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2014/0165(COD) Avoiding trade diversion into the EU of certain key medicines. Codification

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead JURI FERRARA Laura (icon: EFDD EFDD) GERINGER DE OEDENBERG Lidia Joanna (icon: S&D S&D)
Former Responsible Committee JURI
Lead committee dossier:
Legal Basis:
TFEU 207-p2

Events

2016/12/09
   EC - Follow-up document
Details

The Commission presented a report on the application of Regulation (EU) 2016/793 of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines.

The Regulation puts in place safeguards to prevent diversion of medicines from poor developing countries into the European Union.

Supplying poor and developing countries with medicines at sustainable low prices is one of the objectives in the fight against the major diseases of HIV/AIDS, malaria and tuberculosis. In order to achieve this, the European Commission has consistently advocated a policy of "tiered pricing" for medicines, combined with market segmentation between rich and poor countries.

This report is the ninth Report under Article 12(2) of the Regulation which foresees biennially reports by the Commission to the European Parliament and to the Council on the volumes exported under tiered prices registered under the Regulation. It covers the period from 1 January 2014 to 31 December 2015.

Evaluation : the Regulation was evaluated on four criteria: effectiveness, efficiency, coherence and relevance. It was assessed against the REFIT criteria of being fit for purpose, having delivered on its objectives at minimum cost and whether there is potential for simplification.

The analysis of stakeholders' and experts' input by the external contractor found no evidence that there was scope for improving the effectiveness of the Regulation by modifying the list of countries of destination.

Exported products : one company, GlaxoSmithKline / ViiV Healthcare, has medicines registered under the Regulation. These products were registered in 2004 and all aim at the treatment of HIV/AIDS.

During the reference period, six products were exported under tiered prices to China, Honduras, Indonesia, Kenya, Moldova, Nigeria, South Africa, and Uganda.

The products were sold to the countries listed at the price of production, with no mark-up, and therefore in accordance with the criteria of the Regulation.

Documents
COM(2016)0785
EUR-Lex
2016/05/24
   Final act published in Official Journal
Details

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

LEGISLATIVE ACT: Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification).

CONTENT: in the interests of legal clarity and transparency, this Regulation codifies and repeals Council Regulation (EC) No 953/2003 which had been substantially amended several times.

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.

This codified Regulation prohibits the importation into the European Union of tiered-priced products.

Derogations 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 the Regulation’s Annex II.

‘Tiered-priced products’ are any pharmaceutical products used in the prevention, diagnosis or treatment of a disease such as HIV/AIDS, malaria, tuberculosis and related oppotunistic diseases , which are priced in accordance with one of the optional price calculations set out in the Regulation, verified by the Commission or an independent auditor, and and entered in the list of tiered-priced products in Annex I of the Regulation.

More specifically, the Regulation sets:

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 Commission shall monitor on an annual basis the volumes of exports of tiered-priced products listed in Annex I and exported to the countries of destination. It shall report biennially to the European Parliament and to the Council on the volumes exported under tiered prices.

The European Parliament may, within one month of submission of the Commission's report, invite the Commission to an ad hoc meeting of its responsible committee to present and explain any issues related to the application of this Regulation. No later than six months from the date of submission of the report to the European Parliament and to the Council, the Commission shall make the report public.

ENTRY INTO FORCE: 13.6.2016.

DELEGATED ACTS: the Commission may adopt delegated acts to add products to the list of tiered-priced products covered by the Regulation. The power to adopt such delegated acts shall be conferred on the Commission for a period of 5 years from 20 February 2014 (a period that can be tacitly extended for periods of an identical duration). The European Parliament or the Council may raise objections to a delegated act within three months of notification (which may be extended by three months.) If Parliament or Council raise objections, the delegated act will not enter into force.

Documents
Regulation 2016/793
OJ L 135 24.05.2016, p. 0039
2016/05/11
   CSL - Draft final act
Documents
00005/2016/LEX
2016/05/11
   CSL - Final act signed
2016/05/11
   EP - End of procedure in Parliament
2016/04/11
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2016/04/11
   CSL - Council Meeting
2016/04/07
   EC - For information
Documents
SWD(2016)0124
2016/04/07
   EC - For information
Documents
SWD(2016)0125
2016/03/09
   EP - Decision by Parliament, 1st reading
Details

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.

Documents
T8-0076/2016
2016/02/24
   EP - Committee report tabled for plenary, 1st reading
Details

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.

