The European Commission takes the first steps towards building the European Health Union. The Community Executive presented this Wednesday a series of proposals that seek to strengthen the EU health security framework and the role of EU agencies in preparing and responding to crisis. “To intensify the fight against the COVID-19 pandemic and future health emergencies, greater coordination is needed at the EU level,” says the European Commission: “Drawing on the lessons of the current crisis, the proposals will ensure preparedness and Stronger response during current and future health crises. ”
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With a vaccine on the near horizon announced by the Pfizer laboratory, the European Commissioner for Health, Stella Kyriakides, warns: “The vaccine is not going to end the pandemic overnight. Even when the vaccine is there, we will have to continue maintaining the measures until we reach a significant part of the population. Protection measures must be maintained. ”
With Pfizer, the European Commission will sign this Wednesday a contract for up to “300 million doses of vaccines developed by BioNTech and Pfizer”, as announced on Tuesday by the President of the European Commission, Ursula von der Leyen.
“A safe and effective vaccine It is our best chance to defeat the coronavirus and return to our normal lives “, Von der Leyen said in a statement:” In recent months, the European Commission has worked tirelessly to secure doses of possible vaccines. And tomorrow we will authorize a contract for up to 300 million doses of the vaccine developed by the German company BioNTech and Pfizer. “According to Von der Leyen,” this is the most promising vaccine so far. “” Once this vaccine is available “, the president of the European Commission has said, her objective is “to implement it quickly anywhere in Europe. This will be the fourth contract with a pharmaceutical company to buy vaccines. And more will come. Because we need to have a wide portfolio of vaccines based on different technologies. ”
The European Commission has proposed this Wednesday “a solid framework for the preparation, surveillance, risk assessment, early warning and response of the EU.” In this way, “the proposals will provide the EU and Member States with stronger tools to undertake joint actions in a swift, decisive and coordinated way; new crisis mandates for the European Center for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), as well as a cross-border legal framework for health threats “.
The COVID-19 pandemic is not over yet. While the European Commission “has made significant progress within the framework of the EU vaccine strategy and has signed three contracts with pharmaceutical companies for access to safe and efficient future vaccines”, there is still no approved vaccine available and the treatments they are still limited. “That is why it is important to move forward now to ensure stronger preparedness and response during current and future health crises,” says Brussels, announcing that “today’s proposals will be followed by two major initiatives from the Health Union: the Pharmaceutical Strategy for Europe and the European Plan to Fight Cancer “.
To strengthen the coordination mandate by the European Commission and EU agencies, the EU Executive proposes a new regulation on serious cross-border threats to health.
Under the new regulation, the European Union could: adopt common measures at EU level to tackle future cross-border threats to health; declare a public health emergency in the EU; strengthen preparation planning, reporting and auditing within the EU; launch an integrated EU monitoring system for infectious diseases and other health threats.
The new framework will develop recommendations and an EU pandemic and health crisis preparedness plan for the adoption of plans at the national level, along with comprehensive and transparent frameworks for reporting and auditing, reports the European Commission. The preparation of national plans would be supported by the European Center for Disease Prevention and Control and other EU agencies. The plans would be audited and stress tested by the Commission and EU agencies.
In addition, an integrated and reinforced surveillance system will be created at EU level, using artificial intelligence and other advanced technological means.
The new framework will require Member States to intensify reporting on health systems indicators (eg availability of hospital beds, specialized treatment and intensive care capacity, number of staff with medical training, etc.).
The declaration of an EU emergency situation would generate greater coordination and allow the development, storage and procurement of products relevant to the crisis.
Most operational EU agencies
COVID-19 has shown that the European Center for Disease Control and Prevention and the European Medicines Agency “must be strengthened and equipped with stricter mandates to better protect EU citizens and tackle health threats. cross-border “, says the European Commission.
ECDC’s mandate will be strengthened so that it can assist the European Commission and Member States in epidemiological surveillance through integrated systems that allow on-the-spot surveillance; planning, reporting and auditing preparedness and response; provision of non-binding recommendations for risk management; ability to mobilize and deploy the EU Health Task Force to assist local response in Member States; the creation of a network of EU reference laboratories and a network of substances of human origin.
The EMA “is vital to ensure the evaluation, approval and monitoring of medicines available to treat patients in the EU,” says Brussels: “There needs to be a stronger EMA in times of crisis. During the coronavirus outbreak, Cooperation with experts from Member States, evaluations of possible treatments and vaccines based on temporary and exceptional measures, was intensified to allow a response commensurate with the size of the challenge. ”
Thus, the European Commission proposes to strengthen the mandate of the European Medicines Agency “so that it can facilitate a coordinated response at EU level to health crises by monitoring and mitigating the risk of shortages of critical medicines and health products; provide scientific advice on drugs that may have the potential to treat, prevent or diagnose the diseases that cause these crises; coordinate studies to monitor the effectiveness and safety of vaccines; coordinate clinical trials. ”
The European Commission also presented this Wednesday the main elements of the future new EU authority for preparedness and response to health emergencies, which will be proposed at the end of 2021.
New authority for biomedical preparation
“Faced with a completely new pathogen, Europe has lacked access to stocks of relevant medical countermeasures and the vulnerability of the EU supply chains to these critical medical countermeasures was highlighted”, they explain in the European Commission: “The EU also lacked of a coordinated and systematic approach to support the development, production and procurement of necessary medical countermeasures.In fact, there is currently no body comparable to the United States’ Biomedical Research and Advanced Development Authority (BARDA) at the level of the EU to coordinate and promote this work. ”
In her 2020 State of the Union address, European Commission President Ursula von der Leyen promised that the EU will “build a European BARDA for advanced biomedical research and development.” This new authority will support the ability and willingness of the EU “to respond to cross-border threats and emergencies, whether of natural or deliberate origin.”
According to Brussels, “an EU authority would remedy structural gaps in the EU’s healthcare preparedness and response capacity with regard to biomedical development, production and augmentation capacity development. It will also provide a horizon scanning function. , focusing on emerging biomedical technologies that can be scaled up for real-world application during times of crisis. The authority will collaborate with industry, science, academia, and networks of clinical research organizations, with the goal of implementing public-partnerships. successful private “.
Preparatory work for this agency is ongoing and the European Commission will present a proposal for the future agency in the fourth quarter of 2021.
The coronavirus pandemic has shown vulnerabilities in the pharmaceutical supply chain. The proposals this Wednesday include elements that refer to drugs and medical devices, such as closer monitoring of supplies during emergencies, more coordinated clinical trials and advice on reused drugs during health emergencies.
The proposals are designed for health crisis situations, while the pharmaceutical strategy will adopt a longer-term, systemic vision in these areas and therefore complement efforts to ensure a constant supply of medicines and medical devices, during crises. and beyond.
Most of the actions are included in the Commission’s proposal for the EU4Health 2021-2027 program. The EU4Health proposal includes a list of actions, such as creating an EU readiness plan, supporting national health systems stress tests and readiness exercises, training health professionals and investing in digitization .
Some of the work could be funded through other Union programs such as InvestEU. The strengthening of the EU agencies will require an increase in the budget of the agencies to be negotiated with the budgetary authorities.