Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease
Date: 2020-06-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: disease prevention, epidemic, genetically modified organism, infectious disease, marketing standard, medical research, medicinal product, pharmaceutical legislation, public health, testing

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   EUROPEAN COMMISSION  Brussels, 17.6.2020  COM(2020) 261 final 2020/0128 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Background 

The  environmental  risks  of  all  medicinal  products  are  assessed  as  part  of  the 
marketing authorisation procedures, including for medicinal products that contain or 
consist of genetically modified organisms (“GMOs”).  

The  Union  legislation  on  GMOs  encompasses  Directive  2009/41/EC  on  the 
contained  use  of  genetically  modified  microorganisms  (the  “contained  use 
Directive”) and Directive 2001/18/EC on the deliberate release into the environment 
of GMOs (the “deliberate release Directive”). Directive 2001/20/EC on clinical trials 
is  without  prejudice  to  the  application  of  the  GMO  Directives.  There  is  not  a 
common  approach  for  assessment  of  GMO  aspects  of  clinical  trials  with 
investigational medicinal products for human use in the EU as some Member States 
apply the deliberate release Directive, other Member States apply the contained use 
Directive and others decide on a case-by-case basis or apply both.  

The purpose of the Union legislation on GMOs is to protect both human health and 
the environment. However, the specific characteristics of the setting of clinical trials 
in a situation of a public health emergency such as the one created by the COVID-19 
pandemic are not foreseen in Directive 2001/18/EC or Directive 2009/41/EC.  

The  Coronavirus  outbreak  has  created  an  unprecedented  public  health  emergency. 
The  development  of  vaccines  and  therapies  against  the  virus  is  of  major  public 
interest  and  we  are  collectively  called  to  make  safe  and  efficacious  medicinal 
products  available  to  our  citizens  as  soon  as  possible.  Some  of  the  vaccines  under 
development  are  based  on  genetically  modified  viruses  and  may  fall  within  the 
definition of GMO.  It  is  necessary to  adapt  the regulatory  framework on  GMOs so 
that  the  conduct  of  clinical  trials  with  these  vaccines  can  start  within  the  shortest 
possible timelines while ensuring the rights, safety, dignity and well-being of those 
individuals that take part in a clinical trial, as well as the reliability and robustness of 
the data generated and adequate protection of the environment and of human health 
via the environment.  

Doubts  have  been  raised  by  some  Member  States  regarding  the  application  of  the 
provisions  of  Directive  2001/18/EC  and  Directive  2009/41/EC  in  the  situations 
contemplated  in  Article  5(1)  and  (2)  of  Directive  2001/83/EC  and  Article  83  of 
Regulation  (EC)  No  726/2004.  These  provisions  allow  Member  States  to  authorise 
the  supply  and  administration  of  medicinal  products  for  human  use  (including 
medicinal products that contain or consist of GMOs) in the absence of a marketing 
authorisation where there is an urgent need to address the specific needs of a patient, 
for  compassionate  use,  or  in  response  to  the  suspected  or  confirmed  spread  of 
pathogenic  agents,  toxins,  chemical  agents  or  nuclear  radiation  that  could  cause 
harm.  

In  those  exceptional  and  urgent  situations,  where  there  is  a  lack  of  a  suitable 
approved medicinal product, the Union legislator has made a choice that the need to 
protect  public  health  or  the  health  of  individual  patients  and  the  benefits  of  the 
medicinal  product  must  prevail  over  other  considerations,  in  particular  the  need  to 
obtain  a  marketing  authorization  and  consequently,  to  have  available  complete 

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information about the risks posed by the medicinal product, therefore including any 
risks to the environment from medicinal products containing or consisting of GMOs.  

