11.5.3. European survey on donation and transplantation activities
In 2003 the
European Commission conducted a survey (European Commission, 2003) related to
organ transplantation in the 25 EU Member States as well as in Bulgaria, Norway, Romania and Turkey, with the intention of collecting information on the legal
framework related to ethical, organisational and technical aspects in the field
of organ transplantation. The results of this survey are available in the
website of this report.
Authorisation for transplantation procedures
in different countries in relation with the authorisation of organ procurement,
organ transplantation (figure 11.12) organ exchange and organ importation and
exportation are shown in Figures from 11.11 to 11.14.
Figure 11.11. Organ Procurement in different European countries
Figure 11.12. Organ transplantation in different European
Figure 11.13. Exchanges and import/export of organs in different European countries
Figure 11.14. Percentage and absolute numbers of countries with
register in plan in different settings
Only 8 countries
have binding official mechanism for reporting serious adverse events, whereas
in other 12 the system is driven by guidelines.
The criteria for
cadaver organ selection are regulated by technical guidelines in most countries
(23) with only nine having binding selection criteria in place. For the living
donor, 13 countries have binding criteria, while other 15 have technical
shows the different factors included in the risk assessment in the different
countries, and how they are regulated (binding requirements, technical
guidelines or not regulated).
Figure 11.15. Risk assessment criteria in organ transplant
Most of the risk
assessment is governed by technical guidelines. With the exception of
haemodilution of donor samples and prion diseases, where a considerable proportion
of countries do not have any kind of law / guidelines in place, evaluation of
the different criteria in the risk assessment are covered in technical
guidelines in most of the countries surveyed. The use of authorised
laboratories for carrying out the different tests is a binding requirement in
10 countries, although other 15 include this recommendation in technical
The use of
authorised tests for testing the donors is a binding requirement only in seven
of the countries surveyed. However, other 17 include this provision in
technical guidelines. Figure 11.16 shows the biological tests used in the
countries and indicates whether these tests are carried out on a routine basis
or depending on donor characteristics.
Figure 11.16. Biological tests in organ transplant
As Figure 11.16
shows, there is consensus in the use of a number of tests (Anti HIV, Anti HCV,
Ag-Hbs or Treponema Pallidum). However, this does not apply to all tests (HTLV,
Toxoplasmosis or Ag-HIV).
With respect to
tumour markers carried out for donor evaluation, Figure 11.17 shows the
different practices in the countries surveyed. There is wide heterogeneity, but
the results show clearly that few countries carry out these tests on a routine
Figure 11.17. Tumour markers in organs transplants number of
shows the different procedures for the retrieval of organs, their packaging,
labelling, preservation and transport, as well as how the documentation to be
provided with the organ, the quality systems and the audit of accidents are
regulated. It is clear that in most countries these procedures are governed by
Figure 11.18. Organ transplantation procedures.