more effective response can be achieved if scientific expertise and health data are pooled across borders.
  • Europe has the highest burden of chronic diseases which are responsible for 86% of all deaths and 77% of health and long-term care expenditure. But only 18% of European citizens have used online health and care services in the last 12 months.
  • By improving interaction between users and health care providers, mhealth can improve quality of services and better planning by healthcare systems. If widely adopted, annual savings in Europe resulting from use of mhealth applications are estimated at € 69 billion.


The White Paper on the Future of Europe - officially presented at the last eHealth week in Malta - notes that by 2030 Europe will be the oldest region in the world. Expenditure on health and long-term care has been increasing in all EU Member States, and is expected to rise even further as a consequence of an ageing population. Despite an increased spending in health and care, there has been a decline in the average healthy life years of citizens across the EU28. Therefore, enabling a better use of the digital technologies may improve the citizens' health, and address the systemic challenges which our healthcare systems are facing.




Celebrating 25 years of European Health Policy


1992 - Treaty of Maastricht - "The Community shall contribute towards ensuring
a high level of human health protection"


2003 - Start of the first EU Health Programme


2017 - Start of the first 24 European Reference Networks for rare and complex diseases


Please, see the attached flyer celebrating this important anniversary.




Health Inequalities 2017 (updated July 2017)



EuroHealthNet - the European partnership for improving health, equity and wellbeing - addressed the European Institutions with a Call for Actions to reduce Health Inequalities in the EU. The Joint Statement - supported among other notable organisations by the European Patients Forum - has been presented at the last Meeting of the Expert Group on Social Determinants and Health Inequalitie (Luxembourg, 14-15 March 2017).



Key facts:

- Large health inequalities still persist, particularly between Western and Eastern Europe (e.g. life expectancy in Central and Eastern Europe is 8 years lower than the EU average).
- Gap continues to widen, mainly due to the last financial crisis and the budget problems of many Southern countries, to different exposures to health risks, lifestyle and to disparities in high-quality care between national healthcare systems.
- Access to health care varies according to social status, education and gender of patient (In Slovakia, Hungary and Czech Republic, a 65-year-old man with a high level of education can expect to live more than four years longer than one with a low education level).


The two charts below are just an example of the size of health inequality among EU member states.


Life expectancy





VulnerABLE is a pilot project funded by the European Parliament aiming at improving the health of people who are living in vulnerable or isolated contexts across Europe.
The project targets specific groups at risk, such as children and families from disadvantaged backgrounds; those living in rural areas; those with physical, mental and learning disabilities or poor mental health; the long-term unemployed; the inactive; the 'in-work poor'; older people; victims of domestic violence and intimate partner violence; people with unstable housing situations and prisoners.


Over its two-year lifetime, the 'VulnerABLE' project will involve:

  • Interviews with individuals and organisations who work first-hand in the field of health inequalities (such as the World Health Organisation and local authority networks);
  • Detailed research into the health needs of people in isolated and vulnerable situations, including a face-to-face survey and in-depth focus groups with them;
  • Bringing together the leading thinkers in this area and enabling them to contribute to future strategies to prevent isolation and vulnerability;
  • Training materials and capacity-building workshops for national and regional authorities who are active in delivering healthcare services and who have a vital role to play in tackling health inequalities;
  • Regular news updates, direct communication with experts and a one-day conference to spread awareness of the project's findings amongst national and regional authorities; public health experts; health professionals; and other non-governmental organisations (NGOs).

To know more about how the European Union is trying to combat health inequalities, please visit:






EU Sustainable Development Goals




The EU Sustainable Development Goal (SDG) indicator set has been developed based on a broad and inclusive process and takes into account input provided by a large number and variety of actors, including other services of the European Commission, EU Member States, international bodies and civil society organisations. This EU SDG indicator set will be used to produce a first EU SDG monitoring report to be released in November 2017. It means for example that development must meet the needs of the present without compromising the ability of future generations to meet their own needs and that a life of dignity should be granted to all within the planet's limits and reconciling economic efficiency, social inclusion and environmental responsibility.


Goal 3 - Ensure healthy lives and promote well-being for all at all ages - is specifically related to the health care sector.





