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February 1, 2021

AdvaMed Statement on EU Export Restrictions of COVID-19 Vaccines

WASHINGTON, D.C. – AdvaMed President and CEO Scott Whitaker released the following statement on today’s announcement by the European Union that COVID-19 vaccines covered by an Advanced Purchase Agreement (APA) require in many instances prior authorization before they can be exported outside of the European Union: 

“We are very concerned that the EU’s decision today has the potential to restrict or otherwise negatively affect the export of vaccines and key vaccine supplies. In our increasingly interconnected and global economy in which manufacturing depends on international cooperation, we are worried that the EU’s decision could have ripple effects that will ultimately hinder and not help our efforts to bring this pandemic under control. AdvaMed is working closely with our European counterparts to better understand the details and ramifications of this new regulation, and we urge the European Union to reconsider today’s decision.” 

Today, the European Commission released an implementing regulation that requires COVID-19 vaccines covered by an Advanced Purchase Agreement (APA) to in many instances receive prior authorization before they can be exported outside of the EU.

The measure notes that exports should not be restricted more than absolutely necessary and contains the following specific exclusions from its application: 

  • Exports to enable the provisions of supplies in response to humanitarian emergency 
  • Exports to COVAX facilities, especially to those in lower- and middle-income countries  
  • Exports of vaccine purchased and/or delivered through COVAX, UNICEF and PAHO with destination to any other COVAX participating country 
  • Exports of vaccine purchased by Member States under the EU's APA and resold or donated to a third country 

Also excluded from the scope of the regulation are member states of the European Free Trade Area and the Western Balkans, and Annex II countries. Member states are directed to report their decisions to grant or reject requests for export authorization to the Commission, and the Commission will make this information publicly available on a regular basis.   

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.