35 Amendments of Thomas ULMER related to 2008/0238(COD)
Amendment 66 #
Proposal for a directive
Recital 6
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.
Amendment 68 #
Proposal for a directive
Recital 7
Recital 7
Amendment 87 #
Proposal for a directive
Article 2 – paragraph 1 a (new)
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.
Amendment 89 #
Proposal for a directive
Article 3 – point a
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;
Amendment 92 #
Proposal for a directive
Article 3 – point c
Article 3 – point c
Amendment 95 #
Proposal for a directive
Article 3 – point d
Article 3 – point d
(d) ‘donation’ means donating human organs for transplantthe provision of human organs intended for human applications ;
Amendment 98 #
Proposal for a directive
Article 3 – point g
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 ;
Amendment 102 #
Proposal for a directive
Article 3 – point i
Article 3 – point i
(i) ‘procurement’ means a coordinated process by which the donated organs become available;
Amendment 103 #
Proposal for a directive
Article 3 – point i a (new)
Article 3 – point i a (new)
ia)'making available' means the preparation, manipulation, preservation, packaging and transport of human organs;
Amendment 104 #
Proposal for a directive
Article 3 –point j
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;
Amendment 105 #
Proposal for a directive
Article 3 – point j a (new)
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;
Amendment 106 #
Proposal for a directive
Article 3 – point k
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;
Amendment 107 #
Proposal for a directive
Article 3 – point m
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;
Amendment 108 #
Proposal for a directive
Article 3 – point n
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;
Amendment 110 #
Proposal for a directive
Article 3 – point p
Article 3 – point p
(p) ‘transplantation’ means the process of restoring certain functions of the human body by transferring equivalenthuman organs to a recipient;
Amendment 130 #
Proposal for a directive
Article 5 – paragraph 1
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.
Amendment 138 #
Proposal for a directive
Article 8 – paragraph 1 – point b – indent 1
Article 8 – paragraph 1 – point b – indent 1
– identification of the procurement organisation and the donor's hospital, including its address and telephone number;
Amendment 143 #
Proposal for a directive
Article 9 – paragraph 2
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.
Amendment 154 #
Proposal for a directive
Article 13 – paragraph 2
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.
Amendment 155 #
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Member States shall ensure that the procurement of organs is carried out on a non-profit basisnot commercialised.
Amendment 162 #
Proposal for a directive
Article 15 – paragraph 2
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.
Amendment 171 #
Proposal for a directive
Article 17 – title
Article 17 – title
Amendment 175 #
Proposal for a directive
Article 17
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.
Amendment 176 #
Proposal for a directive
Article 18 – title
Article 18 – title
Designation and tasks of the competent authoritiesbody or bodies, organisation(s) or institution(s)
Amendment 178 #
Proposal for a directive
Article 18 – paragraph 1
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.
Amendment 180 #
Proposal for a directive
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
The competent authoritiesy or institution(s) shall, in particular, take the following measures:
Amendment 186 #
Proposal for a directive
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. Member States shall ensure that the competent authoritybody or bodies, organisation(s) or institution(s):
Amendment 187 #
Proposal for a directive
Article 19 – paragraph 1 – point c
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.
Amendment 188 #
Proposal for a directive
Article 19 – paragraph 2
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.
Amendment 189 #
Proposal for a directive
Article 20 – paragraph 1
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.
Amendment 196 #
Proposal for a directive
Article 25 – paragraph 1 – point a
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;
Amendment 197 #
Proposal for a directive
Article 25 – paragraph 1 – point c
Article 25 – paragraph 1 – point c
(c) procedures for ensuring the reporting of unexpected serious adverse events and reactions.
Amendment 198 #
Proposal for a directive
Article 25 – paragraph 2 – point a
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);
Amendment 199 #
Proposal for a directive
Article 25 – paragraph 2 – point b
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.
Amendment 203 #
Proposal for a directive
Annex – Introduction
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: