18 Amendments of Elisabetta GARDINI related to 2011/0401(COD)
Amendment 51 #
Proposal for a regulation
Recital 25
Recital 25
(25) The European Commission does noStem cell therapies have been shown to be effective in certain fields, especially in regenerative medicine. The Union should, therefore, continue to support such research. However, the European Commission acknowledges the ethical concerns raised by research on human embryonic stem cells, for which reason it explicitly does not solicit the use of human embryonic stem cells. The use of adult human stem cells, be they adult or embryonicwith particular reference to cord blood stem cells and induced pluripotent stem cells, if any, depends on the judgement of the scientists in view of the objectives they want to achieve and is subject 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 forbidden.
Amendment 131 #
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Research on human stem cells, both adult and embryonic,activities aiming at developing and improving therapies based on adult human stem cells will be supported. Funding for research on adult human stem cells may be fingrancted, depending both on the contents of the scientific proposal and the legal framework of the Member States involved. In particular, research on stem cells from umbilical cord blood and induced pluripotent stem cells will be supported. 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 313 #
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. Research activities should also respect the legislative or administrative provisions and customs of Member States. All activities should be carried out ensuring a high level of human health protection in accordance with Article 168 TFEU.
Amendment 319 #
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 achieve and isre are considerable differences between national legislations on research using human embryos and human embryonic stem cells. Union policy should not seek to harmonise national legislation. In connection with the Seventh Framework Programme, the Commission stated that it would 'continue with the current practice and [would] not 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 include research activities which destroy human embryos, including for the procurement of stem cells'1. It is desirable to insert this commitment into this Regulation in order to ensure legal certainty. __________________ 1 Point 12 of the Commission statement re 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 (2007-2013), OJ L 412, 30.12.2006, p. 1.
Amendment 327 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) The European Court of Justice has ruled, in case C- 34/101, that Union law precludes human embryonic stem cells from being patented. This Court judgment does not affect national legislation on this kind of research or funding by Member State budgets. However, the judgment has effects for Union law. This Regulation could conceivably be challenged at the European Court of Justice if it did not exclude funding for research using human embryonic stem cells. It is therefore advisable to exclude this kind of research from Union funding, leaving the matter to national research budgets. __________________ 1 Case C-34/10, Judgment of the Court (Grand Chamber) of 18 October 2011, Oliver Brüstle v Greenpeace eV, not yet published.
Amendment 335 #
Proposal for a regulation
Recital 25 b (new)
Recital 25 b (new)
(25b) The Union should encourage scientists whose research is funded by the Union budget to patent their inventions in Europe. As human embryonic stem cells are not patentable, this type of research should be excluded from Union funding and funded exclusively by national budgets.
Amendment 498 #
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 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 537 #
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1
Article 16 – paragraph 1 – subparagraph 1
All the research and innovation activities carried out under Horizon 2020 shall comply with ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols. , the Helsinki Declaration, the Convention of the Council of Europe on Human Rights and Biomedicine signed in Oviedo on 4 April 1997 and its Additional Protocols, the European Convention on Human Rights and its Supplementary Protocols, the UN resolution on human cloning of March 2005, the UN Convention on the Rights of the Child, the Universal Declaration on the human genome and human rights adopted by the UNESCO, the UN Biological and Toxin Weapons Convention (BTWC), the International Treaty on Plant Genetic Resources for Food and Agriculture and the relevant World Health Organisation's resolutions. Those carrying out or participating in research projects concerning ethical sensitive issues like for example DNA, analysis on humans, research on persons not able to give informed consent, research linked to the suffering of vertebrate animals etc. shall seek the approval of the relevant national or local ethics committee prior to the start of the activities. An ethical review will also be implemented systematically by the Commission. In specific cases an ethical review may take place during the implementation of a project. On a yearly basis, the Commission shall inform the European Parliament about their activities in this area, and in addition to this, it shall provide the European Parliament and the Council, with information upon request. During the implementation of this programme, scientific advances and national and international provisions shall be regularly monitored by the Commission so as to take account of any developments.
