2022/0216(COD) Standards of quality and safety for substances of human origin intended for human application
Lead committee dossier:
Progress: Awaiting Parliament's position in 1st reading
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI |
COLIN-OESTERLÉ Nathalie ( EPP)
|
GONZÁLEZ CASARES Nicolás ( S&D),
GLÜCK Andreas ( Renew),
METZ Tilly ( Verts/ALE),
KOPCIŃSKA Joanna ( ECR),
KONEČNÁ Kateřina ( GUE/NGL)
|
Lead committee dossier:
Legal Basis:
TFEU 168-p4
Legal Basis:
TFEU 168-p4Subjects
Events
2024/02/14
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2024/01/30
CSL - Coreper letter confirming interinstitutional agreement
Documents
2024/01/30
EP - Text agreed during interinstitutional negotiations
Documents
2024/01/30
EP/CSL - Act adopted by Council after Parliament's 1st reading
2023/09/12
EP - Results of vote in Parliament
Documents
2023/09/12
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 483 votes to 82, with 59 abstentions, amendments to 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.
The matter was referred back to the committee responsible for inter-institutional negotiations.
Scope
The amended text establishes provisions on:
- exchange of information on availability and stocks of SoHOs, and promotion of actions relating to the security of SoHO supply;
- coordination between competent authorities and the Commission and Union agencies in the event of SoHO related health emergencies.
Members stipulated that this Regulation should not apply to breast milk that is expressed by a mother solely for the purpose of feeding her own child.
Voluntary and unpaid donation
Parliament stated that ‘ SoHO donation ’ means a process by which a person voluntarily and altruistically gives SoHOs from their own body to people in need, or authorises their use after their death. This includes the necessary medical formalities, examination and treatments and monitoring of the SoHO donor, irrespective of whether that donation is successful or not; it also includes when consent is given by an authorised person in accordance with national legislation.
Members stressed the fact that Member States may allow for the compensation or reimbursement from the SoHO entities to living SoHO donors for losses or expenses related to their participation in donations, in accordance with the principle of voluntary and unpaid donation, and for example taking the form of compensatory leave, tax reductions or flat rate allowances set at national level. Compensation or reimbursement should not serve as an incentive for donations or engender financial competition, including cross-border competition, between institutions and entities that are seeking donors. It should not lead to exploitation of vulnerable persons in society . Member States should regulate the advertising of the collection of SoHOs. Any advertising of SoHO donations linked to a financial reward should be prohibited. Recruitment campaigns and advertisements shall not refer to any compensation.
SoHO entities should provide the information in an accurate and clear manner, using terms that are easily understood by the prospective donors or the persons to consent or authorise the donation, and ensure that the consent given is informed consent .
Protection of recipients
SoHO entities should not discriminate against SoHO recipients on any of the grounds listed in Article 21 of the Charter of Fundamental Rights of the European Union, unless it is necessary to protect the health of the SoHO recipient or of the SoHO donor. Such discriminatory action shall be based on scientific evidence.
Where possible, SoHO entities should use technologies to reduce clinical risks for SoHO recipients and offspring from medically assisted reproduction, and to improve the quality of SoHOs.
Members introduced the possibility of a derogation from the obligation to authorise preparations based on substances of human origin in emergency situations or in situations where there is no therapeutic alternative.
Establishment of national emergency plans
In order to ensure EU self-sufficiency in SoHO supply, Member States should draw up national plans to strive for sufficiency of supply of critical SoHOs and contribute to European autonomy in the context of a resilient supply chain.
The national plans should in particular include measures to ensure that the donor base is resilient, actions to make a more efficient use of SoHOs, monitoring of trends in the supply of critical SoHOs as well as measures for cases where national SoHO stocks exceed the national demand and SoHOs are exported to other countries with SoHO shortages.
Members also called on the EU to establish a digital communication channel as part of these national plans, enabling information on the availability of substances of human origin on national territory to be exchanged quickly and efficiently.
EU strategy
By two years after the date of entry into force of this regulation, the Commission should publish a strategy for the promotion of European SoHO supply autonomy . That strategy should set out a roadmap with ambitious targets for each critical SoHO, laid down by the Commission in coordination with national competent authorities, the SCB, the ECDC, the European Parliament, scientists from professional associations and patient associations, as well as with all other relevant stakeholders.
The strategy should set out a roadmap with ambitious targets for each critical SoHO. It should promote actions to:
- support and coordinate communication campaigns at European and national level on the various types of SoHO donations that are available;
- support, through relevant programmes, the training of healthcare workers in hospital and healthcare facilities, to raise awareness concerning SoHO donations;
- coordinate the exchange of best practices linked to optimisation of the use of critical SoHOs.
The strategy should include actions to establish a Union list of critical SoHOs.
SoHO platform
To limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (EU SoHO Platform) to facilitate timely submission of data and reports, to make it possible to share the elements used to determine the regulatory status of a substance, to improve the transparency of national reporting and supervisory activities and ensure better communication, collaboration and coordination in relation to, and exchange of, SoHOs between Member States.
The EU SoHO Platform should also be the main intermediary for reporting SoHO shortages, for cross-border requests for SoHOs and for import and export of SoHOs.
Documents
2023/09/12
EP - Matter referred back to the committee responsible
2023/07/26
EP - Committee report tabled for plenary, 1st reading
Details
The Committee on the Environment, Public Health and Food Safety adopted the report by Nathalie COLIN-OESTERLÉ (EPP, FR) 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.
The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
Scope
The amended text establishes provisions on:
- exchange of information on availability and stocks of SoHOs, and promotion of actions relating to the security of SoHO supply;
- coordination between competent authorities and the Commission and Union agencies in the event of SoHO related health emergencies.
It should be noted that Members stipulated that this Regulation should not apply to breast milk that is expressed by a mother solely for the purpose of feeding her own child.
More stringent measures
Members stressed that the protection of donors and recipients should be ensured through the highest quality and safety standards. They suggested that the principle of voluntary and unpaid donation should be harmonised, in particular with a view to stopping differences in national rules from encouraging citizens to donate in other countries than their own for financial reasons.
Members insisted that EU countries should allow for compensation or reimbursement for losses or expenses, related to their participation in donations, to living donors. This could be facilitated through for example, compensatory leave, tax reductions or flat rate allowances set at the national level. They stressed that compensation should not be used as an incentive to recruit donors, nor lead to the exploitation of vulnerable people. The report also called on the EU to enforce strict rules on advertising around SoHO donations, which should prohibit any references to financial rewards. Moreover, recruitment campaigns and advertisements should not refer to any compensation.
The report also called for greater efforts to harmonise donation frequency rules between the Member States by giving the European Commission the power to adopt delegated acts on this specific matter.
Safeguarding supply
To ensure the autonomy of the EU’s supply of these substances, EU countries should establish national emergency and continuity of supply plans , which should include measures to ensure a resilient donor base, monitoring of the supply of critical SoHOs and proposals to improve cooperation between countries with excess stocks and those experiencing shortages. Members also called for the EU to establish a digital communication channel as part of these national plans, to store and analyse information on SoHOs availability, fluctuations and potential shortages.
EU strategy
Members called for the development of a strategy for the promotion of European SoHO supply autonomy. The strategy should set out a roadmap with ambitious targets for each critical SoHO. It should promote actions to:
- support and coordinate communication campaigns at European and national level on the various types of SoHO donations that are available;
- support, through relevant programmes, the training of healthcare workers in hospital and healthcare facilities, to raise awareness concerning SoHO donations;
- coordinate the exchange of best practices linked to optimisation of the use of critical SoHOs.
The strategy should include actions to establish a Union list of critical SoHOs .
SoHO platform
To limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (EU SoHO Platform) to facilitate timely submission of data and reports, to make it possible to share the elements used to determine the regulatory status of a substance, to improve the transparency of national reporting and supervisory activities and ensure better communication, collaboration and coordination in relation to, and exchange of, SoHOs between Member States.
In order to prevent supply tensions and to ensure donor and recipient security, the Commission should ensure that the EU SoHO Platform is interoperable with the other existing Union platforms, in particular the EMA’s European Shortages Monitoring Platform. The EU SoHO Platform should also be the main intermediary for reporting SoHO shortages, for cross-border requests for SoHOs and for import and export of SoHOs.
Documents
2023/07/18
EP - Vote in committee, 1st reading
2023/03/14
EP - Amendments tabled in committee
Documents
2023/03/14
EP - Amendments tabled in committee
Documents
2023/03/14
EP - Amendments tabled in committee
Documents
2023/01/18
EP - Committee draft report
Documents
2022/12/21
PT_PARLIAMENT - Contribution
Documents
2022/10/26
ESC - Economic and Social Committee: opinion, report
Documents
2022/10/20
EP - COLIN-OESTERLÉ Nathalie (EPP) appointed as rapporteur in ENVI
2022/10/14
CZ_CHAMBER - Contribution
Documents
2022/10/10
ES_PARLIAMENT - Contribution
Documents
2022/09/12
EP - Committee referral announced in Parliament, 1st reading
2022/09/07
EDPS - Document attached to the procedure
Documents
2022/07/14
EC - Document attached to the procedure
Documents
2022/07/14
EC - Document attached to the procedure
Documents
2022/07/14
EC - Document attached to the procedure
Documents
2022/07/14
EC - Document attached to the procedure
Documents
2022/07/14
EC - Legislative proposal published
Details
PURPOSE: to ensure a high level of health protection for EU citizens and ensure access to safe and effective substances of human origin (blood, tissue and cells) (SoHOs).
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: every year, EU patients are treated with 25 million blood transfusions (during emergency surgery, cancer or other care), a million cycles of medically assisted reproduction, over 35 000 transplants of stem cells (mainly for blood cancers) and hundreds of thousands of replacement tissues (e.g., for orthopaedic, skin, cardiac or eye problems).
The EU framework for safety and quality of substances of human origin (SoHOs) has currently three main Directives, respectively for Blood, Tissues and Cells, and Organs , together with implementing legislation.
Although these Directives have harmonised to a certain degree the rules of Member States in the area of safety and quality of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This results in divergences between national rules , which can create obstacles to cross-border sharing of these substances.
A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for these substances, which achieves safety and quality for all parties involved, enhances legal certainty and supports continuous supply, whilst facilitating innovation for the benefit of public health. In addition, the proposal aims to tackle concerns regarding the sufficiency of supply highlighted by the COVID-19 pandemic.
This initiative is part of the EU’s ambition to build a stronger European Health Union.
CONTENT: the proposed Regulation aims to establish measures setting high standards of quality and safety for all substances of human origin intended for human applications and for activities related to these substances, in order to ensure a high level of human health protection, in particular for donors of substances of human origin, recipients of substances of human origin and offspring of medically assisted reproduction.
All substances of human origin would be covered, with the exception of solid organs. Human breast milk is one of the new substances covered by the proposal.
More specifically, the proposal provides for measures to:
- ensure safety and quality for patients receiving SoHO therapies and fully protect them from avoidable risks related to substances of human origin;
- ensure safety and quality for donors of substances of human origin and for children born from donated eggs, sperm or embryos;
- empower the EU and its Member States to better prevent and combat future pandemics (surveillance, data analysis, risk assessment, early warning and rapid response);
- facilitate the development of innovative, safe and effective SoHO therapies ;
- improve the resilience of European health systems (sufficient supply of human-derived substances) by mitigating the risk of shortages.
Specifically, the proposal:
- improves the protection of patients treated with SoHO (recipients) and offspring from medically assisted reproduction, with standards, and how to implement these standards concerning recipient and offspring protection;
- contains provisions on the competent authorities for substances of human origin, which are responsible for the supervisory activities;
- covers all activities that competent authorities undertake in relation to SoHO entities or registration procedures, with the obligation to maintain a register of SoHO entities and to establish a procedure for their registration ;
- describes all general obligations on SoHO entities, namely their registration, the nomination of a Responsible Person if they release substances of human origin for clinical use, as well as obligations regarding the export of SoHOs;
- requires blood and tissue establishments to meet safety and quality standards by following guidelines developed and updated by designated expert bodies such as the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines and Health Care (Council of Europe);
- lays down provisions to ensure the continuity of supply of SoHOs . It covers the obligation for Member States to have national SoHO emergency plans (for SoHOs that are critically important for patients) and the responsibilities of competent authorities and entities regarding supply alerts for critical SoHOs.
A SoHO Coordination Board (SCB) would be established with and for the Member States to support a common implementation of the new Regulation.
The creation of the EU SoHO Platform , to gather all required information, streamline reporting and increase visibility to citizens will give a new impetus to digitalisation.
BUDGETARY IMPLICATIONS: the financial impact of the proposal is estimated at EUR 55.411 million in commitment appropriations for the period 2024-2027. The appropriations will be reallocated within the financial envelope of the EU Health Programme in the Multiannual Financial Framework (MFF) 2021-2027.
Documents
Documents
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE758.999
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2024)000898
- Text agreed during interinstitutional negotiations: PE758.999
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament, 1st reading: T9-0299/2023
- Committee report tabled for plenary, 1st reading: A9-0250/2023
- Amendments tabled in committee: PE740.835
- Amendments tabled in committee: PE745.276
- Amendments tabled in committee: PE745.277
- Committee draft report: PE738.661
- Contribution: COM(2022)0338
- Economic and Social Committee: opinion, report: CES4815/2022
- Contribution: COM(2022)0338
- Contribution: COM(2022)0338
- Document attached to the procedure: OJ C 450 28.11.2022, p. 0007
- Document attached to the procedure: N9-0084/2022
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SEC(2022)0304
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2022)0189
- Document attached to the procedure: SWD(2022)0190
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2022)0191
- Legislative proposal published: COM(2022)0338
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SEC(2022)0304
- Document attached to the procedure: EUR-Lex SWD(2022)0189
- Document attached to the procedure: SWD(2022)0190
- Document attached to the procedure: EUR-Lex SWD(2022)0191
- Document attached to the procedure: OJ C 450 28.11.2022, p. 0007 N9-0084/2022
- Economic and Social Committee: opinion, report: CES4815/2022
- Committee draft report: PE738.661
- Amendments tabled in committee: PE740.835
- Amendments tabled in committee: PE745.276
- Amendments tabled in committee: PE745.277
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2024)000898
- Text agreed during interinstitutional negotiations: PE758.999
- Contribution: COM(2022)0338
- Contribution: COM(2022)0338
- Contribution: COM(2022)0338
Activities
- Nathalie COLIN-OESTERLÉ
Plenary Speeches (2)
- 2023/09/12 Standards of quality and safety for substances of human origin intended for human application (A9-0250/2023 - Nathalie Colin-Oesterlé) (vote)
- 2023/09/12 Standards of quality and safety for substances of human origin intended for human application (A9-0250/2023 - Nathalie Colin-Oesterlé) (vote)
Votes
Normes de qualité et de sécurité des substances d’origine humaine destinées à une application humaine - A9-0250/2023 - Nathalie Colin-Oesterlé - Amendements de la commission compétente - vote en bloc - Am 59 #
2023/09/12 Outcome: +: 380, -: 228, 0: 13
The Left
NI
ID
PPEA9-0250/2023 - Nathalie Colin-Oesterlé - Amendements de la commission compétente - vote en bloc - Am 85 #
2023/09/12 Outcome: +: 517, -: 86, 0: 23
A9-0250/2023 - Nathalie Colin-Oesterlé - Proposition de la Commission #
2023/09/12 Outcome: +: 483, 0: 89, -: 52
| Amendments | Dossier |
| 757 |
2022/0216(COD)
2023/03/14
ENVI
757 amendments...
Amendment 118 #
Proposal for a regulation Recital 1 a (new) (1a) In accordance with Article 1 of the Charter of Fundamental Rights of the European Union, which states that ‘human dignity is inviolable. It must be respected and protected,' and Article 3 of same, the quality and safety standards of SoHOs must respect the physical and mental integrity of the persons concerned, ensure SoHOs are donated with the free and informed consent of those persons and prohibit eugenic principles, financial gain from the human body or its parts and cloning,
Amendment 119 #
Proposal for a regulation Recital 1 a (new) (1a) In accordance with Article 168(1), first subparagraph, of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union, a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities.
Amendment 120 #
Proposal for a regulation Recital 1 b (new) (1b) The scope of this regulation goes beyond the subject matters addressed in previous directives. Reproductive techniques and the use of SoHos as starting materials for medicinal products raise very complex questions that are tackled in a fragmented manner by the Member States in legal and ethical contexts. Both matters require ad hoc legislation that responds effectively to their specific nature.
Amendment 121 #
Proposal for a regulation Recital 1 c (new) (1c) Reproductive techniques, tissue banks and pharmaceutical industries have specific characteristics that make it difficult to establish a common standard to provide the quality, safety and efficacy needed to ensure good practice in these areas.
Amendment 122 #
Proposal for a regulation Recital 1 d (new) (1d) The development of legislation in the areas of reproductive techniques, tissue banks and pharmaceutical industries must reflect the importance of donation and the need for enhanced traceability because of their implications for health-related information and the existence of third parties.
Amendment 123 #
Proposal for a regulation Recital 3 (3) As regards Article 168(4), point (a), TFEU, standards for the safety and quality of organs and SoHOs, blood and blood derivatives should ensure a high level of human health protection. Therefore, this Regulation aims at setting high standards by ensuring, amongst others, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHOs and for recipients, as well as measures to monitor and support the sufficiency of the supply of SoHOs that are critical for the health of patients. In accordance with Article 3 of the Charter of Fundamental Rights of the European Union, these safety standards are based on the fundamental principle that the human body cannot be commercialised, which holds that no SoHO may be sold, as well as on the principle of the unavailability of the human body and the principle that the human body or parts thereof cannot be used for financial gain.
Amendment 124 #
Proposal for a regulation Recital 3 (3) As regards Article 168(4), point (a), TFEU, standards for the safety and quality of organs and SoHOs, blood and blood derivatives should ensure a high level of human health protection. Therefore, this Regulation aims at setting high safety standards by ensuring, amongst others, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHOs and for recipients, as well as measures to monitor and support the sufficiency of the supply of SoHOs that are critical for the health of patients.
Amendment 125 #
Proposal for a regulation Recital 4 (4) Directives 2002/98/EC16and 2004/23/EC17of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and for tissues and cells, respectively. Although these Directives have harmonised to a certain degree the rules of Member States in the area of safety and quality of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This results in divergences between national rules, which can create obstacles to cross-border sharing of these
Amendment 126 #
Proposal for a regulation Recital 4 (4) Directives 2002/98/EC16and 2004/23/EC17of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and for tissues and cells, respectively. Although these Directives have harmonised to a
Amendment 127 #
Proposal for a regulation Recital 5 (5) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. In addition, many authorities and operators work across these sectors. As this Regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors, it would be appropriate that it replaces these Directives and merges the revised provisions into one legal act, with respect for the special characteristics of each of the substances recognised in the technical guidelines set out in this Regulation.
