Amended 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 2001/83/EC and Regulation (EC) No 726/2004 (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2005-11-10
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, 10.11.2005 
COM(2005) 577 final 

2004/0217 (COD) 

Amended 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 2001/83/EC and Regulation (EC) No 726/2004 

(presented by the Commission pursuant to  
Article 250 (2) of the EC Treaty) 

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2004/0217 (COD) 

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 2001/83/EC and Regulation (EC) No 726/2004 

1. 

BACKGROUND 

(Text with EEA relevance) 

Adoption of the proposal- COM(2004) 599 final 

29 September 2004 

Transmission of the proposal to the Council and to the European Parliament 
- COM(2004) 599 final – 2004/0217 (COD) - 
by virtue of article 175, paragraph 1 of the Treaty: 

22 October 2004 

Opinion of the European Economic and Social Committee: 

11 May 2005 

Opinion of the European Parliament – first reading: 

7 September 2005 

2. 

OBJECTIVE OF THE COMMISSON PROPOSAL 

The proposal aims 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 is to improve the health of the children of Europe by increasing 
the research, development and authorisation of medicines for use in children. 

General objectives are to:  

(1) 

increase the development of medicines for use in children;  

(2) 

(3) 

(4) 

(5) 

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;  

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

legislation  on  clinical 

1 

OJ L 121, 1.5.2001, p. 34 

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3. 

3.1. 

OPINION OF THE COMMISSION ON THE AMENDMENTS ADOPTED BY 
THE PARLIAMENT 

Amendments  accepted  by  the  Commission:  4,  5,  7,  10,  15  (1st  part),  17,  18  (1st 
part), 22 (1st part), 33, 34, 35, 39, 40 (60 days, “or the request for a deferral or 
waiver”), 44 (1st part), 45, 46 (2nd part), 58, 62. 

The  Commission  can  accept  the  following  amendments  with  the  wording  proposed  by  the 
European Parliament. 

–  Amendment  4  aimed  at  highlighting  the  objective  of  promoting  the  circulation  of  safe 

medicinal products. 

–  Amendment 5 aimed at highlighting that not all testing in children may be appropriate. 

–  Amendment 7 aimed at clarifying that the conduct of studies in children will not always be 
possible  before  granting  marketing  authorisations  for  adults  and  that  the  provisions  for 
medicines for children should not delay marketing authorisation applications for medicines 
in adults. 

–  Amendment  10  aimed  at  highlighting  the  role  of  the  Paediatric  Committee  in  checking 
compliance with the paediatric investigation plan  and  in giving an opinion on the safety, 
quality and efficacy of a medicine in children. 

–  Amendment  15  (first  part)  aimed  at  highlighting  the  use  of  the  data  on  the  clinical  trials 

database as an information source and to aid the avoidance of unnecessary studies. 

“Recital 28: 

In order to increase the availability of information on the use of medicines in children, and to 
avoid the repetition of studies in children which do not add to the collective knowledge, the 
European  database  provided  for  in  Article  11  of  Directive  2001/20/EC  should  include  a 
European register of clinical trials of medicinal products for paediatric use comprising all 
ongoing,  prematurely  terminated,  and  completed  paediatric  studies  conducted  both  in  the 
Community and in third countries. […]” 

–  Amendment  17  aimed  at  stressing  the  importance  of  taking  account  of  international  data 

when establishing and operating a European clinical trials network. 

–  Amendment 18 (first part) aimed at clarifying that children should not be subjected to any 

unnecessary trials, be they clinical or other. 

“Article 1: 

This Regulation lays down rules concerning the development of medicinal products for human 
use  in  order  to  meet  the  specific  therapeutic  needs  of  the  paediatric  population,  without 
subjecting children to unnecessary clinical or other trials and in compliance with Directive 
2001/20/EC.” 

–  Amendment 22 (first part) aimed at clarifying that the opinion of the Paediatric Committee 
will be the one adopted by the majority of members and that the opinion shall mention any 
divergent positions. 

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“Article 5(1): 

When preparing its opinions, the Paediatric Committee shall use its best endeavours to reach 
a  scientific  consensus.  If  such  a  consensus  cannot  be  reached,  the  opinion  shall  be  the  one 
adopted by the majority of members. The opinion shall mention the divergent positions, with 
the grounds on which they are based.” 

–  Amendments 33 and 39 aimed at ensuring that a rapporteur from the Paediatric Committee 

is appointed. 

–  Amendment  34  aimed  at  clarifying  the  deadline  for  the  European  Medicines  Agency 
(hereinafter, the Agency) to inform the applicant of the Paediatric Committee’s opinion. 

–  Amendment 35 aimed at ensuring the list of waivers is regularly updated and is publicly 

accessible. 

–  Amendment  40  (except  the  last  part)  aimed  at  establishing  a  deadline  for  the  Paediatric 
Committee to adopt an opinion and to clarify that the request and opinion may refer to a 
paediatric investigation plan, deferral or waiver. 

“Article 23: 

If,  after  the  decision  agreeing  the  paediatric  investigation  plan,  the  applicant  encounters 
difficulties  with  its  implementation  such  as  to  render  the  plan  unworkable  or  no  longer 
appropriate, the applicant may propose changes or request a deferral or a waiver, based on 
detailed  grounds,  to  the  Paediatric  Committee.  Within  60  days,  the  Paediatric  Committee 
shall  review  these  changes  or  the  request  for  a  deferral  or  a  waiver  and  adopt  an  opinion 
proposing  their  refusal  or  acceptance.  As  soon  as  the  Paediatric  Committee  adopts  an 
opinion, whether positive or negative, the procedure laid down in Chapter 4 shall apply.” 

–  Amendment  44  (first  part)  aimed  at  establishing  a  European  logo  for  medicines  for 

children.  

“Article 33, first subparagraph: 

Where a medicinal product is granted a marketing authorisation for a paediatric indication 
based  on  the  results  of  studies  conducted  in  compliance  with  an  agreed  paediatric 
investigation plan, the label shall display the name of the medicinal product and, below it, a 
European logo for any paediatric presentation.” 

–  Amendment 45 aimed at ensuring that existing medicines authorised for children should be 

labelled with the European logo. 

–  Amendment  46  (second  part)  aimed  at  establishing  a  publicly  accessible  register  of  the 

deadlines for placing on the market existing products newly authorised for children. 

“Article 34: 

Where medicinal products are authorised with a paediatric indication following completion 
of  an  agreed  paediatric  investigation  plan  and  those  products  have  already  been  marketed 
with other indications, the marketing authorisation holder shall, within two years of the date 
on which the paediatric indication is authorised, place the product on the market taking into 

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account  the  paediatric  indication.  A  publicly  accessible  register  shall  be  set  up  by  the 
competent authorities in order to indicate these deadlines.” 

–  Amendment 58 aimed at ensuring that the scope of the Commission guidance concerning 
the database of clinical trials includes what information should be made public and how the 
Agency should achieve this. 

–  Amendment 62 aimed at clarifying that ongoing, as well as, completed studies should be 
taken  into  consideration  by  the  Paediatric  Committee  when  assessing  paediatric 
investigation plans, waivers and deferrals. 

3.2. 

