Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
Date: 2020-11-11
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Medicines Agency, coronavirus disease, crisis management, epidemic, health control, health legislation, medical device, pharmaceutical product

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   EUROPEAN COMMISSION  Brussels, 11.11.2020  COM(2020) 725 final 2020/0321 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

The unprecedented experience of the COVID-19 pandemic has demonstrated that the 
Union’s  ability  to  coordinate  work  to  ensure  the  availability  of  medicinal  products 
and medical devices and facilitate their development is currently limited. 

During the COVID-19 crisis, ad hoc solutions needed to be found to contain the risk 
of  shortages  of  medicines  and  medical  devices  such  as  ventilators,  surgical  masks 
and COVID-19 test  kits.  The operation of these  mechanisms during the  emergency 
was  made  possible  by  contingent  arrangements  between  the  actors  involved  (the 
Member  States,  the  Commission,  the  European  Medicines  Agency  (‘the  Agency’), 
the  medicinal  product  marketing  authorisation  holders,  and  the  medical  device 
manufacturers  and  authorised  representatives).  This  has  in  some  cases  required  the 
Commission and the Agency to take on tasks requiring ad hoc working methods. For 
these  solutions  to  become  efficient  and  predictable,  the  respective  roles  and 
obligations  of the different  entities should be clarified and anchored in  the relevant 
legislative framework.  

Moreover, for, when a number of medicines purported to treat or prevent COVID-19, 
the  Agency  did  not  always  have  access  to  sufficient  health  data  to  formulate 
coordinated  recommendations  across  the  Union.  The  Agency  provided  scientific 
advice  on  their  development  and  ability  to  fight  COVID-19  to  the  utmost  of  its 
ability, but outside of a formal crisis management structure and without the benefit of 
fast-track  scientific  advice  procedures  and  obligations  on  Member  States  and 
developers to cooperate. In particular, developers indicated a lack of harmonisation 
on  aspects  related  to  clinical  trials,  stemming  mainly  from  the  fact  that  each  trial 
needs to be authorised separately in each Member State.  

A suitable framework to support the work of the Expert Panels on medical devices as 
provided  for  in  Regulation  (EU)  2017/7451  should  also  be  provided  for  in  order  to 
ensure  that  those  panels  can  efficiently  and  effectively  provide  scientific  advice 
relevant for crisis preparedness and management, in addition to their core function to 
provide  opinions  on  the  verification  by  notified  bodies  of  the  clinical  and 
performance assessments for  certain  high-risk medical  devices, including  certain  in 
vitro diagnostic devices. This type of advice is essential for crisis preparedness and 
management,  for  example  in  the  context  of  the  COVID-19  pandemic,  repurposing 
production  lines  for  fast  production  of  ventilators  with  the  associated  minimal 
technical and safety specifications.  

Therefore,  a  clear  framework  for  the  activities  to  be  deployed  by  the  Agency  in 
preparation for and during public health emergencies and other major events should 
be established in order to enhance the Union's capacity to react quickly, efficiently, 
and in a coordinated manner to such emergencies. To be effective and operational in 

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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC OJ L 117, 5.5.2017, p. 1 as 
amended by Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 
amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain 
of its provisions, OJ L 130, 24.4.2020, p. 18. 

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times  of  public  health  emergencies,  the  approach  should  be  based  on  strong 
preparedness. This preparedness can be achieved with the development of common 
tools  and  agreed  methods  for  monitoring,  reporting  and  data  collection.  Gathering 
data on key medicines and medical devices considered the most likely to be impacted 
by  a  health  emergency  or  other  major  event  is  also  a  key  priority.  In  doing  so,  the 
proposed Regulation builds on experience from the COVID-19 pandemic so far and 
on  ad  hoc  solutions  set  up  over  the  last  months  as  well  as  the  management  of 
previous major events in the context of the established incident management plan. As 
part  of  this  plan  the  EU  Regulatory  Network  Incident  Management  Plan  for 
medicines  for  human  use  was  developed  (Incident  Review  Network/IRN).  2  This 
structure is used to continuously monitor events and new information, to review their 
public  health  impact  and  to  take  the  necessary  routine  measures  to  remedy  the 
situation.  The  Incident  Review  Network  will  continue  its  activities  taking  into 
account the new management structure in times of crisis provided by the Medicines 
Steering  Group  established  by  the  proposed  Regulation.  The  proposed  Regulation 
will complement and further develop the core tasks already given to the Agency in 
its  founding  Regulation3,  notably  to  provide  scientific  advice  and  to  assess  the 
quality,  safety  and  efficacy  of  medicinal  products  as  part  of  their  authorisation 
process.  

The general objectives of the proposal are to: 

1. 

2. 

ensure  a  high  level  of  human  health  protection  by  strengthening  the  Union’s 
ability  to  manage  and  respond  to  public  health  emergencies,  which  have  an 
impact on medicinal products and medical devices;  

contribute  to  ensuring  the  smooth  functioning  of  the  internal  market  for  such 
products during public health emergencies. 

The specific objectives of the proposal are to: 

1.  monitor and mitigate potential and actual shortages of medicinal products and 
medical devices considered as critical in order to address a given public health 
emergency  or,  for  medicinal  products,  other  major  events  which  may  have  a 
serious impact on public health; 

2. 

3. 

ensure  timely  development  of  high  quality,  safe  and  efficacious  medicinal 
products  with  a  particular  focus  on  addressing  a  given  public  health 
emergency; 

ensure  smooth  functioning  of  expert  panels  for  the  assessment  of  some  high-
risk  medical  devices  and  avail  of  essential  advice  in  crisis  preparedness  and 
management with regard to the use of medical devices. 

• 

Consistency with existing policy provisions in the policy area 

As part of a package of closely associated measures, the proposal will form part of 
the Union’s overall health response to the COVID-19 pandemic and enhanced crisis 
management framework. The recognition of a public health emergency in accordance 

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https://www.ema.europa.eu/en/documents/other/european-union-regulatory-network-incident-
management-plan-medicines-human-use_en.pdf  
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down  Community  procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human 
and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1. 

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with  the  proposed  Regulation  on  Cross-Border  Health  Threats  would  trigger  the 
activation  of  the  structures  provided  for  within  this  proposal.  The  proposed 
monitoring of potential and actual shortages of medicines and medical devices would 
provide a clear evidence base, which would inform decisions on the need for medical 
countermeasures as provided for in that proposed Regulation.  

The  proposed  measures  would  also  complement  the  considerable  body  of  current 
Union  legislation  in  the  fields  of  medicinal  products  and  medical  devices  by 
supporting the continued implementation of that legislation during times of crisis. By 
facilitating the development of medicines, which have the potential to treat, prevent 
or  diagnose  a  disease  causing  a  public  health  crisis,  the  proposal  will  support  the 
implementation of the current legislation on clinical trials. The Agency and Member 
States  can  use  opinions  and  recommendations  on  such  medicines  in  regulatory 
procedures  leading  to  their  authorisation  for  use  within  the  EU.  By  providing  a 
permanent  structure  within  the  Agency  for  the  functioning  of  expert  panels,  the 
proposal  will  create  the  ability  to  quickly  provide  scientific  advice  and  technical 
support on demand in case of crisis and to support the assessment of certain high-risk 
medical devices. 

While  not  a  central  component  of  the  proposed  Regulation,  it  shall  also  contribute 
indirectly to the EU’s international cooperation priorities in the area of global health. 
Through  the  work  of  the  Emergency  Task  Force,  the  proposed  Regulation  will  not 
only  support  Member  States  but  also  partner  countries,  to  develop  and  access 
potential  treatments  and  vaccines  during  public  health  crises,  thus  supporting  the 
strengthening  of  health  systems  and  global  health  security  preparedness  and 
response. 

• 

Consistency with other Union policies 

This  proposal  is  in  line  with  the  obligations  set  out  in  the  Union’s  Charter  of 
Fundamental Rights and the EU's overarching objectives, including a stronger Health 
Union, a smooth  functioning of the internal  market,  sustainable and resilient health 
systems, and an ambitious research and innovation agenda. In addition, the proposal 
will provide useful input to and synergies with the EU Digital Single Market agenda 
and  in  the  context  of  the  planned  European  Health  Data  Space,  encouraging  and 
supporting  innovation  and  research,  facilitating  access  to  and  analysis  of  data  and 
information,  including  real  world  data  (health  data  generated  outside  the  scope  of 
clinical studies), and by including the Agency in the European Health Data Space IT 
infrastructure,  with  the  purpose,  inter  alia,  of  monitoring  use  and  shortages  of 
medicinal products and medical devices. While this proposal provides for a role for 
the  Agency  in  the  European  Health  Data  Space,  the  details  and  procedures  for 
processing  personal  data  through  that  IT  infrastructure,  including  the  role  of  the 
Agency as a data controller and/or processor will be set out in the planned legislative 
proposal on that data space.  

The proposal contributes to achieving a high level of human health protection and is 
thus  consistent  with  the  Charter  of  Fundamental  Rights  in  this  regard.  Where 
personal  data  is  processed  to  fulfil  the  provisions  of  the  proposed  Regulation,  this 
will be done in line with the relevant Union legislation on  personal data protection, 
namely  Regulation  (EU)  2018/17254  and  Regulation  (EU)  2016/6795  (the  General 

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Regulation (EU) 2018/1725 of the European Parliament and of the Council  of 23 October 2018 on the 
protection of natural persons with regard to the  processing of personal data by the Union institutions, 

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Data Protection Regulation (GDPR)) and build on existing procedures and processes 
within the Agency which are used to meet such requirements.  

The  proposal  is  a  tailored  approach  for  medicine  and  medical  device  management 
focusing  on  public  health  emergency  preparedness.  These  measures  will  be 
complemented by additional actions under the Pharmaceutical Strategy for Europe to 
address structural challenges.  

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposed Regulation would be based on Articles 114 and 168(4)(c) of the Treaty 
on the Functioning of the European Union. Such an approach is based on the general 
and specific objectives of the proposal, namely to ensure the smooth functioning of 
the internal market, also during times of crisis, and to ensure the quality and safety of 
medicinal  products  and  medical  devices  developed  during  such  periods.  This 
approach is also consistent with the legal basis generally used for Union legislation 
on medicinal products and medical devices6. 

• 

Subsidiarity  

Public  health  emergencies  of  the  magnitude  of  COVID-19  have  an  impact  on  all 
Member  States,  which,  on  their  own  are  unable  to  provide  a  sufficient  response. 
Potential  or  actual  shortages  of  (nationally  and  centrally  authorised)  medicines  and 
medical  devices  in  times  of  crises  can  lead  to  the  risk  of  disproportionate  national 
stockpiling or restrictions to single market movements being placed on such goods. 
Such  measures  can  have  a  negative  impact  on  the  free  movement  of  goods.  A 
coordinated  response  at  Union-level  to  monitoring  and  mitigating  the  risk  of 
shortages can help the Member States to be better prepared for a sudden increase in 
demand,  avoid  export  restrictions  within  the  EU  or  excessive  and  uncoordinated 
stockpiling,  resulting  in  an  effective  allocation  of  resources  at  national  and  Union 
level,  maintaining  the  smooth  functioning  of  the  single  market  and  ensuring  an 
overall positive impact on public health.  

Providing scientific advice on medicinal products which have the potential to address 
public  health  emergencies  at  Union-level  can  facilitate  their  market  entry,  ensure  a 
harmonised  approach  to  their  use  across  Member  States,  and  help  to  ensure  such 
products  meet  harmonised  EU  standards  for  their  quality,  safety  and  efficacy. 
Scientific advice can eliminate duplication of efforts and unnecessary research. 

An  uncoordinated  approach  to  the  development  of  medicines,  which  have  the 
potential  to  treat,  prevent,  or  diagnose  diseases  causing  public  health  emergencies 
can cause delays  in  their development  during periods  where time is  of the essence. 
Moreover,  a  lack  of  clear,  Union-level  advice  on  the  use  of  medicines  in  national 
compassionate use programmes or outside of their authorised indications can lead to 

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bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 
Regulation  (EU)  2016/769  of  the  European  Parliament  and  of  the  Council  of  27  April  2016  on  the 
protection of natural persons with regard to the processing of personal data and on the free movement of 
such data, and repealing Directive 95/46/EC, OJ L 119, 4.5.2016, p. 1 
For  example:  Directive  2001/83/EC,  Regulation  (EC)  No  726/2004,  Regulation  (EU)  2017/745,  and 
Regulation (EU) 2017/746 

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a fragmented approach across the Union. In addition, regulators’ access to EU-wide 
health data is limited and scattered across different partners leading to complex and 
slow analysis, undermining the optimal time window for certain interventions. 

• 

Proportionality 

The proposal constitutes a proportionate response to address the problems described 
in section 1. In particular, the proposed requirement of more structured monitoring at 
Union level will avoid duplication and provide a better overview of shortage issues 
of a Union-wide interest.  

The  proposal  does  not  interfere  with  Member  States’  competences  in  decisions  on 
the organisation of health care. The proposal does not interfere with notifications sent 
by  marketing  authorisation  holders  to  the  competent  authorities  when  a  product 
ceases to be on the market according to Article 23a of Directive 2001/83/EC7.  

• 

Choice of the instrument 

The  proposal  takes  the  form  of  a  new  Regulation.  This  type  of  instrument  is 
considered to be the most suitable considering that a key element of the proposal is 
the establishment of a framework at Union-level providing for coordinated action to 
address public health emergencies and major events and gives a number of tasks to 
the  Agency.  The  measures  do  not  require  the  implementation  of  national  measures 
and can be directly applicable.  

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex-post evaluations/fitness checks of existing legislation 

As part of a package of urgent measures based on lessons learnt so far from COVID-
19, the initiative will be supported by an assessment of data collected and exchanges 
held  with  public  and  private  stakeholders  in  the  framework  of  the  COVID-19 
pandemic  on  issues  encountered  and  possible  means  to  address  them.  Considering 
that the initiative will enlarge the scope of existing legislation, it will not be based on 
an  ex  post  evaluation,  as  the  needs  identified  were  not  addressed  by  the  existing 
framework. 

• 

Stakeholder consultations 

Shortages  of  medicines  have  been  a  priority  for  the  Member  States  and  European 
Parliament  for  many  years  as  illustrated  by  several  reports  from  the  European 
Parliament  as  well  as  Council  conclusions  and  discussions  under  recent  Council 
Presidencies.  

