17 Amendments of Peter LIESE related to 2011/0401(COD)
Amendment 54 #
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 is subject to stringent Ethics Review. No project involving the useStem cell therapies have shown their added value in some cases, especially regenerative medicine. In particular stem cell from the umbilical cord and adult stem cells are already led to established treatment. Therefore the Union should continue to support such research. Priority should be given to explore existing or future alternatives to research ofn 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, in particular, stem cells from the umbilical cord, induced pluripotent stem cells and adult stem cells.
Amendment 133 #
Proposal for a regulation
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Research on 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 forbiddenactivities aiming at developing and improving therapies based on human stem cells will be supported. In particular, research on stem cells from the umbilical cord, induced pluripotent stem cells and adult stem cells as any potential future alternatives to embryonic stem cells will be supported.
Amendment 208 #
Proposal for a regulation
Annex I – part II – point 1.4.3. – point c – paragraph 1
Annex I – part II – 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 243 #
Proposal for a regulation
Annex I – part III – point 1.1 – paragraph 3
Annex I – part III – point 1.1 – paragraph 3
Chronic conditions such as cardiovascular disease (CVD), cancer, diabetes, neurological and mental health disorders, overweight and obesity, infertility disorders and various functional limitations are major causes of disability, ill-health and premature death, and present considerable social and economic costs.
Amendment 251 #
Proposal for a regulation
Annex I – part III – point 1.1 – paragraph 4
Annex I – part III – point 1.1 – paragraph 4
In the Union, CVD annually accounts for more than 2 million deaths and costs the economy more than EUR 192 billion while cancer accounts for a quarter of all deaths and is the number one cause of death in people aged 45-64. Over 27 million people in the Union suffer from diabetes and the total cost of brain disorders (including, but not limited to those affecting mental health) has been estimated at EUR 800 billion. Environmental, life-style and socio-economic factors are relevant in several of these conditions with up to one third of the global disease burden estimated to be related to these. However, for other conditions – in particular neurodegenerative diseases – effective prevention strategies will first require a considerable boost in research into their causes and the development of better early diagnosis and treatment options.
Amendment 253 #
Proposal for a regulation
Annex I – part III – point 1.1 – paragraph 4 a (new)
Annex I – part III – point 1.1 – paragraph 4 a (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 255 #
Proposal for a regulation
Annex I – part III – point 1.1 – paragraph 4 a (new)
Annex I – part III – point 1.1 – paragraph 4 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 296 #
Proposal for a regulation
Annex I – part III – point 1.3 – paragraph 5
Annex I – part III – 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 298 #
Proposal for a regulation
Annex I – part III – point 1.3 – paragraph 5
Annex I – part III – 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 especially linked to potential therapy or prevention; 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; 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 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 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)