430 Amendments of Miroslav MIKOLÁŠIK
Amendment 5 #
2018/2098(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to the Optional Protocol to the Convention on the Rights of the Child on the sale of children, child prostitution and child pornography,
Amendment 36 #
2018/2098(INI)
Motion for a resolution
Citation 29 a (new)
Citation 29 a (new)
- having regard to its resolution of 17 December 2015 on the Annual Report on Human Rights and Democracy in the World 2014 and the European Union’s policy on the matter,
Amendment 245 #
2018/2098(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Reiterates its condemnation of the practice of surrogacy, which undermines the human dignity of the woman since her body and its reproductive functions are used as a commodity; emphasises that the practice of gestational surrogacy which involves reproductive exploitation and use of the human body for financial or other gain, in particular in the case of vulnerable women in developing countries, shall be prohibited and treated as a matter of urgency in human rights instruments;
Amendment 251 #
2018/2098(INI)
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Calls for clear principles and legal instruments addressing human rights abuses related to surrogacy, such as exploitation of women and human trafficking, and sale of children;
Amendment 271 #
2018/2098(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Stresses that the sale of children is a serious harm and human rights violation in and of itself, without having to prove any other rights violation such as sexual or labour exploitation;
Amendment 274 #
2018/2098(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Stresses that sale of children in the context of surrogacy shall be prosecuted with a focus primarily on intermediaries, and, should not, unless special circumstances, include surrogate mothers, who may often be regarded as exploited victims;
Amendment 276 #
2018/2098(INI)
Motion for a resolution
Paragraph 23 c (new)
Paragraph 23 c (new)
23 c. Stresses that there is no “right to a child” under international law and therefore the State cannot guarantee or provide it as a good or service; considers that “right to a child” approach constitutes a fundamental denial of the equal human rights of the child and undermines the fundamental premise of children as persons with human rights;
Amendment 278 #
2018/2098(INI)
Motion for a resolution
Paragraph 23 d (new)
Paragraph 23 d (new)
23 d. Calls for establishment of efficient legal and policy framework strengthening the protection of rights of children before birth, especially in order to prevent sex- selective abortions, forced abortions as a part of family planning policies and similar practices incompatible with right to life and human dignity;
Amendment 12 #
2018/2088(INI)
Draft opinion
Recital B
Recital B
B. whereas AI is key to turning Europe into a ‘start-up continent’ by exploiting the latest technologies to generate growth in Europe, in particular in the areas of health technology, healthcare services and programmes, drug discovery, robotic and robot-assisted surgery, and medical imaging and records as well as securing sustainable environment and safe food production;
Amendment 22 #
2018/2088(INI)
Draft opinion
Recital D
Recital D
D. whereas there are strong ethical concerns about the autonomy of robots and their impact on the doctor-patient relationshipuse of word ´autonomous´ for complex AI systems since the autonomy as such can only be attributed to human beings;
Amendment 28 #
2018/2088(INI)
Draft opinion
Paragraph –1 (new)
Paragraph –1 (new)
-1. Underlines that any revolutionary technological progress, particularly in the field of AI and robotics, shall serve human wellbeing;
Amendment 29 #
2018/2088(INI)
Draft opinion
Paragraph –1 a (new)
Paragraph –1 a (new)
-1a. Stresses that AI systems and robots are innovative technological means to improve people´s lives, grow the economy, and address challenges in health, environment, climate change, food safety among many others with human agent being always responsible for their use;
Amendment 30 #
2018/2088(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Commission and the Member States to draw up a fully comprehensive EU Action Plan aimed at creating a European ‘artificial intelligence ecosystem’; in line with the Statement on Artificial Intelligence, Robotics and ´Autonomous´ Systems published by European Group on Ethics in Science and New Technologies in March 2018 and thoroughly address issues of safety, security, prevention of harm and mitigation of risks, human moral responsibility, governance and regulation of AI and robots;
Amendment 68 #
2018/0207(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) In accordance with Article 2 of the Treaty of the European Union, ‘the Union is founded on the values of respect for human dignity, freedom democracy, equality, the rule of law and the respect for human rights, including the rights of the persons belonging to minorities. In particular and in accordance with the Universal Declaration of Human Rights, human dignity is the primary foundation of all fundamental human rights. These values are common to the Member States in a society where pluralism, non- discrimination, tolerance, justice, solidarity and equality between women and men prevail’. Article 3 further specifies that the ‘Union’s aim is to promote peace, its values and the well-being of its people’ and, among others, ‘it shall respect its rich cultural and linguistic diversity, and shall ensure that Europe’s cultural heritage is safeguarded and enhanced’. Those values are further reaffirmed and articulated in the rights, freedoms and principles enshrined in the Charter of Fundamental Rights of the European Union.
Amendment 72 #
2018/0207(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Those fundamental human rights and values must continue to be promoted and enforced and shared among the citizens and peoples and be at the heart of the EU project, on the basis of the idea that fundamental human rights are universal, indivisible, interdependent and interrelated. Therefore, a new Justice, Rights and Values Fund, comprising the Rights and Values and the Justice programmes shall be created in the EU budget. At a time where European societies are confronted with extremism, radicalism and divisions, it is more important than ever to promote, strengthen and defend justice, fundamental human rights and EU values: human rights, respect for human dignity, freedom, democracy, equality, the rule of law. This will have profound and direct implications for political, social, cultural and economic life in the EU. As part of the new Fund, the Justice Programme will continue to support the further development of Union area of justice and cross-border cooperation. The Rights and Values Programme will bring together the 2014-2020 Programme Rights, Equality and Citizenship established by Regulation (EU) No 1381/2013 of the European Parliament and of the Council8 and the Europe for Citizens programme established by Council Regulation (EU) No 390/20149, (hereafter ‘the predecessor Programmes’). __________________ 8 Regulation (EU) No 1381/2013 of the European Parliament and of the Council of 17 December 2013 establishing a Rights, Equality and Citizenship Programme for the period 2014 to 2020 (OJ L 354, 28.12.2013, p. 62) 9 Council Regulation (EU) No 390/2014 of 14 April 2014 establishing the ‘Europe for Citizens’ programme for the period 2014- 2020 (OJ L 115, 17.4.2014, p.3)
Amendment 76 #
2018/0207(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The Justice, Rights and Values Fund and its two underlying funding programmes will focus primarily on people and entities, which contribute to make our common values, fundamental human rights and rich diversity alive and vibrant. The ultimate objective is to nurture and sustain rights-based, equal, inclusive and democratic society. That includes a vibrant civil society, encouraging people’s democratic, civic and social participation and fostering the rich diversity of European society, based on our common history and memory. Article 11 of the Treaty of the European Union further specifies that the institutions shall, by appropriate means, give citizens and representative associations the opportunity to make known and publicly exchange their views in all areas of Union action. Article 17 of the Treaty on the Functioning of the European Union sets out that the Union shall maintain a dialogue with the churches and organisations mentioned in that Article. Churches and religious communities or associations are long- standing primary stakeholders in fostering protection and promotion of fundamental human rights and should be granted the same access as civil society organisations to the relevant funding opportunities.
Amendment 85 #
2018/0207(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to bring the European Union closer to its citizens, a variety of actions and coordinated efforts are necessary. Bringing together citizens in town-twinning projects or networks of towns and supporting civil society organisations in the areas covered by the programme will contribute to increase citizens’ engagement in society and ultimately their involvement in the democratic life of the Union. At the same time supporting activities promoting mutual understanding, diversity, dialogue , including intercultural and interreligious dialogue, and respect for others fosters a sense of belonging and a European identity, based on a shared understanding of European values, culture, history and heritage. Increasing plurality and global migration movements raise the importance of intercultural and inter- religious dialogue in our societies. Full support should be given to inter-religious dialogue as a part of social harmony in Europe and a key element in solving social tensions. Interreligious dialogue could also help to highlight the positive contribution of religion to social cohesion. As religious illiteracy sets the stage for the misuse of religious feelings among the population, support for projects and initiatives developing religious literacy is also important. The promotion of a greater sense of belonging to the Union and of Union values is particularly important amongst citizens of the EU outermost regions due to their remoteness and distance from continental Europe.
Amendment 93 #
2018/0207(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Remembrance activities and critical reflection on Europe’s historical memory are necessary to make citizens, in particular young citizens, aware of the common history, as the foundation for a common future, moral purpose androoted in Europe’s spiritual and moral heritage and based on shared values. The relevance of historical, spiritual, cultural and, intercultural and interreligious aspects should also be taken into account, as well as the links between remembrance and the creation of a European identity and sense of belonging together.
Amendment 101 #
2018/0207(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) Gender-based violenceViolence against women and violence against children and young people constitute a serious violation of fundamental rights. Violence persists throughout the Union, in all social and economic contexts, and has serious repercussions on victims’ physical and psychological health and on society as a whole. Children, young people and women are particularly vulnerable to violence, in particular in close relationships. Action should be taken to promote the rights of the child and to contribute to the protection of children from harm and violence, which pose a danger to their physical and mental health and constitute a breach of their rights to development, protection and dignity. The concept of harm and violence should cover the exposition of children to pornography or gratuitous violence. Combating all forms of violence, promoting prevention and protecting and supporting victims are priorities of the Union which help fulfil individuals’ fundamental rights and contribute to equality between women and men. Those priorities should be supported by the Programme.
Amendment 106 #
2018/0207(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Non-discrimination is a fundamental principle of the Union. Article 19 of the Treaty on the Functioning of the European Union provides for action to combat discrimination based on sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation. Non- discrimination is also enshrined in Article 21 of the Charter. The principle of non- discrimination entails not only that similar situations should not be treated differently, but also that different situations should not be treated in the same way. The specific features of the diverse forms of discrimination should be taken into account and appropriate action should be developed in parallel to prevent and combat discrimination on one or more grounds. The Programme should support actions to prevent and combat discrimination, racism, xenophobia, anti- Semitism, anti-muslim hatred and other forms of intolerance. In that context, particular attention should also be devoted to preventing and combating all forms of violence, hatred, segregation and stigmatisation, including anti-religious stigmatisation, as well as combating bullying, harassment and intolerant treatment. The Programme should be implemented in a mutually reinforcing manner with other Union activities that have the same objectives, in particular with those referred to in the Commission Communication of 5 April 2011 entitled ‘An EU Framework for National Roma Integration Strategies up to 202010’ and in the Council Recommendation of 09 December 2013 on effective Roma integration measures in the Member States11. Authorities at Union and national level have an obligation to prevent discrimination on grounds of belonging to a religious group or carrying out religious acts, whether affiliated to majority or minority religious denominations. Furthermore, focus should not be placed on discrimination of religions, but on people being discriminated because of their religious affiliation or practices. An effective protection by the Member States of the right to conscientious objection, both at the individual and institutional level, especially in the healthcare, pharmaceutical, educational and economical fields, as a fundamental right placed at the basis of democracy and the rule of law should also be supported. __________________ 10 COM(2011)173. 11 OJ C 378, 24.12.2013, p. 1.
Amendment 111 #
2018/0207(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Attitudinal and environmental barriers as well as lack of accessibility hinder the full and effective participation of people with disabilities in society, on an equal basis with others. People with disabilities are faced with barriers to, among other things, access the labour market, benefit from an inclusive and quality education, avoid poverty and social exclusion, enjoy access to cultural initiatives and media, or use their political rights. As a party to the United Nations Convention on the Rights of Persons with Disabilities (the UNCRPD), the Union and all its Member States have committed to promote, protect and ensure the full and equal enjoyment of all human rights and fundamental freedoms by all persons with disabilities. The provisions of the UNCRPD have become an integral part of the Union legal order. Specific needs in the area of disability should be fully taken into account in the relevant funding efforts.
Amendment 114 #
2018/0207(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Article 3(3) TEU requires the Union to promote the protection of the rights of the child, in line with Article 24 of the Charter and the United Nations Convention on the Rights of the Child. The primary responsibility shared between the mother and the father to promote and protect their child’s best interest should be paramount, avoiding the interpretation according to which children and their rights can be seen as separate from their family and parents. Public authorities should strengthen the rights of the child to live in a family environment that ensures harmonious upbringing and growth, the protection of his or her psychological integrity and the development of his or her personality.
Amendment 129 #
2018/0207(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. The general objective of the Programme is to protect and promote fundamental human rights and values as enshrined in the EU Treaties, including by supporting civil society organisations, in order to sustain open, democratic and inclusive societies, as well as other key stakeholders such as churches and religious associations or communities, think tanks, and research and academic institutions.
Amendment 132 #
2018/0207(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) to promote equality and fundamental human rights (Equality and rights strand),
Amendment 150 #
2018/0207(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) increasing citizens’ understanding of the Union, its history, cultural heritage and diversity, as well as of the diversity of historical memories in Europe;
Amendment 177 #
2018/0207(COD)
Proposal for a regulation
Annex I – paragraph 1 – point b
Annex I – paragraph 1 – point b
(b) mutual learning through exchange of good practices among stakeholders to improve knowledge and mutual understanding, including through intercultural and interreligious dialogue, and civic and democratic engagement;
Amendment 272 #
2018/0018(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Coordination Group shall act by consensus, or, where necessary, vote by simplequalified majority. There shall be one vote per Member State.
Amendment 312 #
2018/0018(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 315 #
2018/0018(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
The Commission shall, by means of Delegated Acts, include in Article 5 paragraph 1 of this Regulation a specific product category of medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of medical devices.
Amendment 317 #
2018/0018(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 320 #
2018/0018(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
The Commission shall, by means of Delegated acts, include in Article 5 paragraph 1 of this Regulation a specific product category of in vitro diagnostic medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of in vitro diagnostic medical devices.
Amendment 329 #
2018/0018(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group. Member States may propose additional comparator, which from their point of view represents the relevant evidence-based standard of care in their Member State. In case this proposal has not been taken into account, the relevant Member State may use the mechanism referred to in Article 8 – paragraph 1 a (new).
Amendment 399 #
2018/0018(COD)
Proposal for a regulation
Article 6 – paragraph 12
Article 6 – paragraph 12
12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simplequalified majority of Member States.
Amendment 436 #
2018/0018(COD)
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. This shall not prevent the Member States from complementing the joint clinical assessment with clinical assessments comparing the technology against a comparator which represents the best available evidence based standard of care in this Member State which, despite the Member States request during the scoping face, will not form part of the joint clinical assessment and which is necessary to complete the health technology assessment in that Member State. Any such measure should be justified, necessary and proportionate to achieving this aim. Any national assessment complementing the joint clinical assessment should follow the methodology established in accordance with Article 22. Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so no later than 2 weeks after the Coordination Group has laid down the specific requirements for the joint assessment of the specific technology.
Amendment 486 #
2018/0018(COD)
Proposal for a regulation
Article 13 – paragraph 12
Article 13 – paragraph 12
12. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simplequalified majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.
Amendment 29 #
2017/2131(INL)
Draft opinion
Paragraph 1
Paragraph 1
1. Notes the efforts taken in recent years to achieve a better reconciliation of work and private life; recalls the Commission's proposal for a directive on work-life balance for parents and carers1 presented in April 2017 and encourages the Hungarian government to contribute to its swift adoption; __________________ 1__________________ 1 COM(2017)0253. COM(2017)0253.
Amendment 33 #
2017/2131(INL)
Draft opinion
Paragraph 2
Paragraph 2
Amendment 48 #
2017/2131(INL)
Draft opinion
Paragraph 4
Paragraph 4
Amendment 61 #
2017/2131(INL)
Draft opinion
Paragraph 5
Paragraph 5
5. Recalls that violence against women in Hungary, as in all other Member States, is a persistent structural violation of human rights; calls on the Hungarian government to ratify the Istanbul Convention as soon as possible;
Amendment 69 #
2017/2131(INL)
Draft opinion
Paragraph 6
Paragraph 6
Amendment 82 #
2017/2131(INL)
Draft opinion
Paragraph 7
Paragraph 7
7. Strongly condemns, in this context,Condemns the ill-treatment and discrimination of Roma women in fields such as access to healthcare;
Amendment 89 #
2017/2131(INL)
Draft opinion
Paragraph 8
Paragraph 8
Amendment 15 #
2017/0328(COD)
Draft legislative resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Regrets the decision of the Council which leads to a deepening of the geographical disproportionality with only 9 out of 37 EU decentralised agencies being located in new Member States contrary to the European Council Conclusions 5381/04 and 11018/1/08 which both give priority to new Member States.
