EU NEWS
June 2024 – We are proud to announce that EAP actively contributed to the “Orphan Medical Device Guidance” document, which has now been endorsed and published by the European Commission as MDCG 2024-10.
This document, titled “MDCG 2024-10 – Clinical evaluation of orphan medical devices,” is available on the European Commission website.
Many of the suggestions I contributed on behalf of EAP and the paediatrics community have been included. This marks a significant step forward in ensuring more appropriate conformity assessments of medical devices for children by Notified Bodies across the EU.
The journey is not over: There is a pressing need to address the exorbitant costs associated with conformity assessments, which could otherwise hinder the availability of paediatric medical devices.
The next steps involve lobbying the newly elected EU Parliament, the new EU Commission, and member states to address these financial barriers to ensure that paediatric diagnostic and therapeutic options remain accessible is our ongoing commitment.
A special thanks to the volunteers working on this initiative for their tireless efforts to make a difference:
- E. Arbelo
- M. Antunes
- K. Baciocchi
- A.W. Van Drongelen
- P. Bischoff-Everding
- R. Bombien
- S. Buchholz
- C. Cambiano
- C. Chiumia
- N. Deych
- S. Edwin
- J. Emmanuelle
- A. Fraser
- A.G. Fraser
- M. Gewillig
- V. Hoymans
- L. Hovestadt
- J. Knauer
- B. Koletzko
- R. Kessels
- J. Martins
- M. Meijer
- Melvinto
- M. Neumann
- B. Nuyttens
- D. O’Connor
- P. Piscoi
- J. Russo
- T. Sanchez
- I. Sidiropoulos
- M. Tyka
- A. Villarta
EACCME 3.0 Conference: Industry Support, Bias, Competence-Based Medicine, EDI, Ethics, Green Practice, General Practice/Family Medicine... and much more!
Brussels, 18 March 2024 – EACCME 3.0 Conference Press Release (Read the PDF version here)
One year after the implementation of EACCME 3.0, the EACCME conference was a much-anticipated event. This two-day conference, which took place on 8-9 March 2024 in Brussels, provided an opportunity for CME/CPD stakeholders to discuss and debate about the new criteria. With an attendance of around 150 participants, European and international faculty and up to date discussion topics, the event met its promises. The highlight of the conference was the signing of a collaboration agreement between the UEMS-EACCME and the European Union of General Practitioners (UEMO) in the field of accreditation!
The 6th Conference, organised by the UEMS-EACCME, was entitled EACCME 3.0: The Next Frontier – A Pan-European CME-CPD Partnership. After the usual presentation of the EACCME figures for the past year, the first session addressed the grey areas of industry funding, starting with an interesting comparison between the EFPIA code and the EACCME 3.0 criteria, followed by examples of bad practice taken from applications submitted to the EACCME for review. The second session tackled the complex issue of bias, and how to minimize its effect on CME/CPD programmes. Although commercial bias is often referred to in relation to the funding of a CME/CPD activity, other forms of bias exist such as state, political, cultural…bias which are as equally important. After a presentation of the French accreditation model with CME/CPD activities obeying a framework guaranteeing independence from the industry, the second presentation provided a detailed overview of the different biases that exist, such as publication, unconscious or confirmation bias. A presentation on Competence-Based Medicine and its application to CME/CPD programmes made up the third session, which included the Canadian competency-based medical education (CanMEDS) and the Entrustable Professional Activity (EPA) concepts. The morning session ended with a fourth plenary session on Equality, Diversity and Inclusion (EDI), Ethics and Green Practice. Following practical examples of implementation of these concepts in the organisation of a CME/CPD activity, the question was posed if EACCME should grant extra credits to activities taking these elements into account. The regulator’s point of view was then presented with the accent placed on the notion of trust and its various levels.
The climax of the morning session was an agreement signing session between representatives of the UEMS and UEMO to formalize the collaboration between both organizations in the field of accreditation for general practitioners/family doctors. The UEMS-EACCME is very proud of this achievement in the advancement of CME/CPD for all doctors in Europe and beyond. The EACCME platform will from now on serve as entry point for the submission of activities aimed at general practitioners/family doctors also.