Documents
A8-0038/2016
2015/01/28
   EP - Committee referral announced in Parliament, 1st reading
2014/12/16
   EC - For information
Documents
COM(2014)0737
EUR-Lex
2014/11/11
   EP - Vote in committee, 1st reading
2014/10/10
   EP - Committee draft report
Documents
PE539.695
2014/10/09
   EP - FERRARA Laura (EFDD) appointed as rapporteur in JURI
2014/05/28
   EC - Legislative proposal published
Details

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.

Documents
EUR-Lex
COM(2014)0319

Documents

Activities

Votes

A8-0038/2016 - Laura Ferrara - Vote unique #

2016/03/09 Outcome: +: 664, -: 29, 0: 4
DE IT FR PL ES RO GB BE CZ PT HU SE AT NL EL BG FI SK LT HR DK IE SI LV CY MT LU EE
Total
88
69
68
47
51
31
64
21
20
19
19
18
18
24
20
15
12
12
11
11
11
10
8
7
6
6
5
5
icon: PPE PPE
204

Germany PPE

33

Italy PPE

13

France PPE

19

Poland PPE

21

Spain PPE

17

Romania PPE

12

Belgium PPE

4

Czechia PPE

7

Portugal PPE

6

Hungary PPE

11

Sweden PPE

4

Austria PPE

5

Netherlands PPE

3

Greece PPE

5

Bulgaria PPE

7

Finland PPE

3

Slovakia PPE

6

Lithuania PPE

2

Croatia PPE

5

Ireland PPE

4

Slovenia PPE

5

Latvia PPE

4

Cyprus PPE

2

Malta PPE

3

Luxembourg PPE

2

Estonia PPE

For (1)

Tunne KELAM
1
icon: S&D S&D
177

Germany S&D

24

Italy S&D

29

France S&D

13

Poland S&D

5

Spain S&D

13

Romania S&D

14

United Kingdom S&D

18

Belgium S&D

4

Czechia S&D

4

Portugal S&D

7

Hungary S&D

4

Sweden S&D

5

Austria S&D

5

Netherlands S&D

3

Greece S&D

4

Bulgaria S&D

2

Finland S&D

2

Slovakia S&D

4

Lithuania S&D

2

Croatia S&D

2

Denmark S&D

3

Ireland S&D

For (1)

Nessa CHILDERS
1

Slovenia S&D

For (1)

Tanja FAJON
1

Latvia S&D

1

Cyprus S&D

2

Malta S&D

3

Luxembourg S&D

For (1)

Mady DELVAUX
1

Estonia S&D

For (1)

Marju LAURISTIN
1
icon: ALDE ALDE
65

Germany ALDE

3

France ALDE

7

Spain ALDE

7

Romania ALDE

3

United Kingdom ALDE

1

Belgium ALDE

6

Czechia ALDE

4

Portugal ALDE

2

Sweden ALDE

3

Austria ALDE

For (1)

Angelika MLINAR
1

Netherlands ALDE

7

Bulgaria ALDE

4

Finland ALDE

3

Lithuania ALDE

4

Croatia ALDE

2

Denmark ALDE

2

Ireland ALDE

For (1)

Marian HARKIN
1

Slovenia ALDE

For (1)

Ivo VAJGL
1

Latvia ALDE

1

Luxembourg ALDE

For (1)

Charles GOERENS
1

Estonia ALDE

2
icon: ECR ECR
65

Germany ECR

6

Italy ECR

2

Poland ECR

17

Romania ECR

For (1)

Monica MACOVEI
1

United Kingdom ECR

18

Belgium ECR

4

Czechia ECR

2

Netherlands ECR

2

Greece ECR

Against (1)

Notis MARIAS
1

Bulgaria ECR

2

Finland ECR

2

Slovakia ECR

2

Lithuania ECR

1

Croatia ECR

For (1)

Ruža TOMAŠIĆ
1

Denmark ECR

4
icon: Verts/ALE Verts/ALE
47

Germany Verts/ALE

12

France Verts/ALE

5

Spain Verts/ALE

4

United Kingdom Verts/ALE

6

Belgium Verts/ALE

2

Hungary Verts/ALE

2

Sweden Verts/ALE

3

Austria Verts/ALE

3

Netherlands Verts/ALE

2

Finland Verts/ALE

For (1)