Amendment 10 #
2016/2313(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
- having regard to the Statement from November 2016 on behalf of the European Union and its Member States by H.E. Mr. João Vale de Almeida, Head of the Delegation of the European Union to the United Nations, at the Security Council Debate on 'The situation in Bosnia and Herzegovina',
Amendment 41 #
2016/2313(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
D a. whereas BiH still did not implement the rulings of the European Court of Human Rights (ECHR) in the Sejdić-Finci, Zornić and Pilav cases;
Amendment 42 #
2016/2313(INI)
Motion for a resolution
Recital D b (new)
Recital D b (new)
D b. whereas joint Croatian and Bosniak forces defended Orasje, and on October 31st only the officers of Croatian nationality were arrested for alleged war crimes;
Amendment 48 #
2016/2313(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas BiH is a signatory too the Convention on Environmental Impact Assessment in a Transboundary Context (Espoo, 1991);
Amendment 70 #
2016/2313(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the progress on the implementation of the 2015-2018 Reform Agenda, as well as the country’snd calls for determination toin pursueing further institutional and socio- economic reforms, including the necessary reform of electoral law, that will ensure progress on BiH's path to EU membership as well as ensure equal rights of all three constituent peoples; stresses that harmoniszed implementation of the Reform Agenda is needed to achieve real change across the country and to improve the lives of all BiH citizens; calls for the reform momentum to be maintained in order to transform BiH into a fully effective, inclusive and functional state; regrets that common reform efforts often continue to be hampered by ethnic and political divisions; considers it essential to maintain consensus on EU integration and to advance in a concerted manner on the rule of law, including the fight against corruption and organised crime, the reform of the judiciary and public administration;
Amendment 119 #
2016/2313(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Reiterates its concern about the continued fragmentation into four different legal systems; stresses the need to strengwiftly address any outstanding shortcomings of then judicial independence, including from politry and emphasizes the need for its de-politicization, including in prosecution of war crimes, as well as strengthening judicial pressure,independence and to fighting corruption in the judiciary; urges the rapid adoption of the action plan for the implementation of the 2014-2018 justice sector reform; welcomes the adoption of the law on free legal aid at state level and the introduction by the High Judicial and Prosecutorial Council of guidelines on prevention of conflict of interest, the drafting of integrity plans and disciplinary measures; notes the important role of the Structured Dialogue on Justice in addressing the shortcomings in the BiH judiciary;
Amendment 198 #
2016/2313(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Underlines the need for a substantial improvement in the strategic, legal, institutional and policy frameworks on the observance of human rights; calls for the adoption of a countrywide strategy on human rights and non-discrimination; is concerned about continued discrimination against persons with disabilities in the fields of employment, education and access to health care; calls for developing a comprehensive and integrated approach to the social inclusion of Roma; welcomes the fact that some governments and parliaments have begun discussing LGBTI rights and drawing up specific measures for their protection; welcomes changes to the BiH anti-discrimination law extending the listed grounds for discrimination to age, disability, sexual orientation and gender identity;
Amendment 230 #
2016/2313(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Deplores the fact that BiH is still in breach of the European Convention on Human Rights for not implementing the rulings of the European Court of Human Rights (ECHR) in the Sejdić-Finci, Zornić and Pilav cases; strongly calls for progress to be made in this regard in order to advance the country’'s EU perspective and establish a functional democratic society in which equal rights of all constituent peoples and citizens of BiH is guaranteed;
Amendment 238 #
2016/2313(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Is concerned about cases of political pressure and intimidation against journalists, including physical and verbal attacks, as well as by the lack of transparency in media ownership; emphasises the need to investigate attacks against journalists and ensure proper judicial follow-up; calls on the competent authorities to ensure the independence and financial stability of the three public service broadcasters as well as the political, operational and financial independence of the Communications Regulatory Authority; calls for the digital switchover to be finalised and for a broadband strategy to be drawn up; calls for introduction of legislation to guarantee media pluralism and for programmes to be broadcast in the languages of all of the three constituent peoples;
Amendment 245 #
2016/2313(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Remains concerned by the continued fragmentation, inefficiency and complexity of the education system; calls for countrywide common core curricula and better coordination between the different levels of education governance, in a way to still ensure the right of children to education in their own language; continues to be concerned about the persistently high school-drop-out rates of Roma pupils; regrets the slow progress in addressing and resolving the issue of ‘two schools under one roof’ and other forms of segregation and discrimination in schoolsarding the system' two schools under one roof' calls on the authorities to promote the principles of tolerance and dialogue as well as the right of all constituent peoples to education in their own language;
Amendment 286 #
2016/2313(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Notes that progress in the areas of environmental protection and climate change has been poor; calls on BiH authorities to quickly enhance environmental protection in line with EU standards, including the prevention of transboundary air pollution and especially the pollution caused by the Bosanski Brod oil refinery, whose harmful impact is cutting across borders and affecting the quality of life and the health of people living in Slavonski Brod; maintains that BiH needs to comply in full with its obligations under the Convention on Environmental Impact Assessment in a Transboundary Context (Espoo, 1991) and the Protocol on Strategic Environmental Assessment (Kiev, 2003), not least as regards activities in the Neretva and Trebišnjica river basin;
Amendment 288 #
2016/2313(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Calls on the international community to start a debate on the necessary constitutional reform that will ensure full functionality and stability of BiH; emphasizes that it is crucial to introduce a mechanism that will ensure equal rights of all constituent peoples; in this regards, considers federalization of the state as a possible model;
Amendment 75 #
2016/2310(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the implementation of the political agreement leading to early parliamentary elections on 11 December 2016 and the respect for fundamental freedoms shown at the elections of 11 December 2016; urges all political parties to accept its results in the interest of domestic stability and underlines their responsibility to ensure that there is no backsliding into political crisis; calls for a swift formation of a new government in order to make use of the mandate to carry on with necessary reforms; considers cross- party cooperation essential for addressing pressing domestic and EU-related challenges;
Amendment 114 #
2016/2310(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Underlines the strategic importance of supporting further progress in the process of EU integration and urges once again that the political will be shown to fully implement the Urgent Reform Priorities and the Przhino Agreement; calls on the Commission to assess, at its earliest convenience but before the end of 2017, the country’s progress on implementation and to report back to Parliament; while recalling that long overdue reforms need to be launched and implemented, supports the continuation of the High Level Accession Dialogue (HLAD) for systematically assisting the country in this endeavour; draws attention to the potential negative consequences of further delays in the country’s accession process;
Amendment 117 #
2016/2310(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Takes note of the recommendation by the Commission to open accession negotiations with Macedonia and calls on the Council to address the issue at the earliest convenience after the early parliamentary elections have been held;
Amendment 118 #
2016/2310(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Underlines the significant progress country has made in the process of EU integration and emphasizes the negative consequences of further delaying the process of integration, including the threat to the credibility of the EU enlargement policy and the risk of instability in the region;
Amendment 119 #
2016/2310(INI)
Motion for a resolution
Paragraph 4 c (new)
Paragraph 4 c (new)
4 c. Points out that the current challenges the European Union is facing (BREXIT, migration, radicalism, etc.) should not hinder the enlargement process, rather these challenges have demonstrated the necessity to fully integrate the Western Balkans into EU structures in order to enhance and deepen partnership to overcome international crises;
Amendment 120 #
2016/2310(INI)
Motion for a resolution
Paragraph 4 d (new)
Paragraph 4 d (new)
4 d. Welcomes the high level of legislative alignment with the acquis communautaire and acknowledges the priority given to the effective implementation and enforcement of existing legal and policy frameworks, as in the case of countries already engaged in the accession negotiations;
Amendment 121 #
2016/2310(INI)
Motion for a resolution
Paragraph 4 e (new)
Paragraph 4 e (new)
4 e. Congratulates Macedonia for its continuous fulfilment of its commitments under the Stabilization and Association Agreement (SAA); calls on the Council to adopt the Commission's 2009 proposal to move to the second stage of the SAA, in line with the relevant provisions;
Amendment 127 #
2016/2310(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes somepromising progress in reforming public administration including the steps to implement the new legal framework on human resources management; remains concerned about the politicisation of public administration and that civil servants are subject to political pressure; urges the new government to enhance professionalism, neutrality and independence at all levels; stresses the need to complete the 2017-2022 public administration reform strategy, including by making sufficient budget allocations for its implementation, and to strengthen relevant administrative capacity;
Amendment 186 #
2016/2310(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Welcomes the adoption of the national strategy for equality and non- discrimination 2016-2020; is concerned about impartiality and the independence of the Commission for Protection from Discrimination; reiterates its condemnation of hate speech against discriminated groups; is concerned that intolerance against lesbian, gay, bisexual, transgender and intersex (LGBTI) people persists; reiterates its call for the Anti- Discrimination Law to be aligned with the acquis as regards discrimination on grounds of sexual orientation; underlines again the need to combat discrimination against the Roma, and to facilitate their integration and their access to the education system and the labour market; is concerned about the inhumane physical conditions in prisons, despite a significant increase in the prison budget;
Amendment 204 #
2016/2310(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Is concerned about the lack of implementation of the Law on Equal Opportunities and the limited effectiveness of institutional mechanisms to advance gender equality between men and women; urges the competent authorities to make sufficient budget allocations for its implementation and to improve support services to victims of domestic violence;
Amendment 273 #
2016/2310(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Commends the country for constructive cooperation in addressing the migration crisisnstructive role the country has played in dealing with the challenges of the migration crisis and adhering to the decision of the European Council to close the Western Balkan migration route in March 2016; recommends further actions to ensure capacities to combat human trafficking and migrant smuggling;
Amendment 284 #
2016/2310(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Emphasizes the importance of regional cooperation as a tool to drive the process of EU integration forward and commends country's constructive efforts and proactive contributions in promoting bilateral relations with all countries from the region;
Amendment 293 #
2016/2310(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Welcomes Macedonia’s continued constructive role in regional and international cooperation; commends the increased alignment with EU foreign policy (73 %); reiterates the importance of finalising the negotiations on a bilateral treaty withcommends also the positive focus on bilateral projects in areas of infrastructure, economy and interconnectivity and country's efforts to hold European standards and values at the heart of bilateral relations; encourages the continuation and finalization of the talks on the Treaty of Friendship, Good-Neighbourliness and Cooperation; emphasizes the necessity to respect the history, sovereignty and national and linguistic identity of both Macedonia and Bulgaria;
Amendment 309 #
2016/2310(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the tangible results fromCommends the positive approach which has been applied to strengthen bilateral cooperation, especially in the context of European integration, for increasing mutual trust and promoting good neighborliness in concrete terms; acknowledges positive developments regarding the implementation of the confidence- building measures with Greece, including the visit of Greek Minister of Foreign Affairs to Skopje in August 2016; strongly reiterates its invitation to the Vice- President/High Representative (VP/HR) and the Commission to develop new initiatives to overcome the remaining differences and to work, in cooperation with the two countries and the UN Special Representative, on a mutually acceptable solution on the name issue and to report back to Parliament thereon; calls upon the UN to intensify the mediation process in order to find a mutually acceptable solution regarding the naming dispute with Greece and to request that Greece respects International Law and the 2011 ICJ ruling;
Amendment 314 #
2016/2310(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Welcomes the efforts of the Berlin Process, which demonstrated strong political support for the European perspective of the Western Balkans and that will continue to encourage further reforms in key areas and promote economic developments through core connectivity investments, providing concrete results for the citizens and the entire region; welcomes the establishment of the RYCO (Regional Youth Cooperation Office) and the Western Balkans Fund and requests the EU to take into account the initiatives and projects which have been proposed by Macedonia;
Amendment 318 #
2016/2310(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Commends the country on its chairmanship of the CEI, focusing on economic cooperation and business opportunities, infrastructure and general economic development, including rural development and tourism, as well as on bridging macro-regions throughout 2015;
Amendment 4 #
2016/2223(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
- having regard to the European Court of Auditors report "Combating Food Waste: an opportunity for the EU to improve the resource-efficiency of the food supply chain" (2016)1a , _________________ 1a http://www.eca.europa.eu/en/Pages/DocIt em.aspx?did=40302.
Amendment 16 #
2016/2223(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas according to the World Food Programme (WFP) 795 million people in the world do not have enough food to lead a healthy and active life; whereas poor nutrition causes nearly half (45%) or approximately 3.1 million of deaths in children under the age of five; whereas one in six children in the world are underweight and one in four is stunted; whereas it is therefore not only an economic and environmental but also a moral obligation to reduce food waste1a ; _________________ 1a https://www.wfp.org/hunger/stats.
Amendment 32 #
2016/2223(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas reducing food waste can improve the economic situation for households without lowering the standard of living;
Amendment 113 #
2016/2223(INI)
1. Stresses the urgent need to reduce the amount of food waste in the Union at every step of the supply and consumption chain; in this regard, underlines the importance of political leadership and commitment from both the Commission and Member States; reminds that the European Parliament repeatedly, in its resolutions from 2011, 2012, 2015 and 2016, asked the Commission to take action against food waste;
Amendment 191 #
2016/2223(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Welcomes the recent creation of the EU Platform on Food Losses and Food Waste; reiterates the importance of exchanging best practices, combining knowledge and avoiding duplication with other relevant forums such as for example the EU Retail Forum on Sustainability, the European Food Sustainable Consumption and Production Roundtable, the High Level Forum for a Better Functioning Food Supply Chain, the Consumer Goods Forum;
Amendment 204 #
2016/2223(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Encourages the Commission and the Member States to engage, in cooperation with stakeholders, in improving consumers’ understanding of ‘use by’ dates and ‘best before’ dates; stresses the importance of empowering consumers in order to make informed decisions; asks the Commission to assess whether current EU legislation and current practice in use with ‘use by’ and ‘best before’ dates in different Member States are fit for purpose;
Amendment 238 #
2016/2223(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission and the Member States to promote successful practices of food waste reduction and resource conservation methods already used by stakeholders; encourages the Member States to reduce food waste in public establishments; in this regard emphasizes the importance of educating and engaging children to minimize food waste in school canteens; asks the Quaestors to give priority to actions to reduce food waste in the European Parliament and encourages other European institutions to follow;
Amendment 272 #
2016/2223(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Welcomes the establishment of "Social Grocery Shops", as well as public and private partnerships with charity organizations, to make the best possible use of edible but not sellable food;
Amendment 98 #
2016/2057(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the pharmaceutical sector takes advantage of various innovation incentives such as supplementary protection certificate, data exclusivity or market exclusivity which aim at promoting valuable innovation fulfilling unmet medical needs, and whereas these incentives do not always prove to attain those objectives.
Amendment 123 #
2016/2057(INI)
Motion for a resolution
Recital G
Recital G
G. whereas, due to the current international reference pricing system, the prices of medicines are usually negotiated by means of bilateral and confidential negotiations between the pharmaceutical industry and Member States;
Amendment 133 #
2016/2057(INI)
Motion for a resolution
Recital I
Recital I
I. whereas the entry of generics and biosimilars onto the market is an important mechanism to reduce prices, and whereas there are clear concerns about the strategies to delay this entry;
Amendment 148 #
2016/2057(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. Whereas the European Parliament has shown its strong political commitment to this matter, above all by opening its current legislature to a more open policy for access to medicines;
Amendment 464 #
2016/2057(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to take a very cautious approach and guarantee safety and efficacy in any fast- track approval process and to introduce the concept of conditional authorisation based on effectiveness; in this respect, calls on the Commission to take into consideration the opinion of non-industry related stakeholders;
Amendment 335 #
2016/0382(COD)
Proposal for a directive
Article 2 – paragraph 2 – point e e
Article 2 – paragraph 2 – point e e
(ee) ‘advanced biofuels’ means biofuels that are produced from feedstocks listed in part A of Annex IX; from biomass other than food/feed crops while meeting the EU sustainability regime under the legislation in force.
Amendment 439 #
2016/0382(COD)
Proposal for a directive
Article 7 – paragraph 1 – subparagraph 4
Article 7 – paragraph 1 – subparagraph 4
For the calculation of a Member State’s gross final consumption of energy from renewable energy sources, the contribution from biofuels and bioliquids, as well as from biomass fuels consumed in transport, if produced from food or feed crops, shall be no more than 7% of final consumption of energy in road and rail transport in that Member State. This limit shall be reduced to 3,8% in 2030 following the trajectory set out in part A of Annex X. Member States may set a lower limit and may distinguish between different types of biofuels, bioliquids and biomass fuels produced from food and feed crops, for instance by settingMember States may set a lower limit for the contribution from food or feed crop based biofuels produced from oil crops, taking into account indirect land use change.
Amendment 461 #
2016/0382(COD)
Proposal for a directive
Article 7 – paragraph 4 – point b a (new)
Article 7 – paragraph 4 – point b a (new)
(ba) For promoting the gross final consumption of energy from renewable sources in transport, Member States may set higher national mandates in the transport sector by authorising the use of sustainable biofuels, biomass fuels and renewable liquid and gaseous transport fuel of non-biological origin consumed in the transport sectors produced from feedstocks not included in Annex IX.
Amendment 555 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 1
Article 25 – paragraph 1 – subparagraph 1
1. With effect from 1 January 2021, Member States shall requirset the fuel suppliers to include a minimum share of energy from advanced biofuelsincorporation obligation and shall increase gradually the share of renewable energy from conventional biofuels, as well as advanced and other biofuels and biogas produced from feedstock listed in Annex IX, from renewable liquid and gaseous transport fuels of non-biological origin, from waste-based fossil fuels and from renewable electricity in the total amount of transport fuels they supply for consumption or use on the market in the course of a calendar year.
Amendment 591 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 3
Article 25 – paragraph 1 – subparagraph 3
The greenhouse gas emission savings from the use of conventional, advanced biofuels and other biofuels and biogas produced from feedstock listed in Annex IX shall be at least 70% as of 1 January 2021.
Amendment 601 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 4 – point b – subparagraph 1
Article 25 – paragraph 1 – subparagraph 4 – point b – subparagraph 1
(b) for the calculation of the numerator, the energy content of advanced biofuels and other biofuels and biogas produced from feedstock listed in Annex IXny types of biofuels and biogas, renewable liquid and gaseous transport fuels of non-biological origin, waste based fossil fuels supplied to all transport sectors, and renewable electricity supplied to road vehiclesand rail transport, shall be taken into account.
Amendment 617 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 4 – point b – subparagraph 2
Article 25 – paragraph 1 – subparagraph 4 – point b – subparagraph 2
For the calculation of the numerator, the contribution from biofuels and biogas produced from feedstock included in part B of Annex IX shall be limited to 1.7% of the energy content of transport fuels supplied for consumption or use on the market and the contribution of fuels supplied in the aviation and maritime sector shall be considered to be 1.2 times their energy content.
Amendment 625 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 4 – point b a (new)
Article 25 – paragraph 1 – subparagraph 4 – point b a (new)
(ba) For the calculation of the contribution from electricity produced from renewable sources and consumed in all types of electric vehicles and for the production of renewable liquid and gaseous transport fuels of non-biological origin for the purpose of points (a) and (b), Member States may choose to use either the average share of electricity from renewable energy sources in the Union or the share of electricity from renewable energy sources in their own country as measured two years before the year in question. Furthermore, for the calculation of the electricity from renewable energy sources consumed by electrified rail transport, that consumption shall be considered to be 2,5 times the energy content of the input of electricity from renewable energy sources. For the calculation of the electricity from renewable energy sources consumed by electric road vehicles in point (b), that consumption shall be considered to be five times the energy content of the input of electricity from renewable energy sources;
Amendment 628 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 4 – point b b (new)
Article 25 – paragraph 1 – subparagraph 4 – point b b (new)
(bb) Biofuels produced from feedstocks listed in Annex IX shall be considered to be twice their energy content for the purpose of complying with the target set out in the first subparagraph.
Amendment 629 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 4 – point c a (new)
Article 25 – paragraph 1 – subparagraph 4 – point c a (new)
(ca) For the calculation of both numerator and denominator, only biofuels and bioliquids that are produced from feedstock derived/produced within the EU can be taken into account.
Amendment 637 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 3 – subparagraph 1
Article 25 – paragraph 3 – subparagraph 1
3. To determine the share of renewable electricity for the purposes of paragraph 1 either the average share of electricity from renewable energy sources in the Union or the share of electricity from renewable energy sources in the Member State where the electricity is supplied, as measured two years before the year in question may be used. However, electricity that is supplied to road vehicles and obtained from a direct connection to an installation generating renewable electricity or through power purchase agreements for renewable electricity from the grid, that electricity shall be fully counted as renewable electricity. In both cases, an equivalent amount of guarantees of origin issued in accordance with Article 19 shall be cancelled.
Amendment 651 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 3 – subparagraph 3 – point a – subparagraph 2
Article 25 – paragraph 3 – subparagraph 3 – point a – subparagraph 2
However, electricity obtained from direct connection to an installation generating renewable electricity (i) that comes into operation after or at the same time as the installation producing the renewable liquid and gaseous transport fuel of non- biological origin and (ii) is not connected to the grid, can be fully counted as renewable electricity for the production of that renewable liquid and gaseous transport fuel of non-biological origin. Similarly, electricity obtained through power purchase agreements for renewable electricity shall be fully counted as renewable electricity for the production of that renewable liquid and gaseous transport fuel of non-biological origin.
Amendment 657 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 3 – subparagraph 3 – point b
Article 25 – paragraph 3 – subparagraph 3 – point b
(b) When biomass isor biomass fuels are processed with fossil fuels in a common process, the amount of biofuel in the product shall be established applying adequate conversion factors to the biomass input. In case the process yields more than one product, all products stemming from the process shall be assumed to contain the same share of biofuel. The same rules shall apply for the purposes of Article 27(1).
Amendment 680 #
2016/0382(COD)
Proposal for a directive
Article 25 – paragraph 7
Article 25 – paragraph 7
7. By 31 December 2025, in the context of the biennial assessment of progress made pursuant to Regulation [Governance], the Commission shall assess whether the obligation laid down in paragraph 1 effectively stimulates innovation and promotes greenhouse gas savings in the transport sector, and whether the applicable greenhouse gas savings requirements for biofuels and biogas are appropriate. The Commission shall, if appropriate, present a proposal to modify the obligation laid down in paragraph 1. Any modification should at least maintain levels reflecting advanced biofuels installed and under construction capacity in 2025.
Amendment 1068 #
2016/0382(COD)
Proposal for a directive
Annex IX – Part B – point c
Annex IX – Part B – point c
Amendment 1074 #
Amendment 1086 #
2016/0382(COD)
Proposal for a directive
Annex X – Part A
Annex X – Part A
Amendment 322 #
2016/0023(COD)
Proposal for a regulation
Annex III – part 1 – point a
Annex III – part 1 – point a
(a) from 1 January 20198: acetaldehyde productionwhere mercury is used as a catalyst
Amendment 325 #
2016/0023(COD)
Proposal for a regulation
Annex III – part 1 – point b
Annex III – part 1 – point b
(b) from 1 January 2019: vinyl chloride monomer production1 December 2017 where mercury is used as an electrode or from 11 December 2020 where Article 15 (4) of Directive 2010/75/EU is applied
Amendment 328 #
2016/0023(COD)
Proposal for a regulation
Annex III – part 1 – point b
Annex III – part 1 – point b
(b) from 1 January 201925: vinyl chloride monomer production
Amendment 329 #
2016/0023(COD)
Proposal for a regulation
Annex III – part 1 – point b a (new)
Annex III – part 1 – point b a (new)
(ba) Point (b) shall apply for the production of potassium methylate and ethylate and for vinyl chlorid monomer only from 1 January 2021.
