BETA

35 Amendments of Thomas ULMER related to 2008/0238(COD)

Amendment 66 #
Proposal for a directive
Recital 6
(6) There is therefore a need, while duly respecting the subsidiarity principle pursuant to Article 168(7) TFEU (formerly Article 152(5) TEC), for common quality and safety standards for the procurement, transport and use of human organs at Community level. These standards would facilitate exchanges of organs to the benefit of thousands of European patients in need of this type of therapy each year. Community legislation should ensure that human organs comply with acceptablerecognised standards of quality and safety. Therefore such standards will help to reassure the public that human organs procured in another Member State nonetheless carry the same basic quality and safety guarantees as those obtained in their own country.
2010/03/04
Committee: ENVI
Amendment 68 #
Proposal for a directive
Recital 7
(7) In order to reduce the risks and maximise the benefits of the transplantation process. Member States need to operate an effective national quality programme. This programme should be implemented and maintained throughout the entire chain from donation to transplantation or disposal, and should cover the personnel and organisation, premises, equipment, materials, documentation and record-keeping involved. The national quality programme should include auditing where necessary. Member States should be able to delegate, through written agreements, the responsibility for parts of this programme to European organ exchange organisatDoes not apply to the English versions.
2010/03/04
Committee: ENVI
Amendment 87 #
Proposal for a directive
Article 2 – paragraph 1 a (new)
1a. It shall apply also to parts of organs if it is their function to be used for the same purpose as the entire organ in the human body and to complex tissues.
2010/03/04
Committee: ENVI
Amendment 89 #
Proposal for a directive
Article 3 – point a
(a) ‘authorisation‘ means authorisccreditation, accreditation, designation or licensinguthorisation, licensing or certification, depending ofn the conceptregulatory approaches used in each Member State;
2010/03/04
Committee: ENVI
Amendment 92 #
Proposal for a directive
Article 3 – point c
(c) ‘donor’ means every human source of organs, whether living or deceased ;This amendment does not apply to the English version.
2010/03/04
Committee: ENVI
Amendment 95 #
Proposal for a directive
Article 3 – point d
(d) ‘donation’ means donating human organs for transplantthe provision of human organs intended for human applications ;
2010/03/04
Committee: ENVI
Amendment 98 #
Proposal for a directive
Article 3 – point g
(g) ‘organ’ means both a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with an important level of autonomy and parts of organs if it is their function to be used for the same purpose as the entire organ in the human body and complex tissues ;
2010/03/04
Committee: ENVI
Amendment 102 #
Proposal for a directive
Article 3 – point i
(i) ‘procurement’ means a coordinated process by which the donated organs become available;
2010/03/04
Committee: ENVI
Amendment 103 #
Proposal for a directive
Article 3 – point i a (new)
ia)'making available' means the preparation, manipulation, preservation, packaging and transport of human organs;
2010/03/04
Committee: ENVI
Amendment 104 #
Proposal for a directive
Article 3 –point j
(j) "procurement organisation" means a health care establishment, a team or a unit of a hospital or another body which is authorised by the competent authority to undertakes procurement ofone or more public or private non-profit making body or bodies/organisation(s)/institution(s) engaged particularly in the coordinated process of procuring and making available human organs;
2010/03/04
Committee: ENVI
Amendment 105 #
Proposal for a directive
Article 3 – point j a (new)
ja) 'competent authority' means one or more public or private non-profit making, competent body or bodies/organisation(s)/institution(s) particularly involved in the implementation of this Directive;
2010/03/04
Committee: ENVI
Amendment 106 #
Proposal for a directive
Article 3 – point k
(k) ‘preservation’ means the use of chemical agents, alterations in environmental conditions or other means during processingwhile making available human organs to prevent or retard the biological or physical deterioration of human organsthereof from the procurement until the transplantation;
2010/03/04
Committee: ENVI
Amendment 107 #
Proposal for a directive
Article 3 – point m
(m) ‘serious adverse event’ means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantationthe procurement, preservation and making available of organs that might lead to the transmission of a communicablen infectious disease, to death or a life- threatening, disabling, or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity condition or to the disabling of donors or recipients, necessitate hospitalisation or cause another illness, providing it is not a matter of the side- effects of immune suppression;
2010/03/04
Committee: ENVI
Amendment 108 #
Proposal for a directive
Article 3 – point n
(n) ) ‘serious adverse reaction’ means an unintended or unexpected serious response, including a communicable disease, in the donor or in the recipient associated with any stage of the chain from donation tothe donation, procurement, preservation, making available or transplantation of an organ, that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidityunexpected morbidity; side-effects of immune suppression are excluded;
2010/03/04
Committee: ENVI
Amendment 110 #
Proposal for a directive
Article 3 – point p
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring equivalenthuman organs to a recipient;
2010/03/04
Committee: ENVI
Amendment 130 #
Proposal for a directive
Article 5 – paragraph 1
1. Member States shall ensure that the procurement takes place in procurement organisationsand making available of organs take place through one or more public or private non-profit making body or bodies/organisation(s)/institution(s) that comply with the rules laid down in this Directive.