Amendment 128 #
Proposal for a regulation Recital 5 (5) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. In addition, many authorities and operators work across these sectors. As this Regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors, it would be appropriate that it replaces these Directives and merges the revised provisions into one legal act, taking into consideration the special characteristics of each type of substance.
Amendment 129 #
Proposal for a regulation Recital 6 (6) This Regulation should apply to blood and blood components, as regulated by Directive 2002/98/EC, as well as to tissues and cells, including haematopoietic peripheral blood, umbilical-cord blood and bone-marrow stem cells, reproductive cells and tissues, foetal tissues and cells
Amendment 130 #
Proposal for a regulation Recital 7 (7) Solid organs are excluded from the definition of SoHOs for the purposes of
Amendment 131 #
Proposal for a regulation Recital 8 a (new) (8a) The EU shall further the development of a European SoHO sovereignty with a view to preventing dependency on third countries with regard to sectors and products of strategical importance for the EU.
Amendment 132 #
Proposal for a regulation Recital 8 b (new) (8b) Every step must be taken to prevent the development or the EU playing a role in the development of a paid cell and tissue donation industry.
Amendment 133 #
Proposal for a regulation Recital 9 (9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European
Amendment 134 #
Proposal for a regulation Recital 9 (9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways in order to preserve all properties that ensure their compatibility with recipients, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. The criteria that define when SoHOs or SOHO preparations become products
Amendment 135 #
Proposal for a regulation Recital 9 (9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. When SoHOs qualify or are used in medicinal products regulated by EU legislations mentioned above, only the provisions of this Regulation related to donor protection should be applicable.The criteria that define when SoHOs or SOHO preparations
Amendment 136 #
Proposal for a regulation Recital 10 (10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the
Amendment 137 #
Proposal for a regulation Recital 10 (10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. Furthermore, if minimal processing is needed to restore applicability during a surgical procedure or the manipulation is done within a closed system, the Regulation should not apply as well. When autologous SoHOs are collected and
Amendment 138 #
Proposal for a regulation Recital 10 Amendment 139 #
Proposal for a regulation Recital 10 (10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination or contamination of caregivers, friends or family, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply.
Amendment 140 #
Proposal for a regulation Recital 11 (11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007
Amendment 141 #
Proposal for a regulation Recital 11 (11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, dispensing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps.
Amendment 142 #
Proposal for a regulation Recital 11 (11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, issuing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps.
Amendment 143 #
Proposal for a regulation Recital 12 (12) SoHOs can also be combined with other regulated products before human application. In these circumstances, close interaction between this regulatory framework and other related frameworks is
Amendment 144 #
Proposal for a regulation Recital 12 (12) SoHOs can also be combined with other regulated products before, exclusively, human application. In these circumstances, close interaction between this regulatory framework and other related frameworks is also necessary to ensure a high level of human health protection for all cases where these substances are used.
Amendment 145 #
Proposal for a regulation Recital 12 a (new) (12a) The scope of this regulation shall have no effect on national assisted reproduction legislation. Sexual and reproductive rights are a national competence.
Amendment 146 #
Proposal for a regulation 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.
Amendment 147 #
Proposal for a regulation Recital 13 (13) Given the special nature of SoHOs,
Amendment 148 #
Proposal for a regulation 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
Amendment 149 #
Proposal for a regulation 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
Amendment 150 #
Proposal for a regulation 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
Amendment 151 #
Proposal for a regulation 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
Amendment 152 #
Proposal for a regulation 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 when handling these products and hence 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 from undesirable short-term and long-term side-effects. As different types of donation imply different risks for
Amendment 153 #
Proposal for a regulation 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
Amendment 154 #
Proposal for a regulation 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.
Amendment 155 #
Proposal for a regulation 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
Amendment 156 #
Proposal for a regulation 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
Amendment 157 #
Proposal for a regulation Recital 13 (13) Given the special nature of SoHOs, resulting from their human origin, and the
Amendment 158 #
Proposal for a regulation 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
Amendment 159 #
Proposal for a regulation Recital 13 a (new) (13a) This regulation has no bearing on the right of offspring conceived during fertility treatment to know their provenance under the legislation in force in the Member States.
Amendment 160 #
Proposal for a regulation Recital 14 (14) When a harmful genetic condition is detected in the
Amendment 161 #
Proposal for a regulation Recital 15 (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law
Amendment 162 #
Proposal for a regulation Recital 15 (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law and founded on respect for human dignity, voluntary donation, and the principle that SoHOs cannot be used for financial gain. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence-
Amendment 163 #
Proposal for a regulation Recital 15 (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union
Amendment 164 #
Proposal for a regulation Recital 15 (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law, particularly in the area of conception by means of fertility treatment. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence-
Amendment 165 #
Proposal for a regulation Recital 15 (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and where necessary supported by scientific evidence, and the means of achieving that aim are appropriate and necessary.
Amendment 166 #
Proposal for a regulation Recital 15 (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation
Amendment 167 #
Proposal for a regulation Recital 15 (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or
Amendment 168 #
Proposal for a regulation Recital 15 a (new) Amendment 169 #
Proposal for a regulation Recital 15 a (new) (15a) Human embryos and foetuses and their cells, tissues and organs must not be used for diagnostic, therapeutic, research or experimental purposes.
Amendment 170 #
Proposal for a regulation Recital 16 (16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This
Amendment 171 #
Proposal for a regulation Recital 16 (16)
Amendment 172 #
Proposal for a regulation Recital 16 (16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation should also not interfere with decisions of an ethical nature made by Member States, provided that they adhere to the Charter of Fundamental Rights of the European Union. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health.
Amendment 173 #
Proposal for a regulation Recital 17 (17) This Regulation is not meant to cover research using SoHOs when that research does not involve application to the human body, for example in vitro research or research in animals. However, human substances used in research involving studies where they are applied to the human body should comply with the rules laid down in this Regulation, regarding clinical studies with SoHO.
Amendment 174 #
Proposal for a regulation 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.
Amendment 175 #
Proposal for a regulation Recital 18 (18) A
Amendment 176 #
Proposal for a regulation Recital 18 (18)
Amendment 177 #
Proposal for a regulation 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.
Amendment 178 #
Proposal for a regulation 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.
Amendment 179 #
Proposal for a regulation 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.
Amendment 180 #
Proposal for a regulation 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.
Amendment 181 #
Proposal for a regulation 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.
Amendment 182 #
Proposal for a regulation 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.
Amendment 183 #
Proposal for a regulation 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.
Amendment 184 #
Proposal for a regulation 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.
Amendment 185 #
Proposal for a regulation 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.
Amendment 186 #
Proposal for a regulation 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 and may help to ensure the traceability of the donor. Voluntary and unpaid SoHO donation is also a factor which can contribute to ensuring the traceability of the donor and 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
Amendment 187 #
Proposal for a regulation Recital 18 (18)
Amendment 188 #
Proposal for a regulation 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.
Amendment 189 #
Proposal for a regulation Recital 19 (19) In order to maintain public trust in SoHO donation and use programmes, information that is given to prospective donors, recipients or physicians regarding the likely use and benefits of particular SoHOs or SoHO preparations when applied to recipients should accurately reflect reliable scientific evidence and under no circumstances attribute or imply levels of safety or efficacy not supported by scientific methods. This should ensure that donors, or their families, are not coerced to donate by exaggerated descriptions of benefits and prospective
Amendment 190 #
Proposal for a regulation Recital 20 (20) Competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. While Member States are best placed to identify the competent authority or authorities for each area, for example by geography, topic or substance, they should also be required to designate a single national authority that ensures appropriately coordinated communication with other Member States’ competent authorities and with the Commission. The SoHO National Authority should be considered the same as the designated competent authority in Member States where only one competent authority is designated. The list of all SoHO competent national authorities should be made publicly available.
Amendment 191 #
Proposal for a regulation Recital 20 (20) Competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. While Member States are best placed to identify the competent authority or authorities for each area, for example by geography, topic or substance, they sh
Amendment 192 #
Proposal for a regulation Recital 21 (21) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act independently and impartially. It is therefore important that their function of oversight is separate and independent from the performance of SoHO activities. In particular, competent authorities should be free from undue political influence and from industry interference that might affect their operational impartiality. In order to prevent such interference, it is advisable to make any appointment within these authorities incompatible with decision- making or management positions in the industry.
Amendment 193 #
Proposal for a regulation Recital 21 (21) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act independently and impartially. It is therefore important that their function of oversight is separate and independent from the performance of SoHO activities. In particular, competent authorities should be free from undue political influence and from industry or other actors’ interference that might affect their operational impartiality.
Amendment 194 #
Proposal for a regulation Recital 22 (22) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality, professionalism and transparency. When infringements relate to direct health risks, and the publication of information regarding those infringements can contribute to risk mitigation and the protection of donors, recipients or offspring from medically assisted reproduction, competent authorities should, where necessary, be able to prioritise transparency of their enforcement activities over the protection of confidentiality of the party that has infringed the Regulation.
Amendment 195 #
Proposal for a regulation Recital 22 (22) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities – whose induction training they shall ensure – that act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality, professionalism and transparency. When infringements relate to direct health risks, and the publication of information regarding those infringements can contribute to risk mitigation and the protection of donors, recipients or
Amendment 196 #
Proposal for a regulation Recital 22 a (new) (22a) For the performance of supervisory activities, competent authorities should ensure the impartiality and independence of the inspectors and provide them with training.
Amendment 197 #
Proposal for a regulation Recital 23 (23) The correct application and enforcement of the rules falling within the scope of this Regulation require an appropriate knowledge of those rules. It is therefore important that the staff performing supervisory activities have an appropriate professional background and are regularly trained, in accordance with their area of competence, on the obligations resulting from this Regulation, in order to make informed decisions and to be able to provide the target public with the correct information.
Amendment 198 #
Proposal for a regulation Recital 24 (24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or food, with the aim of ensuring coherent procedures for the
Amendment 199 #
Proposal for a regulation Recital 24 (24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult
Amendment 200 #
Proposal for a regulation Recital 24 (24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or food, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be
Amendment 201 #
Proposal for a regulation Recital 24 (24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or food, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to
Amendment 202 #
Proposal for a regulation 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 203 #
Proposal for a regulation Recital 24 a (new) (24a) Health-care personnel should be informed about, and trained in, the functioning of the entire SoHO supply chain, in particular patient blood management, as recommended by the World Health Organization. Awareness- raising and continuous training for prescribers could avoid the application of SoHOs where therapeutic alternatives are available, in particular by ensuring the best possible use is made of SoHOs.
Amendment 204 #
Proposal for a regulation Recital 24 a (new) (24a) Given the World Health Organization's1 a recommendation that health-care personnel should be informed about, and trained in, patient blood management, prescribers should be made more aware of therapeutic alternatives to the application of this SoHO Regulation. This practice is also liable to limit the flow of SoHOs and ensure security of supply. _________________ 1 a World Health Organization Resolution WHA 63.12, ‘Availability, safety and quality of blood products’, 21.5.2010.
Amendment 205 #
Proposal for a regulation Recital 26 (26) Commission experts should have the necessary medical experience and knowledge to be able to perform controls, including audits, in Member States to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems. Commission controls should also serve to investigate and collect information on enforcement practices or problems, emergencies and new developments in Member States. Official controls should be performed by personnel who are independent, free from any conflict of interest and in particular who are not in a situation which, directly or indirectly, could affect their ability to carry out their professional duties in an impartial manner.
Amendment 206 #
Proposal for a regulation Recital 26 (26) Commission experts should be able to perform controls, including audits, in Member States to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems.
Amendment 207 #
Proposal for a regulation Recital 27 (27) Since SoHO preparations are subjected to a series of SoHO activities prior to their release and distribution, competent authorities should assess and authorise SoHO preparations to verify that a high level of safety, quality and efficacy is achieved consistently by the application of that specific series of activities, performed in that specific manner. When SoHOs are prepared with newly developed and validated collection, testing or processing methods, consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. The extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that SoHO preparation and use. Where a new or modified SoHO preparation poses negligible risks for recipients (or
Amendment 208 #
Proposal for a regulation Recital 27 (27) Since SoHO preparations are subjected to a series of SoHO activities prior to their release
Amendment 209 #
Proposal for a regulation Recital 28 (28) Applicants requesting an authorisation of SoHO preparation should use the Euro GTP II methodologies or equivalent tools to assess the risk level of their SoHO preparation. Applicants should share the results of the risk assessments with competent authorities when requesting authorisation. With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation.
Amendment 210 #
Proposal for a regulation Recital 28 (28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated, following the guidelines specified in this Regulation. The most up- to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end- points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should
Amendment 211 #
Proposal for a regulation Recital 28 (28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of
Amendment 212 #
Proposal for a regulation Recital 28 (28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for medium-term and long- term clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive medium-term and long-term clinical follow-up for a defined number of
Amendment 213 #
Proposal for a regulation Recital 28 a (new) Amendment 214 #
Proposal for a regulation Recital 28 b (new) (28 b) The commitment to publish the clinical results obtained should be a mandatory requirement for clinical studies with SoHO. The existence of a registry of SoHO clinical studies at EU level is critical to facilitate patient participation in clinical studies, to boost multi-centre studies and to foster collaboration to generate more robust results and conclusions, and to make the generated knowledge available to other researchers, healthcare professionals, participants themselves and the general public.
Amendment 215 #
Proposal for a regulation Recital 29 (29) In the interests of efficiency, it should be permitted to conduct clinical outcome studies using the established framework in the pharmaceutical sector for clinical trials, as set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council25, when operators wish to do so.
Amendment 216 #
Proposal for a regulation Recital 30 (30) In order to facilitate innovation and reduce administrative burden, competent authorities should share with each other information on the authorisation of new
Amendment 217 #
Proposal for a regulation Recital 30 (30) In order to facilitate innovation, identify the best solutions and preparations and reduce administrative burden, competent authorities should share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, including for the validation of certified medical devices used for SoHO collection, processing, storage or application to patients. Such sharing could allow authorities to accept previous authorisations granted to other entities, including in other Member States, to use these solutions and products for the benefit of recipients and to thus significantly reduce the requirements to generate evidence.
Amendment 218 #
Proposal for a regulation Recital 30 (30) In order to facilitate innovation and reduce administrative burden, competent authorities
Amendment 219 #
Proposal for a regulation Recital 31 (31) A broad range of public and private organisations influence the safety, quality and efficacy of SoHOs, even if they do not maintain banks of those SoHOs. Many organisations carry out a single SoHO activity, such as collection or donor testing on behalf of one or many organisations that maintain banks of SoHOs. The SoHO entity concept includes this broad range of organisations, from donor registries to
Amendment 220 #
Proposal for a regulation Recital 32 (32) Competent authorities should periodically review the SoHO entities registered in their territory and ensure that those entities that carry out both processing and storage of SoHOs are inspected and authorised as SoHO establishments before starting those activities. A SoHO establishment authorisation should refer to the legal entity, even when one SoHO establishment has many physical sites. Competent authorities should consider the impact on safety, quality and efficacy of the SoHO activities carried out at SoHO entities that do not meet the definition of a SoHO establishment and decide whether particular entities should be subject to establishment authorisations due to the risk or scale associated with their activities. Similarly, SoHO entities that have a poor record in terms of compliance with reporting or other obligations might be suitable candidates for authorisation as SoHO establishments.
Amendment 221 #
Proposal for a regulation 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 demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. Member States should be involved in both the drafting and voting of these guidelines and should follow a transparent process of consultation with other relevant EU authorities and stakeholders. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines are based on the most up-to-date scientific evidence and 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 222 #
Proposal for a regulation 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 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. When assesing scientific guidlines, it is important that the Commission, the ECDC, and the EDQM involve existing scientific, donor, and patient representative groups.
Amendment 223 #
Proposal for a regulation 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 224 #
Proposal for a regulation 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
Amendment 225 #
Proposal for a regulation 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
Amendment 226 #
Proposal for a regulation 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
Amendment 227 #
Proposal for a regulation 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 228 #
Proposal for a regulation Recital 34 (34) Where evidence demonstrates that specific processing steps reduce or eliminate the risk of transmission of specific infectious or non-infectious disease agents, the quality and safety standards for the verification of donor eligibility by means of donor health evaluations, including testing, and the related guidelines for their implementation, should take this evidence into account. Thus, in the case of, for example, plasma for fractionation, that in a subsequent step in the manufacturing process of medicinal products undergoes sterilisation steps,
Amendment 229 #
Proposal for a regulation 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
Amendment 230 #
Proposal for a regulation 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
Amendment 231 #
Proposal for a regulation Recital 35 (
Amendment 232 #
Proposal for a regulation 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,
Amendment 233 #
Proposal for a regulation 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/EC
Amendment 234 #
Proposal for a regulation 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
Amendment 235 #
Proposal for a regulation 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
Amendment 236 #
Proposal for a regulation 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
Amendment 237 #
Proposal for a regulation 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
Amendment 238 #
Proposal for a regulation Recital 36 (36) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council 27
Amendment 239 #
Proposal for a regulation 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 and the Union should promote the
Amendment 240 #
Proposal for a regulation 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. To ensure long-term sustainability, the campaigns should primarily focus on increasing the donor base for low-frequency donations. As there is a need to ensure the availability of SoHOs for medical treatments, Member States should support the establishment of public donation facilities and promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing the collection capacity and 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 241 #
Proposal for a regulation 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 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
Amendment 243 #
Proposal for a regulation 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 (37) It is necessary to promote information and awareness campaigns at national and Union level on the importance
Amendment 245 #
Proposal for a regulation 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 ensuring the broadest possible doner base and to help European citizens to decide whether to become donors during
Amendment 246 #
Proposal for a regulation 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 and the Union should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing
Amendment 247 #
Proposal for a regulation Recital 37 (37) It is necessary and beneficial to all parties 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-
Amendment 248 #
Proposal for a regulation 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
Amendment 249 #
Proposal for a regulation 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,
Amendment 250 #
Proposal for a regulation 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
Amendment 251 #
(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
Amendment 252 #
Proposal for a regulation 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
Amendment 253 #
Proposal for a regulation 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
Amendment 254 #
Proposal for a regulation 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
Amendment 255 #
Proposal for a regulation Recital 37 (37) It is necessary to promote information and awareness campaigns at national and Union level on the importance
Amendment 256 #
Proposal for a regulation 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,
Amendment 257 #
Proposal for a regulation Recital 37 a (new) Amendment 258 #
Proposal for a regulation 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 259 #
Proposal for a regulation Recital 37 a (new) (37 a) As recommended by the World Health Organisation (WHO), Member States should additionally support optimal clinical use of SoHOs, particularly where there are alternatives which can reduce the demand for SoHOs. In such fashion, Member States should ensure efficient implementation of the Patient Blood Management (PBM), which improves patients’ safety by minimising the risks associated with transfusion and improve patient outcomes, while at the same time ensuring sufficiency of blood supplies and reducing financial pressure on health system.
