BETA

Activities of Antoni COMÍN I OLIVERES

Plenary speeches (34)

Annual report 2018 on the human rights and democracy in the world and the European Union's policy on the matter (debate)
2020/01/14
Dossiers: 2019/2125(INI)
Distortion of European history and remembrance of the Second World War (topical debate)
2020/01/15
Rights of indigenous peoples (debate)
2020/01/29
EU strategy for mobility and transport: measures needed until 2030 and beyond (debate)
2020/01/29
EU response to devastation following floods in Spain (debate)
2020/01/30
The illegal trade in companion animals in the EU (debate)
2020/02/11
Dossiers: 2019/2814(RSP)
Preparation of the Extraordinary European Council Meeting of 20 February 2020 on the Multiannual Financial Framework (debate)
2020/02/12
Gender Equality Strategy (debate)
2020/02/12
EU coordinated action to combat the COVID-19 pandemic and its consequences (continuation of debate)
2020/04/16
Dossiers: 2020/2616(RSP)
Conclusions of the extraordinary European Council meeting of 23 April 2020 - New MFF, own resources and Recovery plan (debate)
2020/05/13
Dossiers: 2020/2631(RSP)
Vaccines and therapeutics in the context of Covid-19 (debate)
2020/05/14
Foreign policy consequences of the COVID-19 crisis - The PRC national security law for Hong Kong and the need for the EU to defend Hong Kong's high degree of autonomy - The EU's response to the possible Israeli annexation in the West Bank (debate)
2020/06/18
Dossiers: 2020/2665(RSP)
Foreign policy consequences of the COVID-19 crisis - The PRC national security law for Hong Kong and the need for the EU to defend Hong Kong's high degree of autonomy - The EU's response to the possible Israeli annexation in the West Bank (debate)
2020/06/18
Dossiers: 2020/2665(RSP)
The role of cohesion policy in tackling the socio-economic fallout from COVID-19 (debate)
2020/07/10
Dossiers: 2020/2644(RSP)
Draft Council decision on the system of own resources of the European Union (continuation of debate)
2020/09/14
Dossiers: 2018/0135(CNS)
The need for an immediate and humanitarian EU response to the current situation in the refugee camp in Moria (debate)
2020/09/17
European Climate Law (debate)
2020/10/06
Dossiers: 2020/0036(COD)
The impact of Covid-19 outbreak on long-term care facilities (debate)
2020/10/08
Police brutality within the EU (debate)
2020/10/20
Police brutality within the EU (debate)
2020/10/20
EU measures to mitigate social and economic impact of Covid-19 (debate)
2020/10/21
Programme for the Union's action in the field of health for the period 2021-2027 (“EU4Health Programme”) (debate)
2020/11/12
Dossiers: 2020/0102(COD)
Situation of Fundamental Rights in the European Union – Annual Report for the years 2018-2019 (debate)
2020/11/24
Dossiers: 2019/2199(INI)
Pharmaceutical strategy for Europe (debate)
2020/11/26
EU Security Union Strategy (debate)
2020/12/16
Dossiers: 2020/2791(RSP)
EU global strategy on COVID-19 vaccinations (debate)
2021/01/19
Implementation of the Common Foreign and Security Policy - annual report 2020 - Implementation of the Common Security and Defence Policy - annual report 2020 - Human Rights and Democracy in the World and the EU policy on the matter - annual report 2019 (debate)
2021/01/19
Dossiers: 2020/2208(INI)
Humanitarian and political situation in Yemen (debate)
2021/02/09
Dossiers: 2021/2539(RSP)
The state of play of the EU’s COVID-19 Vaccination Strategy (debate)
2021/02/10
Programme for the Union’s action in the field of health for the period 2021-2027 (‘EU4Health programme’) (debate)
2021/03/09
Dossiers: 2020/0102(COD)
Declaration of the EU as an LGBTIQ Freedom Zone (debate)
2021/03/10
Dossiers: 2021/2557(RSP)
System of own resources of the European Union – Own resource based on non-recycled plastic packaging waste and certain aspects of the GNI-based own resource – Collection of own resources accruing from value added tax (debate)
2021/03/24
Dossiers: 2018/0132(APP)
Russia, the case of Alexei Navalny, military build-up on Ukraine's border and Russian attack in the Czech Republic (debate)
2021/04/28
Dossiers: 2021/2642(RSP)
Programme for the environment and climate action (LIFE) 2021-2027 (debate)
2021/04/29

Shadow opinions (1)

OPINION on a Farm to Fork Strategy for a fair, healthy and environmentally friendly food system
2021/04/23
Committee: DEVE
Dossiers: 2020/2260(INI)
Documents: PDF(142 KB) DOC(78 KB)
Authors: [{'name': 'Benoît BITEAU', 'mepid': 197512}]

Oral questions (2)

LGBTI-free zones in Poland within the scope of the Rete Lenford case
2020/06/17
Dossiers: 2020/2778(RSP)
Documents: PDF(63 KB) DOC(11 KB)
Waiver of patent protection to speed up vaccine production in the EU
2021/03/01
Documents: PDF(48 KB) DOC(10 KB)

Written explanations (8)

Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (A9-0004/2020 - Guy Verhofstadt)

We do not like the decision taken by the British people in June 2016 but we must respect it. The decisions of the citizenship must be respected. We would love to see the UK to come back to the EU, and this will happen when, among other things, the EU has become a truly democratic project where no one will ever think to exit. We have voted in favour of the Withdrawal Agreement but with a heavy heart.
2020/01/29
Verification of credentials (A9-0015/2020 - Lucy Nethsingha)

. ‒ We support this report because it is important to make a thorough verification of credentials. We also support the fact that Mr Oriol Junqueras i Vies is a Member of the European Parliament and as such the EP should not make any decision regarding his rights as MEP, as well as asking all Member States, all EU institutions, and the EU as a whole, to respect and guarantee the rulings of the European Court of Justice (ECJ).
2020/01/30
Gender pay gap (B9-0069/2020, B9-0073/2020, B9-0083/2020, B9-0084/2020)

. ‒ We support this initiative because, as many others, we are also in favour of reaching the complete equality between men and women. The gender pay gap has to be corrected also thanks to the help of the European Commission and the other European institutions and agencies.
2020/01/30
An EU strategy to put an end to female genital mutilation around the world (B9-0090/2020, B9-0092/2020)

We support this motion because we deplore female genital mutilation everywhere, wherever it is practiced or defended. The EU must push for an end to such an abhorrent deed, one of the most diminishing and violent made to women, and above all the young.
2020/02/12
Proposed mandate for negotiations for a new partnership with the United Kingdom of Great Britain and Northern Ireland (B9-0098/2020)

. ‒ We support this motion because we also look forward to the best partnership possible between the EU and the UK. We do not wish to see any kind of punishment behaviour from the EU, and no distrustful behaviour from the UK. The EU and the UK have a historic opportunity to remake their relationship for the next decades, one of mutual respect and cooperation. This is what our citizens and businesses demand from MEPs and officials. In our case, the UK is Catalonia’s fifth destination in terms of exports, and nearly 40% of Catalan SMEs tend to export to that country. We will not let them down. Finally, we deplore and reject the point of this motion that says that any agreement as regards Gibraltar will need Spain’s assent. Gibraltar has been a British overseas territory since the beginning of the 18th century, and any agreement on Gibraltar will need the assent, mainly and mostly, of Gibraltar’s people.
2020/02/12
The illegal trade in companion animals in the EU (B9-0088/2020)

We support this motion because the welfare of animals is linked to the welfare of people. Trafficking in animals, many of them not vaccinated or without the necessary permits and certifications, means trafficking in diseases. This report reminds us that more than 70% of new diseases are of animal origin. The saddest thing is that this matter could be avoided: the Commission must strengthen the implementation of Regulation 576/2013 and impose sanctions on those stakeholders who profit from this traffic. In addition, the illegal trade of pets in the EU undermines the proper functioning of the single market because there is a bad practice in the digital sale purchase. Finally, customs authorities should increase cooperation, communication and training between themselves in terms of pet trade, and we would like to encourage all those who read this that the best is not to buy a pet, but to adopt it.
2020/02/12
Stocktaking of European elections (A9-0211/2020 - Pascal Durand)

This report puts forward very important points that should be addressed in order to improve the democratic functioning of the EU, such as the establishment of a single EU electoral authority, the need to increase the role of European political parties, and the reform of the democratic process for choosing the Commission President before the next European elections of 2024.Despite our support for these points and the excellent work carried out by the rapporteur, Mr. Pascal Durand, we feel compelled to vote against the Report. The reason is that the amendments deploring the fact that elected MEP Oriol Junqueras was not able to take his rightful seat because of the non-recognition of his immunity by the Spanish Supreme Court, which keeps him unfairly imprisoned, and stressing that the European Parliament is the only body competent to waive the immunity of its Members, were rejected.We consider that the case of Mr. Oriol Junqueras is of the utmost importance for the upholding of the Rule of Law in the EU. The vote against mentioning the ECJ ruling of December 19th affecting Oriol Junqueras and myself also shows that some MEPs in this house do everything they can to deny reality.
2020/11/25
European Citizens' Initiative - Minority Safepack (B9-0403/2020, B9-0405/2020)

The European Citizens’ Initiative ‘Minority SafePack – one million signatures for diversity in Europe’ is a clear proof of the will of the 1 123 422 European citizens calling on the European Commission to protect EU national minorities from some centralist Member States that discriminate against their linguistic minorities.We have always supported this proposal and we find it very positive for the defence of Catalan language speakers, since it denounces linguistic discrimination and promotes the presence of the language in culture, in the school system, in media and public administrations.Unfortunately, we abstained in our final vote because we do not find the proposal in the education system ambitious enough, as the only ones who have their fundamental rights threatened by language impositions are members of minorities.We call on the European Commission to accept this European citizens’ initiative and to respect the will of European citizens.
2020/12/17

Written questions (64)

International Mother Language Day – let’s make the European Union genuinely multilingual
2020/02/25
Documents: PDF(43 KB) DOC(10 KB)
Compliance with the Water Framework Directive (WFD) and the Floods Directive (FD) in the Ebro Delta
2020/02/25
Documents: PDF(43 KB) DOC(10 KB)
Violence against women on the rise in Pakistan
2020/03/12
Documents: PDF(49 KB) DOC(10 KB)
Question on the requisition of medical equipment in Spain, and COM (2020)0112 on the economic aspects of the COVID-19 crisis
2020/03/20
Documents: PDF(51 KB) DOC(10 KB)
Compliance with the Late Payment Directive in Spain during the COVID-19 crisis
2020/03/23
Documents: PDF(41 KB) DOC(9 KB)
Flight cancellations during the COVID-19 pandemic
2020/03/31
Documents: PDF(40 KB) DOC(10 KB)
Spanish Supreme Court statement on the release of prisoners during the coronavirus emergency
2020/04/02
Documents: PDF(42 KB) DOC(10 KB)
COVID-19 apps: technology and data protection
2020/04/16
Documents: PDF(42 KB) DOC(10 KB)
Under-reporting of COVID-19-related deaths
2020/04/21
Documents: PDF(41 KB) DOC(10 KB)
Government control of the media and freedom of expression in the Member States during the COVID-19 crisis
2020/04/24
Documents: PDF(44 KB) DOC(10 KB)
Possible violation of the European Convention on Human Rights and the Charter of Fundamental Rights of the European Union in Spain
2020/05/04
Documents: PDF(52 KB) DOC(10 KB)
Discrimination against EU citizens based on their origin
2020/05/19
Documents: PDF(42 KB) DOC(10 KB)
Nissan's closure of its factories in Catalonia
2020/05/29
Documents: PDF(41 KB) DOC(9 KB)
Late payment of subsidies to employees
2020/06/02
Documents: PDF(41 KB) DOC(10 KB)
The LTGBI flag and other non-official flags are banned in Spanish public institutions
2020/06/11
Documents: PDF(43 KB) DOC(10 KB)
Lack of data on the creative and cultural sectors (CCS)
2020/06/12
Documents: PDF(51 KB) DOC(10 KB)
Forced labour in Uyghur detention camps in China
2020/06/15
Documents: PDF(42 KB) DOC(10 KB)
VP/HR Borrell’s compliance with the principles governing the conduct of Members of the Commission
2020/06/24
Documents: PDF(42 KB) DOC(10 KB)
Disability focal points
2020/07/01
Documents: PDF(53 KB) DOC(11 KB)
Disability focal points
2020/07/01
Documents: PDF(53 KB) DOC(11 KB)
New deadline for the exemption on duties and VAT for equipment and medicine needed to fight against COVID‑19
2020/07/07
Documents: PDF(43 KB) DOC(10 KB)
Lack of investigation into the Spanish Crown’s implication in a money laundering case
2020/07/15
Documents: PDF(43 KB) DOC(10 KB)
Changes to Commission Decision (EU) 2020/2146 enabling public and non-profit organisations to combat the effects of COVID-19
2020/07/20
Documents: PDF(41 KB) DOC(9 KB)
Spain’s compliance with the Late Payments Directive during the COVID-19 crisis
2020/07/20
Documents: PDF(42 KB) DOC(10 KB)
Supplementary question about the Spanish Supreme Court statement on the release of prisoners during the coronavirus emergency
2020/07/27
Documents: PDF(40 KB) DOC(9 KB)
Surveillance of political opponents in Spain
2020/08/17
Documents: PDF(55 KB) DOC(11 KB)
Surveillance of political opponents in Spain
2020/08/27
Documents: PDF(60 KB) DOC(10 KB)
Mass arrest of LGBTI activists in Poland
2020/09/01
Documents: PDF(58 KB) DOC(11 KB)
The High Representative for Foreign Affairs and Common Security Policy supports a Francoist minister
2020/09/04
Documents: PDF(47 KB) DOC(10 KB)
Concerns about the intended merger between CaixaBank and Bankia
2020/09/07
Documents: PDF(45 KB) DOC(10 KB)
True cross-border access to online content in the EU
2020/09/08
Documents: PDF(48 KB) DOC(10 KB)
Possible competition distortion by auditing firms in the EU
2020/09/17
Documents: PDF(44 KB) DOC(10 KB)
Serious concerns about the announced closure of Saint Gobain glass factory located in the municipality of l’Arboç (Catalonia)
2020/09/24
Documents: PDF(40 KB) DOC(9 KB)
The Digital Economy and Society Index (DESI)
2020/09/25
Documents: PDF(42 KB) DOC(9 KB)
Updated deadline for the exemption on duties and VAT for equipment and medicine needed to fight against COVID‑19
2020/10/01
Documents: PDF(43 KB) DOC(10 KB)
2020 Rule of Law Report
2020/10/02
Documents: PDF(41 KB) DOC(10 KB)
Renegotiation of the Energy Charter Treaty: alignment with the Paris Agreement before the 2021 COP and next steps envisaged by the EU
2020/10/12
Documents: PDF(49 KB) DOC(10 KB)
Energy Charter Treaty renegotiation: the EU’s position regarding fossil fuels protection, the Investor-State Dispute Settlement mechanism and public information
2020/10/12
Documents: PDF(51 KB) DOC(10 KB)
Delay in the transposition of Directive 2018/1808 in Spain
2020/10/15
Documents: PDF(42 KB) DOC(10 KB)
Potentially excessive costs for military equipment in Spain amid the COVID-19 pandemic
2020/10/15
Documents: PDF(51 KB) DOC(10 KB)
Police brutality in Spain not being investigated
2020/10/22
Documents: PDF(42 KB) DOC(11 KB)
The leader of the Spanish People’s Party’s boasting about his party’s influence over the Commission
2020/10/22
Documents: PDF(50 KB) DOC(10 KB)
The situation of Bernardo Caal, defender of human rights in Guatemala and prisoner of conscience
2020/10/28
Documents: PDF(46 KB) DOC(10 KB)
Coercive labour programmes in Tibet
2020/10/29
Documents: PDF(65 KB) DOC(11 KB)
EU Recovery Funds for regions and cities
2020/10/29
Documents: PDF(40 KB) DOC(9 KB)
Euro coins with the effigy of former Spanish king Juan Carlos I
2020/12/24
Documents: PDF(41 KB) DOC(10 KB)
Privacy, malware and decryption
2021/01/25
Documents: PDF(43 KB) DOC(10 KB)
Energy price in Spain
2021/01/26
Documents: PDF(47 KB) DOC(10 KB)
Allowing couples without legal documents that prove their relationship to reunite during the pandemic
2021/01/27
Documents: PDF(40 KB) DOC(10 KB)
The ECtHR has given another judgment against Spain for failing to investigate a case of torture of a detained person
2021/01/28
Documents: PDF(46 KB) DOC(10 KB)
Extraction of a sixth dose from Pfizer-BioNTech vaccine vials
2021/01/29
Documents: PDF(39 KB) DOC(9 KB)
The Vice-President / High Representative of the European Union for Foreign Affairs and Security Policy calls on Russia to release Aleksei Navalny
2021/02/03
Documents: PDF(43 KB) DOC(10 KB)
Clarification concerning the COVID-19 vaccine supply cuts in the EU
2021/02/03
Documents: PDF(59 KB) DOC(11 KB)
The right to artistic freedom in Spain
2021/02/12
Documents: PDF(42 KB) DOC(10 KB)
European Citizens’ Initiative as a tool for citizens’ participation in the EU decision-making process
2021/02/15
Documents: PDF(50 KB) DOC(10 KB)
Commission’s plans to strengthen European public health and ensure a level playing field for SMEs in the industrial hemp sector
2021/02/16
Documents: PDF(51 KB) DOC(10 KB)
The case of Mikel Zabaltza
2021/02/26
Documents: PDF(49 KB) DOC(10 KB)
Torture in Tibet
2021/03/26
Documents: PDF(50 KB) DOC(10 KB)
AstraZeneca vaccine production and black market in vaccines
2021/03/30
Documents: PDF(51 KB) DOC(11 KB)
Conclusion of the EU’s accession to the Istanbul Convention
2021/04/16
Documents: PDF(49 KB) DOC(10 KB)
Legal consequences of a denouncement by a Member State of an international agreement signed by the European Union
2021/04/16
Documents: PDF(58 KB) DOC(10 KB)
Regional and minority languages on the Conference on the Future of Europe multilingual digital platform
2021/04/21
Documents: PDF(43 KB) DOC(10 KB)
Impact of the Commission’s statement of 14 April on the vaccination rollout in developing countries
2021/04/21
Documents: PDF(42 KB) DOC(10 KB)
Compliance with the Late Payment Directive and companies receiving Next Generation EU Funds in Spain
2021/04/21
Documents: PDF(42 KB) DOC(10 KB)

Amendments (535)

Amendment 3 #

2021/2025(INI)

Motion for a resolution
Citation 15
— having regard to the European Convention for the Protection of Human Rights and Fundamental Freedoms, the European Social Charter, the case law of the European Court of Human Rights and the European Committee of Social Rights, the Council of Europe Framework Convention for the Protection of National Minorities (FCNM) and the European Charter for Regional or Minority Languages (ECRML) and the conventions, recommendations, resolutions, opinions and reports of the Parliamentary Assembly, the Committee of Ministers, the Human Rights Commissioner, the European Commission Against Racism and Intolerance, the Steering Committee on Anti- Discrimination, Diversity and Inclusion, the Venice Commission, the Advisory Committee on the FCNM, the Committee of Experts of the ECRML and other bodies of the Council of Europe,
2021/04/26
Committee: LIBE
Amendment 31 #

2021/2025(INI)

Motion for a resolution
Recital C a (new)
C a. whereas respect for the rights of minorities is a part of the political criteria an accession-candidate country must fulfil at the time of accession; whereas while the Union has an important role in ensuring respect for the rights of national and linguistic minorities in candidate- countries, it so far hasn't yet adopted any benchmarks for its Member States in this area, thus making possible that Member States backtrack on their commitments; whereas the 2020 report, too, misses to cover the rights of national and linguistic minorities;
2021/04/26
Committee: LIBE
Amendment 32 #

2021/2025(INI)

Motion for a resolution
Recital C b (new)
C b. whereas the European Parliament has already called on the European Commission to adopt a common framework of Union minimum standards for the protection of rights of persons belonging to minorities, which are strongly embedded in a legal framework guaranteeing democracy, the rule of law and fundamental rights throughout the Union1a; _________________ 1aEuropean Parliament Resolution of 13 November 2018 on minimum standards for minorities in the EU (OJ C 363, 28.10.2020, p. 13)
2021/04/26
Committee: LIBE
Amendment 209 #

2021/2025(INI)

Motion for a resolution
Paragraph 17 a (new)
17 a. Calls on the Commission to include in its next reports detailed analyses and recommendations on the situation of the rights of autochthonous national and linguistic minorities, including through the involvement of the European Union Agency for Fundamental Rights; stresses that this is an area where it should establish strong links and synergies with the Council of Europe, and in particular with its Advisory Committee on the Framework Convention for the Protection of National Minorities and the Committee of Experts of the European Charter for Regional or Minority Languages;
2021/04/26
Committee: LIBE
Amendment 75 #

2021/2011(INI)

Draft opinion
Paragraph 2
2. Asks the Commission to set ambitious product design requirements for easy removal of CRMs; calls for ambitious minimum recycled CRM content targets; requests that the Commission propose new collection schemes to increase collection rates of waste products containing CRMs; asks the Commission to propose dedicated recycling targets for CRMs, by extending the approach suggested in the proposal for a regulation on batteries and waste batteries (COM(2020)0798) to other product groups, to improve resource circularity and efficiency;
2021/05/04
Committee: ENVI
Amendment 105 #

2021/2011(INI)

Draft opinion
Paragraph 3
3. Calls on the Commission and the European Raw Materials Alliance to prioritise CRM extraction from existing mines and waste dumps over new mining; requests that the Commission assess whether current due diligence and environment rules are sufficient to guarantee minimal environmental impact of potential new mining projects in the EU, and to ensure reclamation once mining activities are completed;
2021/05/04
Committee: ENVI
Amendment 139 #

2021/2011(INI)

Draft opinion
Paragraph 4
4. Believes that mining permits should include requirements and targets for the proper recovery of all CRMs; requests that the Commission urgently implement Parliament’s demands in its resolution of 27 April 2017 on implementation of the Mining Waste Directive2 ;[1];[1] OJ C 298, 23.8.2018, p. 132. __________________ 2 OJ C 298, 23.8.2018, p. 132.
2021/05/04
Committee: ENVI
Amendment 160 #

2021/2011(INI)

Draft opinion
Paragraph 6
6. Believes that mining should be forbidden in nature conservation areas and that restoration should be obligatory for the ongoing mining activities in these areas; calls on the Commission to evaluate legislative options to ensure that local communities are fully involved in the permit procedures for new industrial and new mining projects.
2021/05/04
Committee: ENVI
Amendment 180 #

2021/2011(INI)

Draft opinion
Paragraph 6 a (new)
6a. Recalls that responsible sourcing and due diligence are key issues throughout the raw materials value chain; and that, given the EU’s high dependence on imports, sustainable and responsible sourcing from third countries must be guaranteed.
2021/05/04
Committee: ENVI
Amendment 186 #

2021/2011(INI)

Draft opinion
Paragraph 6 b (new)
6b. Reminds that control over natural resources too often opens the door to armed conflicts or social inequality, and that the Union should take into account such risks when addressing its policies regarding CRM sourced in third countries, especially
2021/05/04
Committee: ENVI
Amendment 53 #

2021/0000(INI)

Draft opinion
Paragraph 5
5. Supports the Commission’s guidance to Member States to include in their Recovery Plans investments and reforms in flagship areas under the green transition that are in line with the EU’s objective of achieving climate neutrality by 2050 at the latest – such as renewable energy, renovation, sustainable mobility, the circular economy and biodiversity – given their potential to create jobs and growth.
2021/01/28
Committee: ENVI
Amendment 59 #

2021/0000(INI)

Draft opinion
Paragraph 5 a (new)
5a. Underlines the Commission’s call to Member States to engage as soon as possible in a broad policy dialogue that includes all relevant stakeholders and regional, economic and social partners, to prepare their Recovery and Resilience plans; and stresses the importance of establishing robust coordination mechanisms with local governments under this aim;
2021/01/28
Committee: ENVI
Amendment 64 #

2021/0000(INI)

Draft opinion
Paragraph 5 b (new)
5b. Underlines that Member States’ Recovery Plans are an opportunity for the transition into a social and solidarity- based economy and to an economic democracy; and asks the Commission to review the national Plans under this scope and to ensure that SME and other small stakeholders are not left behind in the implementation of the Plan’s projects and proposals;
2021/01/28
Committee: ENVI
Amendment 69 #

2021/0000(INI)

Draft opinion
Paragraph 5 c (new)
5c. Stresses that social and human development is the main driver for economic growth, as far as planetary bounds are respected, and that therefore other indicators than GDP must be considered to assess economic success, so that social and human development is truly taken into account;
2021/01/28
Committee: ENVI
Amendment 1 #

2020/2274(INI)

Motion for a resolution
Citation 2
— having regard to the UN Convention on Biological Diversity (CBD) of 1992, and the upcoming 15th meeting of the Conference of the Parties thereto (COP15),
2021/03/09
Committee: DEVE
Amendment 2 #

2020/2274(INI)

Motion for a resolution
Citation 7 a (new)
— having regard to Global Biodiversity Outlook 5 of the Secretariat of the Convention on Biological Diversity of 15 September 2020,
2021/03/09
Committee: DEVE
Amendment 3 #

2020/2274(INI)

Motion for a resolution
Citation 7 b (new)
— having regard to the UN Summit on Biodiversity of 30 September 2020,
2021/03/09
Committee: DEVE
Amendment 4 #

2020/2274(INI)

Motion for a resolution
Citation 7 c (new)
— having regard to the UN 2030 Agenda for Sustainable Development and to the Sustainable Development Goals (SDGs),
2021/03/09
Committee: DEVE
Amendment 14 #

2020/2274(INI)

Motion for a resolution
Citation 11 a (new)
— having regard to the Streamlining European Biodiversity Indicators (SEBI) 2020, issued by the Environmental European Agency,
2021/03/09
Committee: DEVE
Amendment 17 #

2020/2274(INI)

Motion for a resolution
Citation 18 a (new)
— having regard to the in-depth analysis entitled “The link between biodiversity loss and the increasing spread of zoonotic diseases”, published by its Directorate-General for External Policies in December 2020,
2021/03/09
Committee: DEVE
Amendment 19 #

2020/2274(INI)

Motion for a resolution
Citation 18 c (new)
— having regard to the IPBES Workshop Report on Biodiversity and Pandemics of 29th October 2020,
2021/03/09
Committee: DEVE
Amendment 28 #

2020/2274(INI)

Motion for a resolution
Recital B
B. whereas according to the IPBES 2019 global assessment report on biodiversity and ecosystem services, most of the Aichi Biodiversity Targets for 2020 willhave been missed;
2021/03/09
Committee: DEVE
Amendment 35 #

2020/2274(INI)

Motion for a resolution
Recital C b (new)
C b. whereas there is scientific evidence for a complex link between biodiversity loss and the increasing risk of zoonotic diseases such as COVID-19;
2021/03/09
Committee: DEVE
Amendment 60 #

2020/2274(INI)

Motion for a resolution
Recital G a (new)
G a. whereas the total ecological footprint of the EU-27 Member States plus the United Kingdom is high and is now more than twice the biocapacity available in the region, and this results in a large ecological deficit, which has negative consequences for the environment within and outside Europe;
2021/03/09
Committee: DEVE
Amendment 68 #

2020/2274(INI)

Motion for a resolution
Recital I
I. whereas in addition to international trade, illegal wildlife trade and illegal trade in timber and raw materials can accelerate the degradation and destruction of biodiversity in countries with weak institutions and environmental regulations;
2021/03/09
Committee: DEVE
Amendment 72 #

2020/2274(INI)

Motion for a resolution
Recital I b (new)
I b. whereas there are overlaps between biodiversity hotspots and areas suffering from poverty, as most conservation hotspots are located in countries with a high prevalence of poverty and food insecurity;
2021/03/09
Committee: DEVE
Amendment 88 #

2020/2274(INI)

Motion for a resolution
Paragraph 2
2. Calls for the EU to address the root causes of global biodiversity loss and to mainstream obligations on conservation and the sustainable use of resources into broader development policies;
2021/03/09
Committee: DEVE
Amendment 108 #

2020/2274(INI)

Motion for a resolution
Paragraph 6 a (new)
6 a. Highlights the direct and indirect impacts of EU Economy on global biodiversity and that EU has special responsibility for global biodiversity conservation and sustainable use of biological diversity
2021/03/09
Committee: DEVE
Amendment 116 #

2020/2274(INI)

Motion for a resolution
Paragraph 8
8. Regrets the fact that the EU budget for supporting external biodiversity policy remains considerably low in comparison with that earmarked for climate change policies and that environmentally harmful subsidies have not been phased out;
2021/03/09
Committee: DEVE
Amendment 124 #

2020/2274(INI)

Motion for a resolution
Paragraph 10
10. Recalls that the effectiveness of EU external biodiversity policy depends on policy coherence between biodiversity and other key EU external policies, such as trade and investment agreements;
2021/03/09
Committee: DEVE
Amendment 126 #

2020/2274(INI)

Motion for a resolution
Paragraph 10 a (new)
10 a. Underlines the need to implement an accessible, transparent, and publicly available screening system to identify and mitigate potential biodiversity risk of development projects funded by EU.
2021/03/09
Committee: DEVE
Amendment 131 #

2020/2274(INI)

Motion for a resolution
Paragraph 11
11. Urges the EU to mainstream biodiversity and ecosystem services into all policy areas, notably agriculture, fisheries, energy, mining, trade and climate change;
2021/03/09
Committee: DEVE
Amendment 147 #

2020/2274(INI)

Motion for a resolution
Paragraph 15
15. Recalls that agriculturale and food production both depends and has ve significant impacts on biodiversity;
2021/03/09
Committee: DEVE
Amendment 162 #

2020/2274(INI)

Motion for a resolution
Paragraph 17 a (new)
17 a. Recalls that agricultural development projects should comply with the international and EU environmental and social standards, especially those related to deforestation-free and land- neutral trade chains;
2021/03/09
Committee: DEVE
Amendment 186 #

2020/2274(INI)