Following the COVID-19 pandemic, coordinating EU health policies, strengthening 
crisis management and increasing EU production of essential medicinal products and 
medical  devices have  also been identified  as a priority by the Council.  In addition, 
several Member States have called for coordination to ensure availability of critical 
medicines,  including  vaccines  and  medical  devices  during  the  COVID-19  and 
potential future health crises. 

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Directive  2001/83/EC  of  the  European  Parliament  and  of  the  Council  of  6  November  2001  on  the 
Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p.67 

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In  its  resolution  on  shortages  of  medicines  of  17  September  20208,  the  European 
Parliament calls on the Commission to implement fast-track and innovative solutions 
to  mitigate  medicines  shortages  and  calls  on  the  Commission,  the  Agency  and  the 
national regulatory authorities to build on all the pragmatic efforts made during the 
COVID-19 crisis. The proposed Regulation would allow the Agency, to achieve part 
of the vision outlined in the European Parliament’s resolution.  

Medicinal  product  interest  groups  including  associations  representing  respectively 
hospital  pharmacists,  community  pharmacists,  consumer  associations,  wholesale 
distributors, and medical doctors, have expressed concerns in relation to the recurrent 
problems  of  shortages  of  medicines  in  the  EU.  Such  interest  groups  have  renewed 
long-standing calls for action on this during the COVID-19 pandemic given the acute 
impact  it  has  had  on  the  supply  of  certain  medicinal  products  during  the  current 
crisis.The  COVID-19  pandemic  has  been  extremely  challenging  for  the  medical 
devices industry, which has had to adapt to a sharp increase on demand in a climate 
of lack of coordination. Medical Device interest groups have recurrently requested a 
clearer view of EU demand in order to ensure that production capacity will meet the 
needs of Member States, which is essential to avoid shortages. The lack of EU-wide 
scientific  advice  on  medical  devices  during  the  current  crisis  has  also  been 
highlighted as an area that the expert panels can contribute to in future crises. 

• 

Impact assessment 

Due to its urgent nature this proposal is not accompanied by an impact assessment. 
The  initiative  will  enlarge  the  scope  of  the  existing  legislation.  These  changes  are 
mainly  based  on  an  assessment  of  the  data  collected  during  the  first  months  of  the 
pandemic and exchanges held with public and private stakeholders in the framework 
of  the  COVID-19  pandemic  on  issues  encountered  and  possible  means  to  address 
them.  As  regards  medical  devices,  the  proposal  takes  into  account  the  impact 
assessment undertaken in preparation for Regulation (EU) 2017/745 and Regulation 
(EU) 2017/746.  

• 

Fundamental rights 

The  proposed  Regulation  contributes  to  achieving  a  high  level  of  human  health 
protection as set out in Article 35 of the EU Charter of Fundamental Rights. Where 
personal  data  is  processed  based  on  this  proposal  it  will  be  done  in  line  with  the 
relevant  Union  legislation  on  personal  data  protection  namely,  Regulation  (EU) 
2018/1725  and  Regulation  (EU)  2016/679  (the  General  Data  Protection  Regulation 
(GDPR)).  

4. 

BUDGETARY IMPLICATIONS 

The  implementation  of  this  proposal  has  no  impact  on  the  current  Multiannual 
Financial Framework 2014-2020.  

The  financial  impact  on  the  EU  budget  post-2020  will  be  part  of  the  next 
Multiannual Financial Framework.  

The budgetary implications are mainly related to: 

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European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an 
emerging problem (2020/2071(INI)) 

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5. 

• 

– 

– 

– 

– 

administrative support (e.g. to ensure the secretariat of the Executive Steering 
Groups for medicinal products and medical devices, and the Emergency Task 
Force, establish and maintain networks of single points of contacts, provide the 
secretariat  for  the  medical  device  expert  panels,  coordinate  independent 
vaccines  effectiveness  and  safety  monitoring  studies  using  relevant  data  held 
by public authorities); 

scientific support (e.g.  provide scientific  advice  on medicines which have the 
potential  to  treat,  prevent  or  diagnose  diseases  and  technical  assessments  and 
advice on medical devices by expert panels; 

IT support (e.g. establish, host, and maintain streamlined electronic monitoring 
and reporting tools); 

remuneration in the form of a special allowance to national experts involved in 
expert panels on medical devices. 

OTHER ELEMENTS 

Detailed explanation of the specific provisions of the proposal 

The proposal aims to complement the measures directed at improving the overall EU 
crisis management framework by addressing the specific issues related to medicinal 
product  and  medical  device  sectors  and  the  tasks  of  the  Agency.  It  would  thus 
introduce new rules for the Agency with the objective to provide mechanisms within 
the Agency to: 

–  Monitor and mitigate potential and actual shortages of medicinal products and 
medical devices considered as critical in order to address a given public health 
emergency or, for medicinal products, major event; 

– 

– 

Provide  advice  on  medicinal  products,  which  have  the  potential  to  treat, 
prevent  or  diagnose  the  disease  in  question.  Such  advice  would  cover  both 
medicinal  products  under  development, 
those  used  under  national 
compassionate  use  programmes,  and  those  already  authorised  for  a  different 
indication but with the potential to also treat, prevent or diagnose the disease in 
question (repurposed medicines).  

Provide  a  well-managed  and  sustainable  structure  to  coordinate  the  expert 
panels on medical devices, which will be involved in the assessment of specific 
high-risk  medical  devices  and  device  types  relevant  for  health  crisis 
management and provide scientific advice essential in crisis preparedness and 
crisis management.  

The  proposal  also  seeks 
inter-Agency  cooperation  during  such 
emergencies,  most  notably  with  the  European  Centre  for  Disease  Prevention  and 
Control (ECDC).  

to  ensure 

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2020/0321 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on a reinforced role for the European Medicines Agency in crisis preparedness and 
management for medicinal products and medical devices 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Articles 114 and 168(4)(c) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national parliaments, 
After consulting the European Economic and Social Committee9,  
After consulting the Committee of the Regions10, 

Acting in accordance with the ordinary legislative procedure, 

Whereas:  

(1) 

(2) 

(3) 

Pursuant to Articles 9 and 168 of the Treaty on the Functioning of the European Union 
(‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union 
the  Union  is  to  ensure  a  high  level  of  human  health  protection  in  the  definition  and 
implementation of all Union policies and activities. 

The unprecedented experience of the COVID-19 pandemic has demonstrated that the 
Union should be more effective in managing the availability of medicinal products and 
medical  devices  and  in  developing  medical  countermeasures  to  address  the  threats 
posed to public health. The Union’s ability to do so has been severely impeded by the 
absence  of  a  clearly  defined  legal  framework  for  managing  its  response  to  the 
pandemic,  and  also  by  the  limited  degree  of  Union  preparedness  in  case  of  a  public 
health emergency impacting a majority of Member States.  

The often complex supply chains of medicinal products and medical devices, national 
export  restrictions  and  bans,  border  closures  impeding  the  free  movement  of  those 
goods,  and  uncertainty  related  to  their  supply  and  demand  in  the  context  of  the 
COVID-19 pandemic have led to significant impediments to the smooth functioning of 
the  single  market  and  to  addressing  the  serious  threats  to  public  health  across  the 
Union.  

(4) 

Dealing  with  the  issue  of  shortages  of  medicinal  products  has  been  a  long-standing 
priority  for  the  Member  States  and  European  Parliament  as  illustrated  by  several 

9 
10 

OJ C , , p. . 
OJ C , , p. . 

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(5) 

(6) 

(7) 

(8) 

(9) 

reports  from  the  European  Parliament11  as  well  as  discussions  under  recent 
Presidencies of the Council of the European Union.  

The  COVID-19  pandemic  has  exacerbated  the  problem  of  shortages  for  certain 
medicinal  products  considered  as  critical  in  addressing  the  pandemic,  and  has 
highlighted  the  structural  limitations  in  the  Union’s  ability  to  rapidly  and  effectively 
react to such challenges during public health crises. 

The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in 
demand  for  medical  devices  such  as  ventilators,  surgical  masks,  and  COVID-19  test 
kits while disruption of production or limited capacity to  rapidly increase production 
and the complexity and global nature of the supply chain for medical devices, led to a 
negative impact on supply. Those issues resulted in new entities being involved in the 
production  of  those  products,  which  subsequently  resulted  in  bottlenecks  in 
conformity  assessment,  as  well  as  the  prevalence  of  non-compliant,  unsafe,  and  in 
some  cases  counterfeit  products.  It  is  therefore  appropriate  to  establish  long-term 
structures  within  an  appropriate  Union  body  to  ensure  monitoring  of  shortages  of 
medical devices resulting from a public health emergency.  

Uncertainty  of  supply  and  demand  and  the  risk  of  shortages  of  essential  medicinal 
products  and  medical  devices  during  a  public  health  emergency  like  the  COVID-19 
pandemic  can  trigger  export  restrictions  amongst  Member  States  and  other  national 
protective measures, which can seriously impact the functioning of the internal market. 
Furthermore, shortages of medicinal products can result in serious risks to the health 
of patients in the Union due to their lack of availability, which can cause, medication 
errors,  increased  duration  of  hospital  stays,  and  adverse  reactions  caused  by  the 
administration of unsuitable products  used as a substitute for unavailable ones. With 
respect to  medical  devices, shortages  can lead to a lack of diagnostic resources  with 
negative consequences for public health measures, a lack of treatment or deterioration 
of the disease and may also prevent health professionals from adequately carrying out 
their  tasks.  Those  shortages  can  also  have  a  significant  impact  on  controlling  the 
spread of a given pathogen caused by, for example, an insufficient supply of COVID-
19  test  kits.  It  is  therefore  important  to  address  the  question  of  shortages  and  to 
reinforce and formalise monitoring of critical medicinal products and medical devices.  

Safe and efficacious medicinal products that treat, prevent or diagnose diseases which 
cause public health emergencies, should be developed and made available within the 
Union  as  soon  as  possible  during  such  emergencies.  The  COVID-19  pandemic  has 
also  highlighted  sub-optimal  coordination  and  decision-making  as 
regards 
multinational clinical trials, and Union-level advice on the use of medicinal products 
in national compassionate use programmes or outside of their authorised indications in 
the  Union,  causing  delays  in  the  adoption  of  research  outcomes  and  in  the 
development and availability of new or repurposed medicines. 

During the COVID-19 pandemic ad hoc solutions, including contingent arrangements 
between the Commission, the European Medicines Agency (‘the Agency’), marketing 
authorisation  holders,  manufacturers  and  Member  States,  had  to  be  found  to  achieve 
the  objective  of  making  available  safe  and  efficacious  medicinal  products  to  treat 
COVID-19 or prevent its spread, and to facilitate and speed up the development and 
marketing authorisation of treatments and vaccines. 

11 

European Parliament resolution of 17 September 2020 on the shortage of medicines – how to address an 
emerging problem (2020/2071(INI)) 

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(10) 

In  order  to  ensure  a  better  functioning  of  the  internal  market  of  those  products  and 
contribute  to  a  high  level  of  human  health  protection,  it  is  therefore  appropriate  to 
approximate the rules  on monitoring of shortages of medicinal products  and medical 
devices,  and to  facilitate the research and development of medicinal products,  which 
may have the potential to treat, prevent, or diagnose diseases that cause public health 
crises.  

(11)  This  Regulation  aims  to  ensure  the  smooth  functioning  of  the  internal  market  as 
regards  medicinal  products  and  medical  devices,  with  a  high  level  of  human  health 
protection being fundamental in those aims. Moreover, this Regulation aims to ensure 
the  quality,  safety  and  efficacy  of  medicinal  products  with  the  potential  to  address 
public health emergencies. Both objectives are being pursued simultaneously and are 
inseparably linked whilst one not being secondary to the other. As regards Article 114 
TFEU,  this  Regulation  establishes  a  framework  for  the  monitoring  and  reporting  on 
shortages  of  medicinal  products  and  medical  devices  during  public  health  crises.  As 
regards  Article  168(4)(c)  TFEU,  this  Regulation  provides  for  a  strengthened  Union 
framework ensuring the quality and safety of medicinal products and medical devices. 

(12) 

In  order  to  improve  crisis  preparedness  and  management  for  medicinal  products  and 
medical devices and increase resilience and solidarity across the Union, the procedures 
and the respective roles and obligations of different concerned entities involved should 
be clarified. The framework should build on the ad hoc solutions identified so far in 
the response to the COVID-19 pandemic.  

(13)  A  harmonised  system  of  monitoring  of  shortages  of  medicinal  products  and  medical 
devices  should  be  established,  which  will  facilitate  appropriate  access  to  critical 
medicinal products  and  medical  devices during  public health emergencies and major 
events,  which  may  have  a  serious  impact  on  public  health.  That  system  should  be 
complemented with improved structures to ensure appropriate management of public 
health  crises  and  coordinate  and  provide  advice  on  the  research  and  development  of 
medicinal  products  which  may  have  the  potential  to  address  public  health 
emergencies. In order to facilitate the monitoring and reporting on potential or actual 
shortages of medicinal products and medical devices, the Agency should be able to ask 
and obtain information and data from the concerned marketing authorisation holders, 
manufacturers and Member States through designated points of contact. 

(14)  The operational phase of the work of the Steering Groups and Emergency Task Force 
provided  for  in  this  Regulation  should  be  triggered  by  the  recognition  of  a  public 
health  emergency  in  accordance  with  Regulation  (EU)  2020/[…]  on  Cross-Border 
Health Threats and, as regards the Medicines Steering Group, the existence of a major 
event. Continuous monitoring of the risk to public health from major events, including 
manufacturing issues, natural disasters and bioterrorism with the potential to affect the 
quality, safety, efficacy or supply of medicinal products should also be ensured.  

(15)  With respect to medicinal products, an executive steering group should be established 
within  the  Agency  to  ensure  a  robust  response  to  major  events  and  to  coordinate 
urgent actions within the Union in relation to the management of issues relating to the 
supply  of  medicinal  products.  The  Steering  Group  should  establish  lists  of  critical 
medicinal  products  to  ensure  monitoring  of  those  products  and  it  should  be  able  to 
provide  advice  on  the  necessary  action  to  take  to  safeguard  the  quality,  safety,  and 
efficacy of medicinal products and ensure a high level of human health protection.  

(16)  The Executive Steering Group on Shortages and Safety of Medicinal Products should 
benefit from the Agency’s extensive scientific expertise as regards the evaluation and 

EN 

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(17) 

supervision  of  medicinal  products  and  should  further  develop  the  Agency’s  leading 
role  in  coordinating  and  supporting  the  response  to  shortages  during  the  COVID-19 
pandemic.  

