European response to ongoing health crisis—a dental dealers’ perspective
BRUSSELS, Belgium: Activities at EU level are currently dominated by the SARS-CoV-2 pandemic, and the European Commission (EC) is coordinating the EU’s response in all affected policy areas. This article focuses on a selected number of measures and policy developments directly relevant to the daily activities of dental dealers within the EU.
During recent lockdowns, dentists in many EU countries have been restricted to providing only urgent treatments. Such restrictions inevitably had, and continue to have, economic consequences for the entire dental sector, including for dental dealers. In order to cushion the negative economic consequences, EU member states adopted measures such as grant schemes aimed at supporting affected businesses and sectors. At EU level, considerable funds were made available to support those economically affected by the crisis in member states. EU leaders agreed on a general recovery package of €1.8 trillion and on additional economic measures that aimed at supporting member states in dealing with the adverse economic consequences of the pandemic.
One important decision was the postponement of the implementation date of the medical device regulation (EU) 2017/745 (MDR), which had been expected to enter into force on 26 May 2020. At the start of the pandemic, the availability of medical devices—such as personal protection equipment—became a top priority for EU institutions. Health institutions were faced with sudden shortages of much needed equipment, and on 3 April, the EC proposed postponing the entry into force of the MDR by one year. Such postponement was needed in order to avoid additional difficulties and risks of shortages or delays in the availability of essential medical devices. The risk existed that national authorities and conformity assessment bodies might not have sufficient capacity to comply with the new regulation and that this could result in additional delays in availability of key medical devices. Three weeks later, on 24 April 2020, the EC’s proposal was passed in the European Parliament and Council and was officially adopted. Consequently, the entire medical device sector was granted an additional year to prepare for the entry into force of the new regulation and was free to focus on its most essential task of the moment: making available sufficient key medical devices to all health institutions in need.
The EC also intervened in reaction to sudden decisions by member states to close national borders. Such decisions threatened to hamper the free movement of essential goods and workers in key sectors. The EC attempted, by means of guidance documents, to limit the adverse impact of the reintroduction of national borders and advised member states to install so-called green lanes to allow for a continuous flow of goods across the EU and to avoid bottlenecks at internal borders.
An additional development related to the EC’s strategies for vaccines and vaccination in the fight against the pandemic. Its vaccine strategy rests, firstly, on securing the production of vaccines in the EU and on the availability of sufficient supplies of vaccine doses. To this end, the EC secured contracts with pharmaceutical companies—on behalf of member states—for hundreds of millions of doses. Secondly, the applicable regulations were adapted in light of the urgency of the situation, and use was made of existing regulatory flexibility in order to accelerate vaccine development while maintaining quality, safety and efficacy standards.
The EC has begun developing a common vaccination strategy for member states. According to contracts entered into with pharmaceutical companies, each member state will receive doses based on a pro rata population distribution key. Doses will initially be limited, and vaccinations will first be given to priority groups. It is important for dental dealers to note that these priority groups include, inter alia, healthcare workers, long-term care facility workers and essential workers outside the health sector. Based on the EC’s guidance, member states must define and implement a priority list of key population groups and a phased vaccination approach.
The pandemic will continue to be the main focus of the activities of EU institutions in the coming months, and many of the initiatives being developed are relevant for the dental sector. It, therefore, remains highly important for dental dealers, as relevant stakeholders, to stay up to date, to identify key priority areas and to get involved.