COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EU STRATEGY ON COVID-19 THERAPEUTICS
Date: 2021-05-06
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU strategy, clinical trial, coronavirus disease, epidemic, international cooperation, market approval, medical research, pharmaceutical product, public procurement, therapeutics

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 6.5.2021  COM(2021) 355 final/2  CORRIGENDUM This document corrects COM(2021)355 final of 6.5.2021. Correction of a footnote. Concerns the English version only.  The text shall read as folllows:   COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS EU STRATEGY ON COVID-19 THERAPEUTICS  
 
 
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE AND THE COMMITTEE OF THE REGIONS 

EU STRATEGY ON COVID-19 THERAPEUTICS 

STRONGER TOGETHER: AN ‘END TO END’ APPROACH ON COVID-19 THERAPEUTICS 

The COVID-19 pandemic has inflicted unprecendented human, social and economic costs in 
the  European  Union  and  around  the  world.  The  skills  and  dedication  of  scientists,  coupled 
with sustained research and innovation efforts at both European and international level, have 
led  to  the  development  of  several  effective  vaccines.  However,  the  vaccines  will  not 
eliminate the disease overnight and therapeutics will still be needed for patients in hospitals 
and  at  home,  including  people  suffering  from  ‘long  COVID’  (the  long-term  effects  of 
COVID-19 infection). For these reasons, therapeutics will continue to play a significant role 
in  the  response  to  COVID-19,  complementing  the  successful  EU  strategy  for  COVID-19 
vaccines1. 

While  it  took  less  than  a  year  after  the  outbreak  of  the  pandemic  to  start  the  vaccination 
campaign,  the  availability  of  therapeutics  for  affected  patients  is  still  limited.  So  far, 
remdesivir  is  the  only  therapeutic  authorised  at  EU  level  for  treating  COVID-19.  Efforts 
remain fragmented and there is no common framework for the development and deployment 
of targeted therapeutics in the EU. To complement the EU strategy for COVID-19 vaccines, a 
reinforced and strategic approach to developing, manufacturing and procuring safe and 
effective COVID-19 therapeutics at EU level will limit the need for hospitalisation, speed 
up recovery times and ultimately save lives. 

This  approach  will  cover  a  wide  range  of  areas,  including  research,  development, 
authorisation,  production  and  the  procurement  of  safe  and  effective  novel  or  repurposed 
therapeutics,  tailored  to  the  different  disease  phases  (including  recovery)  and  degrees  of 
severity – caused both by the original strain of SARS-CoV2 and its variants. Joint EU efforts 
on therapeutics will also  pay particular attention to  research on, and the treatment  of, ‘long 
COVID’, which is characterised by symptoms persisting after the normal recovery period and 
requires a different therapeutic approach. While implementing the strategy actions, particular 
attention  will  be  taken  to  ensure  access  and  availability  of  medicines  for  children  and  the 
most vulnerable patients like for example elderly patients and persons with disabilities. 

Since  the  outbreak  of  the  pandemic,  the  Commission,  the  Member  States  and  the  industry 
have  taken  action  on  various  fronts,  in  particular  on  antivirals  and  neutralising  antibodies 
against SARS-CoV2. The Commission mobilised research funds from the start, the European 
Medicines Agency (EMA) engaged with national medicines agencies and industry to support 
the  authorisation  of  promising  therapeutics,  and  large-scale  joint  procurement  contracts  on 
behalf  of  Member  States  supported  timely  access  to  treatments  such  as  remdesivir  and 
intensive care unit (ICU) medicines. 

However, more coordinated efforts are needed to boost ongoing initiatives and develop 
new  ones,  in  order  ultimately  to  improve  the  prospects  of  recovery  for  all  COVID-19 

1   COM(2020) 245 final. 

1 

 
                                                 
patients. This EU strategy on COVID-19 therapeutics draws on an ‘end to end’ approach to 
building a broad portfolio of COVID-19 therapeutics. It covers the full lifecycle of medicines 
from  research,  development,  selection  of  promising  candidates,  fast  regulatory  approval, 
manufacturing and deployment to final use. 

The  strategy  will  build  on  existing  efforts  to  ensure  a  coordinated  EU  approach  to  achieve 
this ambitious but realistic objective. Building on experience from the EU vaccines strategy, 
the  Commission  is  ready  to  mobilise  all  available  tools  and  resources  to  ensure  a  genuine 
gear-change in the development and delivery of safe and effective therapeutics for COVID-
19 patients, with the aim of having three new therapeutics available by October 2021 and 
possibly two more by the end of the year. This could make a significant difference in the 
treatment of COVID-19 patients in a real-world setting. 