In  order  to  ensure  that  safe,  high  quality,  and  efficacious  medicinal  products,  which 
have the potential  to  address  public health emergencies, can be developed and made 
available  within  the  Union  as  soon  as  possible  during  public  health  emergencies,  an 
emergency  task  force  should  be  established  within  the  Agency  to  provide  advice  on 
such  medicinal  products.  The  Emergency  Task  Force  should  provide  advice  free  of 
charge  on  scientific  questions  related  to  the  development  of  treatments  and  vaccines 
and  on  clinical  trial  protocols,  to  those  organisations  involved  in  their  development, 
such  as  marketing  authorisation  holders,  clinical  trial  sponsors,  public  health  bodies, 
and  academia,  irrespective  of  their  exact  role  in  the  development  of  such  medicinal 
products.  

(18)  The  work  of  the  Emergency  Task  Force  should  be  separate  from  the  work  of  the 
scientific committees of the Agency and should be carried out without prejudice to the 
scientific  assessments  of  those  committees.  The  Emergency  Task  Force  should 
provide  recommendations  with  regard  to  the  use  of  medicinal  products  in  the  fight 
against the disease that is responsible for the public health crisis. The Committee for 
Medicinal  Products  for  Human  Use  should  be  able  to  use  those  recommendations 
when preparing scientific opinions on compassionate or other early use of a medicinal 
product prior to marketing authorisation.  

(19)  The establishment of the Emergency Task Force should build on the support provided 
by  the  Agency  during  the  COVID-19  pandemic,  notably  as  regards  scientific  advice 
on clinical trials design and product development as well as the ‘rolling’ review i.e. on 
an  on-going  basis,  of  emerging  evidence  to  allow  a  more  efficient  assessment  of 
medicinal products including vaccines during public health emergencies.  

(20) 

Individual  research  entities  may  agree  together,  or  with  another  party,  to  act  as  a 
sponsor  in  order  to  prepare  one  harmonised  Union-wide  clinical  trial  protocol,  yet 
experience during the COVID-19 pandemic has shown that initiatives to set up large 
multinational  trials  struggle  to  materialise  due  to  the  lack  of  a  single  entity  that  can 
undertake  all  the  responsibilities  and  activities  of  a  sponsor  within  the  Union,  while 
interacting with multiple Member States. It is therefore appropriate for the Agency to 
identify and facilitate such initiatives by giving advice on the possibilities to act as a 
sponsor  or,  where  applicable,  to  define  respective  responsibilities  as  co-sponsors  in 
accordance  with  Article  72  of  Regulation  (EU)  536/2014.  Such  an  approach  would 
strengthen  the  research  environment  in  the  Union,  and  promote  harmonisation  and 
avoid  subsequent  delays  in  integrating  the  results  of  research  to  a  marketing 
authorisation. A Union sponsor could benefit from Union research funding available at 
the time of the public health emergency  as well as  existing clinical  trial networks to 
facilitate the development, application, submission, and running of the trial. This may 
be particularly valuable for trials established by Union or international public health or 
research organisations. 

(21)  With  respect  to  medical  devices,  an  executive  steering  group  on  medical  devices 
should be established to coordinate urgent actions within the Union in relation to the 
management of supply and demand issues of medical devices, and to establish a list of 
critical devices in the case of a public health emergency.  

(22)  This Regulation also provides the Agency with a role to support the expert panels on 
medical  devices  designated  under  Commission  Implementing  Decision  (EU) 

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11 

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(23) 

2019/139612 to provide independent scientific and technical assistance to the Member 
States,  the  Commission,  the  Medical  Device  Coordination  Group  (MDCG),  notified 
bodies and manufacturers. 

in  response 

In addition to their role in clinical evaluation assessments and performance evaluations 
of  certain  high  risk  medical  devices  and  in  vitro  diagnostic  medical  devices  in 
accordance  with  Regulation  (EU)  2017/74513  and  Regulation  (EU)  2017/74614 
respectively,  as  well  as  providing  opinions 
to  consultation  by 
manufacturers  and  notified  bodies,  the  expert  panels  should  play  an  essential  role  in 
the  preparedness  for  and  management  of  public  health  crises  for  medical  devices, 
including those devices which have the potential to address public health emergencies. 
The panels  are to  provide scientific, technical,  and clinical  assistance to  the Member 
States,  the  Commission,  and  the  Medical  Device  Coordination  Group  (MDCG).  In 
particular the panels are to contribute to the development of guidance on a number of 
points  including  clinical  and  performance  aspects  for  specific  devices,  categories,  or 
groups of devices or specific hazards related to a category or group of devices, develop 
clinical  evaluation  and  performance  evaluation  guidance  in  line  with  the  state  of  the 
art, and contribute to the identification of concerns and emerging issues on safety and 
performance. 

(24)  Given  the  Agency’s  long-standing  and  proven  record  of  expertise  in  the  field  of 
medicinal  products  and  considering  the  Agency’s  experience  from  working  with  a 
multitude of groups of experts, it is appropriate to establish the appropriate structures 
within the Agency to monitor potential shortages of medical devices in the context of a 
public health emergency and to provide the Agency with a mandate to host the expert 
panels  on  medical  devices.  This  would  allow  for  long-term  sustainability  for  the 
functioning of the panels and provide clear synergies with related crisis preparedness 
work for medicinal products. Those structures would in no way change the regulatory 
system  or  the  decision-making  procedures  in  the  area  of  medical  devices  already  in 
place  in  the  Union,  which  should  remain  clearly  distinct  from  the  one  for  medicinal 
products. 

(25) 

In order to facilitate the work and the exchange of information under this Regulation, 
provision should be made for the establishment and management of IT infrastructures 
and synergies with other existing IT systems or systems under development, including 
the EUDAMED IT platform for medical devices. That work should also be facilitated 
by,  where  appropriate,  emerging  digital  technologies  such  as  computational  models 
and simulations for clinical trials, as well as data from the EU Space Programme such 
as the Galileo geolocation services, and Copernicus earth observation data. 

(26)  Rapid  access  and  exchange  of  health  data,  including  real  world  data  i.e.  health  data 
generated  outside  of  clinical  studies,  is  essential  to  ensure  effective  management  of 
public  health  emergencies  and  other  major  events.  This  Regulation  should  allow  the 

12 

13 

14 

Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for 
the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards 
the designation of expert panels in the field of medical devices OJ L 234, 11.9.2019, p. 23 
Regulation (EU) 2017/745 of the European Parliament and of the  Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC OJ L 117, 5.5.2017, p. 1. 
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro 
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU 
OJ L 117, 5.5.2017, p. 176. 

EN 

12 

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Agency  to  use  and  facilitate  such  exchange  and  be  part  of  the  establishment  and 
operation of the European Health Data Space infrastructure.  

(27)  During a public health emergency or in relation to a major event, the Agency should 
ensure cooperation with the European Centre for Disease Prevention and Control and 
other  Union  Agencies  as  appropriate.  Such  cooperation  should  include  data  sharing, 
including data on epidemiological forecasting, regular communication at an executive 
level, and invitations to representatives of the European Centre for Disease Prevention 
and  Control  and  other  Union  Agencies  to  attend  meetings  of  the  Emergency  Task 
Force,  the  Medicines  Steering  Group,  and  the  Medical  Devices  Steering  Group,  as 
appropriate.  

(28)  Since the objectives of this Regulation cannot be sufficiently achieved by the Member 
States alone due to the cross-border dimension of public health emergencies and major 
events  and  can,  therefore,  be  better  achieved  at  Union  level,  the  Union  may  adopt 
measures, in accordance with the principle of subsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality, as set 
out  in  that Article, this Regulation  does not  go  beyond what  is  necessary  in  order to 
achieve those objectives.  

(29) 

In  order  to  ensure  that  sufficient  resources  are  available  for  the  work  provided  for 
under  this  Regulation,  expenditure  of  the  Agency  should  be  covered  by  the 
contribution from the Union to the Agency’s revenue.  

(30)  The  European  Data  Protection  Supervisor  has  been  consulted  in  accordance  with 
Article 42(1) of Regulation (EU) No 2018/172515 and has adopted an opinion.16 

(31) 

In  accordance  with  Article  168(7)  of  the  Treaty,  this  Regulation  fully  respects  the 
responsibilities  of  the  Member  States  for  the  definition  of  their  public  health  policy 
and for the organisation and delivery of health services and medical care as well as the 
fundamental rights and principles recognised by the Charter of Fundamental Rights of 
the European Union including the protection of personal data, 

HAVE ADOPTED THIS REGULATION: 

Chapter I 

General Provisions 

Article 1 

Subject Matter 

This  Regulation  provides  for,  within  the  European  Medicines  Agency  (‘the  Agency’),  a 
framework for and the means to: 

15 

16 

Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the 
protection of natural persons with regard to the  processing of personal data by the Union institutions, 
bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 
45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 
[insert reference once available] 

EN 

13 

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(a) 

(b) 

(c) 

(d) 

prepare for and manage the impact of major events on medicinal products for human 
use  and  of  public  health  emergencies  on  medicinal  products  for  human  use  and  on 
medical devices; 

monitor  and  report  on  shortages  of  medicinal  products  for  human  use  and  medical 
devices; 

provide  advice  on  medicinal  products  for  human  use  with  the  potential  to  address 
public health emergencies;  

provide  support  for  the  expert  panels  designated  in  accordance  with  Implementing 
Decision (EU) 2019/1396. 

Article 2 

Definitions 

For the purposes of this Regulation, the following definitions shall apply: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

‘public  health  emergency’  means  a  public  health  emergency  at  Union  level 
recognised  by  the  European  Commission  in  accordance  with  Article  23(1)  of 
Regulation (EU) 2020/[…]17; 

‘medicinal product’ means a medicinal product as defined in point (2) of Article 1 of 
Directive 2001/83/EC of the European Parliament and of the Council; 

‘medical device’ means both a medical device as defined in point (1) of Article 2 of 
Regulation (EU) 2017/745, read in conjunction with point (a) of Article 1(6) of that 
Regulation,  and  an  in  vitro  diagnostic  medical  device  as  defined  in  point  (2)  of 
Article 2 of Regulation (EU) 2017/746; 

‘shortage’  means  that  supply  of  a  medicinal  product  for  human  use  or  a  medical 
device does not meet demand for that medicinal product or medical device; 

‘developer’ means any legal or natural person seeking to generate scientific data with 
regard  to  the  quality,  safety  and  efficacy  of  a  medicinal  product  as  part  of  that 
product’s development; 

‘major event’ means an event which is likely to pose a serious risk to public health in 
relation  to  medicinal  products  in  more  than  one  Member  State.  Such  an  event 
concerns a deadly threat or otherwise serious threat to health of biological, chemical, 
environmental or other origin or incident that can affect the supply or quality, safety, 
and efficacy of medicinal products. Such an event may lead to shortages of medicinal 
products  in  more  than  one  Member  State  and  necessitates  urgent  coordination  at 
Union level in order to ensure a high level of human health protection. 

17 

[insert  reference  to  the  Regulation  of  the  European  Parliament  and  of  the  Council  on  serious  cross-
border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […]. 

EN 

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Chapter II 

Monitoring and mitigating shortages of critical medicinal 
products and management of major events 

Article 3 

The Executive Steering Group on Shortages and Safety of Medicinal Products  

The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the 
Medicines Steering Group’) is hereby established as part of the Agency. It shall meet 
either in person or remotely, in preparation for or during a public health emergency 
or  following  a  request  for  assistance  referred  to  in  Article  4(3).  The  Agency  shall 
provide its secretariat. 

The Medicines Steering Group shall be composed of a representative of the Agency, 
a representative of the Commission and one senior representative per Member State. 
Each Member State shall appoint their representative. Members may be accompanied 
by experts in specific scientific or technical fields. 

The Medicines Steering Group shall be chaired by the Agency. The Chair may invite 
third  parties,  including  representatives  of  medicinal  product  interest  groups  and 
marketing authorisation holders to attend its meetings. 

The  Medicines  Steering  Group  shall  establish  its  rules  of  procedure  including 
procedures  relating  to  the  working  party  referred  to  the  paragraph  5  and  on  the 
adoption of lists, sets of information, and recommendations. The rules of procedure 
shall enter into force after receiving a favourable opinion from the Commission and 
the Management Board of the Agency. 

The  Medicines  Steering  Group  shall  be  supported  in  its  work  by  a  working  party 
comprised  of  single  points  of  contact  related  to  shortages  from  national  competent 
authorities for medicinal products established in accordance with Article 9(1). 

The Medicines Steering Group shall be responsible for fulfilling the tasks referred to 
in Article 4(4) and Articles 5 to 8.  

Article 4 

Monitoring of events and preparedness for major events and public health emergencies  

The  Agency  shall  continuously  monitor  any  event  that  is  likely  to  lead  to  a  major 
event or a public health emergency. 

To  facilitate  the  monitoring  task  referred  to  in  paragraph  1,  the  national  competent 
authorities,  through  the  single  points  of  contact  referred  to  in  Article  3(5),  shall, 
based on the reporting criteria specified by  the  Agency pursuant  to  Article 9(1)(b), 
report to the Agency on any event, including a shortage of a medicinal product in a 
given  Member  State,  that  is  likely  to  lead  to  a  major  event  or  a  public  health 
emergency. Where a national competent authority informs the Agency of a shortage 
of a medicinal product in a given Member State, it shall provide the Agency with any 
information received from the marketing authorisation holder pursuant to Article 23a 
of  Directive  2001/83/EC.  Based  on  a  report  of  an  event  from  a  national  competent 

1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

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15 

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3. 

4. 

5. 

authority and in order to understand the impact of the event in other Member States, 
the  Agency  may  request  information  from  the  national  competent  authorities, 
through the working party referred to in Article 3(5). 

Where  the  Agency  considers  that  an  actual  or  imminent  major  event  needs  to  be 
addressed,  it  shall  inform  the  Commission  and  the  Member  States  thereof.  The 
Commission, on its own initiative or following a request from one or more Member 
States,  or  the  Executive  Director  of  the  Agency  may  request  the  assistance  of  the 
Medicines Steering Group to address the major event.  

The  Medicines  Steering  Group  shall  inform  the  Commission  and  the  Executive 
Director of the Agency, once it considers that the major event has been sufficiently 
addressed. On the basis of that information or on its own initiative, the Commission 
or the Executive Director may confirm that the assistance of the Medicines Steering 
Group is no longer needed.  