Motion for a resolution
Paragraph 22
22. Highlights the EU’s responsibility to reduce the indirect drivers of biodiversity loss, by systematically including biodiversity and safeguards against landgrabs in trade negotiations and dialogues with developing countries;
2021/03/09
Committee: DEVE
Amendment 201 #

2020/2274(INI)

Motion for a resolution
Paragraph 25
25. Stresses that the deterioration of biodiversity and ecosystems have both direct and indirect impacts on public health, and the link between increasing spread of zoonotic diseases and biodiversity loss;
2021/03/09
Committee: DEVE
Amendment 206 #

2020/2274(INI)

Motion for a resolution
Paragraph 26
26. Recalls that ecological restoration is critical for the implementation of the ‘One Health’ approach, and the awareness on the links between biodiversity, which signals a healthy ecosystem, and human and animal health; underlines that air, water and soil quality, as well as processes such as pollination, depend on healthy ecosystems and biodiversity;
2021/03/09
Committee: DEVE
Amendment 238 #

2020/2274(INI)

Motion for a resolution
Paragraph 36
36. Underlines the fact that environmental crime poses a global threat to nature conservation, sustainable development, stability and security;
2021/03/09
Committee: DEVE
Amendment 14 #

2020/2273(INI)

Motion for a resolution
Citation 3 a (new)
- having regard to the European Environment Agency (EEA) report of 19 October 2020 entitled "State of Nature in the EU - Results from reporting under the nature directives 2013-2018",
2021/02/22
Committee: ENVI
Amendment 28 #

2020/2273(INI)

Motion for a resolution
Citation 8 a (new)
- having regard to the Directorate- General for Internal Policies report of December 2020 entitled "The link between biodiversity loss and the increasing spread of zoonotic diseases",
2021/02/22
Committee: ENVI
Amendment 85 #

2020/2273(INI)

Motion for a resolution
Recital C
C. whereas the evidence available suggests that it is not too latstill possible to halt and reverse current trends in the decline of biodiversity if significant efforts are made4 ; _________________ 4 Global Biodiversity Outlook 5.
2021/02/22
Committee: ENVI
Amendment 97 #

2020/2273(INI)

Motion for a resolution
Recital C a (new)
Ca. whereas the growing internalisation of economies through delocalised processes of production and consumption exert multiple impacts on nature at a global scale and beyond the EU territory;
2021/02/22
Committee: ENVI
Amendment 106 #

2020/2273(INI)

Motion for a resolution
Recital C b (new)
Cb. whereas the Secretariat of the UN Convention on Biological Diversity has strongly encouraged local and subnational action for biodiversity, on the understanding that decentralised planning serves as an effective support to deploy global biodiversity strategies;
2021/02/22
Committee: ENVI
Amendment 167 #

2020/2273(INI)

Motion for a resolution
Paragraph 2
2. Recalls the conclusions of the IPBES report of 2019, according to which nature is globally declining at a rate unprecedented in human history and around 1 million species are threatened with extinction; strongly regrets that the Union has neither fully met the 2020 biodiversity strategy objectives set in 2010 nor the global Aichi Biodiversity Targets;
2021/02/22
Committee: ENVI
Amendment 267 #

2020/2273(INI)

Motion for a resolution
Paragraph 4
4. Expresses strong support for the targets of protecting at least 30 % of the Union’s marine and terrestrial areas, and of strictly protecting at least 10 % of these areas, including primary and old-growth forests; stresses that these should be binding and implemented by Member States in accordance with science-based criteria and biodiversity needs; underlines that in addition to increasing protected areas, their quality and connectivity of protected areas should be ensured and clear conservation plans implemented;
2021/02/22
Committee: ENVI
Amendment 349 #

2020/2273(INI)

Motion for a resolution
Paragraph 5
5. Welcomes the upcoming legislative proposal on the EU Nature Restoration Plan and reiterates its call for a restoration target of at least 30 % of the EU’s land and seas, which should be implemented by each Member State consistently throughout their territory; considers that in addition to an overall restoration target, ecosystem- specific targets should be set, with a particular emphasis on ecosystempromoting natural processes for the dual purposes of biodiversity restoration and climate change mitigation and adaptation; stresses that after restoration, no ecosystem degradation should be allowed;
2021/02/22
Committee: ENVI
Amendment 412 #

2020/2273(INI)

Motion for a resolution
Paragraph 6 a (new)
6a. Stresses that the Biodiversity Strategy has to adopt a global perspective and take into account the Union's external responsibility and the extra- territorial dimension of biodiversity loss;
2021/02/22
Committee: ENVI
Amendment 454 #

2020/2273(INI)

Motion for a resolution
Paragraph 7 a (new)
7a. Highlights the need to consider urban and territorial planning as a key tool for nature conservation, since it can lay out landscape and ecological connectivity measures and effectively integrate green infrastructure;
2021/02/22
Committee: ENVI
Amendment 458 #

2020/2273(INI)

Motion for a resolution
Paragraph 7 b (new)
7b. Is aware of the difficulties regarding sea use through marine spatial planning, especially to design marine protected areas beyond the jurisdictional waters of Member States; calls on Member States to fully implement the Marine Spatial Planning Directive;
2021/02/22
Committee: ENVI
Amendment 562 #

2020/2273(INI)

Motion for a resolution
Paragraph 11
11. Stresses that all fishing activities must be subject to maximum sustainable yield levels, or to maximum economic sustainable yield levels where possible, especially in the Mediterranean Sea; with zero tolerance of illegal fishing practices and the elimination of by- catches of sensitive species;
2021/02/22
Committee: ENVI
Amendment 617 #

2020/2273(INI)

Motion for a resolution
Paragraph 12
12. Insists that priority for protected areas must be environmental conservation and restoration and that no activity in these areas should undermine this goal; calls on the Commission to avoidphase out and ultimately ban future marine renewable energy developments and bottom-trawling fishing within Marine Protected Areas;
2021/02/22
Committee: ENVI
Amendment 677 #

2020/2273(INI)

14. Stresses that the Union’s tree planting initiatives should be based on proforestation, close to nature forestry, sustainable reforestation and the greening of urban areas; calls on the Commission to ensure that these initiatives are carried out only in a manner compatible with and conducive to the biodiversity objectives;
2021/02/22
Committee: ENVI
Amendment 709 #

2020/2273(INI)

Motion for a resolution
Paragraph 15 a (new)
15a. Calls on the Commission to urgently put forward a proposal for an EU legal framework based on mandatory due diligence regarding wildlife trade (under the CITES Convention) and taking into account impacts on biodiversity loss in third countries;
2021/02/22
Committee: ENVI
Amendment 941 #

2020/2273(INI)

Motion for a resolution
Paragraph 23
23. Calls on the Commission to provide an assessment of all subsidies harmful to the environment, including those that cause harm beyond the Union's borders, with a view to their phasing out by 2030 at the latest; reiterates its calls for the reorientation of taxation systems towards an increased use of environmental taxation;
2021/02/22
Committee: ENVI
Amendment 972 #

2020/2273(INI)

Motion for a resolution
Paragraph 24
24. Highlights the need for a legally binding biodiversity governance framework, similar to the Climate Law, which steers a path to 2050 through a set of binding objectives, including targets for 2030 and the COP15 commitments, and which establishes a monitoring mechanism with smart indicators, such as the ecological footprint; calls on the Commission to submit a legal proposal to this end in 2022;
2021/02/22
Committee: ENVI
Amendment 1002 #

2020/2273(INI)

Motion for a resolution
Paragraph 25 a (new)
25a. Calls on the Commission to scale up and align all EU policies with the Biodiversity Strategy 2030 and to apply the principle of policy coherence for nature conservation;
2021/02/22
Committee: ENVI
Amendment 1005 #

2020/2273(INI)

Motion for a resolution
Paragraph 25 b (new)
25b. Calls on the Commission to encourage Member States to update, align and adopt their own biodiversity strategies under the framework of the EU Biodiversity Strategy 2030, and to count on the role of subnational governments, cities and other local authorities to effectively tackle biodiversity loss at all scales, as suggested by the UN CBD Secretariat;
2021/02/22
Committee: ENVI
Amendment 1008 #

2020/2273(INI)

Motion for a resolution
Paragraph 25 c (new)
25c. Urges the Commission to consider the extra-territorial dimension of biodiversity loss, especially on developing countries, and to scientifically assess the overall impact of the EU on global biodiversity;
2021/02/22
Committee: ENVI
Amendment 1143 #

2020/2273(INI)

Motion for a resolution
Paragraph 29 a (new)
29a. Calls on the Commission and Member States to join efforts to reach an agreement on marine biological diversity beyond national jurisdictions; recalls that the establishment of MPAs in areas beyond national jurisdictions must be supported by socio-economic and ecological impact assessments based on the best available scientific advice;
2021/02/22
Committee: ENVI
Amendment 1202 #

2020/2273(INI)

Motion for a resolution
Paragraph 31
31. Underlines that the successful implementation of the strategy depends on the involvement of all actors and sectors, and on an "all public administrations" approach that includes regional and local authorities; calls on the Commission to create a stakeholder platform for discussion and to ensure an inclusive, equitable and just transition;
2021/02/22
Committee: ENVI
Amendment 13 #

2020/2260(INI)

Draft opinion
Paragraph 1
1. Urges a shift away from industrial farming and trade- oriented agricultural policies and towards support for food sovereignty and local and regional market, food security, poverty reduction, local and regional markets, and inclusive and fair global supply chains; recalls that agroecology’s capacity to reconcile the economic, environmental and social dimensions of sustainability has been widely recognised;
2021/02/25
Committee: DEVE
Amendment 15 #

2020/2260(INI)

Draft opinion
Paragraph 1 a (new)
1 a. Welcomes the upcoming legislative proposal on an EU Code and monitoring framework for responsible business and marketing conduct in the food supply chain; believes that the Code should lay down robust due diligence standards for agri-food companies and should be accompanied by binding targets and measures to discourage non-compliance, such as administrative or economic sanctions, and ensure sustainable practices in the food value chain;
2021/02/25
Committee: DEVE
Amendment 28 #

2020/2260(INI)

Draft opinion
Paragraph 2
2. Insists that EU funding for agriculture must be in line with Agenda 2030 and prioritise investments in agroecology, agroforestry and crop diversification; highlights the need to finance and develop green business models that support better animal farming and promote short food supply chains within the EU rather than boosting subsidized export-oriented food products that cause harm to local producers in developing countries and exacerbate their dependence on foreign imports; stresses the importance of preserving agricultural biodiversity, local animal and plant breeds and local varieties;
2021/02/25
Committee: DEVE
Amendment 37 #

2020/2260(INI)

Draft opinion
Paragraph 2 a (new)
2 a. Stresses that the Farm to Fork (F2F) strategy should contribute to the attainment of the Sustainable Development Goals at European and global levels; calls on the Commission and Member States to establish an EU platform to monitor and assess the implementation of the EU F2F Strategy and ensure that multilateral mechanisms, such as the Food and Agriculture Organization of the United Nations (FAO), incorporate all the elements of the F2F approach in their policy recommendations;
2021/02/25
Committee: DEVE
Amendment 48 #

2020/2260(INI)

Draft opinion
Paragraph 3 a (new)
3 a. Calls on the European Commission to strengthen its approach to ensure the Right to Adequate Food, implement the UN Declaration on the Rights of Peasants and Other People Working in Rural Areas, improve the working conditions of farm workers and the income of small-scale farmers that are part of international food supply chains, and ensure that the precautionary principle is included for all food safety requirements in developing countries;
2021/02/25
Committee: DEVE
Amendment 61 #

2020/2260(INI)

Draft opinion
Paragraph 4
4. StressesNotes that the Farm to Fork lays out principles for a cleaner, pesticide-free EU agricultural sector with reduced reliance on fertiliser and decreased greenhouse-gas emissions; stresses, in this regard, that the EU-Mercosur Agreement is inconsistent with the Green Deal and the Farm to Fork Strategy, in particular its reduction of dependence on animal feed and industrial animal production, increasing organic farming, improving animal welfare, reversing biodiversity loss, and the shift to a more plant-based diet and shorter supply chains;
2021/02/25
Committee: DEVE
Amendment 64 #

2020/2260(INI)

Draft opinion
Paragraph 4 a (new)
4 a. Calls on the Commission to ensure that the Carbon Border Adjustment Mechanism (CBAM) is gradually extended to food imports with lower standards for carbon footprints in products like meat, dairy and animal feed; believes that the CBAM should be used as a key tool to promote self-sufficient and sustainable food systems in developing countries;
2021/02/25
Committee: DEVE
Amendment 65 #

2020/2260(INI)

4 b. Highlights that EU trade policy should contribute to obtain ambitious commitments from third countries on animal welfare, the use of pesticides and the fight against antimicrobial resistance; calls on the Commission to ensure that all products imported to, and exported out of the EU by trade partners fully respect EU standards in the field of animal welfare, the use of pesticides and the fight against antimicrobial resistance; stresses that EU development cooperation must support local farmers and producers from developing countries to comply with relevant EU regulations and standards;
2021/02/25
Committee: DEVE
Amendment 68 #

2020/2260(INI)

Draft opinion
Paragraph 5
5. Stresses that EU free trade agreements (FTAs) should not disrupt local agriculture, damage small producers or exacerbate dependency on food imports; calls into question international trade rules which allow dumping through the WTO green box; calls on the Commission to review international trade relations to make food systems sustainable and fair, and integrate environmental and social objectives in a comprehensive and holistic manner across all trade agreement provisions; welcomes the Commission’s commitment to compliance of EU trade agreements with the Paris Agreement, and calls for market access in FTAs to be conditional on compliance with process and production methods criteria; calls on the Commission to strengthen the enforcement mechanism of the trade and sustainable development (TSD) chapters and use it as a tool to foster a more diverse and sustainable food system, and to ensure that no provisions in the FTAs undermine the objectives and standards enshrined in the TSD chapters;
2021/02/25
Committee: DEVE
Amendment 79 #

2020/2260(INI)

Draft opinion
Paragraph 6
6. Denounces the EU’s double standards on pesticides, which allow the export from the EU of hazardous substances banned in the EU; stresses that the EU legislation does not prohibit the export of pesticides banned in the EU to third countries, allowing companies to make profits by selling these chemicals to non-EU countries; points out that the EU should play a stronger role in supporting the establishment of the new UN mechanism to promote a phase-out of highly hazardous pesticides globally; calls on the Commission to stand firm in its commitment under the Chemicals Strategy for Sustainability to ensure that hazardous pesticides banned in the European Union are not produced for export, and to ensure that no banned pesticides are allowed as residues in food placed on the European market;.
2021/02/25
Committee: DEVE
Amendment 157 #

2020/2260(INI)

Motion for a resolution
Citation 40 a (new)
- having regard to the Directorate- General for Internal Policies report of December 2020 entitled “The link between biodiversity loss and the increasing spread of zoonotic diseases”,
2021/02/18
Committee: ENVIAGRI
Amendment 229 #

2020/2260(INI)

Motion for a resolution
Recital B
B. whereas Europe’s food system shouldmust deliver food and nutrition security in a way that contributes to improve social well- being and maintains and restores ecosystem health; whereas currently, the food system is responsible for a range of impacts on human and animal health and on the environment, the climate and biodiversity; whereas the way in which we produce and consume food needs to transform in order to ensure coherence with and achievement of the SDGs, the Paris Agreement, the Convention on Biological Diversity and EU policies, particularly in the areas of sustainability, the environment, climate, public health, animal welfare, food and economic sustainability for farmers;
2021/02/18
Committee: ENVIAGRI
Amendment 304 #

2020/2260(INI)

Motion for a resolution
Recital C
C. whereas the European model of a multifunctional agricultural and farming sector, driven by family farms, continues to ensure quality food production, local supply chains, good agriculture practices, compliance with high environmental standards and vibrant rural areas throughout the EU;
2021/02/18
Committee: ENVIAGRI
Amendment 392 #

2020/2260(INI)

Motion for a resolution
Recital D a (new)
Da. whereas in free-market economy systems food prices should reflect environmental costs apart from internalizing direct production costs; whereas EU tax systems should aim to ensure that the price of different foods reflects their real costs in terms of use of finite natural resources, pollution, GHG emissions and other environmental externalities;
2021/02/18
Committee: ENVIAGRI
Amendment 597 #

2020/2260(INI)

Motion for a resolution
Paragraph 2
2. Welcomes the announcement of an impact-assessed proposal for a legislative framework for sustainable food systems; invites the Commission to use this proposal to set out a holistic common food policy aimed at reducing the environmental and climate footprint of the EU food system in order to make Europe the first climate- neutral continent by 2050 and strengthen its resilience to ensure food security in the face of climate change and biodiversity loss, leading a global transition towards sustainability from farm to fork, based on the principle of a multifunctional agricultural sector while ensuring consistency between policies by taking into account the existing legislation in order to enable all actors in the European food system to develop long-term plans based on realistic and transparent objectives; suggests that the respective base lines and progress achieved in each Member State be taken into account, while promoting the exchange of know-how and best practices between Member States; stresses the need to incluconsider the entire food and beverage chains including processing, marketing, distribution and retail and to tax food and beverage production under an emission reduction scheme to achieve climate neutral food in 2040;
2021/02/18
Committee: ENVIAGRI
Amendment 643 #

2020/2260(INI)

Motion for a resolution
Paragraph 2 a (new)
2a. Welcomes the announcement of tax incentives that drive the transition to a sustainable food system and encourage consumers to choose sustainable and healthy diets, like the Commission’s proposal on VAT rates (currently being discussed in the Council) that could allow Member States to make more targeted use of rates, for instance to support organic fruit and vegetables;
2021/02/18
Committee: ENVIAGRI
Amendment 943 #

2020/2260(INI)

Motion for a resolution
Paragraph 4
4. Emphasises the importance of recognising the significant impact of agriculture and especially animal production on greenhouse gas (GHG) emissions, biodiversity loss, freshwater and groundwater pollution/over- exploitation and land use; stresses the need to enhance natural carbon sinks and reduce agricultural emissions of carbon dioxide, methane and nitrous oxide, in particular in the feed and livestock sectors; calls for regulatory measures and targets to ensure progressive reductions in all GHG emissions in these sectors;
2021/02/18
Committee: ENVIAGRI
Amendment 1341 #

2020/2260(INI)

Motion for a resolution
Paragraph 10
10. Underlines that robust and reliablee need to strengthen legal frameworks for the fisheries and aquaculture sector should proviin order the basis foro ensure better protection measures with subsequent increases in fish populations and more clarity regarding the use of space and licenses in aquaculture, allowing for greater predictability for investments; stresses that good traceability mechanisms and high sustainability standards for all products sold on EU markets, included those imported from outside the EU, are essential to ensure transparency for consumers, the sector and the different administrations, and to achieve the targets of the Green Deal and the SDGs;
2021/02/18
Committee: ENVIAGRI
Amendment 1388 #

2020/2260(INI)

Motion for a resolution
Paragraph 11
11. Expresses its deep concern about the emergence of zoonotic diseases that are transferred from animals to humans (anthropozoonoses), such as COVID-19, Q fever, avian influenza and the new strain of influenza A (H1N1), which is exacerbated by the expansion of human activity, anthropogenic climate change, the destruction of biodiversity, environmental degradation and our current food production systems;
2021/02/18
Committee: ENVIAGRI
Amendment 1486 #

2020/2260(INI)

13. Urges the Commission to follow up on Directive (EU) 2019/633 on unfair trading practices22 and implement legal action beyond the EU code of conduct on responsible business and marketing practices by producing a monitoring framework for the food and retail sectors and providing for legal action if progress in integrating economic, environmental and social sustainability into corporate strategies is insufficient, and in so doing promoting and rewarding the efforts of sustainable agricultural producers while increasing the availability and affordability of healthy, sustainable food options and reducing the overall environmental footprint of the food system; stresses the importance of halting and addressing consolidation and concentration in the grocery retail sector in order to ensure fair prices for farmers while underlining the need to include and show environmental external costs in food prices; _________________ 22 OJ L 111, 25.4.2019, p. 59.
2021/02/18
Committee: ENVIAGRI
Amendment 1752 #

2020/2260(INI)

Motion for a resolution
Paragraph 18
18. Welcomes the fact that the strategy rightly recognises the role and influence of the food environment in shaping consumption patterns and the need to make it easier for consumers to choose healthy and sustainable diets; reiterates the importance of promoting sustainable diets by raising consumer awareness of the impacts of consumption patterns and providing information on diets that are better for human health and have a lower environmental footprint; underlines that food prices must send the right signal to consumers; welcomes, therefore, the strategy’s objective that the healthy, environmentally respectful and sustainable choice should become the most affordable one; urges the Commission to present legal or fiscal instruments by 2022 to translate this principle into practice, phasing out harmful subsidies to farming practices and food production systems not aligned under this principle;
2021/02/18
Committee: ENVIAGRI
Amendment 1887 #

2020/2260(INI)

Motion for a resolution
Paragraph 20
20. Highlights the recognition in the strategy that Europeans’ diets are not in line with recommendations for healthy eating, and that a population-wide shift in consumption patterns is needed towards more healthy and plant-based foods and less red and processed meat, sugars, salt, and fats, which will also benefit the environment; emphasises that EU-wide guidelines for sustainable and healthy diets would bring clarity to consumers on what constitutes a healthy and sustainable diet and inform Member States’ own efforts to integrate sustainability elements in national dietary advice; calls on the Commission to develop such guidelines and specific actions to effectively promote healthy plant-based diets and to promote stronger coordination between all public and private stakeholders, including local governments;
2021/02/18
Committee: ENVIAGRI
Amendment 1955 #

2020/2260(INI)

Motion for a resolution
Paragraph 21 a (new)
21a. Welcomes the EU Commission proposal for an Action Plan on organic farming to help Member States stimulate both supply and demand for organic products to reach the objective of at least 25% of the EU’s agricultural land under organic farming by 2030; urges the EU Commission to support Member States and the retail sector to sign agreements on increasing sales of organic food;
2021/02/18
Committee: ENVIAGRI
Amendment 1966 #

2020/2260(INI)

Motion for a resolution
Paragraph 22
22. Calls for a revision of public procurement legislation, including minimum mandatory criteria in schools and other public institutions to encourage organic and local food production and to promote more healthy diets by creating a food environment that enables consumers to make the healthy choice; emphasises that public procurement legislation should also include obligations for rewarding ‘true pricing’ of food, including external environmental costs, that give the right price signals to consumers making healthy, environmentally respectful sustainable food the most easy and affordable choice;
2021/02/18
Committee: ENVIAGRI
Amendment 2194 #

2020/2260(INI)

Motion for a resolution
Paragraph 26
26. Recalls the global responsibility of European food systems and their key role in setting global standards for food safety, environmental protection and animal welfare; calls on the Commission and the Member States to ensure that all food and feed products imported to the EU fully meet relevant EU regulations and standards and to provide development assistance to support primary producers from developing countries in meeting those standards; welcomes the Commission’s intention to take the environmental impacts of requested import tolerances into account; calls upon the EU Commission to adopt legislation for a carbon border adjustment mechanism not only for the ETS-sectors, but also for food imported to the EU from countries with lower standards for climate policies for the agricultural sector, lower standards for deforestation policies, or higher carbon footprints per kg, for products like meat, dairy and animal feed, compared to European equivalent products;
2021/02/18
Committee: ENVIAGRI
Amendment 9 #

2020/2215(INI)

Draft opinion
Paragraph 1
1. Reaffirms that sExpresses its concern on the rise of extremist discourse that threatens the upholding of Sexual and rReproductive health and rights (Human Rights (SRHR) both within and outside the EU; reaffirms that SRHR) are grounded in human rights, are fundamental elements of human dignity, and remain crucial to achieving gender equality;
2020/12/11
Committee: DEVE
Amendment 24 #

2020/2215(INI)

Draft opinion
Paragraph 2
2. Calls for the elimination of harmful practices such as female genital mutilation (FGM) and early and forced child marriage; is extremely concerned that more than 200 million girls and women worldwide have been forced to undergo FGM; calls for full access to physical and psychological care by interculturally sensitive and trained personnel; recalls that girls living in the EU territory are also subject to the risk of suffering FGM while visiting their countries of origin, mainly in the framework of family visits; considers that it is important that all member States, including regional and local administrations, share their best practices on protocols to prevent FGM committed to girls that travel to countries or regions where FGM is significantly practiced; calls on all EU Member States who have not done so yet to enact specific criminal law on FGM in order to prosecute this crime more effectively when it is committed outside their territories;
2020/12/11
Committee: DEVE
Amendment 33 #

2020/2215(INI)

Draft opinion
Paragraph 3
3. Condemns any violations of SRHR, including failures to provide access to comprehensive sexuality education (CSE), family planning services and maternal healthcare; stresses the importance of improving the availability of contraceptive methods in developing countries, especially for adolescent girls who are at greater risk of complications in case of pregnancy; affirms that all women and girls are entitled to make their own free and informed choices with regard to their sexual and reproductive health and lives;
2020/12/11
Committee: DEVE
Amendment 37 #

2020/2215(INI)

Draft opinion
Paragraph 3 a (new)
3a. Reminds that the quality of maternal healthcare is an important indication of the development of a country; believes that development cooperation should help partner countries to uphold the right to health in the context of pregnancy and childbirth through the establishment of decent maternal health services that effectively decrease infant mortality, as well as deaths related to complications of childbirth;
2020/12/11
Committee: DEVE
Amendment 43 #

2020/2215(INI)

Draft opinion
Paragraph 4
4. Insists that CSE programmes in the school system are important as they provide age-appropriate information about puberty, the menstrual cycle, pregnancy and, childbirth and prevention of sexually transmitted diseases; recalls the role of non-governmental organisations as service providers and advocates for SRHR; underlines that CSE programmes help prevent early pregnancy and marriage, which lead to girls dropping out of school and being excluded from the labour market;
2020/12/11
Committee: DEVE
Amendment 56 #

2020/2215(INI)

Draft opinion
Paragraph 5
5. Recalls that safe and legal abortion care is anchored in women’s and adolescent girls' health and rights; warns about the worrying backlash on women’s rights over their bodies in both developing countries and the EU; stresses the need for the full implementation of the Maputo Protocol, especially Article 14;
2020/12/11
Committee: DEVE
Amendment 61 #

2020/2215(INI)

Draft opinion
Paragraph 6
6. Calls for the Gender Action Plan III to give more prominence to its SRHR thematic policy area given the tremendous impact of the COVID-19 pandemic on women and girls in developing countries; believes that in order to ensure that no one is left behind the SRHR thematic policy area of GAPIII should ensure that no woman or girl is discriminated because of her belonging to a particular social class, ethnicity, religion, race or disability group; notes that regional and local administrations, in their role of administrations closest to citizens and civil society, can play a key role to ensure that no one is left behind when implementing the SRHR thematic policy of GAP III;
2020/12/11
Committee: DEVE
Amendment 76 #

2020/2215(INI)

Draft opinion
Paragraph 7
7. Calls on the EU to secure adequate and well-targeted funding for SRHR in its development cooperation policy; stresses that it is essential to ensure that development cooperation policy involves civil society organisations which are directly implicated in the defence of SRHR in developing countries;
2020/12/11
Committee: DEVE
Amendment 80 #

2020/2215(INI)

Draft opinion
Paragraph 8
8. EBelieves that the EU needs to promote that all partner countries integrate SRHR services into national public health strategies and programmes; emphasises that SRHR services should be gender-responsive, rights-based, youth- friendly and available to all, regardless of age or marital status or economic resources, including during conflicts and disasters;
2020/12/11
Committee: DEVE
Amendment 95 #

2020/2215(INI)

Draft opinion
Paragraph 9
9. Reiterates its call on both parties of the new agreement between the EU and the Organisation of African, Caribbean and Pacific States to commit to the promotion, protection and fulfilment of SRHR free from discrimination, coercion and violence and to the full implementation of the International Conference on Population and Development’s Programme of Action; calls on the Commission to take into account SRHR when negotiating and enforcing human rights clauses in trade agreements;
2020/12/11
Committee: DEVE
Amendment 102 #

2020/2215(INI)

Draft opinion
Paragraph 10
10. Recalls that asylum seekers and refugees are too often victims of human trafficking and forced prostitution; points out that asylum seekers and refugees have more problems to access maternal care, contraceptive methods, safe abortion or services to prevent sexually transmitted diseases; insists that effective access to SRHR for these populations is critical for their survival.;
2020/12/11
Committee: DEVE
Amendment 106 #

2020/2215(INI)

Draft opinion
Paragraph 10 a (new)
10a. Considers that violations of SRHR are often deeply engrained in societal values built upon the patriarchal concept of women’s role within the family and their ability to reproduce; underlines the need for development cooperation programmes to boost cultural change in order to improve societal views on SRHR; believes that actions aiming at empowering civil societies in partner countries, mainly organizations defending the rights of women and girls, are vital in order to generate new societal attitudes and consensus that facilitate the recognition of SRHR.
2020/12/11
Committee: DEVE
Amendment 5 #

2020/2134(INI)

Draft opinion
Paragraph 1
1. Stresses that developing countries are the most exposed to climate change, and that their human rights activists and environmental defenders are particularly subjected to threats, repression and judicial persecution for defending their land, heritage and environment from the consequences of the exploitation of natural resources; considers that the protection of human rights defenders should be a prominent objective within the thematic pillar of the new Neighbourhood, Development and International Cooperation Instrument;
2020/10/16
Committee: DEVE
Amendment 23 #

2020/2134(INI)

Draft opinion
Paragraph 2
2. Is deeply concerned about the increased criminalisation and persecution of environmental activists in developing countries by governments and multinational companies that are investing in the exploitation of natural, non- renewable resources, thus contributing to deforestation, loss of biodiversity and human rights violations, mostly affecting indigenous peoples; invites the Commission to introduce a duty to protect these groups in its upcoming legislative proposal on business due diligence;
2020/10/16
Committee: DEVE
Amendment 42 #

2020/2134(INI)

Draft opinion
Paragraph 3
3. Believes that in the next few years climate change will create more environmental migrants from developing countries, and that in order to better protect their human rights, environmental refugee status needs international recognition; calls on the Commission to submit a legislative proposal to grant temporary or subsidiary protection to persons who may have had to temporarily move to the EU because of the catastrophic effects of climate change;
2020/10/16
Committee: DEVE
Amendment 70 #

2020/2134(INI)