Heidi HAUTALA
1

Lithuania Verts/ALE

For (1)

Bronis ROPĖ
1

Croatia Verts/ALE

For (1)

Davor ŠKRLEC
1

Denmark Verts/ALE

For (1)

Margrete AUKEN
1

Slovenia Verts/ALE

For (1)

Igor ŠOLTES
1

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

Claude TURMES
1

Estonia Verts/ALE

For (1)

Indrek TARAND
1
icon: GUE/NGL GUE/NGL
48

Germany GUE/NGL

8

Italy GUE/NGL

3

France GUE/NGL

2

Spain GUE/NGL

10

United Kingdom GUE/NGL

1

Czechia GUE/NGL

2

Portugal GUE/NGL

4

Sweden GUE/NGL

For (1)

Malin BJÖRK
1

Netherlands GUE/NGL

3

Greece GUE/NGL

6

Finland GUE/NGL

For (1)

Merja KYLLÖNEN
1

Denmark GUE/NGL

For (1)

Rina Ronja KARI
1

Ireland GUE/NGL

4

Cyprus GUE/NGL

2
icon: ENF ENF
36

Italy ENF

5

France ENF

Abstain (1)

Dominique BILDE
18

Poland ENF

2

Romania ENF

1

United Kingdom ENF

Against (1)

Janice ATKINSON
1

Belgium ENF

For (1)

Gerolf ANNEMANS
1

Austria ENF

4

Netherlands ENF

4
icon: NI NI
13

Germany NI

For (1)

Udo VOIGT

Against (1)

Martin SONNEBORN
2

France NI

3

Poland NI

1

United Kingdom NI

For (1)

Diane DODDS
1

Hungary NI

2

Greece NI

4
icon: EFDD EFDD
41

Italy EFDD

17

France EFDD

1

Poland EFDD

1

United Kingdom EFDD

18

Czechia EFDD

Abstain (1)

Petr MACH
1

Sweden EFDD

2

Lithuania EFDD

For (1)

