Opinion of the Commission pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a Regulation of the European Parliament and of the Council 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 amending the proposal of the Commission in accordance with Article 250 (2) of the EC Treaty
Date: 2006-07-19
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, 19.7.2006 
COM(2006) 408 final 

2004/0217 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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 

AMENDING THE PROPOSAL OF THE COMMISSION  
in accordance with Article 250 (2) of the EC Treaty 

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2004/0217 (COD) 

OPINION OF THE COMMISSION 

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, 
on the European Parliament's amendments 
to the Council's common position regarding the  
proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

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 

1. 

BACKGROUND 

(Text with EEA relevance) 

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

22 October 2004

Opinion of the Economic and Social Committee 

11 May 2005

Opinion of the European Parliament - first reading 

7 September 2005

Transmission of the amended proposal to the Council - COM(2005) 577   10 November 2005

Adoption of the Council common position by qualified majority 

10 March 2006

Opinion of the European Parliament - second reading 

1 June 2006

2. 

PURPOSE OF THE 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:  

•  increase the development of medicines for use in children;  

•  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; 

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

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

3. 

OPINION  OF  THE  COMMISSION  ON  THE  AMENDMENTS  BY  THE 
EUROPEAN PARLIAMENT 

3.1. 

Summary of the Commission’s position 

The  Commission  can  accept  in  full  all  amendments  adopted  by  the  European  Parliament. 
They are the result of a compromise package agreed between the European Parliament and the 
Council with a view to the adoption of the Regulation in second reading. The amendments are 
in line with the objectives of the Commission’s proposal and maintain the balance of interests 
achieved in the common position.  

The amendments to the Common Position mainly refer to: 

•  provision for the Commission to adopt guidelines relating to the operation of the 
reward  contained  in  the  Regulation  in  the  form  of  a  six-month  extension  of  the 
supplementary protection certificate; 

•  introduction of a transitional period of five years since entry into force reducing 
the  deadline  for  submission  of  an  application  to  extend  the  supplementary 
protection certificate: 

•  several clarifications on: the rules on independence and impartiality of members 
of  the  Paediatric  Committee;  the  transparency  of  opinions  of  this  Committee; 
pharmacovigilance  and  risk  management;  early  dialogue  between  companies 
developing  medicinal  products  and  the  Paediatric  Committee  on  whether  a 
product  should  be  developed  for  children;  and  the  avoidance  of  delays  in  the 
authorisation of medicinal products for populations. 

The  conclusion  of  the  compromise  package  has  been  facilitated  by  a  declaration  which  the 
Commission made during the June 2006 Plenary session (see annex). 

4. 

CONCLUSION 

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out 
above. 

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OJ L 121, 1.5.2001, p. 34 

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Declaration by the Commission: 

ANNEX 

"In  view  of  the  risks  of  carcinogens,  mutagens  and  substances  toxic  to  reproduction,  the 
Commission  will  request  the  Committee  for  Medicinal  Products  for  Human  Use  of  the 
European  Medicines  Agency  to  draw  up  an  opinion  on  the  use  of  these  categories  of 
substances  as  excipients  of  medicinal  products  for  human  use,  on  the  basis  of  Articles  5(3) 
and  57(1)(p)  of  Regulation  (EC)  No  726/2004  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.  

The  Commission  will  transmit  the  opinion  of  the  Committee  for  Medicinal  Products  for 
Human Use to the European Parliament and the Council.  

Within six-months of the opinion of the Committee for Medicinal Products for Human Use, 
the Commission will inform the European Parliament and the Council of any necessary action 
it intends to take to follow-up on this opinion." 

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