Annexes to COM(2011)352 - 2nd Report on Voluntary and Unpaid Donation of Tissues and Cells - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)352 - 2nd Report on Voluntary and Unpaid Donation of Tissues and Cells. |
|---|---|
| document | COM(2011)352  |
| date | June 17, 2011 |
Finally, in relation to supply, several countries report regular shortages of tissues and cells on a national level (see figure VII).
Figure VII
[pic]
As demonstrated in the figure above, almost half of the reporting countries experience regular shortages of bone marrow, and nine countries report regular shortages of sperm and oocytes. Other tissues and cells subject to shortages include corneas, bones, tendons and skin.
SUMMARY AND CONCLUDING REMARKS
This report shows that Member States overall comply with Article 12 of Directive 2004/23/EC, requiring Member States to take the necessary measures to endeavour to ensure voluntary and unpaid donations of tissues and cells.
Largely in line with the findings of the first report on voluntary and unpaid donation of tissues and cells (issued 2006), this report shows that legislative provisions and guidelines on voluntary and unpaid donation of tissues and cells are well established across the EU. 27 out of the 29 reporting countries have such legislative provisions or guidelines in place.
19 of the reporting countries have some form of compensation or incentive structures for donors of tissues and cells (excluding reproductive cells), such as reimbursement of travel and medical costs. For reproductive cells, about half of the countries provide some forms of compensation or incentives, including reimbursement of travel costs, refreshments and compensation linked to loss of earnings. In addition, four countries give some form of compensation or incentives to relatives of deceased donors.
19 countries have undertaken some form of measures to promote voluntary and unpaid donation of tissues and cells, such as awareness raising and information campaigns. In addition, 23 countries have restrictions or prohibitions on advertising the need for, or availability of, human tissues and cells with a view to offering or seeking financial gain or comparable advantage (in line with article 12 of Directive 2004/23/EC).
Concerning the procurement and supply of tissues and cells, this report shows that the majority of the countries have public collectors/suppliers or a dual system of public and private collectors/suppliers. With regards to supply, 11 countries report having policies in place to endeavour to promote self-sufficiency of tissues and cells, and 17 countries have bilateral or other forms of agreements/collaboration structures to ensure national supply of tissues and cells. However, almost half of the countries report some form of shortages of tissues and cells, including bone marrow and gametes.
As set out in Article 12 of Directive 2004/23/EC, the Commission shall inform the European Parliament and the Council of any necessary further measures it intends to take in the field of voluntary and unpaid donation of tissues and cells. Based on the findings of this report, the Commission will now, together with the Member States, reflect on the potential need for further measures, keeping in mind that the Commission's legal mandate is limited to quality and safety of tissues and cells.
[1] 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.
[2] Directive 2006/17/EC defines reproductive cells as "all tissues and cells intended to be used for the purpose of assisted reproduction".
[3] COM/2006/0593 final.
[4] http://ec.europa.eu/health/blood_tissues_organs/docs/ev_20101206_mi_en.pdf