The afternoon session was dedicated to the presentation of an assessment of CME/CPD systems in Europe and beyond and to an abstract session. The audience then split into various working groups to brainstorm over the morning plenary sessions. Some very constructive feedback came out from these
groups to feed into EACCME 4.0!
On the following day National Accreditation Authorities gave a presentation of their collaboration with EACCME and the implementation of EACCME 3.0 in their country. It was then the turn of External Partners to express their appreciation of their collaboration with the EACCME over the years. And last but not least three groups of providers shared their views and concerns about EACCME 3.0 with the audience. They all acknowledged the openness of EACCME in discussing these issues and are looking forward to the continued collaboration with the EACCME.
All in all, the EACCME Conference was a huge success! The UEMS-EACCME was applauded for investing the necessary time and resources to host such an important event, gather an impressive panel of expert faculty, and promote cooperation amongst the various stakeholders. The UEMS Enlarged Executive presents its grateful thanks to all colleagues involved and looks forward to the next conference in 2026!
The Coalition supports the Council recommendation on vaccine-preventable cancers
31 January 2024 – The Coalition for Vaccination issued a press release after the European Commission published its proposal for a Council recommendation on vaccine-preventable cancers.
European healthcare professionals welcome the European Commission’s recommendation to support EU countries in their efforts to prevent cancer through vaccination against Human papillomaviruses (HPV) and Hepatitis B virus (HBV).
The Coalition is particularly pleased to see that the measures include providing vaccination free of charge and/or fully reimbursed, ensuring that vaccination is easily accessible, and setting a concrete target for HPV vaccination for boys.
Moreover, it is important that EU countries will be supported to strengthen communication efforts and address mis- and disinformation, improve monitoring and reporting of vaccination coverage, and put electronic vaccination registries in place.
Finally, European healthcare professionals agree that immunisation against vaccine-preventable cancers should be integrated into national cancer plans.
The Coalition for Vaccination reaffirms that vaccination is a safe and efficient way of protecting individuals and populations from vaccine-preventable communicable diseases.
Healthcare professionals are trusted sources of information for patients, parents, young people and carers, and they can help families make informed decisions that contribute to public health. Moreover, they can help build vaccine confidence and address mis- and disinformation by sharing facts and reliable information among their communities.
The Coalition for Vaccination, co-chaired by the European Federation of Nurses Associations (EFN), the Standing Committee of European Doctors (CPME), and the Pharmaceutical Group of the European Union (PGEU), calls on the EU policymakers to keep vaccination high on the political agenda.
EAP is proud to be involved in the “Overcoming Obstacles to Vaccination” project consortium to enhance immunization efforts and contribute to public health across diverse fronts.
European Experts Warn About Shortages Of Medical Devices For Children And Give Recommendations On Clinical Investigation And Evaluation
Brussels, 18 August 2023 – Paediatricians across Europe have voiced serious concerns about the evolving shortages of medical devices in the European Union (EU) that are essential for treating sick children. Devices are withdrawn from the market due to markedly increased regulatory requirements and high costs of certifying devices under the revised EU Medical Device Regulation. Urgent action is therefore needed to protect the access to essential medical devices for children.
As part of the EU CORE-MD project (Coordinating Research and Evidence for Medical Devices), the European Academy of Paediatrics (EAP) hosted a high-level expert workshop at the Ludwig Maximilians University Munich, Germany. Experts developed recommendations on clinical investigation and on clinical evaluation of paediatric medical devices considered to be of “high-risk”. Experts from a variety of paediatric clinical subspecialties and European paediatric associations, as well as from a regulatory authority and from the European Commission Directorate General Health and Food Safety contributed.
The paediatric experts agreed on key elements for clinical investigation and evaluation of high-risk medical devices for children:
- The establishment of a European expert panel with competent paediatric experts dedicated to paediatric medical devices is needed to advise on their evaluation
- Recommendations for a facilitated and low-cost evaluation of “orphan medical devices” used on only few patients as well as criteria for assigning an orphan medical device status were defined
- Full transparency and sharing of clinical evidence supporting the evaluation and certification of medical devices is called for, in the interest of patient safety
- Recommendations on approaches of clinical evaluation of medical devices in children were defined, considering ethical aspects and feasibility
- The establishment of European registries of paediatric patients and other patients with rare (orphan) diseases requiring medical devices is called for, to gather additional evidence after market access
The expert recommendations are published in Acta Paediatrica:
Open Positions, Eu-Funded Project: Eap Seeking Postdoctoral Fellow And Phd Candidate
We are excited to announce an opportunity to join the European Academy of Paediatrics (EAP) in a role that contributes to advancing education and knowledge on vaccines and immunization.
