5 Amendments of Eric ANDRIEU related to 2022/0216(COD)
Amendment 242 #
(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 and the Union 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 tethical SoHOs of high quality and safety, including plasma used as the starting material for manufacturing of plasma- derived medicinal products. These measures support European self- sufficiency, based on the broadest possible donor base, with a view to ensuring a more resilient supply system. Member States and the Union should also 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 258 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) The COVID-19 pandemic has had adverse effects on the resilience of the donor base in some countries, whose collection systems rely on a small number of donors donating more frequently than elsewhere. These adverse effects are particularly evident in plasma collections and imports. Member States are urged to develop non-profit and public plasmapheresis programs in order to increase their collection capacity. This will make the donor base more resilient by expanding it as far as possible and, as a result, it will ensure the continuity of supply, including in times of crisis.
Amendment 265 #
Proposal for a regulation
Recital 37 b (new)
Recital 37 b (new)
(37 b) The loss of European sovereignty in the area of public health was thrown into sharp relief during the COVID-19 crisis. In this context, the initiatives for a strong Europe of Health should work in favour of European self-sufficiency, in particular as regards the supply of SoHOs and the ability to minimise the risk of shortages, especially of SoHOs for therapeutic use. Following the publication of the strategy for the promotion of European ethical SoHO supply self- sufficiency, Member States should adopt national priority action programmes for donor recruitment via voluntary unpaid donation.
Amendment 659 #
Proposal for a regulation
Article 55 – paragraph 3 – point e
Article 55 – paragraph 3 – point e
(e) the purpose of the analytical tests that will be performed in course of the donor health evaluation;
Amendment 782 #
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)