13 Amendments of Maria HEUBUCH related to 2016/2096(INI)
Amendment 1 #
Draft opinion
Paragraph -1 (new)
Paragraph -1 (new)
-1. Stresses that the achievement of the right to health for all prevails over the protection of intellectual property rights and depends i.e. on investment in global health research, including health technologies and drugs for poverty-related and neglected diseases (PRNDs);
Amendment 2 #
Draft opinion
Paragraph -1 a (new)
Paragraph -1 a (new)
-1a. Recalls that PRNDs affect more than one billion people, claim millions of lives every year and are primarily endemic in developing countries; notes that tools to prevent, diagnose and treat PRNDs are often still lacking or unsuitable to the conditions of individuals and communities in developing countries;
Amendment 3 #
Draft opinion
Paragraph -1 b (new)
Paragraph -1 b (new)
-1b. Recalls that EDCTP2 shall contribute to the reduction of the social and economic burden of poverty-related diseases in developing countries, in particular in sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, appropriate and affordable medical interventions for poverty-related diseases, in partnership with sub-Saharan Africa;
Amendment 4 #
Draft opinion
Paragraph 1
Paragraph 1
1. Notes with concern that gender discrimination and inequalities occur in health and social care research in developing countries, thereby affecting the development of appropriate and targeted treatments; in particular, points out that patients in developing countries are inadequately represented in pharmacology research; notes that special populations, including children and pregnant women, have been neglected in tuberculosis drug development; stresses the need to collect and store samples for pharmacogenetic study in future clinical trials, based on gender;
Amendment 6 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Recalls that infectious disease (e.g. HIV infection, malaria and anaemia) and adverse pregnancy outcome (e.g. stillbirth) are highest in LMIC; calls for including pregnant women in clinical trials as a way to reduce morbidity and mortality in mothers and infants;
Amendment 7 #
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Recalls that according to WHO, while "mental disorders" denote a range of mental and behavioural disorders, such as depression, bipolar affective disorder, schizophrenia, anxiety disorders, dementia, autism, " mental health" is conceptualised as a state of well-being in which the individual realises his or her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community; welcomes the fact that for the first time, world leaders are recognising the promotion of mental health and well- being, and the prevention of treatment of substance abuse, as health priorities within the global development agenda;
Amendment 8 #
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Recalls that mental health is heavily gendered; stresses that gender inequality, income disparities, women's greater exposure to poverty and overwork, socio-economic discrimination, gender- based violence, including violation of their sexual and reproductive rights, expose them further to mental health disorders of depression and anxiety;
Amendment 10 #
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Highlights that the World Health Organisation (WHO) reports no significant difference between gender for severe mental disorders such as schizophrenia and bipolar disorder, while high gender difference prevails for depression and anxiety;
Amendment 24 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Notes that while 26 PRNDs contributed to 14% of the global disease burden, they received only 1.4% of global health-related R&D expenditure[1]; [1] Research and development expenditure for poverty-related and neglected diseases: an analysis of economic and epidemiological data. The Lancet, 2013 ;
Amendment 25 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls on the EU to promote effective and fair financing of research that benefits the health of all and ensures that innovations and interventions lead to affordable and accessible solutions. In particular, models that dissociate costs of R&D and the prices of medicines should be explored including the opportunities for technology transfer to developing countries;
Amendment 26 #
Draft opinion
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Notes that the past 20 years have seen a considerable shift in the location of industry-sponsored clinical drug trials; these tests being increasingly carried out in low- and middle-income countries, where it is easier to find subjects; less expensive to conduct clinical trials, and where regulatory constraints are either less stringent or less actively monitored;
Amendment 34 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Urges the EU regulatory authorities to ascertain that the same standards regarding clinical trials are complied both within and outside their jurisdictions before granting drug market authorisation;
Amendment 35 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls on developing countries to develop a robust legislative framework with a functional independent control system that comply with World Health Organisation (WHO) Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products and the Declaration of Helsinki (DoH) of the World Medical Association (WMA);