Amendments accepted in principle by the Commission : 1, 2, 6 (1st part), 6 (3rd 
part), 8, 9, 19 (Article 2b), 20, 21, 22 (2nd part), 26 (with 29), 27, 28, 31, 42, 43 (1st 
part and 2nd part), 50, 52 (re data protection), 55, 56, 57, 63, 64, 66, 67, 69 

The Commission can accept in principle the following amendments: 

–  Amendment  1  introducing  into  recital  3  a  specific  mention  of  the  need  for  suitable 

formulations and routes of administration for children, with a minor rewording:  

“Recital 3: 

Problems  resulting  from  the  absence  of  suitably  adapted  medicines  for  children  include 
inadequate  dosing  information  leading  to  increased  risks  of  adverse  reactions  including 
death, ineffective treatment through under-dosing, non-availability to children of therapeutic 
advances  and  suitable  formulations  and  routes  of  administration,  as  well  as  the  use  of 
extemporaneous formulations to treat children which may be of poor quality.” 

–  Amendment 2 clarifying that the aims of the Regulation include increasing availability of 
medicines for children. A slight rewording is necessary; the mention of “where indicated” 
in  the  amendment  is  unnecessary  since  it  is  already  covered  by  the  mention  of  “and  are 
appropriately authorised for use in children”:  

“Recital 4: 

The aim of this Regulation is to facilitate the development and accessibility of medicines for 
use  in  children,  to  ensure  that  medicines  used  to  treat  children  are  subject  to  high  quality, 
ethical  research  and  are  appropriately  authorised  for  use  in  children,  and  to  improve  the 
information  available  on  the  use  of  medicines  in  the  various  paediatric  populations.  These 
objectives should be achieved without subjecting children to unnecessary clinical trials and 
without delaying the authorisation of medicinal products for other age populations.” 

–  Amendment  6  (1st  and  3rd  parts)  concerning  the  independence  and  the  requirements  in 
terms of professional experience of the members of the Paediatric Committee, and the need 
to  ensure  that  any  studies  in  children  have  potential  significant  therapeutic  benefits  for 
them.  Rewording  is  necessary  to  clarify  that  the  members  of  the  Committee  must  have 
experience relevant to the work of the Committee, but that this experience may have been 
gained other than in the pharmaceutical industry. Further rewording is necessary to clarify 
that, when the Paediatric Committee considers the potential significant therapeutic benefits 
of a medicine, these potential benefits relate to either the patients to be included in studies 
or the paediatric population at large. 

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“Recital 8: 

It  is  appropriate  to  create  a  scientific  committee,  the  Paediatric  Committee,  within  the 
European Medicines Agency, hereinafter ‘the Agency’, with expertise and competence in the 
development  and  assessment  of  all  aspects  of  medicinal  products  to  treat  paediatric 
populations.  To  this  end  the  Paediatric  Committee  should  be  independent  of  the 
pharmaceutical industry. The Paediatric Committee should be primarily responsible for the 
assessment and agreement of paediatric investigation plans and for the system of waivers and 
deferrals  thereof.  It  should  also  be  central  to  various  support  measures  contained  in  this 
Regulation. In all its work the Paediatric Committee should consider the potential significant 
therapeutic  benefits  for  the  paediatric  patients  involved  in  the  studies  or  the  paediatric 
population  at  large,  including  the  need  to  avoid  unnecessary  studies.  The  Paediatric 
Committee should follow existing Community requirements, including Directive 2001/20/EC, 
as  well  as  International  Conference  on  Harmonisation  (ICH)  guideline  E11  on  the 
development of medicines for children, and it should avoid any delay in the authorisation of 
medicines for other populations as a result of the requirements for studies in children.” 

–  Amendment 8 intended to clarify that, in some circumstances, it will not be appropriate to 
conduct  studies  in  children  in  parallel  with  studies  in  adults.  The  recital  should  be 
reworded to specify the mechanisms foreseen in the Regulation (waivers and deferral) to 
address such a situation. 

“Recital 11: 

It  is  necessary  to  introduce  a  requirement  for  new  medicinal  products  and  or  authorised 
medicinal products covered by a patent or a supplementary protection certificate to present 
either the results of studies in children in accordance with an agreed paediatric investigation 
plan,  or  proof  of  having  obtained  a  waiver  or  deferral,  at  the  time  of  filing  a  marketing 
authorisation application or an application for a new indication, new pharmaceutical form or 
new route of administration. The paediatric investigation plan should be the basis upon which 
compliance with that requirement is judged. However, that requirement should not apply to 
generics or similar biological medicinal products and medicinal products authorised through 
the  well-established  medicinal  use  procedure,  or  to  homeopathic  medicinal  products  and 
traditional  herbal  medicinal  products  authorised  through  the  simplified  registration 
procedures  of  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.” 

–  Amendments 9, 56, 63 (second part) and 64 providing for the establishment of a research 
programme  into  the  paediatric  use  of  medicinal  products  which  are  not  protected  by  a 
patent  or  supplementary  protection  certificate.  Rewording  is  required  to  specify  that  all 
Community funded research activities must take place within the context of the Research 
and  Development  Framework  Programmes.  The  Commission  services  are  currently 
working  to  include  such  a  programme  in  the  Specific  Programme  on  Health  of  the  7th 
Framework  Programme.  Under  the  “health”  thematic  priority  of  its  7th  Framework 
Programme proposal, the Commission has therefore clearly mentioned “research on child 
health” as one of the strategic issues which should be addressed across activities. Among 
the  different  activities  where  child  health  research  could  be  addressed,  it  is  in  particular 
envisaged  to  put  a  special  emphasis  on  the  specificities  of  children  when  it  comes  to 
translating  clinical  outcome  into  clinical  practice.  It  is  also  envisaged  to  give  specific 
support  to  clinical  studies  which  could  provide  evidence  for  the  appropriate  use  of  off-
patent products currently used in the paediatric populations. 

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“Recital 11a: 

Provision should be made for research into the paediatric use of medicinal products which 
are not protected by a patent or supplementary protection certificate to be financed under 
Community research programmes. 

“Article 39a: 

1.  Funds  for  research  into  medicinal  products  for  children  shall  be  provided  for  in  the 
Community  budget  to  support  studies  relating  to  medicinal  products  or  active  substances 
not covered by a patent or a supplementary protection certificate. 

2.  This  Community  funding  will  be  delivered  through  the  Community  Framework 
Programmes  for  Research,  Technological  Development  and  Demonstration  Activities  or 
any other Community initiatives for the funding of research.” 

–  Amendment 19 as regards the content of the new Article 2b, concerning the inventory of 
therapeutic  needs.  The  first  subparagraph  is  accepted  with  the  wording  proposed  by  the 
European Parliament. Rewording of the second subparagraph is necessary to provide for a 
longer  deadline  for  publication.  The  survey  will  take  two  years  to  complete,  and  the 
Paediatric  Committee  should  be  granted  twelve  months  to  carefully  assess  the  data  and 
adopt  the  inventory.  The  rewording  is  included  in  Article  42  given  that  the  Commission 
does  not  accept  amendment  19  insofar  as  it  entails  moving  the  survey,  inventory  and 
network (Articles 41, 42 and 43 of the Commission proposal) to a new Chapter 1a. 

“Article 42: 

On  the  basis  of  the  information  referred  to  in  Article  41  and  after  consulting  the 
Commission, the Member States and the interested parties, the Paediatric Committee shall 
draw up an inventory of therapeutic needs, in particular with a view to identifying research 
priorities. 

The Agency shall make  public  the  inventory within 3 years of the entry  into force of  this 
Regulation, and shall update it regularly. 