This EU strategy will be scalable for the benefit of COVID-19 patients globally, supporting a 
worldwide  inclusive  approach  via  bilateral  and  regional  partnerships  and  established 
multilateral structures in the fight against the pandemic, and equitable access to treatment. 

1.  RESEARCH, DEVELOPMENT AND INNOVATION 

therapeutics  or  on 

Research,  development  and  innovation  is  the  first  step  to  ensuring  safe  and  effective 
therapeutics.  Research  on  therapeutics  focuses  either  on  discovering  completely  novel 
candidate 
therapeutics.  Very  early  on 
repurposing  existing 
(30 January 2020),  the  Commission  launched  a  first  call  for  research  and  innovation  on 
COVID-192.  To  date,  it  has  supported  45  research  projects  on  COVID-19  therapeutics  and 
treatment  options,  for  a  total  value  of  €119 million.  Projects  in  the  field  of  repurposed 
therapeutics  have  identified  already  existing  medicines  that  have  potential  to  be  used  as 
therapeutics  for  COVID-19,  and  could  be  produced  at  scale  and  made  available  quickly3,4. 
Other  projects  employing  innovative  technologies  such  as  antibody-based  therapies5,6  are 
already delivering substantial results. 

As announced on 17 February 2021, the Commission has mobilised an additional €90 million 
under  Horizon  Europe7.  The  funding  will  support  vaccine  and  therapeutic  trials  to  boost 
prevention  and  treatment.  It  will  also  support  the  development  of  large-scale,  COVID-19-
related  population  studies  on  particular  groups,  and  foster  the  spread  of  networks  outside 
Europe.  Such  studies  and  networks  aim  to  establish  links  between  risk  factors  and  health 

2   https://ec.europa.eu/info/sites/info/files/research_and_innovation/research_by_area/documents/ec_rtd_cv-

projects.pdf 

3   For example, the Exscalate4CoV project in relation to raloxifene. Raloxifene is mainly used to prevent and 
treat  osteoporosis  in  postmenopausal  women.  The  Italian  Medicines  Agency  has  authorised  a  clinical  trial 
for its use in COVID-19 patients with mild symptoms. The trial marks the completion of the first phase of 
the  Exscalate4CoV  project,  which  (through  the  use  of  a  supercomputer  platform)  has  screened  400 000 
compounds (approved drugs and natural products that are safe in humans) for their potential as therapeutics 
for COVID-19. 

4   CARE  (funded  by  the  Innovative  Medicines  Initiative)  brings  together  37  partners  from  industry  and 
academia  to  screen  for  clinically  approved  drugs  in  a  SARS-CoV2  cell-based  assay.  It  has  screened  large 
libraries  of  chemical  compounds  and  identified  antibodies  that  could  be  candidates  for  therapeutic 
development. 

5   The ATAC project has developed a promising second-generation antibody that is effective in neutralising the 

SARS-CoV2 and its variants, and could be used in both prevention and treatment of COVID-19. 

6   The  BRIGHT  project  (supported  by  the  European  Innovation  Council)  is  responsible  for  XAV-19,  an 

antibody-based treatment that is now in clinical development.  

7   A specific ‘emergency’ work programme for health and infrastructures was adopted on 31 March 2021, with 

a call for expressions of interest published on 7 April 2021. 

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outcomesto further inform public health policy and clinical management, including for long 
COVID patients8. 

The  Commission  will  also  set  up  a  COVID-19  ‘therapeutics  innovation  booster’  to  take 
stock  and  develop  a  clear  overview  of  the  COVID-19  therapeutics  projects  under 
development in order to better support the most promising ones from preclinical research to 
market  authorisation. This  platform  will  bring  together  all  relevant  actors,  including  EMA, 
national  authorities,  and  the  private  sector,  to  identify  promising  research  projects  and 
technologies,  their  stages  of  development  and  provide  guidance  on  where  to  best  focus 
investments,  in  order  to  accelerate  innovation.  It  will  build  on  current  initiatives  and 
investments  in  therapeutic  development,  working  in  a  close  cooperation  with  the  European 
Health  Emergency  Preparedness  and  Response  Authority  (HERA)  preparatory  action  on 
mapping therapeutics. Based on this overview, it will support the development of new and 
repurposed  therapeutics  and  help  promising  candidates  progress  to  their  next  stages  of 
development,  mobilising  the  appropriate  financial  instruments  (including  Horizon  Europe, 
InvestEU and EU4Health). It will therefore ensure the coordination of all research projects on 
COVID-19 therapeutics, allowing to stimulate innovation and boost therapeutic development. 