We are seeking a highly motivated postdoctoral fellow (MD with research experience) and a dedicated PhD candidate (MD or Master in medicine/health sciences) to participate in an EU-funded project focused on elevating the Standard of Education and Knowledge on vaccines and Immunization (SEKI, visit the SEKI website here).
Read the full details and description of the roles (PDF).
The application deadline is 15 September 2023.
To apply, please submit the following documents via this online form*:
- 1–3-page motivational letter
- Academic CV
- Certified copies of your degrees
*You are required to sign into a Google account to submit your response (security feature). If you have any trouble, please reach out to us at secretariat@eapaediatrics.eu.
Apply at your earliest convenience to seize this opportunity. We are at your service for questions or more information
EUPHA urges the European Commission to implement a harmonised, EU-wide, mandatory, effective front-of-pack nutrition labelling scheme
The European Public Health Association (EUPHA) urges the European Commission to implement a harmonised, EU-wide, mandatory, effective front-of-pack nutrition labelling scheme urgently and that the current evidence-base identifies Nutri-Score as the preferred option. A previously published position paper by the European Academy of Paediatrics (EAP) drew similar conclusions.
Read the full document: “EUPHA Statement on front-of-pack nutrition labelling in the European Union“ here.
Read the EAP Position paper on the same topic: “Front-Of-Pack Nutrition Labelling: A Position Statement of the European Academy of Paediatrics and the European Childhood Obesity Group” here.
IMMUHUBS Survey - PARTICIPATE!
Dear participants,
We hereby invite you to fill out the SymptomSurvey and contribute to an understanding of the way how people think and behave as a patient, and/or caregivers of a child or elderly adult. The experience of being in the role of patient/caregiver is one of the most pivotal sources of information for strengthening cooperation within a healthcare system. We know how important is that both healthcare professionals and policymakers understand the position of patients and caregivers. Therefore, we are conducting a comprehensive study within the Innovative Immunisation Hubs project, called The SymptomSurvey – led by the Vienna Vaccine Safety Initiative in collaboration with Families Fighting Flu and Make Mothers Matter. The SymptomSurvey is your opportunity to tell healthcare providers how you as a patient or caregiver experience and understand different symptoms. There are no wrong or right answers – the right answer is an honest one – we would like to know how you think. The obtained insights will be used for informing the healthcare system and improving patients’ positions.
Several EAP Members are involved in the IMMUHUBS project, either chairing or participating in a Work Package. Visit the Immuhubs website for more information.
Read More and Take the Survey…
Thank you in advance for your time and answers!
Q And A With Dg Sante Boss Anne Bucher
DG SANTE will see a new commissioner at its helm this fall — but the top civil servant will stick around. Anne Bucher began as director general of the European Commission’s health department on October 1, making her one of the newest director generals to enter office as Brussels prepares for a change in political leadership this year.
Europe Most Vaccine-Skeptic Region In The World, Survey Says
Europe is a deep pocket of doubt when it comes to vaccines. Between 10 percent and 22 percent of people in countries across Europe don’t trust that vaccines are safe, a new survey published Wednesday by the Wellcome Trust found.
How To Convince The Public That Vaccines Are Safe
Populism has entered the realm of public health, with nearly half of Europeans convinced that inoculations can be dangerous to humans. In this installment of Health Care 2024 — a series of symposiums asking leading experts to weigh in on the health care priorities for the next European Commission — POLITICO asks: What can be done to counter vaccine skepticism and convince Europeans that vaccines are safe and beneficial?
Privacy In The Age Of Digital Medicine
Big data has the potential to provide personalized treatment, help researchers tackle the latest diseases and better anticipate epidemics. But it also requires patients to entrust governments and companies with vast troves of personal data.
Stella Kyriakides’ Nomination Puts Patient Advocate In Top Eu Health Post
A professional patient advocate is set to take charge of the Commission’s health department.