Draft opinion
Paragraph 6 a (new)
6a. Calls on the Council and the EEAS, within the framework of the common foreign and security policy, to implement a consistent policy to protect human rights defenders, using the same language and taking the same measures in relation to all States where human rights defenders are under attack;
2020/10/16
Committee: DEVE
Amendment 74 #

2020/2134(INI)

Draft opinion
Paragraph 6 b (new)
6b. Calls on the Council and the EEAS to strengthen the application of their guidelines on support for human rights defenders, to take systematically into consideration measures to protect human rights defenders and, in addition to reacting to specific situations, to develop a long-term strategy to protect human rights defenders as effectively as possible;
2020/10/16
Committee: DEVE
Amendment 77 #

2020/2134(INI)

Draft opinion
Paragraph 6 c (new)
6c. Considers that the Council and the EEAS should present an annual report to the European Parliament on EU action on protecting human rights defenders;
2020/10/16
Committee: DEVE
Amendment 13 #

2020/2129(INL)

Draft opinion
Paragraph 1
1. Acknowledges that there is sufficient strong evidence that shows that the voluntary efforts of Union companies to prevent and mitigate the negative impacts of their behaviour on developing countries have failed as violations of human rights of individuals, in particular worker’s rights, and of local communities, as well as activities that increase the effects of climate change in the most vulnerable countries, are still taking place at the end of the supply chain;
2020/10/09
Committee: DEVE
Amendment 46 #

2020/2129(INL)

Draft opinion
Paragraph 4
4. Stresses that all human rights should be covered by the future legislation; considers that emphasis should be placed on workers and trade union rights, women, children or indigenous people, as well as on the effects of business activity on the environment; stresses that full alignment with existing legal obligations and standards at European and international level should be sought, paying special attention to the ILO Conventions, the Convention on the Elimination of All Forms of Discrimination against Women and the Convention on the Rights of the Child; is of the opinion that the legislation should address all types of human rights abuses;
2020/10/09
Committee: DEVE
Amendment 65 #

2020/2129(INL)

Draft opinion
Paragraph 6
6. Is of the opinion that the new legislation should apply to all sectors, to all types of enterprises, whether public or private, and of all size across the Union; considers that the focus should be placed on the risksclassifying the types of risks entailed by the activities of businesses residing within the Union, and on defining in which States and regions human rights violations are most likely to occur on account of local authorities’ unwillingness or lack of capacity;
2020/10/09
Committee: DEVE
Amendment 67 #

2020/2129(INL)

Draft opinion
Paragraph 6
6. Is of the opinion that the new legislation should apply to all sectors, to all types of enterprises, whether public or private, and of all size across the Union; stresses the importance of government agencies in the Member States taking into account the criteria of the new legislation when carrying out projects supporting the internationalisation of enterprises residing within their territory; considers that the focus should be placed on the risks;
2020/10/09
Committee: DEVE
Amendment 92 #

2020/2129(INL)

Draft opinion
Paragraph 8
8. Underlines the need to design a sound monitoring system and to provide competent authorities (at Union and at national level) with effective instruments to monitor the compliance with the legislation, in particular, at local level; considers that a special effort has to be made to monitor business activities carried out in higher risk countries and regions;
2020/10/09
Committee: DEVE
Amendment 115 #

2020/2129(INL)

Draft opinion
Paragraph 10 a (new)
10a. Stresses the importance of victims of human rights violations caused directly or indirectly by the activities of companies residing within an EU Member State being able to take legal action in the courts of that Member State when the courts in the States in which the human rights violations occurred are unwilling or unable to remedy the harm done; is concerned that victims of human rights violations in the developing countries may encounter difficulties in obtaining effective judicial remedies from courts in the Member States owing to a lack of resources to take legal action; considers that a consultation process involving all interested parties, and in particular trade unions and civil society organisations, needs to be conducted in those areas where human rights violations are most likely to occur, so that mechanisms are established in the future directive on due diligence that guarantee access for the most vulnerable groups to effective judicial protection in Member State courts;
2020/10/09
Committee: DEVE
Amendment 120 #

2020/2129(INL)

Draft opinion
Paragraph 11
11. Is convinced that it is crucial to make the sustainable development chapters of free trade agreements more enforceable and that the new legislation should explore ways of integrating the due diligence requirements into those chapters.; considers that active monitoring of the due diligence mechanisms established in free trade agreements should be one of the main duties of the Chief Trade Enforcement Officer;
2020/10/09
Committee: DEVE
Amendment 12 #

2020/2124(INI)

Draft opinion
Paragraph 2
2. Stresses the ‘policy first’ principle underpinning the European Fund for Sustainable Development Plus (EFSD+), which should enhance coherence and coordination among the EIB, the Commission and Member States in identifying investment operations that can contribute to sustainable development; is of the opinion that the EIB should avoid excessive overreliance on projects implemented by transnational companies and financial intermediaries that do not prioritize development projects, such as private equity funds;
2021/02/03
Committee: DEVE
Amendment 16 #

2020/2124(INI)

Draft opinion
Paragraph 2 a (new)
2 a. Welcomes the commitments made by the EIB towards countering tax evasion of beneficiary companies for development projects; calls on the EIB to prevent companies controlled by entities located in countries listed on the EU blacklist of prohibited jurisdictions from accessing EIB financing; calls on the EIB to require potential beneficiary companies to disclose information about their tax payments in each country in which they operate as a precondition for accessing EIB financing;
2021/02/03
Committee: DEVE
Amendment 27 #

2020/2124(INI)

Draft opinion
Paragraph 3 a (new)
3 a. Notes that the European Ombudsman has opened three inquiries on the EIB concerning the disclosure of information about projects it finances directly, the information about projects administered by national banks or financial institutions, and the access to minutes of the meetings of its Management Committee; calls on the EIB to disclose this information in order to enhance its transparency and accountability;
2021/02/03
Committee: DEVE
Amendment 34 #

2020/2124(INI)

Draft opinion
Paragraph 3 b (new)
3 b. Calls on the Commission to regularly disclose the rationale behind its opinions on the projects financed by the EIB, given that making such information public would clarify the decision-making process for EIB operations covered by the EU guarantee and the contribution of such operations to the Union’s development policy objectives;
2021/02/03
Committee: DEVE
Amendment 37 #

2020/2124(INI)

Draft opinion
Paragraph 4
4. Recalls the need for robust ex ante impact assessments to mitigate the risks of EIB operations on human rights and on environmental, labour and social standards, and the need for meaningful consultations with stakeholders, including civil society organisations; believes that ex ante impact assessments on human rights should be carried out for every project funded by the EIB, especially when implemented by financial intermediaries, and that continuous monitoring of operations on the ground should be ensured; stresses that the EIB needs to deal with complaints in a transparent and effective manner;
2021/02/03
Committee: DEVE
Amendment 1 #

2020/2118(INI)

Motion for a resolution
Citation 5 a (new)
- having regard to the statement of the UN High Commissioner for Refugees of 7 October 2020 to the 71th session of the Executive Committee of the High Commissioner’s Programme,
2021/01/20
Committee: DEVE
Amendment 2 #

2020/2118(INI)

Motion for a resolution
Citation 6 a (new)
- having regard to the United Nations Secretary General's Brief of May 2020 on the impact of COVID-19 on older persons,
2021/01/20
Committee: DEVE
Amendment 5 #

2020/2118(INI)

Motion for a resolution
Citation 15 a (new)
- having regard to the proposal submitted by India and South Africa before the World Trade Organization (WTO) on 2 October 2020 under Article IX:3 and IX:4 of the WTO Agreement asking for a temporary waiver of patent obligations under the TRIPS Agreement for COVID-19 vaccines,
2021/01/20
Committee: DEVE
Amendment 28 #

2020/2118(INI)

Motion for a resolution
Recital A a (new)
Aa. whereas measures to control COVID-19 outbreaks are affecting global food supply chains and are threatening food security in many developing countries;
2021/01/20
Committee: DEVE
Amendment 45 #

2020/2118(INI)

Motion for a resolution
Recital C a (new)
Ca. whereas lower income countries lose more than half what they spend on public health every year to tax havens; whereas tax evasion has especially deprived developing countries from resources to tackle the COVID-19 pandemic;
2021/01/20
Committee: DEVE
Amendment 74 #

2020/2118(INI)

Motion for a resolution
Recital E a (new)
Ea. whereas the COVID-19 pandemic has not put on hold most armed conflicts in the world; whereas populations living in conflict zones and refugees have more difficulties to access COVID-19 treatment and their food insecurity is increasing;
2021/01/20
Committee: DEVE
Amendment 78 #

2020/2118(INI)

Motion for a resolution
Recital E b (new)
Eb. whereas, at the height of the first wave of the COVID-19 pandemic, 168 countries fully or partially closed their borders, with around 90 making no exception for those seeking asylum; whereas some countries have pushed asylum seekers, including children, back to their countries of origin;
2021/01/20
Committee: DEVE
Amendment 82 #

2020/2118(INI)

Motion for a resolution
Recital E c (new)
Ec. whereas strict implementation of intellectual property rights in the framework of the COVID-19 pandemic could severely hinder manufacturing and supply of medical equipment and vaccines to developing countries;
2021/01/20
Committee: DEVE
Amendment 83 #

2020/2118(INI)

Motion for a resolution
Recital E d (new)
Ed. whereas European pharmaceutical industries did not complete their research on coronavirus diseases SARS (2003) and MERS (2012) due to lack of potential economic profitability; whereas the completion of the research on such diseases would have provided knowledge likely to enable faster development of vaccines against COVID-19; whereas the European pharmaceutical industry has received between EUR 200 million and EUR 1.1 billion from the public sector, especially from the Commission;
2021/01/20
Committee: DEVE
Amendment 86 #

2020/2118(INI)

Motion for a resolution
Paragraph 1
1. Welcomes the EU’s global response to the COVID-19 pandemic, which demonstrates its ambition to lead and show solidarity with all partner countries; points out, however, that current funds are essentially reallocated from other budget lines and that the challenge of aid front-loading has to be tackled; calls, therefore, for substantial new funds to be mobilised to assist developing countries worldwide in fighting the direct and indirect consequences of the COVID-19 pandemic; stresses that making safe vaccines available globally in a fast and affordable manner must be one of the first steps; considers that patent rights should not prevent the availability of vaccines against COVID-19 in developing countries, especially when the concerned laboratories have received massive public funding without which the research to produce a vaccine in such a short timeframe could have never been carried out; is worried that compulsory licensing foreseen in the Trade Related Aspects of the Intellectual Property (TRIPS) agreement might not suffice to make vaccines and medical products available in a number of developing countries, since compensation is still to be paid to the companies owning the patents; deems necessary that the EU reconsiders its position and supports the proposal of India and South Africa for a temporary waiver of Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement in order to ensure that life-saving medical products, including vaccines, are effectively available and affordable in all developing countries in the shortest term possible;
2021/01/20
Committee: DEVE
Amendment 97 #

2020/2118(INI)

Motion for a resolution
Paragraph 2
2. Insists that the momentum gained from the common Team Europe approach in terms of joint analysis, joint programming and joint implementation must translate into a new standard for cooperation in the fields of humanitarian aid and development policy, both in law and in practice; considers that the EU should promote that such increased coordination be attained not only between Member States, but also with non-EU donor countries in view of maximizing the efficacy and efficiency of international cooperation and humanitarian aid;
2021/01/20
Committee: DEVE
Amendment 108 #

2020/2118(INI)

Motion for a resolution
Paragraph 3
3. Is deeply concerned about the underfunding of the EU humanitarian aid budget, given the additional humanitarian needs caused by the pandemic and the devastating impacts that such underfunding could have on the provision of critical basic needs for millions of people in the midst of the pandemic, such as food, water, sanitation or health services; calls for a clear distribution of the Solidarity and Emergency Aid Reserve (SEAR) envelope, which should aim to provide balanced coverage of its obligations as follows: neither internal nor external operations may be allocated more than 60 % of the annual amount of the reserve; on 1 October of each year, at least one quarter of the annual amount for ‘year n' must remain available to cover needs arising until the end of that year; as of 1 October, the remaining funds may be mobilised to cover needs arising until the end of that year;
2021/01/20
Committee: DEVE
Amendment 118 #

2020/2118(INI)

4. Underlines that pastoral farming is an ecologically sound, local method of food production and is therefore part of a sustainable food system; considers it essential to support pastoralists by ensuring safe access to local markets during the pandemic in order to make sure that they are able to continue to provide protein-rich food to the local population, that their herds have access to water and grazing land and that mobile community one-health teams monitor the situation and carry out interventions in individual cases but also, where necessary, with a view to maintaining public health; underlines the need to encourage partner countries to ensure that border closures and trade restrictions do not prevent pastoralists from moving their livestock, graze their animals or sell them; calls for cash transfers and food aid for pastoralists, as well as feed aid for herds, as part of livelihood support in humanitarian aid, when this is needed;
2021/01/20
Committee: DEVE
Amendment 129 #

2020/2118(INI)

Motion for a resolution
Paragraph 5
5. Emphasises the need to support the actions of the FAO and the WFP aimed at mitigating hunger and loss of livelihood and building up resilient food systems, such as those to set up a global data facility for the provision of swift information on humanitarian needs, to provide food production assistance and access to diverse, balanced and nutritious food, to organise cash transfers and in-kind food distribution, to stabilise food systems, and to ensure the functioning of local food markets, value chains and systems while focusing on smallholder farmers by implementing sanitary measures in order to prevent the transmission of COVID-19; points out that special measures have to be foreseen in order to ensure that food reaches people living in areas facing special difficulties with regard to food security, such as conflict-affected states or countries that suffer most from climate change;
2021/01/20
Committee: DEVE
Amendment 157 #

2020/2118(INI)

Motion for a resolution
Paragraph 6
6. Underlines that global extreme poverty is expected to rise dramatically in 2020 for the first time in over 20 years, with the COVID-19 pandemic compounding the forces of conflict and climate change and having a particularly hard impact on informal and migrant workers (who represent one quarter of the global workforce), the tourism sector and Latin American and Caribbean economies; highlights, against the backdrop of this extreme crisis, the importance of universal social protection; asks the Commission to work out strategies with partner countries strategies for the economic recovery and job creation and for improving social security systemsactively supporting partner countries to establish social security systems through the provision of economic resources and technical assistance;
2021/01/20
Committee: DEVE
Amendment 182 #

2020/2118(INI)

Motion for a resolution
Paragraph 7 a (new)
7a. Regrets that the pandemic has created an important number of difficulties and restrictions for refugee protection in several countries on the grounds of public health; affirms that protecting the populations against the Covid-19 pandemic and maintaining fair and efficient asylum procedures is compatible; stresses that the EU must promote both within and outside its borders the need to reinstate a fully functioning asylum system and grant access to its territory for all asylum seekers, in accordance with the Geneva Convention Relating to the Status of Refugees;
2021/01/20
Committee: DEVE
Amendment 194 #

2020/2118(INI)

Motion for a resolution
Paragraph 8 a (new)
8a. Reminds that the strengthening of health systems does not have to exclusively take into account the epidemiologic effects of the Covid-19 pandemic on partner countries, but should also consider factors such as the need for managing increased malnutrition caused by the disruptions of food supply chains or the psychological impact of the mitigation measures of Covid-19 outbreaks;
2021/01/20
Committee: DEVE
Amendment 199 #

2020/2118(INI)

Motion for a resolution
Paragraph 9
9. Stresses the need to catch up on routine immunisation programmes as soon as possible and to provide adequate funding for initiatives such as Gavi, the vaccine Alliance, and CEPI, the Coalition for Epidemic Preparedness Innovations; calls on the Commission to ensure that the EU global response to the COVID-19 pandemic does not undermine EU funding for other vital health programmes, including the Minimum Initial Services Package for sexual and reproductive health and programmes targeting the health of women and pregnant women; points out that reallocation of resources away from sexual and reproductive health services in developing countries can severely increase maternal mortality, early pregnancies and sexually transmitted diseases; urges all countries and the Commission to continue to provide services related to sexual and reproductive health and rights (SRHR) as well as routine immunisation services, while ensuring the safety of communities and health workers;
2021/01/20
Committee: DEVE
Amendment 214 #

2020/2118(INI)

Motion for a resolution
Paragraph 10
10. Supports the important work of the WHO and points out its central role as the leading and coordinating authority on the COVID-19 response, while recognising the need for its reform after the acute crisis has been managed in order to strengthen its capacity to prevent threats to global health that might arise in the future and establish mechanisms through which it can increase its responsibility independently of the political interference of each of its members;
2021/01/20
Committee: DEVE
Amendment 236 #

2020/2118(INI)

Motion for a resolution
Paragraph 11 a (new)
11a. Highlights that restrictions against fundamental freedoms to tackle the COVID-19 pandemic have especially affected the human rights of older people in developing countries by aggravating their social exclusion due to movement limitation measures that prevent them from relying on their traditional sources of income, or by impacting their mental health and well-being due to forced isolation; calls on the EU to take into account the situation of older persons in its response to the COVID-19 crisis in developing countries, especially by planning logistic measures which ensure that older persons can receive essential goods, basic services and psychological support;
2021/01/20
Committee: DEVE
Amendment 239 #

2020/2118(INI)

Motion for a resolution
Paragraph 12
12. Is concerned that, since the beginning of the COVID-19 crisis, many governments have used the emergency to justify placing restrictions on democratic processes and the civil space and to oppress minorities; draws attention to the growing negative impact of COVID-19 on all human rights, democracy and the rule of law and calls, therefore, for the strengthening of aid, political dialogue and support for institution-building in all these fields, with particular attention to human rights d; points out that human rights defenders can be even more exposed to attacks during the mobility restrictions imposed to fight the COVID-19 pandemic and stresses the importance that EU delegations especially oversee the action of authorities of non-EU countries with regard to the protection of threatened human rights defenders by keeping contact with them, evaluating potential dangers to their integrity, visiting detained activists, monitoring their trials and advocating for their protection, in accordance with the EU Guidelines for Human Rights Defenders;
2021/01/20
Committee: DEVE
Amendment 249 #

2020/2118(INI)

Motion for a resolution
Paragraph 12 a (new)
12a. Calls on the EU Delegations to actively monitor all violations of civil, political and human rights in partner countries and engage in a positive dialogue with local authorities in order to invite them to not impose restrictions on fundamental freedoms that are not justified according to the principles of necessity and proportionality to prevent the spread of the COVID-19 pandemic;
2021/01/20
Committee: DEVE
Amendment 254 #

2020/2118(INI)

Motion for a resolution
Paragraph 13
13. Welcomes the temporary suspension of debt service payments for the poorest countries announced by the G20 and joins the call on private creditors to follow suit; underlines that the magnitude of the economic and social crisis in the developing world requires more profound and far-reaching measures and encourages the Commission to support international efforts in this regard; considers that interest saved thanks to this suspension should instead be invested in the health sector, which is often severely underfunded in developing countries; highlights that definitive debt cancellations should be considered in some cases, especially in countries holding debts contracted by previous non- democratic regimes or having no financial capacity at all to reimburse their overall debt; considers that debt cancellations should be subject to conditions agreed within multilateral procedures that include the participation of the civil society from both creditor and debtor countries in order to establish country-owned results frameworks that effectively enable partner countries to overcome the consequences of the pandemic and achieve the SDG;
2021/01/20
Committee: DEVE
Amendment 260 #

2020/2118(INI)

Motion for a resolution
Paragraph 14
14. Points out that the budgets of many developing countries were already out of balance before the crisis and that too little funding was allocated to crisis prevention, health systems and social protection; calls on the Commission to take new initiatives to tackle the problems of illicit financial flows, tax evasion and tax fraud in order to improve the tax bases of developing countries; calls, furthermore, for budget support to be directed towards basic services and resilienceonsiders that Member States should take responsibility by actively promoting more international tax coordination for avoiding tax evasion and flight of capital; calls, furthermore, for budget support to be directed towards basic services and resilience; stresses that it is essential to prioritize grants over loans in order to avoid increasing the burden of debt in developing countries, thus enabling them to invest in mitigating the effects of the pandemic and achieving the SDG;
2021/01/20
Committee: DEVE
Amendment 271 #

2020/2118(INI)

Motion for a resolution
Paragraph 15
15. Underlines the fact that the COVID-19 pandemic has led to unprecedented numbers of pupils missing out on months of schooling, constituting a major set-back to efforts in the education sector especially with regard to girls’ and women’s education; reminds that school closures can severely worsen undernutrition since millions of children are dependent on school meals to be properly fed, especially in developing countries; urges governments to use school closures only as a measure of last resort in the fight against the pandemic; presses for education to be kept as a spending priority in EU development policy and for due consideration to be given to the social function of schools; urges governments, in this context, to prioritise support for the most marginalised children and their families; recommends that EU countries share their approaches to keeping up teaching even in times of crisis and asks the EU and its Member States to exploit the potential of remote and digital learning in their international support programmes, while supporting actions to guarantee internet access among all local populations in order to ensure that no one is left behind with regard to online education;
2021/01/20
Committee: DEVE
Amendment 291 #

2020/2118(INI)

Motion for a resolution
Paragraph 16
16. Underlines the importance of assisting and exchanging best practice with partner countries, including capacity- building of local and regional administrations, in identifying vulnerabilities, building up prevention and crisis response mechanisms as well as protecting critical infrastructure in order better to deal with future systemic shocks of all kinds;
2021/01/20
Committee: DEVE
Amendment 302 #

2020/2118(INI)

Motion for a resolution
Paragraph 17
17. Points out that pandemics are often of zoonotic origin; underlines, therefore, the need to support education programmes regarding the dangers of hunting and trading in wild animals as well as the stricter protection of ecosystems and habitats; considers that more EU funds need to be granted to anticipatory research on the links between human health, animal health and ecosystems in order to increase the readiness to respond to future health crises created by virus mutations of zoonotic origin;
2021/01/20
Committee: DEVE
Amendment 306 #

2020/2118(INI)

Motion for a resolution
Paragraph 17 a (new)
17a. Is of the opinion that resilience to future public health crises must also be built upon research on diseases that cause deadly outbreaks in developing countries on a regular basis; regrets that currently there is not enough research to develop vaccines that effectively prevent diseases that are recurrent in developing countries, such as malaria or zika; calls on the EU and Member States to fund more research in view of developing vaccines that prevent future outbreaks of such diseases;
2021/01/20
Committee: DEVE
Amendment 326 #

2020/2118(INI)

Motion for a resolution
Paragraph 19 a (new)
19a. Regrets that only three Member States meet the requirement to dedicate 0.7% of GNI to international aid in 2019; calls on all Member States to increase their national budgets dedicated to development cooperation and humanitarian aid in order to attain a proper humanitarian-development nexus and to effectively tackle the additional needs caused by the COVID-19 pandemic;
2021/01/20
Committee: DEVE
Amendment 16 #

2020/2117(INI)

Draft opinion
Paragraph 2
2. Calls on the Commission to mount an assertive and coordinated international trade policy response geared towards a multilateral, resilient and sustainable recovery in developing countries; calls on the Commission to deepen EU-Africa trade relations through economic partnership agreements, while making the most of the EU’s Aid for Trade Strategy; calls on the Commission and Members States to boost their targeted support for pan-African and sub-regional trade integration arrangements and to ensure that their financial and technical assistance responds to African needs and priorities at all levels, helps to foster regional value chains and production networks, diversify their productive capacities and integrate into regional and global value chains;
2021/03/16
Committee: DEVE
Amendment 21 #

2020/2117(INI)

Draft opinion
Paragraph 2 a (new)
2a. Welcomes the Commission’s intension to strengthen the enforcement mechanism of Trade and Sustainable Development (TSD) chapters and to launch a comprehensive early review in 2021 of the 15-point action plan on the effective implementation and enforcement of TSD Chapters in trade agreements; underlines the need to ensure that no provisions in the FTAs undermine the objectives and standards enshrined in the TSD chapters;
2021/03/16
Committee: DEVE
Amendment 30 #

2020/2117(INI)

Draft opinion
Paragraph 3 a (new)
3a. Underlines that the COVID-19 crisis has highlighted the violations of fundamental rights at work, poor working conditions, lack of fair wages, irregular or excessive working time, discrimination, as well as gender-based violence and harassment; calls on the EU and its Member States to make real progress in the commitment to elaborate the UN binding treaty on business and human rights and enforce the ILO Conventions on decent work in supply chains; calls on the EU to oversee the enforcement of the labour standards set out in the eight core ILO Conventions in developing countries, and to assist them in establishing and reinforcing initiatives, notably partnership programmes, to strengthen the labour inspection systems and to collect more data on how international labour standards address decent work deficits in the global supply chains in order to close identified governance gaps;
2021/03/16
Committee: DEVE
Amendment 38 #

2020/2117(INI)

Draft opinion
Paragraph 4 a (new)
4a. Calls on the Commission to launch an EU Action Plan that focuses on shaping sustainable global supply chains, promoting human rights, social and environmental due diligence standards and transparency, which takes the experiences and lessons learned from the COVID-19 pandemic into account, and to update its 2006 Communication on ‘Promoting decent work for all – the EU contribution to the implementation of the decent work agenda in the world’;
2021/03/16
Committee: DEVE
Amendment 39 #

2020/2117(INI)

Draft opinion
Paragraph 4 b (new)
4b. Stresses that agricultural export subsidies cause enormous damage to local producers, destroy local markets in LDCs and exacerbate their dependence on foreign imports, with a negative impact on food security in particular during the COVID-19 pandemic; calls on the Commission to actively participate in WTO negotiations to abolish agricultural export subsidies, in line with the “Nairobi Package” adopted at the WTO's Tenth Ministerial Conference in 2015;
2021/03/16
Committee: DEVE
Amendment 49 #

2020/2117(INI)

Draft opinion
Paragraph 5 a (new)
5a. Points out that the distribution of COVID-19 vaccines in developing countries, especially LDCs, faces unprecedented challenges due to a lack of logistical capacity, poor transportation and storage, including breaks in the cold chain integrity, and fragile healthcare systems; calls on the Commission to actively support LDCs in the handling and transportation of COVID-19 vaccines in line with international regulatory requirements and ensure that there is no delay in the attainment of mass immunisation against COVID-19 in these countries;
2021/03/16
Committee: DEVE
Amendment 51 #

2020/2117(INI)

Draft opinion
Paragraph 5 b (new)
5b. Is deeply worried that financing constraints and limitations in the supply of vaccines will prevent many LDCs from completing mass immunisation against COVID-19 until 2023 or even later; considers that waiving the patents on the vaccines that have been developed with massive public funding would increase the production of vaccines in all countries that have sufficient industrial capacity and would raise the purchasing capacity of COVAX due to the price lowering of vaccines that such a measure would entail; calls on the Commission to support the proposal of India and South Africa for a temporary waiver of Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement in order to ensure that vaccines are available in all developing countries in the shortest term possible;
2021/03/16
Committee: DEVE
Amendment 68 #

2020/2117(INI)

Draft opinion
Paragraph 7
7. Calls on the Commission to collaborate with developing partner countries in order to facilitate digital infrastructure, establish policy strategies and harmonise regulatory frameworks for e-commerce.; underlines the need for EU development cooperation to contribute to ensuring that populations have general broadband internet access at affordable prices in LDCs;
2021/03/16
Committee: DEVE
Amendment 2 #

2020/2116(INI)

Draft opinion
Paragraph 1
1. Reaffirms that the right to migrate is a human right; calls on the Commission to promote development and humanitarian policies that protect the human and social rights of all migrants, wherever EU action is deployed and irrespective of their legal status; recalls that the Treaties provide that the Union is founded on the respect of human rights and dignity, and therefore considers that the EU migration policy cannot entail human rights violations that weaken the position of the EU in the international arena and the credibility of its foreign policy;
2020/11/04
Committee: DEVE
Amendment 6 #

2020/2116(INI)

Draft opinion
Paragraph 2
2. Recalls that EU development cooperation must have as its main objective the reduction and eradication of poverty and that ite improvement of human security; believes that EU development cooperation must be based on partner countries’ development agendas, following a needcontext-specific needs, population vulnerability assessments and a rights- based approach, and not on EU domestic interests;
2020/11/04
Committee: DEVE
Amendment 22 #

2020/2116(INI)

Draft opinion
Paragraph 3
3. Takes note of the EU’s New Pact on Migration and Asylum; expresses its regret that the proposed measures are insufficient to ensure respect for migrants’ human rights and is especially worried about the externalisation of EU border management and migration control; considers that agreeing on a common migration policy that respects human rights and distributes the burden assumed by the Member States that receive the vast majority of asylum applications is a critical matter for the EU, and that failing to do so will entail a structural threat to the viability of the European integration project;
2020/11/04
Committee: DEVE
Amendment 33 #

2020/2116(INI)

Draft opinion
Paragraph 4
4. Insists on the need for humanitarian corridors and safe and legal migration pathways from neighbouring and developing countries into the EU; stresses that the mere containment of irregular migration does not lead to its effective reduction and only forces migrants to take more dangerous routes;
2020/11/04
Committee: DEVE
Amendment 49 #

2020/2116(INI)

Draft opinion
Paragraph 6
6. Expresses its deep concern about the possible misuse of development funds for border control purposes, including those of the EU Emergency Trust Fund for Africa (EUTF), and the suspected human rights violations linked to the EUTF in Libya, Ethiopia and Niger; considers that these facts prove the need for projects funded by the EUTF to include detailed risk assessments, specially concerning potential violations of human rights, as well as protocols that should foresee the situations that would entail the suspension of a project;
2020/11/04
Committee: DEVE
Amendment 51 #

2020/2116(INI)

Draft opinion
Paragraph 7
7. Deplores the lack of transparency of the EUTF and the fact that Parliament is not involved in its scrutiny; considers that, given their expertise in humanitarian and development affairs, civil society organizations should play a more active role in the identification of needs, should have a say in the formulation of programs and should engage in discussions on how to measure the success of development projects; considers that security projects funded by the EUTF should always focus on people’s right to feel safe in their environment, take into account the needs of the different groups that make up the population of partner countries -with a special regard for minority groups and women- and previously assess their impact on fragile and conflict-affected situations, rather than simply promoting the implementation of foreign policy agendas of EU Member States; regrets that barely 1.5% of the total worth of the EUTF for Africa is allocated to fund regular migration schemes; calls on the Commission to comprehensively review the implementation of the EUTF to ensure that it falls in line with development and humanitarian objectives;
2020/11/04
Committee: DEVE
Amendment 63 #