Amendment 260 #
Proposal for a regulation Recital 37 a (new) (37a) Given the negative effects of the COVID-19 pandemic on the frequency and quantity of plasma donation in some countries, Member States are invited to develop plasmapheresis programmes to increase their collection capacity and donor base.
Amendment 261 #
Proposal for a regulation 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 262 #
Proposal for a regulation Recital 37 a (new) (37 a) To ensure the capacity to better collect more plasma, Member States are encouraged to develop or strengthen their respective plasmapheresis programs. The Commission shall aid them through guidance and the exchange of best practices.
Amendment 263 #
Proposal for a regulation Recital 37 b (new) (37 b) In order to ensure self-sufficiency and sustainability of supply of SoHOs, Member States should establish national SoHO emergency plans setting out measures when the supply situation for critical SoHOs presents or is likely to present a serious risk to human health. Such plans shall include measures, including optimisation of use, that impact demand of critical SoHOs, targets to ensure self-sufficiency of supply of critical SoHOs, donor recruitment and retainment strategy and ways of cooperation between competent authorities, experts and relevant stakeholders. National emergency plans should be further supplemented by the EU Strategy for critical SoHO supply sufficiency, primarily focusing on supply monitoring, reporting obligations and sharing of best practices within the EU.
Amendment 264 #
Proposal for a regulation Recital 37 b (new) (37 b) On the other hand, it is essential to take steps to achieve, as soon as possible, an EU autonomy in the area of SoHO, especially in the case of plasma, which shows an increasing demand due to new therapeutic applications of plasma- derived medicines. Nowadays, the Union suffers from chronic shortages of plasma, resulting in its dependence on imports from third countries. It is necessary to specify the measures to be taken to increase the donor base, always in line with the principles of voluntary and unpaid donation, as well as to improve the infrastructure to enable efficient collection of SoHO, in order to ensure the continued, adequate and safe supply, also in times of crisis.
Amendment 265 #
Proposal for a regulation 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 266 #
Proposal for a regulation Recital 37 c (new) (37 c) In order to reach an appropriate level of autonomy in the Union, it will be necessary to increase the collection of SoHO, but also to ensure its proper and efficient use. The factors and measures affecting SoHO’s demand play a critical role in ensuring the quality, safety and sustainability of the SoHO system. Suboptimal clinical practices and unnecessary use of SoHO compromises patient safety and limits the availability of SoHO for other patients in need. Member States should take measures to promote the optimal use of SoHO, taking into account alternatives that may reduce the demand, always following the most up-to- date scientific guidelines. The competent authorities should train healthcare professionals to make optimal use of SoHO. Member States should draw up national plans to ensure the supply of SoHO, as well as national emergency plans.
Amendment 267 #
Proposal for a regulation Recital 37 d (new) (37 d) In cases where the availability of SoHO preparations or SoHO-derived products depend on profit-making entities, such as some plasma-derived products, there is a risk of altruistic donations turning into disproportionate profits and commercial interests taking precedence over the interests of patients and research. There could even be situations in which some low-profitable products are no longer produced, hampering their accessibility for patients. Similarly, investment in research and innovation for this type of products could be very small or non-existent. Prices of SoHO-derived products, which are obtained from altruistic and unpaid donations, should be fair and transparent. For certain low- profitable products, Member States should encourage research and innovation and should ensure, through negotiations, incentives or public service obligations, that they continue to be manufactured.
Amendment 268 #
Proposal for a regulation 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 agencies and bodies such as the ECDC
Amendment 269 #
Proposal for a regulation 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 at Union level in the field of SoHOs. The SCB should adhere to high degree of transparency of its outputs and all it members, observers and experts should act independently, in the public interest and be free from any external influence that might affect the impartiality of their professional conduct.
Amendment 270 #
Proposal for a regulation 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 271 #
Proposal for a regulation 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
Amendment 272 #
Proposal for a regulation Recital 38 (38) In order to promote a coherent and 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,
Amendment 273 #
Proposal for a regulation 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 274 #
Proposal for a regulation Recital 39 (39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This may sometimes cause
Amendment 275 #
Proposal for a regulation Recital 39 (39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. In case a product could be classified both as SoHO or SoHO preparation and medicinal product, the classification as medicinal product should prevail.The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should keep a compendium of the opinions issued by the SCB or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross-sectoral approach, ensure high protection of public health, and facilitate
Amendment 276 #
Proposal for a regulation Recital 39 (39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. The SCB should receive ongoing and constant relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should monitor these opinions in order to react quickly and in an informed manner to further requests for opinions from other Member States, keep a compendium of the opinions issued by the SCB or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross- sectoral approach and facilitate SoHO innovation.
Amendment 277 #
Proposal for a regulation Recital 39 (39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should keep a compendium of the opinions issued by the SCB, the Classification Advisory Council or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross-sectoral approach and facilitate SoHO innovation.
Amendment 278 #
Proposal for a regulation Recital 40 (40) The concept of a plasma master file (PMF) was established in Commission Directive 2003/63/EC28. Since that
Amendment 279 #
Proposal for a regulation 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 EU SoHO Platform might also be utilized by Member States as a channel for national initiatives and campaigns to encourage the exchange of best practices. Said national campaigns and campaigns shall, in close cooperation with patient organizations, aim to promote donation and sustainable supplies of SoHO products.
Amendment 280 #
Proposal for a regulation 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 EU SoHO Platform should also serve as a reliable source of information for the general public regarding the work of the SoHO Coordination Board, national competent authorities and other expert bodies, including the EDQM, and SoHO entities and establishments.
Amendment 281 #
Proposal for a regulation 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
Amendment 282 #
Proposal for a regulation 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 283 #
Proposal for a regulation 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
Amendment 284 #
Proposal for a regulation 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 and the centralisation of this data in order to apply the most viable solutions, as well as improved transparency of national reporting and supervisory activities.
Amendment 285 #
Proposal for a regulation Recital 42 (42) The processing of personal data under this Regulation should be subject to strict guarantees of confidentiality and should comply with the rules on the protection of personal data laid down in Regulation (EU) 2016/679 of the European Parliament and of the Council and in Regulation (EU) 2018/1725 of the European Parliament and of the Council
Amendment 286 #
Proposal for a regulation Recital 43 (43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform, once established, should be granted within the framework of the European Health Data Space (EHDS) and otherwise should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 287 #
Proposal for a regulation Recital 43 (43) As the EU SoHO Platform requires the processing of personal data, it will be
Amendment 288 #
Proposal for a regulation Recital 43 (43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation. In addition, the personal data and curriculum vitae of the persons responsible for the release of SoHOs should not be made public.
Amendment 289 #
Proposal for a regulation Recital 43 (43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should, once it is established, be granted within the framework of the European Health Data Space and otherwise be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 290 #
Proposal for a regulation Recital 43 (43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection laid down in Article 5 of Regulation (EU) 2016/679. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 291 #
Proposal for a regulation Recital 44 (44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person
Amendment 292 #
Proposal for a regulation Recital 44 (44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the prohibition of making the human body and its parts a source of economic gain, the integrity of the person, the protection of personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable and non-discriminatory access to SoHOs are defined in a transparent manner, on the basis of an objective evaluation of medical needs. This Regulation should therefore be applied
Amendment 293 #
Proposal for a regulation Recital 44 (44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence and criteria of compatibility between donors and recipients, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable access to SoHOs are defined in a
Amendment 294 #
Proposal for a regulation Recital 44 (44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of
Amendment 295 #
Proposal for a regulation 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 296 #
Proposal for a regulation Recital 44 a (new) (44 a) Due to the high sensitivity of donor anonymity and taking into account the rights of offspring born from medically assisted reproduction with third party donation, SoHO entities should ensure donors of reproductive cells are duly informed about the possibility of ID release and the implication hereof, pursuant to provisions laid down in national legislation;
Amendment 297 #
Proposal for a regulation Recital 45 (45) SoHOs, by definition, relate to persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU) 2018/1725. Data on safety and efficacy of new SoHO preparations in recipients should also be shared, with appropriate protective measures and, where possible, anonymised, to allow aggregation at Union level for more robust evidence
Amendment 298 #
Proposal for a regulation Recital 45 (45) SoHOs, by definition, relate to persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU)
Amendment 299 #
Proposal for a regulation Recital 45 (45) SoHOs, by definition, relate to natural persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the
Amendment 300 #
Proposal for a regulation Recital 46 (46) In order to enable better access to health data in the interests of public health, Member States should entrust competent authorities as data controllers within the meaning of Regulation (EU) 2016/679 with powers to take decisions on the access to and re-use of such data, specifying the period for which they are to be retained and how they are to be accessed or the number of persons having access and for how long.
Amendment 301 #
Proposal for a regulation Recital 46 (46) In order to enable better access to health data in the interests of public health, Member States should entrust competent authorities as data controllers within the meaning of Regulation (EU) 2016/679 with powers to take decisions on the access to and re-use of such data. Furthermore, access to secondary data for reseach purposes should be made available via the European Health Data Space, once it is established.
Amendment 302 #
Proposal for a regulation Recital 47 (47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHOs that need to be matched between the donor and
Amendment 303 #
Proposal for a regulation Recital 47 (47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need.
Amendment 304 #
Proposal for a regulation Recital 47 (47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages, using a database to trace the availability thereof in various Member States. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need in the optimal timeframe to achieve the desired results. In this context, the objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 305 #
Proposal for a regulation Recital 47 a (new) (47 a) The objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 306 #
Proposal for a regulation Recital 47 a (new) (47 a) In order to successfully implement this Regulation and ensure high quality and safety standards of SoHOs in the long-term, Member States should enhance education and provide appropriate training for medical personnel regarding SoHO collection, processing, storage, application, transfusion and procurement.
Amendment 307 #
Proposal for a regulation Recital 47 b (new) (47 b) In some cases such as bone marrow or haematopoietic stem cell transplants, the level of donor/recipient compatibility has to be extremely high. Therefore, excellent coordination is needed at a global level, beyond the Union level, so that each patient has more options of finding a compatible donor.
Amendment 308 #
Proposal for a regulation Recital 48 (48) In order to be able to supplement this Regulation where necessary with additional standards concerning the protection of donors, recipients and offspring
Amendment 309 #
Proposal for a regulation Recital 51 a (new) (51a) In view of the significant systemic changes that will result from the entry into force of this draft Regulation, it is essential to give Member States sufficient time to redesign existing national solutions so that they can comprehensively, coherently and reliably amend national legislation in all areas covered by the Regulation;
Amendment 310 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘SoHOs’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction, and for enhanced coordination between Member States to improve the availability and accessibility of SoHO across the Union. This Regulation is without prejudice to national legislation which establishes rules relating to aspects of SoHOs other than their quality and safety and the safety of SoHO donors, recipients and offspring of medically assisted reproduction.
Amendment 311 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘SoHOs’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted
Amendment 312 #
Proposal for a regulation Article 1 – paragraph 1 This Regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘SoHOs’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring
Amendment 313 #
Proposal for a regulation Article 2 – paragraph 1 – introductory part 1. This Regulation shall apply to SoHOs intended for human application, to SoHO preparations, to products manufactured from SoHOs and intended for human application, to SoHO donors
Amendment 314 #
Proposal for a regulation Article 2 – paragraph 1 – introductory part 1. This Regulation shall apply exclusively to SoHOs intended for human application, to SoHO preparations, to products manufactured from SoHOs and intended for human application, to SoHO donors and recipients who have not been duly declared dead, and to the following SoHO activities:
Amendment 315 #
Proposal for a regulation Article 2 – paragraph 1 – point a (a) SoHO donor recruitment; except if the entity is not subject to further SoHO activites as listed in this paragraph.
Amendment 316 #
Proposal for a regulation Article 2 – paragraph 1 – point a (a) SoHO donor recruitment, except if that is the full extent of an entity’s SoHO activity;
Amendment 317 #
Proposal for a regulation Article 2 – paragraph 1 – point h a (new) (ha) SoHO dispensing;
Amendment 318 #
(h a) issuing of SoHOs;
Amendment 319 #
Proposal for a regulation Article 2 – paragraph 1 – point m – point i (new) (i) promotion and coordination actions to ensure SoHO supplies and foster donation culture.
Amendment 320 #
Proposal for a regulation Article 2 – paragraph 1 – point m a (new) (ma) The exchange and sharing of data or information on quantities or stocks of SoHOs, and the promotion of activities related to security of supply;
Amendment 321 #
Proposal for a regulation Article 2 – paragraph 1 – point m a (new) (m a) clinical studies with SoHO.
Amendment 322 #
Proposal for a regulation Article 2 – paragraph 2 – introductory part 2. In cases of autologous use of SoHOs, with the exception of processes involving a substantial manipulation or application intended for a non- homologous use, where:
Amendment 323 #
Proposal for a regulation Article 2 – paragraph 2 – introductory part 2. In cases of autologous use of SoHOs, excluding cases where the processing involves a substantial modification or where its application is non-homologous, where:
Amendment 324 #
Proposal for a regulation Article 2 – paragraph 2 – point c (c) SoHOs are not
Amendment 325 #
Proposal for a regulation Article 2 – paragraph 3 – subparagraph 1 For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes,
Amendment 326 #
Proposal for a regulation Article 2 – paragraph 3 – subparagraph 1 For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, on investigational medicinal products regulated by Regulation 536/2014, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 327 #
Proposal for a regulation Article 2 – paragraph 3 – subparagraph 1 For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, on investigational medicinal products regulated by Regulation 536/2014, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 328 #
Proposal for a regulation Article 2 – paragraph 3 – subparagraph 1 For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients, as well as continuity of SoHO supply, shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 329 #
Proposal for a regulation Article 2 – paragraph 3 – subparagraph 2 By way of derogation from the first subparagraph, in cases where SoHOs,
Amendment 330 #
Proposal for a regulation Article 2 – paragraph 3 – subparagraph 2 By way of derogation from the first subparagraph, in cases where SoHOs, SoHO preparations, or products manufactured from SoHO, as referred to in that subparagraph, are exclusively for autologous use, only those provisions of this Regulation that concern the collection and testing of SoHOs from patients shall apply.
Amendment 331 #
Proposal for a regulation Article 2 – paragraph 4 4. Where non-viable SoHOs or their derivatives, as defined in Article 2, point (17), of Regulation (EU) 2017/745,
Amendment 332 #
Proposal for a regulation Article 2 – paragraph 4 a (new) 4 a. This Regulations further establishes provisions on: (a) national emergency plans and the EU Strategy for critical SoHO supply sufficiency; (b) SoHo Coordination Board; (c) EU SoHO Platform.
Amendment 333 #
(1) ‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the body. It consists of a liquid part, plasma, and a solid consisting of red blood cells, leucocytes and platelets;
Amendment 334 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1)
Amendment 335 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3)
Amendment 336 #
Proposal for a regulation Article 3 – paragraph 1 – point 5 (5) ‘substance of human origin’ (SoHO) means any substance collected from the human body in whatever manner, whether it contains cells or not and whether those cells are living or not. For the purposes of this Regulation, SoHO does not include organs in the sense of Article 3, point (h), of Directive 2010/53/EU, medicinal products regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC and investigational medicinal products regulated by Regulation (EC) No 536/2014;
Amendment 337 #
Proposal for a regulation Article 3 – paragraph 1 – point 5 (5) ‘substance of human origin’ (SoHO) means any substance collected from the human body
Amendment 338 #
Proposal for a regulation Article 3 – paragraph 1 – point 5 (5) ‘substance of human origin’ (SoHO) means any substance collected from the human body in whatever manner, whether it contains cells or not and whether those cells are living or not. For the purposes of this Regulation, SoHO does not include organs in the sense of Article 3, point (h), of Directive 2010/53/EU, but does include substances which can be extracted from them;
Amendment 339 #
Proposal for a regulation Article 3 – paragraph 1 – point 6 (6) ‘human application’ means inserted, implanted, injected, infused, transfused, transplanted, ingested, transferred (as in transfer to the uterus
Amendment 340 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 (7) ‘SoHO activity’ means an action, or series of actions, that has a direct impact on the safety, quality
Amendment 341 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 (8) ‘SoHO donor’ means any person who
Amendment 342 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 (8) ‘SoHO donor’ means any person who has presented themselves freely and voluntarily to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not;
Amendment 343 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 (8) ‘SoHO donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, or a deceased person who has authorised, or on his/her behalf a family member or authorised person, the donation of parts of his/her body after death, whether that donation is successful or not;
Amendment 344 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 (8) ‘SoHO donor’ means a
Amendment 345 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 (8) ‘SoHO donor’ means any
Amendment 346 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 (8) ‘SoHO donor’ means any person who has presented themselves voluntarily to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not;
Amendment 347 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 a (new) (8 a) ‘living SoHO donor’ means a living person who has presented themselves to a SoHO entity, or been presented by a person granting consent on their behalf, in accordance with national legislation, with a view to making a donation of SoHOs, whether that donation is successful or not, for the purpose of application to a person other than themselves, and other than situations of within couple use as defined in point (63);
Amendment 348 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 a (new) (8a) 'donation' means a philanthropic act by a person of freely and voluntarily agreeing to provide a third party with a SoHO from that person's own body. Donations are deemed to be unpaid-for. Donations of reproductive cells are not covered by this Regulation in the case of post-mortem usage, which should be prohibited in all Member States.
Amendment 349 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 a (new) (8 a) ‘SoHO donation’ means a process by which a person – or on his/her behalf a relative or authorised person – voluntarily and altruistically gives parts of their own body to other people in need, or authorises their use after their death. It includes the necessary medical formalities, examinations and treatments and monitoring of the SoHO donor, whether that donation is successful or not;
Amendment 350 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 a (new) (8 a) ‘Living SoHO donor’ means any living person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs either for autologous use or for allogeneic use.
Amendment 351 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 b (new) (8 b) ‘deceased SoHO donor’ means a person who has been referred to a SoHO entity and for whom consent or authorisation, or absence of expressed refusal to donation is in place, in accordance with national legislation;
Amendment 352 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 b (new) (8 b) ‘living donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not;
Amendment 353 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 b (new) (8 b) ‘Deceased SoHO donor’ means any deceased person who donates SoHO after death.
