The establishment by the European Commission of an export authorisation system for Member States to use regarding COVID-19 vaccines, risks delaying and could jeopardise the supply of vaccines to people across Europe and around the world.

While we understand the frustration caused by temporary reductions to the quantities of COVID-19 vaccines being delivered to the European Union and support the EU’s goal to have access to as many vaccines as possible in as short a time as possible, this measure will not help. Manufacturing billions of doses for people across Europe and around the world is an unprecedented challenge involving multiple partners, working around the clock without ever compromising on the quality or safety of the vaccines. Fluctuations in the supply of doses, however frustrating, can be a feature of manufacturing complex biological products.

Because the vaccines produced are complex and make use of novel technologies and ingredients, it is important that policy measures strengthen the global supply chains to boost vaccine production. This export authorisation scheme may force supply chain adjustments, achieving the opposite, including causing customs delays at EU borders.

Moreover, given the global nature of vaccine supply lines, the proposal from the Commission might appear disproportionate and risk retaliatory measures from other regions, putting the supply of manufacturing materials needed to produce COVID-19 vaccines and consumables related to the provision of those vaccines at risk.  Retaliation measures could also extend the scope of the disruption to medicines and other products.

Experience gained in the first wave of the pandemic, underlined the importance of:

• removing export restrictions, as strongly advocated by the European Commission in its relentless efforts at the time (1)
• preventing stockpiling and
• opening borders to ensure the safe supply of medicines to patients across Europe.

This new measure seems to also run counter to the EU's leadership on the ‘Trade in Healthcare Products’ initiative at the WTO. The EU played a key global role supporting medicines supply chains that were designed to work across borders, which makes today’s announcement, with vaccines actually available, disproportionate and counter to the lessons learned to date.

Our focus will continue to be on the R&D of new vaccines and treatments as well as on increasing the capacity of manufacturing facilities and fine-tuning processes to increase supply of approved vaccines as proven by the recent announcement of pharma company collaborations. That endeavour has been made more difficult by today’s announcement.