Commission Directive 2004/33/EC

of 22 March 2004

implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC(1), and in particular points (b) to (g) of the second paragraph of Article 29 thereof,

Whereas:

(1) Directive 2002/98/EC lays down standards of quality and safety for the collection and testing of human blood and blood components, whatever their intended purpose, and for their processing, storage and distribution when intended for transfusion so as to ensure a high level of human health protection.

(2) In order to prevent the transmission of diseases by blood and blood components and to ensure an equivalent level of quality and safety, Directive 2002/98/EC calls for the establishment of specific technical requirements.

(3) This Directive lays down those technical requirements, which take account of Council Recommendation 98/463/EC of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community(2), certain recommendations of the Council of Europe, the opinion of the Scientific Committee for Medicinal Products and Medical Devices, the monographs of the European Pharmacopoeia, particularly in respect of blood or blood components as a starting material for the manufacture of proprietary medicinal products and recommendations of the World Health Organisation (WHO), as well as international experience in this field.

(4) Blood and blood components imported from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood and human plasma, should meet the quality and safety requirements set out in this Directive.

(5) With regard to blood and blood components collected for the sole purpose of, and exclusive use in, autologous transfusion (autologous donation), specific technical requirements should be laid down, as required by Article 2(2) of Directive 2002/98/EC. Such donations should be clearly identified and kept separate from other donations to ensure that they are not used for transfusion to other patients.

(6) It is necessary to determine common definitions for technical terminology in order to ensure the consistent implementation of Directive 2002/98/EC.

(7) The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Directive 2002/98/EC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Definitions

For the purposes of this Directive, the definitions set out in Annex I shall apply.

Article 2

Provision of information to prospective donors

Member States shall ensure that blood establishments provide prospective donors of blood or blood components with the information set out in Part A of Annex II.

Article 3

Information required from donors

Member States shall ensure that upon agreement of willingness to commence the donation of blood or blood components, donors provide the information set out in Part B of Annex II to the blood establishment.

Article 4

Eligibility of donors

Blood establishments shall ensure that donors of whole blood and blood components comply with the eligibility criteria set out in Annex III.

Article 5

Storage, transport and distribution conditions for blood and blood components

Blood establishments shall ensure that the storage, transport and distribution conditions for blood and blood components comply with the requirements set out in Annex IV.

Article 6

Quality and safety requirements for blood and blood components

Blood establishments shall ensure that the quality and safety requirements for blood and blood components comply with the requirements set out in Annex V.

Article 7

Autologous donations

1. Blood establishments shall ensure that autologous donations comply with the requirements set out in Directive 2002/98/EC and the specific requirements set out in this Directive.

2. Autologous donations shall be clearly identified as such and shall be kept separate from allogeneic donations.

Article 8

Validation

Member States shall ensure that all testing and processes referred to in Annexes II to V are validated.

Article 9

Transposition

1. Without prejudice to Article 7 of Directive 2002/98/EC, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 8 February 2005 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 10

Entry into force

This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Article 11

Addressees

This Directive is addressed to the Member States.

Done at Brussels, 22 March 2004.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 33, 8.2.2003, p. 30.

(2) OJ L 203, 21.7.1998, p. 14.

ANNEX I

DEFINITIONS

(as referred to in Article 1)

1. "Autologous donation" means blood and blood components collected from an individual and intended solely for subsequent autologous transfusion or other human application to that same individual.

2. "Allogeneic donation" means blood and blood components collected from an individual and intended for transfusion to another individual, for use in medical devices or as starting material/raw material for manufacturing into medicinal products.

3. "Validation" means the establishment of documented and objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

4. "Whole blood" means a single blood donation.

5. "Cryopreservation" means prolongation of the storage life of blood components by freezing.

6. "Plasma" means the liquid portion of the blood in which the cells are suspended. Plasma may be separated from the cellular portion of a whole blood collection for therapeutic use as fresh-frozen plasma or further processed to cryoprecipitate and cryoprecipitate-depleted plasma for transfusion. It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets. It may also be used for re-suspension of red cell preparations for exchange transfusion or perinatal transfusion.