It  would  be  incoherent  and  contrary  to  the  very  purpose  and  “effet  utile”  of  those 
exemptions,  and  with  the  objective  of  protecting  human  health  in  Directive 
2001/18/EC, Directive 2009/41/EC and in Union legislation on medicinal products, 
to consider that it was the legislator’s intention to still require an authorization under 
Directive  2001/18/EC  or  Directive  2009/41/EC  when  the  legislator,  taking  into 
account  the  objective  of  protecting  human  health  and  the  environment  has  made  a 
choice that in those exceptional and urgent situations the protection of public health 
or the health of individual patients must prevail and has provided an exemption from 
the  authorization  procedure  in  the  Union  legislation  on  medicinal  products. 
Therefore, where Member States adopt decisions pursuant to Article 5(1) and (2) of 
Directive 2001/83/EC or Article 83(1) of Regulation (EC) No 726/2004 concerning 
medicinal  products  containing  or  consisting  of  GMOs,  an  environmental  risk 
assessment  and/or  consent  in  accordance  with  Directive  2001/18/EC  or  Directive 
2009/41/EC are not a prerequisite. 

In  the  current  situation  of  public  health  emergency  created  by  the  COVID-19 
pandemic,  it  is  necessary  to  clarify  the  interpretation  of  Article  5(1)  and  (2)  of 
Directive  2001/83/EC  and  Article  83(1)  of  Regulation  (EC)  No  726/2004  to  avoid 
divergent  interpretations  and  to  ensure  equal  and  as  prompt  as  possible  access  to 
medicinal products for human use intended to treat or prevent COVID-19. Therefore, 
it should be clarified that, where Member States adopt decisions pursuant to Article 
5(1)  and  (2)  of  Directive  2001/83/EC  or  Article  83(1)  of  Regulation  (EC)  No 
726/2004 concerning medicinal products containing or consisting of GMOs intended 
to  treat  or  prevent  COVID-19,  an  environmental  risk  assessment  and/or  consent  in 
accordance  with  Directive  2001/18/EC  or  Directive  2009/41/EC  are  not  a 
prerequisite. 

Reasons for and objectives of the proposal  

The policy objective of this proposed Regulation is to ensure that clinical trials with 
medicinal products for human use that contain or consist of GMOs and are intended 
to treat or prevent COVID-19 can start swiftly and without a prior environmental risk 
assessment  and/or  consent  under  Directive  2001/18/EC  or  Directive  2009/41/EC  in 
so far as there is a valid declaration of pandemic by the World Health Organisation, 
or if COVID-19 is declared an emergency situation in accordance with Decision No 
1082/2013/EU and remains so. 

In  the  situation  of  public  health  emergency  created  by  the  COVID-19  pandemic, 
there  is  an  overriding  interest  in  protecting  human  health.  Moreover,  the  intrinsic 
characteristics of the conduct of clinical trials (i.e. limited number of patients, limited 
volumes  of  medicinal  products  involved  and  administration  in  a  highly  controlled 
environment),  substantially  limit  any  potential  environmental  exposure.  Hospitals 
routinely deal with hazardous biological substances and protocols exist to ensure safe 
handling of biological waste in a hospital setting. In this context, the Commission has 
also adopted guidelines on waste management in the COVID-19 crisis1. 

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https://ec.europa.eu/info/sites/info/files/waste_management_guidance_dg-env.pdf 

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It  is  stressed  that  an  environmental  risk  assessment  for  the  medicinal  products 
covered by this Regulation will be performed before they become widely available in 
the Union as part of the marketing authorisation procedure.   

In addition, it should be clarified that medicinal products for human use containing 
or consisting of GMOs intended to treat or prevent COVID-19 can be administered 
swiftly in the absence of a prior environmental risk assessment and/or consent under 
Directive 2001/18/EC or Directive 2009/41/EC in the exceptional situations foreseen 
in Article 5(1) and (2) of Directive 2001/83/EC,  and Article 83 of Regulation (EC) 
No 726/2004. 

 2. 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY  

Legal basis  

This  proposal  is  based  on  Articles  114  and  168(4)(c)  of  the  Treaty  on  the 
Functioning of the European Union (TFEU).  