In the case of a major event or public health emergency, Articles 5 to 12 shall apply 
as follows:  

(a)  where  the  major  event  or  public  health  emergency  may  affect  the  safety, 

quality, and efficacy of medicinal products, Article 5 shall apply; 

(b)  where  the  major  event  or  public  health  emergency  may  lead  to  shortages  of 
medicinal  products  in  more  than  one  Member  State,  Articles  6  to  12  shall 
apply.  

Article 5 

Evaluation of information and the provision of advice on action in relation to the safety, 
quality, and efficacy of medicinal products related to public health emergencies and major 
events 

Following the recognition of a public health emergency or a request for assistance referred to 
in  Article  4(3),  the  Medicines  Steering  Group  shall  evaluate  the  information  related  to  the 
major event or the public health emergency and consider the need for urgent and coordinated 
action with regard to the safety, quality, and efficacy of the medicinal products concerned.   

The Medicines Steering Group shall provide advice to the Commission and Member States on 
any  appropriate  action  it  believes  should  be  taken  at  Union  level  on  the medicinal  products 
concerned in accordance with the provisions of Directive 2001/83/EC or Regulation (EC) No 
726/2004.18  

Article 6 

Lists of critical medicinal products and information to be provided 

1. 

Following a request for assistance referred to in Article 4(3) and after consultation of 
its  working  party,  the  Medicines  Steering  Group  shall  adopt  a  list  of  medicinal 
products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 
726/2004  which  it  considers  as  critical  during  the  major  event  (‘the  major  event 
critical medicines list ’). The list shall be updated whenever necessary until the major 
event has been sufficiently addressed.  

18 

Regulation (EC) No 726/2004  

EN 

16 

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2. 

3. 

4. 

Immediately  following  the  recognition  of  a  public  health  emergency  and  after 
consultation of its working party, the Medicines Steering Group shall adopt a list of 
medicinal  products  authorised  in  accordance  with  Directive  2001/83/EC  or 
Regulation (EC) No 726/2004 which it considers as critical during the public health 
emergency  (‘the  public  health  emergency  critical  medicines  list’).  The  list  shall  be 
updated  whenever  necessary  until  the  termination  of  the  recognition  of  the  public 
health emergency.  

The Medicines  Steering Group shall adopt a set of information necessary to monitor 
the  supply  and  demand  of  medicinal  products  included  on  the  lists  referred  to  in 
paragraphs  1  and  2  (‘the  critical  medicines  lists’)  and  inform  its  working  party 
thereof. 

The Agency shall immediately publish the critical medicines lists and any updates to 
those  lists  on  its  web-portal  referred  to  in  Article  26  of  Regulation  (EC)  No 
726/2004. 

Article 7 

Monitoring shortages of medicinal products on the critical medicines lists 

On  the  basis  of  the  critical  medicines  lists  and  the  information  and  data  provided  in 
accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and 
demand of medicinal products included on those lists with a view to identifying any potential 
or  actual  shortages  of  those  medicinal  products.  As  part  of  that  monitoring,  the  Medicines  
Steering Group shall liaise, where relevant, with the Health Security Committee established in 
Article 4 of Regulation  (EU) 2020/[…]19 and, in  the case of a public health emergency, the 
Advisory Committee on public health emergencies established pursuant to Article 24 of that 
Regulation. 

Article 8 

Reporting and recommendations on shortages of medicinal products 

For the duration of a public health emergency or following a request  for  assistance 
referred to  in  Article 4(3) and until  its closure, the Medicines Steering Group  shall 
regularly report the results of its monitoring to the Commission and the sub-network 
referred to in Article 9(2), and, in particular, signal any potential or actual shortages 
of medicinal products included on the critical medicines lists. 

the  European  Centre  for  Disease  Prevention  and  Control 

Where requested by the Commission or the sub-network referred to in Article 9(2), 
the Medicines Steering Group shall provide aggregated data and forecasts of demand 
to substantiate its findings. In that regard, the Medicines Steering Group shall liaise 
with 
to  obtain 
epidemiological  data  to  help  forecast  medicinal  product  needs,  and  with  the 
Executive Steering Group on Shortages of Medical Devices referred to in Article 19 
where  medicinal  products  included  on  the  critical  medicines  lists  are  administered 
with a medical device. 

As  part  of  that  reporting,  the  Medicines  Steering  Group  may  also  provide 
recommendations  on  measures,  which  may  be  taken  by  the  Commission,  Member 
States,  marketing  authorisation  holders  and  other  entities  to  prevent  or  mitigate 

[insert reference to adopted text referred to in footnote 4] 

1. 

2. 

3. 

19 

EN 

17 

  EN 

                                                 
4. 

5. 

potential or actual shortages.  In that regard the Group shall liaise, as relevant,  with 
the  Health  Security  Committee  and,  in  the  case  of  a  public  health  emergency,  the 
Advisory Committee on public health emergencies. 

The Medicines Steering  Group may, on its own initiative or upon request  from  the 
Commission,  provide  recommendations  on  measures,  which  may  be  taken  by  the 
Commission,  Member  States,  marketing  authorisation  holders  and  other  entities  to 
ensure preparedness to deal with potential or actual shortages of medicinal products 
caused by public health emergencies or major events. 

The  Medicines  Steering  Group  may  upon  request  from  the  Commission  coordinate 
measures, where relevant, between the national competent authorities, the marketing 
authorisation  holders  and  other  entities  to  prevent  or  mitigate  potential  or  actual 
shortages in the context of a major event or public health emergency. 

Article 9 

Working methods and provision of information on medicinal products 

1. 

In order to prepare for fulfilling the tasks referred to in Articles 4 to 8, the Agency 
shall: 

(a) 

(b) 

(c) 

(d) 

(e) 

specify the procedures for establishing the critical medicines lists; 

specify  the  methods  of  and  criteria  for  the  monitoring,  data  collection  and 
reporting provided for in Articles 4, 7 and 8; 

develop streamlined electronic monitoring and reporting systems; 

establish and maintain membership of the working party referred to in Article 
3(5) comprised of single points of contacts from national competent authorities 
for medicinal products; 

establish  and  maintain  a  list  of  single  points  of  contact  from  marketing 
authorisation holders for all medicinal products for human use authorised in the 
Union,  through  the  database  provided  for  in  Article  57(1)(l)  of  Regulation 
726/2004; 

(f) 

specify  the  methods  for  the  provision  of  recommendations,  advice  and 
coordination of measures provided for in Articles 5 and 8. 

2. 

Following  the  recognition  of  a  public  health  emergency  or  a  request  for  assistance 
referred to in Article 4(3) the Agency shall: 

(a) 

(b) 

(c) 

establish and maintain for the duration of the public health emergency or major 
event, a sub-network of single points of contact  from marketing authorisation 
holders  based  on  the  medicinal  products  included  on  the  critical  medicines 
lists; 

request  information  from  the  points  of  contact  included  in  the  sub-network 
referred to in point (a) and set a deadline for its submission; 

request  information  from  the  single  points  of  contact  from  Member  States’ 
national competent authorities based on the set of information agreed on by the 
Medicines Steering Group and set a deadline for its submission. 

3. 

The information referred to in point (b) of paragraph 2 shall include at least: 

(a) 

the name of the marketing authorisation holder;  

EN 

18 

  EN 

(b) 

the name of the medicinal product;  

(c) 

the country of authorisation and marketing status in each Member State;  

(d)  details of the potential or actual shortage such as actual or estimated start and 

end dates and suspected or known cause; 

sales and market share data; 

details of available alternative medicinal products; 

(e) 

(f) 

(g)  mitigation plans including production and supply capacity; 

(h) 

information from the wholesale distributors and legal person entitled to supply 
the medicinal product to the public.  

Article 10  

Obligations on marketing authorisation holders 

In order to facilitate the monitoring referred to in Article 7 and following a request 
from the Agency, marketing authorisation holders for medicinal products included on 
the critical medicines lists shall submit the information referred to in Article 9(3) by 
the deadline set by the Agency. They shall submit the information through the points 
of  contact  designated  in  accordance  with  Article  9(2)  and  using  the  reporting 
methods and system established pursuant to Article 9(1). They shall provide updates 
where necessary. 

Marketing authorisation holders of medicinal products authorised in the Union shall, 
within  6  months  from  the  date  of  application  of  this  Regulation,  provide  the 
information  required  pursuant  to  Article  9(1)(e)  in  the  form  of  an  electronic 
submission  in  the  database  referred  to  in    Article  57(1)(l)  of  Regulation  (EC)  No 
726/2004.  Those  marketing  authorisation  holders  shall  update  their  submission 
wherever necessary. 

Marketing  authorisation  holders  shall  justify  the  absence  of  any  requested 
information and any delays in providing it by the deadline set by the Agency. 

Where  marketing  authorisation  holders  for  medicinal  products  included  on  the 
critical  medicines  lists  indicate  that  the  submitted  information  contains  information 
of  a  commercially  confidential  nature,  they  shall  identify  the  relevant  parts  and 
clarify the reasons for such an indication. The Agency shall assess the merits of each 
request  and  protect  commercially  confidential  information  against  unjustified 
disclosure. 

Where  marketing  authorisation  holders  for  medicinal  products  included  on  the 
critical  medicines  lists  are  in  possession  of  any  additional  information,  which 
provides  evidence  of  a  potential  or  actual  shortage  they  shall  immediately  provide 
such information to the Agency. 

Following  the  reporting  on  the  results  of  the  monitoring  and  any  recommendations 
on  preventive  or  mitigating  measures  in  accordance  with  Article  8,  marketing 
authorisation  holders  for  medicinal  products  included  on  the  critical  medicines  list 
shall: 

(a) 

provide any comments they have to the Agency; 

1. 

2. 

3. 

4. 

5. 

6. 

EN 

19 

  EN 

(b) 

(c) 

take into account  any recommendations and guidelines  and comply with any 
measures taken at  Union and Member State-level pursuant  to  Articles 11  and 
12; 

inform the Medicines Steering Group of any measures taken and report on the 
results  of  those  measures,  including  information  on  the  resolution  of  the 
potential or actual shortage. 

Article 11 

Obligations on Member States in the monitoring and mitigation of shortages of medicinal 
products 

1. 

In order to facilitate the monitoring referred to in Article 7 and following a request 
from the Agency, Member States shall, by the deadline set by the Agency: 

(a) 

(b) 

(c) 

submit the set of information requested by the Agency including available and 
estimated  data  on  volume  of  demand,  through  its  designated  point  of  contact 
and  using  the  reporting  methods  and  system  established  pursuant  to  Article 
9(1); 

indicate the existence of any commercially confidential information and clarify 
the reasons for such an indication; 

indicate the absence of any requested information, and any delays in providing 
requested information by the deadline set by the Agency. 

Where necessary to fulfil their reporting obligations set out in paragraph 1, Member 
States,  with  the  support  of  the  Agency,  shall  gather  information  and  data  on  stock 
levels  from  wholesale  distributors  and  other  legal  entities  entitled  to  supply  the 
public with medicinal products included on the critical medicines lists. 

Where Member States are in possession of any additional information on volume of 
sales and volumes of prescriptions, including data based on Article 23a of Directive 
2001/83/EC, which provides evidence of a potential or actual shortage of a medicinal 
product included on the critical medicines lists, they shall immediately provide such 
information  to  the  Medicines  Steering  Group  through  their  designated  points  of 
contact. 

Following  the  reporting  on  the  results  of  the  monitoring  and  any  recommendations 
on  preventive  or  mitigating  measures  in  accordance  with  Article  8,  Member  States 
shall: 

(a) 

(b) 

take  into  account  any  recommendations  and  guidelines  and  comply  with  any 
measures taken at Union-level pursuant to Article 12; 

inform the Medicines Steering Group of any measures taken and report on the 
results  of  those  measures,  including  information  on  the  resolution  of  the 
potential or actual shortage. 

2. 

3. 

4. 

Article 12 

Role of the Commission in the monitoring and mitigation of shortages of medicinal products 

The  Commission  shall  take  into  account  the  information  from  and  recommendations  of  the 
Medicines Steering Group and shall: 

EN 

20 

  EN 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

take all necessary action within the limits of the powers conferred on it, with a view 
to  mitigating  potential  or  actual  shortages  of  medicinal  products  included  on  the 
critical medicines lists; 

consider 
authorisation holders, and other entities; 

the  need  for  guidelines  addressed 

to  Member  States,  marketing 

inform  the  Medicines  Steering  Group  of  any  measures  taken  and  report  on  the 
results; 

request  the  Medicines  Steering  Group  to  provide  recommendations  or  coordinate 
measures as provided for in Article 8(3), (4) and (5); 

consider  the  need  for  medical  countermeasures  in  accordance  with  Articles  12  and 
25(b) of Regulation (EU) 2020/[…];20  

liaise with third countries and relevant international organisations, as appropriate, to 
mitigate potential or actual  shortages of medicinal  products  included on the critical 
medicines  list  or  their  active  pharmaceutical  ingredients,  where  those  products  or 
ingredients are imported into the Union and where such potential or actual shortages 
have international implications. 

Article 13 

Communication on the Medicines Steering Group 

The  Agency  shall,  via  its  web-portal  and  other  appropriate  means,  in  conjunction  with 
national competent authorities, inform the public and interest groups with regard to the work 
of the Medicines Steering Group. 

Chapter III 

Medicinal Products with the potential to address public health 
emergencies 

Article 14 

The Emergency Task Force 

1. 

2. 

The Emergency Task  Force is  hereby established as part of the Agency.  It shall be 
convened  during  public  health  emergencies,  either  in  person  or  remotely.  The 
Agency shall provide its secretariat. 