Amendment 563 #
Proposal for a regulation
Article 16 – paragraph 3 – point c a (new)
Article 16 – paragraph 3 – point c a (new)
(c a) research which involves the destruction of human embryos;
Amendment 571 #
Proposal for a regulation
Article 16 – paragraph 3 – point c b (new)
Article 16 – paragraph 3 – point c b (new)
(c b) research using human embryonic stem cells;
Amendment 583 #
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 1138 #
Proposal for a regulation
Annex 1 – Part 2 – point 1 – point 1.4 – point 1.4.3 – point c – paragraph 1
Annex 1 – Part 2 – point 1 – point 1.4 – point 1.4.3 – point c – paragraph 1
Development of platform technologies (e.g. genomics, meta-genomics, proteomics, molecular tools) to enhance leadership and competitive advantage in a wide number of economic sectors. Diagnostic tools will be supported if there is a link to therapy.
Amendment 1142 #
Proposal for a regulation
Annex 1 – Part 2 – point 1 – point 1.4 – point 1.4.3 – point c a (new)
Annex 1 – Part 2 – point 1 – point 1.4 – point 1.4.3 – point c a (new)
(c a) Developing the societal dimension of biotechnology. Focusing on governance of biotechnology for societal benefits including ethical limits.
Amendment 1293 #
Proposal for a regulation
Annex 1 – Part 3 – point 1 – point 1.1 – paragraph 5 – subparagraph 1 (new)
Annex 1 – Part 3 – point 1 – point 1.1 – paragraph 5 – subparagraph 1 (new)
Rare diseases remain major challenge to the EU and the member states. There are 6000 to 8000 rare diseases affecting approx. 30 Million people across Europe. An effective treatment can only be developed if member states cooperate because the cases in any given member state are not enough to do effective research.
Amendment 1295 #
Proposal for a regulation
Annex 1 – Part 3 – point 1 – point 1.1 – paragraph 5 a (new)
Annex 1 – Part 3 – point 1 – point 1.1 – paragraph 5 a (new)
Diseases in children, including premature born children. Health of children is a core priority for the European Union. Similar to rare diseases effective research and treatment can only be developed in a common European effort.
Amendment 1356 #
Proposal for a regulation
Annex 1 – Part 3 – point 1 – point 1.3 – paragraph 5
Annex 1 – Part 3 – point 1 – point 1.3 – paragraph 5
Specific activities shall include: understanding the determinants of health (including environmental and climate related factors), improving health promotion and disease prevention; understanding disease and improving diagnosis; developing effective screening programmes and improving the assessment of disease susceptibility; improving surveillance and preparedness; developing better preventive vaccines; using in-silico medicine for improving disease management and prediction; treating disease; transferring knowledge to clinical practice and scalable innovation actions; better use of health data; active ageing, independent and assisted living; improving palliative medicine, individual empowerment for self-management of health; promotion of integrated care; improving scientific tools and methods to support policy making and regulatory needs; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice, and innovative technologies and approaches.
Amendment 1357 #
Proposal for a regulation
Annex 1 – Part 3 – point 1 – point 1.3 – paragraph 5
Annex 1 – Part 3 – point 1 – point 1.3 – paragraph 5
Specific activities shall include: understanding the determinants of health (including environmental and climate related factors), improving health promotion and disease prevention; understanding disease and improving diagnosis; developing effective screening programmes and improving the assessment of disease susceptibility; improving surveillance and preparedness; developing better preventive vaccines; using in-silico medicine for improving disease management and prediction; treating disease; transferring knowledge to clinical practice and scalable innovation actions; better use of health data; active ageing, independent and assisted living; addressing infertility disorders; individual empowerment for self-management of health; promotion of integrated care; improving scientific tools and methods to support policy making and regulatory needs; and optimising the efficiency and effectiveness of healthcare systems and reducing inequalities by evidence based decision making and dissemination of best practice, and innovative technologies and approaches.
Amendment 1714 #
Proposal for a regulation
Annex 1 – Part 3 – point 6.3 – point 6.3.2 – paragraph 1 a (new)
Annex 1 – Part 3 – point 6.3 – point 6.3.2 – paragraph 1 a (new)