The  proposed  Regulation  aims  to  expedite  the  conduct  of  clinical  trials  with 
medicinal products that contain or consist of GMOs in the current scenario of public 
health  emergency  created  by  the  COVID-19  pandemic  so  as  to  facilitate  the 
availability  of  high  quality,  safe  and  efficacious  medicinal  products  to  treat  or 
prevent COVID-19.  In so far as the proposed Regulation will allow Member States 
to  facilitate  the  development  and/or  availability  of  high  quality  and  safe  medicinal 
products  for  human  use  in  response  to  the  situation  of  public  health  emergency 
created by the COVID-19 pandemic, the adoption thereof should be based on Article 
168(4)(c) TFEU.  

A common approach for all the Union Member States is deemed necessary as threats 
to  health arising  from  the  COVID-19 pandemic  have, by their nature, transnational 
implications. Measures adopted by the Member States should be consistent with each 
other.  Thus,  the  proposed  Regulation  aims  to  create  a  common  approach  for  the 
conduct  of  clinical  trials  with  medicinal  products  that  contain  or  consist  of  GMOs 
intended  to  treat  or  prevent  COVID-19  and  to  clarify  aspects  of  the  application  of 
decisions  by  Member  States  taken  in  accordance  with  Article  5(1)  and  (2)  of 
Directive  2001/83/EC  and/or  Article  83  of  Regulation  (EC)  No  726/2004  to  these 
products. Hence, the proposed Regulation should also be based on Article 114 of the 
TFEU.  

Subsidiarity and proportionality 

The proposal builds on the experience gained with the existing regulatory framework 
for medicines as well as the experience in the application of the legislation on GMOs 
to  medicinal  products  for  human  use.  On  the  basis  of  the  available  evidence,  it  is 
concluded  that  it  is  unlikely  that  the  concerns  arising  from  the  lack  of  tools  in  the 
Union  legislation  to  address  the  specific  characteristics  of  clinical  trials  with 
investigational medicinal products for human use that contain or consist of GMOs in 
the  current  situation  of  public  health  emergency  created  by  COVID-19  will  be 
resolved unless this situation is addressed at Union level. 

In addition, the proposal also aims at clarifying certain aspects of the application of 
provisions of the pharmaceutical acquis that allow the national competent authorities 
to authorise the supply and administration of medicinal products that do not have a 
marketing  authorisation  to  situations  of  urgency  and/or  emergency,  such  as  the 
COVID-19 pandemic. Directive 2001/83/EC and Regulation (EC) No 726/2004 have 

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created  a  harmonised  framework  and  the  clarifications  proposed  will  contribute  to 
optimise the implementation of Articles 5(1) and 5(2) of Directive 2001/83/EC and 
Article  83  of  Regulation  (EC)  No  726/2004  for  medicinal  products  for  human  use 
containing or consisting of GMOs intended to treat or prevent COVID-19.  

The  proposed  rules  aim  at  harmonising  an  area  in  which  application  of  existing 
Union  legislation  and  national  measures  have  proven  insufficient.  Moreover,  the 
proposal is limited in scope so as to avoid going beyond what is necessary to achieve 
the  objectives  pursued  in  the  exceptional  circumstances  created  by  the  COVID-19 
pandemic. 

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS  

EVALUATIONS, 

EX-POST 

OF 

STAKEHOLDER 

The  proposed  Regulation  has  not  been  subject  to  a  public  consultation  or  a 
Commission Impact Assessment. 

The  proposal  is  targeted  in  scope  and  does  not  impose  new  obligations  on  the 
concerned parties. 

4. 

BUDGETARY IMPLICATIONS  

The proposal does not have a budgetary impact for the EU institutions. 