The Sustainable Development Goals (SDGs) and their related targets, approved in September 2015 by the UN General Assembly, provide a new policy framework worldwide towards ending all forms of poverty, fighting inequalities and tackling climate change, while ensuring that no one is left behind. All countries, developed and developing alike, have a shared responsibility to achieve the implementation of the SDGs. On 22 November 2016 the European Commission issued a Communication on 'Next steps for a sustainable European future: European action for sustainability'. The Communication shows the significance of the SDGs for Europe and explains how the EU contributes to reaching them.


Link: http://ec.europa.eu/eurostat/web/sdi







Health NCP Net (HNN 2.0)

Health NCP Net 2.0 (HNN 2.0) is a European project funded by the European Commission under the patronage of Horizon 2020 that is aimed at aligning and enhancing the services that National Contact Points (NCPs) for the Health, Demographic Change and Wellbeing Societal Challenge (SC1) provide to applicants of European funding for Health research across Europe and worldwide.

Health NCPs are individuals nominated by their governments with the mandate to spread awareness, provide specialist advice and on-the ground guidance on Health research funding opportunities within Horizon 2020 and ensuring that the programme is readily accessible to all potential applicants. Health NCPs can guide anyone interested in applying for European funding in health research to identify the right call, guide and support you through the different stages of an application.

The current cycle of HNN 2.0 will run for four years (Dec. 2014 - Nov. 2018) .The consortium is built of 13 NCP institutions that are beneficiaries to the European Commission, under the coordination of Instituto de Salud Carlos III (ISCIII, Spain).


More information about the project available here:






Financing strategic investments in Health


On 27 February 2017, the European Commission, in cooperation with the European Investment Bank (EIB), discussed new forms of investment for innovative forms of healthcare. The event was promoted by the European Fund for Strategic Investments (EFSI), under the Investment Plan for Europe, as an effective financial instrument to support reforms in European health systems.


Key figures

Read more at: https://ec.europa.eu/health/health-eu-newsletter-191-focus_en




ECHI - European Core Health Indicators (updated November 2017)


The European Core Health Indicators (ECHI) are the result of a long-term cooperation between the EU Member States and the European Commission. Three ECHI projects (1998-2001, 2001-2004, 2005-2008) funded under the EU Health Programmes established the first lists of ECHI indicators, aiming to create a comparable source of health data at EU level.

Definitions and data collection are now in place for nearly 60 out of 88 ECHI indicators. The indicators under development still need further refinement before being accessible in the ECHI data tool. ECHI indicators are grouped under five main chapters: Socio-economic situation, health status, health determinants, health services and health promotion.

A relevant example of health services is the distribution of Computer Tomography scanners and Magnetic Resonance Imaging units per 100.000 inhabitants. Indicators are at the crossroads of policy questions and data sets. They reflect a policy interest as well as a selected set of possibilities in terms of what can be calculated.


Medical Technologies (e.g. CT scanners and MR imaging units have been included in ECHI statistics:

Medical technologies: MRI units and CT scanners (I)


For the full list of ECHI, please visit:









At ECR 2017, ESR and UEMS address common EU issues


On Wednesday, 1st March 2017 - at the European Congress of Radiology in Vienna - a Joint Session of the ESR and UEMS took place to celebrate this important and fruitful professional partnership between the two organisations. The ESR started to cooperate with the UEMS in the field of EU affairs a few years ago, but the collaboration has been enhanced with the creation of an ESR office in the Domus Medica Europaea, the house of European Medical Specialist in May 2016.

Regarding hot topics on the European agenda, both organisations believe there is room for improvement in the EU Directive on Professional Qualifications (Directive 2005/36/EC), further amended in 2013. In the Directive´s current form Radiology is listed under two names: Radiology and Diagnostic Radiology, thus creating a problem of terminology in most European countries. Furthermore, the focus is on training duration rather than on contents and criteria, which could be perceived as a major issue by most radiologists.

Additionally, ESR Quality, Safety and Standards Committee - chaired by Prof. J. Adam - has suggested that the minimum number of training years should be raised from four to five in order to be in line with the ESR European Training Curriculum for Radiology, now endorsed by more than sixty national radiology societies.

Despite having been discussed in the past, to date no professional card has been implemented for medical doctors.