Amendment 337 #
2016/0023(COD)
Proposal for a regulation
Annex III – part 2 – paragraph 2 – introductory part
Annex III – part 2 – paragraph 2 – introductory part
The production of sodium or potassium methylate or ethylate and vinyl chlorid monomer shall be carried out in accordance with point (b) of Part I and the following requirements:
Amendment 345 #
2015/2229(INI)
Motion for a resolution
Paragraph 67 f (new)
Paragraph 67 f (new)
67f. Condemns the practice of surrogacy that undermines human dignity of the woman as her body and its reproductive functions are used as a commodity, the practice of gestational surrogacy which involves reproductive exploitation and use of human body for financial or other gain, in particular of vulnerable women in developing countries, shall be prohibited and treated as a matter of urgency in human rights instruments;
Amendment 346 #
2015/2229(INI)
Motion for a resolution
Paragraph 67 g (new)
Paragraph 67 g (new)
67g. Calls for clear principles and international legal instruments addressing human rights issues related to surrogacy aiming at the prevention of human rights abuses, such as exploitation of women and human trafficking, and protection of rights, interests and wellbeing of children;
Amendment 370 #
2015/2229(INI)
Motion for a resolution
Paragraph 72 d (new)
Paragraph 72 d (new)
72d. Calls for the establishment of efficient legal and policy framework strengthening the protection of rights of children before birth, especially in order to prevent sex-selective abortions, forced abortions as a part of family planning policies and similar practices incompatible with the right to life and human dignity;
Amendment 371 #
2015/2229(INI)
Motion for a resolution
Paragraph 72 e (new)
Paragraph 72 e (new)
72e. Calls for an advanced approach to the right to life in order to enhance the protection of a human being in prenatal period;
Amendment 372 #
2015/2229(INI)
Motion for a resolution
Paragraph 72 f (new)
Paragraph 72 f (new)
72f. Emphasizes that abortion shall not be promoted as a form of family planning in the external policies of the EU;
Amendment 1 #
2015/2118(INI)
Motion for a resolution
Citation 2
Citation 2
– having regard to Articles 3, 5 and 23 of the Charter of Fundamental Rights of the European Union,
Amendment 7 #
2015/2118(INI)
Motion for a resolution
Citation 8
Citation 8
– having regard to the 1989 UN Convention on the Rights of the Child, and the Optional Protocol to the Convention on the Rights of the Child on the sale of children, child prostitution and child pornography;
Amendment 9 #
Amendment 10 #
2015/2118(INI)
Motion for a resolution
Citation 9 b (new)
Citation 9 b (new)
– having regard to the Hague Adoption Convention;
Amendment 12 #
2015/2118(INI)
Motion for a resolution
Citation 15 a (new)
Citation 15 a (new)
– having regard to Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells;
Amendment 15 #
2015/2118(INI)
Motion for a resolution
Citation 25 a (new)
Citation 25 a (new)
– having regard to its resolution of 10 March 2005 on the trade in human egg cells;
Amendment 17 #
2015/2118(INI)
Motion for a resolution
Citation 26 a (new)
Citation 26 a (new)
– having regard to its resolution of 16 December 2015 on Human Rights and Democracy in the world 2014 and the European Union policy on that matter;
Amendment 29 #
2015/2118(INI)
Motion for a resolution
Recital B
Recital B
B. whereas THB takes many different forms across many legal and illegal activities, including, but not limited to, agriculture, food processing, prostitution, domestic work, manufacturing, care, cleaning, other types of forced labour (particularly in the service industries), forced begging, forced marriage, illegal adoptions, gestational surrogacy and the trade in human organs, cells and tissues, including trade in reproductive cells as well as foetal cells and tissues;
Amendment 58 #
2015/2118(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas women are exposed to special kinds of reproductive exploitation such as trafficking of their reproductive cells, forced marriage, coerced adoption, prostitution, surrogacy and female genital mutilation;
Amendment 174 #
2015/2118(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Expresses its concern by growing practice of reproductive exploitation of women; calls on the European Commission to include gestational surrogacy as a form of THB as it involves reproductive exploitation and use of human body for financial or other gains; calls upon the Member States to respect their international commitments and to take the necessary actions to stop any involvement of European countries, citizens or companies in surrogacy tourism;
Amendment 176 #
2015/2118(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Recalls that the human body should not be a source of financial gain; calls on the Commission to condemn all sorts of THB with the purpose of the removal of organs and adopt a clear attitude toward illegal trade of organs, tissues and cells, including trade in reproductive cells and foetal tissues and cells;
Amendment 202 #
2015/2118(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Calls on the Member States to ensure gender-specific provision of services to victims of THB that is appropriate to their needs, recognising the form of trafficking to which they have been subjected; highlights that whilst a majority of victims are women and girls, there should be specialised services for victims of all genderswomen and men victims of THB;
Amendment 220 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 3
Article 1 – point 3
Directive 2003/87/EC
Article 9 – paragraphs 2 and 3
Article 9 – paragraphs 2 and 3
Amendment 303 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point a
Article 1 – point 5 – point a
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 2
Article 10a – paragraph 1 – subparagraph 2
The Commission ishall be empowered to adopt a delegated act in accordance with Article 23 to supplement this directive. This act shall also provide for additional allocation from the new entrants reserve for significant production increases by applying the same thresholds and allocation adjustments as apply in respect of partial cessations of operation. To enhance flexibility in the supply of free allowances, the threshold shall be lowered in order to better track real industrial activity variation levels. The threshold shall not exceed 10,000 allowances per year or 5% of the yearly allocation.
Amendment 312 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point a c (new)
Article 1 – point 5 – point a c (new)
Directive 2003/87/EC
Article 10a – paragraph 2 – subparagraph 1
Article 10a – paragraph 2 – subparagraph 1
(ac) In paragraph 2, subparagraph 1 is replaced by the following: 'In defining the principles for setting ex- ante benchmarks infor individual products in each sectors or and sub-sectors, the starting pointbenchmark shall be the average performance of the 10 % most efficient installations for individual products in a sector orand sub-sector in the Community in the years 200713-2008. The Commission shall consult the relevant stakeholders, including the sectors and subsectors concerned17.'
Amendment 319 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point b
Article 1 – point 5 – point b
Directive 2003/87/EC
Article 10a – paragraph 2 – subparagraph 3 – introductory part
Article 10a – paragraph 2 – subparagraph 3 – introductory part
The benchmark values for free allocation shall be adjusted in order to avoid windfall profits and reflect technological progress in the period between 2007-8 and each later period for which free allocations are determined in accordance with Article 11(1). This adjustment shall reduce the benchmark values set by the act adopted pursuant to Article 10a by 1% of the value that was set based on 2007-8 data in respect of each year between 2008 and the middle of the relevant period of free allocation, unlesss shall be adjusted two years before the beginning of each trading period, in order to avoid windfall profits and reflect technological progress, taking into consideration the following:
Amendment 334 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point b
Article 1 – point 5 – point b
(i) On the basis of information submitted pursuant to Article 11, the Commission shall identify whether the values for each benchmark calculated using the principles in Article 10a differ from the annThe Commission shall carry out a detailed impact assessment, taking into account the economic and technical development of industrial plants and processes for the individual reproduction referred to above by more than 0.5% of the 2007-8 value higher or lower annually. If so, that benchmark value shall be adjusted either 0.5% or 1.5% in respect of each year between 2008 and the middle of the period for which free allocation is to be made;s in the individual sectors and subsectors, and consulting the relevant stakeholders, including the sectors and subsectors concerned.
Amendment 343 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point b
Article 1 – point 5 – point b
Directive 2003/87/EC
Article 10a – paragraph 2 – subparagraph 3 – point i a (new)
Article 10a – paragraph 2 – subparagraph 3 – point i a (new)
(ia) By way of derogation the total amount of CO2 from waste gases used for electricity production shall be taken into consideration when calculating the benchmarks.
Amendment 344 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point b
Article 1 – point 5 – point b
Directive 2003/87/EC
Article 10a – paragraph 2 – subparagraph 3 – point i b (new)
Article 10a – paragraph 2 – subparagraph 3 – point i b (new)
'(ib) By way of derogation, products with a share of more than 30% of emissions considered to be unavoidable process emissions, shall be granted 100% free allowances for that type of emissions;'
Amendment 359 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point b
Article 1 – point 5 – point b
Directive 2003/87/EC
Article 10a – paragraph 2 – subparagraph 3 – point ii a (new)
Article 10a – paragraph 2 – subparagraph 3 – point ii a (new)
(iia) By way of derogation, district heating shall be excluded from the adjustment.
Amendment 366 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point b a (new)
Article 1 – point 5 – point b a (new)
Directive 2003/87/EC
Article 10a – paragraph 4
Article 10a – paragraph 4
(ba) paragraph 4 is replaced by the following: '4. Free allocation shall be given to district heating as well as to high efficiency cogeneration, as defined by Directive 2004/8/EC, for economically justifiable demand, in respect of the production of heating or cooling. In each year subsequent to 2013, the total allocation to such installations in respect of the production of that heat shall be adjusted by the linear factor referred to in Article 9.'
Amendment 397 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 5 – point e – point i
Article 1 – point 5 – point e – point i
Directive 2003/87/EC
Article 10a – paragraph 7 – subparagraph 1
Article 10a – paragraph 7 – subparagraph 1
Allowances from the maximum amount referred to Article 10a(5) of this Directive which were not allocated for free up to 2020 shall be set aside for new entrants and, for significant production increases, together with 250 million and for adjustments to the maximum level of free allocation set in paragraph 5. In addition, the allowances placed in the market stability reserve pursuant to Article 1(3) of Decision (EU) 2015/… of the European Parliament and of the Council(*)1814 shall be set aside for this purpose.
Amendment 458 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10b – paragraph 1
Article 10b – paragraph 1
1. Sectors and sub-sectors where the product exceeds 0.2 from multiplying their intensity of trade with third countries, defined as the ratio between the total value of exports to third countries plus the value of imports from third countries and the total market size for the European Economic Area (annual turnover plus total imports from third countries), by their emission intensity, measured in kgCO2 divided by their gross value added (in €)EUR), as well as heat supplied from district heating systems, shall be deemed to be at risk of carbon leakage. Such sectors and sub-sectors shall be allocated allowances free of charge for the period up to 2030 at 100% of the quantity determined in accordance with the measures adopted pursuant to Article 10a.
Amendment 485 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10b – paragraph 2 – point c d (new)
Article 10b – paragraph 2 – point c d (new)
(cd) level of potential competition distortion among sectors and sub-sectors
Amendment 516 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – title
Article 10c – title
Option for transitional free allocation for the modernisation of the energy sector
Amendment 525 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 1
Article 10c – paragraph 1
1. By derogation from Article 10a(1) to (5), Member States which had in 2013 a GDP per capita in €EUR at market prices below 60% of the Union average may give a transitional free allocation to installations forelectricity generation (including co-generation of heat and electricity production) for the modernisation of the energy sector.
Amendment 530 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 1 a (new)
Article 10c – paragraph 1 a (new)
1a. Member States shall be allowed to choose the most preferable free allowances allocation method in line with the following options and investments shall be selected on the basis of: (a) a competitive bidding process, (b) the National Investment Plans allocation which shall be based on criteria and rules referred to in paragraph 2a (new), or (c) a combination of both methods mentioned in point (a) and (b). Any Member State that is allowed to allocate allowances on the basis of this Article shall, by 31 December 2017, submit to the Commission an application containing the proposed allocation methodology.
Amendment 531 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 2 – introductory part
Article 10c – paragraph 2 – introductory part
2. The Member State concerned shall organise a competitive bidding process for projects with a total amount of investment exceeding €10 million to select the investments to be financed with free allocation. This competitive bidding processcompetitive bidding process referred to in point (a) of paragraph 1a shall:
Amendment 537 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 2 – subparagraph 1 – point a
Article 10c – paragraph 2 – subparagraph 1 – point a
(a) comply with the principles of transparency, non-discrimination, equal treatment, technological neutrality and sound financial management;
Amendment 540 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 2 – subparagraph 1 – point b
Article 10c – paragraph 2 – subparagraph 1 – point b
(b) ensure that are eligible to bid only projects which contribute to: - the diversification of their energy mix and sources of supply, - the necessary restructuring, environmental upgrading and retrofitting of the infrastructure, - clean technologies and, - use of cogeneration and/or - modernisation of the energy production, transmission and distribution sectors are eligible to bid; (including district heating systems);
Amendment 549 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 2 – subparagraph 1 – point c – point i
Article 10c – paragraph 2 – subparagraph 1 – point c – point i
(i) on the basis of a cost-benefit analysis, ensure a net positive gain in terms of emission reduction and realise a pre- determined significant level of CO2 reductions;
Amendment 552 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 2 – subparagraph 1– point c – point ii
Article 10c – paragraph 2 – subparagraph 1– point c – point ii
(ii) are additional, clearly respond to replacement and modernisation needs and do not supply a market-driven increase in energy demand;
Amendment 555 #
Amendment 561 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 2 – subparagraph 3
Article 10c – paragraph 2 – subparagraph 3
Amendment 568 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 2 – subparagraph 3 a (new)
Article 10c – paragraph 2 – subparagraph 3 a (new)
The eligible Member States intending to make use of optional free allocation via the National Investment Plans (NIPs) referred to in point (b) of paragraph 1a shall select investments fulfilling the following criteria: - the diversification of their energy mix and sources of supply, - the necessary restructuring, environmental upgrading and retrofitting of the infrastructure, - investment in clean technologies, - use of cogeneration and/or - modernisation of the energy production, transmission and distribution sectors (including district heating systems) While selecting investments for the purpose of NIPs, Member States shall take into account technological neutrality and ensure net positive gain in terms of emissions reduction. Only investments that have obtained all relevant corporate decisions after 24 October 2014 may be counted for this purpose. The method of this selection process and the final results shall be published for public consultation. On this basis, the Member State concerned shall establish and submit a list of investments to the Commission by 30 September 2019. The Commission shall assess the list of investments by 31 March 2020. Within 9 months from the receipt of the list of investments, the Commission may request additional information concerning individual projects. The lack of decision by the Commission within the abovementioned period date means approval of the list of investments as submitted. The list of investments selected under the method referred to in this paragraph may be updated in 2023 and 2027, and submitted to the Commission. This paragraph shall be applied in case of any update.
Amendment 573 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 4
Article 10c – paragraph 4
4. Transitional fFree allocations shall be deducted from the quantity of allowances that the Member State would otherwise auction. The total free allocation shall be no more than 40% of the allowances which the Member State concerned receives in the period 2021-30 pursuant to Article 10(2)(a) spread out in equal annual volumes over the period from 2021-30. Free allocation that is not covered by the necessary expenditure in any given year shall be carried over and claimed during following years of the period between 2021 and 2030 when appropriate expenditure is incurred. Other ways of distributing the total number of allowances dedicated for the free allocation over the period between 2021 and 2030 shall be allowed provided that they are duly justified.
Amendment 574 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 5
Article 10c – paragraph 5
5. AFree allocations to operators shall be madeallowed upon demonstration that an investment selected according to the rules of the competitive bidding procesof incurred expenditure, at the level of a capital group. The free allocations to individual electricity generators (including co- generation of heat and electricity) for the period between 2021 and 2030 shall be determined and published by each of the Member States concerned by 30 September 2019. The allocations along with the list of electricity generators shall be updated in 2023 and 2027. The updated list of electricity generators shasll been carried out submitted to the Commission by 1 January 2024 and 2028 respectively.
Amendment 579 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 6
Article 10c – paragraph 6
6. Member States shall require benefiting electricity generators and network operators to report by 28 February of each year on the implementation of their selected investments. Member States shall report on this to the Commissionannually by 31 March to the Commission on the balance of free allocation and investment expenditure incurred, and the Commission shall make such reports public.
Amendment 584 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 6
Article 1 – point 6
Directive 2003/87/EC
Article 10c – paragraph 6 a (new)
Article 10c – paragraph 6 a (new)
6a. The eligible Member States shall be allowed to transfer unused allowances allocated under paragraph 1a to the Modernisation Fund as well as for auctioning.
Amendment 593 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2003/87/EC
Article 10d – paragraph 1 – subparagraph 2
Article 10d – paragraph 1 – subparagraph 2
The investments supported shall be consistent with the aims of this Directive and the European Fund for Strategic Investments.
Amendment 602 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2003/87/EC
Article 10d – paragraph 2
Article 10d – paragraph 2
2. The fund shall also finance small- scale investment projects in the modernisation of energy systems (including thermal energy, district heating, high efficiency cogeneration, renewable energy, geothermal heat) and energy efficiency. To this end, the investment boardeligible Member States shall develop guidelines and investment selection criteria specific to such projects. in line with the guidance elaborated by an advisory board referred to in paragraph 4.
Amendment 614 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2003/87/EC
Article 10d – paragraph 4 – subparagraph 1
Article 10d – paragraph 4 – subparagraph 1
The fund shall be governed by an investment board and a management commitindividual allocations of each beneficiary Member State from the Modernisation Fund shall be governed by the eligible beneficiary Member Statee, which shall beassisted by the advisory board composed of representatives ofrom the beneficiary Member States, the Commission, and the EIB and three representatives elected by the other Member States for a period of 5 years. The investment board shall be responsible to determine. Individual decisions on financing particular projects shall be taken by the eligible beneficiary Member State. Day-to- day management of the fund shall be executed by the beneficiary Member States. The advisory board shall be responsible for preparing the framework guidance on investment, including a Union-level investment policy, appropriate financing instruments and investment selection criteria. The management committee shall be responsible for the day-to-day management of the fund.
Amendment 626 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2003/87/EC
Article 10d – paragraph 4 – subparagraph 2
Article 10d – paragraph 4 – subparagraph 2
The investmentadvisory board shall elect a representative from the Commission as chairman. The investment board shall strive to take decisionsbe chaired annually by consensus. If the investment board is not able to decide by consensus within a deadline set by the chairman, the investment board shall take a decision by simple majoritye of the beneficiary Member States.
Amendment 632 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2003/87/EC
Article 10d – paragraph 4 – subparagraph 3
Article 10d – paragraph 4 – subparagraph 3
Amendment 640 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Amendment 646 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2003/87/EC
Article 10d – paragraph 5 – introductory part
Article 10d – paragraph 5 – introductory part
5. The beneficiary Member States shall report annually to the management committeeadvisory board on investments financed by the fund. The report shall be made public and include:
Amendment 648 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 7
Article 1 – point 7
Directive 2003/87/EC
Article 10d – paragraph 6
Article 10d – paragraph 6
6. Each year, the management commitbeneficiary Member Statees shall report to the Commission on experience with the evaluation and selection of investments. The Commission shall review the basis on which projects are selected by 31 December 2024 and, where appropriate, make proposals to the management commitrelevant beneficiary Member Statees.
Amendment 662 #
2015/0148(COD)
Proposal for a directive
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
A list of installations covered by this Directive for the fivetwo years beginning on 1 January 2021 shall be submitted by 30 September 2018, and lists for the subsequent fivetwo years shall be submitted every fivetwo years thereafter. Each list shall include information on production activity, transfers of heat and gases, electricity production and emissions at sub- installation level over the fivetwo calendar years preceding its submission. Free allocations shall only be given to installations where such information is provided.
Amendment 115 #
2014/2245(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Bearing in mind that family-run companies, being locally based, are a cornerstone of regional development and territorial cohesion, urges the EU and the Member States to promote businesses of this type and encourage women to become more actively involved in family firms;
Amendment 340 #
2014/2216(INI)
Motion for a resolution
Paragraph 57
Paragraph 57
57. Calls on the EU to actively participate in the 59th session of the Commission on the Status of Women, and to continue to fight against all attempts to undermine the UN Beijing Platform for Action concerning, among other elements, access to education and health as basic human rights, and sexual and reproductive rights; abortion shall not be promoted as a form of family planning.
Amendment 341 #
2014/2216(INI)
Motion for a resolution
Paragraph 57
Paragraph 57
57. Calls on the EU to actively participate in the 59th session of the Commission on the Status of Women, and to continue to fight against all attempts to undermine the UN Beijing Platform for Action concerning, among other elements, access to education and health as basic human rights, and sexual and reproductive rights; abortion shall not be promoted as a sexual and reproductive right.
Amendment 376 #
2014/2216(INI)
Motion for a resolution
Paragraph 68
Paragraph 68
Amendment 386 #
2014/2216(INI)
Motion for a resolution
Paragraph 69
Paragraph 69
Amendment 404 #
2014/2216(INI)
Motion for a resolution
Paragraph 71 a (new)
Paragraph 71 a (new)
71a. Recommends that consideration be given to establishing a legal framework to strengthen protection of the rights of children, including before the moment of birth;
Amendment 52 #
2014/0011(COD)
Proposal for a decision
Recital 3 a (new)
Recital 3 a (new)
(3a) In its resolution of 4 February 2014 (2013/2177(INI)) the European Parliament "stresses that the Commission should address more concretely and in detail the issue of carbon leakage, that the 2030 climate and energy policy targets must be technically and economically feasible for EU industries and that best performers should have no direct or indirect additional costs resulting from climate policies". It also "stresses that the provisions for carbon leakage should provide 100% free allocation of technically achievable benchmarks, with no reduction factor for carbon leakage sectors". It is of paramount importance that the Commission reviews the functioning of Directive 2003/87/EC, in this respect.