ACTIONS  

  Establish a ‘therapeutics innovation booster’ platform – by July 2021. 
  Monitor  and  further  support  research  and  development,  including  on  long  COVID 

based on the results of ongoing and upcoming initiatives under Horizon Europe. 

2.  ENSURING ACCESS TO AND SWIFT APPROVAL OF LARGE-SCALE CLINICAL TRIALS IN THE 

EU 

The main source of evidence for the authorisation of innovative medicines are robust clinical 
trials.  Large-scale,  well-designed  randomised  trials  enrolling  a  sufficient  number  of 
participants  and  using  harmonised  protocols  are  the  basis  for  producing  robust  results  in  a 
timely manner. Trials should include representative participation of population groups, such 
as gender and age groups, people with disabilities and those with a minority ethnic or racial 
background, so as to ensure appropriate safety and efficacy. 

This is why large EU-wide clinical trials for the clinical management of COVID-19 patients 
have  been  developed  in  close  cooperation  with  Member  States  and  with  funding  from 
Horizon 20209.  The  EU-wide  network  for  COVID-19  therapeutic  trials  enables  the  rapid 
integration of new compounds to test. These trials have already yielded results10. 

8   https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-hlth-

2021-corona-01-01 
https://ec.europa.eu/commission/presscorner/detail/en/IP_21_1548  

9   With around €30 million Horizon 2020 funding, an EU-wide network for COVID-19 therapeutic trials was set up 
early on in the pandemic. It is based on two large-scale adaptive platform trials: DisCoVeRy and REMAP-
CAP. 

10   The REMAP-CAP trial has shown that the monoclonal antibodies tocilizumab and sarilumab (normally used 
to treat rheumatoid arthritis) were found to cut the relative risk of death of severely-ill COVID-19 patients 
by 24%. Results from the DisCoVeRy trial (launched in March 2020 by INSERM, in the framework of the 
WHO  Solidarity  trial)  suggest  that  the  treatments  hydroxychloroquine,  lopinavir  and  interferon  have  no 
effect on the clinical improvement of patients. Such results are important, since they can halt treatments that 
previously seemed promising but actually have no benefit. 

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A  common  Trial  Coordination  Board  has  been  set  up  with  participants  from  the  new 
network  for  COVID-19  therapeutics,  representing  all  population  groups,  together  with 
policy-makers,  regulatory  bodies 
It  promotes 
complementarities  between,  and  supports  cooperation  with,  other  EU  and  international 
bodies11, helping to avoid overlaps in their work. With research progressing, promising novel 
candidate  therapeutics,  using  different  therapeutic  action  mechanisms  and  potentially 
impacting on our ability to treat future variants of SARS-CoV2, are now reaching the stage 
where they can be tested in later-stage clinical trials. 

(the  EMA)  and  scientific  experts. 

Under this Strategy, the Commission proposes that €5 million are earmarked for a new action 
under  the  2021  annual  work  plan  (under  preparation)  of  the  EU4Health  programme12  to 
support cooperation in safety assessment, and improve the generation of high-quality safety 
data in clinical trials. 

Clinical trials in the EU need an authorisation by Member States before they can start. In the 
case of multi-country trials, this involves several regulatory bodies (competent authorities and 
ethics committees) in several Member States, often giving rise to different national regulatory 
requirements  and  significant  delays.  Member  States  have  established  a  voluntary 
harmonisation process for coordination; this is free of charge to sponsors, but the assessments 
are  often  long  and  burdensome.  Financial  support  to  cover  costs  associated  with  expedited 
and  coordinated  assessment  by  means  of  such  a  procedure  would  allow  fast  approval  of 
harmonised clinical trial protocols in the EU, making it more attractive as a location for large, 
multi-country trials using master protocols. 

The  way  clinical  trials  are  conducted  in  the  EU  will  undergo  a  major  change  with  the  full 
implementation  of  the  Clinical  Trial  Regulation13  in  January  2022.  This  will  introduce  a 
framework for a robust and agile approval process and regulatory oversight for clinical trials. 
It will facilitate close coordination between Member States for multi-country trials and thus 
promote  harmonisation  and  the  conduct  of  larger,  multi-country  trials  with  broader 
geographical scope, including also Member States with fewer applications at present. 

ACTIONS 

  Support cooperation in safety assessment and improve the generation of high-quality 
safety  data  in  clinical  trials  –  €5 million  to  be  earmarked  under  EU4Health 
programme. 

  Provide national competent authorities with financial support of €2 million under the 
EU4Health  2021  work  programme  for  expedited  and  coordinated  assessments  to 
authorise clinical trials for COVID-19 treatments. 

