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AM\1205208EN.docx PE652.313v01-00 EN United in diversity EN 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))

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Page 1: AMENDMENTS 1 - 69 › doceo › document › INTA-AM... · 2020-05-19 · AM\1205208EN.docx PE652.313v01-00 ENUnited in diversityEN European Parliament 2019-2024 Committee on International

AM\1205208EN.docx PE652.313v01-00

EN United in diversity EN

European Parliament2019-2024

Committee on International Trade

2020/2071(INI)

18.5.2020

AMENDMENTS1 - 69Draft opinionAndrey Kovatchev(PE650.551v01-00)

Shortage of medicines - how to address an emerging problem(2020/2071(INI))

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AM_Com_NonLegOpinion

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Amendment 1Tiziana Beghin

Draft opinionParagraph 1

Draft opinion Amendment

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an open, rules-based trading system is fundamental to ensuring the global availability of medicines;

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines and treatments; emphasises that an open, transparent, rules-based trading system is fundamental to ensuring the global availability of medicines and guaranteeing an easy distribution and use;

Or. en

Amendment 2Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides

Draft opinionParagraph 1

Draft opinion Amendment

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an open, rules-based trading system is fundamental to ensuring the global availability of medicines;

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that the implementation of an open, rules-based trading system is fundamental to ensuring the global availability of medicines and that our vulnerability is not repeated in future emergencies;

Or. en

Amendment 3Raphaël Glucksmann

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Draft opinionParagraph 1

Draft opinion Amendment

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an open, rules-based trading system is fundamental to ensuring the global availability of medicines;

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning supply chains for medical products, and in particular for medicines;

Or. en

Amendment 4Enikő Győri

Draft opinionParagraph 1

Draft opinion Amendment

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an open, rules-based trading system is fundamental to ensuring the global availability of medicines;

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an open, free, fair, rules-based multilateral trading system is fundamental to ensuring the global availability of medicines;

Or. en

Amendment 5Seán Kelly

Draft opinionParagraph 1

Draft opinion Amendment

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global

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supply chains for medical products, and in particular for medicines; emphasises that an open, rules-based trading system is fundamental to ensuring the global availability of medicines;

supply chains for medical products, and in particular for medicines; emphasises that an open, enforceable rules-based trading system is fundamental to ensuring the global availability of medicines;

Or. en

Amendment 6Agnes Jongerius, Biljana Borzan, Kathleen Van Brempt, Inma Rodríguez-Piñero, Costas Mavrides

Draft opinionParagraph 1

Draft opinion Amendment

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that an open, rules-based trading system is fundamental to ensuring the global availability of medicines;

1. Notes that the COVID-19 pandemic has revealed in the starkest possible terms the vital role played by functioning global supply chains for medical products, and in particular for medicines; emphasises that a fair, open, rules-based trading system is fundamental to ensuring the global availability of medicines;

Or. en

Amendment 7Tiziana Beghin

Draft opinionParagraph 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

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Amendment 8Tiziana Beghin

Draft opinionParagraph 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 9Andrey Kovatchev

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures such as export restrictions threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; notes that such protectionist measures are likely to backfire and 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

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measures that support diversification, security of supply and domestic manufacturing of critical products;

Or. en

Amendment 10Tiziana Beghin

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises the lack of independence of medical products supply chains within the Union underlying the dependency on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials such as China and India; stresses that this over-reliance can pose a risk when limitations in production capacity, safety, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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 11Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides

Draft opinionParagraph 2

Draft opinion Amendment

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2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission and Member States to take the necessary legislative measures, policies and incentives to encourage the production of essential APIs and medicines in Europe to guarantee supply at all times and reduce supply dependence from third countries;

Or. en

Amendment 12Emmanuel Maurel

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that the lack of strategic autonomy and the high dependence of the European Union in a key sector such as health and the production of medicines is the concrete expression of the exacerbated free trade as promoted by the European Commission for decades; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term

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strategy focused on ensuring the EU’s open strategic autonomy in health;

Or. en

Amendment 13Emmanuel Maurel

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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; asks for a prior European or Member State allowance to any project of outsourcing health-related or pharmaceutical productions outside the EU;

Or. en

Amendment 14Massimiliano Salini

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical

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raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures, including restrictions on export inside and outside the EU, threaten the proper functioning of global supply chains and potentially undermine the availability of 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, also on the basis of all the factors that adversely affect the availability of drugs;