Since the Directive on Professional Qualifications will be revised in 2020, ESR and UEMS have planned to work together in order to better match the new document with the reality of radiology practice in Europe, to encourage professional mobility and a fair recognition system of CME credits.






European Reference Networks at starting line (updated June 2017)

On 1 March, 2017, 24 thematic European Reference Networks began working, gathering together more than 900 highly specialised healthcare units from 26 different countries. Dr. Vytenis Andriukaitis, European Commissioner for Health and Food Safety, said ERN will save thousands of lives, especially in the case of rare, yet life-threatening diseases, when Doctors often lack the opportunities to network with rare disease specialists.

Through ERN, patients with rare conditions will be able to benefit from the best treatment and advice available and their doctors will have access to a highly-specialised pool of colleagues from all over Europe, maximising synergies between Member States.

The ERNs are just part of a broader strategy to make the European health systems and the related research networks more efficient, accessible and resilient. No one country has the knowledge and capacity to treat all rare and complex conditions, but by exchanging life-saving knowledge at EU-level through ERNs, we can ensure that patients across the EU will have access to the best expertise available - Andriukaitis concluded.


Find out more: http://ec.europa.eu/health/ern/policy_en


In 2017 over 900 highly-specialised medical teams from all over Europe joined their forces in the European Reference Networks. Please find below a link with several videos showing the importance of the European Reference Networks for European patients with rare and complex diseases, their families and doctors.









At the last meeting of the EU Health Policy Platform (Brussels, 5th December 2016), Dr. Jürgen Scheftlein of the EC reported on the state of play since EU Health Policy Platform launch of 21 April 2016. More than 150 health interest groups registered

• More than 500 registered users overall
• Agora, four Thematic Networks (including Patient Safety) and 23 networks of Commission expert and stakeholder groups

• Used by other international organisations: Steering Group of the WHO European Health Information Initiative.
• Notifications to the members of networks about newly uploaded information;
• Bulk upload of documents


Please find the link to the Platform here: https://webgate.ec.europa.eu/hpf/







ADAPT SMART is a 30-month project which is the second phase of the Innovative Medicines Initiative (IMI) under the EU Horizon 2020 framework. IMI2 is a public-private partnership of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Commission. Its aim is to improve health by speeding up the development of, and patient access to, innovative medicines, by facilitating collaboration between the key players (Academia, industry, patient organisations or regulators). IMI itself is a partnership between the European Union and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations). The second Innovative Medicines Initiative, IMI 2, started in 2014 and will run for 10 years


Find more information about ADAPT SMART at: http://adaptsmart.eu





BSS Transposition Project


The BSS -  Basic Safety Standards - Directive (Council Directive 2013/59/Euratom) modernises European legislation on radiation protection by taking account of the latest scientific and technological progress to consolidate the existing Euratom radiation protection work into one single piece of legislation, merging five previous directives and upgrading a recommendation to become legally binding.

The new Directive entails substantial innovative requirements in several different areas, as the protection of patients in medical applications, improving the protection of workers, and enhancing the protection of the public from natural radiation sources.

After entry into force of the Directive 2013/59/Euratom on 6th February 2014, which consolidated many different sets of legislation, Member States will have time until 6th February 2018 to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.

Thus, the European Commission approved a 15-month tender project in May 2016 to monitor the transposition of the BSS Directive into Member States' national legislation and to support its implementation. This project was awarded to a consortium headed by the European Federation of Organisations for Medical Physics (EFOMP). Other participating organisations are the European Society of Radiology (ESR) and the European Federation of Radiographer Societies (EFRS).

Led by the Radiation Protection Subcommittee, the ESR - European Society of Radiology developed a summary of the BSS directive that includes the essentials for diagnostic radiolog and organised a meeting in Brussels, hosted by the European Commission on 24-25 January 2017.







EURO-CAS, the new European eHealth Interoperability Conformity Assessment Scheme (CAS) project is committed to developing and putting in place an operational CAS scheme based on ISO/IEC 17025 requisites that will also meet the interoperability requirements of European eHealth projects as well as national and regional eHealth programs. This will allow testing the interoperability capabilities of products and services for a single digital market in eHealth in Europe in line with the Digital Agenda for Europe and international standards.