In establishing the inventory of therapeutic needs, account shall be taken of the prevalence of 
the conditions in the paediatric population, the seriousness of the conditions to be treated, the 
availability  and  suitability  of  alternative  treatments  for  the  conditions  in  the  paediatric 
population,  including  the  efficacy  and  the  adverse  reaction  profile  of  those  treatments, 
including  any  unique  paediatric  safety  issues,  and  any  data  resulting  from  studies  in  third 
countries.” 

–  Amendment  20  requiring  the  Paediatric  Committee  to  be  operational  within  six  months 
from the date of entry into force of the Regulation. Rewording is necessary to ensure that 
the  dead-line  can  be  met,  considering  that  the  appointment  procedure  for  the  members 
appointed  by  the  Commission  on  the  basis  of  a  public  call  for  expression  of  interest 
(referred to in Article 4(1)(c)) may take longer than six months: 

“Article 3(1), first subparagraph: 

Not  later  than  6  months  after  the  entry  into  force  of  this  Regulation,  a  Paediatric 
Committee  shall  be  established  within  the  European  Medicines  Agency  set  up  under 
Regulation (EC) No 726/2004, hereinafter “the Agency”. The Paediatric Committee shall be 

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considered to be established once the members referred to in Article 4(1)(a) and (b) have 
been appointed.” 

–  Amendment 21 broadening the composition of the Paediatric Committee and providing for 
the consultation of the European Parliament before designation of the members appointed 
by the Commission. 

The Commission accepts the part of the amendment concerning consultation of the European 
Parliament in the case of the members appointed by the Commission on the basis of a public 
call for expression of interest (referred to in Article 4(1)(c)).  

Regarding the number of such members to be appointed by the Commission, it is considered 
that six members is sufficient to ensure that the relevant healthcare professionals and patients 
groups  are  well  represented  on  the  Paediatric  Committee.  Increasing  the  number  of 
Commission appointees from six to ten would lead to the Committee being much larger than 
other committees of the Agency and could result in operational difficulties. 

Regarding the range of expertise to be represented in the Committee, this amendment deals 
exclusively  with  the  members  appointed  by  the  Commission.  However,  the  composition  of 
the  Committee  needs  to  be  considered  in  the context  of  the  whole  of  Article  4.  The  second 
subparagraph of paragraph (1) tasks the Executive Director of the Agency to ensure that the 
combined membership covers at least the listed areas of expertise. Of the areas of expertise 
that  the  European  Parliament  proposes  to  add,  this  list  already  includes  pharmacovigilance 
and pharmacy; public health and general practitioners should be added to the list. The part of 
the amendment relating to “paediatricians and other physicians specialising in the treatment of 
children” is most appropriately dealt with by using the term “healthcare professionals”. 

In view of the enlarged areas of expertise to be covered as a result of this amendment, it is 
appropriate  for  the  Commission,  appointing  six  members  of  the  Committee,  to  cooperate 
closely with Member States, the European Parliament and the Agency during the appointment 
process. 

Therefore,  Article  4(1)(c)  and  the  last  subparagraph  of  Article  4(1)  should  be  reworded  as 
follows: 

“(c) Six persons appointed by the Commission, on the basis of a public call for expressions of 
interest,  and  after  consulting  the  European  Parliament,  in  order  to  represent  health 
professionals and patient associations. 

For  the  purposes  of  points  (a)  and  (b),  the  Member  States  shall  cooperate,  under  the 
coordination  of  the  Executive  Director  of  the  Agency,  in  order  to  ensure  that  the  final 
composition of the Paediatric Committee will cover the scientific areas relevant to paediatric 
medicinal products, and at least including: pharmaceutical development, paediatric medicine, 
general  practitioners,  pharmacy,  paediatric  pharmacology,  paediatric 
research, 
pharmacovigilance, ethics and public health. For the purposes of point (c), the Commission 
shall take  into  account the expertise  provided by the members appointed under points (a) 
and (b).” 

–  Amendment  22  (2nd  part)  concerning  publication  of  the  opinions  of  the  Paediatric 
Committee. This transparency measure should apply to the Agency decisions adopted after 
an  opinion  of  the  Paediatric  Committee,  which  is  a  preparatory  step  for  such  decisions. 
Therefore,  rather  than  an  amendment  to  Article  5,  a  reference  to  publication  should  be 

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included in Article 26, which refers to the decisions of the Agency adopted on the basis of 
Committee’s opinion.  

“Article 26(6): 

Decisions  of  the  Agency  shall  be  made  public,  after  deletion  of  any  information  of  a 
commercially confidential nature.” 

–  Amendments  26  and  29  concerning  the  Paediatric  Committee’s  tasks  as  regards  the 
inventory  of  therapeutic  needs.  The  Commission  accepts  this  amendment  and  the  new 
Article  7(1)(ha).  In  turn,  point  (e)  of  Article  7(1)  needs  to  be  reworded  to  delete  the 
reference to the inventory and avoid duplication. 

“Article 7(1)(e): 

to  advise  on  the  content  and  format  of  data  to  be  collected  for  the  survey  referred  to  in 
Article 41;” 

Article 7(1)(ha): 

to  establish  a  specific  inventory  of  paediatric  medicinal  product  needs,  update  it  on  a 
regular basis and make it publicly available;” 

–  Amendment  27  on  transparency  measures  concerning  the  role  of  the  Committee  and  the 
arrangements  available  for  conducting  pharmaceutical  clinical  trials.  It  is  appropriate  for 
the Committee to advise on communication about the conduct of clinical trials in children, 
but  not  for  it  to  organise  publicity  campaigns  on  its  own  role.  Rewording  is  therefore 
required:  

“Article 7(1)(hb): 

to advise the Agency and the Commission regarding communication on the arrangements 
available for conducting research into medicines for children.” 

–  Amendment 28 providing that the Committee takes into account the results of assessments 
performed  in  third  countries.  Rewording  is  necessary  to  clarify  that  the  Committee  shall 
consider  any  information  available  to  it,  including  information  from  studies  in  third 
countries. 

“Article 7(2): 

When  carrying  out  its  tasks,  the  Paediatric  Committee  shall  consider  whether  or  not  any 
proposed  studies  can  be  expected  to  be  of  significant  therapeutic  benefit  to  the  paediatric 
population. The Paediatric Committee shall take into account any information available to 
it, including any opinions, decisions or advice given by the competent authorities of third 
countries.” 

–  Amendment  31  intended  to  ensure  that  Community  pharmaceutical  legislation,  and  in 
particular  the  rules  on  variations  to  the  terms  of  marketing  authorisations,  apply  where 
relevant  in  the  framework  of  this  Regulation.  However,  the  amendment  is  redundant. 
Article 28 already refers to the application of Regulation (EC) No 726/2004 and Directive 
2001/83/EC,  which  by  definition  includes  their  implementing  measures  such  as 

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Regulations (EC) No 1084/2003 and No 1085/2003, concerning variations to the terms of 
marketing authorisations. 

–  Amendment  42  introducing  a  dead-line  for  the  Agency  to  adopt  a  decision  following  an 
opinion  of  the  Paediatric  Committee  and  providing  that  such  decisions  will  be  duly 
motivated. Rewording is proposed to reduce the mentioned  dead-line  (ten days is judged 
sufficient  for  the  Agency  to  adopt  a  decision)  and  to  clarify  that  motivation  shall  be 
provided by annexing the Committee’s opinion. 