Amendment 53 #
2014/0011(COD)
Proposal for a decision
Recital 3 a (new)
Recital 3 a (new)
(3a) The European Council conclusions of 23 and 24 October 2014 on the 2030 Climate and Energy Policy Framework give clear guidance on the continuation of free allocations and carbon leakage provisions after 2020, stating that "the most efficient installations in the sectors at risk of losing international competitiveness should not face undue carbon costs leading to carbon leakage" and that "future allocations will ensure better alignment with changing production levels in different sectors" and "at the same time, incentives for industry to innovate will be fully preserved and administrative complexity will not be increased." The conclusions further underline that both direct and indirect costs for the respective industry sectors will be taken into account as well as the need for affordable energy prices. It is of paramount importance that the Commission reviews the functioning of Directive 2003/87/EC, in that respect.
Amendment 191 #
2014/0011(COD)
Proposal for a decision
Article 2 a (new)
Article 2 a (new)
Article 2a Review of Directive 2003/87/EC Within six months from the entry into force of this Decision (insert number of this Decision when known), the Commission shall review Directive 2003/87/EC, and shall, in accordance with the ordinary legislative procedure submit a proposal to the European Parliament and the Council, in particular with regard to carbon leakage provisions, ensuring that sectors at risk of carbon leakage, at least at the level of best performers, have no direct and indirect additional costs resulting from the Directive.
Amendment 196 #
2014/0011(COD)
Proposal for a decision
Article 2 a (new)
Article 2 a (new)
Article 2a Review of Directive 2003/87/EC By ...+, the Commission shall review Directive 2003/87/EC, taking into account the conclusions of the European Council of 23 and 24 October 2014, in particular with regard to carbon leakage provisions and the continuation of free allocations, better reflecting changing production levels and incentivising the most efficient performance taking into account direct and indirect carbon costs, and if appropriate shall, in accordance with the ordinary legislative procedure, submit a proposal to the European Parliament and the Council. ________________ + OJ: Please, insert the date: six months from the entry into force of this Decision.
Amendment 3 #
2013/2082(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to the Freedom of Religion or Belief: World Report 2012 conducted by Human Rights without Frontiers International and to the Religious Freedom in the World: Report 2012 conducted by Aid to the Church in Need,
Amendment 58 #
2013/2082(INI)
Motion for a resolution
Paragraph 1 – point l
Paragraph 1 – point l
(l) The Guidelines should include the right to conscientious objection to military service as a legitimate exercise of. Firstly, right to conscientious objection should include the right to freedom of thought, conscience and religion, and thefuse military service. EU should call on countries with a system of compulsory military service to allow for an alternative service of a non-combatant or civilian character, in the public interest and not of a punitive nature, and to refrain from punishing, including through prison sentences, conscientious objectors for failure to perform military service. Secondly, as the right of conscientious objection is of much broader scope and cannot be limited to the refusal of a military service, a person should be at liberty to refuse provision of certain services or treatment; or to undergo certain procedures or treatment which are conflicting with his or her beliefs . This right should not be conditioned by providing a certificate of belonging to a particular religious group on the part of a person appealing to the right to conscientious objection as this right belongs to all human beings without distinction.
Amendment 1 #
2013/2040(INI)
Motion for a resolution
Citation 4
Citation 4
– having regard to the Preamble and to Articles 2, 12, and 24 of the Convention on the Rights of the Child, adopted in 1989, which refer to non- discrimination, the right of the child to be heard, and the protection of maternal, infant and child health, in addition to developing family planning education and services,
Amendment 2 #
2013/2040(INI)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
- having regard to the Declaration of the Right of the Child1 which states that the child, by reason of his physical and mental immaturity, needs special safeguards and care, including appropriate legal protection, before as well as after birth, __________________ 1 Adopted by UN General Assembly Resolution 1386 (XIV) of 10 December 1959
Amendment 5 #
2013/2040(INI)
Motion for a resolution
Citation 15 a (new)
Citation 15 a (new)
- having regard to the US House of Representatives Congressional Record Extension of Remarks entitled "Documents reveal deceptive practices by abortion lobby" on 8 December 2003, demonstrating how abortion promotion groups are planning to push abortion not by direct argument but by twisting words and definitions and bypassing national laws;
Amendment 6 #
2013/2040(INI)
Motion for a resolution
Citation 18 a (new)
Citation 18 a (new)
- having regard to the report of the Parliamentary Assembly of the Council of Europe (PACE) on Prenatal sex selection on 16 September 2011
Amendment 7 #
2013/2040(INI)
Motion for a resolution
Citation 18 b (new)
Citation 18 b (new)
- having regard to the Parliamentary Assembly of the Council of Europe (PACE) resolution 1763 (2010) of 7 October 2010 "The right to conscientious objection in lawful medical care";
Amendment 8 #
2013/2040(INI)
Motion for a resolution
Citation 18 c (new)
Citation 18 c (new)
- having regard to Parliamentary Assembly of the Council of Europe (PACE) motion for resolution of 11 May 2010 on 'Sex-selective abortion – 'Gendercide'', inviting its Member States to 'condemn sex-selective abortion, wherever and whenever it occurs',
Amendment 9 #
2013/2040(INI)
Motion for a resolution
Citation 20 a (new)
Citation 20 a (new)
- having regard to Art. 168 (7) of the Treaty of the Functioning of the European Union stating that Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care;
Amendment 10 #
2013/2040(INI)
Motion for a resolution
Citation 21
Citation 21
– having regard to the Charter of Fundamental Rights of the European Union, especially Article 10 (Freedom of thought, conscience and religion) recognizing the right to conscientious objection;
Amendment 12 #
2013/2040(INI)
Motion for a resolution
Citation 22 a (new)
Citation 22 a (new)
- having regard to ECJ ruling C-34/10 stating that as a matter of scientific fact a new human life begins at conception, and that the human embryo constitutes a precise stage in the development of the human body;
Amendment 13 #
2013/2040(INI)
Motion for a resolution
Citation 26
Citation 26
– having regard to its resolutions of 29 September 19944 on the outcome of the Cairo International Conference on Population and Development, and 4 July 19965 on the follow-up to that Conference, and the numerous reservations expressed by States especially on the issue of SRHR and abortion,
Amendment 15 #
2013/2040(INI)
Motion for a resolution
Citation 32 a (new)
Citation 32 a (new)
- having regard to its recommendation to the Council of 13 June 2013 on the draft EU Guidelines on the Promotion and Protection of Freedom of Religion or Belief (P7_TA(2013)027);
Amendment 17 #
2013/2040(INI)
Motion for a resolution
Recital A
Recital A
A. whereas sexual and reproductive rights are human rights, the violations of which constitute breaches of women's and girls' rights to equalitywomen and girls are entitled to enjoy equal opportunities, non- discrimination based on sex, dignity and health, and freedom from inhuman and degrading treatment;
Amendment 20 #
2013/2040(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas there is no international legal obligation to provide access to abortion based on any ground, including but not limited to health, privacy, non- discrimination or sexual autonomy;
Amendment 22 #
2013/2040(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
A b. whereas the Preamble of the Universal Declaration of Human Rights states: "Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the world," and UDHR Article 3 states, "Everyone has the right to life, liberty and security of person.";
Amendment 23 #
2013/2040(INI)
Motion for a resolution
Recital A c (new)
Recital A c (new)
A c. whereas the International Covenant on Civil and Political Rights (ICCPR) implicitly recognizes the human rights of unborn children by providing in Article 6 that capital punishment "shall not be carried out on pregnant women.";
Amendment 28 #
2013/2040(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas no international legally binding treaties or conventions define the term "sexual and reproductive health and rights" ; whereas the WHO dictionary demonstrates the "inclusive language" approach: "sexual and reproductive health" includes "methods of fertility regulation" which includes "termination of pregnancies (abortion)"
Amendment 67 #
2013/2040(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
K a. whereas UN Treaty monitoring bodies have no competency to interpret these treaties in ways that create new State obligations or that alter the substance of the treaties; accordingly, any UN treaty monitoring body that interprets a treaty to include a right to abortion acts beyond its authority and contrary to its mandate ; whereas such ultra vires acts do not create any legal obligations for states parties to the treaty, nor should states accept them as contributing to the formation of new customary international law;
Amendment 71 #
2013/2040(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recalls that ‘health is a fundamental human right indispensable for the exercise of other human rights’ and that the EU cannot reach the highest attainable standard of health unless the SRHR of all are fully acknowledged and promoted;
Amendment 73 #
2013/2040(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 94 #
2013/2040(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Notes that even though it is a competence of Member States to formulate and implement policies on SRHR, the EU can exercise policy-making competence in the area of public health and of non- discrimination, and support better implementation of sexual and reproductive rights;
Amendment 98 #
2013/2040(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Asserts that, when implementing the specific clauses on the prohibition on coercion or compulsion in sexual and reproductive health matters agreed on at the Cairo International Conference on Population and Development, as well as the legally binding international human rights instruments, the EU acquis communautaire and the Union policy competencies in these matters, Union assistance should not be provided to any authority, organisation or programme which promotes, supports or participates in the management of any action which involves such human rights abuses as coercive abortion, forced sterilisation of women and men, determining foetal sex resulting in prenatal sex selection or infanticide;
Amendment 117 #
2013/2040(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. recalls that there exists no "human right to abortion" under international law, either by way of treaty obligation or under customary international law, and recalls that no international legally binding United Nations treaty can accurately be cited as establishing or recognizing a right to abortion;
Amendment 119 #
2013/2040(INI)
Motion for a resolution
Subheading 2 a (new)
Subheading 2 a (new)
upholds the universal human right to conscientious objection together with the responsibility of the State to ensure that patients are able to access lawful medical care in a timely manner in particular in cases of emergency prenatal and maternal health care, and recalls that no person, hospital or institution shall be coerced, held liable or discriminated against in any manner because of a refusal to perform, accommodate, assist or submit to an abortion or any act which could cause the death of a human foetus or embryo, for any reason;
Amendment 123 #
2013/2040(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Urges the Member States to include the promotion of natural family planning methods in their public health policy;
Amendment 126 #
2013/2040(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Underlines that in no case must abortion be promoted as a family planning method; and recalls that following internationally legally binding obligations every child regardless of sex has the right to appropriate legal protection before as well after birth;
Amendment 131 #
2013/2040(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
Amendment 135 #
2013/2040(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. recalls that abortion is not mentioned in any internationally binding UN human rights treaty;
Amendment 137 #
2013/2040(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 160 #
2013/2040(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on Member States to ensure compulsory,propose age-appropriate and gender- sensitive sexuality and relationship education for all children and adolescents (both in and out of school)sex-specific sexuality, affective and relationship education for adolescents; recalls - with regard to the principle of "Public Policy Doctrine" and internationally accepted standards - that parents or legal guardians of a child have the liberty to ensure that their children receive an education in conformity with their own convictions, and that the child shall not be compelled to receive teaching on sexuality education including the promotion of SHRH and abortion against the wishes of his or her parents or legal guardians, the best interests of the child being the guiding principle; recalls that the right of parents to educate their children according to their religious or non-religious convictions includes their right to deny any undue interference by state or non-state actors in their education;
Amendment 167 #
2013/2040(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Stresses that sexuality education mustay include the teaching of natural family planning methods, the fight against stereotypes and prejudices, shed light on gender and sexual orientation discrimination, based on sex and structural barriers to substantive equality, as well as emphasise mutual respect and shared responsibility;
Amendment 173 #
2013/2040(INI)
Motion for a resolution
Subheading 4
Subheading 4
As regards STI prevention and treatment of STI and Post Abortion Stress Syndrome (PASS)
Amendment 179 #
2013/2040(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Urges the Member States to ensure access to non-judgmental information about the post abortion stress syndrome (PASS) as well as immediate and universal access PASS treatments, provided in a safe and non-judgmental manner;
Amendment 181 #
2013/2040(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission and the Member States to address the specific SRHRneeds for prenatal and maternal health of people living with HIV/AIDS, with a focus on the needs of women, notably by integrating access to testing and treatment and reversing the underlying socioeconomic factors contributing to the risk to women of HIV/AIDS, such as gender inequality and discrimination;
Amendment 186 #
2013/2040(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Condemns any violation of the bodily integrity of women, as well as harmful practices intended to control women's sexuality and reproductive self- determination; underlines that these are serious human rights violations that the Member States have a responsibility to urgently address;
Amendment 197 #
2013/2040(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Reminds the Member States that investments in reproductiveprenatal and maternal health and natural family planning are among the most cost- effective, in terms of development, and the most effective ways to promote the sustainable development of a country;
Amendment 204 #
2013/2040(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Urges the Commission to ensure that European development cooperation adopts a human rights-based approach and that it has a strong and explicit focus, and concrete targets on SRHRprenatal and maternal health;
Amendment 209 #
2013/2040(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. calls on EU delegations in developing countries to work with the governments of those countries to ensure that girl children enjoy their rights without discrimination based on their sex, inter alia by ending the unethical and discriminatory practices of prenatal sex selection, abortion of female foetuses, female infanticide, early forced marriage, female genital mutilation;
Amendment 212 #
2013/2040(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Invites the Commission to maintain in its development priorities the access to quality, affordable, acceptable and accessible prenatal and maternal health care services, relational, affective and sexual education for boys and girls under the prior responsibility of their parents1, voluntary family planning including natural family planning methods, while combating sex based discrimination leading to sex-selective and involuntary abortions, forced sterilization and sexual violence, as well as ensuring the provision of prenatal and maternal health care supplies, including HIV prevention, treatment, care and support without discrimination; __________________ 1 "Parents have a prior right to choose the kind of education that shall be given to their children." Art 26.3 of UNGASS Resolution 217 A (III) of 10 December 1948 (Universal Declaration of Human Rights)
Amendment 215 #
2013/2040(INI)
Motion for a resolution
Paragraph 23 c (new)
Paragraph 23 c (new)
23 c. Urges the Commission and the EEAS to fully respect the reservations on SHRH and abortion expressed by national governments in the concerned international treaties, conventions and programs;
Amendment 216 #
2013/2040(INI)
Motion for a resolution
Paragraph 23 d (new)
Paragraph 23 d (new)
23 d. Further reaffirms the sovereign right of each State to implement the proposals of the present resolution in conformity with its own national laws and with full respect for the various religious and ethical values and cultural backgrounds of its people (Public Policy Doctrine) and in conformity with universally recognized international human rights;
Amendment 217 #
2013/2040(INI)
Motion for a resolution
Paragraph 23 e (new)
Paragraph 23 e (new)
23 e. recalls § 8.25 of the Programme of Action of the International Conference on Population and Development stating: "In no case should abortion be promoted as a method of family planning. (...) Prevention of unwanted pregnancies must always be given the highest priority and every attempt should be made to eliminate the need for abortion. Women who have unwanted pregnancies should have ready access to reliable information and compassionate counselling. Any measures or changes related to abortion within the health system can only be determined at the national or local level according to the national legislative process."
Amendment 1352 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 14 a (new)
Annex 1 – point 14 a (new)
(14 a) Smoking in presence of children can cause sudden infant death
Amendment 1354 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 14 b (new)
Annex 1 – point 14 b (new)
(14 b) Smoking during pregnancy causes premature birth
Amendment 1355 #
2012/0366(COD)
Proposal for a directive
Annex 1 – point 14 c (new)
Annex 1 – point 14 c (new)
(14 c) Children that are forced to smoke passive are more vulnerable to asthma and meningitis
Amendment 86 #
2012/0267(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The traceability of in vitro diagnostic medical devices by means of a Unique Device Identification (UDI) system based on international guidance should significantly enhance the effectiveness of the post-market safety of in vitro diagnostic medical devices due to improved incident reporting, targeted field safety corrective actions and better monitoring by competent authorities. It should also help to reduce medical errors and to fight against counterfeit devices. Use of the UDI system should also improve purchase-policy and stock- management by hospitals, wholesalers and pharmacists and be compatible with other authentication systems already in place in those settings.
Amendment 111 #
2012/0267(COD)
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
Amendment 144 #
2012/0267(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 174 #
2012/0267(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure that, within the limits of its respective activities, the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 177 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
Amendment 179 #
2012/0267(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) fivetwo years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
Amendment 189 #
2012/0267(COD)
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 259 #
2012/0267(COD)
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
In addition, where a reference laboratory is designated in accordance with Article 78, the notified body performing the conformity assessment shall request that reference laboratory to verify by laboratory testing compliance of the device with the applicable CTS, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas specified in Section 5.4 of Annex VIII and in Section 3.5 of Annex IX. Laboratory tests performed by a reference laboratory shall focus on in particular analytic sensitivity and sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.
Amendment 309 #
2012/0267(COD)
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
The Member States shall take all appropriate measures to encourage healthcare professionals, including doctors and pharmacists, users and patients to report to their competent authorities suspected serious incidents referred to in point (a) of paragraph 1. They shall record such reports centrally at national level. Where a competent authority of a Member State obtains such reports, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the incident. The manufacturer shall ensure the appropriate follow-up.
Amendment 80 #
2012/0192(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) In order to allow for independent control as to whether these principles are adhered to, a clinical trial should be subject to prior authorisation, and approval by an ethics committee prior to commencement.
Amendment 253 #
2012/0192(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Ethics Committee 1. Authorisation of a clinical trial shall not be granted before an independent ethics committee has made a positive decision on the clinical trial. The Ethics Committee assessment shall include, in particular, the compliance with the requirements specified in Chapter V, Article 46, Article 47 and Chapter XII. 2. The Ethics Committee shall ensure that the rights, safety and well-being of subjects are protected. It shall be independent of the researcher, independent of the sponsor, and free of any other undue influence. It shall act in accordance with the laws and regulations of the country or countries in which the research is to be conducted and shall abide by all relevant international norms and standards. The Ethics Committee shall consist of a reasonable number of members, who collectively possess the relevant qualifications and experience to be able to review and evaluate the scientific, medical and ethical aspects of the proposed trial. 3. Member States shall take the necessary measures to establish Ethics Committees and facilitate their work.
Amendment 260 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 2
Article 5 – paragraph 1 – subparagraph 2
The sponsor shall propose one of the Member States concerned as reporting Member StateMember States concerned shall determine which state shall be the reporting Member State according to an established procedure based on objective criteria which are set by the Commission.
Amendment 264 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 269 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Within six14 days following submission of the application dossier, the proposed reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 276 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where the proposed reporting Member State has not notified the sponsor within the time period referred to in paragraph 214 days, the clinical trial applied for shall be considered as falling within the scope of this Regulation, the application shall be considered complete, the clinical trial shall be considered a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 280 #
2012/0192(COD)
Proposal for a regulation
Article 5 – paragraph 4 – subparagraph 3
Article 5 – paragraph 4 – subparagraph 3
Where the proposed reporting Member State has not notified the sponsor according to points (a) to (d) of paragraph 2 within threeseven days following receipt of the comments or of the completed application, the application shall be considered complete, the clinical trial shall be considered as falling within the scope of this Regulation, the clinical trial shall be considered as a low-intervention clinical trial if this is claimed by the sponsor, and the proposed reporting Member State shall be the reporting Member State.
Amendment 310 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point a
Article 6 – paragraph 4 – subparagraph 1 – point a
(a) within 10 days from the validation date25 days, but no earlier than 15 days after receipt of the successfully validated application, for low-intervention clinical trials;
Amendment 313 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point b
Article 6 – paragraph 4 – subparagraph 1 – point b
(b) within 25 days from the validation date35 days but no earlier than 20 days after receipt of the successfully validated application for clinical trials other than low- intervention clinical trials;
Amendment 317 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1 – point c
Article 6 – paragraph 4 – subparagraph 1 – point c
(c) within 30 days from the validation date40 days but no earlier than 30 days after receipt of the successfully validated application for any clinical trial with an advanced therapy investigational medicinal product.
