Medicinal products

Commission Implementing Regulation (EU) 2022/20 on setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

https://ec.europa.eu/newsroom/sante/redirection/item/732392/en/259

EU Health Policy

Health Policy Platform Webinar - Thematic Network led by ASPHER on Climate and Health in Europe (11 January 2022, 15.00-16.45 CET)

https://ec.europa.eu/newsroom/sante/redirection/item/732391/en/259

EU Health Policy

Health Policy Platform Webinar - Thematic Network led by ASPHER on Climate and Health in Europe (11 January 2022, 15.00-16.45 CET)

https://ec.europa.eu/newsroom/sante/redirection/item/732087/en/259

Non-communicable diseases

Presentations - Meeting of the Subgroup on Cancer (16 December 2021)

https://ec.europa.eu/newsroom/sante/redirection/item/731760/en/259

Health security and infectious diseases

9th update - Common list of COVID-19 rapid antigen tests

https://ec.europa.eu/newsroom/sante/redirection/item/731762/en/259

Medical Devices

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

https://ec.europa.eu/newsroom/sante/redirection/item/731623/en/259

Medicinal products

Annual report from EMA to the Commission on the application of the Regulation on medicines for children

https://ec.europa.eu/newsroom/sante/redirection/item/731701/en/259

Medicinal products

EU-UK relations: Commission delivers on promise to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta

https://ec.europa.eu/newsroom/sante/redirection/item/731489/en/259

Medicinal products

Questions and Answers on Commission Proposal to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta

https://ec.europa.eu/newsroom/sante/redirection/item/731491/en/259

Cross-border healthcare

Member State Data on cross-border healthcare – Year 2020

https://ec.europa.eu/newsroom/sante/redirection/item/731492/en/259

European Council, 16 December 2021

• COVID-19: European Council reviews the current epidemiological situation and travel guidance in view of Omicron

ladies and gentlemen,

All of us around the table today acknowledged that the combination of the high transmissibility of the Delta variant in parallel with the large vaccination gap and the easing of non-pharmaceutical interventions and personal behaviours has led us to where we are today.

The State of Health in the EU’s Country Health Profiles provide a concise and policy-relevant overview of health and health systems in the EU/European Economic area, emphasizing the particular characteristics and challenges in each country. The 2021 edition has a special focus on the impact and responses of European health systems to the COVID-19 pandemic. Each Country Health Profile provides a short synthesis of:

• health status (including mortality from COVID-19)
• risk factors to health (including behavioural and environmental risks)
• the organisation of the health system and health spending
• the effectiveness, accessibility and resilience of the health system to the pandemic

Today, the Commission published a study on medicines shortages in the EU, which has been requested by stakeholders, the European Parliament and the Council. Shortages present a significant problem for the quality and continuity of patient care, and can also have economic consequences. Though a number of actions have been launched in recent years to address shortages at EU-level, the COVID-19 pandemic has further highlighted the issue of availability of medicines and the vulnerabilities of supply chains. The study published today provides an overview of medicines shortages in the EU, on the basis of available data, as well as an analysis of their roots causes. It also presents an evidence-based assessment of the current legal framework, as well as potential solutions to address shortages through a series of 16 policy measures. The report will feed into the Commission’s on-going work on the Pharmaceutical Strategy, an ambitious, long-term project in the area of health, intended to make the European pharmaceutical system patient-centred, future-proof and crisis-resistant. The Commission aims at presenting a legislative proposal at the end of 2022, including measures to address shortages.

• Health: Commission publishes study on shortages of medicines

Today, the Regulation on Health Technology Assessment (HTA), a deliverable of the EU Pharmaceutical Strategy, has been adopted. The new rules will allow vital and innovative health technologies - such as innovative medicines, certain medical devices, medical equipment and prevention and treatment methods - to be more widely available. The Regulation will also ensure the efficient use of resources, strengthen the quality of HTA across the EU, and save national HTA bodies and industry from duplicating their efforts, reassure business and ensure the long-term sustainability of EU HTA cooperation.

• Health: Commission welcomes the adoption of the Regulation on Health Technology Assessment

Today, the European Commission published an opinion by the Independent Expert Panel on effective ways of investing in health on European solidarity in public health emergencies.

