Procedure
Supplementary protection certificate for medicinal products
2018/0161(COD)·8th term·ENVI / INTA / JURI·COD - Ordinary legislative procedure (ex-codecision procedure)·CompletedProcedure completed
Subjects: Research specific areas · Industrial property, European patent, Community patent, design and pattern · Pharmaceutical products and industry · Multilateral and plurilateral economic and trade agreements and relations
Rapporteur (the Member appointed to lead Parliament's work on this text): DE GRANDES PASCUAL Luis (PPE)
Summary
Proposal on the supplementary protection certificate for medicinal products. The amendments revise recitals on a manufacturing exception for generics and biosimilars, allowing making for export to third countries and for day-1 entry to the Union market after the certificate expires, while debating intellectual property and patent rights, affordability of medicines, and safeguards such as notification duties and due-diligence requirements on the maker and its supply chain.
Procedure timeline
- Committee amendments tabled17 Oct 2018 – 28 Nov 2018
- Procedure completed
556
Amendments
distinct, in window
55
Members
tabled at least one
3
Committee(s)
17 Oct 2018 – 28 Nov 2018
Dates
Official amendment documents
Connections
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Members who amended this procedure
55 Members · by amendment count1🇵🇱
Kosma ZŁOTOWSKI
European Conservatives & Reformists · Poland
42(20 solo)
2🇸🇮Alojz PETERLE
European People's Party (EPP) · Slovenia
42(22 solo)
3🇸🇪Christofer FJELLNER
European People's Party (EPP) · Sweden
34
4🇵🇱Tadeusz ZWIEFKA
European People's Party (EPP) · Poland
34
5🇪🇸Soledad CABEZÓN RUIZ
Socialists & Democrats · Spain
30(1 solo)
6🇮🇹Elisabetta GARDINI
European People's Party (EPP) · Italy
27
7🇮🇹Aldo PATRICIELLO
Patriots for Europe · Italy
27
8🇵🇱Andrzej GRZYB
European People's Party (EPP) · Poland
27
9🇩🇪Tiemo WÖLKEN
Socialists & Democrats · Germany
27
10🇵🇹José Inácio FARIA
European People's Party (EPP) · Portugal
26(24 solo)
11🇫🇷Jean-Marie CAVADA
ALDE · France
26
12🇵🇹António MARINHO E PINTO
ALDE · Portugal
26
13🇮🇹Enrico GASBARRA
Socialists & Democrats · Italy
25
14🇮🇹Sergio Gaetano COFFERATI
Socialists & Democrats · Italy
24
15🇮🇹Stefano MAULLU
European People's Party (EPP) · Italy
24(24 solo)
16🇧🇪Frédérique RIES
Renew Europe · Belgium
23(15 solo)
17🇵🇱Bolesław G. PIECHA
European Conservatives & Reformists · Poland
22
18🇭🇺József SZÁJER
European People's Party (EPP) · Hungary
22(2 solo)
19🇮🇹Alessia Maria MOSCA
Socialists & Democrats · Italy
20(20 solo)
20🇩🇪Daniel CASPARY
European People's Party (EPP) · Germany
18(16 solo)
21🇩🇰Bendt BENDTSEN
European People's Party (EPP) · Denmark
18
22🇩🇪Felix REDA
Greens / EFA · Germany
18(18 solo)
23🇩🇪Birgit COLLIN-LANGEN
European People's Party (EPP) · Germany
16
24🇷🇴Daniel BUDA
European People's Party (EPP) · Romania
16(16 solo)
25🇷🇴Răzvan POPA
Socialists & Democrats · Romania
16(10 solo)
The amendments, in full text
556 amendmentsEvery amendment as tabled — original text, proposed change and justification, with a link to the official PDF.
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