Communication from the Commission to the European Parliament pursuant to the second subparagraph of Article 251 (2) of the EC Treaty concerning the common position of the Council with a view to the adoption of a regulation on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
Date: 2006-03-13
Institutions: European Commission
Subjects: European Medicines Agency, child, child protection, drug surveillance, market approval, medical research, medicinal product, paediatrics, pharmaceutical legislation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 13.3.2006 
COM(2006) 118 final 

2004/0217(COD) 

COMMUNICATION FROM THE COMMISSION TO 
THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning 

the common position of the Council with a view to the adoption of a regulation on 
medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, 
Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 

EN 

   EN 

 
 
 
 
 
2004/0217(COD) 

COMMUNICATION FROM THE COMMISSION TO 
THE EUROPEAN PARLIAMENT 

pursuant to the second subparagraph of Article 251 (2) of the EC Treaty 

concerning 

the common position of the Council with a view to the adoption of a regulation on 
medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, 
Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 

(Text with EEA relevance) 

1. 

BACKGROUND 

Transmission  of  the  proposal  to  the  Council  and  to  the  European 
Parliament - COM(2004) 599 final – 2004/0217 (COD) 

22 October 2004

Date of opinion of the European Economic and Social Committee 

11 May 2005

Date of opinion of the European Parliament - first reading 

7 September 2005

Date of transmission of the Amended proposal COM(2005) 577  

10 November 2005

Date of adoption of the Council common position 

10 March 2006

2. 

OBJECTIVE OF THE COMMISSION PROPOSAL 

The initial proposal aimed to address the current situation in Europe whereby more than fifty 
percent of the medicines used to treat children have not been tested and are not authorised for 
use in children. The health and therefore quality of life of the children of Europe may suffer 
from  a  lack  of  testing  and  authorisation  of  medicines  for  their  use.  The  overall  policy 
objective  was  to  improve  the  health  of  the  children  of  Europe  by  increasing  the  research, 
development and authorisation of medicines for use in children. General objectives were to:  

(1) 

increase the development of medicines for use in children;  

(2) 

(3) 

ensure that medicines used to treat children are subject to high quality research;  

ensure  that  medicines  used  to  treat  children  are  appropriately  authorised  for  use  in 
children; 

(4) 

improve the information available on the use of medicines in children, and;  

EN 

2 

   EN 

 
 
 
 
 
(5) 

achieve these objectives without subjecting children to unnecessary clinical trials and 
trials  (Directive 
in  full  compliance  with  Community 
2001/20/EC1).  

legislation  on  clinical 

3. 

COMMENTS ON THE COMMON POSITION 

3.1. 

Overall remarks on the common position 

The common position has been adopted by the Council by qualified majority. 

To  a  very  large  degree  the  common  position  is  in  line  with  the  Commission’s 
amended  proposal.  In  addition  it  introduces  a  small  number  of  changes  to  the 
Commission’s  amended  proposal  which  improve  the  text  while  maintaining  the 
initial  objectives  of  the  Commission.  Many  of  these  modifications  concern 
improvements in the layout of the text or constitute editorial improvements which do 
not change the meaning or practical application of the Regulation. 

Key amendments proposed by the European Parliament in the first reading, such as 
transparency and membership of the Paediatric Committee, transparency of clinical 
trials in children, provisions in the event of discontinuation of medicines, funding for 
studies,  labelling  of  medicines,  clearer  timelines  for  procedures,  deadlines  for  the 
implementation  of  the  regulation,  avoiding  double  rewards  and  clarifying  in  what 
circumstances rewards will be granted, and on review of the paediatric regulation are 
present in the common position, sometimes with drafting changes to ensure the legal 
consistency of the text and technical workability of the measures and procedures put 
in place. 

3.2. 

European Parliament amendments included in full, in part or in principle in the 
amended  proposal  and  incorporated  in  full,  in  part  or  in  principle  in  the 
common position 

The  following  amendments  have  been  included  in  the  common  position,  in  some 
cases with modifications:  

1  on  suitable  formulations  and  routes  of  administration,  2  on  the  aims  of  the 
Regulation, 4 on the circulation of safe medicinal products, 5 on the scope of testing 
in  the  paediatric  population,  6  (1st  and  3rd  parts)  on  the  members  of  the  Paediatric 
Committee and the need to ensure benefit from studies in children, 7 on the timing of 
testing in the paediatric population, 8 on the timing of studies in children, 9, 56, 63 
(2nd part) and 64 on a research programme into medicines for children, 10 on the role 
of  the  Paediatric  Committee  in  compliance  and  in  assessing  safety,  quality  and 
efficacy  of  a  medicine,  15  (1st  part)  on  the  use  of  the  data  on  the  clinical  trials 
database to avoid unnecessary studies, 17 on taking account of international data, 18 
(1st part) on unnecessary trials, 19 (part) on the inventory of therapeutic needs, 20 on 
the  timing  of  setting  up  the  Paediatric  Committee,  21  on  the  composition  of  the 
Paediatric Committee and providing for the consultation of the European Parliament, 
22 on opinions of the Paediatric Committee and their publication, 26 and 29 on the 
Paediatric  Committee’s  tasks,  27  on  a  communication  role  for  the  Paediatric 