  Explore how to support developers of therapeutics in building capacity for material in 
line with ‘good manufacturing practice’ (GMP) for clinical trials and start providing 
GMP-grade materials. 

11   The  VACCELERATE  EU-wide  network  for  vaccine  trials  was  recently  launched  as  part  of  the  HERA 

Incubator Communication; it builds on experience from the therapeutic trials network. 

12   Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a 
Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, 
and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1). 

13   Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical 
trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). 

4 

 
                                                 
3.  SCANNING FOR CANDIDATE THERAPEUTICS 

The  COVID-19  crisis  has  demonstrated  the  need  to  reinforce  the  timely  availability  of 
scientific advice mechanisms and intelligence to identify effective medicines. To this end, the 
EMA  established  an  ad hoc  EMA  Emergency  Task  Force14  to  identify  and  support  the 
development of promising medicinal products in the fight against COVID-19. The EMA has 
issued scientific advice on as many as 57 COVID-19 therapeutics in development, including 
small  molecules  and  monoclonal  antibodies,  antivirals  and  immunomodulators15,  and  three 
are  under  rolling  review.  This  will  enable  the  establishment  of  a  broader  portfolio  of  ten 
potential COVID-19 therapeutics. 

In addition, under the upcoming HERA proposal, the Commission will propose capacities for 
mapping future developments (emerging technologies for medical countermeasures, such as 
artificial intelligence and high performance computing) and market intelligence and foresight 
(anticipatory action against a possible threat and capability assessments/modelling). This will 
generate  information  for  other  tools  described  in  this  strategy,  including  research  and 
development, and joint procurement. 

In  the  meantime  and  to  complement  the  current  EMA  mapping,  an  additional  HERA 
preparatory  action  under  EU4Health  will  mobilise  €5 million  for  mapping  promising 
therapeutics.  It  will  analyse  their  development  phases,  production  capacities  and  supply 
chains,  including  possible  bottlenecks.  This  will  result  in  an  interactive  mapping  platform 
available for all Member States by mid-2022 at the latest. 

ACTIONS 

  Establish a broader portfolio of ten potential COVID-19 therapeutics and identify five 

of the most promising ones – by June 2021. 

  Set  up  an  interactive  mapping  platform  for  promising  therapeutics,  to  analyse  their 
development phases, production capacities and supply chains – second quarter 2022. 

4.  SECURING SUPPLY CHAINS AND THE DELIVERY OF MEDICINES 

The  Communication  on  Updating  the  2020  new  industrial  strategy16  acknowledged  that 
giving patients access to COVID-19 therapeutics and ensuring that ICUs do not run short of 
medicines  requires  adequate  manufacturing  capacities  and  effective,  predictable  supply 
chains.  It  is  essential  to  develop  and  maintain  a  comprehensive  overview  at  EU  level  of 
various supply chains and their potential strategic dependencies (e.g on active pharmaceutical 
ingredients  imports17)  in  order  to  secure  a  constant  flow  of  all  lifesaving  therapeutics. 
Currently,  public  authorities  do  not  systematically  have  such  an  overview.  The  interactive 
mapping platform for COVID-19 therapeutics will help improve the understanding of these 
supply chains. 

As  outlined  in  the  February  2021  Communication  on  Preparing  Europe  for  COVID-19 
variants:  HERA  Incubator18,  investment  in  innovation  and  manufacturing  capacities  for 

14   i.e. the  body  to  be  established  under  the  proposal  to  reinforce  the  EMA’s  mandate.  It  will  replace  the 

‘COVID-19 EMA pandemic task force’ (the current operational structure). 

15   https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-

19/treatments-vaccines/treatments-covid-19/covid-19-treatments-research-development  

16  COM(2021) 350. 
17  SWD(2021) 352. 
18   https://ec.europa.eu/commission/presscorner/detail/en/fs_21_650 

5 

 
                                                 
vaccines is  one of the cornerstones of  any  future pandemic preparedness and response, and 
part  of  the  EU’s  open  strategic  autonomy.  The  Commission  will  fund  a  €40 million 
preparatory action to support flexible manufacturing and access for COVID-19 therapeutics 
under the EU Fab project, which will set up a network of ‘ever-warm’ production capacities 
for vaccine and therapeutics manufacturing at EU level. This project will become over time 
an asset for the future HERA. 