More info available on EIBIR - European Institute for Biomedical Imaging Research - website: http://www.eibir.org/projects/h2020-projects/euro-cas/?utm_source=EIBIR+Newsletter&utm_campaign=8da7e19ad8-EMAIL_CAMPAIGN_2016_12_01&utm_medium=email&utm_term=0_ade25c085f-8da7e19ad8-163249625







The European Alliance for Medical Radiation Protection Research (EURAMED) is a consortium of associations involved in the application of ionising radiation and radiation protection standards in medicine, namely the European Association of Nuclear Medicine (EANM), the European Federation of Organisations for Medical Physics (EFOMP), the European Federation of Radiographer Societies (EFRS), the European Society of Radiology (ESR) and the European Society for Radiotherapy and Oncology (ESTRO).

The first edition of a strategic research agenda (SRA) for medical radiation protection has been published in July 2016.

EURAMED is a joint initiative of EIBIR chaired by Prof. Christoph Hoeschen (Germany). FInd more at:




Personalised Medicine 2020 and beyond (Updated)


Personalised Medicine is one of the most innovative areas in the future of health research. It has a high potential for patients, citizens, national healthcare systems and the entire EU economy. The implementation of Stratified and Personalized Medicine is, therefore, a major challenge in the health care field and with the launch of the International Consortium of Personalised Medicine (ICPerMed), European countries aim to coordinate health research policy to advance the implementation of personalised medicine.
The Coordination & Support Action (CSA) PerMed was initiated to step up coordination efforts between European key stakeholders to allow synergies and avoid duplication or competition, to ensure maximum transparency and openness preparing Europe for leading the global way. The ultimate goals of the CSA PerMed are:

  • to complement existing activities by identifying and promoting promising research topics,
  • to develop strategic research and innovation agendas in Europe and beyond, and
  • to bring forward the implementation of Personalized Medicine for the benefit of society.

Find more at: http://www.icpermed.eu

Find the new report for 2017 in the attachments!





Health at a Glance: EUROPE 2016


Europeans live almost 7 years more compared to 1990, but this does not necessarily mean that these years are healthy or that risk factors have diminished, the newly released report Health at a Glance: Europe 2016 has highlighted.

The report, published by the European Commission and the Organisation for Economic Co-operation and Development (OECD), thoroughly analysed the state of healthcare across Europe, focusing on Health inequality and disparities in access to EU healthcare systems.


If 17 member states are above the EU average, some Eastern Europe countries are still below. Bulgaria and Latvia recorded the lowest life expectancy (74.5 years) while the highest was marked in Spain (83.3) and in Italy (83.2).

More than 1.2 million Europeans died in 2013 from illnesses and injuries that might have been avoided if public health and prevention policies had been more effective or timelier, while too many well-known risk factors - tobacco, unhealthy nutrition, scarce physical activity, alcohol abuse, stress - are ignored by national decision-makers.


Furthermore, the report remarked the need for more accessible and quality healthcare systems, urging the member states to make efforts to reduce financial barriers to healthcare and strengthen access to primary care. For instance, in Italy and France, the proportion of people reporting unmet needs due to financial reasons among the low-income population increased by more than 50% between 2008 and 2014.


An ageing population, combined with increasing rates of chronic diseases and national budgetary constraints, will require innovative solutions, focusing on developing eHealth, reducing hospital stays and spending "more wisely" on pharmaceuticals, including making full use of opportunities for generic substitutions.


"A key tool to support member states make smarter, more cost-effective investments, is EU cooperation on Health Technology Assessment (HTA), and I hope to make great strides in the coming years," EU Commissioner Dr. Andriukaitis said.


The HTA is a multidisciplinary process to assess the added value and effectiveness of a given health technology - for example medicine, medical devices, diagnostic tools or surgical procedures, over and above existing ones (see more information on HTA below).


To download your copy of the report, please visit:






SPECIAL BREXIT DOSSIER (updated 13 July 2017)



1) Dramatic lack of Radiologists after post-Brexit vote


The chronic shortage of radiologists in UK National Health System is becoming dramatic  following the Brexit vote in June, Royal College of Radiologists (RCR) President Dr. Nicola Strickland said in several interviews last month - and the situation is getting worse.