Amendment 354 #
Proposal for a regulation Article 3 – paragraph 1 – point 9 (9) ‘SoHO recipient’ means the person to whom SoHOs are applied or such an application is envisaged;
Amendment 355 #
Proposal for a regulation Article 3 – paragraph 1 – point 10 (10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm, in vitro fertilisation or any other laboratory or medical intervention that promotes conception and uses SoHOs for the preservation of fertility through collection and storage of SoHO substances for subsequent human application;
Amendment 356 #
Proposal for a regulation Article 3 – paragraph 1 – point 10 Amendment 357 #
Proposal for a regulation Article 3 – paragraph 1 – point 10 (10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm
Amendment 358 #
Proposal for a regulation Article 3 – paragraph 1 – point 10 (10) ‘medically assisted reproduction’ means the facilitation of conception
Amendment 359 #
Proposal for a regulation Article 3 – paragraph 1 – point 11 (11) ‘offspring from
Amendment 360 #
Proposal for a regulation Article 3 – paragraph 1 – point 11 (11) ‘offspring from medically assisted reproduction’ means
Amendment 361 #
Proposal for a regulation Article 3 – paragraph 1 – point 11 (11) ‘offspring from medically assisted reproduction’ means
Amendment 362 #
Proposal for a regulation Article 3 – paragraph 1 – point 11 a (new) (11 a) ‘unborn offspring from medically assisted reproduction’ means embryos and foetuses conceived by medically assisted reproduction;
Amendment 363 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – point a (a) has been subjected to one or more SoHO activities
Amendment 364 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – point b (b) meets a pre-defined specification;
Amendment 365 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – point b (b) meets a pre-defined specification;
Amendment 366 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – point c (c) is intended for application to a recipient for a specific and homologous clinical indication or is intended for distribution for manufacture of a product regulated by other Union legislation, or as the starting and raw material thereof; and
Amendment 367 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – point c (c) is intended for application to a recipient for a specific clinical indication or is intended for distribution for manufacture of a product regulated by other Union legislation, or as the starting and raw material thereof; and
Amendment 368 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – point c a (new) (c a) has not been substantially modified, such as to be considered as a medicinal product or advanced therapy, and is not intended to be applied in a non- homologous manner to the recipient.
Amendment 369 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 – point c a (new) (c a) does not involve a substantial manipulation or is intended for a non- homologous application.
Amendment 370 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 a (new) (12 a) ‘competent authority’ means the body or bodies responsible for SoHO’s activities at national level, designated by each Member State;
Amendment 371 #
Proposal for a regulation Article 3 – paragraph 1 – point 12 b (new) (12 b) ‘national authority’ means the reference competent authority, at national level, appointed by each Member State and responsible for coordinating exchanges with the Commission and with the national SoHO authorities of other Member States;
Amendment 372 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 (13) ‘donor recruitment’ means any information and communication activity aimed at encouraging persons to become SoHO donors;
Amendment 373 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 (13) ‘donor recruitment’ means any activity aimed at informing the public and encouraging persons to become SoHO donors;
Amendment 374 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 (13) ‘donor recruitment’ means any activity aimed at informing and encouraging persons to become SoHO donors;
Amendment 375 #
Proposal for a regulation Article 3 – paragraph 1 – point 14 (14)
Amendment 376 #
Proposal for a regulation Article 3 – paragraph 1 – point 14 Amendment 377 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘processing’ means any operation involved in the non-autologous handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging; in autologous use it means only handling beyond minimal operations including immediate application of SoHO within a closed system;
Amendment 378 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘processing’ means any operation involved in the handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging. It does not include activities involving a substantial modification of SoHOs that would make it a medicinal product or an advanced therapy;
Amendment 379 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘processing’ means any operation involved in the handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging with the exception of activities requiring substantial manipulation;
Amendment 380 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 (15) ‘processing’ means any operation involved in the
Amendment 381 #
Proposal for a regulation Article 3 – paragraph 1 – point 15 Amendment 382 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘quality control’ means several tests or checks, based on common criteria, to confirm that a SoHO activity or SoHO preparation meets pre-defined quality criteria;
Amendment 383 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘quality control’ means
Amendment 384 #
Proposal for a regulation Article 3 – paragraph 1 – point 17 Amendment 385 #
Proposal for a regulation Article 3 – paragraph 1 – point 17 (17)
Amendment 386 #
Proposal for a regulation Article 3 – paragraph 1 – point 17 (17) ‘storage’ means the maintenance of SoHOs under appropriate controlled conditions until distribution or issuing;
Amendment 387 #
Proposal for a regulation Article 3 – paragraph 1 – point 18 (18) ‘release’ means a process through which it is verified that a SoHO or a SoHO preparation meets defined safety and quality criteria and the conditions of any applicable authorisation before distribution, issuing, export or human application;
Amendment 388 #
Proposal for a regulation Article 3 – paragraph 1 – point 18 Amendment 389 #
Proposal for a regulation Article 3 – paragraph 1 – point 18 a (new) (18a) 'disposal' means completely destroying SoHOs for whatever reason. Strict monitoring rules must be complied with so as to ensure that the ultimate purpose of the disposal process is achieved.
Amendment 390 #
Proposal for a regulation Article 3 – paragraph 1 – point 18 a (new) (18a) 'dispensing' means the provision of SoHOs or SoHO preparations, possibly following a medical prescription, for application to a specific recipient;
Amendment 391 #
Proposal for a regulation Article 3 – paragraph 1 – point 20 (20) ‘import’ means activities carried out to bring SoHOs or SoHO preparations into the Union from a third country, including the organisation of such activities
Amendment 392 #
Proposal for a regulation Article 3 – paragraph 1 – point 20 (20) ‘import’ means activities carried out to bring SoHOs or SoHO preparations into the Union from a third country, including the organisation of such activities and physical verification of coherence with associated documentation and of the quality of the preparations, in accordance with EU standards, the appropriateness of transport conditions, the integrity of packaging and the adequacy of labelling before release;
Amendment 393 #
Proposal for a regulation Article 3 – paragraph 1 – point 21 (21) ‘export’ means distribution of SoHOs or SoHO preparations to third countries outside the Union;
Amendment 394 #
Proposal for a regulation Article 3 – paragraph 1 – point 21 a (new) (21 a) ‘non-homologous use’ means a cell or tissue that, when applied to a recipient, ceases to have the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 395 #
Proposal for a regulation Article 3 – paragraph 1 – point 21 b (new) (21 b) ‘homologous use’ means a cell or tissue that when applied in a recipient mantains the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 396 #
Proposal for a regulation Article 3 – paragraph 1 – point 22 (22) ‘clinical outcome monitoring’ means evaluation of the health of a SoHO recipient for the purpose of monitoring the results of a SoHO preparation application, maintaining care and demonstrating safety and efficacy or functionality;
Amendment 397 #
Proposal for a regulation Article 3 – paragraph 1 – point 23 (23) ‘autologous use’ means collection of SoHO from one individual for subequent application to the same individual
Amendment 398 #
Proposal for a regulation Article 3 – paragraph 1 – point 23 (23) ‘autologous use’ means collection of SoHO from one individual for
Amendment 399 #
Proposal for a regulation Article 3 – paragraph 1 – point 24 (24) ‘SoHO entity’ means an organisation legally established in the Union and accredited that carries out one or more of the SoHO activities set out in Article 2(1);
Amendment 400 #
Proposal for a regulation Article 3 – paragraph 1 – point 27 (27) ‘adverse occurrence’ means any incident associated with the donation or human application of SoHO that caused harm to a living SoHO donor, harm to a SoHO recipient or to offspring from medically assisted reproduction or that implied a risk of such harm;
Amendment 401 #
(a) death, i.e. the irreversible cessation of an individual's vital functions by natural causes or as a result of medically assisted suicide;
Amendment 402 #
Proposal for a regulation Article 3 – paragraph 1 – point 28 – point b (b) life-threatening,
Amendment 403 #
Proposal for a regulation Article 3 – paragraph 1 – point 28 – point h a (new) h a) the transfer of embryos other than those intended.
Amendment 404 #
Proposal for a regulation Article 3 – paragraph 1 – point 28 – point i (i) prolonged sub-optimal health of a SoHO donor
Amendment 405 #
Proposal for a regulation Article 3 – paragraph 1 – point 28 – point i a (new) (i a) any other adverse ocurrence specified by the EDQM guidelines.
Amendment 406 #
Proposal for a regulation Article 3 – paragraph 1 – point 28 – point i a (new) (i a) any other adverse occurrences specified by EDQM guidelines;
Amendment 407 #
Proposal for a regulation Article 3 – paragraph 1 – point 29 (29) ‘SoHO rapid alert’ means a communication regarding a
Amendment 408 #
Proposal for a regulation Article 3 – paragraph 1 – point 31 (31) ‘EU SoHO Platform’ means the digital platform established and managed by the Commission
Amendment 409 #
Proposal for a regulation Article 3 – paragraph 1 – point 31 (31)
Amendment 410 #
Proposal for a regulation Article 3 – paragraph 1 – point 31 (31) ‘EU SoHO Platform’ means the digital platform established by the Commission to exchange information concerning SoHO activities which should be interoperable with existing and upcoming frameworks;
Amendment 411 #
Proposal for a regulation Article 3 – paragraph 1 – point 31 (31) ‘EU SoHO Platform’ means the digital platform established by the Commission to exchange information concerning SoHO activities and which is accessible in all the official EU languages;
Amendment 412 #
Proposal for a regulation Article 3 – paragraph 1 – point 33 (33) ‘the compendium of SoHO’ means a list kept up-to-date by the SoHO Coordination Board of decisions, taken at Member State level, and opinions, issued by competent authorities and by the SCB and the Classification Advisory Council, on the regulatory status of specific substances, products or activities and published on the EU SoHO platform;
Amendment 413 #
Proposal for a regulation Article 3 – paragraph 1 – point 34 a (new) (34 a) "Quality risk management system" : means a systematic process for the assessment, control, communication and review of the quality risks of a SoHo or SoHO preparation throughout its life cycle;
Amendment 414 #
Proposal for a regulation Article 3 – paragraph 1 – point 38 (38) ‘Union training’ means training activities for the personnel of competent authorities and, where appropriate, for personnel of delegated bodies performing SoHO supervisory activities;
Amendment 415 #
Proposal for a regulation Article 3 – paragraph 1 – point 40 (40) ‘SoHO establishment’ means a SoHO entity that carries out
Amendment 416 #
Proposal for a regulation Article 3 – paragraph 1 – point 41 (41) ‘critical SoHO’ means a SoHO for which an insufficient supply will result in
Amendment 417 #
Proposal for a regulation Article 3 – paragraph 1 – point 41 (41)
Amendment 418 #
Proposal for a regulation Article 3 – paragraph 1 – point 42 (42) ‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to the supply of critical SoHOs and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for
Amendment 419 #
Proposal for a regulation Article 3 – paragraph 1 – point 42 (42) ‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to the supply of critical SoHOs and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for
Amendment 420 #
Proposal for a regulation Article 3 – paragraph 1 – point 42 a (new) (42 a) ‘Classification Advisory Council’ means a body composed of representatives of the SoHO Coordination Board, the European Medicines Agency and the Medical Device Coordination Group with the responsibility of assisting the Member States and the Commission in determining the regulatory status of a substance, product or activity covered by this Regulation;
Amendment 421 #
Proposal for a regulation Article 3 – paragraph 1 – point 42 b (new) (42 b) ‘SoHO Coordination Board (SCB)’ means a body set up by this Regulation to promote coordination between Member States on SoHO;
Amendment 422 #
Proposal for a regulation Article 3 – paragraph 1 – point 45 (45)
Amendment 423 #
Proposal for a regulation Article 3 – paragraph 1 – point 45 (45) ‘technical guidelines’ means a description of a series of methodological procedures and parameters, updated in accordance with the latest scientific evidence, that, if followed, achieve a level of quality and safety of a SoHO activity or a SoHO preparation that is considered to be acceptable as a means to comply with regulatory standards;
Amendment 424 #
Proposal for a regulation Article 3 – paragraph 1 – point 47 – introductory part (47) ‘traceability’ means the ability to locate and identify SoHOs during any step from collection through processing and storage
Amendment 425 #
Proposal for a regulation Article 3 – paragraph 1 – point 47 – introductory part (47) ‘traceability’ means the ability to locate and identify SoHOs during any step from collection through processing and storage to
Amendment 426 #
Proposal for a regulation Article 3 – paragraph 1 – point 51 (51) ‘imputability’ means the likelihood that a serious adverse occurrence, in a SoHO donor, is related to the donation
Amendment 427 #
Proposal for a regulation Article 3 – paragraph 1 – point 51 (51) ‘imputability’ means the likelihood that a
Amendment 428 #
Proposal for a regulation Article 3 – paragraph 1 – point 51 (51) ‘imputability’ means the likelihood that a
Amendment 429 #
Proposal for a regulation Article 3 – paragraph 1 – point 59 (59) ‘EDQM SoHO monograph’ means a specification of the critical quality parameters related to the therapeutic indication of a particular SoHO preparation defined by the European Directorate for the Quality of Medicines and HealthCare of the Council of Europe;
Amendment 430 #
Proposal for a regulation Article 3 – paragraph 1 – point 60 Amendment 431 #
Proposal for a regulation Article 3 – paragraph 1 – point 60 (60) ‘Annual SoHO Activity Report’ means the annual report published by the Commission aggregating the data reports from SoHO entities carrying out the following activities: donor recruitment, collection, storage, distribution, import, export and human application of SoHOs;
Amendment 432 #
Proposal for a regulation Article 3 – paragraph 1 – point 61 (61)
Amendment 433 #
Proposal for a regulation Article 3 – paragraph 1 – point 61 (61) ‘SoHO for reproducti
Amendment 434 #
Proposal for a regulation Article 3 – paragraph 1 – point 62 (62) ‘third party donation’ means a donation of SoHO for reproducti
Amendment 435 #
Proposal for a regulation Article 3 – paragraph 1 – point 62 a (new) (62 a) ‘ID release’ means disclosure of personal identifying information about reproductive cells donor to donor- conceived offspring;
Amendment 436 #
Proposal for a regulation Article 3 – paragraph 1 – point 63 (63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction
Amendment 437 #
Proposal for a regulation Article 3 – paragraph 1 – point 63 (63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction from two persons with an intimate physical relationship (‘partners’) , where one person supplies their own oocytes and the other person supplies their own sperm;
Amendment 438 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64)
Amendment 439 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good of
Amendment 440 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64)
Amendment 441 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good of any quantifiable losses associated with donation, without any net gain or loss;
Amendment 442 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good of any
Amendment 443 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good of any
Amendment 444 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good of any
Amendment 445 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good
Amendment 446 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good
Amendment 447 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good
Amendment 448 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good
Amendment 449 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good
Amendment 450 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 (64) ‘compensation’ means making good
Amendment 451 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 a (new) (64 a) 'financial neutrality' means that no financial gain or loss will be incurred by compensated donors as a result of the donation;
Amendment 452 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 a (new) (64 a) ‘reimbursement’ means the reimbursement of costs incurred by the donor associated with the donation process;
Amendment 453 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 a (new) (64a) 'financial neutrality of a donation' means that there will be no financial gains or losses for a donor as a result of a donation;
Amendment 454 #
Proposal for a regulation Article 3 – paragraph 1 – point 64 b (new) (64 b) ‘financial neutrality’ means a situation in which the donor does not experience net economic gains or losses associated with a donation;
Amendment 455 #
Proposal for a regulation Article 3 – paragraph 1 – point 65 (65) ‘allogeneic
Amendment 456 #
Proposal for a regulation 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 457 #
Proposal for a regulation 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 458 #
Proposal for a regulation 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 459 #
Proposal for a regulation 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 460 #
Proposal for a regulation 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 461 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 a (new) (70 a) ‘informed consent’ means consent by the donor to make a free and non- coercive donation or consent by the recipient to accept a treatment with a SoHO, after receiving clear, comprehensive and comprehensible information;
Amendment 462 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 a (new) Amendment 463 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 b (new) (70b) 'patient blood management' means an innovative organisational approach for optimising the care of patients with haemorrhagic disorders, for example anaemia, which is based on the following three pillars: (a) optimising the patient's blood mass; (b) minimising blood loss; (c) improving the patient's tolerance to anaemia;
Amendment 464 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 a (new) (70a) 'patient blood management' means an innovative organisational approach for the best possible management of patients undergoing surgery at risk of bleeding, based on the following three pillars: (a) optimising the patient's blood mass; (b) minimising blood loss; (c) improving the patient's tolerance to anaemia;
Amendment 465 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 b (new) (70 b) ‘European autonomy’ means the situation where the Union has the capacity to self-supply SoHO, being self- sufficient from third countries to cover most of the demand, with the exception of those SoHOs which require global management due to their intrinsic characteristics.
Amendment 466 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 b (new) (70b) ‘donor base resilience’ means the capacity of the donation collection system to rely on a large number of donors to address the emergence of a health crisis;
Amendment 467 #
(70c) ‘free and informed consent’ means that the donor’s agreement has been obtained freely without coercion and after access to clear, comprehensive information in line with his or her capacity to understand;
Amendment 468 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 c (new) (70 c) ‘SoHO clinical study’ means an experimental evaluation of a SoHO or a SoHO preparation in humans, with the objective of drawing conclusions regarding its efficacy and safety.
Amendment 469 #
Proposal for a regulation Article 3 – paragraph 1 – point 70 d (new) (70d) 'national self-sufficiency' means Member States' lack of dependence on another State as regards the collection and manufacture of SoHOs, the transport of those substances and any other SoHO activity.
Amendment 470 #
Proposal for a regulation Article 4 – paragraph 1 1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on condition that those national measures are compatible with Union law
Amendment 471 #
Proposal for a regulation Article 4 – paragraph 1 1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on
Amendment 472 #
Proposal for a regulation Article 4 – paragraph 1 1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation in order to comply with national provisions in this field on condition that those national measures are
Amendment 473 #
Proposal for a regulation Article 4 – paragraph 1 1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on condition that those national measures are compatible with
Amendment 474 #
Proposal for a regulation Article 4 – paragraph 1 a (new) 1a. Member States may introduce additional measures to help set up a national and European supply chain and to achieve the objective of national self- sufficiency. Such measures may also aim to reinforce the principle of voluntary and unpaid donation.
Amendment 475 #
Proposal for a regulation Article 4 – paragraph 2 2. Member States
Amendment 476 #
Proposal for a regulation Article 5 – paragraph 3 – point a (a) have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined by
Amendment 477 #
Proposal for a regulation Article 5 – paragraph 3 – point b – point ii (ii) to order the immediate suspension or cessation of a SoHO activity that poses immediate risk to SoHO donors, SoHO recipients or the general public or do not comply with the conditions of its authorisation or the requirements of this Regulation;
Amendment 478 #
Proposal for a regulation Article 5 – paragraph 3 – point c (c) have sufficient
Amendment 479 #
Proposal for a regulation 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 480 #
Proposal for a regulation 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 481 #
Proposal for a regulation 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 482 #
Proposal for a regulation 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 483 #
Proposal for a regulation Article 5 – paragraph 3 – point c (c) have sufficient resources,
Amendment 484 #
Proposal for a regulation 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 485 #
Proposal for a regulation Article 5 – paragraph 4 4. Each Member State shall designate a single SoHO National Authority, in conformity with Member States’ constitutional requirements, responsible for coordinating exchanges with the Commission and with other Member States’ SoHO National Authorities. The Commission shall make publicly available the list of SoHO National Authorities on the EU SoHO Platform.