“Article 26(4): 

The Agency shall adopt a decision within a period not exceeding 10 days following receipt of 
the  Paediatric  Committee's  definitive  opinion.  This  decision  shall  be  communicated  to  the 
applicant in writing, and will annex the definitive opinion of the Paediatric Committee.” 

–  Amendment 43 (1st and 2nd part) clarifying that the results of all paediatric studies should 
be included in the summary of the product characteristics and, where the information is of 
use to patients, in the package leaflet, with some rewording.  

“Article 29(1), second subparagraph: 

Where authorisation is granted, the results of all those studies, concerning both the paediatric 
indications authorised and those which were not, shall be included in the summary of product 
characteristics  and,  provided  that  the  competent  authority  deems  the  information  to  be  of 
use to patients, in the package leaflet of the medicinal product.” 

–  Amendment  50  providing  that,  if  a  company  stops  commercialising  a  product  authorised 
for  a  paediatric  indication  when  that  product  benefited  from  a  reward  or  incentive  in  the 
Regulation,  then  the  company  will  be  compelled  to  allow  another  company  access  the 
marketing authorisation dossier to be able to continue marketing of the product. Rewording 
is  necessary  to  clarify  that  the  periods  of  protection  granted  by  the  reward  or  incentive 
should  have  expired  for  this  provision  to  apply.  It  is  appropriate  to  provide  also  for  the 
possibility  for  marketing  authorisation  holders  to  transfer  the  marketing  authorisation, 
instead of relying on Article 10c of Directive 2001/83/EC, in order to fulfil the obligations 
contained  in  this  provision.  It  is  also  appropriate  to  add  a  recital  to  justify  this  new 
provision. 

“Recital 23a: 

It is necessary in the interest of public health to ensure the continuing availability of safe 
and effective medicinal products authorised for paediatric indications developed as a result 
of  this  Regulation.  If  a  marketing  authorisation  holder  intends  to  withdraw  such  a 
medicinal  product  from  the  market,  then  arrangements  must  be  in  place  so  that  the 
paediatric population can continue to have access to it. In order to help to achieve this, the 
Agency  must  be  informed  in  good  time  of  any  such  intention  and  should  make  that 
intention public. 

Article 35a: 

If  a  medicinal  product  is  authorised  for  a  paediatric  indication  and  the  marketing 
authorisation holder has benefited from the rewards or incentives of Article 36, 37 or 38, 
and  these  periods  of  protection  have  expired,  if  the  marketing  authorisation  holder 

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discontinues  placing  the  medicinal  product  on  the  market,  the  marketing  authorisation 
holder  shall  transfer  the  marketing  authorisation  or  allow  a  third  party  to  use  the 
pharmaceutical,  pre-clinical  and  clinical  documentation  contained  in  the  file  of  the 
medicinal product on the basis of Article 10c of Directive 2001/83/EC.  

The marketing authorisation holder shall inform the Agency of its intention to discontinue 
the placing on the market of the product no less than six months before the interruption in 
the placing on the market. The Agency shall make this fact public.” 

–  Amendment 52 (2nd part) concerning the exclusion of the extension of the supplementary 
protection  certificate  for  products  which  have  received  any  form  of  data  or  market 
exclusivity for the same paediatric use in the EU. 

Data exclusivity is a form of protection which does not have to be applied for; every time a 
marketing authorisation for a medicinal product is granted, a period of data exclucivity starts 
to  run  pursuant  to  Articles  14(11)  of  Regulation  (EC)  No  726/2004  or  10  of  Directive 
2001/83/EC. Thus, the exclusion of an extension of the supplementary protection certificate 
for  products  which  have  received  any  form  of  data  or  market  exclusivity  for  the  same 
paediatric  use  in  the  EU  is  inappropriate,  since  it  would  mean  in  practice  that  any  product 
with  a  paediatric  indication  already  authorised  would  be  deprived  from  an  extension  of  the 
supplementary  protection  certificate,  even  if  new  research  was  done  on  the  paediatric 
indication  (e.g.  to  extend  it  to  a  new  paediatric  subpopulation  or  to  develop  a  specific 
paediatric formulation). 

However, the principle of avoiding double rewards based on the same research should apply 
in  the  following  situation.  The  new  Article  10(1)  of  Directive  2001/83/EC,  as  amended  by 
Directive 2004/27/EC, provides that the period of marketing protection shall be extended by 
one  year  if  the  marketing  authorisation  holder  obtains  an  authorisation  for  a  new  indication 
which is judged to bring a significant clinical benefit in comparison with existing therapies. In 
the  case  of  a  new  paediatric  indication,  this  additional  year  of  marketing  exclusivity  should 
not  be  granted  together  with  the  six-month  extension  of  the  supplementary  protection 
certificate based on the same research.  

To avoid these cumulative rewards, a new paragraph should be included in Article 36: 

“Article 36(5): 

In  the  case  of  an  application  under  Article  9  which  leads  to  the  authorisation  of  a  new 
paediatric indication, paragraphs 1, 2 and 3 shall not apply if the applicant applies for and 
obtains  a  one-year  extension  of  the  period  of  marketing  protection  for  the  medicinal 
product concerned, on the grounds that this new paediatric indication brings a significant 
clinical benefit in comparison with existing therapies, in accordance with Article 14(11) of 
Regulation  (EC)  No  726/2004  or  the  last  subparagraph  of  Article  10(1)  of  Directive 
2001/83/EC.” 

–  Amendment  55  concerning  public  access  to  the  inventory  ofincentives.  Rewording  is 
necessary  to  avoid  inconsistency  in  the  text  of  the  provision  which  would  otherwise 
contain references to both publication and public availability. 

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“Article 39(3): 

Within  18  months  of  the  entry  into  force  of  this  Regulation,  the  Commission  shall  make 
publicly  available  a  detailed  inventory  of  all  incentives  provided  by  the  Community  and 
Member States to support research into, and the development and availability of, medicinal 
products for paediatric use. This inventory shall be updated regularly and these updates shall 
also be made publicly available.”  

–  Amendment 57 concerning public access to details of trials conducted in accordance with a 
paediatric  investigation  plan  and  included  in  the  European  database  created  by  Directive 
2001/20/EC  (clinical  trials  directive).  Since  all  paediatric  clinical  trials  conducted  in  the 
Community  are  already  covered  by  Directive  2001/20/EC  and  entered  into  the  European 
database,  the  first  paragraph  of  the  provision  needs  to  make  it  clear  that  the  additional 
requirement introduced by this Regulation is to enter details of clinical trials conducted in 
third countries and contained in agreed paediatric investigation plan. 

Rewording  is  also  necessary  in  the  second  subparagraph  of  the  amendment  (paragraph  1a 
below) to clarify which clinical trials’ results should be made public, by adding a reference to 
trials  submitted  to  the  competent  authorities  on  the  basis  of  Articles  44  and  45.  It  is  not 
considered appropriate for the Agency to publish conclusions on the information submitted. 
Rather,  any  conclusions  reached  by  the  competent  authorities  on  the  basis  of  clinical  trial 
results should lead to updates of product information, as stated in Articles 29, 44 and 45. 

In order to reflect the public availability of information concerning clinical trials in children, 
it is appropriate to add additional wording at the end of recital 28. 

“Recital 28: 

[…] Part of the information concerning paediatric clinical trials entered into the database, 
as well as, details of the results of all trials submitted to the competent authorities, should 
be made public by the Agency.” 