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2020/0128 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on the conduct of clinical trials with and supply of medicinal products for human use 
containing or consisting of genetically modified organisms intended to treat or prevent 
coronavirus disease 

(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 
Article 114 and 168(4)(c),  

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 Committee,  

After consulting the Committee of the Regions,  

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

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Coronavirus  disease  (COVID-19)  is  an  infectious  disease  caused  by  a  newly 
discovered coronavirus. On 30 January 2020, the World Health Organization (WHO) 
declared  the  outbreak  a  public  health  emergency  of  international  concern.  On  11 
March 2020, WHO characterised COVID-19 as a pandemic.  
Directive 2001/83/EC of the European Parliament and of the Council2 and Regulation 
(EC)  No  726/2004  of  the  European  Parliament  and  of  the  Council3  require  that 
applications for authorisation to place a medicinal product on the market, in a Member 
State or in  the  Union, be accompanied by a dossier containing the results of clinical 
trials carried out on the product. 

It follows from Article 9(2) of Directive 2001/20/EC of the European Parliament and 
of  the  Council4  that,  before  commencing  any  clinical  trial,  sponsors  are  required  to 
request authorisation from the competent authority of the Member State in which the 
clinical  trial  is  to  be  conducted.  The  purpose  of  the  authorisation  is  to  protect  the 

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 331, 28.11.2001, p. 67). 
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down  Union  procedures  for  the  authorisation  and  supervision  of  medicinal  products  for  human  and 
veterinary use and establishing a European Medicines Agency (OJ L136, 30.4.2004, p. 1). 
Directive  2001/20/EC  of  the  European  Parliament  and  of  the  Council  of  4  April  2001  on  the 
approximation of the laws, regulations and administrative provisions of the Member States relating to 
the implementation of good clinical practice in the conduct of clinical trials on medicinal products for 
human use, (OJ L121,1.5.2001, p.34).  

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(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

rights, safety and well-being of persons taking part in clinical trials, and to ensure the 
reliability and robustness of the data generated by the clinical trial. 

In accordance with Article 9(7) of Directive 2001/20/EC, the authorisation for clinical 
trials  is  without  prejudice  to  the  application  of  Directives  2001/18/EC5  and 
2009/41/EC6 of the European Parliament and of the Council.  

Article  6  of  Directive  2001/18/EC  provides  that  a  release  into  the  environment  of 
Genetically  Modified  Organisms  (GMOs)  for  any  other  purpose  than  for  placing  on 
the  market  is  subject  to  a  notification  and  to  written  consent  by  the  competent 
authority of the Member State within whose territory the release is to take place. The 
notification  is  to  include  an  environmental  risk  assessment  performed  in  accordance 
with  Annex  II  to  Directive  2001/18/EC  and  a  technical  dossier  supplying  the 
information specified in Annex III to that Directive. 

Directive  2009/41/EC  ensures  that  the  risks  to  human  health  and  the  environment 
associated with the contained use of genetically modified micro-organisms is assessed 
on  a  case-by-case  basis.  To  that  end,  Article  4(2)  of  that  Directive  provides  that  the 
user is to assess the risks that the specific type of contained use may pose, using as a 
minimum the elements of assessment and the procedure set out in Sections A and B of 
Annex III to that Directive. 

Clinical  trials  necessitate  the  performance  of  multiple  operations,  including,  for 
example,  the  manufacture,  transport  and  storage  of  the  investigational  medicinal 
products,  packaging  and  labelling,  the  administration  thereof  to  trial  subjects  and 
subsequent  monitoring  of  the  subjects  and  the  disposal  of  waste  and  unused 
investigational  medicinal  products.  Those  operations  may  fall  within  the  scope  of 
Directive  2001/18/EC  or  Directive  2009/41/EC  in  cases  where  the  investigational 
medicinal product contains or consists of GMOs. 

Experience  shows  that,  in  clinical  trials  with  investigational  medicinal  products 
containing  or  consisting  of  GMOs,  the  procedure  to  achieve  compliance  with  the 
requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental 
impact assessment and authorization by the competent authority of a Member State is 
complex and may take a significant amount of time.  

