38 Amendments of Max ORVILLE related to 2022/0216(COD)
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 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 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 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 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 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 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 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 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 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 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 827 #
Proposal for a regulation
Article 68 a (new)
Article 68 a (new)