This is an HTML version of an attachment to the Freedom of Information request 'la SANTE en ligne et dossier de patient'.




 
Ref. Ares(2021)4519071 - 12/07/2021
EUROPEAN COMMISSION 
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY 
 
Health systems, medical products and innovation 
  Digital Health, European Reference Networks  
Head of Unit 
Brussels,  
SANTE/IMG/AEJ/aj 
Sophie Petitjean 
By email only
ask+request-9513-
xxxxxxxx@xxxxxxxx.xxx  

 
Subject: Reply to your email of 18 May 2021 
 
Dear Ms Petitjean,  
We refer to your email of 18 May whereby you ask about the state of play of the projects 
on 1M+ genomes, DARWIN and the Joint Action TEHDaS. 
The Joint Action Towards the European Health Data Space (TEHDaS) is a project 
focused on secondary use of health data. It is being carried out by 25 European countries 
and co-ordinated by the Finnish Innovation Fund, Sitra. The project started in February 
2021 and will run for 30 months. The Joint Action is set up under the Third EU Health 
Programme and has a budget of EUR 2.5 million (Member States will contribute with 
EUR 1.66 million making the total budget for the Joint Action to be EUR 4.16 million). 
A code of conduct for health data processing will be supported outside the Joint Action 
as a separate initiative. 
The Joint Action will support the Commissions work on the European Health Data Space 
(EHDS) by bringing together actors relevant to secondary use of data in the EU, collect 
the best practice available in the EU on the secondary use of data, and develop concepts 
and options necessary for efficient secondary uses of health data. These concepts and 
options will focus on governance, data quality, infrastructure and empowering citizens 
with regards to secondary health data use in the EU. The project consists of eight work 
packages (three administrative and five thematic). More information is available on the 
project’s website. 
The Data Analysis and Real World Interrogation Network (DARWIN EU) is the  future 
infrastructure that will support medicines regulatory decision-making by:  
a)  establishing and expanding a catalogue of observational data sources for use in 
medicines regulation; 
b)  providing, through a distributed network, access and analysis of high-quality, 
validated real world data on the uses, safety and efficacy of medicines;  
c)  addressing specific questions through high-quality, non-interventional studies, 
including developing scientific protocols, interrogating relevant data sources and 
interpreting and reporting study results. 
 
Commission européenne, B-1049 Bruxelles / Europese Commissie, B-1049 Brussel - Belgium. Telephone: (32-2) 299 11 11. 
E-mail: xxxxxxxxxxxxxxxx@xx.xxxxxx.xx 
  
 
 

 
DARWIN EU will connect the European medicines regulatory network to the European 
Health Data Space (EHDS). DARWIN will include a coordination centre for the 
exchange of queries and information across European medicines agencies and the EMA, 
and it will be integrated in the broader EHDS infrastructure network for access to real-
world health data. The call for tender for establishing the coordination centre is available 
here, with an estimated total value of EUR 52 million. The expected yearly maintenance 
cost of DARWIN is EUR 16 million, which may be covered by the fees collected by the 
EMA. However, this is currently under review, and therefore could be subject to change. 
This yearly amount includes the operation of the Coordination Centre and its integration 
in the EHDS, the operation of the associated infrastructure, and the execution of routine 
and complex data analysis studies. More information is available on the project’s 
website. 
The 1+ Million Genomes initiative has the potential to improve disease prevention, allow 
for more personalised treatments and provide new impactful research. I attach the 1+ 
Million Genomes roadmap covering the period of 2020 to 2022. I also provide a link to 
the CORDIS website in order to consult the information on the EU funding of the 
project. 
I hope this overview is helpful. 
Yours sincerely,  
   [Electronically signed]  
 
Ioana-Maria Gligor 
Annex: 1+ Million Genomes Roadmap 2020-2022