Esta es la versión HTML de un fichero adjunto a una solicitud de acceso a la información 'Commission meetings with BusinessEurope'.






     
                            
                     
 
 
Mr. V. Dombrovskis, Executive Vice-President and Commissioner for Trade 
Mrs. S. Kyriakides, Commissioner for Health and Food Safety 
Mr. T. Breton, Commissioner for the Internal Market 
 
 
Brussels, 12 February 2021 
 
 
Dear Executive Vice President, Dear Commissioners, 
 
We are writing to you on behalf of Business Europe, EFPIA, and Medicines for Europe to express our 
serious concern regarding Implementing Regulation 2021/111 announced on 29 January that has 
made the exportation of vaccines and certain ingredients thereof subject to an export authorisation. 
While we recognise the importance of transparency regarding vaccine production and supply in 
relation to the Advanced Purchase Agreement contracts, we believe this proposal is disproportionate 
and possibly counter-productive. 
 
The proposed mechanism, which does not allow for automaticity in clearance of exports, goes well 
beyond the transmission of factual information on production and supplies, and legally enables 
Member States to restrict exports without clear cause. This could delay and undermine the supply of 
vaccines as well as medicines in Europe and around the world, and undermines the EU’s clear policy 
objective to cooperate with international partners e.g. under COVAX and other initiatives. We fail to 
understand why such a broad and disruptive measure, affecting all COVID-19 vaccine production in 
the EU, is deemed necessary. 
 
In line with the joint-association letter of 10 April 2020, we believe that globally integrated supply 
chains are vital to ensure quality, safety, innovation and distribution of medical and protective 
equipment and all medicines including in this case vaccines.1 Imposing restrictions on exports poses 
the following important concerns: 
x  The export authorisation system runs counter to the EU’s 8 April 2020 Communication and long-
standing position of defending strong and resilient global supply chains and open trade2. It also 
risks undermining the EU’s leadership at the WTO where it leads on the ‘Trade in Healthcare 
Products’ initiative, as well as at the WHO where it has made multiple commitments to partner 
for global vaccination. These initiatives look inconsistent with the measures taken last week. 
x  Notwithstanding the Commission’s assessment that the measure is WTO compliant, should trade 
partners retaliate, there is a clear risk of a negative impact on the ability to produce vaccines or 
indeed other medicinal products given that imports of vital ingredients or components of vaccines 
that are sourced from outside the EU (e.g. viral vectors or lipids) could be delayed or stopped. 
Moreover, trade partners may also retaliate beyond COVID-19 related medicines and vaccines, 
broadening any impact of the measure to other industries and sectors. These reactions may not 
become apparent until a first negative export authorisation decision is taken. Also, trade partners 
that have adapted or think of adapting restrictive approaches to exports of COVID-19 vaccines and 
treatments, are now given a good argument why they should or could do this.  
 
1   https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/european-industry-trade-and-supply-
chain-needs-to-respond-to-covid-19/ [accessed 30 January 2021] 
2   https://ec.europa.eu/info/sites/info/files/communication-commission-guidelines-optimal-rational-supply-medicines-
avoid.pdf [accessed 30 January 2021] 





                            
                     
 
x  Given the speed at which vaccine producers have built their global supply chains to ramp up 
vaccine production, it is vital to make sure all newly adopted policies are aimed at strengthening 
these global supply lines. This export authorisation scheme forces adjustments and adds red tape 
in the preparation for exports which could lead to additional delays and/or temporary reductions 
in supply capacities, aggravating the very situation the measure tries to solve. 
x  Since its effective implementation, it is now becoming apparent that the authorisation scheme 
not only applies to final COVID-19 vaccines, but that, for example, clinical trial materials and 
samples are in scope and require an export authorisation as well. Inclusion of these non-
commercial products complicates and delays sharing of information, materials and knowledge to 
do global testing – for example on vaccine efficacy against new strains that are emerging. 
x  Finally, we believe that this measure sends a negative, long-term, signal about investment and 
manufacturing in Europe to global industries who want to manufacture final products in the region 
to meet global demand. This directly contravenes one of the flagship objectives of the 
pharmaceutical strategy: to increase Europe’s attractiveness as a manufacturing base to increase 
EU resilience.  
 
Earlier this year, Sanofi indicated it will start to produce 100 million doses of the Pfizer/BioNTech 
vaccine in 2021, while Novartis announced that the company has signed an initial agreement to 
support production of Pfizer/BioNTech vaccines. More recently Pfizer indicated to produce another 
75 million doses for the EU in Q2 2021, and GSK indicated that they would support the manufacturing 
efforts by producing of up to 100 million doses of CureVac’s first generation COVID-19 vaccine 
candidate in 2021. Also, Bayer is planning to manufacture an additional 160 million doses of CureVac’s 
vaccine in 2022 to further expand their supply network and overall capacity and supply using Bayer’s 
manufacturing network. These announcements, combined with cooperation and voluntary licensing 
agreements to increase contract manufacturing and to remove potential regulatory hurdles, are the 
best tried and tested solutions to ramp up production and supply of vaccines for EU Member States 
and their citizens as well as to support the EU’s commitments to help other countries. 
 
Because we understand the pressure to rapidly vaccinate the EU population, and want to do all we 
can to support that objective, we ask for the EU to support the industry in its unparalleled efforts to 
increase manufacturing capacity of COVID-19 vaccines. There are various ways in which this would be 
possible. Firstly, by ensuring open trade and global supply chains that are free to operate to maximise 
production of vaccines and flow of vaccines to patients. Secondly, we ask the EU to consider the 
removal of the export authorisation scheme as soon as possible, or – alternatively – discuss measures 
that could in practice reduce the negative effects by streamlining practical implementation of the 
scheme, while increasing transparency of production and exports of vaccines.  
 
We believe that a constructive dialogue between the key actors is needed to achieve our joint goals. 
The COVID-19 fight is one only a united front can win. 
 
Yours sincerely, 
 
 
 
 
Business Europe   
    
 
 
EFPIA  
 
 
 
 
 
 
 
 
Medicines for Europe