A third of UK radiologists already come from abroad and new recruitment campaigns have been launched in the past 6 months, without success. Fears generated by Brexit hurricane and potential visa restrictions led overseas consultants not to fill the vacancies, as uncertainty on British politics would made impossible to relocate with their families to the British Isles.

Dr. Strickland added Health Secretary Jeremy Hunt's proposal to train an additional 1,500 doctors each year will not possibly solve the problem, as only a small number of them will choose the radiology specialty and they won't even come through the system until 2030.

According to a census released by the Royal College of Radiologists (RCR) on 10 September 2016, demand for imaging services increases, but the supply of radiologists does not, if we just consider that between 2012 and 2015, the consultant radiologist workforce in Scotland grew by 5%, but the number of CT and MRI scans rose by 55%.

A key finding is that 99% of U.K. radiology departments could not already meet scan and x-ray reporting demands. Severe diseases as aggressive cancers may go undiagnosed and life-saving treatments become unavailable because of the shortage, while patients would be forced to seek for urgent treatment abroad.


2) Hard Brexit: towards a possible nightmare for British radiology?


After Prime Minister Theresa May´s decision to support a full and radical break from the EU, the British National Health System - NHS and the Royal College of Radiologists find themselves in a dramatic situation: while the Government has made clear it wants to allow current EU immigrants, a significant part of the the workforce, to remain after Brexit, almost nothing has been done in the last months to combat the increasing shortfall in radiologists, warns the President of the Royal College of Radiologists - Dr. Nicola Strickland.

With controls on qualified immigration, recruiting a new generation of radiologists is becoming more and more difficult - Dr. Strickland added - and reliance on teleradiology could be the only solution.

Among many other consequences, the European Medicines Agency (EMA) will probably relocate from its current headquarters in London, meaning Britain will lose a prestigious institution in the healthcare field and the power of influencing health policies.

Furthermore, UK policymakers still need to decide if to secure a deal with EFTA and how to cope with the European Committee for Standardisation after rejecting the European Union and the related European Economic Area agreements. A complicated transition period in import-export of CE marks and standards, with a bad impact on imaging hardware and IT products in the UK market.


3) Severe risk of Radioactive Isotopes shortages


Radioactive isotopes play a crucial role in cancer diagnosis and treatment. While facing Brexit negotiates, the Royal College of Radiology highlighted how most materials for PET/CT scanning are manufactured in the U.K., but the rest of the country's radioisotope supply is still imported from Europe and other regions, thus creating a serious risk of future shortages if the UK leaves the Euratom treaty under Brexit.










Joint IAEA and WHO Position Statement on the Bonn Call-for-Action


The International Conference on Radiation Protection in Medicine: Setting the Scene for the Next Decade held  in 2012 in Bonn, Germany had the specific purpose of identifying urgent  issues arising in medical radiation protection.

Participants from 77 different countries attended the Conference, whose main outcome has certainly been a proposal on incoming priorities regarding radiation protection in the next decade. This specific outcome has been called Bonn Call for Action.


Its aims are:

a) to strengthen the radiation protection of patients and health workers overall;

b) to attain the highest benefit with the least possible risk to all patients by the safe and appropriate use of ionizing radiation in medicine;

c) to aid the full integration of radiation protection into health care systems;

d) to help improve the benefit/risk-dialogue with patients and the public;

e) to enhance the safety and quality of radiological procedures in medicine.


Please, find the full text of the Bonn Call for Action in the attachment below.



Safety Standards for protection against dangers arising from Ionising Radiation


Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation introduced specific articles relating to two different areas:

  • Justification of medical exposures with respect to new types of practices and the interrelation with bio-medical research and early detection of diseases (art. 55 (2))
  • Accidental and unintended exposures of individuals subject to medical exposure focusing on specific requirements on notification and recording of significant events (art. 63 in conjunction with art. 96).

This Directive establishes uniform basic safety standards for the protection of individuals subject to occupational exposures, besides the medical and public exposures against the dangers arising from ionising radiation. Sources of ionising radiation can be processed radioactive materials, nuclear installations, natural radionuclides, x-ray machines and cosmic radiation. The Directive applies inter alia to the manufacture, production, processing, handling, disposal, use, storage, holding, transport of radioactive material and certain radiation emitting installations as well as the exposure of workers to radiation.