The complexity of that procedure increases greatly in the case of multi-centre clinical 
trials conducted in several Member States, as sponsors of clinical trials need to submit 
multiple  requests  for  authorisation  to  multiple  competent  authorities  in  different 
Member  States  in  parallel.  In  addition,  national  requirements  and  procedures  for  the 
environmental risk assessment and consent by competent authorities for the release of 
GMOs  under  Directive  2001/18/EC  vary  greatly  from  one  Member  State  to  another. 
Whereas  in  some  Member  States  a  single  request  for  authorisation  concerning  the 
conduct  of  the  clinical  trial  and  the  GMO  aspects  can  be  submitted  to  a  single 
competent authority, in other Member States parallel requests need to be submitted to 
different  competent  authorities.  Furthermore,  some  Member  States  apply  Directive 
2001/18/EC,  others  apply  Directive  2009/41/EC  and  there  are  Member  States  that 
apply either Directive 2009/41/EC or Directive 2001/18/EC depending on the specific 

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Directive  2001/18/EC  of  the  European  Parliament  and  of  the  Council  of  12  March  2001  on  the 
deliberate  release  into  the  environment  of  genetically  modified  organisms  and  repealing  Council 
Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1). 
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained 
use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75). 

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circumstances of a clinical trial, so it is not possible to determine a priori the national 
procedure  that  is  to  be  followed.  Other  Member  States  apply  both  Directives  at  the 
same time, to different operations within the same clinical trial. Attempts to streamline 
the  process  through  informal  coordination  between  Member  States’  competent 
authorities  have  not  borne  fruit.  There  are  also  variations  between  national 
requirements as to the contents of the technical dossier. 

(10)  This  makes  it  particularly  difficult  to  perform  multi-centre  clinical  trials  with 
investigational medicinal products that contain or consist of GMOs in several Member 
States.  

(11)  The COVID-19 pandemic has created an unprecedented public health emergency that 
has claimed the life of thousands of people, affecting in particular the elderly and those 
with pre-existing health conditions. In addition, the very drastic measures that Member 
States  have  had  to  adopt  to  contain  the  spread  of  the  disease  have  inflicted  major 
disruptions to national economies and the Union as a whole.  

(12)  COVID-19  is  a  complex  disease  that  affects  multiple  physiological  processes. 
Potential  treatments  and  vaccines  are  in  development.  Some  of  the  vaccines  in 
development  contain  attenuated  viruses  or  live  vectors,  which  may  fall  within  the 
definition of GMO. 

(13) 

In this situation of public health emergency, it is of major interest for the Union that 
safe  and  efficacious  medicinal  products  to  treat  or  prevent  COVID-19  can  be 
developed and be made available within the Union as soon as possible. 

(14)  To achieve the objective of making available safe and efficacious medicinal products 
to treat or prevent COVID-19, a range of measures have been taken at Union level by 
the  European  Medicines  Agency  (EMA)  and  by  the  network  of  national  competent 
authorities  to  facilitate,  support  and  speed  up  the  development  and  marketing 
authorisation of treatments and vaccines.  

(15)  To  generate  the  robust  clinical  evidence  necessary  to  support  applications  for 
marketing  authorisation  of  medicinal  products  to  treat  or  prevent  COVID-19  multi-
centre clinical trials involving several Member States will need to be conducted.  

(16) 

It  is  of  paramount  importance  that  clinical  trials  with  investigational  medicinal 
products  against  COVID-19  containing  or  consisting  of  GMOs  can  be  conducted 
within the Union, that they can begin as soon as possible, and that they are not delayed 
due to the complexity of differing national procedures put in place by Member States 
in implementation of Directives 2001/18/EC and 2009/41/EC. 

(17)  The  main  objective  of  the  Union  legislation  on  medicinal  products  is  to  safeguard 
public  health.  That  legislative  framework  is  supplemented  by  the  rules  in  Directive 
2001/20/EC laying down specific standards for the protection of clinical trial subjects. 
Directives 2001/18/EC and 2009/41/EC have the objective of ensuring a high level of 
protection of human health and the environment, through the assessment  of the risks 
from  the  deliberate  release  or  the  contained  used  of  GMOs.  In  the  unprecedented 
situation  of  public  health  emergency  created  by  the  COVID-19  pandemic,  it  is 
necessary that the protection of public health prevails. For this purpose, it is necessary 
to grant a temporary derogation, for the duration of the COVID-19 pandemic, limited 
to clinical trials with investigational medicinal products to treat or prevent COVID-19. 
During the period in  which the temporary derogation applies,  the environmental risk 
assessment and consent under Articles 6 to 11 of Directive 2001/18/EC and Articles 6 

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to  13  of  Directive  2009/41/EC  should  not  be  a  prerequisite  for  the  conduct  of  those 
clinical trials.  

