Explanatory Memorandum to COM(2020)849 - Common framework for the use, validation and mutual recognition of COVID-19 rapid antigen tests in the EU - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2020)849 - Common framework for the use, validation and mutual recognition of COVID-19 rapid antigen tests in the EU. |
|---|---|
| source | COM(2020)849  |
| date | 18-12-2020 |
1. CONTEXT OF THE PROPOSAL
• Reasons for and objectives of the proposal
As outlined in the Commission Communication on short-term EU health preparedness for COVID-19 outbreaks 1 , adopted on 15 July 2020, robust testing strategies and sufficient testing capacities are essential aspects of preparedness and response to COVID-19. They allow for early detection of potentially infectious individuals with a view to swiftly isolate them from the rest of the population and therefore avoid infections and transmission within communities. Moreover, they are a prerequisite to adequate contact tracing to limit the spread through prompt and targeted isolation or quarantine measures.
Effective testing also contributes to fostering free movement of persons and to the smooth functioning of the internal market in the context of the COVID-19 pandemic. Since the beginning of the pandemic, the field of diagnostic COVID-19 tests has been rapidly evolving, further underpinning the central role it plays in outbreak control. The appropriate use of COVID-19 tests, which includes putting in place sufficient testing volumes for target populations, providing the opportunity for repeated testing and ensuring a rapid turnaround time between the test request and result, are elements that play a significant role in reducing the spread of SARS-CoV-2.
For an effective management of the different stages of the pandemic, it is vital to understand what information different tests can deliver, as elaborated in the guidelines adopted on 15 April by the Commission 2 . Currently, the most reliable methodology for testing of cases and contact tracing is the RT-PCR (reverse transcription polymerase chain reaction) assay, which is a nucleic acid amplification test (NAAT). RT-PCR assays were among the earliest available tests when the pandemic reached the European continent. While RT-PCR testing rates have increased across the EU, resulting in the identification of more COVID-19 positive cases, laboratories are struggling to ensure that sufficient resources and capacities are in place to keep up with demands. The constant high demand has resulted in relative shortages of RT-PCR testing materials and longer testing turnaround times, thereby limiting the effective implementation of mitigation measures as well as swift contact tracing.
In this context, Member States are increasingly turning to the possibility of using rapid or point of care tests (e.g. antigen tests) in specific settings 3 . This new generation of faster and cheaper COVID-19 tests, allowing for a test result in often less than 30 minutes, is increasingly entering the market. On 28 October 4 , the Commission adopted a Recommendation setting out guidance for countries regarding key elements to be considered for their COVID-19 testing strategies, including the use of rapid antigen tests. On 18 November, the Commission adopted a Recommendation on the use of rapid antigen tests for the diagnosis of COVID-19 5 , published together with technical guidelines on the use of rapid antigen tests, developed by the European Centre for Disease Prevention and Control (ECDC) 6 .
On 2 December, Member States called for the adoption of a common approach for the use of rapid antigen tests (complementary to RT-PCR tests) and the intensification of coordination efforts as regards the facilitation of mutual recognition of test results was broadly recognised as a high priority in almost all interventions 7 .
On 4 December, the Presidency progress report on EU coordination in response to the COVID-19 pandemic 8 recommended that: “[…] Member States should continue to exchange regularly on national testing strategies, including on the use of rapid antigen tests. Agreement on settings where these tests can be performed as well as on their validations will facilitate mutual recognition of test results”.
During the meeting of the European Council on 10 December 9 , EU Heads of State or Governments adopted conclusions on COVID-19, in which they called on the Commission to present a proposal for a Council Recommendation on a common framework for rapid antigen tests and for the mutual recognition of test results.
• Consistency with existing policy provisions in the policy area
This recommendation serves to implement the existing provisions in the policy area, namely recommendations to EU Member States concerning the use of diagnostic COVID-19 tests and the implementation of COVID-19 testing strategies in the EU.
• Consistency with other Union policies
This recommendation is in line with other Union policies, including those regarding public health and medical devices.
2. LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY
• Legal basis
The Treaty on the Functioning of the European Union (TFEU), and in particular Article 168(6), thereof.
• Subsidiarity (for non-exclusive competence)
Article 168(6) TFEU enables the Council to adopt, based on a proposal from the Commission, recommendations for the purposes set out in Article 168 TFEU.
A consistent and common approach regarding the use, validation and mutual recognition of COVID-19 rapid antigen tests contributes to the good functioning of the single market and avoids duplication of efforts across the EU. Moreover, if follows a request of Member States to have a harmonised and joint approach. This would also facilitate sharing of experiences and allow for more efficient and better targeted restrictive measures.
• Proportionality
The present proposal takes account of the evolving epidemiological situation and all available relevant evidence. The authorities of the Member States and the Schengen Associated Countries remain responsible for implementing the proposed Council Recommendation. The proposal is suitable for achieving the intended objective and does not go beyond what is necessary and proportionate.
3. RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS
• Ex-post evaluations/fitness checks of existing legislation
N/A
• Stakeholder consultations and impact assessment
This proposal takes into account discussions with Member States, particularly those that took place in the context of the Health Security Committee and the Integrated Political Crisis Response (IPCR), since the start of the COVID-19 pandemic. While no separate impact assessment was undertaken, the proposal takes into account the evolving epidemiological situation and is based on all available relevant evidence and scientific advice.
4. BUDGETARY IMPLICATIONS
None