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European Parliament 2019-2024 Committee on International Trade 2020/2071(INI) 18.5.2020 AMENDMENTS 1 - 69 Draft opinion Andrey Kovatchev (PE650.551v01-00) Shortage of medicines - how to address an emerging problem (2020/2071(INI)) AM\1205208EN.docx PE652.313v01-00 EN United in diversityEN AM_Com_NonLegOpinion PE652.313v01-00 2/37 AM\1205208EN.docx EN Amendment 1 Tiziana Beghin Draft opinion Paragraph 1 Draft opinion Amendment 1. Notes that the COVID-19 pandemic 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms has revealed in the starkest possible terms the vital role played by functioning global the vital role played by functioning global supply chains for medical products, and in supply chains for medical products, and in particular for medicines; emphasises that particular for medicines and treatments; an open, rules-based trading system is emphasises that an open, transparent, fundamental to ensuring the global rules-based trading system is fundamental availability of medicines; to ensuring the global availability of medicines and guaranteeing an easy distribution and use; Or. en Amendment 2 Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides Draft opinion Paragraph 1 Draft opinion Amendment 1. Notes that the COVID-19 pandemic 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms has revealed in the starkest possible terms the vital role played by functioning global the vital role played by functioning global supply chains for medical products, and in supply chains for medical products, and in particular for medicines; emphasises that particular for medicines; emphasises that an open, rules-based trading system is the implementation of an open, rules- fundamental to ensuring the global based trading system is fundamental to availability of medicines; ensuring the global availability of medicines and that our vulnerability is not repeated in future emergencies; Or. en Amendment 3 Raphaël Glucksmann AM\1205208EN.docx 3/37 PE652.313v01-00 EN Draft opinion Paragraph 1 Draft opinion Amendment 1. Notes that the COVID-19 pandemic 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms has revealed in the starkest possible terms the vital role played by functioning global the vital role played by functioning supply supply chains for medical products, and in chains for medical products, and in particular for medicines; emphasises that particular for medicines; an open, rules-based trading system is fundamental to ensuring the global availability of medicines; Or. en Amendment 4 Enikő Győri Draft opinion Paragraph 1 Draft opinion Amendment 1. Notes that the COVID-19 pandemic 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms has revealed in the starkest possible terms the vital role played by functioning global the vital role played by functioning global supply chains for medical products, and in supply chains for medical products, and in particular for medicines; emphasises that particular for medicines; emphasises that an open, rules-based trading system is an open, free, fair, rules-based multilateral fundamental to ensuring the global trading system is fundamental to ensuring availability of medicines; the global availability of medicines; Or. en Amendment 5 Seán Kelly Draft opinion Paragraph 1 Draft opinion Amendment 1. Notes that the COVID-19 pandemic 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms has revealed in the starkest possible terms the vital role played by functioning global the vital role played by functioning global PE652.313v01-00 4/37 AM\1205208EN.docx EN supply chains for medical products, and in supply chains for medical products, and in particular for medicines; emphasises that particular for medicines; emphasises that an open, rules-based trading system is an open, enforceable rules-based trading fundamental to ensuring the global system is fundamental to ensuring the availability of medicines; global availability of medicines; Or. en Amendment 6 Agnes Jongerius, Biljana Borzan, Kathleen Van Brempt, Inma Rodríguez-Piñero, Costas Mavrides Draft opinion Paragraph 1 Draft opinion Amendment 1. Notes that the COVID-19 pandemic 1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms has revealed in the starkest possible terms the vital role played by functioning global the vital role played by functioning global supply chains for medical products, and in supply chains for medical products, and in particular for medicines; emphasises that particular for medicines; emphasises that a an open, rules-based trading system is fair, open, rules-based trading system is fundamental to ensuring the global fundamental to ensuring the global availability of medicines; availability of medicines; Or. en Amendment 7 Tiziana Beghin Draft opinion Paragraph 1 a (new) Draft opinion Amendment 1 a. Recalls the need to step up medicine production capacities in Europe ensuring the adequate availability of needed pharmaceuticals and limiting delivery bottlenecks; Or. en AM\1205208EN.docx 5/37 PE652.313v01-00 EN Amendment 8 Tiziana Beghin Draft opinion Paragraph 1 b (new) Draft opinion Amendment 1 b. Asks the Commission and Member States to allocate resources to support the reconversion of chemical plants in the EU for the production of active pharmaceutical ingredients in order to decrease dependency on third countries; Or. en Amendment 9 Andrey Kovatchev Draft opinion Paragraph 2 Draft opinion Amendment 2. Recognises that the EU depends on 2. Recognises that the EU depends on a narrow set of countries for a large a narrow set of countries for a large proportion of its imports of active proportion of its imports of active pharmaceutical ingredients and chemical pharmaceutical ingredients and chemical raw materials; stresses that this over- raw materials; stresses that this over- reliance can pose a risk when limitations in reliance can pose a risk when limitations in production capacity, excess demand or production capacity, excess demand or protectionist measures threaten the proper protectionist measures such as export functioning of global supply chains and restrictions threaten the proper functioning potentially undermine the availability of of global supply chains and potentially medicines in the EU; calls on the undermine the availability of medicines in Commission to present a long-term the EU; notes that such protectionist strategy focused on ensuring the EU’s open measures are likely to backfire and strategic autonomy in health; undermine global productive capacity as a whole; underlines that maintaining a stable and predictable trade and investment environment is the best way to leverage global manufacturing capacity when there is a surge in the demand for medicines; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy in health including through concrete PE652.313v01-00 6/37 AM\1205208EN.docx EN measures that support diversification, security of supply and domestic manufacturing of critical products; Or. en Amendment 10 Tiziana Beghin Draft opinion Paragraph 2 Draft opinion Amendment 2. Recognises that the EU depends on 2. Recognises the lack of a narrow set of countries for a large independence of medical products supply proportion of its imports of active chains within the Union underlying the pharmaceutical ingredients and chemical dependency on a narrow set of countries raw materials; stresses that this over- for a large proportion of its imports of reliance can pose a risk when limitations in active pharmaceutical ingredients and production capacity, excess demand or chemical raw materials such as China and protectionist measures threaten the proper India; stresses that this over-reliance can functioning of global supply chains and pose a risk when limitations in production potentially undermine the availability of capacity, safety, excess demand or medicines in the EU; calls on the protectionist measures threaten the proper Commission to present a long-term functioning of global supply chains and strategy focused on ensuring the EU’s open potentially undermine the availability of strategic autonomy in health; medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy in health and reliable tools to check and increase the quality, safety, origin and compliance with the EU regulatory framework and avoid counterfeiting; Or. en Amendment 11 Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides Draft opinion Paragraph 2 Draft opinion Amendment AM\1205208EN.docx 7/37 PE652.313v01-00 EN 2. Recognises that the EU depends on 2. Recognises that the EU depends on a narrow set of countries for a large a narrow set of countries for a large proportion of its imports of active proportion of its imports of active pharmaceutical ingredients and chemical pharmaceutical ingredients and chemical raw materials; stresses that this over- raw materials; stresses that this over- reliance can pose a risk when limitations in reliance can pose a risk when limitations in production capacity, excess demand or production capacity, excess demand or protectionist measures threaten the proper protectionist measures threaten the proper functioning of global supply chains and functioning of global supply chains and potentially undermine the availability of potentially undermine the availability of medicines in