4 Amendments of Jessica POLFJÄRD related to 2022/0216(COD)
Amendment 228 #
Proposal for a regulation
Recital 34
Recital 34
(34) Where evidence demonstrates that specific processing steps reduce or eliminate the risk of transmission of specific infectious or non-infectious disease agents, the quality and safety standards for the verification of donor eligibility by means of donor health evaluations, including testing, and the related guidelines for their implementation, should take this evidence into account. Thus, in the case of, for example, plasma for fractionation, that in a subsequent step in the manufacturing process of medicinal products undergoes sterilisation steps, certain donor eligibility criteria used for donation of plasma for transfusion might not be necessary nor appropriate. Some Member States and SoHO entitites have introduced screening criteria that have been perceived to constiute discimination, notably against men who have sex with men. It is appropriate to lay down that such criteria to shall be science-based to avoid the perception that health systems engage in discrimination.
Amendment 245 #
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to ensuring the broadest possible doner base and to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability and equal access of SoHOs for medical treatments, Member States should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Union. Member States are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 700 #
Proposal for a regulation
Article 58 – paragraph 2 a (new)
Article 58 – paragraph 2 a (new)
2 a. Such measures shall not directly or indirectly be construed to constitute discrimination between donors on any of the grounds of discrimination recognised by Article 21 of the Charter of Fundamental Rights, notably discrimination based on sexual orientation. Member States shall report any restrictions that SoHO entities impose that can reasonably be seen to constitute such discrimination and provide a summary of the scientific evidence used to justify these measures to protect donors or offspring.
Amendment 735 #
Proposal for a regulation
Article 58 – paragraph 14 – subparagraph 2 – point b a (new)
Article 58 – paragraph 14 – subparagraph 2 – point b a (new)
(b a) in the case of medically assisted reproduction with third party donation, the applicable rules to protect the data of the donor in the Member State and if the donation was made outside the Member State, the applicable rules in that jurisdiction.