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European Commission report on the implementation of EU Directive 2010

European Commission report on the implementation of EU Directive on standards of quality and safety of human organs intended for transplantation

On the 5th of January THe European Commission released its report on the implementation in EU Member States of Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation.

The Directive was adopted in July 2010 with entry into force in August 2010 and requires Member States to regularly report to the European Commission on implementation at national level. The Directive lays down rules to ensure quality and safety standards for organ transplantation as well as to ensure that donors and recipients across Europe are guaranteed the same quality, safety and legal standards. Article 17 of the Directive especially provides a list of eight tasks each of which shall be the responsibility of one or several competent authority(ies) which Member States shall designate. These tasks are :

(a) establishing and keeping updated a framework for quality and safety,

(b) ensuring the regular control or audit of procurement organisations and transplantation centres,

(c) grant, suspend or withdraw the authorisations of procurement organisations or transplantation centres,

(d) put in place a reporting system and management procedure for serious adverse events and reactions,

(e) issue appropriate guidance to healthcare establishments, professionals and other parties involved in all stages of the chain from donation to transplantation or disposal,

(f) participate in the network of competent authorities and coordinate at national level input to the activities of that network,

(g) supervise organ exchange with other Member States and with third countries,

(h) ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ transplantation activities.

 You will find below main findings of the report.

As requested by the Directive, competent authorities overseeing the activities from donation to transplantation were established in all Member States, ensuring the application of a framework for quality and safety including authorisation, inspection and vigilance of organs; and Ministries of Health often have a fundamental role. When tasks are delegated, delegated bodies are mainly hospitals or European Organ Exchange Organisations, especially Eurotransplant and Scandiatransplant as relevant according to the regional affiliation.  

Tasks in majority performed at the national level are establishing and keeping updated a framework for quality and safety (task a); put in place a reporting system and management procedure for serious adverse events and reactions (SARE – task d);  issue appropriate guidance to healthcare establishments, professionals and other parties involved in all stages of the chain from donation to transplantation or disposal (task e); participate in the network of competent authorities and coordinate at national level input to the activities of that network (task f); ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ transplantation activities (task h).

 The report however underlines that many differences exist between Member States due to diverging national approaches to the legislation (different national transplant systems and systems for acceptance of organs) which in some cases limit cross-border exchanges of organs.

Though, it outlines that some countries have concluded bilateral agreements for exchanging organs or transplant patients with other countries or partners (healthcare establishments), and particularly Austria with Cyprus, and Malta with Italy; while Cyrpus, Italy and Latvia reported to exchange organs with or sending/receiving patients to/from other countries on a bilateral case-by-case basis outside any agreement.  

 As regards consent systems for organ donation, the report notes that EU citizens are “largely supportive of organ donation, independently of the consent system in their country”. While it highlights the two main types of consent systems existing in Europe: the “opt-in” system and the “opt-out” system, the report underlines that sixteen Member States and Norway have adopted an optout system at national level, while seven Member States have an opt-in system in place and four have a mixed system (for instance different systems in place in the different regions). However, the Commission points that “regardless of the consent system applied in the country, it is standard practice to approach family members of the deceased prior to any procurement decision”.

 23 countries out of the 29 surveyed (28 EU Member States plus Norway) have introduced registers or records for living donors, most of which had set it before the Directive. In sixteen of them, the record is set at national level, while in four a record is kept at the international level (their national data on living donors being included in the relevant record hosted by the European Organ Exchange Organisation they are member of). Significant differences are noted between Member States in the content and type of data captured in the register. Six countries reported not to have a register in place, but three of them plan to establish one soon (Croatia, Portugal, Slovenia).

The report also reveals that a majority of countries (27/29) provide a follow-up to living donors after donation. The European Commission notes that “the follow-up of living donors and the development of registers to document this follow-up are important aspects in the implementation of the organ legislation and still areas where Member States need to make progress” and thus confirms its willingness to continue supporting Member States in the field.

Overall, the European Commission concludes that while the implementation of the Directive in EU Member States is “overall considered adequate”, the set-up of the national organisations can be fragmented and vary significantly between countries, stressing the importance of “a good coordination within and between countries”. It particularly notes that improvement shall be driven in some areas and especially as regards the follow up of both recipients and living donors or in terms of regulations for operating procedures or for authorisations of procurement/transplant organisations.

To read the full report click here.


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