Amendment 486 #
Proposal for a regulation Article 5 – paragraph 4 a (new) 4 a. Member States shall designate their SoHO National Authorities to create a national plasma strategy, in order to increase their collection capacity and the security of the collection and patients, as well as ensuring the sufficient training and know-how of staff working on SoHO;
Amendment 487 #
Proposal for a regulation Article 7 – paragraph 2 2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Personnel shall not have engaged in any activity, beyond an appropriate point in time prior to working for the competent authorities concerned, which may detract from their independence.
Amendment 488 #
Proposal for a regulation Article 7 – paragraph 2 2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. All relevant personnel shall make an annual declaration of their interests, which shall be published on the authorities’ web-portal.
Amendment 489 #
Proposal for a regulation Article 7 – paragraph 2 2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation of incompatibility that may, directly or indirectly, affect the impartiality of their professional conduct.
Amendment 490 #
Proposal for a regulation Article 8 – paragraph 1 1. Without prejudice to Article 75,
Amendment 491 #
Proposal for a regulation Article 8 – paragraph 1 1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human health. They shall also be transparent about the criteria used for the assessment and authorisation of SoHO preparations and SoHO entities.
Amendment 492 #
Proposal for a regulation Article 8 – paragraph 1 1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions t
Amendment 493 #
Proposal for a regulation Article 9 – paragraph 1 1. Competent authorities shall be responsible for the SoHO supervisory activities referred to in Chapter III in order to verify the effective compliance of SoHO entities and SoHO preparations authorised in their territory with the requirements set out in this Regulation.
Amendment 494 #
Proposal for a regulation 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 495 #
Proposal for a regulation Article 9 – paragraph 2 – point b (b) procedures to ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;
Amendment 496 #
Proposal for a regulation Article 9 – paragraph 2 – point c (c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities efficiently, safely and effectively;
Amendment 497 #
Proposal for a regulation Article 9 – paragraph 2 – point c (c) appropriate and properly
Amendment 498 #
Proposal for a regulation Article 14 – paragraph 1 1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with authorities established in other relevant Union legislation referred to in Article 2(3),
Amendment 499 #
Proposal for a regulation Article 14 – paragraph 1 1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with
Amendment 500 #
Proposal for a regulation Article 14 – paragraph 2 – subparagraph 1 Amendment 501 #
Proposal for a regulation Article 14 – paragraph 2 – subparagraph 1 In the course of the consultation referred to in paragraph 1, the competent authorities
Amendment 502 #
Proposal for a regulation Article 14 – paragraph 2 – subparagraph 2 Amendment 503 #
Proposal for a regulation Article 14 – paragraph 2 – subparagraph 2 The
Amendment 504 #
Proposal for a regulation Article 14 – paragraph 2 – subparagraph 2 a (new) 2 a.In deviation from paragraphs 1 and 2, the following procedure shall apply when a substance or product may possibly be considered a medicinal product: (a) The question shall automatically be referred to the EMA and the SCB and the full dossier shall be made available. (b) The EMA and the SCB shall establish a permanent panel for reviewing such questions.The panel shall, where relevant, also consult other authorities mentioned in paragraph 1, such as the Medical Devices Coordination Group. (c) The panel shall seek to reach an opinion by consensus.An opinion adopted by consensus shall be implemented by the competent authorities.If no consensus can be reached, the question shall be referred to the Commission for a decision in accordance with paragraph 4. The members of the panel shall be appointed by the EMA and the SCB based on their specific expertise, including for the EMA in particular expertise in the area of advanced therapy medicinal products. The EMA shall ensure the secretariat of the panel and collaborate with the SCB in maintaining the compendium.
Amendment 505 #
Proposal for a regulation Article 14 – paragraph 3 3. The competent authorities shall inform the
Amendment 506 #
Proposal for a regulation Article 14 – paragraph 3 a (new) Amendment 507 #
Proposal for a regulation Article 14 – paragraph 4 – subparagraph 1 The Commission may, upon a duly substantiated request of a Member State following the consultation referred to in paragraphs 1 and 2, or on its own initiative after a consultation with the SCB and relevant advisory bodies established under Union legislation referred to in Article 2(3), by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, in case questions arise in that respect, notably when these questions cannot be resolved at the Member State level, or in discussions between the SCB and the advisory bodies established in other relevant Union legislation, in accordance with Article 68(1), point (b).
Amendment 508 #
Proposal for a regulation Article 14 – paragraph 4 – subparagraph 1 The Commission may, upon a duly substantiated request of a Member State
Amendment 509 #
Proposal for a regulation Article 14 – paragraph 4 – subparagraph 1 The Commission may, upon a duly substantiated request of a Member State or the Classification Advisory Council, following the consultation referred to in paragraph 1,
Amendment 510 #
Proposal for a regulation Article 14 – paragraph 5 Amendment 511 #
Proposal for a regulation 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, or in the case of paragraph 2a, the EMA.
Amendment 512 #
Proposal for a regulation Article 14 – paragraph 6 6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated
Amendment 513 #
Proposal for a regulation Article 14 – paragraph 6 6. The consultation
Amendment 514 #
Proposal for a regulation Article 14 – paragraph 7 – subparagraph 1 The Commission may, by means of implementing acts, lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation
Amendment 515 #
Proposal for a regulation Article 14 – paragraph 7 – subparagraph 1 The Commission may, by means of implementing acts, lay down rules concerning procedures for consultation referred to in paragraph 1
Amendment 516 #
Proposal for a regulation Article 14 – paragraph 7 – subparagraph 1 The Commission may, by means of
Amendment 517 #
Proposal for a regulation Article 14 – paragraph 7 – subparagraph 2 Those
Amendment 518 #
Proposal for a regulation Article 16 – paragraph 1 – point a (a) have, or have access to, a sufficient number of personnel so that SoHO supervisory activities can be performed
Amendment 519 #
Proposal for a regulation Article 16 – paragraph 2 – point a (a) before any inspection procedure is initiated, declare in writing any direct or indirect interests referred to in Article 7(2)
Amendment 520 #
Proposal for a regulation Article 16 – paragraph 2 – point d (d) participate regularly in training at national or European level in the subject matter and on the obligations of competent authorities resulting from this Regulation, as referred to in paragraph 3 so as to be up to date with any changes or updates to the provisions of the Regulation.
Amendment 521 #
3. Competent authorities, in cooperation with delegated bodies as necessary, shall develop and implement training programmes at national level for the purpose of ensuring that personnel performing SoHO supervisory activities receive the training referred to in paragraph 2, points (b), (c) and (d). Competent authorities shall maintain records of the training undertaken by their personnel. Competent authorities shall provide opportunities for their personnel to participate in the Union training referred to in Article 69 where such Union training is available and appropriate.
Amendment 522 #
Proposal for a regulation Article 17 Amendment 523 #
Proposal for a regulation Article 18 – paragraph 3 – point e Amendment 524 #
Proposal for a regulation Article 20 – paragraph 3 3. SoHO preparation authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific SoHO preparation, that Member State may decline to recognise the validity
Amendment 525 #
Proposal for a regulation Article 21 – paragraph 1 1. Competent authorities shall have procedures in place to allow that applications for the authorisation of SoHO preparations are submitted in accordance with Article 41. They shall provide guidelines and templates for the submission of applications for SoHO preparation authorisation. When developing these guidelines and templates, competent authorities shall
Amendment 526 #
Proposal for a regulation Article 21 – paragraph 2 – point c (c) grant a conditional authorisation for the use of the SoHO preparation in all cases where clinical outcome data is required for authorisation, pursuant to Article 22(4), points (d) and (e); In this case, an appropriate information for practitioners and patients on the conditional nature of the authorization is put in place by the SoHO entity ;
Amendment 527 #
Proposal for a regulation Article 21 – paragraph 4 4. Competent authorities shall conclude the SoHO preparation authorisation steps, referred to in paragraph 2 of this Article, within 3 months from receipt of the application, excluding the time needed for clinical outcome monitoring or studies. They may suspend this time limit for the duration of the consultation processes referred to in Article 14(1) and (2) or if further information are required from the SoHO entity who made the request.
Amendment 528 #
Proposal for a regulation Article 21 – paragraph 6 – subparagraph 1 – point a (a) such preparation, or any of the activities performed for that preparation, do not comply with the conditions of its
Amendment 529 #
Proposal for a regulation Article 21 – paragraph 8 8. Competent authorities may, in accordance with national legislation, withdraw the authorisation of a SoHO preparation if the competent authorities have confirmed that the SoHO preparation in question does not comply with subsequently updated criteria for authorisation or the SoHO entity has
Amendment 530 #
Proposal for a regulation Article 21 a (new) Article 21a Exceptional derogation from the obligation to authorise SoHO preparations in situations where there is no therapeutic alternative 1. By way of derogation from Article 21 of this Regulation, and after consulting the relevant best practices approved and documented by the SCB in accordance with Article 68(1)(c), the competent authorities may authorise, on an exceptional basis and at the request of a prescribing doctor within a SoHO entity, SoHO preparations in situations where the procedures referred to in Article 21 have not been followed, provided that: (a) provision has been made for the use of such preparations for a given patient, in cases where that patient has no therapeutic alternative, when treatment cannot be postponed or when his or her condition is life-threatening; (b) the preparation is deemed to be safe and effective on the basis of the available clinical data. 2. The competent authorities shall inform the national SoHO authority of the authorised derogation. The national SoHO authority shall inform the Commission and the other Member States of any decision to authorise the distribution or preparation for immediate application of SoHOs in accordance with paragraph 1.
Amendment 531 #
Proposal for a regulation Article 21 a (new) Article 21 a Conditional authorisation of SoHO preparations in exceptional situations 1. In exceptional cases, and subject to a medical prescription, the competent authorities may consult the best practices approved and documented by the SCB in accordance with Article 68(1)(c) and authorise the conditional and temporary use of certain SoHOs preparations in cases where: (a) the potential recipient of those SoHO preparations is at vital risk, has no available therapeutic alternatives and their treatment cannot be postponed; (b) available clinical data indicate that the SoHO preparation will be safe and effective. 2. The competent authorities shall, without undue delay, enter information on conditional authorisations of SoHO preparations into the EU SoHO Platform referred to in Chapter XI. 3. After receiving conditional and temporary authorisation for a SoHO preparation, the SoHO entity shall, in parallel, initiate a regular authorisation procedure for that SoHO preparation in accordance with Article 21.
Amendment 532 #
Proposal for a regulation Article 22 – paragraph 1 1. The assessment of a SoHO preparation
Amendment 533 #
Proposal for a regulation Article 22 – paragraph 5 5. When assessing the SoHO preparation pursuant to paragraph 4, points (e) and (g), competent authorities shall
Amendment 534 #
Proposal for a regulation Article 24 – paragraph 5 5. Competent authorities shall ensure that the specific induction training is complemented by regular specialised training for assessment of processing methods and technologies used for specific types of SoHO preparations and by continuous training, as appropriate, throughout the career of the assessors to keep step with technical developments in the field. Competent authorities shall make all reasonable efforts to ensure that assessors that participate in joint assessments have completed the relevant Union training referred to in Article 69(1) and are included in the list referred to in Article 69(5).
Amendment 535 #
Proposal for a regulation Article 25 – paragraph 2 2. Competent authorities shall authorise as SoHO establishments the SoHO entities that both process and store or process and release or store and release SoHOs in accordance with Article 27.
Amendment 536 #
Proposal for a regulation Article 25 – paragraph 4 Amendment 537 #
Proposal for a regulation Article 25 – paragraph 6 – subparagraph 1 a (new) Amendment 538 #
Proposal for a regulation Article 26 – paragraph 1 1. Competent authorities shall establish and maintain a system for receiving and processing requests for the authorisation of importing SoHO entities. SoHO entities shall ensure that SoHOs and their preparations are imported where European supply management and the domestic supply chain are not compromised.
Amendment 539 #
Proposal for a regulation Article 26 – paragraph 3 3. Importing SoHO entity authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation or the entity has ceased to conduct SoHO activities. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific importing SoHO entity authorisation, that Member State may decline to recognise the
Amendment 540 #
Proposal for a regulation Article 26 – paragraph 4 – subparagraph 1 The Commission shall adopt implementing acts to specify uniform procedures and working methods for establishing and maintaining an importing SoHO entity authorisation system. Such entities shall comply with the technical and ethical specifications in force within the Union in order to maintain an optimal level of quality, safety and efficiency.
Amendment 541 #
Proposal for a regulation Article 27 – paragraph 1 1.
Amendment 542 #
Proposal for a regulation Article 27 – paragraph 1 1. Competent authorities shall provide guidelines
Amendment 543 #
Proposal for a regulation Article 27 – paragraph 2 – point a Amendment 544 #
Proposal for a regulation Article 27 – paragraph 2 – point b (b) assess the application on the basis of the provisions of national administrative law;
Amendment 545 #
Proposal for a regulation Article 27 – paragraph 2 – point e (e) carry out an on-site system inspection of the applicant SoHO establishment in the year following the launch of the site and, where applicable, of third parties contracted by the SoHO establishment to perform SoHO activities, pursuant to Article 29;
Amendment 546 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 1 – point a (a) does not comply with the conditions of its authorisation or the provisions of this Regulation;
Amendment 547 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 1 – point a (a) does not comply with the conditions of its authorisation or the provisions of this Regulation;
Amendment 548 #
Proposal for a regulation Article 27 – paragraph 3 – subparagraph 1 – point a a (new) (a a) does not follow up on corrective or preventive action following an inspection by national authorities pursuant to Article 29(14); and
Amendment 549 #
Proposal for a regulation Article 27 – paragraph 5 5. Competent authorities may, in accordance with national legislation, withdraw the authorisation of a SoHO establishment if the competent authorities have confirmed that the SoHO establishment no longer complies with
Amendment 550 #
Proposal for a regulation Article 28 – paragraph 1 1.
Amendment 551 #
Proposal for a regulation Article 28 – paragraph 2 – point a Amendment 552 #
Proposal for a regulation Article 28 – paragraph 2 – point b (b) assess the application on the basis of the provisions of national administrative law;
Amendment 553 #
Proposal for a regulation Article 28 – paragraph 5 – point a (a) that the SoHO entity in question does not comply with the conditions of the authorisation or the provisions of this Regulation;
Amendment 554 #
Proposal for a regulation Article 28 – paragraph 5 – point b (b) that this non-compliance, or suspected non-compliance, implies a risk to the safety of SoHO donors, recipients or offspring from medically assisted reproduction.
Amendment 555 #
Proposal for a regulation Article 28 – paragraph 7 7. Competent authorities may, in accordance with national legislation, withdraw the authorisation of an importing SoHO entity if the competent authorities have confirmed that the importing SoHO entity no longer complies with updated criteria for authorisation or the importing SoHO entity has
Amendment 556 #
Proposal for a regulation Article 28 – paragraph 9 9. By derogation from paragraph 1, in
Amendment 557 #
Proposal for a regulation 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
Amendment 558 #
Proposal for a regulation 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,
Amendment 559 #
Proposal for a regulation Article 29 – paragraph 11 11. The interval between
Amendment 560 #
Proposal for a regulation 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 561 #
Proposal for a regulation Article 29 – paragraph 11 11. The interval between
Amendment 562 #
Proposal for a regulation Article 29 – paragraph 16 16. For the purpose of standardised inspections referred to in paragraph 1 of this Article, competent authorities shall consult the relevant best practices agreed
Amendment 563 #
Proposal for a regulation Article 31 – paragraph 4 – subparagraph 2 a (new) The inspection shall be conducted in the official language of the country concerned, including the inspection report. Forms in all the official languages of the European Union shall be acceptable during the submission of an inspection application.
Amendment 564 #
Proposal for a regulation Article 31 – paragraph 6 a (new) 6 a. 7. In exceptional cases, an inspection request may be refused or dismissed if it has not been justified.
Amendment 565 #
Proposal for a regulation Article 32 – paragraph 1 – subparagraph 2 In exceptional cases, competent authorities may consider that a person’s considerable and relevant experience may exempt this person from the requirement set out in the first subparagraph. They shall also perform their duties impartially, transparently and free from conflicts of interest.
Amendment 566 #
Proposal for a regulation Article 32 – paragraph 1 a (new) 1 a. All inspectors shall act in an impartial manner and be independent of any direct or indirect conflicts of interest. Inspectors shall declare such impartiality in writing; such declarations shall be made available on the authorities’ web- portal.
Amendment 567 #
Proposal for a regulation Article 32 – paragraph 2 2. Competent authorities shall provide inspectors with a specific induction training before inspectors take up their
Amendment 568 #
Proposal for a regulation Article 32 – paragraph 2 2. Competent authorities
Amendment 569 #
Proposal for a regulation Article 32 – paragraph 3 – point a (a) the inspection techniques and procedures to be followed, including practical exercises and conflict of interest rules;
Amendment 570 #
Proposal for a regulation Article 32 – paragraph 5 5. Inspectors may be assisted by technical experts provided that the competent authorities ensure that those experts comply with the requirements of this Regulation, in particular with the obligations set out in Articles 7 and 76. Competent authorities shall ensure that inspectors have not worked as assessors as defined in Article 24 of this Regulation for at least one year.
Amendment 571 #
Proposal for a regulation Article 34 – paragraph 1 1. Competent authorities shall verify that SoHO entities have appropriate procedures in place to ensure traceability and coding of SoHOs as referred to in Article 45. The authorities shall ensure that enhanced traceability is put in place for donations where the medical, bioethical and legal implications are of particular relevance. In such cases, access to information and traceability shall be guaranteed for the recipient and the offspring conceived following fertility treatment.
Amendment 572 #
Proposal for a regulation Article 34 – paragraph 2 2. Competent authorities shall establish procedures for the unique identification of SoHO establishments that are subject to the provisions on the Single European Code in Article 46. Competent authorities shall ensure that such identification complies with the technical standards defined for that coding system. For this purpose, competent authorities may preferably use a SoHO establishment identification code generated by the EU SoHO Platform.