2010/03/04
Committee: ENVI
Amendment 138 #
Proposal for a directive
Article 8 – paragraph 1 – point b – indent 1
– identification of the procurement organisation and the donor's hospital, including its address and telephone number;
2010/03/04
Committee: ENVI
Amendment 143 #
Proposal for a directive
Article 9 – paragraph 2
2. The Competent authority shall indicate in the accreditation, designation, authorisation or licence which activities the transplantation centre concerned may undertake.
2010/03/04
Committee: ENVI
Amendment 154 #
Proposal for a directive
Article 13 – paragraph 2
2. Member States shall prohibit advertising the need for or,the offering or making availabilityle of, human organs where such advertising hasith a view to offering or seeking financial gain or comparable advantage.
2010/03/04
Committee: ENVI
Amendment 155 #
Proposal for a directive
Article 13 – paragraph 3
3. Member States shall ensure that the procurement of organs is carried out on a non-profit basisnot commercialised.
2010/03/04
Committee: ENVI
Amendment 162 #
Proposal for a directive
Article 15 – paragraph 2
2. Member States shall ensure that living donors are selected on the basis of their health and medical history, including a psychological evaluation if deemed necessary, by qualified and trained professionals. Such assessments may provide for the exclusion of persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or a serious risk to themselves. Member States shall also ensure that living donors are legally insured.
2010/03/04
Committee: ENVI
Amendment 171 #
Proposal for a directive
Article 17 – title
Anonymisation of donors and recipientsData protection
2010/03/04
Committee: ENVI
Amendment 175 #
Proposal for a directive
Article 17
Member States shall take all necessary measures to ensure that all personal data of donors and recipients processedgathered and processed in connection within the scopeimplementation of this Directive in the organ donation process are rendered anpseudonymous so that neitherin order to protect donors norand recipients remainfrom identifiablecation by unauthorised third parties.
2010/03/04
Committee: ENVI
Amendment 176 #
Proposal for a directive
Article 18 – title
Designation and tasks of the competent authoritiesbody or bodies, organisation(s) or institution(s)
2010/03/04
Committee: ENVI
Amendment 178 #
Proposal for a directive
Article 18 – paragraph 1
Member States shall designate the competent authority, or authorities (hereafter competent authority),public or private, non-profit making body or bodies/organisation(s)/institution(s) particularly involved in the implementation of these provisions responsible for implementing the requirements of this Directive.
2010/03/04
Committee: ENVI
Amendment 180 #
Proposal for a directive
Article 18 – paragraph 2 – introductory part
The competent authoritiesy or institution(s) shall, in particular, take the following measures:
2010/03/04
Committee: ENVI
Amendment 186 #
Proposal for a directive
Article 19 – paragraph 1 – introductory part
1. Member States shall ensure that the competent authoritybody or bodies, organisation(s) or institution(s):
2010/03/04
Committee: ENVI
Amendment 187 #
Proposal for a directive
Article 19 – paragraph 1 – point c
(c) establishes and maintains a register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
2010/03/04
Committee: ENVI
Amendment 188 #
Proposal for a directive
Article 19 – paragraph 2
2. Member States shall, upon the request of the Commission or another Member State, provide information on the register of procurementhealth care establishments, teams or departments of a hospital org anisatioother establishment authorised to procure human organs and transplantation centres.
2010/03/04
Committee: ENVI
Amendment 189 #
Proposal for a directive
Article 20 – paragraph 1
1. The Commission shall set up a network of the competent authoritiesbody (bodies), organisation(s) or institution(s) with a view to exchanging information on the experience acquired with regard to the implementation of this Directive.
2010/03/04
Committee: ENVI
Amendment 196 #
Proposal for a directive
Article 25 – paragraph 1 – point a
(a) rules for the updating and transmission of information on human organs and donor characterisation as detailed in the Annex;
2010/03/04
Committee: ENVI
Amendment 197 #
Proposal for a directive
Article 25 – paragraph 1 – point c
(c) procedures for ensuring the reporting of unexpected serious adverse events and reactions.
2010/03/04
Committee: ENVI
Amendment 198 #
Proposal for a directive
Article 25 – paragraph 2 – point a
(a) the interconnection between the reporting systems on unexpected adverse events and reactions referred to in Article 11 (3);
2010/03/04
Committee: ENVI
Amendment 199 #
Proposal for a directive
Article 25 – paragraph 2 – point b
(b) the establishment and ability to functioning of the network of the competent authorities referred to in Article 20.
2010/03/04
Committee: ENVI
Amendment 203 #
Proposal for a directive
Annex – Introduction
For the purpose of Article 7 the following information shall be gathered by the procurement organisation or procurement team on the characteristics of the organ and of the donor, following testing where necessarybearing in mind the individual circumstances, and processed in line with the legal requirements on the protection of personal data and confidentiality. In the absence of data, a decision shall be taken about the transplant after individual risk assessment of the donor and the recipient:
2010/03/04
Committee: ENVI