Procedure
Supplementary protection certificate for medicinal products
2018/0161(COD)·8th term·ENVI / INTA / JURI·COD - Ordinary legislative procedure (ex-codecision procedure)·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
Committees
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)
2Alojz PETERLE
European People's Party (EPP) · 🇸🇮 Slovenia
42(22 solo)
3Christofer FJELLNER
European People's Party (EPP) · 🇸🇪 Sweden
34
4Tadeusz ZWIEFKA
European People's Party (EPP) · 🇵🇱 Poland
34
5Soledad CABEZÓN RUIZ
Socialists & Democrats · 🇪🇸 Spain
30(1 solo)
6Elisabetta GARDINI
European People's Party (EPP) · 🇮🇹 Italy
27
7Aldo PATRICIELLO
Patriots for Europe · 🇮🇹 Italy
27
8Andrzej GRZYB
European People's Party (EPP) · 🇵🇱 Poland
27
9Tiemo WÖLKEN
Socialists & Democrats · 🇩🇪 Germany
27
10José Inácio FARIA
European People's Party (EPP) · 🇵🇹 Portugal
26(24 solo)
11Jean-Marie CAVADA
ALDE · 🇫🇷 France
26
12António MARINHO E PINTO
ALDE · 🇵🇹 Portugal
26
13Enrico GASBARRA
Socialists & Democrats · 🇮🇹 Italy
25
14Sergio Gaetano COFFERATI
Socialists & Democrats · 🇮🇹 Italy
24
15Stefano MAULLU
European People's Party (EPP) · 🇮🇹 Italy
24(24 solo)
16Frédérique RIES
Renew Europe · 🇧🇪 Belgium
23(15 solo)
17Bolesław G. PIECHA
European Conservatives & Reformists · 🇵🇱 Poland
22
18József SZÁJER
European People's Party (EPP) · 🇭🇺 Hungary
22(2 solo)
19Alessia Maria MOSCA
Socialists & Democrats · 🇮🇹 Italy
20(20 solo)
20Daniel CASPARY
European People's Party (EPP) · 🇩🇪 Germany
18(16 solo)
21Bendt BENDTSEN
European People's Party (EPP) · 🇩🇰 Denmark
18
22Felix REDA
Greens / EFA · 🇩🇪 Germany
18(18 solo)
23Birgit COLLIN-LANGEN
European People's Party (EPP) · 🇩🇪 Germany
16
24Daniel BUDA
European People's Party (EPP) · 🇷🇴 Romania
16(16 solo)
25Răzvan 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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