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En En Amendments 1 European Parliament 2019-2024 Committee on Environment, Public Health and Food Safety 2020/2071(INI) 8.6.2020 AMENDMENTS 1 - 329 Draft report Nathalie Colin-Oesterlé (PE650.394v01-00) Shortage of medicines - how to address an emerging problem (2020/2071(INI)) AM\1206740EN.docx PE652.627v01-00 EN United in diversityEN AM_Com_NonLegReport PE652.627v01-00 2/151 AM\1206740EN.docx EN Amendment 1 Nathalie Colin-Oesterlé Motion for a resolution Citation 7 Motion for a resolution Amendment — having regard to Directive — having regard to Directive 2001/83/EC of the European Parliament 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on and of the Council of 6 November 2001 on the Community code relating to medicinal the Community code relating to medicinal products for human use and Article 81 products for human use and Article 81 thereof concerning an adequate and thereof concerning an adequate and uninterrupted supply of medicinal uninterrupted supply of medicinal products, products, and Article 23a thereof on notifying the competent authority if a product ceases to be placed on the market on a temporary or permanent basis, Or. fr Amendment 2 César Luena Motion for a resolution Citation 7 Motion for a resolution Amendment — having regard to Directive — having regard to Directive 2001/83/EC of the European Parliament 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on and of the Council of 6 November 2001 on the Community code relating to medicinal the Community code relating to medicinal products for human use and Article 81 products for human use and the obligations thereof concerning an adequate and set out in Article 81 thereof concerning an uninterrupted supply of medicinal appropriate and uninterrupted supply of products, medicinal products, Or. es Amendment 3 Véronique Trillet-Lenoir, Martin Hojsík, Susana Solís Pérez, María Soraya Rodríguez Ramos, Irena Joveva, Irène Tolleret, Bernard Guetta, Laurence Farreng, Sylvie Brunet, Fabienne Keller, Christophe Grudler, Nicolae Ştefănuță, Chrysoula Zacharopoulou AM\1206740EN.docx 3/151 PE652.627v01-00 EN Motion for a resolution Citation 7 a (new) Motion for a resolution Amendment - having regard to the assessment report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Or. en Amendment 4 Véronique Trillet-Lenoir, Martin Hojsík, Susana Solís Pérez, María Soraya Rodríguez Ramos, Irena Joveva, Irène Tolleret, Bernard Guetta, Laurence Farreng, Sylvie Brunet, Fabienne Keller, Christophe Grudler, Nicolae Ştefănuță, Chrysoula Zacharopoulou, Ondřej Knotek Motion for a resolution Citation 7 b (new) Motion for a resolution Amendment - having regard to the Council Conclusions of 8 June 2010 on ‘Equity and Health in All Policies: Solidarity in Health’, Or. en Amendment 5 Véronique Trillet-Lenoir, Martin Hojsík, Susana Solís Pérez, María Soraya Rodríguez Ramos, Irena Joveva, Irène Tolleret, Bernard Guetta, Laurence Farreng, Sylvie Brunet, Fabienne Keller, Christophe Grudler, Nicolae Ştefănuță, Chrysoula Zacharopoulou Motion for a resolution Citation 8 a (new) PE652.627v01-00 4/151 AM\1206740EN.docx EN Motion for a resolution Amendment - having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, Or. en Amendment 6 Joanna Kopcińska Motion for a resolution Citation 11 a (new) Motion for a resolution Amendment - having regard to the Regulation 2020/561 amending Regulation 2017/745 on medical devices, as regards the dates of application of certain of its provisions, Or. en Amendment 7 César Luena Motion for a resolution Citation 13 Motion for a resolution Amendment — having regard to the proposal for a — having regard to the proposal for a regulation of the European Parliament and regulation of the European Parliament and of the Council on health technology of the Council on health technology assessment and amending Directive assessment and amending Directive 2011/24/EU (COM(2018) 0051), 2011/24/EU (COM(2018) 0051), and to the European Parliament legislative resolution of 14 February 2019 on said proposal; Or. es AM\1206740EN.docx 5/151 PE652.627v01-00 EN Amendment 8 Tiemo Wölken Motion for a resolution Citation 13 a (new) Motion for a resolution Amendment - having regard to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and to the Doha Declaration on the TRIPS Agreement and Public Health, Or. en Amendment 9 Véronique Trillet-Lenoir, Martin Hojsík, Susana Solís Pérez, María Soraya Rodríguez Ramos, Irena Joveva, Irène Tolleret, Bernard Guetta, Laurence Farreng, Sylvie Brunet, Fabienne Keller, Christophe Grudler, Nicolae Ştefănuță, Chrysoula Zacharopoulou Motion for