2010/0214(COD)

Duty-free treatment: specified pharmaceutical active ingredients and products (amend. Annex I to Regulation (EEC) No 2658/87)

Procedure completed

General
Activities
Documents
Votes
History

2010/0214(COD) Duty-free treatment: specified pharmaceutical active ingredients and products (amend. Annex I to Regulation (EEC) No 2658/87)

Role	Committee	Rapporteur
Opinion	ENVI
Opinion	IMCO
Lead	INTA	MOREIRA Vital (S&D)
Opinion	ITRE

Lead committee dossier: INTA/7/03532
Legal Basis TFEU TFEU 207

Subjects

Links

Activites

2010/12/31 Final act published in Official Journal
- Regulation 2010/1238
- OJ L 348 31.12.2010, p. 0036
2010/12/15 Final act signed
2010/12/15 End of procedure in Parliament
2010/12/10 Act adopted by Council after Parliament's 1st reading
#3057
2010/12/10 Council Meeting
2010/11/25 CSL Final Agreement
2010/11/23 Text adopted by Parliament, 1st reading/single reading
- T7-0411/2010 summary
  
  The European Parliament adopted by 639 votes to 3, with 19 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council providing for duty-free treatment for specified pharmaceutical active ingredients bearing an "international non-proprietary name" (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and amending Annex I to Regulation (EEC) No 2658/87. Parliament adopted its position at first reading under the ordinary legislative procedure (former co-decision procedure) taking over the Commission proposal.
- Results of vote in Parliament
2010/11/11 Committee report tabled for plenary, 1st reading/single reading
- A7-0316/2010
- ENVI
- IMCO
- INTA INTA/7/03532 MOREIRA Vital S&D
- ITRE
2010/10/26 Vote in committee, 1st reading/single reading
- ENVI
- IMCO
- INTA INTA/7/03532 MOREIRA Vital S&D
- ITRE
2010/10/20 Committee draft report
- PE450.762
2010/09/07 Committee referral announced in Parliament, 1st reading/single reading
- ENVI
- IMCO
- INTA INTA/7/03532 MOREIRA Vital S&D
- ITRE
2010/07/27 EP officialisation
2010/07/27 Legislative proposal
- COM(2010)0397 summary
  
  PURPOSE: to amend Annex I to Council Regulation (EEC) No 2658/87 in order to extend duty-free treatment in the European Union to the above-mentioned pharmaceutical and chemical products. PROPOSED ACT: Regulation of the European Parliament and of the Council. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207 of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the Record of Discussions of the Trade in Pharmaceutical Products is an arrangement between the most important pharmaceutical producing countries to reduce to zero and on an MFN basis their WTO bindings of duties on certain pharmaceutical products, including active ingredients and intermediates. The Parties to the Agreement are the EU, US, Japan, Canada, Switzerland, Norway and Macao (China). The arrangement originally covered over six thousand products. However, given that new pharmaceutical products are constantly being developed, the arrangement envisages periodic reviews. The Parties agreed to "meet under the auspices of the Council for Trade in Goods of the WTO, normally at least once every three years, to review the product coverage with a view to including, by consensus, additional pharmaceutical products for tariff elimination." The coverage was first reviewed in 1995-1996 and as a result an extra 465 products received duty free treatment. The second review in 1998 (implemented in July 1999) resulted in an extra 639 products receiving duty free treatment. The third review in 2006 resulted in the addition of 1290 products. A fourth review of the products covered by the Record was launched in 2009, in accordance with Article 3 of the Record, which requires Participants to review at least once every three years the product coverage with a view to including additional pharmaceutical products for tariff elimination. The EU participated in these technical discussions. In the course of these discussions, Participants concluded that additional INNs and pharmaceutical intermediates used for production and manufacture of finished pharmaceuticals should be granted duty-free treatment and that the list of specified prefixes and suffixes for salts, esters or hydrates of INNs should be expanded, thereby adding 718 new substances to the list of products eligible for duty-free treatment. This proposal invites the Council and Parliament to authorize the addition of 718 supplementary chemical and pharmaceutical products to the existing list of 8619 duty-free products on their imports into the EU. BUDGETARY IMPLICATION: this proposal has no implications for the EU budget.
- DG Trade, DE GUCHT Karel

Documents

Legislative proposal published: COM(2010)0397
Committee draft report: PE450.762
Committee report tabled for plenary, 1st reading/single reading: A7-0316/2010
Decision by Parliament, 1st reading/single reading: T7-0411/2010
Results of vote in Parliament: Results of vote in Parliament
: Regulation 2010/1238
: OJ L 348 31.12.2010, p. 0036