Furthermore,  building  on  the  experience  of  the  EU  Task  Force  for  Industrial  Scale-up  of 
COVID-19 vaccines, the Commission will facilitate cooperation between actors in the supply 
chain  to  ensure  that  available  therapeutics  are  produced  in  sufficient  quantity  as  soon  as 
possible.  In  the  context  of  a  surge  in  demand,  it  remains  crucial  to  ensure  the  speedy 
production of current and new therapeutics against COVID-19. To support the industry, the 
Commission will organise matchmaking events for all supply chain actors, so that they can 
find solutions for the bottlenecks encountered. 

The  Commission  supports  cooperation  between  undertakings  where  necessary  to  scale  up 
research  and  development,  production  or  supply,  and  where  the  companies  acting  alone 
would not be in a position to do so. Where necessary, it provides competition law guidance, 
e.g. in light of the criteria set out in the Antitrust Temporary Framework Communication19. 
To  date,  it  has  provided  guidance  in  relation  to  the  production  of  vaccines20  and  essential 
medicines  for  COVID-19  treatment21.  EU  State  aid  rules  in  the  Temporary  Framework22 
enable Member States to take swift and effective action to help companies, in particular small 
and  medium-sized  enterprises,  to  increase  capacities  to  produce  and  supply  COVID-19 
medicines and active substances. 

ACTIONS 

  Pan-European matchmaking events for therapeutics industrial production – starting in 

third quarter 2021. 

  Support  flexible  EU  manufacturing  and  access  to  COVID-19  therapeutics  under  the 

EU Fab project, with €40 million in EU funding to be earmarked in 2021. 

5.  ENSURING A RAPID AND FLEXIBLE REGULATORY PROCESS 

The EU’s regulatory system allows for significant flexibility when it comes to authorisation 
procedures  in  the  context  of  public  health  emergencies,  while  making  sure  that  medicinal 
products are safe. In particular, the Commission, together with the EMA, is: 

i)  stepping up engagement with developers; 
ii)  offering scientific support to accelerate review procedures23; 

iii)  making full use of conditional marketing authorisations; 

19   C(2020) 3200. 
20   See comfort letter on vaccines upscale production: 

https://ec.europa.eu/competition/antitrust/comfort_letter_coronavirus_matchmaking_event_25032021.pdf 
For additional information on the matchmaking event, see:   
https://matchmaking-event-towards-vaccines-upscale.b2match.io/  

21   See comfort letter on improving the supply of urgently needed critical hospital medicines to treat COVID-19 

patients: https://ec.europa.eu/competition/antitrust/medicines_for_europe_comfort_letter.pdf  

22   See practical guidance for Member States and list of COVID-19-related State aid decisions approved to date, 

including for research and 
development:https://ec.europa.eu/competition/state_aid/what_is_new/covid_19.html  

23   https://www.ema.europa.eu/en/human-regulatory/overview/supporting-smes 

6 

 
                                                 
 
iv)  providing flexibility in relation to labelling and packaging requirements; and 

v)  providing 

flexibility 

in 

relation 

to  manufacturing, 

import  distribution  and 

pharmacovigilance activities. 

These  flexible  approaches  are  already  being  used  to  speed  up  the  assessment  of  promising 
COVID-19  vaccines  and  therapeutics.  First,  in  emergency  situations,  it  is  possible  to  use  a 
rolling  review,  allowing  the  EMA  to  check  data  from  ongoing  studies  as  they  become 
available,  before  a  formal  application  for  the  (conditional)  marketing  authorisation  is 
submitted. Currently, the EMA is conducting rolling reviews of three COVID-19 therapeutics 
building  on  monoclonal  antibodies  and  seven  rolling  reviews  for  promising  COVID-19 
therapeutics are expected to start by the end of 2021. 

The  Commission  can  also  grant  conditional  marketing  authorisations,  as  it  did  for 
remdesivir24.  These  are  based  on  a  less  comprehensive  dataset  than  would  normally  be  the 
case, subject to a positive benefit-risk balance. The work is then completed at a later date on 
the basis of the incoming data. Together with the EMA, the Commission will work towards 
granting  conditional  marketing  authorisation  for  three  new  COVID-19  therapeutics  by 
October 2021. 

these 

therapeutics  at  national 

Member States can provide access to medicines in advance of their authorisation, including 
through  compassionate-use25  or  emergency-use  authorisation  mechanisms.  The  EMA 
provides harmonised advice on which Member States can base their decisions authorising the 
use  of 
level  before  formal  (conditional)  marketing 
authorisations are issued. This has been done for remdesivir before the conditional marketing 
authorisation  was  granted,  dexamethasone  and  medicines  consisting  of  monoclonal 
antibodies against SARS-CoV226. 
The  Commission  is  considering  a  legislative  proposal27  for  an  EU  emergency-use 
authorisation of medicinal  products  that would ensure an even  faster access  to  medicinal 
products in the context of public health emergencies. 