Member States will have time until the 6 February 2018 to complete the process of transposition into their national regulations.





Personalised Medicine Report (updated)


The Directorate-General for Research and Innovation has released the Personalised Medicine Conference Report after the conference which took place in Brussels on June 1-2, 2016. This report addresses the broader policy perspective and challenges by showcasing both integrated healthcare models in Member States and business approaches which involve patients more directly in their healthcare. Attached, the Council´s Conclusions on Personalised Medicine for patients. Please find the full report in the attachments below.

An International Consortium for Personalised Medicine (ICPerMed) was initiated during several workshops organised by the European Commission throughout 2016. ICPerMed aims to provide a flexible framework for cooperation between its member organisations.


More information regarding the Consortium available at:










Health Technology Assessment (HTA) (updated July 2017)


Health Technology Assessment (HTA) is a research-based tool to support decision-making in healthcare. HTA assesses the added value of new health technologies over existing ones, including medical devices anjd diagnostic tools.

HTA is used with a view to improving the quality and efficiency of public health interventions and the sustainability of the entire healthcare system, involving both national and regional players. The European Commission has recently published an inception impact assessment for an initiative on HTA, planned for the fourth quarter of 2017 which will be preceded by a public stakeholder consultation due to be launched in late autumn 2016.


On 22 September 2016, DG SANTE met with EUCOMED and EDMA representatives, both members of MedTech Europe alliance in relation to the recent publication of the DG SANTE Inception Impact Assessment (IIA) on strengthening the EU cooperation on HTA (14 September). Representatives of the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry, COCIR were also present as observers. The morning session, hosted by EUCOMED, focused on medical devices while the afternoon session, focused on in vitro diagnostics,  was introduced by EDMA. The objective of the meeting was primarily for the European Commission to present the initiative strengthening the EU cooperation on HTA and to explain the next steps including the imminent public consultation and recently launched studies; and for the medical technologies sectors to provide initial comments on the initiative.


Update - please find below the link to the consultation on HTA:



The European Network for Health Technology Assessment currently focuses on a core model for HTA, consisting of nine domains:


- definition of the health problem and current use of technology;

- description and technical characteristics of the technology;

- issues of safety; issues of clinical effectiveness; cost and economic evaluation;

- ethical aspects; organisational aspects; patient and social aspects; and legal aspects.


The Commission has received some 250 replies to its public consultation on strengthening EU cooperation on Health Technology Assessment, 25% of which from citizens and 75% from stakeholders. Almost all respondents acknowledge the usefulness of HTA and 87% consider that EU cooperation on HTA should continue beyond 2020. Of those who support sustainable EU cooperation on HTA, many think the scope should include pharmaceuticals and consider that medical technologies should also be covered.




In the attachments at the bottom of the page, you can find the minutes of the 8th meeting of the HTA Network, held in Brussels on March 29, 2017.





Agreement reached on Medical Devices and In-vitro Diagnostics (Updated April 2017)


On 25 May 2016, the Dutch Presidency of the Council of the European Union and the European Parliament have reached a draft agreement on the medical devices and in vitro diagnostic medical devices regulations. This agreement comes after a four-year long legislative process initiated by the European Commission's 2012 Proposal for a Regulation on medical devices and Proposal for a Regulation on in vitro diagnostic medical devices to replace the three existing medical devices directives. The Commission had considered a revision of the existing regulatory framework necessary to enhance the safety of medical devices while allowing patients to benefit from harmonised rules for timely and innovative health care solutions.

Devices will in future become fully traceable and patients receiving implantable devices must be informed of the product's key facts. Non-confidential information will be made available publicly through the central database European Databank on Medical Devices (Eudamed).

Another consequence will be the adoption of tighter rules for the notified bodies that are responsible for assessing medical devices, ensuring they have available qualified personnel to conduct factory inspections. The new regulation will also hold manufacturers responsible for continuous follow-up on the quality and safety of devices placed on the market, mandating manufacturers to monitor and act promptly in case emergencies arise.

Serge Bernasconi, CEO of MedTech stresses the importance of collecting necessary funds from public and private stakeholders (e.g. Governmental Health Agencies, Industry Representations) to fully implement the agreement, and confirms that industry bodies EDMA and Eucomed will actively support their members in the challenging transition towards a new, less bureaucratic regulation.