Article 40(1) and (1a): 

1.  The  European  database  created  by  Article  11  of  Directive  2001/20/EC  shall  include 
clinical  trials  carried  out  in  third  countries  which  are  contained  in  an  agreed  paediatric 
investigation  plan,  in  addition  to  the  clinical  trials  referred  to  in  Articles  1  and  2  of  that 
directive. In the case of such clinical trials carried out in third countries, the details listed 
in  Article  11  of  that  directive  shall  be  entered  into  the  database  by  the  addressee  of  the 
Agency’s decision on a paediatric investigation plan. 

By  way  of  derogation  from  that  provision,  the  Agency  shall  make  public  part  of  the 
information on paediatric clinical trials entered in the European database. 

1a. Details of the results of all the trials referred to in paragraph 1 and of any other trials 
submitted  to  competent  authorities  in  compliance  with  Articles  44  and  45  shall  be  made 
public by the Agency, whether or not the trial was terminated prematurely.” 

–  Amendment 63 (first part) on the financing of the work of the Paediatric Committee by the 
Community contribution provided for in Article 67 of Regulation (EC) No 726/2004, with 
a minor rewording. 

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“Article 47: 

The Community contribution provided for in Article 67 of Regulation (EC) No 726/2004 shall 
cover the work of the Paediatric Committee, including scientific support provided by experts, 
and  of  the  Agency,  including  the  assessment  of  paediatric  investigation  plans,  scientific 
advice  and  any  fee  waivers  provided  for  in  this  Regulation,  and  shall  support  the  Agency’s 
activities under Articles 40 and 43 of this Regulation.” 

–  Amendment  66  concerning  publication  of  the  names  of  those  infringing  the  regulation. 
Rewording  is  necessary  to  include  infringement  of  any  implementing  measure  adopted, 
and not only of implementing regulations. 

“Article 48(4): 

The  Commission  shall  publish  the  names  of  anyone  infringing  the  provisions  of  this 
Regulation or of any implementing measures adopted pursuant to it, and the amounts of and 
reasons for the financial penalties imposed.” 

–  Amendment 67 on the review of the operation of the Regulation and, in particular, of the 
system  of  rewards  and  incentives.  Rewording  is  necessary  to  ensure  that  a  public  health 
assessment is conducted alongside the economic assessment, in order to be able to judge 
the overall benefits against costs of the Regulation, and to extend the assessment not only 
to  the  reward  measures  of  Articles  36  and  37  but  equally  to  the  incentive  measures  of 
Article 38. 

It is considered appropriate to provide for the possibility of a further report on the application 
of the rewards and incentives, including the public health assessment of the application of the 
Regulation,  if  insufficient  data  are  available  after  six  years,  considering  that  Article  56 
provides for a staggered application of the requirements of Articles 8 and 9 and the fact that 
the extension of the SPC or the market exclusivity for orphan medicines will occur at the end 
of the period of protection. 

“Article 49(2):  

2.  Within  six  years  of  entry  into  force  of  this  Regulation,  the  Commission  shall  publish  a 
general  report  on  experience  acquired  as  a  result  of  its  application,  including  a  detailed 
inventory of all medicinal products authorised for paediatric use since its entry into force. 

The  report  shall  also  contain  an  analysis  of  the  application  of  Articles  36-38.  This  shall 
include an assessment of the economic impact of the rewards and incentives, together with 
an analysis of the estimated consequences for public health that have accrued as a result of 
the application of the Regulation, with a view to proposing any necessary amendments. 

If  insufficient  data  are  available  within  six  years  of  entry  into  force  of  the  Regulation  to 
analyse the application of Articles 36-38, taking into consideration particularly the number 
of medicinal products having obtained a reward or incentive as well as the date of expiry of 
such rewards or incentives, the Commission shall publish this analysis, as described in the 
previous  subparagraph,  in  a  further  report  within  ten  years  of  entry  into  force  of  the 
Regulation.” 

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–  Amendment 69 on the eligibility of paediatric studies initiated prior to entry into force to 
be  included  in  a  paediatric  investigation  plan  is  redundant  since  the  Commission  has 
accepted amendment 62 which deals with the same situation. 

3.3. 

Amendments not accepted by the Commission : 3, 6 (2nd part), 11, 12, 13, 14, 15 
(2nd  and  3rd  part),  16,  18  (2nd  part),  19  (no  to  moving  Articles),  19  (Article  2a, 
Article 2c and Article 2d) 23, 24, 25, 30, 32, 36, 37, 38, 40 (last part), 41, 43 (3rd 
part), 44 (2nd part), 46 (1st and 3rd parts), 47, 48, 49, 51, 52 (re patents), 53, 54, 
65, 68, 70, 71, 83. 

–  The  Commission  does  not  accept  amendments  3  and  16  aimed  at  moving  recital  (29)  to 
recital (4a), while maintaining the text of the recital unchanged. Recitals should follow the 
order of the Regulation and the Commission does not accept amendment 19 insofar as it 
entails  moving  the  survey,  inventory  and  network  (Articles  41,  42  and  43  of  the 
Commission proposal) to a new Chapter 1a. 

–  The  Commission  does  not  accept  amendment  6  (second  part)  tasking  the  Paediatric 
Committee with the ethical assessment of paediatric investigation plans. Although ethical 
aspects of clinical trials in children will need to be considered by the Paediatric Committee 
when assessing and agreeing paediatric investigation plans, its primary responsibility will 
be scientific. Ethics in clinical trials are subject to the provisions of Directive 2001/20/EC, 
and not this Regulation, and of ethics committees, rather than the Paediatric Committee. 

–  The Commission does not accept amendments 11 and 46 aimed at introducing flexibility to 
the  deadline  for  placing  on  the  market  existing  medicinal  products  newly  authorised  for 
children. A provision encouraging marketing authorisation holders to place the product on 
the market “as much as possible” within one year does not create any legal obligation (the 
legal  obligation  is  to  market  within  two  years).  As  regards  the  amendment  allowing  the 
competent authorities to grant derogations to the deadlines when they have administrative 
delays,  Community  pharmaceutical  legislation  contains  clear  deadlines  for  competent 
authorities  to  grant  marketing  authorisations  for  medicinal  products.  Community 
legislation  also  foresees  deadlines  for  national  decisions  concerning  the  pricing  and 
reimbursement of medicinal products.  

–  The  Commission  does  not  accept  amendment  12  stating  in  a  recital  that  a  European 
paediatric form should be set up for the collection of data on medicinal products authorised 
in the Member States. There is no corresponding provision to reflect the amendment to this 
recital, in the Commission proposal or in the amendments proposed. 

–  The Commission does not accept amendment 13 providing in a recital that, where there is 
cause for concern and a risk management system is set after marketing authorisation, this 
system  should  operate  under  the  responsibility  of  the  Paediatric  Committee.  There  is  no 
corresponding  provision  in  the  Commission  proposal  or  in  the  amendments  proposed  to 
reflect the amendment to this recital. Moreover, the marketing authorisation and the post-
authorisation  obligations  to  be  fulfilled  by  the  marketing  authorisation  holder  are 
monitored  by  the  competent  authorities  granting  the  marketing  authorisation,  and  not  by 
the Paediatric Committee. 