The  pandemic  has  shown  that,  in  times  of  crisis,  every  day  counts  in  the  effort  to  save 
lives28.  The  proposal  would  therefore  complement  the  current  regulatory  toolbox  with  an 
emergency-use authorisation at EU level. This crisis response mechanism, which today exists 
only at national level, would allow for a simplified while still safe procedure compared to the 
conditional marketing authorisation, by which Member States would jointly agree to market 
medicinal products  with  shorter deadlines, under  specific liability  and monitoring rules  and 
ensuring the safety of the product. 

Timely  access  to  real-world  data  and  real-world  evidence  for  research  and  development  is 
also  key  for  therapeutics  development  and  their  quicker  scientific  assessment.  The 
Commission  will  launch  a  pilot  project  before  its  future  proposal  for  a  European  Health 
Data  Space,  which  is  aimed  at  facilitating  access  to,  and  the  exchange  of,  health  data 
collected  in  the  course  of  healthcare  provision,  for  research,  policy-making  and  regulatory 

24   https://www.ema.europa.eu/en/documents/other/summary-compassionate-use-remdesivir-gilead_en.pdf  
25   https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use  
26   https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/article-53-opinions 
27    As referred to in the Communication on “HERA Incubator: Anticipating together the threat of COVID-19 

variants”, COM(2021) 78 final of 17 February 2021. 

28   As of week 2021-15, 662 622 deaths had been reported in the EU/EEA. The 14-day COVID-19 death rate 
for the EU/EEA, based on data collected by the European Centre for Disease Prevention and Control from 
official  national sources  for 30 countries,  was 77.6 (country range: 0.0-353.4) per million population. The 
rate has been stable for seven weeks. 

7 

 
                                                 
purposes.  This  pilot  will  facilitate  the  EMA’s  and  national  medicine  agencies’  access  to 
real-world data in order to check the safety and efficacy of therapeutics. 

ACTIONS 

  Work  towards  granting  an  authorisation  for  three  new  COVID-19  therapeutics  –  by 

October 2021. 

  Subject  to  research  and  development  outcomes,  start  seven  rolling  reviews  for 

promising COVID-19 therapeutics (EMA) – by end 2021. 

  Launch  pilot  project  ahead  of  upcoming  European  Health  Data  Space  proposal, 
financed by EU4Health to facilitate the EMA’s and national medicine agencies’ access 
to real-world data to check the safety and efficacy of therapeutics – third quarter 2021. 

6.  FLEXIBLE,  FIT-FOR-PURPOSE  AND  WELL-RESOURCED  FINANCING  AND  PROCUREMENT 

CAPACITIES 

The  Joint  Procurement  Agreement  for  medical  countermeasures29  provides  for  a 
voluntary mechanism enabling participating countries and EU institutions to jointly purchase 
medical  countermeasures  for  different  categories  of  cross-border  health  threat,  including 
vaccines,  antivirals  and  other  therapeutics.  It  aims  to  improve  preparedness  to  mitigate 
serious  cross-border  threats  to  health  and  secure  more  equitable  access  to  specific  medical 
countermeasures,  greater  security  of  supply  and  more  balanced  prices  for  the  participating 
countries. 

On 8 October 2020, the Commission signed a joint procurement framework contract with the 
pharmaceutical  company  Gilead  for  the  supply  of  up  to  500 000  treatment  courses  of 
remdesivir. All  participating countries were able to  place their orders to  procure remdesivir 
directly. It also directly purchased doses under the Emergency Support Instrument, for a total 
of €70 million, and distributed these to Member States. Since late October 2020, it has signed 
over 70 joint procurement contracts for 19 medicines (analgesics, antibiotics, muscle relaxers, 
anaesthetics,  resuscitation,  including  dexamethasone,  etc.)  to  treat  more  severe  COVID-19 
cases in ICUs. 

The Commission is ready to conclude further  joint procurement contracts to facilitate the 
equitable  availability  of,  and  access  to,  new  COVID-19  therapeutics  across  the  EU. 
Currently,  discussions  are  ongoing  on  three  new  joint  procurements  for  COVID-19 
therapeutics  awaiting  marketing  authorisations  from  the  Commission  on  the  EMA’s 
recommendation. 

However, while joint procurement agreements have proved successful in securing equitable 
access  to  medicines  for  all  interested  Member  States,  the  instrument  has  also  shown  its 
limitations. The Commission will consider streamlined solutions in this context to maximise 
the strategic role of joint procurement in achieving key preparedness goals – emphasising fair 
access,  choice,  quality,  sustainability  and  value  for  public  spending,  while  enabling 
adaptation to national conditions. 