During  public  health  emergencies,  the  Emergency  Task  Force  shall  undertake  the 
following tasks: 

(a) 

providing  scientific  advice  and  reviewing  the  available  scientific  data  on 
medicinal products  with  the potential to address the public health emergency, 
including  requesting  data  from  developers  and  engaging  with  them  in 
preliminary discussions; 

(b) 

reviewing clinical trial protocols and providing advice to developers on clinical 
trials  to  be  conducted  in  the  Union  for  medicinal  products  intended  to  treat, 

20 

[insert reference to adopted text referred to in footnote 4] 

EN 

21 

  EN 

                                                 
(c) 

(d) 

(e) 

(f) 

prevent,  or  diagnose  the  disease  causing  the  public  health  emergency,  in 
accordance with Article 15; 

providing  scientific  support  to  facilitate  clinical  trials  to  be  conducted  in  the 
Union for medicinal products intended to treat, prevent, or diagnose the disease 
causing  the  public  health  emergency.  Such  support  shall  include  advice  to 
sponsors  of  similar  or  linked  planned  clinical  trials  on  the  establishment,  in 
their  place,  of  joint  clinical  trials  and  may  include  advice  on  establishing 
agreements  to  act  as  a  sponsor  or  as  co-sponsor  in  accordance  with  Articles 
2(14) and 72 of Regulation (EU) 536/2014; 

contributing  to  the  work  of  the  scientific  committees,  working  parties  and 
scientific advisory groups of the Agency;  

providing scientific recommendations with regard to the use of any medicinal 
product, which may have the potential to address public health emergencies, in 
accordance with Article 16;  

cooperating  with  Union  bodies  and  agencies,  the  World  Health  Organization, 
third  countries,  and  international  scientific  organisations  on  scientific  and 
technical  issues  relating  to  the  public  health  emergency  and  to  medicinal 
products which may have the potential to address public health emergencies, as 
necessary. 

The  Emergency  Task  Force  shall  be  composed  of  representatives  of  the  scientific 
committees,  working  parties,  and  staff  members  of  the  Agency,  the  coordination 
group  established  in  accordance  with  Article  27  of  Directive  2001/83/EC,  and  the 
Clinical  Trials  Coordination  and  Advisory  Group  established  in  accordance  with 
Article  85  of  Regulation  (EU)  536/2014.21  External  experts  may  be  appointed  and 
representatives of other Union bodies and agencies be invited on an ad hoc basis, as 
necessary. It shall be chaired by the Agency. 

The  composition  of  the  Emergency  Task  Force  shall  be  approved  by  the 
Management  Board  of  the  Agency.  The  Executive  Director  of  the  Agency  or  their 
representative  and  representatives  of  the  Commission  shall  be  entitled  to  attend  all 
meetings. 

The  Chair  may  invite  representatives  of  Member  States,  members  of  scientific 
committees  of  the  Agency  and  working  parties,  and  third  parties,  including 
representatives of medicinal product interest groups, marketing authorisation holders, 
developers  of  medicinal  products,  clinical  trial  sponsors,  representatives  of  clinical 
trial networks, and interest groups representing patients and healthcare professionals 
to attend its meetings. 

The Emergency Task  Force shall establish its rules of procedure  including rules on 
the adoption of recommendations. The rules of procedure shall enter into force after 
receiving a favourable opinion from the Commission and the Management Board of 
the Agency. 

The  Emergency  Task  Force  shall  perform  its  tasks  as  a  body  separate  from,  and 
without prejudice to the tasks of the scientific committees of the Agency as regards 

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 

3. 

4. 

5. 

6. 

7. 

21 

EN 

22 

  EN 

                                                 
the  authorisation,  supervision  and  pharmacovigilance  of  the  concerned  medicinal 
products  and related regulatory  actions to  ensure the quality, safety  and  efficacy of 
those  medicinal  products.  The  Emergency  Task  Force  shall  take  account  of  any 
scientific  opinion  issued  by  those  committees  in  accordance  with  Regulation  (EC) 
No 726/2004 and Directive 2001/83/EC. 

Article 63 of Regulation (EC) No 726/2004 shall apply to the Emergency Task Force 
as regards transparency and the independence of its members.  

The  Agency  shall  publish  information  about  the  medicinal  products  that  the 
Emergency  Task  Force  considers  may  have  the  potential  to  address  public  health 
emergencies and any updates on its web-portal. 

Article 15 

Advice on clinical trials  

During  a public health emergency, the Emergency  Task Force shall review clinical 
trial protocols submitted or intended to be submitted in a clinical trial application by 
developers of medicinal products as part of an accelerated scientific advice process. 

Where  a  developer  engages  in  an  accelerated  scientific  advice  process,  the 
Emergency Task force shall provide such advice free of charge at the latest 20 days 
following the submission to the Agency of a complete set of requested information 
and  data  by  the  developer.  The  advice  shall  be  endorsed  by  the  Committee  for 
Medicinal Products for Human Use.  

The Emergency Task Force shall establish procedures for the request and submission 
of  the  set  of  information  and  data  required,  including  information  on  the  Member 
State or States where an application for authorisation of a clinical trial is submitted or 
is intended to be submitted. 

The  Emergency  Task  Force  shall  involve  representatives  of  the  Member  State  or 
States  where  an  application  for  authorisation  of  a  clinical  trial  is  submitted  or  is 
intended to be submitted in the preparation of the scientific advice. 

When  authorising  a  clinical  trial  application  for  which  scientific  advice  has  been 
given, Member States shall take that advice duly into account. 

Where  a  developer  is  the  recipient  of  scientific  advice,  the  developer  shall 
subsequently submit the data resulting from clinical trials to the Agency following a 
request made pursuant to Article 16.  

Without  prejudice  to  the  provisions  of  this  Article,  the  scientific  advice  shall 
otherwise  be  provided  to  those  developers  in  accordance  with  the  procedures 
established pursuant to Article 57 of Regulation EC (No) 726/2004.  

Article 16 

Review of medicinal products and recommendations on their use 

Following the recognition of a public health emergency, the Emergency Task Force 
shall undertake a review of the available scientific data on medicinal products, which 
may have the potential to be used to address the public health emergency. The review 
shall be regularly updated during the public health emergency. 

8. 

9. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

1. 

EN 

23 

  EN 

2. 

3. 

4. 

5. 

6. 

7. 

In preparation of the review, the Emergency Task Force may request information and 
data  from  marketing  authorisation  holders  and  from  developers  and  engage  with 
them  in  preliminary  discussions.  The  Emergency  Task  Force  may  also,  where 
available,  make  use  of  observational  studies  of  health  data  generated  outside  of 
clinical studies taking into account their reliability.  

Based  on  a  request  from  one  or  more  Member  States,  or  the  Commission,  the 
Emergency  Task  Force  shall  provide  recommendations  to  the  Committee  for 
Medicinal Products for Human Use for an opinion in accordance with paragraph 4 on 
the following: 

(a) 

(b) 

the  compassionate  use  of  medicinal  products  falling  under  the  scope  of 
Directive 2001/83/EC or Regulation (EC) No 726/2004; 

the  use  and  distribution  of  an  unauthorised  medicinal  product  in  accordance 
with Article 5(2) of Directive 2001/83/EC. 

Following receipt of the recommendation, the Committee for Medicinal Products for 
Human  Use  shall  adopt  an  opinion  on  the  conditions  for  use,  the  conditions  for 
distribution and the patients targeted. The opinion shall be updated where necessary. 

Member States shall take account of the opinions referred to in paragraph 4. Where 
Member  States  make  use  of  such  an  opinion,  Article  5(3)  and  (4)  of  Directive 
2001/83/EC shall apply. 

In  the  preparation  of  its  recommendations  provided  pursuant  to  paragraphs  3,  the 
Emergency  Task  Force  may  consult  the  concerned  Member  State  and  request  it  to 
provide  any  information  and  data,  which  informed  the  Member  State’s  decision  to 
make  the  medicinal  product  available  for  compassionate  use.  Following  such  a 
request, the Member State shall provide all of the requested information. 

The  Agency  shall  publish  the  opinions  adopted  pursuant  to  paragraph  4  including 
any updates on its web-portal. 

Article 17 

Communication on the Emergency Task Force 

The  Agency  shall,  via  its  web-portal  and  other  appropriate  means  and,  in  conjunction  with 
national competent authorities, inform the public and relevant interest groups with regard to 
the work of the Emergency Task Force. 

Article 18 

IT tools and data 

To  prepare  for  and  support  the  work  of  the  Emergency  Task  Force  during  public  health 
emergencies, the Agency shall: 

(a) 

(b) 

develop  and  maintain  electronic  tools  for  the  submission  of  information  and  data, 
including electronic health data generated outside the scope of clinical studies; 

coordinate  independent  vaccine  effectiveness  and  safety  monitoring  studies  using 
relevant data held by public authorities. Such coordination shall be conducted jointly 
with  the  European  Centre  for  Disease  Prevention  and  Control  and  notably  through 
a new vaccine monitoring platform; 

EN 

24 

  EN 

(c) 

(d) 

as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate 
the  rapid  access  to  or  analysis  of  available  electronic  health  data  generated  outside 
the scope of clinical studies, and the exchange of such data between Member States, 
the Agency, and other Union bodies; 

provide access to the Emergency Task Force to external sources of electronic health 
data including, health data generated outside the scope of clinical  studies, to  which 
the Agency has access. 

Chapter IV 

Monitoring and mitigating shortages of critical medical devices 
and support for expert panels 

1. 

2. 

3. 

4. 

5. 

6. 

1. 

Article 19 

The Executive Steering Group on Medical Devices 

The  Executive  Steering  Group  on  Medical  Devices  (‘the  Medical  Devices  Steering 
Group’) is hereby established as part of the Agency. It shall meet either in person or 
remotely, in preparation for or during a public health emergency. The Agency shall 
provide its secretariat. 

The  Medical  Devices  Steering  Group  shall  be  composed  of  a  representative  of  the 
Agency,  a  representative  of  the  Commission  and  one  senior  representative  per 
Member State. Each Member State shall appoint their representative. Members may 
be accompanied by experts in specific scientific or technical fields. 

The Medical Devices Steering Group shall be chaired by the Agency. The Chair may 
invite  third  parties,  including  representatives  of  medical  device  interest  groups  to 
attend its meetings. 

The Medical Devices Steering Group shall establish its rules of procedure including 
procedures  relating  to  the  working  party  referred  to  in  paragraph  5,  and  on  the 
adoption of lists, sets of information and recommendations. The rules of procedures 
shall enter into force after receiving a favourable opinion from the Commission and 
the Management Board of the Agency. 

The  Medical  Devices  Steering  Group  shall  be  supported  in  its  work  by  a  working 
party  comprised  of  single  points  of  contact  from  national  competent  authorities  for 
medical devices established in accordance with Article 23(1). 

The  Medical  Devices  Steering  Group  shall  be  responsible  for  fulfilling  the  tasks 
referred to in Articles 20, 21, and 22. 

Article 20 

List of critical medical devices and information to be provided 

Immediately  following  the  recognition  of  a  public  health  emergency  and  after 
consultation of its working party, the Medical Devices Steering Group shall adopt a 
list  of  medical  devices  which  it  considers  as  critical  during  the  public  health 
emergency  (‘the  public  health  emergency  critical  devices  list’).  The  list  shall  be 
updated  whenever  necessary  until  the  termination  of  the  recognition  of  the  public 
health emergency.  

EN 

25 

  EN 

2. 

3. 

The  Medical  Devices  Steering  Group  shall  adopt  a  set  of  information  necessary  to 
monitor  the  supply  and  demand  of  medical  devices  included  on  the  public  health 
emergency critical devices list and inform its working party thereof. 

The  Agency  shall  publish  the  public  health  emergency  critical  devices  list  and  any 
updates to that list on its web-portal. 

Monitoring shortages of medical devices on the public health emergency critical devices list 

Article 21 

1. 

2. 

1. 

2. 

3. 

On the basis of the public health emergency critical devices list and the information 
and  data  provided  in  accordance  with  Articles  24  and  25,  the  Medical  Devices 
Steering Group shall monitor supply and demand of medical devices included on that 
list  with  a  view  to  identifying  any  potential  or  actual  shortages  of  those  medical 
devices. As part of that monitoring, the Medical Devices Steering Group shall liaise, 
where  relevant,  with  the  Health  Security  Committee  established  in  Article  4  of 
Regulation  (EU)  2020/[…]22  and  the  Advisory  Committee  on  public  health 
emergencies established pursuant to Article 24 of that Regulation. 

As part of the monitoring, the Medical Devices Steering Group may also make use of 
data from device registries and databanks where such data is available to the Agency. 
In  so  doing,  the  Medical  Devices  Steering  Group  shall  take  into  account  the  data 
generated  pursuant  to  Article  108  of  Regulation  (EU)  2017/745  and  Article  101  of 
Regulation (EU) 2017/746.  

Article 22 

Reporting and recommendations on shortages of medical devices 

For the duration of the public health emergency, the Medical Devices Steering Group 
shall  regularly  report  the  results  of  its  monitoring  to  the  Commission  and  the  sub-
network  referred  to  in  Article  23(1)(b),  and,  in  particular,  signal  any  potential  or 
actual shortages of medical devices included on the public health emergency critical 
devices list. 

Where  requested  by  the  Commission  or  the  sub-network  referred  to  in  Article 
23(2)(b),  the  Medical  Devices  Steering  Group  shall  provide  aggregated  data  and 
forecasts of demand to support its findings. In that regard, the Steering Group shall 
liaise  with  the  European  Centre  for  Disease  Prevention  and  Control  to  obtain 
epidemiological data to help forecast medical device needs, and with the Medicines 
Steering Group referred to in Article 3 where medical devices included on the public 
health emergency critical devices list are used to jointly with a medicinal product. 

As  part  of  the  reporting  referred  to  in  paragraphs  1  and  2,  the  Medical  Devices 
Steering  Group  may  also  provide  recommendations  on  measures,  which  may  be 
taken  by  the  Commission,  Member  States,  medical  device  manufacturers,  notified 
bodies and other entities to prevent or mitigate potential or actual shortages. In that 
regard  the  Group  shall  liaise,  where  relevant,  with  the  Health  Security  Committee 
and the Advisory Committee on public health emergencies. 

22 

[insert reference to adopted text referred to in footnote 4] 

EN 

26 

  EN 

                                                 
4. 

5. 

The Medical Devices Steering Group may, on its own initiative or upon request from 
the Commission, provide recommendations on measures which may be taken by the 
Commission,  Member  States,  medical  device  manufacturers,  notified  bodies  and 
other  entities  to  ensure  preparedness  to  deal  with  potential  or  actual  shortages  of 
medical devices caused by public health emergencies. 

The  Medical  Devices  Steering  Group  may,  upon  request  from  the  Commission 
coordinate  measures,  where  relevant,  between  the  national  competent  authorities, 
manufacturers  of  medical  devices,  notified  bodies,  and  other  entities  to  prevent  or 
mitigate potential or actual shortages in the context of a public health emergency. 

Article 23 

Working methods and provision of information on medical devices  

1. 