Amendment 321 #
2012/0192(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. Until the assessment date, any Member State concerned may communicate to the reporting Member State any considerations relevant to the application. The reporting Member State shall take those considerations duly into account and shall document them in the assessment report. If the assessment report of the reporting Member State deviates from the considerations of the Member States concerned, it shall state the reasons for this deviation in the assessment report.
Amendment 359 #
2012/0192(COD)
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 3 a (new)
Article 8 – paragraph 2 – subparagraph 3 a (new)
Notwithstanding the first and second subparagraphs, in case of other conflict, the Member States involved shall attempt to agree on a conclusion. If no conclusion is found, the Commission shall take a decision on the conclusion after having heard the Member States involved, and, if appropriate, having taken advice from the European Medicines Agency.
Amendment 375 #
2012/0192(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that the assessment is done jointly by a reasonable number of persons, including a significant number of medical doctors, who collectively have the necessary qualifications and experience.
Amendment 409 #
2012/0192(COD)
Proposal for a regulation
Article 15
Article 15
A substantial modification may only be implemented if it has been approved in accordance with the procedure set out in this Chapter, and if it has been approved by an independent ethics committee before its implementation.
Amendment 412 #
2012/0192(COD)
Proposal for a regulation
Article 17 – paragraph 2 – introductory part
Article 17 – paragraph 2 – introductory part
2. Within fourten days following submission of the application dossier, the reporting Member State shall notify the sponsor through the EU portal of the following:
Amendment 425 #
2012/0192(COD)
Proposal for a regulation
Article 20 – paragraph 5 – subparagraph 2
Article 20 – paragraph 5 – subparagraph 2
Notification shall be done by way of one single decision within ten days from the validation dateassessment date according to Article 6 (4).
Amendment 454 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 1 – point d
Article 28 – paragraph 1 – point d
(d) the subject or, where the subject is not able to give informed consent, his or her legal representative has had the opportunity, in a prior interview with a medical doctor who is the investigator or a member of the investigating team, to understand the objectives, risks and inconveniences of the clinical trial, and the conditions under which it is to be conducted and has also been informed of the right to withdraw from the clinical trial at any time without any resulting detriment;
Amendment 460 #
2012/0192(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Any subject or his legal representative may, without any resulting detriment, withdraw from the clinical trial at any time by revoking his or her informed consent. The withdrawal of consent shall not affect the activities carried out based on consent before its withdrawal.
Amendment 463 #
2012/0192(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Informed consent shall be written, dated and signed and given freely by the subject or his or her legal representative after having been ducomprehensively and comprehensibly informed of the nature, significance, implications and risks of the clinical trial, and after having received the corresponding information in writing. It shall be appropriately documented. Where the subject is unable to write, oral consent in the presence of at least one impartial witness may be given in exceptional cases. The subject or his or her legal representative shall be provided with a copy of the document by which informed consent has been given.
Amendment 474 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the informed consent of the legal representative has been obtained, whereby; consent shall represent the subject's presumed will and may be revoked at any time, without detriment to the subject;
Amendment 478 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time is consideredduly taken into account by the investigator;
Amendment 481 #
2012/0192(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point h a (new)
Article 30 – paragraph 1 – point h a (new)
(ha) the Ethics Committee, with expertise in the relevant disease and the patient population concerned, or after taking advice in clinical, ethical and psychosocial questions in the field of the relevant disease and patient population concerned, has endorsed the protocol;
Amendment 487 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point b
Article 31 – paragraph 1 – point b
(b) the minor has received all relevant information in a way adapted to his or her age and maturity, from professionalsa medical doctor (either the investigator or member of the trial team) trained or experienced in working with children, regarding the trial, the risks and the benefits;
Amendment 491 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point c
Article 31 – paragraph 1 – point c
(c) the explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation in, or to be withdrawn from, the clinical trial at any time, is duly taken into consideration by the investigator in accordance with his or her age and maturity;
Amendment 496 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h b (new)
Article 31 – paragraph 1 – point h b (new)
(hb) the corresponding scientific guidelines of the Agency have been followed;
Amendment 498 #
2012/0192(COD)
Proposal for a regulation
Article 31 – paragraph 1 – point h d (new)
Article 31 – paragraph 1 – point h d (new)
(hd) the Ethics Committee, with paediatric expertise or after taking advice in clinical, ethical and psychosocial problems in the field of paediatrics, has endorsed the protocol;
Amendment 513 #
2012/0192(COD)
Proposal for a regulation
Article 32 – paragraph 1 – point e
Article 32 – paragraph 1 – point e
(e) the Ethics committee positively assesses that a direct benefit of the clinicial trial for the patient is to be expected, as well as the fact that the clinical trial poses a minimal risk to, and imposes a minimal burden on, the subject.
Amendment 532 #
2012/0192(COD)
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database and to the public EudraPharm database a summary of the results of the clinical trial.
Amendment 570 #
2012/0192(COD)
Proposal for a regulation
Article 40 – paragraph 2 a (new)
Article 40 – paragraph 2 a (new)
2 a. The responsible Ethics Committee shall be involved in the assessment of this information.
Amendment 47 #
2012/0190(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) To enable the automotive industry to carry out long-term investments and innovation it is desirable to provide indications of how this Regulation should be amended for the period beyond 2020. These indications should be based on an assessment of the necessary rate of reduction in line with the Union's long term climate goals and the implications for the development of cost effective CO2 reducing technology for cars. It is therefore desirable for these aspects to be reviewed, the Commission to make a report and if appropriate proposals made for targets beyond 2020. That report should take into consideration CO2 emissions over the whole life cycle of cars (including manufacture and end-of-life).
Amendment 1 #
2012/0074(NLE)
Proposal for a directive
Recital 1
Recital 1
Amendment 2 #
2012/0074(NLE)
Proposal for a directive
Recital 5
Recital 5
(5) The provisions of this Directive adopted under the Euratom Treaty should supersede those of theTreaty on the Functioning of the European Union updates the indicator parameters set out in Part C of Annex I to Directive 98/83/EC, as regardsnd lays down rules on the cmontamination of drinking water byitoring of the presence of radioactive substances in drinking water.
Amendment 3 #
2012/0074(NLE)
Proposal for a directive
Recital 6
Recital 6
(6) In the event of non-compliance with a parameter that has an indicator function, the Member State concerned should assess whether that non-compliance poses any risk to human health and, where necessary, take remedial action to restore the quality of the waterbe bound to determine the cause thereof, to assess the level of the risk to human health including in the long-term and the possibilities for intervention and, on the basis of these findings, take action to ensure the water supply complies with the quality criteria laid down in this directive as soon as possible. This necessary remedial action may go as far as shutting down the facility concerned if the quality of water requires such action. Priority should be given to action which rectifies the problem at source. Consumers should be informed immediately of the risks, the measures already taken by the authorities and the time necessary for the remedial action to take effect.
Amendment 4 #
2012/0074(NLE)
Proposal for a directive
Recital 7
Recital 7
(7) Consumers should be adequateall be fully and appropriately informed of the quality of water intended for human consumption. via easily accessible publications. Updated information regarding areas at risk from potential sources of radioactive contamination, as well as regional water quality, shall be made available to consumers at all times by local administrations.
Amendment 5 #
2012/0074(NLE)
Proposal for a directive
Article 4 - paragraph 1
Article 4 - paragraph 1
Amendment 6 #
2012/0074(NLE)
Proposal for a directive
Article 6 - paragraph 1
Article 6 - paragraph 1
Member States shall ensure regular and accurate monitoring of water intended for human consumption in accordance with Annex II in order to check that the concentrations of radioactive substances do not exceed the parametric values laid down in accordance with Article 5. Monitoring shall take account of the long-term cumulative exposure of the population and shall be conducted as part of the checks referred to in Article 7 of Directive 98/83/EC on the quality of drinking water intended for human consumption. It shall include reference analyses aimed at establishing the radioactive content of the water and optimising the analysis strategy and periodic analyses in accordance with the methods set out in Annex III. The monitoring frequency for periodic analyses may be adapted through a risk- based approach, based on the results of reference analyses which shall be mandatory in all cases. In such cases, Member States shall communicate both the grounds for their decision and the results of the reference analyses concerned to the Commission and make them available to the public.
Amendment 7 #
2012/0074(NLE)
Proposal for a directive
Article 9 - paragraph 2
Article 9 - paragraph 2
2. Where there is a failure to comply with the parametric values laid defined for radown in accordance with Article 5 occurs, the Member State shall assess whetand for the total indicative dose (TID) from natural sources, the Member State shall immediately assess the level of the risk to human health and the possibilities for intervention, taking into account the local conditions. On the basis of these findings, the Member State shall take action to ensure the water supply complies with the quality criteria laid down in this directive. Where there is a failure poses a risk to human health. In the event that there is such a risk, the Member State shall take remedial action to restore the quality of the water. to comply with the parametric values defined for tritium and for the TID originating from human activities, the Member State shall ensure that the investigation which is to be launched immediately establishes the nature, scale and dosimetric impact of the pollution. That investigation shall take into account all the environments liable to be affected and all exposure pathways. The Member State shall ensure that the necessary corrective action is taken to ensure that the water again meets the parametric values. Solutions should be centred on tackling the pollution at source. The necessary remedial action may go as far as shutting down the facility concerned if the water quality requires such action. The Member State shall ensure that the costs of remedial action are borne by the polluter.
Amendment 8 #
2012/0074(NLE)
Proposal for a directive
Article 9 - paragraph 3
Article 9 - paragraph 3
3. Where the risk to human health cannot be regarded as trivial, the Member State shall ensure that consumers are notified. Member States shall ensure that the results of the analyses performed pursuant to Article 8 are published, made publicly available as soon as possible and included in the reports required under Article 13 of Directive 98/83/EC. Where the risk to human health cannot be regarded as trivial, the Member State, together with the responsible actor(s), shall ensure that consumers are alerted immediately and given complete information related to the risk to human health and on how to cope with the problems encountered, which shall be published and made available on the internet as soon as possible. They shall also ensure that alternative uncontaminated water supplies are provided without delay.
Amendment 9 #
2012/0074(NLE)
Proposal for a directive
Annex I
Annex I
Parameter Parametric value Unit Notes Rado222 Rn 10020 Bq/l Tritium 10020 Bq/l Total indicative 0,10 msSv/year (Note 1) dose Note 1: Excluding tritium, potassium-40, radon and short-lived radon decay products dose (from natural sources) Total indicative 0,01 mSv/year does (from human activity sources) Note 1: Excluding tritium, potassium-40, radon and short-lived radon decay products Or. en (If this compromise is adopted, the parametric values contained in this compromise shall be applied to all other adopted amendments concerned.)
Amendment 78 #
Amendment 79 #
Amendment 5 #
2011/2193(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to the European Parliaments Resolution on the trade in human egg cells from March 10th 2005
Amendment 6 #
2011/2193(INI)
Motion for a resolution
Recital A
Recital A
A. whereas donated tissues and cells, such as skin, bones, tendons, corneas and haematopoietic stem cells, are increasingly used in medical therapies and as starting material for advanced therapy medicinal products (ATMP); whereas the Directive2004/23 asks the Member States to endeavour to ensure voluntary and unpaid donation and endeavour to ensure that the procurement of tissues and cells as such is carried out on a non-profit basis which is a clear legal obligation which can in the case where a Member State does not follow the principal lead to infringement procedure;
Amendment 16 #
2011/2193(INI)
Motion for a resolution
Recital M a (new)
Recital M a (new)
Ma. Whereas the donation of some tissues and cells creates a severe risk for the donor, whereas this risk is particular high in egg-cell donation because of the hormone treatment which is necessary to prepare the donation;
Amendment 17 #
2011/2193(INI)
Motion for a resolution
Recital M b (new)
Recital M b (new)
Mb. Whereas the Charta of Fundamental Rights which is the leading principle for the European Union and legally binding after entering into force of the Lisbon Treaty prohibits making the human body and its parts as such a source of financial gain.
Amendment 18 #
2011/2193(INI)
Motion for a resolution
Recital M c (new)
Recital M c (new)
Mc. Whereas unpaid donation is not only an ethical principle but also necessary to protect the health of the donor and the recipient as the involvement of high amounts of money in the donation process may stimulate the donor to take risks and may hinder the disclosure of risks in his/her medical history.
Amendment 19 #
2011/2193(INI)
Motion for a resolution
Recital M d (new)
Recital M d (new)
Md. Whereas there is a lot of evidence that allogenic cordbloood transplantation is already successful for many patients and there are also serious reports that in some cases autologes treatment with this kind of cells can be successful.
Amendment 20 #
2011/2193(INI)
Motion for a resolution
Recital M e (new)
Recital M e (new)
Me. Whereas serious media again and again report that in the area of tissues and cells the principle of unpaid donation is violated.
Amendment 24 #
2011/2193(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the concluspresentations of the Second Report on Voluntary and Unpaid Donation of Tissues and Cells; which shows that a lot of activities are performed in the Member States to implement the principle of unpaid donation but also shows that still a lot needs to be done
Amendment 31 #
2011/2193(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Asks the Commission to carefully monitor the development in the Member States and to examine carefully any reports by actors in the civil society and media under violation of the principle and draw appropriate consequences if necessary infringement procedures.
Amendment 40 #
2011/2193(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 63 #
2011/2193(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines the importance of mothers donating cord blood and tissue at birth eitherspecially into public or private banks to help treat illnesses and further research in the field;
Amendment 72 #
2011/2193(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on Member States to raise awareness of public and private cord blood banking through information campaigns that may take place, for example, during antprenatal classes; but at the same times not exclude the activities of public cordblood banks including appropriately regulated information campaigns by those private cordblood banks.
Amendment 97 #
2011/2193(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses that in order to guarantee respect for the existing regulatory diversity across Member States whichUnderlines that it is Member States competence to allow, prohibit or regulate research with human embryonic stem cells and in vitro fertilisation but that Member States in this respect need to reflspects differing national values and practices in this field, the s the rules set out in the Directive 2004/23 including the quality and safety and the principal of unpaid donation. Points out that the European Union has limited compe oftence in this areport does not include issues surrounding embryonic stem cell research, therapeutic cloning and in-vitro fertilisation;a and needs to respect when applying this competence the principles of the charter of fundamental rights and the principles applied in the judgement of the European Court of Justice.
Amendment 98 #
2011/2193(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to consider revising the principles governing tissue and cell donation as laid down inpropose as soon as possible a revision of the Directive 2004/23/EC, in order to bring them into line with the principles governing organ donation laid down in Directive 2010/45/EU, and to take into account of scientific developments and the the new legal situation after the entering into force of the Lisbon Treaty and to take into account the scientific developments, the practical experience of actors in the sector and the recommendations of this report;
Amendment 99 #
2011/2193(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Asks the Commission to also propose a revision of Regulation EC 1394/2007 in order to include provision that guarantees the application of the principle of unpaid donation similar to the Directive 2010/45 and to take into account the problems in the implementation of the regulation especially for SMEs.
Amendment 25 #
2011/2107(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the regions, in line with the ‘smart specialisation’ approach, to develop tailored innovation strategies; stresses that territorial cooperation must be optimised with a view to greater complementarity between regions, calls in this regard for a better articulation and coordination between local, regional, national and European authorities;
Amendment 28 #
2011/2107(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls for a stronger intergovernmental participation of Joint Programming measures and under Interreg III B, which strengthens the cooperation in research, development and innovation throughout Europe, also with the view to increase participation and better involvement of new Member States in all European research programmes;
Amendment 55 #
2011/2107(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. In the light of the need to improve the extent to which SMEs are benefiting from support for research and innovation, considers that this should be made a focus of cohesion policy, for example in relation to internationalisation or promotion of entrepreneurship, stresses, in this regard, the need for KICs to focus more on SME participation;
Amendment 67 #
2011/2107(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to strengthen the synergy between different instruments and funds and to develop a multi-fund approach, while respecting the specific conditions set out in the respective legislation;
Amendment 73 #
2011/2107(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls for a clear coordination between existing and new initiatives under the EU2020 strategy.
Amendment 5 #
2011/2043(INI)
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
Amendment 28 #
2011/2043(INI)
Motion for a resolution
Recital G
Recital G
G. whereas delayed investment in Europe compared with other global powers is essentially due to a lack of private investment and the attractiveness of FP7 for the industrial sector is thus not fully demonstrated; but also, beyond the sums involved, there is a clear need for better coordination between the Union, the Member States, and the Unregions,
Amendment 174 #
2011/2043(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the results of FP7 in favour of SMEs, as regards both the 15% target set in the ‘Cooperation’ chapter and the ‘Eurostars’ programme; is of the opinion that better coordination between FP7 and the Structural Funds could facilitate the participation of under-represented Member States; consequently, calls on the Commission and the national and local authorities to improve the link between the cohesion funds and the Research Framework Programme as these funds should be used to enhance research infrastructure to enable research to reach the level of excellence necessary for access to research funds; in this respect underlines the need to set clear objectives and to assess whether the goals were achieved in these Member States;
Amendment 182 #
2011/2043(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the results of FP7 in favour of SMEs, as regards both the 15% target set in the ‘Cooperation’ chapter and the ‘Eurostars’ programme; is of the opinion that better coordination, coherence and synergy between FP7 and the Structural Funds could facilitate the participation of under-represented Member States;
Amendment 183 #
2011/2043(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. In this respect, stresses the importance of cohesion policy as this has become a major source of European support in the field of Research & Development and Innovation, as the Member States – in conformity with the second Community Strategic Guideline on cohesion – have devoted a significant amount of their total financial allocations to R&D&I of a knowledge-based economy, resulting in 246 national or regional operational programmes with around EUR 86 billion allocated to R&D&I;
Amendment 200 #
2011/2043(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Proposes that research and development policies be territorialised; therefore stresses the importance of adapting the research and innovation policies to the specific needs of the territories; notes that since the involvement of regional and local authorities in the design and execution of the research and innovation programmes becomes crucial due to the impossibility of applying the same strategy for development to all the regions;
Amendment 249 #
2011/2043(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Is of the opinion that commercialisation should be included in the parameters of future calls for projects under FP7 in the field of research and innovation;
Amendment 253 #
2011/2043(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Stresses the importance of better assistance in the implementation of policies and programmes that enhance the synergies within the research and development value chain (infrastructures - innovation - job creation);
Amendment 13 #
2011/0401(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Research and innovation activities supported by Horizon 2020 should respect human rights and fundamental ethical principles. The opinions of the European Group on Ethics in Science and New Technologies should be taken into account. Research activities should also take into account Article 13 TFEU and reduce the use of animals in research and testing, with a view ultimately to replacing animal use. Research activities funded by Horizon 2020 should respect the legal provisions and customs of the Member States. All activities should be carried out ensuring a high level of human health protection in accordance with Article 168 TFEU.
Amendment 15 #
2011/0401(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) The European Commission does not explicitly solicit the use ofAttention should be paid to the considerable differences between national legislations of Member States with regard to research using human embryos and human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgement of the scientists in view of the objectives they want to achievUnion research policy should not lead to harmonisation of national legislation of Member States. The Commission should remind its declaration, with regard to the Seventh Framework Programme, to continue the current practice and isnot subjecmit to stringent Ethics Review. No project involving the use of human embryonic stem cells should be funded that does not obtain the necessary approvals from the Member States. No activity should be funded that is forbidden in all Member States. No activity should be funded in a Member State where such activity is forbiddenthe Regulatory Committee proposals for projects which destroy human embryos, including for the procurement of stem cells.1 This commitment should be included in this Regulation in order to ensure legal certainty and continuity. __________________ 1 Point 12 of the Commission statement regarding Article 6 annexed to Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (OJ L 412, 30.12.2006, p. 1).
Amendment 16 #
2011/0401(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) Union research policy and research funding should ensure that scientists whose research is funded from the European Union budget, would patent their inventions in the Union. Not patentable research should be excluded from the EU funding in order to ensure responsible use of the European Union budget.
Amendment 19 #
2011/0401(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) To achieve maximum impact, Horizon 2020 should develop close synergies with other Union programmes in areas such as education, space, environment, competitiveness and SMEs, the internal security, culture and media and with the Cohesion Policy funds and Rural Development Policy, which can specifically help to strengthen national and regional research and innovation capabilities in the context of smart specialisation strategies. ; therefore in the Commission's working document of 22 March 2012 on synergies between Horizon 2020 and Cohesion Policy funds, the principles of excellence to which both the research and development as well as regional development policy ought to adhere, are laid down;
Amendment 32 #
2011/0401(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Linkages and interfaces shall be implemented across and within the priorities of Horizon 2020. Particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies, to bridging from discovery to market application, to cross-disciplinary research and innovation, to social and economic sciences and humanities, to fostering the functioning and achievement of the ERA, to the development of the research into European legal systems, to cooperation with third countries, to ethically responsible research and innovation including gender, and to enhancing the attractiveness of the research profession and to facilitating cross-border and cross- sector mobility of researchers.
