REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on the standards of quality and safety of human organs intended for transplantation
Date: 2015-03-10
Institutions: European Commission
Subjects: data processing, organ transplantation, product quality, product safety, public health













EUR-Lex - 52015DC0123 - EN











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52015DC0123

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on the standards of quality and safety of human organs intended for transplantation /* COM/2015/0123 final */









REPORT
FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
on
the exercise of the power to adopt delegated acts conferred to the Commission
pursuant to Article 24 of Directive 2010/53/EU of the European Parliament
and of the Council of 7 July 2010 on standards of quality and safety of
human organs intended for transplantation
1.                 
Introduction
Directive
2010/53/EU of the European Parliament and of the Council of 7 July 2010 on
standards of quality and safety of human organs intended for transplantation[1] lays
down rules to ensure standards of quality and safety for human organs
(hereinafter ‘organs’) intended for transplantation into the human body, in
order to ensure a high level of human health protection.
Article
7(1) of the Directive provides that organs and their donors must be
characterised before transplantation through the collection of the information
set out in the Annex to the Directive. Part A of the Annex lays down the
minimum data set which has to be collected for each donation in accordance with
Article 7. Part B of the Annex lays down the complementary data set data to be
collected in addition, based on the decision of the medical team, taking into
account the availability of such information and the particular circumstances
of the case.
2.
        Legal basis
Article
24 of the Directive empowers the Commission to adopt, in accordance with the
specified conditions, delegated acts in order to:
a)       
supplement or amend the minimum data set
specified in Part A of the Annex only in exceptional situations where it is
justified by a serious risk to human health considered as such on the basis of
the scientific progress;
b)       
supplement or amend the complementary
data set specified in Part B of the Annex in order to adapt it to scientific
progress and international work carried out in the field of quality and safety
of organs intended for transplantation.
Article
25(1) confers to the Commission the delegated powers referred to in Article 24
for a period of five years following 27 August 2010 and it requires the Commission
to prepare a report in that respect not later than six months before the end of
the five-year period. The delegated powers shall be automatically extended for
periods of an identical duration, unless the European Parliament or the Council
revoke them in accordance with Article 26. The procedure to be followed in case
of objections is set out in Article 27, while a possibility to adopt delegated
acts under an urgency procedure is provided for in Article 28.
3.
        Exercise of the delegation
The Commission has not
yet used the delegated powers conferred by Article 24.
On 26 September 2011,
the Commission convened a meeting of an expert group composed of Member States'
experts in the field of organ donation and transplantation. Following
discussions in this meeting and the consensus opinion of the group, the
Commission concluded that the contents of the data set defined in the Annex to
Directive 2010/53/EU were sufficiently detailed to ensure appropriate quality
and safety standards, and were in line with current clinical practices in
Member States. The experts also expressed their willingness to continue their
work in relation to the content of the complementary data set through voluntary
projects and guidelines, for example within scientific societies, European
Organ Exchange Organisations and EU-funded projects.
As
a result of this meeting, the Commission concluded that delegated powers should
not be used at that stage, as there was no specific need for further details in
the data set already defined. The Commission assessed that the first priority
was the correct and timely transposition and implementation of all requirements
laid down in Directive 2010/53/EU, including in its Annex. The Commission
evaluated the content of the Annex as being sufficiently detailed and in line
with medical practices and scientific state of the art in the transplantation
field. In addition, the Commission, via EU-funding through the EU Health
Programme, was and continues to be able to support Member States cooperation in
the area of “organ and donor characterisation”, in work packages of the
EU-funded projects COORENOR (2010-2012) and FOEDUS (2013-2016). 
4.
        Conclusion
The
Commission is of the view that the delegated powers conferred by Article 24 of
Directive 2010/53/EU should remain in force.
Transplantation
medicine is evolving quickly. Therefore medical practices and scientific
progress may require adaptation of the data set for organ and donor
characterisation, for example with the inclusion of tests not previously available
on a large enough scale to allow for their mandatory inclusion. Such a need may
also arise in an emergency situation related to a new serious risk to human
health (Article 24(a)) where the Commission may be required to adopt delegated
acts through the urgency procedure, in accordance with Article 28 of the
Directive.
In
addition, the EU-funded project FOEDUS will come to an end in 2016 and will
deliver guidelines and further consensus positions on organ and donor
characterisation. This outcome will further support the Commission in assessing
the need to amend the Annex to Directive 2010/53/EU.
[1] OJ L 207, 6.8.2010, p. 14.