67 Amendments of Véronique TRILLET-LENOIR related to 2022/0216(COD)
Amendment 140 #
Proposal for a regulation
Recital 11
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 and (EU) No 536/2014, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, 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 167 #
Proposal for a regulation
Recital 15
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 the means of achieving that aim are science-based, appropriate and necessary.
Amendment 168 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
Amendment 211 #
Proposal for a regulation
Recital 28
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 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. In case the standard treatment or control group is based on medcinal products, the studies are considered as clinical trials as defined and regulated by Regulation 536/2014. 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 218 #
Proposal for a regulation
Recital 30
Recital 30
(30) In order to facilitate innovation and reduce administrative burden, competent authorities shouldmust 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 and to thus significantly reduce the requirements to generate evidence.
Amendment 237 #
Proposal for a regulation
Recital 36
Recital 36
(36) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council27, is a Union agency with the mission of strengthening Europe's defences against communicable diseases. The work of the ECDC on developing and updating guidelines on safety andqua,quality and susainability 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. _________________ 27 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004, establishing a European centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1).
Amendment 262 #
Proposal for a regulation
Recital 37 a (new)
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 268 #
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert agencies and 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 EMA, the Health Emergency Preparedness and Response Authority (HERA) established as a Commission service by Commission Decision of 16 September 2021 and the EDQM and existing professional, scientific and donor and patient representative groups at Union level in the field of SoHOs. Other Union institutions, bodies, offices and agencies should have an observer role. A representative designated by the European Parliament should be able to participate in the SoHO Coordination Board (SCB) as an observer. All members of the SCB should provide declarations of interest.
Amendment 279 #
Proposal for a regulation
Recital 41
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 285 #
Proposal for a regulation
Recital 42
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 . The Commission may also decide that information on SoHO donations are added to donors Electronic Health Records (EHRs).
Amendment 289 #
Proposal for a regulation
Recital 43
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 301 #
Proposal for a regulation
Recital 46
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 311 #
Proposal for a regulation
Article 1 – paragraph 1
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. This Regulation is without prejudice to national legislation which establishes rules relating to aspects of SoHOs other than their efficacy, quality and safety and the safety of SoHO donors.
Amendment 313 #
Proposal for a regulation
Article 2 – paragraph 1 – introductory part
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 and recipients, and to the following SoHO activities that have a direct impact on the safety, quality or efficacy of SoHOs :
Amendment 315 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
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 327 #
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 1
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 334 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) ‘“blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the bodywhole blood collected from a donor and processed either for transfusion or for further manufacturing;
Amendment 335 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘cell’ means a mass of cytoplasm with or without a nucleus,A typical cell is the smallest unit of an organism that ihas bound externally by a cell membrane. Usually microscopic in size, cells are the smallest structural and functional unit of an organism;een generated directly through mitosis. A cell comprises a nucleus (eukaryotic cells) or nucleoid material (prokaryotic cells) and cytoplasma enclosed by a cell membrane.
Amendment 345 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
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 SoHOsliving SoHO donor or deceased SoHO donor, whether that donation is successful or not;
Amendment 350 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
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 353 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘Deceased SoHO donor’ means any deceased person who donates SoHO after death.
Amendment 363 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point a
Article 3 – paragraph 1 – point 12 – point a
(a) has been subjected to one or more SoHO activities, including processing, in accordance with defined quality and safety parameters;
Amendment 380 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15
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 packagingdifferent steps of preparation processes of SoHOs;
Amendment 398 #
Proposal for a regulation
Article 3 – paragraph 1 – point 23
Article 3 – paragraph 1 – point 23
(23) ‘autologous use’ means collection of SoHO from one individual for subequent application to the same individual, with or without further SoHO activities between collection and application;
Amendment 410 #
Proposal for a regulation
Article 3 – paragraph 1 – point 31
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 413 #
Proposal for a regulation
Article 3 – paragraph 1 – point 34 a (new)
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 428 #
Proposal for a regulation
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘imputability’ means the likelihood that a seriousn adverse occurrence, in a SoHO donor, is related to the donation process or, in a recipient, to the application of the SoHOs;
Amendment 429 #
Proposal for a regulation
Article 3 – paragraph 1 – point 59
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 431 #
Proposal for a regulation
Article 3 – paragraph 1 – point 60
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 455 #
Proposal for a regulation
Article 3 – paragraph 1 – point 65
Article 3 – paragraph 1 – point 65
(65) ‘allogeneic usedonor’ means collecany person who make a donation ofto a SoHO from one individualentity for subsequent application to another individual;
Amendment 471 #
Proposal for a regulation
Article 4 – paragraph 1
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 lawbased on scientific evidence, are compatible with Union law, do not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, and are proportionate to the risk to human health.
