[ParlTrack]

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 Commiss~~ and founded on the principle of voluntary and unpaid SoHO donation. Member States should notify the Commission via the SoHO platform set up by this Regulation 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 appropriate and necessary.

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

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.

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

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.

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

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 self- sufficiency in the Union. Member States are also urged t~~voluntary, unpaid donation of SoHOs of high quality and safety, including plasma, used as base material for manufacturing plasma- derived medicinal products. These measures support European self- sufficiency, based on the broadest possible donor base, with a view to ensuring a more resilient supply system and safeguarding the health of donors and recipients. Member States and the Union should also 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.

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

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, quality control testing of SoHOs, and the continuity of supply of these substances, 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.

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

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 interoperable with the other existing Union platforms, to exchange information concerning SoHO activities, in particular between competent authorities, European Union agencies and the Commission;

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)

(70a) ‘donor base resilience’ means the capacity of the donation collection system to rely on a large number of donors;

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

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;

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

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); , unless the equipment has already been assessed and carries EC certification as provided for in Regulations (EU) 2017/7461 aand (EU) 2017/745 for an identical use; _________________ 1 a Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).

2023/03/14
Committee: ENVI

Nathalie COLIN-OESTERLÉ

Proposal for a regulation
Article 62 a (new)

Article 62a Development of a strategy for the promotion of European SoHO supply self- sufficiency 1. Within two years after adoption of this Regulation, the Commission shall publish a strategy for the promotion of European SoHO supply self-sufficiency. That strategy shall set ambitious targets for each SoHO, laid down by the Commission in coordination with national competent authorities, the European Parliament, scientists from professional associations and patient associations, as well as all other relevant stakeholders. Without prejudice to Articles 53 and 54, and in particular the principle of voluntary and unpaid donation, it shall promote action to: (a) publicise at European level the various types of SoHO donations that are achievable; (b) introduce a European day given over to the donation of essential SoHOs; (c) promote an increase in the number of collection centres and extend the opening days and hours of SoHO collection entities and establishments outside traditional working hours; (d) make the professions essential for carrying out SoHO donations more attractive; (e) raise awareness in connection with SoHO donations by healthcare workers in hospitals and healthcare facilities; (f) ensure sound blood stock management in accordance with patient blood management practices. 2. Within two years after publication of that European strategy, Member States shall adopt national priority action programmes for donor recruitment. 3. Those national plans shall take into account the Commission’s strategy for promoting European SoHO self- sufficiency and the SoHO supply guidelines issued by the EDQM. 4. The strategy for promoting European SoHO self-sufficiency shall be revised by the Commission every five years from 2030 onwards. National plans shall be reviewed accordingly within no more than two years after publication of the revised strategy.

2023/03/14
Committee: ENVI

Activities of Nathalie COLIN-OESTERLÉ related to 2022/0216(COD)

Plenary speeches (3)

Reports (1)

Amendments (10)

ParlTrack - 2011-2024