Amendment 573 #
Proposal for a regulation Article 34 a (new) Article 34 a Monitoring of SoHO availability and continuity of supply 1. As part of the national plans to ensure the continuity of SoHO supply referred to in Article 61(a), the competent authorities shall establish a digital platform through which they can exchange information on the availability of SoHO in the national territory in a fast and efficient manner. Through this system, competent authorities may request national SoHO entities to provide information on the availability of a certain SoHO product in specific situations of need. They shall also take into account alerts sent by national SoHO entities concerning the availability of SoHO and potential shortages. The competent authorities shall ensure that this digital platform is available no later than two years after the entry into force of this Regulation. 2. The competent authorities shall be responsible for monitoring the availability of SoHO at national level. They shall provide guidance to SoHO entities to facilitate the exchange of information on the availability of SoHO referred to in Article 46(a). 3. The competent authorities shall store and analyse information on the availability of SoHO and its fluctuations over time, as well as trends in demand and potential shortages of SoHO and shall draw up reports containing that information which may be made available to other Member States through the EU SoHO Platform as defined in Article 73 (Article 35).
Amendment 574 #
Proposal for a regulation Article 35 – paragraph 1 1. Competent authorities shall be responsible for the management of vigilance associated with SoHO activities. They shall provide guidance
Amendment 575 #
Proposal for a regulation Article 35 – paragraph 10 10. Competent authorities shall submit to their SoHO National Authorities a
Amendment 576 #
Proposal for a regulation Article 36 a (new) Amendment 577 #
Proposal for a regulation Article 38 – paragraph 2 2. The responsible person for release of SoHOs shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned and shall have at least 2 years of experience in the relevant field. The SoHO entity shall ensure that the person responsible for the release of SoHO receives adequate and up-to-date training, appropriate to their job and responsibilities, including specific training on those SoHOs that require it.
Amendment 578 #
Proposal for a regulation Article 40 – paragraph 1 1. SoHO entities shall not release or, in an autologous context, prepare and apply immediately to a recipient, SoHO preparations without prior SoHO preparation authorisation. In cases where a SoHO entity modifies an activity carried out for an authorised SoHO preparation, it shall obtain an authorisation for that modified SoHO preparation. A substantial change is a change that has an impact on the quality, safety or efficacy of a SoHO preparation.
Amendment 579 #
Proposal for a regulation Article 40 – paragraph 3 3. SoHO entities may request to their competent authorities a derogation from the requirement for a SoHO preparation authorisation in the exceptional circumstances referred to in Articles 21(a) 64.
Amendment 580 #
Proposal for a regulation Article 41 – paragraph 2 – point a – point ii (ii) any specific SoHO collection procedures with a view to maintaining all the properties to be compatible with recipients;
Amendment 581 #
Proposal for a regulation Article 41 – paragraph 2 – point c (c) in cases where the indicated risk is other than negligible, a proposal for clinical outcome monitoring to demonstrate
Amendment 582 #
Proposal for a regulation Article 41 – paragraph 4 4. SoHO entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to Article 21(2), point (c), and submit the results to their competent authorities. In conducting the clinical investigation study as referred to in paragraph 3, points (b) and (c), for the SoHO preparation concerned, the applicant
Amendment 583 #
Proposal for a regulation Article 41 – paragraph 4 4. SoHO entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to Article 21(2), point (c), and submit the results and their analysis to their competent authorities at the frequency determined in the authorisation . In conducting the clinical investigation study as referred to in paragraph 3, points (b) and (c), for the SoHO preparation concerned, the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of data.
Amendment 584 #
Proposal for a regulation Article 41 – paragraph 5 5. SoHO entities shall not make any change to the chain of activities performed for an authorised SoHO preparation, without the prior written approval of their competent authorities. A substantial change is a change that has an impact on the quality, safety or efficacy of a SoHO preparation. SoHO entities shall also inform their competent authorities of changes in the SoHO preparation authorisation holder’s details.
Amendment 585 #
Proposal for a regulation Article 41 a (new) Article 41 a Clinical studies with SoHO 1. SoHO entities may conduct clinical studies with SoHO, in the context of the monitoring plans defined in Article 41 or beyong it, with the aim of comparing or improving treatments. 2. Clinical studies shall always have the safety and well-being of the participants in the study as a priority and they shall respect the provisions of Articles 53, 54, 55, 56, 58 and 59 of this Regulation, concerning the protection of donors and recipients. SoHO entities intending to start a clinical study shall seek to obtain more robust and reliable data, through collaboration with other SoHO entities, if necessary. 3. SoHO entities must apply for a favorable opinion from the Research Ethics Committee before starting any clinical study. The Committee shall assess the ethical, legal and methodological aspects of the study, to determine the capacity of the study design to draw robust conclusions, as well as well-being and safety-related aspects of the participants, before issuing a favorable opinion for the study. 4. The person responsible for the clinical study shall be adequately trained. 5. Before starting the clinical study, SoHO entities shall register it on the EU SoHO Platform, where they shall also record the results after the end of the study, in accordance with Article 36 (a). 6. SoHO entities shall request approval of the clinical study to competent authorities before starting a clinical study with SoHO, in accordance with Article 36(a). SoHO entities may request assistance regarding administrative, technical and ethical aspects of the clinical study to the competent authorities, in accordance with Article 36(a).
Amendment 586 #
Proposal for a regulation Article 43 – paragraph 1 1. SoHO entities shall send applications for authorisation as importing SoHO entities to their competent authorities of their territory.
Amendment 587 #
Proposal for a regulation Article 43 – paragraph 4 4. The importing SoHO entity authorisation holder shall be based in the Union, and be responsible for the physical reception and visual examination and verification of imported SoHOs prior to their release. The importing SoHO entity shall verify coherence between the SoHO
Amendment 588 #
Proposal for a regulation Article 44 – paragraph 4 4. SoHO entities shall submit to the EU SoHO Platform an annual summary of the data collected pursuant to this Article. In cases where national or international registries collect activity data meeting the criteria defined in the SoHO platform and such registries have been verified by competent authorities as having in place data quality management procedures that ensure accuracy and completeness of data, SoHO entities may delegate the submission of the activity data referred to in this Article to such registries. National competent authorities shall ensure all data from national registries are submitted to the EU SoHO Platform in accordance with Article 18(4). The Commission shall aggregate the annual summaries of the SoHO entities, prepare and publish an Annual SoHO Activity Report.
Amendment 589 #
Proposal for a regulation Article 45 – paragraph 2 – point c (c) does not directly reveal the identity of the donor;
Amendment 590 #
Proposal for a regulation Article 46 – paragraph 2 – point d (d) SoHOs imported into the Union
Amendment 591 #
Proposal for a regulation Article 46 a (new) Amendment 592 #
Proposal for a regulation Article 47 – paragraph 1 1. SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse occurrences, including adverse occurrences detected during clinical outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 41 or as part of a clinical study with SoHO, as referred to in Article 41(a).
Amendment 593 #
Proposal for a regulation Article 47 – paragraph 2 2. Where applicable, SoHO entities shall make all reasonable efforts to encourage prospective parents of children born from third party donation to commit to communicate information concerning any genetic conditions that emerge, as those children grow up, to the SoHO entity
Amendment 594 #
Proposal for a regulation Article 47 – paragraph 3 a (new) 3 a. Where SAO notification concerns public health matters, competent authorities shall communicate essential information to the general public and the SCB without delay.
Amendment 595 #
Proposal for a regulation Article 48 – paragraph 1 1. SoHO establishments shall not carry out any SoHO activities without prior SoHO establishment authorisation. This shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another SoHO entity.
Amendment 596 #
Proposal for a regulation Article 50 – paragraph 1 1. SoHO establishments shall establish, maintain and update, as necessary, a quality management system achieving a high level of quality of SoHOs by
Amendment 598 #
Proposal for a regulation Article 51 – paragraph 1 – introductory part 1. Each SoHO establishment shall designate a physician or embryologist who resides and carries out its tasks in the same Member State and who shall at least fulfil the following conditions and have the following qualifications:
Amendment 599 #
Proposal for a regulation Article 51 – paragraph 1 – point a (a) possession of formal qualification as a physician or have a degree in biology, biotechnology or medical analytics;
Amendment 600 #
Proposal for a regulation Article 51 – paragraph 2 – introductory part 2. The p
Amendment 601 #
Proposal for a regulation Article 51 – paragraph 2 – point b (b) investigation of suspected adverse occurrences in SoHO donors
Amendment 602 #
Proposal for a regulation Article 51 – paragraph 3 3. By derogation from paragraph 2, in the case of SoHO entities that are authorised as SoHO establishments in accordance with Article 25(3), the physician shall be responsible for those tasks that are relevant to the SoHO activities performed by the SoHO entities and that have a direct influence on the health of SoHO donors
Amendment 603 #
Proposal for a regulation Article 52 – paragraph 2 2. SoHO entities shall protect the physical and mental health of living donors before, during and after the donation.
Amendment 604 #
Proposal for a regulation Article 52 – paragraph 2 a (new) 2 a. SoHOs from living donors shall be obtained from individuals whose state of health is such that no adverse effects on their health are expected/likely as a result of donation.
Amendment 605 #
Proposal for a regulation 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 606 #
Proposal for a regulation 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 607 #
Proposal for a regulation Article 53 – paragraph 1 – point a a (new) (a a) ensure that donors are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence, and intended to avoid potential risks to the health of SoHO recipients or donors;
Amendment 608 #
Proposal for a regulation Article 53 – paragraph 1 – point b (b) provide donors or their relatives or any persons granting authorisation on their behalf, in accordance with national legislation, with the information referred to in Article 55 and in a way that is adequate in view of their capacity to understand it, so that they can give free and informed consent;
Amendment 609 #
Proposal for a regulation Article 53 – paragraph 1 – point f (f) verify the eligibility of the donor on the basis of a donor health evaluation, including mental health-related aspects that could be altered by the donation process, that aims to minimise any risk that the donation might pose to the donor’s health;
Amendment 610 #
Proposal for a regulation Article 53 – paragraph 1 – point g (g) document the results of the donor health evaluation referred to in point (f), including donor vaccination schedules;
Amendment 611 #
Proposal for a regulation 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 the
Amendment 612 #
Proposal for a regulation Article 53 – paragraph 1 – point j (j) verify, where justified, 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 613 #
Proposal for a regulation 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
Amendment 614 #
Proposal for a regulation 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
Amendment 615 #
Proposal for a regulation 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
Amendment 616 #
Proposal for a regulation 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
Amendment 617 #
Proposal for a regulation Article 53 – paragraph 1 – point j (j) for donations referred to in paragraph 3, verify, by means of
Amendment 618 #
Proposal for a regulation Article 53 – paragraph 1 – point k (k) develop and implement a plan for monitoring the donor’s health after the donation in cases
Amendment 619 #
Proposal for a regulation Article 53 – paragraph 1 – point k (k) develop and implement a plan for monitoring the donor’s health after the donation in cases
Amendment 620 #
Proposal for a regulation Article 53 – paragraph 1 – point k (k) develop and implement a plan for monitoring the donor’s health after the donation in cases
Amendment 621 #
Proposal for a regulation Article 53 – paragraph 1 – point k (k) develop and implement a plan for
Amendment 622 #
Proposal for a regulation Article 53 – paragraph 1 – point k (k) develop and implement a plan for monitoring the donor’s health after the donation in the case
Amendment 623 #
Proposal for a regulation Article 53 – paragraph 1 – point k (k) develop and implement a plan for monitoring the donor’s health after the donation in the case
Amendment 624 #
Proposal for a regulation Article 53 – paragraph 1 – point k (k) develop and implement a plan for monitoring the donor’s health after the donation in the case
Amendment 625 #
Proposal for a regulation 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
Amendment 626 #
Proposal for a regulation Article 53 – paragraph 2 2. In the course of the donor health evaluations referred to in paragraph 1, point (f), SoHO entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of physical and mental health and their health histories to assure the safety of the donation process for those donors. SoHO entities may perform laboratory tests as part of the donor health evaluations. They shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. The physician, as referred to in Article 51, shall approve the procedure and criteria for donor health evaluations.
Amendment 627 #
Proposal for a regulation 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 at Union level, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them.
Amendment 628 #
Proposal for a regulation 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 629 #
Proposal for a regulation 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 SoHOs 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 630 #
Proposal for a regulation Article 53 – paragraph 6 Amendment 631 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 632 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 633 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for losses related
Amendment 634 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 635 #
Proposal for a regulation 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 and transparent criteria based on quantifiable elements 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 636 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 637 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 638 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 639 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 640 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 641 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 642 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for
Amendment 643 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the SoHO entities to living 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 transparent, 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 644 #
Proposal for a regulation Article 54 – paragraph 2 2. Member States may allow for the compensation or reimbursement from the
Amendment 645 #
Proposal for a regulation Article 54 – paragraph 2 a (new) 2 a. Member States shall ensure that no payment is made in any case for a donation of human tissues and cells. Any donation of human tissues or cells must be made voluntarily by the donor and without any compensation in cash or in kind that might be regarded as payment. Compensation for costs arising in connection with the donation shall, however, be permitted. Compensation may comprise reimbursement of travel expenses and loss of income for the duration of the journey, the donation and any necessary recuperation, as well as payment of small amounts and refreshments.
Amendment 646 #
Proposal for a regulation Article 54 – paragraph 2 a (new) 2 a. Any compensation regime shall not lead to inappropriate financially- driven competition, including cross- border competition, between SoHO establishments and entities over donor recruitment.
Amendment 647 #
Proposal for a regulation Article 54 – paragraph 2 b (new) 2 b. Member States shall take the necessary measures to encourage voluntary and unpaid donations of blood and blood components with a view to ensuring that blood and blood components are in so far as possible provided from such donations.
Amendment 648 #
Proposal for a regulation Article 54 – paragraph 3 3. SoHO entities may compensate or reimburse living donors as provided for by their competent authorities pursuant to paragraph 2. SoHO entities shall report transparently to the competent authorities on the compensation used, and on any changes made in this respect.
Amendment 649 #
Proposal for a regulation Article 54 – paragraph 3 3. SoHO entities may compensate or reimburse donors as provided for by their competent authorities pursuant to paragraph 2. Any compensation or reimbursement must never serve as an inducement to donate.
Amendment 650 #
Proposal for a regulation 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 651 #
Proposal for a regulation Article 54 – paragraph 3 a (new) 3 a. Compensation may under no circumstances be used for promotion or as a claim for recruitment, shall not be an incentive to donate and shall not lead to exploitation of the most vulnerable persons in society or to situations of inappropriate competition for the recruitment of donors.
Amendment 652 #
Proposal for a regulation Article 54 – paragraph 3 a (new) 3 a. Member States shall submit to the Commission and the SCB national provisions setting up the rules for compensation based on financial neutrality and consistent with standards set in this Article.
Amendment 653 #
Proposal for a regulation Article 54 – paragraph 3 b (new) 3 b. The Commission shall assess the ethical aspects of voluntary and unpaid donation and verify that Member States’ compensation and reimbursement systems follow the guidelines specified in this Regulation. This assessment shall determine, inter alia, that such compensations and reimbursements under no circumstances constitute an incentive or a claim to recruit donors, that they do not expose vulnerable people in society to exploitation activities, that they do not undermine public confidence in the donation system or that they do not promote competition between SoHO entities for the recruitment of donors. Member States shall provide the Commission with the information requested to perform this assessment. By [one year after the entry into force of this Regulation], and every three years, the Commission shall submit a report to the Council and the European Parliament assessing the compensation and reimbursement systems in the Member States and, where appropriate, making recommendations to the Member States on how they can be improved. These reports shall be made available to the public.
Amendment 654 #
Proposal for a regulation 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) 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 656 #
Proposal for a regulation Article 55 – title 55 Standards concerning information to be provided prior to consent or authorisation to donate SoHOs
Amendment 657 #
Proposal for a regulation Article 55 – paragraph 3 – point c a (new) (ca) the regular renewal of their consent to the donation at the end of a period set by each Member State;
Amendment 658 #
Proposal for a regulation Article 55 – paragraph 3 – point d (d) the intended use of the donated SoHO, in particular covering proven benefits for the future recipients and any possible research or commercial uses to which the donor should give an informed consent;
Amendment 659 #
Proposal for a regulation 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 660 #
Proposal for a regulation Article 56 – paragraph 1 – subparagraph 1 When the Commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in Articles 53, 54 or 55, in order to ensure convergent and high levels of donor safety, the Commission may adopt
Amendment 661 #
Proposal for a regulation Article 56 – paragraph 1 – subparagraph 2 Those
Amendment 662 #
Proposal for a regulation Article 56 – paragraph 3 3. In order to apply the standards concerning donor protection or elements thereof, referred to in Articles 53, 54 and 55, SoHO entities shall follow the procedures laid down in any delegated and implementing act adopted in accordance with paragraphs 1 and 2 of this Article.
Amendment 663 #
Proposal for a regulation 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 in accordance with what has been decided by the Member State, SoHO entities shall follow:
Amendment 664 #
Proposal for a regulation 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 665 #
Proposal for a regulation Article 56 – paragraph 4 – point a – introductory part (a) the most recent technical guidelines
Amendment 666 #
Proposal for a regulation Article 56 – paragraph 4 – point a – introductory part (a) First of all, the most recent technical
Amendment 667 #
Proposal for a regulation Article 56 – paragraph 4 – point b (b) then, other guidelines accepted by competent authorities, as achieving an equivalent level of donor safety as set by the technical guidelines referred to in point (a);
Amendment 668 #
Proposal for a regulation Article 56 – paragraph 4 – point b (b) other guidelines accepted by competent authorities, as achieving a
Amendment 669 #
Proposal for a regulation 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-
Amendment 670 #
Proposal for a regulation Article 56 – paragraph 5 5. In those cases referred to in paragraph 4, point (a) and (b), for the purpose of Article 30 in conjunction with Article 29, SoHO entities shall be able to demonstrate to their competent authorities, for each of the standards or elements thereof, which and to what extent they follow the respective guidelines referred to in paragraph 4, point (a) and point (b).
Amendment 671 #
Proposal for a regulation Article 56 – paragraph 6 Amendment 672 #
Proposal for a regulation Article 56 – paragraph 6 Amendment 673 #
Proposal for a regulation Chapter VII – title VII SOHO RECIPIENT
Amendment 674 #
Proposal for a regulation Article 57 – title Objectives regarding SoHO recipient
Amendment 675 #
Proposal for a regulation Article 57 – paragraph 1 SoHO entities shall protect the health of SoHO recipients and offspring
Amendment 676 #
Proposal for a regulation Article 57 – paragraph 1 SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.
Amendment 677 #
Proposal for a regulation Article 57 – paragraph 1 SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.