Or. en

Amendment 15Seán Kelly

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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, incorporating exploration into new trading partners for diversification of supply chains;

Or. en

Amendment 16

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Agnes Jongerius, Kathleen Van Brempt, Biljana Borzan, Inma Rodríguez-Piñero, Costas Mavrides

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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 the diversification of its supply chains;

Or. en

Amendment 17Barry Andrews, Nicola Danti, Dita Charanzová, Samira Rafaela, Svenja Hahn, Urmas Paet

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance poses a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open

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strategic autonomy in health; strategic autonomy in health which includes guidelines on the diversification of pharmaceutical supply chains;

Or. en

Amendment 18Enikő Győri

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s open strategic autonomy and resilience in health, in particular by ensuring diversification of supply chains;

Or. en

Amendment 19Raphaël Glucksmann, Agnes Jongerius, Aurore Lalucq

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-

2. Deplores that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-

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reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

reliance poses a risk in times of crises, when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of medicines in the EU; calls on the Commission to present a long-term strategy focused on ensuring the EU’s strategic autonomy in health, strengthening the European production of essential medicines;

Or. en

Amendment 20Emmanouil Fragkos, Geert Bourgeois

Draft opinionParagraph 2

Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of low technology medical supplies, active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

Or. en

Amendment 21Urmas Paet

Draft opinionParagraph 2

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Draft opinion Amendment

2. Recognises that the EU depends on a narrow set of countries for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

2. Recognises that the EU depends on a narrow set of countries, mainly China and India, for a large proportion of its imports of active pharmaceutical ingredients and chemical raw materials; stresses that this over-reliance can pose a risk when limitations in production capacity, excess demand or protectionist measures threaten the proper functioning of global supply chains and potentially undermine the availability of 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;

Or. en

Amendment 22Agnes Jongerius, Biljana Borzan, Kathleen Van Brempt, Inma Rodríguez-Piñero, Costas Mavrides

Draft opinionParagraph 2 a (new)

Draft opinion Amendment

2 a. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains i.a. by establishing a global catalogue of essential emergency healthcare products in order to limit the resort to protectionist measures;

Or. en

Amendment 23Massimiliano Salini

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Draft opinionParagraph 2 a (new)

Draft opinion Amendment

2 a. Insists that the measures proposed in the Commission's upcoming Pharmaceutical Strategy should ensure Europe's central role as an "innovator and world leader", as underlined in President von der Leyen's mission letter to Commissioner Stella Kyriakides, recognising that the start of any EU policy aimed at bringing the production of medicines and active ingredients back into Europe starts by strengthening research;

Or. en

Amendment 24Andrey Kovatchev

Draft opinionParagraph 2 a (new)

Draft opinion Amendment

2 a. Urges the Commission and Member States to conduct an in-depth mapping and analysis of the global supply chains for medicines; demands that, if such a mapping reveals substantial vulnerabilities and risks of supply disruption, remedial action be taken;

Or. en

Amendment 25Barry Andrews, Nicola Danti, Samira Rafaela, Svenja Hahn, Urmas Paet

Draft opinionParagraph 3

Draft opinion Amendment

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3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of well-balanced IP rights in free trade agreements (FTAs) and at the WTO should serve the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances; stresses that public health crises should constitute legitimate grounds for activating such flexibilities; and notes that developing countries may need to rely on these flexibilities in order to respond appropriately to the COVID-19 crisis;

Or. en

Amendment 26Anna Cavazzini, Heidi Hautala

Draft opinionParagraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that a balance must be struck between encouraging innovation, ensuring access to medicines, and protecting public health; underlines that the flexibilities provided in the TRIPS agreement should be used to address potential supply shortages in exceptional circumstances;

Or. en

Amendment 27Raphaël Glucksmann, Aurore Lalucq

Draft opinion

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Paragraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines however that the TRIPS agreement should be reviewed to ensure that it meets developing countries’ access to essential medicines;

Or. en

Amendment 28Emmanuel Maurel

Draft opinionParagraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances; asks for an European Health Exception notified to the WTO and included in all trade agreements, past and future, keeping a zero tariff on pharmaceutical products but allowing parties to provide state aid to their domestic health-related and pharmaceutical sector; asks for a regulation on the disqualification of any future dispute raised by our FTA partners on the health issue;

