Belgium and Portugal do not have rules for inspecting or monitoring health establishments which coordinate or undertake the procurement of human organs despite being required by a 2010 directive to put such rules in place, it has been revealed in a progress reports published by the European Commission at the start of January.
Directive 2010/53/EU covers organ donation, testing, characterisation, procurement, preservation, transport and transplantation. It seeks to ensure that the same quality, safety and legal standards apply to donors and recipients, regardless of their place of residence.
Four years late and basing its findings solely on questionnaires completed by the member states (and Norway), the Commission concludes that implementation of the directive is generally adequate. It notes that a total of 68 competent authorities, including 21 delegated bodies, have been put in place to meet the goals of the directive. It finds, however, that three countries – Belgium, Portugal and Norway – have still to put in place rules for inspecting and monitoring centres that are responsible for transplants (procurement organisations). In contrast, it notes that 22 countries have put in place on-site controls, audits or inspections of procurement centres, conducted every three or five years on average. It also points out that desk-based analysis of the mandatory documentation is also a frequently used in 20 member states and 16 countries report to use both control/audit of procurement organisations and desk-based analysis.
A further source of concern is that only 23 of 29 countries have introduced registers or records for living donors, even though this provision is contained in the directive. The Commission goes on to state that three member states (Croatia, Portugal and Slovenia) plan to establish a register soon.
In conclusion, the Commission states: “Some work might still be needed to improve member states’ follow-up, both of recipients (Ed: for whom there is no compulsory follow-up) and of living donors, and on some aspects of the framework for quality and safety, for example for operating procedures or for authorisations. (Original version in French by Sophie Petitjean)