Rolandas PAKSAS
1

History

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

2021-12-18Show (12) Changes | Timetravel
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Former Responsible Committee
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committee_full
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http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE539.695
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summary
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summary
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2016-03-09T00:00:00
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summary
procedure/Modified legal basis
Rules of Procedure EP 159
procedure/Other legal basis
Rules of Procedure EP 159
procedure/instrument
Old
  • Regulation
  • Repealing Regulation (EC) No 953/2003
New
Regulation
2020-01-19Show (4) Changes | Timetravel
committees/0
type
Responsible Committee
body
EP
associated
False
committee_full
Legal Affairs
committee
JURI
rapporteur
name: FERRARA Laura date: 2014-10-09T00:00:00 group: Europe of Freedom and Direct Democracy abbr: EFDD
shadows
name: GERINGER DE OEDENBERG Lidia Joanna group: Progressive Alliance of Socialists and Democrats abbr: S&D
committees/0
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date
2014-10-09T00:00:00
rapporteur
name: FERRARA Laura group: Europe of Freedom and Direct Democracy abbr: EFDD
shadows
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events/3/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2016-0038&language=EN
New
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events/4/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0076
New
http://www.europarl.europa.eu/doceo/document/TA-8-2016-0076_EN.html
2019-07-06Show (15) Changes | Timetravel
activities
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  • body: EP 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 type: Committee report tabled for plenary, 1st reading/single reading committees: body: EP shadows: group: S&D name: GERINGER DE OEDENBERG Lidia Joanna responsible: True committee: JURI date: 2014-10-09T00:00:00 committee_full: Legal Affairs rapporteur: group: EFD name: FERRARA Laura body: EP responsible: True committee_full: Legal Affairs committee: JURI date: 2016-02-24T00:00:00
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  • date: 2016-04-11T00:00:00 body: CSL type: Council Meeting council: Agriculture and Fisheries meeting_id: 3459
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  • date: 2016-05-11T00:00:00 body: EP type: End of procedure in Parliament
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commission
  • body: EC dg: Legal Service commissioner: BARROSO José Manuel
committees/0
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docs
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  • date: 2014-12-16T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2014/0737/COM_COM(2014)0737_EN.pdf title: COM(2014)0737 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2014&nu_doc=0737 title: EUR-Lex type: For information body: EC
  • date: 2016-04-07T00:00:00 docs: title: SWD(2016)0124 type: For information body: EC
  • date: 2016-04-07T00:00:00 docs: title: SWD(2016)0125 type: For information body: EC
  • date: 2016-05-11T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F16&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 00005/2016/LEX type: Draft final act body: CSL
  • date: 2016-12-09T00:00:00 docs: url: http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2016/0785/COM_COM(2016)0785(ANN)_EN.pdf title: COM(2016)0785 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2016&nu_doc=0785 title: EUR-Lex summary: The Commission presented a report on the application of Regulation (EU) 2016/793 of the European Parliament and of the Council to avoid trade diversion into the European Union of certain key medicines. The Regulation puts in place safeguards to prevent diversion of medicines from poor developing countries into the European Union. Supplying poor and developing countries with medicines at sustainable low prices is one of the objectives in the fight against the major diseases of HIV/AIDS, malaria and tuberculosis. In order to achieve this, the European Commission has consistently advocated a policy of "tiered pricing" for medicines, combined with market segmentation between rich and poor countries. This report is the ninth Report under Article 12(2) of the Regulation which foresees biennially reports by the Commission to the European Parliament and to the Council on the volumes exported under tiered prices registered under the Regulation. It covers the period from 1 January 2014 to 31 December 2015. Evaluation : the Regulation was evaluated on four criteria: effectiveness, efficiency, coherence and relevance. It was assessed against the REFIT criteria of being fit for purpose, having delivered on its objectives at minimum cost and whether there is potential for simplification. The analysis of stakeholders' and experts' input by the external contractor found no evidence that there was scope for improving the effectiveness of the Regulation by modifying the list of countries of destination. Exported products : one company, GlaxoSmithKline / ViiV Healthcare, has medicines registered under the Regulation. These products were registered in 2004 and all aim at the treatment of HIV/AIDS. During the reference period, six products were exported under tiered prices to China, Honduras, Indonesia, Kenya, Moldova, Nigeria, South Africa, and Uganda. The products were sold to the countries listed at the price of production, with no mark-up, and therefore in accordance with the criteria of the Regulation. type: Follow-up document body: EC
events
  • date: 2014-05-28T00:00:00 type: Legislative proposal published body: EC docs: url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=FR&type_doc=COMfinal&an_doc=2014&nu_doc=0319 title: EUR-Lex title: COM(2014)0319 summary: 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.