The European Patients' Forum (EPF) would have expected a closer involvement of patients, but still welcomes the agreement as a means to implement stricter controls on pre-market assessment and post-market surveillance of medical devices, resulting in better safety standards for patients.

The 25 May agreement still needs to be formally adopted by the Council and the Parliament to conclude the legislative process. It is also important to note the transition periods for the new rules, which will apply three years after publication of the medical devices regulation and five years after publication of the vitro diagnostic medical devices regulation.


On 5th April 2017, the European Parliament finally adopted two new regulations imposing stricter rules on medical devices' safety, which, in any case, will not enter into force before mid-2020. The regulations will be fully applicable in three years for medical devices and in five years for in vitro diagnostics.


The two new Regulations bring a number of improvements for medical and in-vitro devices:


- Improve the quality, safety and reliability of medical devices: The new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts to be consulted before placing the device on the market. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. Medical devices such as breast or hip implants will be traceable and the post-market surveillance will be reinforced. In addition, the regulation will provide random inspections of producers' facilities after devices have been placed on the market, as well as stricter controls on notified bodies, which will have to employ medically skilled people.


- Strengthen transparency: The new regulations will make sure that vital information is easy to find for consumers. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED).


- Enhance market surveillance: Once devices are available for use on the market, manufacturers will be obliged to collect data about their performance and EU countries will coordinate more closely in the field of market surveillance.


Please find in the attachments below an interesting presentation on the current status of medical devices and future proposals prepared by DG GROWTH, Internal Market, Industry, Entrepreneurship and SMEs.






Data Protection Legislation and sensitive data


On 25 January 2012, the European Parliament and the European Council have adopted a first draft proposal for the regulation of sensitive personal data with particular regard to their processing, movement or distribution. This had been done to address the uncertainty of a very fragmented legislative framework between 28 Member States and since the last concerning Directive had been adopted in 1995 (Directive 95/46/EC).

In the field of health care, this first proposal has provoked a massive request from medical professionals' organisations, patients´ associations and industry representatives for a more balanced approach to the topic, allowing access to health data and statistics for research purposes. After prolonged discussions, a revised agreement on data protection has been adopted by the European Parliament in April 2016 and officially published in the EU Official Journal on 4th May, 2016.

This Regulation (EU - 2016/679) will apply from 25th May 2018, meaning that Member States still have two years to transpose the provisions of the directive into their national law. It is an essential step to strengthen citizens' fundamental rights in the digital age and facilitate business by simplifying rules for companies in the Digital Single Market; its main outcomes are:

- Personal consent should be given by a clear affirmative act establishing a freely given, specific, informed and unambiguous indication of the data subject's agreement to the processing of personal data, such as by a written statement or by electronic means.

- Processing of personal data for archiving purposes in the public interest, scientific or historical research or statistical purposes should be subject to appropriate safeguards for the rights and freedoms of the data.

- Right to data portability, including the health sector. Furthermore, the data subject will have the right to obtain any automated data which are processed using consent as the legal basis for processing in an easy-to-read format. This could mean hospitals and health and care providers being asked by patients to receive their electronic data in an appropriate format.

- Establishment of an independent supervisory authority for processing personal data at national/regional level which should be provided with the financial and human resources, premises and infrastructure necessary for the effective performance of the tasks.

- Genetic data should be defined as personal data relating to the genetic characteristics of a person which result from the analysis of a biological sample from the person in question, in particular chromosomal, deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) analysis.

- Data subject shall have the right to obtain from the controller the erasure of personal data concerning him/her without undue delay and any person has the right to have their personal data rectified or 'the right to be forgotten' but it still allowed the further retention of data when necessary in the public interest or in the exercise of official authority vested in the controller, for reasons of public interest in the area of public health, for archiving purposes in the public interest, or scientific and historical research purposes.

- Children and consent - parental prior consent is required for use of an under 13 year old's personal data. Member States are free to set their own rules for those aged 13-15. If they choose not to, parental consent is required for children under 16.

Data Protection Officer: organisations/companies above 250 employees must appoint a Data Protection Officer (DPO). This post can be shared with other organisations.