2020/2116(INI)

Draft opinion
Paragraph 8
8. Reiterates that the NDICI budget dedicated to migration should be used to address the root causes of migration and not to control migratory flows or fund external border management.; recalls that tackling the root causes of migration is the only way to achieve effective regulation of migration flows;
2020/11/04
Committee: DEVE
Amendment 20 #

2020/2091(INI)

Motion for a resolution
Recital A a (new)
A a. whereas air pollution is transboundary in nature, but in many cases the harmful effects of poor air quality become a local problem;
2021/02/11
Committee: ENVI
Amendment 33 #

2020/2091(INI)

Motion for a resolution
Recital B a (new)
B a. whereas the regulation of air quality is one of nature’s contribution to people, considered an environmental service;
2021/02/11
Committee: ENVI
Amendment 74 #

2020/2091(INI)

Motion for a resolution
Paragraph 2
2. Notes that AAQ Directives are based on air quality standards that are now 15 to 20 years old, and that some of them are much weaker than current World Health Organization (WHO) guidelines and the levels suggested by the latest scientific evidence on human health impacts; welcomes the commitment made in the European Green Deal to revise air quality standards and align them more closely with WHO standards, especially for particulate matter;
2021/02/11
Committee: ENVI
Amendment 84 #

2020/2091(INI)

Motion for a resolution
Paragraph 3
3. Recommends that revised air quality standards should also cover other non-regulated pollutants with relevant health impacts in the EU or with potential contribution to transboundary air pollution, such as ultrafine particulate matter UFP or PM; highlights the EU’s ambition to lead the transition to a healthy planet, and recalls that in order to become a global leader it should lead by example by adopting, inter alia, ambitious quality standards for all air pollutants;
2021/02/11
Committee: ENVI
Amendment 116 #

2020/2091(INI)

Motion for a resolution
Paragraph 6
6. Stresses that the AAQ Directives do not focus on reducing emissions in places where people suffer most from air pollution, or where concentrations are highest, and that concrete action in this area is needed; notes that lower socio- economic groups are more exposed to air pollution because they are more likely to live close to sources of heavy pollution, both outdoor, such as traffic and industrial areas, and indoor, such as the combustion of low-quality solid fuels for domestic heating; underlines in this regard the need to better reflect human exposure to air pollution in EU law, and urges the Commission to include new indicators in air quality indices, such as population density around monitoring stations and sampling points, as well as to share existing best practices in this regard, such as the establishment of Priority Areas for Quality Air Improvement;
2021/02/11
Committee: ENVI
Amendment 152 #

2020/2091(INI)

Motion for a resolution
Paragraph 9
9. Welcomes the announcement of the Commission’s Zero Pollution Action Plan; recalls the close link between nature conservation and air quality since the regulation of air quality is one of nature’s contribution to people; emphasises that air pollution is a burden that requires a holistic approach; alerts that any new measures will be worthless if air quality is not properly prioritised and mainstreamed in all EU policies, including EU emission source legislation, such as on climate, energy, transport, industry, agriculture and waste, while ensuring better synergies between all policy areas; calls on the Commission and the Member States to cooperate more closely in all areas and at all levels in order to help local authorities achieve cleaner air;
2021/02/11
Committee: ENVI
Amendment 31 #

2020/2072(INL)

Motion for a resolution
Citation 24 a (new)
- having regard to the Annual Reports of the European Commission on monitoring the application of EU law;
2020/07/27
Committee: LIBE
Amendment 32 #

2020/2072(INL)

Motion for a resolution
Citation 24 b (new)
- having regard to the EU Justice Scoreboard 2020 published by the European Commission;
2020/07/27
Committee: LIBE
Amendment 42 #

2020/2072(INL)

Motion for a resolution
Citation 29 a (new)
- having regard to the workings of the OHCHR of United Nations as well as the UN's WGAD (Working Group on Arbitrary Detentions) resolutions on Member States,
2020/07/27
Committee: LIBE
Amendment 43 #

2020/2072(INL)

Motion for a resolution
Citation 29 b (new)
- having regard to the resolutions of the Council of Europe on the situation of the rule of law, democracy and human rights among Member States, as well as its 2019 report on the "Establishment of a European Union mechanism on democracy, the rule of law and fundamental rights";
2020/07/27
Committee: LIBE
Amendment 44 #

2020/2072(INL)

Motion for a resolution
Citation 29 c (new)
- having regard to the rulings of the European Court of Human Rights regarding human rights cases inside the Union and its Member States;
2020/07/27
Committee: LIBE
Amendment 45 #

2020/2072(INL)

Motion for a resolution
Citation 29 d (new)
- having regard to the results of the 44th session of the United Nations Human Rights Council;
2020/07/27
Committee: LIBE
Amendment 46 #

2020/2072(INL)

Motion for a resolution
Citation 29 e (new)
- having regard to the reports published by the UN Special Rapporteur (for national minorities, freedom of speech, defenders of judges and lawyers…) on the situation of human rights, democracy and the rule of law in Member States;
2020/07/27
Committee: LIBE
Amendment 60 #

2020/2072(INL)

Motion for a resolution
Recital A a (new)
Aa. whereas the concept of rule of law must be understood as a democratic rule of law, i.e. a rule of law which is primarily based on the respect for democratic procedures and fundamental rights;
2020/07/27
Committee: LIBE
Amendment 70 #

2020/2072(INL)

Motion for a resolution
Recital B
B. whereas the preceding decade has seen brazen attacks against Union values in several Member States; whereas international comparisons and Parliament resolutions have evidenced considerable democratic backsliding in particular in Hungary and Poland in particular, but also in other Member States; whereas Parliament has been calling since 2016 for a comprehensive, preventive and evidence- based monitoring in this field via an EU mechanism on democracy, the rule of law and fundamental rights;
2020/07/27
Committee: LIBE
Amendment 83 #

2020/2072(INL)

Motion for a resolution
Recital C a (new)
Ca. whereas corruption poses a serious threat to democracy, the rule of law and the fair treatment of all citizens; whereas corruption, by diverting public funds from the purposes of public utility for which they are intended, reduces the level and quality of public services, and therefore of fundamental rights;
2020/07/27
Committee: LIBE
Amendment 87 #

2020/2072(INL)

Motion for a resolution
Recital D a (new)
Da. whereas the results of the Annual report on the monitoring the application of EU law should be taken in account regarding the number of infringements, gravity and their impact on the rule of law for European citizens and companies;
2020/07/27
Committee: LIBE
Amendment 95 #

2020/2072(INL)

Motion for a resolution
Recital F
F. whereas any monitoring mechanism must closely involve stakeholders active in the protection and promotion of democracy, the rule of law and fundamental rights, including civil society, Council of Europe and United Nations bodies, the European Union Agency for Fundamental Rights, national and regional human rights institutions, national and regional parliaments and local authorities; however, the resolutions on the state of democracy, the rule of law and fundamental rights of international institutions must have a differentiated treatment during the process
2020/07/27
Committee: LIBE
Amendment 104 #

2020/2072(INL)

Motion for a resolution
Recital F a (new)
Fa. whereas the new EU Mechanism on Democracy, the Rule of Law and Fundamental Rights must be based on clear and objective indicators in order to ensure an equal treatment to all Member States;
2020/07/27
Committee: LIBE
Amendment 106 #

2020/2072(INL)

Motion for a resolution
Recital F b (new)
Fb. whereas formal independence of the justice system can be undermined through political means if governments try to influence decisions and actions, both privately or through the media;
2020/07/27
Committee: LIBE
Amendment 109 #

2020/2072(INL)

Motion for a resolution
Recital G a (new)
Ga. whereas the accession by the Union to the European Convention for the Protection of Human Rights and Fundamental Freedoms is an obligation under Article 6(2) TEU;
2020/07/27
Committee: LIBE
Amendment 110 #

2020/2072(INL)

Motion for a resolution
Paragraph 1
1. emphasises the urgent need for the Union to develop a robust and positive agenda for protecting and reinforcing democracy, the rule of law and fundamental rights for all its citizens; insists that the Union must remain a champion of freedom and justice in Europe and the world but stresses that in order to be so, the Union needs to have a much higher standard on the defence of democracy and human rights inside the Union and regrets that some Member States refuse to comply with human rights resolutions issued by international bodies;
2020/07/27
Committee: LIBE
Amendment 123 #

2020/2072(INL)

Motion for a resolution
Paragraph 2
2. warns that the Union is facing an unprecedented and escalating crisis of its founding values, which threatens its long- term survival as a democratic peace project; is gravely concerned by the rise and entrenchment of autocratic and illiberal tendencies, further compounded by the COVID-19 pandemic and economic recession, as well as corruption and state capture, in several Member States; underlines the dangers of this trend for the cohesion of the Union’s legal order, the functioning of its single market, the effectiveness of its common policies and its international credibility; notes with concern that the COVID-19 pandemic has been used to limit citizens’ rights and fundamental freedoms as embedded in the Charter of Fundamental Rights of the European Union, including by means of unjustified censorship, fuelling discrimination, disinformation and hate speech; recalls in particular the importance of promoting and defending the rule of law as a precondition for any sound democratic systems as well as for ensuring the protection of fundamental rights and Union values and a prerequisite for upholding all rights and obligations deriving from the Treaties;
2020/07/27
Committee: LIBE
Amendment 135 #

2020/2072(INL)

Motion for a resolution
Paragraph 3
3. recognises that the Union remains structurally ill-equipped to tackle democratic and rule of law backsliding in the Member States; regrets the inability of the Council to make meaningat the procedure provided for in Article 7 TEU cannot be used to its full progress in enforcing Union values in ongoing Article 7 TEU procedures; notes with concern the disjointed natureotential as the unanimity requirement in the European Council - de facto - hampers its application; regrets in this regard, the lack of progress made in the European Council ofn the Union’s toolkit in that fielcurrent Article 7 procedures against Hungary and Poland;
2020/07/27
Committee: LIBE
Amendment 136 #

2020/2072(INL)

Motion for a resolution
Paragraph 3
3. recognises that the Union remains structurally ill-equipped to tackle democratic and rule of law backsliding in the Member States; regrets the inability of the Council to make meaningful progress in enforcing Union values in ongoing Article 7 TEU procedures; notes with concern the disjointed nature of the Union’s toolkit in that field and believes that a new instrument must be put in place which does not depend on the unanimity of Member States;
2020/07/27
Committee: LIBE
Amendment 142 #

2020/2072(INL)

Motion for a resolution
Paragraph 3 a (new)
3a. Recalls that the Union still has no effective mechanisms to monitor, prevent and put an end to systemic threats to the rule of law and democracy in the Member States; welcomes as a meaningful first step the Commission communication on further strengthening the Rule of Law within the Union and the actions set out therein; calls on the Commission to implement the proposed rule of law framework without undue delay; considers it necessary to put in place sanctions that could be effective, dissuasive and proportionate to effectively prevent breaches of rule of law within the Union;
2020/07/27
Committee: LIBE
Amendment 144 #

2020/2072(INL)

Motion for a resolution
Paragraph 3 b (new)
3b. Recalls that the accession of the Union to the European Convention for the Protection of Human Rights and Fundamental Freedoms is a legal obligation under Article 6(2) TEU; recalls that the accession to that convention would constitute a further step in the process of European integration and would enhance the coherence between the Union and the Council of Europe’s further strengthening the protection of fundamental rights and freedoms within the Union; regrets the lack of progress made so far to fulfil this Treaty obligation; calls on the Commission to step up efforts to respect the Treaties and conclude the negotiations without undue delay;
2020/07/27
Committee: LIBE
Amendment 158 #

2020/2072(INL)

Motion for a resolution
Paragraph 5
5. proposes the establishment of an EU mechanism on democracy, the rule of law and fundamental rights (the ‘Mechanism’), building on Parliament’s 2016 proposal and the Commission’s 2020 Rule of Law Report, to be governed by an interinstitutional agreement between Parliament, the Council and the Commission, consisting of an Annual Monitoring Cycle on Union values, covering all aspects of Article 2 TEU, and applying equally, objectively and fairly to all Member States to ensure there are no double standards due to political interests;
2020/07/27
Committee: LIBE
Amendment 161 #

2020/2072(INL)

Motion for a resolution
Paragraph 6
6. underlines that the Annual Monitoring Cycle must contain country- specific recommendations, with timelines and targets for implementation, to be followed up in subsequent annual or urgent reports; stresses that failures to implement the recommendations must be linked to concrete Union enforcement measures that the Commission would need to apply automatically as the violations occur; highlights, the importance of the annual monitoring cycle in order to prevent possible violations of the rule of law and democracy within the Union before they actually occur;
2020/07/27
Committee: LIBE
Amendment 163 #

2020/2072(INL)

Motion for a resolution
Paragraph 6
6. underlines that the Annual Monitoring Cycle must contain country- specific recommendations, with timelines and targets for implementation, to be followed up in subsequent annual or urgent reports; stresses that failures to implement the recommendations must be linked to concrete Union enforcement measures; notes that in such cases in particular, the lack of implementation of the recommendations from international institutions other than the Union, such as the United Nations, the European Court of Human Rights or the Council of Europe, must be fully taken into account;
2020/07/27
Committee: LIBE
Amendment 180 #

2020/2072(INL)

Motion for a resolution
Paragraph 7
7. points out that the Mechanism should consolidate and supersede existing instruments, avoiding unnecessary duplication of existing structures and instruments; calls for the integration and incorporation of existing tools, in particular the Annual Rule of Law Report, the Commission’s Rule of Law Framework, the Council’s Rule of Law Dialogue and the Cooperation and Verification Mechanism (CVM), while increasing complementarity and coherence with other available tools, including infringement procedures under Article 7 TEU, budgetary conditionality once in force, and the European Semester; is of the opinion that the Annual Monitoring Cycle can fulfil the objectives of the CVM for Bulgaria and Romania, thus contributing to equal treatment of all Member States; considers that the three institutions should use the findings from the Annual Monitoring Cycle in their assessment for the purposes of triggering Article 7 TEU and Regulation (EU) 2020/xxxx of the European Parliament and of the Council on the protection of the Union's budget in case of generalised deficiencies as regards the rule of law in the Member States11 ; _________________ 11[instead of xxxx insert final number of 2018/136(COD) in the text and correct OJ reference in footnote] OJ C ..., ....., p. ....
2020/07/27
Committee: LIBE
Amendment 189 #

2020/2072(INL)

Motion for a resolution
Paragraph 8
8. recalls the indispensable role played by civil society, national and regional human rights institutions and other relevant actors in all stages of the Annual Monitoring Cycle, from providing input to facilitating implementation; points out that the accreditation status of national human rights institutions and the space for civil society may themselves serve as indicators for assessment purposes; considers that national and regional parliaments must hold public debates and adopt positions on the outcome of the monitoring cycle; points out that to ensure that the respect for the rights of persons belonging to national minorities is fairly assessed, institutions and civil society organisations in this communities must also play an important role;
2020/07/27
Committee: LIBE
Amendment 205 #

2020/2072(INL)

Motion for a resolution
Paragraph 10
10. is of the view that, in the long-term, strengthening the Union’s ability to promote and defend its constitutional core will require Treaty change; looks forward to the reflection and conclusions ofnotes in particular, that an urgent revision of the Article 7 TEU is needed in order to overcome the unanimity requirement in the European Council; calls for the Conference on the Future of Europe to come up with a meaningful proposal in that regard;
2020/07/27
Committee: LIBE
Amendment 227 #

2020/2072(INL)

Motion for a resolution
Annex I – paragraph 4 – point 4
(4) The three institutions recognise the need for streamlining and strengthening the effectiveness of existing tools designed to foster compliance with Union values. A comprehensive interinstitutional mechanism should therefore be established in order to improve coordination between the three institutions and consolidate initiatives taken previously. In accordance with the Conclusions of the Justice and Home Affairs Council of 6 and 7 June 2013, such a mechanism should operate in 'a transparent manner, on the basis of well defined and measurable criteria and evidence objectively compiled, compared and analysed and on the basis of equality of treatment as between all Member States'.
2020/07/27
Committee: LIBE
Amendment 238 #

2020/2072(INL)

(6) The Annual Monitoring Cycle should consist of a preparatory stage, the publication of an annual monitoring report on Union values including country-specific reporting and recommendations, and a follow-up stage. The Annual Monitoring Cycle should be conducted in a spirit of transparency and openness.
2020/07/27
Committee: LIBE
Amendment 283 #

2020/2072(INL)

Motion for a resolution
Annex I – part 2 – point 9
9. The CommissionA group of experts selected both by the Commission and the European Parliament shall draft the Annual Report based on information gathered during the preparatory stage. The Annual Report should cover both positive and negative developments relating to Union values in the Member States. The Annual Report shall be impartial, based on objectively compiled evidence and respect equality of treatment between all Member States. The depth of reporting should reflect the gravity of the situation in question.
2020/07/27
Committee: LIBE
Amendment 313 #

2020/2072(INL)

Motion for a resolution
Annex I – part 3 – point 16
16. The three institutions acknowledge the complementary nature of the Annual Monitoring Cycle and other mechanisms for the protection and promotion of Union values, in particular the procedure laid down in Article 7 TEU and Regulation (EU) 2020/xxxx. The three institutions commit to avoid unnecessary duplication of existing instruments and integrate and incorporate existing instruments into the Annual Monitoring Cycle as the preferred option. The three institutions commit to take account of the objectives of this Interinstitutional Agreement in Union policies.
2020/07/27
Committee: LIBE
Amendment 314 #

2020/2072(INL)

16. The three institutions acknowledge the complementary nature of the Annual Monitoring Cycle and other mechanisms for the protection and promotion of Union values, in particular the procedure laid down in Article 7 TEU and Regulation (EU) 2020/xxxx. The three institutions commit to avoid unnecessary duplication of existing instruments and integrate and incorporate existing instruments into the Annual Monitoring Cycle as the preferred option. The three institutions commit to take account of the objectives of this Interinstitutional Agreement in Union policies.
2020/07/27
Committee: LIBE
Amendment 6 #

2020/2045(INI)

Motion for a resolution
Citation 4 a (new)
— having regard to the Global Compact for Safe, Orderly and Regular Migration,
2021/05/05
Committee: AFETDEVEBUDG
Amendment 33 #

2020/2045(INI)

Motion for a resolution
Recital D
D. whereas the establishment of both the EUTFs and the Facility for refugees in Turkey (FRT) have been justified by the need for a flexible and swift reaction not possible under the classical institutional framework; whereas the extra-budgetary instruments such as the EUTFs, as well as extraordinary tools such as the FRT, pose challenges with respect to democratic accountability, includingharm democratic accountability and have a direct impact on the role of the European Parliament and also the integrity of the EU budget;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 62 #

2020/2045(INI)

Motion for a resolution
Paragraph 3
3. Notes that Committee Chairs and relevant Members have been granted observer status in meetings of the Strategic Boards of the Trust Funds and in the FRT Steering Committee; notes furtherregrets that this status has not been formally reflected in the Constitutive Agreements of the Trust Funds;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 65 #

2020/2045(INI)

Motion for a resolution
Paragraph 4
4. Continues to expresses concerns overdeplore the limited role of Parliament in the supervision and scrutiny of the Union contributions to the EUTFs; recalls Parliament’s request to monitor the activities of the Operational Committee, and the Strategic Board, and to be involved in the scrutiny over the choice of projects, and in building a dialogue with local CSOs working on the ground and human rights CSOs; calls on the Commission to provide in good time detailed information on the decisions taken in that Committeeose governance structures and to ensure that Parliament is represented at itstheir meetings;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 93 #

2020/2045(INI)

Motion for a resolution
Paragraph 8 a (new)
8 a. Notes that the study of the Policy Department for Budgetary Affairs requested by the CONT Committee in 20181a highlighted a ‘conflict of interest’ in the project selection procedure of the Operational Committe of the Bêkou Trust Fund due to its recurrence to select projects implemented by Member States’ development agencies; _________________ 1a https://www.europarl.europa.eu/RegData/ etudes/STUD/2018/603821/IPOL_STU(20 18)603821_EN.pdf
2021/05/05
Committee: AFETDEVEBUDG
Amendment 115 #

2020/2045(INI)

Motion for a resolution
Paragraph 13
13. Considers that the Trust Fund for Africa should represents an important tool to provide a swift, flexible and, targeted and accountable response to emerging challenges and underlines that common, global challenges, such as migration and forced displacement, or the impact of climate change and economic crises in the context of the ongoing COVID-19 pandemic, make this flexibility and rapidity more necessary than ever;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 121 #

2020/2045(INI)

Motion for a resolution
Paragraph 14
14. WelcomesPoints out the fact that the EUTF for Africa has not sufficiently contributed to the triple humanitarian-development- peace nexus approach, which was not possible with the EU financial instruments under the previous MFF; disapproves that funds of the EUTF for Africa have been used to strengthen borders, encourage deportations and prevent the influx of migrants into the EU; stresses that Official Development Assistance must fund long-term projects to tackle the root causes of forced migration and the drivers of forced displacement, should be allocated to countries based on actual recipients’ needs and development strategies, and should refrain from including conditionality on migration management, readmissions and returns;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 126 #

2020/2045(INI)

14 a. Points out that the short-term focus on implementing restrictive migration measures needs to be downplayed and the focus should be shifted to support human capital and welfare, such as health, education and strengthening social policies and to promote stability, democracy and resilience in Africa;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 127 #

2020/2045(INI)

Motion for a resolution
Paragraph 14 b (new)
14 b. Is concerned that the EUTF for Africa has very broad objectives and that it brings together external relations, home affairs, development cooperation, humanitarian aid and neighbourhood policies, which are different in nature, into a single financial instrument; believes that a direct nexus between these policies can only be established between home affairs and migration policies, on one side, and between development cooperation and humanitarian policies, on the other;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 128 #

2020/2045(INI)

Motion for a resolution
Paragraph 14 c (new)
14 c. Is concerned that barely 1.5% of the total worth of the Trust Fund for Africa is allocated to fund regular migration schemes; stresses that the mere containment of irregular migration does not lead to its effective reduction, only forces migrants to take more dangerous routes and boosts human smuggling networks;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 131 #

2020/2045(INI)

Motion for a resolution
Paragraph 15
15. Welcomes the generally strongRegrets that the absence of a comprehensive analysis of beneficiaries' needs under the EUTF limited the Commission’s ability to demonstrate that the right priorities had been identified and that actions approved were the most relevant to address them, as well as the generally low degree of local ownership, the and the weak involvement of local authorities and civil society organisations (CSOs) in projects supported by the EUTF for Africa; deplores the low transparency of the programming process, mainly regarding the lack of public calls for proposals;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 145 #

2020/2045(INI)

Motion for a resolution
Paragraph 16
16. Notes that the EUTF for Africa made a major contribution to strengthening resilience and implementing the humanitarian- development nexus in fragile contexts; notes further that it alsohas fostered cooperation between different stakeholders, and allowed contributions from non-EU donors, which in the post- Brexit context have acquired particular importance, and increased the visibility of the issue of migration and forced displacement and the EU’s response to it;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 155 #

2020/2045(INI)

17 a. Points out that more than 400 human rights defenders have been killed in Colombia since the beginning of the peace process in 2016, which is the highest deadly rate for human rights defenders in Latin America, and that more than 27,000 people have been internally displaced only this year, which entails a 177% increase with regard to the same period last year; stresses that enormous challenges remain in the implementation of the peace agreement despite the projects funded by the EUTF on the ground; calls on the Colombian government to take decisive steps to protect human rights defenders and prevent the activities of paramilitary organizations;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 191 #

2020/2045(INI)

Motion for a resolution
Paragraph 22
22. Reiterates its request that Turkey respect the principle of non-refoulement, in particular on the Syrian border, and that it not use the flows of refugees against the EU; stresses that Turkey should stop applying a geographical limitation to the 1951 Convention Relating to the Status of Refugees and its 1967 Protocol;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 198 #

2020/2045(INI)

Motion for a resolution
Paragraph 22 a (new)
22 a. Calls on Turkey to refrain from keeping refugees in detention centres with the purpose to make them sign voluntary return forms and to guarantee their access to health care services regardless of their place of registration within the country;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 219 #

2020/2045(INI)

Motion for a resolution
Paragraph 23 a (new)
23 a. Stresses that irregular migration can only be prevented by tackling its root causes, such as extreme poverty, lack of employment, conflicts or climate-related emergencies, and that its mere containment only forces migrants to take more dangerous routes and boosts human smuggling networks;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 222 #

2020/2045(INI)

Motion for a resolution
Paragraph 23 b (new)
23 b. Considers that it is essential to ensure that development cooperation projects are in line with countries’ own development priorities, and fully involve regional and local authorities and civil society actors in their design and implementation; deems it necessary to increase the involvement of CSOs in African and European countries in monitoring the implementation of migration policies and their adherence to human rights frameworks;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 224 #

2020/2045(INI)

Motion for a resolution
Paragraph 23 c (new)
23 c. Underlines that Official Development Assistance cannot be conditional upon cooperation of partner countries in the forced return of their nationals or border management;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 225 #

2020/2045(INI)

Motion for a resolution
Paragraph 23 d (new)
23 d. Points out to the need to address the challenges related to intra-African migration, which makes up almost 90% of migration flows in Africa, in close cooperation with the African Union and in line with its Migration Policy Framework for Africa and Plan of Action 2018-2030;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 230 #

2020/2045(INI)

Motion for a resolution
Paragraph 24 a (new)
24 a. Urges the Commission to present its final comprehensive review on the implementation of the EUTF to ensure that it falls in line with the EU’s development, human rights and humanitarian objectives; regrets that the extension of the EUTF was requested by the Commission in the absence of such review and that there is therefore no evidence to show whether these objectives have been properly assessed and achieved;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 233 #

2020/2045(INI)

Motion for a resolution
Paragraph 24 b (new)
24 b. Points out that projects funded by the Trust Funds should include detailed risk assessments, especially concerning potential violations of human rights; deplores the reported human rights violations linked to the EU Emergency Trust Fund for Africa (EUTF) in Libya, Ethiopia, Eritrea and Niger; calls on the Commission to duly investigate the alleged cases of human rights violations related to the implementation of the Trust Funds;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 243 #

2020/2045(INI)

Motion for a resolution
Paragraph 25
25. Reiterates Parliament’s long- standing insistence that external assistance be financed in full from the Union budget and be implemented in a coherent, sufficient and predictable way, following a streamlined set of rules, based on co- legislated instruments and in full respect of Parliament’s legislative, budgetary and monitoring prerogatives, and of the principles of accountability, transparency, effectiveness and sound budgetary management; reiterates its call for the full involvement of the European Parliament in the supervision and governance of the current EU Trust Funds;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 256 #

2020/2045(INI)

Motion for a resolution
Paragraph 27
27. Is confidentStresses that flexibility of financial instruments has to be compatible with parliamentary oversight, aligned with the sustainable development goals and respectful of the integrity of the EU budget; is confident, in this regard, that the NDICI-Global Europe will allow for increased flexibility and responsiveness, allowing it to continue the activities of the existing Trust Funds and thereby safeguard the unity of the Union budget and the role of the European Parliament;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 262 #

2020/2045(INI)

Motion for a resolution
Paragraph 28
28. In the event of greater needs in the MFF 2021-2027,. advocates increasing the NDICI-Global Europe envelope through a revision of the MFF and the NDICI-Global Europe regulations, or a strengthening of the relevant NDICI-Global Europe budget lines with contributions in the form of external assigned revenue; stresses that, should a need for a duly justified new Trust Fund nevertheless arise, it insists that Parliament must be fully involved from the very outset Parliament must be fully involved from the very outset in any decision taken in this regard and that the creation of new Trust Funds has to be avoided in the future;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 270 #

2020/2045(INI)

Motion for a resolution
Paragraph 29
29. Calls on the Commission to prioritise the nexus approach in the implementation of the NDICI-Global Europe, and calls for the cooperation between EU humanitarian and development actors, notably in post-crisis settings and in protracted crises, to be increased in order to better adapt to local needs and deliver more efficient results; calls on the Commission to ensure that all Union policies are aligned with regard to the principle of policy coherence for development to ensure the effectiveness of the nexus approach;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 278 #

2020/2045(INI)

Motion for a resolution
Paragraph 30
30. Notes that the close-to-ground decision-making procedure and adaptation to the local realities of the EUTFs and the FRT is of high added value, and needs to be mainstreamed in the future programming exercises linked to budgetary instruments for EU external policy;
2021/05/05
Committee: AFETDEVEBUDG
Amendment 9 #

2020/2042(INI)

Motion for a resolution
Citation 3 a (new)
– having regard to the Global Compact for Safe, Orderly and Regular Migration,
2020/10/15
Committee: DEVE
Amendment 10 #

2020/2042(INI)

Motion for a resolution
Citation 3 b (new)
– having regard to UN Human Rights Council Resolution 41/21 of 12 July 2019 on Human Rights and Climate Change,
2020/10/15
Committee: DEVE
Amendment 12 #

2020/2042(INI)

Motion for a resolution
Citation 3 c (new)
– having regard to the UN Human Rights Council resolution on the slow onset effects of Climate Change and Human Rights Protection for cross- border migrants,
2020/10/15
Committee: DEVE
Amendment 13 #

2020/2042(INI)

Motion for a resolution
Citation 3 d (new)
– having regard to the report of the UN Special Rapporteur on extreme poverty of 17 July 2019 in relation to climate change and poverty,
2020/10/15
Committee: DEVE
Amendment 44 #

2020/2042(INI)

Motion for a resolution
Recital D a (new)
Da. whereas the impacts of climate change on vulnerable populations can exacerbate migratory flows to EU Member States; whereas people who are forced to flee their countries due to the effects of climate change are currently not entitled to apply for asylum, subsidiary protection or temporary protection;
2020/10/15
Committee: DEVE
Amendment 52 #

2020/2042(INI)

Motion for a resolution
Recital F
F. whereas poverty and inequality should be understood in a wide sense that includes deprivation of access to vital resources of all kinds, as well as discrimination, which reduces possible life choices and adaptation capabilities; whereas women, children, elderly people, persons with disabilities, national minorities and indigenous people are often subject to discrimination;
2020/10/15
Committee: DEVE
Amendment 73 #

2020/2042(INI)