Amendment 477 #
Proposal for a regulation
Article 5 – paragraph 3 – point b – point ii
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 504 #
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2 a (new)
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 508 #
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
The Commission may, upon a duly substantiated request of a Member State following the consultation referred to in paragraph 1, or on its own initiative, 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), or in accordance with paragraph 2a (c).
Amendment 511 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40, or in the case of paragraph 2a, the EMA.
Amendment 514 #
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1
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 referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant Union legislation referred to in Article 2(3). The Commission may also lay down rules concerning the procedure referred to in paragraph 2a and the operation of the permanent panel in coherence with the specific provisions foreseen in Regulation (EC) 726/2004, Directive 2001/83/EC and Regulation (EU) 2017/745.
Amendment 526 #
Proposal for a regulation
Article 21 – paragraph 2 – point c
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
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
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 authorisation or the requirements of this Regulation; andor
Amendment 529 #
Proposal for a regulation
Article 21 – paragraph 8
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 repeatedly failed to comply with the conditions of its authorisation.
Amendment 541 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Competent authoritiesThe SoHO coordination Board shall provide guidelines and templates to allow that applications from SoHO entities for their authorisation as SoHO establishments are submitted in accordance with Article 49. When developing these guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 545 #
Proposal for a regulation
Article 27 – paragraph 2 – point e
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
Article 27 – paragraph 3 – subparagraph 1 – point a
(a) does not comply with the conditions of its authorisation or the provisions of this Regulation; andor
Amendment 549 #
Proposal for a regulation
Article 27 – paragraph 5
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 updated criteria for authorisation or the SoHO establishment has repeatedly failed to comply with the conditions of its authorisation.
Amendment 550 #
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Competent authoritiesThe SoHO Coordination Board shall provide guidelines and templates to allow that applications from SoHO entities for their authorisation as importing SoHO entities are submitted in accordance with Article 43. In developing these guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 553 #
Proposal for a regulation
Article 28 – paragraph 5 – point a
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; andor
Amendment 555 #
Proposal for a regulation
Article 28 – paragraph 7
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 repeatedly failed to comply with the conditions of its authorisation.
Amendment 578 #
Proposal for a regulation
Article 40 – paragraph 1
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 581 #
Proposal for a regulation
Article 41 – paragraph 2 – point c
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 safety, quality and efficacy of the SoHO preparation, in line with the results of the risk assessment;
Amendment 583 #
Proposal for a regulation
Article 41 – paragraph 4
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
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 586 #
Proposal for a regulation
Article 43 – paragraph 1
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
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 received and the associated documentation and conduct an examination of the integrity of packaging and the compliance of labelling and transport conditions with the relevant standards and technical guidelines as referred to in Articles 57, 58 and 59. The importing SoHO entity shall make sure and certify that the imported SoHOs are of equivalent quality to what is required by European regulations.
Amendment 665 #
Proposal for a regulation
Article 56 – paragraph 4 – point a – introductory part
Article 56 – paragraph 4 – point a – introductory part
(a) the most recent technical guidelines, established through a transparent and comprehensive consultation process with a broad selection of stakeholders based on latest scientific knowledge and relevant expertise , and as indicated on the EU SoHO Platform referred to in Chapter XI, as follows:
Amendment 666 #
Proposal for a regulation
Article 56 – paragraph 4 – point a – introductory part
Article 56 – 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 667 #
Proposal for a regulation
Article 56 – paragraph 4 – point b
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 725 #
Proposal for a regulation
Article 58 – paragraph 10 – point a
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 739 #
Proposal for a regulation
Article 59 – paragraph 4 – point a – introductory part
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
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 784 #
Proposal for a regulation
Article 62 a (new)
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 (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 802 #
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, agencies, bodies, offices and agencior services shall have an observer role. The European Parliament shall designate a technical representative to participate in the SoHO Coordination Board as an observer.
Amendment 807 #
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts, 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 809 #
Proposal for a regulation
Article 67 – paragraph 3
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 817 #
Proposal for a regulation
Article 67 – paragraph 7 a (new)
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 821 #
Proposal for a regulation
Article 68 – paragraph 1 – point b a (new)
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 827 #
Proposal for a regulation
Article 68 a (new)
Article 68 a (new)