1 

OJ L 121, 1.5.2001, p. 34 

EN 

3 

   EN 

 
                                                 
Committee, 28 on assessments performed in third countries, 31 on variations, 33 and 
39  on  Rapporteurs  for  the  Paediatric  Committee,  34  on  the  deadline  to  inform  the 
applicant,  35  on  the  list  of  waivers,  40  (except  the  last  part)  on  modifying  a 
Paediatric  Investigation  Plan,  42  on  Agency  Decisions,  43  (1st  and  2nd  parts)  on 
product information, 44 (1st part) on a European logo, 45 on which medicines should 
be labelled with the European logo, 46 (2nd part) on a register of marketing deadlines, 
50  on  product  withdrawals,  52  (part)  on  the  non  accumulation  of  rewards,  55  on 
public access to the inventory, 57 on public access to details of trials in the European 
database, 58 on the guidance concerning the database of clinical trials, 62 and 69 on 
the type of studies to be considered by the Paediatric Committee, 66 on publication 
of the names of those infringing the regulation, 67 on the review of the operation of 
the Regulation and of the system of rewards and incentives. The Commission notes 
the  divergence  between  the  common  position  and  the  modified  proposal  on  the 
timing and nature of the review. Although the Commission can support the common 
position  in  this  regard  it  has  a  preference  for  the  focus  placed  by  the  modified 
proposal on the six-year review. 

3.3. 

European  Parliament  amendments  not  included  in  the  amended  proposal  and 
not incorporated in the common position 

The  following  amendments  were  neither  included  in  the  amended  proposal  nor 
incorporated in the common position: 

3 and 16 on reordering the recitals, 6 (2nd part), 11 and 46 (1st and 3rd parts) on the 
deadline for placing on the market existing medicinal products newly authorised for 
children, 12 on a recital on a European paediatric form for the collection of data on 
medicinal products, 13 on a recital on the responsibility of the Paediatric Committee 
for risk management, 14 and 51 on the removal of the requirement for a medicinal 
product  to  be  authorised  in  all  Member  States,  15  (2nd  and  3rd  part)  on  national 
clinical  trials  databases,  18  (2nd  part)  on  rare  congenital  conditions,  19  in  terms  of 
reordering  the  articles  and  in  terms  of  redrafting  (other  than  on  the  inventory  of 
therapeutic  needs),  23  on  the  number  of  representatives  of  the  Commission  and  of 
the Executive Director, 24 on interests in the pharmaceutical industry, 25 on the free 
nature of scientific assistance, 30 on on-going paediatric studies, 32 on the scope of 
the requirements, 36, 37 and 38 on the submission of paediatric investigation plans, 
40 (last part) on deadline for the submission of an amended paediatric investigation 
plan,  41  on  the  detailed  rules  of  interaction  with  the  Paediatric  Committee,  43  (3rd 
part) on the paediatric information contained in product information, 44 (2nd part) a 
European competition to design a logo to be used to label medicines for children, 47, 
48, 49 and 83 on pharmacovigilance, 52 (part) on the exclusion of the extension of 
the  supplementary  protection  certificate  for  products  which  have  received  a  patent 
covering the same paediatric use in the EU,  53 on the number of extensions of the 
supplementary  protection  certificate,  54  on  a  simplified  marketing  authorisation 
procedure for orphan drugs, 65 on the harmonisation of national measures enacting 
penalties, 68 on the deadline for submission of an application for an extension of the 
supplementary  protection  certificate,  70  on  transitional  measures  for  paediatric 
investigation plans, 71 on the date of introduction of the requirements. 

EN 

4 

   EN 

 
3.4. 

Other modifications introduced by the Council common position compared with 
the amended proposal 

Recital  5  in  the  amended  proposal  was  modified  to  delete  the  explicit  reference  to 
Article 95 of the Treaty. Although the Commission can accept this deletion, it should 
be noted that the legal basis for the paediatric regulation is Article 95 of the Treaty. 

A new recital 38 was added to the common position on subsidiarity according to an 
inter-institutionally agreed text. The Commission supports this addition. 

Article  2  in  the  amended  proposal  was  modified  in  the  common  position  to  add  a 
definition  of  a  paediatric  use  marketing  authorisation.  This  definition  was  moved 
from  Article  31  of  the  amended  proposal  (renumbered  as  30  in  the  common 
position).  

Article 4 in the amended proposal was modified in the common position to specify 
that all members of the Paediatric Committee will have alternate members and that 
three  members  will  represent  healthcare  professionals  and  three  members  will 
represent patient associations. The Commission does not object to these changes as it 
believes that the relevant expertise and balance of representation will be maintained. 

Article 6 in the amended proposal was deleted in the common position as Regulation 
(EC)  No  726/2004  already  has  strict  rules  for  the  European  Medicines  Agency 
committees  as  regards  independence  and  interests  in  the  pharmaceutical  industry. 
Recital  8  was  correspondingly  strengthened  with  respect  to  the  independence  and 
interests of Paediatric Committee members. The Commission supports these changes 
as  the  independence  and  interests  of  the  European  Medicines  Agency  committee’s 
are definitively dealt with in Regulation (EC) No 726/2004. 