Motion for a resolution
Recital G a (new)
Ga. whereas indigenous peoples are often seen only as victims of climate change as opposed to as persons able to conserve the environment by playing a key role in the fight against climate change; whereas indigenous peoples have to resist the occupation and deforestation of land they have lived on for centuries, as well as incursions on their territory for the extraction of fossil fuels; whereas indigenous populations are often excluded from decision-making procedures on how to adapt to, and mitigate, climate change;
2020/10/15
Committee: DEVE
Amendment 101 #

2020/2042(INI)

Motion for a resolution
Recital L
L. whereas the effects of climate change occur in societies comprising groups with very unequal access to resources enabling them to adapt to, and mitigate, those effects; whereas adaptation action should mainly focus on the most vulnerable and should include increasing the resilience of their dwellings, and the infrastructure they depend on, to extreme weather events, improving their food and water security, helping subsistence farmers to adapt their agricultural methods to changes in rainfall and temperature patterns, and helping poor people in increasingly uninhabitable areas to re- settle;
2020/10/15
Committee: DEVE
Amendment 155 #

2020/2042(INI)

Motion for a resolution
Paragraph 2 – indent 1
- the pursuit of rapid, radical curbing and reduction of global greenhouse gas emissions, including through own emission cuts of up to 65% by 2030,
2020/10/15
Committee: DEVE
Amendment 156 #

2020/2042(INI)

Motion for a resolution
Paragraph 2 – indent 1 a (new)
– beyond the reduction of emissions, the limitation of economic activities, such as deforestation or the destruction of traditional farming models, carried out by companies based in the EU that can adversely affect the ability of vulnerable populations to combat climate change.
2020/10/15
Committee: DEVE
Amendment 190 #

2020/2042(INI)

Motion for a resolution
Paragraph 2 – indent 5 a (new)
– transfer training facilities to developing countries in order to establish robust natural disaster warning and prevention systems, emergency response protocols, food storage facilities, durable infrastructure or public communication networks, among other mitigation measures,
2020/10/15
Committee: DEVE
Amendment 197 #

2020/2042(INI)

Motion for a resolution
Paragraph 2 – indent 5 b (new)
– recognise the decision-making power of vulnerable populations in relation to the adoption of adaptation and mitigation measures,
2020/10/15
Committee: DEVE
Amendment 223 #

2020/2042(INI)

Motion for a resolution
Paragraph 5
5. Reaffirms its commitment to poverty reduction as the fundamental objective of the EU’s development policy and to the implementation of policy coherence for development, especially so far as concerns industrial, commercial, agricultural and migratory policies; intends to strengthen its own contribution to this implementation, with a view, in particular, to helping to build an adequate EU response to the evolving climate crisis;
2020/10/15
Committee: DEVE
Amendment 231 #

2020/2042(INI)

Motion for a resolution
Paragraph 6
6. Reiterates its call for a commitment by the EU and its Member States to set official development aid at 0.7% of GNI by 2020 to significantly increase the adaptation finance they provide and points once more to the need for progress on the issue of loss and damage, for which additional resources should be raised;
2020/10/15
Committee: DEVE
Amendment 249 #

2020/2042(INI)

Motion for a resolution
Paragraph 8 a (new)
8a. Recalls that the private sector has a key role to play in reducing the impact of climate change on vulnerable populations in developing countries; calls on all European companies operating in countries particularly affected by climate change to establish protocols designed to mitigate the impact of their activities on vulnerable populations and to comply with the highest environmental standards laid down in EU legislation; calls on the Member States to take action against companies that do not refrain from engaging in activities that aggravate the climate vulnerability of populations in developing countries; welcomes the fact that the Commission is preparing a proposal for the establishment of a harmonised legal framework on corporate due diligence, and calls on the Commission to ensure its proposal unequivocally includes maintenance of the highest environmental standards as one of the key elements to ensure that business activities do not have a negative impact on human rights in developing countries;
2020/10/15
Committee: DEVE
Amendment 258 #

2020/2042(INI)

Motion for a resolution
Paragraph 9
9. Calls for a common and coordinated international response led by the EU aimed at making progress in the implementation of recognition, protection and support measures for people who are compelled to move within and between countries in the context of disasters and the adverse effects of climate change, including its slow onset effects; encourages the Union to analyse and adopt new approaches, considering examples of regulation at regional level such as the Kampala Convention, and to promote the incorporation of, inter alia, the Guiding Principles on Internal Displacement into the domestic laws of EU Member States and of third states through bilateral and regional agreements;
2020/10/15
Committee: DEVE
Amendment 259 #

2020/2042(INI)

9a. Calls on the Commission to consider proposing an amendment to Article 15 of Directive 2011/95/EU of the European Parliament and of the Council of 13 December 2011 on standards for the qualification of third-country nationals or stateless persons as beneficiaries of international protection in order to recognise the possibility of granting subsidiary protection to persons who, while not qualifying for refugee status, would suffer serious harm if they were forced to return to countries where the impacts of climate change have seriously called the habitability of their homes into question, especially in cases of extreme droughts or floods; calls on the Commission to consider proposing an amendment to Article 2 of Council Directive 2001/55/EC of 20 July 2001 on minimum standards for giving temporary protection in the event of a mass influx of displaced persons and on measures promoting a balance of efforts between Member States in receiving such persons and bearing the consequences thereof, so as to include potential future situations of mass influxes of persons displaced for climate-related reasons as an explicit ground for the Council to issue a decision granting such persons temporary- protection status;
2020/10/15
Committee: DEVE
Amendment 14 #

2020/2027(INI)

Draft opinion
Paragraph 1 a (new)
1a. Recalls that the Union should not merely promote a high level of environmental protection on its own territory, but should also take all possible action to prevent environmental damage anywhere in the world caused by companies based in Member States; recalls that environmental damage is particularly frequent and serious in developing countries due to factors such as less stringent legislative frameworks for environmental protection or the industrial and extractive activity of multinational corporations in those countries;
2020/11/13
Committee: DEVE
Amendment 17 #

2020/2027(INI)

Draft opinion
Paragraph 2
2. Calls on the Commission to consider a proposal for a reform of the Directive on the protection of the environment through criminal law in order to broaden the list of types of conduct classified as environmental offences and to establish a minimum framework of penalties to ensure that it has a deterrent effect throughout the EU; Urges the EU to make the fight against environmental crime an overriding strategic political priority in international judicial cooperation and for the EU institutions and COPs, notably by promoting compliance with MEAs through the adoption of criminal sanctions, through exchanges of best practices and by promoting the enlargement of the scope of the International Criminal Court to cover criminal acts that amount to ecocide;
2020/11/13
Committee: DEVE
Amendment 29 #

2020/2027(INI)

Draft opinion
Paragraph 3
3. Recalls that the Environmental Liability Directive (ELD) is crucial to the implementation of the ‘polluter pays’ principle; deplores the fact that liability rules have largely not been applied and are unable to fulfil their compensatory and preventive functions; believes that, in order to ensure effective compliance with the ‘polluter pays’ principle, the Environmental Liability Directive should establish a strict liability regime for any kind of environmental damage or situation of imminent danger to the environment, including in situations where damage is the result of explicitly authorised activities or where the potential damage of such actions could not have been known when the actions took place, and provide for the non- applicability of statutory limitations to penalty proceedings;
2020/11/13
Committee: DEVE
Amendment 33 #

2020/2027(INI)

Draft opinion
Paragraph 3 a (new)
3a. Considers that, in order to achieve a high level of environmental protection, the scope of the Environmental Liability Directive should be extended to include any type of conduct that is harmful to or creates an immediate risk for the environment, especially any type of imminent risk for, or damage to, water and soil;
2020/11/13
Committee: DEVE
Amendment 38 #

2020/2027(INI)

Draft opinion
Paragraph 4
4. Highlights the barriers to holding companies liable for environmental harm, such as the regime of limited liability, insolvency, barriers to access to justice, latency and causal uncertainty and the lack of detail in the assessment criteria for environmental damage;
2020/11/13
Committee: DEVE
Amendment 41 #

2020/2027(INI)

Draft opinion
Paragraph 4 a (new)
4a. Considers that all Member States should establish strict civil liability regimes to determine the redress to be provided for any direct damage caused to individuals as a result of environmental damage caused by an operator; calls on the Commission to present a legislative proposal to that effect.
2020/11/13
Committee: DEVE
Amendment 48 #

2020/2027(INI)

Draft opinion
Paragraph 5
5. Notes that companies may abuse their limited liability to invest in hazardous industries through separate legal entities in order to externalise environmental costs; recalls the governance gap in global value chains; calls for the scope of strict liability to be extended to parent companies to avoid the risk of moral hazard; stresses the importance of free trade agreements signed by the EU incorporating clauses ensuring a high level of environmental protection in connection with industrial production in developing countries;
2020/11/13
Committee: DEVE
Amendment 55 #

2020/2027(INI)

Draft opinion
Paragraph 6
6. Calls for the development a harmonised framework of mandatory solvency guarantees to cover the ELD liabilities of companies in the event of insolvency to boost the preventive effect of said directive and to search for an optimal mix between future EU legislation on mandatory environmental due diligence, and administrative, civil and criminal enforcement regimes aiming to address environmental harm;
2020/11/13
Committee: DEVE
Amendment 61 #

2020/2027(INI)

Draft opinion
Paragraph 7
7. Stresses the need to improve access to justice for victims of environmental harm, i.e. through collective actions and redress mechanisms, primarily under a binding and enforceable UN treaty on business and human rights; recalls in this regard the exemplary role that the future mandatory due diligence directive should play in connection with the establishment of mechanisms to ensure that victims of environmental damage in third countries have effective access to justice in Member States when the harmful activities have been carried out by companies based in an EU Member State or by legal persons under the control of such companies; calls on the Union and its Member States to push for the creation of an international independent authority in the field of environmental liability.
2020/11/13
Committee: DEVE
Amendment 337 #

2020/0360(COD)

Proposal for a regulation
Recital 20
(20) (20) The Union-wide ten-year network development plan process as basis for the identification of projects of common interest in the categories of electricity and gas has proven to be effective. However, while the European Network of Transmission System Operators for Electricity and for Gas (ENTSOs) and transmission system operators ha. However, a long term vision is needed in order to guarantee the adoption of future-proof methodologies and scenarios contributing to achieve the 2030 climate objectives, the 2040 offshore energy development objectives and important role to play in the process, mn line with the target of climate neutrality as soon as possible and by 2050 at the latest. More scrutiny is required, in particular as regards defining the scenarios for the future, identifying long-term infrastructure gaps and bottlenecks and assessing individual projects, to enhance trust in the process. Therefore, due toindependent expertise and validation is required, notably, a newly created body, the Eneed for independent validation, trgy Infrastructure Council (EIC). In addition, the role of other stakeholders and market participants from the demand-side should be enhanced. The Agency for the Cooperation of Energy Regulators (‘the Agency’) and the Commission should have an increased role in the process, including in the process for of drawing up the Union-wide ten-year network development plan pursuant to Regulation (EU) 2019/943 of the European Parliament and of the Council31 and Regulation (EC) No 715/2009 of the European Parliament and of the Council32 . The Agency should conduct a consultation process involving the Commission, Member States and local governments when applicable and the EIC. The Agency should also operationalise the principle of ‘energy efficiency first’ and ensure that scenarios are leading to the climate neutrality target. The EIC should validate the TYNDP. _________________ 31Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (OJ L 158, 14.6.2019, p. 54). 32Regulation (EC) No 715/2009 of the European Parliament and of the Council of 13 July 2009 on conditions for access to the natural gas transmission networks and repealing Regulation (EC) No 1775/2005 (OJ L 211, 14.8.2009, p. 36).
2021/05/04
Committee: ENVI
Amendment 365 #

2020/0360(COD)

(30a) Expedited procedures can be counterproductive to project development, and the right to appeal against expedited procedures should be granted to stakeholders, including civil society and local authorities. Therefore, in order to ensure the success of projects and to limit appeals, information provided to and consultation of stakeholders, including civil society, is essential. Stakeholders' opinion should be fully taken into account.
2021/05/04
Committee: ENVI
Amendment 452 #

2020/0360(COD)

Proposal for a regulation
Article 3 – paragraph 1 – introductory part
1. Regional groups shall be established (‘Groups’) as set out in Section 1 of Annex III. The membership of each Group shall be based on each priority corridor and area and their respective geographical coverage as set out in Annex I. Decision-making powers in the Groups shall be restricted to Member Statesrepresentatives of the EIC, Member States, local authorities if interested, and the Commission, who shall, for those purposes, be referred to as the decision- making body of the Groups.
2021/05/04
Committee: ENVI
Amendment 462 #

2020/0360(COD)

Proposal for a regulation
Article 3 – paragraph 3 – subparagraph 1 – point a a (new)
(aa) it shall require the approval of the states and the local authorities, to whose territory the project relates; where a state decides not to give its approval, it shall present its substantiated reasons for doing so to the Group concerned;
2021/05/04
Committee: ENVI
Amendment 770 #

2020/0360(COD)

Proposal for a regulation
Article 12 a (new)
Article 12 a Article 12a Long-term scenarios 1. After having conducted an extensive consultation process involving the Commission and at least the organisations representing all relevant stakeholders, as well as concerned local authorities, the EIC shall develop broad long-term scenarios in line with the Union climate neutrality target for the planning horizon up until 2050. 2. The long- term scenarios shall take as a starting point the revised Union 2030 climate and energy targets and set out the path for infrastructure scenarios necessary to achieve the climate neutrality objective as soon as possible in line with the need to limit global temperature increase to 1,5°C, also taking into account the latest available Commission scenarios. They shall be based on the Member States’ energy efficiency and renewable energy potential, and interlink with their National Energy and Climate Plans, as well as the offshore grid planning according to Article 14 of this Regulation. 3. The scenarios shall set binding network development milestones and intermediate steps to be achieved every 5 years in a cycle aligned to the UNFCCC ratchet-up mechanism. 4. The long-term scenarios shall be drafted and updated in coherence with the Ten-Year-Network-Development-Plan as described in Article 12. They shall be published with the corresponding input and output data in a sufficiently accurate form, allowing for transparency while taking due account of applicable legal requirements, including on confidentiality.
2021/05/04
Committee: ENVI
Amendment 1074 #

2020/0360(COD)

Proposal for a regulation
Annex III – Part 1 – point 1 a (new)
(1a) The bodies hereinafter referred to as the “Decision-making bodies” are composed of representatives of the EIC, Member States, concerned local authorities and the Commission.
2021/05/04
Committee: ENVI
Amendment 1197 #

2020/0360(COD)

Proposal for a regulation
Annex VI – point 1 – point h a (new)
(ha) the requirement on project promoters to publish a “transparency report” accessible to the public, containing at least project description, the promoters presentations used during meetings in Groups, list of participants of the Groups. This report shall contain a detailed justification showing how the projects would contribute to the Union’s 2030 climate and energy targets and the climate neutrality objective. It shall also contain measures taken to ensure the full inclusion and participation of local population, indigenous peoples and marginalised communities;
2021/05/04
Committee: ENVI
Amendment 105 #

2020/0322(COD)

Proposal for a regulation
Recital 1
(1) A network for the epidemiological surveillance and control of communicable diseases was set up by Decision No 2119/98/EC of the European Parliament and of the Council.13 Its scope was extended by Decision No 1082/2013/EU of the European Parliament and of the Council14 to strengthen and provide for a further coordinated and wider approach to health security at Union level. The implementation of that legislation confirmed that coordinated Union action on monitoring, early warning of and combating those threats adds value to the protection and improvement of human health. The implementation of this legislation is another sign with which the Union is committed to the conclusions of the Global Conference on Primary Health Care of Astana of 25 and 26 October 2018. _________________ 13Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (OJ L 268, 3.10.1998, p.1). 14Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
2021/04/30
Committee: ENVI
Amendment 106 #

2020/0322(COD)

Proposal for a regulation
Recital 1 a (new)
(1 a) Among the most dangerous pathogens are the respiratory viruses, including orthopoxviruses such as smallpox, or novel influenzas, and coronaviruses. The Union, through its capabilities and know-how, should counter all these potential threats.
2021/04/30
Committee: ENVI
Amendment 110 #

2020/0322(COD)

Proposal for a regulation
Recital 2 a (new)
(2 a) It is therefore necessary that the Union be a full-fledged complementary component of European health systems, providing a guarantee or a last-resource stakeholder in case of serious cross- border health threats. For this reason, the know-how, expertise and capabilities of Union agencies should be strengthened accordingly.
2021/04/30
Committee: ENVI
Amendment 111 #

2020/0322(COD)

Proposal for a regulation
Recital 2 b (new)
(2 b) Knowing that the SARS-CoV-2 virus has been uncannily good at disrupting cellular programming, the Union should prepare itself for all those serious cross-border threats that could have the same levels of cellular disruption, for which the sufficient and most reliable research and capabilities should be deployed.
2021/04/30
Committee: ENVI
Amendment 112 #

2020/0322(COD)

Proposal for a regulation
Recital 2 c (new)
(2 c) In October, 2019, the first Global Health Security Index reported of a world largely unprepared to deal with a pandemic. Inter alia, it stated that there was a lack of political will for accelerating health security in a perpetual cycle of panic and neglect, and that no country was fully prepared. With the current legislation, which builds upon the lessons- learned during the management of the COVID–19 pandemic, the Union wishes to amend this situation and prepare itself for future serious cross-border threats that may originate in epidemics or pandemics.
2021/04/30
Committee: ENVI
Amendment 114 #

2020/0322(COD)

Proposal for a regulation
Recital 3
(3) An important role in the coordination of preparedness and response planning for serious cross-border threats to health is being played by the Health Security Committee (HSC), as formally established by Decision No 1082/2013/EU. This Committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support Member States in the prevention and control of serious cross-border threats to health. The European Parliament should nominate observers for the HSC.
2021/04/30
Committee: ENVI
Amendment 115 #

2020/0322(COD)

Proposal for a regulation
Recital 4 a (new)
(4 a) There is plenty of scientific evidence that shows that health prevention and promotion policies (public health policies) are central to guaranteeing the right to health of citizens, and those are also the most efficient in terms of cost effectiveness. However, even today most of the budgets of the health systems of the majority of Member States are given very little space to policies for disease prevention and health promotion. The COVID-19 pandemic has firmly confirmed the importance of public health policies for our societies.
2021/04/30
Committee: ENVI
Amendment 116 #

2020/0322(COD)

Proposal for a regulation
Recital 4 b (new)
(4 b) It is necessary to remember that these prevention and promotion strategies concern all sectoral policies: fiscal, commercial, economic, agro- environmental, educational, housing, cultural, social assistance, etc. Health in all policies (HiAP) should be a non- negotiable principle of all public policies. An instrument already used at the national level is the so-called Health Test to assess the health impact of the different sectoral policies. It is necessary to deploy a Health Test methodology in all the programmes managed by the Union.
2021/04/30
Committee: ENVI
Amendment 119 #

2020/0322(COD)

Proposal for a regulation
Recital 5
(5) This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning and combatting specific threats of a cross-border nature. Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health matters, covering goods such as pharmaceutical products, medical devices and foodstuffs, in vitro diagnostic medical devices and applications, substances of human origin (blood, plasma, tissues and cells, organs), and exposure to ionising radiation.
2021/04/30
Committee: ENVI
Amendment 121 #

2020/0322(COD)

Proposal for a regulation
Recital 6
(6) The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC. All actions should be consistent with the WHO’s One Health approach, as well as with the Health in All Policies principle, recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies.
2021/04/30
Committee: ENVI
Amendment 128 #

2020/0322(COD)

Proposal for a regulation
Recital 6 a (new)
(6 a) Demographic change and technological innovation are some of the most important challenges facing our health systems. The aging of the population is largely due to the success of our healthcare systems and forces them, at the same time, to a structural transformation: from a healthcare model focused mainly on acute diseases, a shift is needed towards a healthcare model in which chronic diseases gain more weight and pandemics’ risk is significantly reduced. It is important that the Member States accompany each other in this process of transformation of the healthcare model, and for this reason it is necessary to strengthen good practices exchanging mechanisms.
2021/04/30
Committee: ENVI
Amendment 132 #

2020/0322(COD)

Proposal for a regulation
Recital 7
(7) Preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ preparedness and response plans so as to ensure they are compatible within the regional level structures. Where appropriate, regional authorities should participate in the drawing of these plans. To support Member States in this endeavour, targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the Commission and Union Agencies, facilitating the sharing of best practices. To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
2021/04/30
Committee: ENVI
Amendment 136 #

2020/0322(COD)

Proposal for a regulation
Recital 7 a (new)
(7 a) Preparedness and response planning are also essential elements in order to prevent a “doom loop” situation, namely a cycle of negative economic feedback. When the COVID–19 pandemic hit, the world suffered a supply shock, where trade was disrupted,factories and stores closed, then salaries where in danger, the supply shock could turn into a demand shock, and that would further weaken supply, which would increase unemployment and further diminish demand. In order to prevent a subsequent doom loop, the Union should make high- quality preparedness and response planning.
2021/04/30
Committee: ENVI
Amendment 137 #

2020/0322(COD)

Proposal for a regulation
Recital 7 b (new)
(7 b) Ensuring supply chain resilience across the Union is not a primordial mission of the Centre, yet the ECDC can provide data, knowledge, and skills, to the Commission and the EMA in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID– 19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
2021/04/30
Committee: ENVI
Amendment 138 #

2020/0322(COD)

Proposal for a regulation
Recital 7 c (new)
(7 c) It is therefore necessary that the European Medicines Agency (EMA) assist the Commission in assessing the supply chain resilience of these products and devices in order to achieve a sufficient strategic autonomy of the Union in health products and devices. Ensuring supply chain resilience across the Union is not a primordial mission of this authority, yet the EMA should provide data, knowledge, and skills, to the Commission and the ECDC in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID–19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
2021/04/30
Committee: ENVI
Amendment 141 #

2020/0322(COD)

Proposal for a regulation
Recital 8
(8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level, and regional level where applicable. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR)15 . In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that national and regional preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits in Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. _________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
2021/04/30
Committee: ENVI
Amendment 155 #

2020/0322(COD)

Proposal for a regulation
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. This exclusivity clause should entail that the Member States participating in the joint procurement procedure will not be allowed to negotiate and sign parallel contracts with producers. In case these Member States negotiate and sign parallel contracts, they should be excluded from the group of participating countries. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
2021/04/30
Committee: ENVI
Amendment 174 #

2020/0322(COD)

Proposal for a regulation
Recital 10
(10) Unlike for communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other potentially serious cross- border threats to health do not currently necessitate monitoring by EU Agencies. A risk-based approach, whereby monitoring is carried out by Member States and available information is exchanged through EWRS, is therefore more appropriate for such threats. The ECDC should also monitor the impact of communicable diseases on diseases that are not communicable(such as mental diseases), taking into account existing datasets, tools and registers.
2021/04/30
Committee: ENVI
Amendment 179 #

2020/0322(COD)

Proposal for a regulation
Recital 11
(11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance, cancer, and mental health.
2021/04/30
Committee: ENVI
Amendment 183 #

2020/0322(COD)

Proposal for a regulation
Recital 12
(12) In case of cross-border health threats due to a communicable disease, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services in return are dependent on rapid risk assessments by the ECDC to safeguard patients, in need of a therapy from a substance of human origin, from a transmission of such communicable disease. Such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. The ECDC should therefore set up and operate a network of national bloodand regional blood, plasma and transplant services and their authorities to serve this dual purpose.
2021/04/30
Committee: ENVI
Amendment 185 #

2020/0322(COD)

Proposal for a regulation
Recital 13
(13) A system enabling the notification at Union level of alerts related to serious cross-border threats to health has been put in place by Decision No 2119/98/EC in order to ensure that competent public health authorities in Member States and the Commission are duly informed in a timely manner. All serious cross-border threats to health covered by this Regulation are covered by the EWRS. The operation of the EWRS should remain within the remit of the ECDC. The notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one Member State and require or could require a coordinated response at the Union level. To avoid duplication and ensure coordination across Union alert systems, the Commission and ECDC should ensure that alert notifications under the EWRS and other rapid alert systems at Union level are linked to each other to the extent possible so that the competent authorities of the Member States can avoid as much as possible notifying the same alert through different systems at Union level and can benefit from receiving all-hazard alerts from a single coordinated source. The notification system of the EWRS should be an electronic, digital, interoperable platform which may also be built upon distributed ledger technology (DLT) and include data from national and regional competent authorities. Finally, this platform should also be linked to the Health dataspace.
2021/04/30
Committee: ENVI
Amendment 190 #

2020/0322(COD)

Proposal for a regulation
Recital 14
(14) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned. That assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence, independence, impartiality and transparency. The involvement of Union agencies and Commission bodies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach, via a permanent network of agencies and relevant Commission services to support the preparation of risk assessments. In order to achieve a sufficient degree of increased expertise and competences, there should also be an increase of the respective financial and human resources of Union agencies and bodies.
2021/04/30
Committee: ENVI
Amendment 193 #

2020/0322(COD)

Proposal for a regulation
Recital 15
(15) The Member States have a responsibility to manage public health crises at national and regional level. However, measures taken by individual Member States could affect the interests of other Member States if they are inconsistent with one another or based on diverging risk assessments. The aim to coordinate the response at Union level should, therefore, seek to ensure, inter alia, that measures taken at national and regional level are proportionate and limited to public health risks related to serious cross-border threats to health, and do not conflict with obligations and rights laid down in the Treaty on the Functioning of the European Union such as those related to free movement of persons, goods and services.
2021/04/30
Committee: ENVI
Amendment 194 #

2020/0322(COD)

Proposal for a regulation
Recital 16
(16) To this effect, the HSC responsible for the coordination of response at Union level, should assume additional responsibility for the adoption of opinions and guidance for Member States related to the prevention and control of a serious cross border threats to health. Furthermore, should the coordination of national and regional public health measures prove insufficient to ensure an adequate Union response, the Commission should further support Member States via the adoption of recommendations on temporary public health measures.
2021/04/30
Committee: ENVI
Amendment 196 #

2020/0322(COD)

Proposal for a regulation
Recital 17
(17) Inconsistent communication with the public and stakeholders such as healthcare professionals as well as those dedicated to research, development and innovation, can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on robust and independent evaluation of public health risks, to be adapted to national and regional needs and circumstances. In those Member States with regions having health competences, the information should also come from these regions towards their Member State and the Commission. Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. Given the cross- sectoral nature of this type of crises, coordination should also be ensured with other relevant constituencies, such as the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council17 . _________________ 17Decision (EU) 2019/420 of the European Parliament and of the Council of 13 March 2019 amending Decision No 1313/2013/EU on a Union Civil Protection Mechanism (OJ L 77I , 20.3.2019, p. 1).
2021/04/30
Committee: ENVI
Amendment 198 #

2020/0322(COD)

Proposal for a regulation
Recital 18
(18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level, taking into account the urgency of the situation where the Commission may have to recognise the public health emergency level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers, therefore without any type of decision-making competence in order to guarantee that the Commission can act accordingly to the urgent need of recognising the public health emergency at Union level. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.
2021/04/30
Committee: ENVI
Amendment 205 #

2020/0322(COD)

Proposal for a regulation
Recital 19
(19) Before recognising a situation of public health emergency at Union level, the Commission should liaise with the WHO in order to share the Commission’s analysis of the situation of the outbreak and to inform the WHO of its intention to adopt such a decision. Where such a recognition is adopted, the Commission should also inform the WHO thereof. The liaison with the WHO should not question the Union’s strategic autonomy in countering the serious cross-border threats or outbreaks within its borders.
2021/04/30
Committee: ENVI
Amendment 211 #

2020/0322(COD)

Proposal for a regulation
Recital 22
(22) The processing of personal data for the purpose of implementing this Regulation should comply with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council19 . In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by Member States at national and regional level. In this regard, the EWRS includes a messaging function in which personal data, including contact and health data, can be communicated to relevant authorities involved in contact tracing measures. _________________ 19Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
2021/04/30
Committee: ENVI
Amendment 213 #

2020/0322(COD)

Proposal for a regulation
Recital 24
(24) As responsibility for public health is not an exclusively national matter in certain Member States, but is substantially decentralised, national and regional authorities should, where appropriate, involve the relevant competent authorities in the implementation of this Regulation.
2021/04/30
Committee: ENVI
Amendment 216 #

2020/0322(COD)

Proposal for a regulation
Recital 25
(25) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and, where necessary, for other serious cross- border threats to health subject to ad hoc monitoring; the procedures for the operation of the EWRS; the functioning of the surveillance platform; the designation of EU reference laboratories to provide support to national and regional reference laboratories; the procedures for the information exchange on and the coordination of the responses of the Member States; the recognition of situations of public health emergency at Union level and the termination of such a recognition and procedures necessary to ensure that the operation of the EWRS and the processing of data are in accordance with the data protection legislation.
2021/04/30
Committee: ENVI
Amendment 219 #

2020/0322(COD)

Proposal for a regulation
Recital 28
(28) In order to ascertain the state of implementation of the national and regional preparedness plans and their coherence with the Union plan, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of procedures, standards and criteria for the audits aimed at the assessment of preparedness and response planning at national and regional level. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 201621 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 21 OJ L 123, 12.5.2016, p. 1.
2021/04/30
Committee: ENVI
Amendment 221 #

2020/0322(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point b – point i
(i) preparedness plans at Union and national and regional levels;
2021/04/30
Committee: ENVI
Amendment 224 #

2020/0322(COD)

Proposal for a regulation
Article 1 – paragraph 3
3. TIn order to honour the One Health approach and the Health in all policies principle, the implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. The European Health Union, with its regulation on a reinforced mandate for the European Medicines Agency, and its regulation amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control, strengthen the Union health framework in order to address serious cross-border health threats, and shall be funded by the EU4Health programme. It shall be complementary to other Union policies and funds, namely, but not exclusively, actions implemented under the Horizon Europe, the Digital Europe Programme, ESIF. rescEU, ESI, ESF+, Next Generation EU, and SMP.
2021/04/30
Committee: ENVI
Amendment 231 #

2020/0322(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point a – point iii a (new)
(iii a) rare diseases of biological origin;
2021/04/30
Committee: ENVI
Amendment 236 #

2020/0322(COD)