Amendment 34 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point a
Article 16 – paragraph 3 – point a
(a) research activity aiming at human cloning for reproductive, therapeutic or scientific purposes;
Amendment 36 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b
Article 16 – paragraph 3 – point b
(b) research activity intended to modify the genetic heritage of human beings and animals which could make such changes heritable;
Amendment 37 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point c a (new)
Article 16 – paragraph 3 – point c a (new)
(ca) research involving the destruction of human embryos.
Amendment 38 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Research on other types of human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.
Amendment 47 #
2011/0401(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The activities developed under Horizon 2020 should aim at promoting equality between men and women in research and innovation, by addressing in particular thHorizon 2020 funded research activities should comply with the EU acquis communautaire with regard to equal opportunities between men and women. Horizon 2020 should pay attention to excellent science uanderlying causes of gender imbalance, by exploiting the full potential of both female and male to professional qualification of scientific and research personal of both sex involved in researchers, and by integrating the gender dimension into the content of projects in order to improve the quality of research and stimulate innovation. Activities should also aim at the implementation of the principles relating to the equality between women and men as laid down in Articles 2 and 3innovation. In order to assure the effective use of EU funding, the principal distinction for EU research funding should be the excellence of science project and the professional qualification of the Treaty on European Union and Article 8 TFEUsearch staff.
Amendment 50 #
2011/0401(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Research and innovation activities supported by Horizon 2020 should respect fundamental ethical principles. The opinions of the European Group on Ethics in Science and New Technologies should be taken into account. Research activities should also take into account Article 13 TFEU and reduce the use of animals in research and testing, with a view ultimately to replacing animal use. Horizon 2020 funding of research activities must respect the legislative provisions and customs of the Member States. All activities should be carried out ensuring a high level of human health protection in accordance with Article 168 TFEU. (EU Framework Programs must respect the national constitutional law of Member States when establishing funding for research. EU cannot fund research which is not authorized in Member States.)
Amendment 56 #
2011/0401(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) The European Commission does not explicitly solicit the use of human embryonic stem cells. The use of human stem cells, be they adult or embryonic, if any, depends on the judgement of the scientists in view of the objectives they want to achievAttention should be paid to the considerable differences between national legislations of Member States with regard to research using human embryos and human embryonic stem cells. EU research policy should not lead to harmonize national legislation of Member States. The Commission should remind its declaration, with regard to the 7th FRP, to continue the current practice and isnot subjecmit to stringent Ethics Review. No project involving the use of human embryonicthe Regulatory Committee proposals for projects which include research activities which destroy human embryos, including for the procurement of stemll cells should be funded that does not obtain the necessary approvals from the Member States. No activity should be funded that is forbidden in all Member States. No activity should be funded in a Member State where such activity is forbidden1. This commitment should be included in this Regulation in order to ensure legal continuity. __________________ 1 Point 12 of the Commission statement regarding Article 6 annexed to Decision 1982/2006/EC of the European parliament and of the Council of 18 December 2006 concerning the 7th FRP of the EC for research, technological development and demonstration activities, OJ L 412, 30.12.2006, p.1.
Amendment 107 #
2011/0401(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Linkages and interfaces shall be implemented across and within the priorities of Horizon 2020. Particular attention shall be paid in this respect to the development and application of key enabling and industrial technologies, to bridging from discovery to market application, to cross-disciplinary research and innovation, to social and economic sciences and humanities, to fostering the functioning and achievement of the ERA, to the development of research into European legal systems, to cooperation with third countries, to ethical responsible research and innovation including gender, andthe respect of equal opportunities between men and women in research, to enhancing the attractiveness of the research profession for both sexes and to facilitating cross- border and cross- sector mobility of researchers.
Amendment 113 #
2011/0401(COD)
Proposal for a regulation
Article 15 – title
Article 15 – title
Amendment 114 #
2011/0401(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
Horizon 2020 shall ensure the effective promotion of gender equality and the gender dimensiomust respect scientific excellence and professional qualification of research professionals when promoting equal opportunities for men and women in research and innovation content.
Amendment 122 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point a
Article 16 – paragraph 3 – point a
(a) research activity aiming at human cloning for reproductive, therapeutic or scientific purposes;
Amendment 123 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b
Article 16 – paragraph 3 – point b
(b) research activity intended to modify the genetic heritage of human beings and animals which could make such changes heritable;
Amendment 124 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point c a (new)
Article 16 – paragraph 3 – point c a (new)
(ca) research involving the destruction of human embryos;
Amendment 126 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point c b (new)
Article 16 – paragraph 3 – point c b (new)
(cb) research using human embryonic stem cells;
Amendment 135 #
2011/0401(COD)
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Research on other types of human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. No funding shall be granted for research activities that are prohibited in all the Member States. No activity shall be funded in a Member State where such activity is forbidden.
Amendment 9 #
2010/2139(INI)
Motion for a resolution
Recital A
Recital A
A. whereas, according to Article 174 of the Treaty on the Functioning of the European Union, in order to promote its overall harmonious development, the Union shall develop and pursue its actions leading to the strengthening of its economic, social and territorial cohesion, and in particular, the Union shall aim at reducing disparities between the levels of development of the various regions and the backwardness of the least favoured regions such as rural areas, areas affected by industrial transition, and regions which suffer from severe and permanent natural or demographic handicap,
Amendment 11 #
2010/2139(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the strategic dimension of cohesion policy guaranteeing consistency with the European Union priorities - making Europe and its regions more attractive places in which to invest and work, improving knowledge and innovation for growth and creating more and better jobs - is provided and highlighted through Council Regulation (EC) No 1083/2006 (hereinafter: General Regulation), the Community strategic guidelines on cohesion (hereinafter: Strategic Guidelines), the National Strategic Reference Framework (NSRF) and the Operational Programmes (OP),
Amendment 25 #
2010/2139(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. NReiterates its appreciation of the national efforts resulting in average allocation of expenditure for the achievement of the Lisbon agenda of 65% of the available funds in the convergence regions and 82% in the regional competitiveness and employment regions, exceeding the levels originally requested; notes with satisfaction that a total of EUR 63 billion is reported as allocated to Lisbon earmarking projects and that project selection under Lisbon earmarking is at the same level or slightly faster than selection for other actions;
Amendment 30 #
2010/2139(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes that the progress rate among CSG themes is highest in the Territorial Dimension theme (30%), above average for ‘Improving knowledge and innovation for growth’, but below 27.1% in the case of the other two guidelines and that, moreover, selection rates are above average for Lisbon earmarked projects in both Convergence and Regional Competitiveness and Employment objectives, but amount only to 20.5% in the European Territorial Cooperation objective; regrets that, in the absence of output and result indicators for all Member States, the analysis of policy performance as presented in the strategic report has proved to have serious limitations; calls on the Commission, therefore, to review its administrative reporting requirements and calls on the Member States to be more disciplined about providing data on programme implementation;
Amendment 37 #
2010/2139(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Believes that corrective measures need to be promptly taken to improve poor performance in some priority areas; calls on Member States in this context to step up efforts to improve project selection in the delayed themes, and to accelerate implementation of all selected projects so as to avoid the risk of not reaching the agreed objectives;
Amendment 38 #
2010/2139(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Considers that rapid project selection and implementation is particularly needed for the activities aimed at improving human capital, supporting labour markets and enhancing social inclusion in order to overcome the negative impacts of the economic crisis;
Amendment 39 #
2010/2139(INI)
Motion for a resolution
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Highlights the fact that several Member States confirmed that the discipline imposed by the earmarking exercise has improved the quality and focus of programming; moreover Member States unanimously considered that maintaining fundamental priorities of their National Strategic Reference Frameworks and Operational Programmes linked to the Lisbon Strategy is the best instrument to tackle the crisis, and reconfirmed the relevance of the medium and long term objectives set out in these documents;
Amendment 42 #
2010/2139(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Underlines the fact that effective selection and implementation of projects in some areas is hampered by missing relevant preconditions, such as the lack of clear national priorities for certain areas of intervention, belated transposition of EU laws and lack of institutional and administrative capacity; calls therefore on Member States and regions to facilitate policy implementation by tackling these challenges and in particular by improving the legal framework in the field of state aid, public procurement and environmental rules and pursue institutional reforms;
Amendment 57 #
2010/2139(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Considers that the signs of recovery from the crisis are fragile, and in the coming years Europe has to tackle its structural weaknesses, also through Cohesion Policy interventions; stresses therefore the need for a thorough analysis of the impact of measures aimed at counteracting the crisis;
Amendment 65 #
2010/2139(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the particular added value of more synergies between ERDF and ESF, since experience clearly proves that successful performance of ESF-financed programmes is essential in order to maximise the effectiveness of ERDF funding for economic actions; notes also that greater coordination would be welcome between cohesion policy instruments and rural development policy instruments, since achieving more synergies between ERDF and EAFRD is similarly important;
Amendment 75 #
2010/2139(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Considers that strategic reporting, as a valuable tool of monitoring the progress of implementation creates a basis for peer review and strategic debate on EU level, therefore encourages Member States to adopt more analytical and strategic approach while elaborating national reports, and expects stronger focus on outputs, outcomes, as well as reasons for the failure to achieve the targets;
Amendment 9 #
2009/2219(INI)
Draft opinion
Paragraph 1a (new)
Paragraph 1a (new)
Amendment 16 #
2009/2219(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers, in this context, that in future legislation Parliament should insist on an arrangement whereby trade advantages, including those stemming from free trade agreements, can be suspended temporarily by the Commission alone if sufficient evidence of human rights or labour rights violations is found, either on its own initiative oror shall be suspended by the Commission at the request of a certain number of Member State s and/or the European Parliament;
Amendment 18 #
2009/2219(INI)
Draft opinion
Paragraph 3a (new)
Paragraph 3a (new)
3a. Calls for the establishment of an arbitration body with binding powers;
Amendment 21 #
2009/2219(INI)
Draft opinion
Paragraph 4a (new)
Paragraph 4a (new)
4a. Calls on the Commission to clarify the possibility to prosecute multilateral corporations before international courts and tribunals for violations of humanitarian law;
Amendment 26 #
2009/2219(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Calls on the Commission to table a proposal for a regulation banning the import into the EU of goods produced using slave, child or forced labour in violation of basic human rights standards; emphasises that such a regulation would have to enable the EU to investigate specific claims;
Amendment 33 #
2009/2219(INI)
Draft opinion
Paragraph 6a (new)
Paragraph 6a (new)
6a. Underlines that the TRIPS agreements´ provisions shall respect the enjoyment of right to health of the population in developing countries;
Amendment 34 #
2009/2219(INI)
Draft opinion
Paragraph 6b (new)
Paragraph 6b (new)
6b. Calls on the Commission to review the EU export regulations in the field of sale, supply, transfer or export of arms and related materiel of all types, including ammunition, equipment and spare parts, to the countries or to regimes that are likely to use them for internal repression of the civil society and violations of human rights;
Amendment 1 #
2009/2104(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
- having regard to the report by David Matas and David Kilgour entitled 'Bloody Harvest. The killing of the Falung Gong for their organs',
Amendment 3 #
2009/2104(INI)
Motion for a resolution
Recital H
Recital H
H. whereas it is recognised that, ideally, the best way of fighting against organ trafficking and trafficking in personthe trafficking of organs and of human beings for the purpose of the removal ofing organs is to increase the number of available organconstitutes a severe violation of human rights,
Amendment 4 #
2009/2104(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas there is a strong link between illegal organ trafficking and the trafficking of persons for the purpose of removing organs and the legal system of organ donation because, on the one hand, the non-availability of organs in the legal system acts as an incentive for illegal activities, and, on the other, illegal activities severly undermine the credibility of the legal system of organ donation,
Amendment 5 #
2009/2104(INI)
Motion for a resolution
Recital J
Recital J
J. whereas living donation rates also differ substantially between Member States, and it seems that not all Member States realise their potential for living donationcan be a helpful additional measure for patients who cannot get the organ they need via post- mortem transplantation, but emphasising that living donation can only be considered if any illegal activity and payment for the donation has been ruled out,
Amendment 8 #
2009/2104(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the proposal to establish a European Action Plan on Organ Donation and Transplantation for the period 2009- 2015(2009-2015) adopted by the European Commission in December 2008, which sets out a cooperative approach between Member States through a set of priority actions, based on the identification and development of common objectives and the evaluation of donation and transplantation activities through agreed indicators that might help to identify benchmarks and best practices;
Amendment 9 #
2009/2104(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 12 #
2009/2104(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Considers that to ensure that organs available for therapy are not wasted, it is important that there are no legal barriers tois a clearly defined legal framework regarding their use and that society trusts the donation and transplantation system;
Amendment 13 #
2009/2104(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Welcomes the activities of Eurotransplant and Scanditransplant, but notes that exchanges of organs outside these systems and between these systems can be significantly improved, especially for the benefit of patients in small countries;
Amendment 14 #
2009/2104(INI)
Motion for a resolution
Paragraph 9 (renumbering)
Paragraph 9 (renumbering)
Amendment 15 #
2009/2104(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that donation should be voluntary, unpaid and altruistic, and take place in clearly defined legal and ethical contexts;
Amendment 16 #
2009/2104(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Endorses measures which aim at protecting living donors and ensuring that organ donation is made altruistically and voluntarily, without any payment other than compensation which is strictly limited to covermaking good the expenses and inconvenience relating to donationincurred in donating an organ, such as travel expenses, childminding costs, loss of earnings or recovery costs, prohibiting any financial incentives or disadvantages for a potential donor; urges Member States to define the conditions under which compensation may be granted;
Amendment 21 #
2009/2104(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on Member States to reach the full potential of deceased donation by establishing efficient systems for identifying organ donors and by promoting transplant donor coordinators in hospitals across Europe; asks Member States to evaluate the use of organs from "expanded" criteria donors, taking into account (i.e. older donors or those who have certain diseases), taking into account donor and recipient protection and the quality and safety aspects;
Amendment 22 #
2009/2104(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on Member States to explore the promotion of donation from living donors as a complement to deceasedEmphasises that living donation should be seen as subsidiary to post- mortem donations and should only serve as a last resort where no suitable alternative, such as organs from a deceased donor, is available; advises the Member States to allow living donation only among close relatives and between spouses owing to the implicit danger of exploitation; insists that Member States that extend living donation to other groups must have strict regulations in place to prevent any kind of pressure being exerted or payment being made for the donations; .
Amendment 24 #
2009/2104(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Stresses that living donors should be treated in accordance with the highest medical standards and without any financial burden for themselves when a medical problem occurs which is caused by the transplantation process, and any loss of earning as consequence of the transplantation or any medical problem should be avoided. The donors should be protected against discrimination in the social system.
Amendment 25 #
2009/2104(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Points out that there is a link between organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs; eEmphasises that any commercial exploitation of organs that denies an equitable access to transplantation is unethical, is inconsistent with the most basic human values, contravenes Article 21 of the Convention on Human Rights and Biomedicine and is prohibited under Article 3(2) of the EU Charter on Fundamental Rights; stresses that increasing organ availability in the Member States will contribute to a better control of these practices by avoiding citizens of the Union having to search for an organ outside the EU and national legislative and ethical frameworks;
Amendment 26 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Points out that the organ shortage and organ trafficking and trafficking in persons for the purpose of the removal of organs are linked in two ways: firstly, increased organ availability in the Member States would contribute to better monitoring of these practices, by obviating any need for EU citizens to consider seeking an organ outside the EU, and, secondly, illegal activity seriously undermines the credibility of the legal organ donation system:
Amendment 27 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Repeats the recommendations on the fight against the organ trade made in the Adamou-report on organ donation and transplantation1 and takes the view that these should be taken fully into account by the Commission when drafting the action plan; insists that awareness of the problem within the Commission and Europol needs to be increased; 1 European Parliament resolution of 22 April 2008 on organ donation and transplantation: Policy actions at EU level (2007/2210 (INI))
Amendment 28 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 c (new)
Paragraph 23 c (new)
Amendment 29 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 d (new)
Paragraph 23 d (new)
23d. Welcomes the joint Council of Europe/United Nations study on trafficking in organs, tissues and cells and trafficking in human beings for the purpose of the removal of organs;
Amendment 30 #
2009/2104(INI)
Motion for a resolution
Paragraph 23 e (new)
Paragraph 23 e (new)
23e. Notes the report by David Matas and David Kilgour entitled 'Bloody Harvest. The killing of the Falun Gong for their organs', and asks the Commission to present a report on the allegations made in the book to the European Parliament and the Council;
Amendment 31 #
2009/2104(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Strongly rejects the behaviour of some health insurance organisations in encouraging patients to participate in transplant tourism and asks the Member States to monitor strictly and punish such behaviour;
Amendment 32 #
2009/2104(INI)
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24b. Emphasises that patients who have received an organ under illegal circumstances cannot be excluded from healthcare in the European Union; points out that as in any other case a distinction should be drawn between the punishment for illegal activity and the need for treatment;
Amendment 34 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 2
Recital 2
(2) In the area of information, Directive 2001/83/EC lays down detailed rules on the documents to be annexed to the marketing authorisation and intended for information purposes: the summary of product characteristics (distributed to health-care professionals) and the package leaflet (inserted in the product's packaging when it is dispensed to the patient). On the other hand, as regards the disseminationmaking available of information from the marketing authorisation holder to patients and the general public, the Directive only provides that certain information activities are not covered by the rules on advertising, without providing for a harmonised framework on the contents and the quality of non promotional information on medicinal products or on the channels through which this information may be disseminated.made available. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 42 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 4
Recital 4
(4) Experience gained from the application of the current legal framework has also shown that certain restrictions on the possibilities of pharmaceutical companies to providmake information available to patients and the general public result from the fact that the distinction between the notions of advertising and information is not interpreted consistently across the Community. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 46 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 7
Recital 7
(7) In the light of the above and taking into account technological progress with regard to modern communication tools and the fact that patients throughout the European Union have become increasingly active as regards healthcare, it is necessary to amend the existing legislation in order to reduce differences in access to information and to allow for the availability of good-quality, objective, reliable and non promotional information on medicinal products by placing emphasis on the interests of patients. They should have the right to easily access certain information such as a summary of product characteristics, and the package leaflet in electronic and printed form.
Amendment 49 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 8
Recital 8
(8) National competent authorities and health care professionals should remain importantthe main sources of information on medicinal products for the general public. Member States should facilitate the access of citizens to high-quality information through appropriate channels. Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products. This Directive should therefore establish a legal framework for the dissemination of specific information on medicinal products by marketing authorisatWhile there is already a lot of independent information on pharmaceuticals, for example by national authorities or health care professionals, the situation differs very much between Member States and among the different products available. Member States and Commission shoulders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained take much more efforts to facilitate the access of citizens to high-quality information through appropriate channels.
Amendment 53 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 8 a (new)
Recital 8 a (new)
(8a) Without prejudice to the importance of the role played by national competent authorities and health care professionals in better informing patients and the general public, marketing authorisation holders may be an additional source of non-promotional information on their medicinal products. This Directive should therefore establish a legal framework for the making available of specific information on medicinal products by marketing authorisation holders to the general public. The ban on advertising to the general public for prescription-only medicinal products should be maintained.
Amendment 54 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 9
Recital 9
(9) In accordance with the principle of proportionality, it is appropriate to limit the scope of this Directive to the supply of information on prescription-only medicinal products that has been approved by the competent authorities by the marketing authorisation holder, as current Community rules allow the advertising to the general public of medicinal products not subject to prescription, under certain conditions.
Amendment 58 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 10
Recital 10
(10) Provisions should be established to ensure that only high-quality non- promotional information about the benefits and the risks of medicinal products subject to medical prescription may be disseminated. The information should take into account patients needs and expectations in order to empower patients, allow informed choices and enhance the rational use of medicinal products. Therefore, any information to the general public on prescription-only medicinal products should comply with a set of quality criteriabe approved in advance by the competent authorities und should be supplied only in the approved form.