7. "Cryoprecipitate" means a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the plasma.

8. "Washed" means a process of removing plasma or storage medium from cellular products by centrifugation, decanting of the supernatant liquid from the cells and addition of an isotonic suspension fluid, which in turn is generally removed and replaced following further centrifugation of the suspension. The centrifugation, decanting, replacing process may be repeated several times.

9. "Red cells" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed.

10. "Red cells, buffy coat removed" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed.

11. "Red cells, leucocyte-depleted" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed.

12. "Red cells in additive solution" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. A nutrient/preservative solution is added.

13. "Additive solution" means a solution specifically formulated to maintain beneficial properties of cellular components during storage.

14. "Red cells, buffy coat removed, in additive solution" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed. A nutrient/preservative solution is added.

15. "Buffy coat" means a blood component prepared by centrifugation of a unit of whole blood, and which contains a considerable proportion of the leucocytes and platelets.

16. "Red cells, leucocyte-depleted, in additive solution" means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed. A nutrient/preservative solution is added.

17. "Red cells, apheresis" means the red cells from an apheresis red cell donation.

18. "Apheresis" means a method of obtaining one or more blood components by machine processing of whole blood in which the residual components of the blood are returned to the donor during or at the end of the process.

19. "Platelets, apheresis" means a concentrated suspension of blood platelets obtained by apheresis.

20. "Platelets, apheresis, leucocyte-depleted" means a concentrated suspension of blood platelets, obtained by apheresis, and from which leucocytes are removed.

21. "Platelets, recovered, pooled" means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation.

22. "Platelets, recovered, pooled, leucocyte-depleted" means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation, and from which leucocytes are removed.

23. "Platelets, recovered, single unit" means a concentrated suspension of blood platelets, obtained by processing of a single unit of whole blood.

24. "Platelets, recovered, single unit, leucocyte-depleted" means a concentrated suspension of blood platelets, obtained by processing of a single whole blood unit from which leucocytes are removed.

25. "Plasma, fresh-frozen" means the supernatant plasma separated from a whole blood donation or plasma collected by apheresis, frozen and stored.

26. "Plasma, cryoprecipitate-depleted for transfusion" means a plasma component prepared from a unit of plasma, fresh-frozen. It comprises the residual portion after the cryoprecipitate has been removed.

27. "Granulocytes, apheresis" means a concentrated suspension of granulocytes obtained by apheresis.

28. "Statistical process control" means a method of quality control of a product or a process that relies on a system of analysis of an adequate sample size without the need to measure every product of the process.

ANNEX II

INFORMATION REQUIREMENTS

(as referred to in Articles 2 and 3)

PART A

Information to be provided to prospective donors of blood or blood components

1. Accurate educational materials, which are understandable for members of the general public, about the essential nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations, and the important benefits to patients.

2. For both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history, and the testing of donations and the significance of "informed consent".

For allogeneic donations, self-deferral, and temporary and permanent deferral, and the reasons why individuals are not to donate blood or blood components if there could be a risk for the recipient.

For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take place in the presence of a health risk to the individual whether as donor or recipient of the autologous blood or blood components.

3. Information on the protection of personal data: no unauthorised disclosure of the identity of the donor, of information concerning the donor's health, and of the results of the tests performed.

4. The reasons why individuals are not to make donations which may be detrimental to their health.

5. Specific information on the nature of the procedures involved either in the allogeneic or autologous donation process and their respective associated risks. For autologous donations, the possibility that the autologous blood and blood components may not suffice for the intended transfusion requirements.

6. Information on the option for donors to change their mind about donating prior to proceeding further, or the possibility of withdrawing or self-deferring at any time during the donation process, without any undue embarrassment or discomfort.

7. The reasons why it is important that donors inform the blood establishment of any subsequent event that may render any prior donation unsuitable for transfusion.

