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Sundhedsudvalget 2008-09
KOM (2008) 0818 Bilag 4
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The European Affairs Committee and the Committee on Health

The EU-Secretariat of the Folketing

Date:

12 February 2009

Opinion adopted by the

European Affairs Committee of the Danish Parliament

On the Commission’s proposal for a Directive of the European

Parliament and of the Council on standards of quality and safety of

human organs intended for transplantation - COM(2008) 818 final

At the request of COSAC, the European Affairs Committee of the Danish

Parliament has conducted an assessment of whether the “proposal for a

Directive of the European Parliament and of the Council on standards of

quality and safety of human organs intended for transplantation” complies with

the principle of subsidiarity.

It is the assessment of a majority of the European Affairs Committee and the

Committee on Health, composed of the Liberal Party, the Social Democrats,

the Conservatives, the Socialist People’s Party, the Social-Liberal Party and

Ms. Pia Christmas-Møller (Non-attached Member), that the objectives of the

Directive can best be attained through regulation at the European level, and

that the proposal therefore complies with the principle of subsidiarity.

A minority composed of the Danish People’s Party furthermore holds the view

that the subsidiarity principle can be regarded as respected given that the

directive seeks to resolve a concrete problem within the area and that the

purpose of the directive is minimum harmonisation as described by the

Minister of Health in his answer to question no. S 891 and S 1034 (Session of

the Folketing 2008-2009)

Finally a minority composed of the Red-Green Alliance has expressed the

view that they find that the proposal does not comply with the principle of

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subsidiarity. The Red-Green Alliance’s Member of the Health Committee has

handed in the following minority statement:

Minority opinion:

“It emerges clearly from the Government’s explanatory note that the proposal

for a Directive “on standards of quality and safety of human organs intended

for transplantation” does not provide any guarantees for high standards in the

field. That is why Member States preserve the right to maintain and introduce

stricter measures at a national level.

Hence it follows that the directive does not guarantee that the exchange of

human organs and substances of human origin, blood and blood derivatives

across borders will be facilitated.

When the Government finds the proposal in compliance with principle of

subsidiarity, it simply underlines the fact that the principle has no real

substance”.

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