In order to prepare for fulfilling the tasks referred to in Articles 20, 21, and 22, the 
Agency shall: 

(a) 

specify  the  procedures  for  establishing  the  public  health  emergency  critical 
devices list;  

(b)  develop streamlined electronic monitoring and reporting systems; 

(c) 

(d) 

(e) 

establish and maintain membership of the working party referred to in Article 
19(5)  comprised  of  single  points  of  contact  from  Member  States’  national 
competent authorities for medical devices; 

establish  and  maintain  a  list  of  single  points  of  contact  from  medical  device 
manufacturers, authorised representatives and notified bodies; 

specify the methods for the provision of recommendations and coordination of 
measures provided for in Article 22. 

2. 

Following the recognition of a public health emergency the Agency shall: 

(a) 

(b) 

(c) 

establish and maintain for the duration of the public health emergency, a sub-
network  of  single  points  of  contact  from  medical  device  manufacturers  and 
notified  bodies  based  on  the  medical  devices  included  on  the  public  health 
emergency critical devices list; 

request  information  from  the  points  of  contact  included  in  the  sub-network 
based  on  the  set  of  information  agreed  on  by  the  Medical  Devices  Steering 
Group and set a deadline for its submission; 

request  information  from  the  single  points  of  contact  from  Member  States’ 
national competent authorities based on the set of information agreed on by the 
Medical Devices Steering Group and set a deadline for its submission. 

3. 

The information referred to in point (b) of paragraph 2 shall include at least: 

(a) 

the  name  of  the  manufacturer  and,  if  applicable,  the  name  of  the  authorised 
representative; 

(b) 

identification of the medical device and the intended purpose; 

(c) 

if applicable, the name and number of the notified body and information on the 
relevant certificate or certificates; 

(d)  details of the potential or actual shortage such as actual or estimated start and 

end dates, and the known or suspected cause; 

EN 

27 

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(e) 

sales and market share data;  

(f)  mitigation plans including production and supply capacity; 

(g) 

(h) 

information  from  concerned  notified  bodies  about  their  resource  capacity  to 
process  applications  and  carry  out  and  complete  conformity  assessments  in 
relation  to  medical  devices  included  in  the  public  health  emergency  critical 
devices list; 

information  on  the  number  of  applications  received  by  concerned  notified 
bodies in relation to medical devices included in the public health emergency 
critical devices list and relevant conformity assessment procedures;  

(i)  where  conformity  assessments  are  on-going,  the  status  of  the  conformity 
assessment  by  the  concerned  notified  bodies  in  relation  to  medical  devices 
included in the public health emergency critical devices list and possible issues 
which  need  to  be  resolved  in  order  to  complete  the  conformity  assessment 
process. 

Obligations on medical device manufacturers, authorised representatives, and notified bodies 

Article 24 

1. 

2. 

3. 

4. 

5. 

In order to facilitate the monitoring referred to in Article 21 and following a request 
from the Agency, medical device manufacturers of the medical devices included on 
the  public  health  emergency  critical  devices  list  and,  where  necessary,  concerned 
notified  bodies,  shall  submit  the  information  requested  by  the  deadline  set  by  the 
Agency.  They  shall  submit  the  information  requested  through  the  points  of  contact 
designated  in  accordance  with  Article  23(2)  and  using  the  reporting  methods  and 
system  established  pursuant  to  Article  23(1).  They  shall  provide  updates  wherever 
necessary.  

Medical  device  manufacturers  and  notified  bodies  shall  justify  the  absence  of  any 
requested  information  and  any  delays  in  providing  it  by  the  deadline  set  by  the 
Agency. 

Where  manufacturers  of  medical  devices  included  on  the  public  health  emergency 
critical  devices  list  and  concerned  notified  bodies  indicate  that  the  submitted 
information  contains  information  of  a  commercially  confidential  nature,  they  shall 
identify the relevant parts and clarify the reasons for such an indication. The Agency 
shall  assess  the  merits  of  each  request  and  protect  such  commercially  confidential 
information against unjustified disclosure.  

Where  manufacturers  of  medical  devices  included  on  the  public  health  emergency 
critical devices list and concerned notified bodies are in possession of any additional 
information,  which  provides  evidence  of  a  potential  or  actual  shortage,  they  shall 
immediately provide such information to the Agency. 

Following  the  reporting  on  the  results  of  the  monitoring  and  any  recommendations 
on  preventive  or  mitigating  measures  in  accordance  with  Article  22,  manufacturers 
of medical devices included on the public health emergency critical devices list and 
concerned notified bodies shall: 

provide any comments they have to the Agency; 

(a) 

(b) 

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(c) 

(d) 

take  into  account  any  recommendations  and  guidelines  and  comply  with  any 
measures taken at  Union and Member State-level pursuant  to  Articles 25  and 
26; 

inform the Medical Devices Steering Group of any measures taken and report 
on the results, including information on the resolution of the potential or actual 
shortage. 

6. 

Where  manufacturers  of  medical  devices  included  on  the  public  health  emergency 
critical  devices list  are established outside the  Union  and are unable to  provide the 
information  required,  in  accordance  with  this  Article,  it  shall  be  provided  by  the 
authorised representatives.  

Article 25 

Obligations on Member States in the monitoring and mitigation of shortages of medical 
devices 

1. 

In order to facilitate the monitoring  referred to in Article 21 and following a request 
from the Agency, Member States shall, by the deadline set by the Agency: 

2. 

3. 

4. 

(a) 

(b) 

(c) 

submit the set of information requested by the Agency, including information 
about  needs  related  to  the  medical  devices  included  in  the  public  health 
emergency critical devices list, and available and estimated data on the volume 
of  demand,  through  its  designated  point  of  contact  and  using  the  reporting 
methods and  system established pursuant  to Article 23(1); 

indicate  the  existence  of  any  commercially  confidential  information,  and, 
clarify the reasons for such an indication;  

indicate the absence of any requested information, and any delays in providing 
requested information by the deadline set by the Agency. 

Where necessary to fulfil their reporting obligations set out in paragraph 1, Member 
States  shall  gather  information  from  manufacturers,  importers,  distributors  and 
notified bodies on medical devices included on the public health emergency critical 
devices list. 

Where  Member  States  are  in  possession  of  any  additional  information,  which 
provides  evidence  of  a  potential  or  actual  shortage,  they  shall  immediately  provide 
such  information  to  the  Medical  Devices  Steering  Group  through  their  designated 
points of contact. 

Following the reporting on the results of the monitoring  and any recommendations 
on preventive or mitigating measures in accordance with Article 22, Member States 
shall: 

(b) 

consider the need to provide for temporary exemptions at Member State level 
pursuant  to  Article  59(1)  of  Regulation  (EU)  2017/745  or  Article  54(1)  of 
Regulation  (EU)  2017/746  with  a  view  to  mitigating  potential  or  actual 
shortages of medical devices included on the public health emergency critical 
devices list; 

(c) 

take  into  account  any  recommendations  and  guidelines  and  comply  with  any 
measures taken at Union-level pursuant to Article 26; 

EN 

29 

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(d) 

inform the Medical Devices Steering Group of any measures taken and report 
on the results of those measures, including information on the resolution of the 
potential or actual shortage. 

Article 26 

Role of the Commission in the monitoring and mitigation of shortages of medical devices 

The  Commission  shall  take  into  account  the  information  from  and  recommendations  of  the 
Medical Devices Steering Group and shall: 

(a) 

(b) 

(c) 

(d) 

(e) 

take all necessary action within the limits of the powers conferred on it, with a view 
to mitigating potential or actual shortages of medical devices included on the public 
health  emergency  critical  devices  list,  including,  where  necessary,  granting 
temporary  exemptions  at  Union  level  pursuant  to  Article  59(3)  of  Regulation  (EU) 
2017/745 or Article 54(3) of Regulation (EU) 2017/746; 

consider  the  need  for  guidelines  addressed  to  Member  States,  medical  device 
manufacturers, notified bodies and other entities; 

request  the  Medical  Devices  Steering  Group  to  provide  recommendations  or 
coordinate measures pursuant to Article 22(3), (4) and (5);  

consider  the  need  for  medical  countermeasures  in  accordance  with  Articles  12  and 
25(b) of Regulation (EU) 2020/[…];23 

liaise with third countries and relevant international organisations, as appropriate, to 
mitigate  potential  or  actual  shortages  of  medical  devices  included  on  the  critical 
devices list or their component parts, where those devices or parts are imported into 
the  Union,  and  where  such  potential  or  actual  shortages  have  international 
implications. 

Article 27 

Communication on the Medical Devices Steering Group 

The  Agency  shall,  via  its  web-portal  and  other  appropriate  means  and,  in  conjunction  with 
national competent authorities, inform the public and relevant interest groups with regard to 
the work of the Medical Devices Steering Group. 

Article 28 

Support for the expert panels on medical devices 

The Agency shall, on behalf of the Commission, from 1 March 2022  onwards, provide the 
secretariat  of  the  expert  panels  designated  in  accordance  with  Implementing  Decision  (EU) 
2019/1396  and  provide  the  support  necessary  to  ensure  that  those  panels  can  efficiently 
perform  their  tasks  as  set  out  in  Article  106(9)  and  (10)  of  Regulation  (EU)  2017/745.  The 
Agency shall:  

(a) 

provide administrative and technical support to the expert panels for the provision of 
scientific opinions, views and advice; 

(b) 

facilitate and manage remote and physical meetings of the expert panels;  

23 

[insert reference to adopted text referred to in footnote 4] 

EN 

30 

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(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

1. 

2. 

3. 

1. 

24 

ensure that the work of the expert panels is carried out in an independent manner in 
accordance with  Article  106(3), second subparagraph of Regulation  (EU) 2017/745 
and  establish  systems  and  procedures  to  actively  manage  and  prevent  potential 
conflicts of interest in accordance with Article 106(3), third subparagraph and Article 
107 of that Regulation; 

maintain  and  regularly  update  a  web-page  for  the  expert  panels  and  make  publicly 
available on the web-page all information necessary to ensure the transparency of the 
activities of the expert panels, including justifications of notified bodies where they 
did not follow the advice of the expert panels provided pursuant to Article 106(9) of 
Regulation (EU) 2017/745;  

publish  the  scientific  opinions,  views,  and  advice  of  the  panels  while  ensuring 
confidentiality  in  accordance  with  Article106(12)  second  subparagraph  and  Article 
109 of Regulation (EU) 2017/745; 

ensure that remuneration and expenses are provided to the experts in accordance with 
Article 11 of Implementing Decision (EU) 2019/1396; 

monitor  compliance  with  the  panels’  common  rules  of  procedure  and  available 
guidelines and methodologies relevant to the functioning of the panels; 

provide  annual  reports  to  the  Commission  on  the  work  undertaken  by  the  expert 
panels, including the number of opinions, views and advice delivered. 

Chapter V 

Final Provisions 

Article 29 

Cooperation between Steering Groups 

The  Agency  shall  ensure  cooperation  between  the  Medicines  and  Medical  Devices 
Steering  Groups  in  relation  to  measures  to  address  major  events  and  public  health 
emergencies. 

Members of the Medicines and Medical Devices Steering Groups and their working 
parties may attend each other’s meetings and working parties and, where appropriate, 
cooperate on monitoring exercises, reporting and opinions. 

In agreement with the Chairs, joint meetings of the Medicines and Medical Devices 
Steering Groups may be held. 

Article 30 

Confidentiality 

Unless otherwise provided for in this Regulation and without prejudice to Regulation 
(EC) No 1049/200124 and existing national provisions and practices in the Member 
States  on  confidentiality,  all  parties  involved  in  the  application  of  this  Regulation 

Regulation  (EC)  No  1049/2001  of  the  European  Parliament  and  of  the  Council  of  30  May  2001 
regarding  public  access  to  European  Parliament,  Council  and  Commission  documents,  OJ  L  145, 
31.05.2001, p. 43 

EN 

31 

  EN 

                                                 
shall respect the confidentiality of information and data obtained in carrying out their 
tasks in order to protect the following: 

(a) 

(b) 

personal data in accordance with Article 32; 

commercially  confidential  information  and  trade  secrets  of  a  natural  or  legal 
person, including intellectual property rights; 

(c) 

the effective implementation of this Regulation. 

All  parties  involved  in  the  application  of  this  Regulation  shall  ensure  that  no 
commercially confidential information is shared in a way which has the potential to 
enable undertakings  to  restrict or distort  competition in  the meaning of  Article 101 
TFEU. 

Without  prejudice  to  paragraph  1,  information  exchanged  on  a  confidential  basis 
between  competent  authorities  and  between  competent  authorities  and 
the 
Commission  and  the  Agency  shall  not  be  disclosed  without  the  prior  agreement  of 
the authority from which that information originates. 

Paragraphs 1, 2, and 3 shall not affect the rights and obligations of the Commission, 
the Agency, Member States and other actors identified in this Regulation with regard 
to  the  exchange  of  information  and  the  dissemination  of  warnings,  nor  the 
obligations of the persons concerned to provide information under criminal law. 

The  Commission,  the  Agency,  and  Member  States  may  exchange  commercially 
confidential information and, where necessary to protect public health, personal data, 
with  regulatory  authorities  of  third  countries  with  which  they  have  concluded 
bilateral or multilateral confidentiality arrangements. 

2. 

3. 

4. 

5. 

Article 31 

Entry into Force 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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32 

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LEGISLATIVE FINANCIAL STATEMENT 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE ............................................... 35 

Title of the proposal/initiative .................................................................................... 35 

Policy area(s) concerned ............................................................................................ 35 

The proposal relates to ............................................................................................... 35 

Objective(s) ................................................................................................................ 35 

1.4.1.  General objective(s) ................................................................................................... 35 

1.4.2.  Specific objective(s) ................................................................................................... 35 

1.4.3.  Expected result(s) and impact .................................................................................... 36 

1.4.4. 

Indicators of performance .......................................................................................... 36 

1.5. 

Grounds for the proposal/initiative ............................................................................ 37 

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for roll-out of 
the implementation of the initiative ........................................................................... 37 

1.5.2.  Added value of Union involvement (it may result from different factors, e.g. coordination 
gains, legal certainty, greater effectiveness or complementarities). For the purposes of this 
point 'added value of Union involvement' is the value resulting from Union intervention which 
is additional to the value that would have been otherwise created by Member States alone.
 .................................................................................................................................... 37 

1.5.3.  Lessons learnt from similar experiences in the past .................................................. 38 

1.5.4.  Compatibility with the Multiannual Financial Framework and possible synergies with other 

appropriate instruments .............................................................................................. 39 

1.5.5.  Assessment of the different available financing options, including scope for redeployment

 .................................................................................................................................... 39 

1.6. 