Proposal for a regulation
Article 2 – paragraph 2
2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues, such as non- communicable diseases, or health consequences such as mental health conditions.
2021/04/30
Committee: ENVI
Amendment 240 #

2020/0322(COD)

Proposal for a regulation
Article 2 – paragraph 6
6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national and regional systems in the fields covered by this Regulation, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Regulation.
2021/04/30
Committee: ENVI
Amendment 243 #

2020/0322(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 3
(3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of developing or have developed a communicable or infectious disease, through manual or other technological means;
2021/04/30
Committee: ENVI
Amendment 245 #

2020/0322(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 4
(4) ‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues as well as their impact on non- communicable diseases or health consequences such as mental health conditions;
2021/04/30
Committee: ENVI
Amendment 252 #

2020/0322(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘Health in all policies’ means health in all policies as defined in Regulation (EU) .../... EU 4 Health [OJ: ...]
2021/04/30
Committee: ENVI
Amendment 253 #

2020/0322(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘One Health approach’ means One health approach as defined in Regulation(EU) .../... EU 4 Health [OJ: ...]
2021/04/30
Committee: ENVI
Amendment 263 #

2020/0322(COD)

Proposal for a regulation
Article 4 – paragraph 2 – point d a (new)
(d a) support policies that guarantee the health in all policies principle and the One Health approach;
2021/04/30
Committee: ENVI
Amendment 265 #

2020/0322(COD)

Proposal for a regulation
Article 4 – paragraph 2 – point d b (new)
(d b) exchange good practices in order to make it easier for Member States to make the transition towards a healthcare model where aging and chronicity have gained relevance;
2021/04/30
Committee: ENVI
Amendment 266 #

2020/0322(COD)

Proposal for a regulation
Article 4 – paragraph 2 – point d c (new)
(d c) strengthen public sector participation in health research strategies, in coherence with the Horizon Europe programme, in order to reinforce the necessary resources so that all strategic health research that cannot be done without public support may be carried out;
2021/04/30
Committee: ENVI
Amendment 269 #

2020/0322(COD)

Proposal for a regulation
Article 4 – paragraph 5
5. The secretariat shall be provided by the Commission and shall be instituted within the competent directorate general of the Commission.
2021/04/30
Committee: ENVI
Amendment 273 #

2020/0322(COD)

Proposal for a regulation
Article 4 – paragraph 7 – introductory part
7. Member States shall designate one representative and not more than two alternate members of the HSC in each working formation referred to in paragraph 1. Member States shall designate their representatives and alternate members within 30 days after the entry into force of this Regulation. In case a representative or an alternate representative cedes her or his responsibilities within the HSC, the Member State shall designate a substitute or substitutes within 30 days.
2021/04/30
Committee: ENVI
Amendment 274 #

2020/0322(COD)

Proposal for a regulation
Article 4 – paragraph 7 – subparagraph 1 a (new)
In case the Member State has not designated any substitute within 30 days after the termination of the previous representative or alternate member, the HSC shall nevertheless continue its undertakings after an official letter sent to the Member State by the Chair of the HSC.
2021/04/30
Committee: ENVI
Amendment 276 #

2020/0322(COD)

Proposal for a regulation
Article 4 – paragraph 7 – subparagraph 1 b (new)
The European Parliament shall nominate two observers, elected by its Committee on Environment, Public Health and Food Safety. These observers shall be elected during the European Parliament’s mandate. Each observer shall be elected for a maximum of five years.
2021/04/30
Committee: ENVI
Amendment 287 #

2020/0322(COD)

Proposal for a regulation
Article 5 – paragraph 2
2. The Union preparedness and response plan shall complement the national and regional preparedness and response plans established in accordance with Article 6.
2021/04/30
Committee: ENVI
Amendment 291 #

2020/0322(COD)

Proposal for a regulation
Article 5 – paragraph 3 – point a
(a) the timely cooperation between the Commission, the Member States, regions with health competences, and the Union agencies;
2021/04/30
Committee: ENVI
Amendment 292 #

2020/0322(COD)

Proposal for a regulation
Article 5 – paragraph 3 – point b
(b) the secure exchange of information between the Commission, Union agencies, regions with health competences, and the Member States;
2021/04/30
Committee: ENVI
Amendment 294 #

2020/0322(COD)

Proposal for a regulation
Article 5 – paragraph 3 – point c
(c) the epidemiological surveillance and monitoring, as well as the impact of communicable diseases on non- communicable diseases;
2021/04/30
Committee: ENVI
Amendment 316 #

2020/0322(COD)

Proposal for a regulation
Article 6 – title
National and regional preparedness and response plans
2021/04/30
Committee: ENVI
Amendment 324 #

2020/0322(COD)

Proposal for a regulation
Article 6 – paragraph 1
1. When preparing national and regional preparedness and response plans each Member State and region with health competences shall coordinate with the Commission in order to reach consistency with the Union preparedness and response plan, also inform without delay the Commission and the HSC of any substantial revision of the national and regional plan.
2021/04/30
Committee: ENVI
Amendment 333 #

2020/0322(COD)

Proposal for a regulation
Article 7 – paragraph 1 – introductory part
1. Member States shall by the end of November 2021 and every 2 years thereafter provide the Commission with a report on their preparedness and response planning and implementation at national and regional level.
2021/04/30
Committee: ENVI
Amendment 338 #

2020/0322(COD)

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a
(a) identification of, and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national and regional level for the health sector, as provided to the WHO in accordance with the IHR;
2021/04/30
Committee: ENVI
Amendment 365 #

2020/0322(COD)

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point c
(c) implementation of national and regional response plans, including where relevant implementation at the regional and local levels, covering epidemic response; antimicrobial resistance, health care associated infection, mental health, and other specific issues.
2021/04/30
Committee: ENVI
Amendment 371 #

2020/0322(COD)

Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
The report shall include, whenever relevant, interregional preparedness and response elements in line with the Union and national and regional plans, covering in particular the existing capacities, resources and coordination mechanisms across neighbouring regions.
2021/04/30
Committee: ENVI
Amendment 375 #

2020/0322(COD)

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
The report shall include country profiles for monitoring progress and developing action plans to address identified gaps at national and regional level.
2021/04/30
Committee: ENVI
Amendment 377 #

2020/0322(COD)

Proposal for a regulation
Article 7 – paragraph 5 a (new)
5 a. The notification platform shall use the distributed ledger technology (DLT) and include data from national and regional competent authorities and shall be linked to the Health data space.
2021/04/30
Committee: ENVI
Amendment 384 #

2020/0322(COD)

Proposal for a regulation
Article 8 – paragraph 1
1. Every 3 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national and regional plans and their coherence with the Union plan. Such audits shall be implemented with the relevant Union agencies, aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in Article 7(1).
2021/04/30
Committee: ENVI
Amendment 407 #

2020/0322(COD)

Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point b
(b) promoting the interoperability of national and regional preparedness planning and the intersectoral dimension of preparedness and response planning at Union level;
2021/04/30
Committee: ENVI
Amendment 412 #

2020/0322(COD)

Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point e
(e) monitoring progress, identifying gaps and actions to strengthen preparedness and response planning, including in the field of research, at national, regional and at Union levels.
2021/04/30
Committee: ENVI
Amendment 426 #

2020/0322(COD)

Proposal for a regulation
Article 11 – paragraph 2
2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national and regional preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools.
2021/04/30
Committee: ENVI
Amendment 441 #

2020/0322(COD)

Proposal for a regulation
Article 12 – paragraph 2 – point c
(c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product. Member States that run parallel negotiation processes, having reached the signature or not of such processes, shall be excluded from the group of participating countries;
2021/04/30
Committee: ENVI
Amendment 476 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 1
1. The network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) shall ensure a permanent communication between the Commission, the ECDC, the EMA and the competent authorities responsible at national, and where applicable regional, level for epidemiological surveillance.
2021/04/30
Committee: ENVI
Amendment 477 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 2 – point b
(b) detect and monitor any multinational communicable disease outbreaks with respect to source, time, population and place in order to provide a rationale for public health action, as well as its impact on non-communicable diseases or health consequences like mental health conditions;
2021/04/30
Committee: ENVI
Amendment 480 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 2 – point c
(c) contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve those programmes at the national , regional and Union level;
2021/04/30
Committee: ENVI
Amendment 485 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 2 – point h
(h) identify research priorities and needs, and implement relevant research activities with the aim of anticipating future health hazards;
2021/04/30
Committee: ENVI
Amendment 487 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 2 – point h a (new)
(h a) make mitigation plans containing preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains, as well as including production and supply capacity;
2021/04/30
Committee: ENVI
Amendment 490 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 3 – introductory part
3. The national and regional competent authorities referred to in paragraph 1 shall communicate the following information to the participating authorities of the epidemiological surveillance network:
2021/04/30
Committee: ENVI
Amendment 493 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 3 – point f
(f) information about contract tracing monitoring systems developed at national and regional level.
2021/04/30
Committee: ENVI
Amendment 496 #

2020/0322(COD)

Proposal for a regulation
Article 13 – paragraph 4
4. When reporting information on epidemiological surveillance, the national and regional competent authorities shall, where available, use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1.
2021/04/30
Committee: ENVI
Amendment 518 #

2020/0322(COD)

Proposal for a regulation
Article 14 – paragraph 6 a (new)
6 a. The surveillance platform shall use the distributed ledger technology (DLT) and include data from national and regional competent authorities and shall be linked to the health data space where possible.
2021/04/30
Committee: ENVI
Amendment 519 #

2020/0322(COD)

Proposal for a regulation
Article 15 – paragraph 1
1. In the area of public health or for specific areas of public health relevant for the implementation of this Regulation or of the national and regional plans referred to in Article 6, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national and regional reference laboratories to promote good practice and alignment by Member States on a voluntary basis on diagnostics, testing methods, use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States.
2021/04/30
Committee: ENVI
Amendment 521 #

2020/0322(COD)

Proposal for a regulation
Article 15 – paragraph 2 – introductory part
2. The EU reference laboratories shall be responsible in particular for the following tasks to coordinate the network of national and regional reference laboratories, in particular, in the following areas:
2021/04/30
Committee: ENVI
Amendment 523 #

2020/0322(COD)

Proposal for a regulation
Article 15 – paragraph 2 – point g
(g) training in current and innovative research procedures and skills.
2021/04/30
Committee: ENVI
Amendment 524 #

2020/0322(COD)

Proposal for a regulation
Article 15 – paragraph 2 – point g a (new)
(g a) obtaining, recording and sharing information about innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma- derived products;
2021/04/30
Committee: ENVI
Amendment 525 #

2020/0322(COD)

Proposal for a regulation
Article 15 – paragraph 3
3. The network of EU reference laboratories shall be operated and coordinated by the ECDC., with a governance structure where national and regional reference laboratories and networks shall cooperate;
2021/04/30
Committee: ENVI
Amendment 529 #

2020/0322(COD)

Proposal for a regulation
Article 15 – paragraph 4 – introductory part
4. The designations provided for in paragraph 1 shall follow a public selection process, be limited in time, with a minimum period of 5 years, and be reviewed regularly. Designations shall establish the responsibilities and tasks of the designated laboratories. Groups or coalitions of laboratories shall also be eligible for such designation.
2021/04/30
Committee: ENVI
Amendment 533 #

2020/0322(COD)

Proposal for a regulation
Article 16 – paragraph 1 a (new)
1 a. The network shall share information on developments that are still not harmonised throughout the Union, such as plasma-derived products.
2021/04/30
Committee: ENVI
Amendment 540 #

2020/0322(COD)

Proposal for a regulation
Article 17 – paragraph 1
1. Following an alert notified pursuant to Article 19 concerning a serious cross- border threat to health referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) or (d) of Article 2(1), Member States shall, in liaison with the Commission and on the basis of the available information from their monitoring systems, inform each other through the ‘Early Warning and Response System’ (‘EWRS’) and, if the urgency of the situation so requires, through the HSC about developments with regard to the threat concerned at national and regional level.
2021/04/30
Committee: ENVI
Amendment 543 #

2020/0322(COD)

Proposal for a regulation
Article 18 – paragraph 1
1. The EWRS shall enable the Commission and the competent authorities responsible at national and regional level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determining the measures that may be required to protect public health.
2021/04/30
Committee: ENVI
Amendment 551 #

2020/0322(COD)

Proposal for a regulation
Article 18 – paragraph 2 a (new)
2 a. The EWRS shall establish interoperable databases with Member States, and regions where applicable. The ECDC shall coordinate the data exchange processes, from assessing the data requirement, transmission and collection, up to data updates and processing. The EWRS shall assess the implementation of distributed ledger technology (DLT).
2021/04/30
Committee: ENVI
Amendment 554 #

2020/0322(COD)

Proposal for a regulation
Article 18 – paragraph 3
3. Each Member State shall designate the competent authority or authorities responsible at national and regional level for notifying alerts and determining the measures required to protect public health, for the purposes of early warning and response.
2021/04/30
Committee: ENVI
Amendment 556 #

2020/0322(COD)

Proposal for a regulation
Article 19 – paragraph 1 – introductory part
1. National and regional competent authorities or the Commission shall notify an alert in the EWRS where the emergence or development of a serious cross-border threat to health fulfils the following criteria:
2021/04/30
Committee: ENVI
Amendment 559 #

2020/0322(COD)

2. Where the national and regional competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, they shall at the latest simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.
2021/04/30
Committee: ENVI
Amendment 562 #

2020/0322(COD)

Proposal for a regulation
Article 19 – paragraph 3 – introductory part
3. When notifying an alert, the national and regional competent authorities and the Commission shall promptly communicate through the EWRS any available relevant information in their possession that may be useful for coordinating the response such as:
2021/04/30
Committee: ENVI
Amendment 564 #

2020/0322(COD)

Proposal for a regulation
Article 19 – paragraph 3 – point g
(g) public health measures implemented or intended to be taken at national and regional level;
2021/04/30
Committee: ENVI
Amendment 567 #

2020/0322(COD)

Proposal for a regulation
Article 19 – paragraph 4
4. The Commission shall make available to the national and regional competent authorities through the EWRS any information that may be useful for coordinating the response referred to in Article 21, including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health already transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty.
2021/04/30
Committee: ENVI
Amendment 571 #

2020/0322(COD)

Proposal for a regulation
Article 20 – paragraph 1 – introductory part
1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level or upon request of the HSC referred to in Article 21 or on its own initiative, make promptly available to the national, and regional where appropriate, competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures. That risk assessment shall be carried out by:
2021/04/30
Committee: ENVI
Amendment 576 #

2020/0322(COD)

Proposal for a regulation
Article 20 – paragraph 3 – subparagraph 1
The Commission shall make the risk assessment available to the national, and regional where appropriate, competent authorities promptly through the EWRS, and, if appropriate, through linked alerts systems. Where the risk assessment is to be made public, the national, and regional where appropriate, competent authorities shall receive it prior to its publication.
2021/04/30
Committee: ENVI
Amendment 578 #

2020/0322(COD)

Proposal for a regulation
Article 20 – paragraph 4
4. The Commission shall ensure that information that may be relevant for the risk assessment is made available to the national, and regional where appropriate, competent authorities through the EWRS and to the HSC.
2021/04/30
Committee: ENVI
Amendment 579 #

2020/0322(COD)

Proposal for a regulation
Article 21 – paragraph 1 – point a
(a) national and regional responses, including research needs, to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this Regulation;
2021/04/30
Committee: ENVI
Amendment 592 #

2020/0322(COD)

3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission on the nature, purpose and scope of those measures, especially in cross-border regions, who shall also be accordingly informed.
2021/04/30
Committee: ENVI
Amendment 595 #

2020/0322(COD)

Proposal for a regulation
Article 21 – paragraph 3 a (new)
3 a. Where the public health measures that a Member State adopts to counter a serious cross-border threat to health lasts or is extended for more than 14 days, it shall inform the other Member States and the Commission about the scientific evidence that justify the necessity, suitability and proportionality of the continuity of such measures to attain the purpose stated in the communications referred to in paragraphs 2and 3.
2021/04/30
Committee: ENVI
Amendment 598 #

2020/0322(COD)

Proposal for a regulation
Article 22 – paragraph 2 – point b
(b) respect the responsibilities of the Member States, and the regions where appropriate, for the definition of their health policy and for the organisation and delivery of health services and medical care;
2021/04/30
Committee: ENVI
Amendment 599 #

2020/0322(COD)

Proposal for a regulation
Article 22 – paragraph 2 – point c
(c) be necessary, suitable and proportionate to the public health risks related to the threat in question, avoiding in particular any unnecessary restriction to the free movement of persons, of goods and of services, and to the rights, freedoms and principles enshrined in the Charter of Fundamental Rights of the European Union.
2021/04/30
Committee: ENVI
Amendment 602 #

2020/0322(COD)

Proposal for a regulation
Article 22 – paragraph 2 – point c a (new)
(c a) assess the overall strategic implications of the public health measures proposed in the recommendation, with special regard for their economic, political, social and psychological consequences.
2021/04/30
Committee: ENVI
Amendment 616 #

2020/0322(COD)

Proposal for a regulation
Article 24 – paragraph 2
2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects. The Commission shall make public the selected experts and the professional and/or scientific backgrounds that support their nomination. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad- hoc basis.
2021/04/30
Committee: ENVI
Amendment 631 #

2020/0322(COD)

6 a. The minutes of the Advisory Committee shall be public.
2021/04/30
Committee: ENVI
Amendment 632 #

2020/0322(COD)

Proposal for a regulation
Article 25 – paragraph 1 – point b
(b) mechanisms to monitor shortages of, develop, procure, managufacture, produce, manage, store, distribute and deploy medical countermeasures;
2021/04/30
Committee: ENVI
Amendment 635 #

2020/0322(COD)

Proposal for a regulation
Article 26 – paragraph 1
1. The EWRS shall include a selective messaging functionality allowing personal data, including contact and health data, to be communicated only to national and regional competent authorities involved in the contact tracing measures concerned. That selective messaging functionality shall be designed and operated so as to ensure safe and lawful processing of personal data and to link with contact tracing systems at Union level.
2021/04/30
Committee: ENVI
Amendment 636 #

2020/0322(COD)

Proposal for a regulation
Article 26 – paragraph 5
5. Personal data may also be exchanged in the context of automated contact tracing, with the user’s consent, and using contact tracing applications. In order to ensure a sufficient degree of data privacy, the Commission shall assess the use of technologies such as blockchain.
2021/04/30
Committee: ENVI
Amendment 639 #

2020/0322(COD)

(b) procedures for the interlinking of the EWRS with contact tracing systems at Union and international level;
2021/04/30
Committee: ENVI
Amendment 114 #

2020/0321(COD)

Proposal for a regulation
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public healthshown the difficulties of Member States to cope with a cross-border or global health emergency, and has therefore demonstrated the need to strengthen the competences of the Union in order to be more effective, efficient and expeditious in managing the availability of medicinal products and medical devices, in asserting supply chains of medicinal products and medical devices, and in developing medical countermeasures to address the threats posed to public health. The unprecedented experience of the COVID- 19 pandemic has also underlined the risks to human health posed by zoonotic spill- overs triggered by global biodiversity loss and wildlife over-exploitation. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.
2021/04/28
Committee: ENVI
Amendment 125 #

2020/0321(COD)

Proposal for a regulation
Recital 2 a (new)
(2a) It is therefore necessary that the Union be a full-fledged complementary component of European health systems, providing a guarantee or a last-resource stakeholder in case of serious cross- border health threats. For this reason, the know-how, expertise and capabilities of Union agencies should be strengthened accordingly.
2021/04/28
Committee: ENVI
Amendment 142 #

2020/0321(COD)

Proposal for a regulation
Recital 5
(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products, devices and services considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s ability to rapidly, efficiently and effectively react to such challenges during public health crises.
2021/04/28
Committee: ENVI
Amendment 144 #

2020/0321(COD)

Proposal for a regulation
Recital 5 a (new)
(5a) It is therefore necessary that the Agency assist the Commission in assessing the supply chain resilience of these products and devices in order to achieve a sufficient strategic autonomy of the Union in health products and devices. Ensuring supply chain resilience across the Union is not a primordial mission of the Agency, yet the European Medicines Agency (EMA) should provide data, knowledge, and skills, to the Commission and the ECDC in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID–19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
2021/04/28
Committee: ENVI
Amendment 147 #

2020/0321(COD)

Proposal for a regulation
Recital 6
(6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body to ensure monitoring of shortages of medical devices resulting from a public health emergency. These structures should, among other obligations, assess supply chain resilience and reliance.
2021/04/28
Committee: ENVI
Amendment 161 #

2020/0321(COD)

Proposal for a regulation
Recital 9
(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers and Member States, had to be found to achieve the objective of making available safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines. These ad-hoc solutions should be taken into account as well as all the lessons learned during the pandemic in order to better use the Agency’s potential to face future outbreaks.
2021/04/28
Committee: ENVI
Amendment 166 #

2020/0321(COD)

Proposal for a regulation
Recital 10
(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. The Union's actions should be consistent with the WHO’s One Health approach, as well as with the Health in All Policies principle, recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies.
2021/04/28
Committee: ENVI
Amendment 174 #

2020/0321(COD)

Proposal for a regulation
Recital 11
(11) This Regulation aims to ensure the smooth functioning of the internal market as regards medicinal products and medical devices, withas well as a high level of human health protection being fundamental in those aims. Moreover, this Regulation aims to ensure the quality, safety and efficacy of medicinal products with the potential to address public health emergencies. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other. As regards Article 114 TFEU, this Regulation establishes a framework for the monitoring and reporting on shortages of medicinal products and medical devices during public health crises. As regards Article 168(4)(c) TFEU, this Regulation provides for a strengthened Union framework ensuring the quality and safety of medicinal products and medical devices.
2021/04/28
Committee: ENVI
Amendment 178 #

2020/0321(COD)

Proposal for a regulation
Recital 12
(12) In order to improve crisis preparedness and management for medicinal products and medical devices and increase resilience and solidarity across the Union, the procedures and the respective roles and obligations of different concerned entities involved should be clarified. The framework should build on the ad hoc solutions identified so far in the response to the COVID-19 pandemic that have proven effective and operative and that can provide foundational protocols on which to build upon.
2021/04/28
Committee: ENVI
Amendment 182 #

2020/0321(COD)

Proposal for a regulation
Recital 13
(13) A harmonised system of monitoring of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and access to critical medicinal products, devices and applications in major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research, innovation and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to ask demand and obtain information and data from the concerned marketing authorisation holders, manufacturers and Member States through designated points of contact. Should any of the aforementioned stakeholders not give information to the Agency in the time lapse established by the Agency, the Commission should assist the Agency in obtaining such information, with the prospect of an eventual sanction, which should also be duly made available to the public.
2021/04/28
Committee: ENVI
Amendment 188 #

2020/0321(COD)

Proposal for a regulation
Recital 13 a (new)
(13a) The Agency, together with the Commission, should also do its upmost to counterbalance smear campaigns and disinformation on medicines, medical products, devices or applications, in order to ensure proper information to the public.
2021/04/28
Committee: ENVI
Amendment 192 #

2020/0321(COD)

Proposal for a regulation
Recital 15
(15) With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products. The Steering Group should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health protection. The World Health Organization Model List of Essential Medicines for adults and for children is the best base for the identification of critical medicinal products at Union level.
2021/04/28
Committee: ENVI
Amendment 196 #

2020/0321(COD)

Proposal for a regulation
Recital 16 a (new)
(16a) In order to facilitate the prevention, monitoring and reporting of shortages of medicinal products, devices and applications, the Agency and the Commission should establish an electronic platform to track and follow medicinal products, devices and applications throughout the supply chain. This platform should also be a one-stop shop for marketing authorisation holders and wholesale distributors to provide required information during major health events. This platform should use the distributed ledger technology (DLT) and include data from national and regional competent authorities. The platform should, among other duties, determine the volume of stock, the capabilities of all stakeholders linked in the supply chain or chains, the actual, current and foreseeable level of demand. This platform should also obtain, record and share information.
2021/04/28
Committee: ENVI
Amendment 197 #

2020/0321(COD)

Proposal for a regulation
Recital 16 b (new)
(16b) Finally, this platform should also be linked to the Health data space and managed by the Agency and the Commission.
2021/04/28
Committee: ENVI
Amendment 198 #

2020/0321(COD)

Proposal for a regulation
Recital 17
(17) In order to ensure that safe, high quality, and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the Union as soon as possible during public health emergencies, an emergency task force should be established within the Agency to provide advice on such medicinal products. The Emergency Task Force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products. The lessons learned during the COVID pandemic should be taken into account in order to better use the Agency’s potential to face future health crises.
2021/04/28
Committee: ENVI
Amendment 201 #

2020/0321(COD)

Proposal for a regulation
Recital 18
(18) The work of the Emergency Task Force should be separate from the work of the scientific committees of the Agency and should be carried out without prejudice to the scientific assessments of those committees, although communication between these two bodies should be guaranteed. The Emergency Task Force should provide recommendations with regard to the use of medicinal products in the fight against the disease that is responsible for the public health crisis. The Committee for Medicinal Products for Human Use should be able to use those recommendations when preparing scientific opinions on compassionate or other early use of a medicinal product prior to marketing authorisation.
2021/04/28
Committee: ENVI
Amendment 206 #

2020/0321(COD)

Proposal for a regulation
Recital 20 a (new)
(20a) The Emergency Task Force should build on the trial networks to ensure that adequate data on new medicinal products, devices and applications, and it could build also upon the HERA Incubator, presented by Communication of 17 February 2021 “HERA Incubator: Anticipating together the threat of COVID-19 variants” [COM(2021) 78 final].
2021/04/28
Committee: ENVI
Amendment 207 #

2020/0321(COD)

Proposal for a regulation
Recital 21
(21) With respect to medical devices, an executive steering group on medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical devices in the case of a public health emergency. The executive steering group on medical devices should be managed by the Commission and the Agency.
2021/04/28
Committee: ENVI
Amendment 254 #

2020/0321(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point b a (new)
(ba) set up an interoperable and digital database at Union level to track, monitor, report and share information on shortages of medicinal products, devices and applications;
2021/04/28
Committee: ENVI
Amendment 297 #

2020/0321(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
(fa) ‘Health in all policies’ means health in all policies as defined in Regulation (EU) .../... EU 4 Health [OJ: ...]
2021/04/28
Committee: ENVI
Amendment 300 #

2020/0321(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f b (new)
(fb) ‘One Health approach’ means One health approach as defined in Regulation(EU) .../... EU 4 Health [OJ: ...]
2021/04/28
Committee: ENVI
Amendment 301 #

2020/0321(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f c (new)
(fc) ‘zoonosis’ means an infectious disease that has jumped from a non- human animal to humans through zoonotic spill-over;
2021/04/28
Committee: ENVI
Amendment 302 #

2020/0321(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f d (new)
(fd) ‘zoonotic spill-over’ is the spread of a non-human disease to humans resulting in zoonosis;
2021/04/28
Committee: ENVI
Amendment 303 #

2020/0321(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f e (new)
(fe) 'veterinary medicinal product' means a medicinal product as defined in point (1) of Article 4 of Regulation (EU) 2019/6 of the European Parliament and the Council;
2021/04/28
Committee: ENVI
Amendment 304 #

2020/0321(COD)

(ff) 'supply' means total volume of stock of a medicinal product, a medical device, or a medical application, that is placed on the market by a marketing authorisation holder or a manufacturer;
2021/04/28
Committee: ENVI
Amendment 305 #

2020/0321(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f g (new)
(fg) ‘supply chain’ is a steps-based network of activities, information and resources between a manufacturer company and its suppliers willing to produce and distribute a specific product to the final buyer;
2021/04/28
Committee: ENVI
Amendment 311 #

2020/0321(COD)

Proposal for a regulation
Article 3 – paragraph 2
2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fieldThose Member States with devolved competences in health may appoint a representative from a regional competent authority who will represent the whole Member State. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers.
2021/04/28
Committee: ENVI
Amendment 336 #

2020/0321(COD)

Proposal for a regulation
Article 3 – paragraph 5
5. The Medicines Steering Group shall be supported in its work by a working party comprised of single points of contact related to shortages from national, and where applicable regional, competent authorities for medicinal products established in accordance with Article 9(1).
2021/04/28
Committee: ENVI
Amendment 349 #

2020/0321(COD)

Proposal for a regulation
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event that is likely to lead to a major event or a public health emergency in coordination with the national and regional competent authorities.
2021/04/28
Committee: ENVI
Amendment 354 #

2020/0321(COD)

Proposal for a regulation
Article 4 – paragraph 2
2. To facilitate the monitoring task referred to in paragraph 1, the national, and where applicable regional, competent authorities, through the single points of contact referred to in Article 3(5) or the digital interoperable database referred to in Article 1(b) and Article 12(g), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency on any event, including a shortage of a medicinal product in a given Member State, that is likely to lead to a major event or a public health emergency. Where a national, and where applicable regional, competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC. Based on a report of an event from a national or regional competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national and where applicable regional, competent authorities, through the working party referred to in Article 3(5).
2021/04/28
Committee: ENVI
Amendment 364 #

2020/0321(COD)

Proposal for a regulation
Article 4 – paragraph 3
3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall inform the Commission and the Member States thereof. The Commission, on its own initiative or following a request from one or more Member States, or the Executive Director of the Agency mayshall request the assistance of the Medicines Steering Group to address the major event.
2021/04/28
Committee: ENVI
Amendment 365 #

2020/0321(COD)

Proposal for a regulation
Article 4 – paragraph 5 – point a
(a) where the major event or public health emergency may affect the production, manufacturing, safety, quality, distribution and efficacy of medicinal products, devices and applications Article 5 shall apply;
2021/04/28
Committee: ENVI
Amendment 366 #

2020/0321(COD)

Proposal for a regulation
Article 5 – title
Evaluation of information and the provision of advice on action in relation to the production, manufacturing, safety, quality, distribution and efficacy of medicinal products, devices and applications related to public health emergencies and major events
2021/04/28
Committee: ENVI
Amendment 368 #

2020/0321(COD)

Proposal for a regulation
Article 5 – paragraph 1
Following the recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the production, manufacturing, safety, quality, distribution and efficacy of the medicinal products, devices and applications concerned.
2021/04/28
Committee: ENVI
Amendment 377 #

2020/0321(COD)