RÉUNION DU COLLÈGE : Points à l'ordre du jour

Le Collège des commissaires se réunit cet après-midi à Strasbourg. Au cours de la réunion, les membres du Collège discuteront d'un paquet de mesures liées à l'énergie et l'action pour le climat, y compris de propositions sur le marché du gaz, les émissions de méthane, les bâtiments, l'agriculture du carbone et la séquestration du carbone.

The European Food Safety Authority (EFSA) has re-evaluated the risks of bisphenol A (BPA) in food and proposes to considerably lower the tolerable daily intake (TDI) compared to its previous assessment in 2015. EFSA’s conclusions on BPA are explained in a draft scientific opinion that is open for public consultation until 22 February 2022 (new extended deadline).All interested parties are encouraged to contribute to the consultation.

• Food Safety: EFSA launches public consultation on Bisphenol A as food contact material

Campylobacteriosis was the most reported zoonosis in the EU in 2020, with 120,946 cases compared to more than 220,000 the previous year. It was followed by salmonellosis, which affected 52,702 people compared to 88,000 in 2019. The number of reported foodborne outbreaks also fell by 47%. These findings are based on the annual EU One Health zoonosis report, by EFSA and ECDC.

One of the missions of the European Commission is to verify that the standards set out in European Union (EU) legislation on food and feed safety, food quality, animal health and welfare, plant health, EU quality standards and certain areas of human health, are correctly implemented in Member States and in third countries, for their exports to the EU.

Medical Devices - Sector

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices

https://ec.europa.eu/newsroom/sante/redirection/item/731012/en/259

Non-communicable diseases

Flash Report - Stakeholder Webinar on Healthier together – EU Non-Communicable Diseases Initiative (15 December 2021)

https://ec.europa.eu/newsroom/sante/redirection/item/731065/en/259

Non-communicable diseases

Flash report - Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases (15 December 2021)

https://ec.europa.eu/newsroom/sante/redirection/item/731066/en/259

Medicinal products

Questions and answers (version 19) - Safety features for medicinal products for human use

https://ec.europa.eu/newsroom/sante/redirection/item/731251/en/259

Indicators and data

Indicator on Injuries: home, leisure, school: register-based incidence (ECHI 29b) updated with most recent statistics

https://ec.europa.eu/newsroom/sante/redirection/item/731067/en/259

EU Health Policy

Presentations and recording now available! #Webinar: First OASES EU wide conference - Making medical deserts bloom (10 December 2021)

https://ec.europa.eu/newsroom/sante/redirection/item/730821/en/259

EU Health Policy

Presentations and recording now available! #Webinar: Virtual launch event - State of Health in the EU: Country Health Profiles 2021 and Companion Report

https://ec.europa.eu/newsroom/sante/redirection/item/730838/en/259

On 1 January 2022, 620 new members will join the European Reference Networks, as unanimously approved by the ERN Board of Member States. As a result of the current call there will be nearly 1,500 ERN units in 27 Member States and Norway. This milestone enlargement extends the geographical scope of the ERNs, and the possibility of patients with rare and low prevalence as well as complex diseases and conditions to access highly specialised healthcare.

The new 620 healthcare units will join the Networks in 24 EU Member States and Norway (except Bulgaria, Malta and Luxembourg). The highest number of new applicants - 43 - have been accepted to ERN RITA - the European Reference Network that aims to improve the care of patients with Rare Immunological Disorders. 38 new applicants will join EURACAN – the ERN that connects patients who have rare adult solid cancers, and 36 applicants will join ERN EuroBloodNet - the ERN in Rare Hematological Diseases (RHD). The highest number of healthcare units is going to join the ERNs in Italy (145), Germany (84) and Spain (68), and the lowest in Latvia and Slovenia (4), Estonia (3) and Cyprus (2). Greece joins as a new country to have healthcare units in the ERNs - with 18 units.

The ERNs system is an innovative model of virtual healthcare and collaboration. It successfully brings together the most specialised centres (now nearly 1,500 healthcare units) across the EU to speed up diagnosis, improve standards of care and generate knowledge and new evidence for patients living with rare or low prevalence and complex diseases, working according to the principle that it should be knowledge that travels, not the patient.

In 2017, when the ERNs were established, nearly 900 healthcare units joined 24 European Reference Networks.

More information: Overview | Public Health (europa.eu)