1.7. 

2. 

2.1. 

2.2. 

2.2.1. 

2.2.2. 

2.3. 

3. 

3.1. 

Duration and financial impact of the proposal/initiative ........................................... 40 

Management mode(s) planned ................................................................................... 40 

MANAGEMENT MEASURES ................................................................................ 41 

Monitoring and reporting rules .................................................................................. 41 

Management and control system(s) ........................................................................... 41 

Justification of the management mode(s), the funding implementation mechanism(s), the 
payment modalities and the control strategy proposed .............................................. 41 

Information concerning the risks identified and the internal control system(s) set up to mitigate 
them ............................................................................................................................ 41 

Measures to prevent fraud and irregularities .............................................................. 42 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE ............ 42 

Heading(s) of the multiannual financial framework and expenditure budget line(s) affected
 .................................................................................................................................... 42 

3.2. 

Estimated impact on expenditure ............................................................................... 43 

EN 

33 

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3.2.1.  Summary of estimated impact on expenditure ........................................................... 43 

3.2.2.  Estimated impact on EMA's appropriations............................................................... 45 

3.2.3.  Estimated impact on EMA's human resources ........................................................... 47 

3.2.4.  Compatibility with the current multiannual financial framework ............................. 51 

3.2.5.  Third-party contributions ........................................................................................... 51 

3.3. 

Estimated impact on revenue ..................................................................................... 52 

EN 

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LEGISLATIVE FINANCIAL STATEMENT 'AGENCIES' 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative 

Proposal for a Regulation of the European Parliament and of the Council on a reinforced role 
for  the  European  Medicines  Agency  in  crisis  preparedness  and  management  for  medicinal 
products and medical devices 

1.2. 

Policy area(s) concerned 

Policy area: Cohesion, Resilience and Values 

Activity: Health  

1.3. 

The proposal relates to  

X a new action  
 a new action following a pilot project/preparatory action25  

X the extension of an existing action  

 a merger of one or more actions towards another/a new action  

1.4. 

Objective(s) 

1.4.1.  General objective(s)  

The proposal aims to: 

– 

– 

ensure  a high level  of human health protection  by strengthening the Union’s ability to 
respond to and manage public health emergencies, which have an impact on medicinal 
products and medical devices;  

contribute  to  ensuring  the  smooth  functioning  of  the  internal  market  for  such  products 
during public health emergencies. 

1.4.2. 

Specific objective(s)  

Specific objectives 

1.  Monitor  and  mitigate  potential  and  actual  shortages  of  medicinal  products  and  medical 
devices  considered  as  critical  in  order  to  address  a  given  public  health  emergency  or,  for 
medicinal products, other major events which may have a serious impact on public health; 

2. Ensure the quality, safety and efficacy of medicinal products which may have the potential 
to address a given health emergency;  

3. Ensure smooth  functioning of expert panels  for the assessment of some high-risk medical 
devices and avail of essential advice in crisis preparedness and management with regard to the 
use of medical devices. 

25 

As referred to in Article 58(2)(a) or (b) of the Financial Regulation. 

EN 

35 

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1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

The initiative should contribute to ensuring that shortages of medicinal products and medical 
devices  considered  as  critical  in  addressing  a  given  health  emergency  and,  for  medicinal 
products,  a  major  event,  are  avoided  across  the  Union.  By  doing  so,  those  products  should 
ultimately remain available to patients in sufficient numbers even during such emergencies.  

Member  States  and  medicines  and  medical  device  manufacturers  should  benefit  from  a 
coordinated approach at Union level. A permanently established mechanism to be used during 
emergencies within the Agency to monitor and report on potential and actual shortages, should 
allow for a better and more timely flow of information between authorities and manufacturers. 
This  should  allow  for  necessary  action  to  be  taken  by  the  Commission,  Member  State 
authorities  and  manufacturers  to  mitigate  potential  or  actual  shortages.  Such  a  framework 
should  reduce  the  risk  of  uncoordinated  stockpiling  of  such  products  and  allow  for  the 
continued flow of goods across the single market so that they reach the areas that need them 
most as the impact of public health emergencies peaks at different times across the Union.  

The initiative should also contribute to ensuring that medicines which may have the potential 
to treat, prevent or diagnose diseases which result in public health emergencies are identified 
early on, benefit from timely scientific advice, and are subject to a robust assessment of their 
quality, safety and efficacy. By doing so, those products should ultimately reach the market in 
a timely manner and provide safe and effective treatment and prevention options for patients.  

In  the  context  of  the  European  Health  Data  Space,  the  initiative  should  also  contribute  to 
providing  access  to  health  data  for  research  and  regulatory  purposes,  supporting  better 
decision-making (regulators and policy makers) throughout the product lifecycle on medicines 
with timely, valid and reliable data from real world healthcare settings. This should integrate 
the Agency into the future infrastructure for a European Health Data Space, allowing for the 
use of data for research, policy-making and evidence-based tools.  

Member States and manufacturers should benefit from a coordinated approach at Union level 
on  the  advice  given  on  clinical  trial  protocols  and  the  use  of  such  medicines  in  national 
indications – so-called ‘off-label use’.  

1.4.4. 

Indicators of performance  

Specify the indicators for monitoring progress and achievements. 

Detailed objectives  and  expected  results  including  performance  indicators  will  be  established  by 
the  annual  work  programme,  while  the  Single  Programming  Document  will  set  out  overall 
strategic  objectives,  expected  results  and  set  of  performance  indicators.  The  key  performance 
indicators for the Agencies as well as the guidelines for the Single Programming Document and 
the Consolidated Annual Activity Report developed by the Commission should be respected. 

For work on shortages of medicines and medical devices: 

– 

Number of medicines at risk of shortages or in shortages in the EU Member States 

For the work on medicines which may have the potential to address public health emergencies: 

– 

Number  of  recommendations  and  amount  of  advice  issued  by  the  Emergency  Task 
Force. 

For the expert panels:  

– 

Number of opinions issued annually. 

EN 

36 

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For  the  Agency’s  participation  in  the  European  Health  Data  Space  digital  infrastructure  that 
supports the use of health data for better decision-making: 

– 

Number of studies enabled, using the future infrastructure of the European Health Data 
Space 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term including a detailed timeline for roll-out of 

the implementation of the initiative 

Upon  the  entry  into  force  of  the  Regulation,  the  Agency  should  put  in  place  the  framework 
which  will  be  used  to  manage  future  public  health  emergencies  (crisis  preparedness  and 
response)  including  the  development  of  procedures  for  data  submission,  reporting  and 
monitoring  tools,  and  rules  of  procedure  and  working  methods  for  the  Steering  Groups  and 
Emergency Task Force. This will allow for the immediate operationalisation of those groups 
as soon as a public health emergency has been recognised (crisis management). 

From March 2022 at the latest the Agency should begin to host the secretariat of and ensure 
support for the medical device expert panels on a permanent basis. 

The building and deployment of European Health Data Space infrastructure within the Agency 
will enable the Agency to access  or query real  world  data to  better support decision-making 
throughout  the  product  lifecycle  on  medicines  should  begin  in  2021,  and  progress  in  full 
alignment with the establishment of the overall European Health Data Space. 

1.5.2.  Added  value  of  Union  involvement  (it  may  result  from  different  factors,  e.g.  coordination 
gains,  legal  certainty,  greater  effectiveness  or  complementarities).  For  the  purposes  of  this 
point 'added value of Union involvement' is the value resulting from Union intervention which 
is additional to the value that would have been otherwise created by Member States alone. 

Reasons for action at European level (ex-ante)  

Public  health  emergencies  of  the  magnitude  of  COVID-19  have  an  impact  on  all  Member 
States,  which,  on  their  own  are  unable  to  provide  a  sufficient  response.  Potential  or  actual 
shortages of medicines and medical devices in times of crises can lead to the risk of national 
stockpiling or restrictions to single market movements being placed on such goods, which can 
have  a  negative  impact  on  the  free  movement  of  goods.  An  uncoordinated  approach  to  the 
development  of  medicines,  which  may  have  the  potential  to  treat,  prevent,  or  diagnose 
diseases  causing  public  health  emergencies  can  cause  delays  in  their  development  during 
periods where time is of the essence. Moreover, a lack of clear, Union-level advice on the use 
of  medicines  in  national  compassionate  use  programmes  or  outside  of  their  authorised 
indications  can  lead  to  a  fragmented  approach  across  the  Union.  Additionally,  regulators 
access  to  EU-wide  health  data  is  limited  and  scattered  across  different  partners  leading  to 
complex and slow analysis undermining the optimal time window for certain interventions. 

Expected generated Union added value (ex-post)  

A coordinated response at Union-level to monitoring and mitigating the risk of shortages can 
help to avoid actions such as uncoordinated stockpiling being taken and therefore have both a 

EN 

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positive impact on public health and maintain the smooth functioning of the single market. In 
the same vein, providing scientific advice on medicinal products which have the potential to 
address  public  health  emergencies  at  Union-level  can  facilitate  their  market  entry,  ensure  a 
coordinated  approach to  their use  across Member States, and help  to  ensure such treatments 
meet  harmonised  Union  standards  for  their  quality,  safety  and  efficacy,  whilst  avoiding 
duplication  of  efforts  and  unnecessary  research.  Integrating  the  Agency  into  the  European 
Health Data Space digital health infrastructure can support better decision-making throughout 
the product lifecycle on medicines and can facilitate access and analysis of real world health 
data  in  a  timely  and  reliable  manner.  This  would  support  health  policy  making  including: 
legislative  development,  impact  and  monitoring  of  implementation,  design  of  healthcare 
systems and more informed decision-making on cost-effectiveness. Ultimately, this action can 
benefit patients with a faster access to innovative medicines and safe and effective use. 

1.5.3.  Lessons learnt from similar experiences in the past 

The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union’s 
ability  to  coordinate  work  to  ensure  availability  of  medicinal  products  and  medical  devices 
and facilitate the development of medical countermeasures is limited, among other things, by 
the  absence  of  a  structured  mechanism  to  monitor  and  quickly  address  shortages  of  such 
products. 

During the COVID-19 crisis, ad hoc solutions had to be found to contain the risk of shortages 
of medicines and medical devices such as ventilators and the medicines used with them (such 
as  the  EU  Executive  Steering  Group  and  the  Clearing  House).  The  operation  of  these 
mechanisms  during  the  emergency  was  made  possible  by  contingent  arrangements  between 
the actors involved (the Commission, the Agency, the Member States). For these solutions to 
become  efficient  and  predictable,  it  has  become  apparent  that  the  respective  roles  and 
obligations  of  the  different  actors  should  be  clarified  and  solidly  anchored  in  the  legislative 
framework that applies to their operations. 

Equally,  when  a  number  of  medicines  were  purported  to  treat  or  prevent  COVID-19,  EMA 
provided scientific advice on their development and ability to fight COVID-19 to the utmost 
of its ability, but  outside of a formal  crisis  management  structure  and without  the benefit of 
fast-track  scientific  advice  procedures  and  obligations  on  Member  States  and  developers  to 
cooperate.  In  particular,  developers  indicated  a  lack  of  harmonisation  on  aspects  related  to 
clinical trials, stemming mainly from the fact that each trial needs to be authorised separately 
in each Member State.  

Integrating  the  Agency  into  the  European  Health  Data  Space  digital  health  infrastructure  to 
support better decision-making throughout the product lifecycle on medicines  should leverage 
initiatives  (e.g.  FDA/Sentinel,  Health 
on 
learnt  from  other  equivalent 
the  knowledge  advances  achieved  by 
Canada/CNODES,  PMDA)  as  well  as  from 
complementary initiatives (e.g. EHDEN, ELIXIR, VAC4EU, OHDSI). 

lessons 

the 

These lessons learnt thus provide a solid basis for the establishment of a clear framework for 
the  activities  to  be  deployed  by  the  Agency  during  public  health  emergencies,  in  order  to 
enhance the Union's capacity to react quickly, efficiently and in a coordinated manner to such 
emergencies. 

EN 

38 

  EN 

 
1.5.4.  Compatibility  with  the  Multiannual  Financial  Framework  and  possible  synergies  with  other 

appropriate instruments 

The  Agency  should  cooperate  and  promote  synergies  with  other  Union  bodies  and 
decentralised  agencies,  such  as  the  European  Centre  for  Disease  and  Control  (ECDC), 
European Food Safety Authority (EFSA) and take full advantage and ensure consistency with 
the  EU4Health  programme  and  other  EU  programmes  financing  actions  in  the  domain  of 
public health. 

As  from  2022,  the  Agency  would  take  over  some  tasks  currently  performed  by  the 
Commission under the Health programme Expert panels (JRC). 

1.5.5.  Assessment of the different available financing options, including scope for redeployment 

The European Commission has no expertise to assess medicinal products with the potential to 
treat  public  health  emergencies.  The  European  Medicines  Agency  is  the  suitable  body  to 
conduct  the  proposed  tasks.  Nevertheless,  the  European  Commission  will  participate  in  the 
management of the Executive Steering Groups without additional resources.  

Involvement of Member States’ national authorities will also be a crucial factor since access to 
health  data  may  require  strict  requirements  to  be  fulfilled  at  national  level  by  participating 
health data providers.  

EN 

39 

  EN 

 
 
 
 
1.6. 

Duration and financial impact of the proposal/initiative 

 limited duration  

–    Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–    Financial impact from YYYY to YYYY 

 unlimited duration 

–  Implementation with a start-up period from Jan 2021 to Dec 2021, 

–  followed by full-scale operation. 
1.7.  Management mode(s) planned26  

 Direct management by the Commission through 

–    executive agencies  

 Shared management with the Member States  

 Indirect management by entrusting budget implementation tasks to: 

 international organisations and their agencies (to be specified); 

the EIB and the European Investment Fund; 

 bodies referred to in Articles 70 and 71; 

 public law bodies; 

 bodies governed by private law with a public service mission to the extent that they provide 
adequate financial guarantees; 

  bodies  governed  by  the  private  law  of  a  Member  State  that  are  entrusted  with  the 
implementation of a public-private partnership and that provide adequate financial guarantees; 

  persons  entrusted  with  the  implementation  of  specific  actions  in  the  CFSP  pursuant  to 
Title V of the TEU, and identified in the relevant basic act. 