Proposal for a regulation
Article 6 – paragraph 2
2. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The World Health Organization Model List of Essential Medicines for adults and for children shall be used as the base for its identification of critical medicinal products at Union level. The Agency shall make the public health emergency critical medicines list within 12 months after the entry into force of this Regulation. The list shall be updated whenever necessary until the termination of the recognition of the public health emergency as well as with the Commission and the European Centre for Disease Prevention and Control.
2021/04/28
Committee: ENVI
Amendment 381 #

2020/0321(COD)

Proposal for a regulation
Article 6 – paragraph 2 a (new)
2 a. In case of an eventual zoonotic spill-over, the Medicines Steering Group shall work with the other relevant bodies of the Agency in order to counter it as soon as possible.
2021/04/28
Committee: ENVI
Amendment 389 #

2020/0321(COD)

Proposal for a regulation
Article 6 – paragraph 4 a (new)
4 a. The Agency, under its own assessment, shall establish an open, digital and interoperable database with information on expected and actual shortages of critical medical products, devices and applications. The database shall contain information on but not limited to: a. Trade name and international non- proprietary name; b. Indication; c. Reason for the shortage; d. Start and end dates; e. Member States and/or regions affected, especially cross-border regions; f. Possible consequences to non- communicable diseases or conditions, such as mental health and possible medical solutions and other measures; g. Information for healthcare professionals and patients, including information on alternative treatments. This database shall be accessible to the public. The Agency shall include the national, and where applicable regional, registries on medicine shortages on its web-portal.
2021/04/28
Committee: ENVI
Amendment 402 #

2020/0321(COD)

Proposal for a regulation
Article 7 – paragraph 1
On the basis of the critical medicines lists and the information and data provided in accordance with Articles 10 and 11, the Medicines Steering Group shall monitor supply and demand of medicinal products included on those lists with a view to identifying any potential or actual shortages of those medicinal products. As part of that monitoring, the Medicines Steering Group shall liaise, where relevant, with the Health Security Committee established in Article 4 of Regulation (EU) 2020/[…]19 and, in the case of a public health emergency, the Advisory Committee on public health emergencies established pursuant to Article 24 of that Regulation. The Medicines Steering Group shall provide the aggregated data and demand forecasts from the digital interoperable platform referred to in Article1(b) and Article 12(g). _________________ 19 [insert reference to adopted text referred to in footnote 4]
2021/04/28
Committee: ENVI
Amendment 436 #

2020/0321(COD)

Proposal for a regulation
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national, and where applicable regional, competent authorities, the marketing authorisation holders and other entities to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
2021/04/28
Committee: ENVI
Amendment 438 #

2020/0321(COD)

Proposal for a regulation
Article 8 – paragraph 5 a (new)
5 a. In case any of the aforementioned stakeholders does not give information to the Agency in the time lapse established by the Agency, the Commission shall assist the Agency in obtaining such information, with the prospect of an eventual sanction, which should also be duly informed to the public. This sanction shall be established in an implementing regulation.
2021/04/28
Committee: ENVI
Amendment 440 #

2020/0321(COD)

Proposal for a regulation
Article 8 – paragraph 5 b (new)
5 b. The Agency, together with the Commission, shall also present recommendations to the Commission to counterbalance smear campaigns and disinformation on medicines, medical products, devices or applications, in order to ensure proper information to the public.
2021/04/28
Committee: ENVI
Amendment 446 #

2020/0321(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point a
(a) specify the procedures for establishing the critical medicines lists, ensuring adequate consultation with consumers, patients and healthcare professionals and a high level of transparency;
2021/04/28
Committee: ENVI
Amendment 457 #

2020/0321(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point d
(d) establish and maintain membership of the working party referred to in Article 3(5) comprised of single points of contacts from national, and where applicable regional, competent authorities for medicinal products;
2021/04/28
Committee: ENVI
Amendment 470 #

2020/0321(COD)

Proposal for a regulation
Article 9 – paragraph 2 – point c
(c) request information from the single points of contact from Member States’ national, and where applicable regional, competent authorities based on the set of information agreed on by the Medicines Steering Group and set a deadline for its submission.
2021/04/28
Committee: ENVI
Amendment 484 #

2020/0321(COD)

Proposal for a regulation
Article 9 – paragraph 3 – point g
(g) mitigation plans containing preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains, as well as including production and supply capacity;
2021/04/28
Committee: ENVI
Amendment 511 #

2020/0321(COD)

Proposal for a regulation
Article 10 – paragraph 5
5. Where marketing authorisation 5. holders for medicinal products included on the critical medicines lists are in possession of any additional information, which provides evidence of a potential or actual shortage they shall immediately provide such information to the Agency. National, or where applicable regional, competent authorities shall facilitate patient and consumer reporting of medicine shortages through the digital interoperable database referred to in Article 1(b) and Article 12(g). Aggregated data from these reports shall be shared by the sub-network of single points of contact from national, or where applicable regional, competent authorities referred to in Article 3(5) with the Steering Group to inform recommendations on medicine shortage management.
2021/04/28
Committee: ENVI
Amendment 550 #

2020/0321(COD)

Proposal for a regulation
Article 12 – paragraph 1 – point f a (new)
(fa) assist the Agency in building the digital and interoperable database referred to in Article 1(b) and Article12(g), with the following main tasks: i. facilitate the prevention, monitoring and reporting of shortages of medicinal products, devices and applications, ii. track and follow medicinal products, devices and applications throughout the supply chain, iii. determine the volume of stock, the capabilities of all stakeholders linked in the supply chain or chains, the actual, current and foreseeable level of demand obtain, iv. record and share information about innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma-derived products.
2021/04/28
Committee: ENVI
Amendment 551 #

2020/0321(COD)

Proposal for a regulation
Article 12 – paragraph 1 – point f b (new)
(fb) sanction those marketing authorisation holders, manufacturers or Member States that do not comply with the demands of information by the Agency;
2021/04/28
Committee: ENVI
Amendment 556 #

2020/0321(COD)

Proposal for a regulation
Article 13 – paragraph 1
The Agency shall, via its web-portal and other appropriate means, in conjunction with national, or where applicable regional, competent authorities, inform the public and interest groups with regard to the work of the Medicines Steering Group, ensuring the sharing of information by the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers. The Agency shall assess the transparency of the undertakings of the Medicines Steering Group, taking into account principles of transparency and accountability.
2021/04/28
Committee: ENVI
Amendment 588 #

2020/0321(COD)

Proposal for a regulation
Article 15 – paragraph 1
1. During a public health emergency, the Emergency Task Force shall review clinical trial protocols submitted or intended to be submitted in a clinical trial application by developers of medicinal products as part of an accelerated scientific advice process, taking into account possible innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma-derived products.
2021/04/28
Committee: ENVI
Amendment 625 #

2020/0321(COD)

Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
(da) build the digital and interoperable database as referred to in Article1(b) and Article 12(g).
2021/04/28
Committee: ENVI
Amendment 630 #

2020/0321(COD)

Proposal for a regulation
Article 19 – paragraph 2
2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The Steering Group shall also include a representative of the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers. The Agency shall assess the transparency of the undertakings of the Executive Steering Group on Medical Devices, taking into account principles of transparency and accountability.
2021/04/28
Committee: ENVI
Amendment 637 #

2020/0321(COD)

Proposal for a regulation
Article 19 – paragraph 3
3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups to attend its meetings ensuring the sharing of information by the Patients’ and Consumers’ Working Party as well as a representative of the Healthcare Professionals’ Working Party as observers.
2021/04/28
Committee: ENVI
Amendment 644 #

2020/0321(COD)

Proposal for a regulation
Article 19 – paragraph 5
5. The Medical Devices Steering Group shall be supported in its work by a working party comprised of single points of contact from national, and where applicable regional, competent authorities for medical devices established in accordance with Article 23(1).
2021/04/28
Committee: ENVI
Amendment 665 #

2020/0321(COD)

Proposal for a regulation
Article 22 – paragraph 5
5. The Medical Devices Steering 5. Group may, upon request from the Commission coordinate measures, where relevant, between the national, and where applicable regional, competent authorities, manufacturers of medical devices, notified bodies, and other entities to prevent or mitigate potential or actual shortages in the context of a public health emergency.
2021/04/28
Committee: ENVI
Amendment 671 #

2020/0321(COD)

Proposal for a regulation
Article 23 – paragraph 1 – point a
(a) specify the procedures for establishing the public health emergency critical devices list, ensuring adequate consultation with consumers, patients and healthcare professionals and a high level of transparency;
2021/04/28
Committee: ENVI
Amendment 674 #

2020/0321(COD)

Proposal for a regulation
Article 23 – paragraph 1 – point c
(c) establish and maintain membership of the working party referred to in Article 19(5) comprised of single points of contact from Member States’ national, and where applicable regional, competent authorities for medical devices;
2021/04/28
Committee: ENVI
Amendment 677 #

2020/0321(COD)

Proposal for a regulation
Article 23 – paragraph 2 – point c
(c) request information from the single points of contact from Member States’ national, and where applicable regional, competent authorities based on the set of information agreed on by the Medical Devices Steering Group and set a deadline for its submission.
2021/04/28
Committee: ENVI
Amendment 684 #

2020/0321(COD)

Proposal for a regulation
Article 23 – paragraph 3 – point f
(f) mitigation plans, containing preventative measures to ensure the continued supply of critical medical devices as well as including production and supply capacity;
2021/04/28
Committee: ENVI
Amendment 694 #

2020/0321(COD)

Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)
(ca) regional authorities with devolved health policy competences shall also comply with Article 25 and provide this information both to the national competent authority and to the Agency.
2021/04/28
Committee: ENVI
Amendment 67 #

2020/0320(COD)

Proposal for a regulation
Recital 3
(3) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. From the challenges experienced in responding to the pandemic it became clear that the Centre’s role in the Union’s framework for health crisis preparedness and response should be strengthened and improved taking into account the lessons learned during the pandemic in order to better use the Centre’s potential to face future outbreaks.
2021/04/07
Committee: ENVI
Amendment 81 #

2020/0320(COD)

Proposal for a regulation
Recital 6
(6) In this respect, the Centre should be tasked with providing epidemiological information and its analysis, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases. Its actions should be consistent with a One- Health approach, as well as with the Health in All Policies principle, recognising the interconnections between human and animal health and the environment and the cross-sectoral character of health policies. In this sense, the Centre should also take into account the complex links between biodiversity loss and zoonotic disease risk. It should monitor the capacity of the national health systems to respond to communicable disease threats, in particular given the importance of this information in the preparation of the national preparedness and response plans. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, provide guidelines for treatment and case management based on a thorough assessment of the latest evidence, support epidemic and outbreak responses in Member States and third countries, including field response, and provide timely objective, reliable and easily accessible information on communicable diseases to the public. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health hence contributing to EU’s commitment to reinforcing partners’ preparedness and response capacity, both globally and internally, with the aim to communicate smoothly with specialists at Union, Member States and regional level. Finally, the Centre should keep a network with its peers in third countries, and share best practices achieved both in the Union and elsewhere.
2021/04/07
Committee: ENVI
Amendment 89 #

2020/0320(COD)

Proposal for a regulation
Recital 6 a (new)
(6a) Ensuring supply chain resilience across the Union is not a primordial mission of the Centre, yet the Centre should provide data, knowledge, and skills, to the Commission and the European Medicines Agency in order to ensure supply chain resilience in the Union. Supply chain resilience is part of the four working groups of the COVID– 19 taskforce of the European Medicines Agency, alongside the therapeutic response, business continuity and impact, and human resources.
2021/04/07
Committee: ENVI
Amendment 97 #

2020/0320(COD)

Proposal for a regulation
Recital 7 a (new)
(7a) The Centre should keep a thorough vigilance on modern epidemics such as mental health consequences deriving from communicable diseases, or mental health pathologies such as depression, anxiety, or sleep deprivation. In this regard, the Centre should follow up and share information with the Member States and the regions on how to improve the situation.
2021/04/07
Committee: ENVI
Amendment 110 #

2020/0320(COD)

Proposal for a regulation
Recital 9
(9) With a view to enhance the effectiveness of epidemiological surveillance of communicable diseases and of the related special health issues in the Union, the Centre should be tasked with the further development of digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence distributed ledger technology (DLT), in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiological surveillance and follow- up systems. Such digital platforms and applications should be developed with integrated EU space generated data with the intention to be integrate them in the future European Health Data Space as governed by the Union legislation.
2021/04/07
Committee: ENVI
Amendment 113 #

2020/0320(COD)

Proposal for a regulation
Recital 10
(10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform accurate risk assessment and response, the Centre should in particular monitor and report on trends in communicable diseases, support and facilitate evidence-based response action, provide recommendations for improvement of communicable disease prevention and control programmes established at the national and Union level, monitor and assess the capacity of national health systems for diagnosis, prevention and treatment of communicable diseases, including in a gender-sensitive way, identify population groups at risk requiring specific measures, analyse the correlation of disease incidence with societal and environmental factors, identify possible zoonotic spillovers, and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities, also in the field of anticipatory research for health, knowing that this type of research puts its focus more on anticipating and preventing future health risks, complementing that research that seeks to solve current health challenges. The Centre should work with nominated national and, where appropriate, regional focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.
2021/04/07
Committee: ENVI
Amendment 121 #

2020/0320(COD)

Proposal for a regulation
Recital 11
(11) The Centre should help strengthen the capacity within the Union to diagnose, detect, identify and characterise infectious agents which may threaten public health by ensuring the operation of the network of Union reference laboratories in accordance with Regulation (EU) …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. This network is responsible for the promotion of good practice and alignment on diagnostics, testing methods, training in current and innovative procedures and use of tests, in order to ensure uniform surveillance, notification and reporting of diseases, as well as strengthened quality of testing and surveillance.
2021/04/07
Committee: ENVI
Amendment 127 #

2020/0320(COD)

Proposal for a regulation
Recital 12
(12) Where in case of cross-border health threats posed by communicable diseases, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services are dependent on rapid and urgent risk assessments by the Centre to safeguard patients in need of a therapy from a substance of human origin from the transmission of such a communicable disease. Such risk assessments serve as the basis for appropriate adaptation of measures setting standards for quality and safety of the substances of human origin. The Centre should therefore establish and operate a network of national blood and transplant services and their authorities to serve this purpose.
2021/04/07
Committee: ENVI
Amendment 133 #

2020/0320(COD)

Proposal for a regulation
Recital 13
(13) With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should develop a framework for the prevention of communicable diseases, which addressetaking into account the close relationship between nature deterioration and increasing emergence of zoonotic diseases. This framework should address such issues as vaccine preventable diseases, antimicrobial resistance, health education, health literacy, mental health, interlinkages between health and nature and behaviour change.
2021/04/07
Committee: ENVI
Amendment 141 #

2020/0320(COD)

Proposal for a regulation
Recital 14
(14) The Centre should enhance preparedness and response capabilities at regional, national and Union level by providing scientific and technical expertise to the Member States and the Commission. In this context the Centre, in close collaboration with the Member States, regional centres where appropriate, and the Commission, should carry out various actions, including the development of Union and national preparedness and response plans and preparedness monitoring and evaluation frameworks, provide recommendations on capacities to prevent, prepare and respond to disease outbreaks and on the strengthening of national health systems. The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena, zoonotic disruptions and spillovers, or new diseases of unknown origin, including in third countries, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with agencies, competent bodies and organisations operating in the field of data collection both in the Union and abroad.
2021/04/07
Committee: ENVI
Amendment 153 #

2020/0320(COD)

Proposal for a regulation
Recital 15
(15) Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]] provides for the early warning and response system enabling the notification at Union level of alerts related to serious cross-border threats to health which continues to be operated by the ECDC. Given that modern technologies can be of substantial support to combat health threats and to contain and reverse epidemics, the ECDC should work on updating this system to enable the use of artificial intelligence technologies and interoperable and privacy-preserving digital tools, such as distributed ledger technology, or mobile applications, with tracing functionalities identifying at- risk individuals.
2021/04/07
Committee: ENVI
Amendment 155 #

2020/0320(COD)

Proposal for a regulation
Recital 16
(16) The Centre should establish appropriate capacities to support international and field response, in accordance with Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. These capacities should enable the Centre to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’, to assist local responses to outbreaks of diseases. The Centre should therefore ensure capacity to carry out missions to Member States as well as in third countries and to provide recommendations on response to health threats. These recommendations should be highly regarded in all Member States in case an outbreak is considered by the Centre to be a high threat. These teams will also be able to be deployed under the Union Civil Protection Mechanism with the support of the Emergency Response Coordination Centre. The Centre should also support the strengthening of preparedness capacities under the International Health Regulations (IHR) in third countries, in order to address serious cross border threats to health and the consequences thereof.
2021/04/07
Committee: ENVI
Amendment 167 #

2020/0320(COD)

Proposal for a regulation
Recital 19
(19) This Regulation should not confer any regulatory powers on the Centre. For this purpose, the Centre should take all technological means necessary to strengthen its cybersecurity processes and hardware.
2021/04/07
Committee: ENVI
Amendment 181 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation ( EC) No 851/2004
Article 2 – paragraph 1 – point 6 a (new)
(6a) ‘Health in All Policies’ means Health in All Policies as defined in point (10) of Article 2 of Regulation (EU)2021/522 of the European Parliament and of the Council (‘EU4Health Programme’); __________________ 1a Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).
2021/04/07
Committee: ENVI
Amendment 182 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation ( EC) No 851/2004
Article 2 – paragraph 1 – point 6 b (new)
(6b) ‘One Health approach’ means a One Health approach as defined in point (5) of Article 2 of Regulation (EU) 2021/522;
2021/04/07
Committee: ENVI
Amendment 183 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation ( EC) No 851/2004
Article 2 – paragraph 1 – point 6 c ( new )
(6c) ‘zoonosis’ means an infectious disease that has jumped from a non- human animal to humans through zoonotic spillover;
2021/04/07
Committee: ENVI
Amendment 184 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation ( EC) No 851/2004
Article 2 – paragraph 1 – point 6 d ( new )
(6d) ‘zoonotic spillover’ means the spread of a non-human disease to humans resulting in zoonosis;
2021/04/07
Committee: ENVI
Amendment 194 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 2
In the case of other outbreaks of illnesses of unknown origin, such as zoonotic spillovers, that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that clearly is not caused by a communicable disease, the Centre shall act only in cooperation with the competent body upon request from that body.
2021/04/07
Committee: ENVI
Amendment 198 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 3
In pursuing its mission, the Centre shall take full account of the responsibilities of the Member States, the Commission and other Union bodies or agencies, and of the responsibilities of international organisations active within the field of public health, in order to ensure comprehensiveness, coherence and complementarity of action. Special cooperation shall be foreseen with the European Medicines Agency, the European Environmental Agency and the Commission.
2021/04/07
Committee: ENVI
Amendment 211 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point b a (new)
(ba) identify possible zoonotic spillovers;
2021/04/07
Committee: ENVI
Amendment 215 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point e
(e) monitor health systems’ capacity and support health administrations in their assessment of the capacity of their health systems relevant to the management of communicable disease threats and other special health issues;
2021/04/07
Committee: ENVI
Amendment 233 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point j
(j) provide, upon request of the Commission or the Health Security Committee (‘HSC’), easily accessible and evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures.
2021/04/07
Committee: ENVI
Amendment 234 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point j a (new)
(ja) ensure vigilance on modern epidemics such as mental health consequences deriving from communicable diseases, or mental health pathologies such as depression, anxiety, or sleep deprivation.
2021/04/07
Committee: ENVI
Amendment 237 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point j b (new)
(jb) cooperate with relevant Union bodies and agencies to help ensure supply chain resilience across the Union;
2021/04/07
Committee: ENVI
Amendment 238 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point j c (new)
(jc) provide recommendations to relevant Union bodies and agencies on how to improve policies under the Health in All Policies principle; those recommendations shall be established done together with the European Environmental Agency;
2021/04/07
Committee: ENVI
Amendment 252 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point c
(c) identify, within the scope of the mission of the Centre, recognised competent bodies and public health experts who could be made available to assist in Union responses to health threats, such as by undertaking missions to Member States regions and, where necessary, third countries, in order to provide expert advice and field investigations in the event of disease clusters or outbreaks.;
2021/04/07
Committee: ENVI
Amendment 270 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point a
(a) ensure the further development of the digital platforms and applications supporting epidemiological surveillance at Union level, supporting Member States, including the platform for surveillance established under Article 14 of Regulation (EU) .../... [the SCBTH Regulation], supporting Member States and, where applicable, regions and local entities, with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services;
2021/04/07
Committee: ENVI
Amendment 302 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point d
(d) monitor and assess health systems’ capacity for diagnosis, prevention and treatment of specific communicable diseases as well as patients’ safety, and provide support to relevant Union bodies and agencies, Member States, and regions and local entities, where appropriate;
2021/04/07
Committee: ENVI
Amendment 320 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 5 – subparagraph 3
National focal points and operational contact points nominated for disease- specific interactions with the Centre shall form disease-specific or disease-group- specific networks whose tasks shall include the transmission of national surveillance data as well as mandatory guidelines for the prevention and control of communicable diseases, such as those of zoonotic spillover, to the Centre.
2021/04/07
Committee: ENVI
Amendment 326 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 8 – subparagraph 1
The Centre shall ensure the operation of the network of Member State services supporting transfusion, transplantation, plasma-derived medicines, and medically assisted reproduction to allow for continuous and rapid access to sero- epidemiological data via sero- epidemiological surveys within the population, including assessment of donor population exposure and immunity. Participation in that network by Member States shall be compulsory.
2021/04/07
Committee: ENVI
Amendment 337 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 1
1. The Centre shall support Member States, and regions where appropriate, to strengthen their communicable disease prevention and control systems.
2021/04/07
Committee: ENVI
Amendment 342 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 2
2. The Centre shall develop a framework for the prevention of communicable diseases and special issues, including zoonotic spillover, vaccine preventable diseases, antimicrobial resistance, health education, health literacy, mental health and behaviour change.
2021/04/07
Committee: ENVI
Amendment 346 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 2 a (new)
2a. The Centre shall provide recommendations to the relevant Union bodies and agencies on how to improve policies under the ‘Health in All Policies’ principle. Those recommendations shall be established together with the European Environment Agency.
2021/04/07
Committee: ENVI
Amendment 436 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point c
(c) unusual epidemic phenomena or new communicable diseases of unknown origin, including thosezoonotic spillovers, happening both in the Union and in third countries;
2021/04/07
Committee: ENVI
Amendment 442 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point c
Regulation (EC) No 851/2004
Article 11 – paragraph 2 – point c
(c) work in close cooperation with the competent bodies of the organisations operating in the field of data collection from the Union, third countries, the WHO, and other international organisations, ensuring robust safeguards concerning transparency and accountability; and
2021/04/07
Committee: ENVI
Amendment 448 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point d
Regulation (EC) No 851/2004
Article 11 – paragraph 4
4. In the situations of urgency related to severity or novelty of a serious cross- border threat to health or to the rapidity of its spread among the Member States, the Centre shall make available epidemiological forecasts as referred to in point (g) of Article 5(4), upon request of the Commission, the European Medicines Agency, or a Member State, in an objective, reliable, transparent and easily accessible way and on the basis of the best available information.
2021/04/07
Committee: ENVI
Amendment 477 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 16 – point b
Regulation (EC) No 851/2004
Article 14 – paragraph 5 – point i – subparagraph 1
determine the rules governing the languages of the Centre, including the possibility of a distinction between the internal workings of the Centre and the external communication, taking into account the need to ensure access to, and participation in, the work of the Centre by all interested parties in both cases and in all languages of the Union.
2021/04/07
Committee: ENVI
Amendment 488 #

2020/0320(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 21
Regulation (EC) No 851/2004
Article 21 – paragraph 6 a (new)
6a. For the purpose of confidentiality, the Centre shall provide itself with high- quality cybersecurity technology.
2021/04/07
Committee: ENVI
Amendment 163 #

2020/0300(COD)

Proposal for a decision
Recital 9 a (new)
(9a) The Union should commit to a shift towards a sustainable well-being economy with the SDGs as the foundation. A wellbeing economy considers that public interests should determine economics, and not the other way around. It prioritises what truly matters: the wellbeing of all citizens, combining prosperity with equity and with social progress within planetary boundaries, protecting the planet’s resources for future generations and other species. Shifting to a wellbeing economy requires a governance approach, which puts people and their wellbeing at the centre of policy and decision-making. In order to achieve that, the Union will need to establish new indicators of economic performance and social progress 'beyond GDP' since it does not reflect depreciation of natural capital.
2021/03/11
Committee: ENVI
Amendment 217 #

2020/0300(COD)

Proposal for a decision
Recital 14 a (new)
(14a) There is an increasing body of knowledge and ongoing workstreams in the Joint Research Centre, the European Environment Agency and other organisations on the notion of planetary boundaries (e.g. freshwater use, land use change, ocean acidification) and on the Union consumption footprint. Advancing that work is important to inform policy makers and stakeholders as well as to support the identification of key systemic challenges. It is also important to assess the global impact of the Union policies and agreements, especially on the environmental and wellbeing status of developing countries, in view of seeking synergies between the Union’s environmental improvement and that of third and least developed countries.
2021/03/11
Committee: ENVI
Amendment 231 #

2020/0300(COD)

Proposal for a decision
Recital 17 a (new)
(17a) Whilst monitoring progress towards the 8th EAP priority objectives will initially be based on existing indicators, there is a need to transition to a way of measuring progress toward these objectives which can take into account and measure progress on systemic change. Such a monitoring framework would need to take into account the effects of feedback loops, tipping points, policy incoherence, global impacts beyond the Union borders and lock-in effects. The mid-term evaluation of the 8th EAP should include, inter alia, an assessment of progress made towards the development of such an evolved monitoring framework with the aim of deploying it in the context of the 8th EAP for the 2025-2030 period.
2021/03/11
Committee: ENVI
Amendment 239 #

2020/0300(COD)

Proposal for a decision
Recital 18 a (new)
(18a) Pursuant to Article 191 of the Treaty on the Functioning of the European Union (TFEU), Union policy on the environment is to aim at a high level of protection and is to be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should, as a priority, be rectified at source, that the polluter should pay and that there is a global responsibility concerning nature conservation.
2021/03/11
Committee: ENVI
Amendment 254 #

2020/0300(COD)

Proposal for a decision
Article 1 – paragraph 2
2. The 8th EAP aims at accelerating the transition to a climate-neutral, sustainable, toxic-free, resource-efficient, clean and circular renewable energy-based and resilient economy in a just and inclusive way, and endorsesat protecting, restoring and improving the quality of the environment including air, water, and soil, and at halting and reversing biodiversity loss and tackling the degradation of ecosystems, putting Europe’s biodiversity on a path to recovery by 2030. It endorses and builds on the environmental and climate objectives of the European Green Deal and its initiatives.
2021/03/11
Committee: ENVI
Amendment 272 #

2020/0300(COD)

Proposal for a decision
Article 1 – paragraph 3
3. The 8th EAP forms the basis for achieving the environmental and climate objectives defined under the United Nations 2030 Agenda and its Sustainable Development Goals and its monitoring framework constitutes the environment and climate part ofshall contribute to the EU’s efforts to measure progress towards greater sustainability, including climate neutrality and resource efficiency, wellbeing, equity and resilience.
2021/03/11
Committee: ENVI
Amendment 281 #

2020/0300(COD)

Proposal for a decision
Article 2 – paragraph 1
1. The 8th EAP shasll have the long- term priority objective for 2050 thathat by 2050 at the latest citizens live well, within the planetary boundaries in a regenerative and sustainable well-being economy where nothing is wasted, no net emissions of greenhouse gases are produced and economic growth is decoupled from resource use and environmental degradationbiodiversity loss is tackled and climate neutrality is achieved. A healthy environment underpins the well- being of citizens, biodiversity thrives and natural capital is protected, restored and valued in ways thatand the health of citizens, and directly depends on the recovery of biodiversity and the conservation and protection of nature. It also allows for the enhancement of resilience to climate change and other environmental risks. The Union sets the pace for ensuring the prosperity of present and future generations globally.
2021/03/11
Committee: ENVI
Amendment 350 #

2020/0300(COD)

Proposal for a decision
Article 2 – paragraph 2 – point f
(f) promoting environmental sustainability and reducing key environmental and climate pressures related to production and consumption, land use and pollution, in particular in the areas of energy, industrial development, buildings and infrastructure, mobility and the food system, international trade and food systems including agriculture, fisheries and aquaculture.
2021/03/11
Committee: ENVI
Amendment 397 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point b – indent 3
paying careful attention tosystematically evaluating synergies and potential trade-offs between economic, environmental and social objectives for all initiatives so as to ensure that citizens’ needs for nutrition, housing and mobility arewellbeing is met in a sustainable way that leaves no-one behind and does no harm to developing countries;
2021/03/11
Committee: ENVI
Amendment 403 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point b – indent 3 a (new)
– developing practices and carrying out activities that support local and regional authorities in meeting their objectives;
2021/03/11
Committee: ENVI
Amendment 415 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point b – indent 4 a (new)
– taking into account the consumption footprint of the Union beyond its political borders;
2021/03/11
Committee: ENVI
Amendment 431 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point d
(d) mobilising sustainable investments from public and private sources, including of funds and instruments available under the Union budget, via the European Investment Bank and at national level, consistent with the Union's sustainable finance strategy, and ensuring the right synergies, while making sure that sufficient investment can be allocated at the level where it is most needed and most effectively employed, ensuring that local and regional communities have adequate resources for implementation on the ground;
2021/03/11
Committee: ENVI
Amendment 465 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point f a (new)
(fa) identifying and quantifying environmental impacts beyond the Union political borders, with a view to ensure a proper assessment of the Union environmental footprint and to share responsibility on global biodiversity conservation;
2021/03/11
Committee: ENVI
Amendment 467 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point f b (new)
(fb) ensuring the full participation of, and cooperation with, local and regional authorities across all dimensions of environmental policy-making through a collaborative and multi-level governance approach;
2021/03/11
Committee: ENVI
Amendment 532 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point k – indent 5
– ensuring that the Union and the Member States’ financial assistance to third countries promotes the UN 2030 Agenda does not undermine any of the SDGs and helps to perform better on environmental and climate SDGs.
2021/03/11
Committee: ENVI
Amendment 537 #