Amendment 64 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminatmake available only high-quality information and to distinguish non-promotional information from advertising, the types of information which may be disseminatedmade available should be defined. It is appropriate to allow marketing authorisation holders to disseminatmake available the contents of the approved summaries of product characteristics and package leaflet, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product-related information. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 67 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 11
Recital 11
(11) In order to further ensure that marketing authorisation holders disseminate only high-quality information andcompetent authority- approved high-quality information in approved form and in order to distinguish non-promotional information from advertising, the types of information which may be disseminated should be defined. It is appropriate to allow marketing authorisation holders to disseminate the contents of the approved summaries of product characteristics and package leaflets, information that is compatible with those documents without going beyond their key elements, and other well-defined medicinal product- related informationcluding the "drug-fact-box".
Amendment 72 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12
Recital 12
(12) Information to the general public on prescription-only medicinal products that has been approved by the competent authorities should only be provided through specific channels of communication, including Internet and health-related publications, by the marketing authority holder to avoid that the effectiveness of the prohibition on advertising is undermined by unsolicited provision of information to the public. Where information is disseminated via television or radioby the marketing authority holder via television, radio or newspapers, magazines and similar publications, patients are not protected against such unsolicited information and such disseminsupply of information should therefore not be allowed.
Amendment 74 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 12 a (new)
Recital 12 a (new)
(12 a) The internet is a major source of information for a growing number of patients. This trend is likely increase in the coming years. In order to adapt to this development and to add to the growing importance of e-health, information on medicinal products should also be made available via independent national health internet websites. These websites should be monitored by competent authorities in the Member States. Member States in co- operation with stakeholders such as health care professionals or patient organisations should be responsible for managing these websites.
Amendment 75 #
2008/0256(COD)
Proposal for a directive - amending act
Recital 14
Recital 14
(14) Monitoring of information on prescription-only medicinal products should ensure that marketing authorisation holders only disseminate information which is in compliance with Directive 2001/83/EC. Member States should adopt rules establishing effective monitoring mechanisms and allowing effective enforcement in cases of non-compliance. Monitoring should be based on the control of information prior to its dissemination, unless the substance of thesupply. Only such information thas already been agreedt has been approved in advance by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoringshould be provided, and it should be provided in the approved form only.
Amendment 88 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 1a (new)
Article 86 – paragraph 2 – indent 1a (new)
– correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;
Amendment 95 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 1
Article 1 – point 1
Directive 2001/83/EC
Article 86 – paragraph 2 – indent 4
Article 86 – paragraph 2 – indent 4
- information by the marketing authorisation holderon medicinal products that has been approved by the competent authorities in the Member States and that has been made available to the general public oin medicinal productapproved form by the marketing authorisation holder and that is subject to medical prescription, which is subject to the provisions of Title VIIIa.
Amendment 108 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 2
Article 1 – point 2
Directive 2001/83/EC
Article 88 – paragraph 4
Article 88 – paragraph 4
4. The prohibition set out in paragraph 1 shall not apply to vaccination campaigns and other campaigns in the interest of public health carried out by the industry and approved by the competent authorities of the Member States.
Amendment 111 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a (new), to be inserted before Article 100a
Article 100 - a (new), to be inserted before Article 100a
Article 100 -a Member States and the European Commission shall support independent information on medical products to the general public. To this end the Member States shall present a national program on information to patients following consultation with stakeholders such as health care professionals and patient organisations. Information shall be presented in electronic as well as in printed form. The Commission shall provide assistance and organise the exchange of best practice. Member States and the Commission shall grant financial support to independent drug information centres, encourage the development of independent, continuing education programmes for health professionals and the development of their critical appraisal skills.
Amendment 112 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 - a a (new), to be inserted before Article 100a
Article 100 - a a (new), to be inserted before Article 100a
Amendment 116 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 a - paragraph 1
Article 100 a - paragraph 1
1. Member States shall allow the marketing authorisation holder to disseminatmake available, either directly or indirectly through a third party, information that is acting in the name of the marketing authorization holder, information that has been approved by the competent authorities to the general public or members thereof on authorised medicinal products subject to medical prescription provided that ithis information and the way it is supplied is in accordance with the provisions of this Title. Such information shall not be considered advertising for the purposes of the application of Title VIII. When such information is made available, the marketing authorisation holder and any third party shall be identified, and any third party that acts on behalf of the marketing authorisation holder shall be clearly identified as such.
Amendment 129 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – introductory part and point a
Article 100 b – introductory part and point a
The following types of information onmarketing authorisation holder shall, in respect of authorised medicinal products subject to medical prescription may be disseminated by the, marketing authorisation holder available to the general public or members thereof: a) the summary of product characteristics, labelling and package leaflet of the medicinal product, as approved by the competent authorities, and the publicly accessible version of the assessment report drawn up by the competent authorities;. A drug-fact-box shall be added to the package leaflet. The information provided in the drug-fact-box shall be presented in a form that is clearly legible, prominent and clearly distinguishable from the rest of the text. This drug-fact-box shall contain a short description of the necessary facts of the medicinal product in order to enable the patient to understand the utility and the possible risks of the medicinal product and in order to apply the medicinal product safely and in the right way. It shall also contain a short summary of the results of the clinical trials. Before supplying it, the drug-fact-box shall be approved by the competent authorities; and prior to such approval, patient organizations shall be heard in an appropriate way in order to guarantee a form that is suitable to the patients. This information shall be made available both in electronic and printed form in all languages of the EU and in a format accessible to people with disabilities.
Amendment 146 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point b
Article 100 b – point b
b) information which does not go beyond the elements of the summary of product characteristics, labelling and the package leaflet of the medicinal product, and the publicly accessible version of the assessment report drawn up by the competent authorities, but presents them in a different way;
Amendment 162 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 b – point d
Article 100 b – point d
d) medicinal product-related information about non-interventional scientific studies, or accompanying measures to prevention and medical treatment, or. Such information which presents the medicinal product in the context of the condition to be prevented or treatedshall be vetted by the Agency prior to its being made available in accordance with Article 20 b (1) of Regulation EC (No) 726/2004.
Amendment 165 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – introductory part
Article 100 c – introductory part
Information on authorised medicinal products subject to medical prescription disseminatedthat has been approved by the competent authorities and is made available by the marketing authorisation holder to the general public or members thereof shall not be made available on television or radio. It, radio or newspapers, magazines and similar publications. The marketing authorisation holder shall be allowed to supply the information approved in Article 100b on the internet. This information shall not be supplied to the general public or members thereof unasked or actively and shall only be made available through the following channels:
Amendment 182 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 c – point b
Article 100 c – point b
b) marketing authorisation holders' internet websites on medicinal products, to the exclusion of unsolicited material actively distributed to the general public or members thereof;
Amendment 190 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 d – paragraph 1 a (new)
Article 100 d – paragraph 1 a (new)
1a. Within one year of the entry into force of this Directive, the Commission shall, following a public consultation with patient and consumer organisations, doctor and pharmacist organisations, Member States and other interested parties, present to the European Parliament and the Council an assessment report regarding the readability and the accuracy of the summaries of product characteristics and the packaging leaflets and their value to the general public and healthcare professionals. Following an analysis of the above data, the Commission shall, if appropriate, put forward guideline proposals to improve the layout and the content of the summaries of product characteristics and of the packaging leaflet to ensure they are a valuable source of information for the general public and healthcare professionals.
Amendment 231 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 g – paragraph 1 – subparagraph 1
Article 100 g – paragraph 1 – subparagraph 1
1. Member States shall ensure that there are adequate and effective methods of monitoring to avoid misuse when information on authorised medicinal products subject to medical prescription is disseminated by the marketing authorisation holder to the general public or members thereofmisuse is avoided by securing that only the marketing authorisation holder supplies information, and only such information which has been approved by the competent authorities about approved medicines subject to medical prescription, and in the form which has been approved for the dissemination to the general public or members thereof. By way of derogation Member States may continue those types of control mechanism which they have been implemented before 31.12.2008. The Commission verifies and approves these systems.
Amendment 248 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 1 – subparagraph 1
Article 100 h – paragraph 1 – subparagraph 1
1. Member States shall ensure that marketing authorisation holders register Internet websites containing authority- approved information on medicinal products with the national competent authorities of the Member State of the country code Top Level Domain used by the website concerned, prior to making it available to the general public. Where the website does not use a country code Top Level Domain, the marketing authorisation holder shall select the Member State of registration.
Amendment 259 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 – subparagraph 2
Article 100 h – paragraph 2 – subparagraph 2
Internet websites registered in accordance with paragraph 1 shall not allow the identification of members of the general public which have access to those websites without their explicit prior consent or the appearance therein of unsolicited material actively distributed to the general public or members thereof. Those websites shall not contain web-TVInternet websites may provide video content if it is useful for the safe and effective use of the medicine. Video contents shall only reflect the package leaflet, the summary of the characteristics and the drug-fact-box and hints how to use this medicine safe and effectively. Before publication video contents must be approved by the competent authorities.
Amendment 267 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 2 a (new)
Article 100 h – paragraph 2 a (new)
2a. The registered internet websites shall display a notification at the top of each website page informing the public that the information contained therein is developed by a named marketing authorization holder. A link to the EudraPharm database on medicinal products shall also be included in that notification.
Amendment 274 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point a
Article 100 h – paragraph 4 – point a
(a) If a Member State has reasons for doubts as to whether the translation of the reproduced information is correct, it may require a marketing authorisation holder to provide for a certified translation of the authority-approved information disseminated on the Internet website registered with the national competent authority of another Member State.
Amendment 275 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 4 – point b
Article 100 h – paragraph 4 – point b
(b) If a Member State has reasons for doubts as to whether the authority- approved information disseminated on an Internet website registered with the national competent authorities of another Member State complies with the requirements of this Title, it shall inform that Member State of the reasons for its doubts. The Member States concerned shall use their best endeavours to reach agreement on the action to be taken. If they fail to reach an agreement within two months, the case shall be referred to the Pharmaceutical Committee set up by Decision 75/320/EEC. Any necessary measures may only be adopted after an opinion has been delivered by that Committee. Member States shall take account of opinions delivered by the Pharmaceutical Committee and shall inform the Committee of how its opinion has been taken into account.
Amendment 279 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 h – paragraph 5
Article 100 h – paragraph 5
5. Member States shall allow marketing authorisation holders which have registered Internet websites in accordance with paragraphs 1 to 4 to include a statement therein to the effect that the site has been registered and is subject to monitoring in accordance with this Directive. The statement shall identify the national competent authority monitoring the website concerned. It shall also specify that the fact that the website is monitored does not necessarily mean that all the information on the website has been subject to prior approval.
Amendment 288 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 j – point a
Article 100 j – point a
a) keep available for the competent authorities or bodies responsible for monitoring information on medicinal products that have approved the information in advance, a sample of all information disseminatedmade available in accordance with this Title and information on its volume of disseminatprovision, together with a statement indicating the persons to whom it is addressed, the method of disseminatprovision and the date of first disseminatprovision,
Amendment 295 #
2008/0256(COD)
Proposal for a directive - amending act
Article 1 – point 5
Article 1 – point 5
Directive 2001/83/EC
Article 100 l
Article 100 l
By [insert specific date five years from the entry into force of amending directive] at the latest, the Commission shall publish a report on the experience acquired in the implementation of this Title after consulting the patient organisations and the members of health care professions and shall also assess the need for a review thereof. The Commission shall submit this report to the European Parliament and to the Council.
Amendment 99 #
2008/0238(COD)
Proposal for a directive
Article 3 – point g
Article 3 – point g
(g) "organ" means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy; and parts of organs, if it is their function to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;
Amendment 161 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 1 a (new)
Article 15 – paragraph 1 a (new)
1 a. Living donations shall be seen as complementary to post-mortem donations and only serve as a last resort where no suitable alternative, such as an organ from a deceased donor, is available. Living donations shall in principle be restricted to donations among close relatives and spouses due to the implicit danger of exploitation.
Amendment 164 #
2008/0238(COD)
Proposal for a directive
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. In order to comply with the principle of non-commercialisation of the human body, Member States shall ensure that possible compensation for living donors is strictly limited to ensuring healthcare insurance for donation-related long-term medical conditions and to making good the expenses relating to the donation, such as travel expenses, child minding costs, loss of earnings or costs of recovery, and prohibiting any financial incentives for a potential donor.
Amendment 60 #
2008/0142(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This Directive respects the fundamental rights and observes the general principles of law as recognised in particular by the Charter of Fundamental Rights of the European Union. The right of access to healthcare and the right to benefit from medical treatment under conditions established by national law and practices are recognised by Article 35 of the Charter of Fundamental Rights of the European Union. Specifically, this Directive has to be implemented and applied with due respect for the rights to private and family life, protection of personal data, equality before the law and the principle of non- discrimination, the fundamental ethical choices of Member States and the right to an effective remedy and to a fair trial, in accordance with the general principles of law, as enshrined in Articles 7, 8, 20, 21, 47 of the Charter.
Amendment 65 #
2008/0142(COD)
Proposal for a directive
Recital 5 a (new)
Recital 5 a (new)
(5a) This Directive respects and does not prejudice the freedom of each Member State to decide what type of healthcare it considers appropriate. No provision of this Directive should be interpreted in such a way as to undermine the fundamental ethical choices of Member States, in particular as regards the protection of the right to life of every human being.
Amendment 87 #
2008/0142(COD)
Proposal for a directive
Recital 11
Recital 11
(11) As recognised by the Member States in the Council Conclusions on Common values and principles in European Union Health Systems there is a set of operating principles that are shared by health systems throughout the Community. These operating principles include quality, safety, care that is based on evidence and ethics, patient involvement, redress, the fundamental right to privacy with respect to the processing of personal data, and confidentiality. Patients, professionals and authorities responsible for health systems must be able to rely on these shared principles being respected and structures provided for their implementation throughout the Community. It is therefore appropriate to require that it is the authorities of the Member State on whose territory the healthcare is provided, who are responsible for ensuring compliance with those operating principles. This is necessary to ensure the confidence of patients in cross-border healthcare, which is itself necessary for achieving patients' mobility and free movement of provision of healthcare in the internal market as well as a high level of health protection. In view of these common values it is nevertheless accepted that Member States take different decisions on ethical grounds as regards the availability of certain treatments and the concrete access conditions. This Directive is without prejudice to ethical diversity. It does not impose on Member States to make treatments and services accessible their territory or to reimburse costs for those treatments (received in another Member State) which are not allowed under national laws, regulations and codes of conduct of the medical professions.
Amendment 385 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Subject to the provisions of this Directive, in particular Articles 7, 8 and 9, the Member State of affiliation shall ensure that insured persons travelling to another Member State with the purpose of receiving healthcare there or seeking to receive healthcare provided in another Member State, will not be prevented from receiving healthcare provided in another Member State where the treatment in question is among the benefits provided for by the legislation, including administrative regulations, guidelines and codes of conduct of the medical professions, of the Member State of affiliation to which the insured person is entitled. The Member State of affiliation shall reimburse the costs to the insured person, which would have been paid for by its statutory social security system had the same or similar healthcare been provided in its territory. Healthcare can only be considered as being similar if it does not contravene the laws, regulations and codes of conduct of the medical professions of the Member State of affiliation. In any event, it is for the Member State of affiliation to determine the healthcare that is paid for regardless of where it is provided.
Amendment 413 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Member State of affiliation may impose on a patient seeking healthcare provided in another Member State, the same conditions, criteria of eligibility and regulatory and administrative formalities including codes of conduct of the medical professions for receiving healthcare and reimbursement of healthcare costs as it would impose if the same or similar healthcare was provided in its territory, in so far as they are neitherot discriminatory nor an obstacle to freedom of movement of persons.
Amendment 416 #
2008/0142(COD)
Proposal for a directive
Article 6 – paragraph 3
Article 6 – paragraph 3
Amendment 112 #
2008/0018(COD)
Proposal for a directive
Article 10 – paragraph 2 – subparagraph 1
Article 10 – paragraph 2 – subparagraph 1
2. The manufacturer shall mark the warnings in an accurate, clearly visible, clearand easily legible mand accurate mannerner, so that they are conspicuously displayed on the toy, on an affixed label or on the consumer packaging and, if appropriate, on the instructions for use which accompany the toy. Small toys that are sold without packaging shall have appropriate warnings affixed to them.
Amendment 115 #
2008/0018(COD)
Proposal for a directive
Article 10 – paragraph 2 – subparagraph 2
Article 10 – paragraph 2 – subparagraph 2
Warnings specifying the minimum and maximum ages for users shall be visible, legible and conspicuously displayed on the packaging of toys and at the point of sale.
Amendment 118 #
2008/0018(COD)
Proposal for a directive
Article 10 – paragraph 2 – subparagraph 2 a (new)
Article 10 – paragraph 2 – subparagraph 2 a (new)
The Commission shall prepare guidelines concerning the way the warnings should be presented. These guidelines shall be drawn up together with the various stakeholders and Member State authorities taking into account developments in scientific and technical knowledge.
Amendment 121 #
2008/0018(COD)
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Member States may require warnings and safety instructions, or some of them, toThe warnings referred to in this article and in Annex V and any safety instructions shall be presented in their own official language or languages of the Member State whenre the toys are placed on the market in their territory.
Amendment 122 #
2008/0018(COD)
Proposal for a directive
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
3a. Notifying authorities shall establish Safety Notification Points at which childcare professionals and consumers may report the non-conformity of toys or accidents related to the use of a toy.
Amendment 125 #
Amendment 129 #
2008/0018(COD)
Proposal for a directive
Article 45 – paragraph 1 a (new)
Article 45 – paragraph 1 a (new)
1a. The Commission shall, where necessary to ensure the health and safety of children, specify, in detail, the essential safety requirements set out in Annex II (e.g. by establishing limit values or other restrictions for certain chemicals other than those listed in points 7 and 8 of Part III of Annex II, limit values for noise, limit values for speed, etc.) and shall establish a list of toys requiring EC type- examination for the purposes of Part II of Annex I. Those specifications shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 46 (2).
Amendment 131 #
2008/0018(COD)
Proposal for a directive
Article 52
Article 52
Member States shall not impede the placing on the market of toys which are in accordance with Directive 88/378/EEC and which were placed on the market before this Directive entered into force or at the latest 23 years after this Directive entered into force.
Amendment 132 #
2008/0018(COD)
Proposal for a directive
Article 54 a (new)
Article 54 a (new)
Article 54a Review The Commission shall review this Directive, based on the evaluations of the relevant Scientific Committee and the opinion of the expert group, every eight years.
Amendment 136 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 3
Annex II – Part III – point 3
3. Without prejudice to the application of the restrictions under the first sentence of point 2, the use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1 and 2 according to Directive 67/548/EEC in individual concentrations equal to or greater than the relevant concentrations established for the classification of preparations containing the substances in accordance with the provisions of Directive 1999/45/EC shall be prohibited, except if the substances are contained in components of toys or micro- structurally distinct parts of toys that are not accessible to any physical contact by children. The use in toys of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) category 3 according to Directive 67/548/EEC in individual concentrations equal to or greater than 0,1% shall be prohibited. At the earliest opportunity, this limit shall be reviewed on the basis of an opinion of the competent scientific committee and a decision as referred to in Article 45(2).
