Ref. Ares(2021)4519071 - 12/07/2021
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Health systems, medical products and innovation
Digital Health, European Reference Networks
Head of Unit
By email only:
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
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.
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 c
all 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 roadm
ap 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
I hope this overview is helpful.
Annex: 1+ Million Genomes Roadmap 2020-2022