Activities of Kateřina KONEČNÁ related to 2022/0216(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Amendments (27)
Amendment 149 #
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 174 #
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 toThis solidarity should be built from the local and regional levels up to the national and EU self-sufficiency spreading the burden of donation evenly across the EU population and ensuring that donors gain an adequate public recognition. Each Member State shall pay the proattecntion of human healthto its own self-sufficiency and contribute accordingly. 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. SoHOs donation advertisements play an important role in getting people to donate.The significant amount of information that provides people with an idea and reasons for SOHOs donations plays an important role in how people view donation and the out coming results.Member States shall allow and regulate the advertisement for SOHOs collection.However, any advertising of SOHOs donation linked to a financial reward must be strictly banned in all Member States regardless of the medium used.Recruitment campaigns and advertisement should not refer to any compensation to avoid above mentioned risks and negative social impact. _________________ 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 202 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24 a) Education in current science concerning SoHO application and transfusion as well as the whole process of SoHO procurement must receive more attention during formal mandatory medical training. Member States are encouraged to establish certain areas such as transfusion medicine as an independent medical subject with structured training, including medical speciality schools and programmes for continuous medical education for all medical staff. Training and better information of the prescribers would reduce the risk of unnecessary application of SoHO.
Amendment 223 #
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 based on scientific evidence 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 demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the same 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 227 #
Proposal for a regulation
Recital 33 a (new)
Recital 33 a (new)
(33 a) It is important that the Commission, the ECDC, the EDQM, when assessing scientific guidelines to be implemented at the Union level, involve, when appropriate existing professional, scientific, donor and patient representative groups at Union level in the field of SoHOs.
Amendment 230 #
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 the member 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. 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 inclusive 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 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 241 #
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. Where SoHO is the starting material, such as with plasma derived medicinal products, a more comprehensive reflection over the overall supply chain is needed to ensure equitable patient access to these products.
Amendment 243 #
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. Such services should prevent the fragmentation of SoHO supply among multiple suppliers without certainty that all products, including rare ones, remain accessible to all patients.
Amendment 244 #
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 alsaiming to increasinge self- sufficiency in the Union, based on a large donor base with low frequency donations so as to ensure the resilience of the supply system. 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 261 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) Member States are encouraged to develop or strengthen plasmapheresis programmes to ensure capacity to collect more plasma and the Commission shall assist them in this task by providing guidance and facilitating the exchange of best practices.
Amendment 316 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) SoHO donor recruitment, except if that is the full extent of an entity’s SoHO activity;
Amendment 406 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point i a (new)
Article 3 – paragraph 1 – point 28 – point i a (new)
(i a) any other adverse occurrences specified by EDQM guidelines;
Amendment 445 #
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 605 #
Proposal for a regulation
Article 52 – paragraph 2 a (new)
Article 52 – paragraph 2 a (new)
2 a. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation.
Amendment 620 #
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 628 #
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHO that can be donated on a frequent and repeated basis , shall register such donors and the results of their donor health evaluations in a cross- entity registry that allows interconnection with other such registries, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them.
Amendment 632 #
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 legislationmaking good any expenses and inconveniences associated with their donation. Compensation should not lead to inappropriate competition (e.g. financially-driven competition), including cross-border competition, between establishments and entities over donor recruitment.
Amendment 650 #
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3 a. Member States shall submit reports to the Commission on these standards two years after the entry into force of this Regulation, and thereafter every three years. On the basis of these reports the Commission shall inform the European Parliament and the Council of any necessary further measure it intends to take at the EU level.
Amendment 654 #
Proposal for a regulation
Article 54 – paragraph 3 b (new)
Article 54 – paragraph 3 b (new)
3 b. On the basis of those reports, the Commission shall be empowered to adopt delegated acts in accordance with Article 77 in order to establish a single register of European donors.
Amendment 655 #
Proposal for a regulation
Article 54 – paragraph 3 c (new)
Article 54 – paragraph 3 c (new)
3 c. Member States shall regulate the advertisement for SOHOs collection. Any advertising of SOHOs donation linked to a financial reward must be strictly banned in all Member States regardless of the medium used. Recruitment campaigns and advertisement should not refer to any compensation.
Amendment 693 #
Proposal for a regulation
Article 58 – paragraph 2 – point b
Article 58 – paragraph 2 – point b
(b) testing of donors for communicable diseases using certified and validated testing methods or other methods deemed adequate by EDQM and ECDC guidelines;;
Amendment 761 #
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 796 #
Proposal for a regulation
Article 65 – paragraph 1
Article 65 – paragraph 1
Member States mayshall take additional measures to the ones set out in their national SoHO emergency plans to ensure availability of critical SoHOs, supply in case of shortages on their territory, on a case-by-case basich as the creation of national plans to increase donations. Member States taking such measures shall inform the other Member States and the Commission without undue delay and give reasons for the measures taken.
Amendment 803 #
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, permanently invite patients, consumers, and health professionals as well as representatives of the industry, 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 818 #
Proposal for a regulation
Article 67 a (new)
Article 67 a (new)
Amendment 833 #
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 shall occur by respecting the autonomy of EU legislation and shall take into account EU principles on transparency and stakeholder participation.
Amendment 872 #
Proposal for a regulation
Article 86 – paragraph 1
Article 86 – paragraph 1
The Commission shall, by … [OP please insert the date = five years after the date of application of this Regulation] assess the application of this Regulation, produce an evaluation report on the progress towards achievement of the objectives of this Regulation and present the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. The Commission should publish every two years, starting with the date of the application of this Regulation, a progress report on the status of plasma collection in the EU, in order to evaluate the progress made on plasma collection as a critical SoHO at the EU level, to promote the exchange of best practices and relevant evidence and experience across Member States.