(18)  With a view to  ensure  a high level  of protection to  the environment,  sites where the 
genetic  modification  of  wild-type  viruses  takes  place  and  related  activities,  should 
continue  to  be  subject  to  compliance  with  the  Directive  2009/41/EC.    Hence,  the 
above-referred  temporary  derogation  should  not  apply  to  the  manufacturing  of  the 
medicinal product.  In addition, sponsors should be required to implement appropriate 
measures  to  minimize  negative  environmental  impacts  that,  on  the  basis  of  the 
available  knowledge,  may  be  expected  as  a  result  from  the  intended  or  unintended 
release of the medicinal product into the environment. 

(19)  Consequently, for applications for marketing authorisation under Regulation (EC) No 
726/2004 or Directive 2001/83/EC for medicinal products intended to treat or prevent 
COVID-19 for which the clinical trials would be covered by the derogation provided 
for  in  this  Regulation,  the  applicant  should  not  be  required  to  include  the  written 
consent  of the competent  authority for the deliberate release into the environment  of 
GMOs  for  research  and  development  purposes  as  set  out  in  Part  B  of  Directive 
2001/18/EC.  

(20)  This Regulation does not affect the Union rules on medicinal products for human use. 
As  provided  in  the  fourth  subparagraph  of  Article  6(3)  of  Regulation  (EC)  No 
726/2004, the environmental impact of medicinal products containing or consisting of 
GMOs  intended  to  treat  or  prevent  COVID-19  will  continue  to  be  assessed  by  the 
European Medicines Agency in parallel with the evaluation of the quality, safety and 
efficacy  of  the  medicinal  product  concerned,  respecting  the  environmental  safety 
requirements set out in Directive 2001/18/EC.  

(21)  Directive  2001/20/EC  will  continue  to  apply  and  clinical  trials  with  investigational 
medicinal  products  containing  or  consisting  of  GMOs  intended  to  treat  or  prevent 
COVID-19  will  continue  to  require  written  authorisation  granted  by  the  competent 
authority in each Member State in which the trial will be conducted. Compliance with 
ethical  requirements  and  good  clinical  practice  in  the  conduct  of  clinical  trials  will 
continue to be mandatory as well as compliance with good manufacturing practice in 
the  manufacture  or  importation  of  investigational  medicinal  products  containing  or 
consisting of GMOs.  

(22)  As a general rule, no medicinal product may be placed on the market in the Union or 
in a Member State unless a marketing authorisation has been granted by the competent 
authorities  under  Regulation 
(EC)  No  726/2004  or  Directive  2001/83/EC. 
Nonetheless,  Directive  2001/83/EC  and  Regulation  (EC)  No  726/2004  provide  for 
exceptions  from  this  requirement  in  situations  characterised  by  the  urgent  need  to 
administer  a  medicinal  product  to  address  the  specific  needs  of  a  patient,  for 
compassionate use, or in response to the suspected or confirmed spread of pathogenic 
agents,  toxins,  chemical  agents  or  nuclear  radiation  that  could  cause  harm.  In 
particular, Article 5(1) of Directive 2001/83/EC allows Member States to fulfil special 
needs, to exclude from the provisions of that Directive medicinal products supplied in 
response  to  a  bona  fide  unsolicited  order,  formulated  in  accordance  with  the 
specifications  of  an  authorised  health-care  professional  and  for  use  by  an  individual 
patient under his or her direct personal responsibility. Under Article 5(2) of Directive 
2001/83/EC,  Member  States  may  temporarily  authorise  the  distribution  of  an 
unauthorised  medicinal  product  in  response  to  the  suspected  or  confirmed  spread  of 
pathogenic  agents,  toxins,  chemical  agents  or  nuclear  radiation  any  of  which  could 

