Swedish Parliament

Dossier COD/2008/0255

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards information to the general public on medicinal products for human use subject to medical prescription, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Subsidiarity deadline: 09/04/2012
 
Scrutiny Information

Scrutiny date: 26/07/2012

  A reasoned opinion has been sent

No Important information to exchange

No Veto

Information on parliamentary scrutiny

COM (2008) 662
Passed on to the Committee on Health and Welfare 8 January 2009.
The Committee deliberated with the Government on the matter the 19th of May 2009.
The Government’s proposed Swedish position:
In the Government’s view it is positive that the proposal contains a continued ban on advertising of prescription pharmaceuticals and that patients should not be forced to receive unsolicited information.  The Government is also positive to a harmonized regulatory framework in the EU regarding information on pharmaceuticals in that it should be allowed within the Union for the public to obtain qualitative and reliable information on prescription pharmaceuticals. However, the Government cannot accept the presented proposal in its current form, since it conflicts in several ways with the Freedom of the Press Act and the Fundamental Law on the Freedom of Expression.
The Chair noted that there is support for the Government’s reported standpoint. A joint statement was added by the members from the Social Democratic Party, the member from the Left Party and the member from the Green Party.
 


COM (2011) 632
Passed on to the Committee on Health and Welfare.

The Committee on Health and Welfare deliberated with the Government on the matter on 2011-11-15.


COM(2012) 49
Referred to the Committee on Health and Welfare.

The Committee decided on 2012-02-16 to ask the Government to present its assessment on the application of the principle of subsidiarity in the draft legislative act.

The Committee has concluded that the proposal is in breach of the principle of subsidiarity. A proposal for a reasoned opinion has been submitted to the Chamber for consideration in statement 2011/12:SoU18 Subsidiaritetsprövning av kommissionens förslag om ändring av förordning vad gäller information till allmänheten om receptbelagda humanläkemedel.

The statement has been debated and decided upon by the Chamber. Consideration concluded with the Chamber adopting a reasoned opinion.

The Commission's reply to the statement from the Swedish Parliament has been received.


Summary
In this matter the Committee examines the Commission’s amended proposal for a regulation of the European Parliament and Council amending Council regulation (EC) No. 726/2004 as regards information to the general public on medicinal products for human use subject to medical prescription, COM(2012) 49.
The Committee does not consider the proposal in its present form to be in compliance with the principle of subsidiarity. The Committee therefore proposes that the Riksdag should decide to submit a reasoned opinion in accordance with Chapter 10, Article 6 of the Riksdag Act.


Lisbon Treaty procedures
 
  Reasoned opinion

30/03/2012 | Reasoned opinion of the Riksdag

A reasoned opinion was transmitted to the European Parliament, the Council and the Commission on 30 March 2012

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