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Or. en

Amendment 29Tiziana Beghin

Draft opinionParagraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances and solve the current problems related to the use of compulsory licencing;

Or. en

Amendment 30Emmanouil Fragkos, Geert Bourgeois

Draft opinionParagraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products and one of the most research intensive region in this area in the world; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

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Or. en

Amendment 31Andrey Kovatchev

Draft opinionParagraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments and for maintaining EU's global competitive advantage in innovation; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

Or. en

Amendment 32Massimiliano Salini

Draft opinionParagraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments and EU's competitive position in innovation; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

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Or. en

Amendment 33Agnes Jongerius, Kathleen Van Brempt, Biljana Borzan, Inma Rodríguez-Piñero

Draft opinionParagraph 3

Draft opinion Amendment

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement can be used to address potential supply shortages in exceptional circumstances;

3. Emphasises that the EU is a leading global exporter of pharmaceutical products; notes that the protection and enforcement of IP rights in free trade agreements (FTAs) and at the WTO is crucial to the development of new medicines and treatments; underlines that the flexibilities provided in the TRIPS agreement should be used to address potential supply shortages in exceptional circumstances;

Or. en

Amendment 34Agnes Jongerius, Kathleen Van Brempt, Biljana Borzan, Inma Rodríguez-Piñero, Raphaël Glucksmann, Costas Mavrides

Draft opinionParagraph 3 a (new)

Draft opinion Amendment

3 a. Acknowledges that the EU’s recent trade agreements includes clear rules on commercial aspects of intellectual property rights, which generally acknowledge the issuing of compulsory licences in line with the TRIPS agreement; however, provisions such as data exclusivity enhanced patent protection and the protection of trade secrets, could possibly make it more difficult for many countries to invoke such clauses to their fullest effect; calls upon the Commission to give the

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Parliament an assessment of what role the EU free trade agreements and TRIPS can provide in this situation, including whether the Commission is considering guidelines in which voluntary licensing could be encouraged over immediate compulsory licensing;

Or. en

Amendment 35Enikő Győri

Draft opinionParagraph 3 a (new)

Draft opinion Amendment

3 a. Welcomes the commitment of the Commission to ensuring that emergency measures designed to tackle COVID-19 effects must be targeted, proportionate, transparent, temporary and consistent with WTO rules;

Or. en

Amendment 36Danuta Maria Hübner

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally; stresses the importance that the future agreement between the United Kingdom and the EU allows both sides to respond to emerging health threats, whilst also ensuring the

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supply of medicines and medical products in the best possible manner;

Or. en

Amendment 37Roman Haider

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system is one important way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally; another way to ensure the EU`s strategic autonomy in health is to include the pharmaceutical production of certain products, like penicillin, which is produced within the EU currently only by Novartis in Kundl/Austria, into the IPCEI programme (Important Projects of Common European Interest);

Or. en

Amendment 38Andrey Kovatchev

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally; recalls that

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difference in regulatory frameworks and standards for medicinal products can create an obstacle to trade; encourages the adoption of international standards to ensure the quality and safety of imported final or intermediate medicinal products and the inclusion of strong regulatory cooperation provisions in EU bilateral trade agreements to ensure that all medicinal products destined for the European market fulfill the applicable quality standards;

Or. en

Amendment 39Raphaël Glucksmann, Aurore Lalucq

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Welcomes the Commissioner for Internal Market’s statements on the reshoring of strategic supply chains; notes that a functioning multilateral trading system guaranteeing multiple sources of manufacturing for essential medicines could serve as a complement to the European production;

Or. en

Amendment 40Massimiliano Salini

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple

4. Emphasises that a broad network of FTAs that take into account components of intellectual property, together with a functioning multilateral trading system

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sources of manufacturing for essential medicines are available and regulatory standards converge globally;

constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally in order to maintain in Europe and the world a strong innovation framework able to withstand future health crises;

Or. en

Amendment 41Tiziana Beghin

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Emphasises that a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and easily checked against any counterfeiting in order to fully comply with regulatory standards in Europe and globally;

Or. en

Amendment 42Barry Andrews, Nicola Danti, Dita Charanzová, Samira Rafaela, Svenja Hahn, Urmas Paet