Amendment 678 #
Proposal for a regulation Article 57 – paragraph 1 SoHO entities shall protect the health of SoHO recipients and
Amendment 679 #
Proposal for a regulation Article 57 – paragraph 1 a (new) SoHO entities shall ensure that recipients are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence and intended to avoid potential risks to the health of donors or recipients;
Amendment 680 #
Proposal for a regulation Article 58 – title 58 Standards concerning protection of SoHO recipients and of offspring
Amendment 681 #
Proposal for a regulation Article 58 – title Standards concerning SoHO recipient
Amendment 682 #
Proposal for a regulation Article 58 – paragraph 1 1. SoHO entities shall establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction. In the case of medically assisted reproduction, the option of the respective persons refusing genetic screening should be retained and the procedure is subject to national legislation according to the principle of subsidiarity hence with regard to the transmission of genetic diseases to offspring, the provisions apply only if Member States decide to allow this technology, and subsequently if it corresponds to the wish of the donor or the recipient
Amendment 683 #
Proposal for a regulation Article 58 – paragraph 1 1. SoHO entities shall, based on latest technical guidelines from the EDQM and the ECDC, establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction.
Amendment 684 #
Proposal for a regulation Article 58 – paragraph 1 1. SoHO entities shall establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients
Amendment 685 #
Proposal for a regulation Article 58 – paragraph 1 1. SoHO entities shall establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients
Amendment 686 #
Proposal for a regulation Article 58 – paragraph 1 1. SoHO entities shall establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients
Amendment 687 #
Proposal for a regulation Article 58 – paragraph 2 – introductory part 2. In the procedures referred to in paragraph 1, SoHO entities shall
Amendment 688 #
Proposal for a regulation Article 58 – paragraph 2 – introductory part 2. In the procedures referred to in paragraph 1, SoHO entities shall
Amendment 689 #
Proposal for a regulation Article 58 – paragraph 2 – point a Amendment 690 #
Proposal for a regulation Article 58 – paragraph 2 – point a Amendment 691 #
Proposal for a regulation Article 58 – paragraph 2 – point b Amendment 692 #
Proposal for a regulation Article 58 – paragraph 2 – point b Amendment 693 #
Proposal for a regulation 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 694 #
Proposal for a regulation 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 695 #
Proposal for a regulation Article 58 – paragraph 2 – point c Amendment 696 #
Proposal for a regulation Article 58 – paragraph 2 – point c Amendment 697 #
Proposal for a regulation Article 58 – paragraph 2 – point c (c) when feasible and deemed appropriate by the relevant technical guidelines, using processing technologies that reduce or eliminate any potential communicable pathogens.
Amendment 698 #
Proposal for a regulation Article 58 – paragraph 2 – point c a (new) (ca) a list of contagious or chronic diseases or infections that are or may be communicable, which must be explicitly formalised and shared between Member States.
Amendment 699 #
Proposal for a regulation Article 58 – paragraph 2 a (new) 2 a. of communicable disease transmission from SoHO donors to recipients by combining, at least, the following measures: (i) reviewing and evaluating the donors’ current and past health, travel and relevant behavioural histories to allow the application of temporary or permanent deferrals when risks cannot be fully eliminated by donor testing; (ii) testing of donors for communicable diseases using certified and validated testing methods, or other methods considered appropriate in accordance with the guidelines defined in Article 59; (iii) when feasible and suitable according to the guidelines defined in Article 59, using processing technologies that reduce, inactivate or eliminate any potential communicable pathogens.
Amendment 700 #
Proposal for a regulation Article 58 – paragraph 2 a (new) 2 a. Such measures shall not directly or indirectly be construed to constitute discrimination between donors on any of the grounds of discrimination recognised by Article 21 of the Charter of Fundamental Rights, notably discrimination based on sexual orientation. Member States shall report any restrictions that SoHO entities impose that can reasonably be seen to constitute such discrimination and provide a summary of the scientific evidence used to justify these measures to protect donors or offspring.
Amendment 701 #
Proposal for a regulation Article 58 – paragraph 2 b (new) 2 b. of non-communicable disease transmission, including genetic conditions and cancer, from donors to the recipients or to offspring from medically assisted reproduction by combining, at least, the following measures: (i) reviewing the donors’ current and past health to allow temporary or permanent deferral of donors that carry a risk of transmitting cancerous cells or other non- communicable diseases that might be passed to a recipient by SoHO application; (ii) where the transmission of genetic conditions is an identified risk, and in particular in the case of medically assisted reproduction with third party donation: - testing donors for those conditions, as indicated by prevalence or severity as presenting the highest risk;or - testing prospective recipients to identify any relevant genetic risk, combined with testing donors for such identified genetic conditions to ensure matching that will prevent the concerned condition in the offspring.
Amendment 702 #
Proposal for a regulation Article 58 – paragraph 2 c (new) 2 c. of communicable or non- communicable disease transmission to the recipients through cross-contamination of donations during collection, processing, storage and distribution by measures that ensure that physical contact between SoHOs from different donors is avoided or, in cases where combining donations is necessary for efficacy of the SoHO preparation, is minimised.
Amendment 703 #
Proposal for a regulation Article 58 – paragraph 2 d (new) Amendment 704 #
Proposal for a regulation Article 58 – paragraph 2 e (new) 2 e. that any reagents and solutions added to SoHOs or coming in contact with SoHOs during collection, processing, storage and distribution might be transmitted to recipients and have a toxic, or other, detrimental effect on their health by combining, at least, the following measures: (i) specifying such reagents and solutions prior to their purchase; (ii) verifying any required certifications of such reagents and solutions; (iii) demonstrating the removal of such reagents and solutions, when necessary, prior to distribution.
Amendment 705 #
Proposal for a regulation Article 58 – paragraph 2 f (new) Amendment 706 #
Proposal for a regulation Article 58 – paragraph 2 g (new) 2 g. that SoHOs cause an immune reaction in recipients by combining, at least, the following measures: (i) accurately typing and matching of patients to donors, when such matching is necessary; (ii) correctly distributing SoHOs to the correct recipients pursuant to Article 45.
Amendment 707 #
Proposal for a regulation Article 58 – paragraph 2 h (new) Amendment 708 #
Proposal for a regulation Article 58 – paragraph 3 Amendment 709 #
Proposal for a regulation Article 58 – paragraph 3 Amendment 710 #
Proposal for a regulation Article 58 – paragraph 3 – point b – introductory part (b) where the transmission of genetic conditions is a
Amendment 711 #
Proposal for a regulation Article 58 – paragraph 3 – point b – point ii (ii) testing prospective recipients to identify any relevant genetic risk, combined with testing donors for such identified genetic conditions to ensure matching that will prevent the concerned condition in the offspring. In the case of medically assisted reproduction, the option of the respective persons refusing genetic screening should be retained and the procedure is subject to national legislation according to the principle of subsidiarity hence with regard to the transmission of genetic diseases to offspring, the provisions apply only if Member States decide to allow this technology, and subsequently if it corresponds to the wish of the donor or the recipient.
Amendment 712 #
Proposal for a regulation Article 58 – paragraph 4 Amendment 713 #
Proposal for a regulation Article 58 – paragraph 4 Amendment 714 #
Proposal for a regulation Article 58 – paragraph 5 Amendment 715 #
Proposal for a regulation Article 58 – paragraph 5 Amendment 716 #
Proposal for a regulation Article 58 – paragraph 6 Amendment 717 #
Proposal for a regulation Article 58 – paragraph 6 Amendment 718 #
Proposal for a regulation Article 58 – paragraph 7 Amendment 719 #
Proposal for a regulation Article 58 – paragraph 7 Amendment 720 #
Proposal for a regulation Article 58 – paragraph 7 – point a (a) conducting comprehensive process validation and equipment qualification as referred to in Article 41(2), point (a)(vii)
Amendment 721 #
Proposal for a regulation Article 58 – paragraph 8 Amendment 722 #
Proposal for a regulation Article 58 – paragraph 8 Amendment 723 #
Proposal for a regulation Article 58 – paragraph 9 Amendment 724 #
Proposal for a regulation Article 58 – paragraph 9 Amendment 725 #
Proposal for a regulation Article 58 – paragraph 10 – point a (a) apply SoHO preparations to recipients without proven benefit, except in the context of a clinical investigation approved in the context of a conditional authorisation of the SoHO preparation by their competent authority pursuant to Article 41(4) or compassionate use and experimental therapy as described in Article 61;
Amendment 726 #
Proposal for a regulation Article 58 – paragraph 10 – point a (a) apply SoHO preparations to recipients without proven benefit, except in the context of a clinical investigation approved in the context of a conditional authorisation of the SoHO preparation by
Amendment 727 #
Proposal for a regulation Article 58 – paragraph 10 – point b (b) apply SoHO preparations to recipients unnecessarily. SoHO entities shall make an optimal use of SoHO, taking into account therapeutic alternatives, and following the most up-to- date scientific guides specified in Article 59 ;
Amendment 728 #
Proposal for a regulation Article 58 – paragraph 10 – point c a (new) (c a) prioritise cosmetic uses over clinical uses, especially in the event of a possible shortage of SoHO.
Amendment 729 #
(ca) undermine the requirements of traceability and the right of individuals to know their genetic origin.
Amendment 730 #
Proposal for a regulation Article 58 – paragraph 11 – subparagraph 1 Amendment 731 #
Proposal for a regulation Article 58 – paragraph 11 – subparagraph 1 For the measures referred to in paragraphs 2, point (a) and
Amendment 732 #
Proposal for a regulation Article 58 – paragraph 11 – subparagraph 2 For donors that donate repeatedly, the interviews referred to in the first subparagraph may be limited to aspects that might have changed
Amendment 733 #
Proposal for a regulation Article 58 – paragraph 14 – subparagraph 2 – point a (a) the safeguards intended to protect their data and the data of the offspring
Amendment 734 #
Proposal for a regulation Article 58 – paragraph 14 – subparagraph 2 – point a a (new) (a a) donor anonymity and the possibility of ID release and the implication hereof for medically assisted reproduction with third party donation of reproductive cells, pursuant to provisions laid down in national legislation;
Amendment 735 #
Proposal for a regulation Article 58 – paragraph 14 – subparagraph 2 – point b a (new) (b a) in the case of medically assisted reproduction with third party donation, the applicable rules to protect the data of the donor in the Member State and if the donation was made outside the Member State, the applicable rules in that jurisdiction.
Amendment 736 #
Amendment 737 #
Proposal for a regulation Article 58 – paragraph 16 16. Where, in the case of risk to SoHO recipients and offspring
Amendment 738 #
Proposal for a regulation Article 59 – title Implementation of the standards concerning recipient
Amendment 739 #
Proposal for a regulation Article 59 – paragraph 4 – point a – introductory part (a) First of all, the most recent technical guidelines, as indicated on the EU SoHO Platform referred to in Chapter XI, as follows:
Amendment 740 #
Proposal for a regulation Article 59 – paragraph 4 – point b (b) then,other guidelines accepted by competent authorities as achieving an equivalent level of safety and quality of SoHOs as set by the technical guidelines referred to in point (a);
Amendment 741 #
Amendment 742 #
Proposal for a regulation Article -62 (new) Amendment 743 #
Proposal for a regulation Article 62 – title Establishment of national SoHO
Amendment 744 #
Proposal for a regulation 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 745 #
Proposal for a regulation Article 62 – paragraph 1 1. Member States, in collaboration with National SoHO Authorities, shall draw up national SoHO
Amendment 746 #
Proposal for a regulation Article 62 – paragraph 1 a (new) 1 a. The Commission and the SCB shall provide guidance and support to the Member States when establishing national emergency plans and promote best-practice sharing within the Union.
Amendment 747 #
Proposal for a regulation Article 62 – paragraph 2 Amendment 748 #
Proposal for a regulation Article 62 – paragraph 2 2. Member States shall make all reasonable efforts, in line with voluntary unpaid principle established in this Regulation, 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-
Amendment 749 #
Proposal for a regulation 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
Amendment 750 #
Proposal for a regulation 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 strongly encourage the collection of SoHO with
Amendment 751 #
Proposal for a regulation 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
Amendment 752 #
Proposal for a regulation 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
Amendment 753 #
Proposal for a regulation 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
Amendment 754 #
Proposal for a regulation 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
Amendment 755 #
Proposal for a regulation 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
Amendment 756 #
Proposal for a regulation 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
Amendment 757 #
Proposal for a regulation 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
Amendment 758 #
Proposal for a regulation 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
Amendment 759 #
(1) 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 760 #
Proposal for a regulation 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 761 #
Proposal for a regulation 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 762 #
Proposal for a regulation 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 763 #
Proposal for a regulation 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 764 #
Proposal for a regulation 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 765 #
Proposal for a regulation Article 62 – paragraph 2 a (new) Amendment 766 #
Proposal for a regulation Article 62 – paragraph 3 – point a a (new) (a a) evidence-based measures that impact demand of critical SoHOs;
Amendment 767 #
Proposal for a regulation Article 62 – paragraph 3 – point a b (new) (a b) quantitative targets to ensure self- sufficiency of supply of critical SoHOs;
Amendment 768 #
Proposal for a regulation Article 62 – paragraph 3 – point a c (new) (a c) strategy on optimisation of use of critical SoHOs;
Amendment 769 #
Proposal for a regulation Article 62 – paragraph 3 – point a d (new) (a d) critical SoHO donor recruitment and retainment strategy, including communication campaigns and education programmes;
Amendment 770 #
Proposal for a regulation Article 62 – paragraph 3 – point c a (new) (c a) stakeholder engagement;
Amendment 771 #
Proposal for a regulation Article 62 – paragraph 3 – point f a (new) Amendment 772 #
Proposal for a regulation Article 62 – paragraph 3 – point f a (new) (f a) a strategy for communication to and with citizens and national authorities.
Amendment 773 #
Proposal for a regulation Article 62 – paragraph 3 – point f a (new) (f a) communication strategy for the general public.
Amendment 774 #
Proposal for a regulation Article 62 – paragraph 3 a (new) 3 a. Member States shall submit their emergency plans to the Commission and the SCB within 2 years after entry into force of this Regulation.
Amendment 775 #
Proposal for a regulation Article 62 – paragraph 6 6. Member States shall review regularly 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. Member States shall inform without delay the Commission and the SCB of any substantial revision of the national plans.
Amendment 776 #
Proposal for a regulation Article 62 – paragraph 6 6. Member States shall review
Amendment 777 #
Proposal for a regulation Article 62 – paragraph 6 6. Member States shall
Amendment 778 #
Proposal for a regulation Article 62 – paragraph 7 – subparagraph 1 – introductory part The Commission may adopt
Amendment 779 #
Proposal for a regulation Article 62 – paragraph 7 – subparagraph 1 – point b (b) the role of stakeholders and the supportive role of the ECDC and the EDQM in the establishment and operation of national SoHO emergency plans.
Amendment 780 #
Proposal for a regulation Article 62 – paragraph 7 – subparagraph 2 Those
Amendment 781 #
Proposal for a regulation Article 62 a (new) Amendment 782 #
Proposal for a regulation Article 62 a (new) Amendment 783 #
Proposal for a regulation Article 62 a (new) Amendment 784 #
Proposal for a regulation Article 62 a (new) Article 62 a European autonomy in the supply of SoHO The Commission shall, within two years of the entry into force of this Regulation, publish a strategy for promoting increased European autonomy in the provision of SoHOs. The strategy shall contain specific objectives and an accompanying calendar to be defined jointly by the European Commission in consultation with relevant national authorities, the European Parliament and relevant proffessional, scientific, industry, donor and patient representative groups.
Amendment 785 #
Proposal for a regulation Article 62 a (new) Article 62 a Public Service Obligation SoHO entities collecting or processing blood or blood components in a Member State are, within the limits of their responsibilities, obliged to ensure an appropriate and continuous supply of these SoHOs and SoHO preparations in that Member State in order to meet the needs of patients.
Amendment 786 #
Proposal for a regulation Article 62 b (new) Article 62 b European SoHO autonomy 1. By two years after the entry into force of this Regulation, the Commission shall submit a report to the Council and the European Parliament assessing the different measures applicable to secure the SoHO supply at national level, in the Member States, and at Union level. This report shall include measures to promote donation, in a manner compatible with the principles of voluntary and unpaid donation defined in paragraph 54 – such as informative and awareness-raising campaigns for citizens on the benefits of donation, as well as measures for the efficient use of SoHO. Based on the results of this report, the Commission shall develop a plan to promote European SoHO autonomy and give recommendations to Member States to implement measures in this regard in their national plans, described in Article 61 (a). 2. The plan for a European autonomy proposed by the Commission shall be reviewed every 5 years. 3. The Commission shall work with Member States to promote public participation in SoHO donation activities, in particular with regard to critical SoHO, with a view of ensuring resilient supply and a significant increase in donation rates where risks of shortages are identified. In doing so, it shall encourage the collection of SoHO through strong public and non-profit sector participation.
Amendment 787 #
Proposal for a regulation Article 63 – paragraph 1 1. Critical SoHO entities shall without undue delay launch a SoHO supply alert to their competent authorities in case of a significant interruption, indicating the underlying reason, the expected impact on
Amendment 788 #
Proposal for a regulation Article 63 – paragraph 1 a (new) Amendment 789 #
Proposal for a regulation Article 63 – paragraph 3 3. The SoHO National Authorities
Amendment 790 #
Proposal for a regulation Article 63 – paragraph 3 3. The SoHO National Authorities
Amendment 791 #
Proposal for a regulation Article 64 – title Derogation from the obligations to authorise SoHO preparations in public health emergency situations
Amendment 792 #
Additional
Amendment 793 #
Proposal for a regulation Article 65 – paragraph 1 Member States may take additional measures to the ones set out in their national SoHO emergency plans to ensure critical SoHOs supply in case of shortages on their territory, on a case-by-case basis. Member States taking such measures shall inform the other Member States and the Commission without undue delay and give reasons for the measures taken. Member States may also exercise their powers to develop national plans to increase donations or ensure the quality supply of SoHOs.
Amendment 794 #
Proposal for a regulation Article 65 – paragraph 1 Member States may take additional measures to the ones set out in their national SoHO
Amendment 795 #
Proposal for a regulation Article 65 – paragraph 1 Member States may take additional measures to the ones set out in their national SoHO emergency plans to ensure critical SoHOs supply in case of shortages on their territory, on a case-by-case basis. Member States taking such measures shall inform the other Member States, the SCB and the Commission without undue delay and give reasons for the measures taken.
Amendment 796 #
Proposal for a regulation Article 65 – paragraph 1 Member States
Amendment 797 #
Proposal for a regulation Article 65 a (new) Article 65 a Plans to ensure continuity of supply to SOHO entities SoHO entities carrying out SoHO activities related to critical SoHOs shall have in place a plan to ensure continuity of supply of its own entity that supports the implementation of the national SoHO continuity of supply plan referred to in Article 61 (a).
