BETA

Procedure completed, awaiting publication in Official Journal



2014/0165(COD) Avoiding trade diversion into the EU of certain key medicines. Codification
RoleCommitteeRapporteurShadows
Lead JURI FERRARA Laura (EFD) GERINGER DE OEDENBERG Lidia Joanna (S&D)
Lead JURI
Lead committee dossier: JURI/8/00466
Legal Basis TFEU 207-p2

Activites

  • 2016/05/11 Final act signed
  • 2016/05/11 End of procedure in Parliament
  • #3459
  • 2016/04/11 Council Meeting
  • 2016/04/11 Act adopted by Council after Parliament's 1st reading
  • 2016/03/09 Decision by Parliament, 1st reading/single reading
    • T8-0076/2016 summary
  • 2016/02/24 Committee report tabled for plenary, 1st reading/single reading
    • A8-0038/2016 summary
  • 2015/01/28 Committee referral announced in Parliament, 1st reading/single reading
  • 2014/11/11 Vote in committee, 1st reading/single reading
  • 2014/05/28 Legislative proposal published
    • COM(2014)0319 summary
    • DG {'url': 'http://ec.europa.eu/dgs/legal_service/', 'title': 'Legal Service'}, BARROSO José Manuel

Documents

  • Legislative proposal published: COM(2014)0319
  • Committee report tabled for plenary, 1st reading/single reading: A8-0038/2016
  • Decision by Parliament, 1st reading/single reading: T8-0076/2016

History

(these mark the time of scraping, not the official date of the change)

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2016-05-24T00:00:00
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Final act published in Official Journal
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Regulation 2016/793
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2016-04-11T00:00:00
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Agriculture and Fisheries
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2016-04-11T00:00:00
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Awaiting signature of act
activities/4/docs/0/text
  • The European Parliament adopted by 664 votes to 29, with 4 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codified text).

    Parliament adopted its position at first reading, taking over the Commission proposal. The proposal in question aims to codify Council Regulation (EC) No 953/2003 which has been substantially amended several times. The proposal contains a straightforward codification of the existing texts without any change in their substance.

    The proposed codified Regulation serves the purpose of preventing tiered priced products from being imported into the Union. Exemptions are laid down for certain situations on the strict condition that it is ensured that the final destination of the products in question is one of the countries listed in Annex II. More specifically, the proposal lays down:

    • the criteria for establishing what is a tiered-priced product;
    • the conditions under which the customs authorities shall take action;
    • the measures which shall be taken by the competent authorities in the Member States.

    The term ‘tiered-priced product’ shall mean any pharmaceutical product which is used in the prevention, diagnosis or treatment of a disease, referred to in Annex IV, and which is priced in accordance with one of the optional price calculations set out in the Regulation, verified by the Commission or an independent auditor and entered in the list of tiered-priced products set out in Annex I.

procedure/stage_reached
Old
Awaiting Council 1st reading position / budgetary conciliation convocation
New
Provisional agreement between Parliament and Council on final act
activities/4/docs
  • url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0076 type: Decision by Parliament, 1st reading/single reading title: T8-0076/2016
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Vote in plenary scheduled
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Decision by Parliament, 1st reading/single reading
procedure/stage_reached
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Awaiting Council 1st reading position / budgetary conciliation convocation
activities/3/docs/0/text
  • The Committee on Legal Affairs adopted the report by Laura FERRARA (EFD, IT) on the proposal for a regulation of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines (codified text).

    The committee recommended the European Parliament to adopt its position at first reading, taking over the Commission proposal as adapted to the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission.

    According to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the proposal in question contains a straightforward codification of the existing texts without any change in their substance.

    Price segmentation between developed country markets and the poorest developing country markets is necessary to ensure that the poorest developing countries are supplied with essential pharmaceutical products at heavily reduced prices. Therefore, those heavily reduced prices cannot be understood as a reference for the price to be paid for the same products in developed country markets.

    The proposed codified Regulation serves the purpose of preventing tiered priced products from being imported into the Union. Exemptions are laid down for certain situations.

activities/4/date
Old
2016-03-08T00:00:00
New
2016-03-09T00:00:00
activities/4/type
Old
Indicative plenary sitting date, 1st reading/single reading
New
Vote in plenary scheduled
activities/3/docs
  • url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2016-0038&language=EN type: Committee report tabled for plenary, 1st reading/single reading title: A8-0038/2016
activities/0/docs/0/text/0
Old

PURPOSE: codification of Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

CONTENT: in the interests of clarity and transparency of Union law, the purpose of this proposal is to undertake a codification of Council Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines.

Council Regulation (EC) No 953/2003 has been substantially amended several times. It is recalled that in 1987, the Commission decided to instruct its staff that all acts should be codified after no more than ten amendments, stressing that this is a minimum requirement. The Edinburgh European Council in December 1992 confirmed the importance of codification as it offers certainty as to the law applicable to a given matter at a given time.

The European Parliament, the Council and the Commission agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-track adoption of codification instruments.

The new Regulation will supersede the various acts incorporated in it; it fully preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments as are required by the codification exercise itself.

New

PURPOSE: codification of Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: Council Regulation (EC) No 953/2003 has been substantially amended several times. On 1 April 1987, the Commission decided to instruct its staff that all acts should be codified after no more than ten amendments, stressing that this is a minimum requirement. The Conclusions of the Presidency of the Edinburgh European Council (December 1992) confirmed this, stressing the importance of codification.

The European Parliament, the Council and the Commission have agreed, by an interinstitutional agreement dated 20 December 1994, that an accelerated procedure may be used for the fast-track adoption of codification instruments.

CONTENT: in the interests of clarity and transparency of Union law, the purpose of this proposal is to undertake a codification of Council Regulation (EC) No 953/2003 to avoid trade diversion into the European Union of certain key medicines.

The new Regulation will supersede the various acts incorporated in it; it fully preserves the content of the acts being codified and hence does no more than bring them together with only such formal amendments as are required by the codification exercise itself.

Price segmentation between developed country markets and the poorest developing country markets is necessary to ensure that the poorest developing countries are supplied with essential pharmaceutical products at heavily reduced prices. Therefore, those heavily reduced prices cannot be understood as a reference for the price to be paid for the same products in developed country markets.

The proposed codified Regulation serves the purpose of preventing tiered priced products from being imported into the Union. Exemptions are laid down for certain situations under the strict provision that it is ensured that the final destination of the products in question is one of the countries listed in Annex II. More specifically, the proposed Regulation lays down:

  • the criteria for establishing what is a tiered priced product;
  • the conditions under which the customs authorities shall take action;
  • the measures which shall be taken by the competent authorities in the Member States.
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2016-04-12T00:00:00
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  • group: S&D name: GERINGER DE OEDENBERG Lidia Joanna
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  • group: S&D name: GERINGER DE OEDENBERG Lidia Joanna
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  • group: S&D name: GERINGER DE OEDENBERG Lidia Joanna
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  • DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel
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European Commission
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  • body: EC dg: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service commissioner: BARROSO José Manuel
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reference
2014/0165(COD)
subtype
Codification
legal_basis
Treaty on the Functioning of the EU TFEU 207-p2
stage_reached
Preparatory phase in Parliament
summary
Repealing Regulation (EC) No 953/2003
instrument
Regulation
title
Avoiding trade diversion into the EU of certain key medicines. Codification
type
COD - Ordinary legislative procedure (ex-codecision procedure)
subject