Serious cross-border threats to health

The COVID-19 pandemic and particularly the severe acute respiratory disease causing both premature death and chronic lung conditions, has caused an unprecedented worldwide health crisis. The scale of the crisis demonstrates more than ever the importance of EU actions to tackle serious cross border health threats.

Teva provides medicines to more than 200 million patients around the world every day. Our mission is to improve the lives of patients across the globe. As proven during the COVID-19, a vibrant dialogue between competent authorities, policy makers and industry is needed to achieve our common objectives to secure sustainable and equitable access to medicines for patients.

The European Cancer Organisation supports the actions being taken by the European Commission to analyse structural shortcomings in how the EU conducts health cooperation, exposed in light of the 2020 COVID-19 pandemic experience.

Sanofi welcomes the overall ambition of the Health Union. It is essential to fundamentally strengthen Europe’s ability to “work together to detect, prepare and respond collectively” to make healthcare systems more resilient and prepared for health emergencies.

Illumina welcomes the European Commission’s proposal for a regulation to enable the Union to react more rapidly and trigger the implementation of preparedness and response measures for cross-border threats to health. This year, the world has faced a public health crisis, the likes of which has not been seen for generations.

The European Union and all its Member States have ratified the United Nations Conventions on the Rights of Persons with Disabilities (CRPD). This international treaty creates specific obligations relevant for the EU and all Member States in the creation of the European Health Union Package.

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring for critically ill patients. We welcome the EU Commission’s initiative update current rules on serious cross-border health threats to health.

The COVID-19 pandemic has clearly shown opportunities for a strengthened and improved EU health security framework, ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the Commission’s proposal for a Regulation on serious cross-border health threats, providing a stronger and more comprehensive legal framework allowing the Union to react rapidly and trigger the implementation of…

The proposal goes in the right direction as it respects the competences of the EU and the Member States (MS). EU action must always be based on, or prepare for, a serious cross-border threat to health. Health Security Committee: Coordination by the Health Security Committee (HSC) and the IPCR mechanism has proved insufficient in the wake of the Covid-19 crisis.

Filed in German · English published by the European Commission

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster acting, and affordable tuberculosis (TB) drugs. It is part of a group of Product Development Partnerships (PDPs), which aim to address existing market failures by linking the public, private, and philanthropic sectors.

Grifols welcomes the opportunity to provide input on the Regulation on serious cross-border health threats. During recent public health crises, including COVID-19 and Ebola, Grifols has contributed our expertise in the development of plasma-derived therapeutics and diagnostics to aid in the response to these health emergencies. We look forward to working with the Commission to improve resilience.

The Covid-19 pandemic represents an unprecedented experience for all of us and for the EU’s remit in responding to cross-border health threats. In this regard, Vaccines Europe believes that the proposals from the Commission to strengthen the resilience and preparedness of Europe against serious cross border health threats should build on the lessons learned from the COVID-19 pandemic and provide for a clear…

EIT Health Response to Consultation on Proposal for a Regulation on Serious Cross-border Health Threats • In early 2020, Europe, along with the rest of the world, was struck by the greatest public health challenge of recent times – a pandemic of global proportions. COVID-19 posed a significant threat to our society, our economy, and our way of life. During the pandemic agility and speed were of critical importance.

The European Safety Federation (ESF) welcomes the European Commission proposals on “European Medicines Agency – strengthened role to address public health emergencies”. Being the European organisation representing the Personal Protective Equipment (PPE) suppliers, ESF is very much pleased by the Commission’s intention to devote proper support to the European health system, especially with the unprecedented COVID-19…

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity. We welcome the proposed Regulation strengthening Europe’s preparedness against serious cross-border health threats, and believe that it can be improved further to ensure it delivers on its objectives.

The European Social Insurance Platform (ESIP), representing statutory social security institutions in the EU, Switzerland and the UK, welcomes the legislative proposals on strengthening crisis preparedness. While Member States (MS) are responsible for the definition of national health policies, we believe that situations of common public health concern require coordinated actions and cooperation.

Taking the lessons learned from COVID-19, APOGEN has two main reflection points on the proposal: 1. We highlight the important challenges of using joint procurement (JP) for generic multisource medicines. The joint procurement of ICU medicines during the pandemic was not an efficient way to secure medicines supply.

MedTech Europe welcomes the objective of the European Commission’s proposed ‘Health Union’ package of 11 November 2020. Better coordination and pooling of efforts are needed across the Union to strengthen Europe’s preparedness to tackle future public health emergencies, and the proposed Regulation on serious cross-border threats to health constitutes an important step in this direction.

Taking the lessons learned from COVID-19, Medicines for Europe has two main reflection points on the proposal. 1.We highlight the important challenges of using joint procurement (JP) for generic multisource medicines. The joint procurement of ICU medicines during the pandemic was not an efficient way to secure medicines supply.

Taking the lessons learned from COVID-19, Medicines for Poland has two main reflection points on the proposal. 1. We highlight the important challenges of using joint procurement (JP) for generic multisource medicines. The joint procurement of ICU medicines during the pandemic was not an efficient way to secure medicines supply.

The proposal reveals a serious gap completely unjustified in light of the lessons that we should have learned from the pandemic: there is no reference to the role and involvement of actors of the civil society and Patient Advocacy Groups (PAGs) who can be called in support of the institutions and for the benefit of the communities.

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the proposal for a regulation 2020/0322 within the framework of better cross-border crisis preparedness and management.

Overall, an increased EU collaboration and joint preparedness for future health crises is a laudable initiative with many potential benefits for Europe’s major research universities. Some points that deserve more specific comments are as follows: The plan for a network of reference laboratories should more specifically take into account also academic facilities and national research infrastructures to optimise…

The coronavirus pandemic has hit the European Union (EU) and the world hard. The EU wants to learn from the challenges of this crisis and to be better prepared for future health crises. To this end, on 11 November 2020, the European Commission presented three proposals for regulations under the umbrella of the creation of a European Health Union: The proposal for a regulation on serious cross-border threats to…

Filed in German · English published by the European Commission

Member States’ cooperation during the coronavirus pandemic has revealed weaknesses in the area of public health. The German Social Security Committee welcomes the Commission’s intention, within the framework of the current Treaties, to develop constructively the structures of cooperation between the Member States and European and national institutions.

Filed in German · English published by the European Commission

The European Society of Radiology welcomes the European Commission’s proposal for a stronger and more comprehensive legal framework to react rapidly and trigger the implementation of preparedness and response measures to cross-border health threats. Medical imaging maintains an essential role in the diagnostic process of COVID19.