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Emphasises that a broad network of FTAs together with a fully functioning multilateral trading system with the World Trade Organisation and an operational Appellate Body at its core constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory

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standards converge globally;

Or. en

Amendment 43Anna Cavazzini, Heidi Hautala

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Emphasises that keeping all options open to ensure the adequate availability of needed pharmaceuticals, including by authorising the import of medicines produced abroad under compulsory licenses, is the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally; calls on the EU to provide for exception clauses in European rules on data- and market exclusivity so that Member States can effectively use compulsory licenses;

Or. en

Amendment 44Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides

Draft opinionParagraph 4

Draft opinion Amendment

4. Emphasises that a broad network of FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

4. Emphasises that a broad network of fair and well implemented FTAs together with a functioning multilateral trading system constitute the best way of guaranteeing that multiple sources of manufacturing for essential medicines are available and regulatory standards converge globally;

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Or. en

Amendment 45Enikő Győri

Draft opinionParagraph 4 a (new)

Draft opinion Amendment

4 a. Emphasizes the need for a broader trade and health initiative within the WTO that aims to enhance cooperation and develop guidance to ensure a coordinated response in the event of shortage of essential medical supplies;

Or. en

Amendment 46Anna Cavazzini, Heidi Hautala

Draft opinionParagraph 5

Draft opinion Amendment

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products should be exempted from retaliation in trade disputes;

5. Takes notes of recent proposals to extend the scope of the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for future negotiations to respect the policy space of all countries in order to ensure their strategic autonomy and the access of their citizens to pharmaceutical and medicinal products; stresses that medical products should be exempted from retaliation in trade disputes;

Or. en

Amendment 47Andrey Kovatchev

Draft opinion

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Paragraph 5

Draft opinion Amendment

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products should be exempted from retaliation in trade disputes;

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products and medicines, including in their intermediate forms, should be exempted from retaliation in trade disputes;

Or. en

Amendment 48Massimiliano Salini

Draft opinionParagraph 5

Draft opinion Amendment

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products should be exempted from retaliation in trade disputes;

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products and pharmaceuticals, including in their intermediate forms, should be exempted from retaliation in trade disputes;

Or. en

Amendment 49Tiziana Beghin

Draft opinionParagraph 5

Draft opinion Amendment

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and

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medicinal products; stresses that medical products should be exempted from retaliation in trade disputes;

medicinal products; stresses that medical products should be exempted from retaliation in trade disputes and easily accessible;

Or. en

Amendment 50Barry Andrews, Nicola Danti, Samira Rafaela, Svenja Hahn, Urmas Paet

Draft opinionParagraph 5

Draft opinion Amendment

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; calls for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products should be exempted from retaliation in trade disputes;

5. Strongly encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement; urges for its scope to be extended to all pharmaceutical and medicinal products; stresses that medical products should at all times be exempted from retaliation in trade disputes;

Or. en

Amendment 51Agnes Jongerius, Kathleen Van Brempt, Biljana Borzan, Inma Rodríguez-Piñero, Raphaël Glucksmann, Costas Mavrides

Draft opinionParagraph 5 a (new)

Draft opinion Amendment

5 a. Notes that the whole world is fighting the COVID-19 pandemic, as no available medication that can fight the disease has been found yet; calls upon the Commission to coordinate with the WTO and the WHO that all countries, and in particular the developing countries, have equal access in case of any breakthrough drugs; encourages all member states to make efforts to establish a pool of patent rights for COVID-19 technologies at the WHO;

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Or. en

Amendment 52Jörgen Warborn

Draft opinionParagraph 5 a (new)

Draft opinion Amendment

5 a. Calls also for the EU to unilaterally and temporarily eliminate tariffs on medical and pharmaceutical products to facilitate imports of these goods;

Or. en

Amendment 53Agnes Jongerius, Kathleen Van Brempt, Biljana Borzan, Inma Rodríguez-Piñero

Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

deleted

Or. en

Amendment 54Emmanuel Maurel

Draft opinionParagraph 6

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Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; asks for an European directive allowing Member States to force, within 5 years, quotas of domestic production of various drugs (for instance basic drugs like acetaminophen or antibiotics, also substances needed in critical care units, like opiates or anesthetics), raw materials needed for their production, medical devices and medical clothing.

