29 Amendments of Alexandr VONDRA related to 2022/0216(COD)
Amendment 146 #
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 185 #
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 226 #
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as a means to demonstratone of the means to be compliancet with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. Member States may decide that SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the samrecognised guidelines that are based on scientific evidence and achieve an appropriate level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 229 #
Proposal for a regulation
Recital 35
Recital 35
(35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are thealsomember States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P- TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation, without prejudice to the Union’s legal autonomy. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility criteria for the prevention of the transmission of cancer and other non- communicable diseases and the assurance of safety and quality during collection, processing, storage and distribution. It should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this Regulation. In order to comply with the Union requirements for review of Union legislation, a transparent and open stakeholder consultation process shall be put in place for the development of those provisions and guidelines from the expert bodies.The committees referred to and any working parties and scientific advisory groups established within those committees shall develop appropriate contacts with public and private key stakeholders, including patients, consumers, health professionals, and industry representatives. _________________ 26 Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
Amendment 236 #
Proposal for a regulation
Recital 36
Recital 36
(36) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council27, is a Union agency with the mission of strengthening Europe's defences against communicable diseases. The work of the ECDC on developing and updating guidelines on safety and quality of SoHOs from a communicable disease threat perspective, should be considered an important contribution in the field of SoHOs in the Union and should be reflected in this Regulation. In addition, the ECDC established an expert network for the Microbial Safety of SoHOs, which ensures the implementation of the requirements on the ECDC’s relations with the Union Member States and EEA Member States stated in Regulation (EC) No 851/2004, regarding strategic and operational collaboration on technical and scientific issues, surveillance, responses to health threats, scientific opinions, scientific and technical assistance, collection of data, identification of emerging health threats, and public information campaigns related to the safety of SoHOs. This SoHO expert network should provide information or advice in relation to relevant outbreaks of communicable diseases, in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease. In order to comply with the Union requirements for review of Union legislation, a transparent and participatory stakeholder consultation process shall be put in place for the development of those provisions and guidelines from the expert bodies.The committees referred to and any working parties and scientific advisory groups established within those committees shall develop appropriate contacts with public and private key stakeholders, including patients, consumers, health professionals, and industry representatives. _________________ 27 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004, establishing a European centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1).
Amendment 249 #
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 270 #
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific and donor and patient representative groups and industry experts at Union level in the field of SoHOs. When seeking the input of expert bodies such as the ECDC and the EDQM, the SCB shall have due regard to their respective areas of expertise and avoid duplication.
Amendment 273 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38 a) The Commission shall cooperate with the EDQM in relation to the guidelines issued by that body. Such cooperation is without prejudice to the autonomy of Union law and should take into account Union principles on transparency and stakeholder participation.
Amendment 278 #
Proposal for a regulation
Recital 40
Recital 40
(40) The concept of a plasma master file (PMF) was established in Commission Directive 2003/63/EC28. Since that Directive provided for a specific regulatory role for the European Medicines Agency (EMA) in relation to authorisation of plasma for fractionation, the SCB should also collaborate with the relevant EMA expert working groups to exchange experience and good practices so that criteria for the eligibility of donors of plasma for fractionation and of donors of blood for transfusionare implemented by Member States in a consistent and coherent way. _________________ 28 Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 159, 27.6.2003, p. 46).
Amendment 446 #
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 456 #
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 480 #
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 494 #
Proposal for a regulation
Article 9 – paragraph 2 – point a
Article 9 – paragraph 2 – point a
(a) a sufficient number of suitably qualified personnel and subject matter experts on specific types of SoHOs to carry out the supervisory functions provided for in this Regulation;
Amendment 512 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40.
Amendment 557 #
Proposal for a regulation
Article 29 – paragraph 5 – introductory part
Article 29 – paragraph 5 – introductory part
5. By derogation from paragraph 4, competent authorities may conduct inspections, in full or in part, by means of a remote document reviewinspection, provided that:
Amendment 558 #
Proposal for a regulation
Article 29 – paragraph 7 – subparagraph 1
Article 29 – paragraph 7 – subparagraph 1
Inspectors shall verify that SoHO establishments meet the general standards concerning SoHO donor protection laid down in Article 53, the standards concerning the voluntary and unpaid nature of SoHO donations laid down in Article 54, the standards concerning information to be provided prior to consent or authorisation laid down in Article 55 and the general standards concerning recipient and offspring protection laid down in Article 58, as applicable.
Amendment 559 #
Proposal for a regulation
Article 29 – paragraph 11
Article 29 – paragraph 11
11. The interval between two on-site inspections shall not exceed 4 yearsould be decided based on the necessary frequency to mitigate any identified risks and it should be unified across the EU risk-based approach.
Amendment 616 #
Proposal for a regulation
Article 53 – paragraph 1 – point j
Article 53 – paragraph 1 – point j
(j) verify, by means of a registry, that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in Article 56 and demonstrate that their health is not compromised;
Amendment 619 #
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;
Amendment 639 #
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 664 #
Proposal for a regulation
Article 56 – paragraph 4 – introductory part
Article 56 – paragraph 4 – introductory part
4. For those standards concerning donor protection or elements thereof for which no implementing act has been adopted, in order to apply such standards or elements thereof, and upon decision of EU Member States, SoHO entities shall follow:
Amendment 668 #
Proposal for a regulation
Article 56 – paragraph 4 – point b
Article 56 – paragraph 4 – point b
(b) other guidelines accepted by competent authorities, as achieving an equivalent comparable level of donor safety as set by the technical guidelines referred to in point (a);
Amendment 669 #
Proposal for a regulation
Article 56 – paragraph 4 – point c
Article 56 – paragraph 4 – point c
(c) where the guidelines referred to in points (a) or (b) do not address a particular technical method, other technical methods in line with relevant internationally recognised guidelines and scientific evidence in peer- reviewed scientific publications, where available.
Amendment 758 #
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 involvementinvolvement of all relevant stakeholders.
Amendment 765 #
Proposal for a regulation
Article 62 – paragraph 2 a (new)
Article 62 – paragraph 2 a (new)
Amendment 799 #
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 exshall, 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 aspercts as appropriateof the Board’s work, under conditions determined beforehand by the Board. Other Union institutions, bodies, offices and agencies shall have an observer role.
Amendment 823 #
Proposal for a regulation
Article 68 – paragraph 1 – point e
Article 68 – paragraph 1 – point e
(e) liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards within their respective areas of expertise, and with the EMA on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2003/63/EC, to support the harmonised implementation of standards and technical guidelines;
Amendment 834 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. Such cooperation is without prejudice to the autonomy of Union law and should take into account Union principles on transparency and stakeholder participation.
Amendment 856 #
Proposal for a regulation
Article 74 – paragraph 3 – subparagraph 1
Article 74 – paragraph 3 – subparagraph 1
The Commission shall adopt implementing acts to ensure uniformity, compatibility and comparability laying down technical specifications for the EU SoHO Platform, including its functions, the roles and responsibilities of each of the parties listed in paragraph 1, the retention periods for personal data and the technical and organisational measures to ensure the safety and security of personal data processed.