10 Amendments of Stanislav POLČÁK related to 2022/0216(COD)
Amendment 177 #
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, programmes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Voluntary and unpaid SoHO donation is also a factor which can contribute to high safety standards for SoHOs and therefore to the protection of human health. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be necessary to ensure that donors are not financially disadvantaged by their donation. Thus, compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed, posing risks to their own health and to that of prospective recipients. Such compensation should, therefore, be set by national authorities, at a level appropriate in their Member State to reach such objectives. _________________ 24 Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (March 2018). Available at https://rm.coe.int/guide-financial- gain/16807bfc9a.
Amendment 253 #
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 sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 449 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of any lossexpenses and inconveniences associated with donation;
Amendment 457 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70 a) ‘risk-based approach’ shall mean one that uses techniques to determine the areas of risk where ‘risk’ is identified as the probability of an event occurring that will have an impact on the achievement of objectives, taking into account the severity of its outcome and/or the likelihood of non-detection by other methods.
Amendment 484 #
Proposal for a regulation
Article 5 – paragraph 3 – point c
Article 5 – paragraph 3 – point c
(c) have sufficient resources, operational capacity, and subject matter expertise to achieve the aims of, and fulfil their obligations under, this Regulation;
Amendment 560 #
Proposal for a regulation
Article 29 – paragraph 11
Article 29 – paragraph 11
11. The interval between two on-site inspections shall be decided based on the necessary frequency to mitigate any identified risks and shall not exceed 4 years.
Amendment 641 #
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 partimaking good any expenses and inconveniences associpation ined with their 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.
Amendment 752 #
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 SoHOs with a strong public and non- profit sector involvementthe involvement of all relevant stakeholders.
Amendment 762 #
Proposal for a regulation
Article 62 – paragraph 2 a (new)
Article 62 – paragraph 2 a (new)
2 a. Member States shall also establish national plans to increase sufficiency for critical SoHOs in the Union. The European Commission shall provide guidance and support, such as promoting the exchange of best practices and relevant evidence and experience, across Member States.
Amendment 798 #
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 observers to attend its meetings, and may cooperate with other external experts as appropriateshall, in agreement with the Commission, invite representatives of the industry, including both the public and private sector, as well as consumers, patients and health professionals, to participate in certain aspects of the Board’s work, under conditions determined beforehand by the Board. Other Union institutions, bodies, offices and agencies shall have an observer role.