Or. en

Amendment 55Roman Haider

Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that whereas - a complete repatriation of medical supply chains is not possible in a global economy; a gradual repatriation of strategic medicine production secures the stock of medical products within the EU, also during times of crisis, and strengthens the EUs independence from foreign producers who might impose protectionist measures; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

Or. en

Amendment 56Emmanouil Fragkos, Geert Bourgeois

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Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of medical supply chains is neither possible or desirable as global medical markets and global specialisation is to the benefit of the EU; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

Or. en

Amendment 57Barry Andrews, Nicola Danti, Samira Rafaela, Svenja Hahn, Urmas Paet

Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy nor is it desirable; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises; calls on the Commission to explore the creation of a common European strategic reserve of medicines, building on the rescEU stockpile initiative.

Or. en

Amendment 58

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Danuta Maria Hübner

Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s multilateral partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit individual states from resorting to protectionist measures, such as import and/or export restrictions during health crises.

Or. en

Amendment 59Raphaël Glucksmann, Agnes Jongerius, Aurore Lalucq

Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of all medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

Or. en

Amendment 60Urmas Paet

Draft opinion

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Paragraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work more closely between each other, with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

Or. en

Amendment 61Enikő Győri

Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of medical supply chains is not possible neither should be the aim in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

Or. en

Amendment 62Anna Cavazzini, Heidi Hautala

Draft opinionParagraph 6

Draft opinion Amendment

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6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to damaging measures during health crises.

Or. en

Amendment 63Tiziana Beghin

Draft opinionParagraph 6

Draft opinion Amendment

6. Underlines that a complete repatriation of medical supply chains is not possible in a global economy; urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises.

6. Urges the Commission and the Member States to work with the EU’s partners, the WHO and WTO, on establishing an international framework that can prevent the breakdown of supply chains and limit resort to protectionist measures during health crises especially considering the lack of EU medicine production facilities.

Or. en

Amendment 64Agnes Jongerius, Kathleen Van Brempt, Biljana Borzan, Inma Rodríguez-Piñero, Raphaël Glucksmann, Costas Mavrides

Draft opinionParagraph 6 a (new)

Draft opinion Amendment

6 a. Calls upon the Commission and the Member States to make sure that there is a constant and reliable supply of medical products; stresses that the development of medical products has to be

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in line with the international standards of human rights, in compliance with the Paris agreement, and that labour rights are in compliance with the ILO conventions; calls on the Commission that to maintain a level playing field in the internal market a common European approach for binding supply chain law is urgently needed;

Or. en

Amendment 65Andrey Kovatchev

Draft opinionParagraph 6 a (new)

Draft opinion Amendment

6 a. Calls on the Commission and the Member States to ensure the swift and full implementation - and if needed a revision - of the regulation on FDI screening, in which health care should be included as a strategic sector;

Or. en

Amendment 66Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides

Draft opinionParagraph 6 a (new)

Draft opinion Amendment

6 a. Highlights the importance that the European Commission takes all necessary measures to combat speculation, fraud and price abuses in the trade of essential medical substances;

Or. en

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Amendment 67Agnes Jongerius, Kathleen Van Brempt, Biljana Borzan, Inma Rodríguez-Piñero, Raphaël Glucksmann, Costas Mavrides

Draft opinionParagraph 6 b (new)

Draft opinion Amendment

6 b. Emphasises the importance of European safety standards for medical products; urges the Commission to check medical products entering our internal market that they uphold to the European safety standards; calls upon the Commission to ensure that consumer protection is prioritised in the WTO negotiations on e-commerce in negotiation;

Or. en

Amendment 68Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides

Draft opinionParagraph 6 b (new)

Draft opinion Amendment

6 b. Calls on the Commission to exercise leadership at global level to ensure that developing countries have guaranteed access to and supply of essential medicines, especially in emergencies;

Or. en

Amendment 69Inma Rodríguez-Piñero, Agnes Jongerius, Javier Moreno Sánchez, Costas Mavrides

Draft opinionParagraph 6 c (new)

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Draft opinion Amendment

6 c. Stresses the importance of ensuring universal access to vaccines and medical treatment, especially in cases of emergency and for new diseases for which no treatment exists, as in the case of Covid-19; urges a close collaboration between the WHO and the WTO to ensure the supply of the vaccine once it is found; at the same time, calls on the Commission to strengthen its mechanisms for the joint procurement of medicines in order to guarantee universal access to treatment for all citizens regardless of their place of residence.

Or. en