Charles Michel President of the European Council Rue de la Loi 175 1048 Brussels

Brussels, 24 February 2021

Dear President,

In light of your upcoming videoconference with the Heads of State and Government this Thursday and Friday, please allow us to share with you our expectations on the vaccination and production strategy of the and its Member States.

First of all, we are pleased with the recent initiatives taken by the European Commission such as the establishment of a Task Force to scale-up vaccine production and the setting-up of the “HERA Incubator” to address the growing threats of new variants and increase production capacities accordingly. The future of our Union is at stake: Europe has shown solidarity with the most affected countries and has decisively invested in research and innovation to develop a vaccine in less than a year. These great results notwithstanding, Europe now has to concretely deliver in the vaccine rollout within its borders and beyond. We need to deliver on the promises made that 70% of Europeans will be vaccinated by the end of summer and we call on the Member States to do everything in their capacity to achieve this.

Recent reports about positive research results are also showing that the vaccines greatly reduce virus transmission. This must drive us to work even more convincingly towards scaling- up production. Europe simply must do whatever it takes to end this pandemic and its tragic human, social and economic consequences.

In light of this, we appreciate your videoconference with the Members of the European Council taking place later this week, for which we have high expectations. Please allow us to specify the following next steps that we believe need to be taken both by the Commission and Member States.

Firstly, we expect progress on the issue of a common European vaccination certificate to prove an individual has been successfully vaccinated. While this will be an important building block to return to normal life on our continent, it must be clear that this can only become a precondition for anything once the whole population has access to vaccines. Only EMA- approved vaccines can be covered by this initiative, in order to ensure public safety in Europe.

In the meantime, this could also act as a positive incentive to get vaccinated, by allowing individuals who received successful vaccination to travel freely.

Secondly, we ask the Council to agree immediately on a robust common regime for flights arriving from third-countries with a high virus mutation rate like Brazil or South Africa by applying a strict quarantine regime for travellers arriving from such areas, while completely prohibiting unnecessary journeys. We acknowledge the rights of Member States to introduce border controls when there is a high incident rate, especially with the mutated virus, and encourage EU countries to do everything to bring the figures down so that cross-border movement can be restored without the many currently existing limitations.

Thirdly, a European Pharmaceutical Alliance should be established to ensure that industry and policy-makers collaborate closely with each other in order to increase the capacity of existing production sites, to repurpose production sites currently not part of the production chain and to create new production sites.

Fourthly, the legislation regulating production processes should be reviewed to make it fit for purpose. We should harmonise rules and regulatory requirements across the EU, for example on packaging, and internationally, for example on quality control of raw materials, to improve and accelerate certification and distribution. We need to speed up the Good Manufacturing Practices (GMP) approval by using data from production site validation to get GMP approval processes going, following the same philosophy as rolling controls for faster approval of vaccines, for new sites.

Furthermore, we must develop new and extend the scope of existing Mutual Recognition Agreements on GMP certificates with more countries, which match our high manufacturing standards to make it easier to include sites in third countries in a production and supply chain, without giving up our European standards. This would allow for broadening the production capacity worldwide in times of crisis.

Fifthly, we need all possible efforts to use the existing vaccines more efficiently. The highest possible political involvement is necessary to put pressure on BioNTech/Pfizer and Moderna as well as the European Medicines Agency to agree on a framework that allows using 7 doses from the BioNTech/Pfizer vaccine and 11 doses from the Moderna vaccine while safeguarding the effectiveness of the vaccines. The Commission and Member States should encourage doctors to do so without compromising on the safe and effective use of the vaccines.

Last but not least, Europe should develop a strategy to grant the EU access to strategic areas by creating public-private partnerships or full public ownership for the establishment of a strategic production capacity, which under normal market condition would not have a business case. While fully respecting intellectual property rights, Europe must make clear that this crisis is not business as usual, but a fully-fledged European security matter. Companies should be motivated to co-operate with and do a comprehensive technology-transfer to third countries for the production vaccines. This particularly, but not only, applies to the adaptation of already approved vaccines to existing and potentially new mutants. Such technology transfer should be supported with public money.

For this very same reason, our European action should not take place in isolation. With the COVAX initiative only being able to cover vaccination for 20% of the world population, we need a united initiative of industrialised, open, democratic countries in the form of a Vaccine Alliance. These states must stick together not only for the good of their citizens, but also to be global leaders and ensure vaccination of the world population. It is our humanitarian obligation to do everything we can to help the world to defeat this virus and its mutations.

In order to kick-start such a process, the EU should immediately engage with US President Joe Biden to create an alliance to scale-up vaccine production globally. US and European companies own the key to the solution to the pandemic with the mRNA technology, especially when it comes to the adaptation of the vaccine to new mutations. Europe and the US need to co-operate further with the rest of the world. To address global vaccination needs, we must either produce the necessary doses in Europe or initiate production in other parts of the world, with European support. To ensure that, our common joint goals must be that, by mid-2022, the vast majority of the world population will have been vaccinated, if necessary also with vaccines adapted to mutations.

The EPP Group strongly believes Europe cannot continue just to solve one problem at a time: we must anticipate the development of the virus and prevent what we can foresee. Therefore, we trust we can count on your support for the above proposals and we are looking forward to continuing working together to make sure Europe and its Member States deliver in this important endeavour to end the pandemic.

Yours sincerely,

Manfred Weber Chairman EPP Group

Esther de Lange Vice-President EPP Group

Peter Liese EPP Group Coordinator ENVI

Christian Ehler EPP Group Coordinator ITRE