Amendment 798 #
Proposal for a regulation 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
Amendment 799 #
Proposal for a regulation 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
Amendment 800 #
Proposal for a regulation 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
Amendment 801 #
Proposal for a regulation 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
Amendment 802 #
Proposal for a regulation Article 67 – paragraph 2 2. Each Member State shall nominate
Amendment 803 #
Proposal for a regulation 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
Amendment 804 #
Proposal for a regulation 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
Amendment 805 #
Proposal for a regulation 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
Amendment 806 #
Proposal for a regulation 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 appropriate, in order to ensure a multidisciplinary and diverse representation of stakeholders in the SoHO sector. Other Union institutions, bodies, offices and agencies shall have an observer role.
Amendment 807 #
Proposal for a regulation 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, stakeholders and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, particularily the ones defining boardelines with other legislation, shall have an observer role.
Amendment 808 #
Proposal for a regulation Article 67 – paragraph 2 a (new) 2 a. Permanent and alternate members of the SCB shall act independently, in the public interest and free from any external influence. SCB permanent and alternate members shall have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Permanent and alternate members of the SCB shall make an annual declaration of their interests, which shall be available in the EU SoHO Platform.
Amendment 809 #
Proposal for a regulation Article 67 – paragraph 3 3. Member States shall submit the names and affiliation of their nominated members to the Commission, who shall publish the membership list in the EU SoHO Platform. The list setting out the authorities, organisations or bodies to which the SoHO Coordination Board participants belong shall be published on the Commission's website.
Amendment 810 #
Proposal for a regulation Article 67 – paragraph 3 3. Member States shall submit the names and affiliation of their nominated members to the Commission, who shall
Amendment 811 #
Proposal for a regulation Article 67 – paragraph 3 a (new) 3 a. The Commission shall make publicly available SCB agendas, minutes and guidance documents on the EU SoHO Platform.
Amendment 812 #
Proposal for a regulation Article 67 – paragraph 4 4. The
Amendment 813 #
Proposal for a regulation Article 67 – paragraph 6 – point j (j) the rules for declarations regarding conflict of interests of SCB members, alternates, observers and invited experts;
Amendment 814 #
Proposal for a regulation Article 67 – paragraph 6 – point k a (new) (k a) make available to the public a summary of the topics discussed at the meetings.
Amendment 815 #
Proposal for a regulation Article 67 – paragraph 7 – subparagraph 1 The Commission shall, by means of
Amendment 816 #
Proposal for a regulation Article 67 – paragraph 7 – subparagraph 2 Those
Amendment 817 #
Proposal for a regulation Article 67 – paragraph 7 a (new) 7 a. The rules of procedure, guidance, agendas and minutes of the meetings of the the SoHO Coordination Board shall be published on the Commission's website unless such publication undermines the protection of a public or private interest, as defined in Article 4 of Regulation (EC) No 1049/2001.
Amendment 818 #
Proposal for a regulation Article 67 a (new) Amendment 819 #
Proposal for a regulation Article 68 – paragraph 1 – point a (a) in collaboration with other authorities designated in other relevant Union legislation, preparing opinions at the request of competent authorities in accordance with Article 14(
Amendment 820 #
Proposal for a regulation Article 68 – paragraph 1 – point b (b) when preparing the opinions referred to in point (a) of this paragraph,
Amendment 821 #
Proposal for a regulation Article 68 – paragraph 1 – point b a (new) (b a) participating in the permanent panel referred to in Article 14(2 a) and in the procedure referred to in that paragraph.
Amendment 822 #
Proposal for a regulation Article 68 – paragraph 1 – point d (d) recording information notified in accordance with Article 14(
Amendment 823 #
Proposal for a regulation 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 824 #
Proposal for a regulation Article 68 – paragraph 1 – point f a (new) (f a) ensuring coordination regarding supply continuity and sufficiency of critical SoHOs;
Amendment 825 #
Proposal for a regulation Article 68 – paragraph 1 – point g a (new) Amendment 826 #
Proposal for a regulation Article 68 a (new) Amendment 827 #
Proposal for a regulation Article 68 a (new) Amendment 828 #
Proposal for a regulation Article 69 – paragraph 1 – subparagraph 1 The Commission shall organise Union training in cooperation with the Member States
Amendment 829 #
Proposal for a regulation Article 70 – paragraph 1 – introductory part 1. The Commission, with the agreement of the Member State and in duly justified cases, shall perform controls, including audits, in the Member States to verify the effective application of the requirements relating to:
Amendment 830 #
Proposal for a regulation Article 70 – paragraph 1 – introductory part 1. The Commission
Amendment 831 #
Proposal for a regulation Article 71 – paragraph 1 The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM.
Amendment 832 #
Proposal for a regulation 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 be based on the highest scientific standards, be proactive in identifying future needs and be transparent, involving the relevant stakeholders in consultations related to the development of the technical guidelines.
Amendment 833 #
Proposal for a regulation 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 834 #
Proposal for a regulation 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 835 #
Proposal for a regulation Article 71 – paragraph 1 The
Amendment 836 #
Proposal for a regulation Article 71 – paragraph 1 a (new) The Commission shall ensure that those guidelines reflect the interests of Member States and, where appropriate, may adopt implementing acts laying down standards in line with those interests.
Amendment 837 #
Proposal for a regulation Article 71 – paragraph 1 a (new) The Commission shall evaluate the transparency in the procedures and development of the technical guidelines by the EDQM and their suitability to the needs and interests of the Member States.
Amendment 838 #
Proposal for a regulation Article 72 – paragraph 1 – point a (a) providing secretariat and technical, scientific and logistic support to the SCB and its working groups and to the Classification Advisory Council;
Amendment 839 #
Proposal for a regulation Article 72 – paragraph 2 2. With regard to the support referred to in paragraph 1, point (a), the Commission shall, in particular, organise the meetings of the SCB and its working groups
Amendment 840 #
Proposal for a regulation Article 73 – paragraph 1 1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange, registration and storage of information concerning SoHO activities in the Union, as provided for in this Regulation. To ensure optimal use of the EU SoHO Platform, the Commission shall:
Amendment 841 #
Proposal for a regulation Article 73 – paragraph 1 1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange of information concerning SoHO activities and supply of critical SoHOs in the Union, as provided for in this Regulation.
Amendment 842 #
Proposal for a regulation Article 73 – paragraph 1 – point a (new) (a) develop the technical and functional specifications of the EU SoHO Platform, including the data exchange mechanism for the exchange with existing national systems and the format for electronic submission;
Amendment 843 #
Proposal for a regulation Article 73 – paragraph 1 – point b (new) Amendment 844 #
Proposal for a regulation Article 73 – paragraph 1 – point c (new) (c) develop relevant guidance for reporting through the EU SoHO Platform;
Amendment 845 #
Proposal for a regulation Article 73 – paragraph 1 – point d (new) (d) ensure data interoperability between the EU SoHO Platform, Member States’ IT systems and other relevant IT systems and databases, such as the EMA’s European Shortages Monitoring Platform or systems defined in the European Health Data Space, without duplication of reporting;
Amendment 846 #
(e) ensure that the Commission, national authorities and competent authorities, SoHO entities, SCB, ECDC, EMA, EDQM and other relevant bodies have adequate levels of access to the information contained in the EU SoHO Platform to carry out their tasks;
Amendment 847 #
Proposal for a regulation Article 73 – paragraph 1 – point f (new) (f) ensure that confidential information sent to the system is protected from unjustified disclosure;
Amendment 848 #
Proposal for a regulation Article 73 – paragraph 1 – point g (new) (g) ensure that the EU SoHO Platform is fully operational at the latest 2 years after the entry into force of this Regulation, and develop an implementation plan for the Platform.
Amendment 849 #
Proposal for a regulation Article 73 – paragraph 1 a (new) 1 a. Information collected through the EU SoHO Platform on SoHO shortage alerts, SoHO shortages and demand trends, cross-border SoHO requests and resolutions, or import and export of SoHO to third countries outside the EU will be used for the monitoring, prevention and management of SoHO shortages in the EU, as well as to enhance the EU SoHO autonomy, as part of the plan defined in Article 62 (a).
Amendment 850 #
Proposal for a regulation Article 73 – paragraph 4 Amendment 851 #
Proposal for a regulation Article 74 – paragraph 2 2. The EU SoHO platform shall also provide a secure environment for the exchange of information between competent authorities
Amendment 852 #
Proposal for a regulation Article 74 – paragraph 2 a (new) 2 a. The EU SoHO Platform shall also be the main intermediary for reporting SoHO shortages and for cross-border requests of SoHO. National authorities shall issue and receive shortage alerts that cannot be resolved at Member State level, as well as SoHO cross-border requests and shall be able to respond to them. National authorities, aware of the national availability of SoHO, as referred to in Article 34(a), shall use the EU SoHO Platform to report any SoHO shortages that may lead to a public health emergency or severe ocurrence.
Amendment 853 #
Proposal for a regulation Article 74 – paragraph 2 b (new) 2 b. In the event of a SoHO-related health emergency or for the purpose of preventing potential threats, alerts issued through the EU SoHO Platform shall allow for rapid situational awareness by the Commission, competent authorities and other relevant bodies so that action can be taken as soon as possible as set out in Regulation (EU) 2022/2371 on serious cross-border threats to health.
Amendment 854 #
Proposal for a regulation Article 74 – paragraph 2 c (new) 2 c. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.
Amendment 855 #
Proposal for a regulation Article 74 – paragraph 2 d (new) 2 d. The EU SoHO Platform shall contain a record of clinical studies with SoHO and their results, as referred to in Article 36 (a).
Amendment 856 #
Proposal for a regulation 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.
Amendment 857 #
Proposal for a regulation Article 74 – paragraph 3 – subparagraph 1 The Commission shall adopt
Amendment 858 #
Proposal for a regulation Article 74 – paragraph 3 – subparagraph 2 Those
Amendment 859 #
Proposal for a regulation Article 75 – paragraph 1 – introductory part 1. Unless otherwise provided for in this Regulation
Amendment 860 #
Proposal for a regulation Article 75 – paragraph 1 – point a (a) natural persons with regard to the processing of personal data in accordance with Article 76;
Amendment 861 #
Proposal for a regulation Article 75 – paragraph 3 3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and competent authorities with regard to the exchange of information and the dissemination of alerts, nor the obligations of persons to provide information under national criminal law or other applicable law, including on access to information.
Amendment 862 #
Proposal for a regulation Article 75 – paragraph 5 – introductory part 5. Competent authorities
Amendment 863 #
Proposal for a regulation Article 75 – paragraph 6 – point b (b) the information or data made available to the public does not
Amendment 864 #
Proposal for a regulation Article 76 – paragraph 3 3. Personal data, including data concerning health, required for the application of Articles 35, 36, 41 and 47, Article 53(1), points (f) and (g), Article 53(3), and Article 58(11), (13) and (14), shall only be processed for the purpose of ensuring safety and quality of SoHOs and protecting the concerned SoHO donors, SoHO recipients and offspring from medically assisted reproduction. Those data shall be directly related to the performance of the supervisory activities and SoHO activities concerned and be limited to the extent necessary and proportionate for that purpose. The Commission shall adopt implementing acts laying down categories of personal data necessary to fulfilling the above listed obligations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Amendment 865 #
Proposal for a regulation Article 76 – paragraph 3 a (new) 3 a. Any re-use of personal data of SoHO donors, recipients and offspring born from medically assisted reproduction shall be provided in an anonymised format. Where, in duly justified cases, the purpose of the data processing cannot be achieved with anonymised data, pseudonymised data format may be used.
Amendment 866 #
Proposal for a regulation Article 76 – paragraph 6 6. In relation to their responsibilities to process personal data to comply with the obligations of this Regulation, the SoHO entities and competent authorities of the Member States shall be regarded as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679 and they are bound by the rules of that Regulation. The same provisions shall apply to any third party contracted by a SoHO entity for the processing of personal data, who shall be considered a processor as defined in Article 4, point (8) of the GDPR.
Amendment 867 #
Proposal for a regulation Article 77 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 14(7), 28(10), 42(3), 53(6), 56(1), 58(15), 62(7), 62a(4), 67(7), 69(6), 73(4), 74(3) and 76(8) shall be conferred on the Commission for an indeterminate period of time from … [OP please insert the date = date of entry into force of this Regulation].
Amendment 868 #
Proposal for a regulation Article 77 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 28(10), 42(3),
Amendment 869 #
Proposal for a regulation Article 77 – paragraph 3 3. The delegation of power referred to in Articles 14(7), 28(10), 42(3), 53(6), 56(1), 58(15), 62(7), 62a(4), 67(7), 69(6), 73(4), 74(3)and 76(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 870 #
Proposal for a regulation Article 80 – paragraph 1 Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by … [OP please insert the date =
Amendment 871 #
Proposal for a regulation Article 84 – paragraph 1 Without prejudice to the dates of application referred to in Article 87 and the transitional provisions provided for in this Chapter, the Commission is empowered to adopt the delegated acts referred to in Articles 42(3), 67(7) and 73(4) and the implementing acts referred to in Articles 26(4), 43(6), 44(3), 46(3)
Amendment 872 #
Proposal for a regulation 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.
Amendment 873 #
Proposal for a regulation Article 87 – paragraph 1 – subparagraph 2 Unless otherwise provided for in paragraph 2, it shall apply from … [OP please insert the date = t
Amendment 874 #
Proposal for a regulation Article 87 – paragraph 2 – subparagraph 1 Article 81(3) to (6) and Article 82(3) shall apply from … [OP please insert the date =
source: 740.835
|
History
(these mark the time of scraping, not the official date of the change)
2024-03-06Show (2) Changes | Timetravel
| docs/11 |
|
| events/8/docs |
|
2024-02-16Show (2) Changes | Timetravel
| events/7 |
|
| events/8 |
|
2024-02-14Show (1) Changes | Timetravel
| docs/10 |
|
2024-02-13Show (1) Changes | Timetravel
| links |
|
2024-01-04Show (1) Changes | Timetravel
| events/4 |
|
2023-11-23Show (2) Changes | Timetravel
| committees/0 |
|
| committees/0 |
|
2023-11-22Show (1) Changes | Timetravel
| committees/0/shadows/1/mepref |
197443
|
2023-11-11Show (4) Changes | Timetravel
| docs/4/docs/0/url |
Old
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:450:TOCNew
https://eur-lex.europa.eu/oj/daily-view/L-series/EN/TXT/?uri=OJ:C:2022:450:TOC |
| docs/10/date |
Old
2022-10-13T00:00:00New
2022-10-14T00:00:00 |
| docs/11/date |
Old
2022-12-20T00:00:00New
2022-12-21T00:00:00 |
| docs/12/date |
Old
2022-10-09T00:00:00New
2022-10-10T00:00:00 |
2023-09-26Show (2) Changes | Timetravel
| docs/10 |
|
| events/4/summary |
|
2023-09-14Show (4) Changes | Timetravel
| docs/10 |
|
| events/4 |
|
| events/5 |
|
| forecasts |
|
2023-09-09Show (2) Changes | Timetravel
| forecasts/0 |
|
| forecasts/0 |
|
2023-08-22Show (1) Changes | Timetravel
| docs/11 |
|
2023-08-12Show (2) Changes | Timetravel
| docs/10 |
|
| events/3/summary |
|
2023-08-08Show (2) Changes | Timetravel
| docs/10 |
|
| events/3/docs |
|
2023-07-27Show (2) Changes | Timetravel
| events/3 |
|
| procedure/stage_reached |
Old
Awaiting committee decisionNew
Awaiting Parliament's position in 1st reading |
2023-07-22Show (2) Changes | Timetravel
| events/2 |
|
| procedure/Other legal basis |
Rules of Procedure EP 159
|
2023-06-09Show (1) Changes | Timetravel
| committees/0/shadows/1/name |
Old
GLÜCK AndreasNew
GLUECK Andreas |
2023-04-27Show (1) Changes | Timetravel
| forecasts |
|
2023-03-23Show (3) Changes | Timetravel
| docs/7 |
|
| docs/8 |
|
| docs/9 |
|
2023-02-02Show (1) Changes | Timetravel
| docs/6/docs/0/url |
https://www.europarl.europa.eu/doceo/document/ENVI-PR-738661_EN.html
|
2023-01-20Show (8) Changes | Timetravel
| docs/0 |
|
| docs/7 |
|
| docs/7/date |
Old
2022-10-14T00:00:00New
2022-10-13T00:00:00 |
| docs/8 |
|
| docs/8 |
|
| docs/8/date |
Old
2022-10-10T00:00:00New
2022-10-09T00:00:00 |
| docs/9 |
|
| events/0 |
|
2023-01-19Show (9) Changes | Timetravel
| docs/0 |
|
| docs/6 |
|
| docs/7 |
|
| docs/7 |
|
| docs/8 |
|
| docs/8/date |
Old
2022-10-13T00:00:00New
2022-10-14T00:00:00 |
| docs/9 |
|
| docs/9/date |
Old
2022-10-09T00:00:00New
2022-10-10T00:00:00 |
| events/0 |
|
2023-01-18Show (1) Changes | Timetravel
| docs/5 |
|
2023-01-09Show (1) Changes | Timetravel
| docs/6/body |
Old
ES_SENATENew
ES_PARLIAMENT |
2022-12-21Show (8) Changes | Timetravel
| docs/0 |
|
| docs/5 |
|
| docs/5/date |
Old
2022-10-14T00:00:00New
2022-10-13T00:00:00 |
| docs/6 |
|
| docs/6 |
|
| docs/6/date |
Old
2022-10-10T00:00:00New
2022-10-09T00:00:00 |
| docs/7 |
|
| events/0 |
|
2022-12-17Show (8) Changes | Timetravel
| docs/0 |
|
| docs/5 |
|
| docs/6 |
|
| docs/6 |
|
| docs/6/date |
Old
2022-10-13T00:00:00New
2022-10-14T00:00:00 |
| docs/7 |
|
| docs/7/date |
Old
2022-10-09T00:00:00New
2022-10-10T00:00:00 |
| events/0 |
|
2022-11-29Show (1) Changes | Timetravel
| docs/4 |
|
2022-11-18Show (2) Changes | Timetravel
| docs/4 |
|
| docs/5 |
|
2022-10-22Show (2) Changes | Timetravel
| committees/0 |
|
| committees/0 |
|
2022-10-15Show (2) Changes | Timetravel
| commission |
|
| committees/0/shadows/1 |
|
2022-10-08Show (1) Changes | Timetravel
| committees/0/shadows |
|
2022-09-28Show (1) Changes | Timetravel
| docs/0/docs/0 |
|
2022-09-16Show (3) Changes | Timetravel
| events/1 |
|
| procedure/dossier_of_the_committee |
|
| procedure/stage_reached |
Old
Preparatory phase in ParliamentNew
Awaiting committee decision |
2022-07-28Show (2) Changes
| docs/0 |
|
| events/0/summary |
|