a resolution Citation 14 a (new) Motion for a resolution Amendment - having regard to Commission communication of 27 May 2020 on "Europe's moment: Repair and Prepare for the Next Generation", Or. en Amendment 10 Véronique Trillet-Lenoir, Martin Hojsík, Susana Solís Pérez, María Soraya Rodríguez Ramos, Irena Joveva, Irène Tolleret, Bernard Guetta, Laurence Farreng, Sylvie Brunet, Fabienne Keller, Christophe Grudler, Nicolae Ştefănuță, Chrysoula Zacharopoulou Motion for a resolution Citation 14 b (new) PE652.627v01-00 6/151 AM\1206740EN.docx EN Motion for a resolution Amendment - having regard to Commission communication of 27 May 2020 on "The EU budget powering the recovery plan for Europe", Or. en Amendment 11 Mairead McGuinness Motion for a resolution Citation 15 a (new) Motion for a resolution Amendment - having regard to the Commission communication of 20 May 2020 on the EU Biodiversity Strategy for 2030, Or. en Amendment 12 Jan Huitema, Véronique Trillet-Lenoir Motion for a resolution Citation 19 a (new) Motion for a resolution Amendment - having regard to the newly created platforms in light of the current COVID- 19 crisis, such as the European Medicines Agency (EMA) Industry Single Point of Contact (I-SPOC) system, which is streamlining the process of reporting potential medicine shortages in order to prevent them and to flag these shortages as early as possible; having regard that these platforms have enabled and facilitated a dialogue on shortages between stakeholders in the pharmaceutical supply chain and AM\1206740EN.docx 7/151 PE652.627v01-00 EN regulators, Or. en Amendment 13 Cristian-Silviu Buşoi, Dan-Ștefan Motreanu Motion for a resolution Citation 20 a (new) Motion for a resolution Amendment - having regard to the platforms that have been set up under the current COVID-19 crisis in order to prevent medicine shortages and to flag them as early as possible, including the European Medicines Agency (EMA) Industry Single Point of Contact (I-SPOC) system, which streamlines the process for reporting potential shortages, Or. en Amendment 14 Véronique Trillet-Lenoir, Martin Hojsík, Susana Solís Pérez, María Soraya Rodríguez Ramos, Irena Joveva, Irène Tolleret, Bernard Guetta, Laurence Farreng, Sylvie Brunet, Fabienne Keller, Christophe Grudler, Nicolae Ştefănuță, Chrysoula Zacharopoulou Motion for a resolution Citation 23 Motion for a resolution Amendment — having regard to Report No 737 of — having regard to Report No 737 of 27 September 2018 entitled ‘Shortages of 27 September 2018 entitled ‘Shortages of medicines and vaccines: focusing more medicines and vaccines: focusing more closely on public health issues in the closely on public health issues in the medicine supply chain’, drawn up by Jean- medicine supply chain’, drawn up by Jean- Pierre Decool on behalf of the French Pierre Decool on behalf of the French Senate fact-finding mission on the shortage Senate fact-finding mission on the shortage of medicines and vaccines, of medicines and vaccines, which is inspired by the report of the French Academy of Pharmacy of 20 June 2018 PE652.627v01-00 8/151 AM\1206740EN.docx EN on the unavailability of medicines, Or. en Amendment 15 Esther de Lange Motion for a resolution Citation 23 a (new) Motion for a resolution Amendment - having regard to the Commission Guidance concerning foreign direct investment and free movement of capital from third countries, and the protection of Europe’s strategic assets in the context of the COVID-19 emergency, ahead of the application of Regulation (EU) 2019/452 (FDI Screening Regulation), which will be fully operational as from 11 October 2020, Or. en Amendment 16 Tiemo Wölken Motion for a resolution Citation 24 a (new) Motion for a resolution Amendment - having regards to the 2016 Report of the United Nations Secretary General's High-Level Panel on Access to Medicine "Promoting innovation and access to health technologies", Or. en Amendment 17 Joanna Kopcińska AM\1206740EN.docx 9/151 PE652.627v01-00 EN Motion for a resolution Citation 24 a (new) Motion for a resolution Amendment - having regard to the Court's Judgments C-468/06-C-478/06 of 16 September 2008, Or. en Amendment 18 Véronique Trillet-Lenoir, Martin Hojsík, Susana Solís Pérez, María Soraya Rodríguez Ramos, Irena Joveva, Irène Tolleret, Bernard Guetta, Laurence Farreng, Sylvie Brunet, Fabienne Keller, Christophe Grudler, Fredrick Federley, Billy Kelleher, Nicolae Ştefănuță, Chrysoula Zacharopoulou, Karin Karlsbro Motion for a resolution Citation 24 a (new) Motion for a resolution Amendment - having regard to the Commission
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