  • date: 2014-11-11T00:00:00 type: Vote in committee, 1st reading/single reading body: EP
  • date: 2015-01-28T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2016-02-24T00:00:00 type: Committee report tabled for plenary, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2016-0038&language=EN title: A8-0038/2016 summary: 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.
  • date: 2016-03-09T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0076 title: T8-0076/2016 summary: 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.
  • date: 2016-04-11T00:00:00 type: Act adopted by Council after Parliament's 1st reading body: EP/CSL
  • date: 2016-05-11T00:00:00 type: Final act signed body: CSL
  • date: 2016-05-11T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2016-05-24T00:00:00 type: Final act published in Official Journal summary: PURPOSE: the codification of Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines. LEGISLATIVE ACT: Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification). CONTENT: in the interests of legal clarity and transparency, this Regulation codifies and repeals Council Regulation (EC) No 953/2003 which had been substantially amended several times. 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. This codified Regulation prohibits the importation into the European Union of tiered-priced products. Derogations 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 the Regulation’s Annex II. ‘Tiered-priced products’ are any pharmaceutical products used in the prevention, diagnosis or treatment of a disease such as HIV/AIDS, malaria, tuberculosis and related oppotunistic diseases , which are priced in accordance with one of the optional price calculations set out in the Regulation, verified by the Commission or an independent auditor, and and entered in the list of tiered-priced products in Annex I of the Regulation. More specifically, the Regulation sets: 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 Commission shall monitor on an annual basis the volumes of exports of tiered-priced products listed in Annex I and exported to the countries of destination. It shall report biennially to the European Parliament and to the Council on the volumes exported under tiered prices. The European Parliament may, within one month of submission of the Commission's report, invite the Commission to an ad hoc meeting of its responsible committee to present and explain any issues related to the application of this Regulation. No later than six months from the date of submission of the report to the European Parliament and to the Council, the Commission shall make the report public. ENTRY INTO FORCE: 13.6.2016. DELEGATED ACTS: the Commission may adopt delegated acts to add products to the list of tiered-priced products covered by the Regulation. The power to adopt such delegated acts shall be conferred on the Commission for a period of 5 years from 20 February 2014 (a period that can be tacitly extended for periods of an identical duration). The European Parliament or the Council may raise objections to a delegated act within three months of notification (which may be extended by three months.) If Parliament or Council raise objections, the delegated act will not enter into force. docs: title: Regulation 2016/793 url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32016R0793 title: OJ L 135 24.05.2016, p. 0039 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2016:135:TOC
other
  • body: EC dg: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service commissioner: BARROSO José Manuel
procedure/Modified legal basis
Old
Rules of Procedure of the European Parliament EP 150
New
Rules of Procedure EP 159
procedure/dossier_of_the_committee
Old
JURI/8/00466
New
  • JURI/8/00466
procedure/final/url
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32016R0793
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https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32016R0793
procedure/instrument
Old
Regulation
New
  • Regulation
  • Repealing Regulation (EC) No 953/2003
procedure/subject
Old
  • 4.20.01 Medicine, diseases
  • 4.20.04 Pharmaceutical products and industry
  • 6.20.02 Export/import control, trade defence
  • 6.30.02 Financial and technical cooperation and assistance
  • 7.30.02 Customs cooperation
New
4.20.01
Medicine, diseases
4.20.04
Pharmaceutical products and industry
6.20.02
Export/import control, trade defence, trade barriers
6.30.02
Financial and technical cooperation and assistance
7.30.02
Customs cooperation
procedure/summary
  • Repealing Regulation (EC) No 953/2003
2016-05-28Show (3) Changes | Timetravel
activities/9
date
2016-05-24T00:00:00
docs
type
Final act published in Official Journal
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url
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32016R0793
title
Regulation 2016/793
procedure/stage_reached
Old
Procedure completed, awaiting publication in Official Journal
New
Procedure completed
2016-05-13Show (3) Changes | Timetravel
activities/7
date
2016-05-11T00:00:00
body
CSL
type
Final act signed
activities/8
date
2016-05-11T00:00:00
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EP
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End of procedure in Parliament
procedure/stage_reached
Old
Awaiting signature of act
New
Procedure completed, awaiting publication in Official Journal
2016-04-14Show (3) Changes | Timetravel
activities/5
date
2016-04-11T00:00:00
body
CSL
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Council Meeting
council
Agriculture and Fisheries
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3459
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2016-04-11T00:00:00
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EP/CSL
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Act adopted by Council after Parliament's 1st reading
procedure/stage_reached
Old
Provisional agreement between Parliament and Council on final act
New
Awaiting signature of act
2016-03-18Show (1) Changes | Timetravel
