European Council, 16 December 2021
CYBERMED NEWS - Higher Medical Scientifc Information and Research
CYBERMED NEWS - Higher Medical Scientifc Information and Research
European Council, 16 December 2021
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:
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.
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.
In the context of the COVID-19-pandemic, the President of the European Parliament has established a number of measures to contain the spread of the virus and to safeguard Parliament's core activities. The current precautionary measures do not affect work on legislative priorities. Core activities are maintained to ensure the smooth running of the institution's legislative, budgetary, and scrutiny functions.
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.
The high-level Conference 'EU animal welfare - today & tomorrow' took place on 9 December and was a hybrid event, opened by Commissioner Kyriakides and the Slovenian Presidency, represented by Mr Jože Podgoršek, Minister of Agriculture, Forestry and Food.
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.
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.
The Commission is today putting forward a common and coordinated EU approach to address effectively the challenges from the resurgence of COVID-19 in many Member States this autumn.
Today, the European Medicines Agency (EMA) has given a positive opinion on two COVID-19 treatments - Ronapreve and Regkirona - identified by the Commission as promising therapeutics under the EU Strategy on COVID-19 Therapeutics. Both are treatments for use during the early stages of infection based on antiviral monoclonal antibodies.
Today and tomorrow, the Commission is hosting a pan-European matchmaking event to accelerate and upscale the development and production of COVID-19 medicines in Europe, as part of the actions under the EU Strategy on COVID-19 Therapeutics.
Last night, the European Parliament and the Council reached an agreement on a reinforced role for the European Centre for Disease Prevention and Control (ECDC). The revised ECDC mandate will allow the agency to take a stronger role in supporting the EU and its Member States in the prevention and control of communicable disease threats and improve European preparedness for future health challenges.
President, Honourable Members,
We are witnessing a worryingly rapid rising number of COVID-19 cases across the EU. Europe is now in the middle of yet another wave and this is of serious concern to us all – and I want to thank this house for this timely discussion.
Today, the European Commission published an implementation roadmap and progress indicators for Europe’s Beating Cancer Plan to monitor developments on the ten flagship initiatives as well as its other actions. The roadmap will undergo regular review by the Implementation Group.
Ladies and gentlemen,
I am delighted to join you at today’s Colorectal Cancer Screening Summit.
Let me begin by thanking Digestive Cancers Europe for gathering a community of experts to discuss the importance and practicalities of population based screening practices across Europe.
160,000 people die of colorectal cancer in the EU every year.
Ladies and Gentlemen,
Every year, on World AIDS Day, we remember those who lost their lives to the AIDS epidemic, we recognise the progress made until now, and we celebrate those inspirational leaders who fought so hard to get us to where we are today.
Ladies and gentlemen,
I am delighted to join you for this last meeting of the EU Platform on Food Losses and Food Waste under its current mandate.
This is an occasion to reflect on past achievements and your valuable contributions.
This Platform brought everyone together: public authorities, food business operators, research institutes and universities, and non-governmental organisations.
And it has has built momentum for change.
Your recommendations reflect this wealth of contributions. They offer valuable guidance for regulators and the general public, on what each and every one can and should do to prevent food losses and food waste.
Your know-how has helped pinpoint EU priorities, reflected in the Platform’s first sub-groups, on food donation, food waste measurement and date marking.
With your help, we have developed EU guidelines to facilitate food donation and food use as animal feed – while always ensuring food safety.
You have contributed to our common food waste measurement and its consistent monitoring at all levels – from farm to fork, across the EU.
And, thanks to your commitment to lasting change, you have defined a clear roadmap, showing the way forward and inspiring others to take concrete steps to remove food waste from our food systems.
The European Commission follows the continuous progress in modern biotechnology, to consider how the EU can benefit from innovation in the food and agricultural sector while maintaining high safety standards.
In the last decade, a variety of new techniques has been developed, based on advances in biotechnology.
EFSA has completed its assessments of emergency authorisations granted by 11 EU Member States for the use of neonicotinoid-based insecticides on sugar beet in 2020 and 2021.
Today, the Commission published the results of the first coordinated control plan on the authenticity of herbs and spices launched by DG SANTE and carried out by twenty-one EU Member States, Switzerland and Norway.
EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of COVID-19 developed by Eli Lilly Netherlands BV, after the company informed the Agency that it was withdrawing from the process.
Today, the European Commission approved the eighth contract with a pharmaceutical company with a view to purchasing its potential vaccine against COVID-19. The contract with Valneva provides for the possibility for all EU Member States to purchase almost 27 million doses in 2022. It also includes the possibility to adapt the vaccine to new variant strains, and for Member States to make a further order of up to 33 million additional vaccines in 2023.
The Council today gave its final go-ahead for the adoption of a regulation on health technology assessment. Thanks to the new rules, innovative, safe and effective health technologies will be more quickly available for patients. Producers of medicines and medical devices will benefit because submission procedures will be simplified.
Today, the European Parliament and the Council reached a political agreement on a reinforced role for the European Medicines Agency (EMA) in preparation for and during health crises. The revised EMA mandate will allow the Agency to closely monitor and mitigate shortages of medicines and medical devices during major events and public health emergencies, and to play a key role in facilitating the development and faster approval of medicines which could treat or prevent a disease causing a public health crisis.
Welcoming the agreement today, Vice-President for Promoting our European Way of Life, Margaritis Schinas, and Commissioner for Health and Food Safety, Stella Kyriakides, made the following statement:
“Today, we are moving one step closer to a stronger European Health Union that is ready to face the next health crisis. The European Medicines Agency has been at the forefront of our work throughout the COVID-19 pandemic and has played a key role in advising, assessing and authorising vaccines and medicines to prevent and treat COVID-19. It is thanks to the rigorous assessment of EMA that our citizens can have trust and confidence that vaccines and therapeutics used in the EU are safe and effective.
A stronger EMA means that we can count on a coordinated EU response in mitigating and preventing medicine and medical devices shortages and ensuring faster approval and availability of new medicines to address crises in the future.
Today's agreement is an important step for a stronger and more resilient EU. But we also need to strengthen the European Centre for Disease Prevention and Control, adopt new rules for cross-border health treats, and set up the emergency framework for the European Health Emergency Preparedness and Response Authority.
The Commission proposals are on the table and we call on all institutions to work together to find a way forward as quickly as possible. Every day counts.”
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Minister Darias, President Barbón, Minister Fernández Muñiz,
Distinguished guests, ladies and gentlemen,
None of us can predict the future. However, we need to be able to anticipate it and to prepare for it.
That means understanding better today what choices are necessary to shape our world tomorrow.