Votes

Report: Moreira A7-0316/2010 - Single vote

2010/11/23

Position	Total	ALDE	ECR	EFD	GUE/NGL	NI	PPE	S&D	Verts/ALE	correctional
For	639	73	49	16	26	13	240	170	52	1
Against	3	0	0	1	0	2	0	0	0	0
Abstain	19	0	0	9	1	9	0	0	0	0

History

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

2012-02-09

activities	added	body EP date 2010-07-27 type EP officialisation date 2010-07-27 docs text PURPOSE: to amend Annex I to Council Regulation (EEC) No 2658/87 in order to extend duty-free treatment in the European Union to the above-mentioned pharmaceutical and chemical products. PROPOSED ACT: Regulation of the European Parliament and of the Council. IMPACT ASSESSMENT: no impact assessment was carried out. LEGAL BASIS: Article 207 of the Treaty on the Functioning of the European Union (TFEU). CONTENT: the Record of Discussions of the Trade in Pharmaceutical Products is an arrangement between the most important pharmaceutical producing countries to reduce to zero and on an MFN basis their WTO bindings of duties on certain pharmaceutical products, including active ingredients and intermediates. The Parties to the Agreement are the EU, US, Japan, Canada, Switzerland, Norway and Macao (China). The arrangement originally covered over six thousand products. However, given that new pharmaceutical products are constantly being developed, the arrangement envisages periodic reviews. The Parties agreed to "meet under the auspices of the Council for Trade in Goods of the WTO, normally at least once every three years, to review the product coverage with a view to including, by consensus, additional pharmaceutical products for tariff elimination." The coverage was first reviewed in 1995-1996 and as a result an extra 465 products received duty free treatment. The second review in 1998 (implemented in July 1999) resulted in an extra 639 products receiving duty free treatment. The third review in 2006 resulted in the addition of 1290 products. A fourth review of the products covered by the Record was launched in 2009, in accordance with Article 3 of the Record, which requires Participants to review at least once every three years the product coverage with a view to including additional pharmaceutical products for tariff elimination. The EU participated in these technical discussions. In the course of these discussions, Participants concluded that additional INNs and pharmaceutical intermediates used for production and manufacture of finished pharmaceuticals should be granted duty-free treatment and that the list of specified prefixes and suffixes for salts, esters or hydrates of INNs should be expanded, thereby adding 718 new substances to the list of products eligible for duty-free treatment. This proposal invites the Council and Parliament to authorize the addition of 718 supplementary chemical and pharmaceutical products to the existing list of 8619 duty-free products on their imports into the EU. BUDGETARY IMPLICATION: this proposal has no implications for the EU budget. celexid CELEX:52010PC0397:EN type Legislative proposal published title COM(2010)0397 body EC commission DG Trade Commissioner DE GUCHT Karel type Legislative proposal date 2010-09-07 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP responsible False committee_full Environment, Public Health and Food Safety committee ENVI body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO body EP responsible True committee INTA date 2010-09-29 committee_full International Trade rapporteur group S&D name MOREIRA Vital body EP responsible False committee_full Industry, Research and Energy committee ITRE date 2010-10-20 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE450.762 type Committee draft report title PE450.762 body EP type Committee draft report date 2010-10-26 text The Committee on International Trade adopted the report drafted by Vital MOREIRA (S&D, PT) on the proposal for a regulation of the European Parliament and of the Council providing for duty-free treatment for specified pharmaceutical active ingredients bearing an "international non-proprietary name" (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and amending Annex I to Regulation (EEC) No 2658/87. It recommended that the European Parliament adopts its position at first reading under the ordinary legislative procedure (former co-decision procedure) taking over the Commission proposal. body EP committees body EP responsible False committee_full Environment, Public Health and Food Safety committee ENVI body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO body EP responsible True committee INTA date 2010-09-29 committee_full International Trade rapporteur group S&D name MOREIRA Vital body EP responsible False committee_full Industry, Research and Energy committee ITRE type Vote in committee, 1st reading/single reading date 2010-11-11 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2010-0316&language=EN type Committee report tabled for plenary, 1st reading/single reading title A7-0316/2010 body EP committees body EP responsible False committee_full Environment, Public Health and Food Safety committee ENVI body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO body EP responsible True committee INTA date 2010-09-29 committee_full International Trade rapporteur group S&D name MOREIRA Vital body EP responsible False committee_full Industry, Research and Energy committee ITRE type Committee report tabled for plenary, 1st reading/single reading