- National data protection authorities, also called supervisory authorities will continue to exist to protect fundamental rights in relation to data processing and to facilitate the free flow of personal data within the Union. Some countries (e.g. Germany) can keep more than one supervisory authority, but one of them has to be nominated as the representative on the new European Data Protection.

-  Creation of the European Data Protection Board, which is established as a body of the Union with legal personality. The Board shall be composed of the head of one supervisory authority of each Member State and of the European Data Protection Supervisor and will ensure the consistent application of the Regulation, together with opinions, guidelines and best practices.

- Introduction of levels of fine up to 4% of the annual worldwide turnover for companies who misuse personal data, abuse the rights of the data subject or fail to implement requirements of the Regulation.

To summarise, the new regulation provides a more balanced approach between protecting privacy and making sensitive data available for research projects, where grounds of public interest (e.g. public health purposes) allow it. The processing of personal data concerning health may still be necessary for reasons of public interest in the areas of public health, without consent of the data subject. This in the consideration of the fact that sensitive data could be used to:

-  better understand diseases and improve treatments

-  understand patterns and trends in public health

-  plan services that make the best of limited financial resources

-  monitor the safety of drugs and treatments

-  compare the quality of care provided in different states of the Union.

Once again, the new regime does not entirely rule out the relevance of national provisions. As stated in Recitals 8 and 10, in fact, the Regulation provides a margin of manoeuvre for Member States' to restrict or specify its rules.

In addition to the EU legislative framework, the Organisation for Economic Cooperation and Development (OECD) establishes that "Informed consent has become the pillar for protecting individual's autonomy where research involves human subjects." In particular, the OECD data protection legislation grants patients (as data subjects) a number of rights once identifiable data are processed. The following are included:

- to be aware of the processing of their data, its purposes, the identity of the data controller, the identity of the possible recipients of the data;

-  to have access to a copy of the information comprised in their personal data;

-  to object to processing;

-  to prevent processing for direct marketing;

-  to object to decisions being taken by automated means;

-  to have inaccurate personal data rectified, blocked, erased or destroyed;

-  to claim compensation for damages caused by a breach of the Privacy Directive.

Member States are allowed to apply more stringent rules to legitimize the data subject's consent, through the provision of written consent or preventing consent from being the sole basis to authorize the generally prohibited processing of personal health data. The data subject may always revoke the given consent at any time and without justification. This will impede further processing, but not making past operations retrospectively unlawful. Consent must be a "freely given, specific and informed indication of the data subject's wishes". The Privacy Directive does not require the consent to be in written form.

- Freely given consent: "Free" consent means a voluntary decision, by an individual in possession of all of his faculties, taken in the absence of coercion of any kind, be it social, financial, psychological or other. Furthermore, agreeing to undergo a certain medical treatment does not automatically furnish an explicit consent to the processing of personal data collected during such treatment.

Specific consent: "Specific" consent must relate to a well-defined, concrete situation in which the processing of medical data is envisaged.

Informed consent: "Informed" consent means consent by the data subject based upon an appreciation and understanding of the facts and implications of an action: The individual concerned must be given, in a clear and understandable manner, accurate and full information of all relevant issues (...) such as the nature of the data processed, purposes of the processing, the recipients of possible transfers, and the rights of the data subject. This includes also an awareness of the consequences of not consenting to the processing in question.

Consent withdrawal: The consent could be considered as the weakest way to process data as the data subject has a total control on it without any consideration on the "scientific interest" for the whole society. The withdraw of consent may occur damage to the data controller as it can invalidate all the research in some cases even when the data subject has no real or valid reason.



(find out more of the EU current initiatives for eHealth in the attachment below).

Find also attached below an interesting position-paper report from the European Patients´ Forum.



Radiation Protection in Europe


Please find below the link to the current framework of Radiation Protection legislation in Europe.




Radiation Protection publications in the EU:



Radiation Protection events and seminars:










EU BAROMETER 2016 - Health Sector





pdf2016_ehealth leaflet.pdf
pdfCouncil Conclusions Personalised Medicine for Patients.pdf
pdfPosition Paper on eHealth
pdf25 years of European Health Policy.pdf
pdfMinutes 8th HTA meeting.pdf
pdfProposal Medical Devices.pdf

Friday, November 24, 2017