11 Amendments of Pernille WEISS related to 2022/0216(COD)
Amendment 154 #
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 256 #
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 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 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 sectthe provision of SoHO services accor dinvolvement in the provision of SoHO serviceg to their own model of supply of SoHOs, in particular for critical SoHOs and the related research and development.
Amendment 282 #
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. The online platform could be further used for the sharing of best practice between Member States with regard to initatives, such as campaigns, to support the supply of SoHOs.
Amendment 295 #
Proposal for a regulation
Recital 44 a (new)
Recital 44 a (new)
(44 a) Highlights that anonymous donations of eggs, sperm or embryos for the purpose of medically assisted reproduction carries risks to the children born from this. Risks entail insufficient access to information about medical history, as available medical data of the donor may evolve after the time of donation, as well as a breach of the right of the children to information fundamental for their identity. Encourages Member States and the Commission to conduct further studies on this issue, as well as to consider possible measures to ban the practice of anonymous donations of eggs, sperm or embryos for the purpose of medically assisted reproduction. Recalls in this regard that several Member States have already banned the practice of anonymous donation.
Amendment 633 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for losses related to their participation in donations through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit that ensures that allowances are financially neutral and consistent with the standards laid down in this Article. They may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation. In this regard, the Commission shall support the exchange of best practice between Member States.
Amendment 744 #
Proposal for a regulation
Article 62 – paragraph 1
Article 62 – paragraph 1
1. Member States, in collaboration with National SoHO Authorities, shall draw up national SoHO emergency plans setting out measures to be applied without undue delay when the supply situation for critical SoHOs presents or is likely to present a serious risk to human health. In this regard, the Commission shall support the exchange of best practice between Member States.
Amendment 755 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. Member States shall make all reasonable efforts to promote public participation in SoHO donation activities, in particular for critical SoHOs, with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected. In so doing, they shall encourage the collection of SoHO with a strong public and non- profit sector involvementthe involvement of all relevant stakeholders.
Amendment 760 #
Proposal for a regulation
Article 62 – paragraph 2 a (new)
Article 62 – paragraph 2 a (new)
2 a. Member States, in collaboration with National SoHO Authorities, shall draw up national SoHO plans setting out measures to support the open strategic autonomy for supply of critical SoHOs, in the context of resilient global supply chains. In this regard, the Commission shall support the exchange of best practice between Member States.
Amendment 772 #
Proposal for a regulation
Article 62 – paragraph 3 – point f a (new)
Article 62 – paragraph 3 – point f a (new)
(f a) a strategy for communication to and with citizens and national authorities.
Amendment 777 #
Proposal for a regulation
Article 62 – paragraph 6
Article 62 – paragraph 6
6. Member States shall review regularlyat least on an annual basis review their national SoHO emergency plans to take into account changes in the organisation of competent authorities and experience gained from implementing the plans and simulation exercises.
Amendment 804 #
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts and observshall, where relevant, invite experts and other relevant stakeholders to attend its meetings, and mayto cooperate with other external experts as appropriateon aspects of its work. Such stakeholders may include actors of the public and private sector, patients, health professionals, and researchers. Other Union institutions, bodies, offices and agencies shall have an observer role.