Stella Kyriakides, 63, is a breast cancer patient, the daughter of a breast cancer patient, and a past president of the Continent’s most prominent breast cancer patient group: Europa Donna. A medical psychologist, she’s also proven to be a savvy and sympathetic political operator, according to people who’ve seen her in action in the Cypriot parliament.
Juncker’s Vaccination Legacy Needs A Booster Shot
Jean-Claude Juncker’s tenure as European Commission president will end with an unchecked resurgence of measles — despite his unusual intervention on a health-related matter. On Thursday, Juncker blamed “stupid mistrust” of vaccines, in part, for deaths from preventable diseases in Europe. People who decline immunizations are “playing with fire,” he warned.
How Europe Can Better Tackle Rising Cancer Incidence
Cancer, the second leading cause of death globally according to the World Health Organisation, is responsible for an estimated 9.6 million deaths in 2018. In light of projections that the cancer incidents in Europe will double by 2035, a new survey conducted by Central and Eastern European Cancer Action Group (CEECAG), has identified large differences between Europe’s west and central and eastern countries in handling cancer.
Vaccine Innovation: Europe’s Crucial Role In Advancing Global Public Health
Vaccination is a success story. Over the last century, vaccines have eliminated or nearly eliminated many diseases that were once widespread and often fatal, such as smallpox and polio, writes Nanette Cocero, the Global President of Pfizer Vaccines.
Better Access To Health Innovation Is Kyriakides’ Top Priority (And Hardest Task)
With increased powers, Health Commissioner-designate Stella Kyriakides is tasked with striking a difficult balance between making sure there is a steady supply of affordable medicines and ensuring that EU pharma industry remains a world leader in innovation.
Center-Right Meps Call For Special Eu Parliament Committee On Cancer
The European People’s Party (EPP), the biggest political group in the EU assembly, will ask for the creation of a special parliamentary committee to help formulate a new EU-wide plan to combat cancer. EURACTIV.com and EURACTIV.cz report from Strasbourg.
Romanian Presidency Of The Eu Aims For Council Conclusions On Amr In June
The Romanian Presidency of the EU has tentatively scheduled the adoption of conclusions on Antimicrobial Resistance (AMR) and associated infections for Health Council on the 14th of June. The document will outline joint efforts among the EU member states on this pressing health issue.
According to Romania’s Health Minister, Sorina Pintea, one of the main goals of these Conclusions is to define common approaches between the human, veterinary, and environmental sectors.
More Action Needed To Reduce Digital Marketing Of Unhealthy Products To Children, Says Who/Europe
The new WHO/Europe report “Monitoring and restricting the digital marketing of unhealthy products to children and adolescents” highlighted the need for greater monitoring of the digital marketing of alcohol, tobacco and unhealthy food products.
According to the report, although there is scare data on children’s digital lives, children’s time spent online, including on social media, has steadily grown, meaning that their exposure to digital marketing has also increased. The report urgently calls for developing and implementing a set of tools for monitoring the exposure of children to digital marketing.
The full report is available HERE.
Ec Vice-President Katainen Urges For Eu Greater Action Against Disinformation On Vaccination
The European Commission Vice-President Jyrki Katainen, who is temporarily responsible for the Health and Food Safety portfolio following Commissioner Andriukaitis’ resignation, called for greater actions on vaccine confidence.
In an op-ed entitled “Vaccinating Against Misinformation”, Vice-President Katainen stressed the importance of taking immediate EU action against the misinformation epidemic (online and offline): “We have to join forces at EU level and work together to increase vaccination coverage and confidence as well as ensure access to vaccines for all.”
The full op-ed can be read HERE.
New European Parliament Coordinator For Children’s Rights
On 11 December, Ms Anna Maria Corazza Bildt (Swedish MEP, EPP) has been appointed by the European Parliament President, Mr Antonio Tajani, as the institution’s new coordinator for children’s rights. She will be the new European Parliament spokesperson on this topic, and will have to promote, respect and safeguard the rights of children and young people in all of the institution’s policies and legislation.
The official press release from the European Parliament can be found here.
New European Commission Report On The State Of Health In The Eu
On 22 November 2018, the European Commission launched the second cycle of the State of Health in the EU with the release of a new report – Health at a Glance: Europe 2018. Developed in cooperation with the OECD, the report focuses on the health status of EU citizens and it analyses the performance of the health systems of the 28 EU member states, 5 candidate countries and 3 EFTA countries.