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cause  harm.  Under  Article  83(1)  of  Regulation  (EC)  No  726/2004,  Member  States 
may make a medicinal product for human use available for compassionate reasons to a 
group of patients with a chronically or seriously debilitating disease or whose disease 
is  considered  to  be  life-threatening,  and  who  cannot  be  treated  satisfactorily  by  an 
authorised medicinal product.  

(23)  Doubts  have  been  expressed  by  some  Member  States  about  the  interaction  of  the 
above-mentioned provisions with the GMO legislation. In the light of the urgent need 
to make available vaccines or treatments for COVID-19 available to the public as soon 
as they are ready for this purpose, and to avoid delays or uncertainties as regards the 
status of these products in certain Member States, it is appropriate that, where Member 
States  adopt  decisions  pursuant  to  Article  5(1)  and  (2)  of  Directive  2001/83/EC  or 
Article  83(1)  of  Regulation  (EC)  No  726/2004  concerning  medicinal  products 
containing  or  consisting  of  GMOs  intended  to  treat  or  prevent  COVID-19,  an 
environmental risk assessment or consent in accordance with Directive 2001/18/EC or 
Directive 2009/41/EC are not a prerequisite. 

(24)  Since the objective of this Regulation, namely to provide a temporary derogation from 
the  Union  legislation  on  GMOs  to  ensure  that  the  conduct  of  clinical  trials  in  the 
territory of several Member States with investigational medicinal products containing 
or consisting of GMOs intended to treat or prevent COVID-19 is not delayed and to 
clarify  the  application  of  Article  5(1)  and  (2)  of  Directive  2001/83/EC  and  Article 
83(1) of Regulation (EC) No 726/2004 as regards those products, cannot be achieved 
by the Member States but can, by reason of its scale and effects, 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 the light of the 
importance of ensuring a high level of protection of the environment in all policies and 
in accordance with the proportionality principle, this Regulation should be limited to 
the  present  situation  of  emergency  which  involves  an  urgent  threat  to  human  health 
where it is not possible to attain otherwise the objective to protect human health and 
does not go beyond what is necessary in order to achieve that objective. 

(25) 

In view of that urgency, it is considered to be appropriate to use the exception from the 
eight-week  period  referred  to  in  Article  4  of  Protocol  No  1  on  the  role  of  national 
Parliaments in the European Union, annexed to the Treaty on European Union, to the 
Treaty  on  the  Functioning  of  the  European  Union  and  to  the  Treaty  establishing  the 
European Atomic Energy Community. 

(26)  Given  the  aforementioned  objectives  of  this  Regulation,  to  ensure  that  clinical  trials 
with medicinal products to treat or prevent COVID-19 can start without delay and to 
clarify  the  application  of  Article  5(1)  and  (2)  of  Directive  2001/83/EC  and  Article 
83(1)  of  Regulation  (EC)  No  726/2004  as  regards  those  products,  this  Regulation 
should enter into force as a matter of urgency. 

HAVE ADOPTED THIS REGULATION: 

Article 1 

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

(1) 

(2) 

the definition of “clinical trial” in point (a) of Article 2 of Directive 2001/20/EC; 

the  definition  of  “investigational  medicinal  product”  in  point  (d)  of  Article  2  of 
Directive 2001/20/EC; 

EN 

9 

  EN 

(3) 

(4) 

1. 

2. 

3. 

1. 

2. 

1. 

the definition of “medicinal product in point” 2 of Article 1 of Directive 2001/83/EC; 

the definition of “genetically modified organism” (GMO) in point (2) of Article 2 of 
Directive 2001/18/EC.  