2020/0300(COD)

Proposal for a decision
Article 3 – paragraph 1 – point k – indent 5 a (new)
– ensuring that nature degradation and environmental impacts are not delocalized and that there is a global responsibility concerning nature conservation;
2021/03/11
Committee: ENVI
Amendment 579 #

2020/0300(COD)

Proposal for a decision
Article 4 – paragraph 3 – point c
(c) delivering policy-relevant and systemic analyses, and contributing to implementing policy objectives at Union and nation, national, regional and local level;
2021/03/11
Committee: ENVI
Amendment 595 #

2020/0300(COD)

Proposal for a decision
Article 4 – paragraph 4
4. The Commission shall regularly examine data and knowledge needs at Union and nation, national and, when necessary, local level, including the capacity of the European Environment Agency and the European Chemicals Agency to carry out the tasks referred to in paragraph 3.
2021/03/11
Committee: ENVI
Amendment 605 #

2020/0300(COD)

Proposal for a decision
Article 5 – paragraph 1
By 31 March 2029, the Commission shall carry out an evaluation of the 8th EAP, based on the assessment of the headline indicators. The Commission shall submit a report to the European Parliament and to the Council containing the main findings of that evaluation, accompanied, if the Commission deems appropriate, by a legislative proposal for the next environmental action programme. Such a legislative proposal shall be presented in a timely manner, with a view to avoiding a gap between the 8th and the 9th EAP.
2021/03/11
Committee: ENVI
Amendment 20 #

2020/0289(COD)

Proposal for a regulation
Recital 3
(3) In its Communication to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions of 11 December 2019, entitled ‘The European Green Deal’ the Commission committed itself to consider revising Regulation (EC) No 1367/2006 to improve access to administrative and judicial review at Union level for citizens and environmental non- governmental organisations who have concerns about the compatibility with environmental law of decisions with potential effects on the environment. The Commission also committed to take action to improve their access to justice before national courts in all Member States; to this end, it issued a Communication on ‘Improving access to justice in environmental matters in the EU and its Member States’.
2021/03/11
Committee: ENVI
Amendment 88 #

2020/0289(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EC) No 1367/2006
Article 2 – paragraph 1 – point g
(g) ‘administrative act’ means any non- legislative act adopted by a Union institution or body, which has legally binding and external effects and contains provisions that may, because of their effects, contravene environmental law within the meaning of point (f) of Article 2(1), excepting those provisions of this act for which Union law explicitly requires implementing measures at Union or national level;’
2021/03/11
Committee: ENVI
Amendment 3 #

2020/0157M(NLE)

Draft opinion
Paragraph 1
1. Strongly supports the conclusion of the negotiations on the Voluntary Partnership Agreement (VPA) between the EU and Honduras, which not only promotes sustainable trade in legal timber products, but also aims to address illegal logging and improve forest governance, law enforcement and transparency, human rights, transparency, accountability and institutional resilience;
2020/12/17
Committee: DEVE
Amendment 8 #

2020/0157M(NLE)

Draft opinion
Paragraph 2
2. Welcomes the commitment shown by Honduras and the progress made so far, and is aware that the full implementation of the VPA will be a long-term process entailing the adoption of a whole batch of legislation to establish the Timber Legality Assurance System (TLAS) and to make it operational; stresses that the implementation of the VPA will require sustained political will, as well as the dedication of significant human and financial resources to running the TLAS; stresses that EU Delegations should play a key role in overseeing that Honduran authorities effectively include all the relevant stakeholders in the process towards the establishment of a fully operational TLAS and the implementation of the VPA; believes that parliamentary oversight of the implementation process of the VPA is needed, especially with regard to holding regular exchange of views with the independent auditor appointed by the Honduras-EU Joint Implementation Committee;
2020/12/17
Committee: DEVE
Amendment 10 #

2020/0157M(NLE)

Draft opinion
Paragraph 2 a (new)
2 a. Is concerned that timber products can be imported into Honduras as long as those products were produced in accordance with the laws of the country where the trees were harvested because of the lower due diligence standards that can exist in those countries and the ulterior incorporation of these products into goods subsequently exported to the EU internal market;
2020/12/17
Committee: DEVE
Amendment 12 #

2020/0157M(NLE)

Draft opinion
Paragraph 3
3. Calls on the Commission to allocate funding to accompany the implementation of the VPA as part of the next programming period of the EU bilateral programmes (2021-2027), especially with regard to the assistance for establishing a truly independent FLEGT licensing authority entrusted by the EU;
2020/12/17
Committee: DEVE
Amendment 18 #

2020/0157M(NLE)

Draft opinion
Paragraph 5
5. Welcomes the fact that the VPA’s definition of legality explicitly refers to the rights of Indigenous and Afro-descendant Peoples of Honduras living in forest areas and to the principles of free, prior and informed consent (FPIC); welcomes that the rights of forestry sector workers are also recognized in the VPA's definition of legality, and believes that ensuring full alignment of Honduran law with ILO standars and effective respect of labour rights should be a priority of the Honduras-EU Joint Implementation Committee;
2020/12/17
Committee: DEVE
Amendment 21 #

2020/0157M(NLE)

Draft opinion
Paragraph 6
6. Recalls that land tenure has been a major source of violence and human rights abuses in Honduras; believes, in this context, that the VPA process could contribute to clarifying land tenure rights; deplores that human rights violations and attacks on human rights defenders, including enforced disappearances and murders, are recurrent and many times go unpunished; believes that the EU should help to improve the operational capacity of the Honduran protection mechanism for human rights defenders;
2020/12/17
Committee: DEVE
Amendment 26 #

2020/0157M(NLE)

Draft opinion
Paragraph 7
7. Emphasises that the success of the Agreement will also depend, inter alia, on tackling fraud and corruption; underlines that the VPA should not be considered as a mere trade agreement but as a tool to improve rule of law and human rights enforcement in Honduras; calls on the Commission to ensure that Honduras’s National Commission on Human Rights (CONADEH) duly monitors and assesses human rights violations; considers that independent civil society organisations should be involved from the very beginning in the monitoring of human rights and institutional resilience;
2020/12/17
Committee: DEVE
Amendment 29 #

2020/0157M(NLE)

Draft opinion
Paragraph 8
8. Calls for the EU to ensure the coherence of the VPA agreement with all of its policies., especially with regard to the establishment of a robust compulsory due diligence framework for European companies operating in third countries that makes those companies liable for damages linked to their activity in these countries and the effective enforcement of human rights clauses in trade agreements;
2020/12/17
Committee: DEVE
Amendment 31 #

2020/0157M(NLE)

Draft opinion
Paragraph 8 a (new)
8 a. Reminds that the current VPA builds upon the association agreement signed by the Union with Central America’s countries in 2012, entering into force in 2013, and whose legal dispositions already foresee comprehensive sustainable development criteria but only a mention on human rights in its preamble; calls on the Commission to increase mentions on human rights defence and guarantees in all free trade agreements (FTAs) and association agreements (AA) with third countries.
2020/12/17
Committee: DEVE
Amendment 196 #

2020/0102(COD)

Proposal for a regulation
Recital 12 a (new)
(12a) Demographic change and technological innovation are some of the most important challenges facing our health systems. The aging of the population is largely due to the success of our healthcare systems and forces them, at the same time, to a structural transformation: from a healthcare model focused mainly on acute diseases, it is necessary to move towards a healthcare model in which chronic diseases gain more weight. It is important that the Member States accompany each other in this process of transformation of the healthcare model, and for this reason it is necessary to strengthen good practices exchanging mechanisms. TheEU4Health programme should play an important role in guiding these exchanges.
2020/07/16
Committee: ENVI
Amendment 240 #

2020/0102(COD)

Proposal for a regulation
Recital 16 a (new)
(16a) We now know that social and economic determinants are a persistent source of inequalities in health. One of the priority objectives of Member States' public health systems should be the fight against these inequalities. The COVID- 19pandemic has threatened the European population as a whole, but once again the most economically vulnerable populations have been the most affected. It is essential that the projects of the EU4Health programme are managed in accordance with the general and transversal objective of reducing health inequalities. Likewise, the EU4Health programme's projects should also serve to assist Member States in the reformulation of the budgets of their health systems, with the aim of making them more clearly redistributed according to the criteria of health inequalities of the population.
2020/07/16
Committee: ENVI
Amendment 310 #

2020/0102(COD)

Proposal for a regulation
Recital 19 a (new)
(19a) There is plenty of scientific evidence that shows that health prevention and promotion policies (public health policies) are central to guaranteeing the right to health of citizens, and those are also the most efficient in terms of cost effectiveness. However, even today most of the budgets of the health systems of the majority of Member States are given very little space to policies for the prevention and promotion of health. The COVID-19 pandemic has firmly confirmed the importance of public health policies for our societies. For this reason, it is necessary that the projects of the EU4Health programme accompany Member States to reformulate the budgets of their health systems in order to fulfil greater financial strength to these policies.
2020/07/16
Committee: ENVI
Amendment 318 #

2020/0102(COD)

Proposal for a regulation
Recital 19 b (new)
(19b) Likewise, it is absolutely necessary to remember that these prevention and promotion strategies concern all sectoral policies: fiscal, commercial, economic, educational, housing, cultural, social assistance, etc. "Health in all policies" (HiAP) should be a non-negotiable principle of all public policies. An instrument already used at the national level is the so-called Health Test to assess the health impact of the different sectoral policies. It is necessary to deploy a Health Test methodology of all the programmes managed by the Union.
2020/07/16
Committee: ENVI
Amendment 381 #

2020/0102(COD)

Proposal for a regulation
Recital 25 a (new)
(25a) The COVID-19 crisis has confirmed the perspective according to which it is convenient to strengthen the participation of the public sector in health research strategies to avoid that these are limited by strictly commercial criteria. In line with Horizon Europe, the EU4Health programme needs to help strengthen the resources necessary so that all strategic health research that cannot be done without public support may be carried out.
2020/07/16
Committee: ENVI
Amendment 434 #

2020/0102(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
(10a) "health in all policies principle": policy formulation approach that systematically considers health implications of decisions in all sectors, seeking synergies and avoiding the harmful effects on health of policies outside the health sector, in order to improve population's health and health equity. It develops the capacity of health policy professionals to recognise and support the development goals of other sectors, recognising the interdependent nature of social, economic, and environmental development;
2020/07/16
Committee: ENVI
Amendment 540 #

2020/0102(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 4 a (new)
(4a) accompany the Member States in the reformulation of the budgets of their health systems so that they are more clearly redistributed according to the criteria of inequalities in population health;
2020/07/16
Committee: ENVI
Amendment 591 #

2020/0102(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 9
(9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, and scaling up networking through the European Reference Networks and other transnational networks, as well as exchange good practices in order to make it easier for Member States to make the transition towards a healthcare model where aging and chronicity have gained relevance;
2020/07/16
Committee: ENVI
Amendment 608 #

2020/0102(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 10 a (new)
(10a) support policies that guarantee the principle "health in all policies";
2020/07/16
Committee: ENVI
Amendment 609 #

2020/0102(COD)

Proposal for a regulation
Article 4 – paragraph 1 – point 10 b (new)
(10b) strengthen public sector participation in health research strategies, in coherence with the Horizon Europe programme, in order to reinforce the necessary resources so that all strategic health research that cannot be done without public support may be carried out;
2020/07/16
Committee: ENVI
Amendment 239 #

2020/0036(COD)

Proposal for a regulation
Recital 14 a (new)
(14 a) In order to achieve a successful adaptation to climate change, the Union should set up, among other measures, own resources coming from the Emission Trading Scheme (ETS), as well as a tax on maritime and aviation fuels. Without an adequate availability of economic resources for the application of National Energy and Climate Plans, derived from this Regulation in all levels of the public administration, national plans will be good but their objectives will be impossible to achieve.
2020/06/08
Committee: ENVI
Amendment 241 #

2020/0036(COD)

Proposal for a regulation
Recital 14 b (new)
(14b) The Union should set up a carbon border tax in order to make the objectives set up in this regulation compatible with the competitivity of European companies, especially SMEs. The carbon border tax is the most efficient tool in order to ensure that the compliance of this Regulation’s objectives keeps intact the competitivity of European companies as regards to companies from third countries.
2020/06/08
Committee: ENVI
Amendment 308 #

2020/0036(COD)

Proposal for a regulation
Recital 18 a (new)
(18a) Member States are structured in different administrative levels, some of them as federated or autonomous regional entities (NUTS 2), which have relevant competences as regards to climate mitigation and adaptation, and as regards to the reduction of greenhouse emissions. Some may even have established greenhouse reduction targets in their climate mitigation and adaptation plans. Mitigation may be enhanced by total or partial regional decentralisation of management on sources such as waste, agriculture and livestock, mobility, energy efficiency or forest management. The implementation of greenhouse emissions’ reduction measures should be made by decentralised administrative levels that are closer to the citizen. Mitigation measures should be based on the combination of top-down and bottom-up measures in order to achieve effective results. In terms of adaptation, the local component in the implementation of the measures is a more critical element than when it regards to mitigation. There may not be adaptation measures of general application since in each case the circumstances of each territory should be incorporated. If mechanisms for monitoring, follow-up and coordination of how the measures are being implemented internally in Member States are not established, the results cannot be successful in mitigation as well as in adaptation measures.
2020/06/08
Committee: ENVI
Amendment 317 #

2020/0036(COD)

Proposal for a regulation
Recital 18 b (new)
(18b) The level of ambition of this Regulation is very high. Nevertheless, it is difficult to believe that this very demanding objective could be achievable if climate neutrality is assessed only in the Union as a whole, and it should also be assessed in every and each one of the Member States.
2020/06/08
Committee: ENVI
Amendment 328 #

2020/0036(COD)

Proposal for a regulation
Recital 19 a (new)
(19a) According to the latest IPCC recommendations, the two systems that generate the highest greenhouse emissions are fossil-based energetic systems and food systems, based on high levels of ruminant meat and milk intake. Therefore, together with the objective of achieving an industrial and transport model free from carbon emissions, it is also essential to advance towards a food system with lower meat intake. The Union should set up the necessary measures to avoid the collision between sectoral policy objectives and climate objectives.
2020/06/08
Committee: ENVI
Amendment 466 #

2020/0036(COD)

Proposal for a regulation
Article 2 – paragraph 3
3. By September 20201, the Commission shall review the Union’s 2030 target for climate referred to in Article 2(11) of Regulation (EU) 2018/1999 in light of the climate-neutrality objective set out in Article 2(1), and explore options for a new 2030 target of 50 to 55% emission reductions compared to 1990. Where the Commission considers that it is necessary to amend that target, it shall make proposals to the European Parliament and to the Council as appropriateorder for the reduction of emissions to be 65% compared to 1990.
2020/06/08
Committee: ENVI
Amendment 493 #

2020/0036(COD)

Proposal for a regulation
Article 2 – paragraph 4
4. By 30 June 2021, the Commission shall assess how themend Union legislation implementing the Union’s 2030 target would need to be amended in order to enable the achievement of 650 to 55 % emission reductions compared to 1990 and to achieve the climate-neutrality-objective set out in Article 2(1), and considershall takinge the necessary measures, including the adoption of legislative proposals, in accordance with the Treaties.
2020/06/08
Committee: ENVI
Amendment 653 #

2020/0036(COD)

Proposal for a regulation
Article 3 – paragraph 3 – point d a (new)
(da) food systems with high ruminant meat intake;
2020/06/08
Committee: ENVI
Amendment 719 #

2020/0036(COD)

Proposal for a regulation
Article 3 – paragraph 3 – point j a (new)
(ja) good practices, legislation or policies made by Member States, regions or local entities prior or during the entry into force of this Regulation;
2020/06/08
Committee: ENVI
Amendment 782 #

2020/0036(COD)

Proposal for a regulation
Article 4 a (new)
Article 4a Fiscal measures to achieve adaptation to climate change In order to achieve the adaptation measures set up in Article 4, the Commission shall by March 2021 adopt proposals for regulations to establish the following fiscal measures for the Union carbon budget set up in Article 3a: a) a border carbon tax in order to make the objectives of this Regulation compatible with the competitivity of the Member States as regards to companies from third countries; b) own resources coming from the ETS; c) a tax on maritime and aviation fuels. (The article 3a mentioned in this amendment refers to AM 38 of Mme Guteland, rapporteur for this proposal of a regulation.)
2020/06/08
Committee: ENVI
Amendment 796 #

2020/0036(COD)

Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point a
(a) the collective progress made by all Member States, as well as every Member State considered individually, towards the achievement of the climate-neutrality objective set out in Article 2(1) as expressed by the trajectory referred to in Article 3(1);
2020/06/08
Committee: ENVI
Amendment 805 #

2020/0036(COD)

Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point b
(b) the collective progress made by all Member States, as well as every Member State considered individually, on adaptation as referred to in Article 4.
2020/06/08
Committee: ENVI
Amendment 895 #

2020/0036(COD)

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point a
(a) the consistency of national and regional measures identified, on the basis of the National Energy and Climate Plans or the Biennial Progress Reports submitted in accordance with Regulation (EU) 2018/1999, as relevant for the achievement of the climate-neutrality objective set out in Article 2(1) with that objective as expressed by the trajectory referred to in Article 3(1);
2020/06/08
Committee: ENVI
Amendment 903 #

2020/0036(COD)

Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point b
(b) the adequacy of relevant national and regional measures to ensure progress on adaptation as referred to in Article 4.
2020/06/08
Committee: ENVI
Amendment 916 #

2020/0036(COD)

Proposal for a regulation
Article 6 – paragraph 2
2. Where the Commission finds, under 2. due consideration of the collective progress assessed in accordance with Article 5(1), that a Member State’s measuresmeasures adopted by Member States, as well as by regions with legislative powers on climate change and environmental policies, are inconsistent with that objective as expressed by the trajectory referred to in Article 3(1) or inadequate to ensure progress on adaptation as referred to in Article 4, it may issue recommendations to that Member State. The Commission shall make such recommendations publicly available.
2020/06/08
Committee: ENVI
Amendment 933 #

2020/0036(COD)

(a) the Member State, as well as the regions with legislative powers on climate change and environmental policies, concerned shall take due account of the recommendation in a spirit of solidarity between Member States and the Union and between Member States;
2020/06/08
Committee: ENVI
Amendment 937 #

2020/0036(COD)

Proposal for a regulation
Article 6 – paragraph 3 – point b
(b) the Member State, as well as the regions with legislative powers on climate change and environmental policies, concerned shall set out, in its first progress report submitted in accordance with Article 17 of Regulation (EU) 2018/1999, in the year following the year in which the recommendation was issued, how it has taken due account of the recommendation. If the Member State or the regions with climate change-related competences concerned decides not to address a recommendation or a substantial part thereof, that Member State shall provide the Commission its reasoning;
2020/06/08
Committee: ENVI
Amendment 971 #

2020/0036(COD)

Proposal for a regulation
Article 7 – paragraph 1 – point e
(e) any supplementary information on environmentally sustainable investment, by the Union and Member Stat, Member States, and regions with legislative powers on climate change and environmental policies, including, when available, investment consistent with Regulation (EU) 2020/… [Taxonomy Regulation].
2020/06/08
Committee: ENVI
Amendment 978 #

2020/0036(COD)

Proposal for a regulation
Article 7 a (new)
Article 7a European Union Network on Climate Change 1. By 31 December 2021, the Commission shall set up the European Union Network on Climate Change (EUnCC), an independent scientific advisory panel on climate change, consisting of scientists selected on the basis of their expertise in the climate change field and proposed by regions, coalition of regions or local entities. 2. The Commission shall ensure that the governance structure of the EUnCC guarantees its scientific autonomy, including of Union and regional institutions. 3. The relevant committee of the European Parliament shall make an opinion as regards to any appointment to the EUnCC, based exclusively on the scientific autonomy of EUnCC’s members. 4. The EUnCC shall monitor the greenhouse gas emission reductions in the Union, Member States and regions, taking into account the Union’s carbon budget provided for in Article 3. 5. The EUnCC shall assess the consistency of measures and progress made to achieve climate neutrality by 2050 at the latest. 6. The EUnCC shall, on an annual basis, report its findings under paragraph 3 to the Commission and the relevant committee of the European Parliament. The EUnCC shall guarantee full transparency to the public and make its information available in all the official languages of Member States.
2020/06/08
Committee: ENVI
Amendment 45 #

2019/2184(INI)

Motion for a resolution
Recital D
D. whereas the principles of ownership and, alignment, suitability, stability, multilateralism, resource sufficiency and focusing on results, inclusive partnerships, transparency and accountability, should underpin all forms of development cooperation;
2020/09/25
Committee: DEVE
Amendment 80 #

2019/2184(INI)

Motion for a resolution
Paragraph 1
1. Stresses that effectiveness means delivering more and better impact, achieving the SDGs and leaving no-one behind; believes that when EU support is aligned with partner countries’ own efforts, giving priority to official development aid being appropriate to these countries' needs over any other interests donor countries may have, and delivered through their institutions and systems in support of priorities that have been agreed through inclusive and equitable policy processes, the impact is bigger, faster and more sustainable;
2020/09/25
Committee: DEVE
Amendment 108 #

2019/2184(INI)

Motion for a resolution
Paragraph 5
5. Calls on the Commission and the Council to scale up joint programming between the EU and its Member States, with the aim of securing a European voice with which to move forward towards commonly defined policy objectivbetter multilateral planning of national development cooperation policies, which should take into account innovative financing methods such as blending and guarantees; stresses the need, where stable and transparent institutions have a presence in partner states, to increase the emphasis on donations, rather than credit, to prevent the increase in partner countries' external debt hobbling opportunities for economic growth and their capacity to focus government action on social priorities; calls for clear, actionable commitments towards joint implementation and evaluation and for shared accountability mechanisms towards citizens;
2020/09/25
Committee: DEVE
Amendment 196 #

2019/2184(INI)

Motion for a resolution
Paragraph 14
14. Reiterates its request that the Council and the Member States set out a clear timeline for reaching the target of raising the ODA budget to 0.7 % of GNI, preventing volatility and a lack of stability in Member States' official development aid resources, and that the Commission present a concrete action plan defining how additional resources will be leveraged towards achieving the SDGs; points out that without this sufficient and stable volume of resources agreed by the UN General Assembly in 1970 being dedicated to official development aid, it is not realistic to conceive of achieving the SDGs, particularly with regard to ensuring that no one is living below the extreme poverty line.
2020/09/25
Committee: DEVE
Amendment 89 #

2019/2157(INI)

Draft opinion
Paragraph 1 a (new)
1a. Notes that the European Forest Strategy should incorporate a greater variety of objectives into forest management, including the conservation of biodiversity, the recovery of ecological processes, and the adaptation to climate change, in line with the European Green Deal; stresses that the Strategy should establish long-term goals for forest management, and plan at the landscape level in order to allow the coexistence of all the tiles of any forest’s heterogeneous mosaic;
2020/04/30
Committee: ENVI
Amendment 121 #

2019/2157(INI)

Draft opinion
Paragraph 2 a (new)
2a. Notes that although best-preserved forests, from which no products are extracted, are few, they should be given the attention they deserve, as they make a contribution to knowledge, health and ecotourism that we cannot deny to future generations; stresses that Natura 2000, as the European ecological habitat conservation network, should play a crucial role in the European Forest Strategy; is of the opinion that Natura 2000 should be key to guarantee the protection and conservation of forests;
2020/04/30
Committee: ENVI
Amendment 223 #

2019/2157(INI)

Draft opinion
Paragraph 5 a (new)
5a. Expresses its concern on the biodiversity loss occurring in the Union, something that needs to be also stopped by the European Forest Strategy; reminds that the loss of biodiversity is an internal problem of the Union; notes that the Strategy should protect the last fragments of mature forests in the Union due to their importance as biodiversity reservoirs and as a way to increase forest resilience; emphasises that the Strategy should promote a zero-impact silviculture on soil and landscapes;
2020/04/30
Committee: ENVI
Amendment 234 #

2019/2157(INI)

Draft opinion
Paragraph 5 b (new)
5b. Urges to improve knowledge about the dynamics of Mediterranean ecosystems in terms of their maturity and disturbance regime, which could also allow for new management models to be established; urges also to improve the professional training in the field of forestry in order to allow for new forest management objectives to be adapted to the needs of the 21st century; proposes to adapt Rural Development Plans (RDPs) in order to incorporate adequate funding for the measures previously outlined;
2020/04/30
Committee: ENVI
Amendment 247 #

2019/2157(INI)

Draft opinion
Paragraph 5 c (new)
5c. Emphasises the therapeutic function of forests, which have direct positive consequences for human health and the quality of life of citizens; stresses that forests also contribute to the socio- economic development of Europe’s rural territories, including the distribution of income to the most depopulated areas of the Union thanks to ecotourism, one of the most demanded modalities within the tourism industry;
2020/04/30
Committee: ENVI
Amendment 98 #

2019/2156(INI)

Motion for a resolution
Recital E
E. whereas increased protection of forests provides opportunities for economic development, particularly at the level of local communities; whereas forests have a therapeutic function with direct positive consequences for human health and quality of life, and could therefore also contribute to the socioeconomic development of rural areas;
2020/05/08
Committee: ENVI
Amendment 190 #

2019/2156(INI)

Motion for a resolution
Paragraph 3 a (new)
3a. Notes that mature forests should be given the attention they deserve, as they make a contribution to knowledge and health that we cannot deny to future generations; expresses its concern on the biodiversity loss occurring in several parts of the world due to climate change and recalls that the loss of biodiversity should also be a priority for the Union;
2020/05/08
Committee: ENVI
Amendment 39 #

2019/0017(COD)

Proposal for a regulation
Recital 1 a (new)
(1a) The Union should guarantee that new measures are taken in order to integrate the objectives established in the Paris Agreement and the provisions presented in the Communication of the Commission of 11 December 2019 on the European Green Deal. Therefore, the Union should also integrate maritime emissions into the overall Union objectives to decrease greenhouse gas emissions in order not to pose a threat to the efforts made by other economic sectors that will have to achieve climate neutrality by, maximum, 2050, as foreseen in the European Green Deal.
2020/03/20
Committee: ENVI
Amendment 46 #

2019/0017(COD)

Proposal for a regulation
Recital 3
(3) The European Parliament's Resolution of Februaryresolutions of the European Parliament of 14 March 2019 on climate change and of 28 November 20149 on a 2030 framework for climate and energy policiesthe climate and environmental emergency urged to achieve climate neutrality by 2050. The European Parliament also called on the Commission and the Member States to set a binding Union 2030 target of reducing greenhouse gas emissions by at least 40% compared to 1990 levels. The European Parliament also noted that all sectors of the economy would need to contribute to the reduction of greenhouse gas emissions if the Union is to deliver its fair share of global efforts.
2020/03/20
Committee: ENVI
Amendment 53 #

2019/0017(COD)

Proposal for a regulation
Recital 5
(5) Building on the 2011 Union White paper on transport18 , in 2013 the Commission adopted a strategy for progressively integrating maritime emissions into the Union's policy for reducing greenhouse gas emissions19 . Furthermore, the Commission set up an ambitious road towards the achievement of climate neutrality by, maximum, 2050, in its Communication on the European Green Deal of 11 December 2019. __________________ 18 https://ec.europa.eu/transport/sites/transpor t/files/themes/strategies/doc/2011_white_p aper/white-paper-illustrated- brochure_en.pdf. 19 COM (2013) 479.
2020/03/20
Committee: ENVI
Amendment 67 #

2019/0017(COD)

Proposal for a regulation
Recital 8
(8) Under the Paris Agreement that was adopted in December 2015 at the 21st Conference of the Parties of the United Nations Framework Convention on Climate Change (UNFCCC)23 , the Union and its Member States have undertaken an economy-wide reduction target. Efforts to limit international maritime emissions through the International Maritime Organisation (IMO) are under way and should be encouraged. The IMO adopted24 in October 2016 a data collection system for fuel oil consumption of ships ("the global IMO DCS"). Furthermore, the Commission’s Communication on a European Green Deal of 11 December 2019 seeks to reach climate neutrality by 2050 as well as cutting greenhouse gas emissions at 55%. __________________ 23 Paris Agreement (OJ L 282, 19.10.2016, p. 4–18). 24IMO Resolution MEPC.278(70) amending MARPOL Annex VI.
2020/03/20
Committee: ENVI
Amendment 71 #

2019/0017(COD)

Proposal for a regulation
Recital 13
(13) Content of monitoring plans should be streamlined so as to take into consideration the global IMO DCS except for the parts of the plan which are necessary to ensure that only Union-related data are monitored and reported under the EU MRV Regulation. Therefore, any "per voyage" provisions should remain as part of the monitoring plan. The Commission should also assist the Member States by sharing expertise and good practices, as well as the implementation of new technologies, with the objective to decrease administrative barriers and to retrieve data efficiently and securely.
2020/03/20
Committee: ENVI
Amendment 85 #

2019/0017(COD)

Proposal for a regulation
Recital 15
(15) The objective of Regulation (EU) 2015/757 is to monitor, report and verify CO2 emissions from ships calling at EEA ports as the first step of a staged approach to reduce greenhouse gas emissions. This cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level. The Commission should assist the competent authorities of the Member States, also those which may have devolved these competences to regional or local entities, by sharing good practices, information and training about new technologies, and duly implementing the provisions set up in this Regulation. The global IMO DCS should be taken into account and this Regulation ensures the continued comparability and reliability of collected data based on a single set of requirements. The Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
2020/03/20
Committee: ENVI
Amendment 147 #

2019/0017(COD)

Proposal for a regulation
Article 1 - paragraph 6 a (new)
Regulation (EU) 2015/757
Article 21 a (new)
(6a) The following Article 21a is inserted: “Article 21a Overall Assessment 1. By 31 December 2024, the Commission shall assess the correct overall implementation of this Regulation, taking into account developments to decrease greenhouse gas emissions from maritime transport and at fulfilling the Union’s commitments under the Paris Agreement and the objectives under the European Green Deal. 2. The Commission shall propose additional measures to reduce air pollutants from ships with the introduction of new technologies, laid down in the assessment, after a consultation undertaken with the competent authorities. 3. The assessment shall be accompanied by a proposal to amend this Regulation. The Commission shall take into account the report or reports that the European Parliament might produce on this matter during the years prior to the assessment.
2020/03/20
Committee: ENVI