6 Amendments of Åsa WESTLUND related to 2008/0260(COD)
Amendment 31 #
Proposal for a directive – amending act
Recital 5 a (new)
Recital 5 a (new)
(5a) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem and an emerging public health concern. Actions to reduce the potentially harmful impacts on the European environment especially on surface water, groundwater and drinking water and public health are needed. Therefore, measures should also be taken to monitor the adverse environmental effects of medicinal products on public health or the environment. This must not lead to the withdrawal of the authorisation for drugs necessary for treating life-threatening or serious diseases.
Amendment 32 #
Proposal for a directive – amending act
Recital 5 a (new)
Recital 5 a (new)
(5a) Research must be promoted to develop more targeted drugs to avoid side effects for patients and address environmental effects.
Amendment 85 #
Proposal for a directive – amending act
Article 1 – point 1 – point b a (new)
Article 1 – point 1 – point b a (new)
Directive 2001/83/EC
Article 1 – point 14 a (new)
Article 1 – point 14 a (new)
(ba) The following point is inserted: “(14a) Adverse environmental effect: This includes noxious effect on public health or the environment, especially in surface water, groundwater and drinking water related to the environmental appearance of pharmaceuticals or their degradation products, or mixtures of pharmaceuticals and their degradation products.”
Amendment 90 #
Proposal for a directive – amending act
Article 1 – point 1 – point (c a) (new)
Article 1 – point 1 – point (c a) (new)
Directive 2001/83/EC
Article 1 – point 28 a (new)
Article 1 – point 28 a (new)
(ca) point 28a is replaced by the following: “(28a) Risk-benefit balance: An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks defined in point 28 […].”
Amendment 102 #
Proposal for a directive – amending act
Article 1 – point 2 – point -a (new)
Article 1 – point 2 – point -a (new)
Directive 2001/83/EC
Article 8 – paragraph 3 – point (i)
Article 8 – paragraph 3 – point (i)
(-a) a new indent ) is inserted after the second indent in point (i): “– ecotoxicological tests,”
Amendment 264 #
Proposal for a directive – amending act
Article 1 – point 24 a (new)
Article 1 – point 24 a (new)
Directive 2001/83/EC
Article 119 a (new)
Article 119 a (new)