–  The  Commission  does  not  accept  amendments  14  and  51  which  aim  to  remove  the 
requirement for a medicinal product to be authorised in all Member States as a prerequisite 
for  the  extension  of  the  supplementary  protection  certificate.  The  paediatric  regulation 

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aims  to  ensure  that  children  throughout  the  EU  are  provided  with  safe  and  effective 
medicines,  and  this  is  achieved  through  the  requirement  that  an  extension  of  the 
supplementary  protection  certificate  is  available  only  if  the  product  is  authorised  in  all 
Member  States.  Experience  has  shown  that  market  forces  alone  do  not  ensure  the 
availability of medicines for children. Medicinal products are frequently not authorised in 
Member States where there is no patent or where the population is small.  

Amendment 51 proposes that the supplementary protection certificate be granted in Member 
States were marketing authorisation procedures are still in progress. However, Article 36, in 
relation to Article 29, provides that the extension of the supplementary protection certificate is 
only  granted  if  information  on  the  paediatric  studies  conducted  is  included  in  the  product 
information  when  an  authorisation  is  granted.  For  this  reason,  marketing  authorisation 
procedures should be completed for the extension of the supplementary protection certificate 
to be granted. 

Furthermore,  in  the  operation  of  the  mutual  recognition  and  decentralised  procedures  of 
Directive  2001/83/EC  as  amended  by  Directive  2004/27/EC,  Member  States  have  only  30 
days  from  the  assessment  by  the  reference  Member  State  to  grant  marketing  authorisations. 
Differences  in  the  operation  of  national  competent  authorities  should  therefore  not  lead  to 
significant variation in the authorisation date in the different Member States. 

–  The  Commission  does  not  accept  amendment  15  (second  and  third  parts)  concerning 
national  clinical  trials  databases  and  the  avoidance  of  the  repetition  of  studies  already 
performed  in  third  countries.  The  need  to  avoid  duplication  of  studies  is  adequately 
addressed in recital 8 of the Regulation. In addition, there is no corresponding provision to 
reflect  the  amendment  to  this  recital,  in  the  Commission  proposal  or  in  the  amendments 
proposed.  

–  The  Commission  does  not  accept  amendment  18  (second  part)  introducing  amongst  the 
objectives  of  the  Regulation  a  specific  mention  of  medicinal  products  intended  for  the 
treatment of rare congenital conditions suffered by children. The Regulation applies to all 
paediatric  populations  and  to  all  diseases  suffered  by  children  (including  rare  congenital 
diseases)  and  it  is  not  appropriate  to  single  out  in  Article  1  any  specific  disease  or 
condition.  In  any  case,  any  specific  therapeutic  needs  of  children  suffering  from  rare 
congenital conditions will be addressed through the inventory of therapeutic needs (Article 
42 of the Commission proposal). 

–  The  Commission  does  not  accept  amendment  19  insofar  as  it  entails  moving  the  survey, 
inventory  and  network  (Articles  41,  42  and  43  of  the  Commission  proposal)  to  a  new 
Chapter  1a.  The  various  provisions  of  Title  VI  (communication  and  co-ordination 
provisions),  where  the  mentioned  provisions  are  included  in  the  Commission  proposal, 
should be maintained to ensure the overall architecture of the Regulation.  

–  The Commission does not accept amendment 19 as regards the content of the new Article 
2a tasking the Member States with collecting available data on existing uses of medicinal 
products  and  drawing  up  of  an  inventory  of  therapeutic  needs  within  a  year.  The 
Commission proposal provides for a survey conducted by the Member States of available 
existing data on the use of medicines in the paediatric population (Article 41). These data 
are  provided  to  the  Agency  and  they  form  the  basis  of  the  European  inventory  of 
therapeutic  needs  of  children  (Article  42).  It  is  more  appropriate  to  have  one  European 
inventory  than  25  individual  Member  State  inventories.  Besides,  a  one  year  dead-line  is 

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impractical:  the  collection  of  such  data  is  time  consuming  and,  in  addition,  before  the 
collection starts the Paediatric Committee is to be established (within six months of entry 
into force, according to amendment 20 which the Commission accepts in principle) and has 
to provide guidance on the form, content and format of the data to be submitted. 

–  The Commission does not accept amendment 19 as regards the content of the new Article 
2c  concerning  the  implementing  strategy  of  the  European  network.  This  text  on  the 
network  is  the  same  as  Article  43(3)  of  the  Commission  proposal.  However,  the 
amendment,  by  omitting  paragraphs  1  and  2  of  the  same  Article  which  provide  for  the 
creation of the network, would lead to a text which does not make sense. Therefore, Article 
43 should be maintained as in the original Commission proposal. 

–  The Commission does not accept amendment 19 as regards the content of the new Article 
2d  tasking  the  Commission  and  the  Member  States  with  the  establishment  of  a  research 
programme  into  the  paediatric  use  of  medicinal  products  which  are  not  protected  by  a 
patent  of  supplementary  protection  certificate.  Amendments  9,  56  and  63,  which  the 
Commission  accepts  in  principle,  would  lead  to  Community  funding  for  off-patents 
medicines for children. It would not be appropriate to have a separate provision tasking the 
Member States with a duplicate responsibility. 

–  The Commission does not accept amendment 23 limiting the number of representatives of 
the Commission and of the Executive Director of the Agency which may attend Paediatric 
Committee meetings. In certain circumstances, the Commission or the Executive Director 
of the Agency may need to be represented by more persons, taking into consideration the 
items for discussion at each meeting. It should be stressed that such representatives will be 
observers and not members of the Committee. 

–  The Commission does not accept amendment 24 which provides that all direct interests of 
members  of  the  Paediatric  Committee  relating  to  the  pharmaceutical  industry  shall  be 
entered in a publicly accessible register. The amendment is unnecessary; according to the 
first  subparagraph  of  Article  6,  individuals  with  such  direct  interests  are  excluded  from 
serving on the Committee. 

–  The  Commission  does  not  accept  amendment  25  aiming  at  specifying,  in  the  provision 
listing  the  tasks  of  the  Paediatric  Committee,  that  scientific  assistance  will  be  free  of 
charge. The free nature of scientific advice under the Regulation is already provided for in 
Article  27.  In  addition,  Article  46(3)  specifies  that  assessments  by  the  Committee  will 
equally  be  free  of  charge.  It  would  be  inconsistent  to  refer  in  Article  7(1)  to  scientific 
advice being free of charge and not of scientific assessments. 

–  The Commission does not accept amendment 30 concerning the inclusion, in the marketing 
authorisation  application  for  a  new  product,  of  details  of  on-going  paediatric  studies  and 
the  time-frame  for  their  completion,  to  address  the  situation  where  it  will  not  be 
appropriate to conduct studies in children in parallel with studies in adults. The amendment 
is redundant. The possibility of a “deferral” is specifically included in the proposal to deal 
with  this  situation  and  is  referred  to  explicitly  in  Article  8(1)(d)  which  deals  with  the 
marketing  authorisation  application  requirements  for  new  products.  Thus,  the  marketing 
authorisation  application  must  contain,  alternatively,  the  study  results  (indent  (a))  or  the 
proof  that  the  Agency  has  granted  a  deferral  or  a  waiver  (indents  (b),  (c)  and  (d)).  If  a 
deferral  has  been  granted,  the  deferral  decision  will  contain  the  time  table  to  complete 
studies  (Article  22).  Therefore,  this  amendment  requiring  a  timetable  for  completion  of 

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studies  as  well  as  the  Agency’s  decision  in  that  regard  is  already  contained  in  Article 
8(1)(d). 