More information can be found here.
Council Recommendation On Vaccines
During the 7th of December EPSCO meeting, EU health ministers adopted the Recommendation on strengthened cooperation against vaccine-preventable diseases. Although it is not a legally-binding act, the document sets out a number of actions that the EU member states, as well as the European Commission, should take, while respecting their competencies.
Some examples of proposed actions are: strengthening vaccine supply, communication and education activities related to the benefits of vaccination, and the establishment of a European Vaccination Information Sharing system.
The full recommendation can be read here.
Romanian Presidency Of Pesco And Of The Council Of The European Union
On 6th of December, Romania symbolically took over the Presidency of the Employment, Social Policy, Health and Consumer Affairs Council configuration (EPSCO), in the context in which Romania will hold the Presidency of the Council of the EU from 1st of January 2019.
The Romanian Presidency declared that it has the following health priorities for the next 6 months (the duration of its Presidency): (i) AMR and infectious diseases; (ii) Vaccination; (iii) Access to medicines; (iv) e-Health (digital health); and (v) Mobility of patients. The timetable of health-related events and meetings will be made public on 1st of January 2019.
More information can be found here.
Dg Sante And Ema Publish Joint Action Plan On Medicines For Children In Europe
The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) announced the publication of a joint Action Plan on Medicines for Children in Europe.
With the goal of addressing challenges identified in the European Commission’s ten-year report on the implementation of the Paediatrics Legislation, the joint Action Plan will focus on five key items:
- Identification of paediatric needs;
- Stronger cooperation between decision-makers;
- Timely completion of paediatric investigation plans (PIPs);
- Improving the handling of PIPs;
- Greater transparency around paediatric medicines.
The full Action Plan can be read here.
Who European Region Shows Mixed Vaccination Outcomes
In the midterm review of its European Vaccine Action Plan 2015-2020, the World Health Organization pointed out that its European region has shown “mixed outcomes” in terms of vaccination. The same report shows that European region will not eliminate measles and rubella by 2020. Regional vaccination rates for the diphtheria-tetanus-pertussis (DTP) vaccine are also declining.
Further information can be found on the full report.
Romanian Presidency Of The Eu Hints At Their Health Priorities
In an emailed statement, Romanian Minister Sorina Pintea mentioned the country, which will take over the EU Presidency from Austria in January 2019, will have access to medicines as one its health priorities. Romania will also work towards narrowing the gap in supply between EU member states.
The full list health priorities for the Romanian Presidency of the EU is will soon be finalised and publicly announced on their official website.
Anne Bucher Appointed New Director-General Of Dg Sante
The European Commission has appointed Anne Bucher as the new Director-General of their Directorate-General for Health and Food Safety (DG SANTE). Starting her new role on the 1st of October, Bucher will replace Xavier Prats Monné, who will retire after 4 years as DG SANTE’s Director-General and 32 years of overall service in the European Commission.
Anne Bucher has previously worked in the directorates-general for economic affairs; and for communications, networks content and technology. She currently serves as the chair of the Commissions’ Regulatory Scrutiny Board.
More information can be found here.
Health Policies In The Upcoming Eu Budget (2021 – 2027)
On the 2nd of May, the European Commission adopted the legislative proposal the future EU budget for 2021 – 2017, also called the Multiannual Financial Framework (MFF). Within this new MFF, health has been incorporated into the European Social Fund Plus (ESF+) programme, and it is supposed to support public health policies and access to medical products.
The new health strand will have to achieve its objectives through the reduction of inequalities in public health capacities among and within EU member states. However, it must do this with a reduced budget of only EUR 413 million. The Commission has reiterated the fact that the Health Strand will receive a (financial) boost from other EU financial instruments (i.e. the European Regional Development Fund, Horizon Europe, InvestEU Fund, etc.). More information can be found
European Commission Proposes Council Recommendation On Strengthened Cooperation Against Vaccine Preventable Diseases
In April 2018, the European Commission proposed a (non-binding) Council Recommendation through which it hopes to reduce vaccine-preventable disease across the European Union. Although the EU member states are in charge of their vaccination policies, the Commission hopes to strengthen their cooperation in order to tackle vaccine hesitancy, improve coordination on vaccine procurement, support research and innovation, and strengthen overall cooperation on vaccine preventable diseases.