Amendment 147 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 7 – subparagraph 1
Annex II – Part III – point 7 – subparagraph 1
7. Toys shall not contain the following allergenic fragrances: (1) Alanroot (Inula helenium) (2) Allylisothiocyanate (3) Benzyl cyanide (4) 4 tert-Butylphenol (5) Chenopodium oil (6) Cyclamen alcohol (7) Diethyl maleate (8) Dihydrocoumarin (9) 2,4-Dihydroxy-3-methylbenzaldehyde (10) 3,7-Dimethyl-2-octen-1-ol (6,7- Dihydrogeraniol) (11) 4,6-Dimethyl-8-tert-butylcoumarin (12) Dimethyl citraconate (13) 7,11-Dimethyl-4,6,10-dodecatrien-3- one (14) 6,10-Dimethyl-3,5,9-undecatrien-2- one (15) Diphenylamine (16) Ethyl acrylate (17) Fig leaf, fresh and preparations (18) trans-2-Heptenal (19) trans-2-Hexenal diethyl acetal (20) trans-2-Hexenal dimethyl acetal (21) Hydroabietyl alcohol (22) 4-Ethoxy-phenol (23) 6-lsopropyl-2-decahydronaphthalenol (24) 7-Methoxycoumarin (25) 4-Methoxyphenol (26) 4-(p-Methoxyphenyl)-3-butene-2-one (27) 1-(p-Methoxyphenyl)-1-penten-3-one (28) Methyl trans-2-butenoate (29) 6-Methylcoumarin (30) 7-Methylcoumarin (31) 5-Methyl-2,3-hexanedione (32) Costus root oil (Saussurea lappa Clarke) (33) 7-Ethoxy-4-methylcoumarin (34) Hexahydrocoumarin (35) Peru balsam (Myroxylonpereirae Klotzsch) (36) 2-Pentylidene-cyclohexanone (37) 3,6,10-Trimethyl-3,5,9-undecatrien-2- one (38) Verbana oil (Lippia citriodora Kunth) (39) Amyl cinnamal (40) Amylcinnamyl alcohol (41) Anisyl alcohol (42) Benzyl alcohol (43) Benzyl benzoate (44) Benzyl cinnamate (45) Benzyl salicylate (46) Cinnamal (47) Cinnamyl alcohol (48) Citral (49) Citronellol (50) Coumarin (51) Eugenol (52) Farnesol (53) Geraniol (54) Hexyl cinnamaldehyde (55) Hydroxy-citronellal (56) Hydroxy- methylpentylcyclohexenecarboxaldehyde (57) Isoeugenol (58) Lilial (referred to in the Cosmetics Directive in entry 83 as: 2-(4-tert- Butylbenzyl) propionaldehyde (59) d-Limonene (60) Linalool (61) Methyl heptine carbonate (62) 3-methyl-4-(2,6,6-trimethyl-2- cyclohexen-1-yl)-3-buten-2-one (63) Oakmoss extracts (64) Treemoss extracts
Amendment 150 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 7 – subparagraph 3
Annex II – Part III – point 7 – subparagraph 3
Amendment 339 #
2008/0018(COD)
Proposal for a directive
Annex II – Part III – point 7
Annex II – Part III – point 7
7. Toys shall not contain the following allergenic fragrances: (1) Alanroot (Inula helenium) (2) Allylisothiocyanate (3) Benzyl cyanide (4) 4 tert-Butylphenol (5) Chenopodium oil (6) Cyclamen alcohol (7) Diethyl maleate (8) Dihydrocoumarin (9) 2,4-Dihydroxy-3-methylbenzaldehyde (10) 3,7-Dimethyl-2-octen-1-ol (6,7- Dihydrogeraniol) (11) 4,6-Dimethyl-8-tert-butylcoumarin (12) Dimethyl citraconate (13) 7,11-Dimethyl-4,6,10-dodecatrien-3- one (14) 6,10-Dimethyl-3,5,9-undecatrien-2- one (15) Diphenylamine (16) Ethyl acrylate (17) Fig leaf, fresh and preparations (18) trans-2-Heptenal (19) trans-2-Hexenal diethyl acetal (20) trans-2-Hexenal dimethyl acetal (21) Hydroabietyl alcohol (22) 4-Ethoxy-phenol (23) 6-lsopropyl-2-decahydronaphthalenol (24) 7-Methoxycoumarin (25) 4-Methoxyphenol (26) 4-(p-Methoxyphenyl)-3-butene-2-one (27) 1-(p-Methoxyphenyl)-1-penten-3-one (28) Methyl trans-2-butenoate (29) 6-Methylcoumarin (30) 7-Methylcoumarin (31) 5-Methyl-2,3-hexanedione (32) Costus root oil (Saussurea lappa Clarke) (33) 7-Ethoxy-4-methylcoumarin (34) Hexahydrocoumarin (35) Peru balsam (Myroxylonpereirae Klotzsch) (36) 2-Pentylidene-cyclohexanone (37) 3,6,10-Trimethyl-3,5,9-undecatrien-2- one (38) Verbana oil (Lippia citriodora Kunth). (39) Musk ambrette (40) 4-Phenyl-3-buten-2-one (41) Amyl cinnamal (42) Amylcinnamyl alcohol (43) Benzyl alcohol (44) Benzyl salicylate (45) Cinnamyl alcohol (46) Cinnamal (47) Citral (48) Coumarin (49) Eugenol (50) Geraniol (51) Hydroxycitronellal (52) Hydroxymethylpentylcyclohe xenecarboxaldehyde (53) Isoeugenol However, the presence of traces of these substances shall be allowed provided that such presence is technically unavoidable in good manufacturing practice. In addition the following allergenic fragrances shall be listed if added to toys, as such, at concentrations exceeding 0,01 % by weight: (1) Amyl cinnamal (2) Amylcinnamyl alcohol (3) Anisyl alcohol (4) Benzyl alcohol (5nisyl alcohol (2) Benzyl benzoate (63) Benzyl cinnamate (7) Benzyl salicylate (8) Cinnamal (9) Cinnamyl alcohol (10) Citral (11) Citronellol (12) Coumarin (13) Eugenol (14) Farnesol (15) Geraniol (14) Citronellol (5) Farnesol (6) Hexyl cinnamaldehyde (17) Hydroxy-citronellal (18) Hydroxy- methylpentylcyclohexenecarboxaldehyde (19) Isoeugenol (20) Lilial (referred to in the Cosmetics Directive in entry 83 as: 2-(4-tert- Butylbenzyl) propionaldehyde (21Lilial (8) d-Limonene (229) Linalool (2310) Methyl heptine carbonate (24) 11)3-methyl-4-(2,6,6-trimethyl-2- cyclohexen-1-yl)-3-buten-2-one (125) Oakmoss extracts (2613) Treemoss extracts
Amendment 134 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 17
Recital 17
(17) For other sectors covered by the Community scheme, a transitional system should be foreseen for which grants free allocation in 2013 would be 80% of the amount that corresponded to the percentage of the overall Community- wide emissions, throughout the period 2005 to 2007 that those installations emitted as a proportion of the annual Community-wide total quantity of allowances. Thereafter, the free allocation should decrease each year by equal amounts resulting in no free allocation in 2020o the extent feasible, based on sector specific benchmarks.
Amendment 144 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 18
Recital 18
(18) TransitionalIn the absence of an international agreement which provides for equal treatment of the sectors affected, free allocation to installations should be provided for through harmonised Community-wide rules (sector specific "benchmarks") in order to minimise distortions of competition within the Community. These rules should take accountbe based ofn the most greenhouse gas and energy efficient techniques and technologies, and take account of the potential, including the technical potential, to reduce emissions, substitutes, alternative production processes, use of biomass, renewables and greenhouse gas capture and storage and renewables. Any such rules should not give incentives to increase emissions and ensure that an increasing proportion of these allowances is aper unit of productioned. Allocations must be fixed prior to the trading period so as to enable the market to function properly. They shall also avoid undue distortions of competition on the markets for electricity and heat supplied to industrial installations. These rules should apply to new entrants carrying out the same activities as existing installations receiving transitional free allocations. To avoid any distortion of competition within the internal market, no free allocation should be made in respect of the production of electricity by new entrants. Allowances which remain in the set-aside for new entrants in 2020 should be auctioned. In defining the principles for setting benchmarks in individual sectors, the Commission should consult with the sectors concerned.
Amendment 146 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 18
Recital 18
(18) Transitional free allocation to installations should be provided for through harmonised Community-wide rules ("benchmarks") in order to minimise distortions of competition within the Community. These rules should take account of the most greenhouse gas and energy efficient techniques, substitutes, alternative production processes, use of biomass, renewables and greenhouse gas capture and storage. Any such rules should not give incentives to increase emissions and ensure that an increasing proportion of these allowances is auctioned. Allocations must be fixed prior to the trading period so as to enable the market to function properly. They shall also avoid undue distortions of competition on the markets for electricity and heat supplied to industrial installations. They shall further avoid undue distortions of competition between industrial activities carried out in installations operated by a single operator and production in outsourced installations. These rules should apply to new entrants carrying out the same activities as existing installations receiving transitional free allocations. To avoid any distortion of competition within the internal market, no free allocation should be made in respect of the production of electricity by new entrants, which is not the case of electricity recovered from unavoidable waste gases and other residues, and electricity produced in connection with industrial heat consumption for the own consumption of the operators of the installations. Allowances which remain in the set-aside for new entrants in 2020 should be auctioned.
Amendment 177 #
2008/0013(COD)
Proposal for a directive – amending act
Recital 20
Recital 20
(20) The Commission should therefore review the situation by June 2011 at the latest, consult with all relevant social partners, and, in the light of the outcome of the international negotiations, submit a report accompanied by any appropriate proposals. In this context, the Commission should identify whichn analytical report assessing the situation with special regard to energy -intensive industry sectors or sub-sectors are likely to be subject to carbon leakage not later than 30 June 2010. It should base its analysis on the assessment of the inability to pass on the cost of required allowances in product prices without significant loss of market share to installations outside the Community not taking comparable action to reduce emissions. Energy-intensive industries which are determined to be exposed to a significant risk of carbon leakage could receive a higher amount of free allocation orsectors exposed to a significant risk of carbon leakage. This report should be accompanied by any appropriate proposals which may include adjusting the proportion of allowances received free of charge and, as a complementary measure, an effective carbon equalisation system could be introduced, with a view to putting installations from the Community which are at significant risk of carbon leakage and those from third countries on a comparable footing. Such a system could apply requirements to importers that would be no less favourable than those applicable to installations within the EU, for example by requiring the surrender of allowances but also address exports. Any action taken would need to be in conformity with the principles of the UNFCCC, in particular the principle of common but differentiated responsibilities and respective capabilities, taking into account the particular situation of Least Developed Countries. It would also need to be in conformity with the international obligations of the Community including the WTO agreement.
Amendment 389 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 3
Article 10a – paragraph 1 – subparagraph 3
The measures referred to in the first subparagraph shall, to the extent feasible, establish harmonised sector specific benchmarks to ensure that allocation takes place in a manner that gives incentives for greenhouse gas and energy efficient techniques and for reductions in emissions, by taking. They shall be based on the most efficient techniques and technologies, and take into account of the most efficient techniquepotential, including the technical potential, to reduce emissions, substitutes, alternative production processes, and the use of biomass and greenhouse gas capture and storage, and. The measures shall not give incentives to increase emissions per unit of production. No free allocation shall be made in respect of any electricity production. In defining the principles for setting benchmarks in individual sectors, the Commission shall consult with the sectors concerned.
Amendment 400 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 3
Article 10a – paragraph 1 – subparagraph 3
The measures referred to in the first subparagraph shall, to the extent feasible, ensure that allocation takes place in a manner that gives incentives for greenhouse gas and energy efficient techniques and for reductions in emissions, by taking account of the most efficient techniques, substitutes, alternative production processes, use of biomass and greenhouse gas capture and storage, and shall not give incentives to increase emissions. No free allocation shall be made in respect of any electricity production, except for electricity produced in connection with industrial heat consumption or produced from residues from an industrial process provided that it is for the own consumption of the operators of the installations; such allocations shall be made under the same allocation principles as applied to that industrial activity as mentioned in Annex I. However, where a waste gas from a production process is used as a fuel, all allowances shall be allocated for free to the operator of the installation generating the waste gas according to the same allocation principles as applied for that installation.
Amendment 492 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 6 – subparagraph 3
Article 10a – paragraph 6 – subparagraph 3
No free allocation shall be made in respect of any electricity production by new entrants, except for electricity produced in connection with industrial heat consumption or produced from residues from an industrial process provided that it is for the own consumption of the operators of the installations; such allocations shall be made under the same allocation principles as applied to that industrial activity as mentioned in Annex I. However, where a waste gas from a production process is used as a fuel, all allowances shall be allocated for free to the operator of the installation generating the waste gas with the same allocation principles as applied for that installation.
Amendment 509 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 7
Article 10a – paragraph 7
7. SUntil an international agreement enters into force and subject to Articles 10b and 28, the amount of allowances allocated free of charge under paragraphs 3 to 6 of this Article [and paragraph 2 of Article 3c] in 2013to installations not covered by paragraph 2 in 2013 and each subsequent year shall be 8100% of the quantity determined in accordance with the measures referred to in paragraph 1 and thereafter the free allocation shall decrease each year by equal amounts resulting in no free allocation in 2020without changing the total quantity of allowances according to Article 9.
Amendment 524 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 – point 8
Article 1 – point 8
Directive 2003/87/EC
Article 10a – paragraph 8
Article 10a – paragraph 8
Amendment 540 #
2008/0013(COD)
Proposal for a regulation – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2003/87/EC
Article 10a - paragraph 9
Article 10a - paragraph 9
Amendment 587 #
2008/0013(COD)
Proposal for a directive – amending act
Article 1 - point 8
Article 1 - point 8
Directive 2003/87/EC
Article 10b
Article 10b
1. Not later than June 2011 and thereafter every five years, the Commission shall, in the light of the outcome of the international negotiations and the extent to which these lead to global greenhouse gas emission reductions, whilst providing for equal treatment of competing industries and after consulting with all relevant social partners, submit to the European Parliament and to the Council an analytical report assessing the situation with special regard to energy-intensive sectors or sub- sectors that have beeno determined to beheir exposured to significant risks of carbon leakage. This shall be accompanied by any appropriate proposals, which may include: - adjusting the proportion of allowances received free of charge by those sectors or sub-sectors under Article 10a; - inclusion in the Community scheme of importers of products produced by the sectors or sub-sectors determined in accordance with Article 10a. Any binding sectoral agreements which lead to global emissions reductions of the magnitude required to effectively address climate change, and which are monitorable, verifiable and subject to mandatory enforcement arrangements shall also be taken into account when considering what measures are appropriate. according to paragraph 3. 2. The analytical report referred to in paragraph 1 shall be accompanied by any appropriate proposals, which take into consideration the timeframe until full implementation and shall include: - adjusting the proportion of allowances received free of charge by those sectors or sub-sectors under Article 10a; - for leakage effects not covered by other measures carbon equalisation systems for exporters and importers of products produced by the sectors covered by Article 10a. Such systems shall not reduce liquidity of the allowance market. Any binding sectoral agreements which provide for equal treatment of competing industries and which are monitorable, verifiable and subject to mandatory enforcement arrangements shall also be taken into account when considering what measures are appropriate. 3. In the determination referred to in paragraph 1, the Commission shall take into account the extent to which it is possible for the sector or sub-sector concerned to pass on the cost of the required allowances in product prices without significant loss of market share to installations operating in countries outside the Community that did not impose equivalent and verifiable constraints on emissions, taking into account the following: (a) the extent to which auctioning would lead to a substantial increase in production cost; (b) the extent to which it is possible for individual installations in the sector concerned to reduce emission levels for instance on the basis of the most efficient techniques; (c) market structure, relevant geographic and product market, the exposure of the sectors to international competition; (d) the effect of climate change and energy policies implemented, or expected to be implemented outside the EU in the sectors concerned; (e) the effect of passing through CO2 costs in electricity prices in the sector or sub- sector concerned. For the purposes of evaluating whether the cost increase resulting from the Community scheme can be passed on, estimates of lost sales resulting from the increased carbon price or the impact on the profitability of the installations concerned may inter alia be used. That measure, designed to amend non- essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article [23(3)].
Amendment 323 #
2007/2285(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission to promote best medical practices as well as information campaigns on obesity-related risks and abdominal obesity in particular; urges the Commission to provide infexplormation about the dangers of home diets, especially if they involve the use of anti-obesity drugs taken without medical prescriptionof the potential role of clinically proven weight loss medication to complement, where appropriate, healthy diets and exercise;
Amendment 39 #
2007/0297(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Manufacturers' compliance with the targets under this Regulation should be assessed at the Community level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium in respect of each calendar year from 2012 onwards. The premium should be modulated as a function of the extent to which manufacturers fail to comply with their target. It should increase over time. In order to provide a sufficient incentive to take measures to reduce specific emissions of CO2 from passenger cars, the premium should reflect technological costs. The amounts of the excess emissions premium should be considered as revenue for the budget of the European Unionbut at the same time to ensure that the penalty is proportional by comparison with other sectors' CO2 emissions and consistent with other CO2-reduction instruments, the level of the premium should be based on the amount to be paid under the European emissions trading system.
Amendment 67 #
2007/0297(COD)
Proposal for a regulation
Article 1
Article 1
This Regulation establishes CO2 emission performance requirements for new passenger cars in order to ensure proper functioning of the internal market and achieve the EU's overall objective that the average new car fleet should achieve CO2 emissions of 120 g CO2/km. The Regulation sets the average CO2 emissions for new passenger cars at 130 g CO2/km by means of improvement in vehicle motor technology as measured in accordance with Regulation (EC) No 715/2007 and its implementing measures. This Regulation will be complemented by additional measures corresponding to 10 g/km as part of the Community's integrated approach. intended to achieve a further reduction of 10 g/km as part of the Community's integrated approach. In 2014, on the basis of a stock-taking exercise and a legislative impact assessment, the Commission shall propose medium- and long-term targets for newly- registered vehicles as from 2020 and submit them to the Council and Parliament for a decision. At the same time, the Commission shall submit a proposal for a comprehensive approach to identifying all measures to reduce CO2 emissions, with the aim of removing the distinction between engine-/vehicle- related and additional measures and eco- innovations. A target shall be set for 2020 which guarantees, through the aggregate impact of all relevant measures, a reduction in average CO2 emissions of at least 20% by comparison with 2008. In that connection, the Commission shall take account of the possible incorporation of road transport into the European emissions trading system, as proposed in the context of the revision of that trading system. As the basis for this proposal, a comprehensive assessment of the implications for the automobile industry and for upstream sectors shall be drawn up. This shall include a cost-benefit analysis, in the light of all relevant technological innovations designed to reduce CO2 emissions, covering all segments of the car market. When a long-term target is set, due account shall be taken of developments relating to international climate protection agreements.
Amendment 93 #
2007/0297(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point f a (new)
Article 3 – paragraph 1 – point f a (new)
(fa) ‘eco-innovation’ means any technological innovation which, regardless of driver behaviour, delivers a proven, quantifiable contribution to reducing CO2 emissions and which is not included or insufficiently taken into account in the new European testing cycle (Regulation (EC) No 715/2007) and is not covered by the additional measures referred to in Article 1.
Amendment 112 #
2007/0297(COD)
Proposal for a regulation
Article 4
Article 4
For the calendar year commencing 1 January 2012 and each subsequent calendar year, each manufacturer of passenger cars shall ensure that itn 2012 25%, in 2013 50%, in 2014 75% and in 2015 and each subsequent calendar year 100% of the fleet’s average specific emissions of CO2 do not exceed itsthe specific emissions target for a manufacturer's fleet determined in accordance with Annex I or, where a manufacturer is granted a derogation under Article 9, in accordance with that derogation.
Amendment 125 #
2007/0297(COD)
Proposal for a regulation
Article 4 – subparagraph 1 a (new)
Article 4 – subparagraph 1 a (new)
For manufacturers which produce cars with specific CO2 emissions which are 20%, 30%, 40% and 50% lower than the target set in Annex I, when average specific CO2 emissions are calculated every new vehicle registered over the period to 2015 inclusive shall be counted as two, three, four or five, in keeping with the percentage by which emissions fall below the set target.
Amendment 138 #
2007/0297(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. For the year beginning 1 January 20102 and each subsequent year, each Member State shall record information for each new passenger car registered in its territory in accordance with Part A of Annex II.
Amendment 169 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The excess emissions premium pursuant to Article 1 shall be: (a) in relation to excess emissions in the calendar year 2012, 20 eurosEUR 10; (b) in relation to excess emissions in the calendar year 2013, 35 eurosEUR 20; (c) in relation to excess emissions in the calendar year 2014, 60 euros; andEUR 30; (d) in relation to excess emissions in the calendar year 2015 and subsequent calendar years, 95 eurosEUR 40.
Amendment 182 #
2007/0297(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. The amounts of the excess emissions premium shall be considerpaid into a fund which must be used asto revenue for the budget of the European Unionduce CO2 emissions in the road transport sector and for research into new, energy-efficient technologies.
Amendment 202 #
2007/0297(COD)
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Amendment 225 #
2007/0297(COD)
Proposal for a regulation
Article 11
Article 11