Comments 

26 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the  BudgWeb  site: 
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx. 

EN 

40 

  EN 

 
 
 
                                                 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

All  Union  agencies  work  under  a  strict  monitoring  system  involving  an  internal  control 
coordinator,  the  Internal  Audit  Service  of  the  Commission,  the  Management  Board,  the 
Commission, the Court of Auditors and the Budgetary Authority. This system is reflected and laid 
down in the EMA’s founding regulation. 

the 

financial 

framework 

(2019/715)  and 

In  accordance  with  the  Joint  Statement  on  the  EU  decentralised  agencies  (  the  ‘Common 
Approach’), 
related  Commission 
regulation 
Communication C(2020)2297, the annual work programme and Single Programming Document of 
the Agency shall comprise detailed objectives and expected results including set of performance 
indicators. The  Agency  will accompany  its  activities  included  in  its  working  programme  by  key 
performance  indicators.  The  activities  of  the  Agency  will  be  then  measured  against  these 
indicators  in  the  Consolidated  Annual  Activity  Report.  The  annual  work  programme  shall  be 
coherent  with the  multi-annual  work  programme  and  both  shall  be  included  in  an  annual  Single 
Programming  Document  which  shall  be  submitted to  the  European  Parliament,  the  Council,  and 
the  Commission.  The  Management  Board  of  Agency  will  be  responsible  for  supervision  of  the 
administrative, operational and budgetary efficient management of the Agency. 

2.2.  Management and control system(s)  

2.2.1. 

Justification  of  the  management  mode(s),  the  funding  implementation  mechanism(s),  the 
payment modalities and the control strategy proposed 

The  annual  EU  subsidy  is  transferred  to  the  Agency  in  accordance  with  its  payment  needs  and 
upon its request. 

The Agency will be subject to administrative controls including budgetary control, internal audit, 
annual  reports  by  the European  Court  of  Auditors, the annual  discharge  for  the  execution  of  the 
EU  budget  and  possible  investigations  conducted  by  OLAF  to  ensure,  in  particular,  that  the 
resources  allocated  to  agencies  are  put  to  proper  use.  The  activities  of  the  Agency  will  also  be 
subject to the supervision of the Ombudsman in accordance with Article 228 of the Treaty. These 
administrative controls provide a number of procedural safeguards to ensure that account is taken 
of the interests of the stakeholders. 

2.2.2. 

Information  concerning  the  risks  identified  and  the  internal  control  system(s)  set  up  to 
mitigate them 

The main risk relates to under- or non-implementation of the tasks foreseen. In order to mitigate 
this, sufficient resources should be made available in both financial and staffing terms. 

EN 

41 

  EN 

 
 
 
 
2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy. 

Anti-fraud  measures  are  provided  for  in  Article  69  of  Regulation  (EC)  No  726/2004  and  the 
framework financial Regulation (2019/715). The Executive Director and the Management Board 
of  the  Agency  will  take  the  appropriate  measures  in  accordance  with  the  Internal  Control 
Principles applied across all EU institutions. In line with the Common Approach and Article 42 of 
the framework financial Regulation, an anti-fraud strategy has been developed and is followed by 
the Agency.  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Given the on-going reflection on the creation of an ‘EU BARDA’, the Commission retains the 
right to adjust the proposed resources and staff allocation when a precise proposal for an ‘EU 
BARDA’ is tabled. 

3.1. 

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget  line(s) 
affected  

  Existing budget lines  

In order of multiannual financial framework headings and budget lines. 

Heading of 
multiannual 
financial 
framework 

Number  

Budget line 

Type of  
expenditure 

Contribution  

Diff./Non-
diff.27 

from 
EFTA 
countries28 

from 
candidate 
countries29 

from third 
countries 

within the meaning 
of Article 21(2)(b) 
of the Financial 
Regulation  

2 

06.100301 

Diff. 

YES 

NO 

NO 

NO 

  New budget lines requested  

In order of multiannual financial framework headings and budget lines. 

Budget line 

Type of 
expenditure 

Contribution  

Heading of 
multiannual 
financial 
framework 

Number  

[XX.YY.YY.YY] 

Diff./non-
diff. 

from 
EFTA 
countries 

from 
candidate 
countries 

from third 
countries 

within the meaning 
of Article 21(2)(b) 
of the Financial 
Regulation  

YES/NO  YES/NO  YES/NO 

YES/NO 

27 
28 
29 

Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidates from the Western Balkans. 

EN 

42 

  EN 

 
 
 
 
 
 
                                                 
3.2. 

Estimated impact on expenditure  

3.2.1. 

Summary of estimated impact on expenditure  

Heading of multiannual financial  
framework  

Number  Heading 2 : Cohesion, Resilience and Values 

EUR million (to three decimal places) 

[Body]: EMA 

Title 1: 

Title 2: 

Title 3: 

TOTAL appropriations 
for EMA 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

3.065 
3.065 
0.725 
0.725 

3.315 
3.315 
0.775 
0.775 

3.800 
3.800 
0.900 
0.900 

4.300 
4.300 
1.000 
1.000 

4.300 
4.300 
1.000 
1.000 

4.300 
4.300 
1.000 
1.000 

Year 

2027 et 
seqq. 

4.300 
4.300 
1.000 
1.000 

24.000 

18.000 

18.000 

10.000 

10.000 

10.000 

10.000 

24.000 

18.000 

18.000 

10.000 

10.000 

10.000 

10000 

27.790 

22.090 

22.700 

15.300 

15.300 

15.300 

15.300 

27.790 

22.090 

22.700 

15300 

15.300 

15300 

15.300 

TOTAL 

27.380 
27.380 
6.400 
6.400 

100.000 

100.000 

133.780 

133.780 

Commitments 
Payments 

Commitments 

Payments 

Commitments 

Payments 

Commitments 

Payments 

(1) 

(2) 

(1a) 

(2a) 

(3a) 

(3b) 

=1+1a 
+3a 

=2+2a 

+3b 

EN 

43 

EN 

 
 
 
 
 
 
 
 
Heading of multiannual financial  
framework  

7 

‘Administrative expenditure’ 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

Year 

2027 et 
seqq. 

TOTAL 

EUR million (to three decimal places) 

DG: <…….> 

 Human Resources  
 Other administrative expenditure  

TOTAL DG <…….> 

Appropriations  

TOTAL appropriations 
under HEADING 7 
of the multiannual financial framework  

(Total  commitments  = 
Total payments) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

Year 

2027 et 
seqq. 

TOTAL 

EUR million (to three decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 7 
of the multiannual financial framework  

Commitments 

Payments 

27.790 

22.090 

22.700 

15.300 

15.300 

15300 

15.300 

133.780 

27.790 

22.090 

22.700 

15.300 

15.300 

15.300 

15.300 

133.780 

EN 

44 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on EMA's appropriations  

–    The proposal/initiative does not require the use of operational appropriations  

–    The proposal/initiative requires the use of operational appropriations, as explained below: 

Indicate 
objectives and 
outputs  

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

OUTPUTS 

Commitment appropriations in EUR million (to three decimal places) 

Year 
2025 

Year 
2026  

Year 

2027 et seqq. 

TOTAL 

 

Type30 

Average 
cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

o
N

Cost 

Total 
No 

Total 
cost 

SPECIFIC OBJECTIVE No 1 Monitor and mitigate potential and actual shortages of medicines and medical devices considered as critical in order to address 
a given public health emergency 

Medicines 
Steering Group 

Devices Steering 
Group 

5.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

11.000 

5.000 

1.000 

1.000 

1.000 

1.000 

1.000 

1.000 

11.000 

Expert Panels 

0 

2.000 

2.000 

2.000 

2.000 

2.000 

2.000 

12.000 

Subtotal for specific objective No 1 

10.000 

4.000 

4.000 

4.000 

4.000 

4.000 

4.000 

34.000 

SPECIFIC OBJECTIVE No 2 Ensure the quality, safety and efficacy of medicinal products which may have the potential to address a given health 
emergency 

30 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 

EN 

45 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
Emergency Task 
Force 
vaccine platform 

Subtotal for specific objective No 2 

5.000 

5.000 

10.000 

1.000 

  5.000 

6.000 

1.000 

5.000 

6.000 

1.000 

5.000 

6.000 

1.000 

5.000 

6.000 

1.000 

5.000 

6.000 

1.000 

5.000 

6.000 

11.000 

35.000 

46.000 

SPECIFIC OBJECTIVE No 3 Allow timely access and analysis of EU-wide health data to support better decision-making throughout the product lifecycle on 
medicines (development, authorisation, performance monitoring) with valid and reliable real world evidence 

Node Reuse data 

Subtotal for specific objective No 3 

4.000 

4.000 

8.000 

8.000 

8.000 

8.000 

0 

0 

0 

0 

0 

0 

0 

0 

20.000 

20.000 

TOTAL COST 

24.000 

18.000 

18.000 

10.000 

10.000 

10.000 

10.000 

100.000 

EN 

46 

EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on EMA's human resources  

3.2.3.1.  Summary  

–    The  proposal/initiative  does  not  require  the  use  of  appropriations  of  an 

administrative nature  

–    The proposal/initiative requires the use of appropriations of an administrative 

nature, as explained below: 

EUR million (to three decimal places) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

Temporary agents (AD 
Grades) 

Temporary 
(AST grades) 

agents 

Contract staff 

Seconded National 
Experts 

2.700 

3.000 

3.450 

3.750 

3.750 

3.750 

0.450 

0.450 

0.450 

0.750 

0.750 

0.750 

0.640 

0.640 

0.800 

0.800 

0.800 

0.800 

0 

0 

0 

0 

0 

0 

Year 

2027 et 
seqq. 

TOTAL 

3.750 

0.750 

0.800 

24.150 

4.350 

5.280 

0 

0 

TOTAL 

3.790 

4.090 

4.700 

5.300 

5.300 

5.300 

5.300 

33.780 

Staff requirements (FTE): 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

Year 

2027 et 
seqq. 

TOTAL 

Temporary agents (AD 
Grades) 

Temporary 
(AST grades) 

agents 

Contract staff 

Seconded National 
Experts 

18 

20 

3 

8 

3 

8 

23 

3 

10 

25 

5 

10 

25 

5 

10 

25 

5 

10 

25 

5 

10 

25 

5 

10 

TOTAL 

29 

31 

36 

40 

40 

40 

40 

40 

EN 

47 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please indicate the planned recruitment date and adapt the amount accordingly (if recruitment 
occurs  in  July,  only  50 %  of  the  average  cost  is  taken  into  account)  and  provide  further 
explanations.  

EN 

48 

  EN 

 
3.2.3.2.  Estimated requirements of human resources for the parent DG 

–  X  The proposal/initiative does not require the use of human resources.  

–    The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full amounts (or at most to one decimal place) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

Year 

2027 et 
seqq. 

 Establishment plan posts (officials and 

temporary staff) 

XX 01 01 01 (Headquarters and 
Commission’s Representation 
Offices) 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

 External staff (in Full Time Equivalent 

unit: FTE)31 

XX 01 02 01 (AC, END, INT from 
the ‘global envelope’) 

XX 01 02 02 (AC, AL, END, INT 
and JPD in the Delegations) 

XX 01 04 
yy32 

- at 
Headquarters33 

- in 
Delegations  

XX 01 05 02 (AC, END, INT – 
Indirect research) 

10 01 05 02 (AC, END, INT – 
Direct research) 

Other budget lines (specify) 

TOTAL 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from the DG who are already assigned to 
management of the action and/or have been redeployed within the DG, together if necessary 

31 

32 
33 

AC = Contract Staff; AL = Local Staff; END = Seconded National Expert; INT = agency staff; JPD = 
Junior Professionals in Delegations .  
Sub-ceiling for external staff covered by operational appropriations (former ‘BA’ lines). 
Mainly for the Structural Funds, the European Agricultural Fund for Rural Development (EAFRD) and 
the European Fisheries Fund (EFF). 

EN 

49 

  EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
with any additional allocation which may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints. 

Description of tasks to be carried out: 

Officials and temporary staff 

Staff at EMA to perform analysis of regulatory questions from the development, authorisation 
and supervision of medicines by EMA and NCA committees, scientific overview of the studies, 
integration  of  study  results  into  the  core  medicinal  product  assessment  work  of  the  EMA, 
contract management, legal, administration and IT support. 

External staff 

Description  of  the  calculation  of  cost  for  FTE  units  should  be  included  in  the  Annex  V, 
section 3.  

EN 

50 

  EN 

 
 
 
3.2.4.  Compatibility with the current multiannual financial framework  

–    The proposal/initiative is compatible the current multiannual financial framework. 

–    The  proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

The  proposed  additional  budget  for  EMA  may  be  financed  by  a  reduction  of  the  EU4Health  budget  in  future 
years. 

–    The  proposal/initiative  requires  application  of  the  flexibility  instrument  or  revision  of 

the multiannual financial framework34. 

3.2.5.  Third-party contributions  

–  The proposal/initiative does not provide for co-financing by third parties.  

–  The proposal/initiative provides for the co-financing estimated below: 

EUR million (to three decimal places) 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

Specify  the  co-financing 
body  

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

TOTAL 
co-financed  

appropriations 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

Year 

2027 et 
seqq. 

p.m. 

p.m. 

Total 

p.m. 

p.m. 

34 

See Articles 11 and 17 of Council Regulation (EU, Euratom) No 1311/2013 laying down the multiannual financial 
framework for the years 2014-2020. 

EN 

51 

  EN 

 
 
 
                                                 
3.3. 

Estimated impact on revenue  

–    The proposal/initiative has no financial impact on revenue. 

–    The proposal/initiative has the following financial impact: 

– 

– 

– 

 

 

 

Appropriation
s available for 
the current 
financial year 

on own resources  

on other revenue  

please indicate, if the revenue is assigned to expenditure lines  

EUR million (to three decimal places) 

Impact of the proposal/initiative35 

Year 
2021 

Year 
2022 

Year 
2023 

Year 
2024 

Year 
2025 

Year 
2026  

Year 

2027 et 
seqq. 

Budget revenue line: 

Article …………. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

p.m. 

For miscellaneous ‘assigned’ revenue, specify the budget expenditure line(s) affected. 

Specify the method for calculating the impact on revenue. 

35 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. 
gross amounts after deduction of 20 % for collection costs. 

EN 

52 

  EN