–  The  Commission  does  not  accept  amendment  32  which  provides  that  Article  9(1)  of  the 
Regulation  should  also  apply  to  medicinal  products  falling  within  the  scope  of  Article 
3(2)(b) of Regulation (EC) No 726/2004 (optional scope of the centralised procedure). The 
amendment is unnecessary, since Article 9(1) applies to all applications for authorisation 
of  new  indications,  including  paediatric  indications,  new  pharmaceutical  forms  and  new 
routes  of  administration  of  authorised  medicinal  products  protected  by  a  patent  or  a 
supplementary protection certificate, regardless of the route of authorisation chosen (i.e. it 
also  applies  to  products  falling  under  the  optional  scope  of  the  centralised  procedure). 
Besides,  Article  29(1)  of  the  Commission  proposal  opens  the  centralised  procedure  to 
marketing  authorisation  applications  which  include  one  or  more  paediatric  indications 
selected  on  the  basis  of  studies  conducted  in  compliance  with  an  agreed  paediatric 
investigation  plan.  In  addition,  Article  30  of  the  Commission  proposal  provides  that 
applications  referred  to  in  Article  9  relating  to  products  authorised  through  the  mutual 
recognition  procedure  may  obtain  an  opinion  from  the  Committee  on  Human  Medicinal 
Products  of  the  Agency.  This  in  turn  will  lead  to  a  Commission  Decision  which  will  be 
binding on Member States. 

–  The  Commission  does  not  accept  amendments  36,  37  and  38  providing  that  applications 
for  agreement  of  paediatric  investigation  plans  shall  include  a  summary  report;  reducing 
the  deadline  for  validation  of  such  applications  by  the  Agency  from  30  to  10  days;  and 
removing  the  deadline  for  industry  to  submit  and  discuss  its  plans  for  paediatric  studies 
with the Paediatric Committee. 

To have a summary report prepared by the Agency, rather than the applicant, is of significant 
value to the later assessment by the Paediatric Committee. This is consistent with the working 
of the Committee on Orphan Medicinal Products. In turn, for a summary report to be prepared 
by the Agency, ten days is insufficient. 

As regards the  deadline for  submission of paediatric investigation plans, the  introduction of 
the  paediatric  investigation  plan  in  the  legal  framework  concerning  medicinal  products  for 
human use aims at ensuring that development of medicines for children becomes an integral 
part  of  the  development  of  medicinal  products,  integrated  into  the  development  programme 
for adults. It is appropriate to set a deadline for the submission of a paediatric investigation 
plan in order to ensure early dialogue between the sponsor and the Paediatric Committee on 
whether studies are required and if so, the type of studies and their timing compared to studies 
in adults. In fact, the dead-line provided for in Article 17(1) is a dead-line to submit a draft 
plan, and not a dead-line for the initiation of studies in children. Furthermore, the plan may 
contain a request for a deferral of the initiation or completion of studies, and an agreed plan 
can  be  subsequently  modified.  The  amendment,  by  deleting  the  deadline,  could  lead  to  a 
situation  where  products  would  almost  never  be  investigated  in  children  early  during  the 
product’s  development  and  this  would  deny  children  innovation  and  be  to  the  detriment  of 
public health. 

To clarify that the intention of the deadline is to allow for early dialogue, the following should 
be added at the end of recital 7: 

“Recital 7: 

[…] It is appropriate to set a deadline for the submission of a paediatric investigation plan 
in order to ensure early dialogue between the sponsor and the Paediatric Committee. As the 

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development  of  medicinal  products  is  a  dynamic  process  dependent  on  the  result  of  on-
going studies, provision should be made for modifying an agreed plan where necessary.” 

–  The Commission does not accept amendment 40 (last part) aimed at establishing that the 
Paediatric  Committee  propose  a  deadline  for  the  submission  of  an  amended  paediatric 
investigation  plan.  The  provision,  as  contained  in  the  Commission  proposal,  allows  the 
company  to  request  modifications  to  an  agreed  plan.  This  request  is  the  modified  plan, 
hence it is unnecessary for the opinion on the modified plan to contain a dead-line for the 
submission of yet another modified plan. 

–  The  Commission  does  not  accept  amendment  41  aimed  at  defining  the  detailed  rules 
governing  the  interaction  between  the  applicant,  the  rapporteur  and  the  Paediatric 
Committee.  In  keeping  with  the  practice  of  other  existing  committees  at  the  Agency, 
details on the interaction between the rapporteurs and the applicants should be detailed in 
the rules of procedure of the Committee, to be adopted following the procedure defined in 
Article 5(2). 

–  The  Commission  does  not  accept  amendment  43  (third  part)  aimed  at  dictating  that 
paediatric  information  contained  in  product  information  (the  summary  of  product 
characteristics  and  patient  information  leaflet)  should  always  clearly  state  the  paediatric 
indications approved and those that are not. The way information on indications that have 
been  approved  and  those  that  have  not,  as  well  as  information  on  contra-indications,  is 
presented  in  product  information  is  the  subject  of  detailed  scientific  guidelines  at 
Community  level.  The  spirit  of  this  amendment  is  clearly  reflected  in  these  guidelines, 
which are regularly updated to reflect advances in science. It is considered that to introduce 
this  amendment  would  prevent  the  provision  of  information  to  patients  and  healthcare 
professionals from evolving to reflect best practice.  

–  The  Commission  does  not  accept  amendment  44  (second  part)  aimed  at  creating  a 
European  competition  to  design  a  logo  to  be  used  to  label  medicines  for  children.  The 
choice  of  the  logo  and  guidance  on  how  it  will  be  applied  will  require  the  expertise  of 
specialists  in  paediatric  medicines  and  the  labelling  of  medicines.  Furthermore,  it  is 
considered appropriate to have the logo chosen as soon as possible after entry into force of 
the regulation, and a competition to choose the logo would be likely to delay this adoption 
and would exclude input from relevant specialists. 

It is necessary to include a new subparagraph to provide for how the logo will be selected: 

“Article 33, second subparagraph: 

The logo shall be selected by the Paediatric Committee within one year of entry into force 
of the regulation.” 

–  The Commission does not accept amendments 47, 48, 49 and 83 which aim to duplicate or 
amend  some  of 
the  Community 
the  pharmacovigilance  provisions  contained 
pharmaceutical  legislation.  It  should  be  noted  that  the  general  provisions  of  the 
Community pharmaceutical legislation, which apply to all medicinal products authorised to 
be placed on the market of the Community, have recently been revised with the adoption of 
Regulation  (EC)  No  726/2004  and  Directives  2004/27/EC  and  2004/28/EC.  New 
funding  of 
provisions 
pharmacovigilance  and  the  public  accessibility  of  adverse  reaction  data  are  amongst  the 

risk  management  systems,  communication, 

relating 

to 

in 

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numerous new pharmacovigilance provisions in the revised pharmaceutical legislation. To 
duplicate  some  of  the  measures  in  this  Regulation  and  to  slightly  amend  some  of  these 
would create legal uncertainty. 

Specifically regarding amendment 47, the Commission proposal already grants the competent 
authority  with  the  power,  whenever  it  has  cause  for  concern,  to  require  a  risk  management 
system  to  be  put  in  place.  To  make  the  requirement  for  a  risk  management  system 
compulsory,  even  when  there  is  no  particular  cause  for  concern,  adds  unnecessary 
administrative burden and will interfere with clinical care thereby acting as a barrier to access 
to medicines. 