The full EC proposal can be found
Who Independent High-Level Commission (Ihlc) Releases Noncommunicable Diseases (Ncds) Report
In preparation for the UN General Assembly’s third High-level Meeting on the prevention and control of noncommunicable diseases (NCDs), which will take place on the 27th of September 2018 in New York, the WHO Independent High-Level Commission (IHLC) published its “NCDs – Time to Deliver” report on the 1st of June 2018.
In the document, the WHO Commission identifies “bold recommendations to enable countries to curb the world’s leading causes of death”. Although the focus is primarily on meeting the Sustainable Development Goal target 3.4 (reducing premature mortality from NCDs), the report analyses the impact of NCDs and of mental health problems on children and young people.
The full report can be accessed
Health Priorities Of The Future Austrian Presidency (July – December 2018)
In preparation for the UN General Assembly’s third High-level Meeting on the prevention and control of noncommunicable diseases (NCDs), which will take place on the 27th of September 2018 in New York, the WHO Independent High-Level Commission (IHLC) published its “NCDs – Time to Deliver” report on the 1st of June 2018.
In the document, the WHO Commission identifies “bold recommendations to enable countries to curb the world’s leading causes of death”. Although the focus is primarily on meeting the Sustainable Development Goal target 3.4 (reducing premature mortality from NCDs), the report analyses the impact of NCDs and of mental health problems on children and young people.
The full report can be accessed
Dg Health Publishes 2017 Country Health Profiles
Through its Directorate-General for Health and Food Safety (DG HEALTH), the European Commission (EC) has made available the 2017 Country Health Profiles for each of the EU member states. Prepared in cooperation with the OECD and the European Observatory on Health Systems and Policies, the Profiles take stock of the state of health, main risk factors and health systems performance of each country.
The documents also analyse key child health elements such as obesity, vaccination and immunisation, life expectancy and access to health across all societal groups.
In addition to each member state’s report, the EC also presented an interactive EU map with comparisons between each country’s key health figures and the EU average. All the tools can be found here.
Ecdc Warns About Measles Outbreaks In Europe
A new European Centre from Disease Control and Prevention (ECDC) report shows high measles rates in EU countries such as Romania, Italy, Germany and Greece in 2017. The majority of the cases listed (87%) were due to the lack of, or incomplete, immunisation.
Other countries, such as the UK, France and Sweden are reporting worrying emerging outbreaks; while in Greece, 2 of the 968 reported measles cases resulted in death.
The full ECDC’s Monthly Report on Measles and Rubeola can be read here.
Eu Health Promotion And Disease Prevention Knowledge Gateway Launched
The EU has launched its Health Promotion and Disease Prevention Knowledge Gateway, a complete and user-friendly online platform with up-to-date information on key prevention elements of non-communicable diseases. The Gateway presents key data, definitions, policy updates and recommendations for best-practices and actions on diet and physical activity, as well as alcohol-related harm and marketing of food and (non-alcoholic) beverages to children and adolescents. Furthermore, it showcases societal impact aspects and the economic cost of non-communicable diseases.
Created in collaboration with public health experts in EU Member States, the Gateway seeks to present structured and succinct public health information for decision- and policy-makers, public health professionals and the general public alike.
The EU Health Promotion and Disease Prevention Knowledge Gateway is hosted by the EU Joint Research Centre and can be found here.
Refugee Children Health Concerns Highlighted In New Unicef Report
The EU has launched its Health Promotion and Disease Prevention Knowledge Gateway, a complete and user-friendly online platform with up-to-date information on key prevention elements of non-communicable diseases. The Gateway presents key data, definitions, policy updates and recommendations for best-practices and actions on diet and physical activity, as well as alcohol-related harm and marketing of food and (non-alcoholic) beverages to children and adolescents. Furthermore, it showcases societal impact aspects and the economic cost of non-communicable diseases.
Created in collaboration with public health experts in EU Member States, the Gateway seeks to present structured and succinct public health information for decision- and policy-makers, public health professionals and the general public alike.
The EU Health Promotion and Disease Prevention Knowledge Gateway is hosted by the EU Joint Research Centre and can be found here.
