On 6 October 2020, Spanish Member of the European Parliament (MEP) María Soraya Rodríguez Ramos of the Renew Europe Group posed a written parliamentary question to the European Commission:
“The report presented on Thursday by the European Centre for Disease Prevention and Control (the ECDC) notes that Europe is far from reaching herd immunity, with the prevalence of people with antibodies well below 15 %. In this situation it is essential that Member States have sufficient testing capacity and a rigorous contact track and trace system. Although virus testing capacity has increased, capacity for scaling this up and making it more accessible in order to control the pandemic and find asymptomatic carriers is still very limited. This has led to many people in Europe finding an easy solution by purchasing tests on the Internet that give them no legal or medical guarantees. Also worrying is the fact that these tests are not being carried out by properly trained healthcare professionals and that test results may be misinterpreted or the bio-medical waste not be properly disposed of.
Allowing European pharmacy networks to sell and carry out these tests would be one way of possibly reversing this trend. Given this, does the Commission have any recommendations on the feasibility of drawing up common guidelines for COVID-19 testing by non-medical practitioners and establishing a truly European COVID-19 detection network?”
On 25 January 2021, Health and Food Safety Commissioner Stella Kyriakides responded on behalf of the European Commission stating: “The organisation and delivery of healthcare is the competence of the Member States. However, the Commission continues to work closely with Member States to coordinate national responses to COVID-19, including via the Health Security Committee (HSC) where common approaches on testing are discussed.
The Commission adopted a recommendation on COVID-19 testing strategies, including the use of rapid antigen tests, as part of a set of additional measures to reinforce preparedness and response.
It announces that the Commission will work with Member States towards creating a framework for evaluation, approval and mutual recognition of rapid tests. In addition, the Commission will establish an information repository of rapid antigen tests and validation study results as they become available across the EU.
The Commission is also supporting Member States with the purchase of rapid antigen tests via a joint procurement for rapid antigen tests and a purchase under the Emergency Support Instrument.
On 18 November 2020, the Commission adopted a recommendation to provide further guidance on the selection of rapid antigen tests. Building on these elements, on 18 December 2020, the Commission adopted a proposal for a Council recommendation on a common framework for the use, validation and mutual recognition of rapid antigen tests.
Prior to this, the Commission issued Recommendations for a common EU testing approach for COVID-19.
As part of the proposed European Health Union package, the Commission is proposing revisions to Decision 1082/2013, which includes strengthening laboratory capacities EU-wide by creating an EU reference laboratory to allow for alignment on diagnostics, serological testing, testing methods and use of certain tests.”
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