date 2010-11-23 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2010-0411 text The European Parliament adopted by 639 votes to 3, with 19 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council providing for duty-free treatment for specified pharmaceutical active ingredients bearing an "international non-proprietary name" (INN) from the World Health Organisation and specified products used for the manufacture of finished pharmaceuticals and amending Annex I to Regulation (EEC) No 2658/87. Parliament adopted its position at first reading under the ordinary legislative procedure (former co-decision procedure) taking over the Commission proposal. type Decision by Parliament, 1st reading/single reading title T7-0411/2010 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=19038&l=en type Results of vote in Parliament title Results of vote in Parliament body EP type Text adopted by Parliament, 1st reading/single reading body CSL date 2010-11-25 type CSL Final Agreement date 2010-12-10 body type Act adopted by Council after Parliament's 1st reading date 2010-12-10 body CSL type Council Meeting council Competitiveness (Internal Market, Industry, Research and Space) meeting_id 3057 date 2010-12-15 body type Final act signed date 2010-12-15 body EP type End of procedure in Parliament date 2010-12-31 text PURPOSE: to extend the provision of duty-free treatment for specified pharmaceutical active ingredients bearing an 'international non-proprietary name' (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals. LEGISLATIVE ACT: Regulation (EU) No 1238/2010 of the European Parliament and of the Council amending Annex I to Council Regulation (EEC) No 2658/87 as regards the provision of duty-free treatment for specified pharmaceutical active ingredients bearing an 'international non-proprietary name' (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals. CONTENT: following a first-reading agreement with the European Parliament, the Council adopted a regulation on the provision of duty-free treatment for specified pharmaceutical active ingredients bearing an 'international non-proprietary name' (INN) from the World Health Organization and specified products used for the manufacture of finished pharmaceuticals. At the WTO Uruguay Round, an arrangement was concluded between the most important pharmaceutical producing countries to reduce to zero and on an MFN basis their WTO bindings of duties on certain pharmaceutical products, including active ingredients and intermediates. The parties to the agreement are the EU, US, Japan, Canada, Switzerland, Norway and Macao (China). The arrangement originally covered over six thousand products. However, given that new pharmaceutical products are constantly being developed, the arrangement envisages periodic reviews. Reviews took place in 1995-1996, 1998 and 2006 (Pharma I, II, and III reviews), and resulted in the addition of almost 2400 products. The fourth review (Pharma IV) was launched in 2009. In the course of these discussions, participants concluded that additional INNs (international non-proprietary names) and pharmaceutical intermediates used for production and manufacture of finished pharmaceuticals should be granted duty-free treatment and that the list of specified prefixes and suffixes for salts, esters or hydrates of INNs should be expanded, thereby adding 718 new substances to the list of products eligible for duty-free treatment. Consequently, this Regulation authorises the addition of 718 supplementary chemical and pharmaceutical products to the existing list of 8619 duty-free products on their imports into the EU. ENTRY INTO FORCE AND APPLICATION: from 01/01/2011. type Final act published in Official Journal docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32010R1238 title Regulation 2010/1238 url http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2010:348:SOM:EN:HTML title OJ L 348 31.12.2010, p. 0036
committees	added	body EP responsible False committee_full Environment, Public Health and Food Safety committee ENVI body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO body EP responsible True committee INTA date 2010-09-29 committee_full International Trade rapporteur group S&D name MOREIRA Vital body EP responsible False committee_full Industry, Research and Energy committee ITRE
links	added	National parliaments url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2010&number=0214&appLng=EN title IPEX European Commission url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2010&DocNum=0214 title PreLex
other	added	body EC dg Trade commissioner DE GUCHT Karel
procedure	added	dossier_of_the_committee INTA/7/03532 reference 2010/0214(COD) subtype Legislation legal_basis Treaty on the Functioning of the EU TFEU 207 stage_reached Procedure completed instrument Regulation title Duty-free treatment: specified pharmaceutical active ingredients and products (amend. Annex I to Regulation (EEC) No 2658/87) type COD - Ordinary legislative procedure (ex-codecision) final url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32010R1238 title Regulation 2010/1238 subject 4.20.04 Pharmaceutical products and industry 6.20.01 Agreements and relations in the context of the World Trade Organisation (WTO) 6.20.04 Community Customs Code, tariffs, preferential arrangements, rules of origin 6.20.05 Multilateral economic and trade agreements and relations

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