Article 7 in the amended proposal was renumbered as 6 in the common position and 
modified to include the additional task of the Paediatric Committee of recommending 
a  symbol  for  the  labelling  of  medicines  indicated  for  children.  Paragraph  2  of  that 
article  was  amended  in  the  common  position  to  stipulate  that  the  Paediatric 
Committee shall consider whether or not proposed studies can be expected to be of 
significant  therapeutic  benefit  to  an  /  or  fulfil  a  therapeutic  need  of  the  paediatric 
population. The Commission does not object to this change. 

Article 9 of the modified proposal was renumbered as 8 in the common position and 
modified to clarify that the requirements for the results of studies in children or an 
Agency  decision  on  a  waiver  or  deferral  shall  cover  both  the  existing  and  the  new 
indications,  pharmaceutical  forms  and  routes  of  administration.  The  Commission 
fully supports this change. 

Article 16 in the amended proposal was renumbered as 15 in the common position 
and modified to clarify that Paediatric Investigation Plans related to the requirements 
of Articles 8 and 30 may be submitted for agreement. The Commission supports this 
change. 

EN 

5 

   EN 

 
Article 18 in the amended proposal was renumbered as 17 in the common position 
and modified to state that the Committee shall consider whether or not the measures 
proposed  to  adapt  the  formulation  of  the  medicinal  product  for  use  in  different 
subsets of the paediatric population are appropriate. The Commission fully supports 
this change. 

Article 24 in the amended proposal was renumbered as 23 in the common position 
and modified to clarify that when the applications are submitted in accordance with 
the procedure set out in Articles 27 to 39 of Directive 2001/83/EC, the verification of 
compliance,  including,  as  appropriate,  requesting  an  opinion  of  the  Paediatric 
Committee,  shall  be  conducted  by  the  reference  Member  State.  The  Commission 
supports this change. 

Article 25 in the amended proposal was renumbered as 24 in the common position 
and modified to clarify that incentives provided for in Article 38 would also not be 
granted in the event of non compliance detected during the scientific assessment. The 
Commission does not object to this change, however, it is noted that the provisions 
of Article 38 are pure incentives and not rewards for requirements.  

Article 26 in the amended proposal was renumbered as 25 in the common position 
and modified to set the deadline at 10-days for the Agency to transmit the opinion of 
the Paediatric Committee to the applicant. The Commission supports this change. 

Article 33 in the amended proposal was renumbered as 32 in the common position 
and  modified  to  state  that  the  package  leaflet  shall  contain  an  explanation  of  the 
meaning of the symbol, to provide that the Commission select the symbol based on a 
recommendation  from  the  Paediatric  Committee  and  to  clarify  the  transitional 
arrangements. Recital 17 in the amended proposal on the labelling of medicines for 
children was renumbered 18 in the common position and was amended to bring it in 
line with the revised article. The Commission supports this change as this will ensure 
the best use of the expertise of the Paediatric Committee. 

Article 35 in the amended proposal was renumbered as 34 in the common position 
and modified to bring the definition of risk management system in line with current 
scientific knowledge. The Commission supports this change. 

Article 40 in the amended proposal was renumbered as 41 in the common position 
and  modified  to  clarify  who  would  submit  clinical  trial  results  to  the  Agency.  The 
Commission supports this change. 

Article 41 in the amended proposal was renumbered as 42 in the common position 
and modified to set a deadline for the Paediatric Committee to provide guidance on 
the data to be collected by the Member States. The Commission supports this change. 

Article 44 in the amended proposal was renumbered as 45 in the common position 
and  modified  to  clarify  that  it  is  the  Marketing  Authorisation  Holder  that  should 
submit any paediatric studies already completed, to clarify the competent authorities’ 
role in updating product information. The Commission supports this change. 

EN 

6 

   EN 

 
Article 45 in the amended proposal was renumbered as 46 in the common position 
and  modified  to  clarify  the  competent  authorities’  role  in  updating  product 
information. The Commission supports this change. 

Article  50  in  the  amended  proposal  was  deleted  in  the  common  position  as  the 
provision  was  judged  to  be  unnecessary  given  the  provisions  of  Article  11  of  the 
amended  proposal  (Article  10  of  the  common  position).  The  Commission  supports 
this change. 

Article 52 in the amended proposal was modified in the common position to: define 
‘application  for  an  extension  of  the  duration’;  to  clarify  the  procedures  when 
Supplementary Protection Certificate applications are pending; to clarify the contents 
of an application for an Supplementary Protection Certificate extension and how to 
submit  such  an  application;  to  clarify  that  extensions  may  be  revoked  if  granted 
contrary to the provisions of the paediatric regulation and how this will occur; and, to 
clarify the appeals system. The Commission supports these changes. 

Article 54 in the amended proposal was renumbered as 55 in the common position 
and  modified  to  add  a  new  task  for  the  Agency  to  take  decisions  related  to  the 
operation of the paediatric regulation.  

4. 

CONCLUSION 

The Commission supports the common position. 

EN 

7 

   EN