3 Amendments of Sirpa PIETIKÄINEN related to 2022/0216(COD)
Amendment 153 #
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. This Regulation should therefore include principles and technical rules to monitor and protect donors. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a need for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and plasma should be considered to imply a significant risk.
Amendment 486 #
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4 a. Member States shall designate their SoHO National Authorities to create a national plasma strategy, in order to increase their collection capacity and the security of the collection and patients, as well as ensuring the sufficient training and know-how of staff working on SoHO;
Amendment 625 #
Proposal for a regulation
Article 53 – paragraph 1 – point k
Article 53 – paragraph 1 – point k
(k) develop and implement a plan for monitoring the donor’s health after the donation in cases where the SoHO donations imply a significant risk to a donor as referred to in paragraph 3;