29   As of April 2020, the Joint Procurement Agreement had been signed by 37 signatories, including all EU and 
EEA  countries,  the  UK,  Albania,  Montenegro,  North  Macedonia,  Serbia,  and  Bosnia  and  Herzegovina,  as 
well as Kosovo* (* This designation is without prejudice to positions on status, and is in line with UNSCR 
1244/1999 and the ICJ Opinion on the Kosovo declaration of independence). 

8 

 
                                                 
Further  account  needs  to  be  taken  of  the  special  requirements  of  procuring  in  emergency 
contexts.  To  achieve  greater  speed  and  flexibility  in  the  current  legal  framework, 
participating Member States and other joint  procurement agreement signatories would need 
to: 

i)  adhere to shorter administrative deadlines; 

ii)  use a distribution key where the resources being procured prove to be scarce; 

iii)  place a certain percentage of orders in the first few months of the contract; and 

iv)  refrain  from  engaging  in  parallel  procurement  processes  for  the  same  products  or 

services. 

Finally, the Commission is also ready to make use of other EU mechanisms and mobilise all 
necessary funding to procure COVID-19 therapeutics, including where appropriate by means 
of advance purchase agreements or the ‘innovation partnership’ procurement procedure30, 
allowing  the  development  and  purchase  of  therapeutics  that  are  not  yet  available  on  the 
market, or direct purchasing and donation. This may also include the emergency stockpiling 
of therapeutics under rescEU, as part of the Union Civil Protection Mechanism, bearing in 
mind the need to ensure complementarity with other EU programmes. 

By  engaging  EU  funds  while  pooling  negotiating  power  at  EU  level,  advance  purchase 
agreements put the EU and its Member States in  a position to leverage scale in discussions 
with the industry and ensure equity of access, in a way that cannot be achieved with multiple 
and sometimes competing national and European channels. 

ACTIONS 

  Launch  new  joint  procurements  of  COVID-19  authorised  therapeutics  in  the  EU  on 

behalf of Member States – by end 2021. 

  Explore  the  possibility  of  engaging  with  Member  States  in  advance  purchase 
agreements or innovation partnerships with producers of promising new therapeutics. 
  Review  options  for  a  fast-track  pathway  for  joint  procurement  of  medical 

countermeasures. 

  Stockpiling of therapeutics under rescEU/Union Civil Protection Mechanism. 

7.  INTERNATIONAL COOPERATION 

Collaboration on therapeutics is also crucial at global level. The Commission is committed to 
working  together  with  international  partners  on  COVID-19  therapeutics.  The  EU  will 
intensify its cooperation with lower- and middle-income countries to strengthen their health 
systems and healthcare workforce, so as to ensure equitable and timely access to high-quality 
and  affordable  medicines.  In  the  spirit  of  European  solidarity,  the  Union  Civil  Protection 
Mechanism allows the Commission to support (financially and/or logistically) Member States 
willing to donate therapeutics to countries impacted by the crisis and in need of assistance as 

30   Innovation  partnership  is  a  relatively  new  type  of  public  procurement  procedure  provided  for  in  Directive 
2014/24/EU. It can be used only  in cases  where  no solution for a public buyer’s needs is available on the 
market. The main feature of the innovation partnership is that the innovation occurs during the performance 
of  the  contract.  In  most  other  procedures,  the  public  buyer  knows  what  type  of  solution  it  is  buying: 
innovation occurs in the pre-contracting phase and usually ends with the conclusion of the contract, when the 
solutions’ exact features are agreed. 

9 

 
                                                 
demonstrated  most  recently  in  responding  to  the  request  for  assistance  from  India31. 
Furthermore,  the  Commission  is  exploring  how  to  support  the  enabling  environment  for 
manufacturing  health  products,  while  strengthening  research  capacity  and  public  health 
institutes  in  partner  countries  around  the  globe  (including  their  capacity  to  generate 
evidence), through the EU’s external relations instruments and the international cooperation 
component of Horizon Europe. 

As the current chair of the  International Coalition of Medicines Regulatory Authorities, 
the EMA (together with the Commission) is working with international partners to expedite 
and  streamline  the  development,  assessment  and  availability  of  COVID-19  therapeutics 
worldwide. In particular, in December 2020, it started piloting a new ‘OPEN’ initiative32 to 
increase  international  collaboration  with  the  Committee  for  Medicinal  Products  for 
Human  Use  on  its  evaluation  of  COVID-19  vaccines  and  therapeutics.  Through  the 
confidentiality  arrangements  that  they  have  concluded  with  third  parties  (including  the 
EMA’s  ad hoc  COVID-19  confidentiality  arrangements)  and  through  the  EU’s  mutual 
recognition agreements, the Commission and the EMA are able to use information produced 
by international regulators, avoid duplication and focus efforts on at-risk areas. The EMA 
collaborates  and  actively  exchanges  information  with  other  non-EU  national  medicines 
agencies  and  the  World  Health  Organization  (WHO)  to  speed  up  the  development  of 
therapeutics and vaccines, including for virus variants. 

