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 Directive of the European Parliament and of the Council on setting standards of quality and safety for the donation, procurement, testing, processing, storage, and distribution of human tissues and cells amending the proposal of the Commission pursuant to Article 250 (2) of the EC Treaty
Date: 2004-02-05
Institutions: European Commission
Subjects: health policy, organ transplantation, quality standard, safety standard

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.2.2004 
COM(2004) 80 final 

2002/0128 (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 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on setting standards of quality and safety 
for the donation, procurement, testing, processing, storage, and distribution of human 
tissues and cells 

AMENDING THE PROPOSAL OF THE COMMISSION 
pursuant to Article 250 (2) of the EC Treaty 

EN 

   EN 

 
 
 
  
 
 
2002/0128 (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 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on setting standards of quality and safety 
for the donation, procurement, testing, processing, storage, and distribution of human 
tissues and cells 

1. 

INTRODUCTION 

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is 
to  deliver  an  opinion  on  the  amendments  proposed  by  the  European  Parliament  at  second 
reading.  The  Commission  sets  out  its  opinion  below  on  the  amendments  proposed  by 
Parliament.  

2. 

BACKGROUND 

Date  of  transmission  of  the  proposal1  to  the  European  Parliament  and  the 
Council (2002/0128(COD)) 
Date of the opinion of the European Economic and Social Committee2 
Date of the opinion of the European Parliament3, first reading: 

Date of transmission of the amended proposal (10122/03 SAN 130 CODEC 
779). 
Date of adoption of the common position4: 

Adoption by Parliament of the Resolution, 
second reading : 

3. 

PURPOSE OF THE PROPOSAL 

20.06.2002

11.12.2002

10.04.2003

30.05.2003

22.07.2003

16.12.2003

The aims of this proposal are to establish European Community legislation setting standards 
for  the  quality  and  safety  of  tissues  and  cells  of  human  origin  used  for  application  in  the 
human  body,  in  particular  to  strengthen  suitability  and  screening  of  donors,  and  establish 
requirements for establishments and their accreditation. 

1 
2 
3 
4 

OJ C 227 E, 24.09.2002, p.505. 
OJ C 85, 08.04.2003, p.44. 
Not yet published in the OJ. 
OJ C 240 E, 7.10.2003, p. 12. 

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The  text  also  provides  a  mechanism  for  lay  down  provisions  for  a  register  of  accredited 
establishments, quality system, training, traceability and regulation of imports and exports.  

4. 

OPINION  OF  THE  COMMISSION  ON  THE  AMENDMENTS  BY  THE  EUROPEAN 
PARLIAMENT 

A compromise package concerning the proposed amendments of the European Parliament and 
which includes three draft declarations involving the Commission(in the attached annex), was 
submitted to the European Parliament for the Plenary session on 15 December 2003 with the 
endorsement of the Council. 

The  amendments  approved  by  the  Parliament  reflect  the  compromise  agreement  reached 
between  Parliament  and  Council,  the  compromise  is  acceptable  to  the  Commission.  These 
amendments  are  in  line  with  the  Common  position  of  the  Council,  accepted  by  the 
Commission5, and they respect all issues considered essential by the Commission to guarantee 
a high level of protection in the area of quality and safety of human tissues and cells. 

The following amendments were accepted: 4, 6, 12, 23, 25, 27, 37, 45, 57, 58, 59, 60, 61, 62, 
63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76 and 77. They concern: 

Amendment  4,  recital  on  promotion  of  worldwide  standards;  Amendment  6,  recital  for 
clarification  of  the  scope;  Amendment  12,  recital  for  clarification  on  accreditation  of 
establishments; Amendments 23, 27, 67 and 73, on traceability; Amendment 25 on labelling; 
Amendment  37,  75  and  76  clarification  on  comitology;  Amendment  45,  clarification  on  the 
roles  of  third  parties;  Amendment  57,  recital  on  promotion  of  donation,  Amendment  58 
clarification  on  specific  risks  of  cells,  Amendment  59,  recital  on  equal  access  and 
transparency; Amendment 60, recital on reconstruction of the donor’s body; Amendment 61 
and  69  on  voluntary  and  unpaid  donations;  Amendment  62,  recital  on  access  to  tissues  and 
cells  for  establishments;  Amendment  63,  mention  of  the  chapter  of  human  rights  and  the 
Convention;  Amendments  64  and  72  on  anonymity;  Amendment  65,  recital  on  comitology; 
Amendment  66,  guidelines  for  inspection  and  training;  Amendment  68  on  import; 
Amendment  70  on  non  profit  procurement;  Amendment  71,  editorial  clarification; 
Amendment 74 on provisions in case of termination of activities in the tissue establishments 
and Amendment 77, new annex on information to the donor. 

5. 

CONCLUSION 

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

5 

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 on the adoption of a 
Directive of the European Parliament and of the Council on setting standards of quality and safety for 
the  donation,  procurement,  testing,  processing,  storage,  and  distribution  of  human  tissues  and  cells 
/* SEC/2003/0906 final - COD 2002/0128. 

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ANNEX 

Declarations  of  the  commission  within  the  framework  of  the  second  reading  on  the 
proposal setting standards of quality and safety for the donation, procurement, testing, 
processing, storage, and distribution of human tissues and cells 

Declaration on Organ Transplantation 

"The  important  differences  between  organ  transplantation  and  the  use  of  other  human 
substances such as blood, tissues and cells mean that a specific approach for organs in order to 
ensure safety and quality is necessary. 

Such an approach in the current situation characterised by shortage of organs has to balance 
two  factors:  the  need  for  organs'  transplantation  which  is  usually  a  matter  of  life  and  death 
with the need to ensure high standards of quality and safety. 

The  Commission  believes  that  before  considering  any  proposal  it  is  necessary  to  conduct  a 
thorough  scientific  evaluation  of  the  situation  regarding  organ  transplantation.  The 
Commission will present a report on the conclusions of the analysis it undertakes as soon as 
possible." 

Declaration on the future development of the relevant technical criteria  

"In the absence of specific Community legislation on the processing, preservation, storage and 
distribution  of  tissues  and  cells  intended  for  industrially  manufactured  products  the  Council 
and  the  Commission  agree  that  the  concerns  raised  by  the  Parliament  in  respect  of  the 
requirements  to  be  determined  for  establishments  operating  in  this  field,  such  as  the 
requirement  to  operate  on  a  24-hour  basis,  will  be  addressed  in  the  development  of  the 
relevant technical requirements referred to in article 28 of the Directive". 

Declaration on the future development of the relevant technical criteria  

"The  Council  and  the  Commission  agree  that  the  concerns  raised  by  the  Parliament  at  first 
reading  as  regards  the  Annexes  originally  proposed  by  the  Commission  will  be  taken  into 
account in the development of the relevant technical requirements referred to in article 28 of 
the Directive " 

4