Specifically  regarding  amendment  48,  the  Commission  agrees  to  the  objective  of  the 
amendment.  However,  provisions  concerning  information  on  pharmacovigilance  matters  to 
the  public  already  exist  and  apply  to  all  medicinal  products  authorised  in  the  Community 
(Article 24(5) of Regulation (EC) No 726/2004 and Article 104(9) of Directive 2001/83/EC). 
The  repetition  of  similar  provisions  in  this  Regulation  is  unnecessary  and  could  lead  to 
difficulties of interpretation. 

Specifically  regarding  amendment  49,  the  Commission  agrees  to  the  objective  of  the 
amendment.  However,  provisions  concerning  public  funding  of  pharmacovigilance  already 
exist  and  apply  to  all  medicinal  products  authorised  in  the  Community  (Article  67(4)  of 
Regulation (EC) No 726/2004 and Article 102a of Directive 2001/83/EC). The repetition of 
similar  provisions  in  this  Regulation  is  unnecessary  and  could  lead  to  difficulties  of 
interpretation. 

Specifically  regarding  amendment  83,  the  Commission  agrees  to  the  objective  of  the 
amendment. However, provisions concerning the public accessibility of adverse reaction data 
already exist and apply to all medicinal products authorised in the Community (for example, 
Article 26, subparagraph 3 of Regulation (EC) No 726/2004 and Article 102, subparagraph 2 
of  Directive  2001/83/EC).  The  repetition  of  similar  provisions  in  this  Regulation  is 
unnecessary and could lead to difficulties of interpretation. 

–  The  Commission  does  not  accept  amendment  52  (first  part  relating  to  patents)  which 
excludes an extension of the supplementary protection certificate for products whose active 
substance has already benefited from a patent covering the paediatric use or formulation. 

This amendment would run counter to the objective, central to this Regulation, of stimulating 
research  into  medicines  for  children.  New  paediatric  research  into  substances  which  may 
already have paediatric indications covered by a patent or supplementary protection certificate 
(for instance, to extend the use of the product to other paediatric subpopulations or to better 
adapt  it  to  the  specific  needs  of  children)  would  be  discouraged.  Moreover,  it  would 
discourage paediatric research by third parties (different holders of patents or supplementary 
protection  certificates).  This  would  also  be  difficult  to  reconcile  with  the  purpose  of  the 
regulation  governing  the  supplementary  protection  certificate  (Regulation  (EEC)  No 
1768/92),  which  aims  at  giving  sufficient  protection  to  all  research,  including  new 
applications of an existing product. 

However, and  in line with the purpose of this amendment, it is appropriate to clarify in the 
Regulation that the rewards associated with a completed agreed Paediatric Investigation Plan 
should only be triggered by research completed after entry into force of the Regulation. In this 
way,  it  will  be  ensured  that  any  extension  of  the  supplementary  protection  certificate  or  of 

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market  exclusivity  under  Articles  36  and  37  of  this  Regulation  is  based  on  new  paediatric 
research. Articles 29(3) and Article 44(3) should be reworded as follows: 

“Article 29(3): 

If  the  application  complies  with  all  the  measures  contained  in  the  agreed  completed 
paediatric investigation plan and if the summary of product characteristics reflects the results 
of  studies  conducted  in  compliance  with  that  agreed  paediatric  investigation  plan,  the 
competent  authority  shall  include  within  the marketing  authorisation  a  statement  indicating 
compliance  of  the  application  with  the  agreed  completed  paediatric  investigation  plan.  For 
the  purpose  of  the  application  of  Article  44(3),  this  statement  shall  also  indicate  whether 
significant  studies  contained  in  the  agreed  Paediatric  Investigation  Plan  have  been 
completed after the entry into force of this regulation” 

Article 44(3): 

Without prejudice to the previous paragraph, the rewards of Articles 36 and 37 shall only 
be granted provided that significant studies contained in an agreed Paediatric Investigation 
Plan are completed after the entry into force of this regulation.” 

–  The Commission does not accept amendment 53 which aims to exclude the possibility of 
more than one extension of the supplementary protection certificate per medicinal product. 
The  amendment  is  redundant,  since  the  provision  is  already  provided  for  in  Article  52, 
indent (5), which amends Article 13 of Regulation (EEC) No 1768/92 (the supplementary 
protection certificate regulation). 

–  The  Commission  does  not  accept  amendment  54  which  aims  to  offer  the  applicant  an 
additional  possibility  which  would  simplify  the  marketing  authorisation  procedure  for 
orphan drugs. The procedures for authorisation of orphan medicinal products are identical 
to those for all other medicinal products, and they are not the subject of this Regulation. 
Furthermore,  there  are  already  provisions  in  the  existing  Community  pharmaceutical 
legislation  to  allow,  where  appropriate,  the  early  authorisation  of  orphan  medicinal 
products,  such  as  the  provisions  on  accelerated  assessment  or  conditional  marketing 
authorisation of Regulation (EC) No 726/2004 (Article 14). 

–  The Commission does not accept amendment 65 which aims to promote the harmonisation 
of  national  measures  enacting  penalties,  but  does  not  provide  any  means  to  ensure  such 
harmonisation.  Harmonisation  of  national  measures  would  demand  the  adoption  of 
Community legislation in the field. 

–  The  Commission  does  not  accept  amendment  68  which  aims  to  reduce  the  deadline  for 
submission of an application for an extension of the supplementary protection certificate. It 
takes  approximately  two-years  to  conduct  the  necessary  studies  and  obtain  a  marketing 
authorisation  for  a  generic  medicinal  product.  If  the  deadline  of  two-years  is  not 
maintained,  then  there  is  a  risk  that  generic  manufacturers  will  start  to  invest  in  a  new 
generic  product  and  that  subsequently  the  access  to  the  market  will  be  prevented  by  an 
extension of the supplementary protection certificate.  

–  The  Commission  does  not  accept  amendment  70  which  aims  to  introduce  transitional 
measures  relating  to  paediatric  investigation  plans.  Applications  submitted  prior  to  the 
entry  into  force  of  the  regulation  cannot  include  findings  from  studies  with  agreed 

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investigation  plans  since  there  will  be  no  legal  basis  in  the  pharmaceutical  legislation  or 
competent committee within the Agency to agree paediatric investigation plans in advance 
of  the  entry  into  force  of  the  Regulation.  However,  this  does  not  mean  that  research  in 
advance  of  the  entry  into  force  is  discouraged.  In  accordance  with  Article  44(2)  (see 
amendment  62),  existing  and  on-going  studies  at  the  time  of  entry  into  force  of  the 
regulation  shall  be  taken  into  consideration  by  the  Paediatric  Committee  once  the 
regulation comes into operation. 

–  The  Commission  does  not  accept  amendment  71  which  reduces  the  number  of  months 
from  entry  into  force  of  the  Regulation  from  which  the  requirements  of  Articles  8  and  9 
shall  apply.  The  shortened  deadlines  are  considered  unworkable.  Articles  8  and  9  place 
requirements  on  applicants  for  marketing  authorisations  to  present  either  the  results  of 
studies in children, or proof of having obtained a waiver or a deferral. After the entry into 
force of the regulation, the Paediatric Committee will need to be set up (within 6 months, 
see amendment 20). It is judged that 12 months will be required of having the Paediatric 
Committee operational to ensure that companies are able to agree paediatric investigation 
plans, deferrals or waivers, so that the requirement can function. 

4. 

CONCLUSION 

In  keeping  with  Article  250,  paragraph  2,  of  the  EC  treaty,  the  Commission  modifies  its 
proposal along the lines indicated above. 

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