The  Commission  is  actively  engaged  in  the  Access  to  COVID-19  Tools  Accelerator,  a 
global  collaborative  project  to  accelerate  the  development  and  production  of,  and  equitable 
access to, COVID-19 tests, therapeutics and vaccines. Set up in response to a call from G20 
leaders in  March 2020 and launched by the WHO, the Commission,  France and the  Bill  & 
Melinda  Gates  Foundation  in  April  202033,  it  brings  together  governments,  scientists,  civil 
society, foundations, charities and global health organisations. 

Equitable access to therapeutics means equitable supply by governments and companies. The 
Commission is promoting cooperation between the EU-funded European platform trials and 
the  Access  to  COVID-19  Tools  Accelerator  partnerships,  in  particular  to  ensure  the  rapid 
sharing of clinical evidence for the assessment of therapeutics and candidate vaccines, and to 
facilitate  the  global  roll-out  and  uptake  of  therapeutics  that  successfully  exit  research  and 
development.  It  will  also  continue  to  promote  a  ‘trade  and  health’  initiative  in  the  World 
Trade Organization with a view to facilitating trade in essential goods in the context of health 
emergencies. 

At the Global Health Summit in Rome, co-hosted by Italy and the EU on 21 May 2021, G20 
leaders,  international  and  regional  organisation  heads  and  representatives  of  global  health 
bodies  will  share  lessons  learned  from  the  pandemic  and,  following  consultation  of  the 
scientific  community  and  civil  society  organisations,  agree  on  principles  for  further 
cooperation  and  joint  action  to  prevent  future  global  health  crises,  in  a  spirit  of  global 
solidarity. 

31   Responding to India’s request for assistance under the Union Civil Protection Mechanism, submitted on 23 
April 2021, many Member States offered needed medical supplies (including oxygen and remdesivir). For 
more  details  see:  https://ec.europa.eu/echo/news/india-eu-civil-protection-mechanism-continues-coordinate-
emergency-supplies_en 

32   https://www.ema.europa.eu/en/news/ema-covid-19-assessments-open-non-eu-regulators  
33   https://www.who.int/news/item/10-09-2020-coronavirus-global-response-access-to-covid-19-tools-

accelerator-facilitation-council-holds-inaugural-meeting  

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ACTIONS 

  Engage  with  international  partners  to  develop  COVID-19  therapeutics  and  ensure 

their fair distribution. 

  Reinforce, together with Member States, engagement in the therapeutics pillar of the 

Access to COVID-19 Tools Accelerator. 

  Step  up  EU  support  for  affected  countries  through  the  Union  Civil  Protection 

Mechanism. 

CONCLUSIONS AND NEXT STEPS 

While  safe  and  effective  vaccines  against  COVID-19  are  increasingly  available,  the 
development and deployment of therapeutics and diagnostics also remain a priority when it 
comes to saving lives. Joint EU action, within a common strategic framework on therapeutics 
is  urgently  needed  to  enhance  and  accelerate  significantly  the  return  to  normality  for 
economic  and  social  life  in  the  EU  and  across  the  world.  The  Commission  will  implement 
this  EU  strategy  for  COVID-19  therapeutics  together  with  the  Member  States  and  the 
European  Parliament,  thus  contributing  to  equitable  and  affordable  access  to  the  most 
appropriate and effective therapeutics in the shortest possible timeframe. 

These  actions  are  part  of  the  strong  European  Health  Union,  in  which  all  EU  countries 
prepare  and  respond  together  to  health  crises  and  ensure  the  availability  of  affordable  and 
innovative medical supplies – including the therapeutics needed to treat COVID-19. 

This  framework  will  be  further  strengthened  by  the  establishment  of  the  HERA,  due  to  be 
proposed by the European Commission in 2021, which will ensure that the EU can anticipate 
and  respond  effectively  to  serious  cross-border  health  threats,  and  builds  on  the 
pharmaceutical strategy for Europe34, which will create a future-proof regulatory framework, 
supporting  research  and  technologies  resulting  in  safe  and  effective  therapeutics  that  reach 
patients. 

34 COM(2020) 761 final. 

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