Division 2.2.4 Safety of blood, tissues and cells, organs (Article 3.2.a., Annex — points 2.6., 2.7.)

United Kingdom

Activities related to substances of human origin aim to promote quality, safety and sufficiency not only to prevent the transmission of diseases but also to give backing to (sanction) their therapeutic use for the benefit of patients.

Significant progress has been made with the entry into force of the legislation on blood^f1 ^f2. There is now a need to give an impetus to ensuring equivalent recognition of inspections of blood establishments among Member States through the development and implementation of commonly accepted criteria and standards;
Previous efforts to support the optimal use of blood have met with limited success. In order to ensure better therapeutic use of substances of human origin, support needs to be given to the development of tools that promote evidence-based best practice;
In spite of the adoption of the Directive related to tissues and cells^f3, specifications related to their designation and therapeutic use in the EU lack commonality. In order to facilitate the exchange of substances of human origin and to monitor the health of living donors, actions are needed to improve measures and procedures, such as common terminologies and development of registers ^f4.
There is a need to encourage donation and the optimal use of blood products. Actions should be directed towards the sharing of best practice and information on recruitment of donors and on training in the use of blood components.

Annotations

Footnotes

f1

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

f2

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) (OJ L 91, 30.3.2004, p. 25).

f3

Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).

f4

Refer also to FP6 Scientific Support to Policies, 5th Call, SSP-5A Areas 2.1 & 2.2.

See: http://fp6.cordis.lu/index.cfm?fuseaction=UserSite.FP6ActivityCallsPage&ID_ACTIVITY=500

Notes on Division 2

Footnotes

f1: Decision No 1513/2002/EC of the European Parliament and of the Council of 27 June 2002 (OJ L 232, 29.8.2002, p. 1).
f3: Council Decision 2002/834/EC of 30 September 2002 adopting a specific programme for research, technological development and demonstration ‘Integrating and Strengthening the European Research Area’ (2002-2006) (OJ L 294, 29.10.2002, p. 1).
f4: The CORDIS web site links to the FP6 Priority 1 is http://www.cordis.lu/lifescihealth/ssp.htm

Notes on Division 2.2

Footnotes

f1

Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (OJ L 268, 3.10.1998, p. 1).

2000/57/EC: Commission Decision of 22 December 1999 on the early warning and response system for the prevention and control of communicable diseases under Decision No 2119/98/EC of the European Parliament and of the Council (notified under document number C(1999) 4016) (OJ L 21, 26.1.2000, p. 32).

2000/96/EC: Commission Decision of 22 December 1999 on the communicable diseases to be progressively covered by the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (notified under document number C(1999) 4015) (OJ L 28, 3.2.2000, p. 50).

2002/253/EC: Commission Decision of 19 March 2002 laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (notified under document number C(2002) 1043) (OJ L 86, 3.4.2002, p. 44).

f2

Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1).

f3

See http://europa.eu.int/comm/health/ph_threats/Bioterrorisme/bioterrorism01_en.pdf