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.
2016-03-15Show (1) Changes | Timetravel
procedure/stage_reached
Old
Awaiting Council 1st reading position / budgetary conciliation convocation
New
Provisional agreement between Parliament and Council on final act
2016-03-11Show (3) Changes | Timetravel
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
activities/4/type
Old
Vote in plenary scheduled
New
Decision by Parliament, 1st reading/single reading
procedure/stage_reached
Old
Awaiting Parliament 1st reading / single reading / budget 1st stage
New
Awaiting Council 1st reading position / budgetary conciliation convocation
2016-03-05Show (3) Changes | Timetravel
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
2016-03-04Show (1) Changes | Timetravel
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
2016-03-03Show (1) Changes | Timetravel
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.
2016-03-01Show (1) Changes | Timetravel
activities/4/date
Old
2016-04-12T00:00:00
New
2016-03-08T00:00:00
2016-02-26Show (11) Changes | Timetravel
activities/1/committees/0/rapporteur/0/group
Old
EPP
New
EFD
activities/1/committees/0/rapporteur/0/mepref
Old
51ec673bb819f2575200063f
New
53b2d98fb819f205b0000062
activities/1/committees/0/rapporteur/0/name
Old
SVOBODA Pavel
New
FERRARA Laura
activities/2/committees/0/rapporteur/0/group
Old
EPP
New
EFD
activities/2/committees/0/rapporteur/0/mepref
Old
51ec673bb819f2575200063f
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53b2d98fb819f205b0000062
activities/2/committees/0/rapporteur/0/name
Old
SVOBODA Pavel
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FERRARA Laura
activities/3
date
2016-02-24T00:00:00
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EP
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Committee report tabled for plenary, 1st reading/single reading
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committees/0/rapporteur/0/group
Old
EPP
New
EFD
committees/0/rapporteur/0/mepref
Old
51ec673bb819f2575200063f
New
53b2d98fb819f205b0000062
committees/0/rapporteur/0/name
Old
SVOBODA Pavel
New
FERRARA Laura
procedure/stage_reached
Old
Awaiting committee decision
New
Awaiting Parliament 1st reading / single reading / budget 1st stage
2016-02-17Show (9) Changes | Timetravel
activities/1/committees/0/rapporteur/0/group
Old
ECR
New
EPP
activities/1/committees/0/rapporteur/0/mepref
Old
53b2d930b819f205b0000053
New
51ec673bb819f2575200063f
activities/1/committees/0/rapporteur/0/name
Old
DUDA Andrzej
New
SVOBODA Pavel
activities/2/committees/0/rapporteur/0/group
Old
ECR
New
EPP
activities/2/committees/0/rapporteur/0/mepref
Old
53b2d930b819f205b0000053
New
51ec673bb819f2575200063f
activities/2/committees/0/rapporteur/0/name
Old
DUDA Andrzej
New
SVOBODA Pavel
committees/0/rapporteur/0/group
Old
ECR
New
EPP
committees/0/rapporteur/0/mepref
Old
53b2d930b819f205b0000053
New
51ec673bb819f2575200063f
committees/0/rapporteur/0/name
Old
DUDA Andrzej
New
SVOBODA Pavel
2016-02-13Show (1) Changes | Timetravel
activities/3
date
2016-04-12T00:00:00
body
EP
type
Indicative plenary sitting date, 1st reading/single reading
2015-11-04Show (1) Changes | Timetravel
activities/0/docs/0/celexid
CELEX:52014PC0319:EN
2015-06-21Show (3) Changes | Timetravel
activities/1/committees/0/shadows
  • group: S&D name: GERINGER DE OEDENBERG Lidia Joanna
activities/2/committees/0/shadows
  • group: S&D name: GERINGER DE OEDENBERG Lidia Joanna
committees/0/shadows
  • group: S&D name: GERINGER DE OEDENBERG Lidia Joanna
2015-06-04Show (1) Changes | Timetravel
activities/0/docs/0/celexid
CELEX:52014PC0319:EN
2015-05-27Show (1) Changes | Timetravel
links/European Commission/title
Old
PreLex
New
EUR-Lex
2015-03-12Show (3) Changes | Timetravel
activities/2
date
2015-01-28T00:00:00
body
EP
type
Committee referral announced in Parliament, 1st reading/single reading
committees
procedure/dossier_of_the_committee
JURI/8/00466
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting committee decision
2014-11-25Show (6) Changes | Timetravel
activities/0
date
2014-05-28T00:00:00
docs
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EC
type
Legislative proposal published
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activities/0/body
Old
EP
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EC
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  • DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel
activities/0/date
Old
2014-12-16T00:00:00
New
2014-05-28T00:00:00
activities/0/docs
  • url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=FR&type_doc=COMfinal&an_doc=2014&nu_doc=0319 title: COM(2014)0319 type: Legislative proposal published celexid: CELEX:52014PC0319:EN
activities/0/type
Old
Indicative plenary sitting date, 1st reading/single reading
New
Legislative proposal published
2014-11-13Show (2) Changes | Timetravel
activities/1
date
2014-11-11T00:00:00
body
EP
type
Vote in committee, 1st reading/single reading
committees
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Rules of Procedure of the European Parliament EP 150
2014-11-09Show (5) Changes
activities
  • date: 2014-05-28T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=FR&type_doc=COMfinal&an_doc=2014&nu_doc=0319 title: COM(2014)0319 type: Legislative proposal published celexid: CELEX:52014PC0319:EN body: EC type: Legislative proposal published commission: DG: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service Commissioner: BARROSO José Manuel
  • date: 2014-12-16T00:00:00 body: EP type: Indicative plenary sitting date, 1st reading/single reading
committees
  • body: EP responsible: True committee: JURI date: 2014-10-09T00:00:00 committee_full: Legal Affairs rapporteur: group: ECR name: DUDA Andrzej
  • body: EP responsible: True committee_full: Legal Affairs committee: JURI
links
European Commission
other
  • body: EC dg: url: http://ec.europa.eu/dgs/legal_service/ title: Legal Service commissioner: BARROSO José Manuel
procedure
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
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