Article 2 

All  operations  related  to  the  conduct  of  clinical  trials,  including  packaging  and 
labelling, storage, transport, destruction, disposal, distribution, supply, administration 
or use of investigational medicinal products for human use containing or consisting 
of  GMOs  intended  to  treat  or  prevent  COVID-19,  with  the  exception  of  the 
manufacturing  of  the  investigational  medicinal  product,  shall  not  require  a  prior 
environmental risk assessment and/or consent in accordance with Articles 6 to 11 of 
Directive  2001/18/EC  or  Articles  6  to  13  of  Directive  2009/41/EC  when  these 
activities  relate  to  the  conduct  of  a  clinical  trial  authorised  in  accordance  with 
Directive 2001/20/EC. 

Sponsors  shall  implement  appropriate  measures  to  minimize  foreseeable  negative 
environmental  impacts  resulting  from  the  intended  or  unintended  release  of  the 
investigational medicinal product into the environment. 

By way of derogation from Article 6(2)(a) of Regulation (EC) No 726/2004 and from 
the  second  indent  of  the  fourth  paragraph  of  point  1.6  of  Part  I  of  Annex  I  to 
Directive  2001/83/EC,  in  applications  for  marketing  authorisations  for  medicinal 
products intended to treat or prevent COVID-19, the applicant shall not be required 
to include a copy of the written consent of the competent authority to the deliberate 
release  into  the  environment  of  GMOs  in  accordance  with  Part  B  of  Directive 
2001/18/EC.  

Article 3 

Articles  6  to  11  and  13  to  24  of  Directive  2001/18/EC  and  Articles  6  to  13  of 
Directive  2009/41/EC  shall  not  apply  to  operations  related  to  the  use  of  medicinal 
products  containing  or  consisting  of  GMOs  that  are  intended  to  treat  or  prevent 
COVID-19,  including  packaging  and  labelling,  storage,  transport,  destruction, 
disposal, distribution, supply, administration but excluding the manufacturing of the 
medicinal product, in any of the following cases: 

(a)  where  such  medicinal  products  have  been  excluded  from  the  provisions  of 

Directive 2001/83/EC by a Member State pursuant to its Article 5(1);  

(b)  where  such  medicinal  products  have  been  authorised  by  a  Member  State 

pursuant to Article 5(2) of Directive 2001/83/EC ; or 

(c)  where such medicinal products are made available by a Member State pursuant 

to Article 83(1) of Regulation (EC) No 726/2004. 

Where  feasible,  Member  States  shall  implement  appropriate  measures  to  minimize 
foreseeable  negative  environmental 
intended  or 
unintended release of the investigational medicinal product into the environment.  

impacts  resulting  from 

the 

This  Regulation  applies  as  long  as  COVID-19  is  regarded  as  a  pandemic  by  the 
World  Health  Organisation  or  as  long  as  a  Commission  decision  recognising  a 

Article 4 

EN 

10 

  EN 

2. 

3. 

situation of public health emergency due to COVID-19 in accordance with Article 12 
of  Decision  No  1082/2013/EU  of  the  European  Parliament  and  of  the  Council7 
applies. 

The Commission shall, when the conditions for the cessation of application referred 
to  in  paragraph  (1)  are  fulfilled,  publish  a  notice  in  the  Official  Journal  of  the 
European Union to that effect.  

Clinical trials within the scope of Article 2 that have been authorised under Directive 
2001/20/EC  prior  to  the  publication  of  the  notice  referred  in  paragraph  (2)  may 
validly  continue  and  be  used  in  support  of  a  marketing  authorisation  application  in 
the absence of an environmental risk assessment and/or consent in accordance with 
Articles 6 to 11 of Directive 2001/18/EC or Articles 6 to 13 of Directive 2009/41/EC. 

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

Article 5 

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 

7 

Decision  No  1082/2013/EU  of  the  European  Parliament  and  of  the  Council  of  22  October  2013  on 
serious  cross-border  threats  to  health  and  repealing  Decision  No  2119/98/EC  (OJ  L  293,  5.11.2013, 
p. 1). 

EN 

11 

  EN