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.

(http://ec.europa.eu/health/ph_threats/human_substance/documents/organ_survey.pdf).

Authorisation for transplantation procedures

The requirements 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 countries

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 guidelines.

Figure 11.15 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 guidelines.

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 basis.

Figure 11.17. Tumour markers in organs transplants number of countries

Figure 11.18 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 technical guidelines:

Figure 11.18. Organ transplantation procedures.