8. Information on the responsibility of the blood establishment to inform the donor, through an appropriate mechanism, if test results show any abnormality of significance to the donor's health.

9. Information why unused autologous blood and blood components will be discarded and not transfused to other patients.

10. Information that test results detecting markers for viruses, such as HIV, HBV, HCV or other relevant blood transmissible microbiologic agents, will result in donor deferral and destruction of the collected unit.

11. Information on the opportunity for donors to ask questions at any time.

PART B

Information to be obtained from donors by blood establishments at every donation

1. Identification of the donor

Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.

2. Health and medical history of the donor

Health and medical history, provided on a questionnaire and through a personal interview performed by a qualified healthcare professional, that includes relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or health risks to themselves.

3. Signature of the donor

Signature of the donor, on the donor questionnaire, countersigned by the health care staff member responsible for obtaining the health history confirming that the donor has:

(a) read and understood the educational materials provided;

(b) had an opportunity to ask questions;

(c) been provided with satisfactory responses to any questions asked;

(d) given informed consent to proceed with the donation process;

(e) been informed, in the case of autologous donations, that the donated blood and blood components may not be sufficient for the intended transfusion requirements; and

(f) acknowledged that all the information provided by the donor is true to the best of his/her knowledge.

ANNEX III

ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

(as referred to in Article 4)

1. ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

Under exceptional circumstances, individual donations from donors who do not comply with the following criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases must be clearly documented and subject to the quality management provisions in Articles 11, 12, and 13 of Directive 2002/98/EC.

The following criteria do not apply to autologous donations.

1.1. Age and body weight of donors

>TABLE>

1.2. Haemoglobin levels in donor's blood

>TABLE>

1.3. Protein levels in donor's blood

>TABLE>

1.4. Platelet levels in donor's blood

>TABLE>

2. DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

The tests and deferral periods indicated by an asterisk (*) are not required when the donation is used exclusively for plasma for fractionation.

2.1. Permanent deferral criteria for donors of allogeneic donations

>TABLE>

2.2. Temporary deferral criteria for donors of allogeneic donations

2.2.1. Infections

Duration of deferral period

After an infectious illness, prospective donors shall be deferred for at least two weeks following the date of full clinical recovery.

However, the following deferral periods shall apply for the infections listed in the table:

>TABLE>

2.2.2. Exposure to risk of acquiring a transfusion-transmissible infection

>TABLE>

2.2.3. Vaccination

>TABLE>

2.2.4. Other temporary deferrals

>TABLE>

2.3. Deferral for particular epidemiological situations

>TABLE>

2.4. Deferral criteria for donors of autologous donations

>TABLE>

ANNEX IV

STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS

(as referred to in Article 5)

1. STORAGE

1.1. Liquid storage

>TABLE>

1.2. Cryopreservation

>TABLE>

2. TRANSPORT AND DISTRIBUTION

Transport and distribution of blood and blood components at all stages of the transfusion chain must be under conditions that maintain the integrity of the product.

3. ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS

3.1. Autologous blood and blood components must be clearly identified as such and stored, transported and distributed separately from allogeneic blood and blood components.

3.2. Autologous blood and blood components must be labelled as required by Directive 2002/98/EC and in addition the label must include the identification of the donor and the warning "FOR AUTOLOGOUS TRANSFUSION ONLY".

ANNEX V

QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

(as referred to in Article 6)

1. THE BLOOD COMPONENTS

>TABLE>

2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

2.1. Blood and blood components must comply with the following technical quality measurements and meet the acceptable results.

2.2. Appropriate bacteriological control of the collection and manufacturing process must be performed.

2.3. Member States must take all necessary measures to ensure that all imports of blood and blood components from third countries, including those used as starting material/raw material for the manufacture of medicinal products derived from human blood or human plasma, shall meet equivalent standards of quality and safety to the ones laid down in this Directive.

2.4. For autologous donations, the measures marked with an asterisk (*) are recommendations only.

>TABLE>